Teva Challenges Gilead Patent Application for HIV Treatment

May 8, 2017

drug cocktailThis ruling relates to a treatment for HIV consisting of a single once-a-day dosage that includes a combination of two or three different active ingredients.

Israel Patent Application No. 169243 to Gilead is titled “PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY”. It is the national phase of PCT/US2004/000832 filed on 13 January 2004 and claiming priority from a couple of US provisional applications filed on 14 January 2003. Gilead purchased Triangle so that they would have the capability of producing both  FTC and TDF and in a press release in Bioworld in 2002 which quoted Gilead’s Chairman and CEO, they announced their intention to develop a single dosage formulation that included TDF and FTC, referring to the chemicals by their trade names of Viread and Coviracil. This announcement preceded the priority date and since they announced that they did not anticipate difficulties in formulating the combination, their announcement undermined claims 1 and 12 directed to the combination of TDF and FTC in the standard dosages of Viread and Coviracil. There were additional independent claims for FTC and TDF together with an additional active ingredient – either Reyataz, Kaltera or Sustiva. However, that combination was used in a clinical trial for treating Hepatitis B that was also prior art. This ruling addresses and clarifies the requirements for prior art to be anticipating and what is required to provide an inventive step. It also relates to the issues of claim support, enablement and utility.

History

GileadIsrael Patent Application No. 169243 to Gilead is titled “PHARMACEUTICAL COMPOSITIONS FOR COMBINATION ANTIVIRAL THERAPY”. It is the national phase of PCT/US2004/000832 filed on 13 January 2004 and claiming priority from a couple of US provisional applications filed on 14 January 2003. On allowance the Application published for opposition purposes and Teva filed an opposition on 26 March 2009 and four months later submitted a detailed statement of case. On 1 February 2010, the Applicant requested permission to correct the application, and on 21 April 2010, Teva requested that the proposed amendments to the claims be refused. There was an intermediate ruling on this by the Commissioner on 22 June 2010, and on 27 June 2010 Teva withdrew their challenge to the amendments and the opposition continued with the amended claim-set. On 8 May 2011, the Opposer submitted an amended statement of case and Gilad submitted their response on 1 January 2012. On 23 September 2012, the Opposer’s evidence was submitted in the form of two affidavits, by Professor Richard Novak and by Professor Joseph Fortunak. On 24 July 2013, Gilad submitted their response in the form of Affidavits by Professor Robert Redfield and Professor G Stahly, and on 10 April 2014 further affidavits were submitted in response to points raised. Read the rest of this entry »


Publication on the Internet Prior to filing Israel Design Applications

July 26, 2016

Shoe publicity     Shoe publicity 2

Background

This ruling clarifies the extent that apparently pre-filing date publications on the Internet may be used to prevent design registration in Israel.

Although there is draft legislation making its way through the system, in Israel designs are currently protected by the archaic Patent and Design Ordinance of 1924, a legacy from the British Mandate. One of its oddities is that absolute novelty is required and there is no grace period. An even odder oddity is that only absolute local novelty is required and someone bringing a design into Israel for the first time is entitled to register it prior to importing and is entitled to up to 15 years of protection.

The previous Commissioner, Dr Meir Noam, grew tired of waiting for the Knesset and the Ministry of Justice to get their acts together and in a Commissioner of Patents Circular decreed that publication on the Internet, particularly in the design registers of foreign patent offices that are accessible on line from Israel via their websites,  would be considered as available in Israel and novelty destroying. Although arguably ultra vires, the Circular was never challenged. There remains a question as to what other Internet publications are novelty destroying, and the present ruling addresses this issue.

A third oddity is that unlike much of the rest of the world where Examination of designs is only for conformance to formalities, in Israel design applications are substantively examined in terms of novelty and the Examiners may search newspaper press-releases, Applicant’s website and, it transpires, various web-sites offering goods for sale.

This case

Naalei Nayot (1994) LTD submitted several Israel design applications including Application Nos. 55280, 55283,55288, 55289, 55291, 55270, 55271, 55278 and 55279. All these applications were submitted on 26 February 2014 in class 2(04) that covers footwear, socks and stockings.

The applications were submitted together with other design applications that were either registered or were abandoned due to issues raised during the examination process. These nine applications were rejected in a single office action of 17 June 2015 which resulted in the Applicant requesting a hearing that was subsequently held on 18 October 2015.

The nine applications fall into three categories as follows:

  • Applications 55288, 55291, 55270 and 55279 were considered as lacking novelty and originality as required by Section 30(1) of the Patents and Design Ordinance 1924. These rejections were based on two Facebook advertisements on the Applicant’s Facebook page. These advertisements from 20 February 2014 preceded the application date and appeared to show the shoes.
  • Applications 55280, 55283, 55289, 55291 and 55271 received office actions on 5 February 2012 that alleged a lack of novelty and originality as required by Section 30(1) of the Patents and Design Ordinance 1924 on the basis of sales illustrations from various advertisements. When the applicant responded to the objection, the Examiner again forwarded a publication on Naalei Nayot’s Facebook page.
  • Application 55278 was rejected on the basis of an advertisement on the Applicant’s website. In this instance, during the hearing, the Applicant withdrew the application and a decision issued on 18 October 2015.

Regarding the other eight applications, the Applicant does not consider the advertisements and the Facebook advert that the Examiner cited as being novelty destroying prior art.

The Applicant argued that advertisements by others are third-party Internet adverts that are not connected to the Applicant and should therefore be considered carefully. The websites are frequently updated marketing sites, and so their trustworthiness is suspect. In particular, the dated consumer comments relating to products, some of which are anonymous, may not have related to the specific products at all!

The Applicant supported their position from a ruling by Deputy Commissioner Jacqueline Bracha concerning design application 51593 and 50594 Tequila Cuervo, S.A. DE C.V. (9 June 2014), to the effect that a publication on a sales website does not necessarily knock out the novelty of a subsequently filed design application. As stated in paragraphs 44 and 45 thereof:

In our case, due to the nature of the website, it is reasonable to accept that the images and prices of goods shown will be updated in response to market changes. Unlike news-like content that is clearly dated or official press-releases and the like, the contents of advertising websites cannot be clearly dated and thus cannot be used to reliably establish a date for information published.

The above should not be understood to imply that only official websites of patent offices around the world have the required standard for the patent office circular (which states that applications for designs submitted in other jurisdictions that are accessible over the internet from Israel are considered as prior art preventing design registration in Israel where, under the current regime from 1924, only local novelty is required – MF) The circular allows other official publications to be relied upon including internet catalogs, and applicant’s websites so long as they enable a clear date to be established. Where the source of the advert is the applicant itself, in a press release or on applicant’s website, the applicant can respond to allegations of prior publication.

The challenge to the Office Action is, therefore, the date and trustworthiness of the advertisement cited by the Examiner as being prior art.

The applicant’s challenge to the Facebook publications cited by the Examiner fall into two categories. The first is that they are not full disclosures in that they do not show the design in full. Applicant submits that the cited publication shows a cupboard or a shoe box and the shoes included are not fully visible. The view is from above and from a distance, and does not teach the design to the extent it is taught in the application itself. The Applicant claims that the Facebook advertisement is not directed to consumers and is inherently different from sales sites that enable to the consumer to select and rotate the image of products displayed. They are inherently different from a catalogue or from a vendor’s website.
A second challenge raised by the Applicant is that the Facebook citations against the second group were first raised in a second office action during reexamination. Thus, with regard to the Facebook citation, we are not concerned so much with the fact of publication as per section 30(1) of the Ordinance, but with the degree of exposure of the design in the advertisements predating the filing date, with respect to their photographic quality.

Publication on General Sales Sites

After examining all the publications in vendors’ websites, the present Commissioner, Asa Kling, declared that the publications are reliable. As to the date of the publication, where this is not included within the advertisement on the website, it is possible to determine this from readers’ feedback which is dated. One can assume that if on a specific date there is a web surfer’s comment on an Internet page regarding a product for sale, that product was on sale at least on the date of the response. The content of the responses leaves no doubt that the products illustrated were those that are under discussion in this ruling.

One has to be careful when relating to Internet publications (see Request for Trademarks 187385 and 187386 (GHI) and the opposition to trademarks 200701 and 200702 (GHI stylized) in Gemology Headquarters International vs. Gemology Institute of America 28 May 2012 (henceforth GHI). In our case, after further consideration of the publications that the Examiner relied upon, it is determined that there is reliable information regarding the publication of the design in the general sales sites. As the inquiry stands up to the warning given earlier with regards to the Tequila case, the burden of proof is on the Applicant to show that the publication relied upon by the Examiner is unreliable and insufficient to serve as prior publication of the requested design.

As stated in GHI, the assumption may be rebutted by an expert opinion of by other means that the publication was not at the time indicated on the site, but the Applicant has failed to bring such proof.

This is similar to citations brought as prior art in patent applications. Of relevance in this regard is the notice from the European Patent Office concerning Internet citation (Official Journal EPO 8-9/2009 (the underlining is by Commissioner Kling):

“Establishing a publication date has two aspects. It must be assessed separately whether a given date is indicated correctly and whether the content in question was indeed made available to the public as of that date. The nature of the internet can make it difficult to establish the actual date on which information was made available to the public: for instance, not all web pages mention when they were published. Also, websites are easily updated yet most do not provide any archive of previously displayed material, nor do they display records which enable members of the public – including examiners – to establish precisely what was published and when…. Finally, it is theoretically possible to manipulate the date and content of an internet disclosure (as it is with traditional documents). However, in view of the sheer size and redundancy of the content available on the internet, it is considered very unlikely that an internet disclosure discovered by an examiner has been manipulated. Consequently, unless there are specific indications to the contrary, the date will be accepted as being correct”.

It is emphasized that as far as the surfers’ comments are concerned, it is evident that the website content was available for a long period, and this is sufficient to remove the novelty of (anticipate) subsequently filed design applications in Israel where there is no reason to assume that a host of readers comments all had their dates changed.

Having ruled that the dates are reliable, there is no dispute that the designs in the Internet website are fully disclosed and this renders the discussion regarding the quality of the Facebook publication moot, as is the question of when the partial publication on Facebook occurred. Thus the website publication of 55271, 55280, 55283 and 55289 is considered sufficient to render the applications unregisterable and the Examiner was correct to refuse them.

Publication on Facebook

There is a further claim that the publication on Facebook was never intended for the consumer. The Commissioner admits that he didn’t understand this claim. The intended recipient of a publication is irrelevant to the fact that there was a publication. The Examiner was correct that the fact the pictures were publicly available is sufficient to destroy the novelty of a subsequently submitted design application. This position is supported by the authors of Russel-Clarke and Howe on Industrial Designs, 8th ed., Sweet & Maxwell (2010), where, on page 13 it is stated:

In general there will be publication if articles to which the design is applied are manufactured, displayed or used in such a way that members of the public will or might see them. It is not necessary that the articles should have been sold. Prior use does not mean use by the public, but use in public as opposed to use in private.

According to the Examiner, the illustrations allow the shoes to be appraised by a visual test, in that the pictures of the featured design may be compared with other designs and what is required is a general appreciation of the design and not all the minor features thereof. The Examiner considered that the Facebook advertisement shows that stylistic elements of all the shoes shown in the illustration in sufficient detail to be novelty destroying.

Section 2 of the Ordinance defines a design as follows:

“Design” does not only mean the outline, shape, example or decoration that makes a mass-produced article distinctive, whether by hand, by machine, by chemical treatment, by a separate shape or an adjoined part, as it appears to the viewer in the finished product, and as can be visually determined. The term design does not include any method or principle or anything else other than a mechanical object.

In Appeal 7125/98 “Miforal Industries Jerusalem vs. Klil Industries LTD 57(3) 702 Nevo 8 May 2003, in paragraph 10 of the ruling this is explained:

The correct comparison needs to be made by comparing the general impression that a design makes on the eye of the relevant consumer. The emphasis is on the general impression from the article considered in its entirety., where the assumption is that the consumer does not have an experts attention to detail, but is also more interested that a passer-by Appeal 1187/94 Sela Concrete Devices LTD vs. Ackerstein Industries LTD [8] 291.

Thus in many fields, a design will be examined in its entirety rather than being analyzed into constituent elements. See  Patent Office ruling concerning designs 22424, 22433, 22783, 23767 Klil Industries LTD of 7 August 1997

By applying the general visual appearance test of the Ordinance as fleshed out in the case-law, the question in our case is whether the normal consumer exposed to a picture in an advertisement on Facebook would be sufficiently impressed by the general appearance that he would identify the shoes for which design applications were filed. The Commissioner considers this unlikely.

The nature of the Facebook advertisement is high-resolution coloured photographs. However, the photos show some of the shoes almost in their entirety and others are only partially visible. The soles of none of the shoes are visible.

As the Applicant noted, viewing the photographs on Facebook is insufficient to give a feel for the whole shoe, since each show is only shown from one specific angle which is a general front birds-eye view. The photos do not show the design elements of each shoe, such as decorative elements in detail. As the Applicant explained, apart from the question of the intention of the advertisement, the publication of the shoes in these advertising photographs is not the same as their display on a website showing all angles.

Furthermore, with respect to the articles under discussion,one cannot deny that the heel of a shoe is a significant design consideration. For many of the shoes shown, the heel is not illustrated, nor is the view from behind, which is of significance to the purchaser as will be detailed hereinbelow.

For example, with reference to design application number 55288,  the Facebook illustration does not show the heel engaging straps of the shoe, but only the front upper section.

With reference to Application Number 55279, the Facebook photograph leaves a difficulty in determining whether the shoe is a high-heeled shoe or a platform shoe. There is also a difficulty in understanding the internal profile of the shoe which is clear from the figures submitted. The show of design application number 55291 is not clear from the Facebook image which does not show clearly if the shoe has a high heel or not, and what the back-of-heel straps look like. These are, however, clear from the images of the application as filed.

Application 55270 is shown on Facebook, but the position of the back-of-heel strap and of other elements such as floral decorations is not clear. Thus it appears that the Facebook images do not reveal the design in its entirety.

Applications 25280, 55283, 55289, 55291 and 55271 are not clearly shown on Facebook.

In conclusion, Application numbers 55288, 55291, 55270 and 55279 were rejected whilst Applications 25280, 55283, 55289, 55291 and 55271 were allowed to be registered, (as noted previously 55278 was abandoned prior to the hearing).

Ruling by Commissioner Kling concerning various shoe design applications submitted by Naalei Nayot, 1 June 2016.

COMMENT

This ruling provides much needed clarification regarding to what extent a design shown in a photograph on an Internet website is novelty destroying. However, I respectfully submit that the commissioner is wrong in this case. (Actually that’s not strictly true. The Commissioner is right by definition. It is only a court ruling that can over-turn his decision. What I mean is that I think that the standard for an image to be novelty destroying should not be the same as for registering a design. A registration should include front, back, left, right, top and bottom plan views, and also a perspective view. I think that an earlier publication of a view that observers see should be adequate to anticipate a design application and to render it non-registerable.

After the Christian Loboton case, I understand that some people choose shoes because they have a particular colour sole and are willing to pay a premium for this. Actually this isn’t true. Some people are willing to pay more for a particular designer’s products, and will accept red soles as a distinguishing trademark. Clearly the arrangement of grips and studs on the soles of sports shoes have a purpose, and whether the ankle is strapped in or not is also of some interest, but, like the height of a heel, it is functional. Women wear high heels to look taller (yes I’ve also seen Kinky Boots and accept that they also cause the buttocks to clench sexily). Essentially heel size is functional. I think that people primarily choose the aesthetic elements of a shoe design based on the impression it provides to someone looking down from in front. It is for precisely this reason that the Facebook adverts show the shoe from this perspective.  A good design will be available for different sports with different grips on the sole and, I suspect, will be available in low, medium and high heel options. Furthermore, whether a shoe has high heels or not is usually visible from a raised front view.

Without viewing the particular images and the specific shoe designs it is difficult to challenge the Commissioner’s ruling, but I am skeptical.  I think that Former Deputy Commissioner Smulevezh was correct in the Ackerstein kerb-stone decision to rule that one views kerb-stones from the top and front and thus a publication not showing the underside and back surfaces is still a publication. I think this should apply to shoes as well; most people wear them on their feet at ground level. They chose shoes to compliment outfits based on what the shoes look like from a bird’s-eye view from the front. This is not a bird’s-eye view at all. It’s the view that others, and indeed the wearer himself / herself see.

I can accept that a purchaser may be interested in what the inside of a shoe looks like, but I do not consider this to be part of the aesthetic design protected by a design registration. Shoes are designed to be worn. When worn on a foot, the inside design features of a shoe are hidden, as is the sole.  I would expect Naalei Naot to complain about competitors making shoes that are otherwise identical except viewed from underneath or when considering the inside. This is why they register designs. An otherwise identical shoe to one that is registered design, that is differentiated by having a tartan lining and a manufacturer’s signature written on the part of the sole connected to the heel that does not get appreciable wear, should, in my opinion, be considered infringing.


Opposition to IL 178249 Dropped After Claim Amendment, but then Rejected Due to Lack of Novelty

March 8, 2016

solifenacin

Il 178249 to Astellas Pharma Inc is a patent application titled “PHARMACEUTICAL COMPOSITION FOR USE IN SOLID FORMULATION CRYSTALLINE SOLIFENACIN OR SALT THEREOF AND A PROCESS FOR ITS PREPARATION”. On allowance, back in 2012, it was opposed.

Following the Statement of Claims, Astellas requested various claim amendments, some of which were allowed and some were opposed. The Applicant requested a further amendment and the Opposer did not object, so the amended claims published for Opposition purposes.

This amended claims set (version 5) is now subject to a judicial decision under Section 34. Based on her analysis, the Deputy Commissioner, Ms Jacqueline Bracha considers the claimed invention as lacking novelty and inventive step, and therefore provisionally refuses it under Sections 4 and 5 of the Israel Patent Law 1967. The Applicant has 30 days to appeal this decision.

The claimed invention is a pharmaceutical preparation that includes solid formulation crystalline solifenacin or a salt thereof in a concentration of up to 77% as measured by NMR. The relevant date is the filing date of the priority document which is 25 March 2004.

The specification itself states that this preparation was known, as was its crystalline state and its method of manufacture, and its effectiveness in treating urinary diseases.  The amorphous state was present in tablets on sale prior to the priority date, and the Applicant is requested to answer whether this amorphous phase is indeed inherently present and if so,how and why it affects the novelty of the invention as claimed.

The Applicant claims that the percentage amorphous material in the tablet affects the efficacy and moisture during manufacture affects  the amount of amorphous material in the pills. PEG is used as a binder but this is not claimed and so is not part of the claimed preparation.  Apendix IX of the Statement of Opposition shows that exposure of pharmaceuticals to moisture degrades them, and this occurs more in amorphous regions. as stated in reference:

“What we can conclude from this analysis is that medium effects due to residual water in the amorphous state can be significant, but that the direction and extent of this effect will depend on the nature (e.g., polarity, specific solvation) of the transition state for the particular reaction causing degradation.”

Reference 10 states that wet granulation affects the degradation rate.

From the above, it is clear that persons of the art would expect the amount of amorphous active material to affect the rate of degradation, the extent of degradation over time and to reduce degradation  one should protect from moisture. Consequently the claimed invention is obvious.

The Statement of Opposition shows that the pill was on sale before the priority date.

 

The Application is therefore provisionally refused, and the Applicant has 30 days to respond.


Unsupported Claims for Dental Plate Lifter Cost Patentee 149,000 Shekels in Costs

March 8, 2016

plate lifter

IL 199377 is a patent titled “EXPANDABLE DEVICES FOR DISPLACING THE SCHNEIDERIAN MEMBRANE” it was invented by Ben-Zion Carmon back in  2001 and is a patent of Division of an earlier Application.

When Carmon attempted to enforce the patent against Miambi LTD and Dr Ehraim Kfir, the defendants attempted to cancel the patent and successfully managed to limit its scope.

In Israel Law, a party that successfully manages to oppose a patent, have it cancelled or have its scope narrowed, is entitled to costs. In this case, Miambi LTD requested costs of 1,012,418 Shekels from Ben-Zion Carmon since back in December 2014, they managed to get some of the claims cancelled.

I wrote up the original ruling here.

The main claim was:

A device for displacing the Schneiderian membrane from the floor of the maxillary sinus comprising: a rigid conduit for insertion through the maxillary bone towards said Schneiderian membrane, an expandable inflatable container, a connector, a filling tube, a reservoir having a flowable filling material and injecting mechanism, the distal portion of said connector being connected to said conduit, the proximal portion of said connector being connected to said filling tube, said filling tube being connected to said reservoir, said injecting mechanism being configured for the insertion of said filling material from said reservoir through said filling tube inside said container so at least part of said
container being expanded to protrude distally to the distal end of said conduit inside said maxillary sinus to displace said Schneiderian membrane.

The reason why the patent was severely narrowed was that the claimed structure, an expandable inflatable container, a connector, a filling tube, a reservoir having a flowable filling material and injecting mechanism, simply wasn’t supported.

In my write-up at the time, I noted that the practical joke sold as a plate lifter has the same structure, and so this wasn’t novel.

That as may be, PCZL, representing the patentee, alleged that they would appeal the decision and therefore requested that the costs ruling be stayed, and thereby created a chain of letters and responses that generally procrastinated. The Israel Patent Office noted that the authority for staying a decision is in the hands of the Court of Appeals (The District Court) and not in the hands of the Adjudicator of Intellectual Property, Ms Yaara Shoshani Caspi who heard the original case. The Court never ordered a staying of the costs ruling.

Claims and Evidence of Both Parties

Miambi LTD and Dr Ehraim Kfir alleged that the cancellation proceedings and the associated costs were caused by the legal action brought by Ben-Zion Carmon to enforce the patent against them. They alleged that the action was baseless and was filed in bad faith by Ben-Zion Carmon and caused them to invest substantial resources in defending themselves. Dr Kfir appended an Affidavit relating to consultation fees from Gilat Baraket & Co. as evidence of costs accrued. They alleged that the case dragged on before the Patent Office due to the complicated technology involved. The costs comprised three elements:

  1. 412,000 Shekels for work by the Attorney of Record, Adv. Rahmani, but no documentation was provided to support this cost
  2. 350,418 Shekels in consultation fees to Gilat Baraket & Co. , with various invoices to support this claim
  3. 250,000 Shekels for 250 hours work by Dr Kfir himself in fighting this law-suit.

Pearl Cohen Zedek Latzer raised some creative defenses on behalf of their client:

  1. Ben-Zion Carmon is a private individual and to award costs against him would be a rare precedent. Indeed, he shouldn’t have to pay costs at all
  2. There was no scientific complexity here and the cancellation proceedings was an off-shoot of the Infringement Proceeding in the District Court
  3. The costs request was laconic. No evidence was filed to support Adv. Rachmani’s time or Dr Kfir’s, and the statements from Gilat Bareket & Co, were not sufficiently detailed
  4. The costs requested were unreasonable and disproportionate
  5. Gilat Bareket & Co are not consultants, but representatives and it is unreasonable to charge Carmon twice for two sets of lawyers fees
  6. Ms Pugatsch’s costs of 80,000 Shekels for preparing an Affidavit was ridiculous, since Carmon’s witness, Prof. Ciaco only charged 5920 Shekels.
  7. Citing previous rulings, the costs for Dr Kfir’s time were unreasonable since his work as CEO of the company requires him to work on such matters
  8. Since Adv. Rachmani is a minor share-holder in Miambi LTD and provides legal aid on an ongoing basis, he can be considered an employee who is performing his regular work and thus his costs are not refundable

Discussion and Ruling

The guidelines for cost rulings are set out in Bagatz 891/05 (Tnuva) which discusses the work done, legal and factual complexity, stage that proceedings reached, bahaviour of the parties, equitable and inequitable behaviour and the like.

Where actual costs are requested, the onus is on the plaintiff to prove that these costs were indeed incurred and were necessary. As ruled in Opposition 113433 Smithklin beecham Corporation (SKB) vs. Teva (30 May 2005) not all costs are recoverable.

Turning now to the three cost elements:

  1. Rachmani’s costs of 412000 Shekels were for a detailed list of actions but the time involved and hourly rate were not detailed. Certainly some of the time spent and costs requested, such as those for initiating intermediate proceedings that were unsuccessful. Although a minor share-holder he is not a worker. It is acceptable since he provides on-going legal services that he will be paid from costs award and not per action and so lack of invoices is not critical problem. In general, a fair recompense for his work can be assessed by approximation
  2. It is not clear what Dr Kfir did in his 250 hours, after all Adv. Rachmani was inside counsel of the firm. Furthermore, Dr Kfir is, himself, a named party. He does not, therefore deserve costs.
  3. The costs for Gilat Bareket’s work were not detailed. There is no clear correlation between the list of actions detailed in Dr Kfir’s affidavit and the Gilat Bareket’s Some invoices precede their submission to be co-counsel.  Adv. Rima Pugatsch’s opinion was blled for in two invoices. The breakdown between these is not clear and the basis for the cost was not detailed. This makes it impossible for the Patent Office to assess whether the costs were fair. Thus a fair price for Gilat Bareket’s work can only be assessed by estimation.
  4. PCZL’s allegation of double representation is rejected, since the case is factually and legally compex.

Ruling

More or less by weight, Costs were approximated as follows:

  • 90,000 Shekels for Adv. Rachmani’s time
  • 45000 Shekels for Gilat Bareket’s consultancy
  • 8000 Shekels for the Opinion by Ms Rima Pugatsch
  • 3000 Shekels for requesting costs
  • 3000 Shekels for having to file additional papers after the main ruling.

Total costs of 149,000 Shekels should be paid within 10 days.

COMMENT

The claimed invention was not supported by the specification and the divisional patent should not have issued. I still maintain that structurally the claim relates to a plate lifter and thus lacks novelty.

Pearl Cohen should have told Dr. Carmon not to attempt to enforce the patent against Mumbai. However, as with the Origin Source case and the Air-Conditioning unit support brackets Pearl Cohen have a history of attempting to enforce patents where there is no infringement and the patents should not have issued. The delaying tactics they’ve employed here are also typical of their modus operandi.


Camtek Invalidates another Orbotech Patent

May 25, 2015

Duck Shoot

IL 131283 titled ” Apparatus and methods for inspection of objects” was filed on 5 August 1999. After its eventual allowance it published for opposition purposes on 8 July 2008. On 7 October 2008 Camtek filed a notice of opposition and on 5 November 2008 they filed their Statement of Case.

Both sides submitted their evidence and on 28 March 2010, the Applicant requested to correct the specification, and submitted amended claims. On 24 May 2010 Camtek announced that they had no objections to the amendments, but reserved the right to raise further issues in the opposition itself. The parties submitted their statements and evidence regarding the amended claims, and, after a hearing back in March 2013, this ruling has now issued.

The patent in question relates to automated optical inspection and the main claim of the patent in question is as follows:

A method for image processing comprising:

generating representations of boundaries of known elements in the image;

identifying candidate defects in the image, in hardware, thereby to generate a hardware candidate defect identifier output including hardware candidate defect identifiers;

receiving the hardware candidate defect identifiers and said representations of boundaries;

generating a window of  interest surrounding at least some of said hardware candidate defect identifiers and said representations of boundaries;

identifying at least one false alarm within said window of interest, in software;

and identifying additional candidate defects in the image, in software.

There are a further 6 dependent claims.

The underlined parts were the result of the amendment during the opposition, which, since it is a narrowing restriction, is procedurally acceptable.

Opposer’s Case

In the Statement of Opposition, Camtek opposed the patent issuing on the basis of Sections 3, 4, 5, 12, 13 and 18 of the Law.

Re Section 3 – Camtek alleged that the patent isn’t directed to a device or process, and at best is an attempt to monopolize a computer process or algorithm per se.

Camtek considers the claimed invention to lack novelty as anticipated separately in three earlier publications:

  1. West at al, ‘The Automatic Visual Inspection of Printed Circuit Boards’ Circuit World Vo. 8 No.2 (1982)
  2. West, ‘A system for the Automatic Visual Inspection of Bare-Printed Circuit Boards’, IEER Transactions on Systems, Man and Cybernetics, Vol. SMC -14, No.5 (1984)
  3. US 5,619,429; M. Aloni at al, Apr. 8 1997

These publications allegedly render the claimed invention obvious, whether considered separately or in combination.

Camtek further accused Orbotech of inequitable behavior in having not brought the existence of US 5,619,429 (which was assigned to Orbot Instruments) to the attention of the Examiner contrary to the duty of disclosure. Camtek also alleged that the amendments to claim 1 designed to attempt to distinguish the claimed invention from that of 5,619,429 did nothing to rectify the failure of Orbotech to bring this to the Examiner’s attention. Finally, Camtek argued that the claims lacked clarity and were not supported by the specification.

Orbotech’s Position

Orbotech denies all of Camtek’s allegations. According to Orbotech, the claimed invention differs from each of the cited art by including at least one element not described therein. In particular, none of the citations relates the step of:

“Generating a window of interest surrounding at least some of said hardware candidate defect identifiers and said representations of boundaries”

Orbotech did not consider it is required to address the issue of inventive step (obviousness) since Camtek had merely submitted a list of prior art references and had not shown how they can be combined to teach the claimed invention. Similarly, the lack of clarity and support issues were denied and Orbotech noted that they weren’t substantiated in Camtek’s statement of case.

Evidence

Camtek’s position was supported by an affidavit from Dr Shimon Koren, the director of Technology in the Microelectronics Division at Camtek. Koren considered that the claimed invention is a known methodology for image analysis that combines hardware and software stages and a standard way of defining areas of interest. He considers that using software or dedicated hardware was simply a design choice and the claimed elements were the foundation of software engineering in the field, and known to all persons of the art at the priority date. Specifically, any further image processing on a feature of interest requires the preliminary determination of a boundary to the region of interest, whether automated, by hardware or software, or manually, and there was nothing novel and certainly not inventive in this. [I find this argument compelling, as I have written up about a dozen patents for Siemens CAD vision for detecting lung and breast cancer by image analysis of XRay photographs, and everything starts with drawing a line around the field of interest].

Koren does not understand the relevance of “identifying at least one false alarm within said window of interest, in software; and identifying additional candidate defects in the image, in software.” And, as a person of the art, Korens considers that these claimed steps are simply confusing, hence the lack of clarity objection. Koren further expounded on the lack of novelty and inventiveness with respect to the prior art referenced above.

Orbotech submitted an Affidavit of the Director of their Core Technology Algorithm Group, a Dr Rippa, who is a coinventor of the claimed invention.

Dr Rippa stated that the present invention claims a process for identifying and segmenting candidate defects or preselected areas of interest, whereas the prior art merely describes a process for identifying and segmenting candidate defects. Dr Rippa concedes that the hierarchical examinations where each stage filters through candidate defects picked up by the proceeding stage were known to persons of the art. However, the present invention is not necessarily hierarchical in that the areas of interest with their generated boundaries are not necessarily subjected to additional filtering steps. Furthermore, algorithms per se. are not claimed, but rather a process ran on a physical system [so the invention is to be considered as patentable subject matter].

Additionally, Dr Rippa denied the allegations of lack of clarity, claiming that repeated indications provide greater certainty. [I can’t see how this jells with previous statement about the method not necessarily being hierarchical, nor can I see how the wording of the claim supports this interpretation].

Furthermore Dr Rippa also considers that there are significant differences between hardware and software and using hardware where the claimed invention specifies software will be inefficient.

Finally, Dr Rippa related to the cited art and opined that they do not render the claimed invention known or obvious.

The Ruling

Ms Yaara Shoshani Caspi considered that the invention related to the ‘window’ which was not properly described in the application. She found Dr Koren’s explanation convincing, whereas she found Dr Rippa’s explanation incoherent. She also noted that Dr Rippa, as an inventor and witness for the defendant, was more likely to provide misleading testimony. [The ‘defendant’ is the applicant. The issue is an opposition. Both sides have financial interests or the patent would not be opposed. Camtek are not acting out of respect for the integrity of the register].

It seems that during cross-examination, Dr Rippa changed his story, and didn’t seem able to make up his mind whether candidates were segmented or whether also previously defined areas were segmented.

Camtek and their witness, Dr Koren argued that once an area is selected, it requires to be segmented and the window drawing exercise is the same regardless. The point of novelty was, in their opinion, a question of semantics and not  one of substance. The issue is not one of terminology but whether Orbotech was describing something new or not.

It seems that Dr Rippa retracted his original statement and accepted that once a window was drawn, the enclosed space was checked as to whether it fulfilled the criteria of defects or not. Dr Koren argued convincingly that the examination of predetermined windows was for calibration purposes, to help recognize defects. Since Orbotech failed to convincingly argue that hardware was advantageous over software for this purpose, the argument that hardware was chosen specifically was not given any weight. The upshot of the above is that Orbotech was claiming to segment candidate flaws and then to examine them and the adjudicator did not consider this novel or inventive. The additional step  of finding additional candidates was not considered clear and could not, therefore, be used as saving grace. In this regard, the adjudicator noted a dissonance between the claim, the representative figure and the affidavit.

Ms Shoshani-Caspi, did, however, find that the although directed to an algorithm, since the algorithm was for use on a machine having certain functionality, the invention should be considered technological and not software per se or a thought process.

Having defined the invention as segmenting candidate flaws and then examining them, the adjudicator found that each of the publications:

  • West at al, ‘The Automatic Visual Inspection of Printed Circuit Boards’ Circuit World Vo. 8 No.2 (1982)
  • West, ‘A system for the Automatic Visual Inspection of Bare-Printed Circuit Boards’, IEER Transactions on Systems, Man and Cybernetics, Vol. SMC -14, No.5 (1984)
  •  US 5,619,429; M. Aloni at al, Apr. 8 1997

Separately anticipates  the claimed invention, rendering it known in contradistinction to Section 4 of the Patent Law 1967. Being known, the claimed invention could not be considered inventive in contradistinction to Section 5 of the Patent Law 1967.

That said, the adjudicator did not find the claims unsupported or evidence of inequitable behavior.

Despite the Opposer failing to specify the flaws of the dependent claims, the adjudicator did not find redeeming features in any of these. The patent was found to be invalidated and costs of 15000 Shekels were awarded to Camtek.

Comment

Once again, Camtek, represented by Adv.Adi Levit, has successfully invalidated an Orbotech patent. However, unlike the recent case where Camtek invalidated Orbotech’s IL 179995 patent and the Deputy Commissioner Ms Jacqueline Bracha ruled costs of 296,895 Shekels.as Orbotech forgot to appeal Camtek’s detailed costs submission, the costs awarded in this case were a mere 15000 Shekels which does not seem to be a lot for a case that has been dragging on for 7 years.


Can post priority-date publications that describe clinical practice be considered prior art?

February 5, 2015

exforce

Israel Patent Application No. 140665 to Novartis tited “Use of Combiantion Compositions comprising Valsartan and Amlodipine n the preparation of medicaments for the treatment and prevention of diabetes related hypertension” relates to preparations including  Valsartan and Amlodipine for treating high blood pressure and diabetes.

The application was a national phase of PCT/EP1999/004842 from 9 July 199 and claims priority from an earlier US patent application.  The patent was allowed and published for opposition purposes on 23 December 2012 and is being opposed by both Teva Pharmaceuticals LTD. and by Unipharm LTD.

The Opposers submitted an expert opinion from a Professor Chimlichman to the effect that the combination was known from various publications and his treatment of hyper-tension and thus were lacking novelty at the priority date.

On response to evidence by the Applicant, the Opposers submitted a second opinion in which he relied on two publications from after the priority date to determine novelty and inventiveness at the time of the priority date. Since these publications were not prior art, the Applicant requested that they were deleted from the opinion and expunged from the record.

Professor Chimlichman claimed that his treatment before the priority date was supported by GYH Lip et al., “The `Birmingham Hypertension Square` for the Optimum Choice of Add-in Drugs in the Management of Resistant Hypertension”, Journal of Human Hypertension (1998) 12, 761-763. Whilst the publication itself was certainly published after the priority date, it relates to clinical tests using the combination of the two drugs and must have been written prior to being published and describes what the authors knew prior to the priority date.

Furthermore, a response to Lip et al. subsequently published in the same journal provides additional evidence that the combinatory effect was known.

Whilst accepting that the two publications were not themselves prior art, the opposers argued that they indicate the state of the art at the priority date and should be examined on their merits and not expunged from the record. Furthermore, the additional evidence was brought in response to statements my Professor Daloph, the expert witness of the Applicant.

The Opponents cited Unipharm vs. SmithKline Beechan and Orbotech vs Camtek to support their argument that the papers should be examined on their merits.

The Ruling

Opposers are limited in what they can submit in response to the patentee’s evidence. They are not allowed to widen the statement of case. In this instance the additional evidence is supplementary evidence to support their main grounds of opposition, i.e. that the combination was known. There is no evidence given to explain why these papers weren’t submitted in the original round of evidence. The Opposer submits his evidence first and is entitled to respond to the counter-evidence. This gives him a procedural advantage and allowing the submission of additional evidence that could have been submitted in the first submission unfairly disadvantages the applicant.

In this case, the additional information is not prior art in the public domain, or it would not have been accepted for publication. It post-dates the application and is, therefore, not prior art. The Deputy Commissioner did not consider this material as indicating what was widely known prior to the priority date. The Opposers are trying to use the citations of Lip to show what was known prior to the priority date, and to do this, they should have submitted these citations in their statement of case.

Whilst not wishing to rule out using a paper that provides history of what was known earlier, the Deputy Commissioner warns against the danger of a hindsight bias and of reading the authors conclusions into the prior art.

As to the Opposers argument that the Applicant should have submitted an affidavit to support the evidence, Ms Bracha rejected this as the dates are not contested and so an affidavit is unnecessary.

In conclusion, Ms Bracha ruled that Sections 25-26 and 86-88 of the second opinion should be deleted. Legal costs of 5000 Shekels were ruled against the opposers.

COMMENT

In the DSM  vs. Mifalei Migun case, Judge Judith Schitzer of the District Court correctly ruled that one does not have to submit an affidavit with every piece of evidence or statement, so the Deputy Commissioner is correct on this account.

As to the late submission of evidence however, I think that the Opposers can fairly be penalized for not timely submitting these papers by having interim costs awarded against them for not submitting the evidence earlier, but the evidence should be related to substantively if it testifies to what was practiced prior to the patent being filed and not thrown out on procedural grounds. Ultimately the purpose of the Opposition proceeding is to clarify novelty and inventiveness to protect the public interest. If a drug becomes patented and should not be, the public will pay monopoly prices. Sure, the opposers have to answer as to why these papers were submitted late. Maybe the applicant should be given a second chance to respond and compensated for delays, but I disagree with this decision to throw out what could be key evidence.


Cancellation Proceeding Against IL 199377 – a patent for a plate lifter!

January 12, 2015

 

plate lifter

The following decision relates to the entitlement to the priority date of a an invention claimed in a divisional patent that was asserted against a competitor. The Commissioner ruled that the claims of the divisional were not adequately supported by the priority document of the parent application and so the priority claim was lost and the patent was cancelled. A careful reading of the independent claims leads me to conclude that the device, as claimed, is a plate lifter – one of those toys used by practical jokers to move objects at the dinner table.

******************

IL 199377 “Inflatable Devices for Moving Schneider Membranes” is a patent owned by Dr Ben-Zion Carmon. Dr Ephraim Kfir  and Miambi LTD filed a request to cancel the patent under section 73b of the Israel Patent Law 1967.  IL 199377 was filed in June 2009 and is a Divisional Application of IL 152732 which was filed on 10 November 2002 and is a national stage entry of WO 2001/085062  that claims priority from a US application that eventually issued as US 7,771,482.

IL 199377 had an accelerated examination due to a threat from Dr Ephraim Kfir and Miambi LTD, and was allowed on 30 November 2010 and, as no oppositions were filed, the patent issued on 1 March 2011.

On 2 May 2011, Dr Ben-Zion Carmon sued Dr Ephraim Kfir and Miambi LTD in the Petach Tikveh District Court claiming infringement. A negotiated settlement was reached on 5 July 2011, under which the infringement suit would be withdrawn and Dr Ephraim Kfir and Miambi LTD would request cancellation of the patent.

The cancellation proceeding was filed, together with an affidavit by a patent attorney showing why the claimed invention was not new. Carmon responded with an affidavit from a Professor of Mouth & Jaws. The Opposer requested that Applicant’s affidavit be struck from the record. After a hearing, the patent office decided to rule on the admissibility of the Applicant’s affidavit in the main case.

The technology relates to grafting bone into the upper jaw prior to implanting dental prosthetics, and to the occasional need to move the Schneider membrane into the sinus cavity to allow introducing bone growing material into the base of the cavity for attachment of dental implants.

Grounds for the Cancellation included allegations that the claimed invention was not supported by the parent application or the priority document, that the claimed invention was not known to the applicant at the effective filing date and that the claimed invention is not new.

According to Patent Attorney Rimma Pugatsch Shendelzon who appeared as an expert witness for the plaintiff, the parent patent and the priority document related to a device that included a sacrificial material, and which facilitated bone growth to replace the material lost. In contrast, the continuation related to an inflatable material designed to separate the Shneider membrane from the base of the sinus. The invention claimed in the divisional lacked support from the parent and thus was only entitled to its actual filing date of 16 June 2009. Consequently, it lacked novelty due to the earlier WO 2007/129312 whose Applicant was Dr Kfir, and also due to EP 1174094, WO1996/013221, US 5,685,716, and lacked inventive step over the combination of WO1996/013221 and US 5,685,716.  Furthermore, US 2007/1565251 to Carmon himself rendered the present invention both known and non-inventive.

In response, Carmon claimed that the parent application included a number of inventions, some of which dealt with causing bone growth and others with moving tissues such as membranes. Carmon referred to Page 34 lines 1-20 of the priority document, which he claimed was directed to an inflatable device for raising the Schneider membrane. He alleged that the invention was well supported by the priority document, from page 44 line 18 to page 46 line 21 and by figures 14-22. He considered that allegations of lack of support for the invention in the priority document required support by an expert in the field (presumably physiology or dentistry) and without this, the cancellation request was groundless and should be thrown out. He considered that by virtue of the priority document, the divisional was entitled to priority and was filed as a divisional application by right and under the instruction of an Examiner. He referred to WO1996/013221 and argued that it did not render the claimed invention either anticipated or obvious.

In an expert opinion appended to his response, Professor Chowshu opined that the claims of the patent were well supported by the both the parent and the priority document. He held that the publications indeed described a number of applications for raising the sinus, some of which included a soluble container of bone material, and which were optional but not the core of the invention. The device could be an elastic material that is not biodegradable such as silicone. He considered that any person of the art would have understood that the purpose of the container is to widen and raise the Schneider membrane, and other properties such as solubility are optional and depend on the selected material. The expert further opined that one could not invent an inflatable, soluble device for displacing the Schneider membrane without creating an inflatable non-soluble device (I think the intention is inflatable regardless of solubility properties which are apparent only later). He considered that WO1996/013221 did not anticipate the claimed invention.

In summary, Carmon emphasizes that all the claims are fairly supported in the specification (of the parent) and all the experts, including his witness but also the examiners in the US and Israel concurred. Because he was entitled to priority, he did not see necessary to relate to the art cited.

Ruling

Section 73b of the Israel Patent Law 1967 states that the Commissioner may cancel any patent for any reason that could be used to oppose its issuance, at the instigation of any third-party.

The difference between an opposition proceeding and a cancellation proceeding is the assumption of validity of an issued patent, where the onus of showing invalidity falls on the third-party. Support for this is found, inter alia in 345/78 Hughes Aircraft vs State of Israel and others, PD MD (4) 45, 02 (1990).

The Commissioner considers that the question of validity consists of finding support for the independent claims 1 and 67 in the parent application, and the effective date of independent claims 1 and 67, vis-a-vis the dates of the prior art.

The invention relates to dental surgery, specifically to implants that widen the upper jaw to support dental implants. The question is how a person of the art with full knowledge of the field but without a glimmer of inventive capability would understand the prior art.

Both Carmon and Kfir are involved in developing dental procedures.  Both they and the two expert witnesses were extensively cross-examined in the hearing. Since the parties have questioned the competence of the witnesses, the Commissioner has to relate to this issue. Carmon alleged that Kfir has a commercial interest and so his testimony is valueless, and the patent attorney is not an expert in dental surgery. Kfir countered that the expert witness’ testimony is professionally inaccurate and non-objective.

The Commissioner was impressed with Professor Chowshu as a professional within the field of dental and bone implants. He noted that the patent attorney Ms Reima Pugatch-Shendelson had a Master’s Degree in Bio-Medical Engineering and had expertise in patents and patent law. The Commissioner acknowledged that he did have initial reservations regarding the competence of a patent attorney without formal education in dental surgery to be an expert witness in this case. However, during cross-examination she demonstrated her competence and provided explanations to the commissioner.

Citing Technip France SA’s Patent [2004] R. P. C. 46 on expert witnesses:

“Their primary function is to educate the court in the technology – they come as teachers, as makers of the mantle for the court to don. For that purpose it does not matter whether they do or do not approximate to the skilled man. What matters is how good they are at explaining things”.

The commissioner was satisfied with Ms Rimma Pugatsch Shendelzon’s performance to consider her an expert witness. He noted that she had declared her employment by Reinhold Cohen, and her connection to Gilat Bareket who represented the party in the infringement proceedings and that she was a paid expert. However, he did not consider that this should prejudice her standing as a witness, but should merely be born in mind.

In contradistinction, Advocate Meir Dahan’s analysis for the defendant of the infringement action which was not submitted as a sworn statement, and a second paper submitted by the patentee were, however, considered as non-objective and of dubious value.

There were certainly similarities between the statement of claims as filed in the infringement action and the opinion of the expert witness (implicitly implying that the opinion was prepared by the lawyers). However, the expert witness should familiarity with his statement and stood behind it.

An attempt was made to show that Professor Chowshu was a technical consultant to a competing firm and had a conflict of interest. This was dismissed as being additional evidence that was submitted too late to be taken into account, was available to the plaintiff earlier, was not critical in determining the outcome of the case and was submitted late in the day. Since Professor Chowshu was not a court selected objective and independent witness, but was one who was selected and paid for by one of the parties, this revelation was hardly key in reaching a fair ruling.

Claim 1 is as follows:

  1. A device for displacing the Schneiderian membrane from the floor of the maxillary sinus comprising: a rigid conduit for insertion through the maxillary bone towards said Schneiderian membrane, an expandable inflatable container, a connector, a filling tube, a reservoir having a flowable filling material and injecting mechanism, the distal portion of said connector being connected to said conduit, the proximal portion of said connector being connected to said filling tube, said filling tube being connected to said reservoir, said injecting mechanism being configured for the insertion of said filling material from said reservoir through said filling tube inside said container so at least part of said
    container being expanded to protrude distally to the distal end of said conduit inside said maxillary sinus to displace said Schneiderian membrane.

Claim 67 recites:

  1. A device for displacing the Schneiderian membrane from the floor of the maxillary sinus comprising: an expandable inflatable container for insertion through the maxillary bone towards said Schneiderian membrane, a rigid hollow connector, a filling tube, a reservoir having a flowable filling material and injecting mechanism, the external diameter of the distal portion of said connector being smaller than the largest external diameter of said connector, said distal portion of said connector being connected to the proximal portion of said container, the proximal portion of said connector being connected to said filling tube, said filling tube being connected to said reservoir, said injecting mechanism being configured for the insertion of said filling material from said reservoir through said filling tube inside said container so at least part of said container being expanded to protrude distally to the distal end of said connector inside said maxillary sinus to displace said Schneiderian membrane.”

In 2626/11 Hasin Eish TaAsiyot LTD vs. Koniel Antonio (Israel) LTD it is stated that the specification cannot provide protection beyond that claimed. Section 73b states that the Commissioner may cancel patents at the request of a third party if there are grounds under which the patent should not have issued. Referring to Section 31, the Commissioner considers inadequate support as grounds for cancellation. To establish whether or not there is sufficient support, the scope of the claims should be compared to the specification and figures, with the adjudicator putting himself in the shoes of the average person of the art. The comparison should not be a simple technical exercise of finding supporting words (see Terrell on the Law of Patents, Edition 16, 2006 (P. 68) Sweet and Maxwell.

The Commissioner considers that the structural elements required are the expandable inflatable container and the flowable filling material. He found that every reference to the Schneiderian membrane related to an absorbent insert that released a bone growth promoting material. There was no reference to any other fluids, other than those that promoted bone growth.

The Commissioner dismissed the support suggested by the patentee as being taking phrases out of context and ignoring other phrases. This was considered illegitimate, and quoting 407/89 Zuk Or vs. Car Security LTD (1994), he noted that “patent documents are written by the inventor himself, in his own words and with very little restrictions in how they are written. A lack of clarity in a phrase or term may be solved by reference to other parts of the document but one cannot selectively use phrases in the specification and ignore others to support the inventor’s interpretation.

To provide support for the claims, page 15 lines 12-59 were added.to the Summary prior to the patent issuing. This does not explain the claimed invention in greater detail than the wording of the claim. There are still phrases in the specification that specify that the container is totally or partially absorbed and that the container is periodically filled with a biocompatible material, which teaches away from a closed hydraulic fluid.

The plaintiff noted that there was no teaching for removing the device which implied that the devices considered were left in place. The patentee countered that the removal was obvious to persons of the art. The Commissioner found the plaintiff’s contention more convincing. He also accepted their argument that a careful lifting of the Schneiderian membrane would require a control device to prevent over-inflation. (with the absorbable solution, the bone replaces the membrane, blocking off the sinus so the tearing of the membrane is not a problem).

In conclusion, the Commissioner held that the specification did not support an inflatable container and an inflating liquid.

The Background clearly states that:

“The present invention is unique because it is the only device combining together a bioresorbable barrier, a graft material and an expansion device therefore avoids most of the forgoing drawback and permits a more simplified and effective means for bone regeneration:..” 

This was seen as clearly teaching away from the claims that were filed in the divisional and rendered them lacking in support.

Importantly, terms like ‘can be’ and ‘preferably’ that peppered the specification could not allow the patent to be widened indefinitely.

 

COMMENTS

Medical procedures are not patentable subject matter in Israel (or indeed, in most other countries, except the US). Devices used in medical procedures may be

The independent claims describe a rigid tubing with an inflatable container at one end and a reservoir at the other. A ‘plate lifter’ – one of those toys for running under the table-cloth to spook the dinner table (useful for showing Elijah sipping the wine on Seder Night) has all the structural limitations of the device. The structure claimed in the independent claims has been around for much longer than 20 years and the claims lack novelty.

I disagree with the Commissioner’s assumption that the only issue is whether the independent claims are novel and inventive at the time of appropriate priority. If the main claims are entitled to the priority date, I believe that the dependent claims still have to examined as to whether they are entitled to the priority and whether at the relevant date are novel and inventive.

It seems to me that if the invention claimed in divisional is not supported by the parent application, the divisional application may be considered as a patent of addition. The parent application cannot be cited against the continuation as novelty destroying, nor does the divisional need to be non-obvious over the parent application. However, the divisional application does require to be prima facie patentable over the remaining prior art at the time of its filing.

I am not sure that a professor of dentistry is better than a patent attorney at establishing what a patent publication fairly teaches. The professor in the case seems to imply that from the teaching of the specification, the extrapolation required to get to the claims is not significant. Professors are usually experts in their field and they are not well suited to put themselves into the position of persons of the art. To obtain a PhD requires original research. It requires insights. The professor in this case may well believe that the claimed invention of the divisional is obvious from the specification, but that is not the question. The question is whether it is taught, and it isn’t.

It is important that the adjudicator is aware that exerts are paid and are thus not objective. He should not be wowed by titles such as “Professor” or be dismissive of a mere patent attorney. The question is the competence of the witness. The expert testimonies should help clarify the questions requiring a legal ruling. It is clear that the patent attorney in this case was chosen because of her academic background, and while patent attorneys do not claim to be legal or technical experts, they generally are rather good at noting what is implicit or explicit in a publication as this is the basis of patent prosecution and what they do on a day to day basis. Professors may or may not be good witnesses. The question of whether the difference between the parent application and the claims of the divisional warrants a second peer-reviewed paper is a different one from whether the divisional is entitled to priority.

The experts selected by parties in legal proceedings are often friends of the party. They are generally paid for their work. They are rarely objective. Neither patent attorneys nor professors will generally dirty their names by testifying what they do not believe. The adjudicator sitting in judgment is supposed to use the witnesses to help clarify to himself what the documents are about. Adv. Kling is an aeronautical engineer. He is not a dentist. Many judges lack technical knowledge completely. They should, however, be competent to read a technical passage and to understand with the help of experts what it states.

This decision is a correct one, but it is worrying that none of the parties, including the Israel examiner, the commissioner, the patent attorney witness and the lawyers for the plaintiff realized that the main claims include a plate lifter. The Examiner, knowing that this was made special due to an apparent infringement, should have made certain that the claims were adequately supported by the specification. Had either action occurred, this rather long and laborious decision (21 pages in the original) could have been rather shorter and more entertaining.