Isscar Opposes Hanita Patent for Milling Tool

June 15, 2017

Hanita Metal Factory ltd. applied for Israel Patent Application No. 177336 and, on allowance, it published for opposition purposes. Isscar opposed the patent issuing.  The applicant requested to amend the specification and neither Isscar, nor the public opposed, so the opposition concerns the amended specification.

The parties submitted their statements of case and evidence and then a hearing was held on 10 January 2017. The parties then submitted summaries and the Opposer filed their response to the summary.

The Application in question is titled “Chatter resistant end mill” and has one independent claim with seven dependent claims. The independent Claim 1 of the Application is as follows:

“A chatter-resistant end mill or shell mill or burr, comprising a shank portion and at least one cutting portion divided into a plurality of teeth by flutes disposed between said teeth, each tooth having at least one cutting edge,
Wherein a first angle separating said cutting edge of a first tooth from the cutting edge of a second tooth adjacent to said first tooth in a first direction is different from a second angle separating second cutting edge of said first tooth from the cutting edge of a third tooth adjacent to said first tooth in a second direction opposite the first direction,
Wherein a third angle separating the cutting edge of said second tooth from the cutting edge of a fourth tooth adjacent to said second tooth in said first direction is equal to an equal spacing angle defined by a value of 360 degrees divided by the number of said plurality of teeth,
Wherein one flute of the flutes is disposed between two adjacent teeth which are spaced apart at an angle exceeding said equal spacing angle, the one flute being wider and deeper than another one of the flutes.”

Thus the claimed invention includes a shank portion, a cutting portion, flutes, a tooth, a cutting edge, and various spaced apart cutting elements having angles defined in the dependent claims which are fairly clear when read together with the figures shown below.

Milling toolThe basis of the Opposition was various patents, catalogues and Russian metalworking standards. The claims were considered as claiming more than the disclosure deserved and that they were insufficiently supported. The Opposers also claimed that the effective date of the Application should be post-dated to the date of the claim amendment and then the claims could be disqualified by the Applicant’s own prior art.

The cutting tools claimed were carbides and the Russian standards were for Stainless steel cutting tools. The Applicant considered the standards were therefore irrelevant.

RULING

The burden of proof in patent opposition procedures is initially on the Applicant, see 665/84 Sanofi vs. Unipharm ltd. and 645-06-13 Unipharm vs. lilly Icos 25 January 2014. The Opposer does have to bring evidence to support their challenge (see Il 143977 Astra Zeneca vs. Unipharm, but then the Applicant has to prove that the claims are patentable.

In this instance, the grounds of the Opposition are lack of novelty, lack of inventive step, and insufficient disclosure as required by Sections 4, 5 and 13 respectively.

Novelty

Section 4 defines the novelty requirement as follows.

  1. An invention is deemed new if it was not published, in Israel or abroad, before the application date—
    (1) by written, visual, audible or any other description, in a manner that enables a skilled person to make it according to the particulars of the description;
    (2) by exploitation or exhibition, in a manner that enables a skilled person to make it according to the particulars thus made known.

To cancel the Novelty of an Application a single piece of prior art has to fully describe the elements of the invention in a manner that enables persons of the art to make the invention. See Appeal 345/87 Hughes Aircraft vs. State of Israel p. d. 44(4) 45 (page 105 of the ruling).

The first rule is that to prove novelty destroying prior publication one has to identify a single document that describes the invention in its entirely and it is not sufficient to create a mosaic of different documents to create a general picture.

Hughes also states that:

A general description is insufficient to remove novelty if it is not enabling and does not provide enough signposts leading to the invention of the patent.

The requirement for showing the invention is explained in Appeal 4867/92 Sanitovsky vs. Tams ltd et al, p.d. 50(2), 509:

On one hand, the defense of a patent includes not just that described in the claims, but also the core of the invention [MF – what the British case-law refers to as the pith and marrow in a somewhat odd mixed metaphor] (section 49). On the other hand one can claim a lack of novelty when accused of infringement (section 4) not just when a piece of prior art describes all the elements of the invention, but also then the prior discloses the core of the invention.

The essence of the invention is that part that is central and essential to the workings of the invention in contradistinction to elements that can be substituted for or left out entirely. the main core will remain protected even if an essential element is switched for another that performs the identical function. 
Page 515-516.

See also See also Appeal 793/86 Michael Porat. vs. Z.M.L. Modern Medical Equipment, p.d. 44(4); 578 pages 583-584.

The Opposer considers that the claimed elements are described in the prior art. A brief summary of the art cited by the Opposers follow’s.

F10 is a “Drilling Groove Milling Cutter” that relates to a four-edged drilling groove milling cutter having end and peripheral cutting edges.”

F13 is titled “Roughing and Finishing Rotary Tool Apparatus and Method” and is described as follows:

“The rotary cutting tool of the present invention employs roughing and finishing blades on the same tool to produce roughing and finishing cuts in one cutting operation. The rotary cutting tool preferably has a roughing flute adjacent to each roughing blade and a finishing flute adjacent to each finishing blade. In highly preferred embodiments, the finishing flutes are smaller than the roughing flutes… The flutes are therefore preferably unequally spaced. In some highly preferred embodiments, the blades are unequally circumferentially spaced and are immediately behind the flutes. At least one finishing blade preferably extends radially farther than at least one roughing blade.”

Witness for the Applicant, Mr Hina admitted that element j of the application is mentioned in both F10 and F13:

Commissioner: … to the best of my understanding, we have just asked a very simple question, does F10  as translated into English in F10A show the 360 degree divided into sections, yes or no? If so, please refer to where it shown in this publication.

Mr Hina responded No.

Patent Attorney Luzzatto : you write that element j is not found in F13, correct?

Mr Hina: I repeat there is something not defined in the indices.

The test explained in Hughes Aircraft requires one publication to teach all elements. Since this is not the case, the claimed invention is novel.

Inventive Step

The second grounds for cancellation was a lack of inventive step contrary to Section 5 which states:

An inventive step is a step which does not, to an average skilled person, appear obvious in the light of information published before the application date in ways said in section 4.

Unlike Novelty which requires a single document to teach an invention, an Inventive Step can be disqualified by a number of citations that provide a picture of what was known at the Application date:

The basic question of inventive step is determined by considering the total professional knowledge in the relevant field, and to do so it is legitimate to join different publications into a general picture Appeal 3314/77 [1] page 209. However, one must always bear in mind that the joining together of the disparate documents must be obvious to persons of the art at the date in question; for if it requires an inventiveness to do so, particularly where scattered crumbs of knowledge are gathered together – the general picture obtained is not obvious and one cannot say that the patent has no inventive step.” –page 111.

See also Sanitovsky pages 515-516 and Appeal 793/86 Michael Porat vs. Tzamal Modern Medical Equipment, p.d. 44(4) 578, 585.

Thus unlike novelty where a single document is required to teach an invention, as far as Inventive Step is concerned, one can combine disparate documents so long as it would have been obvious to an average person of the art to do so.

Appeal 47/87 Hasam Reliable Defense Systems vs. Abraham Bahri, p.d. 45(5) 194 states that to show a lack of inventive step, one may cobble together different pieces of prior art.

The question of inventive step is determined by comparison to professional knowledge in the relevant field by combining disparate references without forgetting that their combination has to, itself, be obvious, so that if it requires an inventive step to combine the publications, particularly where disparate elements are collected from all over the place, the picture is not obvious and one cannot state that the invention lacks an inventive step. 

Thus one has to consider whether persons of the art would have a motivation to combine the publications at the relevant date. See Opposition to IL 138347 Sarin Technologies ltd. vs. Ugi Technologies, 14 January 2008.

The US case-law developed a thumb rule for inventive step by combining publications or known elements under which one has to consider the teaching, suggestion or motivation to make the combination (see Section 51 of the ruling).

Further on (paragraph 51):

The Board of Appeals of the European Patent Office takes an approach known as the “could/would approach” to consider if a combination includes an inventive step. A combination of known elements is not considered obvious merely because a person of the art could have combined them, unless he would have been motivated to combine them to achieve some advantage.

Mr Bulhov testified that when designing a new tool bit, persons of the art deal with two issues” judder and removal of the scrap. There is no dispute that cutting tools with different angles were known and that the angle separation could provide stability. Mr Bulhov testified admitted that prior to the filing date, milling at two different angles was known.

The first piece of prior art cited, which was a catalogue from 2003, shows that Applicants were marketing a four angled milling bit, where two of the angles were different.  The accompanying text stated “Chatter-free machining, avoids resonance vibration due to patent pending flute form design and constant, unequal flute spacing.”

Publications F18 and F19 are Russian standards titled “End Mills with Cylindrical Shank” and ” End Mills with Tapered Shank” respectively.

The Commissioner rejects Applicant’s claim that the standards merely recommend the invention but do not require it, since that is not sufficient to make the invention non-obvious, and establishes that the relevant features were known in the art. See Opposition to IL 166626 Teva Pharmaceuticals vs. Astra Zeneca LTD, 11 March 2017. https://blog.ipfactor.co.il/2017/04/20/patent-to-astrazeneca-successfully-opposed-by-teva/

F18 and F19 are Russian language documents that are difficult to date, but the most recent versions are 1996 which was 10 years before the filing date of the present invention. Although in Russian, the documents are directed to tool makers and are prior art in all respects Page 21 of F18 and page 4 of F18 states that “Mills shall be manufactured with non-uniform circumferential tooth pitch as shown in Fig. 3 and Table 3.”

Specific cutting angles are given for the various grooves.

The Applicant argues that since these specifications relate to high-speed steels and not carbides, they are not relevant. The Applicant considers that judder in carbides is a more serious problem. The Commissioner considers that the Applicant’s claim is weak as the claims and indeed the specification are not limited to carbides or indeed, to other specific materials. The Applicant has not explained why the choice of cutting tool material would lead to the assumption that the angles are different and the publications themselves, though directed to HSS do not teach away from other materials.

Thus element J is taught by F18 and F19 and persons of the art could be expected to combine this with other elements to reduce judder.

Publication F10

Publication 10 teaches a milling tool with two pairs of flutes, such that each pair of flutes has the same angle.  The Applicant alleges that this teaches against having three separate angles as claimed, and thus F10 cannot be combined with F18 and F19 and does not teach the claimed invention.

It appears that the invention described in F10 combines two properties: the cutting surfaces are of different lengths and the angles of the flutes. The invention claimed in F10 directs persons of the art to combine wide flutes with long cutting surfaces:

“Therefore, according to the invention, larger chip spaces are provided for the long cutting edges having the unfavorable chips than for the short cutting edges having the favorable chips… By the interaction of the two features, the invention provides the possibility of optimum coordination of cutting edge length and chip space on the drilling groove milling cutter.”

The large scraps created by the large cutting edges require large flutes. Thus flutes 10 and 11 in Figures 2 and 3 of F10 are larger than flute 12 and 13. Thus F10 teaches the additional element claimed:

“On account of their width, the chips produced by the main drilling cutting edges require larger chip grooves than the chips of the intermediate drilling cutting edges. For this reason, the pitches 10, 11, located in each case in front of the rake faces of the main drilling cutting edges, as far as the next intermediate drilling cutting edge are configured to be greater than the pitches 12, 13 in front of the rake faces of the intermediate drilling cutting edges.”

F133

A publication is considered as being prior art that may be combined with other publications if a person of the art would consider it obvious to do so. Citing R. Carl Moy, “Moy’s Walker on Patents”, 4th ed. 2009, p. 9-48 – 9-50 the Commissioner concludes that where the publications are trade publications in the field of interest one can assume that persons of the art would know about them, and the publication in question relates to milling tools with different sized flutes to minimize judder.

In light of the above, the Commissioner considers that the principles of reducing judder by different width flutes are known and together with F19 and F19, 4 and 5 fluted milling tools are known.

Furthermore, the dependent claims lack inventive step. These relate to difference cutting edge angles along the shank. Such variations are described in F13 and F13a and are referred to as unequal flute spacing. Thus the dependent claims are also not patentable. Claims 2and 4 claim standard ranges for the angles. Claim 4 claims different dimensions as described in F10 and claims 5 and 7 describe variations taught in F13 and F1a. Claim 8 relates to standard cutting edges.

Thus the Application lacks inventive step.

Adequate Disclosure

Section 13a of the Law states that:

the specifications shall end with a claim or claims that define the invention, on condition that each said claim reasonably arise out of the subject described in the specification.

This means that the claims define the scope of protection sought. The claims should be interpreted with respect to the specification taken as a whole, including the text and drawings. See Hughes 65.

In Appeal 8802/06 Unipharm vs. Smithkline Beecham from 18 May 2011 it is stated: that:

In accordance with Section 13 of the Patent Law, the protection of the invention is determined by the claims that define the invention, and not be the specification as understood in Section 12, which includes the title and description (see Hughes p. 68); however one can refer to the specification to explain the nature claims  (see Appeal 2972/95 Yosef Wolf and Partners, ltd. vs Beeri Press Limited Partnership,

A ‘Greedy’ claim is one that attempts to protect more than it discloses. The extent that this term can be used with reference to the requirements of Section 13(a) is given in Appeal 1008/58 American Cyanamid vs. Lepitit et al. page 261 from 4 April 1960. See also Opposition by Teva to IL 142809 to Pharmacia AB from 26 February 2015. .

The Opposer claims that claim 1 is greedy in that it has much wider scope than is supported by the specification. The Applicant disputes this and argues that following the voluntary amendment, flute B is defined as the longest and deepest flute:

“Wherein one flute of the flutes is disposed between two adjacent teeth which are spaced apart at an angle exceeding said equal spacing angle, the one flute being wider and deeper than another one of the flutes.”

Page 8 does state that flute B is deeper and wider than flute A

“The flute 32 relating to angle B is wider and deeper than the flute 34 relating to angle A, so as to improve coolant feed and facilitate chip clearance and removal when teeth work with higher feed per teeth compared to equal tooth space dividing (by angle A).”

The specification provides that the angle of flute B is large than the angle of flute A. Amended claim 1 requires that the angle of flute B is the largest angle. This is not supported in the specification which only compares flute B with flute A. So amended claim 1 is not fairly supported by the specification.

Conclusion

Claim 1 is not-inventive and also is not adequately supported. The Opposition is accepted and IL 177336 is rejected. Costs may be claimed in accordance with circular MN 80.

COMMENT

I accept that the claims encompass combinations of known elements to create a cutting tool that is new.  I also accept that unless one limits oneself to a specific tool design, the claims will always be wider than that demonstrated. My problem is that the type of features described are functional rather than aesthetic. At present, Israel design examiners consider functional features as non-patentable. We could even extend this and consider such cutting tool elements as replaceables and use public policy to restrict protection.  If, however, we wish to encourage research and development of better performing cutting tools, we should provide some sort of protection for them to prevent immediate copying. Israel does not have a petty patent system or protection for purely functional design. It seems to me, therefore, that combining elements from different publications for tool bits to create a novel bit, should be patentable. We could limit the protection to combinations described and maybe the claims are overly wide. Perhaps what is missing here is dependent claims for specific tried and tested drill bits.

By training, I am a materials scientist and engineer. My PhD research was in hard metals and coatings. I did not study milling and though I understand the purpose of the various elements, I am inclined to agree with the Commmissioner that there is a rebuttable assumption that a design element known for a HSS tool would not be appropriate for a carbide tool. However, carbides are much harder and hence more brittle. Optimizing a new tool is not intuitive and probably is the result of much experimentation, but I don’t know if the combination has an inventive step. Shamgar’s guidelines in Hughes Aircraft are fine and dandy, but one really needs experts on cutting and milling to determine whether the combination of known elements in a new product of this type does or does not include an inventive step.


Patent Application for Poultry Processing System Refused By Examiner is allowed by Deputy Commissioner

June 9, 2017

One of the nice things about the Israel patent system is that the Applicant has the right to appeal Examiner’s claim rejections to the Commissioner. The process is rather smoother, cheaper and faster than Appeals in Europe and the US.

Israel Patent Application Number IL 190482 to Ecolab Inc titled “SYSTEM AND METHOD FOR ON-SITE RECLAMATION, RECONDITIONING AND REAPPLICATION OF POULTRY PROCESSING WATER” is the national stage entry of a PCT application US/2006/038333 submitted in October 2006.

poultry processingThe invention relates to recycling water used for processing poultry and reusing for the same purpose. The first office action of 14 January 2013 found the Application non-patentable due to it lacking an inventive step over US 2005/0016934. The Applicant requested allowance under section 17c, based on the corresponding Australian issued patent no. AU 2006303885 that had issued in 2011. However the Examiner considered that the Applicant should deal substantively with the obviousness objection before the patent could be allowed.

On 8 December 2016, after five rounds of claim amendments, the Examiner finally refused the application under regulation 45 of the Patent Regulations 1968.

In the meantime, the corresponding Canadian patent, CA 2618436 issued with virtually identical claims. However the US patent application was refused, as was an Appeal to the PTAB, due to US 6,182,833 to Zittel, US 6,802,984 to Perkins and US 5,470,472 to Baird, none of which were cited in Israel.

The main claim is as follows:

“1. A treatment system for on-site reclamation, reconditioning, and re-use of poultry processing water, wherein said treatment system is connectable to a washing system, said treatment system comprising:
(a) an inlet line connected to a first receptacle within the washing system forcollecting said processing water leaving said washing system;
(b) a rotary filter, said filter retains solids greater than 0.001 to 0.010 inches, wherein the inlet line is connected to the rotary filter for filtering debris from the processing water collected in said first receptacle;
(c) a channel for removing said debris filtered from said rotary filter;
(d) a dispenser comprising equipment for preparing an antimicrobial solution, and a plurality of spray nozzles positioned proximate to said filter;
(e) a second receptacle for collecting water and antimicrobial solution from the rotary filter and from the dispenser, said second receptacle having a fluid capacity of 100 to 2000 gallons;
(f) piping for circulating said processing water through said washing system and said treatment system and for returning said processing water to said washing system; and,(g) a plurality of air operated diaphragm pumps for circulating the processing water through said piping;
wherein said dispenser is configured for dispensing antimicrobial solution and water onto said filter, and wherein the treatment system comprises only one disinfecting mechanism consisting of the dispenser as a source of antimicrobial solution and the rotary filter and second receptacle as receptacles of antimicrobial solution.”

The Examiner’s decision to reject the Application was based on the following reasons:

  • The application lacks inventive step over US 2005/0016934;
  • The Applicant failed to explain why the invention was an improvement over the prior art, especially US 2005/0016934, and did not provide data showing that it was more efficient. Consequently, the Examiner considered that adding the anti-microbial solution during or after filtering were equivalent and the differences were well understood to persons of the art.
  • Since over US 2005/0016934 shows a rotating filter with sprinklers, there is no technical problem to add ozone to the filter in addition to or instead of the oxidation described in over US 2005/0016934.

The Applicant responded by offering to add a further element to claim 1, thereby narrowing the scope of the patent and providing an inventive step.

The additional narrowing feature is as follows:

“(d) a dispenser comprising equipment for preparing an antimicrobial solution, and a plurality of spray nozzles positioned proximate to said filter, said dispenser spray nozzles configured for dispensing antimicrobial solution continuously onto the filter for 10-60 seconds every 5 minutes to 5 hours; ”

The Applicant similarly applied to amend independent claim 9 as follows:

“(e) dispensing an antimicrobial solution and water onto said filtering apparatus by means of dispenser comprising a plurality of spray nozzles positioned proximate to said rotary filter by spraying water onto said filtering apparatus for between 10 to 60 seconds every 5 minutes to 5 hours at a force of between 0.6 to 6 pounds-force when measured from 12 inches away from said filtering apparatus and constantly spraying said water at a force of between 0.1 to 0.5 pounds-force when measured from 12 inches away from said filtering apparatus, thereby removing the retained solids from said filter thus forming a waste stream and removing bacteria from reclaimed water;”

The Deputy Commissioner Ms Jacqueline Bracha considered this sixth claim amendment in a hearing on 24 April 2017.

Discussion

The claimed invention was considered novel, so the Examiner concentrated on inventive step over US 2005/0016934 as required by Section 5 of the Law.

Section 5 states:

Inventive Step is an improvement that is not considered self-evident to persons of the art based on publications preceding the Application date as per section 4.

Different approaches for determining inventive step are given in the ruling concerning IL 219732 to Celgene Corporation. According to both the US and the British approaches, one has to identify the prior art available to persons of the art, to identify the differences and to determine whether there is an inventive step that wasn’t known to persons of the art at the relevant date.

In 345/87  Hughes Aircraft Company vs. State f Israel p.d. 44(4) 45 (1990) paragraph 49 it was established that the inventive step does not need to be big.

The prior art relied upon by the Examiner is US 2005/0016934 which describes a system for recycling water after processing poultry by treating the used water to remove solids, fats, oils, and pathogens for reuse of the water in further poultry treatment.

The common elements are: two receptacles for collecting the water, one of which is for collecting the water after use in the washing system; sprinklers, filters for filtering waste from the water after use; a pipe for removing waste, a pump for circulating the water through the system, and a diaphragm pump operating on compressed air to cause the water flow.

There are, however, differences between the cited art and the claimed invention. The filter in the claimed invention rotates and is situated after the first receptacle, whereas that in the system described in US 2005/0016934 is upstream of the first receptacle so that the water is filtered before the anti-microbial solution is added.

The addition of the anti-microbial solution in the claimed invention is by sprinkling onto the rotating filter at an earlier stage that in the cited art wherein the anti-microbial solution is added after two filtration stages. Furthermore, in the system of the application, the anti-microbial solution is added in one stage, in the filter, so there is one disinfectant stage that occurs concurrently with the filtering. In contradistinction, in the cited art, there are two disinfectant stages, where ozone is first used, and then chlorine is added (see [0027] and [0030]. Introducing ozone into the system requires a second stage wherein the ozone acts on water in the receptacle to kill microorganisms in the water. The addition of chlorine is actually optional and it is introduced at different stages not detailed in US 2005/0016934.

The claimed invention includes a dividing system with sprinklers that includes equipment for preparing the antimicrobial solution and sprinklers for its introduction into the filters such that water without the antimicrobial material is continuously sprinkled whereas the water with the antimicrobial material is intermittently added as per the claims. In US 2005/0016934 the water flows continuously.

The Applicant claims that the differences between the claimed invention and the prior art are sufficient to provide an inventive step, since the early addition of the antimicrobial solution enables it to act continuously without needing to wait. Furthermore, in the claimed invention the filtering and sterilizing are combined, whereas in the cited art, the washing of the filter is only intended to remove waste.

The Applicant argued that the long period in which the antimicrobial solution is in the system allows a weaker antimicrobial system than that required in the cited art.

RULING

The Deputy Commissioner considers that the differences between the cited art and the claimed invention require persons of the art to apply an inventive step. At least the Examiner failed to cite similar features found in related systems that are required to substantiate the allegation of lack of inventive step.

The Deputy Commissioner disagrees with one allegation of the Examiner; that the Applicant failed to explain the advantages of the claimed invention over the prior art. The Deputy Commissioner does not consider that the Applicant has to provide external evidence that the invention is superior to the prior art. The advantageous feature(s) have to appear in the specification at the time of filing so that the Applicant does not invent during Examination. Furthermore, a different system that is not necessarily superior, but which operates in a different manner may be patentable, if the differences are not obvious to persons of the art.

In light of the above, IL 190482 is allowed for publication for third-party opposition.

COMMENT

The Deputy Commissioner notes that the Israel Law refers to an inventive step and then explains that a non-obvious difference that is not necessarily advantageous is all that is required.

To my mind, the US law requires the claimed invention to be non-obvious, whereas the UK and EP approach requires an inventive step. The wherein clause in the US points out a non-obvious feature, and the characterized by clause in Europe points to an inventive step. The two requirements are not the same.

That as may be, the US board of appeal rejected the invention in light of specific art. I think that for purposes of efficiency, the Deputy Commissioner should have referred the application back to the Examiner to consider that art in light with Israel law since one assumes that oppositions or cancellation proceedings will raise the issues found persuasive in the US. Then again, perhaps it is better for the Commissioner or a judge to consider such issues.


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 »


Patent to Astrazeneca  Successfully Opposed by Teva

April 20, 2017

Rosuvastatin_structure.svgRosuvastatin is a member of the statin class of drugs that is used in combination with exercise, diet, and weight-loss to treat high cholesterol and related conditions, and to prevent cardiovascular disease.

Israel Patent IL 166626 to Astrazeneca is the National Phase of PCT/GB2003/003463 filed in August 2003 and titled ” Process for preparing the calcium salt of rosuvastatin 

The Application was allowed and published for opposition in September 20011 and Teva filed an Opposition. A hearing was held in July 2015, and by June 2016 both sides had finished submitting their summaries and counter summaries.

The patent covers a process for obtaining (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid calcium salt. The application included 27 claims of which the first, independent claim is as follows: Read the rest of this entry »


Unipharm Successfully Opposes Novartis Patent for Panobinostat Lactate Salts

March 26, 2017

PanobinostatThis ruling relates to an opposition against a patent application by Novartis for Panobinostat  which is a hydroxamic acid  that acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor).  On 23 February 2015 the drug received FDA accelerated approval for use in patients with multiple malignancies, and on 28 August 2015 it was approved by the European Medicines Agency for the same use.

The Opposer claimed that the drug was described in the Applicant’s earlier published PCT application and was thus both anticipated (known) and obvious. The Commissioner rejected the anticipation claim but accepted that in light of the earlier publication, it was obvious and lacked an inventive step.

Due to the ruling being rather interesting but only available in Hebrew, and since these Israeli rulings can and do have an effect on validity of corresponding patents elsewhere, I have translated the decision in full. At the end I have made some general comments.

Background

NovartisNovartis AG filed Israel Patent Application Number 195087 titled “ANHYDROUS LACTATE SALTS OF ANHYDROXY-3-[4-[[[2-(2-METHYL-1HINDOL-3 YL)ETHYL]AMINO]METHYL] PHENYL] – 2E-2-PROPENAMIDE AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME” as a national phase of PCT/US2007/070558 that was filed on 7 June 2006 and claims priority from US 60/804523 and US 60/869993, two US provisional patent applications filed in June and December 2006 respectively. The Israel national phase entry was submitted on 3 November 2008 and, on allowance, published for opposition purposes on 31 October 2012.

UnipharmUnipharm opposed the application on 3 January 2013. Subsequently, on 26 June 2013, Novartis requested to correct the application and, since neither Unipharm nor anyone else opposed this, the application was corrected and this ruling concerns an opposition to the amended application.

The parties submitted their claims and evidence and a hearing was held Read the rest of this entry »


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.


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.