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

 

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.

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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 A negotiated settlement was reached on 5 July 2011, under which the infringement suit would be withdrawn and Dr Ephraim Kfir and Miambi LTD would request cancellation of the patent.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.

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