Post-filing recognition of a drug compound’s unexpected property may not be sufficient to establish the compound’s nonobviousness.

Cindy Chen | July 24, 2014

Bristol-Myers Squibb Company v. Teva Pharmaceuticals USA, Inc.

June 12, 2014

Summary

The Federal Circuit found that a patent claim directed to a drug compound for treating hepatitis B was invalid as an obvious modification to a structurally similar lead compound. In so finding, the Federal Circuit dismissed evidence of later discovery, after the time of invention, that the lead compound was highly toxic and therapeutically useless. The Federal Circuit then determined that evidence of the drug compound’s later-discovered unexpected lack of toxicity was insufficient to prove nonobviousness, despite additional evidence demonstrating the drug compound’s unexpectedly high potency and unexpectedly high barrier to resistance. The Federal Circuit’s decision may have taken some bite out of the court’s precedents that an invention’s properties and advantagesneed not be fully known as of the filing date of the patent application to be relevant to nonobviousness.


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Not All Secondary Considerations are Probative of Nonobviousness

Lee Wright | July 23, 2014

Galderma Labs v. Tolmar, Inc.

December 11, 2013

Before NEWMAN, BRYSON, and PROST, Circuit Judges. Opinion for the court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit Judge NEWMAN.

SUMMARY

This Hatch-Waxman case is based on Tolmar’s filing of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic drug (Differin® Gel,0.3%), which is a topical medication containing 0.3% by weight adapalene approved for the treatment of acne.


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CAFC reminds applicants to be wary of functionally defined genus claims

Linda Shapiro | July 22, 2014

AbbVie Deutschland GMBH & CO., KG et al., v. Janssen Biotech, Inc.

July 1, 2014

Panel:  Lourie, O’Malley, and Chen. Opinion by Lourie. Concurring opinion by O’Malley.

Summary

 Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date.


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KSR does not do away with the requirement that the Patent Office provide documentary evidence to show that structural elements of a claim were known in the art

Rob Raheja | July 22, 2014

K/S HIMPP v. Hear-Wear Technologies, LLC

May 27, 2014

Panel: Lourie, Dyk and Wallach. Opinion by Lourie. Dissent by Dyk.

Summary

The Federal Circuit found that the Board of Patent Appeals and Interferences (“Board”) and the Examiner did not err during an inter partes reexamination of U.S. Patent No. 7,016,512 in refusing to accept a conclusory assertion from the third party requester that particular structural elements of claims 3 and 9 were known prior art elements in the absence of documentary evidence on the record because an assessment of basic knowledge and common sense as a replacement for documentary evidence for core factual findings lacks substantial evidence support. The Federal Circuit also found that the decision of the Board was not contrary to the holding in KSR.

Details

This is an appeal from a decision of the Board in an inter partes reexamination affirming the reexamination Examiner’s decision not to reject claims 3 and 9 of U.S. Patent No. 7,016,512 (“’512 patent”) as obvious.

Claims 3 and 9 recite:

3. The at least partially in-the-canal module for a hearing aid of claim 2 wherein said insulated wiring portion is terminated by a plurality of prongs that provide a detachable mechanical and electrical connection to an audio processing module.

9. The hearing aid of claim 8 wherein said insulated wiring portion is terminated by a plurality of prongs that provide a detachable mechanical and electrical connection to said behind-the-ear module.

Hear-Wear is owner of the ’512 patent. During prosecution of the application, the Examiner rejected claims 3 and 9 as obvious by concluding that “providing a plurality of prongs for the electrical connections or for the plugs is known in the art.” The Examiner did not take an Official Notice. Hear-Wear did not dispute the Examiner’s assertion of “known in the art”; instead, Hear-Wear amended independent claims and all claims were allowed.

The PTO granted a third party request by HIMPP for inter partes reexamination of the ’512 patent. In its request for the inter partes reexamination, HIMPP did not submit documentary evidence to show that the features of claims 3 and 9 were “known in the art.” Relying on the statement by the Examiner during the prosecution of the application, HIMPP argued that claims 3 and 9 would have been obvious because “such detachable connections were known at the time of the alleged invention as concluded by the Examiner during prosecution” and the modification of the primary reference to include detachable connections for a signal cable “would have been no more than the predictable use of prior art elements according to their established functions.”

The reexamination Examiner did not agree with HIMPP’s position because HIMPP failed to provide documentary evidence in support of their position.  The Examiner maintained the patentability of claims 3 and 9. Hear-Wear appealed to the Board. The Board also disagreed with the  HIMPP position that the limitations of claims 3 and 9 were “well known” as HIMPP failed to point “to any portion of the record  for underlying factual support for the assertion. The Board stated that it was ‘not persuaded that the record before [it] adequately conveys that the particular distinct connection structures set forth in those claims are disclosed.’”

“The Board also found that during the original prosecution the Examiner never took official notice with respect to the ‘plurality of prongs’ feature of claims 3 and 9, and that there was no further indication that Hear-Wear acquiesced to the alleged position of official notice so as to qualify the limitations of the claims as admitted prior art.” Accordingly, the Board affirmed the Examiner. HIMPP timely appealed to the Federal Circuit.

The issue on appeal was whether the Board’s refusal to accept a conclusory assertion from HIMPP that particular structural elements of claims 3 and 9 were known prior art elements in the absence of documentary evidence on the record was contrary to the holding in KSR.

In KSR International Co. v. Teleflex Inc., “the Supreme Court criticized a rigid approach to determining obviousness based on the disclosures of individual prior art references that were already on the record, with little recourse to the knowledge, creativity, and common sense that an ordinarily skilled artisan would have brought to bear when considering combinations or modifications.”

The majority found that KSR was distinguishable from the instant case because the instant “case involves the lack of evidence of a specific claim limitation, whereas KSR related to the combinability of references where the claim limitations were in evidence.”

In view of the majority’s interpretation of the KSR, the majority found that “[t]he Board’s decision was correct because an assessment of basic knowledge and common sense as a replacement for documentary evidence for core factual findings lacks substantial evidence support.” Also, the majority found that “the Board’s holding is not inconsistent with KSR’s caution against the overemphasis on publications and patents for combining or modifying prior art that are already on the record.”

Also, the majority stated that the Board’s position is supported by the USPTO examination procedure as neither the Board nor the Examiner determined that the facts at issue met the standard justifying official notice.

“Although a patent examiner may rely on common knowledge to support a rejection, that is appropriate only in narrow circumstances. See M.P.E.P. § 2144.03 (“It would not be appropriate for the examiner to take official notice of facts without citing a prior art reference where the facts asserted to be well known are not capable of instant and unquestionable demonstration as being well-known.”)”

“If an examiner chooses to rely on personal knowledge to support the finding of what is known in the art, and the applicant adequately traverses that assertion, then the examiner must provide an affidavit or declaration setting forth specific factual statements and explanations to support that finding. 37 C.F.R. § 1.104(d)(2); M.P.E.P. § 2144.03(c).”

In the absence of any evidence on the record to support the HIMPP’s position that claims 3 and 9 were known prior art elements, the Federal Circuit affirmed the Board’s decision to refuse to adopt HIMPP’s obviousness contention.

In the dissent’s view the majority’s holding is inconsistent with the Supreme Court’s decision in KSR.  In the dissent’s view precluding the Patent Office from relying on their own common knowledge and common sense would significantly impair the agency’s ability to review applications adequately and undermines the purpose of the post-grant agency review.

Takeaway

As a general rule, the use of an Official Notice regarding structural elements to reject claims is improper. This is because the substantial evidence requires the Patent Office to provide a record that includes sufficient documentary evidence to enable judicial review; otherwise, as noted in this case by Judge Lourie, “‘basic knowledge” or ‘common sense’ as a replacement for documentary evidence for core factual findings in a determination of patentability” would “render the process of appellate review for substantial evidence on the record a meaningless exercise.” Notwithstanding, an Official Notice based on personal knowledge regarding structural features of a claim if not adequately traversed may render the noticed facts as admitted prior art. Therefore, always adequately traverse the Official Notice and ask the Examiner to produce documentary evidence or an affidavit. Also, in the absence of an Official Notice, the rejection based on the Examiner’s assertion that certain structural features are “know in the art” should also be traversed on the premise that a prima facie case is absent as necessary structural element is not shown.

Full Opinion

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