PGR Challenge to Genus Claims Fails Because of Enabling Disclosure of Species in Pre-AIA Priority Applications

Mar 15, 2022

Reading Time : 3 min

The challenged claims were methods of improving human endurance during exercise. The claims included the step of administering an amount of an inorganic nitrate from a specified range that was based on body weight. The petitioner did not dispute that the PCT applications disclosed the claimed range, rather, even with the disclosures, a skilled artisan would have to perform undue experimentation to practice the full scope of the claims. The petitioner argued that the upper end of the range encompassed lethal doses of the inorganic nitrate, as shown on a webpage archived by the Wayback Machine. The petitioner also argued that the only working example in the PCT applications was a much lower dose of nitrate, which could only show hope, but not support, for the higher range. The petitioner supported its arguments with expert testimony. The petitioner also challenged the dependent claims for lack of written description of various elements.

The PTAB first found that the archived webpage was inadmissible because it had not been authenticated. The PTAB explained that the petitioner could have verified the webpage as a business record under FRE 901(b)(1), further noting that other evidence had been authenticated by a declarant. But even though the webpage itself was inadmissible, the PTAB explained that the petitioner’s expert could rely on the webpage to form an opinion.

Turning to whether the priority applications were enabling under the Wands factors, the PTAB found the petitioner’s expert’s evidence unpersuasive. First, the working example of the challenged patent disclosed a dose that was tested and that, contrary to petitioner expert’s opinion, was not lethal. Second, the PTAB distinguished the challenged patent from the patent at issue in Amgen, Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021). In Amgen, the court found that undue experimentation was required because there were too few examples of antibodies compared with the scope of the large genus claims and amount of effort required to find all of the antibodies. By contrast, the challenged patent’s disclosure allowed the skilled artisan to practice the claims by “simply administer[ing] a different dosage to the human.” Moreover, the challenged patent explained that the particular condition that is the source of the lethality associated with nitrates does not result from the claimed method. Because the petitioner’s expert failed to address this discrepancy, the expert’s testimony was of little probative value.

Finally, the PTAB considered the petitioner’s written description arguments. The PTAB found that a skilled artisan would not have understood the inventors to lack possession of the inventions of the dependent claims. The limitation requiring that the dose be given “at least three days prior to exercise” was supported by the example in which a dose was given more than three days prior to exercise. Similarly, a limitation requiring administration “once a day” was supported by the disclosures of dosing ranges using units in the form “mmol/kg/24h” and administering “single bolus doses.” And the limitation requiring a combination of the nitrate and “at least one additive” had support from disclosures in the priority applications of using the nitrates with antimicrobials, pH stabilizers, flavors, sweeteners, colors, and emulsifiers.

The PTAB concluded that, on the record before it, the petitioner had not met its burden of showing that any of the claims failed to trace priority to an application filed before March 16, 2013. Thus, the challenged patent was ineligible for PGR, and the petition was denied.

Practice tip:

PGR is not available if the challenged claims trace priority to an application filed before March 16, 2013. It is petitioner’s burden to provide sufficient evidence to meet this threshold issue. Because this critical requirement for PGR eligibility often relies on expert testimony, a petitioner should scrutinize its written description and enablement arguments, as well as the supporting expert testimony. Conversely, a patent owner seeking denial of institution should review carefully petitioner’s arguments and supporting evidence, and challenge any identified weaknesses pre-institution.

Human Power of N Company v. Heartbeet Ltd., PGR2021-00110, Paper 7 (PTAB Feb. 25, 2022)

Share This Insight

Previous Entries

IP Newsflash

May 30, 2025

A district court recently dismissed a patent infringement complaint for improper venue under 28 U.S.C. § 1400(b), finding that the storage and distribution of products from an Amazon warehouse was not sufficient to establish that warehouse as a regular and established place of business in the district.

...

Read More

IP Newsflash

May 27, 2025

The Federal Circuit affirmed a District of Delaware finding of non-infringement in an ANDA litigation due to the patentee’s clear and unmistakable disavowal of claim scope during prosecution. Specifically, the court held that statements made during prosecution of a parent application before the asserted claims were allowed amounted to a prosecution disclaimer that extended to subsequent patents in the family. In reaching this conclusion, the court rejected an attempt by the patentee to resurrect the claim scope through a unilateral, self-serving statement made in later applications in the family.

...

Read More

IP Newsflash

May 13, 2025

The Federal Circuit recently affirmed a district court’s holding that patent term extension (PTE) for a reissued patent was properly based on the issue date of the original patent and not that of the reissued patent. The Federal Circuit concluded that, where both the original and reissued patents claimed a drug product under regulatory review, using the issue date of the original patent to calculate PTE comports with both the purpose of the Hatch-Waxman Act and the related statutory context.

...

Read More

IP Newsflash

May 12, 2025

The Patent Trial and Appeal Board recently declined to institute a petition for IPR that was filed on the same day that the petitioner filed another petition challenging the same claims of the same patent. The board was not persuaded by petitioner’s arguments that a second petition was needed due to alleged claim construction issues or the number, length or scope differences of the challenged claims.

...

Read More

IP Newsflash

May 9, 2025

The USPTO Director vacated the board’s decision to institute inter partes review based on an erroneous application of the Fintiv factors. Specifically, the Director found that the board placed too much emphasis on Petitioner’s Sotera stipulation, and not enough emphasis on the investment in the parallel litigation. Weighing the factors as a whole, the Director determined that institution should be denied.

...

Read More

IP Newsflash

May 9, 2025

In an institution decision following the USPTO’s withdrawal of its Fintiv Memo, the board addressed discretionary denial of an IPR under Fintiv in view of a parallel ITC investigation. The board noted it would not consider the now-rescinded June 2022 memo from then-director Vidal which instructed that the PTAB would not deny institution of an IPR or PGR under Fintiv when the request is based on a parallel ITC investigation. The board conducted a Fintiv analysis in view of the ITC investigation, but ultimately determined that discretionary denial was not warranted in this particular situation.

...

Read More

IP Newsflash

April 23, 2025

The Federal Circuit recently refused to apply collateral estoppel to claims of a patent asserted in district court litigation based on a Patent Trial and Appeal Board (PTAB) decision finding similar claims from the same patent unpatentable because the PTAB applied a lower burden of proof than what is required to invalidate claims in district court.

...

Read More

IP Newsflash

April 7, 2025

The Central District of California denied a defendant’s motion to dismiss or transfer plaintiff’s first-filed declaratory judgment action based on defendant’s later-filed patent infringement suit in Wisconsin.  Though suit was seemingly imminent when defendant advised plaintiff it might be infringing defendant’s patents, plaintiff responded by requesting a licensing agreement in lieu of litigation. The court found that plaintiff’s action was not anticipatory forum-shopping litigation because plaintiff only filed suit after defendant neglected to respond to its licensing offer.

...

Read More

© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.