{4 minutes to read}  In a recent case, the Federal Circuit upheld the USPTO’s interpretation of the Patent Term Adjustment (PTA) statute that limits the availability of PTA for time spent appealing an Examiner’s rejections only. 

The portion of the PTA statute at issue says:

[I]  the issue of an original patent is delayed due to . . .

(iii) Appellate review by the Patent Trial and Appeal Board or by a Federal court in a case in which the patent was issued under a decision under review reversing an adverse determination of patentability, the term of the patent shall be extended 1 day for each day of the pendency of the proceeding, order, or review, as the case may be.

PTA for this type of delay is referred to as “Type C” PTA.

The Courts analyzed two issued patents. The District Court held that the “…unambiguous language imposes two requirements: that an adverse determination of patentability be reversed, and that the application reviewed in that appeal issues as a patent as a result of that reversal.” Applying this interpretation to the prosecution history of the patents at issue, the district court held that no Type C PTA was due.

The Federal Circuit generally agreed with the District Court’s interpretation of the PTA statute as being in accordance with its “unambiguous language.” Thus, the Federal Circuit only reviewed the record to assess whether the “two requirements” for Type C delay were met:

1. Was an adverse determination of patentability reversed?

2. Did the application issue a patent as a result of that reversal?

Concerning the first patent, the court acknowledged that the Board held one of the claims unpatentable, but for reasons different than those discussed by the examiner during prosecution. According to the Federal Circuit, what matters for Type C PTA is that “[t]he adverse determination of unpatentability remained before and after the appeal.”

The Federal Circuit also agreed with the District Court’s second reason for denying PTA — The statutory requirement was not met because the claim that was ultimately issued differed substantively from the claim under review.

Turning to the second patent, the Federal Circuit again rejected the plaintiff’s arguments and reiterated that the PTA statute requires reversal of “an adverse determination of patentability,” not just a reversal of individual rejection(s). Even though the District Court reversed the anticipation rejection of claim 1, the claim remained unpatentable after the appeal because of the pending obviousness-type double patenting rejection. Thus, the first prong of the Type C PTA test was not met.

The Federal Circuit also found the second patent to fail the second prong of the Type C PTA test, because “[t]he patent, as issued, did not include the claim as appealed.” Rather, as noted above, the plaintiff canceled the claim and obtained claims based on a different claim set.

According to this decision, for a Type C PTA to be available, it is not sufficient to obtain reversal of specific rejections; a claim that was unpatentable before the appeal must be patentable after the appeal, and the claim that ultimately grants must not differ substantively from the claim on appeal. This suggests that applicants should consider structuring their appeals such that reversal of the appealed rejections will result in the allowability of at least some claims.

Silvia Salvadori, PhD Salvadori Law Silvia@salvdorilaw.com

{3 minutes to read}  In a recent case, the Federal Circuit found that the claim language at issue was ambiguous, and relied on the prosecution history for claim construction without requiring the prosecution history to reveal a “clear and unmistakable disclaimer” of the plain meaning of the claims.

Claim 1 is representative of the claims of the case:

1. A method for enhancing the condition of unbroken skin of a mammal by reducing one or more of wrinkling, roughness, dryness, or laxity of the skin, without increasing dermal cell proliferation, the method comprising topically applying to the skin a composition consisting of a concentration of adenosine in an amount effective to enhance the condition of the skin without increasing dermal cell proliferation, wherein the adenosine concentration applied to the dermal cells is 10^-4 M to 10^-7 M.

The patent specification described human skin as a surface layer called “the epidermis” with a deeper layer called “the dermis.” Claim 1 described applying a composition to the skin surface topically, reaching a certain concentration in the dermal cells below the surface.

The Federal Circuit reviewed the claim construction de novo, and in this case noted that the relevant claim language was not plain on its face, but rather contained evident uncertainties that weighed against the plaintiff’s construction. On the other hand, the court found that the specification and prosecution history showed that the “wherein” clause should have been read to refer to the concentration of adenosine in the composition applied to the skin’s surface. According to the Federal Circuit, the specification described compositions having adenosine concentrations of 10^-4 M to 10^-7 M.

The specification did not describe specific numerical molar concentration figures … after penetration through the skin into the dermis, or a measurement of concentration as an amount of adenosine per unit of volume of dermal cells.

The last clause was added during prosecution based on a dependent claim.

The applicants distinguished the invention from prior art references “in which concentrations are measured before application to the skin, with no suggestion of a difference in the location of concentration measurement.”

The examiner’s reasons for allowance stated: The “[i]nstant claims are directed to a method of enhancing the condition of unbroken skin . . . where the method comprises administering adenosine, at a concentration of 10^-4 M to 10^-7 M, to the skin.”

Thus, the Federal Circuit concluded that the prosecution history required that the wherein clause’s reference to the recited concentrations being applied to the dermal cells be read as referring to concentrations of the composition applied to the skin’s surface.

In conclusion, if applicants have specific concerns about the examiner’s reasons for allowance, they should consider filing comments to clarify the record.

Silvia Salvadori, PhD Salvadori Law Silvia@salvdorilaw.com

{4 minutes to read}  To further support the acceleration of innovations in the fight against COVID-19, the United States Patent and Trademark Office (USPTO or Office) is extending the modified COVID-19 Prioritized Examination Pilot Program, which provides a prioritized examination of certain patent applications. Requests that comply with the pilot program’s requirements and are filed on or before December 31, 2022, will be accepted. The USPTO will evaluate whether to terminate or further extend the program during this extension period.

The COVID-19 Track One Notice indicated that an applicant may request a prioritized examination without payment of the prioritized examination fee and associated processing fee if:

1. The patent application’s claim(s) covered a product or process related to COVID-19.
2. The product or process was subject to an applicable Food and Drug Administration (FDA) approval for COVID-19 use, and 
3. The applicant met other requirements noted in the COVID-19 Track One Notice.

As of May 16, 2022, 261 patents had been issued from applications granted prioritized status under the pilot program. The average total pendency, from the filing date or later submission of a request for continued examination, to the issue date for those applications was 280 days. The shortest pendency from filing to issue date for those applications was 75 days.

The Third Extension Notice indicated that the pilot program would expire on June 30, 2022. In the current notice, the USPTO is further extending the pilot program by setting the expiration date as December 31, 2022. The Office will evaluate whether to terminate or further extend the program during this fourth extension period. If the USPTO determines that an additional extension of the pilot program is appropriate, the Agency will publish a subsequent notice to the public. 

COVID-19 Prioritized Examination Pilot Program Description:

• Applications must contain one or more claims to a product or process related to COVID-19.
• Such claimed product or process must be subject to an applicable Food and Drug Administration (FDA) approval for COVID-19 use.
• The request must include a certification that the applicant qualifies for either small or micro entity status and an executed Application Data Sheet (ADS) meeting the requirements of 37 CFR 1.53(f)(3)(i).
• Applicants must file a grantable request under this initiative using the USPTO patent electronic filing system (EFS-Web or Patent Center) if filing the request in a utility application.
• Applicants should use Pilot Program Form PTO/SB/450 to request participation in the pilot. 

The pilot is open to non-continuing, original, nonprovisional utility or plant patent applications filed with an acceptable request to participate original, nonprovisional utility or plant applications making a benefit claim under 35 U.S.C. 120, 121, or 365(c) to one prior nonprovisional application or one prior international application designating the United States filed with an acceptable request to participate utility or plant applications, including the national stage of a prior international application, in which an acceptable request to participate has been filed with or after a request for continued examination (RCE) if no prior RCE was granted prioritized examination status. 

The fees set forth in 37 CFR 1.17(c) and (i)(1) are not required to participate in the program. Any application that claims the benefit of the filing date of two or more previously filed non-provisional U.S. applications or international applications designating the United States under 35 U.S.C. 120, 121, or 365(c) is not eligible for participation in this pilot but the applicant may request prioritized examination under 37 CFR 1.102(e).

Benefit claims to one or more prior provisional applications under 35 U.S.C. 119(e) or foreign priority claims under 35 U.S.C. 119(a)-(d) or (f) will not cause a non-provisional application to be ineligible for this pilot.

Silvia Salvadori, PhD Salvadori Law Silvia@salvdorilaw.com

{1 minute to read} Inventors and small businesses that meet certain financial thresholds and other criteria may be eligible for free legal assistance in preparing and filing a patent application. The Patent Pro Bono Program is a nationwide network of independently operated regional programs that match volunteer patent professionals with financially under-resourced inventors and small businesses for the purpose of securing patent protection. Each regional program provides services for residents of one or more states.

Requirements

In general, the requirements are:

Income:

The inventors’ gross household income should be less than three times the federal poverty level guidelines, though some regional programs may have different criteria.

Knowledge

The inventors must demonstrate knowledge of the patent system in one of two ways:

• Having a provisional application already on file with the USPTO, or
• Successful completion of the certificate training course.

Invention

The inventors must be able to describe the particular features of their invention and how it works.

Each of the regional programs may have additional specific requirements for admission.

Silvia Salvadori, PhD Salvadori Law Silvia@salvdorilaw.com

{2 minutes to read}  In December of last year, the United States Patent and Trademark Office (USPTO) issued a notice of proposed rulemaking (NPRM) to seek public feedback on a proposal to revise the rules of practice for issuing patents electronically. Under the current rule (37 CFR 1.315), the USPTO is required to deliver or mail a patent “upon issuance to the correspondence address of record.” Under the proposed changes, the USPTO would no longer physically deliver the patent by mailing it but would issue the patent electronically via their patent document viewing systems (i.e., Patent Center and Patent Application Image Retrieval (PAIR)). Patentees would also be able to download and print their electronically issued patents through these systems.

Per guidance issued by the U.S. Department of State, the United States Patent and Trademark Office (USPTO) has terminated engagement with officials from Russia’s agency in charge of intellectual property, the Federal Service for Intellectual Property (commonly known as Rospatent), and with the Eurasian Patent Organization. The USPTO has also terminated engagement with officials from the national intellectual property office of Belarus.

On January 6, 2022, the United States Patent and Trademark Office (USPTO) announced a new pilot program: The Deferred Subject Matter Eligibility Response (DSMER). This pilot program is designed to evaluate how deferred applicant responses to subject matter eligibility (SME) rejections affect examination efficiency and patent quality as compared to traditional compact prosecution practice.

In a recent case, the Federal Circuit reversed the USPTO Patent Trial and Appeal Board (PTAB) decision finding certain method claims obvious, because the evidence did not support the PTAB’s finding that a person of ordinary skill in the art would have had a reasonable expectation of success. Notably, the court instead found the prior art to report failure.

In a recent case, Eli Lilly and Co. v. Teva Pharmaceuticals International GmbH, the Federal Circuit upheld the validity of Teva’s patents directed to specific methods of treatment using an “effective amount” of certain antibodies. The court agreed with the Patent Trial and Appeal Board (PTAB) that the claim preambles were limiting, and that obviousness required proof of a reasonable expectation of success in achieving the recited purpose.

In a recent case, Omni MedSci, Inc. v. Apple Inc., the Federal Circuit held that the language the inventor agreed to via his employment agreement “did not effectuate a present automatic assignment of [his] patent rights.”

The following are the facts of this case.