Product-by-Process Claim: The Focus is On the Product and Not the Process of Making It

Attorney: Marina I. Miller, Ph.D.
September 6, 2022

Kamstrup A/S appealed a final written decision of the Patent Trial and Appeal Board (“the Board”). The Board found claims 1–15 of Kamstrup’s U.S. Patent No. 8,806,957 unpatentable as obvious or anticipated. On appeal, Kamstrup challenged the Board’s claim constructions. In addition, Kamstrup challenged the Board’s anticipation and obviousness determinations largely on the basis that the Board erred in rejecting Kamstrup’s claim construction arguments.<... Read more

Federal Circuit Revisits Assignor Estoppel

Attorney: Richard D. Kelly
August 18, 2022

On August 11, 2022, the Federal Circuit issued its opinion in the remand of Hologic, Inc. v Minerva Surgical, Inc. from the Supreme Court’s decision limiting the application of assignor estoppel to where the assignor is taking in litigation a position inconsistent with his prior representations in assigning the patent. In this case the issue was whether the issued claims are materially broader than the claims in the assigned application, Minerva Surgical, Inc. v. Hologic, Inc., 141 S. Ct. 2298, 2302, 2309 (2021). The Supreme Court in Minerva refused to discard the concept of assignor estoppel but instead held that the concept comes with limits and “reaches only as far as the equitable principle long understood to lie at its core.” The Supreme Court held that assignor estoppel “applies only when an inventor says one thing (explicitly or implicitly) in assigning a patent and the opposite in litigating against the patent’s owner.” Id. at 2304. Stated differently, where the assignor has not any explicit or implicit representations which conflict with an invalidity defense.<... Read more

Does Claim Construction For Patent Opinions Now Require a Crystal Ball? (Pavo Solutions, Part III)

August 16, 2022

In my first post about Pavo Solutions v. Kingston Technology a few weeks ago, I noted that the Federal Circuit rewrote claim language in the asserted patent by changing the claim element "for pivoting" from case to cover. The claim element in question read as follows:<... Read more

Bio/Pharma IPRs: Will Institution Rates Rise in Response to USPTO Initiatives?

Attorneys: Richard D. Kelly and Elissa Sanford
August 12, 2022

When it comes to IPR petitions filed in the Bio/Pharma space, USPTO data tells us that while Bio/Pharma petitions make up only 8% of the total petitions filed for the fiscal year of 2022 (through June 30, 2022), there is a high intuition rate for those Bio/Pharma petitions. According to USPTO statistics, 80% of the Bio/Pharma cases have been instituted so far this year.  Put differently, 59 of the 74 petitions reviewed were subsequently granted.<... Read more

Teva Files Certiorari Petition in "Skinny" Label Case

Attorney: Richard D. Kelly
August 9, 2022

On July 11, Teva filed its petition for certiorari from the Federal Circuit’s second decision in its “skinny label” litigation with GSK, 7 F.4th 1320 (Fed, Cir. 2022). The petition makes many of the same arguments that Teva made before the Federal Circuit but the inconsistency of the Federal Circuit’s decision in GSK with three prior decisions standout. Its yet another example of the Federal Circuit’s lack of discipline in following its own precedent. While Teva rightly complains that the decision creates uncertainty around the skinny label provisions of 21 U.S.C. § 355(j)(2)(A)(viii), the real uncertainty is created by the Federal Circuit’s unfortunate habit of ignoring its own precedent upon which parties rely in making decisions.<... Read more

Sure, A Court Can Rewrite Patent Claims. But Can It Change A Disclosure? (Pavo Solutions, Part II)

August 8, 2022

After discussing a court’s ability to rewrite patent claim language in view of the Federal Circuit’s decision in Pavo Solutions v. Kingston Technology (Pavo Solutions, Part I), my post last week noted that there was more to the story, including the issue of whether a court could rewrite a patent’s disclosure. Here are a few thoughts on that issue.<... Read more

Can A Court Rewrite Claim Language During Claim Construction? If You Don't Ask For It, You'll Never Know (Pavo Solutions, Part I)

August 3, 2022

In Pavo Solutions v. Kingston Technology (June 2022), the Federal Circuit rewrote claim language in the asserted patent by changing the claim element "for pivoting" from case to cover. The claim element in question read as follows:<... Read more

Obviousness Must Consider Function / Intended Use of Prior Art Device

Attorney: Derek Lightner, Ph.D.
August 2, 2022

On July 22, 2022, the Patent Trial and Appeal Board (PTAB) reversed an examiner’s assertion of obviousness in the case of Ex parte Jaeger (Appeal 2021-002641, USSN 15/559,117). The issue in Jaeger was whether the addition of known element to a prior art device was obvious where the combination was not consistent the purpose / operation of the prior art device.<... Read more

Cardex – Patent Eligibility – It's The Claims That Matter

Attorney: Richard D. Kelly
July 25, 2022

On July 18 the Federal Circuit in Cardex, Inc. v. Eurofins Viracor, Inc., affirmed the district court decision finding that diagnostic method claims directed to detecting organ transplant rejections in U.S.P.s 8,703,652 (‘652), 9,845,497 (‘497), and 10,329,607 (‘607) were not patent eligible. The following claim from ‘652 is representative of the claims on appeal, emphasis in the decision:<... Read more

FDA Stays Juul Ban, Announces Plan To Implement New Policies

Attorney: Elissa Sanford
July 7, 2022

On June 23, 2022, the FDA banned the sale of Juul’s tobacco-and menthol-flavored products. The agency’s reasoning was that Juul’s applications did not have sufficient toxicological evidence to support the marketing of the products as appropriate for protecting public health.  Juul has long since been on the FDA’s radar for past marketing practices including the marketing of their now-discontinued fruit or candy-like flavors, which were viewed as appealing to minors.  The company secured an emergency stay on June 24, asserting that the FDA did not fully consider its 125,000 page application which purportedly contained studies showing how the products expose users to lower levels of harmful toxins as compared to conventional cigarettes.  Juul also cited political pressure as the FDA’s motivation due to an “inappropriate” level of interference from Congress.<... Read more