Posts Tagged: "patent claims"

Patenting Antibodies: Written Description Considerations in Antibody Patents

The Amgen v. Sanofi decision put most functional antibody claims into question, including epitope and competitive binding claims, as well as antibody claims based on a newly characterized antigen. After Amgen v. Sanofi, non-sequence based antibody claims may become more difficult to obtain before the USPTO from a written description standpoint.  Yet, to fully protect the essence of the invention and avoid design-arounds, such claims are extremely valuable to patent owners. To obtain antibody genus claims beyond those defined by sequences, the patent applicant will need to make and test a sufficient number of representative antibodies across the claimed genus, or establish a clear structure/function relationship among the members of the genus.  Patent applicants should carefully assess the amount of data they have acquired, in comparison to the scope of claims that they wish to obtain, before rushing to the Patent Office.

USPTO Issues Guidance on Effects of Supreme Court’s Decision in SAS Institute on PTAB Trials

On Thursday, April 26th, the U.S. Patent and Trademark Office issued new guidance regarding the effects of the U.S. Supreme Court’s judgment in SAS Institute Inc. on America Invents Act (AIA) trial proceedings held before the Patent Trial and Appeal Board (PTAB). Along with the new guidance, the USPTO also announced a webinar with PTAB Chief Judge David Ruschke taking…

The CAFC Split Non-precedential Decision in Exergen v. Kaz Raises Interesting Issues About Eligibility Determinations

In Exergen Corporation v. Kaz USA, No. 16-2315 (March 8, 2018), the Federal Circuit, in a split non-precedential opinion, affirmed a holding that Exergen’s claims directed to methods and apparatuses for detecting core body temperature were directed to patentable subject matter under 35 U.S.C. § 101… The majority held that the district court did not clearly err in finding that it was unconventional to use temperature scanning technology to measure arterial temperature beneath the skin… Judge Hughes dissented, arguing that the majority erred by relying on the natural law in determining inventiveness at step two… Judge Hughes seems to suggest that the correct step-two inquiry should be whether, assuming the natural phenomenon were known, it would have been conventional to combine that phenomenon with existing technology to practice the asserted claims.

Reasonable Expectation of Success to the Rescue

In the last several months, lack of a reasonable expectation of success was a major factor in the reversal of two obviousness rulings by the Federal Circuit. One originated from the Patent Trial and Appeals Board (“Board”) (In Re Stepan Company, Aug. 25, 2017) (“In re Stepan”) and the other from a district court Genzyme Corporation v. Dr. Reddy’s Lab., Dec. 18, 2017, (“Genzyme”). In re Stepan emphasizes that reasonable expectation of success requires a motivation to do more than simply vary all parameters or try all possible choices until success is achieved. In Genzyme, the Court explained that a hypothesis presented in passing in a reference, without more, is not enough for an ordinarily skilled person to have a reasonable expectation of success. While In re Stepan has relevance for patent applicants facing conclusory obviousness rejections, Genzyme is cautionary for patent challengers banking too heavily on isolated, unsupported statements as a basis for obviousness.

Patenting Antibodies: Obviousness Considerations

This article analyzes obviousness issues related to antibody patents at the Patent Trials and Appeal Board (PTAB) and in federal courts. We review several cases categorized by type of claims in search of trends on what types of antibody-related claims are more likely to survive an obviousness challenge… These cases are highly fact-specific, but a few broad observations may be made. To our knowledge, no claims directed to an antibody claimed purely by structure have been challenged, except for those of an ADC (KADCYLA®), where both the antibody part and the drug part of the conjugate were previously known. An antibody broadly claimed by function may be considered obvious “[i]f any one method of achieving any single embodiment [of such claim] would have caused a person of ordinary skill in the art to anticipate success.” Abbott GMBH, 971 F. Supp.2d at 186. Objective indicia of nonobviousness have been helpful, but only where there was a clear nexus between the objective evidence and the claims.