Posts Tagged: "patent claims"

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.

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…

In Exergen Corporation v. Kaz USA, No. 16-2315 (March 8, 2018), the Federal Circuit, in a split non-precedential opinion, affirmed a holding that Exergen’s claims directed to methods and apparatuses for detecting core body temperature were directed to patentable subject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.

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.

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.

Unlike the Board’s anticipation determinations, which contravened the only permissible findings that could be drawn from the prior art under the proper constructions of the relevant claim terms, the obviousness determinations involved “potentially lawful but insufficiently or inappropriately explained” factual findings. In re Van Os, 844 F.3d 1359, 1362 (Fed. Cir. 2017). The Board failed to explain its reasoning to allow the Court to determine whether its findings would be lawful. When faced with similarly deficient factual findings, the Court has “consistently vacated and remanded for further proceedings.” Id. Consequently, the Court vacated the Board’s obviousness rejections with respect to claims 1-3, 5-8, and 21, and remanded for further factual findings and explanation on this issue.

The Federal Circuit reiterated that the on-sale bar does not exempt commercial agreements between a patentee and its supplier or distributor. It is the commercial character of the transaction that is more relevant than the parties involved when assessing whether there was a commercial offer for sale.

The central issue before the Federal Circuit was whether there was a genuine issue of material fact that TSA’s performance of those steps could be attributed to Travel Sentry, such that Travel Sentry could be held singularly responsible for directly infringing Tropp’s method claims. Slip Op. at 13. The district court had answered this question in the negative… The Federal Circuit rejected the district court’s interpretation of divided infringement as too narrow and, accordingly, vacated its summary judgment of non-infringement.

Based on the governing Federal Circuit case law, where the patent claim at issue is directed to a specific component (such as a specific enantiomer) of a prior art mixture (such as a racemic drug material), it does not appear that there is anything to be gained by a patent challenger, from an anticipation standpoint, simply by virtue of the fact that the specific component inherently exists within that prior art mixture/composition. In other words, while a claim to such an isolated component may potentially be vulnerable to an anticipation attack, the anticipatory reference needs to specifically identify and characterize the component, and must teach how to isolate the component. Absent this sort of “slam dunk” scenario, a patent challenger’s success is likely to rise or fall with the merits of its obviousness argument(s). The critical factors in the obviousness analysis will likely be whether the claimed component was known to be responsible for the activity of the prior art mixture/composition; whether the process used to isolate the claimed component was challenging, or better yet still from the patentee’s perspective, whether the process was inventive; whether the prior art as a whole would have enabled one of ordinary skill in the art to isolate the claimed component; and whether the claimed component exhibits any unexpectedly superior properties relative to the prior art mixture/composition.

The Federal Circuit heard the case of Microsoft Corp. v. Biscotti, Inc. After Biscotti, Inc. (“Biscotti”) sued Microsoft Corp. (“Microsoft”) for patent infringement, Microsoft filed three unsuccessful inter partes reviews (“IPR”) challenging certain claims of U.S. Patent No. 8,144,182 (“the ‘182 patent”) as anticipated or obvious. The ‘182 patent relates to tools and techniques for providing video calling solutions. The IPRs focused on independent claims 6 and 69, and their dependent claims. On appeal Microsoft challenged the Board’s standard of review… The Federal Circuit reiterated that anticipation is a question of fact subject to substantial evidence review, that ultimate claim construction and claim construction relying solely on intrinsic evidence is subject to de novo review, and subsidiary factual findings based on extrinsic evidence are reviewed for substantial evidence.

When a rule becomes a target, it ceases to be a good rule.  In the three years since the Supreme Court issued its opinion in Alice, there have been positive changes to patent applications, but there remains a long-term risk that patent practitioners will use tricks to beat the Alice test.  Here, we focus on the changes to patent applications by drafters, as well as changes to patent applications that have issued since Alice… Previous analyses have reported that patent specification length has been increasing since long before 2010. As shown in Figure 3, from 2010 to 2013, the average patent application length was approximately 12,417 words. However, from 2015 and 2017, the average patent application length increased to over 14,700 words… Alice appears to have resulted in positive developments, such as narrowing the scope of claims and increasing disclosure of technical benefits of inventions in the specification.

Patents allow you to protect your inventions, license the use of the inventions of others, and introduce additional revenue streams to your business. Patents also require investments of time and money to maximize their usefulness. By focusing your investment and efforts on optimizing the usability of patents of value, you can improve the validation that your applications read on markets of interest, and that further your portfolio goals, help tune a patent portfolio by developing indication of use (IoU) of some applications regarding products of interest, and early cost savings by avoiding applications with challenges or concerns, use applications as soon as they are granted and improve utilization of filed inventions by identifying continuation opportunities… There are many ways that patent strengthening can improve a portfolio. By focusing on optimizing the quality of patents of value you can achieve maximum ROI from their use, and you can minimize the cost by avoiding lower-value applications as well as their future maintenance.

Means plus function claiming allows the drafter to claim the invention based on functionality rather than the more traditional (and preferred) claiming technique that employs structure within the body of the claim itself… If there is no structure in the specification the person of skill in the art cannot save the disclosure by understanding what the drafter intended to be covered by the means plus function limitation in the claims. Thus, means-plus-function claims are valid at the mercy of the specification, and only to the extent that the specification contains support for the structures that define the means… The Federal Circuit does not blindly elevate form over substance when evaluating whether a particular claim limitation invokes means treatment. See Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1584 (Fed. Cir. 1996) (“We do not mean to suggest that section 112(6) is triggered only if the claim uses the word ‘means.’”).

One of the most valuable benefits of Open Prosecution is when a patentee is forced to enforce a patent. If the patentee filed for a Continuation, it could file for an additional patent with new Claims but the same Priority Date as the original patent, and add it to the lawsuit. And, of course, before that second patent is issued, the patentee files for yet another Continuation. The plaintiff in a patent infringement lawsuit can use an Open Prosecution model to continue to introduce new patents as a counter-strategy to the IPRs filed by the defendant. More than a few patent infringement lawsuits ended in favorable settlements once the defendant realized it had a formidable opponents with additional patents up its prosecution sleeve.

Crafting a proper hypothetical claim is a prerequisite to whether a theory of infringement under the doctrine of equivalents would also ensnare the prior art. The burden to present a proper hypothetical claim cannot be shifted, and a hypothetical claim cannot be broader for the alleged range of equivalents, and not otherwise narrower.