In my view, Obviousness is the most fundamental of patent law doctrines, and certainly much of the work of patent attorneys is to convince patent examiners that the claims are not obvious.
In 1931, the United States Supreme Court decided a landmark case on the patentability of inventions, De Forest Radio Co. v. General Electric Co., 283 U.S. 664 (1931), amended, 284 U.S. 571 (1931). The case involved a patent infringement suit over an improved vacuum tube used in radio communications. While the case predated the codification of the nonobviousness requirement in 35 U.S.C. § 103 as part of the Patent Act of 1952, it nonetheless applied a similar requirement for "invention."
I wanted to review the case because it is one relied upon in the recent Vanda v. Teva petition, with the patentee arguing that the court's standard from 1931 has been relaxed by the Federal Circuit's "reasonable expectation of success" standard. The decision also provides an interesting case study in the way that the court seems to blend considerations of obviousness and
Although non-precedential, the Federal Circuit's new decision in Sumitomo Pharma v. Vidal offers the important conclusion that a patentee has no standing to appeal an invalidity holding once the patent expires, absent some showing of likely infringement during the prior six years. Sumitomo Pharma Co. v. Vidal, No. 22-2276 (Fed. Cir. April 5, 2024). The case is not so bad for the patentee because
The pending obviousness petition in Vanda v. Teva has prompted me to look back on some of the key Supreme Court cases cited in the briefs. Last week, I wrote about Atlantic Works v. Brady, 107 U.S. 192 (1883) in a blog post titled The Quest for a Meaningful Threshold of Invention. Today, I'm looking at Dow Chemical Co. v. Halliburton Oil Well Cementing Co., 324 U.S. 320 (1945), an obviousness case decided just a few years before a rewriting of the 1952 Patent Act. At the time, the doctrine was identified as "want of invention," but the court's analysis is familiar to anyone practicing patent law today.
I have been following the ongoing case of Natera v. NeoGenomics that is currently on appeal before the Federal Circuit. Docket No. 24-1324. The technology in these cases has amazing potential and I have several friends who have used these techniques to detect early stage cancer.
The particular litigation here centers on Natera's US Patent No. 11,519,035 issued on December 6, 2022 that covers a method of detecting cancer through analysis of cell-free DNA (cfDNA) obtained from blood samples. The basic idea is that small fragments of DNA that are released into the bloodstream by cells, including cancer cells. High throughput extraction and sequencing technologies can then be used to detect mutations and their potential associated risk factors, including the presence of cancer and the specific type of cancer. cfDNA cancer screening has lots of advantages, most notably, it is almost non-invasive (blood sample) and provides potential early across the entire body. It can be particularly effective for detecting reemergence of cancer for someone in remission because the particular mutation is already known. This is known as a "tumor-informed" test.
Natera's '035 patent is directed to methods for amplifying and sequencing cell-free DNA (cfDNA) to detect cancer. The claimed invention involves three key steps: (1) tagging cfDNA with universal adaptors, (2) amplifying 25-2,000 single nucleotide polymorphism (SNP) loci in a single reaction volume, and (3) performing massively parallel sequencing. Each of these steps were known in the prior art, but the combination of all three appears to be new. NeoGenomics is accused of infringing through its use of its RaDaR, an independently developed cancer-detection test that purportedly employs a similar process for analyzing cfDNA to provide highly sensitive detection of cancerous mutations. NeoGenomics disagrees, arguing the claims require the tagging and targeted amplification to occur in separate PCR reactions with different primer sets, and that its approach combines this process.
In April 2024, the Federal Circuit issued a significant decision vacating a district court's judgment that Janssen Pharmaceuticals' dosing regimen patent claims were nonobvious. Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258 (Fed. Cir. Apr. 1, 2024). The case involved Janson's U.S. Patent No. 9,439,906, which claims methods of treating schizophrenia by administering specific doses of the long-acting injectable antipsychotic paliperidone palmitate.
Teva filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Janssen's Invega Sustenna product, which embodies the claimed methods. In the ensuing Hatch-Waxman litigation, Teva stipulated to infringement but challenged the patent on obviousness and indefiniteness grounds. Following a bench trial Judge Cecchi (D.N.J.) rejected Teva's invalidity defenses, and Teva appealed.
On appeal, Judge Prost authored a unanimous opinion affirming the district court's indefiniteness determination but vacating and remanding on obviousness. Overall, this is a bad case for pharmaceutical formulary patents.
This post focuses on the court's obviousness holding and its potential implications for pharmaceutical method of treatment claims more broadly. I make three key claims. . .
In a recent decision, the Federal Circuit vacated a judgment of invalidity and remanded for a new trial, holding that the district court's jury instruction on objective indicia of nonobviousness constituted prejudicial legal error. The case, Inline Plastics Corp. v. Lacerta Group, LLC, No. 2022-1954 (Fed. Cir. Mar. 27, 2024), involved patents relating to tamper-resistant and tamper-evident food containers.
The Federal Circuit's recent decision in Virtek Vision International ULC v. Assembly Guidance Systems, Inc. focuses on the motivation to combine aspect of the obviousness analysis. The court's ruling emphasizes that the mere existence of prior art elements is not sufficient to render a claimed invention obvious; rather, there must be a clear reason or rationale for a person of ordinary skill in the art to combine those elements in the claimed manner. In the case, the IPR petitioner failed to articulate that reasoning and thus the PTAB's obviousness finding was improper.
My recent discussion of Vanda v. Teva references the landmark Supreme Court case of Atlantic Works v. Brady, 107 U.S. 192 (1883). I thought I would write a more complete discussion of this important historic patent case.
Atlantic Works has had a profound impact on the development of patent law, particularly in shaping the doctrine of obviousness, but more generally providing theoretical frameworks for attacking "bad patents." As discussed below, I believe the case also provides some early insight into the new AI inventorship dilemma.
The case addressed the validity of a patent granted to Edwin L. Brady for an improved dredge boat design. The Supreme Court ultimately reversed the lower court's decision upholding the patent and found instead that Brady's claimed invention lacked novelty and did not constitute a patentable advance over the prior art.
The U.S. Supreme Court is weighing whether to grant certiorari in Vanda Pharmaceuticals v. Teva Pharmaceuticals. I have been closely watching this obviousness case that could have significant implications beyond the pharmaceutical industry. The following essay provides an overview of the key legal issues at stake and introduces Teva's recent briefing.
The case centers on the proper legal standard for determining when an invention is "obvious" and therefore unpatentable under 35 U.S.C. § 103. In particular, Vanda argues that the Federal Circuit has unduly raised the non-obviousness hurdle -- barring patents based upon a "mere reasonable expectation of success" or that certain experiments would have been obvious to try, even though the result was not known.
In Sisvel v. TCT Mobile and Honeywell, the Federal Circuit has affirmed the PTAB's IPR findings that the claims are obvious. The non-precedential decision provides further insight into the Federal Circuit's reasonable expectation of success test.
Sisvel's U.S. Patent 8,971,279 covers a method of sending Semi-Persistent Scheduling (SPS) deactivation signals that essentially "piggyback" on existing messages. SPS is a technique used in LTE networks to more efficiently allocate radio resources to user equipment (UE) for periodic transmissions, such as Voice over IP (VoIP). In SPS, the base station pre-allocates resources to the UE for a set period of time, reducing the need for frequent scheduling requests and grants. SPS deactivation signals are messages sent by the base station to the UE to indicate that the pre-allocated resources are being released and are no longer available for the UE's periodic transmissions. These signals are necessary to free up the resources when they are no longer needed, allowing them to be reassigned to other UEs or used for other purposes.
In the context of Sisvel's '279 patent, the invention was directed to a specific method of sending SPS deactivation signals by filling a preexisting binary field (the resource indication value or "RIV") with all "1"s. This 111111111 technique was intended to provide a more efficient way of signaling SPS deactivation while still ensuring that the deactivation message would not be mistaken for a valid resource allocation message. In the patented system, the string of ones would always be processed as an invalid value and never mistaken for a valid resource allocation message, providing stability to the network, regardless of size.
TCT Mobile and others petitioned for IPR, asserting that the challenged claims were obvious based on various combinations of prior art, including Samsung and Dahlman. The PTAB found the claims unpatentable as obvious, and Sisvel appealed.
In a short nonprecedential decision, the Federal Circuit affirmed a PTAB IPR decision finding claims 15-25 of U.S. Patent No. 8,671,132 ('132 patent) unpatentable under 35 U.S.C. § 103 over combinations of prior art references. Daedalus Blue LLC v. Vidal, No. 2023-1313, slip op. at 2 (Fed. Cir. Mar. 13, 2024). The key issue on appeal was whether the Gelb reference qualified as analogous art for the purposes of the obviousness analysis. Daedalus unsuccessfully argued that the PTAB erred in two respects: (1) by finding Gelb to be in the same field of endeavor as the '132 patent, and (2) by determining that Gelb is reasonably pertinent to the problems addressed by the '132 patent. This post discusses the analogous arts test and provides key guidance to patent attorneys in today's post-AIA world.
The Federal Circuit has affirmed the PTAB's finding that Pfizer's pneumococcal vaccine patent is obvious, but has vacated and remanded the Board's denial of Pfizer's motion to amend certain claims. Pfizer Inc. v. Sanofi Pasteur Inc., No. 19-1871 (Fed. Cir. Mar. 5, 2024); U.S. Patent No. 9,492,559. Pfizer v. Sanofi Opinion.
Elon Musk was instrumental in the initial creation of OpenAI as a nonprofit with the vision of responsibly developing artificial intelligence (AI) to benefit humanity and to prevent monopolistic control over the technology. After ChatGPT went viral in late 2022, the company began focusing more on revenue and profits. It added a major for-profit subsidiary and completed a $13+ billion deal with Microsoft -- entitling the industry giant to a large share of OpenAI's future profits and a seat on the Board.
In a new lawsuit, Elon Musk alleges that OpenAI and its CEO Sam Altman have breached the organization's founding vision. [Musk vs OpenAI].
I wanted to consider some recent PTAB jurisprudence on patent eligibility under 35 U.S.C. § 101. The following post reviews four recent eligibility cases. In all four cases the PTAB found the claims lacked eligibility. Two of the cases affirmed examiner rejections while the other two added eligibility as a new grounds for rejection after finding that the examiner erred in their 102/103 rejections. All four cases here involve communications technology where the patent applicant was seeking to claim the functional operational steps without describing any new "technology." I have a second post coming with recent device 101 cases from the PTAB.
Earlier this week, the USPTO published updated examination guidelines regarding obviousness determinations under 35 U.S.C. §103. While these new guidelines are not legally binding, they offer important insight into how the Office plans to apply an even more flexible approach to obviousness -- something Director Vidal sees as mandated by the Supreme Court’s 2007 decision in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). (2500 words).
Overall the guidance here suggests that the office is looking to make non-obviousness a larger hurdle via increased flexibility. Still, the guidelines spend some time on the requirements of a prima facie case; the necessity of both evidence and reasoning to support any obviousness rejection; and consideration of all evidence before the examiner. Obviousness is already the most common rejection - with the vast majority of applications being initially rejected as obvious. It will be interesting to see whether the rates go up even further following this new guidance.
This post breaks down the guidelines and walks through some potential strategies for patent applicants.
In a recent decision, the Federal Circuit held that a claimed range reciting narrower values than those described in the patent specification can still satisfy the written description requirement under 35 U.S.C. § 112(a). RAI Strategic Holdings, Inc. v. Philip Morris Prods. S.A., No. 22-1862 (Fed. Cir. Feb 9, 2024). Reversing a PTAB post-grant review decision, the court ruled that claims reciting a heating element with having a length of 75-85% of the disposable aerosol-forming substance had adequate written description support even though the specification only described broader ranges, such as “about 75% to about 125%.” Id.
The Federal Circuit is hearing oral arguments today in the design patent case of LKQ Corporation v. GM Global Technology Operations LLC 21-2348. Judge Stoll's opinion in the case sides with the patentee GM on the issue of obviousness -- affirming a PTAB decision in favor of the patentee. LKQ's appellate team led by Prof. Mark Lemley argues that Federal Circuit's obviousness standard (known here as the Rosen-Durling test) makes it too difficult to actual reject or cancel design patent claims. Lemley argues for a much more flexible and common sense approach as required by KSR. The USPTO's amicus agrees Federal Circuit law should be expanded, but not as far as suggested by LKQ. GM argues for the status quo.
According to the listing, the en banc panel today consist of Chief Judge Moore, and Circuit Court Judges Lourie, Dyk, Prost, Reyna, Taranto, Chen, Hughes, Stoll, and Stark. Not listed is Judges Cunningham and Newman.
