The US Patent and Trademark Office (USPTO) issued a Notice clarifying its practice as to situations that will require additional information about whether a delay in seeking the revival of an abandoned application, acceptance of a delayed maintenance fee payment, or acceptance of a delayed priority or benefit claim was unintentional. 85 FED. REG. 12222 (Mar. 2, 2020).
The EU Unified Patent Court (UPC) announced a launch date of April 1, 2023, however, the announced date should be regarded as a statement of intent for it could change. The launch timing has been the subject of various delays and setbacks, several due to unresolved legal issues. The UPC has also published an almost final list of judges. German Federal Court of Justice Judge Klaus Grabinski, who played a key role in drafting the UPC Rules of Procedure, will head the UPC. The majority of UPC judges will only be engaged with their UPC activities part-time (about 50% or 20% of their total work commitment).
The UPC judges are set to receive special training starting in March 2023, only one month prior to the announced launch date of the UPC, leading many to doubt that the April 1 date will be met. Once the new court is operational, owners of European patents will be able to litigate patent disputes across most EU Member States in a single proceeding, eliminating the need to proceed on a country-by-country basis.
Assuming the announced launch date is maintained, the “sunrise period” before the UPC becomes fully operational will commence on January 1, 2023. This sunrise period will last for three months, during which patent owners that do not wish for their existing European patents to be subject to UPC jurisdiction may opt out of such jurisdiction by filing a formal notification to that effect. The European Patent Office has also announced that during the sunrise period, European patent applicants whose applications are ready for grant will, if they wish, be able to delay the formal grant of the application until the UPC becomes operational so that unitary patent protection can be obtained.
The UPC has issued an implementation roadmap for events leading up to the entry into force of the UPC Agreement, with the court opening its doors and starting to receive cases as of April 1, 2023.
The US Patent & Trademark Office (PTO) is seeking public input and guidance on proposed initiatives directed at bolstering the robustness and reliability of patents. The request for comments was spurred in part by US President Joe Biden’s July 9, 2021, executive order on Promoting Competition in the American Economy, and a June 8, 2022, letter from Senators Leahy, Blumenthal, Klobuchar, Cornyn, Collins and Braun raising concerns about patent thickets.
The PTO identified four broad topics and initiatives that it is considering:
- Prior Art Searching
- Support for Patent Claims
- Request for Continued Examination (RCE) Practice
- Restriction, Divisional, Rejoinder and Non-Statutory Double Patenting Practice.
The PTO seeks comments on 11 main questions and several sub-questions. The first five questions are directed to the PTO initiatives while questions six through 11 address concerns raised by the senators.
- How should the PTO facilitate an applicant’s submission of prior art that is not accessible in the Patents End-to-End Search system (e.g., “on sale” or prior public use)?
- How, if at all, should the PTO change claim support requirements and/or continuation practice?
- How, if at all, should the PTO change RCE practice?
- How, if at all, should the PTO limit or change restriction, divisional, rejoinder and/or non-statutory double patenting practice?
- Provide any other input on any of the proposals listed under the PTO initiatives.
- How would eliminating terminal disclaimers, thus prohibiting patents that are obvious variants of one another, affect patent prosecution strategies and overall patent quality?
- Should patents that are tied together by a terminal disclaimer because of an obviousness-type double patenting rejection stand or fall together if their validity is subsequently challenged?
- Should the PTO require a second look by a team of patent quality specialists before issuing a continuation patent on a first office action?
- Should there be heightened examination requirements for continuation patents?
- Should the PTO implement a rule change that requires any continuation application to be filed within a set timeframe of the ultimate parent application?
- If filing fees were increased to cover the actual cost of obtaining a patent, would this increase patent quality? And if the fees for continuation applications were increased, would applicants be less likely to file continuations for obvious variants?
Among the proposals under consideration are whether to require applicants to identify corresponding support in the original disclosure for each claim in a continuation application, whether applications should be reassigned to a different examiner after a set number of RCEs are filed, whether the PTO should adopt the unity of invention standard, and whether divisionals should be filed within a set time period.
Click here for further details on the PTO initiatives.
Comments must be received by January 3, 2023, to ensure consideration.
In what may be another blow to diagnostic patents, the US Court of Appeals for the Federal Circuit affirmed the patent ineligibility of claims that it held to be directed to detecting natural phenomena by conventional techniques. CareDx, Inc. v. Natera, Inc., Case No. 2022-1027 (Fed. Cir. July 18, 2022) (Lourie, Bryson, Hughes, JJ.)
CareDx is the exclusive licensee of three Stanford University patents directed to diagnosing or predicting organ transplant status by using methods to detect a donor’s cell-free DNA (cfDNA). When an organ transplant is rejected, the recipient’s body destroys the donor cells, releasing cfDNA from the donated organ’s dying cells into the blood. Detecting the naturally increased levels of donor cfDNA (due to the deteriorating organ condition) can be used to diagnose the likelihood of an organ transplant rejection.
The representative claims were summarized as having four steps for detecting a donor’s cfDNA in a transplant recipient:
- “Obtaining” or “providing” a “sample” from the recipient that contains cfDNA
- “Genotyping” the transplant donor and/or recipient to develop “polymorphism” or “SNP” “profiles”
- “Sequencing” the cfDNA from the sample using “multiplex” or “high-throughput” sequencing, or performing “digital PCR”
- “Determining” or “quantifying” the amount of donor cfDNA.
CareDx filed two lawsuits, one alleging that Natera’s kidney transplant rejection test infringed the patents, and another alleging that Eurofins Viracor’s various organ transplant rejection tests infringed one of the patents. Natera and Eurofins moved to dismiss the complaints for failing to state a claim because of a lack of patent-eligible subject matter under 35 U.S.C. § 101. The magistrate judge who reviewed the motions recommended that they be denied, finding that the claims were a “purportedly new, unconventional combination of steps” to detect natural phenomena. Although the recommendation was vacated with regard to Natera because the complaint was amended, the district court adopted the magistrate’s recommendation as to Eurofins with modified reasoning that the patent “specifications raise doubts about the patents’ validity” by suggesting that the steps were neither new nor unconventional. Still, the district court was wary of ruling prematurely and denied the motion so that the parties could conduct discovery to develop the record on what was considered conventional in the art.
Following expert discovery relating to § 101 eligibility, Natera and Eurofins moved for summary judgment on patent ineligibility. The district court denied summary judgment, citing a factual dispute as to the conventionality of the techniques for performing the claimed methods. Natera and Eurofins moved for certification of interlocutory appeals of the district court’s denial. After conferring with the parties, the district court agreed to reconsider its decision in view of case law raised in the certification motion. After reconsideration, the district court granted the summary judgment motions of ineligibility, finding that the asserted claims were directed to the detection of natural phenomena—specifically, the presence of donor cfDNA in a transplant recipient and the correlation between donor cfDNA and transplant rejection—and concluding that based on the specification’s many admissions, the claims recited only conventional techniques.
CareDx appealed, arguing [...]
PTO Proposes Standardization of the Patent Term Adjustment Statement Regarding Information Disclosure Statements
The US Patent & Trademark Office (PTO) announced on July 12, 2022, that it intends to revise the rules pertaining to patent term adjustment to require that the patent term adjustment statement regarding information disclosure statements (IDS) be submitted on a PTO form. The PTO believes that the use of the form will streamline prosecution and be more accurate and efficient by eliminating the need for a manual review of the patent term adjustment statement.
The regulations in 37 CFR 1.704(c)(1) through (14) establish the circumstances that constitute an applicant’s failure to engage in reasonable efforts to conclude processing or examination of an application and the resulting reduction of any patent term adjustment. 37 CFR 1.704(d)(1) also provides a safe harbor for filing IDS. Filing only an IDS in compliance with §§ 1.97 and 1.98 or a request for continued examination with only a compliant IDS is not considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(6), (8), (9) or (10) if it is accompanied by the required statement. The statement required to accompany the paper or request for continued examination must affirm that each item of information contained in the IDS meets one of the following requirements:
- It was first cited in any communication from a patent office in a counterpart foreign or international application or from the PTO, and this communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS.
- It is a communication that was issued by a patent office in a counterpart foreign or international application or by the PTO, and this communication was not received by any individual designated in § 1.56(c) more than 30 days prior to the filing of the IDS.
The PTO proposes adding new paragraph (d)(3) to 37 CFR 1.704(d), which requires filers to submit the patent term adjustment statement under 37 CFR 1.704(d)(1) on a form PTO/SB/133 to derive the safe harbor benefit under 37 CFR 1.704(d). Form PTO/SB/133 includes the required statement described above. Filers who submit a 37 CFR 1.704(d)(1) patent term adjustment statement without using the form PTO/SB/133 and filers who submit the form PTO/SB/133 with any modification to the patent term adjustment statement will not receive the benefit of the safe harbor under 37 CFR 1.704(d). Under such circumstances, the IDS or the request for continued examination, with no submission other than an IDS, will be treated as unaccompanied by a patent term adjustment statement under 37 CFR 1.704(d)(1).
Comments on the proposed rule must be received by September 12, 2022, to ensure consideration.
A panel of the US Court of Appeals for the Federal Circuit considered whether the Patent Commissioner, on assuming the role of the US Patent & Trademark Office (PTO) Director, can constitutionally evaluate the rehearing of Patent Trial & Appeal Board (Board) inter partes review (IPR) decisions. The panel concluded that neither Appointments Clause jurisprudence nor the Federal Vacancies Reform Act (FVRA) impeded the Commissioner from exercising the PTO Director’s authority. Arthrex, Inc. v. Smith & Nephew, Inc. et al., Case No. 18-2140 (Fed. Cir., May 27, 2022) (Moore, C.J.; Reyna, Chen, JJ.)
Approximately one year ago, Arthrex succeeded in the Supreme Court of the United States on its argument that the Appointments Clause of the Constitution was violated unless a presidentially appointed and Senate-confirmed officer (such as the PTO Director) could review the Board’s final IPR decisions. (United States v. Arthrex, Inc.) The case returned to the PTO on remand. At the time, the position of PTO Director was vacant, and there was no acting director. Pursuant to the FVRA, the Commissioner of Patents (a position filled by the Secretary of Commerce) exercised the PTO Director’s authority to review Board decisions and ultimately rejected Arthrex’s challenge to the Board’s unpatentability determination. Arthrex appealed.
Arthrex contended that the Commissioner could not constitutionally exercise the PTO Director’s IPR review authority without running afoul of the Appointments Clause, that the FVRA barred the Commissioner’s exercise of authority and that the Commissioner violated separation of powers. Arthrex also challenged the ruling on the merits. None of these challenges were successful.
First, the Federal Circuit concluded that Arthrex reinforced long-settled Supreme Court precedent that an inferior officer could exercise a principal officer’s authority constitutionally on a temporary basis without violating the Appointments Clause. Here, the Court concluded that the Commissioner’s exercise of the PTO Director’s IPR review authority until a new director was installed presented no problem.
Second, the FVRA provides a statutory framework for the exercise of a principal officer’s duties under certain circumstances, which, if the law applied, would not have allowed the Commissioner to review IPR decisions. However, the Federal Circuit explained that the FVRA narrowly governs only those duties of an officer that are statutorily non-delegable (i.e., which US Congress has required to be exercised personally by the officer). According to the Court, such provisions did not apply here because nothing demonstrated that the PTO Director’s newly created authority to review IPR decisions was non-delegable.
Third, the Federal Circuit rejected Arthrex’s argument that the Commissioner’s service as the PTO Director violated the line of precedent that limits Congress’ ability to circumscribe the president’s removal authority for superior officers. Arthrex contended that the Commissioner, a non-superior officer, could be removed only for “misconduct or nonsatisfactory performance” and therefore could not fill the role of the PTO Director. The panel disagreed, explaining that the president could name an acting director “with the stroke of a pen,” and so the limits on removing the Commissioner from his role as Commissioner [...]
Only under Rare Circumstances Can the Patent Trial & Appeal Board Find Proposed Substitute Claims Unpatentable on Its Own
The US Court of Appeals for the Federal Circuit addressed, for the first time, the issue of when the Patent Trial & Appeal Board (Board) may raise a ground of unpatentability that was not advanced by a petitioner in relation to proposed substitute claims. The Court upheld the standard defining the “rare circumstances” in which such a ruling is proper while questioning the Board’s reasoning and application of the standard. Hunting Titan, Inc. v. DynaEnergetics Europe GMBH, Case Nos. 20-2163; -2191 (Fed. Cir. Mar. 24, 2022) (Prost, C.J., Reyna, Hughes, JJ.) (Prost, C.J., concurring).
Hunting Titan challenged DynaEnergetics’ patent in an inter partes review (IPR) based on anticipation and obviousness grounds. The Board found all the original claims of the patent unpatentable as anticipated. DynaEnergetics moved to amend to add proposed substitute claims. Hunting Titan opposed the motion to amend but advanced only obviousness grounds against the proposed substitute claims. The Board determined sua sponte that the proposed substitute claims were unpatentable as anticipated and, therefore, denied the motion to amend. DynaEnergetics requested rehearing, and the Precedential Opinion Panel (POP) reversed the Board’s denial of the motion to amend and determined that Hunting Titan did not prove that the proposed substitute claims were unpatentable.
The POP decided that “only under rare circumstances” should the Board sua sponte raise a ground for unpatentability not advanced by the petitioner in relation to proposed substitute claims. The rare circumstances include only two situations:
- When the petitioner is not involved in the motion to amend, such as when a petitioner chooses not to oppose the motion or ceases to participate in the proceeding altogether
- When evidence of unpatentability is readily identifiable and persuasive, such as if the substitute claims are unpatentable for the same reasons as the original claims.
The POP stated that in most circumstances, it is best to rely on the adversarial system and expect the petitioner to raise the unpatentability grounds for consideration.
The Federal Circuit upheld the POP’s standard for when the Board may sua sponte find proposed substitute claims unpatentable but also found the POP’s reasoning “problematic” because it placed too much emphasis on the adversarial system. The Court noted that Board proceedings, such as IPRs, are fundamentally a review of an earlier administrative proceeding, as opposed to civil litigation, The POP’s rationale was based on the public interest being served by an adversarial system rather than on the public interest being served by maintaining integrity of the patent system.
The Federal Circuit also questioned the POP’s application of its new standard to the case at hand, noting that the readily identifiable evidence exception should have been applied when the Board found the proposed substitute claims unpatentable for the same reasons it found the original claims to be unpatentable.
In her concurring opinion, Chief Judge Prost noted that “[i]t makes little sense to limit the [Board], in its role within the agency responsible for issuing patents, to the petitioner’s arguments.” Instead, “the Board must determine whether the [...]
Patent Venue Statute Doesn’t Apply to Third-Party Counterclaim Defendant; Acts in Furtherance of Partnership May Be Imputed to Partner for Venue Purposes
The US Court of Appeals for the Federal Circuit affirmed a district court’s determination of proper venue, finding that the patent venue statute, 28 U.S.C. § 1400(b), does not apply to a third-party counterclaim defendant and that acts done by separate entities in furtherance of a partnership can be imputed to a partner for purposes of venue determination. The Federal Circuit also affirmed and reversed jury verdicts of adequate written description and patent co-ownership. BASF Plant Sci., LP v. Commonwealth Sci. and Indus. Rsch. Org., Case Nos. 20-1415; -1416; -1919; -1920 (Fed. Cir. Mar. 15, 2022) (Newman, Taranto, Chen, JJ.) (Newman, J., dissenting).
Commonwealth Scientific and Industrial Research Organisation (CSIRO), a research arm of the Australian government, owns six patents directed to the engineering of plants, particularly canola, to produce specified oils not native to the plants. BASF Plant Science is a plant biotechnology company. CSIRO and BASF each explored genetic modification of familiar oilseed crop plants, such as canola, to get them to produce omega-3 long-chain polyunsaturated fatty acids (LCPUFAs), commonly known as “fish oil,” that could be fed to farm-raised fish and are beneficial to human health. In 2007, CSIRO and BASF discussed a focused collaboration and in 2008 entered into a two-year Materials Transfer and Evaluation Agreement (MTEA) to advance that goal. In 2010, following the conclusion of the MTEA, CSIRO partnered with another Australian government entity, Grains Research and Development Corporation, and private company, Nuseed, to commercialize its products. CSIRO granted Nuseed an exclusive license to CSIRO’s LCPUFA technology and patents. In 2011, BASF entered into a commercialization agreement with Cargill. BASF developed a canola seed line that it used to apply for regulatory approvals, which Cargill used in cross-breeding work. As part of the joint project, BASF deposited seeds with the American Type Culture Collection (ATCC) to support BASF’s patent applications.
During this period, BASF and CSIRO entered negotiations for BASF to take a license to CSIRO’s LCPUFA technology, but the negotiations broke down. In 2016, Nuseed sent Cargill a letter identifying multiple CSIRO patents and inviting Cargill to discuss CSIRO’s omega-3 patent portfolio. In April 2017, BASF sued Nuseed in the District of Delaware, seeking a declaratory judgment that BASF did not infringe certain CSIRO patents listed in the 2016 letter. The District of Delaware dismissed the case for lack of jurisdiction.
In 2017, BASF filed a declaratory judgment action in the Eastern District of Virginia against CSIRO, Nuseed and Grains Research (collectively, CSIRO). CSIRO filed an answer and counterclaims asserting infringement of the asserted patents against BASF and Cargill. BASF entered the case as a party and asserted co-ownership of the asserted patents under the MTEA. Cargill moved to dismiss the counterclaims for lack of personal jurisdiction and improper venue. The district court denied the motion, determining that it had personal jurisdiction over Cargill and that venue was proper. Cargill did not dispute that it had a regular and established place of business in the Eastern District of Virginia but argued that it [...]
The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision that claims to a ballistic parachute were obvious over the prior art based on knowledge attributable to artisans and denying the patentee’s motion to substitute proposed amended claims, finding that they lacked written description. Fleming v. Cirrus Design Corp., Case No. 21-1561 (Fed. Cir. Mar. 10, 2022) (Lourie, Hughes, Stoll, JJ.)
Cirrus Design filed a petition for inter partes review on certain claims of Fleming’s patent related to ballistic parachute systems on an aircraft. The challenged claims relate to an autopilot system that increases the aircraft’s pitch, reduces the aircraft’s roll or changes the aircraft’s altitude when a ballistic parachute deployment request is made. Fleming moved to amend some of the challenged claims, effectively cancelling those claims. In its final written decision, the Board found the remaining original claims obvious over the prior art and found that the amended claims lacked written description and were indefinite. Fleming appealed both the obviousness determination and the denial of the motion to amend.
Fleming argued that the Board’s obviousness determination was incorrect because the prior art did not disclose the commands to the autopilot to alter the aircraft’s pitch, roll or altitude. The Board acknowledged that neither of the primary prior references included the claimed commands upon the receipt of a deployment request, but nevertheless, concluded that a person of ordinary skill in the art would have had the motivation to combine the prior art disclosures to arrive at the claimed invention. The Federal Circuit concluded that the Board’s findings were supported by substantial evidence, citing to the Supreme Court’s 2007 KSR decision for the proposition that it is appropriate to consider a person of ordinary skill in the art’s knowledge, creativity and common sense, so long as they do not replace reasoned analysis and evidentiary support. Here the Court noted with approval the Board’s finding that aircraft autopilots are programmable and can perform flight maneuvers and deploy a parachute. The Court also noted that an artisan would have understood that certain maneuvers, such as stabilizing at an appropriate altitude, should be performed prior to deploying a whole-aircraft parachute. The Board concluded that a person of ordinary skill in the art would be motivated to reprogram the autopilot to take Fleming’s proposed actions prior to releasing the parachute to improve safety outcomes.
Fleming also appealed the Board’s rejection of his argument that the prior art taught away from claimed invention because a person of ordinary skill in the art would deem the combination unsafe. He argued that the prior art taught that autopilot systems should not be used in the sort of emergency situations that would lead to the deployment of a ballistic parachute. The Board rejected that argument, and the Federal Circuit found that the substantial evidence supported the Board’s determination that the prior art did not teach that a person of ordinary skill in the art would never use an autopilot system during [...]
The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction, finding that the district court did not abuse its discretion, clearly err in its underlying factual findings or abuse its discretion in setting the scope of the preliminary injunction. BlephEx, LLC v. Myco Indus., Inc., Case Nos. 2021-1149; -1365 (Fed. Cir. Feb. 3, 2022) (Moore, Schall, O’Malley, JJ.)
Myco sells AB Max, a mechanical device with an attached swab used for treating an eye condition known as blepharitis. Myco began marketing AB Max at a trade show in February 2019. One month later, BlephEx filed an application that later issued as a patent. The patent is directed toward cleaning debris from an eye during treatment of ocular disorders, including blepharitis. According to the patent, prior art treatment for blepharitis included at-home treatment where the patient would use a cotton swab, fingertip or scrubbing pad to scrub the eyelid margin in order to remove debris. Patients would often fail to adequately cleanse the eyelid margin, however. The patent’s solution is an electromechanical device with an attached swab for use by an eyecare professional to clean the patient’s eyelid margins.
The day the patent issued, BlephEx sued Myco and its chairman, John R. Choate, alleging that Myco’s AB Max infringed BlephEx’s newly issued patent. BlephEx moved the district court for a preliminary injunction prohibiting Myco from selling, distributing or offering the AB Max for sale. Myco opposed, arguing that a prior art reference (Nichamin) raised a substantial question of invalidity. The district court disagreed with Myco and granted the injunction. The district court noted that to anticipate, a prior art reference must disclose all elements of a claim arranged as in the claim, and Nichamin did not disclose combining the electromechanical applicator device depicted in one embodiment with a swab disclosed in another. The district court also rejected Myco’s argument that the patent examiner failed to consider Nichamin because he did not substantively discuss it during prosecution. The district court further rejected Myco’s obviousness argument as unsupported by expert evidence, finding Myco failed to overcome “the safety concerns of attaching a swab that is soaked in an abrasive to the Nichamin hand-held device.”
After the district court granted the preliminary injunction, Myco moved for reconsideration and argued that the preliminary injunction was overbroad because the AB Max had noninfringing uses. The district court rejected Myco’s argument, finding it was untimely and presented hypothetical noninfringing uses that were “outweighed by evidence that the only actual use of the AB Max was to treat anterior blepharitis,” which would likely infringe the asserted patent. Myco appealed.
The Federal Circuit affirmed the preliminary injunction grant. With respect to Myco’s anticipation argument, the Court found “Myco offers nothing other than attorney argument as to what the highly skilled artisan would do,” and this was insufficient to raise a substantial question of validity. The Court also noted that Myco had “put all of its eggs in the anticipation basket” and fatally failed [...]