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PTO Proposes Deferred Responses for Subject Matter Eligibility Rejections

In a January 6, 2022, Federal Register notice, the US Patent and Trademark Office (PTO) announced its intention to implement a pilot program to evaluate the effects of permitting applicants to defer responding to subject matter eligibility (SME) rejections in certain patent applications. Under this pilot program, applicants may receive invitations to participate if their applications meet the program’s criteria, including a criterion that the claims in the application necessitate rejections on SME and other patentability-related grounds. An applicant who accepts the invitation to participate in this pilot program must still file a reply addressing all the rejections except SME rejections in every office action mailed in the application but is permitted to defer responding to SME rejections until the earlier of final disposition of the application or the withdrawal or obviation of all other outstanding rejections.

Invitations to participate in the Deferred Subject Matter Eligibility Response pilot program will be mailed during the period between February 1, 2022, and July 30, 2022. The PTO may extend, modify or terminate the pilot program depending on the workload and resources necessary to administer the program, feedback from the public and the program’s effectiveness.

Because satisfaction of non-SME conditions for patentability (e.g., novelty, nonobviousness, adequacy of disclosure and definiteness) may resolve SME issues as well, the pilot program may result in improved examination efficiency and increased patent quality.

An examiner may invite a prospective applicant to participate in the pilot program by including a form paragraph in the first office action on the merits. An applicant receiving an invitation to participate in the pilot program may elect to accept or decline the invitation. If an applicant wishes to participate in the program, they must file a properly completed request form PTO/SB/456 concurrently with a timely response to the first office action on the merits. The request form must be submitted via the PTO’s patent electronic filing systems.

The limited waiver permits the applicant to defer addressing the SME rejections until the earlier of final disposition of the participating application or the withdrawal or obviation of all other outstanding rejections. A final disposition is the earliest of the following:

  • Mailing of a notice of allowance
  • Mailing of a final office action
  • Filing of a notice of appeal
  • Filing of a request for continued examination
  • Abandonment of the application.

Applicants must address the SME rejections in a response to a final rejection or the filing of a request for continued examination.

The public is invited to submit comments, which must be received by March 7, 2022, to ensure consideration.




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Improper Claim Construction Requires Partial Remand of Obviousness Determination

The US Court of Appeals for the Federal Circuit issued decisions in two separate inter partes reviews (IPRs), one involving a patent related to radio frequency communication systems and the other involving a patent related to multi-processor systems. Intel Corporation v. Qualcomm Incorporated, Case No. 20-1664 (Fed. Cir. Dec. 28, 2021) (Prost, Taranto, Hughes, JJ.); Intel Corporation v. Qualcomm Incorporated, Case Nos. 20-1828, -1867 (Fed. Cir. Dec. 28, 2021) (Prost, Taranto, Hughes, JJ). Based on issues of claim construction and obviousness, the Court affirmed in part and vacated in part the Patent Trial and Appeal Board’s (Board) decision in the radio frequency communication systems patent IPR and vacated the Board’s decision in the multi-processor systems patent IPR.

Radio Frequency Communication System Patent IPR (1664)

In the IPR related to the radio frequency communication systems patent, Intel proposed that the claim term “radio frequency input signal” should take its ordinary meaning of an input signal having a radio frequency. Qualcomm argued that a person of skill in the art reading the patent would understand the phrase to reference the radio frequency signal that is received before down-conversion, and thus proposed that the term should mean “a signal centered at a carrier frequency at which the signal was transmitted/received.” The Board agreed with Qualcomm based on the intrinsic evidence.

Intel argued before the Board that certain claims of the radio frequency communication systems patent would have been obvious in light of the Der reference and the Valla reference. Qualcomm argued that a skilled artisan would not have been motivated to combine Der and Valla, because Der’s transistor would defeat the intended purpose of Valla’s amplifier. The Board agreed with Qualcomm. Qualcomm also submitted substitute claims. The Board accepted the substitute claims after finding that a skilled artisan would have lacked reason to combine Der and the Burgener reference to achieve the substitute claims. Intel appealed.

The Federal Circuit first addressed the threshold question of whether it had jurisdiction since no lawsuit had been filed against Intel. Despite the absence of any lawsuit against Intel itself, the Court found that Intel had standing because it had engaged in acts that previously resulted in assertion of the patent against one of Intel’s customers. Because Intel continues to sell the relevant products to that customer and others, it must address the risk of an infringement suit by Qualcomm. Qualcomm also refused to offer a covenant not to sue or stipulate that it would not reassert its prior infringement allegations involving the Intel products. The Court found that this refusal made Intel’s risk more than “mere conjecture or hypothesis.” Therefore, the Court found that Intel had standing to pursue the appeal.

Turning to the merits, the Federal Circuit affirmed the Board’s construction of “radio frequency input signal.” The Court explained that while both parties’ proposed constructions had appeal when considered in a vacuum, the proper inquiry required analysis of the surrounding claim language and specification. The Court found that linguistic clues in the claims suggested that [...]

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Rounding Error: Intrinsic Evidence Informs Plain and Ordinary Meaning

Vacating a stipulated infringement judgment based on an incorrect claim construction, the US Court of Appeals for the Federal Circuit explained that it is improper to isolate claim language from the intrinsic evidence when determining the plain and ordinary meaning of a disputed term. AstraZeneca AB v. Mylan Pharms. Inc., Case No. 21-1729 (Fed. Cir. Dec. 8, 2021) (Stoll, J.) (Taranto, J., dissenting).

AstraZeneca sued Mylan Pharmaceuticals for infringement of three patents listed in the US Food and Drug Administration’s (FDA) orange book covering the Symbicort® pressurized metered-dose inhaler for the treatment of asthma and COPD. 3M submitted an abbreviated new drug application (ANDA) to the FDA to manufacture and sell a generic version of the Symbicort® inhaler and certain interests to the ANDA were later transferred to Mylan. After receiving a Paragraph IV letter from Mylan, AstraZeneca filed an infringement suit.

Shortly before trial, the district court held a claim construction hearing to determine the meaning of “0.001%,” the claimed concentration of PVP (one of the active ingredients). The district court construed the term based on its “plain and ordinary meaning, that is, expressed with one significant digit.” Based on this definition, Mylan stipulated to infringement and the district court entered judgment. The district court held a bench trial on invalidity, ultimately determining that Mylan did not prove that the claims were invalid as obvious. Mylan appealed the stipulated judgment stemming from the claim construction determination and the judgment of no invalidity.

First, Mylan challenged the district court’s claim construction of “0.001%.” AstraZeneca argued that the district court improperly construed the term to encompass a range from 0.0005% to 0.0014%. Mylan contended that, in view of the specification and the prosecution history, the term was to be defined precisely at 0.001% with only “minor variations” allowed. The Federal Circuit agreed, finding that Mylan’s proposed construction was more properly aligned with the patent’s description as further informed by the prosecution history.

The Federal Circuit stated that the proper construction of 0.001% only allowed minor variations from 0.00095% to 0.00104%. There was no dispute that the term 0.001% would ordinarily encompass the range of 0.0005% to 0.0014%. AstraZeneca argued that this “ordinary meaning” would control absent lexicography or disclaimer. The Court disagreed, finding that it would improperly isolate the term from the claim language, specification and patent prosecution history. The Court explained that the “ordinary meaning” is not the ordinary meaning in the abstract but is instead the “meaning to the ordinary artisan after reading the entire patent,” and therefore the claims must be read in view of both the written description and the prosecution history. The Court’s rationale for narrower construction was based on the intrinsic record reflecting that the written description and prosecution history showed that very minor differences in PVP concentration would impact stability.

The Federal Circuit found that the written description explained that stability was one of the most important factors and that even very minor differences in PVP concentration could impact stability. The written description also [...]

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Shots Fired: Challenger Must Have Requisite Standing Before Appealing Unfavorable IPR Decisions

The US Court of Appeals for the Federal Circuit found, in the context of an appeal from an inter partes review (IPR) decision, that the appellant had Article III standing and affirmed a Patent Trial & Appeal Board (Board) decision, holding the challenged claims unpatentable as obvious. ModernaTX, Inc. v. Arbutus Biopharma Corporation, Case No. 20-2329 (Fed. Cir. Dec 2, 2021) (Lourie, J.)

Arbutus owns a patent pertaining to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (such as one or more interfering RNA), methods of making the SNALP, and methods of delivering and/or administering the SNALP.” Moderna petitioned for IPR of the patent, asserting three grounds:

  1. Moderna alleged that all claims of the challenged patent would have been anticipated and/or obvious in light of International Pat. Publ. WO 2005/007196 (‘196 PCT) or US Pat. Publ. 2006/0134189 (‘189 publication).
  2. Moderna alleged that all claims of the challenged patent would have been obvious over a combination of the ‘196 PCT, the ‘189 publication, Lin and Ahmad.
  3. Moderna alleged that all claims of the challenged patent were anticipated by US Pat. Publ. 2006/0240554 (‘554 publication), and alternatively that the claims would have been obvious over the ‘554 publication.

The Board rejected each of Moderna’s allegations, finding that the claims were not unpatentable as obvious. Moderna appealed.

Before addressing Moderna’s appeal on its merits, the Federal Circuit addressed whether Moderna had proper standing to challenge the Board’s decision. The Court stated that well-established precedent dictates that an appellant seeking review of a Board decision in an IPR must have suffered an injury in fact that is fairly traceable to the challenged conduct of the appellee and is likely to be redressed by a favorable judicial decision. The Court underscored that under IPR statute, there is no standing requirement for petitioners to request institution of IPR by the Board, meaning that a requester need not have a concrete stake in the outcome. Additionally, where the statue itself grants judicial review (such as in the case of an IPR), standing criteria of immediacy and redressability may be “relaxed.” Nonetheless, the Court explained that a party’s participation in the underlying IPR alone does not confer standing on that party to appeal the Board decision before an Article III court such as the Federal Circuit. The party seeking review (in this case Moderna) must show that it possesses requisite injury for standing to appeal.

Moderna asserted that substantial risk existed that Arbutus would bring an infringement suit against Moderna based on Moderna’s COVID-19 vaccine if the challenged patent was to remain valid. In support, Moderna submitted a declaration from its senior vice president and deputy general counsel that Moderna was working to harness proprietary mRNA technology and planned on releasing and applying for emergency use authorization for a COVID-19 vaccine in December 2020. The declaration also described how Arbutus’s conduct created a substantial risk that it would bring subsequent infringement action against Moderna. An example of such conduct was a series of public statements [...]

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Post-AIA Patents Are Not Shielded from Interferences

Addressing the applicability of interference proceedings to patent applications filed after the Leahy-Smith America Invents Act (AIA) was enacted, the Patent Trial & Appeal Board (Board) found it proper to declare an interference between a patent application with a priority date before March 16, 2013, the AIA implementation date, and a patent with a priority date after March 16, 2013. SNIPR Technologies Limited v. The Rockefeller University, Pat. Interf. No. 106,123 (DK) (PTAB Nov. 19, 2021) (Katz, APJ).

The AIA switched the US patent system from a “first to invent” to a “first inventor to file” system. In line with this change, the AIA eliminated the patentability requirement under 35 U.S.C. § 102(g), regarding whether another inventor made the invention first, and the interference proceeding under 35 U.S.C. §135 for determining who invented the claimed invention first. Section 3(n)(2) of the AIA provides a timing provision relating to this change. Under this section, the interference proceeding “shall apply to each claim of an application for patent, and any patent issued thereon, for which the amendments made by this section also apply, if such application or patent contains or contained at any time, a claim [having a priority date before March 16, 2013].”

The US Patent & Trademark Office (PTO) declared an interference between several patents owned by SNIPR and a pending application to The Rockefeller University. The claims involved were drawn to a method of killing or modifying specific bacteria in a mixed population of bacteria with different species using the CRISPR-mediated gene editing technology. The Rockefeller application asserted a priority date of February 7, 2013 (i.e., pre-AIA), while the SNIPR patents asserted the priority date of May 3, 2016 (i.e., post-AIA). SNIPR argued that the interference proceeding was improper since all involved patents were filed after the AIA was enacted.

The Board rejected SNIPR’s argument, explaining that Section 3(n)(2) provides for continuation of interference under certain circumstances. The Board noted that the patentability requirement under 35 U.S.C. §102(g) and interference still apply to each claim having a priority date before March 16, 2013, such as the claims of Rockefeller’s involved application. Accordingly, when the Rockefeller claims would otherwise be allowable, except for the existence of an interference with other claims such as SNIPR’s claims, Section 3(n)(2) necessarily calls for an interference proceeding between the Rockefeller application and the SNIPR patents. Otherwise, the PTO would not be able to determine whether Rockefeller was entitled to a patent under 35 U.S.C. §102(g).

The Board further reasoned that, instead of ending all interferences at the implementation of the AIA, US Congress enacted Section 3(n)(2) to continue the interference proceeding as applicable to certain cases after AIA. Congress also did not explicitly require that cases involved in interferences must all have priority dates before March 16, 2013. Therefore, the Board found that Congress contemplated interferences between pre-AIA and post-AIA applications and patents. Accordingly, the Board ruled in Rockefeller’s favor, finding it was the first to invent the claimed technology.




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Obvious to Try Requires Reasonable Expectation of Success Tethered to Claimed Invention

Addressing obviousness in the context of method of treatment claims using particular drug dosages, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) final written decision holding that Teva failed to prove obviousness because it failed to show a reasonable expectation of success. Teva Pharms., LLC v. Corcept Therapeutics, Inc., Case No. 21-1360 (Fed. Cir. Dec. 7, 2021) (Moore, C.J.)

Corcept filed a New Drug Application (NDA) for Korlym, a 300 mg mifepristone tablet administered to certain patients with Cushing’s syndrome. The US Food and Drug Administration (FDA) approved Corcept’s application but required a drug-drug interaction clinical trial to determine drug safety when co-administered with strong CYP3A inhibitors such as ketoconazole (Lee memorandum). Corcept conducted the drug-drug interaction study and received a patent relating to methods of treating Cushing’s syndrome by co-administering mifepristone and a strong CYP3A inhibitor based on the data from the Lee memorandum.

Teva sought post-grant review of the patent after Corcept asserted it against Teva in district court. Teva argued that the patent would have been obvious in view of Korlym’s label and the Lee memorandum and submitted a supporting expert declaration. The Board held that Teva failed to prove that a skilled artisan would have had a reasonable expectation of success for safe co-administration of more than 300 mg of mifepristone with a strong CYP3A inhibitor, and thus failed to prove that the patent was obvious. Teva appealed, arguing that the Board erroneously required precise predictability rather than reasonable expectation of success in achieving the claimed invention, and that the Board did not apply Federal Circuit prior art range precedents.

The Federal Circuit affirmed the Board’s decision. Turning first to reasonable expectation of success, the Court explained that the analysis must be tied to the scope of the claimed invention. Because the patent required safe administration of a specific amount of mifepristone, the Board did not err in requiring Teva to show a reasonable expectation of success for a specific mifepristone dosage. Applying this correct standard, the Court found that the evidence supported that a skilled artisan would have had no expectation as to whether co-administering dosages of mifepristone above the 300 mg/day threshold set forth in the Korlym label would be successful. The Federal Circuit also agreed with the Board that Teva’s expert testimony supported a finding of no expectation of success in achieving the claimed invention based on inconsistent testimony before and after institution.

Turning next to the applicability of Federal Circuit prior art range precedents, the Federal Circuit found that Teva had failed to prove that the general working conditions disclosed in the prior art encompassed the claimed invention. Substantial evidence supported the Board’s finding that there was no overlap in ranges because the prior art (Korlym label and industry publications) capped the range of co-administration dosages at 300 mg/day. The Court also noted that Teva’s reliance on mifepristone monotherapy dosages to create an overlap in the claimed ranges failed because the patent claims [...]

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PTO Will Transition to Electronic Issuance of Patents and Trademarks

The US Patent & Trademark Office (PTO) announced on December 10, 2021, that it intends to transition to electronic issuance of patents and trademarks in 2022. Under the current rule (37 C.F.R § 1.315), the PTO must deliver or mail a patent “upon issuance to the correspondence address of record.” The PTO will soon issue a notice of proposed rulemaking to seek public feedback on revising the rules of practice to issue patents electronically. Under the proposed changes, the PTO would no longer mail patents to the applicant. Instead, the PTO would issue patents electronically via the Patent Center and Patent Application Image Retrieval, from which the patents could be downloaded and printed.

While no changes to the trademark rules are necessary, the PTO will also issue a public request for comments on replacing paper registration certificates with digital versions.

The PTO believes that electronic issuance will reduce the time it takes for a patent or trademark to issue by about two weeks.

Once the transition is complete, applicants can still receive a paper copy of the issued patents and trademark registration certificates with an embossed gold seal and the director’s signature (i.e., a ribbon certificate) for a fee of $25 per copy.




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Exclusive Licensee Has Constitutional but Not Statutory Standing

The US Court of Appeals for the Federal Circuit vacated the dismissal of an exclusive licensee’s complaint for lack of statutory and constitutional standing, despite affirming that the licensee had no statutory standing where the district court erroneously found no constitutional standing. Univ. of So. Florida Res. Found., Inc. v. Fujifilm Med. Sys. U.S.A., Inc., Case No. 20-1872 (Fed. Cir. Nov. 23, 2021) (sealed opinion issued Oct. 22, 2021) (Stoll, J.)

In April 1997, the University of South Florida (USF) received an invention disclosure related to a workstation-user interface for digital mammography. In September 1997, the inventors, USF and the USF Research Foundation (USFRF) entered into a revenue allocation agreement assigning all rights in the invention to USF. The inventors also entered into a separate assignment agreement in 2002. The patent issued in 2003. The revenue allocation agreement was later followed by a nunc pro tunc license agreement, which recited an effective date of July 1997.

In May 2016, USFRF sued Fujifilm Medical Systems for infringement of the issued patent. USFRF pled that USF assigned its rights in the issued patent to USFRF such that USFRF was “currently the owner” of the patent. In June 2019, Fujifilm moved for summary judgment, arguing that USFRF lacked statutory standing because USF had not fully assigned the patent to USFRF. Five days later, USFRF amended its complaint to state that it was an exclusive licensee (i.e., it was not the assignee).

In May 2020, the district court dismissed the case, finding that USFRF lacked both statutory and constitutional standing. Analyzing the nunc pro tunc license agreement, the district court found a lack of statutory standing because the agreement was silent on (and thus did not transfer to USFRF) the right to sue to enforce the patent. The district court also found that USFRF lacked constitutional standing because USFRF had not established that the invention disclosure number in the license agreement corresponded to the issued patent and had not shown that the nunc pro tunc agreement was signed before the complaint was filed. USFRF appealed.

The Federal Circuit analyzed both statutory and constitutional standing and affirmed the district court’s finding with respect to statutory standing, reasoning that this case was analogous to others in which an exclusive licensee lacked statutory standing because the right to sue was either not transferred or only partially transferred. The Federal Circuit found that the district court had clearly erred with respect to constitutional standing, however. First, the Court held that there had been sufficient evidence tying the invention disclosure identified in the assignment agreement to the issued patent. Second, the Court found that it did not matter when the nunc pro tunc agreement was signed because the original revenue allocation agreement was signed before the complaint was filed and conveyed at least one exclusionary right to USFRF—enough for USFRF to have constitutional standing.

Because “the district court’s dismissal was predicated on constitutional standing,” the Federal Circuit remanded for further proceedings, including determination of whether USFRF may join USF.

[...]

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IPR on Written Description? Claims Found Unpatentable Based on Lack of Entitlement to Priority Date

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) ruling, based on a written description analysis, that certain claims were invalid as anticipated by an earlier priority application from the same family. Indivior UK Ltd. v. Dr. Reddy’s Labs. S.A., Case Nos. 20-2073, -2142 (Fed. Cir. Nov. 24, 2021) (Lourie, J.) (Linn, J., concurring in part and dissenting in part).

Indivior’s patent, which issued from a fifth continuation application claiming priority back to 2009, claimed orally dissolvable films with therapeutic agents. Some of the claims recited numeric ranges, such as “about 40% wt to about 60% wt of a water-soluble polymeric matrix.” Instead of a range, one claim recited a specific amount of “about 48.2% wt” of the polymeric matrix. The patent’s specification did not expressly mention the claimed ranges or the specific 48.2% amount, but it did contain tables comprising quantities of polymer from which Indivior contended a person of ordinary skill in the art could calculate the percentage of polymer by weight.

Indivior argued that the polymer weight percentage limitations were supported by the priority application and, therefore, the patent was entitled to that priority date. Dr. Reddy’s contended that since the polymer weight percentage limitations were added later, an intervening patent publication (Myers) was prior art and anticipated the claims. Indivior did not contest that if Myers was prior art, it anticipated the claims. As a result, the Board’s decision on anticipation under 35 U.S.C. §102 turned on the priority analysis which, in turn, hinged on written description. The Board found that the tables disclosed formulations from which the “48.2% wt” could be calculated and, thus, claims reciting that limitation were not anticipated by Myers. However, the Board found that the claimed ranges (i.e., about 40% wt to about 60% wt) were not disclosed in the specification, and those claims were therefore anticipated by Meyers. Indivior appealed the Board’s anticipation finding, and Dr. Reddy’s appealed the no anticipation finding.

The Federal Circuit first analyzed the specification and concluded that there was no written description support for the broader range of “about 40% wt to about 60% wt.” The Court explained that the range was not disclosed in the specification, the specific values of 40% and 60% were not disclosed and there was another “inconsistent” teaching for weights of “at least 25%.” The Court noted that two specific tables in the specification “do not constitute ranges; they are only specific, particular examples. For written description support of a claimed range, more clarity is required.” The Court explained that “[h]ere, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the [] application to create an otherwise unstated range. That is not a written description of the claimed range.” The Court applied similar analysis in finding lack of written description for other claims reciting a slightly different range. Ultimately, the Court agreed that there was no written [...]

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Federal Circuit Reverses Judge Stark Decision, Finds Computer Network Patent Eligible

The US Court of Appeals for the Federal Circuit concluded that a representative claim was directed to a patent-eligible improvement to computer functionality, and therefore reversed a decision authored by Judge Leonard P. Stark as a sitting judge in the US District Court for the District of Delaware. Mentone Solutions LLC v. Digi International Inc., Case Nos. 21-1202, -1203 (Fed. Cir. Nov. 15, 2021) (Moore, C.J.) (nonprecedential).

Mentone Solutions sued Digi International for infringement of Mentone’s patent directed to an improvement in dynamic resource allocation in a GPRS cellular network utilizing shifted uplink status flags (USF). Digi moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing that the patent claims were not patent eligible under 35 U.S.C. § 101. The district court granted the motion to dismiss, holding that the representative claim was patent ineligible for being “directed to the abstract idea of receiving a USF and transmitting data during the appropriate timeslots.” Mentone appealed.

The Federal Circuit began its analysis with a detailed explanation of the claimed technology and how its use of a “shifted USF” improved the normal operation of the communication system, noting that the shifted USF specifically allowed a mobile station to access previously restricted multi-slot configurations.

Reviewing the district court’s § 101 eligibility determination de novo, the Federal Circuit applied the Supreme Court’s two-step Alice framework, first determining whether the representative claim was directed to an abstract idea. The Court explained that in cases involving software, step one often turns on whether the claim focuses on specific asserted improvements in the computer’s capabilities rather than on an abstract idea which merely invoked a computer as a tool.

The Federal Circuit compared the claim in issue to those at issue in Packet Intelligence v. NetScout Sys., in which the Court found that the challenged claims were directed to a problem unique to computer networks and that the patent specification provided details on how the solution to the network problem was achieved. In Packet Intelligence, the Court looked to the patent specification to inform its understanding of the claimed invention and found that the specification made clear that the claimed invention solved a challenge unique to computers.

Similarly, in this case, the Federal Circuit explained that the representative claim did not recite generalized steps to be performed on a computer but rather a particular method of breaking the timing between the downlink USF and the subsequent uplink transmission. The Court noted that the term “shifted USF” was coined by the inventor, and that the specification and figures informed the Court’s understanding of the term, the claimed invention, the technical solution and how the elements of the claim work together to provide the solution. The Court concluded that the claimed invention solved a challenge unique to computer networks and was directed to patent-eligible improvements in computer functionality.

The Federal Circuit rejected the district court’s characterization of the claim as directed to the abstract idea of “receiving a USF and transmitting data during the appropriate [...]

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