Patent Docs

USPTO News Briefs

January 2, 2022

By Donald Zuhn —

USPTO Proposes Electronic Issuance of Patents

In a notice of proposed rulemaking published last month in the Federal Register (86 Fed. Reg. 71209), the U.S. Patent and Trademark Office is proposing to issue patents electronically through its patent document viewing systems (i.e., Patent Center and Patent Application Image Retrieval (PAIR)). As a result of the proposed changes to the rules, the Office would no longer issue patents on paper or physically deliver patents by mailing them to the correspondence address, and 37 C.F.R. § 1.315, which states that "[t]he patent will be delivered or mailed upon issuance to the correspondence address of record," would be removed and reserved.

Currently, the Office issues "letters patent" as paper copies bound with a cover sheet that has both an embossed seal and the signature of the USPTO Director. Under the proposed process, the Office would issue patents electronically under a new digital USPTO seal and with a digital signature from the USPTO Director. The notice indicates that the electronic issuance of patents will allow the Office to issue patents approximately two weeks faster than the current process. Stakeholders and patentees, however, would still have the option of ordering certified copies or paper presentation copies of patents.

The notice provides some historical background regarding the Office's efforts to establish beginning-to-end electronic processing for patent applications, noting that the Office implemented an electronic filing system in 2001, launched the Image File Wrapper system to replace paper processing of patent applications in 2003, and initiated the e-Office Action Program in 2007. According to the notice, electronic issuance of patents would be another step in the Office's effort to continue streamlining its service delivery processes. The notice also indicates that the Office is also considering electronically issuing reexamination certificates, statutory invention registrations, patent term extension certificates, and certificates of correction.

The notice provides some advice to stakeholders regarding best practices in view of the proposed change to the patent issuance process. In particular, the Office notes that:

Under the proposed electronic patent issuance process, the USPTO would issue the patent shortly after the payment of the issue fee. As a result, applicants would have less time, after the payment of the issue fee, to file continuing applications, Quick Path Information Disclosure Statements, or petitions under 37 CFR 1.313(c) to withdraw an application from issue. Therefore, the best practice would be for applicants to file these submissions as early as possible. Preferably, continuing applications should be filed before the payment of the issue fee.

The Office also encourages Applicants to participate in the e-Office Action Program in order to receive Issue Notifications, as the Office "foresees the possibility that a patent may issue electronically before the applicant receives a mailed Issue Notification," and the use of the e-Office Action Program would "avoid this possibility."

The Office's notice indicates that comments regarding the proposed changes should be submitted by February 14, 2022 to ensure consideration, and that such comments should be submitted through the Federal eRulemaking Portal.

USPTO Proposes Change to Receipt Date for Patent Electronic Submissions

In a notice of proposed rulemaking published last month in the Federal Register (86 Fed. Reg. 69195), the U.S. Patent and Trademark Office is proposing to amend the patent rules of practice to provide that the receipt date of correspondence submitted via the Office's electronic filing system will be the date in the Eastern time zone when the Office receives the correspondence, as opposed to the date on which the correspondence is received at the correspondence address in Alexandria, Virginia. The Office notes that the change is necessary because the Office is in the process of placing servers in Manassas, Virginia, and anticipates that in the future it might provide servers outside of the Eastern time zone. According to the notice, the change to the rules will ensure consistency and predictability with respect to correspondence receipt dates as the date of receipt for electronic submissions will no longer depend upon the location of the Office's servers.

The Office also proposes changing the rules to define "Eastern time" as meaning Eastern Standard Time or Eastern Daylight Time in the United States, as appropriate. Finally, the notice points out that because the Office does not "strictly require" the use of an address when patent-related correspondence is submitted via the Office's electronic filing system, the proposed changes to the rules would exclude such correspondence from the address marking requirements of 37 C.F.R. § 1.1(a). The Office notes, however, that Applicants may continue to provide an address on correspondence submitted via the Office electronic filing system consistent with § 1.1(a), but that the inclusion of an address is not mandatory.

The Office's notice indicates that comments regarding the proposed changes should be submitted by February 7, 2022 to ensure consideration, and that such comments should be submitted through the Federal eRulemaking Portal.

USPTO Delays Implementation of Voluntary CLE Certification

In a notice of proposed rulemaking published last month in the Federal Register (86 Fed. Reg. 71453), the U.S. Patent and Trademark Office announced that it would be "delaying indefinitely" the implementation of voluntary continuing legal education (CLE) certification.

In August 2020, the Office initially proposed allowing registered patent practitioners (and individuals granted limited recognition to practice before the USPTO in patent matters) to voluntarily certify to the Director of the Office of Enrollment and Discipline (OED) that they had completed 6 credits of CLE in the preceding 24 months (including 5 hours of CLE in patent law and practice and 1 hour of CLE in ethics). The Office published proposed CLE requirements in October 2020 and sought public comment regarding those proposed requirements. By the close of the comment period in January 2021, the Office had received 26 comments. In June 2021, the Office announced that voluntary CLE certification would commence in the spring of 2022. The Office's latest notice, however, has now delayed implementation of voluntary CLE certification.

The notice indicates that the Office will provide at least 120 days' notice prior to implementation of voluntary CLE certification, and the Office will issue final CLE guidelines and specific instructions for making the certification prior to any implementation date.
Conference & CLE Calendar

January 2, 2022

January 19, 2021 – "Top Patent Law Stories of 2021" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

January 19, 2022 – "Challenging the Validity of Patent Rights in Australia: Options and Strategies" (Spruson & Ferguson) – 4:00 pm (ET)

January 25, 2022 – "User Interfaces — What Can You Patent?" (J A Kemp) – 4:00 pm to 5:00 pm (GMT)
Webinar on Top Patent Law Stories of 2021

January 1, 2022

McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar on the "Top Patent Law Stories of 2021" on January 19, 2022 from 10:00 am to 11:15 am (CT). Since 2007, the Patent Docs weblog has presented an annual, end-of-the-year review of the top stories in patent law. In this presentation, Patent Docs co-authors Donald Zuhn, Kevin Noonan, and Michael Borella will take a look back at the top patent stories of 2021, many of which will likely impact patent applicants and practitioners in the coming year.

While there is no fee to participate, attendees must register in advance. Those wishing to register can do so here. CLE credit is pending for the states of California, Illinois, New Jersey, New York, North Carolina, and Virginia.
Webinar on Challenging Validity of Australian Patents

January 1, 2022

Spruson & Ferguson will be offering a webinar entitled "Challenging the Validity of Patent Rights in Australia: Options and Strategies" on January 19, 2022 at 4:00 pm (ET). Mike Zammit and Doug Horton of Spruson & Ferguson will discuss:

• The life cycle of a standard Australian patent;
• Pre-grant challenges: (a) third party observations, (b) substantive oppositions (including appeals to a Court) and (c) re-examination;
• Post-grant challenges: (a) re-examination, and (b) revocation before the Courts; and
• Several case studies will be provided.

While there is no cost to participate in the program, those interested in attending the webinar can register here.
Webinar on Patentability of User Interfaces

January 1, 2022

J A Kemp will be offering a webinar entitled "User Interfaces — What Can You Patent?" on January 25, 2022 from 4:00 pm to 5:00 pm (GMT). Dominic Forsthye and Callum Docherty of J A Kemp will look at the EPO's approach to excluded matter as applied to user interfaces, using examples from case law to try to make sense of what can and cannot be patented at the EPO, and will discuss practical tips for drafting and prosecuting UI applications at the EPO to increase chances of success. The webinar will address the following topics:

• The EPO's approach to excluded subject-matter
• Examples from case law to highlight how the EPO approaches user interfaces
• Technical effect, and arguments that can be employed to highlight technical effect
• A brief review of the UK approach to user interfaces
• Practical drafting tips for user interface inventions

There is no registration fee for this webinar. However, those interested in registering for the webinar, should do so here.
Alpek Polyester, S.A. v. Polymetrix AG (Fed. Cir. 2021)

December 30, 2021

By Kevin E. Noonan —

While the Federal Circuit has patent law as its principal focus, as a U.S. Circuit Court of Appeals, questions come before the Court on more mundane, procedural matters (which, sometimes being dispositive, does not reduce their importance to the parties and occasionally the rest of us). One such case was decided on December 16th in Alpek Polyester, S.A. v. Polymetrix AG (complicated, as should be evident from the caption, by involving non-US. parties and having putatively infringing activities arising both here and abroad).

The case arose over Polymetrix's asserted infringement of U.S. Patent Nos. 7,790,840, 7,868,125, and 7,192,545 owned by Alpek (a Mexican company) and exclusively licensed to co-Plaintiff DAK Americas LLC (a U.S. company), the patent claim being directed to methods for producing polyethylene terephthalate (PET) resins; because the matters on appeal were exclusively procedural there was no need in the opinion (or here) to delve into the scope of the claims any further. Defendant Polymetrix is a Swiss company in the business of supplying equipment and engineering services for constructing plants for making PET resin (while not making the resin itself, i.e., it provides the means but not the product and thus did not itself practice the claimed methods).

The activity that prompted the lawsuit was Polymetrix contracting with a Polish company, Indorama Ventures Poland sp. z o.o. ("IVP") wherein Polymetrix equipped a manufacturing plant located in Wloclawek, Poland to run the patented process. When the work was completed Polymetrix entered into a "commissioning" period during which the plant was tested (using the patented process to product PET resin); during this time Polymetrix retained ownership of the equipment and IVP withheld payment until the installation passed appropriate tests.

Jurisdiction arose in the U.S. when IVP sent to affiliates in the U.S. (Auriga Polymers and AlphaPet Inc.) samples of PET resin made in the Wloclawek plant using Polymetrix equipment to perform the patented process. There were three instances of this importation, including one wherein an AlphaPet employee brought the sample into the country personally. Alpek sued following these activities, alleging that Polymetrix induced infringement under 35 U.S.C. § 271(b) (the predicate literal infringement lying under the provisions of § 271(g)). While the opinion references "a complicated and protracted international discovery process" that ensued, only three incidents were worthy of the Court's consideration. The first involved failure of Defendant Polymetrix to disclose under Federal Rule of Civil Procedure 26 the identity of IVP's director, Mr. Saini (the relevance of this failure being Polymetrix's reliance on a declaration in support of a summary judgment motion at issue in this appeal). Second was disputed testimony in a deposition (of a Rule 30(b)(6) witness representing Auriga) that Polymetrix owned the plant in Wloclawek, Poland, supporting Alpek's motion to amend its complaint to include an allegation of direct infringement under § 271(g). The third and final discovery dispute involved an assertion of privilege by Polymetrix over an opinion of counsel concerning Alpek's infringement allegations, which Alpek alleged had been waived by disclosure to a potential corporate suitor.

Polymetrix filed a summary judgment motion that it did not infringe, which the District Court granted. The District Court rejected Alpek's arguments that there were disputed issues of material fact, denied Alpek's motion to strike the Saini testimony due to failure to satisfy Rule 26 when Polymetrix did not identify him as someone with knowledge about the company and its activities, and held that the misstatement at deposition was inadmissible under Federal Rule of Evidence 602 because the witness lacked personal knowledge regarding importation of PET resin made in the Polish plant using the patented process. The District Court also denied Alpek's motion to amend the complaint as being untimely. This appeal followed.

The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges O'Malley and Stoll. The opinion addresses the four arguments raised by Alpek on appeal:

• First, Alpek argues that the court abused its discretion by disregarding [the Rule 30(b)(6) witness's] admission that the July 17, 2014 sample was brought into the United States 'for Polymetrix' [arguing that the statement was admissible because the witness's testimony under Rule 30(b)(6) does not require personal knowledge to be admissible].

• Second, Alpek argues that the court erred by finding that Polymetrix did not ratify IVP's importation by using test results from the United States [by receiving and relying on test results it knew were produced by Auriga and AlphaPet in the U.S.]

• Third, Alpek argues that the court erred in failing to recognize fact disputes that stem from Polymetrix's ownership of the equipment under a Swedish law interpretation of the contract[ and]

• [F]ourth, Alpek argues that the court erred by declining to strike the Saini declaration upon which Polymetrix heavily relied to support its summary judgment motion [based on Federal Rule of Civil Procedure 37].

Polymetrix's counterargument was based on the causation prong of § 271(b), i.e., that its activities did not cause IVP to import into the U.S. PET resin samples for testing. Regarding Alpek's first argument, Polymetrix contended that the witness misspoke due to misunderstanding the question (which the witness clarified at the time during subsequent testimony during the deposition). The Federal Circuit, applying Eighth Circuit law appropriate for reviewing the District Court's decision here, noted that in the Eighth Circuit evidence to be considered on summary judgment must be "admissible evidence," citing Crews v. Monarch Fire Prot. Dist., 771 F.3d 1085, 1092 (8th Cir. 2014) (emphasis in original) (citing Nooner v. Norris, 594 F.3d 592, 603 (8th Cir. 2010). Under the applicable abuse of discretion standard, the Federal Circuit found no abuse (noting that the witness did not testify at trial and "would not [have been] admissible at trial under Federal Rule of Evidence 801(d)(2)" nor Federal Rule of Civil Procedure 32(a)(3) relating to the testimony of an adverse party. The opinion also distinguished seemingly contrary precedent in General Mills Operations, LLC v. Five Star Custom Foods, Ltd., 703 F.3d 1104, 1110 (8th Cir. 2013), because the disputed testimony was not by an adverse party's witness. Finally, the Federal Circuit did not find Alpek's argument persuasive insofar as it relied on two words ("for Polymetrix") "excerpted from one question in one deposition in the larger context of a protracted discovery process that lasted years" and was asserted by Alpek for an inducement argument that was "contrary to the overwhelming majority of the evidence which demonstrates that Polymetrix had no knowledge or concern about where, when, or how IVP conducted performance tests." In the panel's view the evidence showed the witness simply misspoke. The Court found no genuine issue of material fact here that would justify the "delay and expense" of a trial.

Regarding Alpek's second argument, the Federal Circuit did not see any genuine issue of material fact on the evidence, which the Court considered to be supported only with "a conclusory assertion by [Alpek's] expert." According to the opinion, the "overwhelming majority of the evidence" supported a finding that AlphaPet was not the source of the data relied upon by Polymetrix with regard to the performance of the Polish plant (including agreement with the District Court that Alpek blundered when it asserted that this data "match[ed] up almost exactly," the opinion stating that "If the AlphaPet test results were really the source of the data for Polymetrix's report, we can discern no reason why the two sets of data would not match up exactly" (emphases in opinion).

As for Alpek's third argument, the Federal Circuit agreed with the District Court that the details of Swedish contract law, asserted to support Alpek's contention that under that law Polymetrix was responsible for the activities in the Polish plant, were "inapposite." "As a matter of American law," according to the opinion, 'the mere fact that Polymetrix owned the plant equipment is wholly insufficient for Alpek to meet its burden of proving that Polymetrix took active steps to induce IVP to infringe," citing MGM Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 935–36 (2005), in support for this principle.

Finally, the Court rejected Alpek's fourth argument, based in part on the breadth of the District Court's discretion on discovery matters and enforcement of the Civil Procedure rules. The Federal Circuit saw none of the surprise or prejudice the Rule was intended to prevent, in view of the "more than 1,000 documents produced during discovery" bearing the witness's name.

Having dispensed with the summary judgment portion of the appeal, the panel turned to the District Court's denial of Alpek's motion to amend its complaint. Here the Court found no justification for Alpek's failure to file its motion by the deadline date the District Court had established, and the panel rejected Alpek's allegations that witness testimony adduced during a deposition that occurred after the deadline alerted it to the factual bases for the amended complaint, i.e., that Polymetrix was a literal infringer under § 271(g). And Alpek's arguments, according to the opinion, "consist[ed] of mere disagreement with the magistrate judge's view of the facts." Under these circumstances the Federal Circuit affirmed denial of Alpek's motion to amend.

The final issue considered by the Court was Alpek's motion to compel production of attorney opinion based on waiver due to disclosure to Polymetrix's corporate suitor. The Court agreed with Polymetrix that the panel need not address the issue because it "has no bearing on the district court's summary judgment ruling." The opinion notes that Alpek had the burden of showing that Polymetrix caused IVP's infringement of the patents-in-suit, while the opinion even if offered into evidence would only address Polymetrix' intent to induce infringement, citing Omega Patents, LLC v. CalAmp Corp., 920 F.3d 1337, 1352–53 (Fed. Cir. 2019). Because the District Court's basis for granting summary judgment was Alpek's failure to establish Polymetrix's causation of IVP's asserted infringement, "the issue of intent did not factor into the district court's grant of summary judgment" according to the Court (emphasis in opinion). This issue, in view of the Court's affirmance of the District Court's grant of summary judgment, was thus moot according to the panel.

Alpek Polyester, S.A. v. Polymetrix AG (Fed. Cir. 2021)
Nonprecedential disposition
Panel: Circuit Judges Lourie, O'Malley, and Stoll
Opinion by Circuit Judge Lourie
PTAB Sets Motions and Times in CVC vs. Sigma Interference No. 106,132

December 28, 2021

By Kevin E. Noonan —

Following a telephone conference held on August 16th (a transcript of which can be found here) between the Board and representatives of Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") and Senior Party Sigma-Aldrich, the Board issued its Order on September 20th authorizing motions and setting times under 37 C.F.R. §§ 104(c) and 121.

As it had in its Order setting motions and times in related Interference No. 106,133 between Sigma-Aldrich and Junior Party the Broad Institute, Harvard University, and MIT, the Order begins with the Board's rejection of any of these motions being "threshold" motions (as the parties had argued), stating that "[p]atentability over the prior art is not now, and never has been, a 'threshold issue.'" Further, the Board stated that "a holding during the course of interference that a party's claims are unpatentable over prior art does not necessarily deprive that party of standing on the central issue of an interference—priority," citing 37 C.F.R. § 41.201, noting that a party in an interference having claims deemed unpatentable "may still have a basis to show the opponent is not entitled to a patent because the opponent was not the first to invent the interfering subject matter." This raises the possibility that the outcome of an interference may be that neither party is entitled to a patent on claims falling within the scope of the Interference Count.

Regarding Junior Part CVC's Motions List, the Board DEFERRED CVC'S Substantive Preliminary Motion No. 1, which CVC characterized as a "threshold" motion, that sought to have a finding of no interference-in-fact based on CVC's allegations that Sigma-Aldrich's application-in-interference was properly governed under the "first inventor to file" provisions of the Leahy-Smith America Invents Act; the basis for this allegation was that Sigma-Aldrich's application-in-interference "contains or contains at any time" (emphasis in brief) subject matter not entitled to priority to an application filed prior to enactment of the AIA. The Board considered this not as a motion for no interference-in-fact, as CVC maintained, but rather as a motion for unpatentability and thus agreed to consider granting the motion and hearing CVC's arguments during the priority phase of the interference.

The Board GRANTED CVC leave to file Substantive Preliminary Motion No. 2 under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) for benefit of priority to U.S. Provisional Application Nos. 61/652,086, filed May 25, 2012 ("P1"), or 61/716,256, filed October 19, 2012 ("P2"). The Board designated this as CVC SUBSTANTIVE MOTION 1 and also granted CVC's request to extend the page limit for CVC's Motion and Sigma-Aldrich's Opposition to 45 pages.

The Board GRANTED CVC leave to file Substantive Preliminary Motion No. 3 seeking to have the Board deny Sigma-Aldrich benefit of priority to its earliest provisional application, No. 61/734,256, filed December 6, 2012. The Board designated this as CVC SUBSTANTIVE MOTION 2.

The Board GRANTED CVC leave to file Substantive Preliminary Motion No. 4 seeking the Board to change the Count, including the alternative portion of the Count to recite Sigma-Aldrich's involved claim 33 instead of 31 as declared. The Board designated this as CVC SUBSTANTIVE MOTION 3.

The Bared DEFERRED CVC's proposed Preliminary Motions 5-7 which sought to file motions under 37 C.F.R. § 41.121(a)(1) for unpatentability of Sigma-Aldrich's claims in this interference. The Board noted that it would consider authorizing these motions during the priority phase.

The Board GRANTED CVC leave to file proposed Contingent Miscellaneous Motion No. 8 under 37 C.F.R. § 41.121(a)(3), asking the Board to add claims of U.S. Patent Nos. 10,731,181 and 10,745,716, designating this motion as CVC MOTION 4. The Board DENIED (without prejudice). The Board DENIED CVC leave to file Contingent Miscellaneous Motion No. 9 under 37 C.F.R. § 41.121(a)(3), asking the Board to add claims in Sigma-Aldrich's U.S. Patent Application Nos. 15/188,927; 15/188,931; 16/943,767; and 17/208,477 to this Interference because these claims had not yet been allowed.

Finally, CVC's request to file a motion under 37 C.F.R. § 41.208(a)(4) seeking judgment based on priority was DEFERRED until the priority phase.

Turning to Sigma-Aldrich's Motions list, the Board GRANTED Sigma-Aldrich leave to file its proposed Preliminary Motion No. 1 under 37 C.F.R. § 41.121(a)(1)(i) to change the Count to Count 2:

Proposed Count 2 (reciting in the alternative claim 31 of Sigma-Aldrich's Application No. 15/456,204 as in the Count as declared):

156. A method of cleaving or editing a target DNA molecule or modulating transcription of at least one gene encoded thereon, the method comprising:
contacting a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)—CRISPR associated (Cas) (CRISPR-Cas) system comprising:
    a) a single molecule DNA-targeting RNA comprising
        i) a targeter-RNA that hybridizes with the target sequence, and
        ii) an activator-RNA that hybridizes with the targeter-RNA to form a double-stranded RNA duplex of a protein-binding segment,
wherein the targeter-RNA and the activator-RNA are covalently linked to one another with intervening nucleotides; and
    b) a Cas9 protein,
wherein the single molecule DNA-targeting RNA forms a complex with the Cas9 protein, thereby targeting the Cas9 protein to the target DNA molecule
whereby said target DNA molecule is cleaved or edited or transcription of at least one gene encoded by the target DNA molecule is modulated, and
wherein said contacting occurs in a eukaryotic cell.

157. The method of Claim 156, wherein, prior to the contacting step, the method comprises:
introducing into the eukaryotic cell containing the target DNA molecule:
    1) the single molecule DNA-targeting RNA, or a DNA molecule comprising a nucleotide sequence that (i) encodes the single molecule DNA targeting RNA and (ii) is operably linked to a regulatory element operable in said eukaryotic cell; and
    2) the Cas9 protein, an RNA molecule comprising a nucleotide sequence encoding the Cas9 protein, or a DNA molecule comprising a nucleotide sequence that (i) encodes the Cas9 protein and (ii) is operably linked to a regulatory element operable in said eukaryotic cell.

164. The method of Claim 157, wherein the method comprises creation of a double strand break in the target DNA molecule which is repaired by a homology-directed repair mechanism which incorporates a sequence of a donor polynucleotide into the target DNA molecule, thereby editing the target DNA molecule.

(CVC Application No. 15/947,680)

The Board designated this as SIGMA MOTION 1.

The Board DENIED Sigma-Aldrich leave to file its proposed Contingent Motion No. 2 to deny CVC benefit of Application Nos. 61/757,640, filed Jan. 28, 2013 ("CVC P3"), or 61/765,576, filed Feb. 15, 2013 ("CVC P4"), under 37 C.F.R. § 41.121(a)(1), as "moot ab initio," on the grounds that:

[A] motion to change a count must show why the movant should be accorded any benefit for the proposed count and may overcome the presumption that the opponent is entitled to its earliest accorded benefit date by showing in the motion why the opponent should not be accorded benefit of an earlier application with respect to the proposed count. (See Standing Order 8 ¶ 208.2.)

And thus any arguments in this proposed motion should be presented in SIGMA MOTION 1.

The Board DEFERRED until the priority phase Sigma-Aldrich's proposed Substantive Preliminary Motion No. 3 that CVC's claims were unpatentable.

The Board DISMISSED (as moot) Sigma-Aldrich's request for a Protective Order, instead the Board issuing an ORDER that Sigma-Aldrich could submit a protective order to keep its Priority Statement under seal until the priority phase of the interference, suggesting Sigma-Aldrich use the protective order filed in Interference 106,115 "as reference."

Sigma-Aldrich's request to file a motion under 37 C.F.R. § 41.208(a)(4) seeking judgment based on priority was DEFERRED until the priority phase.

In addition to these Motion requests, Sigma-Aldrich requested that the requirement under 37 C.F.R. § 41.121(d) that the parties file separate statements of material fact be waived; the Board DENIED this request. The Board GRANTED the parties' request that the deadlines for filing and service be extended to 8:00 pm for filing and 11:00 pm, respectively, for all papers filed and served in the interference. The Board WAIVED the requirement for sequential exhibit numbers and ORDERED that exhibits could be filed within two business days of the due date for any paper in which they were cited. The Board also granted Sigma-Aldrich's request that it correct certain typographical errors in the caption.

The Board set out the following briefing schedule, subject to agreement by the parties to change the schedule for TIME PERIODS 1-6.

TIME PERIOD 1 ………………………………………………….29 October 2021
File motions
File (but serve one business day later) priority statements
TIME PERIOD 2 ………………………………………………..10 December 2021
File responsive motions to motions filed in TIME PERIOD 1
TIME PERIOD 3 …………………………………………………..21 January 2022
File oppositions to all motions
TIME PERIOD 4 ………………………………………………………4 March 2022
File all replies
TIME PERIOD 5 ………………………………………………………15 April 2022
File request for oral argument
File motions to exclude.
File observations
TIME PERIOD 6 …………………………………………………………6 May 2022
File oppositions to motions to exclude
File response to observations
TIME PERIOD 7 ………………………………………………………..20 May 2022
File replies to oppositions to motions to exclude
DEFAULT ORAL ARGUMENT DATE ………………………………………………TBD
Quest Diagnostics Investments LLC v. Hirshfeld (Fed. Cir. 2021)

December 27, 2021

By Donald Zuhn –-

Earlier today, the Federal Circuit affirmed the final determination by the U.S. Patent and Trademark Office Patent Trial and Appeal Board finding claims 1, 2, and 4-14 of U.S. Patent No. 8,409,862 unpatentable as either anticipated or obvious.

The '862 patent is directed to using mass spectrometry to detect low levels of testosterone in female humans. The '862 patent explains that while testosterone levels are much lower in females as compared to males, testosterone can be purified prior to mass spectrometry, which can improve the limit of detection. Claims 8 and 9, which were relevant to the appeal, require the detection of testosterone at concentrations of less than 5 ng/dL or less than 1 ng/dL in the sample, respectively.

Laboratory Corporation of America Holdings had petitioned for inter partes review of the claims found by the Board to be unpatentable, arguing that claims 8 and 9 would have been obvious in view of Clarke, an abstract found on a CD from the 49th annual conference of the American Society for Mass Spectrometry (ASMS) held in May 2001, or as obvious in view of Clarke in combination with another reference (Draisci). The opinion notes that "Clarke details a method for detecting low levels of testosterone and describes a method similar to the '862 patent—wherein testosterone is purified before mass spectrometry." The opinion also notes that Clarke discloses the detection of testosterone down to 50 pg/mL, which is equivalent to 5 ng/dL.

On appeal, Quest argued that the Board erred with respect to two of its findings: first, that Clarke was valid prior art as a printed publication, and second, that claims 8 and 9 would have been obvious in light of Clarke or Clarke in combination with Draisci. Regarding the first determination, the Board noted that the ASMS sent the CD containing Clarke (and approximately 1,600 other abstracts) to thousands of ASMS members, and that the CD was available in the University of Wisconsin-Madison library before the priority date of the '862 patent. The Board also noted that the CD permitted users to search abstracts using certain keywords. Regarding the second determination, the Board concluded that it would have been obvious to reach detection limits below 5 ng/dL and 1 ng/dL based on the teachings of Clarke or Clarke with Draisci, finding that a skilled artisan would have been motivated to achieve a lower level of detection and would have reached these levels by optimizing several experimental parameters (in particular, by increasing the volume of the sample and modernizing the equipment).

With regard to Clarke, Quest argued that this reference was not a printed publication because it was not publicly accessible. In particular, Quest pointed out that Clarke was on a CD with approximately 1,600 other abstracts and that the CD provided minimal indexing, which made Clarke "an obscure, inaccessible reference." The Federal Circuit, however, disagreed, stating that "although Clarke was surrounded by hundreds of other abstracts, the ASMS distributed the CD to the specific people most motivated to search the CD and find Clarke" (emphasis in opinion). The Federal Circuit also noted that the CD allowed for some keyword searching using several mass spectrometry-related keywords, even if the keyword "testosterone" could not be searched. The Federal Circuit therefore concluded that substantial evidence supported the Board's finding that Clarke was publicly available and thus prior art.

With regard to the Board's finding of obviousness with respect to claims 8 and 9, Quest argued that there was no motivation to modify Clarke to increase sensitivity, that there was no reasonable expectation of success in doing so, and that there was a documented failure of others. The Federal Circuit first found that substantial evidence supported the Board's conclusion that there was a motivation to improve the sensitivity of methods measuring testosterone. Quest had specifically argued that 5 ng/dL and 1 ng/dL of testosterone are below the clinically relevant range of testosterone, but the Court was unpersuaded that this would have discouraged the development of more sensitive methods. The Court next found that substantial evidence supported the Board's finding that a skilled artisan would have had a reasonable expectation of success of achieving a lower level of detection, noting that the Board had recognized a number of parameters, including increasing the sample volume, that a skilled artisan could have modified to reach 5 ng/dL or 1 ng/dL detection. Finally, the Court was unpersuaded by Quest's argument that Kushnir et al., 52(1) CLIN. CHEM. 120–28 (2006), demonstrated a failure of others to reach detection levels of 5 ng/dL or 1 ng/dL without derivatizing testosterone. "Given the deferential standard of review, as well as the differences in Kushnir's detection method relative to the claims at issue," the Board "decline[d] to say that the Board erred in determining that Kushnir fails to establish nonobviousness." The Federal Circuit therefore found that substantial evidence supported the facts underlying the Board's conclusion that claims 8 and 9 would have been obvious in view of Clarke.

Finding that substantial evidence supported both of the Board's findings that were challenged by Quest, the Federal Circuit affirmed the Board's finding that claims 1, 2, and 4–14 of the '862 patent were unpatentable as either obvious or anticipated.

Quest Diagnostics Investments LLC v. Hirshfeld (Fed. Cir. 2021)
Nonprecedential disposition
Panel: Chief Judge Moore and Circuit Judges Clevenger and Chen
Opinion by Circuit Judge Chen
PTAB Sets Motions and Times in Broad vs. Sigma Interference No. 106,133

December 26, 2021

By Kevin E. Noonan —

Following a telephone conference held on August 16th (a transcript of which can be found here) between the Board and representatives of Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) and Senior Party Sigma-Aldrich, the Board issued its Order on September 20th authorizing motions and setting times under 37 C.F.R. §§ 104(c) and 121.

The Order begins with the Board's rejection of any of these motions being "threshold" motions (as the parties had argued), stating that "[p]atentability over the prior art is not now, and never has been, a 'threshold issue.'" Further, the Board stated that "a holding during the course of interference that a party's claims are unpatentable over prior art does not necessarily deprive that party of standing on the central issue of an interference—priority," citing 37 C.F.R. § 41.201, noting that a party in an interference having claims deemed unpatentable "may still have a basis to show the opponent is not entitled to a patent because the opponent was not the first to invent the interfering subject matter." This raises the possibility that the outcome of an interference may be that neither party is entitled to a patent on claims falling within the scope of the Interference Count.

Turning to Junior Party Broad's motions, Broad requested in its proposed Substantive Preliminary Motion No. 1 to change the Count under 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2).* The justification here as in earlier interferences (Nos. 106,115 and 106,126) was to provide "a count broad enough to cover Broad's best proofs, which are directed to CRISPR-Cas9 systems using dual-molecule RNA but not including a donor polynucleotide sequence." Broad argued in the alternative a proposed Substitute Count 2:

A CRISPR-Cas9 system, for use in a eukaryotic cell, comprising:
    a) a Cas9 or a nucleic acid encoding the Cas9 and
    b) an RNA or a nucleic acid encoding the RNA, wherein the RNA is a dual RNA comprising a CRISPR RNA (crRNA) and a trans activating crRNA (tracrRNA) or wherein the RNA is a chimeric RNA comprising a crRNA fused to a tracrRNA,
wherein the crRNA directs the Cas9 to a target sequence in a eukaryotic cell, whereby a site-specific, double-strand break is introduced, or the target sequence is edited.

or, as in this interference as declared, claim 31 of U.S. Application No. 15/456,204.

Alternative proposed Substitute Count 3 recited:

A method comprising: introducing into, or expressing in, a eukaryotic cell having a DNA molecule,
    (I)    a Cas9 protein or one or more nucleotide sequences encoding the Cas9 protein;
    (II)   an RNA or one or more nucleotide sequences encoding the RNA, the RNA comprising: (a) a first RNA comprising a first ribonucleotide sequence and a second ribonucleotide sequence, and (b) a second RNA; and
    (III) a template polynucleotide;
    wherein the second RNA forms an RNA duplex with the second ribonucleotide sequence, and wherein, in the eukaryotic cell, the first ribonucleotide sequence directs the Cas9 protein to a target sequence of the DNA molecule, whereby the Cas9 cleaves both strands of the DNA molecule and the cleavage is repaired by integration of the template polynucleotide into the DNA molecule in the eukaryotic cell.

or, as in this interference as declared, claim 31 of U.S. Application No. 15/456,204; the Board notes that the first alternative portion of proposed Substitute Count 3 corresponds to Broad Application No. 16/177,403 claim 52 which has not been deemed allowable in ex parte examination.

The Board understood these proposed Substitute Counts to be directed to common subject matter directed to CRISPR-mediated DNA cleavage in eukaryotic cells and that Broad may argue that certain of its claims designated as corresponding to Count 1 in the Declaration of Interference do not correspond to Count 3. The Board GRANTED Broad's request to be filed as BROAD MOTION 1 directed at substituting proposed Substitute Count 3 for the Count in the interference as declared.

Broad's proposed Contingent Motion No. 1 requested leave to file a motion under 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) to add claims in Broad applications not designated as corresponding to the Count as declared. These include claims 1, 40, and 41 of Application No. 15/160,710; claims 74, 94, and 95 of U.S. Application No. 15/430,260; and claims 52-56 of U.S Application No. 16/177,403 (although these claims have not been deemed allowable by the Office). The Board GRANTED Broad's request to be filed as BROAD MOTION 2.

The Broad's proposed Contingent Motion No. 2 requested leave to file a motion under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(2), designating various claims as not corresponding to Substitute Count 3 on a variety of grounds. The Board GRANTED Broad's request to be filed as BROAD MOTION 3.

The Board DENIED Broad's proposed Motion No. 4 seeking judgment of unpatentability under 37 C.F.R. §§ 41.121(a)(1)(iii) on the basis that Sigma-Aldrich's involved application (Application No. 15/456,204) is not entitled to priority benefit to its first provisional application, U.S. Application No. 61/734,256, for failing to provide an adequate written description and for failing to provide a constructive reduction to practice of the claimed subject matter. The basis for the Board's denial was that "the motion will not further the inquiry into priority of invention of the count." The Board DEFERRED consideration of whether to authorize a motion regarding unpatentability of Sigma-Aldrich's claims-in-interference until the priority phase.

Instead of considering Broad's final proposed Preliminary Motion under 37 C.F.R. § 41.121(a)(3), the Board entered an ORDER requiring both parties to provide notice of any allowed claims to the Board and the examiners of its application and DENIED this request as moot.

Finally, Broad's request to file a motion under 37 C.F.R. § 41.208(a)(4) seeking judgment based on priority was DEFERRED until the priority phase.

For Sigma-Aldrich's motions requests, the Board DENIED request for Motion No. 1 seeking to terminate the interference without entering judgment based on Broad lacking standing. In its Motions List, Sigma-Aldrich argued that Broad's patents and applications having claims corresponding to the Count were not entitled to proceed because they were subject to the first-inventor-to-file provisions of the Leahy-Smith America Invents Act. Unfortunately for Sigma-Aldrich, its counsel argued during the teleconference that Broad's claims could be subject to both the preclusions under the AIA of showing an invention date earlier than its filing date and be subject to the provisions of pre-AIA 35 U.S.C. § 102(g). The Board confessed that the basis of this argument was unclear, and that Sigma-Aldrich had not articulated a persuasive argument for why the interference was improvidently declared.

Sigma-Aldrich's second proposed Substantive Motion was to challenge Broad's entitlement to be accorded benefit of its provisional applications for failure to provide a constructive reduction to practice of an embodiment falling within the scope of Count 1. The Board GRANTED this request and designated this SIGMA MOTION 1.

Sigma-Aldrich's third proposed Substantive Motion was to have the Board designate Broad's application No. 15/330,876 as not corresponding to the Count. The Board GRANTED this request and designated this SIGMA MOTION 2.

Sigma-Aldrich's fourth proposed Motion was for a protective order (analogous to protective orders imposed in other interferences involving CVC and Broad and these patents and applications; see "CRISPR Housekeeping" and "ToolGen Files Proposed Protective Orders in CRISPR Interferences"). The Board issued an ORDER that Sigma-Aldrich could submit a protective order to keep its Priority Statement under seal until the priority phase of the interference, suggesting Sigma-Aldrich use the protective order filed in Interference 106,115 "as reference." The motion request was thus DENIED as moot.

Sigma-Aldrich's request to file a motion under 37 C.F.R. § 41.208(a)(4) seeking judgment based on priority was DEFERRED until the priority phase.

In addition to these Motion requests, Sigma-Aldrich requested that the requirement under 37 C.F.R. § 41.121(d) that the parties file separate statements of material fact be waived; the Board DENIED this request. The Board GRANTED the parties' request that the deadlines for filing and service be extended to 8 o'clock pm for filing and 11 o'clock pm, respectively, for all papers filed and served in the interference. The Board WAIVED the requirement for sequential exhibit numbers and ORDERED that exhibits could be filed within two business days of the due date for any paper in which they were cited.

The Board set out the following briefing schedule, subject to agreement by the parties to change the schedule for TIME PERIODS 1-6.

TIME PERIOD 1 ………………………………………………….29 October 2021
File motions
File (but serve one business day later) priority statements
TIME PERIOD 2 ………………………………………………..10 December 2021
File responsive motions to motions filed in TIME PERIOD 1
TIME PERIOD 3 …………………………………………………..21 January 2022
File oppositions to all motions
TIME PERIOD 4 ………………………………………………………4 March 2022
File all replies
TIME PERIOD 5 ………………………………………………………15 April 2022
File request for oral argument
File motions to exclude
File observations
TIME PERIOD 6 …………………………………………………………6 May 2022
File oppositions to motions to exclude
File response to observations
TIME PERIOD 7 ………………………………………………………..20 May 2022
File replies to oppositions to motions to exclude
DEFAULT ORAL ARGUMENT DATE ………………………………………………TBD
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December 24, 2021

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