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  • FCBA Program on Hot Topics in IP

    Fcbalogo
    The Federal Circuit Bar Association (FCBA) will be offering a CLE program on "Hot Topics in IP 2019" on September 20, 2019 from 11:30 am to 4:30 pm (ET) at the Hotel Du Pont in Wilmington, DE.  The program will include presentations on the following topics:

    • Don't Be Abstract: Section 101 Through the Legislative Lens
    • Excellence in Persuasion: Advocacy from a Judicial Perspective
    • Read the Signs: Supreme Court Decisions This Term and Next

    Additional information regarding the program can be found here.  The registration fee for the program is $275 (BPLA members) or $295 (non-members).  Those interested in registering for the program, can do so here.

  • PTAB Redeclares CRISPR Interference and Grants Leave for Some (But Not All) of Parties’ Proposed Motions

    By Kevin E. Noonan —

    USPTO SealOn Monday, the Patent Trial and Appeal Board (PTAB) issued an Order deciding which of the parties' (University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier, Junior Party, abbreviated to "CVC" throughout, and The Broad Institute, Massachusetts Institute of Technology, and Harvard University, Senior Party) proposed motions it will deign to consider in the first (appropriately called "motions") phase of the newly declared interference regarding priority of invention to CRISPR technology.  The Board also and separately redeclared the interference and by doing so avoided considering one of CVC's motions (that arrived at Berkeley's desired outcome nevertheless).

    To recap, late last month the parties submitted to the PTAB their proposed motions for the initial phase of the interference.  As is typically the case in these submissions, each party filed motions to place them in the best procedural position for the main event in the interference, a determination of who deserved priority to CRISPR, specifically embodiments of the technology for use in eukaryotic cells.

    As a reminder, an interference proceeds in two stages.  The first stage involves the parties presenting motions that can modify the count, have certain claims declared outside the scope of the count (or vice versa), seek to establish an earlier priority date, and ask for a finding that their opponents' claims are invalid under any of the provisions of the patent statute.  If these motions are not decided in a way that would disqualify one or both parties, then the interference will move to a second stage, where the Junior Party (CVC, unless it can establish an earlier priority filing date) will present its proofs of conception and reduction to practice and the Senior Party will be permitted to oppose.  The Senior Party is under no obligation to present proofs earlier than its earliest filing date unless the Junior Party evinces evidence of (at least) earlier conception.  In practice, the parties can both be expected to submit their priority evidence.

    Turning to the Board's decision, their Order considered the Broad's motions first.  The Broad's motions were predicated on their contention that this interference is "barred by res judicata, collateral estoppel, and law of the case" over the earlier-concluded interference (No. 106,048).  The Broad's Motion 1 under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1) is for judgment based on interference estoppel, citing MPEP § 2308.03(b):  "A judgment of no interference-in-fact bars any further interference between the same parties for claims to the same invention as the count of the interference"; the Broad asked that this motion be expedited. Motion 2 under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1) is related, for judgment based on CVC's failure to add a claim in the '048 interference reciting the linkage limitation, citing Woods v. Tsuchiya, 745 F.2d 1571, 1582 (Fed. Cir. 1985), and Ex parte Aoki, No. 2012-010117, 2015 WL 3827164 (P.T.A.B. June 15, 2015), for support.  The Broad further requested the Board issue a Notice to Show Cause (considered by the Board to be Motion 3) why this interference is not precluded by judgment in the earlier '048 interference, based on the "showing" that CVC cannot antedate actual reduction to practice of applying CRISPR to eukaryotic cells in view of evidence of record in the '048 interference (CVC "cannot win on the merits" according to this portion of the Broad's argument).

    The Board GRANTED authorization for the Broad to file one motion based on these various theories of estoppel, but because the Board realized that a decision in the Broad's favor would be dispositive (and perhaps indicating an inclination to agree with the Broad's position) the Board designated this motion to be expedited, setting a date of September 20th for the Broad to file its motion.  CVC will be able to file an opposition only if the Board authorizes it after the Board has reviewed the Broad's motion.

    The Broad's Motion 4 (contingent) under 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) and Motion 5 (contingent) under 37 C.F.R. 1 §§ 41.121(a)(1)(i) and 41.208(a)(2) asks the Board to substitute the count with an alternative count that would be "broad enough to cover Broad's best proofs," specifically:

    Proposed Count 2 (Motion 4)

    A method comprising:
        introducing into, or expressing in, a eukaryotic cell having a DNA molecule,
        (I) a Cas9 protein or a nucleotide sequence encoding the Cas9 protein, and
        (II) RNA or a nucleotide sequence encoding the RNA, the RNA comprising:
            (a) a targeter-RNA or a first RNA, the first RNA comprising a first ribonucleotide sequence and a second ribonucleotide sequence, and
            (b) an activator-RNA or a second RNA,
        wherein (II) (a) and (II) (b) are fused to one another or are covalently linked to one another with intervening nucleotides; and
        wherein, in the eukaryotic cell, the activator-RNA or the second RNA form an RNA duplex with the targeter-RNA or the second ribonucleotide sequence, and the targeter-RNA or the first ribonucleotide sequence directs the Cas9 protein to a target sequence of the DNA molecule, and the DNA molecule is cleaved or edited or at least one product of 20 the DNA molecule is altered.

    Proposed Count 3 (Motion 5):

    A method, in a eukaryotic cell, of cleaving or editing a target DNA molecule, or altering expression of at least one product encoded by the target DNA molecule, the method comprising:
        contacting, in a eukaryotic cell, a target DNA molecule having a target sequence with an engineered and/or non-naturally-occurring Type II Clustered 8 Regularly Interspaced Short Palindromic Repeats (CRISPR)-CRISPR associated 9 (Cas) (CRISPR-Cas) system comprising:
        a) a Cas9 protein,
    and
        b) RNA comprising
            i) a targeter-RNA that is capable of hybridizing with the target sequence of the DNA molecule or a first RNA comprising (A) a first sequence capable of hybridizing with the target sequence of the DNA molecule and (B) a second sequence; and
            ii) an activator-RNA that is capable of hybridizing to the targeter-RNA to form an RNA duplex in the eukaryotic cell or a second RNA comprising a tracr sequence that is capable of hybridizing to the second sequence to form an RNA duplex in the eukaryotic cell,
        wherein, in the eukaryotic cell, the targeter-RNA or the first sequence directs the Cas9 protein to the target sequence and the DNA molecule is cleaved or edited or at least one product of the DNA molecule is altered.

    The Board GRANTED the Broad authorization to file one motion to substitute one of the proposed counts, that "describes the interfering subject matter and sets the scope of admissible proofs in a way that is just to both parties."  The Board directed the Broad to ¶208.2 of the Standing Order for the requirements of motions to substitute a count.

    Motion 6 through Motion 9, all under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(2) ask the Board to designate most of the Broad's claims as not corresponding to any or various permutations of the counts, in an effort to limit the Broad's exposure to losing their claims.

    The Board GRANTED the Broad authorization to file one motion addressing whether these various claims correspond to the count.

    Motion 10 under 37 C.F.R. §§ 41.121(a)(1)(ii) and 41.208(a)(3) requests priority benefit of the Broad's prior applications, having an earliest priority date of December 12, 2012; in view of the extensiveness of the list the Broad requests "at least" 35 pages for its motion and brief.

    The Board GRANTED the Broad authorization to file one motion for priority benefit to one of these provisional applications.  The Order also specifies the nature and form of the evidence (detailed claim charts) the Board wishes to see in support of this motion, absent any argument regarding the priority claim (although the claim charts do will not count against the page limit).  The Board did not grant the Broad's request for additional pages over the page limit (25 pages; ¶121.2 of the Standing Order).

    Motion 11 under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(1) seeks judgment against CVC on the grounds that the CVC claims are unpatentable for failure to satisfy the written description and/or enablement requirements of 35 U.S.C. § 112(a) and under 35 U.S.C. § 102(a) and/or 35 U.S.C. § 102(e) and 35 U.S.C. § 103, based on "the PTAB's binding finding that a POSA in 2012 would require the results of successful eukaryotic experiments to have a reasonable expectation of success that CRISPR-Cas9 could be made to work in eukaryotic cells, and given that D1 and D2 indisputably fail to disclose any eukaryotic experiments," and citing numerous scientific references (including Broad references).

    The Board DENIED authorization to file this motion "because it will not further the inquiry into priority of invention of the count" and "because even if decided in favor of the Broad, would not be dispositive of the interference" because the invalidity grounds asserted in the proposed motion did not encompass all CVC's claims-in-interference.  The portion of the motion directed to the prior art is DEFERRED because these issues are likely to overlap with the priority issues to be determined in the priority phase, according to the Board.

    Motion 12 under 37 C.F.R. §§ 41.121(a)(3) asks the Board to require CVC to keep the Broad and the Board apprised of any notice of allowance in any pending, related applications.

    The Board DENIED authorization to file this motion, but (in boldface type) notified the parties that "both parties are required to file a notice with the Board if a notice of allowance is issued for claims that share the priority chain of the currently involved claims."  The Order also notes that the other requests regarding CVC's applications are moot in view of the redeclaration, including these applications within the scope of the interference.

    The Broad's final motion, for priority, is DEFERRED because it will only be relevant if the parties reach the priority phase.

    With regard to CVC's Motions, Motion 1 is an "expedited" miscellaneous motion under 37 C.F.R. § 41.121(a)(3) for benefit of an earlier non-provisional application and for the Board to redeclare the interference with CVC as the Senior party.  The basis for this motion is that the specification of the applications-in-interference have an identical specification to CVC's USSN 13/842,859, filed 3/15/2013 (pre-AIA).  CVC asked the Board to take these actions sua sponte because identical specifications are entitled to priority under 35 U.S.C. § 120.  CVC's Motion 2 requests benefit of priority to earlier provisional and non-provisional applications.

    The Board GRANTED authorization to file one motion that will not be expedited, and the Board refused to grant priority sua sponte.  As with the Broad's motion, the Board will grant priority to only one of the asserted priority applications (and the Board cautions that it does not need arguments regarding applications for which the Board has accorded priority benefit).  Also, the Board expressly did not authorize any increase in the page limit for this motion.

    Motion 3, under 37 C.F.R. § 41.121(a)(1), asks the Board to treat the Broad's claims under the changes in the law effected by the Leahy-Smith America Invents Act with regard to Section 102 and 103 of the Patent Act, and for judgment that these claims are unpatentable under 35 U.S.C. § 103 over U.S. Patent Application Publication No. 2016/0298138.  Motion 4 asks for judgment of unpatentability if the Broad applications and patents are entitled to pre-AIA treatment, under 35 U.S.C. § 103 over US 2016/0298138 to Sigma in view of extensive prior art contained in the Appendix.

    The Board DEFERRED authorization of these motions until the priority phase because, as above, resolution of these issues would not be dispositive, and because the Board will still need to decide the priority issue under 35 U.S.C. §102(g).

    Motion 5, under 37 C.F.R. § 41.121(a)(1) asks for judgment of unpatentability under 35 U.S.C. § 102(f) or (if post-AIA) 35 U.S.C. § 115(a) for "failure to name all inventors of the alleged invention.

    The Board DEFERRED authorization of these motions until the priority phase because "the facts of inventorship may overlap with the facts of priority."

    Motion 6 under 37 C.F.R. § 41.121(a)(1) asks for the Board to find the Broad liable for inequitable conduct.

    The Board DENIED authorization for CVC to file this motion, on the basis that it is premature, and these issues may overlap with issues arising during the priority phase.  The Order does permit CVC to request authorization for this motion at the conclusion of the priority phase.

    Motion 7 is a miscellaneous motion under 37 C.F.R. § 41.121(a)(3) to add CVC's U.S. Application Nos. 16/276,361; 16/276,365; 16/276,368; and 16/276,374 to the interference.

    The Board DENIED authorization to file this motion on the grounds it is moot because the Board redeclared the interference and included these applications.

    Like the Broad, CVC asked authorization to file a motion for priority, which the Board DEFERRED because it will only be relevant if the parties reach the priority phase.

    The Board also authorized CVC to file a miscellaneous motion that its Priority Statement be filed under seal.  The Board set an expedited schedule to be filed September 5th and, as with the Broad's expedited motion no opposition is authorized unless the Board deems it necessary.  The Order cautions that the interference and CVC's applications are publicly accessible and suggests that only "personal information" would likely be permitted to be redacted or filed under seal.

    The Order also specifies that the parties should consolidate arguments rather than ask for extra pages in their briefs.  Statements of material facts also are not waived and will be included in these page limits but claim charts will not.

    The Order concludes with the schedule of the motions for each party as follows (with the caveat that while the deadlines for Time Periods 1-6 can be changed by stipulation neither Time Period 7 nor the default Oral Argument date can be changed):

    TIME PERIOD 1                                                              October 4, 2019
    File motions
    File priority statements
    (but serve one business day later)

    TIME PERIOD 2                                                              October 25, 2019
    File responsive motions to motions
    filed in TIME PERIOD 1

    TIME PERIOD 3                                                              December 6, 2019
    File oppositions to all motions

    TIME PERIOD 4                                                              January 17, 2020
    File all replies

    TIME PERIOD 5                                                              February 28, 2020
    File request for oral argument
    File motions to exclude evidence
    File observations

    TIME PERIOD 6                                                              March 20, 2020
    File oppositions to motions to exclude
    File response to observations

    TIME PERIOD 7                                                              April 3, 2020
    File replies to oppositions to
    motions to exclude

    DEFAULT ORAL ARGUMENT DATE                                    TBD

    Separately, the Board redeclared the interference to add four of CVC's pending applications to the interference.  There are no other changes to the declaration; the Broad and its co-owners remain Senior Party and CVC remains Junior Party (although as the Board noted in its accompanying Order this could change depending on the outcome of the motions the parties are authorized to file), nor were there any other changes in the patents and applications in interference, the accorded priority benefits nor the claims for each party corresponding to the count (i.e., substantially all of them).  As the interference has been set out the Board seems ready to address all remaining issues between the parties to produced (subject to appeal) a final determination of who owns CRISPR.

    Except, of course, for Sigma-Aldrich's claims, which are unmentioned both in the redeclared interference, the Board's Order or the conference call between the parties and the Board earlier this month.

  • Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC (Fed. Cir. 2019)

    By Kevin E. Noonan —

    Federal Circuit SealThe Federal Circuit applied the constitutional principle under Article III that there must be a case or controversy for a federal court to enter judgment (in this case, of invalidity) in ANDA litigation that can be vitiated by a statutory disclaimer of patent claims prior to judgment.  The Court also applied principles of chemical obviousness and its "lead compound" analysis to affirm the District Court's determination that Defendants had not shown that claims in a related patent-in-suit were obvious.

    The case arose in ANDA litigation involving Sanofi's Jevtana® (cabazitaxel), having the structure:

    Image 1
    where the methoxy groups at the C7 and C10 positions distinguished cabazitaxel from prior art docetaxel, which had hydroxyl groups at these positions.  At trial, Sanofi initially asserted claims 7, 11, 14-16, 21, 26, and 30 of Orange Book-listed U.S. Patent No. 8,972,592, which claims methods for treating drug-resistant prostate cancer with cabazitaxel, and U.S. Patent No. 5,847,170, which claims the compound itself as well as pharmaceutical compositions thereof:

    Claim 1:

    1.  4α-Acetoxy-2α-benzoyloxy-5β,20-epoxy-1β-hy-droxy-7β,10β-dimethoxy-9-oxo-11-taxen-13α-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenylpropionate.

    Claim 2:

    2.  A pharmaceutical composition comprising at least the product according to claim 1 in combination with one or more pharmaceutically acceptable diluents or adjuvants and optionally one or more compatible and pharmacologically active compounds.

    The opinion set forth the developmental history of cabazitaxel:

    Cabazitaxel was the product of a multi-year research program aimed at identifying taxane analogs with better activity than docetaxel in resistant tumors.  By making substitutions at multiple positions on docetaxel with various functional groups, Sanofi scientists synthesized several hundred compounds and tested their activities.  Of this group, cabazitaxel was one of two compounds that entered into human studies.  It obtained FDA approval in 2010.

    While ANDA litigation was proceeding, the Patent Trial and Appeal Board (PTAB) invalidated all asserted claims of the '592 patent for obviousness.  Facing denial of its motion to amend in the IPR, Sanofi filed a statutory disclaimer of claims 7, 11, 14-16, and 26.  (In a footnote, the opinion notes that the Federal Circuit thereafter vacated the Board's decision and remanded for consideration regarding Sanofi's motion to amend during the IPR, which remains pending.)  Despite this, the District Court entered judgment against all claims of the '592 patent that had been raised at trial for being invalid for obviousness; separately the Court entered judgment that Defendants had failed to show claims 1 and 2 of the '170 patent were invalid for obviousness.

    The Federal Circuit vacated the District Court's decision regarding disclaimed claims 7, 11, 14-16, and 26 of the '592 patent because no case or controversy existed at the time the Court issued its opinion, and affirmed the District Court with regard to the '170 patent, in an opinion by Judge Lourie joined by Judges Moore and Taranto.  On appeal, Defendants argued that the possibility that Sanofi would be able to amend the claims in IPR maintains a case or controversy with regard to "future" issue or claim preclusion defenses in possible future litigation between the parties.  The Federal Circuit agreed with Sanofi that the statutory disclaimer removed the "case or controversy" requirement under Article III of the Constitution.  This requirement, the Court asserts, must be "'real and substantial' and 'admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts,'" citing MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118, 127 (2007) (alteration in original) (quoting Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240–41 (1937)).  The requirement is "highly similar" to the standing requirement, which is that "a plaintiff must 'present an injury that is concrete, particularized, and actual or imminent; fairly traceable to the defendant's challenged behavior; and likely to be redressed by a favorable ruling,'" citing Dep't of Commerce v. New York, 139 S. Ct. 2551, 2565 (2019) (quoting Davis v. Fed. Election Comm'n, 554 U.S. 724, 733 (2008)).  Finally, the opinion states that the "actual controversy must be extant at all stages of review, not merely at the time the complaint is filed," citing Steffel v. Thompson, 415 U.S. 452, 459 n.10 (1974) (emphasis added).  Applying these principles to the facts, the Court had little difficulty arriving at the conclusion that, at the time the District Court entered its judgment there was no controversy with regard to these claims, which Sanofi had disclaimed (which left the '592 patent "as though the disclaimed claim(s) had 'never existed,'" citing Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291, 1299 (Fed. Cir. 2011) (quoting Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998)).

    The panel rejected Defendants' allegation that they would lose the possibility of the issue preclusion defense "should Sanofi obtain amended claims and assert them against Defendants."  This is not sufficient to satisfy the case or controversy requirement, according to the opinion, first because the relevance of the disclaimed claims to a future issue preclusion defense was speculative, and second, the Defendants failed to establish that the District Court judgment pertaining to the disclaimed claims "is material to a possible future suit."  And the panel refused Defendants' invitation to provide an advisory opinion on "the claim preclusion arguments that they intend to make . . . should Sanofi secure amended claims at the Board and then assert them against Defendants."

    Turning to the District Court's decision that Defendants had not shown by clear and convincing evidence that claims 1 and 2 of the '170 patent were invalid for obviousness, the panel relied on the Court's decision in Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., that a challenger must "identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound."  492 F.3d 1350, 1357 (Fed. Cir. 2007).  The opinion reviewed the District Court's "extensive [factual] findings" based on the testimony of "seven witnesses and seventeen prior art references" in arriving at its conclusion that the District Court had not erred.  This analysis centered on the question of the motivation and rationale of the skilled worker to modify prior art docetaxel by simultaneously replacing hydroxyl groups with methoxy compounds at positions C7 and C10.  Defendants argued that this modification would be motivated to increase the lipophilicity of docetaxel to interfere with its binding by P-glycoprotein (Pgp), a plasma membrane-associated protein pump that rendered cells resistant to cytotoxic drugs (like docetaxel) by extruding these compounds from the cell.  The panel credited the District Court's determination that the prior art cited in support of increased lipophilicity as a way to decrease Pgp extrusion did not disclose taxanes or show any relationship between lipophilicity and Pgp extrusion for taxanes.  Concerning Defendants' assertion of prior art related to possible substitution positions in the canonical taxane structure, the panel agreed with the District Court's characterization that Defendant had cherry-picked the data in the cited references to reach the pattern of substituents exhibited by cabazitaxel and thus rejected them.  Secondary considerations (commercial success, failure of others) also supported the District Court's decision that Defendants had not established obviousness of claims 1 and 2 of the '170 patent by clear and convincing evidence.

    The Federal Circuit also rejected Defendants' argument in their declaratory judgment counterclaims that "a skilled artisan would have: (1) been motivated to modify docetaxel to reduce Pgp-related drug resistance; (2) knew that this could be accomplished by increasing lipophilicity of the C7 and C10 positions; and (3) determined that methoxy substitutions were the 'smallest, most conservative' modification to achieve that goal" as the product of hindsight.  The panel reviewed the District Court's assessment of the asserted prior art, the deficiencies of this art and Defendants' arguments and reached the conclusion that these arguments were the product of hindsight.

    Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC (Fed. Cir. 2019)
    Panel: Circuit Judges Lourie, Moore, and Taranto
    Opinion by Circuit Judge Lourie

  • The Chamberlain Group, Inc. v. Techtronic Industries Co. (Fed. Cir. 2019)

    By Michael Borella —

    Federal Circuit SealAnother week and another technology patent falls to a patentable subject matter challenge under Alice Corp. v. CLS Bank Int'l.  In this case, the patentee may have effectively shot itself in the foot with its own statements made in the specification.  But the Federal Circuit also provides its clearest explanation yet (but one that is still not clear enough) of how it expects the second part of the Alice analysis to be carried out.

    Chamberlain sued Techtronic Industries (TTI) and several other parties in the Northern District of Illinois, contending infringement of U.S. Patent No. 7,224,275.  TTI moved the District Court for judgment as a matter of law that the '275 patent was invalid under 35 U.S.C. § 101.  The District Court denied the motion and TTI appealed.

    Claim 1 of the '275 patent was deemed representative by the parties.  It recites:

    1.  A movable barrier operator comprising:
        a controller having a plurality of potential operational status conditions defined, at least in part, by a plurality of operating states;
        a movable barrier interface that is operably coupled to the controller;
        a wireless status condition data transmitter that is operably coupled to the controller, wherein the wireless status condition data transmitter transmits a status condition signal that:
            corresponds to a present operational status condition defined, at least in part, by at least two operating states from the plurality of operating states; and
            comprises an identifier that is at least relatively unique to the movable barrier operator, such that the status condition signal substantially uniquely identifies the movable barrier operator.

    Notably, the claim does not cover an entire garage door opening apparatus, such as a track, pulley, cable, or belt.  It effectively involves only a controller (e.g., a microprocessor), the movable barrier interface (e.g., a motor), and a wireless transmitter.

    The Alice test is used to determine whether claims are eligible for patenting under § 101.  One must first decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.  If so, then one must further decide whether any element or combination of elements in the claim is sufficient to ensure that the claim amounts to significantly more than the judicial exclusion.  But elements or combinations of elements that are well-understood, routine, and conventional will not lift the claim over the § 101 hurdle.  While this inquiry is generally carried out as a matter of law, factual issues can come into play when determining whether something is well-understood, routine, and conventional.

    The District Court found that the claimed invention was "not directed to the transmission of data, but to garage door openers that wirelessly transmit status information."  Ultimately, the District Court found that "the asserted claims are directed to a particular improvement over prior art which uses a particular manner of sending and experiencing data," which it deemed patent-eligible in light of [the Federal Circuit's] decision in Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc.

    On Appeal, the Federal Circuit applied the Alice test.  The Court quickly concluded that claim 1 was directed to abstract idea of "wirelessly communicating status information about a system."  Driving this outcome was the specification, and in particular the fact that the "only described difference between the prior art movable barrier operator systems and the claimed movable barrier operator system is that the status information about the system is communicated wirelessly, in order to overcome certain undesirable disadvantages of systems using physical signal paths."  The Court noted that the identified abstract idea was similar to those found ineligible in various other Federal Circuit cases, such as Amdocs (Israel) Ltd. v. Openet Telecom, Inc.; Affinity Labs of Tex., LLC v. DIRECTV, LLC; and Affinity Labs of Texas, LLC v. Amazon.com Inc.  The Court also seemed put off by the claim's breadth, as it wrote that it is "not limited to a specific implementation of a technological improvement to communication systems . . . [r]ather . . . a system that wirelessly communicates status information."  The Court further found that the wireless communication is not a technological improvement.  Notably, "that the claimed invention transmits data wirelessly and therefore does not rely on a wired path is not itself a technological improvement, but rather simply a feature of wireless communication, which the specification explains was already a basic, conventional form of communication."

    Chamberlain argued that the claims involved a non-abstract and "novel combination of its prior art movable barrier operator with a transmitter that is wireless."  But the Court found this argument to be based on a field of use limitation and therefore still abstract under Alice.  Additionally, Chamberlain attempted to establish that the physical aspects of the claimed invention were enough to avoid the abstract idea classification.  But, using reasoning that should surprise no one at this point, the Court stated that this was not the case when using "off-the-shelf technology for its intended purpose."

    The Court then applied the second part of the Alice test.  It observed that "[t]he specification describes each individual element of the asserted claims—including the controller, the interface, and the wireless data transmitter—as 'well understood in the art.'"  Chamberlain argued that "the ordered combination of . . . elements provides the inventive concept because there is no evidence in the record that a new type of movable barrier operator that includes an integrated controller and a wireless transmitter to transmit a status signal was well-understood, routine and conventional to a skilled artisan."  In response, the Federal Circuit explained that:

    The appropriate question is not whether the entire claim as a whole was well-understood, routine and conventional to a skilled artisan (i.e., whether it lacks novelty), but rather, there are two distinct questions: (1) whether each of the elements in the claimed product (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field, and (2) whether all of the steps as an ordered combination add nothing to the laws of nature that is not already present when the steps are considered separately.

    The Court never explained what exactly it means for all steps of an ordered combination to add nothing over the steps considered separately.

    In any event, the Court went on to state that "the specification makes clear that transmitting information wirelessly was conventional at the time the patent was filed and could be performed with off-the-shelf technology [and] wireless transmission is the only aspect of the claims that [Chamberlain] points to as allegedly inventive over the prior art."  Further, "[w]ireless communication cannot be an inventive concept here, because it is the abstract idea that the claims are directed to."  As the Court found no inventive concept, the claim failed the Alice test.

    Accordingly, the Federal Circuit reversed the District Court and held the asserted claims invalid under § 101.

    This case is another example of judicial-exception-creep, in line with that of ChargePoint, Inc. v. SemaConnect, Inc.  Similar to that decision, an invention that adds particular communication abilities to a physical device is rendered an "abstract idea" because the Court found that the only innovative part of what is claimed was the (allegedly abstract) communication itself.  Of course, the specification served to quickly sink the claim by admitting that all claimed elements were known in some fashion or another (even if the combination was not), but under the current patent-eligibility regime even a more carefully-worded application would have likely led to the same outcome.

    The invention here (as in ChargePoint) might have been more rationally invalidated on grounds of obviousness, though its 2003 priority date was well before wireless transceivers were being added to all kinds of conventional devices.  Nonetheless, § 101 is once again the wrong tool for applying the prior art motivated invalidation.  There are other parts of the statute to serve that function.

    The Chamberlain Group, Inc. v. Techtronic Industries Co. (Fed. Cir. 2019)
    Panel: Circuit Judges Lourie, O'Malley, and Chen
    Opinion by Circuit Judge Chen

  • University of California/Berkeley Granted Yet Another CRISPR Patent

    By Kevin E. Noonan —

    University of California-BerkleyOn Tuesday, the U.S. Patent and Trademark Office granted U.S. Patent No. 10,385,360 to the University of California/Berkeley, directed to an aspect of its CRISPR technology (where CRISPR is an acronym for Clustered Regularly lnterspaced Short Palindromic Repeats).  The independent claims of the '360 patent read as follows:

    1.  A nucleic acid molecule encoding a single molecule DNA-targeting RNA, wherein the single molecule DNA-targeting RNA comprises: (a) a DNA-targeting segment comprising a nucleotide sequence that is complementary to a target sequence in a target DNA molecule, and (b) a protein-binding segment comprising two complementary stretches of nucleotides that hybridize to form a double stranded RNA (dsRNA) duplex, wherein said two complementary stretches of nucleotides are covalently linked to one another with intervening nucleotides, wherein the DNA-targeting segment is positioned 5' of both of said two complementary stretches of nucleotides, and wherein the single molecule DNA-targeting RNA is capable of forming a complex with a Cas9 protein and targeting the complex to the target sequence of the target DNA molecule.

    4.  A composition comprising: (1) a single molecule DNA-targeting RNA, or a nucleic acid encoding said single molecule DNA-targeting RNA, wherein the single molecule DNA-targeting RNA comprises: (a) a DNA-targeting segment comprising a nucleotide sequence that is complementary to a target sequence in a target DNA molecule, and (b) a protein-binding segment comprising two complementary stretches of nucleotides that hybridize to form a double stranded RNA (dsRNA) duplex, wherein said two complementary stretches of nucleotides are covalently linked to one another with intervening nucleotides, wherein the DNA-targeting segment is positioned 5' of both of said two complementary stretches of nucleotides, and wherein the single molecule DNA-targeting RNA is capable of forming a complex with a Cas9 protein and targeting the complex to the target sequence of the target DNA molecule; and (2) one or more of: (i) a nuclease inhibitor, (ii) a buffering agent, and (iii) a pharmaceutically-acceptable, non-toxic carrier or diluent.

    The priority relationship of the '360 patent to the rest of the Berkeley portfolio is set forth on the face of the patent:

    This application is a continuation of U.S. patent application Ser. No. 15/435,233 filed Feb. 16, 2017 (U.S. Patent No. 10,407,697, issue date Sep. 10, 2019), which is a continuation of U.S. patent application Ser. No. 15/138,604 filed Apr. 26, 2016 (U.S. Patent No. 10,113,167, issued Oct. 30, 2018), which is a continuation of U.S. patent application Ser. No. 14/685,502 filed Apr. 13, 2015 (U.S. Patent No. 10,000,772, issued Jun. 19, 2018), Ser. No. 14/685,504 filed Apr. 13, 2015 (U.S. Patent No. 10,301,651, issued May 28, 2019), Ser. No. 14/685,513 filed Apr. 13, 2015 (abandoned), Ser. No. 14/685,514 filed Apr. 13, 2015 (abandoned), Ser. No. 14/685,516 filed Apr. 13, 2015 (abandoned), and Ser. No. 14/942,782 filed Nov. 16, 2015 (U.S. Patent No. 10,227,611, issued Mar. 12, 2019), each of which is a continuation of U.S. patent application Ser. No. 13/842,859 filed Mar. 15, 2013 (U.S. Patent No. 10,266,850, issued Apr. 23, 2019), which claims the benefit of U.S. Provisional Patent Application Nos. 61/652,086 filed May 25, 2012, 61/716,256 filed Oct. 19, 2012, 61/757,640 filed Jan. 28, 2013, and 61/765,576, filed Feb. 15, 2013, each of which applications is incorporated herein by reference in its entirety.

    None of these patents are involved in the recently declared interference, nor are they the subject of the Board's order to inform the Board and Senior Party, the Broad Institute, should they be allowed.  The claims correspond to an RNA component of a CRISPR-Cas9 complex for performing "gene editing" rather than the more comprehensive claims reciting the entire system.

    The prosecution history shows no rejection on either the written description nor enablement provisions of 35 U.S.C. § 112(a), which is curious in view of the breadth of the claims (which can be read as comprising "a DNA-targeting segment comprising any nucleotide sequence that is complementary to any target sequence in a target DNA molecule").  In view of the recent penchant for the Federal Circuit to be concerned about claim breadth (see "Enzo Life Sciences, Inc. v. Roche Molecular Systems, Inc. (Fed. Cir. 2019)" and "Amgen Inc. v. Sanofi (Fed. Cir. 2017)").  These circumstances — at least in theory — leave these claims vulnerable to invalidation should Berkeley attempt to enforce them against a putative infringer (perhaps, for example, anyone licensing the Broad patents) or more immediately a post-grant review challenge before the Patent Trial and Appeal Board.

    The "Reasons for Allowance" of these claims is instructive regarding at least how the USPTO is thinking about CRISPR:

    The instant claims recite "a single molecule DNA-targeting RNA" comprising "a DNA targeting segment" and "a protein-binding segment," wherein the protein-binding segment comprises "two complementary stretches of nucleotides that hybridize to form a double stranded RNA (dsRNA) duplex, wherein said two complementary stretches of nucleotides are covalently linked to one another with intervening nucleotides" and wherein the "single molecule DNA targeting RNA is capable of forming a complex with a Cas9 protein and targeting the complex to the target sequence of the target DNA molecule".

    The closest prior art is Siksnys (US 9,637,739) and Siksnys (WO 2013/141680) each of which claim priority to US 61/625,420 (filed April 17, 2012) and US 61/613,373 (filed March 20, 2012), which are both prior to the instant effective filing date of May 25, 2012.  These priority documents describe a method of assembling a CRISPR-Cas9 DNA cleavage complex by combining Cas9, crRNA, tracrRNA, and RNase III (see Example 2) or just Cas9, crRNA, and tracrRNA (see Example 3).  Siksnys further discloses the criticality of the tracrRNA molecule to the assembly of a functional Cas9-crRNA DNA cleavage complex (see Figure 16).  These disclosures are supported by US 61/613,373 filed March 20, 2012.  In addition, Deltcheva (Deltcheva et al. (2011) Nature, 471:602-607 and supplementary data published online March 30, 2011) is a relevant prior art.  Deltcheva teaches that "tracrRNA is required for crRNA maturation in S. pyogenes" (see Figure 1).  Deltcheva further illustrates that "Co-processing of tracrRNA and pre-crRNA requires both endogenous RNase III and Csnl in vivo" (see Figure 2), wherein Csnl is a synonym for Cas9. Deltcheva illustrates that this crRNA maturation occurs via hybridization between the crRNA and the tracrRNA to form a dsRNA duplex (see Figure 1).  These disclosures indicate that the prior art recognized both the dsRNA duplex formation between crRNA and tracrRNA and further recognized the criticality of the tracrRNA to the maturation of the crRNA and to the assembly of the Cas9-crRNA cleavage complex.

    However, the prior art did not sufficiently describe or recognize the presence of the tracrRNA molecule in the Cas9-crRNA DNA cleavage complex itself.  This is supported by Siksnys' characterization of the DNA cleavage complex as a "Cas9-crRNA complex" (see Figure 15), which refers only to two components, and the characterization of a "ternary complex" (see description of Figure 14), which refers to the Cas9-crRNA in a complex with the target dsDNA (see Figure 14), for example.  Because the prior art as a whole did not sufficiently describe or recognize the presence of the tracrRNA molecule in the Cas9-crRNA DNA cleavage complex, one of ordinary skill in the art would not have had sufficient motivation to "covalently link" the crRNA and the tracrRNA molecule together with "intervening nucleotides" to form a "single molecule" DNA-targeting RNA as required by the instant claims.  The claims recite eligible subject matter at least because naturally occurring crRNAs and tracrRNAs that hybridize to form a dsRNA duplex capable of forming a complex with a Cas9 protein are not "covalently linked to one another with intervening nucleotides" to form a "single-molecule" DNA-targeting RNA as required by the instant claims.  Accordingly, this structural feature renders the claimed subject matter markedly different from its naturally occurring counterpart.

    This allowance is consistent with the PTAB's judgment of no interference-in-fact in Interference No. 106,048, affirmed by the Federal Circuit, stating "Broad has provided sufficient evidence to show that its claims, which are all limited to CRISPR-Cas9 systems in a eukaryotic environment, are not drawn to the same invention as UC's claims, which are all directed to CRISPR-Cas9 systems not restricted to any environment.  Specifically, the evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRI SPR-Cas9 systems in any environment, including in prokaryotic cells or in vitro, because one of ordinary skill in the art would not have reasonably expected a CRISPR-Cas9 system to be successful in a eukaryotic environment.  This evidence shows that the parties' claims do not interfere." (see Interference No. 106,048, "Decision on Motions" mailed February 15, 2017, page 2).  The PTAB's judgment involved and was applicable to all claims of US Patent 8,906,616.

    Accordingly, because the claims of US 8,906,616 have been deemed to be "limited to . . . a eukaryotic environment", and because the instant claims are not limited to a eukaryotic environment, the instant claims do not interfere with the claims of US Patent 8,906,616 or any other claim deemed to be "limited to . . . a  eukaryotic environment."

  • Conference & CLE Calendar

    CalendarAugust 29, 2019 – "How Late Is Too Late? Setting the Timeline for Patent Protection" (Fitch Even) – 12:00 to 1:00 pm (EDT)

    September 9, 2019 – "The Evolving Patent Eligibility of Life Sciences Method Claims" (Practising Law Institute) – 11:00 am to noon (EDT)

    September 17, 2019 – "Best Practices for Patenting Chemical and Material Compositions" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 am to 11:15 am (CT)

    September 17, 2019 – "A Primer on the Laws of Cannabis, Marijuana and CBD" (Loeb & Loeb LLP) – 1:00 to 2:00 pm (ET)

    October 3-4, 2019 – Paragraph IV Disputes Master Symposium (American Conference Institute) – Chicago IL

  • Webcast on Patent Eligibility of Life Sciences Method Claims

    PLI #1Practising Law Institute (PLI) will be offering a one-hour webcast on "The Evolving Patent Eligibility of Life Sciences Method Claims" on September 9, 2019 beginning at 11:00 am (EDT).  Patent Docs author Donald L. Zuhn, Jr. of McDonnell Boehnen Hulbert & Berghoff LLP will moderate a panel consisting of Brian A. Cocca of Regeneron Pharmaceuticals, Inc.; June E. Cohan of the Office of Patent Legal Administration at the U.S. Patent and Trademark Office; and Sarah E. Fendrick of McDonnell Boehnen Hulbert & Berghoff LLP.  The panel will discuss:

    • Recent Federal Circuit decisions regarding the patent eligibility of diagnostic method claims and method of treatment claims;
    • What can be distilled from these decisions to better draft patent eligible life sciences method claims;
    • How these decisions are impacting the examination of life sciences method claims at the USPTO;
    • And what may lay ahead in view of the petition for certiorari in Vanda Pharmaceuticals v. West-Ward Pharmaceuticals.

    The registration fee for this webcast is $299.  Those interested in registering for the webcast, can do so here.

  • MBHB Webinar on Patenting Chemical and Material Compositions

    MBHB Logo 2McDonnell Boehnen Hulbert & Berghoff LLP will be offering a live webinar entitled "Best Practices for Patenting Chemical and Material Compositions" on September 17, 2019 from 10:00 am to 11:15 am (CT).  In this presentation, MBHB attorneys Steven Sarussi and James Suggs will provide strategies and practice tips for dealing with the uncertainty of the ever-changing patent law landscape, in the U.S. and abroad, with respect to chemical patent applications, at the time of drafting and during prosecution, with a focus on being prepared to overcome rejections during prosecution, and to provide broad but defensible coverage. Topics will include:

    • Future-proofing your chemical and compositional patent applications for worldwide prosecution
    • Functional claiming in the chemical space
    • Combination inventions and how to claim them
    • Strategies for overcoming rejections — even unreasonable ones
    • Providing claims in prosecution that are defensible in later proceedings

    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 Cannabis, Marijuana, and CBD Law

    Loeb & LoebLoeb & Loeb LLP will be offering a webinar entitled "A Primer on the Laws of Cannabis, Marijuana and CBD" on September 17, 2019 from 1:00 to 2:00 pm (ET).  Monique Bhargava, Brian Heidelberger, Caroline Hudson, and David Levine of Loeb & Loeb LLP will discuss:

    • The locations (across the United States) where cannabis and marijuana are legal
    • The advertising and marketing laws as applied to:
        – Food, drugs and cosmetics
        – Influencers
        – Events
    • The most recent trademark and IP issues in relation to the cannabis and marijuana industry
    • The latest on M&A and other corporate-related matters in the industry

    While there is no cost to participate in the program, advance registration is required.  Those interested in attending the webinar can register here.

  • Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH (Fed. Cir. 2019)

    By Donald Zuhn —

    Federal Circuit SealEarlier this month, in Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH, the Federal Circuit affirmed a decision by the U.S. District Court for the Eastern District of Virginia granting a motion for judgment as a matter of law filed by Appellee Genetic Veterinary Sciences, Inc., d/b/a Paw Prints Genetics ("PPG"), and as a result, found that the asserted claims of U.S. Patent Nos. 9,157,114 were patent ineligible under 35 U.S.C. § 101.  The Federal Circuit also affirmed the District Court's denial of a motion to dismiss PPG's complaint for lack of subject-matter jurisdiction and lack of personal jurisdiction filed by Appellants LABOKLIN GmbH & Co. KG ("LABOKLIN") and the University of Bern ("the University").

    The '114 patent, which is owned by the University, relates to in vitro methods for genotyping Labrador Retrievers, in order to discover whether a dog might be a genetic carrier of Hereditary Nasal Parakeratosis ("HNPK"), a disease that causes crusts and fissures to appear on a dog's nose.  A professor at the University discovered that the presence of HNPK in Labrador Retrievers resulted from a point mutation in the gene SUV39H2.  Claims 1-3 of the '114 patent recite:

    1.  An in vitro method for genotyping a Labrador Retriever comprising:
    a) obtaining a biological sample from the Labrador Retriever;
    b) genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO: 1 and
    c) detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO: 2.

    2.  The method according to claim 1, wherein the genotyping is achieved by PCR, real-time PCR, melting point analysis of double-stranded DNA, mass spectroscopy, direct DNA sequencing, restriction fragment length polymorphism (RFLP), single strand conformation polymorphism (SSCP), high performance liquid chromatography (HPLC), or single base primer extension.

    3.  The method of claim 1, wherein the genotyping utilizes a primer pair comprising a first primer and a second primer, each comprising a contiguous span of at least 14 nucleotides of the sequence SEQ ID NO: 2 or a sequence complementary thereto, wherein:
    a) said first primer hybridizes to a first DNA strand of the SUV39H2 gene;
    b) said second primer hybridizes to the strand complementary to said first DNA strand of the SUV39H2 gene; and
    c) the 3' ends of said first and second primers are located on regions flanking the position 972 of SEQ ID NO: 2, or of nucleotide positions complementary thereto.

    The University, which is an instrumentality of the Swiss Confederation having a place of business in Bern, Switzerland, granted an exclusive license for the '114 patent to LABOKLIN, which is a German company with its principal place of business Bad Kissingen, Germany.  LABOKLIN entered into two sublicenses of the '114 patent in the United States.  PPG offers laboratory services for testing for genetic variations and mutations known to cause certain diseases in dogs, including a test for detecting the presence of a mutation in the SUV39H2 gene.

    In January 2017, after obtaining the consent of the University, LABOKLIN sent a cease-and-desist letter to PPG asserting that PPG had infringed the '114 patent.  PPG responded by filing suit against LABOKLIN and the University and seeking a declaratory judgment that the asserted claims of the '114 patent are patent ineligible under § 101.  LABOKLIN and the University moved to dismiss PPG's complaint for lack of subject-matter jurisdiction and lack of personal jurisdiction.  The District Court, however, issued an Order finding jurisdiction established over both LABOKLIN and the University.  The dispute proceeded to trial on PPG's invalidity defense, and following the close of both parties' evidence, but before the case was submitted to the jury, the District Court granted PPG's motion for judgment as a matter of law and found the asserted claims patent-ineligible under § 101.

    On appeal, LABOKLIN and the University argued that the District Court lacked personal jurisdiction over LABOKLIN because LABOKLIN lacked sufficient contacts with the forum, and lacked personal and subject-matter jurisdiction over the University because the University enjoyed sovereign immunity.  With respect to Appellants' argument that the District Court lacked personal jurisdiction over LABOKLIN, the Federal Circuit disagreed with Appellants' assertion that a cease-and-desist letter along with licensing activity in the forum was not enough to confer jurisdiction.  The Federal Circuit stated that "[a]s the District Court aptly pointed out, here, 'LABO[KLIN] is not merely a remote patentee assisting a U.S. company with enforcement, but instead, it is the U.S. enforcer.'"  The Federal Circuit therefore determined that the facts of the case established that LABOKLIN's activities satisfy the minimum contacts requirement without offense to due process, and thus, personal jurisdiction over LABOKLIN in the District Court was reasonable and fair.

    Turning to Appellants' argument that the District Court lacked personal and subject-matter jurisdiction over the University because the University enjoyed sovereign immunity, the Federal Circuit began by noting that under the Foreign Sovereign Immunities Act ("FSIA"), "a foreign state is presumptively immune from the jurisdiction of United States courts; unless a specified exception applies, a federal court lacks subject-matter jurisdiction over a claim against a foreign state," and that under 28 U.S.C. § 1605(a)(2), if a foreign state engages in "commercial activity . . . in the United States," an exception to sovereign immunity applies.  Citing Intel Corp. v. Commonwealth Sci. & Indus. Research Org., 455 F.3d 1364, 1370 (Fed. Cir. 2006), the Court further noted that a defendant's "acts of (1) obtaining a United States patent and then (2) enforcing its patent so it could reap the profits thereof—whether by threatening litigation or by proffering licenses to putative infringers—certainly" are commercial activity.

    In response to Appellants' argument that the University was presumptively immune from the jurisdiction of U.S. courts under the FSIA because the District Court erred in finding that the commercial activity exception under the FSIA applied to the University's immunity, the Federal Circuit explained that "[t]he University cannot claim immunity in the District Court because it obtained a U.S. patent and then participated in licensing and enforcing the '114 patent, which constitutes 'commercial activity' under the FSIA."  The Court also explained that "it matters not to [the Court's] analysis that it was LABOKLIN that physically wrote and sent the cease-and-desist letter to PPG, because the University conceded that it still retained substantial rights in the patent, such that the University, as the sole 'patentee,' ultimately controlled enforcement of the '114 patent."  The Federal Circuit therefore determined that the commercial activity exception to sovereign immunity applied such that the District Court properly exercised subject-matter jurisdiction over the University pursuant to § 1605(a).

    On the issue of patent eligibility, LABOKLIN and the University argued on appeal that the asserted claims are directed to a patent-eligible application of the discovery of the underlying natural phenomenon because the asserted claims claim a man-made laboratory procedure.  The Federal Circuit, however, disagreed with Appellants' argument.

    The Federal Circuit began its patent eligibility analysis by briefly reviewing four of its previous decisions:  Ariosa Diagnostics, Inc. v. Sequenom, Inc.; In re BRCA1- & BRCA2-Based Hereditary Cancer Test Patent Litigation; Vanda Pharmaceuticals, Inc. v. West-Ward Pharmaceuticals International Ltd.; and Natural Alternatives International, Inc. v. Creative Compounds, LLC.  The Court then declared that "[h]ere, the Asserted Claims are not directed to a new and useful method for discovery because they begin and end with the point discovery of the HNPK mutation in the SUV39H2 gene," adding that:

    [C]laim 1 simply states that the search for the mutation involves the laboratory examination of Labrador Retriever DNA, which resulted in the revelation of the mutation.  The mutation location itself and the fact that it is inherited through male and female dog carriers mating are both natural phenomena.

    Noting that "the plain language of claim 1 demonstrates that it is directed to nothing more than 'observing or identifying' the natural phenomenon of a mutation in the SUV39H2 gene," the Court determined that "the Asserted Claims are directed to natural phenomenon at Alice step one."

    The Federal Circuit also disagreed with Appellants' argument that the claimed methods apply a new discovery of the SUV39H2 gene and develop novel genotyping methods for Labrador Retrievers, finding instead that "[n]othing in claim 1's language suggests the invention of a new method for genotyping."  In affirming the District Court's finding of patent ineligibility, the Federal Circuit determined that "the Asserted Claims provide no tangible result save the observation and detection of a mutation in a dog's DNA."  So, while such discovery constituted "a positive and valuable contribution," the Federal Circuit found that "these claims fall short of statutory patentable subject matter."

    Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH (Fed. Cir. 2019)
    Panel: Circuit Judges Wallach, Hughes, and Stoll
    Opinion by Circuit Judge Wallach