IPR claim construction and obviousness findings affirmed (insufficient evidence of nexus between claims and license agreements)

Siemens Mobility, Inc. v. USPTO

Docket No. 2019-1732, -1752 (IPR2017-01669, -02044
September 8, 2020

Brief Summary: Board IPR claim construction and obviousness conclusions affirmed (e.g., insufficient evidence nexus between claims and secondary considerations (license agreements)).

Summary: Siemens appealed two IPR final written decisions (FWDs) holding certain claims of US 6,609,049 and US 6,824,110 directed to methods and systems for automatically activating a train warning device unpatentable for obviousness. The method claims included “maintaining a database of locations…and corresponding regulations”, “obtaining a position of the train” (and speed in ‘049 claims), “select[ing] a next upcoming location”, “determining a point at which to activate the warning device”, “and activating the warning device at the point.” The system claims include a “control unit” that carries out the method steps and “further require that the database receive wireless updates.” Westinghouse challenged the claims as obvious in view of the Byers and Michalek US patents. Siemens argued the Board misconstrued “corresponding regulations”. The FC panel explained that “[t]he Board…declined to import from the specification that would require multiple regulations for individual locations” and relied on the “plain language of the claims” (“nothing in the claim language restricting the form or nature of correspondence between regulations and locations”) which it concluded the Byers patent “discloses, teaches, or suggests”. The FC panel agreed with the Board’s claim construction since, e.g., requiring “multiple regulations per location would eliminate the option of one regulation encompassed by the use of the article ‘a’” (N. Am. Vaccine, FC 1993 (“explaining that ‘a’ has a ‘normal singular meaning’ but can mean one or more”)) and is supported by the specification (e.g., “Figure 2 clearly contemplates locations for which only one regulation is stored and applied.”) Siemens also argued “the Board misinterpreted the law regarding secondary considerations”. The FC panel explained that effective evidence of secondary considerations must show a “nexus…between the merits of the claimed invention and the evidence offered” (Stratoflex, FC 1983) and “[t]he patentee bears the burden of establishing” that nexus (WMS Gaming, FC 1999). Siemens submitted evidence of licensing which the FC panel explained “is not an ‘infallible guide to patentability’” (EWP, FC 1985) and that here “the licenses are of little evidentiary value” (DyStar, FC 2006; Agrizap, FC 2008) (e.g., “employee testimony…related to…a ‘horn sequencing patent’ or addressed ‘automatic horn activation,’ without any connection to the language of the claims”). The FC panel also agreed with the Board’s conclusions of invalidity for obviousness.

Posted in Inter Parties Review (IPR), IPR, Obviousness, Obviousness (Secondary Considerations) | Leave a comment

DC claim construction affirmed; refusal to correct inventorship vacated/remanded (“AIA did not narrow the meaning of ‘error’”)

Egenera, Inc. v. Cisco Systems, Inc.

Docket No. 2019-2015, -2387
August 28, 2020

Brief Summary: DC claim construction affirmed; refusal to allow Egenera to correct inventorship vacated/remanded (“AIA did not narrow the meaning of ‘error’”).

Summary: Egenera appealed DC claim construction of the claims of US 7,231,430 relating to enterprise server systems and application of judicial estoppel to prevent Egenera from relisting an inventor delisted during a copending IPR proceeding, leading to its holding of invalidity for failing to name all inventors. Egenera argued the DC misconstrued the “logic to modify” limitation (“at least one control node including logic to modify said received messages to transmit said modified messages”) as a means-plus-function limitation (section 112, para. 6; Williamson, FC 2015 (“presumption against means-plus-function” without the word “means”, “challenger need not show that the limitation is ‘essentially…devoid of anything that can be construed as structure” but “need only show that the structure is not ‘sufficient’”, “[g]eneric terms such as ‘mechanism,’ ‘element,’ ‘device,’ and other…verbal constructs may be used…in a manner that is tantamount to using the word ‘means’ because they ‘typically do not connote sufficiently definite structure’”; TEK, FC 2019; MTD Prods., FC 2019 (may be invoked by “generic terms or black box recitations of structure or abstractions”)). The DC found “that, in the claim language, each ‘logic’ term was ‘described by a specific function’…unaccompanied by ‘structural components’” and “the specification was…‘consistent with an understanding of logic as an abstraction’” (“a generic black box”), thereby “rebut[ing] the presumption against means-plus-function claiming.” The FC panel agreed with the DC that “[a]s used, ‘logic’ is no more than a ‘black box recitation of structure’ that is simply a generic substituted for ‘means’”. The FC panel also concluded the DC identified the correct structure “as corresponding to the claimed functions of the ‘logic to modify’ limitation”, explaining that Egenera agreed with that determination and “cannot now seek a much narrower construction on appeal.” The FC panel therefore affirmed the claim construction order. Egenera also appealed the DC’s refusal to allow it to correct the ‘430 patent inventorship. During the IPR proceeding, Egenera removed one inventor that it argued to the DC was an error under section 256(a)/(b) (“The error of omitting inventors or naming persons who are not inventors shall not invalidate the patent…if it can be corrected as provided in this section.”) The FC panel explained that “ ‘error’ in [section] 256 includes ‘all varieties of mistakes-honest and dishonest’-rather than only unintentional inaccuracy” (Stark, FC 1997; same for reissue under section 251) and that this applied to amended section 256 (amended in the AIA to remove “without ‘deceptive intention’ on the inventor’s part” (“AIA did not narrow the meaning of ‘error’”; “the inequitable-conduct rules…provide a safety valve in the event of deceit”). The FC panel also explained that “[j]udicial estoppel is an equitable doctrine that prevents a litigant from taking a litigation position inconsistent with one successfully asserted in an earlier court proceeding” (New Hampshire, 1st Cir. 2010) which the DC incorrectly applied (e.g., “Egenera advanced no ‘clearly inconsistent’ position” and “would gain no unfair advantage”) and vacated/remanded that part of the decision.

Posted in America Invents Act, Claim Construction, Inventorship | Leave a comment

DC erroneously constructed “antibody” and “antibody fragment”, FC panel finds

Baxalta, Inc. et al. v. Genentech, Inc. et al.

Docket No. 2019-1527MOORE, PLAGER, WALLACH

August 27, 2020

Brief Summary:  DC non-infringement finding vacated and remanded due to erroneous construction of “antibody” and “antibody fragment”.

Summary:    Baxalta appealed DC judgment based on its construction of “antibody” and “antibody fragment” for US 7,033,590.  Baxalta alleged Genetech’s Helibra (emicizub-kxwh) bispecific antibody for treating hemolphilia infringed the ‘590 claims.  Claim 1 of the ‘590 patent is directed to “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increased the procoagulant activity of Factor IXa” while dependent claims 4 and 19 are directed antibodies or antibody fragments (monoclonal, chimeric, humanized (claims 4 and 19, single chain, bispecifici, diabody, di-/oligo-/multimers).  The DC agreed with Genentech that the ‘590 patent requires an “antibody” to include “two identical heavy chains (H chains) and two identical light chains (L chains)” (e.g., “the patentee ‘chose [Genentech’s] narrower definition’ by expressly defining antibodies in column 5 of the patent”).  The DC did “recognize[] that the ‘590 patent claims and discloses ‘bispecific antibodies, which do not have identical heavy and light chains’ and IgM and IgA antibodies, which ‘can have more than two heavy chains and more than two light chains,’ it determined that these claimed embodiments were ‘antibody derivatives’ rather than ‘antibodies’”, citing “an amendment Baxalta made during prosecution” changing the term “derivative” to “fragment” to overcome an enablement rejection (“a disclaimer of antibody derivatives ‘including bispecific antibodies, except antibody fragments”).  The DC also agreed with Genentech that a “fragment” “partially or completely lacks the constant region” and that “the term ‘antibody fragment’ excludes bispecific antibodies.”  The FC panel disagreed because, e.g. “[t]he dependent claims confirm that ‘antibody’ is not so limited” given that each of the chimeric, humanized and bispecific antibodies of dependent claim 4 (and humanized of claim 19) “fall[] outside the [DC’s] construction because each does not ‘only bind[] to the antigen that induced its synthesis or very similar antigens” (see FN3; DC construction…excludes these explicitly claimed embodiments” (Intel. Vent. I, FC 2018; Ortho, FC 2008 (“rejecting a construction that would ‘render several dependent claims meaningless’”); Budde, FC 2001 (“plausible reading of the excerpt in isolation” but “claim construction requires that we ‘consider the specification as a whole, and [] read all portions of the written description, if possible, in a manner that renders the patent internally consistent”); “we read the excerpt in column 5 as a generalized introduction to antibodies rather than a definitional statement” (Luminara, FC 2016)).  The FC panel also disagreed that the prosecution history “confirms the specification’s definition of antibody” because it rejected “the excerpt in column 5” as “definitional” (Phillips, FC 2005; Avid Tech., FC 2016 (no disclaimer “where the alleged disavowel is less than clear”); 3M (FC 2013 (“must be both clear and unmistakable”)).  The FC panel also found that the DC misconstrued “antibody fragment” as the patentee did not “‘clearly express an intent’ to redefine” that term (Thorner, FC 2012).  The DC decision was therefore vacated and remanded.

Posted in Claim Construction, Claim Differentiation, Uncategorized | Leave a comment

DC grant of SJ affirmed due to “an unenforceable agreement to agree”

Phytelligence, Inc. v. Washington State University
Docket No. 2019-2216
August 27, 2020

Brief Summary: DC grant of SJ to WSU affirmed since option agreement was “an unenforceable agreement to agree”, not an “agreement with open terms” that could be deciphered by the court.

Summary: Phytelligence (“PT”; in receivership) appealed DC grant of summary judgment (SJ) in favor of WSU regarding sale and delivery of a specific type of apple tree (WA 38) and infringement of its COSMIC CRISP trademark. In 2012, PT and WSU entered into a Propagation Agreement that “forbid [PT] from selling WA 38 trees ‘unless [PT] ha[d] authorization to do so under a separate contract with [WSU], or an agent of [WSU], in accordance with Section 4 of this Agreement.” Section 4 describes an “option to participate as a provider and/or seller in [WSU] licensing programs” including the provision that “if the Cultivar is officially released by WSU and becomes available for licensing…[PT] will need to sign a separate contract with [WSU], or an agent of [WSU], to exercise this option.” In 2013, “WSU issued an ‘Announcement of Opportunity’…to companies interested in commercializing WA38”, including PT which did not submit a proposal. In 2014, WSU accepted Proprietary Variety Management’s (PVM’s) proposal and granted PVM and exclusive license that required any industry participant to be a member of the Northwest Nursery Improvement Institute (“NNII”). In 2017, PT notified WSU of its desire to “exercise its option under the Propagation Agreement”. WSU directed PT to contact PVM for a license, which it did, but then “rejected PVM’s requirement to become a NNII member.” WSU then offered PT three new options for exercising its option, including two that did not require NNII membership, which PT rejected. WSU then revoked its offer to PT. WSU was granted SJ after the DC agreed with it “that Section 4 was an unenforceable ‘agreement to agree’ pursuant to Washington state law” (“it required ‘a further meeting of the minds of the parties before a complete and enforceable agreement’” exists) and not “an enforceable ‘agreement with open terms’” as PT argued. The FC panel agreed with the DC that “the plain terms of the agreement provide that [PT’s] options turns on a future contract between the parties” which “renders Section 4 an unenforceable agreement to agree”. The FC panel also explained that Section 4 is not an “agreement with open terms” as in P.E. Systems (Wash. 2012) since the court has “no objective method for determining the terms of the ‘separate contract’”. The FC panel also disagreed that PT’s extrinsic evidence supports its “open terms” argument since, e.g., “the email communications…indisputably indicate that that the time the parties executed the Propagation Agreement, WSU did not commit to any definite terms of a future license” or that there was any agreement as to a “Form License”. Thus, the DC’s grant to SJ to WSU was affirmed.

Posted in Licensing, Uncategorized | Leave a comment

IPR decision finding Anacor’s KERYDIN® patents invalid for obviousness affirmed

Anacor Pharmaceuticals, Inc. v. Flatwing Pharmaceuticals, LLC

Docket No. 2019-2264-2267 (IPR2018-00168-00171, -01358-01361)
August 27, 2020 (Non-precedential)

Brief Summary: IPR decisions finding Anacor’s tavaborole (5%) (KERYDIN®) patents invalid for obviousness affirmed (e.g., “concentration is a result-effective variable”).

Summary: Anacor appealed four IPR final written decisions (FWDs) holding all the claims of Orang Book patents US 9,549,938; 9,566,289; 9,566,290; and 9,572,823 (shared specifications; previously invalidated US 7,582,621 also listed on OB (FC 2018)) relating to the treatment of fungal infections using the boron-containing compound tavaborole (5%) (KERYDIN®) invalid for obviousness in view of Austin (WO publication), Brehove (US publication), and Samour (US 6,224,887). The ‘621 patent was previously invalidated in view of Austin and Brehove which were found to disclose topical compositions of boron-containing compounds like tavaborole for treating fungal infections (e.g., “structural and functional similarities” to tavaborole). In the FWDs leading to this appeal, the Board “rejected Anacor’s argument that Samour teaches away from a 5% concentration” (“in favor a 10%-econazole composition”) and found that “Samour does not ‘criticize or otherwise discourage the use of 5% w/w of antifungal agent’”. The FC panel also rejected Anacor’s argument because “Samour’s teachings barely even suggest a ‘preference for an alternative’ approach…let alone discourage a skilled artisan from pursuing a 5%-antifungal composition, as is required for a reference to teach away” (DePuy, FC 2009; Adams, US 1966). The FC panel also found that “[t]he Board reasonably credited testimony from Flatwing’s expert that the claimed composition could have been made according to well-known formulation techniques”, “the existence of the Brehove reference describing in vivo inhibition of a common fungus with organoboron compositions…is especially damaging to Anacor’s arguments”, “the inventors evidently did not consider formulating organoborons a great challenge”, and “there is no dispute that a skilled artisan would have appreciated that concentration is a result-effective variable” (In re Aller, CCPA 1955). Thus, the DC decision was affirmed.

Posted in Inter Parties Review (IPR), IPR, Obviousness, Obviousness-Teaching Away | Leave a comment

DC denial of Takeda’s permanent injunction affirmed based on License Agreement definitions

Takeda Pharm. U.S.A., Inc. v. Mylan Pharm. Inc.

Docket No. 2020-1407, -1417
July 31, 2020

Brief Summary: DC decisions denying Takeda a permanent injunction affirmed due to Final Court Decision regarding Licensed Patents as defined in License Agreement.

Summary: Takeda appealed DC denial of its request for a preliminary injunction (PI) in an ANDA suit regarding Takeda’s Colcrys® product (colchicine), an oral formulation used to treat gout. In the suit, Tekada alleged infringement of 17 Orange Book (OB) patents. Takeda and Mylan settled the litigation through a 2017 Settlement Agreement that allowed Mylan to sell generic colchicine on a date “after the date of a Final Court Decision (as defined in Exhibit A) holding that all unexpired claims of the Licensed Patents that were asserted and adjudicated against a Third Party are either (i) not infringed, or (ii) any combination of not infringed and invalid or unenforceable” (Section 1.2(d)). The “Licensed Patents” include the 17 OB patents, a “Final Court Decision” is a non-appealable (other than to the Supreme Court), federal court final judgment, and a “Third Party” is a person other than Takeda or Mylan. The License Agreement also included Section 1.10 stating that if Mylan breaches Section 1.2, it “would cause Takeda irreparable harm.” In a separate litigation against Hikma (the “West-Ward Litigation”) involving eight of the Licensed Patents, five were dismissed with prejudice and three were found by the Delaware DC in December 2018 not be infringed by Hikma’s § 505(b)(2) colchicine product Mitigare®, and Takeda did not appeal that decision. Based on that decision, Mylan notified Takeda it would “immediately start selling” its generic colchicine product and Takeda responded with a letter that “declined to indicate whether Takeda would pursue legal action against Mylan prior to breach of the License Agreement.” Mylan subsequently launched its product in November 2019 and Takeda then filed a complaint including a request for a PI leading to this appeal. The DC denied Takeda’s request for a PI after finding Takeda “failed to show it is likely to succeed on the merits or that it will suffer irreparable harm” (e.g., “[m]oney damages would remedy any harm”) and that “Section 1.2(d) was triggered by the West-Ward Litigation even though it did not relate to all of the Licensed Patents.” The DC also found that Section 1.2(d) was not “limited to generic equivalents of Colcrys® to the exclusion of 505(b)(2) products like Mitigare®” (e.g., “Section 1.2(d) makes no mention of generic Colcrys® products.” (Lorillard Tobacco, Del. 2006 (“the court is ‘constrained by…the parties’ words and the plain meaning of those words”); “We cannot rewrite the License Agreement because Takeda failed to communicate its intent.” (FN4)). The FC panel also agreed Takeda could not show irreparable harm (e.g., “unlikely Takeda can show that Mylan breached the License Agreement” and so “stipulation of irreparable harm according to Section 1.10 is not applicable”, “Takeda makes no credible assertion that it cannot be compensated by monetary damages” (Winter, US 2008)). The DC decision was therefore affirmed. Judge Newman’s dissent argued that “the accelerating event” had not occurred (e.g., “different FDA approval for different uses…not a generic counterpart of Colcrys®”).

Posted in Generics / ANDA, Licensing | Leave a comment

IPR obviousness decision vacated and remanded for insufficient explanation

Alacritech, Inc. v. Intel Corp., et al.

Docket No. 2019-1467, -1468 (IPR2017-01409-10, -01736-7, IPR2018-00338-9)
July 31, 2020

Brief Summary: IPR obviousness decision vacated and remanded as Board’s explanation was not “articulate a satisfactory explanation for its action”.

Summary: Alacritech (AT) appealed USPTO (“Board”) decision holding the claims of US 8,131,880 directed to “[a]n apparatus for transferring a packet to a host computer system” (“from a host computer’s central processing unit (CPU) to an ‘intelligent network interface card’ (INIC)” including a “flow re-assembler” that “re-assemble[s] a data portion of said first packet with a data portion of a second packet in said communication flow”) unpatentable for obviousness over “Thia” in view of “Tanenbaum”. The FC panel explained that in an IPR “the Board is obligated to ‘provide an administrative record showing the evidence on which the findings are based, accompanied by the agency’s reasoning in reaching its conclusions” (TQ Delta, FC 2019; In re NuVasive, FC 2016 (“perfect explanation” not required “if the agency’s path may reasonably be discerned”, must “articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made”); “the Board’s own explanation” must “be sufficient ‘for us to see that the agency has done its job”). AT appealed the Board decision as to independent claims 1, 32, 41 and 43 and argued that “the Board’s analysis is inadequate to support its finding that the asserted prior art teaches or suggests the reassembly limitations”. The FC panel agreed with AT, finding that “[a]fter briefly reciting some of the parties’ arguments in two terse paragraphs, the Board merely concludes that ‘data portions of packets are reassembled’ in both claim 41 and the asserted prior art” and “[i]n doing so, the Board appears to misapprehend both the scope of the claims and the parties’ arguments.” It explained that “]n]o party disputed that reassembly is disclosed by the asserted prior art”, “[t]he crux of the dispute” being “where reassembly takes place in the prior art and whether that location satisfies the claim limitations” that is “not acknowledged” by the Board which did not “explain how the prior art teaches or suggests reassembly in the network interface”. “As such,” the FC panel wrote, it “cannot reasonably discern whether the Board followed a proper path in determining that the asserted prior art teaches or suggests the reassembly limitations” (e.g., it “did not endorse, adopt, or otherwise suggest that it was persuaded by” Intel’s “arguments, much less explain why it found those arguments persuasive” (Pers. Web Techs., FC 2017); KSR, US 2007 (“rejections on obviousness grounds cannot be sustained by mere conclusory statements”); “the Board’s reasoning appears to be untethered to either party’s position” (Paice LLC, FC 2018)). The FC panel therefore vacated and remanded the Board’s obviousness decision. The FC panel did find “the Board’s finding of a motivation to combine Thia and Tanenbaum” to be “supported by substantial evidence” (e.g., no teaching away (Meiresonne, FC 2017)), and disagreed with AT’s claim construction argument.

Posted in Inter Parties Review (IPR), IPR, Obviousness, Obviousness-Teaching Away | Leave a comment

DC infringement decision affirmed for one patent, preambles found limiting as to two others, money damages affirmed, injunction for two of four accused products vacated

Bio-Rad Labs., Inc., The Univ. of Chicago v. 10X Genomics Inc.

Docket No. 2019-2255, -2285
August 3, 2020

Brief Summary: DC decision of infringement of ‘083 patent under DOE affirmed; preamble found to limit ‘407 and ‘193 patent claims, infringement therefore vacated; money damages affirmed but injunction reversed as to two of the four accused product lines.

Summary: 10X appealed DC finding three Bio-Rad (licensee) patents directed to microfluidic systems (‘083 patent and ‘407 and ‘193 continuations) valid and willfully infringed, its denial of 10X’s request for JMOL, and grant of a permanent injunction against 10X. 10X’s allegedly infringing product lines are Single Cell 3’ Gene Expression, Linked-Reads, Single Cell V(D)J, Single Cell ATAC-seq, and Single Cell CNV. The FC Aug. 2019 order allowed 10X to “continue to sell its Linked-Reads and CNV products subject to the royalty and deposit requirements of the original DC injunction order” (see FN2). 10X challenged the DC’s finding of infringement under the doctrine of equivalents (DOE) due to narrowing amendments made during prosecution (Festo I, US 2002; Festo II, FC 2003 (“[p]rosecution history estoppel arises when a patent applicant narrows the scope of his claims during prosecution for a reason ‘substantial[ly]…relating to patentability’…[a] narrowing amendment is presumed to be a surrender of all equivalents within ‘the territory between the original claim and the amended claim’” (prosecution history estoppel (PHE)) and claim vitiation (Brilliant Instruments, FC 2013 (“another bar to a finding of” DOE infringement); UCB, FC 2019; Deere, FC 2012). The FC panel explained that the presumption of PHE can be overcome if the patentee can show one of the “exceptions” applies (i.e., “tangential relation to the equivalent”, “equivalent was unforeseeable”, or “some other reason suggesting that the patentee could not reasonably be expected to have described the equivalent” (Festo II)). The DC held that the “tangential relation” exception applied and the FC panel agreed because prior art generally relates to the amended subject matter but not the particular subject matter disclosed by the prior art (Amgen, FC 2020; Eli Lilly, FC 2019). Regarding claim vitiation, the FC panel agreed with the DC that 10X’s use of a “negligibly-fluorinated microchannel…is insubstantially different from a non-fluorinated microchannel” such that “[t]he non-fluorinated microchannel claim limitation is not stripped of meaning, or ‘effectively eliminate[d]’”. The FC panel also agreed with the DC “that 10X’s products meet the claimed surface tension limitation”. The DC’s finding of infringement and denial of 10X’s motion for JMOL were therefore affirmed as to the ‘083 patent.

10X argued the DC misconstrued the ‘407 and ‘193 patents by failing to find that “the preambles of these patents’ independent claims are limiting”. 10X argued that the preamble (“[a] method for conducting a reaction in plugs in a microfluidic system, comprising the steps of…”) “limits the claims to…‘on-chip’ reactions only”, while “its accused products are ‘off-chip’ reactions”. The DC found the preambles “provide antecedent basis” but do “not necessarily convert the entire preamble into a limitation” citing TomTom (FC 2015). The FC panel found that the DC misapplied TomTom which “involved a partially-limiting preamble”, while in this case “the preamble…cannot be neatly packaged into two separate portions” and does not “simply recite a method for an intended use or purpose” (e.g., “The term ‘conducting’ in the preamble is not analogous to the non-limiting language at issue in TomTom.” Also citing Eaton, FC 2003; “Under the correct construction, the claimed methods are limited to on-chip reactions.”) The DC’s judgment of infringement of the ‘407 and ‘193 patents were vacated and remanded.

Regarding damages, the FC panel disagreed with 10X that the DC’s consideration of comparable licenses were erroneous (Georgia-Pacific, SDNY 1970; Radio Steel, FC 1986; LaserDynamics, FC 2012 (“This court has often excluded licenses that are technologically or economically non-comparable.”)) The FC panel also found BioRad’s reasonable royalty opinions to be supported by substantial evidence (e.g., expert “evaluated the various licenses at issue and applied the Georgia-Pacific factors”). The FC panel also disagreed with 10X’s apportionment argument (Elbit, FC 2019 (calculation “must reflect the value attributable to the infringing feature of the product, and no more”)), and found the expert testimony to have been properly admitted. The FC panel also found that the DC abused its discretion in granting an injunction against two of 10X’s four product lines since, e.g., the hardship to 10X cannot be mitigated by “non-infringing alternatives”.

Posted in Claim Vitiation, Damages, Doctrine of equivalents, Infringement, Willfullness | Leave a comment

Revised FC opinion maintains invalidity of one independent claim as claiming a natural law and nothing more but vacates and remands DC invalidity decision regarding second independent claim as including “positioning” limitation”

American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, et al.

Docket No. 2018-1763
October 3, 2019 (revised July 30, 2020)

Update (July 30, 2020): Original FC opinion affirmed the DC decision that AA’s claims are ineligible under § 101 since “the mechanism for achieving the desired result” using the “natural” Hooke’s law “are not actually claimed”. In this revised decision, the FC panel affirmed the DC decision that independent claim 22 is ineligible (e.g., “features that are not claimed are irrelevant as to step 1 or step 2 of the Mayo/Alice analysis…[t]he focus of the claimed advance here is simply the concept of achieving that result, by whatever structures or steps happen to work”) but vacated and remanded the DC decision regarding claim 1 (e.g., “unlike claim 22 has an additional limitation of ‘positioning the at least one liner’…[t]he mere fact that any embodiment practicing claim 1 necessarily involves usage of one or more natural laws is by itself insufficient to conclude the claim is directed to such natural laws…the abstract idea basis was not adequately presented and litigated in the” DC). Regarding Judge Moore’s dissent, the FC panel majority disagreed with “its characterization of this case as not involving a recitation of the natural law” since “[i]n all but name…claim 22 recites Hooke’s law” and explained that Mayo’s step 2 analysis does not “require[] an express claim recitation of the natural law” as “the analysis is a substantive one about whether the claim is ‘directed to’ ineligible matter and, if so, whether there is enough that the ineligible subject matter itself to create eligibility.”

Original Brief Summary: DC holding that AAM’s “method for manufacturing” claims are patent ineligible under § 101 affirmed (e.g., “the mechanism for achieving the desired result” using the “natural” Hooke’s law “are not actually claimed”).

Original Summary: AA appealed DC grant of Neapco’s motion for summary judgment (SJ) and holding the asserted claims of US 7,774,911 directed to “[a] method for manufacturing” driveline propeller shafts (“propshafts”) in a way that “attenuate[s] at least two types of vibration transmitted through the shaft” using a “liner” (a “tuned” liner) to be directed to unpatentable subject matter (§ 101). The ‘911 specification explains that “prior art liners, weights, and dampers” have been used to attenuate vibrations during manufacturing, and the FC panel opinion explains that “certain variables related to the liner” can be “changed (…‘tuned’)” to attenuate the vibrations (“Two types of attenuation are relevant here” resistive attenuation and reactive attenuation.”) The DC construed “tuning” (“tuning at least one liner”) “to mean ‘controlling the mass and stiffness of at least one liner to match the relevant frequency or frequencies’”. AAM argued “that it ‘conceiv[ed] of the novel and unconventional concept of ‘tuning’ a liner” that “‘[can] dampen multiple types of vibration’ simultaneously.” The FC panel explained that “[n]either the claims nor the specification describes how to achieve such tuning” and “discloses a solitary example describing the structure of a tuned liner, but does not discuss the process by which that liner was tuned.” It also explained that under the Mayo/Alice test, the court asks “whether the claims are directed to a law of nature, natural phenomenon, or abstract idea” and then “whether the claim embod[ies] some ‘inventive concept’” (Mayo, US 2012; Alice, US 2014). Regarding the first step, the FC panel wrote that it was known in the art “that a liner…could be designed to…function” as an attenuator and that this “at least in part involves an application of Hooke’s law” (“a natural law that mathematically relates the mass and/or stiffness of an object to the frequency with which that object…vibrates”). AAM argued “that the claims are not merely directed to Hooke’s law”, but the FC panel disagreed because “the mechanism for achieving the desired result-are not actually claimed” (Alice; Synopsis, FC 2016; Ariosa, FC 2015; Diehr (US 1981); Flook (US 1978)). The FC panel wrote that “as in Flook,…the claims here do not disclose how target frequencies are determined or how, using that information, liners are tuned to attenuate two different vibration modes simultaneously”, also recognizing “that AAM may be correct” that the claimed system “is more complex than just the bare application of Hooke’s law”. The FC panel also wrote that the enablement issues raised in Judge Moore’s dissent (e.g., “expands 101 well beyond its statutory gate-keeping function and the role of this appellate court well beyond its authority”) are not relevant here without much explanation. The FC panel then concluded that “nothing in the claims qualifies as an ‘inventive concept’” (e.g., “no more than conventional pre- and post-solution activity”), finding AAM’s arguments to be “no more than an elaborated articulation of reasons…why the claims are not directed to a natural law”. Thus, the DC’s decision was affirmed.

Posted in Patent Eligibility (101), Patentability | Leave a comment

DC patent ineligibility holding for Illumina’s fetal DNA-related claims again reversed

Illumina, Inc., Sequenom, Inc. v. Ariosa Diagnostics, Inc. et al.
Docket No. 2019-1419
March 17, 2020

Update (August 3, 2020): In a revision of its March 17, 2020 opinion reversing the DC’s 101 ineligibility decision, the FC panel reversed the DC’s decision on remand finding the claims invalid under 101 for being “directed to an ineligible natural phenomenon”. The FC panel maintained its prior statements that: “This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” The FC panel also maintained its position that “CellzDirect…is instructive” (the inventors “discovered that hepatocytes naturally have that ability, and they exploited that phenomenon in a patent-eligible method”). Judge Reyna dissented, writing that, e.g., “[t]he Majority avoids our claimed advance precedent by reasoning that these claims belong to a distinct category of process claims for ‘method[s] of preparation’”, which “allows claim draftsmanship to evade § 101’s safeguard at the step one inquiry”, and “[t]he method steps under review do not transform the nature of the claims into patent-eligible applications.”

Original Brief Summary: DC finding that Illumina’s fetal DNA-related claims are patent ineligible reversed.

Original Summary: Illumina appealed DC decision finding certain claims of Illumina’s US 9,580,751 and 9,738,931 as ineligible under section 101 for being directed to natural phenomenon. The independent claims of each patent are directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA (e.g., “extracting DNA from a substantially cell-free sample of blood”, “producing a fraction of the DNA extracted”, and “analyzing a genetic locus in the fraction”). In its analysis, the FC panel wrote: “This is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case.” It explained that “it is undisputed that the inventors of the ‘751 and ‘931 patents discovered a natural phenomenon” but also that “at step one of the Alice/Mayo test, ‘it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to’” (CellzDirect, FC 2016; see also Athena, FC 2019 (holding diagnostic claims ineligible), Endo Pharm., FC 2019 (holding method of treatment claims patent-eligible)). The question is whether the inventor “claim the discovered natural phenomenon itself versus eligible subject matter that exploits the discover of the natural phenomenon.” The FC panel adopted “Illumina’s articulation of the natural phenomenon, i.e., that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother’s bloodstream” and found that the claimed “process achieves more that simply observing…or detecting the presence of that phenomenon” (e.g., the claimed “methods include specific process steps…to increase the relative amount of fetal DNA as compared to maternal DNA in the sample”). The claims at issue in the earlier Ariosa decision (FC 2015) were distinguished as being “directed to a method ‘for detecting a paternally inherited nucleic acid’…or a method ‘for performing a prenatal diagnosis’”, the “only operative steps” being “amplifying”, “detecting”, and “subjecting [it]…to a test” or detecting it (e.g., “[T]he inventors…discovered that cell-free fetal DNA exists, and then obtained patent claims that covered only the knowledge that it exists and a method to see that it exists.”) This case was also distinguished from Myriad (US 2013) since “the claims here are not directed to the cell-free DNA itself” (the Myriad claims “were ineligible because they covered a gene rather than a process for isolating it”). The FC panel views CellzDirect as “instructive” in that those inventors “patented an ‘improved process of preserving hepatocytes’” and “not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles.” Thus, the ‘751 and ‘931 claims were found not to be directed to patent ineligible subject matter under step on of the Alice/Mayo test and are therefore patent eligible. Judge Reyna dissented, arguing that “the claims are directed to [the] natural phenomena…that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood” and, e.g., does not “alter[] the naturally occurring substances themselves” (Genetic Techs., FC 2016; Ariosa) and should therefore be ineligible.

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