DC non-infringement decision affirmed due to disclosure-dedication doctrine


Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC

Docket No. 2019-1924
O’MALLEY, REYNA, CHEN
May 8, 2020

Brief Summary: DC finding of no infringement under DOE based on disclosure-dedication doctrine affirmed.

Summary: Eagle appealed DC judgment of non-infringement of US Pat. Nos. 9,265,831; 9,572,796; 9,572,797; and 10,010,533 (four of six Orange Book patents for Eagle’s BELRAPZO® (bendamustine for CLL and indolent B-cell non-Hodgkin lymphoma; NDA N205580). The FC panel opinion explains that all four patents “share the same specification and all independent claims recite essentially the same limitations.” Claim 1 of the ‘796 patent claims “[a] non-aqueous liquid composition comprising…bendamustine…a pharmaceutically acceptable fluid comprising a mixture of polyethylene glycol and propylene glycol…and a stabilizing amount of an antioxidant….” Slayback admitted its generic product did not literally infringe the “pharmaceutical acceptable fluid” limitation which Eagle alleged was infringed under the doctrine of equivalents (e.g., “insubstantially different from the propylene glycol (‘PG’) in the claimed composition”). Slayback argued DOE was inapplicable because “the disclosure-dedication doctrine barred Eagle’s claim…because the asserted patents disclose but do not claim, ethanol as an alternative solvent to PG.” The DC agreed with Slayback since, as explained in this opinion, expert opinion was unconvincing and “[t]he specification expressly and repeatedly identifies ‘ethanol’ as an alternative ‘pharmaceutically acceptable fluid’ to PG” (e.g., in the “Summary of the Invention” and the specification). The FC panel explained that “[t]he disclosure-dedication doctrine bars application of the [DOE]” and “reinforces ‘the primacy of the claims in defining the scope of the patentee’s exclusive right’” (Johnson & Johnston, FC 2002 (“when a patent drafter discloses but declines to claim subject matter…this action dedicates the unclaimed subject matter to the public”); PSC Comput., FC 2004 (“ask whether the specification discloses unclaimed subject matter with ‘such specificity that one of ordinary skill in the art could identify the subject matter that had been disclosed and not claimed’”); Maxwell, FC 1996). Eagle argued the doctrine does not apply to its claims because “a ‘skilled artisan would not understand that ethanol…is an alternative to PG in the separate, claimed ‘PEG/PG/antioxidant’ category of formulations” disclosed in the specification. But the FC panel explained that the doctrine does not require disclosure of “an embodiment that exactly matches the claimed embodiment”, and only needs to “disclosure the unclaimed subject matter ‘as an alternative to the relevant claim limitation’” (Pfizer, FC 2005 (microcrystalline cellulose not identified “as an alternative to ‘saccharide’ that prevents hydrolysis”)). Eagle’s specification, the FC panel found, “repeatedly identifies-without qualification-ethanol as an alternative” and does not “suggest[] that these disclosures of ethanol are limited to certain formulations, or that they do not extend to the claimed formulations.” The DC decision on this point was therefore affirmed, as was its decision as a judgment as a matter of law (“the only reasonable inference”).

Posted in Claim Construction, Doctrine of equivalents, Infringement | Leave a comment

IPR decision of no obviousness vacated and remanded; Grit found to have Article III standing based on previously dismissed (without prejudice) litigation


Grit Energy Solutions, LLC v. Oren Technologies, LLC

Docket No. 2019-1063 (IPR2017-00768)
PROST, NEWMAN, WALLACH
April 30, 2020

Brief Summary: PTAB IPR decision of no obviousness vacated and remanded; Grit found to have Article III standing based on previously dismissed (without prejudice) litigation.

Summary: Grit appealed PTAB IPR decision finding claims 1-7 of US 8,585,341 directed to a “proppant discharge system” (a proppant being “a material, such as sand or other particulates, that prevents ground fractures from closing during hydraulic fracturing”) were not shown to be unpatentable for obviousness in view of a US patent (“Eng Soon”) and a French patent (“Constantin”). Grit argued that while “Eng Soon discloses the opposite of the ‘341 configuration”, Constantin discloses the ‘341 configuration in its claim 5 (obvious over these references, “either alone or in further view of additional prior art”). Grit argued that “Constantin expressly indicates that its depicted embodiment was non-limiting” (that embodiment also disclosing the opposite of the ‘341 configuration) and that because the “use of reference numerals does not limit the scope under French patent law” and “such use should also not limit what the claims disclose.” The PTAB disagreed with Grit, finding that “Constantin’s claim 5 also discloses the pin and receptacle only in the opposite configuration of the ‘341 configuration”, “[t]here is no evidence that person of ordinary skill would understand French patent law and incorporate that law into their understanding of this technical reference”, “disagree[d] with [Grit Energy’s] argument that transposing Eng Soon’s pin and receptable would have been a simple substitution to achieve predictable results”, and patentee (Oren) “present[ed] persuasive evidence that swapping the location of Eng Soon’s pin and receptacle would result in a more expensive system.” In this appeal, Oren argued Grit did not have Article III standing since it “neither committed nor plans to commit acts that create a sufficient threat of litigation” (e.g., “transferred ownership of all products accused of infringement” and “has not identified any concrete plans for future activity”). Grit argued for Article III standing because “Oren previously sued Grit Energy for infringement” (previously dismissed without prejudice) “and Oren is free to reassert those infringement claims”, and the FC panel agreed that Grit has standing (Semtek, US 2001; JTEKT, FC 2018; DuPont, FC 2011). The FC panel also agreed with Grit that the PTAB’s “determination…is unsupported by substantial evidence” as it “rests on an erroneous reading of Constantin’s claim 5” which “plainly teaches that the stud and orifice can be either in the ‘341 configuration or the opposite of the ‘341 configuration” (e.g., “substantial evidence does not support the Board’s determination that claim 5’s parenthetical reference to shutter blade ‘8’ limits its disclosure in such a manner”, the PTAB inappropriately “mapp[ed] the non-limiting example to the claims” and its denial of Grit’s request for rehearing “offered entirely new reasoning to support its conclusion”; Orthopedic Equip., FC 1983 (economic reason not to combine not the same as “some technological incompatibility that prevented their combination”)). The PTAB decision was therefore vacated and remanded. Judge Newman dissented as to the majority’s view of the Constantin reference.

Posted in Article III disputes, Claim Construction, Inter Parties Review (IPR), IPR, Obviousness | Leave a comment

DC ineligibility decision reversed as claims are directed to a (“patent-eligible improvement to computer functionality”


Uniloc USA, Inc. et al. v. LG Electronics USA, Inc. et al.

Docket No. 2019-1835
MOORE, REYNA, TARANTO
April 30, 2020

Brief Summary: DC decision of patent ineligibility under § 101 for being abstract (Alice, step one) reversed and remanded (“patent-eligible improvement to computer functionality”).

Summary: Uniloc appealed DC grant of summary judgment (SJ) to LG after finding the ‘049 patent claims directed to communication systems ineligible under § 101 as being directed to an abstract idea. The DC held the claims to be “directed to the abstract idea of ‘additional polling in a wireless communication system,’ analogizing the claims to the data manipulation claims” held ineligible in Two-Way Media (FC 2017) and Digitech Image (FC 2014), and to “fail to recite an ‘inventive concept sufficient to save the claim[s]’.” The FC panel explained that computer-related patent eligible claims are those that, e.g., “change[] the normal operation of the computer network itself” (DDR Holdings, FC 2014), “improve[] the way computers operate[] and handle[] data” (Enfish, FC 2016), “focus on a ‘specific asserted improvement in computer capabilities” (“not…categorical data storage”) (Visual Memory, FC 2017), including “non-abstract improvement to computer security” (Ancora Techs., FC 2018), “a tool able to instantly access all parts of a complex three-dimensional electronic spreadsheets” (Data Engine, FC 2018), and “an improved use interface” (Core Wireless, FC 2018). Here, the FC panel found “the claims at issue” to be “directed to a patent-eligible improvement to computer functionality, namely the reduction of latency experienced by parked secondary stations in communication systems”, which “eliminates or reduces the delay present in conventional systems where the primary station alternates between polling an sending inquiry messages” (“like the claims in DDR, the claimed invention changes the normal operation of the communication system itself to ‘overcome a problem specifically arising in the realm of computer networks’”; “like the improvement in computer memory we held eligible in Visual Memory, enables the communication system to accommodate additional devices, such as battery-operated additional devices, without compromising performance”). Further, the FC panel explained, “[t]he claims at issue do not merely receipt generalized steps to be performed on a computer using conventional computer activity” as did the patent ineligible claims of Digitech (“gathering and combining data that does not require input from a physical device”) and Two-Way (“using ‘result-based functional language’ without the means for achieving any purported technological improvement”). Disagreeing with LG, the FC panel explained that “[c]laims need not articulate the advantage of the claimed combinations to be eligible” and that neither “[t]he claimed invention’s compatibility with conventional communication systems” nor “the fact that the improvement is not defined by reference to ‘physical’ components” renders the claims abstract. The DC decision was therefore reversed and remanded.

Posted in Patentability, Section 101 (see also Patentability), Software | Leave a comment

Pfizer’s appeal of IPR decision dismissed for lack of Article III standing


Pfizer Inc. v. Chugai Pharmaceutical Co., Ltd.

Docket No. 2019-1513, -1514 (IPR2017=01357, -01358)
REYNA, WALLACH, HUGHES
April 27, 2020 (Non-precedential)

Brief Summary: Pfizer’s appeal of IPR decision finding it did not show invalidity of Chugai’s protein purification claims dismissed for lack of Article III standing.

Summary: Pfizer appealed Board IPR decision finding it did prove the challenged claims of Chugai’s US 7,332,289 and 7,927,815 regarding “methods for purifying proteins by ‘removing contaminant DNA from a sample containing a physiologically active protein’” (e.g., “the surprising finding that contaminant DNA can be efficiently removed…without using complicated chromatographic processes”) unpatentable. The FC panel explained that while “[a]ny person or entity may petition” for institution of an IPR proceeding (JTEKT, FC 2018; Fisher & Paykel, FC 2019), “[a] party that appeals” and IPR decision “to this court…must have Article III standing” (Consumer Watchdog, FC 2014 (“a personal stake in the outcome”); Spokeo, US 2016 (“(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision”)). “To qualify”, the FC panel wrote, “actual controversy must be extant at all stages of review” (Arizonans, US 1997; Momenta, FC 2019) and “where the appellant is not currently engaging in infringing activity, the appellant typically must show that it has concrete plans for future activity that creates a substantial risk of future infringement or would likely cause the patentee to assert a claim of infringement” (JTEKT; DuPont, FC 2018). Citing Phigenix (FC 2017), the FC panel explained that “[a]s the party seeking judicial review, Pfizer bears the burden of establishing standing”. Pfizer argued “that its purported injury in fact stems from Pfizer’s launch of its produce Ruxience® in January 2020” and that the settlement agreement with Genentech authorizing it to begin selling Ruxience® (an authorized biosimilar) did not protect it from Chugai (owned by Roche which also owns Genentech), which was not a party to the settlement agreement and did not provide Pfizer a license to the ‘289 and ‘815 patents. Pfizer filed its notice of appeal on January 30, 2019, but the FC panel noted that “the only evidence of standing…relates to events that occurred much later in 2019” (e.g., FDA approval in July 2019; October 2019 announcement that its biosimilar would start selling in January 2020). Pfizer argued “it was self-evident to the parties’ that there was ‘a product at issue’ when the appeal began”, but the FC panel wrote that that “is not self-evident to the court”. The FC panel also disagreed with Pfizer “that the statutory estoppel effect of 35 U.S.C. 315(e) ‘enhances Pfizer’s stake’” since “there is no evidence that the appellant was or is engaged in any activity that would give rise to a possible infringement suit” (AVX, FC 2019; Gen. Elec., FC 2019; Argentum, FC 2020). The appeal was therefore dismissed.

Posted in Article III disputes, Inter Parties Review (IPR), IPR | Leave a comment

Injunction, damages, infringement and invalidity decisions regarding Illumina’s fetal testing patents affirmed


Verinata Health, Inc., Illumina, Inc. v. Ariosa Diagnostics, Inc., Roche Mol. Sys., Inc.
Docket No. 22018-2198, -2303, -2305, -2306, -2317
REYNA, WALLACH, HUGHES
April 24, 2020 (Non-precedential)

Brief Summary: DC denial of injunction and damages, as well as its refusal to grant JMOL of noninfringement and invalidity, affirmed.

Summary: Illumina appealed the DC denial of permanent injunction and damages issues and Ariosa cross-appealed the DC denial of its motion for a judgment as a matter of law (JMOL) on noninfringement (regarding Ariosa’s Harmony Prenatal Test, versions 1 and 2 (V1, V2)) and invalidity (anticipation, enablement). Illumina’s disputed US 7,955,794 directed to “[a] multiplex for determining whether a sample contains at least 100 different target sequences” by amplifying probes and detecting the resultant amplicons. Verinata’s (an Illumina subsidiary) US 8,318,430 disputed patent is directed to “[a] method for determining a presence of absence of a fetal aneuploidy in a fetus for each of a plurality of maternal blood samples…comprising fetal and maternal cell-free genomic DNA” (NIPT screening). Ariosa argued its tests did not infringe the ‘794 claims literally or under the doctrine of equivalents (DOE) (e.g., “the differences between the claimed amplicons and Ariosa’s readout cassettes are substantial”, “Illumina failed to prove that immobilizing and detecting readout cassettes leads to insubstantially different results from immobilizing and detecting amplicons”), but the FC panel disagreed (e.g., “fails to demonstrate that a reasonable jury could not find infringement under the” DOE, expert testimony “constitutes evidence that a reasonable mind could accept as proving infringement under the” DOE). The DC found that Ariosa was barred from challenging the validity of the ‘794 patent because of assignor estoppel but the FC panel did not reach the issue because it agreed with the DC/jury finding of no invalidity for anticipation (declining “to reweigh the credibility of the parties’ respective expert witnesses” (Impax Labs., FC 2018), concluding jury verdict to be supported by substantial evidence (i4i Ltd., FC 2010)). Ariosa argued the ‘430 patent is not enabled because it “fails to disclose an algorithm for determining the presence or absence of a fetal aneuploidy in the context of a targeted sequencing approach as claimed in claim 1, step (f)”. Ariosa agreed “that the ‘430 patent incorporates by reference disclosures of ‘[m]ethods for determining fetal aneuploidy using random sequencing techniques’” but argued “that a skilled artisan would not be able to adapt those…into non-random sequencing data without undue experimentation”, relying on inventor testimony. The FC panel disagreed, however, finding Illumina’s expert testimony to be that which “a reasonable mind might accept” to show enablement by the specification (Hybritech, FC 1986). The FC panel also found that the DC did not abuse its discretion in denying Illumina’s request for injunctive relief (four-factor eBay test (US 2006)), supplemental damages, and pre-judgment interest (Nichia, FC 2017). The FC panel explained that Illumina had not shown irreparable harm (ActiveVideo Networks (FC 2012) (indirect competition causes “[s]traight-forward monetary harm” “certainly not irreparable”)). The FC panel also found no error with the DC’s choice to consider supplemental damages after this appeal was resolved. The DC decision was therefore affirmed.

Posted in Anticipation (35 USC 102), Doctrine of equivalents, Enablement, Infringement, Software | Leave a comment

Extension under § 156 does not include claimed metabolite not listed on Tecfidera® label


Biogen Int. GmbH v. Banner Life Sciences LLC

Docket No. 2020-1373
LOURIE, MOORE, CHEN
April 21, 2020

Brief Summary: DC judgment that patent extended under § 156 does not included metabolite covered by claim but not listed in Tecfidera® label affirmed.

Summary: Biogen appealed DC judgment that Banner does not infringe the portion of US 7,619,001 that was extended by 811 days under the Hatch-Waxman Act (35 USC § 156) regarding the multiple sclerosis drug Tecfidera® (“DMF”, the dimethyl ester of fumaric acid). The FC panel explains that ‘001 method of treatment claim 1 covers administration of a “pharmaceutical preparation comprising” DMF as well as methyl hydrogen fumarate (MMF which includes only one methyl ester group)) into which DMF is metabolized upon administration and “before the compound reaches its pharmacological site of action.” “The question” in this appeal is whether MMF “covered by the claim, is covered by the extension.” The DC concluded it was not, and the FC panel agreed. The FC panel explained that § 156(b) “limits the scope of the patent extension to ‘any use approved for the product,’ and further, for method of treatment patents, to uses also ‘claimed by the patent’” and that § 156(f) “defines ‘product’ as ‘the active ingredient of…a new drug…including any salt or ester of the active ingredient’” (§ 156(b)(2)). Biogen argued that the DC “misinterpreted ‘product’ in § 156(f)” as not encompassing a deesterfied form of an approved product”, citing Pfizer (FC 2004), and contending that “‘active ingredient’ means ‘active moiety’” (Glaxo, FC 2004 (separate ester compound, not the same active ingredient as its previously approved carboxylic acid); PhotoCure, FC 2004). “But this case”, the FC panel wrote, “is neither a Glaxo case nor a Pfizer case” and “is governed by statute” and “[t]he active ingredient of a given drug product is defined by what is approved and is specified on the drug’s label”, which does not include MMF (“not the approved product”, not “specified on the Tecfidera® label”). Further, while “[e]sters are included in the statutory definition of what can be extended,” “MMF is the de-esterfied form of DMF, not an ester of DMF” and “does not fall within the scope of the ‘001 patent’s term extension under § 156(b)(2). The FC panel also wrote that “[a]ll..precedents, and now this case, rest on the same holding: the term ‘product,’ defined in § 156(f) as the ‘active ingredient…including any salt or ester of the active ingredient,’ has a plain and ordinary meaning that is not coextensive with ‘active moiety’” (Merck, FC 1996; “encompasses the active ingredient that exists in the product as administered and approved-as specified by the FDA and designated on the product’s label-or changes to that active ingredient which serve only to make it a salt or an ester” but not “a metabolite of the active ingredient or its desterfied form”). Biogen’s argument that the DC erred in rejecting its infringement under DOE claim was also rejected because “a product or process cannot logically infringe an extended patent claim under equivalence if it is statutorily not included in the extension under § 156.”

Posted in Extension (156), Patent Term Extension | Leave a comment

Patent ineligibility decision reversed and remanded as claim is “not rendered ineligible for patent simply because it involves an abstract concept”


Cardionet, LLC et al. v. Infobionic, Inc.

Docket No. 2019-1149
DYK, PLAGER, STOLL
April 17, 2020

Brief Summary: DC patent ineligibility decision (section 101) reversed and remanded (“not rendered ineligible for patent simply because it involves an abstract concept”).

Summary: CardioNet (CN) appealed DC dismissal of its infringement complaint after holding the asserted claims related to cardiac monitoring technology patent ineligible under section 101. Independent claim 1 of CN’s US 7,941,207 “detects beat-to-beat timing of cardiac activity, detects premature ventricular beats (irregular beats that interrupt the normal heart rhythm), and determines the relevance of the beat-to-beat timing to atrial fibrillation or atrial flutter, taking into account the variability in the beat-to-beat timing caused by premature ventricular beats”. The dependent claims “further define the features of the device or its operation” (e.g., “relevance determination logic is to accommodate variability”, “compare times between R-waves”, “collecting…and transmitting the data”). The FC panel explains that “[t]he ‘207 patent describes a number of advantages achieved by the claimed cardiac monitoring device” (e.g., “can more accurately distinguish atrial fibrillation and atrial flutter from other types of arrythmias”). The DC concluded that “the ‘idea of using a machine…may well improve the field of cardiac telemetry,’ CardioNet ‘d[id] not identify improvements to any particular computerized technology.’” The FC reviewed the decision de novo (Berkheimer, FC 2018) and explained the Alice two-step test (Alice, US 2014; “abstract ideas”, “the longstanding rule that ‘[a]n idea of itself is not patentable’”, but “an invention is not rendered ineligible for patent simply because it involves an abstract concept”). Under Alice step one, the court must “consider the claims ‘in their entirety…as a whole’” (McRO, FC 2016; Chamberlain, FC 2019 (“the specification is helpful”); Data Engine, FC 2018 (Alice step two not required “[i]f the claims are not directed to a patent-ineligible concept under Alice step 1”). Under Alice step one, the FC panel concluded that “[w]hen read as a whole,” claim 1 “is directed to an improved cardiac monitoring device and not to an abstract idea”, and not “a result or effect that itself is the abstract idea” (e.g., do not “merely invoke generic processes and machinery” (McRO); “the claims ‘focus on a specific means or method that improves’ cardiac monitoring”, “the written description confirms our conclusion”, “dependent claims…further specify the physical features or operation of the device…each…narrows the device’s specific technical features or operations”). The FC panel explained CN’s claims are similar to those of Visual Memory (FC 2017) which found claims “directed to an improved computer memory system, not the abstract idea of categorical data storage” to be patent-eligible (also as in McRO (patent-eligible “method for automatically animating lip synchronization”)). The FC panel also found the DC incorrectly assumed “that the claims are directed to automating known techniques” (e.g., “nothing in the record supports” DC finding “that doctors long used the claimed diagnostic processes”) and disregarded “the written description’s recitation of the advantages of the claimed invention”.

The FC panel also explained that “[t]he analysis under Alice step one is whether the claims as a whole are ‘directed to’ an abstract idea, regardless of whether the prior art demonstrates the idea or other aspects of the claim are known, unknown, convention, unconventional, routine, or not routine” (“in neither Bilski nor Alice did the Court rely on an examination of the prior art as part of its step one inquiry”; Diamond v. Diehr (US 1981); Am. Axle, FC 2019; Data Engine, FC 2018; Enfish, FC 2016 (“confirms this point”)). It also explained that “[c]ontrary to the dissent’s suggestions, we do not hold today that it is impermissible for courts to ‘look[] outside the intrinsic evidence’ as part of their Alice step on inquiry”. The DC decision was therefore reversed and remanded.

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

Claim construction reversed since DC excluded preferred embodiment and “‘equivalent’ does not require mathematical precision”


Rembrandt Diagnostics, LP v. Alere, Inc. et al.

Docket No. 2019-1595, -1648
WALLACH, MAYER, STOLL
April 10, 2020
Non-precedential

Brief Summary: FC panel reverses DC claim construction (e.g., cannot exclude preferred embodiment, “‘equivalent’ does not require mathematical precision”).

Summary: Rembrandt appealed DC construction of its claim of U.S. Pat. No. 6,548,019 to “[a] device for collecting and assaying a sample of biological fluid” using “an assay test strip…disposed within [a] flow control channel…wherein entry of fluid into the flow control channel creates an ambient pressure” therein “equivalent to the ambient pressure outside of the flow control channel”. Before trial, Rembrandt stipulated to noninfringement by Alere’s urine test cups (iCup DX Pro, AmediCheck, DrugSmart, UScreen, iCup A.D.) in light of the DC’s claim construction. Rembrandt argued the “disposed within” limitation “should be ‘accorded its plain and ordinary meaning’” and “should mean…placed or arranged within the flow control channel”, but the DC construed it to mean that “the assay strip is disposed entirely within the flow control channel”. The DC based its construction on the “‘unambiguous’ claim language” specification, Fig. 3, and the prosecution history (intrinsic evidence) that “result[ed] in the exclusion of a preferred embodiment that teaches the loading zone can protrude from the channel.” The FC panel reviewed the DC’s claim construction de novo (Columbia Univ., FC 2016). It found that “the language of claim 1 is ambiguous” (e.g., “the claim language does not definitively support one construction over the other”), the DC construction “excludes the preferred embodiment” which is encompassed by Rembrandt’s construction, the specification (in describing the preferred embodiments) “uses nearly identical language as the disputed claim language”, was not persuaded that the prosecution history includes a clear and unmistakable surrender of claims directed to a preferred embodiment or “that any of the inventors’ statements otherwise require a claim construction that would omit a preferred embodiment” (e.g., in distinguishing the prior art (Elekta, FC 2000 (“‘unambiguous claim language” is “the ‘rare case’ in which the construction must exclude the preferred embodiment” (e.g., preferred embodiment of zero to 45 degrees, claimed 30 to 45 degrees)). Thus, the FC reversed the DC’s construction of “disposed within”.

The DC also construed “equivalent to” to mean “equal to”, but Rembrandt argued it should be “in equilibrium with”. The FC panel explained that this “also presents a close question” but found Rembrandt’s “more consistent with the intrinsic record” (e.g., “the plain language suggests a broader meaning of ‘equivalent to’” (“Similar to the oft-used claim term ‘substantially’, we consider ‘equivalent,’ as used in claim 1, to be a term of degree that does not require mathematical precision” (Ecolab, FC 2001); “[t]he specification also supports a broader interpretation”) and that the related “jury instruction was erroneous and prejudicial.”

Posted in Claim Construction, Prosecution History Estoppel | Leave a comment

Prior knowledge or use, public use, and on-sale bar holdings reversed (e.g., must be accessible to the public)


BASF Corp. v. SNF Holding Company, et al.

Docket No. 2019-1243
LOURIE, REYNA, HUGHES
April 8, 2020

Brief Summary: DC decisions finding prior knowledge or use, public use, and on-sale bar reversed and remanded.

Summary: BASF appealed DC decision granted summary judgment (SJ) that claims 1 and 3-7 of US 5,633,329 are invalid as anticipated and that claim 2 is invalid as obvious. The claims relate to processes for preparing polymers “in a tubular reactor which has a conical taper at the end” for use in waste treatment, paper manufacturing, and mining. The DC concluded that a process performed by a third party, Celanese Corp.’s “Sanwet® Process,” evidences prior art knowledge and use of the patented invention under § 102(a), and was a public-use bar and an on-sale bar to the patented invention under § 102(b). The DC case leading to this appeal was stayed during an IPR of this patent filed by SNF, with the PTAB concluding that SNF failed to prove obviousness (IPR2015-00600). After the IPR decision, SNF was granted SJ for anticipation and obviousness based on the use of Celanese’s use of the Sanwet® Process which was licensed from Sanyo Chem. Ind. with a ten year confidentiality provision (employees and subcontractors were required to sign confidentiality agreements). The DC “agreed with SNF that ‘one person’s use or knowledge’ is all that is required for an invention to be ‘known or used’ by others under § 102(a), and ‘whether prior use is secret or confidential is immaterial’”, and granted SJ on both the public-use and on-sale bars of § 102(b)” (pre-AIA).

The FC panel found the DC’s interpretation to be erroneous because, e.g., “[t]his court has uniformly interpreted the ‘known or used’ prong of § 102(a) to mean ‘knowledge or use which is accessible to the public’” (Carella, FC 1986; Woodland Tr., FC 1998; MMM, FC 2002; In re Borst, CCPA 1965; Penncock, US 1829 (public use as a bar); Gayler, US 1850 (“no prior use or knowledge where the prior user ‘had not made his discovery public, but had used it simply for his own private purpose’”, “confers no benefit on the public, and thus does not suffice as a defense under § 102(a)”)). The FC panel agreed with SNF that “[p]rior knowledge and use by a single person is sufficient” (“[t]he number is immaterial”), but it must be public. The FC panel also explained that “the existence of relevant confidentiality agreement and the degree to which they were honored are evidence of whether prior knowledge and use were accessible to the public but are not necessarily conclusive” (Bernhardt, FC 2004).

The FC panel also found the DC erred in its § 102(b) public use analysis because it “applies to uses of the invention ‘not purposely hidden’” and a “use…not successfully concealed or hidden from those who lack any ‘limitation or restriction, or injunction of secrecy’…is a public use within the meaning of § 102(b)” (Shimadzu, US 1939; Egbert, US 1881Motionless Keyboard, FC 2007; Invitrogen, FC 2005; New Railhead, FC 2002; W.L. Gore, FC 1983 (3rd party sale of product made by secret process does not create a bar to another inventor of the process); City of Elizabeth, US 1877 (“experimental use is not public use”); Dey, FC 2012 (relevant factors in public use analysis)).

The FC panel also reversed the DC’s grant of SJ based on the § 102(b) on-sale defense (Pfaff, US 1998) because “[t]he invention itself must be sold or offered for sale as defined under the UCC (Medicines Co., FC 2016 (en banc)). “[A] process may be sold in a manner which triggers the on-sale bar” (e.g., Metallizing, 2d Cir. 1946 (upon which In re Borst, CCPA 1965 relied)), as is the “sale of a product made by his later-patented process, i.e., the Metallizing rule” (D.L. Auld, FC 1983). The FC panel explained that In re Kollar (FC 2002) stands for the “well-established principle that the grant of a license to practice a patented invention, with or without accompanying technical information, does not itself create an on-sale bar” (Minton, FC 2003; Quanta, US 2008 (“where a product ‘embodie[s] essential features of [the] patented invention,’…a sale of that product is tantamount to a sale of the process performed by that product and thus creates an on-sale bar to the process claims as well”)). But here the FC panel found the agreement between Celanese and Sanyo “was not a sale of the Sanwet® Process” (e.g., “the essential features of the claimed process here were not embodied in a product sold or offered for sale before the critical date”).

Posted in Anticipation (35 USC 102), On-Sale Bar, Public Accessibility, Public Use | Leave a comment

DC indefiniteness findings vacated and remanded (Nautilus standard controls, only general-purpose computer or processor requires a specific algorithm)


Nevro Corp. v. Boston Scientific Corp. et al.

Docket No. 2018-2220, -2349
LOURIE, REYNA, HUGHES
April 9, 2020

Brief Summary: DC grant of SJ based on its indefiniteness finding vacated and remanded (e.g., the correct standard is the Nautilus “reasonable certainty” standard).

Summary: Nevro appealed DC summary judgment (SJ) that certain of its claims of seven patents including method of treatment, system and device claims related to using high-frequency spinal cord stimulation therapy to inhibit pain are invalid for indefiniteness. Boston Scientific (BSC) cross-appealed the DC decision finding certain other claims not indefinite and infringed. In making its decisions, the DC construed the terms “paresthesia-free” (e.g., tingling of the skin), “configured to”, “means for generating”, and “therapy signal”, which the FC panel reviewed in this opinion. The system claimed in illustrative claim 18 of the ‘125 patent comprises a “means for generating a paresthesia-free therapy signal” and illustrative claim 1 of the ‘472 patent describes “[a] method for alleviating pain or discomfort, without relying on paresthesia or tingling to mask the patient’s sensation of pain”. The DC construed paresthesia-free to have the “clear meaning” of “therapy or therapy signal ‘does not produce a sensation usually described as tingling, pins and needles, or numbness” (“based on extrinsic evidence”, “a skilled artisan would be able to quickly determine whether a signal creates paresthesia for any given patient”), but that the term was indefinite in the system and device claims (not indefinite in the method claims). The FC panel reviewed these holdings de novo, explaining to comply with 35 USC 112, the “[c]laims, when viewed in light of the specification and prosecution history, must ‘inform those skilled in the art about the scope of the invention with reasonable certainty’”, “recognizing that absolute precision is unattainable” (Nautilus, US 2014; Interval Lic., FC 2014).

The FC panel found “paresthesia-free” satisfy the definiteness standard for all of the method, system and device claims (“a functional term, defined by what it does rather than what it is”, “[b]ut that does not inherently render it indefinite” (Halliburton, FC 2008); Enzo, FC 2010 (“the ambiguity inherent in functional terms may be resolved where the patent ‘provides a general guideline and examples sufficient to enable a person of ordinary skill in the art to determine the scope of the claims’”); “Definiteness does not require that a potential infringer be able to determine ex ante if a particular act infringes the claims.” Star Sci., FC 2008; Invitrogen, FC 2005; Geneva, FC 2003; Halliburton).

The DC held “configured to” indefinite because it “is susceptible to different constructions” but the FC panel disagreed as the standard is the Nautilus “reasonable certainty” standard, explaining that the DC’s position “would render nearly every claim indefinite so long as a party could manufacture a plausible construction” (“the Supreme Court declined to adopt such a rule” (Nautilus)). Based upon its review of the specification and prosecution history, the FC panel concluded the DC erred in finding “configured to” indefinite and that it means “programmed to”.

The DC “determined that there was ‘not an adequate disclosure of a corresponding structure” for the means-plus-function limitation (112, section 6) “means for generating” limitation. The FC panel disagreed, finding “the specification clearly recites a signal or pulse generator…as the structure”, “not a general-purpose computer or processor”, and therefore “does not require a specific algorithm” (Aristocrat, FC 2008). The FC panel therefore found the DC erred in finding the “means for generating” limitation indefinite.

The DC found “therapy signal” was not indefinite, but the FC panel found it erred in its construction (reviewed de novo as the underlying fact findings relate to extrinsic evidence (Teva, US 2015; Thorner, FC 2012)). The FC panel wrote that “[t]he plain language of the claims makes clear that the claimed ‘therapy signal’ is for pain-relief spinal cord stimulation therapy” and the specification the DC relied upon for its definition “does not meet the exacting standard for redefining” the term (Hill-Rom Servs., FC 2014; Interval Lic., FC 2014).

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