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  • PTAB · Mar 26, 2020 · PGR2018-00001 · APJ Grace Karaffa Obermann · PGR · Rehearing

    The Board denied Patent Owner’s rehearing request, leaving claims 3–30 unpatentable for lack of enablement because the specification does not guide an artisan to practice their full scope without undue experimentation.

    RulingsRehearing decision
    • RehearingRehearing, deniedDenied

      “Upon request for rehearing, we review our decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” Id. Based on an application of those principles, we deny the Request for Rehearing.” slip op. at 2

    • Expert testimonyOther

      “zolendronic acid dosage forms could achieve bioavailabilities as high as 1.1% to “a belie[f] in ‘fairies.’” Req. Reh’g 2 (quoting Dec. 14; Ex. 2014, 137:21–138:8). That testimony represents a small fraction of the totality of evidence that undergirds our finding that an ordinarily skilled artisan generally would have expected that attaining a human bioavailability for zolendronic acid above 1% required an enhancer. See Dec. 12–21 (citing substantial evidence for that proposition). Even if we set aside the testimony misattributed to Dr. Wargin, substantial evidence supports that finding.” slip op. at 3

    • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

      “unenhanced dosage form of zoledronic acid disclosed in Aronhime or Exhibit 2026 would have attained a bioavailability that falls within the scope of the challenged claims. The key is whether an ordinarily skilled artisan, reading the disclosure of the ’268 Patent, would have been equipped to practice the full scope of the claimed invention. We did not overlook or misapprehend Exhibit 2026. We correctly determined that, in this unpredictable field of pharmaceutical formulation, an ordinarily skilled artisan would have required direction (lacking in the Specification or the prior art) explaining how to prepare dosage forms that meet the full range of bioavailabilities embraced by the challenged claims, including the specified high endpoint human bioavailability of about 4%. See, e.g., Dec. 11–12 (citing undisputed evidence of unpredictable nature of the field of invention (Ex. 1005 ¶ 60)).” slip op. at 7

    § 112 disclosure
    Patents in suitUS 9,539,268
  • PTAB · Sep 26, 2017 · IPR2016-00829 · APJ Deborah Katz · IPR · Final written decision

    Claims 1–15 are unpatentable under § 103 over the ’859 publication, Blau, and Simell; claims 3, 6, 11, 14, and 15 also rely on Brusilow ’84.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “We are not persuaded by Patent Owner’s argument that the lack of specific residency/fellowship training or certification, disqualifies Dr. Vaux from providing opinion testimony on the motivations, understandings, and actions of those of ordinary skill in the art. Dr. Vaux testifies that he is “a medical doctor with specialty training in Pediatrics and Clinical Genetics” and is currently Professor and Clinical Chief of the Division of Medical Genetics in the Department of Medicine at UC San Diego. Ex. 1002 ¶ 1. He also testifies: Since 1994, I have regularly diagnosed and treated patients with urea cycle disorders (“UCD”), and continue to do so today. In treating UCD patients, I regularly prescribe nitrogen scavenging drugs and treat patients who are maintained on therapy with nitrogen scavenging drugs. Ex. 1002 ¶ 1. Thus, Dr. Vaux has actually treated UCD patients for at least five years (a requirement recited by Patent Owner, see PO Resp. 16), including prescribing drugs. Patent Owner does not direct us to evidence that Dr. Vaux’s testimony is untruthful or that his treatment of UCD patients is ineffective, indicating that he does not understand how to treat them. Accordingly, even if Dr. Vaux does not have the specialized certificates or particular training that Patent Owner argues are necessary, he has done the job for over twenty years of one who would carry out the claimed methods. We consider this experience more relevant than certificates or training. Thus, we determine that Dr. Vaux is qualified to provide opinions about the motivations, understandings, and actions of one of ordinary skill in the art.” slip op. at 15

    • Skill levelSkill level board ownOther

      “Patent Owner and Petitioner define a person of ordinary skill in the art as having similar qualifications (compare Pet. 8–9, citing Ex. 1002 ¶ 19 with PO Resp. 15–16, citing Ex. 2006 ¶ 26), but Patent Owner argues that the ordinarily skilled artisan must additionally have “at least three years of residency/fellowship training in Medical Genetics, including Biochemical Genetics, followed by certification in Clinical Genetics and Clinical Biochemical Genetics by the American Board of Medical Genetics and Genomics.” PO Resp. 15–16, citing Ex. 2006 ¶ 26. We agree with the qualifications on which the parties agree and find that one of ordinary skill in the art would have an M.D. or equivalent degree, with a residency and specialized training in the diagnosis or treatment of inherited metabolic disorders, such as UCDs and other nitrogen retention disorders. See Pet. 8– 9; PO Resp. 15–16. We also agree with Patent Owner that one of ordinary skill in the art would have experience treating patients with nitrogen retention disorders, including UCDs. See PO Resp. 16.” slip op. at 15

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

      “Nevertheless, we agree with the parties8 that the claim term “upper limit of normal” (“ULN”) means the highest value in a range of normal values. See Pet. 10; PO Resp. 21. We determine that the plain meaning and the broadest reasonable interpretation of the claim term “less than the upper limit of normal” is any value less than the highest value in the range of normal values. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); see 37 C.F.R. § 42.100(b).” slip op. at 11

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “In summary, the ’859 publication teaches that those of skill in the art would have known to use HPN-100 to treat subjects with UCDs. It also teaches that measuring plasma or blood level of ammonia was known to be useful in determining the effectiveness of a drug regimen for a particular patient and that measuring blood ammonia was a known step in adjusting drug dosages. The ’859 publication teaches that maintaining normal plasma ammonia levels was desirable in the art. Although specific measurements of 8 Patent Owner notes that the parties do not dispute the meaning of any of the claim terms. PO Resp. 2. Because the meaning of the terms in the challenged claims are evident from their ordinary meaning and not controversial, we need not provide a separate analysis of them. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“claim terms need only be construed ‘to the extent necessary to resolve the controversy.’ Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).”). plasma ammonia do not necessarily indicate the upper limit of normal consistently across different ways of measuring it, the ’859 publication teaches that treatment would have been considered to be effective when plasma ammonia levels were less than what is determined to be the upper limit of normal in a given case. In addition to the ’859 publication, Petitioner relies on Blau and Simell for the teaching to collect blood from UCD patients after a fast in order to measure plasma ammonia levels. Ex. 1006 at 273 (Table 11.9); Ex. 1005 at 1118; see Pet. 25–26 (citing Ex. 1002 ¶¶ 58, 59); see also id. 1002 ¶ 46, n.2 (citing Ex. 1015 at S11). Anticipating Patent Owner’s argument that Blau relates to diagnosis not treatment of UCDs, Petitioner also cites to Exhibits 1010 and 1015 as evidence that it was generally recommended to measure plasma ammonia after a fast. See Pet. 16, n.2. Exhibit 1010 is a “Lab Update” about measurement in ammonia in blood, and Exhibit 1015 is a publication entitled “Measurement of ammonia in blood.” Both state that most methods recommend collecting a sample from patients who have fasted for at least 6 hours. See Ex. 1010, 4; Ex. 1015, 1. From this evidence, we agree with Petitioner that those of skill in the art would have known that measuring fasting serum ammonia levels, as taught in at least Simell and Blau, was known to be useful with the methods taught in the ’859 publication. In regard to Ground 2, which challenges claim 3 and the claims that depend on it, Petitioner cites Brusilow ’84 for its teaching of measuring a patient’s fasting plasma ammonia level when he or she is admitted, presumably to a hospital, and, in response to elevated levels, treating with the nitrogen scavenging drugs sodium benzoate and phenylacetate. See Pet.” slip op. at 11

    Patent outcomesUS 9,095,559 unpatentable
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 9,095,559
  • PTAB · Jun 9, 2017 · IPR2016-00188 · APJ Toni R Scheiner · IPR · Final written decision

    Claims 1–4 are unpatentable as obvious over van de Putte and Kempeni because the prior art supplied motivation and a reasonable expectation of success for the claimed dosing regimen.

    RulingsFinal written decision
    • Skill levelSkill level board ownDecided for petitioner

      “art as of June 8, 2001—the priority date of the ’135 patent, of which the ’680 patent is a continuation. Petitioner and Dr. Baughman explain that a skilled artisan would possess the skill sets of both a physician treating RA patients and a pharmacokineticist with experience in monoclonal antibodies. Pet. 28; Ex. 1006 ¶ 15; Ex. 1007 ¶ 12, 13. Dr. Baughman describes the ordinarily skilled physician as an M.D. with at least three years of experience treating RA patients, including with one or more anti-TNFα biologic agents. Ex. 1006 ¶ 15; see Pet. 28; Ex. 1007 ¶ 12 (Dr. O’Dell agreeing with Dr. Baughman’s definition of the skilled physician). Dr. Baughman describes the ordinarily skilled pharmacokineticist as having a Ph.D. in pharmacokinetics or a related field, and at least three years of experience with the pharmacokinetics and pharmacodynamics of biologic agents, either in industry or academia. Ex. 1006 ¶ 15; see Pet. 27. Patent Owner’s experts Dr. Gibofsky and Dr. Vinks apply Petitioner’s and Dr. Baughman’s description of the ordinary artisan. Ex. 2065 ¶¶ 53–54; Ex. 2069 ¶¶ 101– 103. We adopt that description of the level of ordinary skill in the art, because it is the description that both parties have applied in this proceeding and it is reflected by the prior art of record.” slip op. at 5

    • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner

      “invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). On the other hand, “a preamble is not limiting ‘where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.’” Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). Here, the steps of the method, dosage amount, timing, route of administration, and active component are all specified in the body of the claim. The phrase “reducing the signs and symptoms of rheumatoid arthritis,” therefore, merely recites an intended use. See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (statements of intended use typically do not limit the scope of a claim because they “usually do no more than define a context in which the invention operates”). Stated another way, the claims do not expressly recite any particular level of efficacy, meaningful or otherwise. Rather, the claims require administering the antibody in a particular dosage amount, by a particular route, at a particular interval—to a patient with moderately to severely active rheumatoid arthritis.” slip op. at 8

    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

      “2. “40 mg dosage unit form” According to the ’680 patent, “dosage unit form” “refers to physically discrete units suited as unitary dosages for the mammalian subjects to be treated; each unit containing a predetermined quantity of active compound[.]” Ex. 1001, 23:9–12. Petitioner contends, “[b]ased upon this definition, a ‘40 mg dosage unit’ form would encompass a syringe filled with 40 mg of D2E7.” Pet. 17.” slip op. at 9

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable

      “Patent Owner does not challenge Petitioner’s showing that the prior art discloses each element of claims 1–4. See generally PO Resp. Based on the full trial record, we determine that van de Putte and Kempeni collectively disclose each limitation of the challenged claims. That is, we agree with Petitioner that van de Putte discloses all of the elements of claims 1–4, with the exceptions of biweekly dosing, and administering the antibody in combination with methotrexate. As explained above, van de Putte discloses a study in which RA patients received weekly doses of 20, 40, or 80 mg of D2E7, or placebo, via subcutaneous self-administration over the course of three months. Ex. 1004, 1. D2E7, therefore, was administered in a pharmaceutically acceptable composition, in unit dosage form. Id. Further, D2E7 is a known recombinant human anti-TNFα antibody having the six CDRs and heavy chain constant region required by claims 1–4, and the amino acid sequences for the variable light and variable heavy chain regions required by claims 2 and 4. Ex. 1001, 3:40–42 (explaining that D2E7 is “described in U.S. Pat. No. 6,090,382, incorporated in its entirety herein by reference”); see Ex. 1008, 2:59–67. Petitioner also shows, by a preponderance of the evidence, that Kempeni accounts for the differences between van de Putte and the recited biweekly dosing frequency required by all of the challenged claims, as well as administering the antibody with methotrexate. Specifically, Kempeni describes a study in which patients received D2E7 via intravenous injection every two weeks for at least 6 months (i.e., 24 weeks), and also teaches that “D2E7 is safe and effective . . . in combination with methotrexate when administered by single and multiple intravenous and subcutaneous injections.” Ex. 1003, 2, 3.” slip op. at 15

    Patent outcomesUS 9,017,680 unpatentable
    Claim construction§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 9,017,680
  • PTAB · Jan 4, 2017 · IPR2015-01490 · APJ Lora M Green · IPR · Final written decision

    Claims 1–3, 10–15, 23, 25, 27, 30, and 41–43 are unpatentable; claims 17 and 47 were not shown unpatentable; claims 28 and 29 were cancelled.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

      “based on the complex as a whole, rather than just the carbohydrate component, as Fishbane related to iron dextran complexes. Reply 10. We agree with Petitioner that the language of the term “substantially non-immunogenic carbohydrate component” itself only requires an assessment of the immunogenicity of the carbohydrate component, and disagree with Patent Owner that the claims require an assessment of the immunogenicity of the iron carbohydrate complex as a whole. In that regard, we note that the Specification of the ’702 patent supports our construction that the “substantially non-immunogenic carbohydrate component” is limited to the carbohydrate component as opposed to the iron carbohydrate complex as a whole. Specifically, the Specification teaches in the background section that previously available iron dextran products suffered from a “high incidence of anaphylactoid reactions . . . believed to be caused by the formation of antibodies to the dextran moiety,” while “[o]ther parenteral iron products (e.g., iron sucrose and iron gluconate) do not contain the dextran moiety, and the incidence of anaphylaxis with these products is markedly lower.” Ex. 1001, 1:53–57; see also id. at 11:3‒4 (“non-immunogenic carbohydrate component; no cross reactivity with anti-dextran antibodies”). Moreover, the language of independent claim 1 itself does not require a non-immunogenic complex, but only specifies that the “iron carbohydrate complex has a substantially non-immunogenic carbohydrate component.” Moreover, we decline to limit the term “substantially non- immunogenic carbohydrate complex” to require an incidence level of lower than 0.6%. Rather, what is supported by the claim language and the Specification is a low risk such that the incidence of adverse events of the carbohydrate complex is lower than dextran. See, e.g., Tr. 53‒54 (counsel for Patent Owner acknowledging that Fishbane was not incorporated by reference, and that it was only cited as a “see generally”).” slip op. at 10

    • Skill levelOther

      “We do not find a significant different between the requirements for the ordinary artisan proposed by Petitioner and Patent Owner. We agree with Petitioner (Pet. 14) that the best evidence of the level of skill in the art are the references themselves, see Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001), and, thus, we need not explicitly adopt either Petitioner’s or Patent Owner’s characterization of the level of skill in the art. Moreover, we note that the result of the analysis regarding the patentability of the claims would be the same under the requirements for the ordinary artisan proposed by either Petitioner or Patent Owner.” slip op. at 12

    • Expert testimonyPetitioner expert creditedDecided for petitioner
    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableInherency foundUnpatentable

      “Petition (Pet. 22–27), we find that Petitioner has demonstrated by a preponderance of the evidence that Geisser teaches all the limitations of claim 1, either inherently or explicitly. That is, we agree with Petitioner that Geisser teaches a method of treating a disease characterized by an iron deficiency, specifically iron deficiency anemia (Pet. 23; Ex. 1003, Abstract, 1:4‒7, 2:4‒7, 9:30‒31). We further agree that Geisser teaches a method of administering an iron carbohydrate complex, that is, iron carboxymaltose, in a single dosage form of at least 0.6 grams of elemental iron, as Geisser teaches administering iron carbohydrate complexes as a single dose of 500‒ 1000 mg of iron. Pet. 23 (citing Ex. 1003, 1:26‒4:1, 8:7-10, 10:14‒17). In that regard, we credit the testimony of Dr. Linhardt that Geiser discloses iron carboxymaltose, and that Geisser describes a general synthetic method that is nearly identical to the method described in the ʼ702 patent. Ex. 1005 ¶¶ 8‒10, 13. In addition, as Geisser teaches one of the iron carbohydrate complexes explicitly recited by claim 1, that is, iron carboxymaltose, it would inherently meet the limitation that the carbohydrate component is substantially non-immunogenic and would have substantially no cross-reactivity with anti-dextran antibodies. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition can not have mutually exclusive properties.”). The teachings of Geisser support that finding, as Geisser specifically teaches that the complexes have low toxicity and a reduced danger of anaphylactic shock. Pet. 23 (citing Ex. 1003, 1:26‒ 2:1, 8:7‒10); see also Ex. 1001, 12:12‒14 (noting that as “[t]he iron carboxymaltose complex (e.g., VIT-45) generally does not contain dextran and [it] does not react with dextran antibodies.”).” slip op. at 18

    Patent outcomesUS 7,754,702 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 7,754,702
  • PTAB · Sep 29, 2016 · IPR2016-00284 · APJ Deborah Katz · IPR · Final written decision

    Claims 1–11 are unpatentable under § 103 over the three combinations of references identified in the decision.

    RulingsFinal written decision
    • ExcludeMotion to exclude, deniedDenied

      “Petitioners argue that Patent Owner’s Exhibits 2022 and 2024 should be excluded because they are not prior art to the ’215 patent. Paper 25, 1–2. Even considering Exhibits 2022 and 2024, we are still persuaded that a preponderance of the evidence shows claims of the ’215 are unpatentable. Accordingly, Petitioners’ motion is dismissed as moot. Petitioners also argue that Patent Owner relies on attorney argument to rebut Petitioners’ challenges, effectively providing impermissible expert evidence, which Petitioners seek to exclude. (Paper 25, 2–6.) We dismiss Petitioners’ argument because attorney argument is not evidence. See Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA 1977) (“Argument of counsel cannot take the place of evidence lacking in the record.”). Therefore, Petitioners’ argument is improperly presented in a motion to exclude evidence. Nevertheless, the issue of evidentiary support for Patent Owner’s arguments is addressed above. Patent Owner argues that evidence relied upon by Petitioners should be excluded. Paper 33. Specifically, Patent Owner seeks to exclude certain portions of Dr. Sondheimer’s cross-examination testimony and Exhibits 1031–1033. Patent Owner acknowledges that “[i]n its Reply (Paper 28), Petitioner has not attempted to rely upon the portions of Dr. Sondheimer’s deposition transcript or the documents Patent Owner seeks to exclude.” Paper 33, 2–3. We dismiss Patent Owner’s motion as being moot. Because Patent Owner cannot point to where Petitioners rely on the testimonial evidence, having apparently not relied on it, we have no basis on which to determine whether the evidence is inadmissible and no basis on which to exclude it. Furthermore, because Exhibits 1031–1033 have not been made of record in this proceeding (see Paper 33, 1), they cannot be excluded.” slip op. at 23

    • Skill levelOther
    • Expert testimonyPetitioner expert creditedOther

      “Petitioners rely on the testimony of Neal Sondheimer, M.D., Ph.D. (Ex. 1002). Dr. Sondheimer testifies that he currently holds several positions at the Children’s Hospital of Philadelphia and the University of Pennsylvania, including Attending Physician in the Division of Biochemical Genetics, Training Director for the Clinical Biochemical Genetics Group, Program Director for Medical Genetics, and Assistant Professor of Pediatrics. Ex. 1002 ¶ 10. Dr. Sondheimer testifies that he has been involved in several research studies about the treatment of urea cycle defects and has co-authored several publications about the use of ammonia-scavenging medications. Id. ¶ 12. We find Dr. Sondheimer to be qualified to provide opinions on the subject matter at issue. Patent Owner does not present the testimony of its own witness to support its arguments.” slip op. at 5

    • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languagePlain and ordinary meaningDecided for petitioner

      “We look to the language of the claim itself and to language in the specification to determine the scope of a claim. To limit a claim beyond what its plain language appears to convey, the patentee “may demonstrate an intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope.” In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1365 (Fed. Cir. 2004) The plain language of independent claims 1–3 recites only the steps of “measuring,” “comparing,” and “administering.” The claims do not include a “targeting” step or steps such as repeated measuring, comparing, and administering, until the fasting blood ammonia level is less than half the upper limit of normal. See Pet. Reply 5–6. Although Patent Owner cites to evidence of the background of the invention, we have not been directed to evidence within the specification of the ’215 patent that clearly limits the claimed methods from being applied at any blood ammonia level greater than half the upper limit of normal. In addition, Patent Owner does not direct us to testimony or other evidence indicating that those skilled in the art would have considered the language of the claims to require “targeting” a certain blood ammonia level or to specify administering drug dosages only when the blood ammonia level is at about that targeted level. On the contrary, the plain terms of the claims contain no such limitations and are broad enough to embrace the administration of drug at higher blood ammonia levels. Accordingly, we conclude that the correct interpretation of Patent Owner’s claims is a method of measuring a fasting blood ammonia level, comparing this level to the upper limit of normal, and administering drug when the level is any level greater than half the upper limit of normal for blood ammonia level.” slip op. at 14

    Patent outcomesUS 8,404,215 unpatentable
    Claim construction§ 103 obviousnesscites KSR
    Patents in suitUS 8,404,215
  • PTAB · Nov 27, 2015 · CBM2014-00159 · APJ Michael W Kim · CBM · Final written decision

    Claims 1–7, 9–11, 13–17, and 20–22 are unpatentable under § 103; the motion to amend claims 23–43 is denied.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

      “Beginning with the claim terms themselves, the word “selectively” is used. We discern that the ordinary and customary usage of this word denotes expressly that a particular account need not function simultaneously as both a merchant account and a purchaser account; a user is permitted expressly to select which account mode is desired at the appropriate point in time. The following disclosure in the Specification is consistent with this understanding: An entity (e.g., a person, business, or other legally recognized entity) preferably creates an account within the payment system. The accounts of the payment system are preferably designed so that an account may selectively function as either a merchant or a purchaser during any particular transaction. In other words, within the scope of all transactions, accounts of the payment system can function as bi-directional transaction accounts. Ex. 1001, 3:15–22. Indeed, here, the Specification discloses expressly that being able to select which account mode is desired is the same as “bi-directional transaction accounts.”” slip op. at 13

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner

      “more properly considered a claim construction. PO Resp. 9. And indeed, when considered in conjunction with Petitioner’s proposed construction, the two constructions are similar. As noted by both Patent Owner and Petitioner, the Specification only mentions “line item data,” or similar wording, as follows: Additionally, as one of the main benefits of having merchant product catalogs integrated into the payment system, line item transaction data can be communicated. The line item data is additionally stored as part of the transaction record of the accounts. This itemized information can be very useful, such as in one application where tax forms are automatically completed by aggregating each category of line item transaction data as appropriate. Ex. 1001, 8:6–13. From the aforementioned portion of the Specification, we determine that the key to a proper construction of “line item data” is that it is information that is itemized and capable of categorization. In other words, “line item data” is an itemized part of a larger whole, more specifically, but not limited to, product catalogs, purchase lists, and transactions records, i.e., at a most granular level, individual products involved in a purchase or sale, as advocated by Petitioner. This focus on itemization and categorization of products is supported by other portions of the Specification cited by the parties, for example, column 2, lines 15–17, which recites that “[t]he integration of the payment system and product catalog functions to enable recording and tracking transactions with itemized detail” (emphases added). See also Ex. 1001, 5:51–55 (“the method may additionally store purchase list information as a transaction record for the merchant account and/or the purchaser account, which functions to form an itemized purchase history” (emphasis added)); 4:4–6 (“[t]he product catalog preferably includes a listing of product descriptions and prices for each product contained within the product catalog” (emphases added)); 4:6–13 (“[a]dditional information may be included for a product such as categories for tax purposes and other purposes, product-related IDs for each distributor of the product (e.g., Stock-Keeping Unit or ‘SKU’), images or media files related to the product, inventory related information (the number of items on hand, on order, etc. at each warehouse location), or any other suitable product-related data” (emphases added)); 4:13–16 (“[t]he product catalog may be a database accessed by outside applications, but may additionally or alternatively include a hosted web-based store through which products can be added to a shopping cart (i.e., a purchase list)” (emphases added)). Accordingly, we construe “line item data” as “itemized information from a larger group of information, related to individual products involved in a purchase or sale, that is capable of categorization,” where non-limiting examples of “line item data” may include one or more of “quantity, description, type, cost, product identifier (e.g., stock keeping unit), tax, duty, shipping or other fees.”” slip op. at 10

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

      “valid reason for combining Bemmel and Dalzell, because Dr. Sadeh- Koniecpol’s opinions of industry custom are unsupported. We are unpersuaded that Dr. Sadeh-Koniecpol’s opinions are unsupported, and especially unpersuaded that Dr. Sadeh-Koniecpol has not provided adequate support regarding the reasons for combining Bemmel and Dalzell. Dr. Sadeh-Koniecpol includes explicit citations to references, in particular Bemmel and Dalzell, for supporting his conclusions, and we determine that any purported “leaps of logic” taken by Dr. Sadeh-Koniecpol are reasonable given the underlying support. For example, Dr. Sadeh-Koniecpol opines that “one of ordinary skill in the art would have been motivated to combine the mobile payment system of Bemmel with the electronic marketplace of Dalzell.” Ex. 1002 ¶ 136. Of course, this paragraph considered in isolation would be an unsupported opinion. Dr. Sadeh-Koniecpol, however, then goes on to support this opinion with explicit citations to Bemmel and Dalzell. Ex. 1002 ¶¶ 137, 139, 140. Dr. Sadeh-Koniecpol then reaches conclusions that we determine flow logically from those citations. Ex. 1002 ¶¶ 138, 141, 142.” slip op. at 21

    • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

      “Patent Owner asserts additionally that the Board should exercise its discretion under 35 U.S.C. § 325(d) and deny the Petition, because similar art was already before the Examiner during prosecution. We note that 35 U.S.C. § 325(d) is normally exercised in a Decision on Institution. Moreover, we have already conducted a full trial in this proceeding subsequent to a Decision on Institution. Furthermore, 35 U.S.C. § 325(d) is discretionary, and insofar as Patent Owner is requesting any vacating of the Decision on Institution, we decline to do so for the reasons set forth above.” slip op. at 28

    Patent outcomesUS 8,396,808 unpatentable
    Claim construction§ 103 obviousnessDiscretionary denialcites KSR · Graham
    Patents in suitUS 8,396,808
  • PTAB · Jun 30, 2015 · IPR2014-00325 · APJ Zhenyu Yang · IPR · Final written decision

    Claims 15–19 are unpatentable because Labtec anticipates them and the combination of Labtec, Birch, and Yang renders them obvious.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionPlain and ordinary meaningOther

      “unexpired patent according to its broadest reasonable construction in light of the specification of the patent in which it appears. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, 778 F.3d 1271, 1280–81 (Fed. Cir. 2015). Under that standard, absent any special definitions, we assign claim terms 1 Leichs et al., Int’l Pub. No. WO 2008/040534 A2, published on April 10, 2008 (Ex. 1017, “Labtec”). 2 Birch et al., U.S. Patent Publication No. 2005/0085440 A1, published on April 21, 2005 (Ex. 1019, “Birch”). 3 Yang et al., U.S. Patent No. 7,357,891 B2, issued on April 15, 2008 (Ex. 1016, “Yang”). their ordinary and customary meaning, as understood by a person of ordinary skill in the art, in the context of the entire patent disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). In the Decision to Institute, we concluded that “film formulation” encompasses film dosage, film composition, or film, but not a formulation that is not in the form of a film. Dec. 11. We also determined that the term “provides an in vivo plasma profile” needs no construction beyond its ordinary meaning. Id. at 12. During trial, the parties did not dispute these constructions. Having considered the complete record developed at trial, we see no reason to change our interpretation of those terms.” slip op. at 4

    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner

      “First, it is a bedrock principle of patent law that the words of the claims themselves define the scope of the patented invention. In re Baxter Int'l, Inc., 678 F.3d 1357, 1362 (Fed. Cir. 2012). None of the challenged claims includes any language to the effect of requiring oral transmucosal absorption. Instead, the claims recite an “orally dissolving film formulation.” Dissolution and absorption are two distinct properties. Thus, “orally dissolving” does not translate into oral transmucosal absorption.” slip op. at 6

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “Nevertheless, the written description requirement does not demand examples or an actual reduction to practice either. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (en banc). Instead, “a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement.” Id. In this case, Labtec lists Suboxone® in Table A as a drug of interest, and describes an oral film that mimics the pharmacokinetics of Suboxone®. Ex. 1017, 22. Labtec describes that the film formulation comprises buprenorphine and naloxone, as recited in claim 15. Id. It states that buprenorphine is to be dosed at 4–16 mg/day. Id. Cmax is 1.84 and 3.0 ng/ml and AUC0-48 is 12.52 and 20.22 hr.ng/ml, for 4 mg and 8 mg buprenorphine, respectively. Id. Labtec further states that “[m]ean peak naloxone levels range from 0.11 to 0.28 ng/ml in dose range of 1–4 mg.” Id. This description amounts to a constructive reduction to practice that describes an oral film with the specified composition and pharmacokinetic profile. Nothing more is needed. Thus, Labtec does not fail as anticipatory prior art merely because it does not disclose any specific embodiment of the recited film.” slip op. at 16

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

      “over the combination of Labtec, Birch,10 and Yang. Pet. 44–45. After reviewing the complete record, we conclude Petitioner has shown by a preponderance of the evidence that one of ordinary skill in the art would have had reason to combine the teachings of Labtec and Yang to make an orally dissolving film as recited in the challenged claims, and would have had a reasonable expectation of success in doing so.” slip op. at 22

    Patent outcomesUS 8,475,832 unpatentable
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR
    Patents in suitUS 8,475,832
  • PTAB · Jun 18, 2015 · IPR2014-00283 · APJ Toni R Scheiner · IPR · Final written decision

    Claim 17 is unpatentable as anticipated by Tachikawa; Petitioner did not prove claim 26 obvious over Tachikawa and Todd because it did not explain how to combine the references.

    RulingsFinal written decision
    • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

      “In each instance, the specification of the ’192 patent uses the term “inertia” in the context of a window cover system that maintains the window cover at a desired position. We determine that the construction of “inertia” offered by Petitioner is consistent with the use of the word in the specification, and would be understood by one of ordinary skill in the art to mean: “a property of matter whereby it remains at rest or continues in uniform motion unless acted upon by some outside force.” Pet. 15. Moreover, as inertia is itself an attribute, or property, of matter, we determine that the word “inherent” does not contribute any additional meaning to the term, or change the way it would be understood by one of ordinary skill in the art.” slip op. at 12

    • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable

      “of Tachikawa’s spring drive for maintaining the position of the cover at different roll-up or roll-down positions.” Pet. Reply 3. In other words, Tachikawa’s spring drive, operating as a constituent element of the window covering system, functions to maintain the window cover at a desired position unless the system is acted on by some outside force. This finding is supported by substantial evidence. Specifically, as noted in the Petition, Tachikawa’s spring 17 constantly generates a torque in the opposite direction and identical to the torque on an operating shaft due to the load of the blinds acting upon the operating shaft, “which has the effect that the force for manipulating the operating shaft in order to perform roll-up and roll-down of the blinds can be a small constant force regardless of the position of the blinds” (Pet. 29; Ex. 1002, 209). Tachikawa teaches that this also has the effect that “the blinds do not fall spontaneously due to the weight of the blinds if roll-up is stopped mid-way, but are rather stopped at that position by the spring torque.” Ex. 1002, 209. We credit the testimony of Petitioner’s witness, Mr. Carlson, that “there are three factors that cause the blinds to ‘stop at the midway position’ (i.e. maintain the position of the cover): 1) the spring torque described above, 2) the inherent inertia necessarily present in all mechanical systems, and 3) the friction that is also inherently present in mechanical systems.” Ex. 1017 ¶ 35.” slip op. at 22

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

      “conclude that Petitioner has failed to prove by a preponderance of the evidence that the window cover system of claim 26 would have been obvious over Tachikawa and Todd. Petitioner points to elements of both references, maps them to elements of claim 26, and argues that it would have been obvious to modify Tachikawa’s window cover system with a plurality of spring drives “depending on the weight and size of a window cover.” Pet. 31–36. Even if we consider this latter argument to be an adequate reason for combining the elements of the references, Petitioner does not explain how one of ordinary skill in the art would go about combining the elements, or what modifications one of ordinary skill in the art necessarily would have made in order to combine the elements. Nor does Petitioner—in the Petition—point to evidence establishing that modifying Tachikawa to have a plurality of spring drives would have been routine for one of ordinary skill in the art. What is missing from the Petition is explicit, “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d at 988; KSR, 550 U.S. at 418.” slip op. at 24

    • ExcludeMotion to exclude, deniedMixed

      “Patent Owner submitted during prosecution of a related application. Tr. 7:4– 17, 24:6–11. Nevertheless, we agree with Patent Owner that § 42.61(b) “does not obviate the requirement of an affidavit attesting to the accuracy of a foreign document under § 42.63(b).” Paper 45 (Reply to Petitioner’s Opposition to the Motion to Exclude Evidence), 2. Considering the totality of the circumstances, we concluded, as discussed during the oral hearing, that it would be appropriate, in this instance, to waive our rules to the extent we would allow Petitioner, within five days from the date of the oral argument, “to submit an affidavit attesting to the accuracy of the translation that was previously submitted” (Tr. 8:2–3), with the proviso that the affidavit “meet the requirement[s] of our rules,” specifically “[42 C.F.R. §§] 42.63, 42.2, and also 1.68” (id. at 8:2–5). Petitioner complied in a timely manner (Paper 50; Ex. 1021). Accordingly, Patent Owner’s Motion to Exclude is denied with respect to Exhibit 1002, and we shall admit and rely on the exhibit.” slip op. at 13

    Patent outcomesUS 6,283,192 mixed
    Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
    Patents in suitUS 6,283,192
  • PTAB · May 28, 2015 · IPR2014-00169 · APJ Toni R Scheiner · IPR · Final written decision

    Claims 15–20 and 22 are unpatentable as obvious over Widlund and Toyo; claim 21 is unpatentable as obvious over Widlund, Toyo, and Kuske.

    RulingsFinal written decision
    • Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner

      “It is within our discretion to assign the appropriate weight to testimony offered by the witnesses. See, e.g., Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. Of Sci. Tech Ctr., 367 F3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). Having weighed the testimony and supporting evidence of Patent Owner’s witness, Mr. Franklin, and Petitioner’s witness, Mr. Gardner, we find Mr. Gardner’s testimony more compelling, and are persuaded, by a preponderance of the evidence, that the disposable garment of claim 15 would have been unpatentable over the combined teachings of Widlund and Toyo.” slip op. at 27

    • ExcludeMotion to exclude, deniedDenied

      “We decline to strike these paragraphs from the record, as we did not consider or rely on them. Patent Owner’s Motion to Exclude is dismissed with respect to paragraphs 1, 4, 5, 11, and 116 of the Gardner Declaration.” slip op. at 30

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

      “Petitioner asserts that it would have been obvious for one of ordinary skill in the art to fold the side panels of Widlund’s training pants over the absorbent assembly in preparation for packaging because “there were only ‘a finite number of identified, predictable solutions’ for positioning side panels of training pants in a package,” and Toyo “recommends folding the side panels over the absorbent body” (id. at 29), to avoid “‘protrusions’ which cause the package of training pants to swell” (id. at 28). Petitioner further asserts that folding Widlund’s pants-type diaper in that manner “will result in the ‘refastenable’ seams 20 being parallel to the absorbent assembly 5 and lying [in] the same plane as each other” (id. at 29), as recited in claim 15.” slip op. at 15

    • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Unpatentable

      “Having weighed the testimony and supporting evidence of Patent Owner’s witness, Mr. Franklin, and Petitioner’s witness, Mr. Gardner, we find Mr. Gardner’s testimony more compelling, and are persuaded, by a preponderance of the evidence, that the disposable garment of claim 15 would have been unpatentable over the combined teachings of Widlund and Toyo.” slip op. at 27

    Patent outcomesUS 8,579,876 unpatentable
    § 103 obviousnesscites KSR
    Patents in suitUS 8,579,876
  • PTAB · Feb 20, 2015 · IPR2013-00575 · APJ Benjamin D M Wood · IPR · Final written decision

    Claims 1–10 are unpatentable: claims 1 and 4–9 are anticipated by Rose; claims 2, 3, and 10 are obvious over the stated combinations. The motion to amend is denied.

    RulingsFinal written decision
    • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner

      “language.” In re NTP, Inc., 654 F.3d 1279, 1288 (Fed. Cir. 2011) (citing Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc)). We find nothing in claim 1—or, for that matter, any of its dependent claims—that requires the stalls to be capable of moving past the cleaning location in a continuous manner, or that excludes intermittent movement past the cleaning location. For example, claim 1 refers several times to the stalls being “at” the cleaning location, which seems to encompass the possibility that the stalls are briefly stopped at the cleaning location. Ex. 1001, 9:14–15, 18–19, 29. Further, we agree with Petitioner that the Specification does not mandate the narrower construction that Patent Owner proposes. Patent Owner is correct that the Specification describes an embodiment in which the platform “rotates continuously.” Ex. 1001, 4:11–12. But “while the specification [should be used] to interpret the meaning of a claim, courts must not import[] limitations from the specification into the claim.” In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (alterations in original) (citing Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005 (en banc) (internal quotation marks omitted)). It is only when “the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction” that the scope of a claim is properly restricted to that of a disclosed embodiment. Liebel- Flarsheim, 358 F.3d at 906. Patent Owner does not direct us to any language in the Specification that it asserts demonstrates such a clear intention to limit the claim scope. Nor do we find any such language. We are also unable to find support in the Specification for Patent Owner’s contention that continuous movement of the platform is required to “avoid tripping up the cows” when the cleaning section deploys and retracts. As for the NIRC, although statements made during the prosecution history, including reexamination proceedings, may be relevant to determining claim scope, E.I. du Pont de Nemours & Co. v. Phillips Petroleum Co., 849 F.2d 1430, 1439 (Fed. Cir. 1988), we are unable to find anything in the NIRC that disclaims the scope of claim 1 to exclude intermittent motion, or that otherwise supports Patent Owner’s interpretation.” slip op. at 9

    • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

      “As discussed above (Sec. II.B.2.a), we find that Rose and Chandler disclose all of the limitations of claim 1, arranged as in the claim. Further, we agree with Petitioner that a person of ordinary skill would have been motivated to combine Rose and Chandler because, inter alia, “Rose expressly points the skilled artisan to the disclosure in Chandler.” Pet. 25. After considering Petitioner’s and Patent Owner’s positions, as well as their supporting evidence, we determine that Petitioner has shown by a preponderance of the evidence that claim 1 is unpatentable under 35 U.S.C. § 103(a) over Rose and Chandler.” slip op. at 21

    • Obviousness (§103) › Objective indicia / secondary considerations › Long-felt need / failure of othersDecided for petitioner

      “Evidence that an invention satisfied a long-felt and unmet need that existed on the patent’s filing date is a secondary consideration of nonobviousness.” Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1332 (Fed. Cir. 2009). In the present case, however, we are not persuaded that there was a long-felt but unmet need for “automated teat sanitization” that existed on the patent’s filing date, as Patent Owner argues, because any such need would have been met by Rose’s automated teat spray device. See Geo. M. Martin Co. v. Alliance Machine Systems Int’l, LLC, 618 F.3d 1294, 1304–05 (Fed. Cir. 2010) (“Where the differences between the prior art and the claimed invention are as minimal as they are here, however, it cannot be said that any long-felt need was unsolved.”). As discussed above (Sec. II.B.2.a), we find that Rose and Chandler disclose all of the limitations of claim 1, arranged as in the claim. Further, we agree with Petitioner that a person of ordinary skill would have been motivated to combine Rose and Chandler because, inter alia, “Rose expressly points the skilled artisan to the disclosure in Chandler.” Pet. 25. After considering Petitioner’s and Patent Owner’s positions, as well as their supporting evidence, we determine that Petitioner has shown by a preponderance of the evidence that claim 1 is unpatentable under 35 U.S.C. § 103(a) over Rose and Chandler. slip op. at 21

    • PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied

      “As the movant, Patent Owner bears the burden of demonstrating, by a preponderance of the evidence, that the proposed substitute claims are patentable. 37 C.F.R. § 42.20(c); see 37 C.F.R. § 42.1(d) (noting that the “default evidentiary standard [in proceedings before the Board] is a preponderance of the evidence”). To demonstrate patentability, Patent Owner must, inter alia, demonstrate that the proposed substitute claims are patentable over the prior art of record, as well as prior art not of record but known to the patent owner. Idle Free Sys., Inc. v. Bergstrom, Inc., Case IPR2012-00027, slip op. at 7 (PTAB June 11, 2013) (Paper 26). In its Motion, Patent Owner asserts that the proposed claims are patentable over two references not of record, but does not address the patentability of the proposed claims over the prior art for which trial was instituted, primarily Rose and Chandler. Mot. to Amend. 12–13. Patent Owner’s failure to address the art of record is fatal to its motion, as the patentability of substitute claim 11 over Rose and Chandler is far from selfevident. It is undisputed that the feature that Patent Owner seeks to add to claim 1, a continuously rotating milking platform, was “conventional” at the time of the invention. See Ex. 1001, 3:47–48, 4:11–12 (continuously rotating platform 22 part of “conventional” milking parlor 22). Indeed, Patent Owner’s expert testifies that at the time the ’094 patent was filed, “the overwhelming majority of rotary parlors in all major dairying nations incorporated continuously moving platforms.” Ex. 2012 ¶ 35. Thus, proposed claim 11 would represent the combination of a known and commonly used milking apparatus with Rose’s automated spray device. Neither Patent Owner nor its expert contend that it would have been beyond ordinary skill at the time of the invention to modify Rose’s automated spray device so that it could be used on a milking apparatus with a continuously rotating platform. See Tr. 36:12–17. Patent Owner has not given us any reason not to conclude that proposed claim 11 is simply the “combination of familiar elements according to known methods . . . yield[ing] predictable results.” KSR, 550 U.S. at 416. Thus, based on the current record, Patent Owner has not carried its burden of demonstrating that proposed claim 11 is patentable over the prior art of record. III. CONCLUSION Petitioner has shown by a preponderance of the evidence that claims” slip op. at 25

    Patent outcomesUS 6,443,094 unpatentable
    Claim construction§ 103 obviousnesscites Phillips · Graham
    Patents in suitUS 6,443,094
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