• Douglas Dynamics, L.L.C. / Douglas Dynamics, Inc. v. Meyer Products LLCSome claims unpatentable
  PTAB · Mar 1, 2017 · IPR2015-01839 · APJ Jacqueline T Harlow · IPR · Final written decision

  Claims 1, 2, 4–7, 28–31, 36, 38, 39, 43, and 44 are unpatentable under § 103(a); claims 8, 32, 33, and 48–54 were not shown unpatentable.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageTerm construed board ownDecided for patent owner

    “The disclosure of the ’829 patent is expressly addressed to the problem of, and a solution for, unreliable and vulnerable electrical connections caused by splicing auxiliary lights into OEM headlight wiring. The Background of the Invention explains that “[t]raditionally, the auxiliary lights were spliced into the existing wiring for the headlights of the vehicle.” slip op. at 11

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner

    “As an initial matter, we observe that whether or not the preamble term “light circuit” is limiting has little bearing on the ultimate disposition of this inter partes review, as it is undisputed that Douglas has identified, for each asserted ground of unpatentability, disclosure of a light circuit. See PO Resp. 11–12. Furthermore, we agree with Douglas that “light circuit” does not connote any structure beyond that explicitly recited in the body of the claims. Indeed, it is unclear that either Meyer or Mr. Ricca disputes such conclusion. For example, Meyer states in its Patent Owner Response that” slip op. at 18

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

    “As a general rule, the words “a” or “an” in a patent claim carry the meaning of “one or more.” Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1342–43 (Fed. Cir. 2008). That rule is particularly applicable 15 where, as here, those words are used in combination with the open-ended antecedent “comprising.” See, e.g., Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed. Cir. 1997). “An exception to the general rule that ‘a’ or ‘an’ means more than one only arises where the language of the claims themselves, the specification, or the prosecution history necessitate a departure from the rule.” Baldwin Graphic, 512 F.3d at 1342–43. We discern no such exception here. First, Meyer has not identified, and we do not discern, any requirement in the language of the claims to support the conclusion that the recited “an auxiliary light connector to connect an auxiliary light” must be a single auxiliary light connector.” slip op. at 15

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

    “As set forth above, Möller explicitly teaches the incorporation of microprocessors and microcontrollers to improve relay-circuitry-based vehicle electronics systems. Ex. 1006, 4:41–48. Contemporaneous prior art 33 references, including Gould and COP8, disclose advantages obtained through the incorporation of microprocessors and microcontrollers into relay circuitry for controlling end devices, further underscoring that an ordinarily skilled artisan would have sought to modify the relay circuitry of Knepel with the microprocessors and microcontrollers of Möller. See Ex. 1010, 9, 11; Ex. 1011, 14. Moreover, Dr. Neuhalfen testifies, without challenge, that it was well-known at the time of invention of the ’829 patent to use microprocessors to control original vehicle lights, as well as auxiliary lights, and identifies numerous advantages that the proposed combination would afford. Ex. 1014 ¶ 59. Indeed, Meyer’s expert, Mr. Ricca, agrees that it would not have been difficult for an ordinarily skilled artisan to supplement the circuit of Knepel to provide microprocessor control of the relays in that circuit. Ex. 1033, 182:6–11. In view of the teachings of Möller itself, and the contemporaneous prior art, as well as the testimony of Dr. Neuhalfen and Mr. Ricca, we find that a person of ordinary skill in the art at the time of the invention would have recognized the value of using known elements, i.e., microprocessors and microcontrollers, as taught by Möller, to improve the relay circuitry for controlling original vehicle lights and auxiliary lights of Knepel. We likewise find that a person of ordinary skill in the art would have appreciated that the microprocessors of Möller could be incorporated into, i.e., used to supplement, the relay circuitry of Knepel. See KSR, 550 U.S. at 418 (an obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account” slip op. at 33

  Patent outcomesUS 6,265,829 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,265,829
• Pharmacosmos A/S v. Luitpold Pharmaceuticals, Inc.Some claims unpatentable
  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
• Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01594 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–8 are unpatentable as anticipated by Hays or obvious over the listed combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

  RulingsFinal written decision

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, claim 1, from which claims 2–8 depend, recites the dosed amount of glycopyrrolate in solution as “an amount ranging from 3.0 wt. % to 4 wt. %.” Because claim 1 describes the dosed amount by the strength/concentration, it supports our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

  • BurdenMixed

    “Petitioner may well be correct that preferring a non-anticholinergic does not necessarily exclude administering “another oral and/or topical therapy for reduction of sweating,” as required by challenged claim 4. Petitioner, however, does not point to any credible evidence or otherwise explain why an ordinary artisan would have chosen another therapy to reduce sweating to be administered in combination with glycopyrrolate. Without some articulated reasoning with rational underpinning as to why an ordinary artisan would have added a second therapeutic for reducing sweating to the transdermal patch of Bodor, which uses the anticholinergic to eliminate the formation of an aqueous layer between the delivery system and the skin to enhance the penetration of the transdermal drug being delivered, Petitioner has not met its burden of demonstrating that claim 4 20 would have been obvious over the combination of Bobrove and Bodor. See KSR, 550 U.S. at 418.” slip op. at 20

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

    “(citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. at 31 (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 72. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 29 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMotivation not foundMixed

    “Bobrove specifically teaches applying a “roll on” glycopyrrolate solution. Ex. 1008, 6:26–27, 6:36–37. It, however, also generally teaches that glycopyrrolate is administered topically. Id. at 4:1. Thus, one of ordinary skill in the art would have had a reason to look for other means to apply glycopyrrolate. As Dr. Guy testifies, “[t]here are a limited number of ways to topically deliver a drug to a patient’s skin.” Ex. 1003 ¶ 16. In addition, Bobrove suggests to avoid the eyes, nose, and mouth during the topical administration. Ex. 1008, 5:37–39. Given these considerations, Bodor provides an effective alternative: a cotton cloth to absorb the drug and rub it on the skin. Ex. 1030, 15:39–54; see also Ex. 1003 ¶ 17 (explaining that, at the time of the invention, an ordinary artisan would have known that use of medicated pads “allowed for topical application of a solution, for example to a subject’s face, while excluding application to sensitive areas such as the eyes or mucous membranes”). Thus, we conclude Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor. In sum, Petitioner has shown, by a preponderance of the evidence, that an ordinary artisan would have had a reason to combine the teachings of Bobrove and Bodor, and that the combination teaches each and every limitation of claims 1 and 2. Claims 4, 5, and 8” slip op. at 19

  Patent outcomesUS 8,252,316 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,252,316
• Dermira, Inc. v. Purepharm, Inc.Some claims unpatentable
  PTAB · Dec 27, 2016 · IPR2015-01593 · APJ Zhenyu Yang · IPR · Final written decision

  Claims 1–3 and 5–10 are unpatentable as anticipated by Hays or obvious over the stated combinations; claim 4 was not shown unpatentable for lack of a reason to add another sweating therapy.

  RulingsFinal written decision

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

    “In interpreting claim terms, the claims themselves provide substantial guidance. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Here, the challenged claims recite the dosed amount of glycopyrrolate in solution as “an amount ranging from 1.0 wt. % to 6 wt. %” (claim 1); “an amount ranging from 2.0 wt. % to 6.0 wt. %” (claim 9); and “an amount ranging from 2.0 wt. % to 4.0 wt. %” (claim 10). Because the claims describe the dosed amount by the strength/concentration, they support our conclusion that term “dosed amount” is not limited by the volume of the glycopyrrolate solution.” slip op. at 6

  • Skill levelSkill level board ownOther

    “The parties disagree over the level of ordinary skill.8 See Pet. 17–18; PO Resp. 3; Reply 9. For purposes of this Decision, we do not need to resolve this dispute because the prior art itself reflects an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 16

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “not qualify as one of ordinary skill in the art because he is not a clinician, physician, or pharmacist. PO Resp. 3–4. We disagree with Patent Owner on this issue. All asserted references relate to topical administration of pharmaceutical compositions. See, e.g., Ex. 1008, 4:1; Ex. 1010, 2:35–38; Ex. 1030, 3:60–61. In addition, the challenged ’524 patent relates to the topical delivery of glycopyrrolate to reduce excessive sweating and minimize side effects. Ex. 1001, Abstract, 1:13–21. Dr. Guy has over 30 years of experience in fields including topical drug delivery, transdermal” slip op. at 16

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

    “water base and a vanishing cream base in 0.5 to 1% concentration. It completely controls gustatory sweating for several days or more.” Pet. 30 (citing Ex. 1009, 1821). Hays instructs that glycopyrrolate solutions should be carefully applied while avoiding the mouth, nose, and eyes. Id. at 31 (citing Ex. 1009, 1798, 1809). For example, it discloses applying a cotton applicator dipped in the glycopyrrolate solution to the skin while holding the hair up out the way to treat patients with gustatory sweating in the hairline. Id. (citing Ex. 1009, 1819). Dr. Guy testifies that an ordinary artisan would have understood the cotton applicator in Hays “as being any of a cotton ball, a cotton pad, a cotton swab, or having a cotton component as a part of a larger applicator.” Ex. 1003 ¶ 90. According to Hays, glycopyrrolate in concentrations of 0.5%, 1.0%, and up to 4% provided effective control of gustatory sweating with no significant side effects. Pet. 31 (citing Ex. 1009, 1819). Thus, we agree with Petitioner that Hays discloses each and every limitation of claim 1.” slip op. at 11

  Patent outcomesUS 8,679,524 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,679,524
• Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.Some claims unpatentable
  PTAB · Jul 7, 2016 · IPR2015-00529 · APJ Robert A Pollock · IPR · Final written decision

  Claims 1–8 and 10–19 are unpatentable as obvious over the INOmax label, Bernasconi, Loh, and Goyal; claims 1, 7, 12, and 14 are also anticipated and obvious over the INOmax label.

  RulingsFinal written decision

  • Expert testimonyOther

    “method of providing pharmaceutically acceptable nitric oxide gas requires providing information to the medical provider to safely administer the nitric oxide gas,” thus “confirm[ing] that the ‘providing . . . information’ step is functionally related to the steps in the claimed method.” PO Resp. 31–33. As an initial matter, whether the claims should be interpreted as requiring such a functional relationship is a legal conclusion. See PO Resp. 13. Patent Owner’s conclusion regarding functional relationship between claim terms is based, at least in part, on an overly-limited reading of “pharmaceutically acceptable nitric oxide gas,” as discussed above. See PO Resp. 27. Further, we do not read the transcript testimony relied on by Patent Owner as clearly admitting a functional relationship between the steps of “providing pharmaceutically acceptable nitric oxide gas” and the information of (ii). See PO Resp. 31–32 (citing Ex. 2022, 78:15–80:4, 81:11–22, 111:2–17)). To the contrary, Dr. Beghetti appears to have testified that the claim elements are not directly related. Ex. 2022, 86:10– 25. Although Patent Owner points to In re Distefano, 808 F.3d at 848, as evidence that a “printed matter analysis includes ‘factual findings’” (PO Sur Reply 4, n.6), which inform the ultimate legal conclusion, we do not find the evidence as a whole compelling.” slip op. at 19

  • ExcludeMotion to exclude, deniedOther

    “IV. PETITIONER’S MOTION TO EXCLUDE Petitioner moves to exclude certain portions of Ex. 2024 on the grounds that they “are declarations and supporting materials submitted during patent examination . . . in violation of 37 C.F.R. § 42.53(a)” and “lack foundation (FRE 602) and authentication (FRE 901) and constitute impermissible hearsay (FRE 901).” Paper 31, 2–3. Petitioner likewise moves to exclude Exhibit 2029 as not relied on in the Patent Owner Response or by Patent Owner’s expert. Id. at 3. As we do not rely on the objected-to materials in this opinion, we dismiss the motion as moot.” slip op. at 45

  • Strike new argumentNew argument disregardedOther

    “V. OBJECTIONS TO DEMONSTRATIVES The parties also submit competing objections to demonstrative exhibits used at trial. Papers 46, 47. Specifically, both parties object to certain slides as setting forth a new argument not previously made in any paper. Papers 46, 47. The parties are reminded that demonstrative exhibits are illustrative only and are not part of the trial record. Indeed, in accordance with our Order on requests for oral argument, neither party filed its demonstratives with the Board. See Paper 45, 2 (“Notwithstanding 37 C.F.R. § 42.70(b), the parties shall not file any demonstrative exhibits in this proceeding without prior authorization from the Board. 37 C.F.R. § 42.5(b). Demonstrative exhibits are intended to be visual aids to assist a party in making its oral presentation and will not be entered into the record of these proceedings.”). Nevertheless, in this Final Written Decision, we rely on the arguments presented properly in the parties’ briefs and the evidence of record and do not consider any new arguments not previously set forth in any paper. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). (“No new evidence or arguments may be presented at the oral argument.”).” slip op. at 45

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “The Applicant amended the preamble of the rejected independent claims to recite “[a] method of providing pharmaceutically acceptable nitric oxide gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to the amendment, the Examiner withdrew the objection. Id. at 765; see id. at 733 (“If all the priority issues are resolved then it appears that the primary reference in the 103 rejection will no longer be prior art.” (italics omitted)). On pages 19 and 20 of its Response, Patent Owner argues that the preamble is, therefore, limiting in light of Catalina Mktg. International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that “clear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates the use of the preamble to define, in part, the claimed invention.” Although the prosecution history shows that amendment of the preamble only indirectly distinguished the claims over the prior art by establishing an earlier priority date, we conclude that both the Applicant and the Examiner treated the preamble as a claim limitation. Accordingly, we agree with Patent Owner that the preamble language “pharmaceutically acceptable nitric oxide gas” is limiting.” slip op. at 11

  Patent outcomesUS 8,846,112 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,846,112
• Medtronic, Inc. v. Nuvasive, Inc.Some claims unpatentable
  PTAB · Feb 11, 2015 · IPR2013-00507 · APJ Stephen C Siu · IPR · Final written decision

  Claims 1–5, 10, 11, 14–17, and 19–28 are unpatentable as obvious over Frey and Michelson; claim 18 was not shown unpatentable.

  RulingsFinal written decision

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

    “Thus, it would have been obvious to one of ordinary skill in the art to have provided an implant with a length of greater than 40 mm (e.g., 42 mm) and at least 2.5 times the width, as recited in claim 1.” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner

    “the capability for posterolateral TLIF procedure.” PO Resp. 30. However, Frey discloses “spinal surgery from a unilateral posterior approach, a lateral approach, an oblique approach, and through laparoscopic or endoscopic instruments from any of a variety of angles or approaches to the spine.” Ex. 1003 ¶ 184. Given that Frey discloses spinal surgery performed “from any of a variety of angles or approaches,” and not just from the posterolateral approach, we are not persuaded by Patent Owner that the “intended purpose” of Frey is to perform spinal surgery from a posterolateral approach, specifically. Rather, Frey discloses that “spinal discs may be displaced or damaged” and “may result in nerve damage, pain, numbness, muscle weakness, and even paralysis.” Ex. 1003 ¶ 3. According to Frey, these issues are addressed by “surgical correction of a collapsed disc space” by “discectomy . . . often followed by restoration of normal disc space height and bony fusion of the adjacent vertebrae to maintain the disc space height.” Id. Hence, the “intended purpose” of the implant of Frey, as explicitly disclosed by Frey, is to correct surgically a collapsed disc space, to restore normal disc space height, and to provide bony fusion of the adjacent vertebrae. We disagree with Patent Owner that incorporating Michelson, which discloses an implant that “engage[s] more of the adjacent vertebrae,” (Ex. 1105, 3:49–50) would have rendered the resulting implant inoperable for Frey’s intended purpose of surgically correcting a collapsed disc space or providing bony fusion of the adjacent vertebrae. Even if the “intended purpose” of Frey is to practice a “TLIF procedure,” as Patent Owner contends, we are not persuaded by Patent Owner’s argument that an implant measuring greater than 40 mm in length would be inoperable in a “TLIF procedure.” As Petitioner explains, U.S. Patent No. 7,815,682 (the ’682 patent) demonstrates that when performing “Transforaminal lumbar interbody fusion (TLIF) procedures,” one of ordinary skill in the art may employ a spinal implant with “a length ranging between 20 and 45 mm.” Pet. Resp. 6 (citing, Ex. 1028, 1:37–38; 4:45). The ’682 patent does not disclose that the use of a spinal implant measuring up to 45 mm in length would render the “TLIF procedure” inoperable.” slip op. at 6

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “We recognize that evidence of secondary considerations must always be considered en route to the determination of obviousness, but its existence alone does not control the conclusion of obviousness. Richardson-Vicks v. Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997). The weight given to evidence of secondary considerations is dependent upon whether there is a nexus between the merits of the claimed invention and the evidence offered. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1539 (Fed. Cir. 1983). Even assuming that NuVasive’s CoRoent XL implant experienced “commercial success,” as Patent Owner asserts, Patent Owner has not demonstrated sufficiently that there is a nexus between the merits of the claimed invention and the evidence offered. For example, Patent Owner argues that NuVasive “pioneered the market for lateral, trans-psoas interbody fusion surgeries,” (PO Resp. 44) but fails to demonstrate sufficiently that any of the disputed claims recite “lateral, trans-psoas interbody fusion surgeries.” We are not persuaded by Patent Owner’s arguments.” slip op. at 11

  • ExcludeOther

    “C. Motion to Exclude In its Motion to Exclude, Patent Owner seeks to exclude the Declaration of Loic Josse (Ex. 1116, “Josse Declaration”). We did not rely on the Josse Declaration in this decision. Therefore, Patent Owner’s motion to exclude is dismissed as moot.” slip op. at 12

  Patent outcomesUS 8,187,334 mixed
  § 103 obviousness
  Patents in suitUS 8,187,334
• Medtronic, Inc. v. Nuvasive, Inc.Some claims unpatentable
  PTAB · Feb 11, 2015 · IPR2013-00508 · APJ Stephen C Siu · IPR · Final written decision

  Claims 1–5, 10, 11, 14–17, and 19–28 are unpatentable under §103; claim 18 was not shown unpatentable because the cited art did not establish its required dimensions.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “Thus, it would have been obvious to one of ordinary skill in the art to have provided an implant with a length of greater than 40 mm (e.g., 42 mm) and at least 2.5 times the width, as recited in claim 1.” slip op. at 7

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “We recognize that evidence of secondary considerations must always be considered en route to the determination of obviousness, but its existence alone does not control the conclusion of obviousness. Richardson-Vicks v. Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997). The weight given to evidence of secondary considerations is dependent upon whether there is a nexus between the merits of the claimed invention and the evidence offered. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1539 (Fed. Cir. 1983). Even assuming that NuVasive’s CoRoent XL implant experienced “commercial success,” as Patent Owner asserts, Patent Owner has not demonstrated sufficiently that there is a nexus between the merits of the claimed invention and the evidence offered. For example, Patent Owner argues that NuVasive “pioneered the market for lateral, trans-psoas interbody fusion surgeries,” (PO Resp. 59) but fails to demonstrate sufficiently that any of the disputed claims recite “lateral, trans-psoas interbody fusion surgeries.” We are not persuaded by Patent Owner’s arguments.” slip op. at 17

  • ExcludeOther

    “C. Motion to Exclude In its Motion to Exclude, Patent Owner seeks to exclude the Declaration of Loic Josse (Ex. 1116, “Josse Declaration”). We did not rely on the Josse Declaration in this decision. Therefore, Patent Owner’s motion to exclude is dismissed as moot.” slip op. at 17

  Patent outcomesUS 8,187,334 mixed
  § 103 obviousness
  Patents in suitUS 8,187,334
• Ariosa Diagnostics v. Isis Innovation LimitedSome claims unpatentable
  PTAB · Sep 2, 2014 · IPR2012-00022 · APJ Lora M Green · IPR · Final written decision

  Claims 1, 2, 4, 5, 8, 19, 20, 24, and 25 are unpatentable as anticipated by Kazakov; claims 3, 12, 13, 15, 18, 21, and 22 were not shown unpatentable.

  RulingsFinal written decision

  • PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner

    “party in interest filed a civil action challenging the validity of a claim of the patent” in § 315(a)(1) of the statute. Paper 20, 4. Under Isis’s interpretation of the statute, “filing” extends beyond the commencement of the civil action and includes raising the affirmative defense of invalidity. Id. We looked to the Federal Rules of Civil Procedure as a guide to interpreting the plain meaning of the statute. Id. We noted that Rule 2 of the Federal Rules of Civil Procedure9 states that “[t]here is one form of action—the civil action,” and Rule 3 states that “[a] civil action is commenced by filing a complaint with the court.” Id. at 5. Defenses are raised in answer to the complaint or in answer to a counterclaim. Id. (citing Fed. R. Civ. P. 12). We concluded, therefore, that when the statute refers to filing a civil action, it refers to filing a complaint with the court to commence the civil action. Id.; see, e.g., Baldwin Cnty. Welcome Ctr. v. Brown, 466 U.S. 147, 149 (1984) (citing Fed. R. Civ. P. 3” slip op. at 11

  • PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner

    “Specifically, the panel in that case looked to the Federal Rules of Civil Procedure in making its determination. Id. at 15. As to the requirement of service, the panel noted that the infringement suit was voluntarily dismissed without prejudice under Fed. R. Civ. P. 41(a). Id. The panel noted further that the Court of Appeals for the Federal Circuit has consistently interpreted the effect of such dismissals as leaving the parties as though the action had never been brought. Id. (citing Graves v. Principi, 294 F.3d 1350, 1356 (Fed. Cir. 2002) (“The dismissal of an action without prejudice leaves the parties as though the action had never been brought”); Bonneville Associates, Ltd. Partnership v. Baram, 165 F.3d 1360, 1364 (Fed. Cir. 1999) (“The rule in the federal courts is that ‘[t]he effect of a voluntary dismissal without prejudice pursuant to Rule 41(a) is to render the proceedings a nullity and leave the parties as if the action had never been brought.’”) (citations and internal quotes omitted.)); Accord, Wright, Miller, Kane, and Marcus, 9 Federal Prac. & Proc. Civ. § 2367 (3d. ed.) (“[A]s numerous federal courts have made clear, a voluntary dismissal without prejudice under Rule 41(a) leaves the situation as if the action never had been filed.”) (footnote omitted). As in the Macauto case, we agreed that the dismissal without prejudice leaves the parties as if the action had never been brought, and concluded that Ariosa was not barred from filing its Petition in IPR2013- 00250 under 35 U.S.C. § 315(b). IPR2013-00250, Paper 26, 3. As a result, we did not address Isis’s arguments (IPR2013-00250, Prelim. Res. 44–46) regarding joinder in the context of the bar under § 315(b). Id.” slip op. at 17

  • PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedDecided for petitioner

    “While the plain language of the statute mentions joinder of “a party” and does not specifically articulate the joinder of issues, it states that “any person who properly files a petition under section 311” may be joined at the Director’s discretion. Thus, there does not appear to be any language in the statute directly prohibiting the joinder of issues by the same party. The legislative history of this section provides little guidance as to the scope of this statutory section. As the final Committee Report noted, under §§ 315(c) and 325(c), “[t]he Director may allow other petitioners to join an inter partes or post-grant review.” See H.R. Rep. No. 112-98, pt.1, at 76 (2011). During the Senate’s March 2011 debates on the AIA, Senator Kyl stated that the USPTO expected to allow liberal joinder of reviews: The Office anticipates that joinder will be allowed as of right— if an inter partes review is instituted on the basis of a petition, for example, a party that files an identical petition will be joined to that proceeding, and thus allowed to file its own briefs and make its own arguments. If a party seeking joinder also presents additional challenges to validity that satisfy the threshold for instituting a proceeding, the Office will either join that party and its new arguments to the existing proceeding, or institute a second proceeding for the patent. 157 Cong. Rec. S 1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl). Senator Kyl, thus, contemplated the joinder of issues as well as the joinder of parties. In addition to noting that §§ 315(c) and 325(c) give the USPTO” slip op. at 19

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

    “the amplification step in the Institution Decision. Both the amplification step and the detecting step of claim 1, however, use very similar language. That is, the amplifying step requires “amplifying a paternally inherited nucleic acid from the serum or plasma sample,” and the detecting step requires “detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.” Applicants could have added “only,” such that the claim read as “only detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample,” but they chose not to do so. See, e.g., Aria, 726 F.3d at 1301 (noting as to the claim limitation of “paternally inherited nucleic acid” that during prosecution before the examiner the inventors could have limited the claims to those nucleic acids that were known in advance to come from the father). Thus, when the “detecting” step is construed in conjunction with the use of “comprising” as the transitional phrase, there is nothing in the language of claim 1 that limits the detecting step to also determining or identifying the detected nucleic acid as being of fetal origin and not being possessed by the pregnant female.” slip op. at 25

  Patent outcomesUS 6,258,540 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 6,258,540
• Nuvasive, Inc. v. Warsaw Orthopedic, Inc.Some claims unpatentable
  PTAB · Jul 10, 2014 · IPR2013-00206 · APJ Stephen C Siu · IPR · Final written decision

  Claims 17–23 were held unpatentable as obvious over Jacobson, Leu, and Brantigan; claims 9–16 and 24–30 were not shown unpatentable on the asserted obviousness grounds.

  RulingsFinal written decision

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

    “ordinary skill in the art to have combined the teachings of Jacobson, Leu, and Brantigan. PO Resp. 50–53. Jacobson discloses advancing instruments laterally into the disc space to perform a “fusion” procedure. Ex. 1004, 5:1– 4, 6:11–13. Leu discloses fusion of the lumbar spine by introducing an “interbody graft” into the disc space. Ex. 1005, p. 603. Brantigan, like Leu, discloses “prosthetic implant devices” that are “suitable for . . . lateral placement in any area of the spine.” Ex. 1006, 2:56–58. We agree with Petitioner that the combination of the known element of performing a spinal fusion procedure by laterally advancing instruments into the disc space (Jacobson) with the known element of using an “interbody graft” in a spinal fusion procedure (Leu and Brantigan) would have resulted in no more than the predictable and expected result of performing a spinal fusion procedure (Jacobson) that includes inserting an implant into a disc space (Leu or Brantigan). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007).” slip op. at 23

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

    “Jacobson, Leu, Brantigan - combinability Patent Owner argues that it would not have been obvious to one of ordinary skill in the art to have combined the teachings of Jacobson, Leu, and Brantigan. PO Resp. 50–53. Jacobson discloses advancing instruments laterally into the disc space to perform a “fusion” procedure. Ex. 1004, 5:1– 4, 6:11–13. Leu discloses fusion of the lumbar spine by introducing an “interbody graft” into the disc space. Ex. 1005, p. 603. Brantigan, like Leu, discloses “prosthetic implant devices” that are “suitable for . . . lateral placement in any area of the spine.” Ex. 1006, 2:56–58. We agree with Petitioner that the combination of the known element of performing a spinal fusion procedure by laterally advancing instruments into the disc space (Jacobson) with the known element of using an “interbody graft” in a spinal fusion procedure (Leu and Brantigan) would have resulted in no more than the predictable and expected result of performing a spinal fusion procedure (Jacobson) that includes inserting an implant into a disc space (Leu or Brantigan). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007).” slip op. at 23

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “of ordinary skill in the art to have combined the teachings of Brantigan with any of Jacobson or Leu because, according to Patent Owner, Brantigan “teaches away from sizing an implant to rest on the apophyseal ring or be sized to occupy substantially the full transverse width of adjacent vertebral bodies.” PO Resp. 51–52, 55–56. This issue was discussed previously above. Patent Owner also argues that it would not have been obvious to one of ordinary skill in the art to have combined the teachings of Brantigan with any of Jacobson or Leu because the “cannulae disclosed by Jacobson and Leu are too narrow to accommodate Brantigan’s implant,” that “a person of ordinary skill in the art would not be able to insert [Brantigan’s] implant in Jacobson’s [system],” and that “the shape of the Brantigan implant is not conducive to insertion through a cannula or similar surgical instrument [as disclosed by Jacobson or Leu].” PO Resp. 52–53. In other words, Patent Owner argues that the combination of Jacobson, Brantigan, and Leu would not have been obvious to one of ordinary skill in the art because the prior art systems are not physically combinable (i.e., Brantigan’s implant allegedly cannot be physically combined with the cannula of either Jacobson or Leu). “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference . . . . Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981); see also In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.”). We are thus not persuaded by Patent Owner’s argument.” slip op. at 24

  • Obviousness (§103) › Objective indicia / secondary considerations › Commercial successObjective indicia no nexusDecided for patent owner

    “Secondary considerations We recognize that evidence of secondary considerations must always be considered en route to the determination of obviousness, but its existence alone does not control the conclusion of obviousness. Richardson-Vicks v. Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997). The weight given to evidence of secondary considerations is dependent upon whether there is a nexus between the merits of the claimed invention and the evidence offered. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1539 (Fed. Cir. 1983).” slip op. at 25

  Patent outcomesUS 8,251,997 mixed
  § 103 obviousnesscites KSR
  Patents in suitUS 8,251,997

Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.