- PTAB · Mar 17, 2017 · IPR2016-01563 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Mylan’s rehearing request, leaving trial instituted only for claims 1 and 10; it found the Petition lacked reasoned obviousness analysis for claims 2–9 and 11–26.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“We will grant a request for rehearing if the requesting party demonstrates “an abuse of discretion” in the decision. 37 C.F.R. § 42.71(c). However, we will grant a request for rehearing only if the requesting party “specifically identif[ies] . . . the place where each matter [that we misapprehended or overlooked] was previously addressed.” Id. § 42.71(d). After considering Petitioner’s Rehearing Request, our Decision, and the evidence currently of record, Petitioner’s Rehearing Request is denied.” slip op. at 2
- BurdenNot shown unpatentable
“See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3), requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim.”). In Harmonic, the Federal Circuit held that “it was Harmonic’s burden to explain to the Board how Haskell combined with Rossmere rendered the challenged claims unpatentable. With respect to claim 11 of the ’291 patent, Harmonic did not do so.” Id. Petitioner here also did not meet its burden with respect to claims 2–9 and 11–26 of the ’927 patent.” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In Galderma, for example, the claim recited a “topically applicable pharmaceutical composition comprising 0.3% by weight of [adapalene] . . . Shroot patents disclosed topical adapalene compositions for treating acne “in a preferred range of 0.01%–1%,” including exemplary formulations containing 0.001%, 0.1%, and 1%. Id. at 735–36. The court noted the Shroot patents were listed in the FDA’s Orange Book for “prior art Differin® 0.1% Gel as well as Differin® Gel, 0.3%.” Id. at 735. The court further noted that other prior art references disclosed the use of 0.3% adapalene lotion in an animal model for acne treatment and taught the use of 0.3% adapalene for other skin conditions “without intolerable irritability.” Id. It was in the foregoing context that the court framed the issue as “whether there was motivation to select the claimed 0.3% adapalene composition in the disclosed range.” Id. at 737–38. The Petition here simply does not provide the same type of context and analysis with regard to the claimed linagliptin dosages, sufficient for us to apply the requested presumption.3” slip op. at 6
§ 103 obviousnessPatents in suitUS 8,673,927 - Mylan Laboratories Limited v. Aventis Pharma S.A.Rehearing deniedPTAB · Jan 26, 2017 · IPR2016-00627 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Mylan’s rehearing request, leaving in place the denial of institution on claims 1 and 2 because its arguments did not show the Board misapprehended or overlooked matters.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. When rehearing a decision on petition, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc. et al., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). Petitioner’s Rehearing Request amounts to a re-argument of the contentions raised in the Petition and rejected by the Board. We briefly address Petitioner’s rehearing contentions below.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundDecided for patent owner
“Kant alone provide motivation to modify Compound 20 in order to select it as a lead compound.” Req. Reh’g 4–5. Our Decision cited and applied the law that governs Petitioner’s lead compound theory. Dec. 11 (citing Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1291–92 (Fed. Cir. 2012); Daiichi Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346, 1354 (Fed. Cir. 2010) (“[T]he attribution of a compound as a lead compound after the fact must avoid hindsight bias; it must look at the state of the art at the time the invention was made to find a motivation to select and then modify a lead compound to arrive at the claimed invention.”) (emphases added); Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). In particular, Daiichi Sankyo provides that a patent challenger must first establish a motivation for a person of ordinary skill in the art (“POSA”) “to select” a lead compound without hindsight bias, an issue addressed at length in our Decision. Dec. 12–14. The motivation to select a lead compound for further modification must be supported with persuasive evidence, whether it be the teachings of the Kant reference, the Klein reference, the knowledge of a POSA reflected in other prior art references, expert testimony, or some combination thereof. We did not “require” a motivation be found in Kant alone. Id. Petitioner misconstrues our Decision” slip op. at 3
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightTeaching away not foundDecided for patent owner
“Graham factor 3 analysis as improper hindsight,” is based on the curious argument that “nowhere does the Petition argue that Compound 20 should be selected as a lead because of its structural similarity to cabazitaxel.” Req. Reh’g 8–9. Yet, the Petition begins, ends, and overflows with characterizations of cabazitaxel as 7,10-dimethoxy docetaxel, and repeatedly points to the structural similarities between docetaxel, Kant Compound 20, and 7,10-dimethoxy docetaxel (cabazitaxel) as the basis for selecting Kant Compound 20 as a lead compound for further modification in view of Klein. See Pet. 1–2 (“the only difference between the two [Kant Cpd 20 and cabazitaxel] is the methyl group on the C-7 hydroxyl”), 6–7 (“Kant discloses 10-methoxy docetaxel (compound 20), which contains the same methoxy group at the C-10 position as 7,10-dimethoxy docetaxel. . . . Compound 20, which is methylated at the C-10 hydroxyl is shown below on the left, adjacent to 7,10-dimethoxy docetaxel for comparison [of the chemical structures]”), 30–31 (“The structure disclosed in Kant [Compound 20] is shown below, adjacent to the compound of claim 1 of the ’170 patent and adjacent to docetaxel. For ease of comparison, the identical portions of the molecules have been depicted in grey.”). We reiterate our determination that Petitioner “errs by starting with a hindsight-biased structural comparison of docetaxel, Kant Compound 20, and cabazitaxel in side-by-side fashion.” Dec. 12.” slip op. at 5
- Expert testimonyPetitioner expert discountedDecided for patent owner
“paragraphs 54–55 and 93–94 of Dr. Jacobsen’s Declaration in our Decision (Req. Reh’g 10), that testimony establishes only that known taxanes could be formulated for intravenous administration by using Cremophor EL. Ex. 1002 ¶¶ 54–55, 93–94. Having further considered the cited Declaration testimony of Dr. Jacobsen, we re-state that it “does not address why a POSA would have simultaneously modified the C-7 and C-10 positions in Kant Compound 20 to optimize lipophilicity [of an unknown taxane], thereby minimizing aqueous solubility, when a POSA would have known docetaxel and paclitaxel were highly lipophilic and insoluble in water, which made their commercial formulation challenging.” Dec. 13 (citing Prelim. Resp. 21–24; Ex. 1006; Ex. 1011, 495; Ex. 1015; Ex. 1019, 1:64–67; Ex. 1020, 206; Ex. 2004, 2:42–44; Ex. 2015, 648; Ex. 2024, 45; Ex. 2025, 91; Ex. 2026, 996). The cited testimony is not inconsistent with the knowledge that docetaxel and paclitaxel were highly lipophilic and challenging to formulate, based on the extensive documentary evidence cited by Patent Owner, which we credited. In short, there was no error in crediting Patent Owner’s cited documentary evidence. See Virnetx Inc. v. Apple Inc., 2016 WL 7174130, at *3 (Fed. Cir. Dec. 9, 2016) (“[T]he PTAB must weigh [expert] testimony against other record evidence in reaching its conclusion, and it may give that testimony less weight, so long as it supports its decision with substantial evidence.”). We also do not agree that we overlooked Dr. Jacobsen’s cited Declaration testimony or that it is inconsistent with Patent Owner’s documentary evidence.” slip op. at 6
§ 103 obviousnessPatents in suitUS 5,847,170 - PTAB · Dec 22, 2016 · IPR2015-00554 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving intact its determination that claims 1–11 are unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Expert testimonyDecided for patent owner
“and 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45–49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.”).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITADecided for petitioner
“We made clear that the controlling description of the specification outweighed Patent Owner’s argument and supporting evidence that specific types of information are required to be read into the “identifying” element of the claims. Id. (“Thus, we construe ‘prescription requests [for GHB] containing information identifying patients’ to refer to information identifying a patient, which may include [Patent Owner’s specifically listed information], but is not limited to that information nor requires all of that information.”) (emphasis added). We also cited to all of the expert testimony on which Patent Owner relied for its claim construction, as an indication that we considered the testimony. Id. at 18 (citing Ex. 2044, 97:11–98:5, 99:18–100:10; Ex. 2046 ¶¶ 39–44). We did the same for the “information identifying . . . any and all medical doctors” language, concluding that: The specification does not suggest that failing to include on the prescription one or more pieces of information from the list of a “medical doctor’s name, license number, DEA number, and physician specialty,” as proposed by Patent Owner, means that a prescription fails to contain information regarding “various credentials,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,668,730 - PTAB · Dec 22, 2016 · IPR2015-00547 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving claims 1–6 unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,765,107 - PTAB · Dec 22, 2016 · IPR2015-00551 · APJ Brian P Murphy · IPR · Rehearing
The Board denied Jazz Pharmaceuticals’ rehearing request, leaving claims 1–15 unpatentable for obviousness over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundDecided for petitioner
“PO Resp. 60. We did not find such testimony persuasive, or particularly credible, in view of Korfhage’s express disclosures, Dr. Valuck’s testimony, and Dr. Bergeron’s deposition testimony. Dec. 57–59 (citing Ex. 1007 ¶ 157; Ex. 1037, 276–77; Ex. 1054, 317:13–320:12; Ex. 2047 ¶ 57–59). Patent Owner’s argument is not persuasive given that the ACA drug distribution system was designed to allow a pharmacist to identify and resolve duplicate prescriptions before deciding whether to distribute the drug to a patient (or delete a duplicate caused by data redundancy). Ex. 1003, 184:24–185:7; Ex. 1005, 314 ¶ 6. We also were persuaded by Dr. Valuck’s testimony that it would have been obvious for one of ordinary skill to modify the ACA system “such that the data stored in the central data repository was distributed across multiple databases, as disclosed by Korfhage in order to accommodate cost, efficiency, and the number of prescription requests and associated data.” Ex. 1007 ¶ 157 (cited at Dec. 57–581).” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“We also agree with Petitioner that Korfhage does not teach away from the use of distributed databases systems, particularly given the acknowledgement of Dr. Bergeron that Korfhage offered solutions to the problems identified. Id. at 59 (citing Ex. 1037, 276–77; Ex. 1054, 317:13–320:12). We did not overlook or misapprehend Patent Owner’s argument and evidence, rather, we declined to credit them in view of the text of Korfhage, Dr. Valuck’s testimony, and Dr. Bergeron’s deposition testimony. Dec. 56– 59. The pages of Korfhage cited and quoted in our Decision disclose multiple factors “driving information systems to the use of distributed document sets and distributed processing,” and set up “[t]hree major problems” only to discuss “simple solution[s],” a position supported by Dr. Valuck. Dec. 57–59 (citing Ex. 1007 ¶ 157; Ex. 1037 at 276–77). Under cross-examination by Petitioner’s counsel, Dr. Bergeron readily acknowledged that Korfhage’s discussion of data redundancy and matching document evaluation “problems” were paired with disclosed solutions, which undercut his declaration testimony (Ex. 2047 ¶¶ 56–65) relied upon by Patent Owner. Ex. 1054, 317:13–320:12. Our Decision credits Dr. Bergeron’s deposition testimony, which acknowledges the distributed database system solutions disclosed in Korfhage, rather than the speculative new problems hypothesized in his declaration and Patent Owner’s Response.” slip op. at 4
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state, and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims. Dec. 19 (emphasis added). We made clear that the controlling description of the specification outweighed Patent Owner’s argument and supporting evidence that specific types of information are required to be read into the “identifying” element of the claims. Id. (“Thus, we construe ‘prescription requests [for GHB] containing information identifying patients’ to refer to information identifying a patient, which may include [Patent Owner’s specifically listed information], but is not limited to that information nor requires all of that information.”) (emphasis added). We also cited to all of the expert testimony on which Patent Owner relied for its claim construction, as an indication that we considered the testimony. Id. at 18 (citing Ex. 2044, 97:11–98:5, 99:18–100:10; Ex. 2046 ¶¶ 39–44). We did the same for the “information identifying . . . any and all medical doctors” language, concluding that: The specification does not suggest that failing to include on the prescription one or more pieces of information from the list of a “medical doctor’s name, license number, DEA number, and physician specialty,” as proposed by Patent Owner, means that a prescription fails to contain information regarding “various credentials,” as recited in the claims. Id. at 20–21 (citing PO Resp. 33–36; Ex. 1001, 2:22–24, 2:41–42, 4:7–8, 4:8–14, 4:18–20, 4:20–22, 4:7–5:67, 8:4–7, 8:40–44, 10:20–23, Figs. 2A–C, 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45–49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence.”).” slip op. at 8
Claim construction§ 103 obviousnesscites PhillipsPatents in suitUS 8,457,988 - PTAB · Dec 22, 2016 · IPR2015-00548 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–16 unpatentable as obvious over the Advisory Committee Art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. STANDARD OF REVIEW A party who requests rehearing bears the burden of showing that a decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
Claim constructioncites PhillipsPatents in suitUS 7,895,059 - PTAB · Dec 22, 2016 · IPR2015-00546 · APJ Jacqueline Wright Bonilla · IPR · Rehearing
The Board denied Patent Owner’s rehearing request, leaving claims 1–8 unpatentable as obvious over the Advisory Committee Art under § 103(a).
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified. 37 C.F.R. § 42.71(d). The party must identify all matters the party believes we misapprehended or overlooked, and the place where each matter was addressed previously in a motion, an opposition, or a reply. Id. “A Request for Rehearing is not an opportunity to re-argue old arguments.” Histologics, LLC v. CDX Diagnostics, Inc., Case IPR2014-00779, slip op. at 4 (PTAB Oct. 16, 2014) (Paper 9). With the aforementioned principles in mind, we address the rehearing arguments presented by Patent Owner.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“nothing in the specification suggests that excluding one or more pieces of information in the list of a “patient’s name, social security number, date of birth, sex, and complete address information, including city, state and zip code,” as proposed by Patent Owner, means that a prescription fails to contain “information identifying the patient,” as recited in the claims.” slip op. at 5
- Claim Construction › Extrinsic evidence (dictionaries, experts)Decided for petitioner
“Id. at 20–22 (citing PO Resp. 33–36; Ex. 1001, 2:28–30, 47–48, 4:13–6:4, 8:4–7, 40–44, 9:56–60, Figs. 2A–C, 9; Ex. 2044, 181:1–23; Ex. 2046 ¶¶ 45– 49). Though we did not discuss the expert testimony, we considered it. For example, on the same page of testimony cited by Patent Owner, Dr. Valuck testified that the information sufficient to identify a patient is “whatever the pharmacist believes is required to sufficiently identify the patient in their professional judgment.” Ex. 2044, 98:2–16. Even so, our Decision puts primary emphasis on the claim language and relevant description of the “identifying” element in the specification, not the extrinsic expert testimony relied upon by Patent Owner. See Perfect Surgical Techniques, Inc. v. Olympus Am., Inc., 841 F.3d 1004, 1012–13 (Fed. Cir. 2016) (“The legal part of claim construction is the determination of the meaning of the term in the claim in light of the patent’s intrinsic record.”); see also Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005) (en banc) (stating that sources outside the specification should not be “used to contradict claim meaning that is unambiguous in light of the intrinsic evidence”).” slip op. at 6
Claim constructioncites PhillipsPatents in suitUS 7,765,106 - Mylan Pharmaceuticals Inc. v. Astrazeneca ABInstitution deniedPTAB · Dec 14, 2016 · IPR2016-01325 · APJ Robert A Pollock · IPR · Institution
The Board denied institution because Mylan did not show a reasonable likelihood of proving claims 1–20 obvious over McLeskey alone or with Howell 1996.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rely on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness, “cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” Id. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 19
- Skill levelSkill level board ownDecided for patent owner
“Person of Ordinary Skill in the Art. The parties’ propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 14–15; Prelim. Resp. 11–12. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“patentable weight, the term “therapeutically significant” should be construed to mean “any blood plasma fulvestrant concentration greater than or equal to at least 2.5 ngml-1 that is achieved for at least 4 weeks after injection.” Pet. 17–18. Patent Owner does not argue that Petitioner’s proposed interpretation is unreasonable, but contends that the meaning of the term is clear from the Specification and context of the claim phrase itself. See Prelim. Resp. 16 (citing Ex. 2003 ¶ 68; Ex. 1001, 9:24–27 (expressly defining “therapeutically significant” fulvestrant blood plasma levels as “at least 2.5 ngml-1, ideally at least 3 ngml-1, at least 8.5 ngml-1, and up to 12 12 Our reasoning extends to the wherein clauses of dependent claims 2 and 10, also challenged by Petitioner at page 16, footnote 9, of the Petition. ngml-1 of fulvestrant [] achieved in the patient.”). We agree with Patent Owner. No express construction of this term is required.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“and 9, “wherein the method achieves a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks,” is merely a statement of intended result entitled to no patentable weight. Pet. 16–17. For the reasons set forth at pages 12–16 of Patent Owner’s Preliminary Response, we do not find Petitioner’s argument persuasive.12 For example, rather than merely stating the result of intramuscularly administering the recited formulation, as Petitioner argues, the wherein clause dictates both the administration duration and dose of the formulation, i.e., an amount sufficient to provide a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks. See Prelim. Resp. 15 (relying on Exhibits 2002 ¶ 37–39, Ex. 2001 ¶¶ 33–37, and citations therein). That these parameters are further limited in claims 2, 10 (“the therapeutically significant blood plasma fulvestrant concentration is at least 8.5 ngml-1”) further indicates that the wherein clauses provide defining characteristics. See Prelim. Resp. 15 (citing Ex. 2003 ¶ 60).” slip op. at 16
Claim construction§ 103 obviousnesscites KSRPatents in suitUS 8,329,680 - Hamilton Beach Brands, Inc. v. F’Real Foods, LLCInstitution deniedPTAB · Nov 30, 2016 · IPR2016-01105 · APJ Brian P Murphy · IPR · Institution
Institution was denied because Petitioner did not show a reasonable likelihood of proving claims 1 and 6–11 anticipated by Neilson or claims 1 and 5–11 obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“October 6, 2014—the date the 2014 Complaint alleging infringement of the ’658 patent was served on Petitioner. Prelim. Resp. 5, 11. It is undisputed, however, that Patent Owner did not own the ’658 patent at the time the 2014 Complaint was filed and served. Pet. 4; Prelim. Resp. 7; Ex. 1030 ¶¶ 5–7. Title to the ’658 patent was transferred to Patent Owner by an assignment executed January 25, 2016. Pet. 4; Prelim. Resp. 9; Ex. 1030 ¶ 7, Ex. C (patent assignment). Accordingly, Patent Owner lacked standing to sue for infringement of the ’658 patent at the time the 2014 Complaint was filed and served. Paradise Creations, Inc. v. UV Sales, Inc., 315 F.3d 1304, 1309 (Fed. Cir. 2003) (“[I]n order to assert standing for patent infringement, the plaintiff must demonstrate that it held enforceable title to the patent at the inception of the lawsuit.”). The patent counts of the 2014 Complaint were jurisdictionally defective, and the defect could not be cured after the filing date of the complaint, e.g., by a subsequent assignment or by joining the patent title holder to the lawsuit. Alps S., LLC v. Ohio Willow Wood Co., 787 F.3d 1379, 1385 (Fed. Cir. 2015), cert. denied, 136 S. Ct. 897 (2016) (“The party asserting patent infringement is ‘required to have legal title to the patents on the day it filed the complaint and that requirement can not be met retroactively.’”) (quoting Abraxis Bioscience, Inc. v. Navinta LLC, 625 F.3d 1359, 1366 (Fed. Cir. 2010)). The Delaware district court was required to—and actually did— dismiss the patent infringement counts of the 2014 Complaint for lack of Article III standing. Ex. 1031 n.1 (Delaware district court order granting motion for voluntary dismissal: “the court lacks jurisdiction to make a judgment on the merits”); see also, Abraxis, 625 F.3d at 1367 (“[T]he action must be dismissed because [plaintiff] lacked standing on the day it filed the action.”); Schreiber Foods, Inc. v. Beatrice Cheese, Inc., 402 F.3d 1198, 1203 (Fed. Cir. 2005) (“[I]f the original plaintiff lacked Article III initial standing, the suit must be dismissed, and the jurisdictional defect cannot be cured by the addition of a party with standing, . . . nor by the subsequent purchase of an interest in the patent in suit.”) (citing Paradise, 315 F.3d at 1309). Thus, the allegation of infringement of the ’658 patent in the 2014 Complaint was not a proper federal pleading and did not trigger the one-year time period under 35 U.S.C. § 315(b). Petitioner was not served with a complaint properly alleging infringement of the ’658 patent until January 2016. The instant petition was filed in May 2016. Accordingly, the Petition is not time-barred under § 315(b).” slip op. at 9
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“unpatentable under 35 U.S.C. § 102(b) and claims 1 and 5–11 as unpatentable under § 103. Pet. 9. Based on the arguments and evidence presented in the Petition and Preliminary Response, we determine Petitioner has not established a reasonable likelihood that it would prevail with respect to at least one of the claims challenged in the Petition. Therefore, institution of an inter partes review is denied.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“of the specification of the patent in which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Petitioner and Patent Owner offer competing constructions for several claim terms. Pet. 18–20; Prelim. Resp. 26–35. We determine that only the following claim terms require express construction for purposes of this Decision. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (citation omitted).” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“position.” During a mixing operation, the ’658 patent describes how the cup holder is reciprocated to move axially upward so the mixing element is in a position within the liquid-filled cup, i.e. the recited “first position,” then reciprocated downward so the mixing element is moved upward to the recited “second position” closer to the opening at the top of the cup, “to allow the blade to pass through the full contents of the cup more than one time.” Ex. 1001, 3:58–64. When the mixing element is moved upward within the cup to the second position, the weight of the splash shield must be sufficient to keep the liquid-filled cup in the cup holder. Id. at 4:3–10 (“heavy enough to create sufficient downward force on the cup to overcome any upward force created by the mixing blade being moved upwardly in the cup”). The force generated by upward movement of the mixing element is not further described in the ’658 patent, although the ’658 patent provides a preferred embodiment where a splash shield weighing 5 pounds (dependent claim 5) provides sufficient downward force to perform the recited function. Id. at 4:20–23. Petitioner argues that “sufficient mass” in claim 1 should be construed in accordance with the interpretation allegedly offered by Patent Owner in the dismissed patent action: “the splash shield applies sufficient weight to the top of the cup to retain the cup in the cupholder during mixing.” Pet. 19 (no citation). Petitioner further argues that “the mass of the splash shield” limitation in claim 6 should be construed in accordance with the construction allegedly offered by Patent Owner in the dismissed patent action: “the splash shield applies sufficient weight to the top of the cup to prevent separation of the cup from the cupholder during mixing.” Id. (no citation). Patent Owner responds with a slightly different interpretation of a splash shield having a “sufficient mass”: “heavy enough to retain the vessel within the holder during relative movement of the mixing element and vessel.” Prelim. Resp. 31 (citing Ex. 1001, 4:3–24; Ex. 2025 (definition of “sufficient”)). Both parties appear to agree that the ’658 patent describes the “sufficient mass” of the splash shield in functional terms as enough weight to retain the vessel or cup within the holder during mixing. Ex. 1001, 3:65– 4:23. Based on the description provided in the ’658 patent, the claim language at issue in claim 1 – “the splash shield having sufficient mass to retain the vessel within the holder during relative movement of the mixing element and vessel from the first position to the second position when liquid is present in the vessel” – is entitled to its plain and ordinary meaning: “the splash shield is heavy enough to create sufficient downward force on the vessel so as to retain the vessel within the holder when the mixing element moves upwardly in the vessel from the first position to the second position when liquid is present.” See Ex. 1001, 4:3–10 (“heavy enough to create sufficient downward force on the cup to overcome any upward force created by the mixing blade being moved upwardly in the cup”). The claim language in claim 6 “the mass of the splash shield preventing separation of the holder and the vessel during translation” is similarly construed to mean “the splash shield is heavy enough to create sufficient downward force on the vessel so as to prevent separation of the holder and the vessel during translation of the mixing element or holder.”” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,520,658 - Institut Straumann AG / Dental Wings Inc. v. Sirona Dental Systems GmbHSome claims unpatentablePTAB · Nov 15, 2016 · IPR2015-01190 · APJ Brian P Murphy · IPR · Final written decision
Claims 1–8 were held unpatentable as obvious over Bannuscher and Truppe; claims 9–10 were not shown unpatentable; the motion to amend was denied.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“interpretation of the language used in claim 1 and the additional limitations of dependent claims 9 and 10. Patent Owner’s proposed construction also impermissibly reads limitations from the preferred embodiment of Figure 5 into claim 1. Patent Owner would limit the pilot hole location exclusively to a position directly over the implant position and require the drill bit to pass through the pilot hole while drilling a bore hole into the patient’s jaw. The language recited in claim 1, in the context of the ’006 specification, does not so-limit the “determinating a pilot hole” step. First, Patent Owner fails to consider the present participle form “determinating”5 at the beginning of the recited method step at issue. As a result, Patent Owner conflates the recited device production step with a specific process for drilling a bore hole into a patient’s jaw during tooth implant surgery. PO Resp. 14–15. For example, Patent Owner relies on Dr. Erickson’s Declaration testimony (and Dr. Benjamin’s deposition testimony) for the proposition that “pilot hole” is a term of art referring to “an initial hole through which a pilot drill passes during an operation.” Ex. 2002 ¶ 37 (cited at PO Resp. 16–17); see also PO Resp. 16–17 (citing Ex. 2023, 24:3– 22, 25:18–27:2, 52:2–9). The ’006 patent does not describe or reference any such “pilot drill” or “initial hole” being made during a tooth implant operation. Regardless, the claim limitation at issue is a step in a method of producing a drill template. It recites defining a pilot hole in a drill template with reference to the surfaces of neighboring teeth, nothing more. The function of actually passing a drill through a pilot hole in a drill template” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Petitioner argues that the term “pseudo-x-ray picture” is not a term that has a commonly understood meaning to a POSA. Pet. 19 (citing Ex. 1002 ¶ 45 [47]). Patent Owner does not comment on the construction of “pseudo-x-ray picture.” PO Resp. 15–19. Having reviewed the complete record, we adopt Petitioner’s argument and evidence in support of Petitioner’s proposed broadest reasonable interpretation of “pseudo-x-ray picture.” Therefore, we adopt Petitioner’s proposed broadest reasonable interpretation of “pseudo-x-ray picture” as “any representation of measured data records of the three-dimensional optical measuring that can be superimposed on an x-ray image.” Pet. 19 (citing Ex. 1002 ¶ 49).” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableInherency not foundNot shown unpatentable
“stylus is used to penetrate the surface of the gum repeatedly to measure the structure of the jaw bone displayed in Figure 25. PO Resp. 30–31 (citing Ex. 1007, 24:53–65 (“[S]tylus member 52 is provided with a sharp stylus 574 (FIG. 1) having a length sufficient[ly] long to penetrate gum tissue and contact the bone surface. . . . [P]ractitioner repeats the procedure of piercing the gum tissue in a region about the desired implantation site and taking point data until enough data has been collected . . . to map . . . the entire surface of bone 558 [Fig. 25] about the implantation site.”)). We agree with Patent Owner and find that the use of a sharp stylus to pierce the gum and take multiple data points via contact digitization of the jaw bone beneath the skin surface is not a 3-D optical measuring of the visible surfaces of a patient’s jaw.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“would have been motivated to combine their teachings with respect to correlating X-ray imaging data of the jaw and 3-D surface data of the jaw and teeth. Reply 22–23 (citing Ex. 1002 ¶¶ 89, 92; Ex. 1008, 1:10–11 (“precise planning of the surgical operation is necessary”); Ex. 1010, 5:19– 25 (“it is possible to carry out the entire implantological, treatment and operation planning on a scientific basis . . . to implement holistic planning results in a precisely clinical manner”)). More particularly, Bannuscher discloses the desire to obtain “all the necessary [clinical] parameters” relevant to pre-surgical implant planning, which can be “combined together” (“correlated” in the language of claim 1) using planning simulation software, for transfer to a drill template. Ex. 1010, 5:44–6:13, 6:24–40, 7:38–8:4. As Dr. Erickson testified, it would have been desirable for a POSA to have as much diagnostic information as possible when planning for dental implant surgery. Ex. 1029, 31:12–21. Truppe discloses the advantage of correlating three-dimensional X-ray imaging data of the jaw and optical imaging data of the jaw and teeth, using simulation software, to obtain a “vivid” representation. Ex. 1008, 2:7–16, 3:19–28, 3:56–58; 4:1–5. Truppe, therefore, discloses a similar process to that disclosed in Bannuscher with respect to correlating 3-D X-ray imaging data and 3-D optical data representing the surfaces of the jaw and teeth, to generate the best possible representation of the patient’s jaw and teeth. Ex. 1002 ¶¶ 89–92. A POSA would have been motivated to use Truppe’s optical measurement system to generate 3-D surface data of the jaw and teeth for use in Bannuscher’s planning simulation software, in order to produce an enhanced image for determining the optimal bore hole and pilot hole in the drill template. Id.; Ex. 2023, 186:8–187:13 (“the optical imaging [of Truppe] would basically just enhance the diagnostic data [of Bannuscher]”). For example, a POSA would have optically measured the plaster model of the jaw and teeth referenced in Bannuscher and the patient’s actual jaw and teeth, as in Truppe, to produce a “vivid” image for correlation with the X-ray imaging data. Ex. 1002 ¶¶ 89, 92.20 Bannuscher’s determination of the optimized bore hole and corresponding pilot hole in the drill template would be based on the enhanced imagery generated from the correlated 3-D data sets. In short, we are persuaded that a POSA would have had reason to incorporate the teaching of Truppe’s enhanced 3-D optical measurement technique into Bannuscher’s method for correlating 3–D X-ray image and model geometry data sets, to determine an optimal bore hole and corresponding pilot hole in the drill template. For the reasons given above, we are persuaded that Petitioner has established a sufficient motivation for a POSA to combine the relevant teachings of Bannuscher and Truppe, with a reasonable expectation of success, by a preponderance of the evidence.” slip op. at 40
Patent outcomesUS 6,319,006 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,319,006
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.