- Salvacion USA, Inc. v. Trutek Corp.InstitutedPTAB · Dec 6, 2024 · IPR2024-00711 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1–3 and 8 on all asserted grounds, finding a reasonable likelihood that Chen anticipates or renders obvious each challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Accordingly, we determine that Petitioner has shown a reasonable likelihood of prevailing in its challenge of claims 1–3, and 8 as anticipated by, or obvious over Chen.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner does not specifically address or dispute Petitioner’s proposed definition or a person of ordinary skill in the art. See generally Prelim. Resp. At this stage of the proceeding, we adopt Petitioner’s proposed level of ordinary skill in the art as we find it consistent with the cited prior art and it is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“of independent claims 1, 2, and 8 are limiting. Prelim. Resp. 7. According to Patent Owner, for these claims, the preamble “recites specific steps in the process that are not recited in the body of the claim or are recited in a way particulate matter; infecting an individual through nasal inhalation; formulation is applied to the skin or tissue of nasal passages; and a thin film.” Id. Petitioner does not allege any contention regarding whether the preamble is limiting. See Pet. 14–16. Based on our review, we agree with Patent Owner that the preamble of independent claims 1, 2, and 8 limits the challenged claims as both the preamble and the body have been used to define the subject matter claimed. See Allen Engineering Corp., v. Bartell Industries, Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). In particular, the preamble is “necessary to give life, meaning and vitality” to the claim, see id., because it provides the only description in the claim for the application site of the formulation, i.e., “to skin or tissue of nasal passages,” and how the formulation is applied, i.e., “in a thin film.” Id.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“one “biocidic agent.” Petitioner asserts that this term means “an agent which has the capacity to neutralize, inactivate, render harmless or kill airborne particles, which include microorganisms, for example viruses and/or bacteria.” Pet. 14. Patent Owner asserts that the term refers to “a chemical substance that destroys or inhibits the growth or activity of living organisms.” Prelim. Resp. 12 (citing Merriam-Webster Dictionary). Independent claim 2 recites a formulation comprising at least one “cationic agent.” Dependent claim 3 recites that the “cationic agent is a polymeric quaternary ammonium compound.” Patent Owner asserts that a “cationic agent” is “a chemical substance that creates a positive electrostatic term. Based on our review, we determine that an explicit construction is not necessary for purposes of our determination whether to institute an inter partes trial, as there is no dispute as to whether the prior art discloses formulations comprising a biocidic agent and a cationic agent.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,163,802 - Vectair Systems Inc. v. Fresh Products, Inc.Institution deniedPTAB · Nov 12, 2024 · IPR2024-00824 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution on all challenged claims because the Petition did not establish that the listings were prior art or provide sufficient evidence and motivation for the obviousness combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing that “there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition.” 35 U.S.C. § 314(a). After considering the Petition, Preliminary Response, and information presented by the parties, we determine that Petitioner has not demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we decline to institute inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“of claims under 35 U.S.C. § 102 or § 103 “only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b). At the institution stage, the “burden is on the petitioner to identify with particularity evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent, and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29, 21 (PTAB Dec. 20, 2019) (precedential). This differs from the standard in a final written decision, at which point “the petitioner bears the burden of establishing by a preponderance of the evidence that a particular document is a printed publication.” Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1375 (Fed. Cir. 2018) (citing Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018)).” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“c. Discussion Having considered the parties’ positions and evidence of record, summarized above, we determine that Petitioner fails to establish a reasonable likelihood that the Amazon Listings were publicly accessible before the priority date of the ’098 patent, and therefore fails to establish a reasonable likelihood that the Amazon Listings qualify as printed publications. As explained in a previous Board decision, “[t]he date that a product was listed as first available on a website . . . is not sufficient evidence that the content of the listing, including the photographs depicted therein, were published at that time.” Next Step Grp., Inc. v. Deckers Outdoor Corp., No. IPR2024-00525, 2024 WL 3678413, at *5 (P.T.A.B. Aug. 6, 2024) (citing Ex parte Basulto, Appeal 2020-00129, 2021 WL 1264902, at *2 (PTAB Apr. 2, 2021) (stating “the date [a] product was listed on Amazon.com is not compelling evidence that the content of [the] listing itself as shown in the document, and the photographs relied on within it were published at that time”). That is because product listings may be updated and photographs of the products may change over time and, therefore, a statement on a commercial website as to when a product was “first available” is insufficient evidence without additional corroborating evidence that the listing itself, or any photograph depicted therein, has not changed over time. See id. (citing Ex parte Zhang, Appeal 2021-000087, 2021 WL 633718 at *3 (PTAB Feb. 16, 2021) (stating “while the [webpage] date indicates that the product information was last updated on [date], there is no additional evidence to corroborate that the picture was publicly accessible on that date”)). In this case, Petitioner does not provide sufficient corroborating evidence that any of the information or images depicted in the Amazon Listings were available and remained unchanged on the website prior to the critical date. In contrast, Patent Owner provides evidence in the form of testimony of Mr. Smith, which we find credible, that the Amazon Listings offering the Wave 3D Urinal Screen for sale could not have existed prior to November 2014, the priority date of the ’098 patent. d. Conclusion In view of the above, we determine that, on this record, Petitioner has not established a reasonable likelihood of prevailing in demonstrating the unpatentability of claims 1, 19, and 38 with respect to Ground 1.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“b. Legal Standard “To satisfy its burden of proving obviousness, a petitioner cannot employ mere conclusory statements. The petitioner must instead articulate specific reasoning, based on evidence of record, to support the legal conclusion of obviousness.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Moreover, “[a] party seeking to invalidate a patent on the basis of obviousness must demonstrate by clear and convincing evidence 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.” See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012) (quotation marks omitted); see also In re Nuvasive, Inc., 842 F.3d 1376, 1383 (Fed. Cir. 2016) (explaining that “conclusory statements” are “insufficient articulations of motivation to combine” prior art references). When an assertion of obviousness “fails to identify any actual reason why a skilled artisan would have combined the elements in the manner claimed,” the assertion of obviousness “is inadequate.” See In re Van Os, 844 F.3d 1359, 1361 (Fed. Cir. 2017). Furthermore, unsupported statements that a combination of elements would have been merely a design choice is insufficient to establish obviousness. See Stryker Corp. v. Karl Storz Endoscopy–America, Inc., IPR2015–00677, Paper 15 at 37 (P.T.A.B. Sept. 2, 2015) (“[t]he mere recitation of the words ‘common sense’ or ‘design choice,’ however, without any evidentiary support, adds nothing to the obviousness equation.” (citing Mintz v. Dietz & Watson, Inc., 679 F. 3d 1372, 1377 (Fed. Cir. 2012)).” slip op. at 17
§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,145,098 - PTAB · Oct 16, 2024 · PGR2024-00028 · APJ Jeffrey N Fredman · PGR · Institution
The Board instituted PGR on claims 1–10 because Petitioner showed it was more likely than not to prevail on obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review under 35 U.S.C. § 324. Institution of a post-grant review is authorized by statute when “the information presented in the petition . . . would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a) (2018). Applying that standard on behalf of the Director (37 C.F.R. § 42.4(a)) and in consideration of the Petition, Preliminary Response, and the evidence of record, we determine that the information presented shows that it is more likely than not that Petitioner would prevail in establishing unpatentability of at least one of claims 1–10 of the ’737 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person having ordinary skill in the art (“PHOSITA”) as of the effective filing date of the challenged claims. Petitioner contends that one of ordinary skill in the art would have been someone with a medical degree and sufficient experience with interventional procedures, specifically with endovascular procedures including extensive use of both angioplasty balloons and occlusion devices. A[nd that a] busy interventionalist could conceivably acquire an adequate level of experience having a minimum of ten years of post-graduate experience as an interventional radiologist, vascular surgeon, interventional cardiologist, or other endovascular interventionist. Such a person would be familiar with various occlusion balloon catheters and their use in performing vascular occlusion procedures including occlusion procedures throughout the vascular system, including occlusion procedures within the aorta. Pet. 10–11 (citing Ex. 1003 ¶ 18). Patent Owner states that: “Solely for purposes of this Preliminary Response, Patent Owner does not object to Petitioner’s definition of a PHOSITA. Patent Owner reserves the right to assert an alternative definition for a PHOSITA in this or another proceeding involving the ‘737 Patent, where appropriate.” Prelim. Resp. 12.” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“• “proximal”: “a portion or component of the preferred vascular occlusion catheter system that is oriented away from the body into which the system is or is intended to be placed.” Ex-1001, 21:52-56. • “distal”: “a portion or component of the preferred balloon catheter system that is oriented toward the body into which the system is or is intended to be placed.” Ex- 1001, 21:56-60.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“We find that the evidence currently of record reasonably supports an interpretation where the claimed proximal hub and flow valve may be in an element/sub-element relationship where the recited flow valve is a portion of the recited proximal hub.” slip op. at 10
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,857,737 - PTAB · Oct 15, 2024 · IPR2024-00766 · APJ Brent M Dougal · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood of proving any challenged claim obvious over the asserted prior-art grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Petitioner bears the burden to demonstrate unpatentability. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). At this preliminary stage, we determine whether the information presented in the Petition shows a reasonable likelihood that Petitioner would prevail in establishing that at least one challenged claim would have been obvious over the prior art. See 35 U.S.C. § 314(a).” slip op. at 5
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentable
“However, each of these asserted modifications is based on a teaching that is not present in Brown. Brown does not teach “a projection that provides resistance against ‘handle’ movement” or that “opening Brown’s ‘cover’ requires bending Brown’s ‘port,’” as asserted by Petitioner. See PO Resp. 22. As repeatedly noted, the identified “projection” appears to be nothing more than a portion of cover 14 the accessory/hose port. Petitioner’s arguments regarding a projection that provides resistance and a bendable port in Brown, appear to be nothing more than an effort to create the limitations of the claims in the prior art based on improper hindsight. For at least the above reasons, the Petition does not show how Brown teaches or suggests all of the limitations of the independent claims.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentable
“Petitioner argues that when cleaning tool 10 (i.e. accessory) is in position on the vacuum, end wall 26 cannot open and, thus, that end wall is inhibited from opening. Pet. 45–46 (citing Ex. 1005, ¶ 37, Fig. 2; Ex. 1002 ¶¶ 143–145 (similar statements from Petitioner’s declarant)). Petitioner then asserts that the catch is therefore inhibited from moving to the disengaged position. Id. at 46. The combination of Dimbylow and Howes does not teach this limitation and Petitioner’s assertions are not persuasive. As can be seen from the above annotated Figure, nothing inhibits Dimbylow’s catch 42 from moving to a disengaged position. See also Prelim. Resp 11–14. Rather, any time Howe’s button is pressed, thereby moving the push-rod (to the right in the Figure), catch 42 would disengage, whether the door opened or not. Though cleaning tool 10 (i.e. accessory) inhibits end wall 26 from opening, it has no impact on movement of catch 42 (i.e. lock engaging member) from the engaged to disengaged position as required by the claim. Thus, the lock engaging member of Petitioner’s combination, i.e., the catch, is not inhibited from moving to a disengaged position when the accessory, i.e., the cleaning” slip op. at 17
- Skill levelSkill level petitioner adoptedOther
“understanding of a person of ordinary skill in the art at the time of the invention (“POSA”). Id. at 13, 17. Petitioner’s declarant asserts that a person of ordinary skill in the art would have had a bachelor’s degree in mechanical engineering or a similar field and 2-3 years of experience in machine design, such as vacuum cleaners. Additional education could offset less experience and vice versa, and a POSA could have also obtained similar knowledge and experience through other means. Ex. 1002 ¶ 42; see also Pet. 22 (making the same assertion without citation to declarant). Patent Owner does not contest the level of skill. Prelim. Resp. 2. We are persuaded, on the present record, that Petitioner’s (and its declarant’s) proposed definition of the ordinarily skilled artisan is consistent with the problems and solutions in the ’477 patent and prior art of record. We adopt the above definition of the level of skill for the purposes of this Decision.” slip op. at 5
Claim construction§ 103 obviousnessPatents in suitUS 10,568,477 - PTAB · Oct 9, 2024 · IPR2024-00733 · APJ Matthew S Meyers · IPR · Institution
The Board instituted IPR on claims 1–14 and all asserted grounds, finding a reasonable likelihood of success based on anticipation by Liddell and obviousness over Simpson and Liddell.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a) (2020). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.”” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingTerm construed petitioner constructionDecided for petitioner
“preamble term “hand carriable” does not limit the claimed apparatuses. “[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.’” Catalina Marketing, 289 F.3d at 808 (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). This rule against giving effect to intended-use language in the preamble “reflects a longstanding substantive aspect of the patent statue—specifically, the ‘well settled’ fundamental principle ‘that the recitation of a new intended use for an old product does not make a claim to that old product patentable.’” Arctic Cat Inc. v. GEP Power Products, Inc., 919 F.3d 1320, 1328 (Fed. Cir. 2019) (quoting In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)). In this case, we view the phrase “hand carriable,” as it appears in the preamble, to be indicative of an intended use of the claimed apparatuses, rather than a structural limitation, and as such, we do not see it to be limiting based on the current record. Patent Owner does not point to any particular structural limitation required by the preamble term “hand carriable.” See Prelim. Resp. 2–10. Although the independent claims each recite “a handle,” the claims do not explicitly tie this limitation to the “hand carriable” language in the preambles. In any case, to the extent the handle recited in the claims may be used for carrying the claimed apparatus, the claims need not rely on the preamble term “hand carriable” for antecedent basis, as the handle limitation is introduced in the body of the claims. In other words, with respect to the functionality of carrying the apparatus by hand, the claim bodies recite “a structurally complete invention.” Catalina Marketing, 289 F.3d at 808.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Reference is prior artInstituted
“reasonable likelihood that it would prevail in challenging the patentability of independent claim 1. In our view, Petitioner’s analysis, on this record, adequately identifies where all the elements of claim 1 are found in Liddell.” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“On the current record, we find that the Petition provides sufficient rationale to modify Simpson in view of Liddell. See Pet. 57–61 (citing Ex. 1002 ¶¶ 250–267). For example, Petitioner contends that one of ordinary skill in the art would have been motivated to incorporate Liddell’s cyclonic separating apparatus into Simpson’s vacuum cleaner in order to reap “the benefits of cyclonic separation, including maintaining steady suction as the separator fills with dirt.” Id. at 59 (citing Ex. 1002 ¶¶ 256– 259). Petitioner explains that Organ establishes that “bagless vacuums like ‘cyclonic’ vacuums were ‘becoming increasingly popular’” in the prior art because they are able “to maintain a consistently high level of suction, even as the collecting chamber fills with dirt” (id. (citing Ex. 1006, 1:8–13)), and relying on the declaration testimony of Dr. Giachetti, argues that one of ordinary skill in the art would have “would have been motivated to substitute Simpson’s dust separation system with a bagless cyclonic separator for the same reason” (id. (citing Ex. 1002 ¶ 281)).” slip op. at 38
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,327,607 - PTAB · Oct 3, 2024 · IPR2024-00648 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR of claims 1–30 on all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–30 of the ’462 patent is unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Design, Eligibility). At this point in the proceeding, we interpret the “in response to” limitation of claim 1 to mean that pembrolizumab is administered to a patient after the patient has been determined to be microsatellite instability high or DNA mismatch repair deficient, regardless of whether pembrolizumab is also administered to other patients. The record is devoid of evidence that one of ordinary skill in the art would have understood treating a patient “in response to” the determination that the patient has a condition to exclude the same treatment of other patients, such as the treatment of control patients not having the condition.” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“5002). Dr. Neugut’s testimony supports Petitioner’s argument that the cited teachings of Brown and Duval, as well as other references, would have motivated a person of ordinary skill in the art to obtain the results of the MSI-H Study Record. See Ex. 1003 ¶¶ 124, 130, 132, 136. Petitioner argues further that Brown and Duval would have motivated one of ordinary skill in the art to obtain the results of the MSI-H Study Record by treating patients with common types of MSI-H cancers, including endometrial, small bowel, and gastric cancers. Pet. 42–43 (citing Ex. 1003, ¶ 136). Petitioner argues further that the state of the art, as demonstrated by Brown and Duval, as well as other references, would have provided one of ordinary skill in the art with a reasonable expectation of success because physicians were actively treating patients with cancers that were known to be MSI-H with PD-1 inhibitors. Pet. 43 (citing Ex. 1016; Ex. 1017; Ex. 1003 ¶¶ 131–132). According to Petitioner, these other references would have “independently urged” those of ordinary skill in the art to treat MSI-H cancer with PD-1 inhibitors or other immunotherapy, such as pembrolizumab, and would have given them a reasonable expectation of success. Pet. 44–45. Petitioner cites, along with other references, Pernot, which states “[colorectal cancers] associated with MSI could lead to a more intense immune response, but also to specific immunoregulatory phenomena, making them good candidates for immunotherapy.” (Ex. 1006,3 3741; see Pet. 43.) Petitioner also cites Champiat, which states that” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner argues that one of ordinary skill in the art relevant to the ’462 patent would have been a medical doctor or a professional in a related field with at least five years of experience with treating cancer. Pet. 11 (citing Neugut Decl., Ex. 1003 ¶ 19). Petitioner argues further that the ordinarily skilled artisan would have had experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and to a pathologist with comparable experience. Id. Patent Owner, having not entered a response, does not dispute Petitioner’s proposal about the POSA’s qualifications on this record.. For this Decision, we adopt and apply Petitioner’s proposal above, which is supported by Dr. Neugut’s testimony and does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 8
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,643,462 - Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc.Rehearing deniedPTAB · Oct 1, 2024 · PGR2024-00008 · APJ Sheridan K Snedden · PGR · Rehearing
The Board denied rehearing and maintained its denial of PGR because Petitioner did not show that Perkins and RCSB PDB made claims 1–30 more likely than not unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“II. LEGAL STANDARD Pursuant to 37 C.F.R. § 42.71(d): A party dissatisfied with a decision may file a single request for rehearing without prior authorization from the Board. The burden of showing a decision should be modified lies with the party challenging the decision. 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. When reconsidering a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion exists where a “decision [i]s based on an erroneous conclusion of law or clearly erroneous factual findings, or . . . a clear error of judgment.” PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567 (Fed. Cir. 1988). A rehearing request is not an opportunity for the requesting party to reargue its case or merely to express disagreement with the underlying decision. Nor is it an opportunity for the moving party to present new arguments that were not in its original submissions.” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Owner’s argument persuasive because Perkins discloses embodiments with “mutations at I182 among a group of 20 other possible locations for modifications,” 13 of which are mutations of specific amino acids that “can be changed to any of the 19 other natural amino acids.” Id. Perkins discloses further that modifications at each of those 20 possible sites can be combined such that “one, two, or more” of the mutations can be made together in other embodiments (Ex. 1006, 17–18), or in other words, “each species [is] combinable to create a vast number of species.” Dec. 35. In addition to the locations of modifications expressly listed in Perkins, Perkins adds yet another option in which “the mutated VSV-G envelope protein is as described in Nikolic et al.” (Ex. 1006, 18), which “describes the crystal structures of VSV G bound to its native LDL-R receptor” that RCSB PDB depicts in entries 5OY9 and 5OYL (Dec. 18). We also considered Dr. Rose’s testimony about the crystal structures depicted in RCSB PDB, namely that a person of ordinary skill in the art would have been motivated to modify Perkins based on the VSV-G crystal structures in the RCSB PDB. Perkins taught that mutations to VSV-G “inhibit binding of VSV-G to the low-density lipoprotein receptor (‘LDL-R’), while preserving the VSV-G protein’s fusogenic function,” and expressly disclosed making a mutation at I182. (See, e.g., Ex. 1005 at 19:29-20:2, 20:29-21:14, 21:16-27; Ex. 1006 at 16.) The VSV-G crystal structures in the RCSB PDB taught that I182 is nearby negatively charged amino acids on the LDL-R. Thus, a person of ordinary skill in the art would have been motivated to incorporate a mutation which negated an interaction with the negatively charged residues in the LDL-R. (Ex. 1005 at 19:29–20:2; Ex. 1006 at 16.) Dec. 37. discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 6
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“discussed above, “Perkins provides a list of many mutations and combination[s] thereof, but provides no direction as to which of the many possible choices is likely to be successful.” Id. at 37–38. Thus, we were not persuaded that choosing an embodiment with a mutation at I182 from Perkins’s other listed embodiments with 20 possible locations for modifications, combinations of modifications at 20 possible locations, and the mutations described in Nikolic and depicted in RCSB PDB is an “easily traversed, small or finite number of alternatives that KSR suggested might support an inference of obviousness.” Id. at 35. In view of these findings, we noted that we did not “find sufficient evidentiary support for a determination that the navigation of RCSB PDB crystal structures to achieve the missing limitation would have been ‘evidently and indisputably within the common knowledge of those skilled in the art.’” Id. at 38.” slip op. at 7
§ 103 obviousnessPatents in suitUS 11,767,366 - PTAB · Sep 27, 2024 · IPR2024-00649 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR of claims 1–28 on all six asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–28 of the ’187 patent are unpatentable.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Anticipation is a question of fact, as is the question of what a prior art reference teaches. In re NTP, Inc., 654 F.3d 1279, 1297 (Fed. Cir. 2011). “Because the hallmark of anticipation is prior invention, the prior art reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates a claim is assessed from the skilled artisan’s perspective. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“The obviousness inquiry also typically requires an analysis of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). A petitioner cannot prove obviousness with “mere conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir. 2016). Rather, a petitioner must articulate a sufficient reason why a person of ordinary skill in the art would have combined the prior art references. In re NuVasive, Inc., 842 F.3d 1376, 1382 (Fed. Cir. 2016).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner argues that we need not construe any terms of the challenged claims to resolve the issues presented in the Petition. Pet. 11. We determine that no express construction of any claim term is necessary to determine whether to institute inter partes review. Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). To the extent further discussion of the meaning any claim term is necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,629,187 - PTAB · Sep 27, 2024 · IPR2024-00647 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted IPR on claims 1–36 because the Petition showed a reasonable likelihood of prevailing on at least one challenged claim across the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving the unpatentability of at least one of claims 1–36 of the ’287 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“summarized above, we are persuaded by Petitioner that the MSI-H Study Record teaches treating colorectal cancer patients after they were determined to be microsatellite instability high or DNA mismatch repair deficient with pembrolizumab. See MSI-H Study Record, Ex, 1005, 4 (Arms and Interventions); see also id., 2 (Study Identification), 3 (Study Description), 4–5 (Outcome Measures), 5–6 (Eligibility); Ex. 1003, ¶¶ 58–62. We are also persuaded that Petitioner has sufficiently shown that there is a reasonable likelihood of a causal relationship in the MSI-H Study Record between treatment of colorectal cancer patients and the determination of their MSI status — all colorectal cancer patients determined to be microsatellite instability high or DNA mismatch repair deficient were treated with pembrolizumab. Whether or not other patients were treated or enrolled in the study does not detract from this teaching.3 Accordingly, we are persuaded by Petitioner that, on this record, the MSI-H Study Record discloses each element of claim 1. In view of the above, we determine that Petitioner has sufficiently shown a reasonable likelihood of establishing that the MSI-H Study Record anticipates claim 1. Patent Owner at this stage does not offer any arguments addressing Petitioner’s substantive showing.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“not disclose the limitation of “in response to determining that the colorectal cancer is microsatellite instability high or DNA mismatch repair deficient, treating a human patient having colorectal cancer that is microsatellite instability high or DNA mismatch repair deficient with a therapeutically effective amount of pembrolizumab,” the record before us supports this limitation being rendered obvious by Pernot and the MSI-H Study Record. Specifically, because Pernot teaches that colorectal cancer patients are good candidates for immunotherapy, the evidence of the current record shows that one of ordinary skill in the art would have had a reason to use to PD-1 inhibitors to treat colorectal cancers. Ex. 1006, 3741; Ex. 1003 ¶ 136. Additionally, the focus in the MSI-H Study Record on a clinical study treating colorectal cancer patients who had been determined to be MSI-H with pembrolizumab indicates that it would have been obvious to test for this condition before treatment. The additional references discussed by Petitioner contribute further to a reasonable likelihood that Petitioner will prevail. For example, Libson reports the successful treatment of a colorectal cancer patient having MSI-H status with a PD-1 inhibitor (Ex. 1057, 463-64) and Champiat discusses evaluating the clinical activity of PD-1 agents in DNA mismatch repair, such as MSI+, colorectal cancer (Ex. 1032, e27817-5). Pet. 44 (citing Ex. 1003 ¶ 49). Thus, based on the current record, we determine that Petitioner presents a reasonable likelihood that the method of claim 1 would have been considered obvious by one of ordinary skill in the art. Accordingly, in view of the above, we are persuaded that there is a reasonable likelihood that Petitioner will prevail with respect to at least one claim challenged under Ground 2 in the Petition.” slip op. at 21
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that a person of ordinary skill in the art (“POSA” or “POSITA”) at the time of the invention would be a medical doctor or a professional in a related field with at least five years of experience with treating cancer. . . . The POSA would also have experience in or access to a person with knowledge of clinical studies for therapeutics and how they work and a pathologist with comparable experience. . . . The inherent anticipation and obviousness grounds discussed herein would not change due to a modestly lesser or greater level of experience. Pet. 11–12 (citing Ex. 1003 ¶ 19). For this Decision, we adopt and apply Petitioner’s proposal above, which does not appear to be inconsistent with the level of skill reflected in the asserted prior art.” slip op. at 7
§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,649,287 - PTAB · Sep 23, 2024 · IPR2024-00623 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR of claims 1–7 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the information presented by the parties, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one of claims 1–7 of the ’974 patent is unpatentable, and we institute inter partes review of all challenged claims on all asserted grounds. Id.” slip op. at 2
- BurdenInstituted
“reference—in order to anticipate under 35 U.S.C. § 102—must not only disclose all elements of the claim within the four corners of the document, but must also disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Whether a reference anticipates a claim is assessed from the skilled artisan’s perspective. See Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive question regarding anticipation [i]s whether one skilled in the art would reasonably understand or infer from the [prior art reference’s] teaching that every claim element was disclosed in that single reference.” (quoting In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991))).” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“2. The Parties’ Contentions The parties agree that the MSI-H Study Record was publicly available by June 12, 2013. (See Pet. 7; see Prelim. Resp. 19 (“JHU submitted the MSI-H Study Record on June 10, 2013, and it was posted on clinicaltrials.gov on approximately June 12, 2013”). In its Preliminary Response, Patent Owner does not dispute Petitioner’s argument (see Pet. 8) that the MSI-H Study Record is prior art under 35 U.S.C. § 102(a) and is not covered by an exception under 35 U.S.C. § 102(b). See Prelim. Resp.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInstituted
“22. Our research group eventually approached Merck. Merck agreed in early 2013 to supply its then-unapproved anti-PD-1 antibody, MK-3475 (pembrolizumab) for use in the study. It was, however, the research team at Hopkins who secured IRB approval, conducted, and paid for the study. On June 12, 2013, the solicitation for patients was first posted on clinicaltrials.gov (Exhibit D). In my mind, the four arms allowed us to try to get at an answer to a question to which we did not know the answer-specifically whether or not patients with MSI-high or MMR deficient tumors would exhibit an improved response when treated with MK-3475, compared with the more common MSS [microsatellite stable] or MMR proficient colon cancers. Thus, the trial covered all patients with colon cancer, MSI and MSS, but separated into two groups. 23. The preliminary results of this study demonstrated clinical responses at an unexpectedly high rate (>50% objective response rate) in the MSI-high (MMR deficient) arm but not in the MSS (MMR proficient) arm. (Ex. 1002, 270–271.) This affidavit, submitted during prosecution of the ’974 patent, supports the argument that an improved outcome of treating a patient with a tumor exhibiting an MSI-high or a MMR deficiency status with pembrolizumab compared to similarly treating a patient without an MSI-high or a MMR deficiency status, a recited in claim 1, is an inherent result. Patent Owner does not dispute this result in the Preliminary Response. See Prelim. Resp. 7 (“The ’974 Patent reports that mismatch repair-deficient colorectal cancers (i.e., MSI-H CRC) had an immune-related objective response rate and immune-related progression-free survival rate of 40% and 78%, respectively—a huge improvement compared to the 0% and 11% rates found in mismatch repair-proficient colorectal cancers (i.e., MSI negative CRC).”).” slip op. at 17
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 11,325,974
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.