DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on 10/12/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The application is a 371 application, filed 10/12/2023, of PCT application PCT/EP2022/060287, filed 04/19/2022, which claims priority benefits from Foreign Application No. IT10/2021000009926, filed 04/20/2021. The effective filing date of this application is 04/20/2021, the filing date of the foreign application.
Claims Status
The amendment filed 10/12/2023 has been entered. Claims 12-26 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/12/2023 and 10/29/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 depends on claim 14, which recites a method of treating a disease or condition susceptible to being improved or prevented by treatment with anti-CTLA4, anti-PD1, and/or anti-PD-L1 antibodies by administering a combination comprising of N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide and at least one CTLA4 checkpoint inhibitor. Claim 16 further recites the method as comprising “immunotherapy of tumors and/or treatment of one or more HDAC6-mediated diseases.” It is unclear whether this immunotherapy is referring to an effect of the method already disclosed in claim 14 (i.e. the method acts as an immunotherapy) or if this limitation is adding a further immunotherapy component not already distinctly claimed in the claim 14.
Claim 17 depends on claim 16. Claim 17 is further indefinite for reciting “wherein the subject is not treated with anti-CTLA4, anti-PD1 and or anti-PDL1 antibodies”, as it is unclear, as written, whether this means the subject has never been treated with these antibodies, is not currently being treated but has been treated with these antibodies, or will not be treated with these antibodies in this method.
Claims 17-19 depend on claims 16 and/or claim 17, and therefore inherit the indefiniteness of their parent claim(s). They fail to resolve the indefiniteness and therefore are also indefinite for the reasons disclosed for their parent claim.
Claim Interpretation
Claim 17 is being interpreted to the method according to claim 16, wherein the subject has not previously been treated with anti CTLA4, anti PD1 and/or anti PDL1 antibodies.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over WO ‘340 (WO2018189340A1; published 10/18/2018).
Regarding claim 12, WO ‘340 teaches a combination comprising N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide (instantly referred to as Compound 8) and a PD-1 checkpoint inhibitor (e.g. Figures 2-5).
WO ‘340 does not explicitly teach N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide with a CTLA4 checkpoint inhibitor.
However, WO ‘340 further teaches each HDAC6 inhibitor compound disclosed, which includes N-hydroxy-4-((5-(thiophen-2-yl)-1H-tetrazol-1-yl)methyl)benzamide, may be used in combination with other drugs, such as CTLA4 checkpoint inhibitors. See p. 41, starting at line 3, as well as claim 5 on p. 172.
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to substitute the PD-1 checkpoint inhibitor with a CTLA4 checkpoint inhibitor in light of WO ‘340 teaching this as a potential substitution and that PD-1/PD-L1 and CTLA4 are the two most common checkpoint inhibition pathways targeted by immunotherapies. Therefore, one checkpoint inhibitor would be the most obvious substitute for another.
One skilled in the art, before the effective filing date of the instant application, would be motivated to substitute the PD-1 checkpoint inhibitor with a CTLA4 checkpoint inhibitor in the combination with N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide to potentially target both commonly targeted checkpoint inhibition pathways (i.e. PD-1/PD-L1 and CTLA4) since WO ‘340 further teaches that HDAC6 inhibition could reduce PD-L1 expression (page 140), and in effect, inhibit the PD-1/PD-L1 pathway. Inhibiting both the PD-1/PD-L1 and CTLA4 pathways through combination therapy is a known endeavor to one skilled in the art, before the effective filing date of the instant application.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success combining these elements since N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide has already been shown to work synergistically in combination with another checkpoint inhibitor, and CTLA4 checkpoint inhibitors are well-known and well-utilized as a monotherapy and in combination therapies.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that a simple substitution of one known element for another to obtain predictable results, when swapping similar features that serve the same purpose, is obvious. The prior art contains a base combination which differs from the claimed combination by the substitution of a checkpoint inhibitor targeting PD-1 for another checkpoint inhibitor targeting CTLA4. The substituted components and their functions were known in the art. One of ordinary skill in the art, before the effective filing date, could have substituted one known element for another, and the results of the substitution would have been predictable since both checkpoint inhibitors have similar end functions, albeit through different pathways.
Claims 13-20 depend on claim 12. The teachings of the references regarding parent claims are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
Regarding claim 13, WO ‘340 further teaches the anti-CTLA4 could specifically be ipilimumab or tremelimumab (page 41).
Regarding claim 14, WO ‘340 further teaches a method of treating three tumor cell lines that are sensitive to an anti-PD-1 antibody, thereby meeting the limitation of susceptible to being improved or prevented by treatment with anti CTLA4, anti PD1 and/or anti PD-L1 antibodies in a subject in need thereof, with the combination therapy in murine models (Example 27, pages 140-141).
Regarding claim 16, WO ‘340 further teaches that diseases associated with HDAC6 include cancer (page 1, paragraph 1) and teach the link between HDAC6 inhibition and PD-1/PD-L1 checkpoint inhibition previously described. As such, the PD-1 sensitive tumors taught by WO ‘340 in regards to the method in claim 14 is a model of a HDAC6-mediated disease. Therefore, the method described previously for claim 14 targeting tumors sensitive to PD-1 checkpoint inhibition inherently encompass using immunotherapies in the treatment of HDAC6-mediated disease, meeting all the limitations of claim 16.
Regarding claim 17, WO ‘340 further teaches administration of the combination to treatment-naïve BALB/c mice (Example 27; page 142 for tumor induction and treatment schedule).
Regarding claim 15, WO ‘340 does not explicitly teach the subject has been previously treated with anti CTLA4, anti PD1 and/or anti PDL1 antibodies and has discontinued this treatment, but it also does not exclude these patients.
The method of WO ‘340 would reasonably inherently include this population of subjects barring teachings otherwise. WO ‘340 further teaches that administering N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide by itself, desirably, shows greater neoantigen immune response compared to the checkpoint inhibitor antibody (Example 27, page 143) and that there are beneficial, possibly synergistic, effects from the combination of HDAC6 inhibiting compounds and the checkpoint inhibitor antibody (e.g. Figures 3-5).
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, that even if a subject had discontinued treatment with anti CTLA4, anti PD1 and/or anti PDL1 antibodies, if because of insufficient treatment effects (and not some adverse reaction to the antibody), it would not preclude a subject from subsequent treatment with the combination therapy, as the N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide, even by itself, has some better effects than a checkpoint inhibitor antibody.
One skilled in the art, before the effective filing date of the instant application, would be motivated to apply this combination therapy to those that were previously treatment-refractive because the combination therapy could provide benefits over the checkpoint inhibitor antibody monotherapy.
One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success since the combination therapy of HDAC6 inhibiting compounds and checkpoint inhibitor antibody has shown benefits over checkpoint inhibitor antibody monotherapy in the tumor models taught by WO ‘ 340. Although Figure 3 shows that checkpoint inhibitor antibody monotherapy and combination therapy with compound 8 have only comparable effects on tumor volume reduction, it would still be reasonably motivated to apply the combination therapy to subjects that did not respond sufficiently to checkpoint inhibitor antibody monotherapy since compound 8 by itself seems to work independently of checkpoint inhibitor antibodies. In other words, even if the subject does not respond sufficiently to anti CTLA4, anti PD1 and/or anti PDL1 antibodies, compound 8 in the combination therapy would still reasonably have treatment effects.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. The scope of the prior art included an analogous method to the instant method, comprising of administering the combination therapy to treatment-naïve subjects, but does not explicitly exclude nor provides data that would prompt exclusion of anti CTLA4, anti PD1 and/or anti PDL1 antibodies treatment-refractory subjects. As treatment design incentives or market forces to treat this subject population would prompt adaptation of combination therapy options that showed promising effects at least as good as the anti CTLA4, anti PD1 and/or anti PDL1 antibodies. The differences between the subjects in the claimed invention and the prior art were already inherently encompassed by reasonable variations of the method taught in the art, although not explicitly stated. One skilled in the art, before the effective filing date of the instant application, in view of the motivation to treat the claimed subject population, could have implemented the claimed variation of the prior art, and the claimed variation would have been reasonably predictable to one skilled in the art, before the effective filing date of the instant application, because of the promising effects of compound 8 both as a monotherapy and in combination therapy.
Regarding claim 18-19, WO ‘340 further teaches the treatment of tumor models for breast cancer, specifically in treatment-naïve mice (Example 27).
Regarding claim 20, WO ‘340 further teaches the components of the combination are administered simultaneously, separately, or sequentially (Example 27).
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over WO ‘340 (WO2018189340A1; published 10/18/2018) as applied to claims 12-20 above, and further in view of Ott et al (Ott, P., et al, A phase I study to evaluate the safety and tolerability of MEDI4736, an anti- programmed cell death-ligand-1 (PD-L1) antibody, in combination with tremelimumab in patients with advanced solid tumors, Meeting Abstract: 2015 ASCO Annual Meeting I, J Clin Oncol 33, TPS3099(2015), published 05/20/2015), as evidenced by NCT01975831 (record submitted 05/11/2015).
Claims 21-26 depend on claim 12 and 20. The teachings of the references regarding the parent claims are incorporated in its entirety for the dependent claims and discussed further below, as is relevant for each claim.
As is relevant to claims 21-26, WO ‘340 teaches that N-hydroxy-4-((5-(thiophen-2-yl)-1H-tetrazol-1-yl)methyl)benzamide is administered daily and orally (Example 27).
WO ‘340 does not explicitly teach the checkpoint inhibitor antibody administration dose and schedule as claimed. WO ‘340 does not explicitly teach that N-hydroxy-4-((5-(thiophen-2-yl)-1H-tetrazol-1-yl)methyl)benzamide is administered two to three times a day. WO ‘340 does not explicitly teach that N-hydroxy-4-((5-(thiophen-2-yl)-1H-tetrazol-1-yl)methyl)benzamide is administered in an amount ranging from 200 mg to 1000 mg BID or from 100 mg to 1000 mg TID.
However, WO ‘340 does teach administration of N-hydroxy-4-((5-(thiophen-2-yl)-1H-tetrazol-1-yl)methyl)benzamide (compound 8) at 5.2 mg/kg orally showed good oral bioavailability (Example 22 and Table 7). WO ‘340 further teaches that, although compound 8 seems to be fairly stable in human samples, it is not 100% stable in human plasma after 4 hours (Example 20 and Table 5). WO ‘340 further teaches the maximum tolerated dose for compound 8 in their murine models was 50 mg/kg once a day (Example 23). WO ‘340 further teaches N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide/compound 8 is administered orally (e.g. Examples 22 and 27).
Further, Ott et al teaches a clinical trial (NCT01975831) for treating solid tumors by administering a combination therapy of an anti-PD-L1 mAb and an anti-CTLA4 mAb, specifically tremelimumab. Ott teaches tremelimumab is administered at 3 mg/kg every 4 weeks, and the clinical trial records for NCT01975831 before the publication date of Ott et al shows that tremelimumab was administered by intravenous infusion, meeting all the limitations of CTLA4 checkpoint inhibitor antibody administration dose and schedule as claimed in claims 21-26.
It would have been obvious to one skilled in the art, before the effective filing date of the instant application, to administer the anti-CTLA4 antibody at a dose and schedule that has already been taught in a clinical trial study design, particularly when used in combination with another PD-1/PD-L1 inhibiting compound, as is taught by Ott et al as evidenced by NCT01975831. It would have been obvious to one skilled in the art, before the effective filing date of the instant application, considering the teachings of WO ‘340 regarding the dosing, stability, bioavailability, and maximum tolerated dose of compound 8 to arrive at the dosing limitations claimed for N-hydroxy-4-((5-(thiophen-2-yl)-1H-tetrazol-1-yl)methyl)benzamide. First, since compound 8 does show some reduced stability after 4 hours in in vitro human plasma (Example 20, Table 5), but also shows low toxicity (Example 18), administering compound 8 more than once a day, but tempered by maximum dose and subject’s convenience, would be a reasonably obvious and motivated improvement to maintain active compound 8 throughout the day.
Regarding claim 25, the claimed amount of compound 8 to administer (200-1000 mg BID or 100-1000 mg TID) is taught in the instant specification as being based on projections of human pharmacokinetics based on bioavailability, clearance, and distribution of compound 8 and human conditions, as well as the dosing regimen (page 13). The specification teaches how these human doses for ITF3756 (i.e. compound 8 in WO ‘340) were predicted using the pharmacokinetics from mice (page 11-12). As such, these dose amounts are clearly a result-effective variable that one skilled in the art would be able to calculate or estimate based on the pharmacokinetics of mice taught by WO ‘340. The dose and maximum tolerated dose would also drive the decision for number of doses to administer in a day.
One skilled in the art, before the effective filing date of the instant application, would be motivated to use reasonably predictable dosing strategies for compound 8 based on pharmacokinetic results in mice to guide the human administration. One skilled in the art, before the effective filing date of the instant application, would be motivated to use, and would have reasonable expectation of success with, known dosing strategies for an anti-CTLA4 antibody, especially in a combination therapy with analogous pathway targets and disease model. One skilled in the art, before the effective filing date of the instant application, would have reasonable expectation of success with determining compound 8’s dosing because the use of drug pharmacokinetics in mice to inform human dosing is a necessary, common, and obvious method to arrive at initial dosing strategies for humans.
KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, (2007), discloses that choosing from a finite number of identified, predictable solution, with a reasonable expectation of success, is obvious. At the time of the invention, the recognized problem with determining dosing strategies for immunotherapy candidates in different combinations and disease conditions often leads one skilled in the art to identify known dosing strategies in humans for these candidates and choose from them, or use data from pertinent mice models to predict human dosing conditions, if previous human dosing conditions are unknown, knowing that one skilled in the art would be able to discern variability requirements depending on a number of factors pertinent to the specific treatment goals. These known and predicted dosing strategies are often the solutions with the most reasonable expectation of success.
Double Patenting
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). The applicant should amend or cancel claims such that the reference and the instant application no longer contain claims directed to the same invention.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Patent No. US11351178B2
Claims 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. US11351178B2 in view of WO ‘340 (WO2018189340A1; published 10/18/2018).
Claims 1-14 of Patent ‘178 are directed towards a combination comprising of a compound, selected from a list consisting of N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide, and a drug, selected from a list consisting of a CTLA4 inhibitor, and a method of using that combination in treating cancer.
Claims 1-14 of Patent ‘178 does not explicitly teach the motivation to specifically select the claimed compound and a CTLA4 inhibitor. Accordingly, claims 1-14 of Patent ‘178 does not explicitly teach the method of using that exact combination and all the specific further limitations of the method instantly claimed in claims 13-20.
However, WO ‘340 does teach all the method limitations for claims 12-20 starting from an analogous combination comprising of N-hydroxy-4-((5-(thiophen-2-yl)-1 H-tetrazol-1-yl)methyl)benzamide and a PD-1 checkpoint inhibitor antibody. The rationale for why it would be obvious, motivated, and reasonably successful to arrive at the particular claimed combination and method from the similar combination claimed in WO ‘340, as discussed previously in the 35 U.S.C. 103 rejection, is the same for starting from the similar combinations for Patent ‘178, and is incorporated in its entirety here.
Claims 21-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. US11351178B2 in view of WO ‘340 (WO2018189340A1; published 10/18/2018) as applied to claims 12-20 above, and further in view of Ott et al (Ott, P., et al, A phase I study to evaluate the safety and tolerability of MEDI4736, an anti- programmed cell death-ligand-1 (PD-L1) antibody, in combination with tremelimumab in patients with advanced solid tumors, Meeting Abstract: 2015 ASCO Annual Meeting I, J Clin Oncol 33, TPS3099(2015), published 05/20/2015), as evidenced by NCT01975831 (record submitted 05/11/2015).
The teachings of claims 1-14 of Patent ‘178 and WO ‘340 regarding instant claims 12-20 are incorporated in its entirety for the instant dependent claims.
Claims 1-14 of Patent ‘178 and WO ‘340 does not explicitly teach the administration dose and schedule for the checkpoint inhibitor antibody and N-hydroxy-4-((5-(thiophen-2-yl)-1H-tetrazol-1-yl)methyl)benzamide as instantly claimed, as discussed previously in the 35 U.S.C. 103 rejection. However, the combination arrived at from Claims 1-14 of Patent ‘178 in view of WO ‘340 is the same as that instantly claimed. The further teachings of WO ‘340 and Ott et al regarding instant claims 21-26 and the rationale for why it would be obvious, motivated, and reasonably successful to arrive at the claimed limitations of the method of using this combination from these teachings, as discussed previously in the 35 U.S.C. 103 rejection, is therefore relevant and incorporated here in its entirety.
Conclusion
No claims are allowed.
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/B.C./Examiner, Art Unit 1645 March 5, 2026
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645