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 .
Claim Status – Response to Restriction/ Election Requirement
Claims 1-60 are currently pending.
Claims 1-3, 12, 21-33 and 47-55 read on the elected invention and are currently active and subject to examination. Claims 4-11, 13-20, 34-46 and 56-60 are withdrawn.
Claim Objections
Claims 1-3, 12, 21-33 and 47-55 objected to because of the following informalities: the structures in the claims do not contain sufficiently clear and dark lines for legibility. Appropriate correction is required.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claims 1-3, 12, 21-33, 47-53 and 55 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
The rejection of claim(s) 1-2, 21-23, 31-33, and 47 under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al. (Supporting information, ACS Infectious Diseases, Vol. 5, No. 3, 326-335, Jan. 35, 2019) (of record, IDS July 24, 2024) is withdrawn.
The rejection of claim(s) 1-3, 21-23, 31-33, 47, 49 under 35 U.S.C. 102(a)(1) as being anticipated by Marino et al. (WO2009097474A1) (of record, IDS Sept. 11, 2023, cite no. 3) is withdrawn.
The above rejections were overcome by Applicant’s amendments to the claims.
Claim Rejections – 35 USC § 103 – Previously Presented
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.
The rejection of claim(s) 1-3, 12, 21-25, 31-33, 47-53 and 55 under 35 U.S.C. 103 as being unpatentable over Daugan et al. (US20190345138A1) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020) (of record, cite no. 12, IDS Mar. 12, 2026) is maintained.
The rejection of claim(s) 1-3, 12, 21-33, 47-53 and 55 under 35 U.S.C. 103 as being unpatentable over Daugan et al. (US20190345138A1) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020), as applied to claim(s) 1-3, 12, 21-25, 31-33, 47-53 and 55 above, and further in view of Wipf (Bioisosterism, p. 43-64, Feb. 14, 2008) is maintained.
Response to Arguments
Applicant's arguments filed July 14, 2026 have been fully considered but they are not persuasive.
Applicant argues that Daugan provides no reason to select Examples 4, 121, 140 or 148 as starting points, and the selection is hindsight (p. 34-35). This argument was fully considered but is not persuasive. Daugan expressly reports inhibitory data for the cited compounds and these compounds have typical inhibitory activity for compounds within this class—pIC50 between 6.0 and 9.0 (Id., p. 122, paragraph [0861]), which is an IC50 value between 1 nM and 1 µM. Compounds 4, 140 and 148 have excellent inhibitory activity for compounds of the class— pIC50 between 8.0 and 9.0 (Id., p. 122, paragraphs [0863], [0868]), which is an IC50 value between 1 and 10 nM. Compounds shown by the reference as among its more potent are precisely the compounds a person of ordinary skill in the art would select for further development. See MPEP § 2143 (“The Federal Circuit in Eisai makes it clear that from the perspective of the law of obviousness, any known compound might possibly serve as a lead compound: “Obviousness based on structural similarity thus can be proved by identification of some motivation that would have led one of ordinary skill in the art to select and then modify a known compound (i.e. a lead compound) in a particular way to achieve the claimed compound.” Eisai, 533 F.3d at 1357, 87 USPQ2d at 1455.”).
Applicant’s reliance on Example 78 as the compound tested in vivo does not establish nonobviousness. The prior art does not need to point to a single lead compound. See Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 91 USPQ2d 1018 (Fed. Cir. 2009) (rejecting Altana’s argument that the prior art must point only to a single lead compound). Moreover, example 78 was relied upon in the rejection of claim 49 and bears the 3,5-difluorophenyl group of Applicant’s elected compound 4. Applicant’s identification of Example 78 as the compound Daugan advances furthest therefore reinforces, rather than recuts, the obviousness of the claimed subject matter.
That Daugan discloses a large number of compounds does not diminish the teaching of any one of them. A reference is available for all that it teaches, including non-preferred embodiments (See MPEP § 2123).
Finally, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The rejection relies solely on the potency data in Daugan and the scaffold relationships set out in Harris.
Applicant argues that there is no motivation to combine Duagan with Harries because Harries is a review article reporting compounds from different programs and does not teach ring-opening (Remarks, p. 35-37). These arguments were fully considered but are not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Harris is relied upon as evidence of what was commonly known in the art: that the dihydropyrazole and the open chain benzylamide are interchangeable at the same position of the RIP1 pharmacophore, providing a person of ordinary skill in the art a reason to modify the dihydropyrazole of Daugan with an open chain benzylamide to produce a RIP1 inhibitor with a reasonable expectation of success.
Harris Figures 11 and 12 present the dihydropyrazoles (compounds 20-22) and the benzylamides (compounds 24-25) as members of the same RIPK1 inhibitor series. Harris compound 25 is an open-chain benzyl hydroxamide bearing the same piperdin-4-ylcarbonyl group attached at the piperdine nitrogen to a 5-fluoropyrimidin-2-yl ring, like the instant claims as well as compound 22 (GSK’547). Harris explicitly identifies alkylbenzylamides as open chain analogues of the dihydropyrazoles (even naming compounds 22 and 25 as analogues):
The tert-butyl substitution at the ketone GSK’963 was mostly replaced by tert-amyl, but other small alkyl substitutions were also explored. Of the variations examined, the azetidin-2-one 23 (Figure 12), was the most potent in both a RIP1 kinase ADP-Glo assay (IC50 = 20 nM) and inhibiting necrosis in HT-29 cells (IC50 = 7 nM). The group also patented a series of alkylbenzylamides, such as 24, which can be viewed as open-chain analogs of this template [58]. Ina subsequent publication, the group further profiled 24, showing good potency in a RIP1 ADP-Glo assay (IC50 13 nM), and demonstrating activity in the TNF-α SIRS mouse model, showing a 100% survival rate following a 6 mg/kg dose, via intraperitoneal injection, compared to 50% survival for the vehicle-treated group [59]. A recent patent publication from Sironax further extended this benzylamide series to include N-pyrimidine piperidine analogs similar to GSK’547, as represented by 25 [60]. This application also included pro-drugs,made by the attaching cleavable groups to the amide nitrogen of 24, which are better absorbed or more metabolically stable than parent. On dosing these prodrugs are then hydrolyzed, typically in the gut or blood, to liberate 24 thus extending the exposure profile of 24 in vivo.
Harris, p. 144.
A person of ordinary skill in the art reading Harries would therefore have understood not merely that open-chain benzylamides exist, but that the benzylamide replaces the dihydropyrazole while retaining biological activity.
Applicant’s argument that Harris also discloses closed-ring azetidinone and isoxazolidine alternatives is also unpersuasive because a disclosure of alternatives does not teach away from any one of them (See MPEP § 2123.II).
Applicant argues that the structure activity relationships are scaffold dependent and that the Daugan compounds are structurally distinct from Harris compounds 20 and 24 (Remarks, p. 36). This argument is not persuasive. The assertion that SAR is scaffold dependent such that the substitution would not have been expected to succeed is an unsupported attorney argument not supported by evidence. No declaration, comparative data, or literature evidence has been provided (See MPEP § 2145.I).
Furthermore, the premise of the argument is incorrect. Applicant characterizes Harris compound 20 and 24 as the only compounds that the rejection relies upon, but the rejection is not confined to these two compounds. Compounds 22 and 25 of Harris are also presented, bearing a relevant heterocyclic structure to the instant invention. The scaffolds are therefore not structurally distinct in the respect Applicant identifies.
Applicant argues that Wipf does not cure the deficiencies of Daugan and Harris (Remarks, p. 37). This argument is not persuasive for the reasons given above. Wipf does not need to cure any deficiency in the combination because no deficiency in the combination of Daugan and Harris has been established.
Reiterated Rejection
Claim(s) 1-3, 12, 21-25, 31-33, 47-53 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daugan et al. (US20190345138A1) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020) (of record, cite no. 12, IDS Mar. 12, 2026).
Claim 1 is directed towards a compound of formula I:
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Daugan teaches similar RIP1 kinase inhibitors largely similar to the compound of formula I. For example:
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Daugan, Specification, p. 47, ex. 4;
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Id., p. 89, ex. 121;
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Id., p. 101, ex. 140;
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Id., p. 106, ex. 148.
These compounds have typical inhibitory activity for compounds within this class—pIC50 between 6.0 and 9.0 (Id., p. 122, paragraph [0861]), which is an IC50 value between 1 nM and 1 µM.
Compounds 4, 140 and 148 have excellent inhibitory activity for compounds of the class— pIC50 between 8.0 and 9.0 (Id., p. 122, paragraphs [0863], [0868]), which is an IC50 value between 1 and 10 nM.
These compounds differ from formula I in that there is a dihydropyrazole instead of an open chain benzylamide. One of ordinary skill in the art would have a reasonable expectation of success to substitute an open chain benzylamide for dihydropyrazole and arrive at the compound of formula I because it is commonly known in the art that benzylamide is a bioisostere of dihydropyrazole in the binding pocket of the RIP1 receptor.
For example, Harris shows that the dihydropyrazole structure has been modified to give open chain analogs (e.g. compound 20 vs. compound 24):
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Harris, Fig. 11, p. 144;
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Harris, Fig. 12, p. 145.
Therefore, claim 1 was prima facie obvious at the time of filing.
Claims 2-3, 12, 21-25, 31-33, 47-48, 50, 51 and 53 read on the compounds 121, 140 and 148 as described in claim 1 above and are prima facie obvious for the reasons given in the rejection of claim 1.
Claim 49 is directed towards the compound of claim 1, wherein R1 is independently selected from F, Cl, cyano, CF3 CF2H and CH3.
One of ordinary skill in the art would have a reasonable expectation of success to develop a RIP1 inhibitor wherein R1 is independently selected from F, Cl, cyano, CF3 CF2H and CH3 because these substituents are commonly known in the art for RIP1 inhibitors.
For example, Daugan teaches similar RIP1 inhibitors wherein R1 is F:
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Id., p. 70, ex. 78.
Therefore, claim 49 was prima facie obvious at the time of filing.
Claim 52 is directed towards the compound of claim 1, wherein R4 is independently selected from F and CH3.
One of ordinary skill in the art would have a reasonable expectation of success to develop a RIP1 inhibitor wherein R4 is independently selected from F, Cl, cyano, CF3 CF2H and CH3 because these substituents are commonly known in the art for RIP1 inhibitors.
For example, Harris teaches similar RIP1 inhibitors wherein R4 is F (compound 27, Fig. 12, p. 125).
Therefore, claim 52 was prima facie obvious at the time of filing.
Claim 55 is directed towards a pharmaceutical composition comprising a compound according to claim 1 and at least one pharmaceutically acceptable carrier. Daugan teaches pharmaceutical compositions comprising the RIP1 inhibitor and a pharmaceutically acceptable carrier (Daugan, Specification, paragraph [0649]). Therefore, claim 55 was prima facie obvious at the time of filing.
Claim(s) 1-3, 12, 21-33, 47-53 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daugan et al. (US20190345138A1) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020), as applied to claim(s) 1-3, 12, 21-25, 31-33, 47-53 and 55 above, and further in view of Wipf (Bioisosterism, p. 43-64, Feb. 14, 2008).
The rejection of claims 1-3, 12, 21-25, 31-33, 47-53 and 55 above as obvious over Daugan in view of Harris is incorporated herein by reference.
Claims 26-30 are directed towards the compound of claim 1, wherein Ar3 is triazole. As shown in the rejection of claim 1 above, Daugan teaches a compound of claim 1 wherein Ar3 is tetrazole. While Daugan does not specifically teach a compound wherein Ar3 is triazole, one of ordinary skill in the art would have a reasonable expectation of success to substitute triazole for tetrazole because N is a known ring equivalent for CH.
For example, see the teachings of Wipf:
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Wipf, p. 45.
Therefore, claims 26-30 were prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Nonstatutory Double Patenting – Previously Presented
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.
The rejection of claims 1, 21-33, 47-51, 53 and 55 on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent no. 12,655,125 (previously copending Application No. 17/998,552) (herein the ‘552 application) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020) (of record, cite no. 12, IDS Mar. 12, 2026) is maintained.
The rejection of claims 1-3, 12, 21-33 and 47-55 on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,454,529 (herein “the ‘529 patent”) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020) (of record, cite no. 12, IDS Mar. 12, 2026) is maintained.
The provisional rejection of claims 1, 21-33, 47-51, 53 and 55 on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 18/561,308 (herein the ‘308 application) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020) (of record, cite no. 12, IDS Mar. 12, 2026) is maintained.
Response to Arguments
Applicant’s notice that the ‘552 patent has issue as U.S. Patent no. 12,655,125 is acknowledged. The rejection is no longer provisional and is restated above over claims 1-21 of the ‘125 patent.
Applicant’s argument that no reason is given for selecting compound 1 from among 281 compounds disclosed in the ‘125 patent is not persuasive (Remarks, p. 38. In a nonstatutory double patenting analysis the comparison is between the claims of the reference patent and the claims under examination. Compound 1 is recited in claim 20 and identifies the compound and no lead-compound selection inquiry is implicated (See UCB, Inc. v. Accord Healthcare, Inc., 890 F.3d 1313, 1323 (Fed. Cir. 2018) “In chemical cases, the double patenting inquiry is not whether a person of ordinary skill in the art would select the earlier compound as a lead compound, but rather whether the later compound would have been an obvious or anticipated modification of the earlier compound.”
Applicant’s remaining arguments regarding Harris are addressed in the response to arguments under 35 U.S.C. § 103 above and are not persuasive here for the same reasons.
Applicant’s further argument that all 319 compounds disclosed in the ‘529 patent have X3 as N, such that a person of ordinary skill in the art would keep X3 as N, is not persuasive (Remarks, p. 39). The ‘529 patent nowhere states that a nitrogen at X3 is critical, nor does it discredit, criticize or otherwise discourage a carbon at that position. Silence as to an alternative is not a teaching away (See UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) (“a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.”)). To the contrary, piperidine is a predominant motif among the RIP1 inhibitors of record. Harris compounds 21, 22, 25 and 27 all employ a piperidine carbocyclic linkage at this position. One of ordinary skill in the art would accordingly have had a reasonable expectation of success in substituting C for N at X3 because piperidine linkages are commonly known in the art for RIP1 inhibitors.
Applicant requests that the provisional rejection be held in abeyance until the claims are otherwise found allowable (Remarks, p. 40). The request is not granted. Because the claims stand rejected on additional groups, the provisional rejection is not the sole ground of rejection and is maintained.
Reiterated rejection
Claims 1, 21-33, 47-51, 53 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent no. 12,655,125 (previously copending Application No. 17/998,552) (herein the ‘552 application) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020) (of record, cite no. 12, IDS Mar. 12, 2026).
Claim 1 is directed towards a compound of formula I:
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The ‘552 application claims compounds largely similar to the compounds of formula I. For example:
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(‘552 application, claim 20).
These compounds differ from formula I in that there is a dihydropyrazole instead of an open chain benzylamide. One of ordinary skill in the art would have a reasonable expectation of success to substitute an open chain benzylamide for dihydropyrazole and arrive at the compound of formula I because it is commonly known in the art that benzylamide is a bioisostere of dihydropyrazole in the binding pocket of the RIP1 receptor.
For example, Harris shows that the dihydropyrazole structure has been modified to give open chain analogs:
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Harris, Fig. 11, p. 144;
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Harris, Fig. 12, p. 145.
Therefore, claim 1 is provisionally rejected on the ground of nonstatutory double patenting.
Claims 21-33, 47-51, and 53 read on the above compound 1 and are provisionally rejected on the same grounds as claim 1.
Claim 55 is directed towards a pharmaceutical composition comprising the compound as is claim 21 of the ‘552 application.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 12, 21-33 and 47-55 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,454,529 (herein “the ‘529 patent”) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020) (of record, cite no. 12, IDS Mar. 12, 2026).
Claim 1 is directed towards a compound of formula I:
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.
For example, claim 55 is directed towards the following compound of formula I of claim 1:
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(instant claim 55).
The ‘529 patent claims largely similar compounds. For example:
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(‘529, claim 26).
This compound differs from instantly claimed compound 4 in two aspects. First in that there is a dihydropyrazole instead of an open chain benzylamide. Second in that X3 is N vs. C.
One of ordinary skill in the art would have a reasonable expectation of success to substitute an open chain benzylamide for dihydropyrazole and C for N for X3 and arrive at the compound of formula I because it is commonly known in the art that benzylamide is a bioisostere of dihydropyrazole in the binding pocket of the RIP1 receptor as well as that X3 is C in most RIP1 inhibitors.
For example, Harris shows that the dihydropyrazole structure has been modified to give open chain analogs and that X3 is C in known RIP1 inhibitors:
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Harris, Fig. 11, p. 144;
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Harris, Fig. 12, p. 145.
Therefore, claim 1 is rejected on the ground of nonstatutory double patenting.
Claims 2-3, 12, 21-33, 47-51 and 53-54 read on the above compounds and are therefore prima facie obvious and rejected on the ground of nonstatutory double patenting for the reasons given in the rejection of claim 1.
Claim 52 is directed towards the compound of claim 1, wherein R4 is F. While the ‘529 patent does not claim a compound wherein R4 is F, one of ordinary skill in the art would have a reasonable expectation of success to obtain a RIP1 inhibitor wherein R4 is F because such RIP1 inhibitors are commonly known in the art. For example, see compound 27 of Harris above (Harris, Fig. 12, p. 145).
Claim 55 of the instant application claims a pharmaceutical composition like claim 27 of the ‘529 application and is therefore rejected on the ground of nonstatutory double patenting.
Given the above teachings, the invention as a whole is unpatentable over the claims of the ‘529 patent in view of Harris.
Claims 1, 21-33, 47-51, 53 and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of copending Application No. 18/561,308 (herein the ‘308 application) in view of Harris (Expert Opinion on Therapeutic Patents, Vol. 31, p. 137-151, published Dec. 4, 2020) (of record, cite no. 12, IDS Mar. 12, 2026). While the claims at issue are not identical they are not patentably distinct because the ‘308 application claims compounds largely similar to formula I. For example:
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(‘308 application, claim 37). The compounds of the ‘308 application are nearly identical to and comparable to the compounds of the ‘552 application for the purposes of the rejection. Claims 1, 21-33, 47-51, and 53 are provisionally rejected on the same grounds as given in the provisional rejection of these claims over the ‘552 application, incorporated herein by reference.
Claim 38 of the ‘308 application claims a pharmaceutical composition as does claim 55 of the instant application and claim 55 is therefore provisionally rejected on the ground of nonstatutory double patenting.
Conclusion
No claim is found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
