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 .
DETAILED ACTION
Claims 23-40 are pending
Claims 26-27, 32-35 and 38-29 are withdrawn from examination as being drawn to a nonelected species.
Claims 23-25, 28-31, 36-37 and 40 are under consideration in the instant office action.
Claim Objections
Claim 25 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Election/Restrictions
Applicant’s election without traverse of the following species in their response dated 08/10/2026 is acknowledged.
Species election I
compound OGM7 (claim 24),
Species election II
malignancy, and glioblastoma as the subspecies of malignancy
Species election III
presence of administration of an additional therapeutic agent, and Temozolamide (claim 31) as the species of additional therapeutic agent,
Examination of the claims are conducted to the extent they read on the elected species. Claims 26-27, 32-35 and 38-29 are withdrawn from examination as being drawn to a nonelected specie.
Claims 23-25, 28-31, 36-37 and 40 are under examination and the requirement for restriction is made final.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 11/21/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application is a continuation of United States Patent Application serial no. 17/602,101, filed 7 October 2021, which is a national stage entry of and claims priority to PCT/US2020/028651, filed 17 April 2020, which claims the benefit of United States provisional application serial no. 62/835,016, filed April 17, 2019.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 cl-31aims 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 23, 28-31, 36-37 and 40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Gunes et al (US 2015/0210717) and Walensky et al. (US2015/03152111) in view or Reuland et al. (PloS ONE, 2011, volume 6, issue 8, pages 1-10) (all references are cited in IDS dated 11/21/2024).
Instant claims are drawn to a method of treating or preventing a malignancy or an autoimmune/inflammatory condition in a mammalian subject in need thereof, comprising administering to the subject a therapeutic 1,2-dihydro-3'H-spiro[indole-3,2'-[1,3,4]thiadiazole]- 2-one agent of Formula I, or a salt thereof:
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wherein R1 is optionally substituted
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wherein the substitution is selected from -H, -CH3, -CH2CH3, -OCH3, -Br, -F, -Cl, and -F3; wherein R2 is -H or -CH3; and wherein R3 and R4 independently are -H, -CH3, -CH2CH3, -OCH3, -CN, -F, -Br, -Cl, -COOCH3, -COOH, -SO2NH2.
Gunes et al. discloses a method of treating or preventing a malignancy in a mammalian subject in need thereof (method of treating cancer (malignancy) in a mammalian subject in need thereof; paragraphs [0086], [0172]), comprising administering to the subject a therapeutic 1,2-dihydro-3'H-spiro[indole-3,2[1,3,4]thiadiazole]-2-one agent of Formula I, wherein R1 is the first recited moiety; wherein R2 is -H; R3 is CH2CH3 and wherein R4 is -H (method comprises administering to the mammalian subject in need thereof a therapeutically effective amount of a compound of formula 9, specifically formula 66 on page 21 shown below ; paragraphs [0086], [0122], [0169], [0172]; page 21), and in a separate embodiment, Gunes et al. discloses wherein R3 is -H (compound of formula 9 wherein R81 represents 0 substituents (R3 is -H); paragraphs [0122]-[0123]).
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Gunes et al. does not provide a single concise embodiment with each of the selected moieties. However, provided that Gunes et al. discloses the chosen substituents (Gunes et al. ; formula 9 from paragraphs [0122]-[0123] and compound 66 on page 21), it would have been obvious to one of ordinary skill in the art, at the time of the invention, to have modified the compound of Gunes et al. , by narrowing the range of substituents so to as select the chosen substituents for Formula I, for enhancing the compound's efficacy as pharmaceutical agent useful in the treatment of cancer or for useful in the induction of cell regeneration (Gunes et al. ; paragraph [0048]).
Walensky et al discloses a method of treating or preventing a malignancy in a mammalian subject in need thereof (method of treating a hyperproliferative disorder in a mammal i.e., cancers such as skin cancers including malignant melanoma, Merkel cell skin cancer, and non-melanoma skin cancer; paragraphs [0099], [0101], [0167]), comprising administering to the subject a therapeutic 1,2-dihydro-3'H- spiro[indole-3,2'[1,3,4]thiadiazole]-2-one agent similar to Formula I, wherein R2 is -H; and wherein R4 is -H (method comprises administering to the mammal in need thereof a therapeutically effective amount of the second compound on page 77; paragraph [0101]; page 77), but Walensky et al does not disclose wherein R1 is the first recited moiety and R3 is -H. However, Gunes et al. discloses wherein R1 is the first recited moiety and R3 is -H (ogremorphin compound shown in figure 21 wherein R3 is napth (R1 is first recited moiety) and R1 is H (R3 is -H); page 95, figure 21 A). It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method, as previously disclosed by Walensky et al , in order to have provided wherein R1 is the first recited moiety and R3 is -H, as previously disclosed by Gunes et al. , for providing 1,2-dihydro-3'H-spiro[indole-3,2'-[1,3,4]thiadiazole]-2-or compound useful in the treatment of proliferative disorders such as cancer (; Walensky et al ; paragraphs [0101], [0167]). Walensky et al further discloses wherein the malignancy is melanoma and skin cancer (a method of treating a hyperproliferative disorder in a mammal i.e., cancers such as skin cancers including malignant melanoma, Merkel cell skin cancer, and non-melanoma skin cancer; paragraphs [0096], [0101], [0167]). Walensky et al also discloses administering to the mammalian subject in need thereof at least one additional therapeutic agent (a method of treating a hyperproliferative disorder in a mammal i.e., cancers such as skin cancers including malignant melanoma, Merkel cell skin cancer, and non-melanoma skin cancer, the method comprising administering to a mammal in need thereof a therapeutically effective amount of the second compound on page 77 and one or more additional therapeutic agents; paragraphs [0096], [0101], [0167], [0206] wherein the at least one additional therapeutic agent is an anticancer agent (treating a hyperproliferative disorder in a mammal comprising administration of a therapeutically effective amount of the second compound on page 77 and an additional therapeutic agent, such as an anticancer agent; paragraphs [0096], [0101], [0167], [0206], [0209]).
Combination of Gunes et al. and Walensky et al. fail to disclose wherein the anticancer agent is temozolomide,
However, Reuland et al. discloses wherein an anticancer agent is Temozolomide (combination treatment comprising anticancer agent temozolomide and ABT-737 induced strong synergistic apoptosis in multiple human melanoma cell lines, demonstrating a promising melanoma treatment method; abstract; page 1, second column, second paragraph). It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the method, as previously disclosed by Walensky et al. in order to have provided wherein an anticancer agent is Temozolomide, as previously disclosed by Reuland et al., for providing pharmaceutical compositions comprising compounds useful in the treatment of melanoma (Walensky et al. ; paragraphs [0101], [0165]; Reuland; abstract).
As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instant claims motivated and guided by the combined teachings of Gunes et al. Walensky et al. and Rauland et al. to arrive at the instant claims.. An ordinarily skilled artisan would be motivated from Gunes et al. and Walensky et al. to utilize compounds such as compound 66 taught by Gunes et al. in the treatment of malignancies and tumors as taught by Walensky et al. They would be motivated to combine that agent with temozolomide as both these agents are known to be useful in the treatment of cancer. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from there having been individually taught in the prior art”. In re Kerkhoven, 626 F .2d 846, 850 205 USPQ 1069, 1072 (CCPA 1980)
As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating all types of malignancies with the instantly claimed compound, absence of evidence to the contrary.
Double Patenting
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 23-25, 28-31, 36-37 and 40 are rejected on the ground of nonstatutory double patenting over claim 1-5 of U. S. Patent No 12,194,027 (‘027) since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because instant claim 23-25, 28-31, 36-37 and 40 are generic to all that is recited in claims 1-5 of 027’ , specifically, The method of treating a malignancy in a mammalian subject with the compound OGM12 in claims 1-5 of '027 is a specie of genus of "compound of formula I" instantly claimed. Therefore subject matter disclosed in claims instant claims 23-25, 28-31, 36-37 and 40 of the instant application are fully taught in claim 1-5 of patent ‘027 and hence anticipates the instant
Conclusion
Claims 23-24, 28-31, 36-37 and 40 are rejected. Claim 25 is objected. No claims are allowed.
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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