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 .
Claim Objections
Claim 25 is objected to because of the following informalities: duplicate “the” in line 1 of the claim. Appropriate correction is required.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 19, and 21 – 25 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, and 12 – 16 of prior U.S. Patent No. U.S. Patent No. US 12060367 B2 to Broeker et. al. (Broeker’367). This is a statutory double patenting rejection.
Examined claims 19 and 21 – 25 differ from the issued claims because instant claim 19 recites a series of optional limitations. Since these limitations are optional, and not required, they do not narrow the scope of the claims relative to what is issued. That is, the claims are of identical scope.
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.
Claims 19 – 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 –– 49 of U.S. Patent No. US 12060367 B2 to Broeker et. al. (Broeker’367).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the invention of Broeker’367 and copending examined application direct to the genus of annulated 2-amino-3-cyano thiophene derivatives. The genus of compounds taught by the claims Broeker’367 in claim 1 is identical to that taught in instant claim 19. Further, the issued patent claims exemplify species within the instantly claimed genus, For example, Broeker’367 recite a compound according claim 1 of the formula (Ia)
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where R3 and5, U, V, W, and Ring A are defined. See reference claims 2. Furthermore, Broeker’367 recite additional compounds species of (reference) claim 1 which anticipate the general formula (I) of examined claim 19. See reference claims 3 – 11, and 18 – 49.
With regard to examined claim 20, Broeker’367 recite a pharmaceutical composition comprising a compound according to (reference) claim 1, or a pharmaceutically acceptable salt thereof, and one or more other pharmacologically active substance(s). See reference claim 17.
However, Broeker’367 fails to recite a pharmaceutical composition comprising one or more pharmaceutically acceptable excipients. See examined claim 20.
Nevertheless, given that the skill level of one of ordinary skill in the art is relatively high it would have been within the purview of such artisan to formulate the composition of Broeker’367 with a pharmaceutical acceptable excipient to facilitate the administration of the compound according to (reference) claim 1. Moreover, the formulation of pharmaceutical compositions with pharmaceutical acceptable excipients is well known in the pharmaceutical arts thus one of ordinary skill in the arts would have a reasonable expectation of accomplishing such formations.
With regard to examined claims 21 – 27, Broeker’367 recite a method for the treatment and/or prevention of cancer comprising administering a therapeutically effective amount of a compound according to (reference) claim 1, or a pharmaceutically acceptable salt thereof, to a human being where the cancer comprises tumor cells harboring a KRAS mutation or an amplification of KRAS wildtype. See reference claims 12 – 16.
However, Broeker’367 fails to recite a method where the subject has been determined prior to treatment as having a cancer characterized by tumor cells harboring a KRAS mutation or amplification of KRAS wildtype. See examined claims 21– 27.
Nevertheless, given that the skill level of one of ordinary skill in the art is relatively high it would have been within the purview of such artisan to incorporate a determination step in the method of treating a cancer harboring a KRAS mutation or amplification of KRAS wildtype.
Claims 19 – 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 12, and 16 – 19 of copending Application No. 18/715150 to Broeker et. al. (reference application; Broeker’150).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to the genus of annulated 2-amino-3-cyano thiophene derivatives.
Specifically, Broeker’150 recite a compound of the formula (I)
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where R1a-5, L, U, V, W, Ring A, Z, and p are defined. See reference claims 1. Furthermore, Broeker’150 recite compounds species of (reference) claim 1 which anticipates the general formula (I) of examined claim 19. See reference claims 3 – 12, and 16. More specifically, the compounds of reference claim 16 such as wherein L is a bond anticipates the general formula (Ib) of examined claim 19. Furthermore, Broeker’150 recite a pharmaceutical composition comprising a compound according to claim 1, or a pharmaceutically acceptable salt thereof, and one or more other pharmacologically active substance(s). See reference claim 19. See examined claim 20. Additionally, Broeker’150 recite a method of treatment or prevention of cancer in a subject in need thereof, comprising administering a therapeutically or prophylactically effective amount of a compound according to claim 1 or a pharmaceutically acceptable salt thereof. See reference claims 17. See examined claims 21. Furthermore, Broeker’150 recite a method said compound or salt is administered in combination with one or more other pharmacologically active substance(s). See reference claim 18. See examined claim 22.
Additionally, Broeker’150 recite a method of treatment or prevention of cancer in a subject in need thereof, comprising administering a therapeutically or prophylactically effective amount of a compound according to claim 1 or a pharmaceutically acceptable salt thereof. See reference claims 17.
However, Broeker’150 fails to recite a method of treating cancer where the cancer is selected from a group consisting of pancreatic cancer, lung cancer, colorectal cancer, cholangiocarcinoma, appendiceal cancer, multiple myeloma, melanoma, uterine cancer, endometrial cancer, thyroid cancer, acute myeloid leukaemia, bladder cancer, urothelial cancer, gastric cancer, cervical cancer, head and neck squamous cell carcinoma, diffuse large B cell lymphoma, oesophageal cancer, gastroesophageal cancer, chronic lymphocytic leukaemia, hepatocellular cancer, breast cancer, ovarian cancer, prostate cancer, glioblastoma, renal cancer and sarcoma. See examined claim 23.
Nevertheless, Broeker’150 does recite a method of treating cancer which is a genus; while the examined applications recites species of cancers that are within the broad genus. Thus it would have been obvious to one of ordinary skill to modify the method of copending Broeker’150 by selecting one of the cancers recited in examined claim 23.
Claims 24 – 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 of copending Application No. 18/715150 to Broeker et. al. (reference application; Broeker’150) in view of Orgovan et. al. ((2020), Small molecule inhibitors of RAS proteins with oncogenic mutations, Cancer and Metastasis Reviews, 39, 1107 – 1126).
Broeker’150 recite a method of treatment or prevention of cancer in a subject in need thereof, comprising administering a therapeutically or prophylactically effective amount of a compound according to (references) claim 1 or a pharmaceutically acceptable salt thereof. See reference claims 17.
However, Broeker’150 rails to recite whether the cancer comprises tumor cells harboring a KRAS mutation or an amplification of KRAS wildtype. See examined claims 24 – 25. Furthermore, Broeker’150 fails to recite a method where the subject has been determined prior to treatment as having a cancer characterized by tumor cells harboring a KRAS mutation or amplification of KRAS wildtype. See examined claims 26 – 27.
Nevertheless, Orgovan et. al. teach that RAS proteins belong to the family of small GTPases and play a crucial role in number of important oncogenic signaling pathways. See page 1107 column 1 paragraph 1. Additionally, Orgovan et. al. teach that as molecular switches, these proteins are essential in regulation of cell proliferation, differentiation and survival. See page 1107 column 1 paragraph 1. Furthermore, Orgovan et. al. teach that RAS proteins are the most frequently mutated proteins in cancer with their missense mutations occurring in more than 30% of human cancers. See page 1108 column 1 paragraph 4. Orgovan et. al. teach that it was also reported in that wild-type KRAS has a tumour-suppressor effect in some KRAS-mutant cancers. See page 1108 column 2 paragraph 2. Hence, Orgovan et. al. teach that selective inhibition of mutant RAS proteins would be necessary. See page 1108 column 1 paragraph 4. Moreover, Orgovan et. al. teach the necessity of other RAS mutant inhibitor raises that while KRAS-G12C mutation occurs most frequently in lung cancers, in the most commonly RAS mutated pancreatic and colon cancers. See page 1120 column 2 paragraph 3. Furthermore, Orgovan et. al. teach KRAS-G12D and G12V mutations are significant as RAS mutant inhibitor targets. See page 1120 column 2 paragraph 3. Moreover, given that the skill level of one of ordinary skill in the art is relatively high it would have been within the purview of such artisan to incorporate a determination step in the method of treating a cancer harboring a KRAS mutation or amplification of KRAS wildtype.
Therefore, it would have been obvious before the effective filing date of the instant application to modify the method of copending Broeker’150 for a method of treating cancer in view of Orgovan et. al. that is to target cancers that harbor a KRAS mutation or an amplification of KRAS wildtype. One of ordinary skill in the art would have been motivated to make this modification because these proteins are essential in regulation of cell proliferation, differentiation and survival. Moreover, one of ordinary skill in the art would have been motivated to make this modification because KRAS-G12C and KRAS-G12D mutations are common. One of ordinary skill in the art would have had a reasonable expectation of success because RAS proteins are the most frequently mutated proteins in cancer with their missense mutations occurring in more than 30% of human cancers.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Discussion of the Prior art
The closet prior art of US Patent Application Publication Number US 2021/0380574 A1 to Abbot et. al. (Abbot’574) teach a compound of formula (I)
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. See page 2 paragraph 0009. Furthermore, Abbot’574 teach compound species of the disclosure as inhibitors of G12C mutant Ras family proteins. See page 2 paragraph 0007.
However, Abbot’574 fails to teach a compound of formula (I)
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where ring A is a bicyclic ring and attached through a spiro linker to the ring that contains Z. See claim 19. Moreover, the prior art does not provide a motivation to make both of these modifications to the annulated 2-amino-3-cyano thiophene core. Thus the prior art of Abbot’574 fails to anticipate or render obvious the compounds of the claims 19 – 20. Hence, claims 19 – 20 are free of the prior art. Moreover, since the method claims of 21 – 27 require the use of one or more of the compounds of the formula delineated in claim 19; and since claims 19 – 20 were formed to be free of the prior art; claims 21 – 27 are also free of the prior art.
Conclusion
Claims 19 – 27 are rejected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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