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 1, 11-12, 31, 40, 62, 73, 79, 83, 85, 127, 132, 139, 143-144, 156, 163, 186, 195 and 201 are pending in the present application.
AMENDMENTS
The amendments filed January 05, 2026 have been entered in the present application file and acknowledged by the Examiner.
Previous Claim Rejections - 35 USC § 102
Claim(s) 1, 40, 195 and 201 were previously rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2020/132071.
Applicant has provided a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in WO ‘071 and the claimed invention were subject to an obligation of assignment to the same person or subject to a joint research agreement.
Therefore, the 102(a)(2) rejection of 10/06/2025 is withdrawn.
Previous Double Patenting Rejection
Claims 1, 40, 195 and 201 were previously rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10 and 23 of U.S. Patent No. 12,391,705.
Until the double patenting rejection is overcome, the rejection is maintained.
Election/Restrictions
The Examiner was able to search the scope of the elected species and compounds encompassed without undue burden, the restriction(election) requirement previously set forth in the Office Action mailed June 20, 2025 has been withdrawn.
Claims 11-12, 31, 62, 73, 79, 83, 85, 127, 132, 139, 143-144, 156, 163 and 186 have been searched and examined on the merits in addition to claims 1, 40, 195 and 20. Applicant’s elected species and invention has been found free of the prior art; however, the present claims are not allowable under 35 U.S.C. 112(b), 35 U.S.C. 102(a)(2) and for non-statutory double patenting issues, which are discussed below.
In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the use. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 163 objected to because of the following informalities:
Claim 163, last two lines, “systemic lupus, erythematous (SLE),” should read “systemic lupus erythematous (SLE),”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 144 and 163 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.
Regarding claim 144, the phrase "melanoma" in parentheses following the recitation of “skin cancer” within the general classes of diseases or conditions renders the claim indefinite because it is unclear whether the limitations following the phrase in parenthesis are part of the claimed invention (e.g, what subtypes of skin cancer are encompassed by the present claims). See MPEP § 2173.05(d).
Regarding claim 163, the phrases “bladder inflammation (cystitis)” and “arthritis (osteoarthritis, rheumatoid arthritis (RA), psoriatic arthritis)” included in the recitation of general classes of diseases of conditions renders the claim indefinite because it is unclear whether the limitations included in parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Applicant can amend claim 144 and claim 163 to delete explicitly recite the list of conditions encompassed by the present methods (i.e. without any parentheses for any conditions or any exemplary conditions for a general class of diseases or conditions) to overcome this rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 12, 85, 127, 132, 139, 143-144, 156, 163, 186 and 195 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2018/237084 A1 (Hadari et al.; Publication Date: 12/27/2019; International Filing Date: 06/20/2018).
Hadari discloses methods and compositions for treating cancers, inflammatory diseases, rasopathies, and fibrotic disease involving aberrant Ras superfamily signaling through the binding of compounds to the GTP binding domain of Ras superfamily proteins including, in certain cases, K-Ras and mutants thereof, and a method for assaying such compositions. See abstract and claims 53 to 136 for various methods and compounds of formula (I).
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Hadari, pg 630
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Hadari, Pg 637
Hadari discloses several compound examples corresponding to the compounds encompassed by present Formula (IB) and Formula (IIB) (see present claims 1, 12 and 85). See the second to last compound on page 630 in Table 3, which corresponds to a compound of Formula (IB) wherein R6 is
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, -NR7R8 is
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, R9 is phenyl, and R10 is
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.
See the second to last compound on page 637 in Table 3, which corresponds to a compound of Formula (IB) wherein R6 is
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70
65
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, -NR7R8 is
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51
114
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, R9 is phenyl, and R10 is
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85
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Hadari, pg 613
See the second compound on page 613 in Table 3, which corresponds to a compound of Formula (IIB) wherein R26 is
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, R27 is hydrogen, R28 is
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.
Hadari discloses a method of inhibiting the function of one or more members of the Ras superfamily, comprising administering to a subject a compound which inhibits the one or more members of the Ras superfamily with an IC50 value of less than 10µM (see present claim 127). See claim 57 of Hadari. Hadari discloses wherein the Ras is HRAS, KRAS, NRAS or a mutant thereof (see present claim 132). See claim 79. Hadari teaches wherein the inhibiting the function of Ras is a treatment, prevention or amelioration of one or more symptoms of cancer (see present claim 139). See claim 87 of Hadari. Hadari discloses wherein the cancer is a solid tumor, including hepatocellular carcinoma, prostate cancer, pancreatic cancer, lung cancer, ovarian cancer, colon cancer, small intestine cancer, biliary tract cancer, endometrium cancer, skin cancer (melanoma), cervix cancer, urinary tract cancer, or glioblastoma (see present claims 143-144). See paragraph [00236] and claims 90-91 of Hadari. Hadari discloses the following in paragraph [00237]:
In certain embodiments, the cancer is a blood borne tumor. In certain embodiments, the blood borne tumor is metastatic. In certain embodiments, the blood borne tumor is drug resistant. In certain embodiments, the cancer is leukemia.
See present claim 156.
Hadari teaches wherein inhibiting the function of Ras is a treatment, prevention or amelioration of one or more symptoms of an inflammatory disease. See claim 102. Hadari provides wherein the inflammatory disease is gastritis, schistosomiasis, cholangitis, chronic cholecystitis, pelvic inflammatory disease, chronic cervicitis, osteomyelitis, inflammatory bowel disease, reflux esophagitis, Barrett’s esophagus, bladder inflammation (cystitis), asbestosis, silicosis, gingivitis, lichen planus, pancreatitis, protease mutation, lichen sclerosis, slaladenitis, bronchitis, Sjogren syndrome or Hashimoto’s thyroiditis (see present claims 139 and 163). See paragraph [00338] and claim 105 of Hadari.
Hadari discloses wherein the inhibiting the function of Ras is a treatment for a rasopathy. See claim 125 of Hadari. Hadari teaches wherein the rasopathy is neurofibromatosis type 1, Noonan’s syndrome or Costello syndrome (see present claims 139 and 186). See paragraph [00347] and claim 128 of Hadari.
Hadari teaches a pharmaceutical composition, comprising the compound or pharmaceutically acceptable salt thereof of present Formula (IB) and Formula (IIB), and a pharmaceutically acceptable carrier (see present claim 195). See paragraphs [00259], [002147]-[002198] and claim 189.
Applicant may provide a declaration or affidavit under 37 CFR 1.130(a) to establish the contribution to the relevant subject matter in the prior art by inventors of the instant application to overcome this rejection. See MPEP 717.01(a)(1) which states:
Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an "unequivocal" statement from the inventor or a joint inventor that he/she (or some specific combination of named joint inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).
The Hadari reference, published December 27, 2019, is available as prior art under 102(a)(1) (in addition to availability as prior art under 102(a)(2)) as there is an additional inventive entity in the prior art reference and the publication date is before the effective filing date of the instant application.
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 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 1, 12, 85, 127, 132, 139, 143-144, 156, 163, 186 and 195 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/237084 A1 (Hadari et al.; Publication Date: 12/27/2019; International Filing Date: 06/20/2018).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Hadari discloses methods and compositions for treating cancers, inflammatory diseases, rasopathies, and fibrotic disease involving aberrant Ras superfamily signaling through the binding of compounds to the GTP binding domain of Ras superfamily proteins including, in certain cases, K-Ras and mutants thereof, and a method for assaying such compositions. See abstract and claims 53 to 136 for various methods and compounds of formula (I).
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Hadari, pg 630
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Hadari, Pg 637
Hadari discloses several compound examples corresponding to the compounds encompassed by present Formula (IB) and Formula (IIB) (see present claims 1, 12 and 85). See the second to last compound on page 630 in Table 3, which corresponds to a compound of Formula (IB) wherein R6 is
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, -NR7R8 is
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, R9 is phenyl, and R10 is
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85
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.
See the second to last compound on page 637 in Table 3, which corresponds to a compound of Formula (IB) wherein R6 is
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70
65
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, -NR7R8 is
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51
114
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, R9 is phenyl, and R10 is
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85
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103
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Hadari, pg 613
See the second compound on page 613 in Table 3, which corresponds to a compound of Formula (IIB) wherein R26 is
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61
73
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, R27 is hydrogen, R28 is
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57
75
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.
Hadari discloses a method of inhibiting the function of one or more members of the Ras superfamily, comprising administering to a subject a compound which inhibits the one or more members of the Ras superfamily with an IC50 value of less than 10µM (see present claim 127). See claim 57 of Hadari. Hadari discloses wherein the Ras is HRAS, KRAS, NRAS or a mutant thereof (see present claim 132). See claim 79. Hadari teaches wherein the inhibiting the function of Ras is a treatment, prevention or amelioration of one or more symptoms of cancer (see present claim 139). See claim 87 of Hadari. Hadari discloses wherein the cancer is a solid tumor, including hepatocellular carcinoma, prostate cancer, pancreatic cancer, lung cancer, ovarian cancer, colon cancer, small intestine cancer, biliary tract cancer, endometrium cancer, skin cancer (melanoma), cervix cancer, urinary tract cancer, or glioblastoma (see present claims 143-144). See paragraph [00236] and claims 90-91 of Hadari. Hadari discloses the following in paragraph [00237]:
In certain embodiments, the cancer is a blood borne tumor. In certain embodiments, the blood borne tumor is metastatic. In certain embodiments, the blood borne tumor is drug resistant. In certain embodiments, the cancer is leukemia.
See present claim 156.
Hadari teaches wherein inhibiting the function of Ras is a treatment, prevention or amelioration of one or more symptoms of an inflammatory disease. See claim 102. Hadari provides wherein the inflammatory disease is gastritis, schistosomiasis, cholangitis, chronic cholecystitis, pelvic inflammatory disease, chronic cervicitis, osteomyelitis, inflammatory bowel disease, reflux esophagitis, Barrett’s esophagus, bladder inflammation (cystitis), asbestosis, silicosis, gingivitis, lichen planus, pancreatitis, protease mutation, lichen sclerosis, slaladenitis, bronchitis, Sjogren syndrome or Hashimoto’s thyroiditis (see present claims 139 and 163). See paragraph [00338] and claim 105 of Hadari.
Hadari discloses wherein the inhibiting the function of Ras is a treatment for a rasopathy. See claim 125 of Hadari. Hadari teaches wherein the rasopathy is neurofibromatosis type 1, Noonan’s syndrome or Costello syndrome (see present claims 139 and 186). See paragraph [00347] and claim 128 of Hadari.
Hadari teaches a pharmaceutical composition, comprising the compound or pharmaceutically acceptable salt thereof of present Formula (IB) and Formula (IIB), and a pharmaceutically acceptable carrier (see present claim 195). See paragraphs [00259], [002147]-[002198] and claim 189.
Hadari also discloses several compound examples corresponding to the compounds encompassed by present Formula (IIB) (see compounds pictured in the Table below).
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Hadari, pg 616
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Hadari, pg 617
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Hadari, pg 641
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Hadari, pg 643
See the last compound on page 616 in Table 3 (Hadari-616), which corresponds to a compound of Formula (IIB) wherein R26 is
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, R27 is hydrogen, R28 is
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.
See the fourth compound on page 617 in Table 3 (Hadari-617), which corresponds to a compound of Formula (IIB) wherein R26 is
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, R27 is -CH3, R28 is
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.
See the second compound on page 641 in Table 3 (Hadari-641), which corresponds to a compound of Formula (IIB) wherein R26 is
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, R27 is -CH3, R28
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86
108
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.
See the second compound on page 643 in Table 3 (Hadari-643), which corresponds to a compound of Formula (IIB) wherein R26 is
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, R27 is hydrogen, R28
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.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The compounds of Hadari (i.e., Hadari-616, Hadari-617, Hadari-641 and Hadari-643) do not have the required substitution pattern of compounds of present Formula (IIB), with regards to the attachment of the moiety at R28.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007). See also MPEP 2144.09(II).
The compounds of Hadari (i.e., Hadari-616, Hadari-617, Hadari-641 and Hadari-643) are all positional isomers of compounds encompassed by present Formula (IIB) with respect to the placement or attachment of the various heterocycles for R28 of the respective Hadari compounds. The person of ordinary skill would envision the presently claimed compound and would expect the compounds to at least have GTP binding domain of Ras superfamily proteins binding activity as shown by Hadari. The fact that the prior art compounds are positional isomers of presently claimed compounds and would be expected to have similar effects is a showing of a reasonable expectation of success.
Therefore, based on the teachings of Hadari, the compounds of formula (IB) and formula (IIB) and relevant claims thereof are prima facie obvious over the prior art.
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 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 1, 12, 31, 40, 62, 73, 127, 132, 139, 143-144, 156, 186, 195 and 201 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-13 and 23 of U.S. Patent No. 12,391,705 in view of WO 2018/237084 A1 (Hadari et al.; Publication Date: 12/27/2019; International Filing Date: 06/20/2018).
Claim 1 of the ‘705 Patent discloses a compound of Formula (IB); see Formula IIIA, IIIB, IIIC, IIID and IIIE in cols 663-673. Claim 1 of the ‘705 Patent discloses a compound of Formula (IC); see Formula IIID in col 671. Claim 1 of the ‘705 Patent discloses a compound of Formula (IE); see Formula IIIE in cols 672. See present claims 1, 12, 31, 40, 62, 73 and 201.
Claim 2 of the ‘705 Patent discloses the following compound in col 691:
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corresponding a to compound of formula (IB) of present claim 31.
Claims 2 and 23 of the ‘705 Patent discloses the following compound in the last row of col 693 and col 698:
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corresponding to the present elected species as well as formula (IC) of present claim 40.
Claim 10 of the ‘705 Patent discloses a pharmaceutical composition comprising the compound or pharmaceutically acceptable salt thereof of claim 1 of the ‘705 Patent and a pharmaceutically acceptable carrier. See present claim 195.
Claim 11 of the ‘705 Patent discloses a method of inhibiting the function of one or more members of the Ras superfamily, comprising administering to a subject the compound or pharmaceutically acceptable salt thereof of claim 1, wherein the one or more members of the Ras superfamily are selected from the group consisting of HRas, KRas, NRas, Rac-1, Rho-A, and a mutant of any of the foregoing. Claim 12 of the ‘705 Patent discloses the method of claim 11 of the ‘705 Patent, wherein the compound or pharmaceutically acceptable salt thereof binds to the GTP binding domain of the one or more members of the Ras superfamily and inhibits the one or more members of the Ras superfamily with an IC50 value of less than 10 micromolar. See present claims 127 and 132.
Claim 13 of the ‘705 Patent discloses a method of treating cancer, or a KRas, NRas, Rac-1, Rho-A or HRas-associated autoimmune leukoproliferative disorder in a subject comprising administering to the subject the compound or pharmaceutically acceptable salt thereof of claim 1, wherein the cancer is hepatocellular carcinoma, prostate cancer, pancreatic cancer, lung cancer, ovarian cancer, colon cancer, small intestine cancer, biliary tract cancer, endometrium cancer, skin cancer, cervix cancer, urinary tract cancer, breast cancer, breast cancer, or brain cancer, optionally wherein the lung cancer is non-small cell lung cancer, the brain cancer is glioblastoma, and the skin cancer is melanoma. See present claims 139 and 143-144.
The ’705 Patent does not disclose a compound of Formula (IIB).
Regarding present claims 156, 163 and 186, the present claims do not exclude embodiments where one of ordinary skill inhibits the function of a Ras and treats a symptom of a solid tumor, such as prostate cancer, by administration of a compound of Formula I or a similar compound thereof of claims 254 or 256 of the ‘644 application.
For the reasons set forth under 35 USC § 103 (which discussion is incorporated here by reference), the instant claims are deemed to be obvious embodiments of the ‘705 Patent since a person having ordinary skill in the art would have been motivated to make the modification due to the teachings of Hadari.
Claims 1, 11-12, 31, 40, 85, 127, 132, 139, 143-144, 156, 163, 186, 195 and 201 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 254-256 of copending Application No. 18/273,644 in view of WO 2018/237084 A1 (Hadari et al.; Publication Date: 12/27/2019; International Filing Date: 06/20/2018).
This is a provisional nonstatutory double patenting rejection.
Claim 1 of the ‘644 application discloses a method of treating fibrosis (see present claim 139) in a subject having a disease comprising a compound of Formula I:
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The compounds of present formula (IA), (IB) and (IC) are encompassed by Formula I of the ‘644 application.
For example, a compound of Formula I of the ‘644 application wherein R1 is
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, R8 is either
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, R9 is methyl or phenyl, and -NR6R7 is
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or
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, corresponds to a compound of present formula (IA) (see present claim 11).
A compound of Formula I of the ‘644 application wherein R1 is
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, R8 is either
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, R9 is methyl or phenyl, and -NR6R7 is
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or
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, corresponds to a compound of present formula (IB) (see present claims 12 and 31).
A compound of Formula I of the ‘644 application wherein R1 is
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, R8 is
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, R9 is methyl, and -NR6R7 is
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78
125
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or
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55
139
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, corresponds to a compound of present formula (IC) (see present claims 40 and 201).
Claim 254 of the ‘644 application discloses the following compound:
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164
260
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The compound of claim 254 of the ‘644 application corresponds to compound of present Formula (IB) wherein corresponds to a compound of Formula (IB) wherein R6 is
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70
65
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, -NR7R8 is
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86
139
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, R9 is phenyl, and R10 is
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76
104
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(see present claim 12).
Claim 255 of the ‘644 application discloses a pharmaceutical composition, comprising the compound or pharmaceutically acceptable salt of claim 254 of the ‘644 application, and a pharmaceutically acceptable carrier (see present claim 195).
Claim 256 of the ‘644 application discloses a compound which binds to the GTP binding domain of one or more members of the Ras superfamily and inhibits the one or more members of the Ras superfamily with an IC50 value of less than 10 micromolar, wherein the compound is the compound or pharmaceutically acceptable salt of claim 254 of the ‘644 application and where the Ras is HRAS, KRAS, or NRAS (see present claim 132).
The ’644 application does not disclose wherein the compound of Formula I of the ‘644 application encompasses compounds of present Formula (IIB). The ’644 application does not disclose wherein the inhibiting the function of one or more members of the Ras superfamily is a treatment, prevention or amelioration of one or more symptoms of cancer, inflammatory disease, rasopathy, Ras-associated autoimmune or leukoproliferative disorder.
Regarding present claims 143-144, 156, 163 and 186, the present claims do not exclude embodiments where one of ordinary skill inhibits the function of a Ras and treats a fibrotic disease by administration of a compound of Formula I or a similar compound thereof of claims 254 or 256 of the ‘644 application.
For the reasons set forth under 35 USC § 103 (which discussion is incorporated here by reference), the present claims are deemed to be obvious embodiments of the ’644 application since a person having ordinary skill in the art would have been motivated to make the modification due to the teachings of Hadari.
Claims 1, 11-12, 31, 85, 127, 132, 139, 143-144, 156, 163, 186 and 195 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of copending Application No. 18/273,646 in view of WO 2018/237084 A1 (Hadari et al.; Publication Date: 12/27/2019; International Filing Date: 06/20/2018).
Claim 1 of the ‘646 application discloses a method of treating fibrosis (see present claim 139) in a subject having a disease comprising a compound of Formula I:
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152
200
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The compounds of present formula (IA) and (IB) are encompassed by Formula I of the ‘646 application.
For example, a compound of Formula I of the ‘646 application wherein R1 is
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93
146
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, R8 is either
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76
47
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, R9 is phenyl, and -NR6R7 is
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77
152
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or
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54
114
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, corresponds to a compound of present formula (IA) (see present claim 11).
A compound of Formula I of the ‘646 application wherein R1 is
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80
83
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, R8 is either
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76
47
media_image21.png
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, R9 is phenyl, and -NR6R7 is
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78
125
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or
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54
114
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, corresponds to a compound of present formula (IB) (see present claims 12 and 31).
The ‘646 application does not disclose wherein the compound of Formula I of the ‘646 application encompasses compounds of present Formula (IIB). The ’646 application does not disclose wherein the inhibiting the function of one or more members of the Ras superfamily is a treatment, prevention or amelioration of one or more symptoms of cancer, inflammatory disease, rasopathy, Ras-associated autoimmune or leukoproliferative disorder.
Regarding present claims 143-144, 156, 163 and 186, the present claims do not exclude embodiments where one of ordinary skill inhibits the function of a Ras and treats a fibrotic disease by administration of a compound of Formula I of claim 1 of the ‘646 application.
For the reasons set forth under 35 USC § 103 (which discussion is incorporated here by reference), the present claims are deemed to be obvious embodiments of the ‘646 application since a person having ordinary skill in the art would have been motivated to make the modification due to the teachings of Hadari.
Claims 1, 12, 31, 85, 127, 132, 139, 143-144, 156, 163, 186 and 195 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1 of copending Application No. 19/228,400 in view of WO 2018/237084 A1 (Hadari et al.; Publication Date: 12/27/2019; International Filing Date: 06/20/2018).
Claim 1 of the ‘400 application discloses a compound which binds to the GTP binding domain of one or more members of the Ras superfamily and inhibits the one or more members of the Ras superfamily with an IC50 value of less than 10 micromolar, wherein the compound is a compound of Formula I.
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235
269
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.
The compounds of present formula (IIB) are encompassed by Formula I of the ‘400 application.
A compound of Formula I of the ‘400 application where R1 is
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80
83
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and R2 is
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70
55
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corresponds to a compound of present formula (IIB) (see present claim 85).
Claim 18 of the ‘400 application discloses a compound which binds to the GTP binding domain of one or more members of the Ras superfamily and inhibits the one or more members of the Ras superfamily with an IC50 value of less than 10 micromolar, wherein the compound is a compound of Formula IIIA.
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270
359
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.
The compounds of present formula (IB) are encompassed by Formula IIIA of the ‘400 application.
A compound of Formula IIIA of the ‘400 application where -NR9R10 is
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78
125
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or
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55
139
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, R11 is
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76
47
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and R12 is phenyl corresponds to a compound of present formula (IB) (see present claims 12 and 31).
The ‘400 application does not disclose a method of inhibiting the function of one or more members of the Ras superfamily, comprising administering to a subject a compound which inhibits the one or more members of the Ras superfamily with an ICso value of less than 10 pM, wherein the compound is the compound or pharmaceutically acceptable salt thereof of claim 1.
For the reasons set forth under 35 USC § 103 (which discussion is incorporated here by reference), the present claims are deemed to be obvious embodiments of the ‘400 application since a person having ordinary skill in the art would have been motivated to make the modification due to the teachings of Hadari.
Allowable Subject Matter
Claim 79 and 83 are 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.
Conclusion
Claims 1, 11-12, 31, 40, 62, 73, 79, 83, 85, 127, 132, 139, 143-144, 156, 163, 186, 195 and 201 are pending in the present application.
Claims 1, 11-12, 31, 40, 62, 73, 85, 127, 132, 139, 143-144, 156, 163, 186, 195 and 201 are rejected
Claims 79 and 83 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/ Primary Examiner, Art Unit 1626
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