Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This Application is a 371 of PCT/CN2022/075732, filed Feb. 9, 2022 and claims foreign priority benefit of CN202110182357.6, filed on February 9, 2021; CN202110251656.0, filed on March 8, 2021; CN202110379326.X, filed on April 8, 2021; CN202110485837.X, filed on April 30, 2021; CN202110825879.3, filed on July 21, 2021; CN202110975205.1, filed on August 24, 2021; CN202 111136266.5, filed on September 27, 2021; CN202111283561.3, filed on November 01, 2021; CN202210072243.0, filed on January 21, 2022; and CN202210113080.6, filed on January 29, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Dec. 19, 2024; Dec. 17. 2023; and Nov. 6, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-15 and 19-20 are currently pending and subject to examination.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
“(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.”
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
“The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”
Claims 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the tumors" in line 1. There is insufficient antecedent basis for this limitation in the claim. The antecedent in claim 19 is “KRASG12D mutation-related tumors” (a qualified phrase) not simply tumors. Claim 20’s use of “the tumors” drops the qualifier of “KRASG12D mutation-related.” This creates ambiguity as to whether “the tumors” means all tumors or specifically the KRASG12D mutation-related tumors.
Furthermore, claim 20 recites “wherein the tumors refer to colorectal cancer and pancreatic cancer.” The phrase “refer to” fails to clearly establish the metes and bounds of the claimed invention with reasonable certainty because the term creates ambiguity as to whether:
The tumors must actually be colorectal cancer or pancreatic cancer;
The tumors are related to or associated with these cancer types; or
These cancer types are merely exemplary of the types of tumors covered by the claim.
“Alternatives may be set forth as ‘a material selected from the group consisting of A, B, and C’ or ‘wherein the material is A, B, or C’ (MPEP § 2173.05(h)). The phrase “refer to” is not a term of art and does not provide a clear standard by which one of ordinary skill in the art could determine whether a particular tumor falls within the scope of the claim. It is unclear whether the claim is limited to only colorectal and pancreatic cancer, or whether other tumors are also encompassed. The use of “and” in conjunction with the vague term “refer to” exacerbates this uncertainty.
Corrections suggested by the examiner:
20. The method of claim 19, wherein the KRASG12D mutation-related tumors are colorectal cancer or pancreatic cancer.
20. The method of claim 19, wherein the KRASG12D mutation-related tumors are selected from the group consisting of colorectal cancer and pancreatic cancer.
Appropriate correction is required.
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 1-15 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dai et al. (US 2023/0242544 A1; published Aug. 3, 2023; effective filing date June 30, 2020).
Claim 1 is directed towards a compound of formula (II), or a pharmaceutically acceptable salt thereof:
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. For example, the following compound is a compound of formula (II):
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(Specification, p.45, Example 1).
Dai teaches multiple species falling within formula (II), including the compound as in example 1:
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(Dai, Specification, p. 58, example 107).
Therefore, claim 1 is anticipated.
Claims 2-15 read on instant example 1/ Dai example 108 and are therefore also anticipated for the reasons given in the rejection of claim 1.
Claim 19 is directed towards a method of treating KRASG12D mutation-related tumors in a subject in need thereof, comprising administering to the subject the compound of claim 1, or a pharmaceutically acceptable salt thereof. Claim 20 is directed towards the method of claim 19, wherein the tumors refer to colorectal cancer and pancreatic cancer.
Dai teaches a method of treating a KRASG12D mutation related tumor in a subject in need thereof, comprising administering to the subject the compound of claim 1:
In some embodiments, the present disclosure provides a method of treating a disease or disorder, e.g., a cancer associated with G12D mutation of KRAS, HRAS and/or NRAS, such as a cancer associated with KRASG12а in a subject in need thereof. In some embodiments, the method comprises administering to the subject a therapeutically effective amount of a compound of the present disclosure (e.g., a compound of Formula I… Determining whether a tumor or cancer comprises a G12D mutation of KRAS, HRAS and/or NRAS is known in the art, either by a PCR kit or using DNA sequencing. In various embodiments, the cancer can be pancreatic, colorectal, lung, or endometrial cancer.
Dai, Specification, p. 80, paragraphs [0158-0159].
Therefore, claims 19-20 are anticipated.
Nonstatutory 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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,410,196 B2 (herein “the ‘196 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘196 patent claims species of compounds falling within claimed formula (II).
Claim 1 is directed towards a compound of formula (II), or a pharmaceutically acceptable salt thereof:
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. The ‘196 patent is directed towards a compound selected from the group consisting of:
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(‘196, claim 1).
As in Formula (II), in the compounds claimed in the ‘196 patent, E1 is -CR3=CH-, L1 is CH2, Ring A is
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T1 is NH, T2 is N, R1 is naphthyl substituted with Rb wherein Rb is F, NH2 and CN, R2 is F and R4 is hexahydro-1H-pyrrolizinyl substituted with R3 wherein R3 is F. Therefore, claim 1 is anticipated by claim 1 of the ‘916 patent.
Claims 2-15 read on the compounds as in claim 1 of the ‘196 patent and are therefore rejected on the same grounds as claim 1.
Claims 1-15 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,410,196 B2 (herein “the ‘196 patent”), as applied to claims 1-15 above, and further in view of Dai et al. (US 2023/0242544 A1; published Aug. 3, 2023; effective filing date June 30, 2020). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘196 patent claims species of compounds falling within claimed formula (II), and it would be obvious to apply compounds falling within formula (II) to the treatment of KRASG12D mutant tumors including colorectal cancer and pancreatic cancer as in claims 19-20 given the teachings of Dai.
The rejection of claims 1-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,410,196 B2 is incorporated herein by reference.
Claim 19 is directed towards a method of treating KRASG12D mutation-related tumors in a subject in need thereof, comprising administering to the subject the compound of claim 1, or a pharmaceutically acceptable salt thereof. Claim 20 is directed towards the method of claim 19, wherein the tumors refer to colorectal cancer and pancreatic cancer.
One of ordinary skill in the art would have a reasonable expectation of success to apply the compounds of formula (II), for example the compounds of claim 1 of the ‘196 patent, to the treatment of KRASG12D mutation-related tumors including colorectal cancer and pancreatic cancer, because compounds of formula (II) are commonly known in the art for the treatment of KRASG12D mutation-related tumors including colorectal cancer and pancreatic cancer.
For example, Dai teaches the following compound falling in the genus of formula (II), highly similar to the compounds of the ‘196 patent, for the treatment of KRASG12D mutation-related tumors including colorectal cancer and pancreatic cancer:
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Dai, Specification, p. 130, paragraph [0450].
In some embodiments, the present disclosure provides a method of treating a disease or disorder, e.g., a cancer associated with G12D mutation of KRAS, HRAS and/or NRAS, such as a cancer associated with KRASG12а in a subject in need thereof. In some embodiments, the method comprises administering to the subject a therapeutically effective amount of a compound of the present disclosure (e.g., a compound of Formula I… Determining whether a tumor or cancer comprises a G12D mutation of KRAS, HRAS and/or NRAS is known in the art, either by a PCR kit or using DNA sequencing. In various embodiments, the cancer can be pancreatic, colorectal, lung, or endometrial cancer.
Dai, Specification, p. 80, paragraphs [0158-0159].
Therefore, claims 19-20 are rejected on the grounds of non-statutory double patenting as being obvious over the ‘196 patent in view of Dai.
Claims 1-15 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 18/880,291 (reference application) (herein “the ‘291 application”) in view of Dai et al. (US 2023/0242544 A1; published Aug. 3, 2023; effective filing date June 30, 2020). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to highly similar piperazine bridge-substituted KRASG12D inhibitors.
Claim 1 is directed towards a compound of formula (II), or a pharmaceutically acceptable salt thereof:
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. The ‘921 application claims highly similar KRASG12D inhibitors of the following formulas:
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. For example, the ‘291 application claims the compound:
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. While this compound differs from formula (II) in the R4 substituent, these compounds are so similar that one of ordinary skill in the art would expect similar properties. For example, Dai teaches similar KRASG12D inhibitors which have R4 as instantly claimed:
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Dai, Specification, p. 130, paragraph [0450].
Regarding ‘291 formula (II), this genus of compounds differs from instant formula (II) by a single nitrogen. One of ordinary skill in the art would have a reasonable expectation of success to replace this nitrogen with a carbon as instantly claimed because Dai teaches KRASG12D inhibitors of formula (II) wherein this group is a substituted carbon as shown above.
As such, claim 1 is provisionally rejected on the ground of nonstatutory double patenting.
Claims 2-15 read on the example compound of the ‘291 application except for the obvious replacement of R4 as taught by Dai and are therefore also provisionally rejected on the ground of nonstatutory double patenting for the rationale as given in claim 1.
Claim 19 is directed towards a method of treating KRASG12D mutation-related tumors in a subject in need thereof, comprising administering to the subject the compound of claim 1, or a pharmaceutically acceptable salt thereof. Claim 20 is directed towards the method of claim 19, wherein the tumors refer to colorectal cancer and pancreatic cancer.
One of ordinary skill in the art would have a reasonable expectation of success to apply the instantly claimed compounds for the treatment of KRASG12D mutant tumors because claim 19 of the ‘291 application are directed towards treating solid tumors with KRASG12D mutations in a subject in need thereof comprising administering the compound of claim 1 to the subject, and the compounds of the ‘291 application are so similar to the instantly claimed compounds that an ordinary artisan would expect similar properties.
While the ‘291 application does not specifically claim the treatment of colorectal and pancreatic cancer, one of ordinary skill in the art would have a reasonable expectation of success to apply the compounds of the instant invention to the treatment of these cancers because Dai teaches the instantly claimed compounds for the treatment of KRASG12D mutant pancreatic and colorectal cancer (Dai, Specification, p. 80, paragraphs [0158-0159]).
Therefore, claims 19-20 are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is found to be allowable.
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.
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/HEATHER DAHLIN/Examiner, Art Unit 1629