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/CN2022/073467, filed January 24, 2022, and claims foreign priority to CN202110172167.6, filed February 8, 2021 in the People’s Republic of China.
Claim Status
Claims 1-7, 9 and 12-17 are currently pending and subject to examination.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 15 been renumbered 16. Misnumbered claim 16 has been renumbered 17.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claims 1-4 and 6-11 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.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of claim 4 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn.
The rejection of claims 8 and 10 under 35 U.S.C. 101 is withdrawn.
The rejection of claim(s) 1-3 and 7-11 under 35 U.S.C. 102(a)(2) as being anticipated by Zhong et al. (12,338,253 B2, Published June 24, 2025) is withdrawn.
The above rejections were overcome by Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(b) – Previously Presented
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.”
Claim 5 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.
Response to Arguments
The Applicant argues that claim 5 is not indefinite because it has been amended to delete the scenario that removing a protecting group gives a compound of formula I (Remarks, p. 49). These arguments were fully considered but are not persuasive. Claim 5 still includes the indefinite scenario where the leaving group or H is attached to K but G binds to Q, and K does not bind to Q:
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(Claim 5).
Reiterated Rejection
Claim 5 is indefinite because it is unclear how G-K-H and G-K-L2 binds Q directly to G when the H or leaving group is on K, so K should be bound directly to Q.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d) – New Grounds of Rejection Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(d):
“(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.”
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
“Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.”
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 fails to limit the subject matter of claim 3 upon which it depends because claim 3 already requires that the compound be a compound of formula IV or formula V because formula IV and V are just different representations of formula I:
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(claim 12)
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(claim 1).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102 – Previously Presented
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.”
The rejection of claim(s) 4 under 35 U.S.C. 102(a)(2) as being anticipated by Zhong et al. (12,338,253 B2, Published June 24, 2025) is maintained.
In their response to arguments, the Applicant did not address the rejection of claim 4.
Claim 4 is directed towards the compound
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(claim 4, compound 235). Zhong teaches the compound:
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(Zhong, Specification, col. 57). This is the same compound as in claim 4 of the instant application.
Therefore, claim 4 is anticipated.
Claim Rejections – 35 USC § 103 – New Grounds of Rejection Necessitated by Amendment
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.
Claim(s) 1-7, 9, and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (12,338,253 B2, Published June 24, 2025).
The applied reference names another inventor (Ying Lu) not named on the instant application. The applied reference has a common applicant and joint inventor(s) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) 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 the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1 of the present application is directed towards a compound of formula I:
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. For example, a compound of formula (I) is
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(Specification, p. 18 and claim 4, compound 157).
Zhong teaches compounds which are highly similar to compounds of formula (I). For example, Zhong teaches compounds which differ from the above compound by the group G:
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(Zhong, Specification, col. 17),
While Zhong does not teach a species falling within formula (I), one of ordinary skill in the art would have a reasonable expectation of success to use the claimed group for G and arrive at the compound of formula (I) because Zhong teaches this subgenus modification.
For example, Zhong teaches that preferred groups for G are:
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(Zhong, Specification, col. 11).
Therefore, claim 1 was prima facie obvious at the time of filing.
Claims 2-4 and 12 read on the above compound and therefore were also prima facie obvious at the time of filing.
Claim 5 is directed towards a preparation method for the compound as claimed in claim 1, comprising the following steps:
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.
Claim 7 is directed towards a compound represented by formula I-1 as in claim 5. Zhong teaches this preparation method, a compound represented by formula I-1, and use of the compound of formula I-1 for manufacturing a compound of formula I, for example:
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Zhong, Specification, col. 93-94.
Therefore, claims 5 and 7 were prima facie obvious at the time of filing.
Claim 6 is directed towards a preparation method for a compound of formula II, comprising the following:
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. Claim 11 is directed towards a compound of formula II-1 as in claim 6.
Zhong teaches this preparation method and a compound of formula II-1:
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Zhong, col. 58-59.
Therefore, claims 6 and 11 were prima facie obvious at the time of filing.
Claim 9 is directed towards a pharmaceutical composition comprising at least one compound of formula I as in claim 1 and optionally a pharmaceutically acceptable excipient.
Zhong teaches pharmaceutical compositions comprising the compounds of the invention and a pharmaceutically acceptable excipient (Zhong, Specification, col. 35, lines 60-65).
Therefore, claim 9 was prima facie obvious at the time of filing.
Claim 13 is directed towards a method of treating a RET-kinase mediated disease, comprising administering a subject with an effective amount of a compound of claim 1. Claim 14 states that the RET kinase mediated disease comprises a gene mediated by a RET gene and/or a RET kinase.
Zhong teaches that the compounds of the invention can be used in such a method:
The present disclosure also provides a method for treating, arresting or preventing a disease or condition mediated by RET activity, which comprises: (1) determining whether the disease or discomfort is related to the dysregulation of the expression, activity or level of a RET gene, a RET kinase protein or any one or more thereof; and (2) if it is determined that the disease or discomfort is related to the dysregulation of the expression, activity or level of the RET gene, the RET kinase protein or any one or more thereof, administering to a patient an effective dose of the compound or the pharmaceutically acceptable salt thereof provided herein or the pharmaceutical composition provided herein.
As a preferred embodiment, the present disclosure also provides a preferred embodiment for the treatment method, wherein the disease or condition mediated by RET activity is cancer and/or cancerometastasis.
Zhong, Specification, col. 37, lines 36-67;
The present disclosure also provides a method for treating irritable bowel syndrome (IBS) and/or pain related to IBS in a patient in need of treatment, which comprises administering to the patient a therapeutically effective amount of the compound of formula I, or the stereoisomer, the racemate, the tautomer, the isotopically labeled compound, the nitrogen oxide or the pharmaceutically acceptable salt thereof, or the pharmaceutical composition thereof disclosed herein.
Id., col. 61, lines 3-10.
Therefore, claims 13-14 were prima facie obvious at the time of filing.
Claim 15 is directed towards the method of claim 14, wherein the RET kinases are selected from RET-WT, V804M, V804L, V804E, G810R, G810S, G810C, G810V, and S904F.
Zhong teaches that the RET kinases are as in claim 15:
The compounds disclosed herein can be used as a highly selective and/or very effective RET inhibitor. Such compounds have strong inhibitory effect on the RET gatekeeper residue mutant RET V804M, RET solvent-front residue mutant G810R and other clinically relevant RET mutants, as well as wt-RET.
Zhong, Specification, col. 67, lines 33-38;
The present disclosure also provides a method for treating an individual suffering from cancer related to RET, wherein the cancer has one or more RET inhibitor resistance mutations, and the RET inhibitor resistance mutations increase the resistance of the cancer to a RET inhibitor that is not at least one of the compound of formula I, and the stereoisomer, the racemate, the tautomer, the isotopically labeled compound, the nitrogen oxide and the pharmaceutically acceptable salt thereof (for example, substitutions at amino acid positions 804, 810 and 904, e.g. V804M, V804L, V804E, G810R, G810S, G810C, G810V and S904F), the method comprising administering at least one of the compound of formula I, and the stereoisomer, the racemate, the tautomer, the isotopically labeled compound, the nitrogen oxide and the pharmaceutically acceptable salt thereof before, during or after administering another anticancer drug.
Id., col. 62, lines 33-50.
Further mutations are listed in Zhong, Specification, col. 36-39.
Therefore, claim 15 was prima facie obvious at the time of filing.
Claim 16 is directed towards the method of claim 13, wherein the cancer is selected from a hematological cancer and a solid tumor.
Zhong teaches the treatment of cancers within the scope of claim 16:
As a preferred embodiment, the present disclosure also provides a preferred embodiment for the treatment method, wherein the disease mediated by RET activity is selected from one or more of the following diseases: lung cancer, papillary thyroid cancer, medullary thyroid cancer, differentiated thyroid cancer, recurrent thyroid cancer, poorly differentiated thyroid cancer, multiple endocrine neoplasia type 2A or 2B (MEN2A or MEN2B, respectively), pheochromocytoma, parathyroid hyperplasia, breast cancer, colorectal cancer, papillary renal cell carcinoma, gastrointestinal gangliocytoma (MEN2A or MEN2B, respectively), pheochromocytoma, parathyroid hyperplasia, breast cancer, colorectal cancer, papillary renal cell carcinoma, gastrointestinal gangliocytoma and a combination thereof.
Zhong, Specification, col. 39, lines 25-38.
Therefore, claim 16 was prima facie obvious at the time of filing.
Claim 17 is directed towards the method of claim 13, wherein the support care comprises preventing or minimizing a gastrointestinal condition associated with a treatment and diarrhea.
Zhong teaches this method:
The present disclosure also provides a method for providing supportive care for a cancer patient, including preventing or minimizing a gastrointestinal disease (for example, diarrhea) related to treatment (including chemotherapy treatment), which comprises administering to the patient a therapeutically effective amount of the compound of formula I, or the stereoisomer, the racemate, the tautomer, the isotopically labeled compound, the nitrogen oxide or the pharmaceutically acceptable salt thereof, or the pharmaceutical composition thereof disclosed herein.
Zhong, Specification, col. 61, lines 11-20.
Therefore, claim 17 was prima facie obvious at the time of filing.
Claim(s) 1-7, 9, and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (12,338,253 B2, Published June 24, 2025), as applied to claims 1-7, 9, and 12-17 above, and further in view of Enamine (“Piperazine Bioisosteres for Drug Design”, 2019, 1 page).
The rejection of claims 1-7, 9 and 12-17 as being obvious over Zhong is incorporated herein by reference.
Claim 1 of the present application is directed towards a compound of formula I:
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.
Zhong teaches compounds which are largely identical to formula I except for G. Zhong teaches compounds in which G is piperazine or bioisosteres of piperazine. For example:
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Zhong, Specification, col. 28.
For example, Zhong teaches that preferred groups for G are:
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(Zhong, Specification, col. 11).
These groups overlap with formula I as in claim 1. While Zhong does not teach that G is the specific spiro or fused heterocycles as in claim 1, one of ordinary skill in the art would have a reasonable expectation of success to substitute piperazine or the bridged heterocycles of Zhong for the spiro or fused heterocycles as in claim 1 because these are well known bioisosteres of piperazine.
For example, Enamine teaches these groups are bioisosteres of piperazine:
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Therefore, claim 1 was prima facie obvious at the time of filing.
Claims 2-4 and 12 also read on the compound of Zhong wherein the piperazine or bridged heterocycle is replaced with a fused or spiro heterocycle as in the above and thus were also 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 – New Grounds of Rejection Necessitated by Amendment
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.
Response to Arguments
The Applicant submits that the deletion of the compound
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renders the rejection moot. These arguments were fully considered but are not persuasive. The applicant did not delete this compound from claim 4.
Rejection
Claims 1-4, 6, 9 and 12-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-92 of U.S. Patent No. 12,338,253 B2 (herein “the ‘253 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘253 patent claims species which fall within the generic formula I claimed herein.
Claim 1 of the present application is directed towards a compound of formula I:
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. For example, a compound of formula I is
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(claim 4, compound 157).
The ‘253 patent claims compounds of formula I:
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(‘253 patent, claim 1), a subgenus of the instantly claimed formula I. For example, a compound claimed by the ‘253 patent is:
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(‘253 patent, claim 67). This compound differs from formula I by the G group, however, the ‘253 patent claims the same G group as in formula I:
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‘253 patent, claim 42.
Therefore, claim 1 is rejected on the ground of nonstatutory double patenting.
Claims 2-4 and 12 read on the compound above and are therefore also rejected on the ground of nonstatutory double patenting. Claim 4 also claims the same exact compound as shown in the 102(a)(2) rejection above, incorporated herein by reference.
Claim 6 is directed towards a preparation method for a compound of formula II, comprising the following:
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. Claim 11 is directed towards a compound of formula II-1 as in claim 6.
The ‘253 patent claims this method of synthesis and the compound of formula II-1:
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‘253 patent, claims 89 and 91.
Therefore, claims 6 and 11 are rejected on the grounds of nonstatutory double patenting.
Claim 9 is directed towards a pharmaceutical composition comprising at least one compound of formula I as in claim 1 and optionally a pharmaceutically acceptable excipient.
The ‘253 patent claims:
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‘253 patent, claim 69;
Therefore, claim 9 is rejected on the grounds of nonstatutory double patenting.
Claim 10 is directed towards a use of the compound in manufacturing a medicament for treating a RET kinase mediated disease, inhibiting RET kinase activity, treating a cancer and/or inhibiting a metastasis associated with the cancer, treating IBC or a pain associated with IBS, providing supportive care for a cancer patient, treating a disease or condition associated with RET, reversing or preventing acquired resistance to an anti-cancer drug, or delaying and/or preventing the development of resistance to an anticancer drug.
Claim 13 is directed towards a method of treating a RET-kinase mediated disease, comprising administering a subject with an effective amount of a compound of claim 1. Claim 14 states that the RET kinase mediated disease comprises a gene mediated by a RET gene and/or a RET kinase.
The ‘253 patent claims a method of treating a disease mediated by RET kinase activity:
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‘253 patent, claim 70.
Therefore, claim 13-14 are rejected on the grounds of nonstatutory double patenting.
Zhong teaches that the compounds of the invention can be used in such a method:
Claim 15 is directed towards the method of claim 14, wherein the RET kinases are selected from RET-WT, V804M, V804L, V804E, G810R, G810S, G810C, G810V, and S904F.
Zhong also claims these mutations:
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‘253 patent, claim 73.
Therefore, claim 15 is rejected on the ground of nonstatutory double patenting.
Claim 16 is directed towards the method of claim 13, wherein the cancer is selected from a hematological cancer and a solid tumor.
Zhong claims the treatment of cancers within the scope of claim 16:
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‘253, claim 77.
Therefore, claim 16 is rejected on the ground of nonstatutory double patenting.
Claims 1-4, 6, 9 and 12-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-92 of U.S. Patent No. 12,338,253 B2 (herein “the ‘253 patent”), and further in view of Enamine (“Piperazine Bioisosteres for Drug Design”, 2019, 1 page).
The rejection of claims 1-4, 6, 9 and 12-16 above as unpatentable over the ‘253 patent is incorporated herein by reference. The rejection of claims 1-7, 9 and 12-17 above as obvious over Zhong in view of Enamine is incorporated herein by reference.
Zhong claims compounds which are largely identical to formula I except for G. Zhong teaches compounds in which G is piperazine or bioisosteres of piperazine. For example:
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Zhong, claim 88.
For example, Zhong claims that preferred groups for G are:
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(Zhong, claim 42.
These groups overlap with formula I as in claim 1. While Zhong claim not teach that G is the specific spiro or fused heterocycles as in claim 1, one of ordinary skill in the art would have a reasonable expectation of success to substitute piperazine or the bridged heterocycles of Zhong for the spiro or fused heterocycles as in claim 1 because these are well known bioisosteres of piperazine.
For example, Enamine teaches these groups are bioisosteres of piperazine:
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Therefore, claim 1 is rejected on the ground of nonstatutory double patenting.
Claims 2-4 and 12 read on the compound of claim 1 above and therefore are also rejected on the ground of nonstatutory double patenting.
Claims 1-7, 9, and 12-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-92 of U.S. Patent No. 12,338,253 B2 (herein “the ‘253 patent”), as applied to claims 1-4, 6 and 9-11 above, and further in view of Zhong et al. (12,338,253 B2, Published June 24, 2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘253 patent claims species which fall within the generic formula I claimed herein and the method of synthesis is disclosed by Zhong, which is 102(a)(2) prior art.
The rejection of claims 1-4, 6, 9 and 12-16 above as unpatentable over the ‘253 patent is incorporated herein by reference. The rejection of claims 1-7, 9 and 12-17 above as obvious over Zhong is incorporated herein by reference.
Claims 5 and 7-8 are rejected on the grounds of obviousness type double patenting as unpatentable over the ‘253 patent in view of Zhong. While the ‘253 patent does not claim the method of synthesis as in claim 5 or the intermediates disclosed therein, it would be obvious to synthesize the compounds by the methods of claim 5 because Zhong teaches the method of claim 5 and the claimed intermediates, as shown in the 103 rejection above.
Claim 17 is directed towards the method of claim 13, wherein the support care comprises preventing or minimizing a gastrointestinal condition associated with a treatment and diarrhea.
Zhong teaches this method:
The present disclosure also provides a method for providing supportive care for a cancer patient, including preventing or minimizing a gastrointestinal disease (for example, diarrhea) related to treatment (including chemotherapy treatment), which comprises administering to the patient a therapeutically effective amount of the compound of formula I, or the stereoisomer, the racemate, the tautomer, the isotopically labeled compound, the nitrogen oxide or the pharmaceutically acceptable salt thereof, or the pharmaceutical composition thereof disclosed herein.
Zhong, Specification, col. 61, lines 11-20.
Therefore, claim 17 is rejected on the ground of nonstatutory double patenting.
Claims 1-4, 6, 9 and 12-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-92 of U.S. Patent No. 12,338,253 B2 (herein “the ‘253 patent”), as applied to claims 1-4, 6 and 9-11 above, and further in view of Andrews et al. (12,338,253 B2, Published June 24, 2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘253 patent claims species which fall within the generic formula I claimed herein and the method of synthesis is disclosed by Zhong, which is 102(a)(2) prior art.
The rejection of claims 1-4, 6 and 9-11 above as unpatentable over the ‘253 patent is incorporated herein by reference.
Claims 5 and 7-8 are rejected on the grounds of obviousness type double patenting as unpatentable over the ‘253 patent in view of Andrews. While the ‘253 patent does not claim the method of synthesis as in claim 5 or the intermediates disclosed therein, one of ordinary skill in the art would have a reasonable expectation of success to synthesize the compounds by the methods of claim 5 and use the claimed intermediates because Andrews teaches this reaction for similar compounds with the same reactive groups.
For example, Andrews teaches the intermediates similar to that claimed in claim 7:
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256
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(Andrews, Specification, col. 263) and
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165
241
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(Andrews, Specification, col. 322). Andrews teaches a specific reaction with the latter compound and K-L1 to produce compounds similar to the compounds of formula I:
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545
306
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Andrews, Specification, col. 323.
Therefore, claims 5 and 7-8 are rejected on the ground of obviousness type double patenting.
Claims 1-4 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-60 of copending Application No. 18/577,791 (reference application) (herein “the ‘791 application”). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed towards compounds of formula I, and the ‘791 application teaches species falling within formula I.
Claim 1 of the present application is directed towards a compound of formula I:
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195
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.
The ‘791 application claims a method of preparing compounds within a subgenus of instant formula I, and species close to the claimed genus:
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136
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(‘791, claim 46),
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128
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(‘791, claim 47), except for G, but the subgenus of the ‘791 application overlaps with the instant application:
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615
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(‘791 application, claim 46).
Therefore, claim 1 is provisionally rejected on the ground of nonstatutory double patenting.
Claims 2-4 read on the compound from claim 47 of the ‘791 application and are therefore provisionally rejected on the ground of nonstatutory double patenting.
Claim 7 is directed towards a compound represented by formula I-1 as in claim 5. Formula I-1:
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213
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(claim 5).
The ‘791 application claims a compound of formula I-1 and a method of manufacturing a compound of formula I from a compound of formula I-1:
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226
437
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‘791 Application, claim 46;
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281
514
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‘791 application, claim 48.
Therefore, claims 7 is 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.
Claims 1-5, 7, 9 and 12-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-60 of copending Application No. 18/577,791 (reference application) (herein “the ‘791 application”), as applied to claims 1-4 and 7-8 above, and further in view of Zhong et al. (12,338,253 B2, Published June 24, 2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are directed towards compounds of formula I, and the ‘791 application teaches species falling within formula I.
The rejection of claims 1-4 and 7-8 above as provisionally rejected over the ‘791 application is incorporated herein by reference. The rejection of claims 1-7, 9, and 12-17 above as obvious over Zhong is incorporated herein by reference.
While the ‘791 application does not claim the synthesis method as in claims 5-6, the intermediates as in claim 11, compositions comprising the compounds of formula I and uses of the compounds of formula I in the manufacture of medicaments or treatments, these methods would be obvious over Zhong as Zhong teaches compounds of formula I, the claimed synthesis methods, their intermediates, compositions comprising compounds of formula I, and uses of compounds of formula I.
Therefore, claims 5-6, 9 and 12-17 are provisionally rejected on the ground of obviousness type 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.
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.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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