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 1-5, 17-20, 23, 26, 27, 29-32, 37-40 and 44 are pending in the application. Claims 1-5, 17, 18, 20, 23, 29, 30, 38 and 39 are rejected. Claim 1, 2 and 27 are objected to. Claims 19, 26, 31, 32, 37, 40 and 44 are withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of Group I, claims 1-5, 17-20, 23, 26, 27, 29-32 and 37-40, and further elected species of “compound 1.012” having the following structure in the reply filed on February 3, 2026 is acknowledged:
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As per MPEP § 803.02(III), the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species appears to be free of the prior art. Therefore, according to MPEP § 803.02(III): should the elected species be found allowable over the prior art, the examination of the Markush claim will be extended. The prior art search will be extended to cover non-elected species or group of species that falls within the scope of a proper Markush grouping which includes the elected species. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping. However, if prior art is found that anticipates or renders obvious the Markush claims with respect to a nonelected species, the Markush claims shall be rejected and claims to the nonelected species held withdrawn from further consideration. Consequently, the prior art search was extended to include the following non-elected species:
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Claims 19, 26, 31, 32, 37, 40 and 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 3, 2026.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2021/036678, filed on June 9, 2021, which claims benefit of Provisional Application No. 63/037,106, filed on June 10, 2020.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on July 17, 2023 and February 3, 2026 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
Claim 1 should be amended to replace “each Re and Rf are independently selected from the group” with “each Re and Rf is independently selected from the group” for sake of clarity. See “Rc and Rd” variable definitions on page 3.
Claim 2 should be amended to replace “each Re and Rf are independently selected from the group” with “each Re and Rf is independently selected from the group” for sake of clarity. See “Rc and Rd” variable definitions on page 5.
Appropriate correction is required.
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 38 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 38 is rejected because it refers to “Table 1” of the instant specification. A claim should particularly point out and distinctly claim the subject matter which the applicant regards as his invention and, under modern claim practice, stand alone to define the invention. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)” It is suggested that Applicant amend claim 38 to recite the compounds disclosed in “Table 1” by name and/or structure.
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.
Claims 1-5, 17, 18, 20, 23, 29, 30, 38 and 39 are rejected under 35 U.S.C. § 103 as being unpatentable over Alam et al. (PCT Publication No. WO 2020/123395 A1; claims benefit of Provisional Application 62/835,853 filed on April 18, 2019).
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.
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Regarding instant claims 1-5, 17, 18, 20, 23, 29, 30, 38 and 39, the broadest disclosure of the prior art invention is represented by the prior art genus (reproduced below) of a compound of Formula (IA’) (see e.g., page 2).
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The prior art also teaches “Formula (IA’) administered in a pharmaceutical composition” and “at least one pharmaceutically acceptable excipient.” See e.g., paragraphs [0012] and [0014]. Furthermore, the prior art teaches Compound 262 having the following chemical structure (see e.g., page 73):
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Compound 262 is encompassed by variable definitions of the prior art Formula (IA’), wherein “w” is CH; “x” is CH; “y” is C-halo; “z” is CH; “R1” is “-Xa-R7,” further wherein “Xa” is “alkylene” (i.e., methylene) and “R7” is “heteroaryl” (i.e., imidazole); and “R2” is -NH-alkyl. See e.g., pages 2 and 3.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 1-5, 17, 18, 20, 23, 29, 30, 38 and 39, the prior art Compound 262 does not read on the instantly claimed compound of Formula I. Namely, the proviso recited in instant claim 1 precludes applying the prior art Compound 262 in an anticipatory rejection. However, the prior art teaches variable “R1” of the prior art Formula (IA’) is defined as “-Xa-R7” wherein “Xa” is “alkylene.” See e.g., page 3. Furthermore, the term “alkylene” is defined in the prior art as follows in paragraph [0030]:
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Therefore, the prior art provides support for the position corresponding to variable “Xa” (indicated below) in Formula (IA’) to be an alkylene other than a methylene.
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For instance, in the prior art Compound 775 (shown below), the “alkylene” (i.e., variable “Xa”) corresponds to an ethylene group (see e.g., page 147):
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As the prior art appears to prefer the non-terminal substitution of variable “Xa” with variable “R7” when “Xa” is an ethylene unit, replacing the methylene of Compound 262 with an ethylene would result, for instance, in the following homologous structure or positional isomer of Compound 262:
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The resulting homolog/positional isomer is encompassed by the instantly claimed compound of Formula I, wherein A is
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; Z is CH; Rc is H; Rd is C1 alkyl; R1 is C1 halo (i.e., chloro); R2 is H; Ra is H; and Rb is C1 alkyl. Accordingly, the prior art teaches a homolog/positional isomer of the instantly claimed compound of Formula I. MPEP § 2144.09 states that homology and isomerism are facts that must be considered with all other relevant facts in determining obviousness. 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) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1-5, 17, 18, 20, 23, 29, 30, 38 and 39, it would, therefore, have been obvious to a person of ordinary skill in the art to arrive at the instant invention by replacing the methylene group (i.e., variable “Xa”) of Compound 262 with an ethylene group (as seen for variable “Xa” in Compound 775). Compounds that differ only by the presence or absence of an extra methyl group are considered to be homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. As stated in In re Grose, 201 USPQ 57, 63, “The known structural relationship between adjacent homologues, for example, supplies a chemical theory upon which a prima facie case of obviousness of a compound may rest.” The homologue is expected to be preparable by the same method and to possess the same general properties. Therefore, at least in the interest of preparing additional methionine adenosyltransferase 1A inhibitor compounds for further experimental analysis, a person of ordinary skill would have been motivated to prepare a homologue of the prior art Compound 262. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210, 1214. See MPEP § 2144.09.
Allowable Subject Matter
Claim 27 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-5, 17, 18, 20, 23, 29, 30, 38 and 39 are rejected. Claim 1, 2 and 27 are objected to. Claims 19, 26, 31, 32, 37, 40 and 44 are withdrawn.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626