DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to a compound of Formula (VI) or a salt, an isomer, or a mixture thereof, in the reply filed on July 31, 2026 is acknowledged.
The traversal is on the ground(s) that the restriction between Invention I, II, and III is improper, because the Examiner made no showing to demonstrate these invention groups are distinct under MPEP § 806.05(f); and fails to establish that the relationship between Invention I, II and IV is intermediate-final product relationship under MPEP § 806.05(j). Applicant further argues that Invention II and Invention III are both drawn to processes for preparing the compound of Invention I, and its use in preparation of Invention IV; and argues that the use of Invention I to prepare another product, i.e., compound of Formula (VII), rather than Invention IV cannot be used to establish the intermediate product (Invention I) is useful for making other products, because compound of Formula (VII) is another intermediate that can be used to synthesize product of Invention IV; and therefore, Formula (VI) does not have any other utility other than for preparing Aficamten. Applicant further argues the Examiner merely states “the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries)” in the restriction requirement, and that lack of elaboration is insufficient to establish why there would be a serious search and/or examination burden. Applicant argues the Examiner provides no specific explanation as to why the groups of inventions would require different fields of search.
This is not found persuasive for the reasons set forth below:
First, Applicant’s arguments against the restriction requirement appears to be grouping invention I, II, and III; and Invention I, II and IV together, and claiming that these groups of invention as a whole are not distinct; However, it is respectfully noted that a restriction requirement evaluates each invention group’s relationship to another invention group, rather than evaluating each invention group’s relationship to all other remaining invention groups collectively. In other words, the examiner evaluates the relationship between two invention groups at a time.
For example, Invention I (claim 1, drawn to compound of formula (VI)) was evaluated against Invention II (claims 2-3, 8-10, drawn to a process of preparing a compound of Formula (VI) and a process of preparing Aficamten); and then Invention I was evaluated against Invention III (claims 4-7 and 11, drawn to a process for the preparation of Aficamten), see the previous Office Action mailed on June 8, 2026. While applicant acknowledged the process of making (Invention II) and product made (Invention I) are considered distinct if one out of the two conditions specified under MPEP § 806.05(f) are met, applicant appears to neglect the fact that the Examiner has established that the process of making (Invention II) can be used to prepare Aficamten, which is evidenced by the disclosure; and said Aficamten is clearly structurally different than compound of formula (VI) that would require the use of different search strategies.
In addition, applicant appears to mischaracterize the restriction requirement by incorrectly stating the relationship between each invention, e.g., between Invention I and Invention III, and between Invention II and Invention IV. For example, applicant traverses the restriction requirement between Invention I and III by citing MPEP § 806.05(f), drawn to process of making and a product made by the process, and argues that the Examiner demonstrates no showing. However, the Examiner has clearly established that Invention III is drawn to process that “uses” the product of Invention I to prepare Aficamten, and that process by itself cannot make the compound of Formula (VI). If Applicant contends the Invention III prepares compound of Formula (VI), the Examiner respectfully request applicant to particularly point out which reaction step positively recited therein is an active step of “preparing” compound of Formula (VI). As stated therein, product and process inventions are considered unrelated if one of the conditions under MPEP § 806.06 are met, and that is the product cannot be used in, or made by, the process. Given that the product of Invention I cannot be made by Invention III as set forth in the previous Office Action, Invention I and III is clearly distinct. Another example is that applicant argues that Invention II and IV has intermediate-final “product” relationship; However, Invention II is clearly not a product, but a process of making. Since the relationship between Invention II and Invention IV presented by the applicant is improper, the arguments are not found persuasive.
With respect to applicant’s argument that Invention I and IV are not patentably distinct, because the use of product of Invention I for synthesizing compound of Formula (VII) cannot be considered as making a product other than Aficamten, because said compound of Formula (VII) is also an intermediate that does not have utility other than synthesizing Aficamten. Said argument appears to be mere argument without factual support. Soley to rebut applicant’s argument that other product, i.e., compound of Formula (VII), has no utility, it is respectfully noted that said compound of Formula (VII) is taught to have other utility according to Chuang et al., such as administering to a subject or preparing Compound No. 551, as set forth in the rejection under 35 USC § 103 below. Lastly, applicant argues the Examiner merely states “the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries)”, and that is insufficient to establish search burden because there is no further elaboration. Said argument is not found persuasive, because the restriction requirement does not only contain such statement. Rather, the restriction requirement explicitly states the classification for each group of invention, and the relationship between each invention pairs are carefully evaluated, and explained why they are considered patentably distinct, for instance, having a different structure or involves different active process steps; and these are clearly an indicator that these differences would require searching different classes/subclass or employing different search strategies summarized in such statement.
In view of the foregoing, applicant’s assertion that the Examiner demonstrates no showing to demonstrate distraction between the groups of inventions appears to be mere argument, because applicant did not particularly point out the supposed errors in each analysis between the invention pairs, and appears to be grouping the inventions incorrectly. Thus, they are not found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2-14 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. Applicant timely traversed the restriction (election) requirement in the reply filed on July 31, 2026.
Status of Claims
Claims 1-14 are pending.
Claims 2-14 are withdrawn.
Claim 1 is under examination in accordance with the elected invention.
Priority
The instant application 18/767,551 filed on July 9, 2024 claims priority to, and the benefits of Foreign Application No. IN202321046243 filed on July 10, 2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 9, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
The amendment to the claims filed on July 31, 2026 is object to under 37 CFR.1.121(c). Claim 8
has been amended to indicate a status identifier “(Currently Amended”; However, said claim does not present with any marking to show the changes as required by 37 CFR 1.121(c)(2). Applicant is required to submit a compliant amendment clearly indicate a status identifier, identifying all additions and deletions to the claim(s). See MPEP 714 and 37 CFR 1.121 with respect to Manner of making amendments in application.
Appropriate correction is required.
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 the abstract contains typographical error, for example, “provides t a novel” includes the term “t” in the phrase and appears to be a typographical error; and appears to contain phrases that a grammatically incorrect, for example, “the provides a method” in line 4. The abstract also contains phrases which can be implied, specifically, the abstract repeatedly described the claimed invention is “novel” or “new”, for instance, “new process” and “novel intermediate compound” are repeatedly recited. Said term “novel” and “new” should deleted from the language of the abstract. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer novel or new, since the scope of the invention no longer embraces what is considered “novel” or “new”. Thus, the incorporation of the term “novel” or “new” into the language of the abstract is not appropriate. Appropriate correction is required.
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).
According to MPEP § 606 with respect to the Title of Invention, the term “New” should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer novel or new, since the scope of the invention no longer embraces what is considered “new”. Thus, the incorporation of the term “new” into the title of the Invention is not appropriate.
The following title is suggested: “PROCESS FOR PREPARATION OF AFICAMTEN”
The disclosure is objected to because of the following informalities:
the specification repeatedly recites the term “novel” or “new” to describe the inventions, for instance, “new process” (see e.g., [0002]) and “novel intermediate compound” (see e.g., [0002]). The term “novel” or “new” should be deleted from the language of the disclosure. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer novel or new, since the scope of the invention no longer embraces what is considered “novel” or “new”. Thus, the incorporation of the term “novel” or “new” into the language of the specification is not appropriate.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Chuang et al. (WO 2019/144041 A1; cited in the IDS filed on July 9, 2024), in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176).
Chung et al. teaches an intermediate 44-3, (R)-N-(5-cyano-2,3-dihydro-1H-inden-1-yl)-1-methyl
-1H-pyrazole-4-cartaoxamide, having the structure of:
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212
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(referring to herein as “Compound 44-3”), which is an intermediate synthesized in the process of synthesizing compound 551 (see e.g., Example 44, [0407]); and further teaches any of the compounds may be used in the methods detailed therein, including, where applicable, intermediate compounds that may be isolated and administered to an individual or subject (see e.g., [0127]). Chung et al. further teaches the compounds and pharmaceutical compositions disclosed therein are believed to act by inhibiting myosin (see e.g., [0140]). Chung et al. further teaches the compounds disclosed and/or described therein include all possible enantiomers, diastereomers, meso isomers and other stereoisomeric forms, including racemic mixtures, optically pure forms and intermediate mixtures thereof (see e.g., [0049]); or may present as salts (see e.g., [0128]). Chung et al. further teaches "halogen" or "halo" refers to fluorine, chlorine, bromine or iodine (see e.g., [0048]).
Chaung et al. does not teach the compound of Formula (VI).
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g.,
“introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar
biological activity, and have been classified as either classical or nonclassical, wherein the classical
bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and
Erlenmeyer’s definition of isosteres shown below:
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470
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464
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(see e.g., p. 3148-3149). Patani et al. further teaches in nonclassical bioisosteres of halogens, halogens have been replaced by electron-withdrawing groups such as cyano or trifluoromethyl group; and further teaches such nonclassical replacements were illustrated in structure-activity relationship study of cholescytokinin-A receptor antagonist shown below:
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314
393
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, and results in retention of antagonistic activity at the CCK-A receptor (see e.g., p. 3172, “6. Halogen Bioisosteres”).
In this case, the difference between the compound 44-3 of Chung et al. and the claimed compound of Formula (VI) is shown below:
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168
445
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by selecting the Compound 44-3 of Chung et al., and then modifying said compound by replacing the cyano moiety (–C≡N) with bromine as the halogen as taught by Patani et al. One would have been motivated to modify compound 44-3 of Chung et al. by selecting bromine as the halogen in place of the cyano substituted on the benzocyclopentane core, because Patani et al. teaches that the replacement of cyano (–C≡N) with halogen constitutes a nonclassical biososteric replacement and that such bioisosteric substitutions are employed in medicinal chemistry for the rational modification of lead compounds to obtain structurally related compounds having similar biological activity; and Chung et al. teaches Compound 44-3 is an intermediate compound that can be administered to an individual or subject for the method described therein, including inhibiting myosin, and teaches halogens includes bromine. Accordingly, one of ordinary skill in the art seeking to arrive at additional analogs of Compound 44-3 would have been motivated to employ the known halogen/cyano bioisosteric replacement technique, including bromine as the halogen, because such modification was a recognized medicinal-chemistry approach for obtaining structurally related analogs while seeking to preserve the biological activity of compound 44-3. One would have reasonably expected that selecting bromine as the halogen to replace the cyano substituted on the benzocyclopentane would provide the corresponding analog while retaining the biological activity associated with compound 44-3’s myosin inhibiting scaffold, thereby arriving at the claimed invention with a reasonable expectation of success.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the
time the application was filed, absent factual evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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