DETAILED ACTION
Receipt of Arguments/Remarks filed on August 26 2026 is acknowledged. Claims 1-14 were/stand cancelled. Claims 15-16 were amended. Claims 15-28 are pending. Claims 19-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 March 17 2026. Claims 15-18 are directed to the elected invention.
Regarding the previous election, in light of the submission of the certified English translation of the FOR priority document and the withdrawal of the rejection over Matsumoto et al. (see below), the previously elected species of JM608 as well as JM642 are free of prior art. The previous election was expanded and still in includes in this rejection the compound of Barbosa et al.
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
Acknowledgement is made of the certified English translation of FOR JAPAN 2020-088499 (05/20/2020) filed August 26 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 20 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Rejections
The amendments filed August 26 2026 are sufficient to overcome the rejection of claims 12 and 14-15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. The cancellation of claims 12 and 14 has rendered these rejections moot. Regarding claim 15, while the examiner does not necessarily agree with applicants’ arguments as the instant claims are not directed to a polymer and end groups which are just bonds are typically identified by a * or a squiggly line. The specification does teach in paragraph 0046 may be directly linked to each other or may be linked (the specification states liked but the examiner believes that is a typo) via a linking group. Therefore, in light of the arguments made by Applicants, the scope of claim 15 is interpreted as a compound which has at least one of the structure shown within the parentheses, but more than one can be part of the compound. There can be any number of atoms between structural units or in the rest of the compound as whole. The end groups are free/open bonds.
The amendments filed August 26 2026 are sufficient to overcome the rejection of claims 11-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims were cancelled.
The submission of the certified English translation of the FOR priority document filed August 26 2026 is sufficient to overcome the rejection of claim(s) 11-18 over Matsumoto et al.
The cancellation of claims 11-13 in the response filed August 26 2026 are sufficient to overcome the rejection over Li et al.
The amendments filed August 26 2026 are sufficient to overcome the rejection of claim 15 under 35 USC 102(a)(1) over Barbosa et al. The claim as amended requires R1 to be an aromatic ring group.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Barbosa et al. (WO2008089307, cited in the Office Action mailed on 12/17/25).
Applicant Claims
The instant application claims the R1 is an aromatic ring group.
The instant application claims a composition comprising the compound and a pharmaceutically acceptable additive.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Barbosa et al. is directed to methods and compositions for the treatment of pain, inflammation and cancer.
A specific compound taught is shown below (claim 116; page 85 line 24).
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CAS Name: N-[1-[(3-Chlorophenyl)amino]-3-isoquinolinyl]acetamide
This compound contains a structural unit that encompasses 1A wherein the substituent is H.
Barbosa et al. teaches
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(claim 106; page 76). Pharmaceutical composition comprising the inhibitor and a pharmaceutically acceptable excipient or diluent is claimed (claim 117).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
While Barbosa et al. teaches R1 can be a variety of different aryl (aka aromatic) substituents, Barbosa et al. does not exemplify an isoquinolinyl acetamide with a R1 substituent other than H. While Barbosa et al. suggests compositions with an excipient or diluent, Barbosa et al. does not exemplify the isoquinolinyl acetamide with an excipient or diluent.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the R1 H of N-[1-[(3-Chlorophenyl)amino]-3-isoquinolinyl]acetamide with an aryl or heteroaryl. It would have been obvious to one of ordinary skill in the art to try any of the specifically taught R1 substituents as a person with ordinary skill has good reason to pursue known options within his or her technical grasp. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an excipient or diluent with the N-[1-[(3-Chlorophenyl)amino]-3-isoquinolinyl]acetamide or the aryl/heteroaryl substituted acetamide to form a pharmaceutical composition. One skilled in the art would have been motivated to utilize a pharmaceutical composition with an excipient or diluent as Barbosa et al. expressly teaches combining the compounds of the invention with an excipient or diluent. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2143 KSR International Co. v. Teleflex Inc., 550 US 398, 82 USPQ 2d 1385 (2007). Either excipient or diluent is an additive as claimed.
Regarding the scope of the claims as amended, as set forth above Barbosa et al. teaches
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Therefore, does Barbosa et al. not only expressly teach aryl, alkylaryl, arylkalkyl, heterocycle, alkylheterocycle or heterocyclealkyl which read on the instantly claimed aromatic group. Other species taught for R1 include OR1A, N(R1A) and NC(O)R1A which when R1A is aryl, alkylaryl, arylalkyl, heterocycle, alkylheterocycle or heterocyclealkyl, these also read on “an aromatic group”. Therefore, when claim 76 is considered as a whole, Barbosa expressly teaches numerous groups reading on the claims. As set forth in the specifically taught compounds R4 can be acetamide (claim 116 identified above).
Regarding claim 16, firstly, the examiner notes that as claim n can 0 and thus the aromatic group does not need to contain a substitution (the X group). As set forth in the definitions of Barbosa et al., aryl means an aromatic ring and includes phenyl. Heteroaryl means an aryl moiety wherein at least one of its carbon atoms has been replaced with a heteroatom which includes pyridyl, etc. Heterocycles include furanyl, etc. (pages 5-6; lines 12-32; 1-16).
Response to Arguments
Applicants’ arguments filed August 26 2026 have been fully considered but they are not persuasive.
Applicants argue that (1) the cited art fails to make obvious the amended claim set as presented. The present invention is based on the inventors finding that a novel compound containing a specific structural unit is effect for treatment of repeat expansion disease based on a specific metric. The invention R1 is particularly preferably an aromatic ring. Because Barbosa et al. neither describes nor suggests compounds binding to a repeat sequence, the above effects of the present invention cannot be expected.
Regarding Applicants’ first argument, firstly, the claims are directed to a compound. Thus, in order to anticipate or render obvious the claimed compound, the prior art merely needs to teach or suggest the same structure. The compounds are not required to possess any particular effect. Furthermore, while R1 is preferably an aromatic ring, nothing in the arguments points to any comparison or any data which establishes an unexpected effect of the aromatic ring compared to other substituents (such as H or alkyl). The instant specification teaches two specific compounds, JM608 and JM642, which the examiner has already indicated is free of prior art (see above). However, the instant claims are much broader in scope than those two compounds and nothing in the specification or the remarks indicate an unexpected effect over the full scope of compounds claimed. The claimed compounds are obvious for the reasons set forth above.
Applicants argue that (2) an invention is not patentable 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. It is argued that evaluation of prima facie case of obviousness of new chemical compounds in light of structurally similar prior art entails a two part. First, what a chemist would have selected as a lead compound and second whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound. It is argued that that one skilled in the art would not have been motivated to modify the compound in the manner of the present invention with a reasonable expectation of success. Applicants argue that there must be a finite number of identified predictable solutions. An obviousness analysis must consider the breadth and number of choices available. Applicants point to case law regarding homologation and ring-walking as well as positional isomers. It is argued that nothing in the prior art provides a teaching or suggestion for making the specific molecular modification.
Regarding Applicants’ second argument, the examiner cannot agree. As set forth in the rejection a compound expressly taught by Barbosa is:
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which corresponds to the instant 1A (inside parentheses) except that there is no aromatic substitution on the isoquinoline ring. The examiner further notes that as argued in response to the 112(b) rejection the structure of 1A includes bonds and thus the rest of the molecule can be anything. Therefore the chlorophenyl of the prior arts compound is not excluded by the instant claim language. Barbosa et al. teaches
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(claim 106; page 76).
The expressly taught compound falls within this scope wherein R4 is an alkylacetamide, R3 is halo and R1 is hydrogen. It is the examiner’s position that it would have been obvious to one of ordinary skill, starting from this expressly taught compound, to substitute R1 of hydrogen with any of the other specifically taught R1. Barbosa et al. not only expressly teach aryl, alkylaryl, arylkalkyl, heterocycle, alkylheterocycle or heterocyclealkyl which read on the instantly claimed aromatic group. Other species taught for R1 include OR1A, N(R1A) and NC(O)R1A which when R1A is aryl, alkylaryl, arylalkyl, heterocycle, alkylheterocycle or heterocyclealkyl, these also read on “an aromatic group”. Aryl groups specifically taught include phenyl as well as furan reading on the expressly recited aromatic groups of claim 16.
Therefore, contrary to Applicants arguments, Barbosa et al. teaches a finite list of compounds for R1 of which many read on the instantly claimed “an aromatic group” and the specifically claimed phenyl and furanyl groups. This is not a homolog or positional isomer argument as the only selection required is a particular species of R1. The federal Circuit has made it clear that from the perspective of the law of obviousness, any known compound might possibly serve as a lead compound. MPEP 2143. Here, the rejection is based on the generic formula taught in Barbosa et al. then starting from an expressly taught compound and then the obviousness of utilizing other expressly taught substituents other than hydrogen on the ring. Since Applicants have not demonstrated any unexpected effect of the claimed aromatic group compared to other substituents such as hydrogen or alkyl, the rejection is maintained. The examiner notes that the teachings of Barbosa et al. as inhibiting Δ5-desaturase activity does not affect patentability because nothing in the claims requires binding to CUG repeats. Furthermore, even if the claim did recite such language, this ability flows from the structure of the compounds and the same compounds in Barbosa et al. are taught.
Conclusion
Applicants’ 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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