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, 3, 5, 10-11, 14, 18-19, 21, 24 and 38-51 are pending
Claims 50-51 are withdrawn from examination as being drawn to a nonelected specie.
Claims 1, 3, 5, 10-11, 14, 18-19, 21, 24 and 38-49 are under consideration in the instant office action.
Election/Restrictions
Applicant’s election without traverse of Group I and the the following species in their response dated 07/14/2025 is acknowledged.
Specie 1: Compound: Applicants elect the following compound 1-4
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Upon further consideration, election of specie requirement is withdrawn and the claims are examined for all the species they encompass.. Claims 50-51 are withdrawn from examination as being drawn to a nonelected specie.
Claims 1, 3, 5, 10-11, 14, 18-19, 21, 24 and 38-49 are under examination and the requirement for restriction is made final.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/12/2025, 10/22/2025 and 4/9/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application is a national phase application under 35 U.S.C. 371 of International Application No. PCT/US2022/04891 1, filed November 4, 2022, which claims the benefit of priority of U.S. Provisional Application No. 63/275,765, filed November 4, 2021.
Written Description rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5, 10-11, 14, 18-19, 21, 24 and 38-49 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claims contain subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, that Applicant had possession of the claimed invention.
As the Federal Circuit has stated:
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872, F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989).
The factors considered in the Written Description requirement are:
(1) level of skill and knowledge in the art,
(2) partial structure,
(3) physical and/or chemical properties,
(4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and
(5) the method of making the claimed invention.
In the instant case, the claims are drawn to compounds found within the Markush group of Formula I:
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It is noted that the applicants claim optionally substituted moieties for many of these variables such as R1, R2, R3, R4, etc. without defining the substituents. As such the possible substituent includes an unlimited group of chemical residues and could even include biological moieties absence of the definition. the variables as shown above represent an enormous genus.
Moreover, Applicant’s specific examples of compounds generally show only a limited number of variables, and do not show many of the broadly claimed groups.
(1) Level of skill and knowledge in the art:
The level of skill to practice the art of the instantly claimed invention is high with regard to synthesis, isolation and structural characterization. Further, the bioassays and structure function assays require a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks
(2) Partial structure: (3) Physical and/or chemical properties: and (4) Functional characteristics:
The partial structure is that of the Markush shown above. Within the Markush are numerous subgenus that are unrelated to one another as indicated by the variables with optionally substituted moieties. Thus, taken together there are literally tens of thousands of structures that are unrelated in a common core.
As provided above, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that Claim 1 is a broad generic claim, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless to any class of compound claimed in a Markush where nearly every position is a variant.
Thre are test results discloses in the instant specification on pages 178-179, compounds 1-125, but while having written description for these compounds, these compounds hardly begin to represent the scope of the genus represented in the Markush.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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 1,3, 5, 21 and 24 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Arimori et al. (WO 2017/110863) (reference already of record)
Instant claims are drawn to a compound of formula (I) shown below with variables as recited in the claims.
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Amori et al. discloses the following compounds T513, T532, T1500, T1519, T73044 and T3063 on pages (41-80)
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Therefore the compounds disclosed by Arimori et al. fully anticipates instant claims 1-5, 7 and 8
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 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.
Claims 1, 3, 5, 10-11, 14, 18-19, 21, 24 and 38-49 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Arimori et al, (WO 2017/110863) and Zheng et al. (Wo 2016/126721 in view of Sida Shen et al. (Expert opinion on therapeutic patients volume 30, no 2, 2019, pages 121-136) (all references are already of record)
Instant claims are drawn to a compound of formula (I) shown below with variables as recited in the claims.
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Arimori et al. discloses the following compounds T513, T532, T1500, T1519, T73044 and T3063 on pages (41-80) which are encompassed by the instatnly claimed compound of formula 1 above.
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Zhang et al. discloses the following compounds of formula I which has the same core structure as instantly claimed (Pages 3-5, claim 1).
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The teach the following compounds which shows the hydroxamate moiety attached to the core (Table 3, page 49)
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The compounds of Zhang et al. differ from the instant compounds , where it has an hydroxamic group instead of the instantly claimed oxadiazole group.
Sida Shen et al. discloses that a person of ordinary skill in the art is aware that most HDAC inhibitors (HDACi) share a common pharmacophore that consists of a zinc-binding group (ZBG) that coordinates with the Zinc Ion located in the bottom of the catalytic cavity, a linker that occupies the hydrophobic tunnel and a a capping group (Cap) that interacts with the rim of the pocket (as illustrated for the HDAC6i Nexurastat A (I) on page 122)
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On page 131, section 5.3, Sida Shen et al. teaches that the trifluoromethyl oxadiazole has been shown to be a useful alternative ZBG to the hydroxamate group. This information is also derivable from the specific inhibitors they disclose which shows that the hydroxamic group can be replaced by an oxadiazole group.
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They further disclose that pheylhdoxamate ha prove a very useful scaffold in the discovery of potent and selective HDAC6 inhibitors, however, weakness of the hydroxamate function such as metabolic instability and mutagenic potential limit its application in the neurological field, where long-term administration is required. They further teach that the recent invention of oxadiazole-based ligands by pharmaceutical companies may provide a new opportunity to optimize the druglike properties of HDAC6i for the treatment of neurodegenerative disease (page 121).
As such it would have been prima facia obvious to a person of ordinary skill in the art to arrive at the instantly claimed compounds motivated and guided by the combined teachings of Arimori et al., Zhang et al. and Sida Shen et al.. An ordinarily skilled artisan would be motivated from Sida Shen et al. and Amari et al. to arrive at the instantly claimed compounds by chemically modifying the compounds of Zhang et al. by replacing the hydroxamic groups with the oxadiazole groups. Sida Shen et al provides explicit motivation with the teachings of the advantage of the oxadiazole-based ligands over the hydroxamate, thus imbuing the ordinary skilled artisan with a reasonable expectation of success, absence of evidence to the contrary.
Conclusion
Claims 1, 3, 5, 10-11, 14, 18-19, 21, 24 and 38-49 are rejected. No claims are allowed Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dierdre (Renee) Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691
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