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 23-37 are pending in the application. Claims 23-37 are rejected. Claim 37 is objected to.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 18, 2026 has been entered.
Priority
This application claims benefit of Provisional Application No. 63/488,007, filed on March 2, 2023, which claims benefit of Provisional Application No. 63/421,844, filed on November 2, 2022, which claims benefit of Provisional Application No. 63/403,515, filed on September 2, 2022.
Restriction
As indicated previously, pursuant to MPEP § 803.02, the Markush claims that read on Applicant’s elected species (structure shown below) were examined fully with respect to the elected species.
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Upon examination, the elected species was found to be anticipated or rendered obvious by prior art; therefore, the Markush claim and claims to the elected species was rejected. The claim(s) and subject matter that did not read on the elected species were NOT examined and searched and were withdrawn from further consideration by the examiner. Accordingly, the search and examination was extended to include the following compounds:
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In response to Applicant’s amendments, filed on May 18, 2026, the Examiner has extended the search and examination to further include the following compounds:
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and
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Response to Amendments
Objections and rejections made in the Office Action mailed February 25, 2026 that do not appear below have been overcome by Applicant’s amendments to the claims and have been withdrawn.
Claim Objections
Claim 37 is objected to because of the following informalities:
Claim 37 should be amended to replace “a compound of claim 23” with -the compound of claim 23- for sake of consistency.
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 23-33 and 37 are 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 23 recites the expression “compound having a structural Formula I” and is rejected as indefinite. The term “having” is open-ended; therefore, it is unclear what additional, unrecited elements- if any- Applicant intended the claim to encompass. It is suggested Applicant replace the aforementioned open-ended expression with a closed-ended transitional phrase which limits the claim to the recited Formula I. Dependent claims 24-33 and 37 do not correct this issue of indefiniteness and are hence rejected.
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.
(1 of 3) Claims 23-31 and 34-37 are rejected under 35 U.S.C. § 102(a)(1) and 35 U.S.C. § 102(a)(2) as being anticipated by Tian et al. (PCT Publication No. WO 2022/166762 A1; August 11, 2022).
Tian et al. teach Compound 1-10-2 having the following chemical structure (see e.g., page 99):
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Regarding instant claims 23-26, 29-31 and 34, the above prior art compound is encompassed by variable definitions of the instantly claimed compound having a structural Formula I, wherein Rj represents hydrogen; Rk is
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, further wherein R2 is hydrogen; R3 is OH; and R4 is –(CH2)nNH2 where n is 1.
Regarding instant claims 27-31 and 34, the above prior art compound is encompassed by variable definitions of the instantly claimed compound having a structural Formula I, wherein Rj represents hydrogen; Rk is
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, further wherein R2 is OH; R3 is hydrogen; and R4 is –(CH2)nNH2 where n is 1.
Regarding instant claim 35, the above prior art compound corresponds to at least the following (i.e., the first compound as recited on page 12 of the claims filed on May 18, 2026):
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Regarding instant claim 36, the above prior art compound corresponds to at least the following (i.e., the second compound as recited on page 24 of the claims filed on May 18, 2026):
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Regarding instant claim 37, the prior art teaches pharmaceutical compositions comprising one or more pharmaceutically acceptable carriers. See e.g., page 174 of attached machine translation.
(2 of 3) Claims 23-28 and 30-32 are rejected under 35 U.S.C. § 102(a)(1) and 35 U.S.C. § 102(a)(2) as being anticipated by Chinese Application No. CN111689980A (September 22, 2020).
The prior art teaches the following chemical compound (see e.g., page 3):
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Regarding instant claims 23-28, 30 and 32, the above prior art compound is encompassed by variable definitions of the instantly claimed compound having a structural Formula I, wherein Rj represents hydrogen; Rk is
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, further wherein R2 is -C1 alkyl; R3 is OH; and R4 is -C1 alkyl.
Regarding instant claims 23-28 and 30-32, the above prior art compound is encompassed by variable definitions of the instantly claimed compound having a structural Formula I, wherein Rj represents hydrogen; Rk is
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, further wherein R2 is -C1 alkyl; R3 is -C1 alkyl; and R4 is OH.
(3 of 3) Claim 36 is rejected under 35 U.S.C. § 102(a)(2) as being anticipated by PCT Publication No. WO 2022/236136 A1 (claims priority to Provisional Application No. 63/185,736 filed on May 7, 2021).
The prior art teaches Compound 6 having the following chemical structure (see e.g., page 26 and also seventh compound as disclosed in paragraph [0057] of 63/185,736):
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Regarding instant claim 36, the above prior art Compound 6 corresponds to the second compound as recited on page 16 of the claims filed on May 18, 2026.
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 33 is rejected under 35 U.S.C. § 103 as being unpatentable over Chinese Application No. CN111689980A (September 22, 2020).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Regarding instant claim 33, the prior art teaches the following chemical compound (see e.g., page 3):
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The above prior art compound is encompassed by variable definitions of the instantly claimed compound having a structural Formula I, wherein Rj represents hydrogen; Rk is
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, further wherein R2 is -C1 alkyl; R3 is OH; and R4 is -C1 alkyl (i.e., -CH3).
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 33, the prior art teaches the position corresponding to instant variable R4 is -CH3 in the above prior art compound (i.e., the prior art compound does not read on the R4 variable definitions required by instant claim 33). However, the broadest disclosure of the prior art invention corresponds to the following genus (see e.g., prior art claim 1) which encompasses the instantly claimed Formula I:
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Moreover, the above prior art genus provides for prior art variables R1 and R2 (which corresponds to the position for instant variable R4) as being defined as inter alia a C1 alkyl or -CF3.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Therefore, it would have been obvious to a person of ordinary skill in the art to substitute a prior art R1/R2 variable (i.e., methyl) of
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with a -CF3 to result in the following structure:
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The above structure is encompassed by instant claim 33, wherein Rj is hydrogen; Rk is
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, and R2 is -C1 alkyl; R3 is OH; and R4 is -C1haloalkyl (i.e., -CF3). At least in the interest of providing additional compounds for downstream application(s), a person of ordinary skill in the art would have been motivated to arrive at the instantly claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CLAYTOR can be reached at (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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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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