NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/CN2022/118080, filed Sep. 9, 2022, which claims benefit of foreign priority to CN 202111061250.2, filed Sep. 10, 2021.
Claims 2, 4-11, 13-19, and 21, as amended, are pending.
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
Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Apr. 9, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to compounds and compositions of formula (I), and Compound 42 as the compound species, having the structural formula,
Elected Compound 42
Claimed Formula (I)
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in the reply filed on May 28, 2026, is acknowledged.
Elected compound 42 reads on formula (I) as recited by claims 2, 4, 5, 7, 11, 13-15, 18, and 19, wherein:
X is CR0, where R0 is hydrogen;
X1 is CR1, where R1 is hydrogen;
X2 is CR2, where R2 is hydrogen;
X3 is CR3, where R3 is methoxy;
X4 is N;
X5 is CR5, where R5 is hydrogen;
Y is O;
ring A is 6-10 membered aryl (phenyl); and
L is C(R9)(R10), where R9 and R10 are each C1-8 alkyl (methyl).
Claims 6, 8, 9, 10, 16, 17, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 28, 2026.
Because the elected compound is free of the prior art, search and examination has been extended to the next species. See MPEP § 803.02.
Claims 2, 4, 5, 7, 11, 13-15, 18, and 19 are currently pending and under consideration.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 4, 7, 11, 13, and 14 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
Here, each of claims 4, 7, 11, and 14 recite definitions of variable groups of formula (I), followed by one or more "preferably" clauses, which more narrowly define the variable groups. The claims are indefinite because there is ambiguity as to whether the feature introduced by the narrower "preferably" language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Similarly, the phrase "for example" renders claim 13 indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
See MPEP §§ 2173.05(c) and (d).
Claim Rejections - 35 USC § 112(d) – Improper Dependency
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 18 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically, claim 18 depends from independent claim 2, but recites compound species which fail to include all the limitations of claim 2.
For example, claim 18 recites compound 4, having the structural formula shown below:
Compound 4 (claim 18)
Formula (I) (claim 2)
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In compounds 4, 10, and 22-24, X1, X2, X3, and X4 are each CRn and Y is -NH-.
However, claim 2 recites the proviso that "when X1 to X4 are each CRn, Y is O or CH2." Thus, at least compounds 4, 10, and 22-24 are excluded from claim 2, such that claim 18 fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
Claims 2, 4, 5, 7, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mai et al. (CN 107513064, cited on the IDS dated 4/9/2024; English translation cited on PTO-892).
Mai et al. exemplify compound (II) (Example 2, para. [0028]), having the structural formula shown below:
Mai et al. Compound (II)
Claimed Formula (I)
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Compound (II) reads on formula (I) as recited by claims 2, 4, 5, 7, 13, and 15, wherein:
X, X2, and X4 are each N;
X1 is a bond;
X3 is CR3, where R3 is hydrogen;
X5 is CR5, where R5 is halogen (chloro);
Y is NH;
ring A is 5-10 membered heteroaryl (thiazolyl); and
L is C(R9)(R10), where R9 and R10 are each hydrogen.
For the foregoing reasons, Mai et al. anticipates claims 2, 4, 5, 7, 13, and 15.
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.
Claims 2, 11, 13-15, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gallatin et al. (WO 2019/046778, cited on the IDS dated 4/9/2024).
Gallatin et al. exemplify compound 207 (Table 1, p. 97), having the structural formula shown below:
Gallatin et al. Compound 207
Claimed Formula (I)
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Compound 207 reads on formula (I) as recited by claims 2, 11, and 13-15, to the extent that:
X is CR0, where R0 is hydrogen;
X1 is CR1, where R1 is hydrogen;
X2 is CR2, where R2 is methoxy;
X3 is CR3, where R3 is methoxy;
X4 is CR4, where R4 is hydrogen;
X5 is CR5, where R5 is hydrogen;
ring A is 6-10 membered aryl (phenyl); and
L is C(R9)(R10), where R9 and R10 are each hydrogen.
The compounds of Gallatin et al. are disclosed in pharmaceutical compositions comprising a pharmaceutically acceptable excipient or carrier (paras. [0010], [0331], [0332]), as recited by claim 19.
Compound 207 of Gallatin et al. differs from compound 4 as recited by claim 18,
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only in that compound 207 is di-substituted by methoxy at positions 6 and 7, rather mono-substituted by methoxy at position 7, and unsubstituted (hydrogen) at position 6.
However, Gallatin et al. exemplify dozens of compounds having either two methoxy substituents at positions 6 and 7 (e.g., compounds 1-6, 8, 19-21, 28-34, 36-38, 40-47, 51-53, 60, 61, 64, 66-69, 81, 82, 85-89, 91-98, 100, 101, etc.); or one methoxy substituent and hydrogen at positions 6 and 7 (e.g., compounds 48, 49, 54-56, 58-59, 62, 63, 65, 70, 71, 73, 75, 77-80, 83, 99, 102-104, etc.).
Furthermore, the compounds of Gallatin et al. are disclosed to have the same mechanism of action as the claimed compounds, as ENPP-1 inhibitors, having utility in pharmaceutical compositions for treating the same diseases, e.g., cancer or viral infections (abstract).
Therefore, it would have been predictable to one of ordinary skill in the art as of the effective filing date to modify compound 207 of Gallatin et al. by exchanging the 6-methoxy group for hydrogen to arrive at claimed compound 4 with a reasonable expectation of success, because the close structural similarity of the prior art compounds, and their identical mechanism of action and utility as the claimed compounds, create a reasonable expectation that compounds with either one or two methoxy groups would exhibit similar properties, functions, and utilities.
As recognized by MPEP § 2144.09, a prima facie case of obviousness may be made when chemical compounds have (1) very close structural similarities and (2) similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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