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 .
Claims 1, 5-12, 16-19, 22-25, 31, 49-59, 67, and 80 are pending in the instant application. Claims 1, 5-12, 17, 19, 23, and 24 are rejected. Claims 16, 18, 22, 25, 31, 49-59, 67, and 80 are objected.
Drawings
The drawings were received on June 16, 2026. These drawings are acceptable.
Response to Amendment and Arguments/Remarks
The amendment and arguments/remarks filed on June 16, 2026 have been fully considered and entered into the application. With regards to the 35 U.S.C. 112(a), 35 U.S.C. 112(b) and 35 U.S.C. 112(d) rejections, the grounds for rejection are moot in view of Applicant’s amendment and the rejections and objections have been withdrawn.
It is noted that the election of species requirement has been withdrawn (i.e., the full scope of the subject matter of claims 1, 5-12, 16-19, 22-25, 31, 49-59, 67, and 80 has been searched and examined in its entirety).
Claim Rejections - 35 USC § 112
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 23 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 23 discloses the limitation “w1 and w2 are each C and w3 and w4 are each N” and claim 22, from which claim 23 depends, discloses the exact same limitation. 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 1, 5, 6, 9, 11, 17, 19, and 24 are rejected under 35 U.S.C. 102(a)(1) as being rejected by CN 108210494 A.
CN 108210494 A discloses the FOXM1 inhibitor FDI-6 with the structure
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(see page 2) for application in anti-hepatic fibrosis. It is disclosed that the liver fibrosis can be caused by alcoholic liver disease (see English translation of abstract), that the compound can be administered as a pharmaceutically acceptable salt and/or complexes with the drug carrier and can be administered by different ways (see English translation of claim 5). Finally, it is disclosed in the examples that a human hepatic stellate cell line and FOXM1 mRNA in human liver cirrhosis were used (see English translation of the description of the figures). Therefore, a method to prevent, inhibit or treat liver disease in a human, wherein the human has alcoholic liver disease, comprising administering a mAChR4 positive allosteric modulator having the structure according to Formula I wherein w4 is N, w1-w3 are C, L is absent, X is aryl substituted with F, R3 is heteroaryl, R1 is CF3, and R2 is hydrogen is anticipated by the reference.
It is noted that the reference does not teach that the compound FDI-6 can be used in the manner instantly claimed (i.e., as a mAChR4 allosteric modulator). However, the intended use of the claimed compound does not patentably distinguish the compound, per se, since such disclosed use is inherent in the reference compound. In order to be limiting, the intended use must create a structural difference between the claimed compound and the prior art compound. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
It is also noted that the term “liver disease” is well known in the art to include liver fibrosis and an “ethanol-induced liver injury” also includes liver fibrosis.
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 1, 5-12, 17, 19, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over CN 108210494 A.
CN 108210494 A discloses the FOXM1 inhibitor FDI-6 with the structure
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(see page 2) for application in anti-hepatic fibrosis. It is disclosed that the liver fibrosis can be caused by alcoholic liver disease (see English translation of abstract), that the compound can be administered as a pharmaceutically acceptable salt and/or complexes with the drug carrier and can be administered by different ways (see English translation of claim 5). Finally, it is disclosed in the examples that a human hepatic stellate cell line and FOXM1 mRNA in human liver cirrhosis were used (see English translation of the description of the figures).
The specific administration methods of claims 7, 8, 10, and 12 are not disclosed in the reference.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention through routine experimentation to arrive at a method to prevent, inhibit or treat liver disease in a human, wherein the human has alcoholic liver disease, comprising administering a mAChR4 positive allosteric modulator having the structure according to Formula I wherein w4 is N, w1-w3 are C, L is absent, X is aryl substituted with F, R3 is heteroaryl, R1 is CF3, and R2 is hydrogen of the instant claims in view of the reference with a reasonable expectation of success. The motivation would have been to find the optimal route of administration of FDI-6 for the treatment of liver fibrosis.
Thus, a prima facie case of obviousness has been established.
Claim Objections
Claims 16, 18, 22, 31, 49-59, 67, and 80 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 25 is objected to for depending on previously canceled claim 20.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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