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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/11/2026 has been entered.
Current Status
This action is responsive to the amended claims of 03/11/2026. Claims 10-18 are pending. Claims 1-9 have been canceled. Claims 10-18 are new. Claims 10-18 have been examined on the merits.
Priority
The effective filing date remains 05/13/2019.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 03/11/2026; no new matter is found.
All previously pending objections and rejections are withdrawn because all previously pending claims 1-9 have been canceled. Note, the new claims have written description support in original claims 1-9.
Response to Amendment
Claim Objections
Claims 10-18 are objected to because of the following informalities. Appropriate correction is required.
Claim 10: please strike the phrase “, a stereoisomer or pharmaceutically-acceptable salt thereof” from the last line. This phrase is already used at the start of the claim. Dependent claims 11-16 and 18 are similarly rejected since they do not fix the issue.
Claim 11 has the following three issues: 1) under R1a, please replace “occurance” with “occurrence”; 2) under R2 please delete the annotated “(i)”:
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; and 3) in the last line “r is: 0, 1, 2, or 3, or a stereoisomer” please replace the final comma with a semicolon, i.e., “r is: 0, 1, 2, or 3; or a stereoisomer”. Dependent claims 12-15 are similarly rejected since they do not fix the issue.
Claim 13: under R2, the 9th and 10th moieties listed each have a hanging parenthesis at the end
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. Please strike the hanging parentheses. Dependent claims 14-15 are similarly rejected since they do not fix the issue.
Claims 13-15 use inconsistent placement of parentheses within the moieties from which R2 is chosen. Claim 13 uses parentheses as follows: “-C(O)-(CH2)r-(3-14 membered carbocycle substituted with 0-3 R2a)”. Specifically, the bolded parentheses around “-(3-14 membered carbocycle substituted with 0-3 R2a)” explicitly constrain the substitution of R2a to the carbocycle. Note, even without the parentheses, the substitution of R2a is expected to only occur on the carbocycle since substitution elsewhere would violate the valency of the substituted atom (e.g., the C in -C(O)- or -CH2-). This notation is used for the 1st-8th and 11th-12th moieties for R2. However, dependent claims 14-15 are not consistent with claim 13’s parentheses placement. In claim 14, the 1st, 3rd, and 9th-10th moieties match claim 13, while the 2nd, 4th-8th, and 11th-12th moieties lack the parentheses used in claim 13. Similarly, in claim 15, the 1st-4th and 9th-11th moieties match claim 13, while the 5th-8th and 12th moieties lack the parentheses used in claim 13. While the substituent R2a can only be found on the group to which it is explicitly constrained in claim 13 (without violating valency), the lack of consistency in parentheses convention between dependent claims and their parent claims should be addressed.
Please, either: 1) amend claims 14-15 to use the same parentheses convention recited in claim 13 or 2) amend claims 13-15 to use the same parentheses convention recited in independent claim 10.
Claim 16: please add a comma following the 3rd to last and the 2nd to last structures.
Claim 17: please add the word “and” before the 48th compound name.
Claims 12-18 lack a claim status identifier; MPEP 714.II.C. necessitates such labels. Please add the appropriate label to all claims.
Claim Rejections - 35 USC § 112
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 12-16 and 18 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 13 is drafted as depending from claim 2; however, claim 2 has been canceled. Thus, the dependency of claim 13 is unclear and the metes and bounds thereof are undefined rendering the claim indefinite. Dependent claims 14-15 are similarly rejected since they do not rectify the underlying issue.
Claim 16 is drafted as depending from claim 16; it is unclear how a claim can depend from itself especially since many of the variables of Formula (I) are not defined within claim 16: i.e., R1 and R3. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
For examination purposes the claim is interpreted as depending from at least claim 10, the broadest claim.
Claim 18 is drafted as depending from claim 1; however, claim 1 has been canceled. Thus, the dependency of claim 18 is unclear and the metes and bounds thereof are undefined rendering the claim indefinite.
For examination purposes the claim is interpreted as depending from the first pending claim: claim 10.
Claims 12-15 each recite under R1: “-O-(CH2)r-(4-10 membered heterocycle substituted comprising carbon atoms and 1-4 heteroatoms selected from N, O, and S(O)p, with 0-3 R1a)”. The word “substituted” is out of place and the phrase “with 0-3 R1a” has no context as to how it is related to the R1 moiety. Thus, the overall structure of this R1 moiety is unclear. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
To overcome: please move the word “substituted” directly before the phrase “with 0-3 R1a”.
Claim 16 recites the limitation R2 is chosen from "
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" on Pg. 11. There is insufficient antecedent basis for this limitation in the claim. Since the parent claim is unclear, for examination purposes claim 10 is used as the parent claim. Parent claim 10 recites R2 is “-C(O)-(CH2)r-4-10 membered heterocycle substituted with 0-3 R2a” wherein R2a is, independently at each occurrence, chosen from a variety of structures. While the R2 structure is a “-C(O)-(CH2)r-4-10 membered heterocycle” (i.e., -C(O)-(CH2)0-piperidine) the substituent -C(O)-Me is not a possible R2a moiety of claim 10. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
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.
Claims 13-16, and 18 are 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. 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.
Claims 13 and 18 each depend from a canceled claim (claim 2 and 1, respectively) and claim 16 depends from itself. Thus, while all three claims are drafted as dependent claims, none of these claims contain a reference to a claim previously set forth. Thus, these claims do not properly further limit a parent claim. Claims 14-15 are similarly rejected since they depend from claim 13 and do not rectify the issue.
Claim 16 also recites a structure for R2 outside of the scope of parent claim 10:
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wherein the substituent -C(O)-Me is not a possible R2a moiety of claim 10. Thus, claim 16 does not properly further limit a parent claim even when the broadest claim is interpreted as the parent claim.
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 10 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DUAN et al. (WO 2016/179460 A1; provided 01/16/2025).
By the amendments of 03/11/2026, the scope of Formula (I) R3 in claims 10 and 18 has been expanded to the scope which was previously rejected by DUAN in the action of 01/16/2025. Currently, R3 encompasses C1-6 alkyl.
Regarding claim 10, DUAN teaches compound 42 (Pg. 191 Table):
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wherein R1 is -(CH2)r-6 membered carbocycle wherein r is 0, R3 is C1 alkyl, and R2 is -C(O)-(CH2)r-6 membered carbocycle substituted with 1 R2a wherein r is 0 and R2a is -C(O)OH.
Regarding claim 18, DUAN teaches a pharmaceutical composition including a compound, stereoisomeric form, pharmaceutical salt, solvate or hydrate as described herein (e.g., compound 42 above) and a pharmaceutically acceptable carrier, diluent, or excipient (Pg. 68 Lines 6-10).
Note: Applicant’s previous amendment (dated 07/16/2025) wherein R3 was narrowed to hydrogen, halogen, or C2-6 alkyl previously overcame this rejection.
Conclusion
Claims 10, 12-16, and 18 are rejected.
Claims 11 and 17 are objected to.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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