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 .
Information Disclosure Statement
The information disclosure statement (IDS) dated November 4, 2025 was in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS document was considered and a signed copy of the 1449 form is attached.
Response to Remarks and Amendments
Applicant’s reply filed November 4, 2025 has been entered. All rejections and objections not explicitly maintained herein are withdrawn.
In response to the rejections made under 35 USC 112(b) and 35 USC 102(a)(1) in the previous action, Applicants have made various claim amendments to the claims previously under consideration (84-86 and 88-93), including amending the claims such that they no longer encompass the species elected for examination. As applicants have noted, those claims are now withdrawn from consideration as reading on a non-elected embodiment and no comment is made on the merits of the withdrawn claims.
Restrictions/Elections
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated in the previous action, the examiner searched the compound based on the elected species and expanded scope, no prior art was found which anticipates the elected species. Thus the search was extended or broadened pursuant to MPEP 803.02 to include the compounds described in the rejections set forth in the previous action. In view of the claim amendment, the scope of search and consideration is again expanded in accordance with MPEP 803.02 to include the compound
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, which is encompassed by newly added claim 81.
Status of Claims
New claims 104-126 have been added with the present amendment. Claims 84-88, 92-103 and new claims 115-126 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species.
Claims 104-114 read on an elected invention and/or elected species/extended scope and therefore remain under consideration to the extent that the read on the elected embodiment and extended scope. It has been determined that the entire scope claimed is not patentable.
Claim Objections
Claim 105 is objected to for containing an extraneous comma (line 3 of R3 definition).
Claim 107 is objected to for lacking singular/plural agreement. In line 1, the word “structures” should be replaced with “structure” to align with the singular claimed “compound.” Claim 107 is further objected to because the list should be in alternative form, with the word “or” separating the last two recited compounds.
Claim 108 is objected to because
The extraneous comma in the third line of the R10 and R11 definition should be deleted. That is, “ring,;” should be replaced with “ring;”
the word “or” should be inserted between
“substituted or unsubstituted aryl,” and “substituted or unsubstituted heteroaryl” as the last members of the alternative list in the definition of R; and
“alkoxy,” and “substituted or unsubstituted C3-C8 heterocyclic ring” as the last members of the alternative list in the definition of R10 and R11.
Claim 109 is objected to because
In the definition of R, “pyrrol” should be replaced with “pyrrole;”
the word “or” should be inserted
between the last two recited definitions of variable R4;
between “phenyl,” and “2, 3, and 4-pyridine” in the definition of the R variable;
between “CH2CH2-OH,” and “piperidine” in the definition of “the substitutions.”
Claim 110 is objected to because
the word “or” should be inserted between the last two recited compounds in the alternative list;
The claim is lacking a period at the end of the claim.
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 104-114 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 pre-AIA the applicant regards as the invention.
Regarding claim 104 and 108, no definition is provided for variable R9, which appears at least in the definition of variables R1 and R4. Since the variable is undefined, the scope of the claimed formula is indefinite. All dependent claims are also rejected for the same reason.
Further regarding claim 109, the claim is indefinite for reciting “p is 2.” There is insufficient antecedent basis for this limitation in the claim. In particular, the p variable only pertains to the R8 definition, and R8 is not included as a variable in claim 109
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.
It is noted that with respect to the rejection below, for the purposes of determining if a reference is a “printed publication” for the purposes of 102(a)(1), MPEP 2128 states the following:
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Specifically regarding electronic publications, such as online databases, as prior art the following is noted:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since the database entries below list the dates that the compounds were entered into the on-line database, the compounds were made publicly available as of those dates in the citation, and the claims are anticipated.
Claim(s) 104, 106 and 113 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the STN Registry database entry for CAS RN 2181921-45-7, which has an entry date of 01 March 2018.
Since the entry date represents the date that the compound entered a publicly available database on STN, this represents the date that each compound was made accessible to the public.
The STN Registry database entry listed above discloses the compound
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which reads on the formula V where X1, X2 and X4 are C; X3 and X5 are N; R1 is methoxy and R3 is methyl. Since the compound disclosed in the prior art has the same structure as the instantly claimed compound, each and every required element of the claim is taught and the claim is anticipated. With respect to the instantly claimed pharmaceutical composition, it is noted that the prior art discloses molar solubility data which describes the anticipatory compound in unbuffered water, which is a pharmaceutically acceptable carrier. Accordingly, the claims are anticipated.
Conclusion
No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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