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 .
Priority
The instant application is a 35 US 371 National Stage filing of international application PCT/US2021/045448, filed August 10, 2021, which claims the benefit of an effective US filing date from provisional application 63/064,262, filed August 11, 2020.
Information Disclosure Statements
The information disclosure statements (IDS) dated February 9, 2023; July 29, 2024; November 8, 2024; February 3, 2025 and November 21, 2025 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Election/Restrictions
Applicant’s election of the invention of Group I, claims 51-62 (renumbered as 51-63 since there were two claims listed as 61 in the previous claim set), in the reply filed November 21, 2025 is acknowledged. Further, Applicant’s election of the species of compound 170,
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in the same reply is also acknowledged. The elected species reads on claims 55, 59, 61-63, and 71-72 within the elected group. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 and the claims drawn to the elected species are allowable, 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 above, the Examiner searched the claimed invention based on the elected species above, wherein: the elected species was found to be allowable over the prior art. The search was expanded to include the additional species described in the rejections herein. Since the scope described herein was not found to be in condition for allowance, it has not been expanded further. Notably, no prior art was discovered over formula III of claim 55 or formula (VI) of claim 61.
Status of Claims
Currently, claims 55-56 and 59-80 are pending in the instant application. Claims 56, 60, 64-70 and 73-80 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species. Claims 55, 59, 61-63, and 71-72 read on an elected invention and species and are therefore under consideration in the instant application to the extent that they read on the elected embodiment.
Claim Objections
Claim 62 is objected to for depending on a rejected base claim, but would be allowable if rewritten in independent form.
Claim Rejections – 35 U.S.C. § 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 55, 59, 61, 63, and 71-72 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.
The claims are rejected as indefinite because the variable R7 appears twice in the recited chemical formulae and is given two different definitions. In claim 55, the first instance is as a phenyl substituent
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, where the variable is defined as
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. The variable appears again in the definition of R4 and R14, where OR7 is listed as an aryl or heteroaryl substituent, and is set forth with a new definition
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. In claim 59, the first instant is as a nitrogen substituent depicted in formula (V), where it is defined as
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. The variable appears again in the definition of R4 and R14, where OR7 is listed as an aryl or heteroaryl substituent, and is set forth with a new definition
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. In 61, the first instance is as a phenyl substituent
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, where the variable is defined as
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. The variable appears again in the definition of R16 and R18, where OR7 is listed as an aryl or heteroaryl substituent, and is set forth with a new definition
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. Any given variable can only have one definition in a chemical formula to avoid confusion and ambiguity in the structure. Appropriate clarification/correction is required.
The claims are rejected because they recite the limitation that R14, R7 and R4 may be S, S(O) or S(O)2. These definitions represent a divalent substituent (i.e. another chemical moiety would be required in order to fill the valence of each of these groups), but the substituents are defined for a monovalent position. It is unclear how this monovalent position could be defined by substituents which are necessarily divalent without also defining what else the moieties are bound to. Any dependent claims that do not recite a particular compound or list of compounds by exact structure does not remedy this issue; therefore, the dependent claims are also 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.
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) 59 and 71 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the STN Registry database entry for CAS RN 1016843-01-8, which has an entry date of 24 April 2008.
Since the entry date represents the date that the compound entered a publicly available database on STN, this represents the date that the 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 G is a methylene group; R7 and R8 together with the nitrogen form a heterocycle (piperazine); and R13 is
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where each of W, X, Y and Z is C-R14; R14 is H; and p is 0. 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.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699