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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 17 and 22-26) in the reply filed on 4 December 2025 is acknowledged.
Claims 18-21, 27, and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4 December 2025.
Claims 17 and 22-26, submitted on 4 December 2025, represent all claims currently under consideration.
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 24 July 2020.
Information Disclosure Statement
One Information Disclosure Statement (IDS), submitted on 24 January 2023, is acknowledged and has been considered.
Drawings
The drawings are objected to because several figures are of poor quality, making the information difficult to interpret. Figures 1(b), 1(c), 3, 7, 8, 10(a), 10(b), 11(a), 11(b), 14, and 16 require replacement with higher quality figures. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 17 and 22-26 are objected to because of the following informalities: The claims are directed towards a compound and its polymorphs, pharmaceutically acceptable salts, metabolites, prodrugs, solvates, co-crystals, stereoisomers, and polymorphs thereof. The claims should be directed towards a single compound, rather than multiple compounds or forms of the compound. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17 and 22-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Factors to be considered in making the determination as to whether one skilled in the art would recognize that applicant was in possession of the claimed invention as a whole at the time of filing include : (a) Actual reduction to practice; (b) Disclosure of drawings of structural chemical formulas; (c) Sufficient identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and
knowledge in the art and (f) Predictability in the art. While all of these factors are
considered, a sufficient number for a prima facie case are discussed below:
The claims at issue claim a compound and its intermediates selected from a group of four compounds, as well as methods of their preparation and methods of treatment using these compounds. The specification defines “intermediates” as “all those molecules that occur in between the reaction pathway and share common structural features with the compounds of the present disclosure” (Paragraph 0059). The specification discloses two such intermediates:
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(Page 33) and
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(Page 38). However, the artisan would recognize that other reaction pathways are capable of producing the compounds which are claimed, with different intermediates being used for the pathways, and all possible intermediates have not been disclosed or described sufficiently within the specification. The artisan would have the general skill to synthesize intermediates which can be used in the reactions of Claims 18-20, as well as those of Claim 17, but without knowing what specific compounds fall into the category of an intermediate as this term encompasses any compound which can occur in the reaction pathway, and shares a common structural feature with the compounds of the disclosure, the artisan would not be able to practice this invention commensurate with the scope of the claims. The artisan would only be able to determine what comprises an intermediate from a posteriori testing, performing different synthesis schemes to determine exactly what can be considered an intermediate of the four claimed compounds. Without specific guidance from the specification as to what exactly can be an intermediate for these compounds, and can be used in the reactions which are claimed, there would be no expectation of predictability for practicing this invention as the definition of what an intermediate is defines an indefinite amount of chemicals. Thus, there is no support in the specification that applicant was in possession of the claimed invention as a whole at the time of filing.
Claims 17 and 22-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Factors to be considered in making the determination as to whether one skilled in the art would recognize that applicant was in possession of the claimed invention as a whole at the time of filing include : (a) Actual reduction to practice; (b) Disclosure of drawings of structural chemical formulas; (c) Sufficient identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and
knowledge in the art and (f) Predictability in the art. While all of these factors are
considered, a sufficient number for a prima facie case are discussed below:
The claims at issue claim a compound and its metabolites selected from a group of four compounds. The specification defines “metabolite” as “all those chemical compounds that are necessary for the metabolism or are formed during the metabolic pathway of a cell” (Paragraph 0061). The specification does not provide any data demonstrating which metabolic pathways these compounds undergo when administered in vivo, or similar data generated from hepatic microsomes demonstrating which specific metabolites form (i.e., glucuronidation, glutathione conjugation, acetylation, etc.) or which pathways these compounds follow when undergoing metabolism (oxidation, hydrolysis, cyclization, etc.). Without knowing how these compounds are modified when undergoing metabolism, the artisan would have no way of knowing which compounds are covered by the scope of these claims, nor would they know how to synthesize these compounds as the specification does not provide any guidance as to how to produce a single metabolite of the claimed compounds. There would be no predictability for practicing this invention as the definition of what a metabolite is defines an indefinite amount of compounds as the pathways which these compounds undergo metabolism through is not defined, and the artisan would have no way of knowing which compounds are considered metabolites without performing metabolic studies using the claimed compounds. Thus, there is no support in the specification that applicant was in possession of the claimed invention as a whole at the time of filing.
Claim Rejections - 35 USC § 112(b)
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 17 and 22-26 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 17 claims two compounds which are cationic (Compounds A and D). However, there is no corresponding anion provided to neutralize the cationic charge, and a cationic compound cannot exist without a corresponding anion. There is no provided anion, causing the metes and bounds of these two compounds to be undefined, and therefore, indefinite. Claims 22-26 are similarly rejected as indefinite as dependent upon an indefinite claim without resolving the underlying issue of indefiniteness.
Claim 22 is 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 22 recites the limitation "wherein the neurodegenerative disease is selected from…" in Lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claims 23 and 24 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. Claims 23 and 24 recite the limitation "wherein the compounds of Formula (I)” in Line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry Number 81-83-4 (Entered STN: 16 November 1984).
STN Registry Number 81-83-4
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anticipates the limitations of Claim 17 because this intermediate can be used in the synthesis of the compounds of the invention. Claim 17 claims intermediates of the claimed compounds, and as such, this compound anticipates the limitations of the claim.
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry Number 81-86-7 (Entered STN: 16 November 1984).
STN Registry Number 81-86-7
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anticipates the limitations of Claim 17 because this intermediate can be used in the synthesis of the compounds of the invention. Claim 17 claims intermediates of the claimed compounds, and as such, this compound anticipates the limitations of the claim.
Claim 17 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Registry Number 1276688-44-8 (Entered STN: 8 April 2011).
STN Registry Number 1276688-44-8 has the structure
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, which is an intermediate of the compounds of Claim 17.
Claims 17 and 22-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson (WO 99/11649; Publication Date: 2 September 1998).
Jackson discloses inhibitors of the nuclei enzyme PARP. More specifically, the invention relates to the use of PARP inhibitors to treat neurological disorders and neurodegenerative diseases, among other conditions (Page 1, Lines 7-28). The compound
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(Page 64) is a demonstrated inhibitor of PARP and is claimed in this invention. This compound can also serve as an intermediate of the compounds of Claim 17. The present invention relates to a pharmaceutical composition comprising an effective amount of a compound that inhibits PARP activity and effects a neuronal activity not mediated by NMDA toxicity and a pharmaceutically acceptable carrier (Page 9, Lines 10-15). Formulations of the present invention suitable for oral administration may be in the form of discrete units such as capsules, cachets, tablets, troche, or lozenges. Formulations may also be in the form of a solution or a suspension in an aqueous liquid or non-aqueous liquid (Page 34, Lines 21-28). The compounds of the invention treat or prevent tissue damage resulting from cell damage or death due to necrosis or apoptosis, and/or effect neuronal activity. These compounds are thought to interfere with more than glutamate neurotoxicity and NO-mediated biological pathways (Page 13, Line 38- Page 14, Line 5). The present invention relates to compounds which inhibit PARP activity and effect a neuronal activity not mediated by NMDA toxicity. The neuronal activity may be selected from the group consisting of stimulation of damaged neurons, promotion of neuronal regeneration, prevention of neurodegeneration, and treatment of a neurological disorder (Page 14, Lines 6-11). A preferred neurological disorder relating to neurodegeneration is selected from the group consisting of Alzheimer’s disease, Parkinson’s disease, Huntington’s Disease, and ALS (Page 14, Lines 18-21).
This compound anticipates the limitations of the claims because this compound functions as an intermediate for the claimed compounds, and as the claims are directed to specific compounds and their intermediates, this compound will meet the functional limitations of Claims 22 and 23.
Conclusion
Claims 17 and 22-26 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625