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 .
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.
Election/Restrictions
Applicant's election with traverse of single synergistic compound in the reply filed on 02/02/2026 is acknowledged. The traversal is on the ground(s) that the common structure of "fused tricyclic system" and specific arrangement of side groups on the outer rings provides a sufficient common structural element to link the compounds falling within the claims for the purposes. This is not found persuasive not all fused tricyclic system would be expected to behave similarly with different synergistic compounds listed in claim 45. Therefore, reasons for election of species requirement as stated in pages 7-8 in the office action of 07/31/2025 is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Applicant elected compliant species of compound of formula I:
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Applicant did not provide a compliant species of synergistic compound.
Examiner did not find prior art on applicant’s elected species. Therefore claim 29 is free of prior art.
Markush search was extended to the species
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, a tricyclic compound where ring B is five membered ring with a N atom, ring A and C are aromatic same as compound of formula I where X is N; R1 and R2 are OCH3; R3 and R4 are CH3. Examiner found prior, therefore Markush search was not extended further to other species according to Markush search practices.
Markush search extended species reads on claims 1, 30-33 and 43-45.
Claims 2-28, 34 and 35-42 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/02/2026.
Current Status of 18/007,935
This Office Action is in response to the original claims of 02/02/2026.
Claims 1, 4-6, 8, 29, 31-33, 35-36, 38 and 40-45 are original; claims 2-3, 9-28 and 34 are withdrawn; claims 7, 30, 37 and 39 are currently amended.
Claims 2-28, 34 and 35-42 withdrawn.
Claims 1, 30-33 and 43-45 are examined.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 09/13/2023. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 06/04/2020.
Claim Interpretation
The position 2-9 of Formula I
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in claim 1 is interpreted to be carbon atoms. Please note if the applicant wants the examiner to interpret the position 2-9 in formula I to include heteroatom, applicant must label the atom in rings A and C to include heteroatom. For example, ring B was appropriately labeled with X, wherein X was defined as C, S, O or N.
Claim Objections
Claim 1 is objected because numbering of the carbon atom overlaps with the bond as shown by the circle
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Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 43 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claims 43 are constructed in “use” form and does not fall within at least one of the four categories of patent eligible subject matter recited in 35 U.S.C. 101 (process, machine, manufacture, or composition of matter)(see MPEP 2173.05(q)).
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 1, 29, 30-33 and 43-45 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
In claim 1, X is defined as C, S, O or N, but a carbon atom has valency of 4 and cannot be independently be C in ring B, without other substituents. As written C in ring B has valency of 2. This renders metes of bound of claim 1 undefined, thus claim is indefinite.
Claims 29 and 43-45 are also rejected as indefinite because they refer back to claim 1 but do not remedy the bases for the rejection of claim 1.
In claim 1, X is defined as C, S, O or N, but a nitrogen atom has valency of 3 and cannot be independently be N in ring B, without other substituents. As written N in ring B has valency of 2. This renders metes of bound of claim 1 undefined, thus claim is indefinite.
Claims 29 and 43-45 are also rejected as indefinite because they refer back to claim 1 but do not remedy the bases for the rejection of claim 1.
In claim 1, R1, R2, R3 and R4 are independently defined as CCH2CH3, but a carbon atom has valency of 4 and cannot be independently be C in CCH2CH3, without other substituents. As written C in CCH2CH3has valency of 2. This renders metes of bound of claim 1 undefined, thus claim 1 is indefinite.
Claims 29 and 43-45 are also rejected as indefinite because they refer back to claim 1 but do not remedy the bases for the rejection of claim 1.
In claim 30, side group is defined as CCH2CH3, but a carbon atom has valency of 4 and cannot be independently be C in CCH2CH3, without other substituents. As written C in CCH2CH3 has valency of 2. This renders metes of bound of claim 30 undefined, thus claim 30 is indefinite.
Claims 31-33 are also rejected as indefinite because they refer back to claim30 but do not remedy the bases for the rejection of claim 30.
Claims 43, drawn to “use of”, is properly interpreted as a “use” claim. As such, the metes and bounds of claims 43 is undefined (hence rendering claim 43 indefinite) since claim 43 attempts to claim a process without setting forth any active steps involved in the process. As such, the artisan has no idea what active steps (active verbs) are needed to conduct the “use” claim. Use claims are indefinite because they merely recite a use without any active, positive steps delimiting how the use is actually practiced. See MPEP 2173.05(q).
Claim 44 is rejected for reciting the term “pro-drug”. The term “pro-drug” is not defined by claim 44. The specification does not provide definition of the term “prodrug”. One of ordinary skill in the art could not reasonably determine the scope of the term “prodrug” (see Zawilska et.al. Pharmacological Reports, 2013, 65, Page 1-14). As drafted “prodrug” in claim 44 renders the metes and bounds of claims 44 indefinite.
Claims 45 are also rejected as indefinite because they refer back to claim 44 but do not remedy the bases for the rejection of claim 44.
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(s) 1 and 30-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem (published 12/17/2017).
Pubmed discloses the compound
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, a tricyclic compound where ring B is five membered ring with a N atom, ring A and C are 6 membered aromatic ring wherein two side groups on ring A have 1,3 relationship and the two side groups in ring C have a 1,4 relationship (claims 31-33); same as compound of formula I where X is N; R1 and R2 are OCH3; R3 and R4 are CH3, anticipating claims 1 and 30-33.
Conclusion
No claims are allowable as written.
Claims 29 is allowable if written independently.
Please note examiner may find prior art for the derivatives of compound of formula I in claim 44. To expedite prosecution applicant may strike the term “derivatives from claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571)272-913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights