NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Jan. 30, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claim 19 has been canceled.
Claims 1-11, 14, 15, 17, and 18 have been amended and incorporate no new matter.
New claim 20 has been added.
Thus, claims 1-18 and 20 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
RESPONSE TO ARGUMENTS
Applicant's amendments and arguments filed Jan. 30, 2026 overcome the rejections set forth in the non-final action dated Jul. 30, 2025, which are withdrawn. However, upon further consideration, new objections and rejections are set forth below.
NEW REJECTIONS
Claim Objections
Claim 2 is objected to because of the following informalities: in line 2, "wherein" is duplicative and should be deleted.
Claim 16 is objected to because of the following informalities: in line 1, "claims 15" should be amended to "claim 15."
Claim 17 is objected to under 37 CFR 1.75(c) as being in improper form because it depends from both claims 1 and 11. A multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n).
Claim 18 is objected to because of the following informalities: lines 4-6 should be amended to insert "and" between "the compound of claim 1 or a pharmaceutically acceptable salt thereof" and "one or more pharmaceutical excipients."
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
1. Claims 1 and 10-18 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 pre-AIA the applicant regards as the invention.
Independent claim 1 is drawn to compounds of formula (I), having the structural formula,
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wherein Ar is defined as a substituted or unsubstituted aromatic ring or a substituted or unsubstituted heteroaromatic ring.
However, the term "substituted" renders the claims indefinite, because the specification does not define the term, which also has no clear, commonly understood definition in the art. While those skilled in the art generally understand what "substituted" means, the term sets no limit on the functional groups or chemical moieties which may added to Ar to yield a compound of formula (I). Thus, formula (I) has no clear boundary, such that one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed compounds.
Because “substituted” has more than one reasonable interpretation, compounds encompassed by the term cannot be clearly distinguished from compounds excluded from the scope of the claims. Thus, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
2. Claim 17 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 pre-AIA the applicant regards as the invention.
As recognized by MPEP § 2173.05(g), when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.
Here, claim 17 is drawn to methods of treating distinct diseases as recited by claim 11, further comprising inhibiting a kinase with an altered expression by contacting the kinase with an effective amount of the compound of claim 1.
However, the specification fails to set forth any objective criteria to distinguish between subjects whose disease is treated by contacting the kinase with a compound of formula (I), and subjects whose disease is treated without contacting the kinase with a compound of formula (I).
As recognized by MPEP § 2111.04, claim scope is not limited by claim language that does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. Giving the claims the broadest reasonable interpretation in light of the specification, the active method step to be carried out is recited by claim 11: administering to a subject in need thereof an effective amount of a compound of formula (I) and one or more pharmaceutical excipients. Presumably, performing this active step inherently results in the compound contacting the kinase and inhibiting it, thereby treating the disease.
Thus, claim 17 simply describes the intrinsic biochemical effect the active step of administering is supposed to accomplish, and thus fails to further limit the scope of claim 11 from which it depends. Further, because Applicant's intent is unclear, infringing methods cannot be distinguished from non-infringing methods, rendering the metes and bounds of the claims indefinite.
3. Claim 20 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 20 recites a method of synthesizing "one or more of compounds 1j, 1m, 13a, 13b, 13c, 13e, and 13f of claim 3."
However, there is insufficient antecedent basis for this limitation in claim 3, because claim 3 recites only compound 1j.
Compounds 1j, 1m, 13a, 13b, 13c, 13e, and 13f are individually recited by claims 3-9, respectively. Thus, it is suggested to amend claim 20 to "one or more of compounds 1j, 1m, 13a, 13b, 13c, 13e, and 13f of claims 3-9."
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629
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