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 of Group I, drawn to a stable crystalline, in the reply filed on 11/20/2025 is acknowledged. 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)).
Claims 1-23 are pending of which claims 16-23 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1-15 have been examined on the merits.
Objections
Claim Objections
Claim 2 is objected due to improper punction and grammar. For example, the use of “and a specifical DSC Melting Range (Endo): 247-253 °C with Peak Temp of 249 °C; and.” create potential confusion and misinterpretation of the claim elements. It is requested Applicant amends the claim to use consistent and appropriate punctuation between the listing of properties.
Claim 8 is objected due to inconsistent spacing between words, which introduce ambiguity and potential confusion and misinterpretation of the claim elements. It is requested Applicant amends the claim to use consistent and appropriate spacing between words throughout the claim.
Claim 10 is objected due to improper punction. For example, the claim ends with “, .” which creates grammatical an structural ambiguity, making it unclear whether the final limitation is complete or if additional element was intended. It is requested Applicant amends the claim to use consistent and appropriate punctuation between the listing of properties.
Claim 15 is objected due to improper punction and grammar. For example, the use of “Microcrystalline cellulose (PHI0I). Sodium Carboxymethyl Starch,” creates potential confusion and misinterpretation of the claim elements. It is requested Applicant amends the claims to use consistent and appropriate punctuation between the listing of properties.
Objection to the specification
The disclosure is objected to because of the following informalities: Table 12 (specification page 39) incorrectly labeled the following cell lines: HELA (ovary), BEL-7402 (ovary), MKN45 (breast). For example, MKN45 is not a breast cancer cell line, and HELA, BEL-7402 are not ovary cell lines. These errors create confusion regarding representation of the in vitro data supporting claim 12.
Appropriate correction is required.
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, 11 and 15 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 1 recites “selected but not limited to”
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The phrase “selected but not limited to using a high boiling point… and using a low boiling point solvent or a mixture of solvents that together have a low boiling point…” is unclear because it implies additional or alternative recrystallization methods beyond high/low-boiling solvents that are explicitly listed, but, however, the specification (page 17-21) discloses no such alternative. Therefore, the phrase “selected but not limited to” is unclear and renders the metes and bounds of the claimed indefinite.
Claims 11 recites “cervix and stomach selected but not limited to the group consisting of PANC-1,”
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The combination of the phrases: “selected but not limited to” and “group consisting of” creates ambiguity as to the full scope of the claim. As a result, a POSITA would not determine the full scope of the claimed invention with reasonable certainty, which renders the metes and bounds of the claimed indefinite.
Claim 15 recites “pharmaceutically acceptable carrier selected but not limited to a group of”
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While the specification (page 29-30, Table 2 and 3) only discloses the listed carrier, thus the phrase “selected but not limited” introduces ambiguity regarding whether other carriers are included. As a result, a POSITA would not determine with certainty the full scope of the claimed composition, which renders the metes and bounds of the claimed indefinite.
Claim Rejections - 35 USC § 112 (Enablement)
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 10-12 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.
Claim 10 recites the use of the claimed compound for inhibiting protein tyrosine kinases (PTKs), a large and structurally divers family of enzymes. While claim 12 further recites inhibition of cancer cell lines of pancreas, prostate, sarcoma, thyroid; however, the specification does not disclose inhibition data for the whole PRK genus, encompassed by the claims. The specification also does not disclose structure-activity relationship, mechanistic explanations, or other technical rational demonstrating that inhibition of the tested kinases, as disclosed in Table 9, is representative of, or predictive for, inhibition across the full PTK genus. Given the functional, structural, and diversity PKTs, and the known unpredictability of kinase inhibition, a POSITA would not reasonably conclude from the limited disclosure that the claimed compound inhibits all PTK species. This is supported the specification (page 37, Table 9) which discloses a limited number of kinases that clearly does not reasonably convey that Applicant was in possession of the claimed compounds against the entire genus of PTKs as claimed.
Similarly, with regard to claim 12, the specification (page 38-39, Table 11-12) discloses in vitro activity only against specific, individual cancer cell line, such as SKOV3 (ovary), SKBR3 (breast), and HCT-116 (colon). However, the claim broadly encompasses inhibition of cancer cell lines of entire cancer types (e.g., pancreas, prostate, lung and colon), which include numerous biologically distinct cell lines with different drug sensitivity. The specification does not provide data or technical rational demonstrating a single disclosed cell line is predictive of activity against all or most cell lines of the same cancer type.
Moreover, the limited disclosure of activity against a small number of specific kinases and individual cell lines does not indicate that applicant was in possession of the full PTK genus or the full range of cancer cell line genera as cited in the claims. Consequently, the lack of enablement of the claimed subject matter at the time of filing, suggest that Applicant did not possess supporting data to the claimed invention.
Subject Matter Free of the Art of Record
The subject matter of claims 1-15 are free of the art of record. The closest prior art is the Guoqing Paul Chen, US 20100048599 “Chen”. While Chen teaches 5 -(2-(4-(4-Fluoro-2-methyl-1H-indol-5-yloxy)-6 methoxyquinolin-7-yloxy)ethyl)-5-aZaspiro[2.4]-heptan-7-one, however there is no motivation for a POSITA to modify the teaching of Chen to arrive at the claimed compound. These claims are not allowable until the objections and 112 issues are resolved.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622