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 present application is the U.S. National Stage Application, pursuant to 35 U.S.C.371, of PCT International Application No.PCT/KR2021/003120 filed March 21, 2021 which claims priority to Korean Patent Application No. 10-2020-0035257 filed on March 23, 2020 and Patent Application No. 10-2021-0018223 filed on February 9, 2021.
Status of the Claims
Claims 1 and 3 have been amended. Claims 4-6 have been cancelled without prejudice or disclaimer. Claim 1 has been amended to correct typographical errors. Claim 3 is amended to remove the “prevention of a neurodegenerative disease” as a condition of dependency on claim 1.
Newly submitted claims 7-15 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 7-15 as presented in the claims filed on January 5, 2026 are directed towards methods for treating a neurodegenerative diseases (as in claim 8, 9 and 13) and cancers (as in claim 10, 11, 14 and 15). These methods of treatment represent an impermissible shift in scope of the invention, as the methods of treatment was not present in the claims filed September 9th, 2022.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 7-15 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1-3 and 7-15 are pending. Claims 7-15 have been withdrawn from further consideration as being directed towards nonelected species. Claims 1-3 are examined on their merits.
35 USC § 112(d) Claim Rejections-Withdrawn
Applicant has canceled claims 4-6 that renders the rejection in the Office Action dated September 5, 2025, moot. The rejection is withdrawn.
35 USC § 102 (a)(1) Claim Rejections Maintained
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.
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.
Claims 1 and 3-6 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number 1515685-74-1, made publicly available on January 9, 2014:
Claim 1 is directed towards the genus compound of Formula I, wherein, R1 can be hydrogen, R2 is a substituted or unsubstituted pyrazole, R4 is represented by any one of the compounds of B-1 to B-29 of Formula I. The genus of CAS Registry Number 1515685-74-1 is shown below.
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The rejection of claims 1 and 3-6 under 35 U.S.C. 102(a)(1) as being anticipated by Xin et.al., (CN103864770 B, issued on June 18, 2014), hereinafter Xin, is maintained.
Response to Applicants Arguments
Applicants’ argument set forth in the response filed January 5th, 2026, regarding claim 1 and 3-6, that the CAS Registry Number 1515685-74-1 and compound 36 of Xin, both of which are the same and the Chemical Formula 1 of claim 1, R3 is either a halogen or a halo C1-C6 alkyl are distinctly not anticipated. Applicant has canceled claims 4-6 as stated above in the status of the claims. Examiner will be referring to remaining claims 1 and 3.
Applicant is correct in pointing out that R3 is either a halogen or halo C1-C6 alkyl and that the compound 36 as taught by Xin does not meet that requirement. However, Xin does teach multiple compounds that include pyrimidinamines and pyridylamines as inhibitors for Hedgehog signal conduction and their preparation, pharmaceutical compositions and use in the treatment of cancer, wherein the cancer is selected from the group consisting of basal cell carcinoma, neurovascular cell carcinoma, medullary cell carcinoma, pancreatic cancer, prostate cancer, liver cancer, colon cancer, small cell lung cancer, breast cancer, rhabdomyosarcoma, esophageal cancer, gastric cancer, biliary tract cancer, multiple myeloma, leukemia, ridge film tumor, malignant glioma, or melanoma utilizing the compound genus of Formula (I), the genus of both Xin and the applicant shown below.
Xin Formula (I)
Applicant’s Formula (I)
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The applicant’s particular requirement for R3 being a halogen or halo C1-C6 alkyl is anticipated by Xin when X can be CH, Y is O and B-12 is selected from the groups identified as R4, where Z is O and m is 1; B-12 shown below;
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And Xin does teach a species of compound 134 as shown below, that does meet the requirement of a halogen or halo C1-C6 alkyl and the other variables of the instant claims.
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Claim 3 is amended to include a pharmaceutical composition comprising the compound represented by Chemical Formula 1 of claim 1, an optical isomer thereof, or a pharmaceutically acceptable salt thereof as an active ingredient.
Although the instant claim is amended to remove the “prevention of a neurodegenerative disease”, the core of the claim as it pertains to claim 1 is the same. As stated above, Xin anticipates the compound of formula (I) of the instant application and the species of compound 134 that anticipates the pharmaceutical salt as an active ingredient.
Allowable Subject Matter
In the Office Action dated September 5, 2025, the Examiner found that claim 2 was free of the art. Applicant has developed a species of the genus of Formula 1.
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Applicant’s particular species, as recited in claim 2, are not found in the art and would not be predictable to one of ordinary skill in the art.
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the generic claim and any intervening claims.
Claim 7 (new) is examined and objected to as being dependent upon a rejected generic claim, but would be allowable if rewritten in independent form including all of the limitations of the generic claim and any intervening claims.
Conclusion
Claims 1, 3 and 8-15 are rejected.
Claims 2 and 7 are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL RANDALL GAUGER whose telephone number is (571)272-1325. The examiner can normally be reached M-F 7:30-5:00.
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/P.R.G./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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