DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. Response to Election/Restriction filed on 4/22/2026 is acknowledged.
3. Claim filed on 4/22/2026 is acknowledged.
4. Claims 1-22 have been cancelled.
5. Claims 23-28 are pending in this application.
6. Claims 23-28 are under examination.
Information Disclosure Statement
7. The IDSs filed 3/7/2025 are acknowledged and presently considered to the extent possible in the time allotted for IDS consideration.
Applicant is advised that the MPEP states the following with respect to large information disclosure statements: “Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.” (see MPEP § 609.04(a)(III)); and “It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974).” (see MPEP § 2004 at item 13).
These statements are in accord with Molins PLC v. Textron, Inc. (33 USPQ 2d 1823 (1995); 48 F.3d 1172 (Fed. Cir. 1995)), which stated that “'burying' a particularly material reference in a prior art statement containing a multiplicity of other references can be probative of bad faith” (Id. at 1831; see also Id. at ), wherein the case presented a situation where the disclosure was in excess of 700 pages and contained more than 50 references. In the instant case, the five IDSs contain over 117 foreign patents, 213 Non patent literatures; and 90 US patents and US patent applications.
Election/Restrictions
8. Applicant’s election without traverse of Group 2 (claims 23-28) and election without traverse of
PNG
media_image1.png
228
360
media_image1.png
Greyscale
as species of agent to be administered; and a patient with an R132C IDH1 mutation as species of subject or patient to be treated in the reply filed on 4/22/2026 is acknowledged. The requirement is made FINAL in this office action.
Group 2 is drawn to a method of treating chondrosarcoma characterized by having an IDH1 mutation in a patient in need thereof comprising administering to the patient a therapeutically effective amount of (S)-N-((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2- oxoethyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide:
PNG
media_image2.png
220
348
media_image2.png
Greyscale
, or a pharmaceutically acceptable salt or hydrate thereof. A search was conducted on the elected species; and these appear to be free of prior art. A search was extended to the genus in claims 23 and 26; and these too appear to be free of prior art. Claims 23-28 are examined on the merits in this office action.
Claim Interpretations
9. With regards to the IDH1 R132X mutation recited in instant claims 24 and 27, in the broadest reasonable interpretation, the Examiner is interpretating such mutation means the amino acid at position 132 of IDH1 can be any amino acid except Arg (R).
Objections
10. The specification is objected to for the following minor informality: The specification recites various chemical formulas/structures on pages 26-44 of instant specification. However, the quality of these chemical formulas/structures is extremely poor. Applicant is required to address this issue.
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
11. Claims 23 and 26 are objected to for the following minor informality: Claim 23 contains the acronym “IDH1”. An acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., isocitrate dehydrogenase 1 (IDH1). The abbreviation can be used thereafter.
Furthermore, Applicant is suggested to amend claims 23 and 26 as “A method of treating chondrosarcoma…in a patient in need thereof, wherein the method comprises administering to the patient…”.
12. Claims 24, 25, 27 and 28 are objected to for the following minor informality: Applicant is suggested to amend these claims as “The method of claim 23, wherein…” or “The method of claim 26, wherein…”.
Rejections
Obviousness Double Patenting
13. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
14. Claims 23-28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 12-18 of US patent 9474779 B2.
15. Instant claims 23-28 are drawn to a method of treating chondrosarcoma characterized by having an IDH1 mutation in a patient in need thereof comprising administering to the patient a therapeutically effective amount of (S)-N-((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2- oxoethyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide:
PNG
media_image2.png
220
348
media_image2.png
Greyscale
, or a pharmaceutically acceptable salt or hydrate thereof.
16. Claims 12-18 of US patent 9474779 B2 are drawn to any one of the
compounds from Table 1; a pharmaceutical composition comprising such compound and a pharmaceutically acceptable carrier; and a method of treating a cancer characterized by an IDH1 mutation, wherein the IDH1 mutation results in a new ability of the enzyme to catalyze NAPH-dependent reduction of α-ketoglutarate to R(-)-2-hydroxyglutarate in a patient, comprising administering to the patient in need thereof such pharmaceutical composition.
The compound recited in instant claims is one of the compound in Table 1 of US patent 9474779 B2; and the recited cancer is one of 9 cancers recited in claim 17 of US patent 9474779 B2.
Therefore, in view of the combined teachings of claims12-18 of US patent 9474779 B2, it would have been obvious to one of ordinary skilled in the art to develop the methods recited in instant claims 23-28.
17. For the same/similar reasoning/rational as the rejection set forth in Sections 14-17 above, instant claims 23-28 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8, 13 and 16 of US patent 9850277 B2.
Examiner’s Notes
18. The methods recited in instant claims 23-28 are free of prior art. The closest prior art is Popovici-Muller et al (WO 2012/009678 A1, filed with IDS). Popovici-Muller et al, throughout the patent, teach a compound of formula (I) and a method of treating cancer characterized by the presence of a mutant allele of IDH1 with such compound, for example, Abstract; and pages 2-3, Section “SUMMARY OF INVENTION”. However, there is no teaching, motivation, or other type of suggestion to modify the compound of formula (I) in Popovici-Muller et al and arrive at the compound used in the methods recited in instant claims 23-28. Therefore, the methods recited in instant claims 23-28 are both novel and unobvious over the prior arts of record.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LI N KOMATSU/Primary Examiner, Art Unit 1658
Prosecution Insights