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 .
Detailed Action
Claims 1-9 and 27-28 are pending and are now evaluated on its merits.
Priority
This application is a continuation of application 16/489,803, filed 08/28/2019, which claims domestic benefit to U.S. provisional application 62/465,992, dated 03/0/2017.
Information Disclosure Statement
The information disclosure statement (IDS) dated 7/17/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. (US 20040176392 A1).
Regarding claims 1-6 and 27, Roth teaches the compound 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-an- Ilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate exhibited as formula 1:
PNG
media_image1.png
329
427
media_image1.png
Greyscale
(Para. 002) as a method for treating excess or abnormal cell proliferation. The structure encompasses the limitations of claims 1-6 and 27 of R1 as hydrogen, R2 as an ester, R3 as an aryl and R4 as hydrogen. Roth further teaches the substitution of the ester of R2 from an ester to a carboxyl by “cleaved in vivo and converted in-vivo into a carboxy group” (para. 0034).
Roth fails to teach the above compound wherein the hydrogen is at position 6 and ester at position 5 of the oxindole ring, however it would have been obvious to someone or ordinary skill in the art at the time of filing to have developed the claimed compound wherein the hydrogen is at position 6 and ester at position 5 by the teachings of Roth. One would have been motivated to do so as the interchangeable R1 and R2 positions of Roth are essentially position isomers, thus having structural similarities evidenced in MPEP § 2144.09(II): Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). There is a reasonable expectation of developing the claimed compound from the teachings of Roth.
Claims 1-9 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Roth et al. (U.S. Patent 6762180), hereinto referred to as Roth2.
Regarding claims 1-9 and 27-28, Roth2 teaches a method for treating cancers of glioblastoma and breast cancer (para. 110) by administration of formula 1
PNG
media_image2.png
184
264
media_image2.png
Greyscale
in combination with the chemotherapeutic agent of cisplatin (para. 111). The embodiments of R1-R5 are explained in claim 1. Of relevance to the claimed invention as taught by Roth2 R1 is taught as H, R2 as a C1-16 alkoxycarbonyl group such as methoxycarbonyl (relevant to claims 3 and 27) and isopropoxycarbonyl (relevant to claim 28) (Pg. 7), R3 as heteroaryl which constitutes furan and pyridine (relevant to claims 8-9) or substituted or unsubstituted phenyl (relevant to claims 4-7), R5 as H and R4 of a phenyl substituted by the embodiments of claimed invention of
PNG
media_image3.png
175
323
media_image3.png
Greyscale
.
Roth2 fails to teach the above compound wherein the hydrogen is at position 6 and ester at position 5 of the oxindole ring, however it would have been obvious to someone or ordinary skill in the art at the time of filing to have developed the claimed compound wherein the hydrogen is at position 6 and ester at position 5 by the teachings of Roth2. One would have been motivated to do so as the interchangeable R1 and R2 positions of Roth are essentially position isomers, thus having structural similarities evidenced in MPEP § 2144.09(II): Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). There is a reasonable expectation of developing the claimed compound from the teachings of Roth2.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-6 and 27 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 10-11 of prior U.S. Patent No. 10981896. Claims 10-11 of U.S ‘896 teaches compounds
PNG
media_image4.png
322
545
media_image4.png
Greyscale
and
PNG
media_image5.png
348
539
media_image5.png
Greyscale
which reads to claimed inventions compound
PNG
media_image6.png
360
505
media_image6.png
Greyscale
with its limitations of R1-R3. This is a statutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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, Kortney Klinkel can be reached at 571-270-5239. 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.
MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627