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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive. Applicant argues (page 4) the prior art teachings of Chen are not obvious to claimed invention because Chen addresses drug resistant cancer cells whereas claimed invention is not limited to drug resistant cancers. Applicant additionally argues (pages 4-6) Chen teaches a wide variety of anticancer medications while exemplifying anticancer drugs of Adriamycin, Vincristine, Taxol and Cisplatin, and the mechanisms of those anticancer medications are different from the mechanisms of claimed Fluorouracil, irinotecan and gemcitabine. Applicant lastly argues the compounds taught by Chen are of structurally different from the structure of claim 24.
It is noted from previous advisory action the mechanisms of taught anticancer drugs by Chen of Fluorouracil, irinotecan and gemcitabine are well known in the art as specified by applicant (pages 5-6), thus would be obvious of the same mechanism to the teachings of Chen. Chen’s exemplified teachings of the above medications does not negate the teachings of the other medications as per MPEP 2123: Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971), A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). It is also known in the art of routine experimentation to treat different cancers with more than one known anticancer drugs, additionally Fluorouracil is known in the art to be the primary chemotherapy drug for colon cancer in which the treatment of that particular cancer is taught by Chen.
On the basis of claim 24 the teachings of Formula II with its embodiments by Chen reads to the structural limitations of the compound of claim 24. Additionally on the basis of Chen just treating drug resistant cancers compared to the cancer itself is unclear as Chen teaches the same compound and anticancer medication for the same cancers as claimed invention. For the above reasons the rejection on record over Chen et al. (US Patent No. 8445532) is maintained.
Applicant has added claim 24, no new matter was added. Claims 11-24 is now evaluated on its merits.
Claim Rejections - 35 USC § 103
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 11-12, 14, 18-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US Patent No. 8445532).
Regarding claims 11-12, 14, 18-22 and 24, Chen teaches a method of treating a tumor having resistance to an anti-cancer drug in a subject, wherein the tumor exhibits either overexpression of at least one selected from the group consisting of P-gp and Bcl-2, or over-activity of glyoxalase I. The method comprising administering to the subject, the anti-cancer drug selected from Cisplatin, Topotecan, Etoposide, Fluorouracil, Irinotecan, Mitoxantrone, Gemcitabine, Oxaliplatin and a therapeutically effective amount of compound (II)
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(relevant to claims 11-12 and 14) (claim 1, page 2 1st para.).
The above compound having R1-R2 as Hydrogen or R2 as C1-C8 alkyl or alkenyl, R5 - R8 as hydrogen (relevant to claim 24), R6 as OH or R7 as OH reads to the claimed invention of formula (I), in which X is H or OH, Y is O, R1 is absent and Y and A bind to form a five membered ring. The cancers being treated taught by Chen includes non-small cell lung cancer, prostate cancer, intestinal cancer, hepatocarcinoma, leukemia, myeloma, lymphoma, mammary cancer, ovary cancer, gastric cancer, esophagus cancer, colonic cancer, or sarcoma (relevant to claims 19-22) (Page 4, 2nd para.) by way of a pharmaceutical composition of the combination of the above compounds with an anti-cancer drug (relevant to claim 18) (Page 8).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have developed a phthalide derivative, with the structural limitations of claimed invention in combination with an anti-cancer drug of Fluorouracil, Gemcitabine, Oxaliplatin or Irinotecan to treat gastric cancer, colonic cancer, non-small cell lung cancer, leukemia, myeloma and lymphoma. One would have been motivated to do so from the teachings of Chen to treat the above cancers by a combination of compound 2
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, which reads to the limitation of claimed structure and an anti-cancer drug of Fluorouracil, Irinotecan, Gemcitabine or Oxaliplatin to treat gastric cancer, colonic cancer, non-small cell lung cancer, leukemia, myeloma and lymphoma.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US Patent No. 8445532) in view of Tisdale, Mechanisms of Cancer Cachexia, Physiological Reviews Vol. 89, April 2009, Pages 381-410.
The teachings of Chen for the above 103 rejections of claims 11-12, 14 and 18-22 are incorporated herein by reference.
Chen fails to teach the combination therapy for attenuating a symptom of cachexia.
However, Tisdale teaches Cachexia is a multifactorial syndrome characterized by progressive loss of body weight, often, but not always, accompanied by anorexia. Tisdale additionally teaches patients with pancreatic or gastric cancer have the highest frequency of cachexia weight loss (page 382 1st para.) and cachexia symptoms are also associated with lung cancer patients.
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the combination therapy taught by Chen to treat gastric and lung cancer in addition to attenuating a symptom of cachexia. One would have been motivated to do so from the teachings of Tisdale on the mechanism and symptoms of cachexia are known to be associated with gastric and lung cancer, wherein gastric cancer patients having the highest frequency of cachexia weight loss. There is a reasonable expectation of attenuating a symptom of cachexia in gastric cancer patients by the combination therapy taught by Chen to treat gastric cancer patients.
Allowable Subject Matter
Claims 13 and 15-17 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 base claim and any intervening claims.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627