DETAILED ACTION
This office action is in response to the applicant’s filing dated January 13th, 2026.
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
This application claims benefit of foreign priority of TW111149353 filed on December 22nd, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 1-8 are pending in the instant application.
Restriction/Election
Applicant’s election without traverse of Group I and election of species of a drug combination comprising regorafenib, gemcitabine and 5-fluorouracil in the reply filed on January 13th, 2026 is acknowledged.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 13th, 2026.
Claim Rejections - 35 USC § 112(b)
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 1-3 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.
Regarding claims 1-3, the language “A use of a drug combination in preparation of a drug for treating a human colorectal carcinoma” fails to clearly define the metes and bounds of the claim. Particularly, it is unclear whether the Applicant intended the instant claims to be drawn to a method of preparation or a method of treatment. See MPEP 2173.05(q).
For the sake of compact prosecution, the Examiner will examine these claims as they read on a method of treating human colorectal carcinoma.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not clearly fall within at least one of the four categories of patent eligible subject matter because they are drawn to “A use of a drug combination” as recited in the first line of claim 1, which is not one of the four categories of patent eligible subject matter. “One cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101") In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961). See MPEP 2173.05(q).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Haque et al (Frontiers in Oncology, (2022),12(992455), 1-8) in view of Merl et al (Expert Opinion on Investigational Drugs, (2009), 18(9), 1257–1264).
Regarding claims 1 and 7-8, Haque teaches the administration of regorafenib in combination with 5-fluorouracil (herein referred to as 5-FU) in human patients with refractory metastatic colorectal cancer. Haque reports that patients treated with the regorafenib and 5-FU combination after failure of multiple prior lines of therapy achieved disease control without new adverse events (page 1, Results; page 3, left column, second and last paragraphs). This demonstrates that the regorafenib and 5-FU combination is known, well tolerated and effective in patients with colorectal cancer.
Haque does not teach a combination that further comprises gemcitabine.
Merl teaches that several clinical trials have evaluated the drug combination of 5-FU and gemcitabine in human patients with colorectal cancer (pages 1259-1261, Table 1). Merl further teaches that 5-FU serves as the backbone of colorectal cancer treatment, and that gemcitabine “acts synergistically with 5-FU” to enhance binding of thymidylate synthase and increases the inhibition of DNA synthesis (page 1258, left column, second paragraph; page 1262, left column, third paragraph).
It would have been prima facie obvious to a person of ordinary skill in the art to combine regorafenib, gemcitabine and 5-FU to treat colorectal cancer. Haque establishes the clinical feasibility and tolerability of reforafenib combined with 5-FU for the treatment of colorectal cancer in human patients; while Merl teaches that gemcitabine and 5-FU metabolic pathways are complimentary, resulting in increased inhibition of DNA synthesis in human patients with colorectal cancer. One of ordinary skill in the art would have recognized that incorporating gemcitabine into the known regorafenib and 5-FU regimen represents a predictable use of prior art elements according to their established functions, with a reasonable expectation of success in at least maintaining baseline therapeutic effectiveness.
“[T]he rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395.
Regarding claims 2-3, The prior art is silent regarding "a cytostatic effect of inhibiting survival of 55% (and 70%) of cancer cells". However, "a cytostatic effect of inhibiting survival of 55% (and 70%) of cancer cells" will naturally flow from the teachings of the prior art (see above rejection), since the same combination (regorafenib, gemcitabine and 5-FU) is being administered to the same subjects (human patients with colorectal cancer). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding "a cytostatic effect of inhibiting survival of 55% (and 70%) of cancer cells", by practicing the methods made obvious by the prior art (treating colorectal cancer in human patients with a drug combination comprising regorafenib, gemcitabine and 5-FU), one will also have "a cytostatic effect of inhibiting survival of 55% (and 70%) of cancer cells", even though the prior art was not aware of it.
Apparently, the Applicant has discovered a new property or advantage ("a cytostatic effect of inhibiting survival of 55% (and 70%) of cancer cells") of the method made obvious by the prior art.
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Taken together, all of this all of this would result in the combination of instant claims 1-3 and 7-8 with a reasonable expectation of success.
Conclusion
Claims 1-3 and 7-8 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691