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 .
Claim Status
Claim listing filed on December 16, 2025 is pending. Claims 2-3, 7-11, 13, 19-21, and 26-32 are canceled. Claims 1, 4-6, 12, 14-15, 17-18, and 25 are amended. Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species. Claims 1, 4-5, 12, 14-18, and 22-25 are examined upon their merits.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 02/17/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. No English copies have been filed for non-patent literature documents #20 and #21. The IDS filed has been considered with the exception of the lined-through references.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claims 2-3, 9-11, 13, 20-21, 26, and 31-32 have rendered all previous rejections directed to these claims moot.
Applicant’s amendments to the specification and claims have overcome all objections of record, and the specification objections and claim objections are withdrawn.
The rejection of Claims 1, 5, 12, 14-18, and 22-25 under 35 U.S.C. 112(b) as being indefinite are withdrawn in view of Applicant’s amendments. The indefinite terms “about,” “approximately,” “such as,” “preferably,” and “substantially” have been deleted. Further, Claim 1 defines “interferon-based therapeutic agent” as interferon α.
The rejection of Claims 1, 4-5, 12, 14-18, and 22-25 under 35 U.S.C. 112(a) as failing to comply with the written description requirement and enablement requirement is withdrawn in view of Applicant’s amendments. Claim 1 is now directed to treating liver cancer, lung cancer, breast cancer, colorectal cancer, or melanoma by administering interferon α in combination with entecavir, oxaliplatin, epirubicin, paclitaxel, or gemcitabine, a method for which the disclosure provides proper written description and enablement.
The rejection of Claims 1, 12, 14-18, and 22-23 under 35 U.S.C. 102(a)(1) as being anticipated by Wada et al. Br J Haematol. 2000 as evidenced by Shudo et al. Expert Opin Drug Metab Toxicol. 2009 is withdrawn in view of Applicant’s amendments. Wada teaches a method of treating multiple myeloma which is not within the scope of cancers listed in amended Claim 1.
The rejection of Claims 1, 4-5, 12, 16-18, and 24-25 under 35 U.S.C. 102(a)(1) as being anticipated by Goujard et al. AIDS. 2012 as evidenced by Palumbo et al. Ther Adv Chronic Dis. 2011 is withdrawn in view of Applicant’s amendments. Goujard teaches a method of treating HIV which is not within the scope of cancers listed in amended Claim 1.
Claim Objections (New, necessitated by amendment)
Claim 1 is objected to because of the following informalities: “wherein the method further comprising administering an additional agent” in line 8 should recite “wherein the method further comprises administering an additional agent” to be grammatically correct. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (New, necessitated by amendment)
Claims 22-25 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.
Claims 22-25 are indefinite because they depend from Claim 21, and Claim 21 is canceled. For the purpose of compact prosecution, Claims 22 and 24 are interpreted to be dependent from Claim 1.
Claim Rejections - 35 USC § 102 (Maintained)
The rejection of Claims 1, 4, 12, 14, 16-18, and 24 under 35 U.S.C. 102(a)(1) as being anticipated by Stefan et al. Anti-Cancer Drugs 2002 (of record) as evidenced by Radwanski et al. J Clin Pharmacol. 1987 (of record) is maintained.
Applicant's arguments filed December 16, 2025 have been fully considered but they are not persuasive. Applicant argues that Stefan teaches that patients with NSCLC only showed a partial response to therapy. Claim 1 is directed to a method for treating. It is of record in the non-final filed 06/17/2025 that "treating" is not defined in the specification and is interpreted as alleviating the symptoms of complications of an established disease, delaying the progression of an established disease, and/or curing or eliminating an established disease (page 7). Therefore, a partial response is encompassed by “treating” in Claim 1.
Applicant argues that Stefan does not teach treatment of liver cancer, breast cancer, colorectal cancer, or melanoma nor does Stefan teach the use of additional agents entecavir, oxaliplatin, epirubicin, or paclitaxel. Applicant argues that Stefan only teaches administering gemcitabine to treat NSCLC. Claim 1 recites “wherein the additional agent is selected from entecavir, oxaliplatin, epirubicin, paclitaxel and gemcitabine” and “wherein the disease is selected from liver cancer, lung cancer, breast cancer, colorectal cancer and melanoma.” The language “selected from” means that the claim is directed to any single agent selected from the list of possible agents and any single disease selected from the list of possible diseases. Because Stefan teaches administering interferon α in combination with gemcitabine to treat lung cancer, the art anticipates the claim limitations.
Claim Rejections - 35 USC § 102 (New, necessitated by amendment)
Claims 1, 4, 12, 14-18, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT00062010 (ClinicalTrials.gov posted June 2003).
The claims are directed to a method of treating lung cancer by administering interferon α in a plurality of consecutive treatment courses in combination with paclitaxel (Claim 1); wherein the interferon α is interferon α2b (Claim 4); the duration of the treatment courses is 2 weeks to 6 weeks and the interval between the consecutive treatment courses is 2 weeks to 6 weeks (Claims 12 and 14-15); the interferon α is administered for 2-25 or more courses (Claim 16); the durations of the treatment courses are the same (Claim 17); the duration of the intervals between treatment courses are the same (Claim 18); and the administration of the interferon and the paclitaxel overlaps (Claim 24).
NCT00062010 teaches a phase II clinical trial wherein patients with recurrent small cell lung cancer are treated by administering interferon α2b on days 1 and 2 of weeks 1-6 and paclitaxel on day 2 of weeks 1-6 (Study Overview and Intervention/Treatment). Courses repeat every 8 weeks, comprising 6 weeks of treatment and two weeks of rest (Intervention/Treatment). The 8-week cycle is repeated until disease progression or unacceptable toxicity is reached (Intervention/Treatment).
Therefore, Claims 1, 4, 12, 14-18, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT00062010.
Claim Rejections - 35 USC § 103 (New, necessitated by amendment)
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, 4-5, 12, 14, 16-18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Stefan et al. Anti-Cancer Drugs 2002 (of record) in view of Mishra et al. Asian J. Pharm. Sci. 2016.
The teachings of Stefan as the apply to Claims 1, 4, 12, 14, 16-18, and 24 are on record in the non-final rejection filed 06/17/2025. Briefly, Stefan teaches a method of treating non-small cell lung cancer by administering gemcitabine once weekly and interferon α2b three times weekly for 3 consecutive weeks followed by one week of rest (abstract; of record).
Stefan fails to teach wherein the interferon is PEGylated (Claim 5).
Mishra teaches that PEGylation has the ability to enhance the retention time of therapeutics by protecting them against various degrading mechanisms active inside a tissue or cell, which consequently improves their therapeutic potential (abstract). The technique of covalently attaching polyethylene glycol (PEG) to a given molecule (“PEGylation”) is a well-established method in the field of targeted drug delivery systems (section 2, paragraph 1). PEGylated interferon α2b displayed a half-life of 27-37 hours with 10-fold lower clearance and minor change in the volume of distribution in comparison to its native form (section 3.2.1.1). PEGylated interferon α2b is sold under the brand name SylatronTM and is approved by the FDA for adjuvant therapy in cancer treatment (section 3.2.1.1). Prolonging the half-life of interferon α can improve patient compliance by enabling once-weekly dosing while maintaining acceptable safety, tolerability, and activity profiles in clinical settings (section 3.2.1.2).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute the interferon α2b taught by Stefan with the PEGylated interferon α2b taught by Mishra. Mishra teaches that PEGylated interferon α2b is publicly available and FDA-approved for cancer treatment, showing that it is safe and effective. The motivation to administer PEGylated interferon α2b instead of interferon α2b is to prolong half-life so that the PEGylated interferon α2b can be administered once a week instead of 3 times a week to improve patient compliance. This pharmacokinetic improvement taught by Mishra could be applied to the treatment method of Stefan with a reasonable expectation of success.
Claims 1, 4, 12, 14, 16-18, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Stefan et al. Anti-Cancer Drugs 2002 (of record) in view of NCT00004063 (ClinicalTrials.gov posted January 2003).
The teachings of Stefan as the apply to Claims 1, 4, 12, 14, 16-18, and 24 are on record in the non-final rejection filed 06/17/2025. Briefly, Stefan teaches a method of treating non-small cell lung cancer by administering gemcitabine once weekly and interferon α2b three times weekly for 3 consecutive weeks followed by one week of rest (abstract; of record).
Stefan fails to teach wherein the additional agent is administered during and between the plurality of consecutive treatment courses (Claim 25).
NCT00004063 teaches a method of treating cancer by administering gemcitabine on days 1, 8, and 17 followed by interferon α on days 16 and 17 wherein courses repeat every 5 weeks in the absence of disease progression or unacceptable toxicity (Detailed Description). Therefore, NCT00004063 teaches administering gemcitabine on weeks 1, 2, and 3; administering interferon α on week 3; and a rest interval on weeks 4-5 which reads on the additional agent being administered during and between courses of interferon α.
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute the dosing schedule taught by Stefan with the dosing schedule taught by NCT00004063. Dosages and administration periods are results-effective variables which can be optimized. In the case of administering gemcitabine and interferon α, one of skill in the art would clearly recognize that doses must be timed sufficiently to maintain the efficacy of the drug in vivo and that the timing of dosages can be variable and could easily be optimized by a treating physician based on the needs and physiology of an individual patient. As such, the dosing schedule would amount to nothing more than routine experimentation that can be optimized on an individual patient basis (see In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977); and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)). As NCT00004063 teaches that gemcitabine can be administered during and between a plurality of consecutive interferon α treatment courses to treat cancer and dosing schedule optimization is routine in the art of medicine and pharmacology, it would be obvious to one of ordinary skill to adjust the dosing schedule of Stefan accordingly to effectively treat lung cancer.
Claims 1, 12, 14-18, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Atzpodien et al. Brit. J. Cancer (2002) in view of Ursic et al. Bioelectrochemistry (2017).
Atzpodien teaches a method of treating melanoma by administering cisplatin on days 1-3 of week 1 in combination with interferon α on day 1 of weeks 4 and 5 (abstract). Five-week treatment cycles were repeated unless progression of disease occurred (Study design). Therefore, the administration of cisplatin (week 1) is between the plurality of consecutive treatment courses of interferon α (weeks 4 and 5).
Atzpodien teaches wherein the additional agent is cisplatin but fails to teach wherein the additional agent is oxaliplatin (Claim 1).
Ursic teaches that oxaliplatin is an analogue of cisplatin (introduction paragraph 1). Both cisplatin and oxaliplatin are platinum-based drugs that bind to DNA and form platinum-DNA adducts (introduction paragraphs 1-2). Cisplatin is used to treat ovarian, testicular, bladder, colorectal, lung as well as head and neck cancers; and oxaliplatin is used to treat colorectal cancer as well as cisplatin-resistant cancers, including stomach, pancreas, ovary, breast and lung cancers (introduction paragraph 1). Ursic specifically compared cisplatin versus oxaliplatin in the treatment of murine melanoma and concluded that both drugs were effective (conclusion paragraph 1).
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (cisplatin and oxaliplatin for treating cancer) (See MPEP 2144.06-II). It would have been obvious to alter the method of cancer treatment taught by Atzpodien to administer a cisplatin analogue (oxaliplatin) instead of cisplatin as both agents are known to treat cancer, specifically melanoma, by the same DNA-damaging mechanism. The motivation to administer oxaliplatin instead of cisplatin is because oxaliplatin is known to be effective in treating cisplatin-resistant cancers.
Double Patenting (Maintained)
1. The provisional rejection of Claims 1, 4-5, 12, and 14-18 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-10, 14-22, and 24-25 of copending U.S. App. No. 18/273,321 is maintained.
2. The provisional rejection of Claims 1, 4-5, 12, 14-18, and 22-25 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-12, 14-19, and 23-24 of copending U.S. App. No. 18/273,323 is maintained.
3. The provisional rejection of Claims 1, 4-5, 12, 14-18, and 22-25 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 9-25 of copending U.S. App. No. 18/099,664 is maintained.
Applicant's arguments filed December 16, 2025 have been fully considered but they are not persuasive. Applicant requests that the Examiner hold these rejections in abeyance until after allowable subject matter is identified. MPEP § 804.I.B.1 states “As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance.” Because no terminal disclaimer has been filed and no showing has been made that the copending claims are patentably distinct, the provisional double patenting rejections are maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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