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 .
Current Status
This action is responsive to the amended claims of 03/30/2026. Claims 1-8 and 16 are pending. Claims 1-8 and 16 have been examined on the merits.
Election/Restrictions
The amendments and remarks of 03/30/2026 have overcome the pending prior art rejections. However, a search for the new limitations in claim 1 still retrieves art for the elected species: dunnione, PD-1 inhibitor, oxaliplatin, and colorectal cancer.
In response to the amendments, the search has also been extended to another species of ICD: sorafenib. The Markush search will not be unnecessarily extended to additional species in this action, per Markush search practice.
The elected and extended species read on claims 1-8 and 16.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 07/10/2021.
While Applicant has provided a certified translation of the Foreign Priority document KR10-2020-0085711, the translated document does not appear to contain support for the last three lines of amended claim 1. The reduction of the recited adverse events is not found in the priority document.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 03/30/2026; no new matter is found.
The 112(b) rejection of claims 1 and 3-4 is withdrawn for claim 1, but maintained over claims 3-4. The rejected phrasing has been amended in claim 1, but has not been changed in claims 3-4. Thus, the rejection is maintained over claims 3-4. The rejection is withdrawn from claim 1 and dependent claims 2, 5-8, and 16.
The 112(d) rejection of claim 2 is withdrawn since claim 1 has been amended so that it does not require all 3 components (dunnione, ICI, and ICD). Thus, claim 2 now properly further limits claim 1.
The 102(a)(1) rejection of claims 1, 3-4, and 16 over MOUSSES is withdrawn in view of the amendments and arguments. Applicant’s argument that MOUSSES does not suggest combination of dunnione and oxaliplatin since both are listed as first compounds (not first and second) is persuasive. Further, the amendments recite reduction of an adverse event, which MOUSSES does not teach.
The 102(a)(1) and 102(a)(2) rejections of claims 1, 4, and 5 over SO is withdrawn in view of the amendments – SO does not teach reduction of the adverse events in claim 1. Examiner acknowledges Applicant’s declaration stating SO is the work of the instant inventors and is commonly owned.
The 102(a)(2) rejection of claims 1-8 and 16 over KWAK is withdrawn in view of the amendments. KWAK is the published PCT underlying the instant application and claims priority to the same foreign document KR10-2020-0085711. While KWAK is by another, the priority document does not support the reduction of the instantly recited adverse events. Thus, KWAK cannot be applied as 102(a)(2) art for the amendments made to instant claim 1.
The 103 rejection of claims 1-8 and 16 over KIM in view of each of: ELOXATIN, KEYTRUDA, and OVERMAN is modified below to account for the amendments made to claim 1.
Applicant argues the combination of dunnione with an ICI and/or ICD results in tumor growth inhibition that is equivalent to or greater than the additive effects of each drug administered alone. This is supported by the data provided in the specification (see Tables 4-34). While the synergistic effect (greater than additive) is not taught in the applied prior art, inhibition equivalent to the additive effect is not unexpected since each compound is known to treat cancer and the combination of such drugs is taught (i.e., the combination should not be antagonistic). Examiner has incorporated reference JIANG (WO 2003/011224) into the modified rejection to support this argument, below.
Applicant also argues addition of dunnione to an ICI/ICD “raises concerns of potentially protecting tumor cells”; however, no evidence is provided to support this argument (e.g., literature, data, etc.). Thus, Examiner cannot consider this evidence (see MPEP 2145.I). Further, JIANG appears to contradict this argument since dunnione is known to inhibit cancer cells (Pg. 39 Table 9).
The 103 rejection of claims 1 and 6 over KIM in view of each of: ELOXATIN, KEYTRUDA, OVERMAN, and ANSEL is modified below to account for the amendments made to claim 1. The same arguments discussed in ¶15 apply here.
The anticipatory double patenting rejection of claims 1 and 4 over claims 1-6 of U.S. Patent No. 11,278,514 is withdrawn. The reference patent is drawn to treatment of different adverse events than the instant claims.
The obviousness-type double patenting rejection of claims 1-8 and 16 over 1-6 of U.S. Patent No. 11,278,514 in view of KIM, ELOXATIN, KEYTRUDA, OVERMAN, and ANSEL is withdrawn for the same reasons as stated above.
The obviousness-type double patenting rejection of claims 1-8 and 16 over claims 1-3 of U.S. Patent No. 12,370,170 in view of KIM, ELOXATIN, KEYTRUDA, OVERMAN, and ANSEL is maintained and modified, below, in response to the arguments discussed in ¶15 and the amendments to claim 1.
The obviousness-type double patenting rejection of claims 1-8 and 16 over claims 1-5 of U.S. Patent No. 12,257,230 in view of KIM, ELOXATIN, KEYTRUDA, OVERMAN, and ANSEL is withdrawn. The reference patent is drawn to treatment of different adverse events than the instant claims.
Response to Amendment
Claim Rejections - 35 USC § 112 - maintained
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 3-4 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 3-4 recite wherein the composition comprises “at least one selected from among an immune checkpoint inhibitor (ICI) and an immunogenic cell death (ICD) inducer”. This phrasing may be interpreted in two alternative ways: 1) the composition comprises at least one immune checkpoint inhibitor (ICI) and an immunogenic cell death inducer (ICD), or alternatively, 2) the composition comprises at least one compound that is either an ICI or an ICD. It is unclear whether only one or both of the ICI and the ICD are required. Thus, the metes and bounds of the claims are undefined rendering the claims indefinite.
Claim Rejections - 35 USC § 102 – necessitated by amendment
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-5, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KIM (US 2019/0083453; cited IDS of 03/13/2024) as evidenced by: JIANG (WO 2003/011224; cited IDS of 03/13/2024) and STOKOL (Stokol, T., Cornell University College of Veterinary Medicine, ECLINPATH, 23 Oct. 2018, pg. 1-3).
Regarding claims 1 and 16, KIM teaches a method for preventing/ameliorating hematopoietic stem cell reduction (i.e., pancytopenia) related to anticancer drug treatment by administering a pharmaceutically effective amount of dunnione
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to a subject (Pg. 32 claim 1); the anticancer drug treatment is sorafenib (Pg. 13 ¶261), i.e., an ICD. KIM teaches a composition comprising dunnione (Pg. 9 ¶178), formulations thereof for oral administration and intravenous injection (Pg. 12 ¶246-247). The cancer is preferably colon and rectal cancers (Pg. 13 ¶257).
JIANG discloses dunnione is a cancer growth inhibitor (Pg. 39 Table 9). The combination of dunnione and sorafenib is expected to exhibit at least equivalent inhibitory activity against cancer cell growth as sum of each of the drugs administered individually since both are known as anticancer drugs. Further, KIM teaches combination of the two and, so, the artisan would expect the combination is not antagonist.
STOKOL discloses pancytopenia encompasses reduction in hematopoietic cells (Pg. 3 Flow Chart). Thus, the treatment of hematopoietic cell reduction is treatment of pancytopenia.
Regarding claims 4-5, KIM teaches, preferably, the anticancer drug (sorafenib) is intraperitoneally injected into the subject and dunnione is orally administered everyday starting 3 days prior to and overlapping with the anticancer drug administration (Pg. 14 ¶265); i.e., sequential and simultaneous administration.
Claim Rejections - 35 USC § 103 – necessitated by amendment
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 1-5, 7-8, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over KIM (US 2019/0083453; cited IDS of 03/13/2024), evidenced by STOKOL (Stokol, T., Cornell University College of Veterinary Medicine, ECLINPATH, 23 Oct. 2018, pg. 1-3), and in view of each of:
ELOXATIN (FDA, Eloxatin (Oxaliplatin) Full Prescribing Information, Revised 03/2020, pg. 1-42, retrieved from www.fda.gov/drugsatfda; provided 11/28/2025),
KEYTRUDA (FDA, Keytruda (Pembrolizumab) Full Prescribing Information, Revised 06/2020, pg. 1-93, retrieved from www.fda.gov/drugsatfda; provided 11/28/2025),
OVERMAN (Overman, M.J. et al., ASCO Ed. Book, 2018, 239-247; provided 11/28/2025), and
JIANG (WO 2003/011224; cited IDS of 03/13/2024).
Determining the Scope and Contents of the Prior Art:
KIM teaches a method for preventing/ameliorating side effects including hematopoietic stem cell reduction (i.e., pancytopenia) related to anticancer drug treatment by administering a pharmaceutically effective amount of dunnione
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to a subject (Pg. 32 claim 1). STOKOL discloses pancytopenia encompasses reduction in hematopoietic cells (Pg. 3 Flow Chart).
KIM also teaches a composition comprising dunnione (Pg. 9 ¶178), formulations thereof for oral administration and intravenous injection (Pg. 12 ¶246-247). KIM further teaches administration of a single anticancer drug or two or more different anticancer drugs (Pg. 32 claim 8). For anticancer treatment it is preferable to administer the anticancer drug alone or in combination with two or more anticancer drugs; in the case of co-administration the drugs can be administered at different times (Pg. 13 ¶258). The cancer is preferably selected from the group including colon and rectal cancers (Pg. 13 ¶257). Preferably, the anticancer drug is intraperitoneally injected into the subject and dunnione is orally administered everyday starting 3 days prior to and overlapping with the anticancer drug administration (Pg. 14 ¶265).
ELOXATIN teaches oxaliplatin in combination with leucovorin is indicated for treatment of colorectal cancer (Pg. 2 sect. 1) as an intravenous infusion (Pg. 2 sect. 2.1). Adverse reactions in colorectal cancer patients included anemia, leukopenia, neutropenia, and thrombocytopenia (Pg. 18 Table 13) – i.e., pancytopenia.
KEYTRUDA teaches pembrolizumab is a PD-1-blocking antibody indicated for the treatment of colorectal cancer that has progressed following treatment with oxaliplatin (Pg. 6 sect. 1.8), administered as an intravenous injection (Pg. 10 sect. 2.4).
OVERMAN teaches the FDA has approved both pembrolizumab and nivolumab for treatment of colorectal cancer (Pg. 239 Abstract). Nivolumab also targets PD-1 (Pg. 242 Table 1).
JIANG teaches dunnione inhibits growth of colon cancer cells (Pg. 39 Table 9).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
KIM, evidenced by STOKOL, does not teach the anticancer drugs are a PD-1 antibody and/or oxaliplatin.
ELOXATIN does not teach administration of dunnione or a PD-1 antibody.
KEYTRUDA and OVERMAN do not teach administration of dunnione.
JIANG does not teach the combination of dunnione with an ICI and/or ICD.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of colorectal cancer and possesses the technical knowledge necessary to make adjustments to the composition administered to a subject to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatments for colorectal cancer and side-effects thereof and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references KIM, evidenced by STOKOL, in view of each of: ELOXTAIN, KEYTRUDA, OVERMAN, and JIANG.
Regarding claims 1-2 and 16, the artisan would be motivated to treat colorectal cancer patients being treated with oxaliplatin and pembrolizumab with the method of KIM (i.e., administration of dunnione) in order to prevent/ameliorate the side effects of pancytopenia. The artisan would have a reasonable expectation of success since KIM teaches administration of dunnione ameliorates pancytopenia caused by anticancer treatments (Pg. 32 claim 1) in colon and rectal cancers (Pg. 13 ¶257). Further, ELOXATIN (Pg. 18 Table 13) teaches pancytopenia as a side-effect. Since KEYTRUDA teaches pembrolizumab treatment for colorectal cancer that has progressed after oxaliplatin treatment (Pg. 6 sect. 1.8), the artisan would have a reasonable expectation of success in combining these two anticancer drugs. Moreover, the artisan would find it obvious to substitute one functional equivalence (the anticancer agents of KIM) for another (oxaliplatin and pembrolizumab) with an expectation of success, since the prior art establishes that both function to treat colorectal cancer.
Since JIANG teaches dunnione is an effective inhibitor of colon cancer (Pg. 39 Table 9), the artisan would have a reasonable expectation of success that by combining dunnione, pembrolizumab, and oxaliplatin, one would have achieved a composition useful for treating colorectal cancer and having a tumor growth inhibition at least equivalent to the sum of effects of each drug alone.
Further, as set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine agents, each of which are taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art.
Regarding the composition, oxaliplatin and pembrolizumab are taught as intravenous injection compositions (ELOXATIN Pg. 2 sect. 2.1; KEYTRUDA Pg. 10 sect. 2.4) and dunnione as a composition (KIM Pg. 9 ¶178). Under the broadest reasonable interpretation, the components of the composition do not have to be formulated in the same dosage form.
Regarding claims 3-4, each of oxaliplatin (ELOXATIN Pg. 2 sect. 2.1), pembrolizumab (KEYTRUDA Pg. 10 sect. 2.4), and dunnione (KIM Pg. 12 ¶247) are taught as formulations for intravenous injection. Thus, the artisan would find it obvious to mix at least one of the two anticancer drugs (oxaliplatin or pembrolizumab) and dunnione in the same injection solution in order to simultaneously administer the two drugs and in order to ameliorate the side effects associated with administration of the anticancer drug.
Further regarding claim 4, the artisan would find the timing/order of administration obvious since there are only two options to choose from: either the drugs are administered at the same time or at separate times (i.e., simultaneous or sequential). Moreover, since each KIM, ELOXATIN, and KEYTRUDA teach compositions of each respective drug (cited above) the artisan would find obvious the sequential administration of each separate composition.
Regarding claim 5, since intravenous injections for oxaliplatin (ELOXATIN Pg. 2 sect. 2.1) and pembrolizumab (KEYTRUDA Pg. 10 sect. 2.4) and oral administrations for dunnione (KIM Pg. 14 ¶265) are preferred, the artisan would be motivated with an expectation of success to administer the drugs accordingly.
Regarding claims 7-8, the artisan would have been imbued with at least a reasonable expectation of success that by combining pembrolizumab with nivolumab (another anti-PD-1 antibody), one would have achieved a composition useful for treating colorectal cancer since both are taught by the prior art as suitable for the treatment of colorectal cancer (OVERMAN Pg. 239 Abstract). As set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art.
Similarly, the artisan would have been imbued with at least a reasonable expectation of success that by combining oxaliplatin with leucovorin (another ICD), one would have achieved a composition useful for treating colorectal cancer since both are taught by the prior art as suitable for the treatment of colorectal cancer, specifically as a combination treatment (ELOXATIN Pg. 2 sect. 1).
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over KIM (US 2019/0083453; cited IDS of 03/13/2024), evidenced by STOKOL (Stokol, T., Cornell University College of Veterinary Medicine, ECLINPATH, 23 Oct. 2018, pg. 1-3), and in view of each of:
ELOXATIN (FDA, Eloxatin (Oxaliplatin) Full Prescribing Information, Revised 03/2020, pg. 1-42, retrieved from www.fda.gov/drugsatfda; provided 11/28/2025),
KEYTRUDA (FDA, Keytruda (Pembrolizumab) Full Prescribing Information, Revised 06/2020, pg. 1-93, retrieved from www.fda.gov/drugsatfda; provided 11/28/2025),
OVERMAN (Overman, M.J. et al., ASCO Ed. Book, 2018, 239-247; provided 11/28/2025), and
JIANG (WO 2003/011224; cited IDS of 03/13/2024), as applied to claim 1;
further in view of:
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53; provided 11/28/2025).
Determining the Scope and Contents of the Prior Art:
KIM, evidenced by STOKOL, and in view of: ELOXATIN, KEYTRUDA, OVERMAN, and JIANG teach the method of claim 1, above. Furthermore, KIM teaches an effective dose of dunnione is 0.001-2000 mg/60 kg per day (Pg. 12 ¶248). ELOXATIN teaches oxaliplatin is administered at 85 mg/m2 as intravenous infusion (Pg. 2 sect. 2.1). KEYTRUDA teaches pembrolizumab is administered at a 200 or 400 mg dosage (Pg. 8 Table 1).
ANSEL teaches the safe and effective dose of a drug depends on a number of
factors including characteristics of the drug, the dosage form, and a variety of patient
factors (Pg. 48 Left Col. para 2) and the effective dose may be different for different
patients (Pg. 48 Left Col. para 4). ANSEL further teaches the schedule of dosage or the
dosage regimen is determined based on a drug’s duration of action, pharmacokinetics,
and characteristics of the dosage form (Pg. 40 Right Col. para 2).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
KIM (evidenced by STOKOL), ELOXATIN, KEYTRUDA, OVERMAN, and JIANG do not teach the instant ratios of dunnione to ICI and ICD individually.
ANSEL does not teach the method of instant claim 1.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of colorectal cancer and possesses the technical knowledge necessary to make adjustments to the composition administered to a subject to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatments for colorectal cancer and side-effects thereof and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references KIM, evidenced by STOKOL, in view of each of: ELOXTAIN, KEYTRUDA, OVERMAN, JIANG, and ANSEL.
Regarding claims 1 and 6, the artisan would have been motivated to optimize the dosage ratios of the combination treatment of dunnione, pembrolizumab, and oxaliplatin.
MPEP 2144.05(II)(A) provides guidance about the routine optimization of prior art conditions: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").”
Furthermore, MPEP 2144.05(I) states: “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
In the instant case, the dosages taught in the prior art are equivalent to the following ratios: dunnione:pembrolizumab = 0.000003:1-10:1; and dunnione:oxaliplatin = 0.000009:1-14:1. These ratios are considered to approach the instantly claimed 1:0.001-1:0.1 wt dunnione:pembrolizumab and 1:0.2-1:5 wt dunnione:oxaliplatin. Since the effective dosing may be different for different patients (ANSEL Pg. 48 Left Col. para 4), the artisan would recognize the dosage ratio as a result-effective variable, i.e., a variable that achieves a recognized result. Thus, the dosage is analogous to the “concentration or temperature” recited in the MPEP and may be optimized by routine experimentation. Absent any evidence to the contrary, given the guidance in the art, the determination of the optimum or workable dosage ratios of the combination treatment would have been well within the practice of the artisan.
Double Patenting – necessitated by amendment
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 16 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,370,170 in view of:
KIM (US 2019/0083453, pub. 21 March 2019, cited IDS of 03/13/2024), evidenced by STOKOL (Stokol, T., Cornell University College of Veterinary Medicine, ECLINPATH, 23 Oct. 2018, pg. 1-3),
further in view of:
ELOXATIN (FDA, Eloxatin (Oxaliplatin) Full Prescribing Information, Revised 03/2020, pg. 1-42, retrieved from www.fda.gov/drugsatfda),
KEYTRUDA (FDA, Keytruda (Pembrolizumab) Full Prescribing Information, Revised 06/2020, pg. 1-93, retrieved from www.fda.gov/drugsatfda),
OVERMAN (Overman, M.J. et al., ASCO Ed. Book, 2018, 239-247),
JIANG (WO 2003/011224; cited IDS of 03/13/2024), and
ANSEL (Ansel, H.C. et al. Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Williams & Wilkins, 7th ed., 1999, pages 48-53).
Determining the Scope and Contents of the Prior Art:
Claims 1-3 of Patent No. ‘170 teach a method of treating the side-effects of an anticancer treatment including hematopoietic stem cell reduction by administration of dunnione.
The teachings of KIM, evidenced by STOKOL, in view of each of: ELOXTAIN, KEYTRUDA, OVERMAN, JIANG, and ANSEL teach the instant claims 1-8 and 16 as laid out in ¶31-32.
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
Patent No. ‘170 claims do not teach the anticancer treatment is oxaliplatin and/or pembrolizumab; nor do the claims teach the cancer is colorectal cancer.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of a method useful for treatment of colorectal cancer and associated symptoms/side-effects and possesses the technical knowledge necessary to make adjustments to the treatment to optimize/enhance the outcomes. Said artisan has also reviewed the problems in the art regarding colorectal treatments and side-effects thereof and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Patent No. ‘170 in view of: KIM (evidenced by STOKOL), ELOXTAIN, KEYTRUDA, OVERMAN, JIANG, and ANSEL.
The reference KIM is a family member of Patent ‘170; thus, the artisan would recognize the teachings are analogous and would have a reasonable expectation of success in applying the claims of ‘170 in view of the teachings of KIM. By the logic laid out in ¶31-32 above, KIM (evidenced by STOKOL) in view of each of ELOXTAIN, KEYTRUDA, OVERMAN, JIANG, and ANSEL teach the instant claims 1-8 and 16. Since KIM and Patent ‘170 are analogous, the same logic applies to Patent ‘170. Thus, the instant claims are obvious in view of the Patent ‘170 and the prior art references.
Conclusion
Claims 1-8 and 16 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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