DETAILED ACTION
Claims 74-93, submitted on October 23, 2023, are pending in the application. Claims 86-91 are withdrawn. Claims 74-84 and 92-93 are rejected for the reasons set forth below. Claim 85 is objected to but would be allowable if rewritten in independent form. No claim is allowed.
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 . 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.
Election/Restrictions
Applicant’s election with traverse of Group I, drawn to a method for reducing the chro-mosomal instability (CIN) associated with a chemotherapy or treating, preventing, or ameliorat-ing CIN resulting from the administration of a chemotherapeutic agent, in the reply filed on March 13, 2026 is acknowledged. The traversal is on the grounds that a “serious burden on the Office does not exist.” See applicant’s Remarks, submitted March 13, 2026, at p. 1. This is not found persuasive because this application was filed under 35 U.S.C. 371, which requires a “unity of invention” analysis when determining whether an application contains multiple inventions. See MPEP1 823 (“The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis).” See also MPEP 1893.03(d) (“unity of invention analysis (not an independent and distinct analysis) is applicable in national stage applications submitted under 35 U.S.C. 371.”). Whether there is a “serious burden” is not a relevant consideration when assessing unity of invention. The requirement is still deemed proper and is therefore made FINAL. Claims 86-91 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on March 13, 2026. Claims 86-91 will not be considered for rejoinder, so the examiner suggests that they be cancelled. See MPEP 821.04.
The requirement for a species election in the communication mailed on January 15, 2026 is hereby withdrawn. Applicant’s election thereof in the response submitted on March 13, 2026 is therefore moot.
Objection to The Specification
The specification is objected to as failing to provide proper antecedent basis for the subject matter of claim 83. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). The written description of the specification should be amended to include a disclosure of maraviroc, vicriviroc, and a combination thereof.
Allowable Subject Matter
Claim 85 is objected to as being dependent upon a rejected base claim, but would be allowable (provided that claim 74 is amended to address the objection discussed immediately below) if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
Claims 74 and 93 objected to because of the following informality: The phrase “to a subject in need thereof” should be inserted after “co-administering” (claim 74) and “administer-ing” (claim 93). Appropriate correction is required.
Claim Rejections – 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 84 is rejected under 35 U.S.C. 112(a) as failing to comply with the written descrip-tion requirement. The claim contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Specifi-cally at issue here are the “hydrate,” “solvate,” “isotopic isomer,” “prodrug,” and “complex” referred to in claim 84. An applicant may satisfy the written description requirement by showing “that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” See MPEP 2163(I). Applicant has not provided any structures, figures, diagrams, or formulas for the claimed hydrates, solvates, isotopic isomers, prodrugs, and complexes. In addition, the search of the prior art reveals that the compounds of formula I are not generally known to exist in any of these forms. The examiner acknowledges, however, that the “pharmaceutically acceptable salts” referred to in claim 84 would have been well known to the skilled artisan. The examiner suggests that “a hydrate thereof, a solvate thereof” and “an isotopic isomer thereof, a prodrug thereof, or a complex thereof” be deleted from claim 84.
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.
Claims 74-83 and 92-93 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The term “CIN antagonist” does not have an established meaning in the art, and appli-cant’s own specification does not provide any definition for this claim term, other than the specific compounds referred to in claims 84-85. For example, it is unclear whether the flavonoid compounds disclosed in US 2017/0087125 A1 by Wu are within the scope of the instant claims, as discussed in detail below.
Also, with respect to claim 84, it is not chemically possible for X or Z to be CH₂. This is because the compound of formula I has a double bond between X and Z, so CH₂ would be a chemical impossibility.
Claim Rejections – 35 USC § 102/103
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.
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 explained in MPEP 2141 et seq. They 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.
Claims 74-82 and 92-93 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2017/0087125 A1 by Wu.
Wu discloses methods for treating cancer using flavonoid compositions, including a method of inhibiting cancer cells by exposing them to an inhibitory dose of the flavonoid (para. 0010). The reference further discloses co-administering to a subject a regimen of chemotherapy in which the flavonoid enhances the efficacy of the second cancer treatment regimen (para. 0011). It is implicit that the flavonoid and the other chemotherapy are administered together, or one after another, within the meaning of instant claims 75-76 (see, e.g., para. 0066, which states that the two drugs may be administered as “single or multiple units”). Wu further discloses “repeating the administration at intervals of at least three times per week” (para. 0088), which is a time period of about every 56 hours and therefore within the meaning of claim 78, as well as an additional dose within the meaning of claim 79. Example chemotherapies include drugs that affect DNA synthesis (para. 0093), anthracyclines (para. 0093), trastuzumab (para. 0082), and immunotherapies (para. 0082-83), which meets the limitations of claims 77 and 80-82. “The flavonoid composition can be administered on a daily basis at a daily dose between 1 to 200 mg/kg body weight” (para. 0012), which meets the limitations of claim 92.
The present application appears to represent applicant’s discovery of a mechanism of action whereby the therapy described in Wu operates. As noted in the rejection under § 112(b), discussed above, it is unclear whether the flavonoid compounds of Wu are within the meaning of “CIN antagonist” as required by the instant claims. The chemical structures of the flavonoid compounds in Wu (para. 0008), however, bear a striking similarity to the compounds of instant claims 84-85, so it is a reasonable conclusion that they are indeed CIN antagonists. Stated another way, it does not appear to be possible to practice the relevant subject matter disclosed in Wu without infringing the instant claims if they were to be allowed. In situations like this, where the prior art seems to be identical to a claimed invention, except the prior art is silent as to an inherent characteristic, it is Office policy to make a rejection under both 102/103. See MPEP 2112 (“Where applicant claims a composition in terms of a function, property or charac-teristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.”). The burden of showing a patentable difference between the instant claims and the teachings of Wu therefore shifts to applicant. See MPEP 2112(V).
Applicant is reminded that the discovery of a previously unappreciated property of the prior art, or of a scientific explanation for the prior art’s functioning, does not render it patentably new to the discoverer. In this case, the mere observation that the flavonoid compounds in Wu are CIN antagonists does not entitle applicant to a patent. The claiming of a new use, new function or unknown property that is inherently present in the prior art—although not neces-sarily specifically disclosed therein—does not make the instant claims patentable. See MPEP 2112(I).
Claims 74 and 83 are rejected under 35 U.S.C. 103 as being unpatentable over Wu as applied to claims 74-82 and 92-93 above, and further in view of US 2014/0105918 A1 by Gomis et al.
The disclosure of Wu is relied upon as set forth above. Note in particular that Wu discloses treating prostate cancer (para. 0002). The difference between the prior art and the claims at issue is that Wu does not specifically disclose administering maraviroc or vicriviroc. Gomis, however, discloses (see, e.g., para. 0162 and 0204) these two drugs were known in the prior art as being useful in the treatment of prostate cancer. One would have viewed substituting one prostate cancer treatment for another as being a matter of routine experimentation and therefore prima facie obvious. See MPEP 2144.06(II) (substituting equivalents known for the same purpose).
Claims 74, 84, and 93 are rejected under 35 U.S.C. 103 as being unpatentable over CN 102070595 A by Zhang et al.
Zhang2 discloses (p. 4) the following compound:
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See also the compounds in Table 1 (pp. 7-11). These compounds are within the scope of formula I as defined in claim 84, so the examiner concludes that they are “a CIN antagonist” within the meaning of claims 74 and 93. The reference describes these compounds as topoisomerase inhibitors that are useful in the treatment of a variety of cancers (p. 7). The reference also discloses that other topoisomerase inhibitors known in the art include camptothecin (p. 3). Although the reference does not specifically disclose the combination of camptothecin and the compounds in Table 1, such a combination would nevertheless have been prima facie obvious for the reasons discussed in MPEP 2144.05(I) (combining equivalents known for the same purpose). It appears that such a combination therapy would be within the meaning of at least instant claims 74 and 93.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
May 20, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 This discussion refers to the English-language machine translation included with this communication.
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