DETAILED ACTION
The preliminary amendment submitted on February 12, 2024 has been entered. Claims 1, 3-5, 9-11, 13, 15, 18-19, and 21 are pending in the application and are rejected for the reasons discussed below. 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 .
Claim Objections
Claim 1 is objected to because of the following informality: there is one instance of “R₁₃” (subscript), which should instead be “R¹³” (superscript). Appropriate correction is required.
Claim Rejections – 35 USC § 112
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.
Claims 18-19 are rejected under 35 U.S.C. 112(a) because the specification does not reasonably provide enablement for any and all disease/disorders or compounds within the scope of the claims at issue. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement require-ment and whether any necessary experimentation is “undue.” These factors include, but are not limited to: the breadth of the claims; the nature of the invention; the level of one of ordinary skill; the level of predictability in the art; the state of the prior art; the amount of direction provided by the inventor; the existence of working examples; and the quantity of experimenta-tion needed to make or use the invention based on the content of the disclosure. See MPEP 2164.01(a).
The breadth of the claims encompasses using compounds of Formula (I) for “treating or preventing a disease, disorder or condition” (see claim 18), that is, any disease or disorder or condition without limitation. As such, the nature of the invention is one of a panacea or “cure all,” which one of skill in the art would not view as credible. The examiner’s search of the prior art reveals that there is no known pharmaceutical composition that is effective at treating any and all diseases. One of ordinary skill in the art, e.g., someone with advanced training or signifi-cant professional experience in the field of medicinal chemistry, pharmacology, or a related tech-nical discipline, would have viewed the instant claims with skepticism, especially in light of the low level of predictability in the pharmaceutical arts.
The “predictability” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily fore-see the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily foresee the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. This will especially be the case where the statement is, on its face, contrary to generally accepted scientific principles, such as in the present situation where claims are directed to a panacea. See MPEP 2164.03.
The search of the prior art reveals that the claimed compounds have no known pharma-ceutical utility. In the absence of this information, one would look to applicant’s specification for information about how the compounds are made and used. Applicant provides process for making the compounds (see the synthesis at pp. 32-39). Applicant also explains that the compounds of Formula (I) are “targeted to the mitochondrial membrane, thus enhancing the apoptotic pathway and potentially overcoming drug resistance by bypassing the cells mechanism of evading the apoptotic pathway” and “are effective through a multi-targeted approach using the lipophilic ion to rapidly penetrate and accumulate in the mitochondrial membrane and the polyphenolic moiety to exert anti-oxidant and antiproliferative effects” (spec. at p. 2). This is in the context of cancer treatment (spec. at pp. 40-53).
Even in the area of cancer treatment, however, the prior art teaches that “targeting a single hallmark or pathway with a single drug (‘magic bullet’) will not likely lead to cancer cure.” See Zugazagoitia et al., Clin. Ther. 2016;38(7):1551-66 at p. 1564. This reference discloses (see, e.g., Table I at p. 1554 and Table II at p. 1556, as well as the discussion thereof) that different cancers are treated with different drugs, so one would not find it credible that the drugs of the instant claims would be useful in treating all cancers.
Applicant does provide evidence that the compounds in question are effective in treating the following types of tumor cells: bile duct cancer (p. 46), brain carcinoma (p. 46), breast carcinoma (pp. 46-47), colon carcinoma (pp. 47-48), endometrial cancer (p. 48), esophagus cancer (p. 48), head and next cancer (p. 48), kidney cancer (pp. 48-49), leukemia (p. 49), lung carcinoma (pp. 49-50), lymphoma (p. 50), ovarian cancer (p. 50), pancreatic cancer (pp. 50-51), prostate carcinoma (p. 51), skin melanoma (pp. 51-52), and stomach cancer (p. 52).
Nowhere, however, does applicant provide a rational explanation for why one would expect the compounds of Formula (I) to be useful for any and all diseases commensurate in scope with the breadth of claims 18-19. In light of the low level of predictability in the pharmaceutical arts, and the lack of direction and working examples in applicant’s specification, the examiner concludes that one of skill in the art would be burdened with undue experimentation when attempting to practice the invention as claimed.
The examiner suggests that claims 18-19 be amended in the following manner:
18. A method of treating a step of administering to a subject in need thereof an effective amount of a compound, or a pharmaceutically acceptable multi-salt or solvate thereof, as defined in claim [[1]] 13 to thereby treat the disease, disorder or condition, wherein the disease, disorder or condition is bile duct cancer, brain carcinoma, breast carcinoma, colon carcinoma, endometrial cancer, esophagus cancer, head and next cancer, kidney cancer, leukemia, lung carcinoma, lymphoma, ovarian cancer, pancreatic cancer, prostate carcinoma, skin melanoma, or stomach cancer.
19. (cancelled)
Claims 1, 3-5, 9-11, 15, 18-19, and 21 rejected under 35 U.S.C. 112(a) as failing to comply with the written description 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. The compounds as claimed are outside of the scope of what applicant has possession of. The examiner acknowledges that the compounds of instant claim 13, which is not included in this rejection are exemplified in the synthesis, tested, and provided as specifically drawn structures.
Double Patenting
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 possi-ble 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 accompa-nied 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, 3-5, 9-11, 15, 18-19, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 9-12, 15, and 18-21 of copending Application No. 18/274,318 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘318 Application claims compounds within the scope of the instant claims, as well as pharmaceutical compositions thereof and methods of using the same for treating cancer. See the claims submitted on February 5, 2024 in the ‘318 Application. For example, the ‘318 Application claims a compound of Formula (I), wherein R1 and R2 are both OH; R3 is hydrogen; R4 is CN; R5 through R9 are each H; n is 1-10; and Z is –[P(R11)3]X. The instant claims and the claims of the ‘318 Application therefore overlap in subject matter. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Citation of Background Prior Art
The prior art made of record (see attached form PTO-892) and not relied upon is consid-ered pertinent to applicant's disclosure. The following reference is cited as being representative of the closest prior art: US 5,527,786 by Kazuyoshi Miyata et al. This reference discloses compounds having the following chemical structure (note the oxidation state of the phosphorous atom indicated by the arrow):
PNG
media_image1.png
268
552
media_image1.png
Greyscale
See the Miyata et al. at col. 1, ll. 20-30. See also the compounds in Table 1 in Example 35 of Miyata et al. In contrast, the compounds of the instant claims are drawn to patentably distinct phosphines. See substituent “Z” of instant claim 1.
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, 7:00 am - 6:00 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 encour-aged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interview-practice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervi-sor, 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.
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 infor-mation 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.
THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
November 24, 2025(revised December 30, 2025)