DETAILED ACTION
Claims 1-8, submitted on April 17, 2024, are pending in the application. Claims 5-8 are withdrawn. Claims 1-4 are rejected for the reasons set forth 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 . 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
The requirement for restriction between Group I, drawn to a compound or composition thereof, and Group II, drawn to a method of treating a patient having cancer, in the action mailed on April 13, 2026 is hereby withdrawn. Applicant’s election thereof is accordingly moot.
The requirement for a species election from among all of the compounds recited in claims 1-2 and 5-6 is modified as follows: the compounds in claims 1-2 will be treated as one group of species, and the compounds in claims 5-6 will be treated as another group. Applicant’s election without traverse of compound 7 in the reply filed on June 12, 2026 is acknowledged. Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected species, there being no allowable generic or linking claim. All of the compounds recited in claims 1-2 have been considered together and are the subject matter of this Office action.
Claim Objections
The claims are objected to because the title of the application appears after the last claim. “Any sheet including a claim or portion of a claim may not contain any other parts of the applica-tion or other material.” See MPEP1 608.01(m) (Form of Claims). The title of the invention is a separate part of the disclosure from the claims, and it “should be placed at the top of the first page of the specification.” See MPEP 606 (Title of Invention). The title should therefore be deleted from the listing of claims. Appropriate correction is required.
Claim Rejections – 35 USC § 103
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 5,654,307 A by Bridges et al.
Bridges discloses compound having the following general chemical formula (see Formula II at col. 5):
PNG
media_image1.png
309
417
media_image1.png
Greyscale
A is a nitrogen atom, and B, D, and E are each a carbon atom (col. 3, ll. 44-46; see the distribution of nitrogen and carbon atoms in the “suitable ring structure” at col. 6, ll. 53-60). Each of R₃, R₄, R₅, and R₆ is a hydrogen atom (col. 4, ll. 24-25). R₈ is an alkyl group having one carbon atom (col. 5, l. 12-13), i.e., a methyl group. X is NR⁷, wherein R⁷ is a methyl group (col. 3, ll. 51-52). The subscript n is zero (col. 3, l. 55), and accordingly R¹ is absent.
Bridges further discloses that Ar is a phenyl group that is substituted with one substituent (m=1; see col. 4, l. 21), wherein the substituent is an alkoxy group having one carbon atom (col. 3, l. 61), i.e., a methoxy group. Although the reference does not specifically disclose the first compound recited in claims 1-2, it nevertheless discloses all of the substituents that constitute such a compound. One would have viewed “compound 2” of claims 1-2 as being a matter of reduction to practice of the generic teachings of the cited reference and therefore prima facie obvious.
Bridges similarly discloses that Ar is an indolyl group (col. 4, ll. 20-23) that is substituted with a methyl group (col. 3, l. 60), which suggests “compound 7” of claims 1-2.
Other such compounds would have been apparent to the skilled artisan.
With respect to claim 2, the reference discloses pharmaceutical compositions (col. 54, l. 62 et seq).
With respect to claims 3-4, the reference discloses methods of administering the compounds to a patient for the treatment of cancer (col. 3, ll. 11-15 and col. 22, ll. 1-24).
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 3-4 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for breast and ovarian cancer, does not reasonably provide enablement for all cancer types. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and 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 certain compounds for “treating a patient having cancer,” that is, any cancer 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 cancers. One of ordinary skill in the art, e.g., someone with advanced training or significant professional experience in the field of medicinal chemistry, pharmacology, or a related technical 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 foresee 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.
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.
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 p. 18). Applicant also provides evidence that the compounds have utility in the treatment of ovarian and breast cancer (spec. at pp. 20-21). This is in the context of in vitro assays for cancer. Nowhere, however, does applicant provide a rational explanation for why one would expect the compounds to be useful for any and all diseases commensurate in scope with the breadth of the claims. 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 experimenta-tion when attempting to practice the invention as claimed.
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. See, e.g., para. 0019 of US 2009/0131414 A1 by De Jonghe et al.
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.
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.
THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
July 8, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
Prosecution Insights