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 .
Status of the Application
Claims 2-3, 5, 8, 10, 14, 18, 21-23, 25, 49, 51-52, 54, 57, 59, 63, 67, and 69-73 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 09/19/2025 are acknowledged. Claims 51-52, 54, 57, 59, 63, 67, and 69-72 remain withdrawn, as being drawn to an unelected invention or specie. Claims under consideration in the instant office action are claims 2-3, 5, 8, 10, 14, 18, 21-23, 25, 49, and 73.
Applicants' arguments, filed 09/19/2025, have been fully considered and they are deemed to be persuasive due to Applicant’s amendment. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 2-3, 5, 8, 10, 14, 18, 21-23, 25, 49, and 73 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of CTCL by administering compound F7D3, does not reasonably provide enablement for the treatment of breast cancer, prostate cancer, colon cancer, lymphoma, ovarian cancer, or CTCL by administering a compound of Formula (I). 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.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, "Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue', not 'experimentation'" (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations" (Wands, 8 USPQ2d 1404). Among these factors are: (i) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of treating breast cancer, prostate cancer, colon cancer, lymphoma, ovarian cancer, or CTCL comprising administering a compound of Formula (I). The breadth of the claims thus covers that every compound of Formula (I) is capable of treating a variety of cancers.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art as shown by Danziger et al that many aspects and modalities are involved in the pharmaceutical art, which as a result makes that art highly unpredictable. Pharmacological activity in general is a very unpredictable area. Note that in cases, involving physiological activity such as the instant case, "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved". Se In re Fisher, 427 F.2d 833,166 USPQ 18, 24 (CCPA 1970).
The article while directed to automated drug design, specifically addresses the issue of steric hindrance which essentially means that the shape, design, including the kinds and amount of substituents greatly affect the ability and efficacy of a drug to bind to the desired receptor and function appropriately. Thus, the use of any compound of formula I, would be unpredictable in treating CTCL.
Within the scope of cancers, Simone (Introduction: Oncology) teaches that for all cancers, "each specific type has unique biologic and clinical features that must be appreciated for proper diagnosis, treatment and study” (pg. 1004). Furthermore, different types of cancers affect different organs and have different methods of growth and harm to the body. Thus, it is beyond the skill of oncologists today to get a given agent to be effective against a number of cancers.
(5) The relative skill of those in the art:
Those of relative skill in the art are those with a level of skill of the authors of the references cites to support the examiner’s position (MD’s or those with advanced degrees and the requisite experience in medicine).
(6) The amount of direction or guidance presented and (7) the presence of absence of working examples:
The specification does not provide a working example of treating CTCL by any compound of Formula (I). Thus, the specification has not provided any guidance as to how one of ordinary skill in the art can treat breast cancer, prostate cancer, colon cancer, lymphoma, ovarian cancer, or CTCL by administering a given compound of Formula (I).
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Simone and Danziger above, and the high unpredictability in the art as evidenced therein, and the lack of guidance provided by the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Response to Arguments
Applicant also argues that “the application provides sufficient disclosure for a person of ordinary skill in the art to conclude that the activity of the claimed compounds against the recited cancers would be predictable.” The Examiner respectfully disagrees since the claimed invention is still drawn towards the treatment of a number of cancers including breast cancer, prostate cancer, colon cancer, lymphoma, ovarian cancer, and CTCL, and it would not be predictable that a compound of Formula (I) can treat a given cancer as recited, as discussed by Simone above.
Applicant argues that “the application provides both guidance and context for the use of compounds of Formula (I) to treat CTCL and other listed cancers, consistent with the understanding of those skilled in the art.” The Examiner respectfully disagrees since although P38γ has been identified as a therapeutic target for certain tumors, such guidance does not provide adequate guidance as to which compound of formula (I) can provide sufficient therapeutic benefit or at what dosage, without undue experimentation.
Applicant also argues that “the specification provides experimental data showing that compounds of Formula (I), including F7D3, suppress the viability of Hut78 cells, a well-established in vitro model for CTCL, in a dose dependent manner. Such data is reasonably correlated to the claimed therapeutic use for treating CTCL…. As described, administration of a compound of Formula (I), for example F7D3, results in a significant dose-dependent reduction in the viability of CTCL cells in a recognized disease model. This data, together with the established use of Hut78 as a CTCL model, are predictive of efficacy in treating CTCL.” The Examiner respectfully disagrees since although Applicant has demonstrated the inhibitory activity of compound F7D3 (see Fig. 14B) in a dose-dependent manner against Hut78 cells, such data does not provide adequate guidance for other compounds of Formula (I) or at what dosage such compounds would achieve adequate inhibitory activity given the teachings of Simone and Danzinger as discussed above.
Conclusion
Claims 2-3, 5, 8, 10, 14, 18, 21-23, 25, 49, and 73 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 ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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