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 .
Maintained Rejections
Rejection of claims 1-8 under 35 USC 112(a) is maintained. Reply to applicant’s arguments follows the repeated text of the rejection of record. The text has been modified to remove references to methods that have been canceled by claim amendments filed on 6/18/26.
Claim Rejections - 35 USC § 112
Notice of AIA Status
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 1-8 are rejected under 35 U.S.C. 112(a), because the specification does not reasonably provide enablement for treating cancer; reducing treatment resistance of a cancer; by administrating the pyrrolo[2,3-d]pyrimidine compound (the compound) as defined in the claims. 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 instant claims are drawn to a method for treating cancer; for reducing treatment resistance of a cancer the methods comprising administering to a patient in need thereof, a pharmaceutically effective amount of a compound of claim 1 or 5 and a pharmaceutically acceptable carrier. The instant specification fails to provide information that would allow the skilled artisan to practice the claimed method as recited in the claims.
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates a method for treating cancer; for reducing treatment resistance of a cancer the methods comprising administering to a patient in need thereof, a pharmaceutically effective amount of a compound of claim 1 and a pharmaceutically acceptable carrier. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites the fact that while Applicant stated in the specification that the compound of the instant invention increases inhibition of cancer stem cell proliferation, can inhibit growth of in vitro lung cancer cell line, can reduce cancer resistance to treatment, treat cancer, prevent metastatic diseases and tumor recurrence, nowhere in the specification did applicant demonstrate actual treatment of any disease, let alone cancer, by administering the compound of claim 1. Additionally, the examiner contends that it is known (see Golub et al., Science, Vol. 286, October 15, 1999, pages 531-537) in the current art that the challenge of cancer treatment has been to target specific therapies to pathogenetically distinct tumor types, to maximize efficacy and minimize toxicity. Cancer classification has been based primarily on morphological appearance of the tumor and that tumors with similar histopathological appearance can follow significantly different clinical courses and show different responses to therapy (Golub et al., Science, Vol. 286, October 15, 1999, pages 531-537 cited in IDS 12/15/23). While Applicant describes how the compound may be useful, nowhere in the specification did applicant demonstrate treatment of any cancer or reducing treatment resistance of any cancer. Given that applicant has yet to provide any data demonstrating treatment of any disease, the examiner contends that applicant has yet to enable the breadth of the claims.
2. The breadth of the claims
The claims are thus very broad insofar as they recite inter alia the “treatment or reducing treatment resistance of every single cancer by administering the aforementioned compound”. Likewise, Applicant does not demonstrate treatment of any of the diseases or disorders delineated in claims 1-8. While “treatment” of cancer might theoretically be possible, as a practical matter it is nearly impossible to achieve treatment of every single cancer in existence with the same compound.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for the use of the compounds to treat any cancer, to treat tumor recurrence or metastatic diseases and subtypes. No reasonably specific guidance is provided concerning useful therapeutic protocols for the disclosed compound, other than that said compound could possibly be useful for. The latter is corroborated by the specification on page 15 and paragraph 0048.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed compound could be predictably used for treatment of every single cancer and reduce treatment resistance of every single cancer as inferred by the claims and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Reply to applicant’s remarks
Applicants have traversed the rejection above in the remarks filed on 6/18/26. The remarks have been fully considered and found to be not persuasive. The main argument presented by the applicants is that the claimed compound is an improvement over Trilaciclib. Applicants rely on the disclosure of US 9,487,530, directed to pharmacological activity of Trilaciclib, for enablement of the currently claimed methods. After examining US 9,487,530, Examiner disagrees with applicant’s assertion. The ’530 patent is directed to activity of Trilaciclib in protection of normal cells during chemotherapy. The described activity is materially different from the claimed method of direct treatment of any cancer and of reducing treatment resistance of any cancer. Examiner conducted a further search for pharmacological uses of Trilaciclib, which also only resulted in documents suggesting supportive care therapy in protecting normal cells by placing the cells into resting stage during chemotherapy treatment. Some newer art (post filing date) also demonstrates myeloprotective effect of Trilaciclib (Qiu et al Front. Pharmacol. 14:1157251). Examiner was unable to find support for therapeutic efficacy of Trilaciclib in treatment of cancer or in reducing treatment resistance of cancer.
Conclusion
Claims 1-8 are pending
Claims 1-8 are rejected
THIS ACTION IS MADE FINAL. 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 YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628
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