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 .
Final Rejection
The Status of Claims:
Claims 1-14 and 16-18 are pending.
Claims 1-14 and 16-18 are rejected.
Claim Rejections - 35 USC § 112
Applicants’ argument filed 7/06/2026 have been fully considered, and are
persuasive.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The rejection of Claims 1-18 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn due to the modification of the claims.
However, in view of the revised claims, a new rejection under 35 U.S.C. 112, first paragraph seems necessary in the following:
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 1-14 and 16-18 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating specific diseases, does not reasonably provide enablement for preventing or reducing the risk of prostate cancer. 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. Applicants are not enabled for preventing or reducing the risk of prostate cancer. The only established prophylactics are vaccines not the enzalutamide compound such as present here. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing or reducing the risk of diseases requires identifying those patients who will acquire the disease before chronic and acute pain occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) The passages from a paragrph# 0004 to a paragrph# 0007 mentions the patient with prostate cancer Applicant intend to treat. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical preventive prostate cancer medicine and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become prevented from getting a cancer before the fact. 6) The artisan using Applicants invention would be a Board Certified physician in prostate cancer diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of any cancers generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent any cancers including prostate cancers generally. That is, the skill is so low that no compound effective generally against any cancers has ever been found let alone one that can prevent such conditions. 7) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed disease.
The Examiner suggests deletion of the word “reducing the risk of ” from the claims.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of Claim(s) 1, 2, 5, 8, 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Averback (US 2021/030842 A1) is withdrawn due to the modification of the claims.
The rejection of Claim(s) 1, 2, 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated clearly by Moyad et al( Research and Reports in Urology 2014:6 , p.71–77) is withdrawn due to the modification of the claims.
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 rejection of Claims 1-14 and 17 under 35 U.S.C. 103 as being unpatentable over NCT02799745 (ClinicalTrials.gov archive [online], 2020.11.27, [retrieved on 2022-04-04], Retrieved from the Internet: <URL: https://www.clinicaltrials.gov/ct2/ history/NCT027997 45? A=46&B=46&C=merged#StudyPageTop>) in view of Averback (US 2021/030842 A1) is withdrawn due to the modification of the claims.
.
Applicants’ Argument
Applicants argue the following issues:
Claims 1-18 are rejected as indefinite under 35 U.S.C. § 112(b). The Office Action asserts that the phrases "proven prostate cancer" and "an amount and for a period of time clinically proven effective" are unclear. To advance prosecution of the application, this response deletes the phrases "histologically proven" and "in an amount and for a period of time clinically proven effective in reducing the risk of prostate cancer progression" from claim 1 and the phrase "histologically proven" from claim 2. The Applicant respectfully requests withdrawal of the rejection.
Claims 1, 2, 5, 8, and 13 are rejected under 35 U.S.C. § 102(a)(2) as anticipated by
Averback (US 2021/030842). To advance prosecution of the application, independent claim 1 is amended to incorporate the recitations of claim 15, which is not subject to the rejection.
The Applicant respectfully requests withdrawal of the rejection.
Claims 1, 2, and 6-8 are rejected under 35 U.S.C. § 102(a)(1) as anticipated by Moyad (Research and Reports in Urology 6, 7 1-77, 2014). To advance prosecution of the application, independent claim 1 is amended to incorporate the recitations of claim 15, which is not subject to the rejection. The Applicant respectfully requests withdrawal of the rejection.
Claims 1-14 and 17 are rejected under 35 U.S.C. § 103 as prima facie obvious over
NCT02799745 (ClinicalTrials.gov archive, 2020) in view of Averback. To advance prosecution of the
application, independent claim 1 is amended to incorporate the recitations of claim 15, which is not
subject to the rejection. The Applicant respectfully requests withdrawal of the rejection.
20010709_1Regarding applicants’ arguments, the Examiner has noted applicants’ argument and they are persuasive. However, as indicated in the above, in view of the revised claims, the new rejection under 35 U.S.C. 112, first paragraph seems necessary. Therefore, the application is not ready for allowance yet.
Conclusion
Claims 1-14 and 16-18 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 TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/TAYLOR V OH/Primary Examiner, Art Unit 1625 8/8/2026
Prosecution Insights