FINAL ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is responsive to the Amendment and Response filed 03 November 2025. Claims 1 has been amended. Claims 9-22 remain withdrawn, and claims 1-8 remain under consideration. Applicant’s amendments and arguments have been thoroughly reviewed, but are not persuasive for the reasons that follow. Any rejections and/or objections not reiterated in this action have been withdrawn. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
With regard to the Request for Interview incorporated into Applicant’s reply of 03 November 2025, it is noted that the Request was (incorrectly) entered into the application as an “Applicant summary of interview”, such that the examiner did not become aware of the request in a timely fashion. The examiner apologizes for any inconvenience caused to Applicant and Applicant’s representative, and would be happy to conduct an interview at a mutually agreeable time. It is suggested that Applicant’s representative contact the examiner directly via phone (571/272-0744) or email (diana.johannsen@uspto.gov), or submit an Automated Interview Request (AIR) (as was recommended in the prior Office action; Applicant is advised that directly contacting the examiner or submitting an AIR are the best ways to ensure that the examiner will be made aware of an interview request). If the examiner does not hear from Applicant’s representative within a month, she will also contact Applicant’s representative by phone regarding interest in scheduling an interview.
Election/Restrictions
Applicant’s election of the species of A) of a gene encoding a protein from both a DNA damage repair and an androgen receptor signaling pathway, and the subspecies of B) breast cancer 1 (BRCA1), in the reply filed on March 23, 2023 is again acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9-22 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 23, 2023.
Claim Rejections - 35 USC § 112(b)/second paragraph
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 FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-8 are indefinite because it is unclear whether independent claim 1 as amended does or does not require a subject identified as/predisposed to developing prostate cancer, such that it is not clear what activities/steps are and are not required to meet the claims. While the preamble of the claim has been amended to recite a “method for reducing the risk of developing prostate cancer in a human subject identified as being predisposed to developing prostate cancer” – such that the claim initially appears to be a method performing with respect to a subject “identified as being predisposed to developing prostate cancer” – the first step of the claim recites “performing an identification process to determine if the human subject is predisposed to developing prostate cancer”, such that it also appears that the claim encompasses methods practiced with respect to subjects of unknown status with regard to prostate cancer predisposition (i.e., the preamble and active steps of the claim are in conflict with one another, at least with regard to some embodiments encompassed thereby). The “performing” of the claim concludes with the statement “wherein the human subject is identified as being predisposed….if” certain outcomes of testing occur, and the claim subsequently states “if the human subject is determined to be predisposed…then treating the human subject”, which claim language appears to set forth actions that are conditional/contingent in nature, rather than required active method steps. Thus, the present claim language is confusing, as the body of the claim recites activities that as performed may potentially result in “identifying” a subject predisposed to developing prostate cancer, whereas the new language of the preamble suggest that such subject may be required. As there are multiple reasonable interpretations of the claim language that impart different meanings and boundaries on what is claimed, further clarification is required.
Claim Rejections - 35 USC § 112(a)/first paragraph
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.
THE FOLLOWING INCLUDES NEW GROUNDS OF REJECTION NECESSITATED BY APPLICANT’S AMENDMENTS:
Claims 1-8 remain 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 methods for “reducing the risk of developing prostate cancer in a human subject” in a human subject identified as being at such a risk (as recited in the claim), does not reasonably provide enablement for methods “for reducing the risk of developing prostate cancer” in any human subject. 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 compliance with the enablement requirement of 35 USC 112(a), including, but not limited to: (A) the breadth of the claims; (B) the nature of the invention; (C) the state of the prior art; (D) the level of one of ordinary skill; (E) the level of predictability in the art; (F) the amount of direction provided by the inventor; (G) the existence of working examples; and (H) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). All evidence related to each of these factors has been considered, and the conclusion that enablement is lacking, as set forth below, is based on the evidence as a whole. (MPEP 2164.01(a)).
The claims are drawn to methods ‘for reducing the risk of developing prostate cancer in a human subject identified as being predisposed to developing prostate cancer” in which an “identification process” is employed “to determine if the human subject is predisposed to developing prostate cancer” (see (I) of independent claim 1), followed by treating “the subject so identified” – i.e., treating a subject “determined to be predisposed to developing prostate cancer” based on meeting criteria specified in the “identification process”; see the language of the “wherein” clause at the end of (I) of claim 1, which sets forth that the human subject is determined to be predisposed “if” two different types of criteria are met, such that the claims do not require the specified outcome (i.e., the conditions set forth in the “wherein” clause are clearly conditional/contingent in nature, not required outcomes). It is reiterated that amended claim 1 is indefinite for the reasons given above, and that the claims as presently written are not clearly limited to subjects with respect to whom the “performing” actually has a positive outcome with regard to “identifying” the subject (rather, the claim state “wherein the human subject is identified….if” multiple criteria are met). While the claims state what is done with regard to treating a subject meeting the criteria in (I), the claims are silent with regard to subjects on whom the “identifying process” is performed who do not meet the criteria set forth in the “identification process”, and it also continues to appear that the claims do not require a positive outcome for that process, at least to the extent the (indefinite) claims are presently understood (in addition to the wording of the noted “wherein” clause, the claims recite “assaying nucleic acid molecules…for the presence or absence” of one or more altered genes, such that the claims clearly embrace multiple possible outcomes of such an “assaying”). It is thus unpredictable as to whether one of skill in the relevant art could actually use/practice the claimed invention with regard to the generally recited “human subject” specified in the preamble of the claim (which recites the use that is considered when evaluating enablement of a claimed invention). While both the teachings of the specification and of the prior art may be consulted and considered in evaluating enablement, none of the claims themselves, the specification, and the teachings of the prior art supply what is missing from the amended claims, which is guidance regarding “reducing the risk of developing prostate cancer in a human subject” other than the specific type of subject identified via the stated process of the claims. While claims may encompass some inoperative embodiments, in the present case, the claim language carves out a specific type of “human subject” via the recitation of particular steps stating how to “reduce the risk” of prostate cancer in such subjects, but the claims continue to encompass (again, based on at least one reasonable interpretation) any “human subject”, and it is unknown and unpredictable (given the noted lack of guidance) what other types of human subjects might potentially be treatable so as to achieve reduction in prostate cancer risk, and whether any amount of experimentation would be sufficient to enable what is claimed beyond the specific type of subject identified via the “identification process”. Accordingly, it would require undue experimentation to use the invention in a manner commensurate in scope with the claims. With regard to dependent claims 2-8, these claims set forth more specific features of the identification process without adding any further activities regarding subjects of the type discussed above, and thus lack enablement for the same reasons given above regarding independent claim 1.
(It is noted that this rejection could potentially be overcome by either amending the claims to clearly/unambiguously limit them to the type of subject “identified” via the “identification process”, or by setting forth alternative actions/steps for “reducing the risk of developing prostate cancer” in human subjects who do not have a positive result for the recited “identification process”.)
The Reply of 03 November 2025 traverses the prior rejection under 35 USC 112(a) on the following grounds.
Applicant states what is required by amended independent claim 1 (Reply pages 8-9), and urges that “the amendment to the preamble of claim 1 brings scope of the claim into direct alignment with the enabling disclosure of the specification” (Reply page 10). The Reply also states that “the invention as claimed in claim 1 and the claims dependent therefrom is adequately described”, and that the Office action “does not make a prima facie case that Applicants did not have possession of the claimed invention” (Reply page 10).
These arguments have been thoroughly considered but are not persuasive. Initially, it is noted that the claims have not been rejected for lacking written description, but only for lacking enablement over their full scope. With regard to enablement, while it appears Applicant may have attempted to amend the claim in a manner consistent with a suggestion from the examiner, the result of the actual amendment is confusion as to what is being claimed (as addressed in the indefiniteness rejection above), and the amended claim still appears to embrace the non-enabled subject matter identified in the rejection. Accordingly, these arguments were not found persuasive.
Conclusion
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 DIANA B JOHANNSEN whose telephone number is (571)272-0744. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm EST.
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, Wu-Cheng Winston Shen can be reached at (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANA B JOHANNSEN/Primary Examiner, Art Unit 1682