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 .
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 .
This action is in response to papers filed 12/23/2025.
Applicant’s election without traverse of Group I and the species of C11orf94, c9orf135, DSP, EGFL6, FST in the reply filed on 5/17/2022 is acknowledged.
Claims 7,10, 15, 56-57,59, 61-64 are pending. Claims 10, 61-64 are withdrawn as being drawn to a list of genes that do not include the elected combination.
Claims 1-6,8-9,11-14,16-55, 58, 60 are cancelled.
The following rejections are maintained with response to arguments following.
This action is FINAL.
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 7,15,56-57,59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 7,15,56-57,59 are drawn to determination of a prostate cancer aggressiveness index value by determining expression of 5 or more biomarkers (step c). The claims are therefore limited to functionality of prostate can er aggressive index value based upon the expression measurement of C11orf94, c9orf135, DSP, EGFL6, FST in any subject.
The claims are drawn to any expression, however, the specification only provides supports for gene expression levels (p 4, 67-68). Therefore although the claims are drawn to measuring expression levels or the recited markers in CD2 and CD14, the specification has not described any other type of expression in these cells and comparison other than gene expression.
With regard to the specific combination of genes, the specification has not provided that levels of the biomarkers linked to one or more clinical data would functionally provide prostate cancer aggressiveness index. The specification discloses that in some embodiments the one or more clinical data can be used as clinical covariates and concatenated with biomarkers levels and input into a sparse rank regression model to provide aggressiveness (p. 4). However, the specification does not describe how to utilize the concatenated of one or more clinical data and the measured levels of the recited biomarkers to identify the prostate cancer aggressiveness index value.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure. However, as discussed above, the specification does not provide identifying prostate cancer aggressiveness index value based upon the levels of biomarkers and one or more clinical data. Table 3 provides a gene signature and clinical covariates, however, the table includes 15 biomarkers and 5 clinical covariates. As such the specification appears to provide an aggressive index value based upon specific genomic biomarkers and clinical covariates, but does not provide that this prostate cancer aggressiveness index value can be utilize using only the biomarkers levels and one of the clinical covariates as set forth in the claims.
The specification asserts that aggressiveness index incorporates 3 endpoints of Gleason grade, number of cores positive, maximum involvement, however, the claims do not require such an analysis (p. 62). As such the specification has not provided a description of the utilization of prostate cancer aggressiveness index value based upon the biomarker analysis and clinical measurement provide in the claims.
In the instant case the specification does not provide the skilled artisan with an adequate written description of particular nucleic acids suitable for performing the claimed method as generically encompassed in the claims.
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that "Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed." (See: 'Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.) In the instant case, the specification fails to teach the necessary common attributes or features of any expression and functionally determining prostate cancer aggressiveness index in view of the species disclosed. As such, one of skill in the art would not recognize that applicant was in possession of the genus encompassed by the broadly claimed invention.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following.
The reply asserts that the specification demonstrates the elected biomarker species (p. 6-7). The reply asserts that the specification provides the specific steps and recited markers in the specification (p. 7). The reply asserts that the specification teaches that biomarker levels can be measured as gene expression, protein expression or activity levels (p. 7). The reply asserts that the specification describes biomarkers levels and clinical covariates are concatenated (p. 7). The reply asserts the reply asserts that the additional biomarkers is within the disclosed genus and that examining based upon only the species is in error as it changes the scope of the written description (p. 8).
These arguments have been reviewed but have not been found persuasive.
The reply appears to assert that the written description should not be analyzed with the species but rather the genus of the claims. However, the claims have been examined based upon the panel that is required in step c. With regard to the specific combination of genes, the specification has not provided that levels of the biomarkers linked to one or more clinical data would functionally provide prostate cancer aggressiveness index. The specification discloses that in some embodiments the one or more clinical data can be used as clinical covariates and concatenated with biomarkers levels and input into a sparse rank regression model to provide aggressiveness (p. 4). However, the specification does not describe how to utilize the concatenated of one or more clinical data and the measured levels of the recited biomarkers to identify the prostate cancer aggressiveness index value. Although the specification provides that one can measure these biomarkers, the specification does not teach now to identify any human subject prostate cancer aggressiveness index value based upon any measured levels and concatenated with any of the listed clinical data.
Conclusion
No claims are allowed.
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 KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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 on 5712723157. 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.
/KATHERINE D SALMON/Primary Examiner, Art Unit 1682