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 4/01/2026.
Applicant's election with traverse of Group I and the species of TMEM240, MROH6, and BEND5 in the reply filed on 9/22/2025 is acknowledged. The arguments were addressed in the nonfinal of 12/05/2025 and made final.
Claims 1-2, 17-28 are pending. Claims 3-16 have been cancelled.
Claims 17-24 are withdrawn as being drawn to a nonelected invention.
The following rejections for claims 1-2 and 25-28 are modified as necessitated by amendment. Response to arguments follow.
This action is FINAL.
Withdrawn Rejections and Objections
The drawing objection made in the previous office action is withdrawn based upon amendments to the claims.
Claims objections made in the previous office action is withdrawn based upon the cancellation of the claims.
The 35 USC 112 Scope of enablement, 35 USC 112b, 35 USC 101, and 35 USC 103 rejections made in the previous office action are withdrawn based upon amendments to the claims.
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 1-2 and 25-28 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.
The claims are drawn to a method for determining increased risk of colorectal cancer in any biological.
The claims are drawn to a very large genus of examining methylation levels in any sample type. Based upon the description in the specification although the skilled artisan could readily use a methylation status analysis, the artisan would first need to determine if it functionally detects increased risk of colorectal cancer in the samples as such the specification has not provided written support for the structures with the recited functionality.
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. The instant specification has not provided the critical structures in any species to functionally detecting increased risk to colorectal cancer.
The specification describes measuring methylation status of MROH6 in human ccFDNA extracts (p. 23-24). The specification measures methylation in colorectal cancer tissue of MROH6 (p. 25). However, the specification does not provide any critical guidance to functionally associated methylation level MROH6 tin any biological sample to risk of colorectal cancer. Rather, the specification provides detection of MROH6 methylation in a sample from human colorectal tissue or plasma.
Herein the claims are drawn to any type of sample in any subject and functionally detecting an increased risk of colorectal cancer however, there is no written support that methylation detection or levels would between the different types of samples would be functionally the same.
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 the transcripts consistently detected across array platforms 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 of markers, encompassed by the broadly claimed invention.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is proved below with response to arguetmsn following. It is noted that many issues provided in the previous office action have been withdrawn based upon amendments to the claims. As such arguments towards those issues are not addressed. The reply asserts that the claims have be amended to the example 1 in the specification (p. 8) and discloses plasma levels of cfDNA (p. 8). These arguments have been reviewed but have not been found persuasive. Although the claims have overcome particular issues, the claims still encompass any sample type. As such the claims are rejected as the specification does not provide that any sample type will provide functionality. It is suggested that the claims be limited to the particular sample types recited in the examples in the specification which have been described by the specification as possessing the recited functionality.
Conclusion
No claims are allowed.
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 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 at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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