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 ACTION
WITHDRAW PREVIOUS ACTION
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn. In particular, a system malfunction included incorrect grounds of rejections on pages 6-14 of the action. The Final Action dated 12/17/25 is VACATED. Corrected rejections are presented herein.
Amendment Entry
2. Applicant’s response to the Non-Final Action dated 4/24/25 is acknowledged. In the amendment filed therein claims 57-67 and 69-70 were modified. New claims 71-76 were added. Claims 1-56 were previously cancelled without prejudice or disclaimer.
3. Currently claims 57-76 are pending and under consideration.
4. Rejections and/or objections of record not reiterated herein have been withdrawn.
Priority
5. This application has a priority date of 10/18/19: This application is a 35 U.S.C. 371 National Phase Entry Application from PCT/US2020/056086, filed October 16, 2020, which claims priority to U.S. Provisional Application Serial No. 62/923,300, filed October 18, 2019.
Information Disclosure Statement
6. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other
Information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the examiner on form PTO-892 or applicant on form PTO-1449 lists the references, they have not been considered. See references listed throughout the disclosure.
7. The information disclosure statement filed 9/15/25 has been considered as to the merits prior to Final Action on the Merits.
Claim Rejections - 35 USC § 112
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.
8. Claims 57-76 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 pre-AIA the applicant regards as the invention.
A. Claim 57 recites “human protein marker analytes associated with colorectal cancer and/or advanced adenoma”. This wording is vague and indefinite because it is not clear as to what markers will be encompassed.
The specification merely describes the disclosure of associated markers in the Background of the Invention but this section only identifies hemoglobin as the marker of interest. Additionally, the example section of the specification outlines a limited number of markers that were initially detected in Table 1. And the only markers that were eventually demonstrated to improved analysis with the FIT test and combined whole blood test are listed in Table 9 were (Hb/C3, Hb/Hp, and Hb/C3/Hp) markers. As recited, the term “protein marker analytes associated with colorectal cancer and/or advanced adenoma” is a relative term which renders the claim indefinite.
The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention because it appears that the scope of the claim is not supported by the disclosure.
The disclosure defines “marker analyte” in its broadest sense, referring to any component or feature of a sample that can be analyzed or assayed to characterize the sample. See page 10. Although, the disclosure also indicates that examples of DNA/RNA marker analytes can be found in WO2015/153289, it is still unclear as to Applicant’s intent. Are DNA/RNA marker analytes required to contain DNA/RNA, be derive from DNA/RNA or markers that are somehow related to DNA/RNA? It is suggested that the actual detected markers are listed in the claims in order to obviate the rejection. Appropriate correction is required.
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.
9. Claims 57-63 and 66-76 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 57 is drawn to a method of characterizing a human stool specimen for marker analytes associated with colorectal cancer and/or advanced adenoma, the method comprising a) providing a stool specimen from a human subject, the stool specimen comprising: i) a first sample comprising a first portion of the stool specimen in a volume of stabilizing solution; and il) a second sample comprising a second portion of the stool specimen in a volume of stabilizing buffer: b) assaying the first sample for amounts of two or more human protein marker analytes associated with colorectal cancer and/or advanced adenoma: c) assaying the second sample for amounts of the same two or more human protein marker analytes; and d) characterizing the stool
specimen as indicating a presence or absence of colorectal cancer and/or advanced adenoma in the human subject based on combined results of step b) and step c).
The written description in this case does not set forth the utility of any and all “assays, stabilizing solutions, stabilizing buffers, and protein marker analytes associated with colorectal cancer/advance adenoma” in an method to characterize markers indicative of colorectal cancer and/or advance adenoma. Therefore the written description does not reasonably convey the claimed subject matter to one of ordinary skill in the art. Neither the specification nor the claims exemplify any and all “stabilizing solutions, stabilizing buffers, and protein marker analytes associated with colorectal cancer/advance adenoma” having differential measurements in the claimed method.
The specification merely describes the disclosure of associated markers in the Background of the Invention but this section only identifies hemoglobin as the marker of interest. Additionally, the example section of the specification outlines a limited number of markers that were initially detected in Table 1. And the only markers that were eventually demonstrated to improved analysis with the FIT test and combined whole blood test are listed in Table 9 were (Hb/C3, Hb/Hp, and Hb/C3/Hp) markers. For example, see page 10 line 25 and page 15 lines 13-16.
There is no guidance as to what additional markers other than hemoglobin, C3, Hb, and Hp would have operable utility in the claimed method being indicative of colorectal cancer and/or advanced adenoma. Additionally, simply analyzing first and second sample in any and all stabilizing solution and stabilizing buffer is not supported by the specification.
The specification teaches a dual assay of the fecal sample by FIT device (fecal immunochemical test with EDTA/TRIS buffer) and whole blood supernatant analysis resulted in improved assay sensitivity.
In other words, Applicant has appeared to demonstrated that testing both the FIT device sample (first sample) and a whole stool sample (second sample) for the same set of human protein markers (hemoglobin, C3, Hb, and Hp) results in improved sensitivity. The improvement is achieved by combining the assay data for the same set of protein marker analytes from a first sample and a second sample from the same stool specimen.
However, the specification does not teach markers, buffers, and assays outside of the limited reagents and markers that are assayed in the experiments (Table 9). It is not clear as to how much modification can occur while maintaining product characteristics and the detection of colorectal cancer and/or advanced adenoma. with respect to the instantly claimed invention. In fact, the specification teaches that one difficulty in testing different protein analysis is protein stability because protein stability in stool samples can be poor. See specification pages 16-19.
There is no guidance as to what protein markers, buffers, and assays (other than the ones taught by the specification); if any can be modified and still produce the results and be utilized for the intended purpose. The specification does not include structural examples of different markers, buffer, or assays. Therefore, the claimed method reads on any number of protein markers, buffers, and assays not taught and enabled by the specification.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117).
The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision (see page 115).
The skilled artisan cannot envision the detailed structure of every possible marker, buffer, or assay as claimed, thus conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of production and or isolation. An adequate description requires more than a mere statement that it is part of the invention and a reference to a potential method of isolating it.
The court indicated that while Applicants are not required to disclose every species encompassed by a genus, the description of a genus is achieved by the recitation of a representative number of molecules falling within the scope of the claimed genus. Therefore the full breadth of the claims, reading on the claimed " fragment(s) thereof” does not meet the written description provision of 35 USC 112, first paragraph.
In re Clarke, 148 USPQ 665, (CCPA 1966) held that; “ It appears to be well settled that a single species can rarely, if ever, afford support for a generic claim. In re Soll, 25 C.C.P.A. (Patents) 1309, 97 F.2d 623, 38 USPQ 189; In re Wahlforss et al., 28 C.C.P.A. (Patents) 867, 117 F.21 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases.
This position is supported by M.P.E.P. 2163(II)(3)(ii), which states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice. It further states that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated, and that a patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.
10. For reasons aforementioned, no claims are allowed.
11. 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LISA V COOK whose telephone number is (571)272-0816. The examiner works a flexible schedule but can normally be reached on Monday-Friday from 9am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lisa V. Cook
Patent Examiner
Art Unit 1642
Hoteling
3/16/26
/LISA V COOK/Primary Examiner, Art Unit 1642