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 .
The response dated 11/18/2025 is acknowledged. Claims 1-6 and 7-8 are pending. Claims 6 was cancelled. Claims 1-6 and 7-8 are considered on the merits below.
Response to Amendment
Applicant's amendments, filed 11//18/2025, with respect to the objection to claim 1 and 112b rejections have been fully satisfied and withdrawn.
In response to the applicant's amendments, the grounds of rejection for claims 1-6 and 7-8 are new compared to the previous action due to the amendment but rely on the same prior art.
Drawings
The drawings are objected to because figures 3a, b, c, and d have data points or numbering that are unclear. Numbers must measure at least .32 cm. (1/8 inch) in
height. They should not be placed in the drawing so as to interfere with its comprehension.
Therefore, they should not cross or mingle with the lines. They should not be placed upon
hatched or shaded surfaces. (37 CFR 1.84 (p)(3)).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to
the Office action to avoid abandonment of the application. Any amended replacement drawing
sheet should include all of the figures appearing on the immediate prior version of the sheet,
even if only one figure is being amended. The figure or figure number of an amended drawing
should not be labeled as "amended." If a drawing figure is to be canceled, the appropriate figure
must be removed from the replacement sheet, and where necessary, the remaining figures must
be renumbered and appropriate changes made to the brief description of the several views of the
drawings for consistency. Additional replacement sheets may be necessary to show the
renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an
application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet"
pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will
be notified and informed of any required corrective action in the next Office action. The
objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Does the claim falls within any statutory category? See MPEP 2106.03. Yes, the claim recites at least one step, including analysis of the HCAs. Thus, the claim is to a process, which is one of the statutory categories of invention.
Step 2A, Prong 1: identify the abstract ideas. Claim 1 includes an analyses step which appears to be a quantification and therefore could be a mental step and an abstract idea.
Step 2A, Prong 2: has the abstract idea been integrated into a particular practical application? No, once the analyses are complete, nothing is done and therefore there is no application much less a particular practical application.
Step 2B: does the claim recite any elements which are significantly more than the abstract idea?
No, the elements outside of the abstract idea include collection of a sample and preparation using hydrolysis and extraction. Both of these step are well understood routine and conventional.
The dependent claims only further refine the abstract idea.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-5 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (Anal Bioanal Chem. 2016 November ; 408(28): 8149–8161, provided on the IDS on 7/5/2022).
Regarding claims 1, 2, 4, 5, and 7, Zhang describes a method for pretreating a biological sample and quantifying heterocyclic amines (HCAs) for early diagnosis of colorectal cancer (abstract and page 8150 “Both toxicological and epidemiological studies link HCAA exposure with elevated cancer risk.[6-10]” and page 8160 citation 6 title “Meat-related mutagens/carcinogens in the etiology of colorectal cancer” and citation 8 title “Combined effects of well-done red meat, smoking, and rapid N-acetyltransferase 2 and CYP1A2 phenotypes in increasing colorectal cancer risk”), the method comprising:
a) collecting a biological sample from a subject by a non-invasive method (abstract “urine collected”);
b) hydrolyzing the biological sample of step a) by treating the biological sample with a strong alkali (page 8151 “The urine samples were then basified by 50 μL of 10 N NaOH.” I.e. alkali hydrolysis);
c) extracting the HCAs from the hydrolyzed blogical sample of step b) using liquid-liquid extraction (page 8151 “The urine samples were then basified by 50 μL of 10 N NaOH.” I.e. alkali hydrolysis And page 8152 “2.25 mL of dichloromethane (DCM) was added to each well of the SLE+ plate, and HCAAs were eluted by gravity.” i.e. Liquid-liquid extraction);
d) quantifying the HCAs of step c) (page 8149 “a sensitive, precise and accurate method that uses isotope dilution LC-MS/MS for simultaneous analysis of structurally diverse HCAAs in human urine samples.”),
wherein the HCAs are 2-amino-1-methyl-6-phenylimidazo[4-5-b]pyridine (PhIP) and 2-amino-3,8-dimethylimidazo[4,5-f]quinoxaline (MeIQx) (page 8159 “Urinary concentrations of PhIP and the two beta-carboline HCAAs evaluated”).
Regarding claim 3, Zhang describes the method of claim 1, wherein the strong alkali is used in an amount of 5 to 15 parts by weight based on 100 parts by weight of the biological sample of step a) (page 8158 “1:50 to 1:10 (10N NaOH: urine sample; v/v)” this would result in the w/w ratio being within the range required by the claim.).
Regarding claim 8, Zhang describes the method of claim 1, wherein the method further comprises
e) diagnosing that the risk of colorectal cancer is higher in people whose levels of the HCAs are higher than those of a normal control group. (Page 8149 “Both toxicological and epidemiological studies link HCAA exposure with elevated cancer risk.”).
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
The applicant argues that (1) the drawing are now sufficient; (2) due to the amendments claim 1 overcomes the 101 rejection; (3) the prior are does not describe the specific compounds of claim 1 (previously claim 6); (4) the prior art does not describe diagnosing or predicting colorectal cancer.
In response to the applicant argument that (1) the drawing are now sufficient, figures 3a-d still have numbers that are not legible.
In response to the applicant argument that (2) due to the amendments claim 1 overcomes the 101 rejection, in this case quantification of the HCAs could still be a mental step, particularly because nothing is done subsequently. Furthermore, collection of a sample, and hydrolysis and extraction are all steps that are well understood routine and conventional. Thus the 101 rejection remains.
In response to the applicant argument that (3) the prior are does not describe the specific compounds of claim 1 (previously claim 6), the arguments seem to indicate that both MeIQx and PhIP are required, however the wording of the claim still only requires that at least one of them are present. In this case the PhIP as indicated in the rejection above.
In response to the applicant argument that (4) the prior art does not describe diagnosing or predicting colorectal cancer, a recitation directed to the manner in which a claim is intended to be used does not distinguish it the prior art. This this case the method is indicating that the quantifying could be used early diagnosis, but does not provide an active step of early diagnosis.
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 EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
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, Lyle Alexander can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
/EMILY R. BERKELEY/
Examiner
Art Unit 1796