Detailed Action
► The applicant's response(s) (filed 03 JUL 2025 and 18 JUL2023) to the Office Action have been entered. Following the entry of the claim amendment(s), Claim(s) 1-11, 13-15, 17-30 as presented in the Supplemental Response filed 18 JUL 2025 is/are pending. Rejections and/or objections not reiterated from the previous office action are hereby withdrawn. The following rejections and/or objections are either newly applied or reiterated. They constitute the complete set presently being applied to the instant application.
► The present application is being examined under the pre-AIA first to invent provisions. 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 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.
Examiner’s Comment
The applicant has filed an Information Disclosure Statement which included a USPTO board decision in Genoscopy, Inc. V. Exact Sciences Corp. (hereinafter – “Genoscopy” indicating that the Claims (i.e. Claims 1-19 of US 11,634,781 – hereinafter US-781’) were unpatentable under 35 USC 103. The Claims of the instant application, although they are not identical, closely mirror those of US-781’ as such the examiner has deemed the following prior art rejection(s) justified. For example, the Claims of US-781’ recite a method for processing and testing a human fecal sample which method comprises dividing said fecal sample into two portions which portions (removed portion– protein portion hereinafter “P” and remaining portion – Nucleic acid portion -hereinafter “NA” ) are independently stabilized, by either a protein stabilizer or a nucleic acid stabilizer. The divided portions P and NA are then transported to medical diagnostic lab wherein the P portion in the protein stabilizing buffer is tested for blood proteins (i.e. fecal occult blood testing e.g. via iFOBT) The second portion of the feces in the nucleic acid stabilizing agent is further processed and tested for nucleic acid(s). As noted above the claims of the instant application closely follow the Claims of US-781’ The instant invention recites a method of testing a human subject for the presence of colorectal adenoma which requires the use of a kit configured for collecting and transporting a pair of fecal sample portions (i.e. P and NA as above). The rejection(s) which follow rely, at least in part , upon the teachings detailed in Genoscopy.
35 U.S.C. 103(a)
► The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
► This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. § 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligations under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of potential 35 U.S.C. § 102(f) or (g) prior art under 35 U.S.C. § 103.
Claim Rejections under 35 USC § 103
► Claim(s) 1-11, 13-15 and 17-30 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Kanaoka et al. [US 2006/0216714 – hereinafter “Kanaoka”] in view of Shuber et al.[WO 2005/113769 i- hereinafter “Shuber”] ; Lenhard et al. [Clin. Gastroenterology. and Hepatology 3: 142-149 (2005) – “Lenhard”] ; Vilkins et al. [AM J. of Gastroenterology 100 : 2519-2525 (2005) – hereinafter “Vilkins”] ; Itzkowitz et al. [Clin. Gastroenterology and Hepatology (2007) – “Itzkowitz”] ; Koga et al. [Cancer Science 99(10) :1977-1983 (2008) – hereinafter Koga and Sugo [US/2010/0216178 – hereinafter “Sugo”].
Kanaoka teach a method for obtaining, processing and testing for one or more CRC tumor markers (e.g. COX-2), see at least para 44. For example, Kanaoka teach that fecal samples were obtained separated into 1 g parts in 5 ml tubes, and then frozen. Kanaoka further samples were tested to measure human hemoglobin (Hb) by immunological fecal occult blood testing to obtain a comparison reference value. Next, after homogenization, RNA was extracted from the samples and cDNA transcribed, and then amplified by PCR. Paras 57-58. Then, using primers CEA (carcinoembryonic antigen protein) and COX-2 were detected. Each of CEA, COX-2, and blood via the iFOBT were detected in patients with colon cancer (almost every time). 63-66. Finally, Kanaoka teach RT-PCR, see at least para 10.
Shuber teach, see at least paras 3-30, a method(s) for preparing nucleic acid containing biological samples for a nucleic acid integrity assay and/or multiple mutation analysis by incubating the biological sample with a stabilization solution that includes a buffer, a chelating agent and a salt.” Shuber discloses methods for preparing nucleic acid-containing biological samples for an assay to detect nucleic acid markers indicative of cancer (e.g. adenomas:). According to Shuber, the method disclosed comprises contacting a patient sample with a stabilization solution stabilizes the DNA so that intact nucleic acids indicative of diseased cells are more effectively detected in a nucleic acid. integrity assay. /d. at 2:7-9. Shuber explains that a stabilization solution “may be particularly useful when samples are not refrigerated or frozen” and if a sample “is obtained at a remote location and mailed or delivered to a testing center.” In one aspect of the Shuber invention, a stool sample may be directly deposited into a sealable container and a stabilization solution may be added to the container, after which the container may be sealed for storage/shipping to a test lab.
Lenhard teach a method for obtaining, processing and testing feces sample by promoter methylation status of gDNA found in a feces sample. Lenhard, further teach the detection of tumor-derived genetic changes in stool is a promising approach for CRC screening. Lenhard also teach the use of fecal occult blood testing (FOBT) alone or in combination with endoscopy.. Lenhard further states that stool samples were collected preoperatively from patients with verified CRCs and before colonoscopy for patients with adenomas larger than one centimeter. Samples were received within ten hours after defecation at the laboratory, subjected to gFOBT (guaiac fecal occult blood testing – a color change test) immediately on receipt, and then stored at -80°C until analyzed for methylated DNA. paras 143, 145. Lenhard expressly teach testing in both symptomatic and asymptomatic patients, see Table 4.
Vilkins teach a method and kit therefor for obtaining and processing human fecal samples. .Vilkins further teach an iFOBT (i.e. immunological fecal occult blood testing). Vilkins further teach determining a heme protein concentration of a fecal sample and that said sample is considered positive above a predetermined threshold, see the section entitled “Fecal Occult blood results” bridging pp. 2522-2523. Also see Tables 1 and 3.
Itzkowitz teach a method of Fecal DNA test for CRC screening which notably teaches the use of a DNA-stabilizing reagent Itzkowitz further explains that subjects were given a special stool collection kit to be mounted on a toilet bowl for sample collection. . Immediately after defecation (in the kit), the subject added 250 ml of a DNA-stabilizing buffer to the stool specimen and then shipped the specimen, at room temperature, overnight, to a laboratory for processing and analyzing.
Koga teach real-time RT-PCR using a fluorophore- labeled TaqMan- type probe in an assay to detect marker mRNAs out of fecal samples.
Sugo teach see at least the abstract and paras 1-4 and 12, a method of using a heme protein stabilizing solution in order to stabilize heme proteins in a fecal sample.
As regards Claim(s) 2, as noted above Lenhard expressly teach screening both symptomatic and asymptomatic patients, see at least Table 4.
As regards Claim(s) 3, 7 and 25 as noted above Kanaoka expressly teach RT-PCR to detect a human mRNA.. Also note Koga
As regards Claim(s) 4, and 26 note the teachings of Lenhard discussed above
As regards Claim(s) 5-6, 27 note that where the general conditions are where the general conditions of a claim are disclosed in the prior art, it is not inventive, absent a showing, to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As regards Claim(s) 8 and 28,note that Kanaoka teach 1g portions, note the teaching cited above.
As regards Claim(s) 9-15, 17-23 and 29-30 note the teachings of Vilkins discussed above.
Conclusion
C. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ethan Whisenant whose telephone number is (571) 272-0754. The examiner can normally be reached Monday-Friday from 8:30 am -5:30 pm EST or any time via voice mail. If repeated attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anne Gussow, can be reached at (571) 272-6047.
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/ETHAN C WHISENANT/Primary Examiner, Art Unit 1683 ethan.whisenant@uspto.gov