DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims Status
Claims 2 & 3 filed on 10/08/2025 are pending. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant application. Response to Applicant’s argument follow. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 103
Claims 2 & 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Imamura (Imamura et al.; Anticancer Research, Vol. 25, pages 2627-2630, April 2005), as cited in the IDS dated 06/21/2022, in view of Garrity-Park (Garrity-Park et al.; American Journal of Gastroenterology, Vol. 103, pages 407-415, August 2007), as cited in the IDS dated 06/21/2022, and Itzkowitz (Itzkowitz & Present; Inflamm Bowel Dis, Vol. 11, pages 314-321, March 2005), as cited in the IDS dated 06/21/2022.
Regarding claim 2, Imamura teaches a method of measuring the methylation status of the RUNX3 gene in colorectal cancer tumor samples (colon sample) using methylation-specific PCR in which the DNA from the colorectal tumor samples (nucleic acid obtained from colon sample) were treated with bisulfite treatment (abstract paragraph lines 1-15; pg. 2627-2628 paragraph bridging pg. 2627 & pg. 2628 lines 1-7; pg. 2628 column 1 1st full paragraph lines 1-3).
Imamura does not teach measuring the hypermethylation of RUNX3 in a human diagnosed with inflammatory bowel disease and does not teach conducting more frequent colonoscopy and biopsy surveillance on said human at least in part on said presence of said hypermethylated RUNX3 nucleic acid.
Garrity-Park teaches that ulcerative colitis (UC), a form of IBD (pg. 407 column 1 1st full paragraph lines 1-3), patients are at increased risk for developing colorectal cancer (CRC) and that there is a need to identify additional screening tools, such as genetic links and markers, to the current standard of annual or biannual surveillance colonoscopies that can pinpoint UC patients at greatest risk for developing CRC (abstract objectives paragraph lines 6-8; pg. 407 paragraph bridging column 1 & 2 lines 1-17; pg. 407-408 paragraph bridging pg. 407 & pg. 408 lines 1-5).
Itzkowitz teaches that inflammatory bowel diseases (IBDs) are associated with an increased risk for developing colorectal cancer and teaches that identification of IBD patients might benefit from colonoscopic surveillance in an effort to limit colorectal cancer morality while avoiding complete colon resection (pg. 314 paragraph bridging column 1 & 2 lines 1-13; pg. 314 column 2 2nd full paragraph lines 3-11). In addition, Itzkowitz teaches that depending on the risk factors and past prevalence of ulcerative colitis (a form of IBD) the patient should undergo surveillance yearly or may require shorter surveillance intervals (conducting more frequent colonoscopy and biopsy surveillance on said human than surveillance colonoscopy and biopsy every year) (pg. 316 column 1 4th full paragraph lines 1-12; pg. 316 column 1 5th full paragraph lines 1-3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have screened for hypermethylation of RUNX3, as taught by Imamura, in human in humans diagnosed with UC (form of IBD) taught in Garrity-Park because Garrity-Park teaches there being a need to identify additional screening tools to surveillance colonoscopy, including genetic markers in UC patients at greatest risk for developing CRC. In terms of the frequency of colonoscopic surveillance, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting hypermethylation of RUNX3 taught in Imamura and the identification of genetic risk factors in UC patients at increased risk for CRC in Garrity-Park to incorporate increasing the frequency of colonoscopy and biopsy surveillance as taught in Itzkowitz because Itzkowitz teaches that the identification of IBD patients might benefit from colonoscopic surveillance in an effort to limit colorectal cancer mortality and avoid total colon resection.
Regarding claim 3, Imamura teaches a method of measuring the methylation status of the RUNX3 gene in colorectal cancer tumor samples (colon sample) using methylation-specific PCR in which the DNA from the colorectal tumor samples (nucleic acid obtained from colon sample) were treated with bisulfite treatment (abstract paragraph lines 1-15; pg. 2627-2628 paragraph bridging pg. 2627 & pg. 2628 lines 1-7; pg. 2628 column 1 1st full paragraph lines 1-3).
Imamura does not teach measuring the hypermethylation of RUNX3 in a human diagnosed with inflammatory bowel disease and does not teach conducting more frequent colonoscopy and biopsy surveillance on a human having the presence of hypermethylated RUNX3 nucleic acid.
Garrity-Park teaches that ulcerative colitis (UC), a form of IBD (pg. 407 column 1 1st full paragraph lines 1-3), patients are at increased risk for developing colorectal cancer (CRC) and that there is a need to identify additional screening tools, such as genetic links and markers, to the current standard of annual or biannual surveillance colonoscopies that can pinpoint UC patients at greatest risk for developing CRC (abstract objectives paragraph lines 6-8; pg. 407 paragraph bridging column 1 & 2 lines 1-17; pg. 407-408 paragraph bridging pg. 407 & pg. 408 lines 1-5).
Itzkowitz teaches that inflammatory bowel diseases (IBDs) are associated with an increased risk for developing colorectal cancer and teaches that identification of IBD patients might benefit from colonoscopic surveillance in an effort to limit colorectal cancer morality while avoiding complete colon resection (pg. 314 paragraph bridging column 1 & 2 lines 1-13; pg. 314 column 2 2nd full paragraph lines 3-11). In addition, Itzkowitz teaches that depending on the risk factors and past prevalence of ulcerative colitis (a form of IBD) the patient should undergo surveillance yearly or may require shorter surveillance intervals (conducting more frequent colonoscopy and biopsy surveillance on a human) (pg. 316 column 1 4th full paragraph lines 1-12; pg. 316 column 1 5th full paragraph lines 1-3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have screened for hypermethylation of RUNX3, as taught by Imamura, in human in humans diagnosed with UC (form of IBD) taught in Garrity-Park because Garrity-Park teaches there being a need to identify additional screening tools to surveillance colonoscopy, including genetic markers in UC patients at greatest risk for developing CRC. In terms of the frequency of colonoscopic surveillance, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting hypermethylation of RUNX3 taught in Imamura and the identification of genetic risk factors in UC patients at increased risk for CRC in Garrity-Park to incorporate increasing the frequency of colonoscopy and biopsy surveillance as taught in Itzkowitz because Itzkowitz teaches that the identification of IBD patients might benefit from colonoscopic surveillance in an effort to limit colorectal cancer mortality and avoid total colon resection.
Response to Arguments
The response traverses the rejection. The response asserts that the Imamura reference does not teach or suggest detecting the presence of hypermethylated RUNX3 nucleic acid obtained from a colon sample of a human diagnosed with inflammatory bowel disease as the presently presented claims require and that instead the Imamura reference discloses detecting hypermethylated RUNX3 in nucleic acid from primary colorectal tumors. This argument has been thoroughly reviewed but was not found persuasive. First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Second, as discussed previously and above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have screened for hypermethylation of RUNX3, as taught by Imamura, in human in humans diagnosed with UC (form of IBD) taught in Garrity-Park because Garrity-Park teaches there being a need to identify additional screening tools to surveillance colonoscopy, including genetic markers in UC patients at greatest risk for developing CRC. In terms of the frequency of colonoscopic surveillance, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the method of detecting hypermethylation of RUNX3 taught in Imamura and the identification of genetic risk factors in UC patients at increased risk for CRC in Garrity-Park to incorporate increasing the frequency of colonoscopy and biopsy surveillance as taught in Itzkowitz because Itzkowitz teaches that the identification of IBD patients might benefit from colonoscopic surveillance in an effort to limit colorectal cancer mortality and avoid total colon resection.
The response also asserts that neither the Garrity-Park reference nor the Itzkowitz reference corrects the deficiencies of the Imamura reference and, in fact, the Garrity-Park and Itzkowitz references never mention detecting the presence of hypermethylated RUNX3 nucleic acid, let alone detecting the presence of hypermethylated RUNX3 nucleic acid using nucleic acid obtained from a colon sample of a human diagnosed with inflammatory bowel disease. This argument has been thoroughly reviewed but was not found persuasive. First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In addition, this argument was not found persuasive for the reasons set forth above.
For these reasons, and the reasons already made of record and modified to address the claims as currently amended, the rejections are maintained and applied to the newly amended claims.
Conclusion
Claims 2 & 3 are rejected.
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 BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/Primary Examiner, Art Unit 1682