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 .
Application Status and Election
Claims 1-10 are pending.
Applicant’s election without traverse of Group III, directed to methods of diagnosing and treating ulcerative colitis (UC) in the reply filed August 18, 2026 is acknowledged. Claims 1-5 and 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups, there being no allowable generic or linking claim. Applicant also elected the biomarker gene MFAP5. However, MFAP5 is not a biomarker gene for UC. Examiner called Applicant’s representative, Roy Issac (Reg No. 58,165) on September 1, 2026 to elect a different species from the biomarker genes listed for UC. Applicant elected ADM as the biomarker for the initial search and consideration.
Claims 6 and 10, along with the biomarker gene ADM are under examination.
Drawings
The drawings are objected to because they were submitted in color, but there is no granted petition to accept color drawings. See 37 CFR 1.84(a)(2) (“The Office will accept color drawings in utility patent applications only after granting a petition filed under this paragraph explaining why the color drawings are necessary”). Applicants must either provide that explanation via a petition and comply with all requirements of 37 CFR 1.84(a)(2)(i)-(iii) OR submit replacement sheets in black and white and include a clear instruction to replace the color drawings with the replacement sheets. The examiner takes no position on whether color drawings are necessary as the only practical medium by which to disclose the subject matter sought to be patented in this utility patent application.
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 § 112(b)
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.
Claim 6 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites “A method of diagnosing and treating ulcerative colitis… measure expression of biomarkers in blood wherein said biomarker is selected from ADM, BMPR1B… and administering one or more therapeutic agents from the treatment of UC, wherein the expression of biomarkers selected from claim 2 is elevated in said patient.” Claim 6 is confusing because it recites diagnosing UC and lists 39 genes as a potential biomarker but then requires that the biomarkers from claim 2 be elevated. Claim 2 is directed to a method of treating Crohn’s Disease (CD), a related but distinct disease from UC. The biomarker genes in claim 2 are similar to the biomarker genes in claim 6, but also include MFAP5, FCGR1BP, FCGR1CP and IGLV3-27 that are not present in the list for UC. The recitation of a closed list of biomarkers in claim 6 and then reference to a different subset of biomarkers from claim 2 renders the claim indefinite since it is not clear what sets of genes need to have increased expression.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 6 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Planell (Planell et al., Journal of Crohn's and Colitis (2017), 1335–1346).
Regarding claim 6, Planell teaches obtaining a blood sample from patients suspected of having ulcerative colitis (UC) (Section 2.1). Planell teaches that S100A12 was upregulated in blood samples having active UC (i.e., S100A12 is a biomarker) (Fig 1). Planell teaches treating patients treated with the anti-TNFa antibodies were in remission and had reduced S100A12 expression in blood (Sections 2.1 and 3.4, and Fig 1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Planell (Planell et al., Journal of Crohn's and Colitis (2017), 1335–1346), as applied to claim 6 above, and further in view of Schniers (Schniers et al., Proteomics Clinical Applications (2017), 11: 1700053).
The teachings of Planell are recited above as for claim 6 and are incorporated here. Briefly, Planell teaches S100A12 is a biomarker for UC that can be detected in blood samples and anti-TNFa antibodies as a treatment for UC. Planell also teaches that tissue biopsies are a useful tool for identifying disease biomarkers (Section 1).
Planell does not teach detecting S100A12 from gut tissue.
Schniers teaches measuring protein levels from UC biopsies (i.e., gut tissue) (Sections 2.1-2.2; Table 1). Schniers teaches S100A12 is highly upregulated in UC gut samples compared to healthy controls (i.e., S100A12 is a biomarker measured from gut tissue) (Table 2).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have additionally measured the levels of S100A12 expression in biopsy samples in the method of diagnosing and treating UC of Planell. It would have amounted to the simple combination of known detection methods by known means to yield predictable results. The skilled artisan would have predicted that S100A12 could be detected from Planell’s UC patient gut tissue because Schniers teaches it was found to be upregulated in UC biopsies. The skilled artisan would have been motivated to have detected S100A12 in both blood samples and biopsy samples to increase sensitivity of diagnosis and rule out false positives from the blood test.
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Chakravarti (US 20090258848 A1, published October 15, 2009) in view of Kwon (US 20110117111 A1, published May 19, 2011). This rejection is also directed to the elected biomarker gene, ADM.
Regarding claims 6 and 10, Chakravarti teaches methods for determining the inflammatory bowel (IBD) status of a subject by identifying biomarkers (Abstract). Chakravarti teaches that ADM is upregulated in Crohn’s disease (CD) as determined from tissue biopsies (i.e., gut tissue) (Table 16, [0311]). Chakravarti teaches that ADM is also slightly upregulated in ulcerative colitis (UC) compared to unaffected individuals (FIGs 6C and 8C). Chakravarti teaches biomarkers can be detected in samples of blood or tissue ([0061]). Chakravarti teaches therapeutic agents for IBD include anti-TNF antibodies, corticosteroids, and immunosuppressants ([0270]).
Chakravarti does not teach ADM as a biomarker for UC.
Kwon teaches adrenomedullin (ADM) is upregulated in UC patient colonoscopy biopsies (i.e., gut tissue) vs normal controls ([0288]; Table 8). Kwon identifies the genes listed in Table 8 as a biomarker ([0007]). Kwon also teaches that samples for biomarker detection can be blood samples ([0013]).
Regarding claims 6 and 8, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have measured ADM levels in both blood and biopsy samples to diagnose a subject having UC before the known treatments taught in Chakravarti. It would have amounted to the simple combination of previously known biomarkers and treatments by known means to yield predictable results. The skilled artisan would have been motivated to include ADM in the list of biomarker genes for UC because the data of both Chakravarti and Kwon teach that ADM levels are upregulated in the UC biopsy samples compared to healthy or unaffected controls. The skilled artisan would have predicted that ADM levels could also be detected in blood samples, and been motivated to use blood samples, because both Chakravarti and Kwon teach that blood samples can be used for biomarker measurement. Blood sampling is less invasive than colonoscopy, which would have also motivated the skilled artisan to use blood samples as a source of biomarker measurement.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE KONOPKA whose telephone number is (571)272-0330. The examiner can normally be reached Mon - Fri 7- 4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached at (571)272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE KONOPKA/Primary Examiner, Art Unit 1635
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