RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 08/25/2025, is acknowledged.
2. Claims 22-23, 61, 66, 70-71, 73 are pending.
3. Applicant’s IDS, 08/25/2025, acknowledged.
4. Claims 66 and 73 are objected to because “PHICAL test kit” is trademark. The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
5. The following new ground of rejection is necessitated by the amendment submitted 08/25/2025.
6. 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.
7. Claims 22-23, 61, 66, 70-71, 73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wyant et al (The American Journal of GASTROENTEROLOGY, 102(2), Oct. 2014.
Wyant et al teach that calprotectin is a neutrophil granule protein released during an inflammatory response. In patients with ulcerative colitis (UC), fecal calprotectin (fCal) concentration is positively correlated with endoscopic activity and thus is considered to reflect intestinal inflammation. Vedolizumab (VDZ), an anti-α4β7 integrin monoclonal antibody, reduces gastrointestinal (GI) inflammation by inhibiting migration of gut-homing memory T cells into the GI tract. In GEMINI 1, a phase 3 study of the efficacy and safety of VDZ in patients with UC, we examined fCal concentrations to document the degree of inflammation
and determine any correlation with response to VDZ induction therapy. Wyant et al teach that in GEMINI 1, patients with moderately to severely active UC were randomly assigned to
receive placebo (PBO) or VDZ 300 mg (induction ITT population) or open-label VDZ at weeks 0 and 2. Response to induction therapy was measured at week 6 using the Mayo Clinic score. Each patient collected an ~20 g stool sample during screening (baseline) and at week 6 for determination of fCal by quantitative enzyme-linked immunosorbent assay (PhiCal test kit). According to the kit, fCal >150 μg/g stool is considered to reflect active UC with this assay. Here using post hoc analysis Wyant et al show the effect of VDZ on fCal concentrations and clinical response and remission using baseline fCal cut-off s of ≤250 and >500 μg/g stool, given the study population had moderately to severely active disease. The results show that PBO- and VDZ-treated patients had a similar degree of inflammation at baseline, as
determined by baseline fCal concentrations and the percentage of patients with fCal ≤250 or ≥500 μg/g (Table 1). Clinical response and clinical remission rates were numerically higher with VDZ than PBO at week 6, regardless of baseline fCal (Table). At week 6, there was a 32% and 69% decrease in the geometric mean of fCal for PBO- and VDZ-treated patients, respectively (P=0.0011). Safety data for the overall study population have been previously reported.
Wynat et al concluded that during induction therapy for UC, VDZ reduced fCal levels, a marker of mucosal inflammation, by a significantly greater extent than PBO and both response and remission rates were higher with VDZ regardless of baseline fCal concentration.
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The reference teachings anticipate the claimed invention.
7. 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.
7. Claims 22-23, 61, 66, 70-71, 73 are rejected under 35 U.S.C. 103 as being unpatentable over Wyant et al (The American Journal of GASTROENTEROLOGY, 102(2), Oct. 2014.
The teachings of Wyant et al have been discussed, supra.
The reference teachings differ from the instant claims only in the recitation of selectign the human patient fro continued treatment with VDZ where the fCAL concentration at week 6 is less than or equal to 250 µg/g and administering vedolizumab to the selected patient.
Given that the percentage of patients with fCal ≤250 or ≥500 μg/g (Table 1). Clinical response and clinical remission rates were numerically higher with VDZ than PBO at week 6, regardless of baseline fCal (Table). At week 6, there was a 32% and 69% decrease in the geometric mean of fCal for PBO- and VDZ-treated patients, those skilled in the art would have had a reason to selected human patient identified with fCal ≤250 or ≥500 μg/g for continue administration of VDZ in the treatment of VDZ because week 6 of VDZ therapy data predicts which UC patients would achieve clinical response and clinical remission rates.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
8. No claim is allowed.
9. 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 extension fee 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 date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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October 4, 2025
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644