DETAILED ACTION
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/06/2025 has been entered.
2. Claims 1, 7, 11, 14, 15, 33 and 38-39, 41-43 are pending.
3. Claims 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
4. Claims 1, 7, 11, 14, 15, 33, 38-39 and 43 are under examination as they read on the following species (i) intravenous administration, a 300 mg dose at 0, 2 and 6 weeks and every 4/8 weeks thereafter; (ii) a subject that had a modified Pouchitis Disease Activity Index (PDAI) of 5 or greater at selection; (iii) the method further comprising administering an antibiotic and “the human subject has a proctocolectomy and ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) at selection”.
5. Applicant’s IDS, filed 10/06/2025, is acknowledged.
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 1, 7, 11, 14, 15, 33, 38-39, 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ClinicalTrils (NCT02790138, 5/31/2016, IDS #2).
NCT02790138 teaches the efficacy and safety of vedolizumab (comprising the claimed SEQ ID NOs) intravenous (IV) in participants with a proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis (UC) who have developed chronic or recurrent pouchitis, or require continuous antibiotic treatment (see Brief Summary). The NCT`138 teaches that the efficacy and safety of 300 mg IV vedolizumab in the treatment of chronic pouchitis within 1 year of screening visit or requiring continuous antibiotics. The patient will receive vedolizumab 300 mg IV at Weeks 0, 2, 6, 14, 22, and 30 alone with concomitant antibiotic treatment with ciprofloxacin 500 mg twice daily through Week 4 (see Detailed Descripton). The NCT`138 teaches that total screening patients using PDAI endoscopic score wherein total score ranges 0 to 6, wherein maximum score indicates worsening of the disease. The Clinicaltrial teaches that inclusion of patients who has a history of ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) completed at least 1 year prior to the Screen Visit, mPDAI ≥ 5. Patients (human) has a history of ileal pouch anal anastomosis (IPAA) for ulcerative colitis (UC) completed at least 1 year prior to the Screening Visit (criteria #4). Patient has pouchitis that is chronic or recurrent, defined by a modified Pouchitis Disease Activity Index (mPDAI) ≥5 and >2 episodes within 1 year of the Screening Visit or requiring long-term continuous low-dose antibiotic therapy taken daily on an ongoing basis (eg, ciprofloxacin 250-500 mg/day or metronidazole 500 mg/day taken for several weeks or months at a time) or frequent pulse antibiotic therapy (Criteria #5). Patient agrees to stop antibiotic therapy on Day 1 of the study and switch to ciprofloxacin through Week 4 of study ( Criteria #6). The overall time to participate in this study is 34 weeks (see Detailed Description).
Claims 26-27, 30, 36-39 are included because while the prior art teachings may be silent as to the claimed outcome results of the claimed method; the method, the product used in the reference method are the same as the claimed method. The Courts have held that there is no requirement that those of ordinary skill in the art know of the inherent property. See MPEP 2131.01(d) and MPEP 2112 - 2113. It is noted that the CAFC recently held in Bristol-Myers Squibb Co. v. Ben Venue Laboratories Inc., 58 USPQ2d 1508 (CA FC 2001) that when a claimed process is not directed to a new use, consists of the same steps described in a prior art reference, and the newly discovered results of the known process directed to the same purpose are inherent, the process is not patentable.
“It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). When “a claimed new benefit or characteristic of an invention otherwise in the prior art” is an inherent property of the old invention, “the new realization alone does not render the old invention patentable.” Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005).
The functions recited in the wherein clause flow naturally from the teachings of the prior art. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”), and Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of... a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”)). Here, the recited functional outcome “achieves remission of pouchitis by about 14 weeks following the initial dose of the anti-α4β7 antibody, wherein remission is defined as pouchitis having a modified Pouchitis Disease Activity Index (mPDAI) of <5 and a reduction in overall mPDAI score of >2 from baseline” would naturally and necessarily flow from inhibition of α4ß7 by administering Vedolizumab. Accordingly, the prior art teaches the same method, the product used in the reference method are the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from inhibition of α4ß7 with the Vedolizumab in treating chronic pouchitis patient has a mPDAI of 5 or greater, a minimum endoscopic subscore of 2 and IPAA for UC.
Applicant’s arguments, filed 08/16/2024, have been fully considered, but have not been found convincing.
The reference teachings anticipate the claimed invention.
Applicant’s arguments, filed 10/06/2025, have been fully considered, but have not been found convincing.
Applicant submits the `138 NCT is subject to the exception provided in AIA 35 USC §1029b)(1)(A) and is thereore disqualified from being used in any rejections under 35USC §102(a)(1). The present application is being examined under first inventorto file provisions of the AIA . Per MPEP § 2153.01, AIA 35 USC 102(b)(1)(A) provides that a disclosure which would otherwise qualify as prior art under AIA 35 USC 102(a)(1) is not prior at if the disclosure was made: (1) One year or less before the effective filing date of the claimed invention; and (2) by the inventor or a joint inventor, or by another who obtained the subject matter directly or indirectly from the inventor or joint inventor." The subject matter of NCT02790138 relied upon by the Examiner to reject the claims was first posted May 31, 2016 one year or less before the effective filing date of the claimed invention (i.e., May 26, 2017). The name of the sponsor of NCT02790138 is Takeda, which is the same party as the Applicant of the above- identified application. Thus, NCT02790138 is subject to the exception provided in AIA 35 U.S.C.§ 102(b)(1)(A) and is not available as prior art to the present claims.
This is not found persuasive simply because there was no evidence that the relied-upon disclosures in NCT `138 were made “by the inventor” to satisfy §102(b)(1)(A). Applicant fails to show that the subject matter of the NCT `138 was previously disclosed by the inventor or a joint inventor. The teachings of the NCT `138 was not co-authored by the instant inventor(s). Takeda is not named on the ADS filed 03/18/2022 as the owner of the instant application “Applicant”. Applicant’s argument is insufficient to disqualify NCT `138 as prior art because Applicant did not explain the inventor’s relationship with Takeda/NCT `138 and did not establish that the inventors were the sole inventor of the relied-upon disclosure in the NCT `138.
Applicant submits at notwithstanding the eligibility of NCT02790138 as prior art, NCT02790138 does not anticipate claim 1, as amended, as it does not teach selecting a human subject that has a minimum endoscopic subscore of 2. Independent claims 1 and 11, as amended, each specify selecting a human subject having chronic pouchitis, wherein the human subject has a modified Pouchitis Disease Activity Index (PDAI) of 5 or greater, has a minimum endoscopic subscore of 2. Claims 7, 14, 15, 18-19, 33 and 38-40 directly or indirectly depend from claims 1 and 11. Contrary to the Office's assertion that NCT02790138 "teaches under eligibility inclusion criteria #4 to include participants with a minimum endoscopic subscore of 2" (see page 3, fourth para. of the Office Action and page 2, penultimate para.), mention of a minimum endoscopic subscore of 2 as an inclusion criterion was not included until version 12 of the NCT02790138 clinical trial study first posted to ClinicalTrials.gov on June 8, 2017, which is after the May 26, 2017 effective filing date of the claimed invention.
This is not found persuasive because the `138 teaches selecting participants with chronic or recurrent pouchitis achieving clinically relevant remission. In particular the `NCT 138 teaches under eligibility inclusion criteria #5 to include patient has pouchitis that is chronic or recurrent, defined by a modified Pouchitis Disease Activity Index (mPDAI) ≥5 and >2 episodes within 1 year of the Screening Visit or requiring long-term continuous low-dose antibiotic therapy taken daily on an ongoing basis (e.g, ciprofloxacin 250-500 mg/day or metronidazole 500 mg/day taken for several weeks or months at a time) or frequent pulse antibiotic therapy.
Given that the patient has chronic or recurrent pouchitis defined by mPDAI ≥5 and >2 episodes within 1 year, the patient must have a minimum endoscopic subscore of 2 by definition. Given that the endoscopic subscore is the same for both the original Pouchitis Disease Activity Index (PDAI) and the modified PDAI (mPDAI). Both PDAI and mPDAI for criteria include endoscopic subscores 6 ( edema, granularity, friability, loss of vascular pattern, mucus exudate and ulceration each with subscore of 1) See table 1. Pouchitis disease activity index of Shen et al (GASTROENTEROLOGY 2001;121:261–267).
Table 1 Pouchitis disease activity index (PDAI)
PNG
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78
572
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Greyscale
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162
546
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Greyscale
Importantly, Table 3 shows PDAI and component Scores of UC patients with Ileal Pouches where in the endoscopy component score for pouchitis is 3.9. Shen et al teach that the greatest difference in component scores was observed between the 2 groups for endoscopic findings, with an 8-fold higher endoscopic score in the pouchitis group compared with the group without pouchitis (see page 263, left col., top ¶).
8. 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.
9. Claims 1, 7, 11, 14, 15, 18-19, 26-27, 30, 33, 36-40 are rejected under 35 U.S.C. 103 as being unpatentable over Bethge et al. (BMJ Open Gastro Feb. 2017;4: e000127, IDS #5) or Mangla et al. (American Journal of Gastroenterology, (October 2016); 111(1):S824‐S825, Abstract #: 1729), each in view of ClinicalTrils (NCT02790138, 5/31/2016, IDS #2).
Bethge et al reported a case of a successful combination therapy of vedolizumab (VDZ) (comprising the claimed SEQ ID NOs) and ETA in a patient with ulcerative colitis with pouchitis and SPA. A 41-year-old patient underwent proctocolectomy with IPAA as a result of refractory pancolitis. Thereafter, he developed severe chronic refractory pouchitis. Subsequently various combinations of antibiotics, mesalazine, steroids and probiotics were administered with only transient response. Owing to increased joint pain and ongoing pouch inflammation treatment with a TNF-inhibitor adalimumab was initiated 3 years after surgery. Owing to persistent pouchitis (chronic) and a severe impact on his quality of life, inhibition of α4/β7-integrin was initiated with the therapeutic antibody vedolizumab (VDZ) at standard dose (300 mg at 0, 2 and 6 weeks) and anti-TNF therapy was stopped. The application intervals were continued every 8 weeks. After 6 weeks of therapy with VDZ, the clinical symptoms of pouchitis disappeared, but SpA substantially worsened with clinical enthesiopathy, peripheral arthritis, significant vertebral pain, further stiffening, a rise in C reactive protein and a BASDAI-Index of 24. Therapy with TNF-inhibitor etanercept (ETA) (50 mg/week) was started in addition to VDZ. After 20 weeks of VDZ endoscopic and histopathological assessment of the pouch revealed normal, uninflamed mucosa (figure 1). After 10 months of treatment the patient is still without any symptoms of pouchitis or joint pain. No side effects of the combination of α4/β7-integrin and TNF-inhibition were seen (Case Report, 2nd & 3d ¶, Fig. 1). Bethge teaches that VDZ was highly effective for the long lasting, refractory pouchitis. VDZ seems to be effective for maintaining remission as well. Especially for patients who suffer from chronic antibiotic refractory pouchitis and show a loss of response this seems to be an alternative therapeutic option. (Discussion, 3rd ¶). Fig. 1 shows that (A) refractory pouchitis with a PDAI of 10, (B) pouch with normal mucosa and PDAI of 4 in week 20 after VDZ; (C) histological aspect of chronic refractory pouchitis, (D) histological aspect of uninflamed pouch mucosa after therapy. PDAI, Pouchitis Disease Activity Index; VDZ, vedolizumab.
Mangla et al teach that restorative proctocolectomy with ileal‐pouch anal anastomosis (IPAA) is the surgical treatment of choice in patients with ulcerative colitis. Pouchitis is the most common complication after IPAA and its treatment has not been standardized. Vedolizumab has been used in the treatment of ulcerative colitis but its use in inflammatory conditions of the pouch has not been evaluated. Retrospective chart review was performed on patients with IPAA and pouchitis in our institution who had been exposed to vedolizumab. Pouchitis was confirmed by evaluation of clinical, endoscopic, and laboratory parameters. We identified 4 patients with ulcerative colitis who underwent restorative proctocolectomy with IPAA and were exposed to vedolizumab after IPAA. A Caucasian male with IPAA and pouch repair/reconstruction and a history of chronic untreated pouchitis developed moderate pouchitis mainly affecting the proximal pouch, refractory to antibiotics, adalimumab and infliximab. He achieved complete mucosal healing one month after four vedolizumab infusions (See Figures). A Caucasian male with recurrent pouchitis refractory to steroids, antibiotics, adalimumab and certolizumab pegol developed prepouch ileitis and pouch inflammation suggestive of Crohn's disease (CD) that responded to three vedolizumab infusions along with antibiotics with mucosal healing after one month. A Caucasian female intolerant to infliximab and adalimumab developed CD of the pouch requiring diverting loop ileostomy due to anal pain. Seven months later she developed pouchitis that responded to three vedolizumab infusions and steroids with repeat pouchoscopy after two weeks revealing scant/rare pouch ulcerations and anal‐ IPAA stricture. A Hispanic female developed proximal pouch and pouch inlet inflammation and cuffitis refractory to antibiotics and adalimumab. She received five vedolizumab infusions, and methotrexate was initiated four weeks after the first vedolizumab infusion. She did not respond to vedolizumab and repeat pouchoscopy one week after the last infusion revealed deep pouch ulcerations and cuffitis. ESR and CRP decreased after treatment in 3 out of 4 patients (See Table). Vedolizumab was successful in the treatment of inflammatory conditions of the pouch in three out of four IPAA patients. Inflammatory markers improved in three out of four patients. Further studies are needed to examine its potential role for treating refractory pouchitis.
The reference teachings differ from the claimed invention only in the recitation that that the administration is intravenously in claim 1, 11, 14, 15; further comprising administering an antibiotic, wherein the antibiotic is discontinued by 4 weeks following the initial administration of the anti-α4β7 antibody in claim 19, wherein the antibiotic is ciprofloxacin in claim 40.
The teachings of the ClinicalTrils (NCT02790138 has been discussed, supra.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the VDZ antibody intravenously as taught by the NCT`138 , and further administer an antibiotic such as ciprofloxacin together with the VDZ and discontinue the antibiotic treatment after 4 weeks in the treatment of chronic pouchitis taught by Bethge et al and Mangla et al reafferences because "[I]t is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). "[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
It is obvious to continue treatment with antibiotic along with the anti-α4β7 antibody in the chronic pouchitis treatment and to eliminate the antibiotic after one month after the initial anti-α4β7 antibody treatment since VDZ alone was effective to treat chronic pouchitis as taught by Bethge and Mangla et al references.
From the reference teachings, 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.
Applicant’s arguments, filed 10/06/2025, have been fully considered, but have not been found convincing.
Applicant submits that NCT02790138 is subject to the exception provided in AIA 35 U.S.C. § 102(b)(1)(A) and is therefore disqualified from being used in any rejections under 35 U.S.C. § 102(a)(1) or 35 U.S.C. § 103.
This is not found persuasive simply because there was no evidence that the relied-upon disclosures in NCT `138 were made “by the inventor” to satisfy §102(b)(1)(A).
Applicant submits that the claims, as amended, specify selecting a human subject that has mPDAI of 5 or greater and a minimum endoscopic subscore of 2 for treatment for treatment with a humanized anti- α4β7 antibody, or antigen binding fragment thereof, and ciprofloxacin for the first 4 weeks of treatment. The claimed method first identifies a patient having pouchitis and selects said patient based on criteria. The claims, as amended, further specify that the subject achieves remission by about 14 weeks following the initial dose, wherein remission is defined as pouchitis having a mPDAI of <5 and a reduction in overall mPDAI score of >2 from baseline. Thus, the invention is based on identification of a certain patient having pouchitis who the Applicant has identified as being able to be treated and achieve certain levels of disease remission and reduction following administration of the claimed antibody and ciprofloxacin only for the first 4 weeks of treatment, as required by the amended claims.
This is not found persuasive because the claimed patient population of pouchitis who is selected by Applicant is by definition the criteria define pouchitis (see Shen et al, GASTROENTEROLOGY 2001; 121:261-267) that pouchitis has the pouchitis disease activity index (PDAI) or mPDAI (without the acute histological inflammation) include a subscore of 6 for endoscopic inflammation (see Table 1). Thus, by definition the prior art pouchitis who has a minimum endoscopic subscore of 2.
Applicant submits that Travis et al (N Engl J Med . 2023 Mar 30;388(13):1191-1200) provides results from the clinical study described in Example 1. Travis et al. states that “all patients received concomitant ciprofloxacin from weeks 1 to 4” (see page 1191, Methods) and that “[t]he primary end point was mPDAI-defined remission (an mPDAI score of ≤ 4 and a reduction from baseline of ≥ 2 in the mPDAI total score) at week 14” (see page 1193, right col., last paragraph). Travis et al. reports that “the incidence of mPDAI defined remission at week 14 was 31% (16 of 51 patients) with vedolizumab” wherein eligible patients “had undergone a proctocolectomy and IPAA for ulcerative colitis that had been performed at least 1 year before screening, and had active chronic pouchitis. Active chronic pouchitis was defined by an mPDAI score of at least 5 and a minimum subscore of 2 on the endoscopic domain (on the basis of findings outside the staple or suture line)” (see page 1191, Abstract, Results and page 1192, right column, last paragraph).
However, Travis et al was not part of the rejection. Travis et al also is not considered prior art since it was published after the filing date of the instant application. Accordingly, Travis is irrelevant to the 103 rejection above.
Applicant submits that none of the cited art teaches or suggests selecting a chronic pouchitis subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2 for treatment. For at least the reason that the cited art fails to teach all of the elements of the claims (i.e., selection of the claimed subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2 for treatment), the rejection should be overcome.
This is not found persuasive because Bethge et al teaches treating UC with severe chronic refractory pouchitis. Mangla et al teaches the treatment of inflammatory conditions of the pouch in IPAA. NCT `138 teaches the treatment of PAII for UC who have developed chronic or recurrent pouchitis defined by mPDAI ≥ 5 and >2 episodes within 1 year of the screening visit.
The claimed patient population of pouchitis who is selected by Applicant is by definition the criteria define pouchitis (see Shen et al. GASTROENTEROLOGY 2001;121:261–267) that pouchitis has the pouchitis disease activity index (PDAI) or mPDAI (without the acute histological inflammation) include a subscore of 6 for endoscopic inflammation (see Table 1). Thus, by definition the prior art pouchitis who has a minimum endoscopic subscore of 2.
Applicant submits that Bethge et al. describes a case study of a single patient who was administered combination therapy with vedolizumab and etanercept for treatment of pouchitis and spondylarthritis (see Title). Bethge et al. does not teach or suggest selecting a subject having a minimum endoscopic subscore of 2. Bethge et al. also does not teach or suggest that the patient administered vedolizumab therein was also administered an antibiotic, let alone ciprofloxacin, as specified by the claims, as amended.
This is not found persuasive because by definition the referenced pouchitis subjects inherently have a minimum endoscopic subscore 2 (see Shen et al. GASTROENTEROLOGY 2001;121:261–267).
Mangla et al. is an abstract that describes “4 patients with ulcerative colitis who underwent restorative proctocolectomy with IPAA and were exposed to vedolizumab after IPAA” (see page ¶824, right col., last full sentence). Mangla et al. is silent regarding an mPDAI score and an endoscopic subscore, and thus does not teach or suggest selecting a subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2. Mangla et al. furthermore does not teach or suggest that the patient administered vedolizumab therein was also administered ciprofloxacin that was discontinued by 4 weeks, as specified by the amended claims.
This is not found persuasive because Mangla et al teaches the treatment of inflammatory conditions of the pouch in IPAA. The referenced pouchitis subjects inherently have a minimum endoscopic subscore 2 (see Shen et al. GASTROENTEROLOGY 2001;121:261–267).
The Office cites to NCT02790138 (which Applicant asserts is subject to an exception and not available as art) to remedy the deficient teachings in Bethge et al. and Mangla et al. of intravenous administration in claims 1, 11, 14, 15; further comprising administering an antibiotic, wherein the antibiotic is discontinued by 4 weeks following the initial administration of the anti-α4β7 antibody, or antigen binding fragment thereof, as specified by claim 19; and wherein the antibiotic is ciprofloxacin as specified in claim 40. NCT02790138 does not teach selecting a human subject that has a minimum endoscopic subscore of 2. Mention of a minimum endoscopic subscore of 2 as an inclusion criterion was not included until version 12 of the NCT02790138 clinical trial study first posted to ClinicalTrials.gov on June 8, 2017, which is after the May 26, 2017 effective filing date of the claimed invention.
Given the teachings of the cited art, one of ordinary skill would not arrive at the claimed invention for at least the reason that the cited references do not teach all of the elements of the claims (e.g., selecting a chronic pouchitis subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2). Thus, without the benefit of Applicant’s specification, one of ordinary skill would not be able to predict that the claimed methods could achieve the defined remission of pouchitis 14 weeks following the initial dose of anti-α4β7 antibody in the subject selected for treatment.
It remains the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the VDZ antibody intravenously as taught by the NCT`138 , and further administer an antibiotic such as ciprofloxacin together with the VDZ and discontinue the antibiotic treatment after 4 weeks in the treatment of chronic pouchitis taught by Bethge et al and Mangla et al reafferences because "[I]t is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). "[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
It is obvious to continue treatment with antibiotic along with the anti-α4β7 antibody in the chronic pouchitis treatment and to eliminate the antibiotic after one month after the initial anti-α4β7 antibody treatment since VDZ alone was effective to treat chronic pouchitis as taught by Bethge and Mangla et al references.
12. Claims 1, 7, 11, 14, 15, 26-27, 30, 33, 36-40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Schmid et al (Int. J. Colorectal Dis, published online: 01/17/2017, IDS), each in view of ClinicalTrils (NCT02790138, 5/31/2016, IDS #2).
Schmid et al teaches a 54-year-old Caucasian male, restorative proctocolectomy with ileoanal pouch anastomosis (IPAA) had become necessary 17 years ago in severe refractory ulcerative colitis. The patient was diagnosed with pouchitis and stenosis with chronic inflammation at the outlet of the feeding limb had necessitated balloon dilatation for several times. The patient was switched to anti-integrin therapy and showed sustained clinical and endoscopic response to Vedolizumab 300 mg i.v. at weeks 0, 2, 6, and every 8 weeks. After five doses, pouch and ileal ulcerations had healed completely (apart from one fourth of the circumference of the afferent limb entry), the stenosis was easily traversable, and edema and mucous exudates were no longer present. Clinically, the patient is now in excellent condition, reports about ten daily stools without any abdominal discomfort (see the whole document).
The reference teachings differ from the claimed invention only in the recitation that the patient has PDAI of 5 or greater, further comprising administering an antibiotic, wherein the antibiotic is discontinued by 4 weeks following the initial administration of the anti-α4β7 antibody in claim 19, wherein the antibiotic is ciprofloxacin in claim 40.
The teachings of NCT`138 have been discussed, supra.
Those of skilled in in the art would have has target the pouchitis diagnosed with mPDAI score of ≥5 because pouchitis by definition is a total mPDAI score of ≥5.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the VDZ antibody intravenously as taught by the NCT`138 , and further administer an antibiotic such as ciprofloxacin together with the VDZ and discontinue the antibiotic treatment after 4 weeks in the treatment of chronic pouchitis taught by Schmid et al because "[I]t is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). "[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
It is obvious to continue treatment with antibiotic along with the anti-α4β7 antibody in the chronic pouchitis treatment and to eliminate the antibiotic after one month after the initial anti-α4β7 antibody treatment since VDZ alone was effective to treat chronic pouchitis as taught by Schmid et al.
The claimed functional outcome are considered inherent properties because the reference teaches a same method, treating same patient with the same compound, same dose, same frequency, same rout of administration.
From the reference teachings, 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.
Applicant’s arguments, filed 10/06/2025, have been fully considered, but have not been found convincing.
Applicant submits that NCT02790138 is subject to the exception provided in AJA 35 U.S.C. § 102(b)(1)(A) and is therefore disqualified from being used in any rejections under 35 U.S.C. § 102(a)(1) or 35 U.S.C. § 103 for the same reasons set forth above.
This is not found persuasive simply because there was no evidence that the relied-upon disclosures in NCT `138 were made “by the inventor” to satisfy §102(b)(1)(A).
Applicant submits that Schmid et al. is a case study that describes “treatment of pouchitis with vedolizumab, but not fecal microbiota transfer (FMT), after proctocolectomy in ulcerative colitis” (see Title) for a single 54-year-old patient. Schmid et al. does not teach or suggest selecting a subject having a minimum endoscopic subscore of 2. Schmid et al. also does not teach or suggest administration of an antibiotic with vedolizumab, let alone ciprofloxacin for the first 4 weeks after the initial dose of vedolizumab.
However, given that Schmid the treatment of pouchitis with vedolizumab after proctocolectomy in UC, wherein the pouchitis is defined with mPDAI score ≥ 5 comprising endoscopic inflammation component has a minimum endoscopic subscore of 2 (See Shen et al. GASTROENTEROLOGY 2001;121:261–267).
Applicant submits that NCT02790138 is subject to the exception provided in AIA 35 U.S.C. §102(b)(1)(A) and is not available as prior art to the present claims. Moreover, Applicant reiterates that contrary to the Office’s allegation, NCT02790138 does not teach selecting a human subject that has a minimum endoscopic subscore of 2.
This is not found persuasive simply because there was no evidence that the relied-upon disclosures in NCT `138 were made “by the inventor” to satisfy §102(b)(1)(A). The referenced pouchitis in the NCT `138 is mPDAI score ≥ 5 comprising endoscopic inflammation component has a minimum endoscopic subscore of 2 (see Shen et al, above).
Applicant submits that one of ordinary skill would not arrive at the claimed invention for at least the reason that the cited art does not teach all of the elements of the claims (e.g., selecting a chronic pouchitis subject having a mPDAI of 5 or greater and a minimum endoscopic subscore of 2). Thus, without the benefit of Applicant’s specification, one of ordinary skill would not be able to predict that the claimed methods could achieve the defined remission of pouchitis 14 weeks following the initial dose of anti-a4B7 antibody in the subject selected for treatment.
It remains the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the VDZ antibody intravenously as taught by the NCT`138 , and further administer an antibiotic such as ciprofloxacin together with the VDZ and discontinue the antibiotic treatment after 4 weeks in the treatment of chronic pouchitis taught by Schmid et al because "[I]t is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). "Only if the 'results of optimizing a variable' are 'unexpectedly good' can a patent be obtained for the claimed critical range." In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618, 620 (CCPA 1977)). "[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
It is obvious to continue treatment with antibiotic along with the anti-α4β7 antibody in the chronic pouchitis treatment and to eliminate the antibiotic after one month after the initial anti-α4β7 antibody treatment since VDZ alone was effective to treat chronic pouchitis as taught by Schmid et al.
13. No claim is allowed.
14. 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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December 16, 2025
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644
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