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 .
Applicant's amendment and reply filed May 5, 2026 have been received and entered into the case. Claims 2 - 3, 19 - 21, 24 and 27 are canceled; claims 1, 4 - 6, 8 - 9, 14 - 18 and 22 - 23 are pending and have been considered on the merits. All arguments have been fully considered.
Claim Rejections - 35 USC § 112
Previous rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn due to the amendment cancelling “or preventing” from claim 1.
Previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn due to cancelation of "or preventing" in claim 1 thereby clarifying the treating population; and canceling claim 2.
Claim Interpretation
Claim 1 recites a method for treating celiac disease in a patient comprising administering an intestinal alkaline phosphatase (IAP), wherein the IAP “has the sequence of” SEQ ID NO:11. The phrase, “has the sequence of” is interpreted as open ended, "having" or "comprising" (see also applicant's specification at page 49, lines 15 - 20). Therefore, the claims are not limited to an IAP consisting of the SEQ ID NO:11; and do not exclude sequences with additional amino acids or terminal sequences.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102a1 as being anticipated by Bristol et al. (WO 2019/183208 IDS filed 09.25.2025, FPD #13; cited by US 2021/0030686) are withdrawn.
Applicant argues that Bristol does not teach the method wherein the subject is on a gluten free diet, or celiac disease that is non-responsive or refractory to a gluten free diet.
This argument is persuasive.
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.
Claims 1, 4 - 6, 8 - 9, 14 - 18 and 22 – 23 are rejected under 35 U.S.C. 103 as being unpatentable over Bristol et al. (WO 2019/183208 IDS filed 09.25.2025, FPD #13; cited by US 2021/0030686) in view of Perrow et al. (2018/0271932).
Regarding claim 1, Bristol teaches a method for treating celiac disease, the method comprising administering a composition comprising intestinal alkaline phosphatase (IAP) (abstract, 0232, p.23, claim 67). Bristol teaches the IAP is a bovine IAP (0027) having the amino acid sequence of SEQ ID NO:11 (See SEQ ID Result No.2, SEQ ID NO:5). Bristol does not specifically teach the patient is on a gluten free diet. However, Bristol specifically teaches treating subjects with celiac disease. At the time the claims were filed, it was well known in the art that celiac is triggered by gluten and that gluten free diets were a first line treatment. In support, Perrow teaches only treatment option for celiac disease patients is a life-long adherence to a gluten-free diet (0004). Thus, at the time the claims were filed, subjects with celiac disease would have also been adhering to gluten free diets as claimed.
Regarding claims 4 and 8 – 9, Bristol teaches patients with celiac disease have symptoms such as abdominal pain, bloating, diarrhea, nausea and fatigue (0249) which may be assessed by Celiac Disease Patient Reported Outcome (CeD PRO).
Regarding claims 5 – 6, although Bristol does not specifically teach the subject has low expression and/or activity of IAP in the mucosa by assaying a sample, Bristol teaches administering to subjects with celiac disease, which is associated with low IAP levels as disclosed by applicant (specification, page 1). Thus, the subjects of Bristol must also have low expression and/or activity of IAP in the mucosa, regardless of how the characterization was assessed.
Regarding claims 14 – 16, Bristol does not teach the method wherein the subject experiences the claimed number of bowel movements or loose stools as scored on the Bristol Form Scale (BSFS) prior to treatment. However, the claimed symptoms were well known common symptoms in subjects with celiac disease. In support, Perrow teaches subject are diagnosed with celiac disease when experiencing 3 – 10 bowel movement a day; 4 – 10 diarrhea or loose stools per day; or more than 3 loose stools with a score of 5 -7 based on BSFS (0038 – 0047). Thus, when treating subjects with diagnosed celiac disease, they would be experiencing the claimed symptoms prior to treatments.
Regarding claims 17 – 18, Bristol does not teach the method wherein the IAP is administered for about 9, 10 or 12 weeks or prior to meals. However, since the IAP is identified as the active component in the method, it is considered a result effective variable. As such, it would have been obvious to one of ordinary skill in the art to optimize the regimen, such as frequency and timing of administration, as a matter of routine practice and experimentation. Moreover, at the time the claims were filed, one of ordinary skill in the art would have been motivated by Bristol and routine practice to optimize the treatment regime of the method disclosed therein with a reasonable expectation for successfully treating celiac disease in a subject.
Regarding claims 22 – 23, the IAP is administered orally (0103) with enteric coating to release into the GI tract (0130).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues that the combination of Bristol and Perrow does not teach the claimed method of administering an IAP having SEQ ID NO: 11 to a subject that is on a gluten free diet, or has celiac disease that is non-responsive or refractory to a gluten free diet; and that the sequence of Bristol has additional N and C terminal sequences not included in SEQ ID NO:11; and Perrow does not teach treating celiac disease with IAP.
However, these arguments fail to persuade.
Bristol specifically teaches administering an IAP “having,” or comprising, SEQ ID NO:11 to patients with celiac disease, while Perrow evidences that these patients practice gluten free diets as a first line treatment. Thus, it is maintained that at the time the claims were filed, subjects with celiac disease would have also been adhering to gluten free diets as claimed.
Regarding the argument that the claimed sequence is shorter than that of the prior art (e.g. does not contain a leader sequence), it is noted that the claims recite that the IAP "has the sequence of" SEQ ID NO:11 which is interpreted as open ended, "having" or "comprising" (see also applicant's specification at page 49, lines 15 - 20). In this regard, the claims do not exclude sequences with terminal sequences and the argument is not commensurate in scope with the claimed invention. Notwithstanding, Bristol teaches the IAP may be bovine, specifically bIAP II or any variant thereof provided that the variant retains at least 80% phosphatase activity, e.g., with a stop codon (0040 - 0044). In this regard, when following the teachings of Bristol, one of ordinary skill in the art would have been motivated to administer variants of the bIAP II provided that the retain the intended activity as directed.
Regarding Perrow, the reference is relied upon to evidence that gluten free diets are a first line treatment. Moreover, the rejection is based on the combination of Bristol and Perrow and not Perrow alone. Note that 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).
Therefore, the claims remain rejected.
No claims are allowed.
Conclusion
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 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.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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