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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 21, 2023, June 23, 2025 and September 25, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 6, 8 – 9, 14 – 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating celiac disease, does not reasonably provide enablement for preventing celiac disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
“Prevention” provides the expectation that the disorder/condition does not occur in response to a challenge or initiating event. While there is no requirement that prevention must be absolute in all cases, there is a reasonable expectation that some element of prevention can be shown. The standard for such is extremely high, and it is expected that the showing will be actual rather than implied, prophetic, or with a model. The standard of enablement is higher for such inventions because effective preventions of disease conditions are relatively rare and may even be unbelievable in the absence of strong supporting evidence.
The analysis of whether a claim is supported by the disclosure requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the art to make and use the claimed invention. The standards for determining whether this burden has been met, is by posing the question: is the experimentation needed to practice the invention undue or unreasonable? While a patent need not teach what is well known in the art, it must teach one in the art how to make and/use the claimed invention without undue experimentation. There are many factors to be considered when determining whether the disclosure satisfies the enablement requirement. These factors include but are not limited to the breadth of the claims; the nature of the invention; the state of the prior art; the level of one of ordinary skill in the art; the level of predictability in the art; the amount of direction provided by the inventor; the existence of working examples; and the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claims include a method for preventing celiac disease in a patient in need thereof comprising administering intestinal alkaline phosphatase (IAP). Celiac disease is an autoimmune disorder that occurs only in individuals with specific genes. The prior art recognizes that while not every individual with these genes will develop celiac disease, there are specific triggers and risk factors that contribute to its development. These include exposure to gluten, infection by certain microorganisms, changes in gut microbiome and other unknown environmental factors (see Richards, 2024). The prior art recognizes avoiding gluten as the primary treatment and also that it is near impossible to avoid gluten 100% of one’s dietary life. The prior art also recognizes that whether preventing celiac disease can be accomplished is unclear (Richards). Examples of ongoing possibilities include manipulating gut bacteria, vaccinations, altering immune system or exposure to gluten within the first year of life (Richards). In this regard, the state of the art is unclear and without predictability. The instant application fails to exemplify any successful prevention of celiac disease. Instead, the specification merely proposes a model for one to follow amounting to nothing more than provide a study population, administer IAP, challenge the population with a gluten free or standard diet. No consideration is given to any other event or exposure that may trigger celiac disease in a gene carrying subject or population. Moreover, the specification fails to provide any guidance for preventing celiac disease beyond administering IAP, resulting in a significant quantity of undue experimentation to practice the method based on the content of the disclosure.
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.
Claims 1 – 6, 8 – 9 and 14 – 24 are 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 1 and its dependents are drawn to a method of preventing or treating celiac disease, however are rendered indefinite for reciting “a patient in need thereof” as the specification fails to define a patient in need of preventing celiac disease. For purposes of examination, the phrase will be interpreted to encompass any subject since the method encompasses preventing celiac disease.
In claim 2, the recitation of “including” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 4 – 6, 8 – 9, 19 – 24 and 27 are rejected 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).
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).
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 claim 19, Bristol teaches the IAP may be human or calf/bovine (0027, claim 52).
Regarding claims 20 – 21 and 24, the IAP comprises an amino acid sequence matching 100% to SEQ ID NO:11 (See SEQ ID Result No.2, SEQ ID NO:5) and SEQ ID NO:2 (See SEQ ID result No.10, SEQ ID NO:2).
Regarding claims 22 – 23, the IAP is administered orally (0103) with enteric coating to release into the GI tract (0130).
Regarding claim 27, Bristol teaches the method for treating celiac disease (abstract, 0232, p.23, claims 67) comprising administering a bovine IAP (0027) having the amino acid sequence of SEQ ID NO:11 (See SEQ ID Result No.2, SEQ ID NO:5), which is formulated for GI release (0130).
The reference anticipates the claimed subject matter.
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 – 3, 14 – 18 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).
Regarding claim 2, 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 limited to unintentional exposure to gluten as claimed.
Regarding claim 3, Bristol does not teach the method wherein the subject has nonresponsive or refractory celiac disease. However, at the time the claims were filed, it was known in the art that patient with non-responsive or refractory celiac disease may undergo an adjunct therapy (See Perrow, 0031 in support). Thus, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to consider the methods of Bristol with refractory celiac subjects as a matter of routine experimentation and practice.
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.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUTH A DAVIS/Primary Examiner, Art Unit 1699