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 remarks filed on 11/13/2025 are acknowledged. Claim 96 is amended. Claims 1-3, 6, 10-12, 43, 57, 202-203, 210, and 222 are cancelled. New claims 267-279 are added. Claims 85, 91, 95-96, 104-105, 126, and 267-279 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II and microbiome-modulating therapy in the reply filed on 11/13/2025 is acknowledged. Claims 85, 91, 95-96, 104-105, 126, and 267-279 are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 4/10/2023, 2/12/2024, 6/5/2024, 8/16/2024, 8/6/2025, 8/25/2025, and 9/23/2025 have been considered. Signed copies are enclosed.
Claim Objections
Claims 85, 105, 267, 272, and 274 are objected to because of the following informalities: the claims contain the acronyms OTU and CFU. While acronyms are permissible shorthand in the claims, the first recitation of the term should include the full recitation followed by the acronym in parentheses. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 85, 91, 95-96, 104-105, 126, and 267-279 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are drawn to methods of treating food allergy in subjects by administering a therapy wherein the subject was determined to have a decreased OTU abundance score relative to a control sample wherein the OTU abundance score was calculated using at least 20 of the OTUs of Table 1.
The specification lists 64 OTUs in Table 1. Each includes a number or filename and some taxonomical information. For many of the OTUs, no genus or species names are provided and information is only provided to the family level. These OTUs do not correspond to information found in the art and no further information about these units is provided in the specification. Therefore, there is no description in the specification of what constitutes a member of a given OTU or how do determine such information. There is no description provided on how to practice the method without this information.
Therefore, the claims do not meet the written description requirements of 35 USC 112a.
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 85, 91, 95-96, 104-105, 126, and 267-279 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 pre-AIA the applicant regards as the invention.
Claims 85 and 267 are indefinite because they refer to a Table in the specification. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Furthermore, the information provided in Table 1 does not actually provide enough information to determine what species or strains are part of a given OTU.
Claim 267 is indefinite because it is dependent on a cancelled claim.
Claim 269 is indefinite because it is not clear how one could treat an allergy that the subject does not have.
Claims 275 and 276 are indefinite because it is not clear what measure is used to determine the percentage of bacteria. For example, the percentage could be determined based on weight, number of cells, number of species, and it is not clear which of these (or any other) measure is to be used.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 268 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim requires the subject to have a food allergy. However, the parent claim is drawn to a method of treating a food allergy in the subject. Therefore, in the parent claim, the subject must have a food allergy and the dependent claim does not further limit the parent. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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, Vanessa Ford can be reached at 571-272-0857. 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.
/BRIAN GANGLE/Primary Examiner, Art Unit 1645