DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on November 12, 2025. Claims 1 and 11 have been amended. Claims 1-20 have been examined and are currently pending.
Examiner’s note: The examiner reached out to the applicant’s representative, Tyler Anne Giglio several times and was not able to connect to facilitate moving the case forward.
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 .
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 1-20 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 11 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 1 and 11 recite the limitation, “…determining a threshold level of the nutritional input that indicates a shift on the immune profile;” which is not supported by the applicant’s specification. The applicant’s specification discloses, “…In such an example, immune machine-learning model 136 may determine the effect of nutritional input 132 on PPAR expression and determine at what threshold level of PPAR the immune category 120 shifts. Achieving a shift may include eliminating some nutritional elements from nutritional input 132. Those nutritional elements may be identified in elimination plan 128.” in paragraph 0050 of the applicant’s originally-filed specification. Paragraph 0050 discloses the determining the threshold level of PPAR in which the immune category shifts. It appears that if the limitation was amended to recite, “…determining a threshold level of the nutritional input that indicates a shift on the immune [category] of the biomarker;” it would address the rejection. Additionally, it would be helpful to highlight the differences between the terms, “immune category” and “immune profile” in the independent claims.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
calculating, using the generated immune machine-learning model, an effect of the nutritional input on the immune profile, wherein calculating the effect of the nutritional input further comprises determining a threshold level of the nutritional input that indicates a shift on the immune profile;
Response to Arguments
Objections to claims 1 and 11 have been withdrawn.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable have been withdrawn.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3682
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