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 .
FOREIGN APPLICATIONS
CHINA 202310930472.6 07/27/2023
Applicant's election with traverse of Group III, claims 1-3, in the reply filed on September 10, 2026 is acknowledged. The traversal is on the ground(s) that the examiner has not demonstrated a serious search and/or examination burden. This is not found persuasive because the inventions are classified separately, showing that each invention has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search. MPEP 808.02.
The requirement is still deemed proper and is therefore made FINAL.
Claims 4-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 10, 2026. Applicant is reminded that when an elected product claim is found allowable, withdrawn claims that include all the limitations of the allowable product claim will be considered for rejoinder.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a preparation comprising LNFP-1 and/or 2’-FL, or the combination of LNFP-1 and 2’-FL, or the combination wherein the ratio of LNFP-1 and 2’-FL is 1: (1-3). Human milk contains LNFP-1 and 2’-FL in a ratio of 1: (1-3), as evidenced by Wang (J. Agric. Food Chem. 2022, 70, 6328-6353). See Table 1, which explains that 2’-FL has 20.50% abundance in human milk and LNFP-I has 7.50% abundance in human milk, for a ratio of about 2.7. Table 3 explains that 2’-FL in human milk reduces allergy, so the functional limitation “with an allergy-alleviating function” is also present in the natural product.
This judicial exception is not integrated into a practical application because the claims are drawn to the product itself and not an application of it. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional elements are recited besides the product of nature.
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (J. Agric. Food Chem. 2022, 70, 6328-6353).
Wang teaches that 2’-FL and LNFP-I are present in human milk. See Table 1, which explains that 2’-FL has 20.50% abundance in human milk and LNFP-I has 7.50% abundance in human milk, for a ratio of about 2.7. Table 3 explains that 2’-FL in human milk reduces allergy, so the functional limitation “with an allergy-alleviating function” is present in the product.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jennewen (WO 2019/110800 A1).
Jennewen teaches an infant formula which contains 2.5 g/L of 2’-FL and 1.0 g/L of LNFPI, which is a ratio of 2.5. Page 21, Table 6. Jennewen also teaches that HMOs reduce the risk of developing allergies. Page 3, lines 1-10.
Jennewen’s composition inherently has an allergy-alleviating function because the current specification exemplifies a concentration of 2.5 mg/ml 2’-FL and Jennewen’s composition meets the exemplified concentration. It is noted that the current specification does not define an effective amount or concentration of compounds for allergy-alleviating function.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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