DETAILED ACTION
Notice of 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 .
Status of Application
Claims 1-11 are pending and subject to examination on the merits.
Priority
The instant application is a 371 of PCT/JP2023/014863 filed 12 April 2023 which claims benefit of foreign priority document JP 2022-066572 filed 13 April 2022 is acknowledged. Said document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 29 April 2026 and 10 October 2024 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without additional elements that integrate the judicial exception into a practical application. An analysis with respect to the claims as a whole reveals that they do not include additional elements that integrate the judicial exception into a practical application. See MPEP 2106.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
Step (1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
Step (Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
Step (Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
Step (2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG)).
Step 1: Yes; the claims are directed to a composition of matter.
Step 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring product/protein, naturally occurring polynucleotide encoding the protein and cell comprising either or both.
Step 2A – Prong 2: No, the claims do not recite any additional elements that integrate the judicial exception into a practical application because the claims appear to be merely drawn to what already exists in nature. The lipase of SEQ ID NO: 14 is termed “KAL-A” throughout the specification. It does not appear that anything has been done to a pre-existing lipase to make instant SEQ ID NO: 14. Rather it appears said lipase has been isolated and “found” from a naturally occurring source (See paragraph 0023 of PG-Pub). As such, there is nothing in the claims which differentiates this naturally occurring enzyme in terms of structure and/or function. Thus, there is ultimately nothing in the claims which integrates the judicial exception into a practical application. This holds true for the polynucleotide encoding the lipase, which would be a naturally occurring polynucleotide or DNA fragment comprising said polynucleotide (claims 2-3). The cell “transformed” with the lipase does not differentiate the naturally occurring cells which produce said lipase (claims 4-5). In addition, the claimed cleaning composition(s) comprising said lipase are merely an intended use and is recited at such a high level of generality that there is nothing in said cleaning compositions to transform the claimed lipase into something different that which naturally occurs (claims 6-10).
Step 2B: As noted in answering that of 2A – Prong 2 above, there is nothing in the claims which amounts to significantly more in terms of structure and/or function and the claims read on naturally occurring enzymes. Thus, the claims are drawn to a judicial exception, namely, a naturally occurring product.
Conclusion
Claims 1-10 are rejected.
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 26 June 2026
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