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 .
Election/Restrictions
Applicant's election with traverse of Group II, claim 7 and the species: a mixture of two enzymes 1) an enzyme sharing at least 95% identity to SEQ ID NO: 1; and 2) an enzyme sharing at least 95% identity to SEQ ID NO: 2 in the reply filed on February 9, 2026 is acknowledged. The traversal is on the ground(s) that the elected composition is not taught in the prior art and therefore constitutes a composition with a special technical feature. This is not found persuasive because in light of the rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1 – 6 are canceled; claims 22 – 27 are added; claims 7, 9 – 27 are pending; claims 10 – 25 and 27 are withdrawn as being drawn to non-elected subject matter; claims 7, 9 and 26 have been considered on the merits insofar as they read on the elected species.
Claim Interpretation
The claims are drawn to a composition comprising a plurality of protease from Aspergillus. The claims recite sequences for the various proteases, however no function or activity is specified. In this regard, the claims do not present any particular function or activity beyond being proteolytic. Looking to applicant’s specification, the sequences are not specifically defined by activity or function. In paragraph 0008 of the published application, the specification appears to identify three types of enzymes in the mixture. Specifically:
Fungal Protease A (a 42 kDa protease with exo- and endo-protease activity obtained from A. oryzae, CAS No. 9025-49-4, (EC) No. 3.4.23.18);
Fungal Protease AM (a 34 kDA protease with peptidase activity obtained from A. melleus, CAS No. 9074-07-1, EC No. 3.4.11.-); and
Fungal Protease A2 (neutral protease obtained from A. oryzae; CAS No. 9025-49-4, EC No. 3.4.24.-).
Initially, both the Fungal Protease A and Fungal Protease AM refer to the same CAS number, making it unclear how the enzymes are different and whether the specification recites a critical error in terms of the listed enzymes. The enzymes are additionally identified by their respective E.C. numbers and are interpreted as:
1) Fungal Protease A, a 42 kDa protease with exo- and endo-protease activity obtained from A. oryzae, (EC) No. 3.4.23.18, or aspergillopepsin I;
2) Fungal Protease AM, a 34 kDA protease with peptidase activity obtained from A. melleus, EC No. 3.4.11.-) or aminopeptidase; and
3) Fungal Protease A2, a neutral protease obtained from A. oryzae, EC No. 3.4.24.-, or metalloproteinase.
Critically, the specification fails to correlate the claimed protease sequences to any particular activity making it impossible to determine the full scope of the claimed invention. The specification refers to the three proteases identified above in figures 1 – 3, as well as various trademarked enzyme mixtures, OPTIZIOME™, P3 HYDROLYZER™, Minogen™, ProHydrolase™ in figures 4 – 18; yet fails to correlate any of these compositions to the claimed invention. In paragraphs 0048 - 0054 of the published application, the specification recites various combinations of the aforementioned enzymes in combination with SEQ ID NO:1 and/or SEQ ID NO: 2, however there is no further disclosure regarding function or activity of the claimed sequences themselves.
For purposes of examination, the claims are interpreted to comprise two proteolytic enzymes from Aspergillus, wherein they “may be used as ingredients in dietary supplements, protein powders, or foods to promote protein digestion, to promote post-prandial plasma amino acid levels,” “to produce a hydrolysate containing free EAAs and free BCAAs,” “to produce a hydrolysate that is more easily digested, more easily absorbed, or both, by the gastrointestinal system of a human or animal,” “produce a hydrolysate that has improved flavor and/or mouthfeel compared to a hydrolysate prepared using currently available enzymes that often produce bitter and/or chalky hydrolysates,” and are “stable and maintain activity over a broad range of temperatures and pH levels, providing additional options for commercial and industrial applications” (paragraphs 0007 of the published application).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7, 9 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Gregory et al. (WO 2019/060851, IDS 07.25.2025 FPD #2, cited by US 2020/0291375) as evidenced by Result 1 SEQ ID NO:1.
Regarding claims 7 and 26, Gregory teaches fungal protease compositions comprising mixtures of Aspergillus proteases (abstract), wherein the enzymes include Aspergillopepsin-1 (00087) (100% identity to SEQ ID NO:1, per Result 1 SEQ ID NO:1), aminopeptidase (claim 6) and alpha-amylase (metalloproteinase) activity (claims 1 – 7). Although the reference does not teach the enzymes having SEQ ID NO:2, it would have been obvious to one of ordinary skill in the art to use enzymes with the same activity as a simple substitution of one known element for another (e.g., enzymes having the same function and activity) to obtain predictable results, such as use in dietary supplements, protein powders (0108), producing a hydrolysate containing free EAAs and free BCAAs (0005), improved flavor and/or mouthfeel compared to a hydrolysate prepared using currently available enzymes that often produce bitter and/or chalky hydrolysates, stable and maintained activity over a broad range of temperatures and pH levels that provided additional options for commercial and industrial applications (0004) as well as increased digestion of protein and amino acids (0004), each of which is attributed to the claimed invention (0007 of the published application).
Regarding claim 9, the compositions may be dehydrated, powdered, granular or freeze dried form (claim 5).
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).
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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.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699
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