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 .
Applicants’ amendment to the claims filed on 10/11/2024 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-3, 5-15, 20-22, 25, 27-28 are pending.
Claims 4, 16-19, 23-24, 26, 29 are canceled.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-3, 5-14 are drawn to the technical feature of an enzyme mixture comprising a plurality of fungal enzymes from members of the genus Aspergillus and Candida, wherein the plurality of fungal enzymes comprises: (a) a protease obtained from A. oryzae, (b) a protease obtained from A. niger, (c) a protease obtained from A. melleus, (d) a lipase obtained from C. rylindracea or a lipase obtained from R. oryzae, (e) an amylase obtained from A. oryzae, and (f) a glucoamylase obtained from A. niger, wherein the enzyme mixture has exopeptidase, endopeptidase, lipase, alpha-amylase, and glucoamylase activities, classified in A61K38/488.
Group II, claims 15, 20-22, 25, 27-28 are drawn to the technical feature of a method for increasing protein digestion, fat digestion, carbohydrate digestion, absorption of amino acids, absorption of fatty acids, absorption of glucose, and/or absorption of iron: for decreasing the maximum plasma concentration of glucose: for lessening the frequency, duration, and/or severity of gastrointestinal symptoms including burping, cramping, distension, flatulence, nausea, reflux, borborygmus, and/or diarrhea: for improving bowel function by improving stool frequency, stool consistency, and/or ease of stool passage; or for improving sleep quality, comprising administering the enzyme mixture of claim 1, or a dietary supplement comprising the enzyme mixture of claim 1, to a subject at least once per day, classified in C12Y301/01003.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical feature for the following reasons:
The inventions of Groups I-II lack unity because even though the inventions of these groups require the technical feature of an enzyme mixture comprising a plurality of fungal enzymes from members of the genus Aspergillus and Candida, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Schuler et al (US 8,071,089 B2, Date of Patent: Dec. 6, 2011, Examiner cited) {herein Schuler}.
Schuler teaches an enzyme mixture comprising a plurality of fungal enzymes from members of the genus Aspergillus and Candida (column 2, lines 45-47).
As such, the shared same or corresponding technical feature among Groups I, II are not a contribution of the prior art.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Notice of Potential Rejoinder
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Election/Restrictions
During a phone call on 2/10/2026, Applicant’s Attorney, Alexander Spiegler, Reg # 56,625 elected with traverse the invention of Group I, claims 1-3, 5-14 .
Claims 4, 16-19, 23-24, 26, 29 are canceled.
Claims 1-3, 5-15, 20-22, 25, 27-28 are pending.
Claims 15, 20-22, 25, 27-28 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-3, 5-14 are pending and examined on the merits.
Priority
Acknowledgement is made of this national stage entry of PCT/US2022/042501 filed on 9/2/2022, which claims domestic priority to U.S. provisional application 63/240,255, filed on 9/2/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/4/2024 and 12/24/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 3/4/2024 are acknowledged and accepted by the examiner.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-10k, 12-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is a naturally occurring microorganism.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is drawn to a composition of matter, which is one of the four statutory categories.
Step 2, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim is directed to a natural phenomenon (product of nature). Said natural phenomenon is a composition of fungal enzymes from Aspergillus and Candida.
Claims 1-3, 5-10, 12-13 are directed towards an enzyme mixture comprising a plurality of fungal enzymes from members of the genus Aspergillus and Candida, wherein the plurality of fungal enzymes comprises: (a) a protease obtained from A. oryzae, (b) a protease obtained from A. niger, (c) a protease obtained from A. melleus, (d) a lipase obtained from C. rylindracea or a lipase obtained from R. oryzae, (e) an amylase obtained from A. oryzae, and (f) a glucoamylase obtained from A. niger, wherein the enzyme mixture has exopeptidase, endopeptidase, lipase, alpha-amylase, and glucoamylase activities. ‘a plurality of fungal enzymes from members of the genus Aspergillus and Candida’ is interpreted as a mixture of naturally occurring microbes that are cultured in the same environment. There is no indication in the specification that the claimed mixture of fungi and their enzymes has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring fungi. Thus, the mixture does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception.
Step 2, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 1 includes the additional elements of the plurality of fungal enzymes comprises: (a) a protease obtained from A. oryzae, (b) a protease obtained from A. niger, (c) a protease obtained from A. melleus, (d) a lipase obtained from C. rylindracea or a lipase obtained from R. oryzae, (e) an amylase obtained from A. oryzae, and (f) a glucoamylase obtained from A. niger, wherein the enzyme mixture has exopeptidase, endopeptidase, lipase, alpha-amylase, and glucoamylase activities. Such a limitation is native to the fungi. Therefore, it does not integrate the judicial exception into a practical application as they are all naturally occurring. Additionally, the enzyme mixture of claim 1 (instant application claim 12) and at least one additional enzyme comprising: a lactase; an alpha-galactosidase; a beta-fructofuranosidase; a cellulase; papain; and/or bromelain (instant application claim 13) do not integrate the judicial exception into a practical application as the recited enzymes are all naturally occurring. Supporting the Examiner’s position is the reference of Andrade et al (2025, Springer, Examiner cited) which is cited to demonstrate that
Aspergillus and Candida are ubiquitous fungi that are isolated together in coastal ecosystems such as southern Brazil (abstract). Absent evidence otherwise, it is the Examiner’s position that since Aspergillus and Candida are derived from the same environment, then said microbes, and the enzymes they produce, are naturally occurring together within said environment. Furthermore, it is the Examiner’s position that a plurality of fungal enzymes comprising a protease obtained from A. oryzae, a protease obtained from A. niger, a protease obtained from A. melleus, a lipase obtained from C. rylindracea , an amylase obtained from A. oryzae, and a glucoamylase obtained from A. niger would necessarily be present within the same environment as they are naturally occurring and unchanged enzymes derived from Aspergillus and Candida. Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The judicial exception is recited without additional limitations amounting to significantly more than the exception. All of the signified additional elements to the judicial exception are considered to be native to the fungi on which the judicial exception is to be performed as noted in Step 2A, Prong 2, and, therefore, do not amount to significantly more than the judicial exception that is claimed because the claim does not include any additional features that could add significantly more to the exception.
In reference to claim 1 of Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948), which recites ‘an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific,’ the inoculant of claim 1 was held to be ineligible subject matter.
Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.
Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.” Myriad, 133 S. Ct. at 2117.
In this regard, as the instant claims recites judicial exceptions that are not integrated into practical application, and no elements that amount to significantly more than the judicial exception as recited, the claims were found not to be drawn to eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Schuler et al (US 8,071,089 B2, Date of Patent: Dec. 6, 2011, Examiner cited) {herein Schuler} in view of Gregory et al (WO 2019060851 A1, Date of Publication: 28 March 2019, Examiner cited) {herein Gregory}.
Claims 1-3, 5-11 are drawn to an enzyme mixture comprising a plurality of fungal enzymes from members of the genus Aspergillus and Candida, wherein the plurality of fungal enzymes comprises: (a) a protease obtained from A. oryzae, (b) a protease obtained from A. niger, (c) a protease obtained from A. melleus, (d) a lipase obtained from C. rylindracea or a lipase obtained from R. oryzae, (e) an amylase obtained from A. oryzae, and (f) a glucoamylase obtained from A. niger, wherein the enzyme mixture has exopeptidase, endopeptidase, lipase, alpha-amylase, and glucoamylase activities.
Claims 12-14 are drawn to a dietary supplement comprising the enzyme mixture of claim 1.
With respect to claims 1, 11 - 14, Schuler teaches an enzyme mixture comprising a plurality of fungal enzymes from members of the genus Aspergillus and Candida (column 2, lines 45-47). Said fungal enzymes are: Aspergillus niger protease (column 2, lines 53-54), Aspergillus melleus protease (column 2, line 19), Aspergillus oryzae amylase (column 2, lines 20), Candida cylindracea lipase (column 2, lines 46-47), Aspergillus niger amyloglucosidase (same as glucoamylase) (column 2, lines 54-55). Since Schuler teaches the structure of an enzyme mixture comprising a plurality of fungal enzymes from members of the genus Aspergillus and Candida, absent evidence otherwise, it is the Examiner’s position that said composition would necessarily comprise an exopeptidase, endopeptidase, lipase, alpha-amylase, and glucoamylase activities. Said composition is an improved supplement to aid in digestion (column 2, lines 35-37). Absent evidence otherwise, it is the Examiner’s position that said composition is a dietary supplement as it improves digestive health in patients with cystic fibrosis (column 2, lines 35-37). Said composition is in capsule or tablet form (column 9, line 22). Absent evidence otherwise, it is the Examiner’s position that said composition is granular, dehydrated and powder as it is known by those of ordinary skill in the art that capsules and tablets are comprised on materials that are in a granular, dehydrated and powder form.
With respect to claims 6-9, 10, Schuler teaches an enzyme composition comprised of Candida cylindracea lipase 1 (Schuler column 10, line 16), a protease from Aspergillus melleus (column 2, lines 19) and A. niger G1 glucoamylase (same as amyloglucosidase) (Schuler column 9, lines 35). Absent evidence otherwise, it is the Examiner position that said enzymes have at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% full-length sequence identity to SEQ ID NO: 5 - Candida cylindracea lipase 1 (Schuler column 10, line 16), SEQ ID NO: 7 - a protease from Aspergillus melleus and SEQ ID NO: 6 - A. niger G1 glucoamylase (same as amyloglucosidase) (Schuler column 9, lines 35) since said recited sequences are not modified.
However, Schuler does not teach a protease obtained from Aspergillus oryzae (claim 1). Schuler does not teach the enzyme concentrations of claims 2 and 3. Schuler does not teach the enzyme mixture of claim 1, wherein the ratio of the 3 fungal proteases : lipase : amylase : glucoamylase is: a) 3600: 120 : 400: 1; or b) 1800-5400 : 30-180 : 200-600 : 0.5-1.5; as measured in hemoglobin unit tyrosine base units (HUT): Federation Internationale Pharmaceutique units (FIP): Sandstedt, Kneen, and Blish method units (SKB): Amyloglucosidase units (AGU) (claim 5). Schulaer does not teach wherein the enzyme mixture comprises at least four, five, six, or seven of SEQ ID NOs: 1, 2, 3, 4 (claim 6). Schuler does not teach wherein the enzyme mixture comprises SEQ ID NOs: 1, 2,3, 4 (claim 7). Schuler does not teach wherein the enzyme mixture comprises SEQ ID NOs: 1, 2, 3, 4 (claim 8). Schuler does not teach wherein the enzyme mixture comprises SEQ ID NOs: 1, 2, and 4 (claim 9).
With respect to claim 1, Gregory teaches a fungal protease composition comprised of mixtures of Aspergillus proteases (abstract). Said composition is comprised of fungal protease from A. oryzae (para 0084), amylase from A. oryzae (para 0084). Furthermore, said composition comprises Aspergillopepsin-1, an aspartic endopeptidase produced by A. oryzae (para 0087). Said composition has endopeptidase (para 0087) and alpha-amylase activities (para 0098).
With respect to claims 2-3, Gregory teaches the amounts or ratios of enzymes may be varied to produce a mixture having enhanced or reduced activity levels (para 0086). Although the references of Schuler in view of Gregory do not explicitly teach the limitations of claims 2-3 (fungal enzyme concentrations), MPEP 2144.05 states"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the fungal enzyme concentrations depending on the particular application. It would be routine for one to arrive at the fungal enzyme concentrations for the application they intend on using the enzyme mixture. Therefore, the above invention would have been prima facie obvious.
With respect to claim 5, although the references of Schuler in view of Gregory do not explicitly teach the limitations of claim 5 (ratio of fungal proteases), MPEP 2144.05 states"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the fungal proteases ratios depending on the particular application. It would be routine for one to arrive at the fungal protease ratios for the application they intend on using the enzyme mixture. Therefore, the above invention would have been prima facie obvious.
With respect to claim 6, 8, 10, Gregory teaches a fungal enzyme composition comprised of Aspergillus oryzae protease sequence (para 0084), A. niger aspergillopepsin I polypeptide (para 0087), - Aspergillus melleus leucine aminopeptidase 1 (para 0021), Aspergillus oryzae alpha amylase (para 0084). Absent evidence otherwise, it is the Examiner’s position that said fungal enzymes have at least 90, 91, 92, 93, 94, 95, 96, 97, 98 or 99% full-length sequence identity to the recited SEQ ID NO: 1 - Aspergillus oryzae protease sequence (Gregory (para 0084), SEQ ID NO: 2 - A. niger aspergillopepsin I polypeptide Gregory (para 0087), SEQ ID NO: 3 - Aspergillus melleus leucine aminopeptidase 1 Gregory (para 0021)
SEQ ID NO: 4 - Aspergillus oryzae alpha amylase Gregory (para 0084) since said sequences are unmodified.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Schuler et al of an enzyme mixture comprising a plurality of fungal enzymes from members of the genus Aspergillus and Candida (column 2, lines 45-47) or combine the teachings of Gregory et al of a fungal protease composition comprised of mixtures of Aspergillus proteases (abstract).
One of ordinary skill in the art would be motivated to either use the teachings of Schuler et al. by itself or combine the teachings of Gregory because Gregory provides the motivation for Schuler to add a protease obtained from A. oryzae because Gregory teaches said protease produces a protein hydrolysate enriched in essential amino acids and/or branched chain amino acids, and may also possess additional beneficial properties (para 0077). One of ordinary skill in the art knowing the benefit of fungal enzymes based on the teachings of Schuler and Gregory would have a reasonable expectation of success to combine A. oryzae protease, taught by Gregory, with the fungal enzyme composition taught by Schuler as Schuler teaches A. oryzae protease can be added to dietary supplements without the need for supplementation with additional essential amino acids or branched chain amino acids from another source (para 0077).
One of skill in the art would have a reasonable expectation of success to make and use the claimed fungal enzyme composition because Schuler provides the basic fungal enzyme composition and its uses and methods of making it. Reference of Gregory provides the teachings of a fungal protease composition comprised of mixtures of Aspergillus proteases (abstract). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Status of the Claims
Claims 4, 16-19, 23-24, 26, 29 are canceled.
Claims 1-3, 5-14 are pending.
Claims 15, 20-22, 25, 27-28 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-3, 5-14 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656