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 A, claims 1-3 in the reply filed on August 24th, 2026 is acknowledged. The traversal is on the ground that, accor. The applicant also alleges that claims 12 and 13 are method claims depending from claim 1. This is not found persuasive because the applicant merely alleges no undue burden on the examiner without support and because the claims withdrawn are drawn to different co. The elected composition is drawn to a species identified within claims 2 and 3. Furthermore, instant claims 12 and 13 are not recited as method claims; they are recited as use claims. Claims 12 and 13 were not included in Group A as recited in the election requirement and were not recited as generic claims in the election requirement. Currently claims 12 and 13 are use claims that would need to be amended to recite a process, machine, manufacture, or composition of matter to conform to U.S. practice for claim presentation (35 U.S.C. 101). Currently claims 1-3 are drawn to the elected species composition. Claims 12 and 13 are withdrawn, being drawn to non-elected non-statutory subject matter. Claims 4-7, 10, withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim.
Claims 1-3 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is November 26th, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed August 19th, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because non-patent literature documents 1 and 2 are incorrectly cited. This IDS recites "PCT/2022/133213" where it should recite "PCT/CN2022/133213". It has been placed in the application file, but the information referred to therein for the lined-through documents has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement (IDS) submitted on May 9th, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement filed April 23rd, 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because there are no copies of non-patent literature documents 1 and 2. It has been placed in the application file, but the information referred to therein for the lined-through documents has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
The information disclosure statement filed April 23rd, 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the applicant has not provided a copy of non-patent literature document 1, and because non-patent literature document 2 is a duplicate citation of the same document cited as non-patent literature document 2 on the IDS received on May 9th, 2025. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings were received on May 20th, 2024. These drawings are acceptable.
Specification
The use of the term NHU, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The applicant’s assistance is requested in correctly reciting any trademarks or tradenames they encounter in the instant disclosure, even if not explicitly pointed out by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites the phrase “dry mass weight”; it is not clear whether this phrase refers to the property of dry mass or the property of dry weight, because mass and weight are formally distinct physical properties.
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 1-3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for making a composition comprising yeast proteins and yeast carbohydrates from Saccharomyces cerevisiae, does not reasonably provide enablement for making a composition comprising 5-30% zymosan (by dry mass) in the composition under any reasonable interpretation of the term "zymosan". The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a composition comprising a yeast protein and zymosan, wherein the yeast protein is coated by the zymosan, which together form a shape of a sphere or an ellipsoid, and wherein when calculated by dry mass, the composition comprises more than 70% yeast protein and 5-30% of zymosan. Thus, the claims taken together with the specification imply that zymosan is a term known in the art, having a consistent meaning among those skilled in the art; so persons of skill in the art would have a consistent interpretation of a compositional limitation of 5-30% zymosan by dry mass.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Hoemann and Sun (WO 2011060553 A1) recites "Zymosan is a yeast ghost structure that is composed of chitin, the GlcNA parent molecule of chitosan, along with mannan polysaccharide, and residual yeast proteins and lipids" (paragraph [00120]).
Jiang et al. (CN 103417967 A) recites "yeast polysaccharide (zymosan) is a macromolecular polysaccharide composite extracted from yeast cell wall, composed of proteins and carbohydrates" (paragraph [0012]).
Sigma (ZYMOSAN A from Saccharomyces cerevisiae Sigma product number Z4250, 1998; non-patent literature document 2 on the IDS received on May 9th, 2025) recites "Zymosan is a polysaccharide prepared from the cell wall of Saccharomyces cerevisiae (bakers' yeast) by a procedure modified from that first reported by Pillemer and Ecker. 1 Zymosan is a light grey-to beige powder, insoluble in water but dispersible in aqueous systems to give a fine suspension. It is defined physically as a hemicellulosic derivative, primarily a glucose polymer. 1,4 Zymosan consists of "ghost cells", and the average diameter of zymosan particles is about 3 µm (compared to the average diameter of yeast cells, 6 µm). 2" (page 1, General Remarks, paragraph 1). Sigma does not recite zymosan comprising protein or lipid components.
Since the biomolecular composition of zymosan remains largely unsolved, means for making a composition comprising 5-30% zymosan by dry mass is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. The prior art references recite distinct biomolecular components of zymosan according to different interpretations of the scope of the term “zymosan”. These components include, but are not necessarily limited to, chitin, mannan-polysaccharide, proteins, lipids, and glucose polymer.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided a method of determining glucan and manno oligosaccharide content (page 11, lines 14-17; page 12; page 13, lines 1-18). However, the specification does not provide a method for determining zymosan content according to the interpretations of the term "zymosan" that are inclusive of proteins and/or lipids.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Hoemann and Sun, Jiang et al., and Sigma, and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to make a composition comprising 5-30% zymosan by dry mass according to certain interpretations of the term "zymosan" that are inclusive of lipids and/or proteins.
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 claims recite a composition comprising yeast protein and zymosa. This judicial exception is not integrated into a practical application because it is not clear that the composition as claimed comprises any constituents chemically or functionally distinct from their naturally occurring counterparts. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it is not clear that any properties of the claimed composition.
The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 1-3 are directed to a composition comprising yeast protein and zymosan, the claims are directed to a composition.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow
the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter
Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at:
https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked
to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines,
manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject
matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The
Office released guidance on December 16, 2014 for the examination of claims reciting natural products
under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and
Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d
1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view
that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and
technological work", and are thus excluded from patentability because "monopolization of those
tools through the grant of a patent might tend to impede innovation more than it would tend to
promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at
2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S.
66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this
"exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980.
The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural
phenomena; i.e., one may not patent every "substantial practical application" of an abstract
idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone
test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119
USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and
resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to
by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo
test, because while a preemptive claim may be ineligible, the absence of complete preemption
does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a
physical product, the courts have often referred to the exception as a "product of nature".
Products of nature are considered to be an exception because they tie up the use of naturally
occurring things, but they have been labeled as both laws of nature and natural phenomena.
See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature
exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281
(1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and
"phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of
nature" and "natural phenomenon" as inclusive of "products of nature".
It is important to keep in mind that product of nature exceptions include both naturally
occurring products and non-naturally occurring products that lack markedly different
characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all
non-naturally occurring products is whether they possess markedly different characteristics from
its closest naturally occurring counterpart.
When a claim recites a nature-based product limitation, examiners use the markedly
different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based
product limitation and determine the answer to Step 2A. Nature-based products, as used herein,
include both eligible and ineligible products and merely refer to the types of products subject to
the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this
analysis to identify product of nature exceptions. If the claim includes a nature-based product
that has markedly different characteristics, then the claim does not recite a product of nature
exception and is eligible. If the claim includes a nature-based product that does not exhibit
markedly different characteristics from its closest naturally occurring counterpart in its natural
state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires
further analysis in Step 2B to determine whether any additional elements in the claim add
significantly more to the exception.
Nature-based Product Claim Analysis
Where the claim is to a nature-based product by itself, the markedly different
characteristics analysis should be applied to the entire product. Where the claim is to a nature-
based product produced by combining multiple components, the markedly different
characteristics analysis should be applied to the resultant nature-based combination, rather than
its component parts. Where the claim is to a nature-based product in combination with non-
nature based elements, the markedly different characteristics analysis should be applied only to
the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its
naturally occurring counterpart.
The markedly different characteristics analysis compares the nature-based product limitation to
its naturally occurring counterpart in its natural state. Markedly different characteristics can be
expressed as the product’s structure, function, and/or other properties, and are evaluated based
on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-
based product limitation does not exhibit markedly different characteristics, then that limitation is
a product of nature exception. If the analysis indicates that a nature-based product limitation
does have markedly different characteristics, then that limitation is not a product of nature
exception. Because the markedly different characteristics analysis compares the nature-based
product limitation to its naturally occurring counterpart in its natural state, the first step in the
analysis is to select the appropriate counterpart(s) to the nature-based product. When there are
multiple counterparts to the nature-based product, the comparison should be made to the
closest naturally occurring counterpart. When the nature-based product is a combination
produced from multiple components, the closest counterpart may be the individual nature-based
components of the combination. Because there is no counterpart mixture in nature, the closest
counterparts to the claimed mixture are the individual components of the mixture, i.e., each
naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281
(comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes.
In order to show a marked difference, a characteristic must be changed as compared to nature,
and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an
incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at
2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have
caused the claimed product to possess at least one characteristic that is different from that of
the counterpart. If there is no change in any characteristic, the claimed product lacks markedly
different characteristics, and is a product of nature exception.
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable
subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter.
YES, the claims are directed to a composition of matter, which is a statutory category within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception (e.g., law of nature, natural phenomenon, or an abstract idea; see MPEP 2106.04). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., composition comprising protein and polysaccharide substances sourced from yeast) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Because the claim states the nature-based products, which are yeast extracts, the markedly different characteristics analysis is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within yeast (instant claim 1). This equates to a yeast extract. The process of creating a yeast extract is by partitioning the starting yeast material into separate compositions based upon some property. The closest naturally occurring counterparts of extracted components are those same components when found existing in the yeast in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the
nature-based product as claimed are not markedly different than the properties of these naturally
occurring counterparts found in nature as these activities would inherently be found in the yeast they
come from. The components which would give the activities claimed in the instant invention would
inherently do the same in nature as there has been nothing done in the instant invention that would
make them act in any different way.
Step 2A: prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a)
identifying whether there are any additional recited elements in the claim beyond the judicial exception
and (b) evaluating those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application.
This judicial exception is not integrated into a practical application because the yeast extract
composition is only comprising the nature-based components. The claims do not integrate the judicial
exceptions into a practical application because in this context, such integration for a claimed product
would be a physical form of the specific practical application instead of a more general composition that
is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more
than the judicial exception because these components and their activity are already found naturally
occurring in nature and the addition of an intended use does not impart any added benefit to the
compounds or integrate the composition into a practical application.
Step 2B evaluates whether the claim as a whole, amounts to significantly more than the recited
exception, i.e., whether any additional element, or combination of additional elements, adds an
inventive concept to the claim (see MPEP § 2106.05(b)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t
any other additional elements to consider, which does not add an inventive concept to the claims. Thus,
the claims are not eligible subject matter under current 35 U.S.C. 101 standards.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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