DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on 10/03/23 and 12/03/25 were filed and entered. The submissions are in compliance with the provisions of 37 CFR 1.97 and have been considered by the Examiner.
Objection to Specification
3. The title of the invention is objected to because of the word “new” which should not be included in a title; (see MPEP 606 and 37 C.F.R. 1.72). The Office recommends “YEAST STRAIN AND ITS USES FOR THE CONTROL OF PHYTOPATHOGENS”.
Claim Status
4. The preliminary amendment, filed 10/03/23, has been entered. Claims 1-27 are pending and under examination. Claims 4-27 are amended.
Claim Objections
5. Claims 1-3 are objected to because of the following informalities: missing article(s). Proper claim construction includes an “A” (or “An”) for the beginning of an independent claim and “The” for the beginning of a dependent claim. Thus, independent claim 1 should read: “A yeast strain…” and dependent claims 2 and 3 should each read: “The yeast strain according to …” Appropriate correction is required.
6. Claims 4, 7, 8, 10, 17, 18, 19 and 23 are objected to because of the following informalities: missing word(s).
Claim 4 missing the word “an” in line 2 (i.e. “…as an active principle”)
Claim 7 is missing the word “or” between last two options.
Claim 8 is missing the words “and” and/or “or” between last two options.
Claim 10 is missing the words “and” and/or “or” between last two options.
Claim 17 is missing the word “or” between last two options.
Claim 18 is missing the word “or” between last two options.
Claim 19 is missing the words “and” and/or “or” between last two options.
Claim 23 is missing the words “and” and/or “or” between last two options.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
7. 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.
8. Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (e.g. nature-based product) without significantly more. The claims recite “Yeast strain belonging to Papiliotrema terrestris species, said strain being deposited at the Westerdijk Fungal Biodiversity Institute with deposit number CBS147138”; which appears to be a naturally occurring yeast isolated by Applicant (see page 3 and Example 1; see also Ke et al. 2018, Toxicological evaluation of b-Galactosidase enzyme produce by Papiliotrema terrestris; Regulatory Toxicology and Pharmacology 92:213-219; of record). Therefore, the product claims are directed to a statutory category and Step 1 of the Subject Matter Eligibility analysis is yes.
However, the judicial exception is not integrated into a practical application because the naturally occurring yeast does not appear to be markedly different from its naturally occurring counterpart, in its natural state, since it was not modified in any way (see Specification at page 3; Table 1; and Example 1). Therefore, these product claims are directed to a judicial exception (i.e. Law of Nature; Nature-based products; thus, Step 2A prong 1 is yes) that is not integrated into a practical application (i.e. Step 2A, prong 2 is no).
Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in claim 1. For claim 2, the options include “fresh cells” and “cells in an aqueous solution” (i.e. water). For claims 3, 4, 5, 7, 8 and 10, the options encompass water (i.e. an aqueous solution; a phytopharmacologically acceptable excipient; in a liquid form; a solution; a chemical compound). For the concentrations in claim 6 it is noted that if one yeast cell is not eligible, then merely congregating ineligible cells together, would not make the otherwise ineligible cells, eligible. For claims 9 and 11, the additional chemical compound encompasses one or more fungicides. However, these additional elements are not sufficient to amount to significantly more than the judicial exception because there is no indication that any of these additional element(s) changes any structural or functional features of the judicial exception per se. Therefore, all the components in the composition function as they would individually, and a mere mixture or aggregation of products, natural or not, does not structurally and/or functionally change the nature-based product from what exists in the environment and that in order to be eligible, every embodiment within the broadest reasonable interpretation of the claim must be eligible.
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exceptions (i.e. naturally occurring yeast). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually because the additional element(s) are recited at a high level of generality and are well-understood, routine, conventional activities engaged in by the scientific community; (see Ke et al. 2018, materials and methods sections). Consequently, the additional element(s) are not sufficient to make the judicial exception eligible for patent protection (Step 2B is no).
Therefore, based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are consequently rejected as ineligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 7, 9, 11, 13, 14, 15, 22, and 25-27 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Further, for claim 7, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “powder”, and the claim also recites “dry powder” and ”wettable” powder each of which is the narrower statement of the limitation (e.g. also see “fluid” followed by “dry fluid”). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 is indefinite for multiple reasons:
Claim 9 contains multiple potential trademark/trade names. For example see (at least) Adavelt® on line 4 and Kiralaxyl® on line 11. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe antifungal compounds and, accordingly, the identification/ description is indefinite. It is noted that Applicant must correct ALL trademarks in the claim.
Claim 9 is also indefinite because of the use of parentheses. Although parenthesis may be appropriate when defining an abbreviation or acronym, the inclusion of parentheses for phrases (e.g. see, at least, claim 9, first page, lines 7, 11; and second page lines 7, 8, 16, 19, etc.), raises uncertainty as to whether the feature in the parentheses is optional or always present. Thus, clarification for ALL improper parentheses is required to ascertain the metes and bounds of the claim. The Office suggests the use of commas or semicolons.
Claim 9 is also indefinite because of improper use of multiple acronyms and/or abbreviations. Acronyms and abbreviations must be spelled out and/or defined upon first use, in order to be understood without requiring reference to the specification (i.e. see MPEP 2173.05(s); claims are to be complete in themselves); therefore, ALL acronyms must be explained/defined (e.g. see, at least, “strain FZB24”; DBCP; DNOC; BLAD; PCNB; SJC17, etc). Thus, clarification for ALL improper acronyms throughout the claim is required to ascertain the metes and bounds of the claim. The Office again suggests the use of commas or semicolons to clearly delineate what is included and what is excluded from the scope of the claim.
Claim 11 is indefinite for all of the same reasons as claim 9.
Regarding claim 13, the phrase "such as" (see multiple uses) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 14, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 15, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 15 recites the broad recitation “Sclerotinia spp.”, and the claim also recites “Sclerotinia sclerotiorum” which is a narrower statement of the limitation (also see similar issues throughout the claim by listing both the broad “spp.” designation and then one or more particular species). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note ALL broad-narrow recitations must be corrected to clearly ascertain the metes and bounds of this claim.
Claim 22 is indefinite because the phrase “…said phytopathogen is selected between …” followed by more than two options with “and” or “and/or” in between what appear to be sets of two pathogens for some pairings, but then lists of one to three pathogens for others. Thus, claim 22 does not make sense as written and clarification is required.
Claim 25 recites “… comprising or consisting in” which renders the claim unclear based on what appears to be the combined use of mutually exclusive transitional phrases. For the purpose of compact prosecution, the claim will be interpreted to have an open (i.e. comprising) transitional phrase; nevertheless, clarification is required.
Claim 26 recites the limitation "the plant" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 25, from which it depends, is directed to crops in particular and not plants in general. Thus, clarification is required.
Claim 27 recites the limitation "the dose" in line 2. There is insufficient antecedent basis for this limitation in the claim because claim 24, from which it depends, does not recite “a dose”. Thus, clarification is required.
Accordingly, clarification is required to remove ambiguity of scope from each of these claims.
Claim Rejections - 35 USC § 112
11. 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.
12. Claims 1-27 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is a biological deposit rejection.
The invention appears to employ novel biological materials, specifically newly isolated strain of Papiliotrema terrestris and the corresponding compositions, kits, and methods of use (see Specification at page 3; Table 1; and Example 1). Since the biological materials are essential to the claimed invention, they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
In the instant case, although Applicants have noted on page 3 of their specification that the biological material was deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required to satisfy the 112(a) requirements.
Claim Rejections - 35 USC § 102/103
13. 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 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.
14. 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.
15. 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.
16. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
17. 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.
18. Claims 1-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ke et al. 2018 (Toxicological evaluation of b-Galactosidase enzyme produce by Papiliotrema terrestris; Regulatory Toxicology and Pharmacology 92:213-219; of record).
Ke teaches aqueous compositions comprising Papiliotrema terrestris at concentrations of 108 to 109 CFU grown in a YM broth (i.e. contains micro- and macro- nutrients) and washed with saline (e.g. see abstract and section 2.1; meeting limitations found in instant claims 1-8 and 10). With regards to the extracellular polysaccharides of the cell biomass in claim 3, it is the Office’s position that the cultured broth necessarily contains the naturally occurring polysaccharides therein. With regards to “a kit” in claim 10, a kit is merely a collection of items, which Ke teaches (see section 2.1).
Therefore, while Ke does not teach the Papiliotrema terrestris species as being deposited at the Westerdijk Fungal Biodiversity Institute with a deposit number CBS147138, the yeast is deemed to be the same, or substantially the same, as the claimed yeast, because both have the same Latin name. Therefore, absence convincing evidence to the contrary, Ke anticipates the invention as claimed because Papiliotrema terrestris and its functional properties cannot be separated; see MPEP 2112.01. Further, MPEP 2112.01 also states that “When the PTO shows a sound basis for believing that the inventions of the Applicant and the prior art are the same, the Applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Alternatively, it would have been prima facie obvious to substitute one Papiliotrema terrestris strain (i.e. in a composition) for another because both would be used for the same purpose as desired (e.g. useful in an aqueous composition for growing yeast). Accordingly, Ke teaches, or at least renders obvious, the product claims because (1) Papiliotrema terrestris cannot be separated from its properties, and/or (2) the prior art teaches a product that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the Papiliotrema terrestris strain) and KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill.
Therefore, the claimed invention is at least prima facie obvious, if not anticipatory, in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
19. No claims are allowed at this time.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. 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, Vanessa Ford can be reached on (571)-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
21. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY MAILLE LYONS/
Examiner, Art Unit 1645
December 31, 2025