DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group I, claims 1, 10-12, 16, 18, 20, and 22, and the species of (A) the combination of 16S rRNA sequence of SEQ ID NO: 24 and ITS sequence of SEQ ID NO: 25 (claim 1), (B) Penicillium expansium (claim 16), and (C) vegetable cell (claim 18), in the reply filed on 23 July 2026 is acknowledged. Claims 4, 25-31, 33, 38, 41, 47, and 50 have been withdrawn. Claims 1, 10-12, 16, 18, 20, and 22 are currently pending and under examination.
This application is a continuation application of 17/666449, filed February 7, 2022, which is a continuation application of International Patent Application No. PCT/US2020/045426, filed August 7, 2020, which claims priority to U.S. Provisional Application No. 62/885114, filed August 9, 2019.
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, 10-12, 16, 18, 20, and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a composition comprising at least one microbe or metabolite produced by the microbe, and a carrier. This judicial exception is not integrated into a practical application because only a composition comprising the microbe/metabolite and a carrier is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the composition comprising the microbe/metabolite and carrier, is claimed.
It is noted that the 2019 Revised Patent Subject Matter Eligibility Guidance, published January 2019, is being followed and referred to in this rejection.
With regard to Step 1, the composition as claimed in claims 1, 10-12, 16, 18, 20, and 22 is a composition of matter.
With regard to Step 2A, prong one, claim 1 encompasses a composition comprising at least one microbe or its produced metabolite, and a carrier. It is noted that the microbe can be a bacterium or yeast, including: Bacillus, Burkholderia, Cutaneotrichosporon, Cyberlindnera, Gluconacetobacter, Gluconobacter, Hanseniaspora, Paraburkholderia, Pseudomonas, Torulaspora, or any combination thereof (see Specification, para. 36); and including specifically Bacillus amyloliquefaciens, Bacillus subtilis, Bacillus velezensis, Cutaneotrichosporon jirovecii, Cutaneotrichosporon moniliiforme, Cutaneotrichosporon mucoides, Cyberlindnera mrakii, Cyberlindnera saturnus, Gluconacetobacter liquefaciens, Gluconobacter cerimus, Hanseniaspora uvarum, Paraburkholderia phytofirmans, Pseudomonas fluorescens, Pseudomonas frederiksbergensis, Pseudomonas lini, Pseudomonas migulae, Torulaspora delbrueckii, and any combination thereof (see Specification, para. 37). All of which are naturally occurring microbes.
Further, the metabolites can comprise a lipopeptide, a dipeptide, an aminopolyol, a protein, a siderophore, a phenazine compound, a polyketide, or a combination thereof (see Specification, para. 37), including those metabolites specifically listed in paragraphs 65-67 of the Specification. All of which are naturally occurring compounds.
Additionally, the carrier is not limited and includes natural substances, including water (see claim 20). Further, the carrier reads on other natural products such as soil and plants.
Claim 1 additionally recites a 16S rRNA sequence and ITS sequence, but it is noted that these sequences are isolated from Gluconobacter cerinus and Hanseniaspora uvarum, respectively. Gluconobacter cerinus is a natural acetic bacterium found, for example, in rotted tissue of sugarbeet root (see Art or Record: Bill), and Hanseniaspora uvarum is a yeast found on fruit, including grapes, and also found in soil, fresh and salt water, mollusks, and mammals (see Art or Record: UC Davis). Thus, both sequences come from natural microbes. Further, it is noted that the sequences only require 90% identity, thus not requiring the specific sequence and encompassing other natural products.
Therefore, claim 1 includes a natural microbe or metabolite and a natural carrier. As such, claim 1 is deemed to be a natural product.
With regard to Step 2A, prong two, claim 1 does not recite any elements in addition to the composition comprising the microbe/metabolite and carrier. As such, there is no additional element in claim 1 that applies or uses the judicial exception in some other meaningful way, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
With regard to Step 2B, claim 1 does not recite any elements in addition to the composition comprising the microbe/metabolite and carrier. As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
With regard to dependent claims 10-12, 16, 18, 20, and 22, these claims recite additional features of the natural products or results that flow from the use of the claimed composition. As such, these claims do not recite additional elements that alone or together amount to significantly more than the judicial exception.
For the forgoing reasons, the composition as claimed is not deemed to encompass patent eligible subject matter under 35 USC §101.
Claim Rejections - 35 USC § 112
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, 10-12, 16, 18, 20, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 10 recite that the 16S rRNA and ITS sequences (SEQ ID NO: 24 and 25) are only required to have 90% identity to the recited sequences of the generic microbe.
These claims and those depending therefrom are considered genus claims that encompass a wide array of microbes. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of species. The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to any species of microbe having 90% identity to SEQ ID NO: 24 and SEQ ID NO: 25.
The purpose of the written description requirement is to ensure that the inventor had
possession, as of the filing date of the application, of the specific subject matter later claimed. A patent specification must describe an invention and do so in sufficient detail that
one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus,
an applicant complies with the written description requirement by describing the invention, with
all its claimed limitations, not that which makes it obvious, and by using such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.
Here, the specification lacks a sufficient variety of species of microbes with less than 100% identity to SEQ ID NO: 24 and 25 that are shown to be effective for the claimed intended use of biocontrol.
Accordingly, the specification fails to provide adequate written description for the claimed composition including a microbe having 90% identity to SEQ ID NO: 24 and 25, and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics of a species of microbe having 90% identity to SEQ ID NO: 24 and 25, that are shown to be effective for the claimed intended use. Absent such teachings and guidance as to the structure and function of these species of microbe having 90% identity to SEQ ID NO: 24 and 25, the specification does not describe the claimed composition in such full, clear, concise and exact terms so as to indicate that applicant had possession at the time of filing of the present application. Thus, the written description requirement has not been satisfied.
Claims 11, 12, 16, 18, 20, and 22 are included in this rejection, as they depend from above rejected claim 1, and fail to remedy the noted deficiencies.
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.
Claim 18 is 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 18 recites that the biocontrol composition comprises a vegetative cell. However, claim 1 indicates that the biocontrol composition can be a microbe or a metabolite thereof. This claim is indefinite, because it is unclear how a metabolite can be a vegetative cell.
Claim Rejections - 35 USC § 102/103
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.
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, 10-12, 16, 18, 20, and 22 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 Park (IDS; WO 2013/042900; Published 2013).
With regard to claims 1, 10, and 16, Park teaches a biocontrol composition for inhibiting Penicillium, including Penicillium expansum, on plants, wherein the biocontrol composition inhibits growth of the Penicillium relative to a control; the biocontrol composition comprises iturin as the biocontrol agent; and a carrier, including water or PBS (Abs.; para. 10-11, 49, 77; claim 10, 12).
Claims 1 are 10 are directed to the metabolite, which is produced by the claimed process (i.e. produced by the at least one microbe having the rRNA and ITS sequences as claimed). "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Here, the lipopeptide iturin as taught by Park is a metabolite produced by a microbe and usable in the biocontrol composition as claimed (see Specification, Para. 65). The metabolite is used for the same purpose as claimed: as a biocontrol agent for inhibiting Penicillium, including Penicillium expansum. The structure and function of iturin is necessarily identical regardless of its source, thus the iturin of Park is structurally and functionally the same as the metabolite produced by the microbe as claimed. Therefore, the iturin as taught by Park is necessarily the iturin that is a metabolite produced by a microbe as claimed, or would have rendered obvious, the metabolite produce by the claimed process.
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"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
With regard to claims 11 and 12, Park teaches or renders obvious the biocontrol composition as claimed, including the components as claimed. As such the results that: growth inhibition of said Pencillium species is shown by a reduction in lesion size or tissue necrosis in produce to which said biocontrol composition as compared to said control that is not exposed to said biocontrol composition; and the biocontrol composition is capable of inhibiting growth of said Penicillium species 5% or more relative to a control not exposed to said biocontrol composition, would naturally flow from the use of the biocontrol composition of Park.
With regard to claim 18, the iturin as taught by Park is necessarily the iturin that is a metabolite produced by a microbe as claimed, or would have rendered obvious, the metabolite produce by the claimed process. As such, the biocontrol composition as claimed is capable of including a microbe that is a vegetative cell.
With regard to claims 20 and 22, Park teaches that the carrier includes water or PBS, and is formulated as a liquid for application (Para. 77).
Conclusion
No claims are allowable.
Art of Record:
Bill et al., Draft genome sequence of Gluconobacter cerinus isolated from stored sugarbeet root, Microbiology Resource Announcements, Vol. 15, Iss. 4, (April 2026), pp. 1-3) (Gluconobacter cerinus is a natural acetic bacterium found, for example in rotted tissue of sugarbeet root).
McLaughlin et al., IDS, US 6,500,425; Published 2002 (biocontrol composition comprising Hanseniaspora uvarum NRRL Y-18527; and a carrier, including water, oil, or wax for inhibiting Penicillium, including Penicillium expansum and Penicillium digitatum, on plants).
UC Davis, Vinticulture & Enology, Hanseniaspora uvarum, Accessed 9/29/2026, Available online at: wineserver.ucdavis.edu/industry-info/enology/wine-microbiology/yeast-mold/hanseniaspora-uvarum (Hanseniaspora uvarum is a yeast found on fruit, including grapes, and also found in soil, fresh and salt water, mollusks, and mammals).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G. Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
