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
Claims 5-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/2025.
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.
Claim 1 is 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 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. It is apparent that Bacillus velezensis GYUN-1190 (accession No: KACC 92512P) is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the strains Bacillus velezensis GYUN-1190 (accession No: KACC 92512P).
The process disclosed in the specification does not appear to be repeatable. It is not clear that the invention will work with commonly available material and it is not apparent if the biological material(s) considered necessary to make and use the invention is both known and readily available to the public. It is noted that there is no indication that Applicants deposited the biological material as disclosed in Claim 1; there is no indication regarding public availability.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirements 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 must 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:
during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
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;
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
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.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a microorganism comprising isolated Bacillus velezensis GYUN-1190 (accession No: KACC 92512P), an active ingredient, a condensate of the culture, a dry solid of the culture or an extract of the culture. This judicial exception is not integrated into a practical application because only this isolated microorganism and its intended use is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the isolated Bacillus velezensis GYUN-1190 (accession No: KACC 92512P) and its intended use, is claimed.
With regards to Step 1, the isolated microorganism as claimed in claims 1-4 is a composition of matter.
With regards to Step 2A, prong one, claims 1 encompasses a microorganism comprising isolated Bacillus velezensis GYUN-1190 (accession No: KACC 92512P). Thus, claim 1 and dependent claims 2-4 are generally directed to a microorganism and its inherent functional capabilities. It is indicated in the Specification of the instant application that Bacillus velezensis GYUN-1190 (accession No: KACC 92512P) is isolated from the soil (Specification, page 7, Lines 1-5). Thus, Bacillus velezensis GYUN-1190 (accession No: KACC 92512P) is a natural bacterial strain that has been isolated from its natural environment. There is nothing to indicate that the isolated Bacillus velezensis GYUN-1190 (accession No: KACC 92512P) is in any way different from its naturally occurring counterpart (e.g. it is not genetically modified to add/delete a gene). The isolation of an organism from the natural environment without any further alteration does not render the organisms non-natural.
With regards to Step 2a, prong two, claim 1 and dependent claims 2-4 do not recite any elements in addition to the isolated Bacillus velezensis GYUN-1190 (accession No: KACC 92512P) and its intended use. The claims are directed to a composition and not to a method of use. Recitation of the intended use of application to plants for inhibiting growth of pathogenic fungus, thereby preventing and controlling plant diseases, does not in any way change the natural structure or inherent functionality of the isolated Bacillus velezensis GYUN-1190 (accession No: KACC 92512P). As such, there is no additional element in claims 1-4 that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the isolated natural Bacillus velezensis GYUN-1190 (accession No: KACC 92512P), such that the claims as a whole are no more than a drafting effort designed to monopolize the exception.
With regards to Step 2b, claim 1 and dependent claims 2-4 do not recite any elements in addition to the isolated Bacillus velezensis GYUN-1190 (accession No: KACC 92512P) and its intended use. The claims are directed to a composition and not to a method of use. Recitation of the intended use of application to plants for inhibiting spore germination, and growth of pathogenic fungus Colletotrichum fructicola or Colletotrichum siamense, causes of apple anthracnose, does not in any way change the natural structure or inherent functionality of the isolated Bacillus velezensis GYUN-1190 (accession No: KACC 92512P). As such, the claims do not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
For the forgoing reasons, the claims are not deemed to encompass patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 102/103
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- 4 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 Xu, W. et al., (CN 111961613 A; published 2020-11-20).
With regards to claims 1-4, Xu, W. et al, teaches Bacillus velezensis (WH-P2-20; CCTCC No. : M2020257) ,preserved by the China Typical Culture Preservation Centre (CCTCCC on July 1, 2020). Wherein, the composition and method are a biocontrol for fungi that includes Colletotrichum species and Colletotrichum fructicola which cause fruit anthracnose, notably in the reference, pear anthracnose (page 2; paragraph 2). The prior art teaches a composition and method to inhibit germination of fungal spores of Colletotrichum species and Colletotrichum fructicola with the application of Bacillus velezensis WH-P2-20 ( page 10, paragraph 5, section titled ‘Test Example 3’) and/or ‘fermentation liquid’ which is composed of the strain and/or extract of the culture, and low molecular weight volatile compounds (page 3, paragraphs 3-9 and 13; pages 3 and 4; paragraph 14; page 9 ‘Test Example 2’, paragraph 1) .
The broadest reasonable interpretation of claim 2, which is not limited to the strain, is any natural volatile compound produced from the strain, condensate, or extract. Since Xu, W. et al teaches a compound, a condensate, volatile compounds or an extract that inhibits mycelial growth or spore germination of the pathogenic fungi, it anticipates the claim.
Xu W. et al., does specify the strain is Bacillus velezensis GYUN-1190 (accession No: KACC 92512P). Note since the USPTO is not equipped to make physical comparisons, a reasonable rationale is provided as to why the claimed strain is considered to be the same. Although Xu W. et al. does not specify the strain accession number, since Xu et al., teaches Bacillus velezensis which is effective as a biocontrol for apple anthracnose and produces a compound, a condensate, volatile compounds or an extract that inhibits mycelial growth or spore germination of pathogenic fungi, therefore Xu et al. is considered to anticipate the claimed strain.
Alternatively, it would have been obvious to one of ordinary skill in the art at the effective date of filing to modify the teachings of Xu, W. et al., and utilize an obvious variant strain. The motivation to use an alternative strain of Bacillus velezensis amounts to the simple substitution of functional equivalents, wherein substitution of one known strain(s) for another would have been obvious based on the shared functional properties of Bacillus velezensis (WH-P2-20; CCTCC No. M2020257): fungistatic and/or fungicidal properties of the dry solid of the culture, filtered fermentation liquid (i.e. extracts of the culture), or low molecular weight volatile organic compounds inhibiting spore germination of Colletotrichum fructicola or Colletotrichum siamense to treat apple anthracnose. One would have reasonable expected success since both are taught to share the same properties of inhibiting the growth of mycelia or preventing spore germination of Colletotrichum fructicola or Colletotrichum sp. that cause apple anthracnose, by way of the bacterial culture, the dry solid of the culture, filtered fermentation liquid (to remove Bacillus velezensis WH-P2-20; CCTCC No. : M2020257), extracts of the culture, and low molecular weight volatile organic compounds.
Regarding claims 3-4, the claims are directed to intended use. Since the prior art teaches Bacillus velezensis which for the reasons discussed above is the same as the instantly claimed strain or an obvious variant the prior art will be capable of performing the intended use. Assuming arguendo, applicant demonstrates the strains are structurally different, the bacterial culture, the dry solid of the culture, filtered fermentation liquid, extracts of the culture, and low molecular weight volatile organic compound produced by obvious variants would be the same.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653