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 .
The amendment filed 05/11/2026 has been entered. Claims 8-11 and 15 have been amended. Claims 1-15 are pending and are under examination.
Drawings
The amendment to the drawings, abstract and specification are acknowledged accordingly the objections are withdrawn.
The objection to claim 8 is withdrawn in view of the amendment to the claim
The rejection of claims 1-15 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn upon provision of complete deposit information.
The rejection of claims 8-11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment to the claims.
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 1-7 and 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 1 is drawn to a bio-fungicide formulation comprising a biologically pure culture of Bacillus amyloliquefaciens (MTCC 25554) and excipients, wherein the Bacillus amyloliquefaciens (MTCC 25554) is present in a range from 1 to 98% (wt./wt.).
Claim 2 is drawn to a bio-fungicide formulation comprising a biologically pure culture of Bacillus subtilis subsp. spizizenii (MTCC 25552) and excipients, wherein the Bacillus subtilis subsp. spizizenii (MTCC 25552) is present in a range from 1 to 98% (wt./wt.).
Claim 3 is drawn to a bio-fungicide formulation comprising a biologically pure culture of Bacillus amyloliquefaciens (MTCC 25555) and excipients, wherein the Bacillus amyloliquefaciens (MTCC 25555) is present in a range from 1 to 98% (wt./wt.).
Claim 4 is drawn to a bio-fungicide formulation comprising a biologically pure culture of Bacillus velezensis (MTCC 25553) and excipients, wherein the Bacillus velezensis (MTCC 25553) is present in a range from 1 to 98% (wt./wt.).
Claim 5 is drawn to a bio-fungicide formulation comprising a biologically pure culture of Bacillus safensis subsp. safensis (MTCC 25556) and excipients, wherein the Bacillus safensis subsp. safensis (MTCC 25556) is present in a range from 1 to 98% (wt./wt.).
Claim 6 is drawn to a bio-fungicide formulation comprising a biologically pure culture of Bacillus spp. and excipients, wherein the Bacillus spp. is selected from the group consisting of Bacillus amyloliquefaciens (MTCC 25554), Bacillus subtilis subsp. spizizenii (MTCC 25552), Bacillus amyloliquefaciens (MTCC 25555), Bacillus velezensis (MTCC 25553), Bacillus safensis subsp. safensis (MTCC 25556), and a combination thereof, wherein the Bacillus spp. is present in a range from 1 to 98% (wt./wt.).
STEP 1: THE CLAIMS ARE DRAWN TO A COMPOSITION OF MATTER
STEP 2A PRONG ONE – THE CLAIM RECITES A JUDICIAL EXCEPTION -SEE MPEP 2106.4
The bacterial strains which were isolated and purified from the soil from many locations. See paragraph 37 of the specification. The isolation of these strains from the soil does not result in markedly different characteristics as compared to the strains as found in soil. These bacteria naturally exist and are products of nature.
Regarding combination of one or more strains, there is no evidence that combining the strains results in markedly different characteristic of any of the strains. Therefore, the combination of strains is nature-based and each bacteria in the combination is compared to its natural counterpart. As set forth above, each of the bacteria is a product of nature.
It is noted that a biopesticide (claim 15) also encompasses natural products e.g. bacteria which would also be considered a product of nature as are the claimed Bacillus. Similarly, the combination of Bacillus strain(s) and a bacteria biopesticide is nature-based and each bacteria in the combination is compared to its natural counterpart. Each of the bacteria is a product of nature there is no evidence that combining the Bacillus strain(s) and a naturally occurring biopesticide e.g. a bacteria biopesticide results in markedly different characteristic of any of the strain(s) and the biopesticide. The bacteria strain(s) and biopesticide in the combination is compared to its natural counterpart and there is no markedly different characteristics from their respective natural counterparts.
The excipient encompasses water which is as product of nature. Aqueous suspension (claim 13) also encompasses a mix of water and the Bacillus strain(s).
There is no evidence that the combination of strain(s) and water results in markedly different characteristic of any of the strain(s) from the natural counterpart.
Each nature based product continues to function as it were in the mixture or combination without a difference in function or chemical properties. In addition, the number or amount of patent ineligible products in the composition does not lend markedly different characteristics from the naturally occurring counterpart.
See In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335-1336 (Fed. Cir. 2014) (“Natural phenomena, including naturally occurring organisms, are not patentable.”). Further, the Supreme Court precedent teaches that neither isolating natural products nor combining them together represents an act of invention that would transform these naturally occurring products into patent eligible subject matter unless their combination results in something "markedly different”. See Ass 'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2117 (2013).
STEP 2A PRONG TWO – THE CLAIM DOES NOT RECITE ADDITIONAL ELEMENTS THAT INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION. SEE MPEP 2106.4
The claims do not recite additional elements that integrate the judicial exception into a practical application such a particular treatment or prophylaxis for a disease or medical condition i.e. affirmatively reciting an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of said action is a step of administering the composition to a subject or object and not merely an intended use of the composition. See MPEP 2106.04(d)(2).
STEP 2B – THE CLAIMS DO NOT AMOUNT TO SIGNIFICANTLY MORE. SEE MPEP 2106.05.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because: In claim 7, the recitation of excipients such as surfactant, encapsulant, adjuvant, sticking agent and preservative is a recited at a high level of generality without stating these are in “effective amount” to confer the function of each of the surfactant, encapsulant, adjuvant, sticking agent and preservative on the composition as a whole.
In conclusion, the claims do not qualify as eligible subject matter under 35 USC 101.
Allowable subject Matter
Claims 8-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Status of Claims
Claims 8-12 are objected to. Claims 1-7 and 13-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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A/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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