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 06/11/2026 has been entered. Claims 1-18, 20-22 and 33-36 have been cancelled. Claims 39-45 are new. Claim 38 is withdrawn. Claims 19, 23-32, 37 and 39-45 are under examination.
Information Disclosure Statement
The information disclosure statement filed 6/11/2026 has been considered and an initialed copy is enclosed.
Claim Rejections Withdrawn
The rejection of claims 19-37 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amendment to the claims.
The rejection of claims 22 and 33-36 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn. All the conditions of 37 CFR §1.801-1.809 have been met.
The rejection of claim 32 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn in view of the amendment to the claim.
The rejection of claim(s) 19 and 23-25 under 35 U.S.C. 102(a)(1) as being anticipated by Almand et al. BMC Res Notes (2019) 12:607. https://doi.org/10.1186/s13104-019-4669-2 , 6 pages is withdrawn in view of the amendment to the claims.
Claim Objections
Claim 37 is objected to because of the following informalities: “Carrier” is repeated twice. Also after the semi-colon in line 5 please insert “and”. Appropriate correction is required.
New Claim Rejection
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 19, 23-32, 37 and 39-45 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim(s) recite(s) a an endospore-forming microorganism, of the genus Bacillus wherein said microorganism is selected from the group consisting of DSM 33855, DSM 33856, DSM 33857 and DSM 33858, and combinations thereof, and wherein said microorganism displays viral decoy receptors on its surface; or a preparation comprising such a microorganism.
Each of the endospore-forming microorganisms bacteria are naturally occurring and therefore are products of nature.
The specification discloses that DSM 33855, DSM 33856, DSM 33857 and DSM 33858 were selected for their ability to bind to viral PEDV particles from a screen of 200 naturally occurring Bacillus strains. See p. 34 lines 17-30.
Claims 19, 23-32: The specification does not disclose that the claimed Bacillus species have any characteristics (structural, functional or otherwise) that are different from the naturally occurring Bacillus.
Because there is no difference between the claimed and naturally bacteria, the claimed Bacillus species do not have markedly different characteristics, and thus each Bacillus is a “product of nature” exception.
Regarding the combination of Bacillus species, the combination are directed to a statutory category, i.e. a composition of matter, and are nature-based products (a mixture of bacteria) which do not have markedly different characteristics. This is because there is no indication in the specification that the claimed combination of Bacillus has any characteristics (structural, functional or otherwise) that are different from the naturally occurring Bacillus. Thus, the combination of bacteria does not have markedly different characteristics from what occurs in nature and is a “product of nature” exception.
Claim 37, 39-45: Regarding the combination of each Bacillus species or combinations thereof with one or more ingredients selected from carriers, proteins, carbohydrates, fats, probiotics, prebiotics, enzymes, vitamins, immune modulators, minerals, amino acids, carriers, coccidiostats, acid-based products, antibiotics and ingredients for treating, preventing or mitigating the course of a condition selected from diarrhea, necrotic enteritis and influenza, the combination is directed to a statutory category, i.e. a composition of matter, and are nature-based products (a mixture of bacteria and the one or more ingredients) which do not have markedly different characteristics.
The one or more ingredients are recited at a high level of generality and each ingredient encompasses a product of nature or nature based product.
For example, carriers such as water, proteins, carbohydrates, fats, probiotics, prebiotics, enzymes, vitamins, immune modulators (e.g. cytokines, lipopolysaccharide) minerals, amino acids encompass those that are nature-based or products of nature.
For example, coccidiostats (e.g. spiramycin which is a product of Streptomyces ambofaciens), antibiotics (e.g. spiramycin) and ingredients for treating, preventing or mitigating the course of a condition selected from diarrhea, necrotic enteritis and influenza encompass those that are nature-based or products of nature.
The combination with the ingredients does not have markedly different characteristics from what occurs in nature and is a “product of nature” exception. This is because there is no indication in the specification that the claimed combination of the Bacillus and a carrier has any characteristics (structural, functional or otherwise) that are different from the naturally occurring Bacillus and the ingredients as they occur in nature. Thus, the combination of bacteria and ingredients do not have markedly different characteristics from what occurs in nature and is a “product of nature” exception.
The combination of natural products should be contrasted with cases like Chakrabarty where the Supreme Court found that, in contrast to the mixture of bacteria in Funk Brothers, “the patentee ha[d] produced a new bacterium (four plasmids were introduced into the bacterium) with markedly different characteristics from any found in nature and one having the potential for significant utility.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).
(“Natural phenomena, including naturally occurring organisms, are not patentable.”). See In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335-1336 (Fed. Cir. 2014). 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).
The claims do not recite additional elements that integrate the judicial exception into a practical application such as 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 Bacillus to a subject and not merely recitation of intended uses of the Bacillus as recited in the all the claims. See MPEP 2106.04(d)(2).
The claims do not recite any meaningful additional limitations, modification(s) or transformation(s) that sufficiently ensures that the claim amounts to significantly more than the exceptions.
Thus, the claim(s) as a whole do not amount to significantly more than the “product of nature” by itself. Thus, the claims does not qualify as eligible subject matter under 35 USC 101.
Status of Claims
Claims 19, 23-32, 37 and 39-45 are rejected. Claim 38 is withdrawn.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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