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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on December 29, 2023 and July 09, 2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Election/Restrictions
Applicant’s election without traverse of Group 1, claim(s) 1 and 11-16 in the reply filed on March 13, 2026 is acknowledged.
Claim(s) 2-10 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim(s) 1 and 11-16 are examined on the merits.
Claim Objections
Claim(s) 1 and 11-16 are objected to because of the following informalities:
In claim 1, “is a Pediococcus acidilactici” should read “is Pediococcus acidilactici”
In claim 11, “is a Pediococcus acidilactici” should read “is Pediococcus acidilactici”
In claim 12, “is a Pediococcus acidilactici” should read “is Pediococcus acidilactici”
In claim 13, “is a Pediococcus acidilactici” should read “is Pediococcus acidilactici”
In claim 14, “is a Pediococcus acidilactici” should read “is Pediococcus acidilactici”
In claim 15, “is a Pediococcus acidilactici” should read “is Pediococcus acidilactici”
In claim 16, “is a Pediococcus acidilactici” should read “is Pediococcus acidilactici”
Appropriate correction is required.
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(s) 1 and 11-16 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 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.
Since the microorganism Pediococcus acidilactici NCIMB 44102 is recited in the claims, it is essential to the invention recited in those claims. It must therefore be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the microorganism.
Since a deposit has been made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney or record over his/her signature, and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 C.F.R. § 1.808.
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.
Claim(s) 1 and 11-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring Pediococcus acidilactici without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claims recite Pediococcus acidilactici NCIMB 44102. Pediococcus species are a naturally occurring bacterium. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception... To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties. "
In this case, applicant's specification states that the claimed species, Pediococcus acidilactici were collected from the guts of chickens and the extracellular vesicles secreted by the bacterium are effective in improving the abundance of gut microbiota ([e.g. a probiotic]) (page 9).
Selection of a particular species of a naturally occurring organism does not create a markedly distinct organism. The selected microorganism would be the same as the identical microorganism because selection only occurs from what exists. Thus, the claims are drawn directly to a product of nature. Thus, the claimed Pediococcus acidilactici NCIMB 44102 cannot display markedly different characteristics in comparison with the naturally occurring counterpart because they are one in the same. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are directed to a composition with an intended use of a pharmaceutical, nutritional supplement, food product, dietary supplement, food additive and feedstuff composition for improving gut microbiota. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'treatment or prophylaxis' consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself." In this case, the additional element in the claims is the combination of the P. acidilactici with additional ingredients to form pharmaceutical, food products, dietary supplements, food additive, feedstuff and nutritional supplements with the lactic acid bacterial strain of P. acidilactici. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter. In addition, applicant's intended use of improving gut microbiota is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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.
Claim(s) 1 and 11-16 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 Lathan et al (WO 2011017040 A1).
The Lathan et al reference teaches a Pediococcus acidilactici organism. The Lathan et al reference teaches a microorganism which appears to be identical to the presently claimed microorganism, based on the fact that both the reference microorganism and the claimed microorganism are from the same genus and species and have the same pharmaceutical properties (such as improving gastrointestinal (e.g. gut) health and being administered as a probiotic). In addition, the probiotic containing the bacterium, P. acidilactici as taught by Lathan et al can be used as a feedstuff, nutritional supplement, food product, dietary supplement, food additive and a pharmaceutical composition, which can all be synonymous terms due to the purpose of providing health benefits in the form of a material in order to be administered to an animal, which includes mammals (e.g. humans). As a result, the prior art reasonably appears to anticipate the claims for the reasons stated above and including that the Lathan et al reference discusses the same bacterial species and that bacterial species has similar pharmaceutical properties as compared to the bacterial species of the present invention.
However, even if the reference microorganism and the claimed microorganism are not one and the same, the reference microorganism would, nevertheless, have rendered the claimed microorganism obvious to one of ordinary skill in the art at the time the claimed invention was made in view of the clearly close relationship between the microorganism as evidenced by their shared taxonomical classification and pharmaceutical characteristics. The selection of a specific strain of a known type of microorganism is considered to be prima facie obvious in the absence of sufficient, clear, and convincing evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NASHARA L MOREAU
Examiner, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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