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 .
Status of the Claims
Claims 1-10 are pending (claim set as filed on 12/15/2023). Claims 9-10 are withdrawn from a restriction/election requirement. Claims 1-8 are currently under examination.
Election/Restrictions
Claims 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected feed and feed additive, there being no allowable generic or linking claim.
Applicant's election with traverse of claims 1-8 in the reply filed on 7/20/2026 is acknowledged. The traversal is on the grounds that the claims do not lack unity because the prior art reference Cormack does not teach the species Prevotella lacticifex as disclosed in the instant specification, but only the genus Prevotella. Applicant also argues that Cormack does not teach the bacterium Prevotella having a 16SrDNA consisting of a nucleotide sequence having 98.7% or higher homology with a nucleotide sequence shown in SEQ ID NO:10 as claimed in claim 1.
This is not found persuasive because the instant claim set does not mention the specific species of the Prevotella bacterium, only the genus. Regardless of the instant specification further defining the bacterium species, the claims themselves do not limit the Prevotella bacterium to that particular species and thus it is improper to read limitations of the specification into the claim. See MPEP 2111. Further, regardless of the sequence identity limitation in claim 1, the invention of Group I and Group II have only the bacterium of the genus Prevotella in common as claims 9-10 (Group II) do not recite the sequence identity limitation.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Although a certified copy of the application was included, no English translation was provided as thus the effective filing date of this application is 12/15/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/15/2023, 1/26/2024, 6/12/2024, and 8/27/2025 were considered, initialed, and attached hereto. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because the text in Figure 1 is blurry and difficult to read. Applicant is required to correct the drawings with legible text. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 4 is objected to because of the following informalities: the bacterial species “bacillus” is not capitalized as is proper for genus naming convention. Appropriate correction is required to correct the recitation to “Bacillus”.
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 5-6 and 8 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 claims 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.
The invention appears to employ novel biological materials, specifically a bacterium of the genus Prevotella identified by accession number NITE BP-03463 and which was deposited in the NITE Patent Microorganisms Depositary. Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement 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 may 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:
(a) during the pendency of this application, access to the invention will be afforded to
the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon
granting of the patent;
(c) 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;
(d) 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
(e) 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.
Claims 1-8 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.
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 by him or her. 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 fails to provide adequate written description for the claimed method of using a Prevotella strain having at least 98.7% homology to the nucleotide sequence set forth in SEQ ID NO: 10 and does not reasonably convey to one skilled in the relevant art that the inventors, at the time of the invention was filed, had possession of the entire scope of the claimed invention. Moreover, the specification does not describe a representative number of species in terms of relevant identifying characteristics of a species of Prevotella with at least 98.7% homology to a nucleotide sequence set forth in SEQ ID NO: 10. Absent of such teachings and guidance as to the structure and function of these Prevotella species with at least 98.7% homology to the nucleotide sequence set forth in SEQ ID NO: 10, the specification does not describe the claimed method in such full, clear, concise, and exact terms as so to indicate that the applicant had possession at the time of the filing of the present application. Thus, the written description requirement has not been satisfied.
Claims 2-8 are rejected for depending on claim 1.
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.
Claims 2-3 and 4 are 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 2 recites the phrase “wherein the bacterium has a property that proportion of malic acid and lactic acid in organic acids in fermentation products is 20% or higher” which renders the claim indefinite. It is unclear if the malic acid and the lactic acid are part of a greater organic acid compound(s) or if they are just the organic acids themselves. Further, it is unclear if the recited 20% or higher refers to the combination of malic acid and lactic acid or them individually. For examination purposes, the limitations are interpreted to mean malic acid and lactic acid are the organic acids in the fermentation products and combined they make up 20% or higher of the fermentation products.
Claim 3 recites the phrase “wherein the bacterium has a property that proportion of succinic acid, malic acid, propionic acid and lactic acid in organic acids in fermentation products is 65% or higher” which renders the claim indefinite. It is unclear if the succinic acid, malic acid, propionic acid and lactic acid are part of a greater organic acid compound(s) or if they are just the organic acids themselves. Further, it is unclear if the recited 65% or higher refers to the combination of the succinic acid, malic acid, propionic acid and lactic acid or them individually. For examination purposes, the limitations are interpreted to mean succinic acid, malic acid, propionic acid and lactic acid are the organic acids in the fermentation products and combined they make up 65% or higher of the fermentation products.
Claim 4 recites the phrases “a major menaquinone” and “a most major bacterial fatty acid of the bacterium is anteiso-C15:0” which render the claim indefinite as one could not ascertain what “major” or “most major” are referring to and the instant specification does not provide a clear definition of the term either. It is unclear if “major” or “most major” means the menaquinone and the bacterial fatty acid are greatest in quantity or if they are merely one of the most prolific menaquinones or bacterial fatty acids present. For examination purposes, the phrases are interpreted to mean MK11 and anteiso-C15:0 are present in the bacterium.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards a natural product without significantly more.
With regards to Step 1, the Prevotella bacterium in claims 1-8 is a natural product.
With regards to Step 2A, prong one, claims 1 and 5-8 recite a Prevotella bacterium. Dependent claims 2-4 recite additional elements of the properties of the Prevotella bacterium. The claimed Prevotella species is considered to be a judicial exception. The specification recites that the Prevotella strain was isolated from dairy cows (see specification pg. 14 – “Example 1”), and there is nothing to indicate that the strain is an any way different from what would be found in nature. The additional claimed elements of the properties of the Prevotella bacterium such as the organic acids it produces, its Gram-negative and non-spore forming status, its catalase test results, its obligate anaerobic status, the acids it does and does not generate when specific sugars are added, the major menaquinone and fatty acid it contains, and its GC content are judicial exceptions as well as they are natural products with no further modifications. Nor do these elements interact with each other in any way to form a materially different structure. It should be noted that the mere isolation of a bacterial organism from its natural environment is not patent eligible, and would require the microbe to be modified (e.g. freeze-dried) in order to be considered a non-natural product and thus patent eligible.
With regards to Step 2A, prong two, claims 1-8 do not recite any additional elements to the Prevotella bacterium to integrate into the instant application. Claims 2-4 recite the properties of the bacterium, but they do not change the natural structure or inherent functionality of the strain to practically integrate it. As such, there are no elements in addition integrated that apply or use the judicial exception in some other meaningful way.
With regards to Step 2B, claims 1-8 do not recite any elements other than the Prevotella bacterium and the additional elements of the bacterium’s properties. As such, claims 1-8 do not recite additional elements that either alone or together amount to significantly more than the judicial exception itself and are therefore not patent eligible.
For the following reasons, claims 1-8 are not deemed to encompass patent eligible subject matter under 35 USC § 101. Claims 2-8 are rejected for depending on claim 1.
Conclusion
Claims 1-8 are not allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/E.R.W./Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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