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 .
Claim Status
The amendment of 02/11/2026 has been entered. Claims 1-8 are pending (claim set as filed on 02/11/2026). Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 of invention Group I, claims 1-4, drawn to was made with traverse in the reply filed on 07/30/2025.
Claims 1-4 are currently under examination and were examined on their merits.
Statement Regarding Deposit Of Biological Material
The Statement Regarding Deposit Of Biological Material filed on 02/11/2026 has been received and considered.
Withdrawn Objections/Rejections
The rejection of claims 1-4 under 35 U.S.C. 112(a) as set forth in the previous Office action is withdrawn in light of Applicant’s Statement Regarding Deposit Of Biological Material filed on 02/11/2026.
The rejection of claims 2-3 under 35 U.S.C. 112(d) set forth in the previous Office action is withdrawn in light of the amendment filed on 02/11/2026.
Specification Objections
The objection of the specification is maintained because the amended Table 10 on page 14 of the specification filed on 02/11/2026 is illegible.
A legible substitute specification in compliance with 37 CFR 1.52(a) and (b) and 1.125 is required.
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 combination of judicial exceptions without significantly more. The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S., 133 S. Ct. 2107, 2116, 106 USPQ2d 1972
(2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S.,132 S.
Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an
eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must
(a) not be directed to a judicial exception or must (b) contain additional elements that
amount to significantly more than the judicial exception itself.
'Directed to a judicial exception' analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claims 1-4 recite the microorganism ‘Clostridiurn beijerinckii SIID27451-B11 strain (accession number NITE BP-02951)’ which is considered a natural phenomenon, since it is a natural isolate (“the inventors have found and isolated SIID27 451-B 11 strain (accession number NITE BP-02951)”; see instant specification, paragraph [0005]). Claim 2 further recites genome sequences SEQ ID NO: 1-5 which are considered inherent to Clostridiurn beijerinckii SIID27451-B11 strain (accession number NITE BP-02951)(see specification, paragraphs [0022]-[0024], Table 8), and claim 3 further recites 16S rDNA sequence SEQ ID NO: 6 which is considered inherent to Clostridiurn beijerinckii SIID27451-B11 strain (accession number NITE BP-02951) (see specification, paragraph [0012]).
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No additional elements are cited that would integrate the judicial exception into a practical application.
'Significantly more' analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims do not include any additional elements other than the judicial exceptions.
Therefore, claims 1-4 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112 (b)
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.
Claim 2 is 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 “SEQ ID NO: 1-5”, which renders the claim indefinite since it is unclear if the claim is attempting to claim all the sequences, i.e. the strain contains all the claimed sequences, or if SEQ ID NO: 1-5 are meant to be claimed in the alternative. One of ordinary skill in the art would be unable to determine the metes and bounds of claim 2.
In the interest of compact prosecution, the Examiner is interpreting claim 2 to the broadest embodiment claimed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 are newly rejected as necessitated by amendment under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Alam et al. (“Production of butyric acid by batch fermentation of cheese whey with Clostridium beijerinckii”, published on 01/01/1988, Journal of Industrial Microbiology, Vol. 2, Issue 6, pages 359-364), hereinafter ‘Alam’.
Alam’s general disclosure relates to “the effect of pH on the fermentation of butyric acid by Clostridium beijerinckii using cheese whey as a substrate” (see entire documents, including abstract).
Regarding claims 1-4, pertaining to Clostridium beijerinckii SIID27451-B11, Alam teaches a Clostridium beijerinckii strain. Alam further teaches that the strain has the ability to produce butyric acid ("The effect of pH on the fermentation of butyric acid by Clostridium beijerinckii using cheese whey as a substrate was studied. Maximum concentrations of the acid were produced when the pH was controlled at 5.5."; see abstract and Fig. 1 on page 361), wherein the produced butyric acid amount is significantly higher than the produced acetic acid amount (see Fig. 1 on page 361).
The Examiner notes that the instantly recited assigned strain number S11D27451-B11 and accession number NITE BP-02951 of the claimed strain are a label and do not further characterize the instant strain.
Pertaining to the genome sequences (instant claim 2), please see above under Claim Rejections - 35 USC 112 (b).
Pertaining to the genome and 16S rDNA sequences (instant claims 2-3), it is noted that Applicant isolated the instant strain based on its ability to produce butyric acid (paragraph [0005]), and conducted 16S rDNA and genome sequence analysis in order to identify the taxonomic characteristics of the isolated strain (instant specification, paragraphs [0009], [0012], [0022]-[0028]; see Table 3 on page 6, and Table 7 on page 12). It is further unclear, how the sequence data of the instant strain relate to the strain’s ability to produce butyric acid. Therefore, the claimed strain is interpretated by its ability to produce butyric acid as described in the instant specification and claims ("the present invention provides Clostridium beijerinckii SIID27451-B 11 strain.", "the present invention provides a method for producing butyric acid using S11D27451-B11 strain"; see specification, paragraph [0006] and Example 1 in paragraphs [0029]). According to the specification, the instant Clostridium beijerinckii strain has the ability to produce butyric acid, wherein the amount of butyric acid produced by the strain is significantly higher than the amounts of other produced organic acids, including acetic acid (see specification, paragraph [0029], Table 11 on page 16).
Alam does not expressly teach wherein the Clostridium beijerinckii strain is Clostridium beijerinckii S11D27451-B11 strain (accession number NITE BP-02951) (instant claims 1-4), wherein Clostridium beijerinckii S11D27451-B11 (accession number NITE BP-02951) has the genome sequences shown in SEQ ID NO: 1-5 (instant claim 2), wherein Clostridium beijerinckii S11D27451-B11 (accession number NITE BP-02951) has a 16S rDNA sequence shown in SEQ ID NO: 6 (instant claim 3), and wherein Clostridium beijerinckii S11D27451-B11 according to claim 1 produces more butyric acid and less lactic acid and acetic acid in a culture solution after anaerobically culturing the strain at 37 °C for 72 hours, compared with Clostridium beijerinckii NBRC 109359T, which is a type strain of Clostridium beijerinckii (instant claim 4).
However, based on Alam's teachings, it is highly likely that Alam's strain and Applicant's strain are the same strain since both strains share the ability to produce butyric acid, wherein the amount of produced butyric acid is significantly higher than the amount of produced acetic acid (see above). Thus, it is highly likely that Alam’s strain has the genome sequences shown in SEQ ID NO: 1 to 5, has a 16S rDNA sequence shown in SEQ ID NO: 6, and produces more butyric acid and less lactic acid and acetic acid in a culture solution after anaerobically culturing the strain at 37 °C for 72 hours, compared with Clostridium beijerinckii NBRC 109359T, which is a type strain of Clostridium beijerinckii.
Still, if there should be a slight variation between Alam's strain and the instantly recited strain, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have used the instant strain in lieu of Alam’s strain since both strains, Alam's strain and the instant strain, belong to the species Clostridium beijerinckii, and share the ability to produce butyric acid, wherein the amount of produced butyric acid is significantly higher than the amount of produced acetic acid.
Response to Arguments
Applicant has traversed the previous rejections of claims 1-4 under 35 U.S.C. 101 (remarks, pages 5-10), and of claims 1-4 under 35 U.S.C. 103 (remarks, pages 10-12) in the reply filed on 02/11/2026. Applicant's arguments have been fully considered but they are not persuasive.
Applicant states that “the claims do not recite a natural product or a natural phenomenon, and are therefore patent eligible” (remarks, page 7).
The Examiner responds that the claimed strain appears to be a natural isolate (see specification, paragraph [0005]), and that the instant specification does not provide evidence that the claimed strain and its genomic sequence and 16S rDNA sequence are non-natural phenomenona, i.e. that the claimed strain was modified by Applicant. As such, the claimed strain with its structural and functional characteristics is considered a judicial exception (see MPEP2106.04(b).
Applicant describes that the claimed strain is structurally and functionally different from the Clostridium beijerinckii type strain (remarks, page 7).
The Examiner responds that, as discussed above, the specification does not clearly and persuasively show that the claimed strain is not a natural isolate or that it has been modified. Merely to show two strains are different does not provide a persuasive argument that the instant strain is not natural - it just shows that it has a different structure and function from another C. beijerinckii strain.
Analyzing several different strains and their characteristics does not change the fact that the strain is naturally occurring. Further, analyzing a strain with a desired characteristic and isolating it, does not change the strain is still natural occurring. The specification clearly teaches analysis and categorizing of naturally occurring strains.
If the claimed strain has been modified by Applicant so that it would be structurally different from the naturally occurring strain, evidence is requested.
Applicant states that “the claimed B11 strain as a whole integrates any judicial exception (of which there are none) into a practical application because the claimed method improves the
technology/technical field related to biological applications, such as medicines for intestinal
regulation, and industrial applications, such as the synthesis of fragrances” (remarks, page 8).
The Examiner responds that the claims do not recite any additional elements that would integrate the judicial exception into a practical application. It is noted that an intended use of a claimed product, such as the recited use in instant claim 4, does not integrate the judicial exception into a practical application, as discussed in the interview on 12/18/2025. Please note that claims 1-4 are product claims, and as such, patentable weight is given to the structure of the product, which is not imparted by the intended use recited in claim 4 (see MPEP 2111.01 (II)).
Applicant describes that “B11 produced almost exclusively butyric acid when the amounts of organic acids contained in the medium (Control) are subtracted.", and that “[t]his specific strain of Clostridium exhibiting this property was not known or obvious” (remarks, page 9). Applicant concludes that “claims 1-4 amount to significantly more than any allegedly recited judicial exception” (remarks, page 9).
The Examiner responds that the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because the claims do not include any additional elements other than the judicial exceptions. As discussed above, the specification does not provide evidence that the strain’s functional characteristics are a non-natural phenomenon, and therefore, the functional characteristics are not considered an additional element that would amount to significantly more.
Applicant states that “the Office Action fails to make a prima facie showing that the asserted strain of Alam is identical or substantially identical to the B11 strain disclosed in the Applicant's specification.” (remarks, page 11).
The Examiner responds that the claimed Clostridium bejierinckii strain is interpretated by its described ability to produce butyric acid at a significantly higher level than acetic acid, as discussed above. Alam teaches a Clostridium bejierinckii strain that produces butyric acid at a significantly higher level than the acetic acid (see Fig. 1 on page 361). As such, it is highly likely that Alam's strain and Applicant's strain are the same strain. However, if there should be a slight variation between Alam's strain and the instantly recited strain, it would have been obvious to a skilled artisan to have substituted Alam’s strain with the claimed strain, since both strains, Alam's strain and the instant strain, belong to the species Clostridium beijerinckii, and share the ability to produce butyric acid, wherein the amount of produced butyric acid is significantly higher than the amount of produced acetic acid.
Applicant states that “the pending application further discloses that different strains of
Clostridium produce different amounts of butyric acid. Id. at Table 11”, and that “the B11 strain
of the pending application produced significantly more butyric acid than the other strains of
Clostridium” (remarks, page 11).
The Examiner responds that comparing the claimed strain to other Clostridium strains recited in the instant specification demonstrates the differences between the claimed strain and the other recited Clostridium strains, but it does not show differences between the claimed strain and Alam’s strain. Applicant is requested to provide evidence how the claimed strain differs from Alam’s strain.
Applicant describes that “the pending application provides unexpected results”, since “the B11 strain produced significantly more butyric acid than the other strains of Clostridium Id. at Table 11” (remarks, page 12).
The Examiner notes that no statistical evaluation of the data shown in Table 11 in the specification is provided. As such, proper interpretation of the presented results is not possible (see MPEP 716.02(b) I).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653