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 .
Claims Status
Claims 1 and 4-8 are pending.
Claims 1 and 5-8 are amended.
Claims 2-3 are canceled.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 06/23/2026 is acknowledged. The examiner notes that the requirement for restriction/election of 04/28/2026 was mistakenly based on claims set of 06/28/2024 and not the amended claims of 06/28/2024. As such, the examiner notes the correction that Group I is drawn to claim 1 of the amended claim set of 06/28/2024. The traversal is on the ground(s) that shared technical feature is not merely the taxonomic names of the microorganism but the ability to produce ergothioneine. Applicants argue that neither Donzella et al. nor Yurkov et al. disclose or suggest the microorganisms have the ability to produce EGT. This is not found persuasive because there is no recitation in claim 1 that states that the microorganisms produce ergothioneine.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election of Species Group 1: Vanrija humicola, in the reply filed on 06/23/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/23/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/28/2024, 08/09/2024, 01/09/2025, 02/07/2025, 03/17/2025, 04/14/2025, 05/02/2025, 07/18/2025, 08/28/2025, 10/17/2025, 11/12/2025, 12/24/20525, 01/07/2026, 01/27/2026, 03/06/2026, 04/16/2026, 05/05/2026, and 06/08/2026 is acknowledged. The submission is in compliance with the provision of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 recites “..a microorganism (NITE BP-03572)” and “…a microorganism (NITE BP-03573)”. The identifiers in parenthesis should be italicized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1 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 1 recites “….closely related to Vanrija humicola”. It is unclear what closely related means or how closely related is quantified or defined, therefore the claim is rendered indefinite. In the interest of compact prosecution, the examiner is interpreting closely related as any species related to Vanrija humicola.
Claim 1 recites “a culture of a microorganism (NITE BP-03572)” and “a culture of a microorganism (NITE BP-03573) and “species (Vanrija sp.)”. It is unclear if the identifiers and species enclosed in parentheses are intended to be limitations of the claim, therefore the claim is rendered indefinite. In the interest of compact prosecution, the examiner is interpreting the microorganism as any culture of a microorganism that is related to Vanrija humicola.
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 1 is 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 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. Claim 1 requires a culture of the microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola to practice the invention. As such, the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the strain NITE BP-03573. There is no indication regarding public availability of NITE BP-03573 in accordance with 37 CFR 1.801-1.809.
If the deposit is made under the terms of the Budapest Treaty, then a statement,
affidavit or declaration by Applicants, or by an attorney of record over his or her
signature and registration number, or by someone in a position to corroborate the
facts of the deposit, that the instant invention will be irrevocably and without restriction
released to the public upon the issuance of a patent, would satisfy the deposit
requirements 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
must 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.
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 1 is rejected under 35 U.S.C. 101 because the claim is directed to a natural product without significantly more. The claim recites a culture of a microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola, Yurkov et al. (Yeast, Vol. 35, pg. 353-400, published May 2018) discloses that a number of soil-borne yeast were isolated and described in the beginning of the twentieth century such as vanrija humicola (see pg. 371). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola in culture is claimed.
With regards to Step 1, the culture of the microorganism (NITE BP-03573) belonging to the species Vanrija sp. closely related to Vanrija humicola is a composition of matter.
With regards to step 2A, prong one, claim 1 is directed to a culture of a microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola. There is nothing to indicate that the microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola is any way different from its naturally occurring counterpart (e.g. it is not genetically modified to add/delete a gene). The isolation of an organism from the natural environment without any further alteration does not render the organism non-natural.
With regards to step 2A, prong two, claim 1 does not recite any elements in addition to the culture of a microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola . Recitation of the intended use of application does not in any way change the natural structure or inherent functionality of the microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) belonging to a species (Vanrija sp.) closely related to Vanrija humicola. As such, there is no additional element in claim 1 that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to the culture of the microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola .
With regards to step 2B, claim 1 does not recite any elements in addition to the culture of the microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola . Recitation of the intended use of application does not in any way change the natural structure or inherent functionality of the culture of the microorganism (NITE BP-03573) belonging to a species (Vanrija sp.) closely related to Vanrija humicola . As such, the claim does not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
For the forgoing reasons, the claim is not deemed to encompass patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imanishi et al. (Genome Announcements, Vol. 6, 10.1128/genomea.00068-18; published March 18, 2018) hereinafter referred to as Imanishi.
With regards to claim 1, Imanishi discloses that Vanrija humicola strain UJ1 is produced in culture media (see pg. 1, 1st paragraph).
Therefore, claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imanishi et al. (Genome Announcements, Vol. 6, 10.1128/genomea.00068-18; published March 18, 2018, PMID: 29545290).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE T LOUNTOS whose telephone number is (571)272-0502. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE THEMISTOCLIS LOUNTOS/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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