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
Claims 6 and 7 are pending and under examination. Claims 1-5 are withdrawn. Claim 8 is cancelled.
Claim Objection
Claim 6 is objected to because of the following informalities: the applicant states “MRS solid culture”, applicant has not provided the full name of the media before providing the acronym; MRS is interpreted by the examiner as DeMan-Rogosa-Sharpe agar. Appropriate correction is required.
Withdrawal of Rejection
The amendment has overcome the rejection under 35 U.S.C. 103. The rejection has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
Claims 6-7 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 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. It is apparent that Pediococcus pentosaceus EL5 and strains thereof, is required to practice the claimed 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 strains Pediococcus pentosaceus EL5.
The process disclosed in the specification does not appear to be repeatable. It is not clear that the invention will work with commonly available material and it is not apparent if the biological material(s) considered necessary to make and use the invention is both known and readily available to the public. It is noted that there is indication that Applicants deposited the claimed viable strain(s) of the biological material and provide public availability of the viable strain(s.
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:
during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
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;
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
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.
Regarding arguments addressed to 35 U.S.C. 112(a)
Applicant's arguments filed 05/25/2026 have been fully considered but they are not persuasive.
Argument A: Regarding arguments addressed to 35 U.S.C. 112(a) rejections: Applicant states that there is more than a single strain of Pediococcus pentosaceus EL5.
Response A: The claims require a number of “effective viable strains of Pediococcus pentosaceus EL5”. In the declaration of deposit according to CFR 1.132, it is unclear what constitutes the deposit for Pediococcus pentosaceus EL5 strain(s) —applicant is requested to provide the BP/4 and BP/9 forms for clarification of what was deposited, including any viable strains, and recite the deposit number(s) in at least one claim. To remedy the current rejection, it is suggested that the applicant recite the deposit of P. pentosaceus EL5 as requested and resubmit the declaration. Further, the Pediococcus pentosaceus EL5 strain should be provided as described in the Specification (paragraph 043) with accession number
Accordingly, the rejection under 112(a)-enablement is retained.
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 6 and 7 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. See MPEP 7.34.01.
Claims 6 and 7 are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
For example:
In claim 6, S2, applicant states “the number of effective viable strains of …” (line 6)—the statement lacks antecedent basis, applicant does not have any number of effective viable strains previously recited in the claim, additionally regarding this limitation it is not clear what accounts for the effective viable strains versus viable strain(s) that may not be effective and what constitutes an effect that is acceptable. The term(s) are not defined by the claim, the specification does not provide a standard for ascertaining what constitutes an effective viable strain and therefore one of ordinary skill in the art would not reasonably be apprised of the scope of the invention.
In claim 6, S3, applicant states “super clean workbench” (line 15)—the statement is a relative term(s) which renders the claim indefinite. The term(s) are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree of what would be considered “super clean” versus a clean workbench, and one of ordinary skill in the art would not reasonably be apprised of the scope of the invention.
Claim 6 has multiple sentences and periods in the middle of the claim, claims must be an object of a sentence; each claim must start with a capitalized letter and end with a period. Applicant should review MPEP 608.01(m). Further, applicant should underline newly amended claim language, brackets and strike-through should only be used to indicate deleted information.
Conclusion
No claims are deemed allowable; however, the claims appear to be clear of the art.
Art of Record
Guiqin, Z. et al., (CN112877238A; published 2021-06-01) and Pediococcus pentosaceus OL77 with 99.4% 16S rDNA sequence identity.
THIS ACTION IS MADE FINAL. 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 ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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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.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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