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 .
Election/Restrictions
Applicant’s election without traverse of Group III, claims 6-8 in the reply filed on 11-16-2025 is acknowledged.
Claims 1-5 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 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 6-8 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 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 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 no indication that Applicants deposited the biological material as disclosed in Claims 6-8; there is no indication regarding public availability.
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.
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 7 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 7 recites the limitation "wherein the ratio of " in line 15. There is insufficient antecedent basis for this limitation in the claim. There is no corresponding ratio recited and what specific entities the ratio is recited to, is not clear. It is not clear if the ratio is referencing the ratio of the strain P. pentosaceus EL5 to the silage raw materials or the total composition of silage raw materials.
Claim 7 recites the limitation "the number of viable strains" in lines 15-16. There is insufficient antecedent basis for this limitation in the claim. There are no corresponding strains recited and a singular strain of P. pentosaceus EL5 is disclosed. Applicant may have meant to share ‘cells’ instead of ‘strains’.
Claim Rejections - 35 USC § 103
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) 6-8 are rejected under U.S.C. 103 as obvious over Rehberger, T. et al., (US20170340682A1; published 2017-11-30) and in view of Guiqin, Z. et al., (CN112877238A; published 2021-06-01).
With regards to claims 6-8, Rehberger, T. et al., teaches the preparation of a fermented silage by mixing silage raw material alfalfa and Pediococcus pentosaceus. Wherein, Pediococcus pentosaceus (a lactic acid bacteria; LAB) are commonly utilized as silage inoculates to promote proper fermentation and optimal preservation of silage (page 2, paragraph 0011). In the prior art, Pediococcus pentosaceus P75 is a LAB in the composition (page 11, paragraph 0205) and the LAB inoculant may be applied at about 1.5 x105 CFU/g of the silage raw materials (page 11, paragraph 0206). Pediococcus pentosaceus and/or other direct fed microbial(s) is used in combination with silage preparation and with forage, feed materials including alfalfa (page 16, paragraph 0327).
The broadest reasonable interpretation of claims 6-8, is a method of a fermentative process to prepare a silage which includes the raw material of alfalfa with Pediococcus pentosaceus EL5.
Rehberger, T. et al., does not teach the strain Pediococcus pentosaceus EL5.
However, Guiqin et al., teaches the strain Pediococcus pentosaceus OL77 having 16S rDNA sequence (SEQ ID NO:1) with 99.4% identity to present SEQ ID NO:1 of Pediococcus pentosaceus EL5, and a biologically pure culture of Pediococcus pentosaceus OL77 (see attached Comparison of Sequences; Exhibit 1). Guiquin et al., teaches the method of Pediococcus pentosaceus OL77 in the fermentation of forage silage, using oat to yield silage at lower temperatures, rapid pH reduction, rapid fermentation, retainment of forage nutrients, and reduced contamination by harmful microorganisms (‘Disclosure of Invention’, paragraph 1).
Subsequently, it would have been obvious to one of ordinary skill in the art to modify the methods of Rehberger, T. et al., with the simple substitution of Pediococcus pentosaceus OL77. The motivation for this modification would be to improve the fermentation process of said forage, alfalfa, to produce a silage with the added benefits taught by Guiquin et al., which includes: the yield of silage at lower temperatures, rapid pH reduction, rapid fermentation, retainment of forage nutrients, and reduced contamination by harmful microorganisms (‘Disclosure of Invention’, paragraph 1). Since, Rehberger, T et al., and Guiquin et al., both teach methods for silage production using Pediococcus pentosaceus strains with forage, it would be prima facie obvious to substitute Pediococcus pentosaceus OL77 in place of Pediococcus pentosaceus P75 to successfully produce a silage using the combined methods described.
Alternatively, it would have been obvious to one of ordinary skill in the art at the effective date of filing to modify the teachings of Rehberger, T. et al. in view of Guiqin et al., and utilize an obvious variant, Pediococcus pentosaceus EL5. The motivation to use an alternative strain of Pediococcus pentosaceus amounts to the simple substitution of functional equivalents, wherein substitution of one known strain for another would have been obvious based on the shared functional properties of the method and composition described in the prior art for Pediococcus pentosaceus P75 (as taught by Rehberger, T. et al.) and Pediococcus pentosaceus OL77 (as taught by Guiqin et al.): a lactic acid bacteria used at about 1.5 x105 - 2.0 x 106 CFU/g of raw materials in the preparation of a silage, in which the raw material is a forage. One would have reasonably expected success, since 16S rDNA from Pediococcus pentosaceus EL5 has 99.4% sequence identity with 16S rDNA from Pediococcus pentosaceus OL77, demonstrating the strains are identical or obvious variants. Also, the combined methods of Rehberger, T et al and Guiqin et al., share the same properties of a silage preparation method, by way of Pediococcus pentosaceus and a raw material of alfalfa.
Since the prior art teaches a silage composed of a raw forage, alfalfa, and Pediococcus pentosaceus, which for the reasons discussed above is the same as the instantly claimed strain or an obvious variant, the prior art will be capable of performing the intended use. Assuming arguendo, applicant demonstrates the strains are structurally different, the method of silage preparation, the raw materials, including Pediococcus pentosaceus and alfalfa are obvious variants and would result in the same outcome.
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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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653