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 .
The Response of 15 June 2026 has been entered.
Claims 1-10 are currently pending.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1-7, and a Bacillus sp. protease in the reply filed on 15 June 2026 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 was made without traverse in the reply filed on 15 June 2026.
Claims 1-7 are considered here with respect to the elected species of protease.
Claim Rejections - 35 USC § 112(b) (indefiniteness)
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.
Claims 1-7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 1, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Claim 1 recites the broad recitation "one or more proteolytic enzyme(s)", and the claim also recites "i.e., protease(s)" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 2, 4, 5 and 7, the claims contain numerous recitations of "preferably" or "more preferably" (claim 2), "such as" (claims 4 and 5), "e.g." or "for example" (claims 4, 5 and 7), which renders the claims indefinite because it is unclear whether the limitation(s) following the phrase(s) are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 recites "wherein the protease is an acid stable serine protease obtained or obtainable from the Genus: … as well as homologous proteases." It is unclear how the phrase "as well as homologous proteases" limits the claim.
For purposes of applying prior art, the claims are examined with respect to the elected species of a Bacillus sp. protease and such that the language following the exemplary terms are non-limiting.
Claim Rejections - 35 USC § 102
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.
Claims 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US20200281225 to Kiarie et al. (cited in IDS of 20 June 2024), as evidenced by Viswanathan et al., Macromolecules 43.12 (2010): 5245-5255.
Regarding claim 1, Kiarie teaches a method for reducing the production of ammonia in the manure of an animal, comprising administering to the animal a feed composition comprising a protease in combination with a microorganism (direct fed microbial (DFM)) ([0007]; [0013]-[0015]; [0017]; [0089]-[0097]; [0240]; Examples 2 and 3; claim 16; Figs. 3 and 5).
Regarding claims 2-4, Kiarie teaches that the protease can be Multifect P3000 ([0092] Examples 2 and 3). Viswanathan evidences that Multifect P3000 is a serine protease from a Bacillus sp. (p. 5247, under Materials).
Regarding claim 7, Kiarie teaches that the protease can be administered in an amount in range of about 1000 units/kg to about 200,000 units/kg feed ([0092]), including 5000 units/kg (Examples 2 and 3).
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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kiarie, as applied to claims 1-4 and 7 above, in view of US20200229463 to Haahr et al.
Claims 5 and 6 differ from Kiarie, as applied to claims 1-4 and 7 above, in that: the protease is acid stable (claim 5); and the protease is acid stable and thermostable (claim 6).
Regarding claim 5, Haahr teaches feed compositions comprising a microbial protease and a microorganism (DFM), wherein the protease is an acid stable S8 serine protease derived from a Bacillus sp. ([0080]; [0093]-[0133]). The protease has significant activity in the acidic pH range and can thus be considered "acid stable" (Example 4, Table 4; Example 15; see also, Published instant Spec. US20250057926, [0017] which cites the PCT counterpart of Haahr as disclosing acid stable proteases). Haahr teaches that proteases are capable of aiding digestion and releasing additional nutrients, and that acid stable proteases allow for activity along the length of the digestive tract which contains segments with acidic pH ([0004]-[0005]).
Regarding claim 6, Haahr teaches that the protease can further be a thermostable protease ([0217]-[0219]; Example 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to carry out the method of Kiarie for reducing ammonia production in an animal by administering a feed comprising a Bacillus-derived serine protease wherein the protease is an acid stable protease as taught by Haahr because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to use an acid stable protease as taught by Haahr in the method of Kiarie because Haahr teaches that acid stability allows the proteases to be active along the length of the digestive tract including acidic segments. Using an acid stable protease as taught by Haahr in the method of Kiarie would have led to predictable results with a reasonable expectation of success because Haahr teaches use of such acid stable proteases in a substantially similar animal feed composition to that of Kiarie, comprising the protease and a microorganism/DFM component.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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