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 .
Response to Amendment
This action is written in response to applicant’s amendments received on 10/8/25.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Objections to the claims are overcome by amendment.
The rejection of claims 2, 3 5, 6, 9-13 under 35 USC 112(a) and (b) is overcome by amendment.
The rejection of claims 1, 2, 4, 5, 7, 9, and 13-15 under 35 USC 102 is overcome by amendment.
Any objection or rejection not reiterated herein has been overcome by amendment.
Information Disclosure Statement
The IDS filed on 9/7/22 has been fully considered except where references have been lined through.
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.
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 1-2, 7-9, and 11-15, are rejected under 35 U.S.C. 103 as being unpatentable over Lichtenstein (US20160369320A1).
Regarding claims 1 and 7, Lichtenstein teaches methods and kits for measuring protease activity in feed (title and abstract). Lichtenstein teaches that a feed sample is contacted with an extraction buffer to form a protease extract (feed extract, instant claim 1a). Lichtenstein teaches the feed extract is mixed with a reaction buffer and a protease substrate (claim 19, instant claim 1b). Lichtenstein teaches the protease substrate can be N-succinyl-Ala-Ala-Pro-Phe-p-nitroanilide (pNA) (claim 21). Lichtenstein teaches p-nitroanilide is a chromophore ([0060]). Ala-Ala-Pro-Phe are amino acids (polypeptide). Lichtenstein teaches the reaction buffer comprises SDS and phosphate (see e.g. claims 5 and 9). Lichtenstein teaches the extraction buffer comprises polyoxyethylene (20) sorbitol monolaurate (claim 18). Lichtenstein teaches polyoxyethylene (20) sorbitol monolaurate is Tween 20 ([0067]). As evidenced by instant specification [0024], Tween 20 is a polysorbate surface active agent. Lichtenstein teaches the extraction solution can be aqueous buffer solution (comprises H20) ([0078]). Lichtenstein teaches the reaction mixture is incubated (claim 13). Lichtenstein teaches that the reaction that occurs results in a color change as the pNA is released from the peptide substrate ([0119], instant claim 1c). Lichtenstein teaches the protease activity is assessed using color change in reaction mixture (claim 1 and claim 6, instant claim 1d). While Lichtenstein does not teach a specific embodiment with a serine protease, Lichtenstein teaches serine proteases are preferred ([0051]) and “those of skill in the art should, in light of the present invention, appreciate that many changes can be made in the specific embodiments which are disclosed and still obtain a like or similar result without departing from the spirit and scope of the invention” ([0102]).
Therefore, it is prima facia obvious to experiment within the options provided within the inventive parameters taught by Lichtenstein.
Regarding claim 2, Lichtenstein teaches the feed sample can be mash animal feed or pelleted animal feed (claim 2) which reads on the broadest reasonable interpretation of instant claim 2 which is drawn to “any form of feed for animals”.
Regarding claim 8, Lichtenstein teaches that in preferred embodiments, the reaction buffer can comprise glycine ([0064]). Lichtenstein teaches the reaction buffer can comprise TRIS (tris(hydroxymethyl)aminomethane), TRIS HCl, 3-{[tris(hydroxymethyl)methyl]amino}propanesulfonic acid (TAPS), N,N-bis(2-hydroxyethyl)glycine (Bicine), tris(hydroxymethyl)methylamine (tris), N-tris(hydroxymethyl)methylglycine (tricine), 3-[N-Tris(hydroxymethyl)methylamino]-2-hydroxypropanesulfonic acid (TAPSO), 4-2-hydroxyethyl-1-piperazineethanesulfonic acid (HEPES), 2-{[tris(hydroxymethyl)methyl]amino}ethanesulfonic acid (TES), 3-(N-morpholino)propanesulfonic acid (MOPS), piperazine-N,N′-bis(2-ethanesulfonic acid) (PIPES), dimethylarsinic acid (cacodylate), saline sodium citrate (SSC), 2-(N-morpholino)ethanesulfonic acid (MES), 2(R)-2-(methylamino)succinic acid (succinic acid), borate, phosphate, acetate, glycine, magnesium or calcium carbonate, and bicarbonate ([0071]).
Regarding claim 9, Lichtenstein teaches that the SDS concentration can be 0.01-10% (claim 5). This overlaps the claimed range and therefore the claimed range is obvious.
Regarding claim 11, Lichtenstein teaches the reaction buffer can comprise NaCl ([0071]). Lichtenstein teaches the reaction buffer can comprise potassium chloride (KCl), reducing agents such as dithiothreitol (DTT), β-mercaptoethanol (BME), and tris(2-carboxyethyl)phosphine (TCEP), bulking agents such as dextran sulfate, polyethylene glycol (PEG), an anti-foaming agent to prevent excessive foaming or frothing, enzymatic inhibitors, and tetraethylene glycol, and others.
Regarding claim 12, Lichtenstein teaches the reaction buffer can comprise glycine ([0071]). Lichtenstein teaches the reaction buffer comprises SDS (claim 9). Lichtenstein teaches the extraction buffer comprises polyoxyethylene (20) sorbitol monolaurate (claim 18). Lichtenstein teaches polyoxyethylene (20) sorbitol monolaurate is Tween 20 ([0067]). As evidenced by instant specification [0024], Tween 20 is a polysorbate surface active agent
Regarding claim 13, Lichtenstein teaches that the reaction mixture can be incubated at 50oC (example 6).
Regarding claim 14, Lichtenstein teaches the signal (protease activity) Can be observed by looking at color differences (qualitatively) (example 7 and fig 8).
Regarding claim 15, MPEP 2141 [R-6] KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007). It is well-settled law that combining printed instructions and an old product into a kit will not render the claimed invention nonobvious even if the instructions detail a new use for the product. See In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). Lichtenstein teaches the kits can comprise an extraction buffer (solution), a protease substrate (comprises a chromophore, see rejection of claim 1), a reaction buffer (comprises SDS, see rejection of claim 1), and instructions for using the kit (“II. Kits” section).
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lichtenstein (US20160369320A1), as applied to claims 1, 2, 4, 5, 7, 9, and 13-15 above, and further in view of Yu (WO2018005229A1). Claim 16 is further evidenced by Foldesi (“Guide to Enzyme Unit Defnitions and Assay Design” retrieved from https://www.biomol.com/resources/biomol-blog/guide-to-enzyme-unit-definitions-and-assay-design#:~:text=A%20standard%20curve%20is%20always,a%20suitable%20range%20of%20concentrations on 5/29/25).
Regarding claim 6, Lichtenstein teaches that the extraction buffer can comprise Tween 20 in the range of 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, or about 1.0% by weight (w/v) ([0081]). Lichtenstein teaches that suitable extraction buffers are known in the art ([0078]). Lichtenstein does not explicitly teach the extraction buffer comprising NaCl.
Yu teaches assays for proteases in feed (abstract). Yu teaches that the feed can be extracted using buffer A (example 5). Yu teaches buffer A comprises NaCl (example 3).
Yu teaches the NaCl concentration in the extraction buffer can be 0.5M (500mM) (example 3).
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the extraction buffer of Yu in the method of Lichtenstein. One of ordinary skill in the art would be motivated to do so because Lichtenstein teaches that suitable extraction buffers are known in the arts. Further, one of ordinary skill in the art would be motivated to do so because these extraction buffers have been successfully used to extract feed before a protease assay is performed, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.
There would be a reasonable expectation of success as both Lichtenstein and Yu are in the same field of endeavor of conducting protease assays on extracted feed.
Regarding claim 16, Yu teaches that standard curves shall be made using standard enzyme concentrations (solutions) (example 6). As evidenced by Foldesi, standard curves are always required to determine enzyme activity (“standard curve” section). Therefore, one of ordinary skill in the arts would be motivated to include standard enzymes for preparing a standard curve.
Response to Arguments
Applicant's arguments filed 10/8/25 have been fully considered but they are not persuasive. Applicant argues that the new claim amendments overcome the rejections (p7-8). This is nor persuasive, see the rejection above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657