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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/27/2025 has been entered.
Status of the Claim
Claims 1, 5-6 and 8-14 are pending. Claims 1 and 5-6 are under examination. Claims 8-14 are withdrawn. Any objections or rejections not repeated below have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 lines 11-15 recite, “an acid stable serine protease derived from Nocardiopsis dassonvillei subsp. dassonvillei DSM 43235 (A1918L1), Nocardiopsis prasina DSM 15649 (NN018335L1), Nocardiopsis prasina (previously alba) DSM 14010 (NN18140L1), Nocardiopsis sp. DSM 16424 (NN018704L2), Nocardiopsis alkaliphila DSM 44657 (NNO19340L2) and Nocardiopsis lucentensis DSM 44048 (NN019002L2).” However, this recitation contains scientific names, which should be italicized. The limitation should read as follows, “an acid stable serine protease derived from Nocardiopsis dassonvillei subsp. dassonvillei DSM 43235 (A1918L1), Nocardiopsis prasina DSM 15649 (NN018335L1), Nocardiopsis prasina (previously alba) DSM 14010 (NN18140L1), Nocardiopsis sp. DSM 16424 (NN018704L2), Nocardiopsis alkaliphila DSM 44657 (NN019340L2) and Nocardiopsis lucentensis DSM 44048 (NN019002L2). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 and 5-6 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 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.
Claim 1 recites, “phytase in such amounts that the specific activity in the feed is between 1,000 FYT/kg feed and 54,000 FYT/kg feed.” The specification states on pg. 3 lines 30-32, “It is at present contemplated that the phytase is administered in such amounts that the specific activity in the final feed is between 1000 FYT/kg feed and 5000 FYT/kg feed.” There is no mention in the disclosure of the phytase activity in the feed being above 5000 FYT/kg feed, let alone 54,000 FYT/kg feed.
Claims 5-6 are rejected based on their dependence to a rejected claim.
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.
Claims 1 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fru et al., US 20170119017 (cited on IDS dated 02/04/2020).
Regarding claim 1, Fru teaches a method for improving the nutritional value of animal feed [0002]. Fru teaches the method comprising the step of administering to the animal a feed (applying to the monogastric animal a feed) comprising at least one protease in combination with at least one phytase [0002], [0101].
Fru teaches wherein the feed comprises (i) a mixture of corn and soybean meal diet (animal feed composition contains at least one vegetable protein or protein source such as maize (corn) and soybeans; [0183]).
Fru discloses the feed comprises (ii) the protease in such amounts that the specific activity in the feed is between 10,000 units/kg feed and 30,000 units/kg feed ([0009], Claim 1). This is the same as the claimed range of 10,000 units/kg feed and 30,000 units/kg feed.
Fru teaches the feed comprises (iii) the phytase in such amounts that the specific activity in the feed is between 1,000 FYT/kg feed and 4,000 FYT/kg feed ([0008], Claim 1). This is within the claimed range of 1,000 and 54,000 FYT/kg feed.
Fru teaches wherein the at least one protease comprises an acid stable serine protease derived from Nocardiopsis dassonvillei subsp. dassonvillei DSM 43235 (A1918L1), Nocardiopsis prasina DSM 15649 (NN018335L1), Nocardiopsis prasina (previously alba) DSM 14010 (NN18140L1), Nocardiopsis sp. DSM 16424 (NN018704L2), Nocardiopsis alkaliphila DSM 44657 (NN019340L2) and Nocardiopsis lucentensis DSM 44048 (NN019002L2) (Claim 7).
Regarding the limitation, “wherein the administering of the feed increases the standardized ileal digestibility of threonine, proline and cysteine available in the feed,” the method of Fru is identical to the claimed method, as shown by the above rejection. Since Fru teaches a substantially identical method to the claimed method, the method of Fru is considered to have the same effects, specifically the effect of increasing the standardized ileal digestibility of threonine, proline and cysteine in a farm animal. Thus, the method of Fru is considered to have the effects as claimed. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claim 5, Fru teaches the phytase is classified as belonging to the EC 3.1.3.26 group (Claim 4).
Regarding claim 6, Fru teaches the protease comprises an acid stable serine protease derived from derived from Nocardiopsis dassonvillei subsp. dassonvillei DSM 43235 (A1918L1), Nocardiopsis prasina DSM 15649 (NN018335L1), Nocardiopsis prasina (previously alba) DSM 14010 (NN18140L1), Nocardiopsis sp. DSM 16424 (NN018704L2), Nocardiopsis alkaliphila DSM 44657 (NN019340L2) and Nocardiopsis lucentensis DSM 44048 (NN019002L2) (Claim 7). As stated in the instant specification pg. 4 lines 23-28, proteases such as those derived from comprises an acid stable serine protease derived from derived from Nocardiopsis dassonvillei subsp. dassonvillei DSM 43235 (A1918L1), Nocardiopsis prasina DSM 15649 (NN018335L1), Nocardiopsis prasina (previously alba) DSM 14010 (NN18140L1), Nocardiopsis sp. DSM 16424 (NN018704L2), Nocardiopsis alkaliphila DSM 44657 (NN019340L2) and Nocardiopsis lucentensis DSM 44048 (NN019002L2) are obtainable from the order Actinomycetales. Thus, the at least one protease of Fru is considered to be an acid stable serine protease obtained or obtainable from the order Actinomycetales.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Cowieson et al., The effect of a mono-component exogenous protease and graded concentrations of ascorbic acid on the performance, nutrient digestibility and intestinal architecture of broiler chickens, in view of Vest et al., Nutrition for the Backyard Flock, University of Georgia Extension, Accessed at: https://extension.uga.edu/publications/detail.html?number=C954&title=nutrition-for-the-backyard-flock# and Lassen et al. (US 20080286415) and as evidenced by Ward et al. (US 20140314910).
Please note the basis of the rejections below for Cowieson and Vest are based off the page numbers added to the reference.
Regarding claims 1 and 6, Cowieson teaches a method for increasing standardized ileal digestibility of threonine, proline and cysteine in a farm animal (increasing E ileal digestibility of nitrogen and all amino acids; Abstract). Cowieson discloses the step of administering to the animal a feed (broiler chickens fed a wheat/soy-based diet; Abstract), as required by claim 1. Cowieson teaches the feed (mixing with wheat meal or soybean meal) comprises at least one protease (exogenous protease) in combination with at least one phytase (pg. 2 paragraph 2.1; Tables 1-2), as required by claim 1.
Cowieson does not disclose wherein the feed comprises (i) a mixture of corn and soybean meal diet, as required by claim 1. Vest teaches a method of providing the right nutrition for chickens by supplying the chickens with all the nutrients they will need to produce meat or eggs (pg. 1 paragraph 2). Vest discloses feeding animals (chickens) a mixture of corn and soybean meal diet (mixing ingredients like corn and soybean meal) as this results in approaching a good balance of necessary amino acids for the chickens (pg. 2 Protein paragraph 2).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified Cowieson to incorporate the teachings of Vest by having the feed be a mixture of corn and soybean meal diet because this mixture results in a feed that approaches a good balance of necessary amino acids for the animal (chicken), as recognized by Vest (pg. 2 Protein paragraph 2).
Cowieson teaches the feed comprises (ii) the protease (RONOZYME ProAct) in such amounts that the specific activity in the feed is 15,000 units/kg feed (pg. 2 paragraph 2.1; Table 2, see footnotes). This is within the claimed range for claim 1 of 10,000 to 30,000 units/kg of feed.
Cowieson teaches the feed comprises (iii) the phytase (RONOZYME HiPhos GT) in such amounts that the specific activity in the final feed is 1000 FYT/kg (pg. 2 paragraph 2.1; Table 1, see footnotes). This is the same endpoint of the claimed range for claim 1 of between 1000 to 54,000 FYT/kg of feed.
Cowieson teaches the protease is RONOZYME ProAct, a serine protease (pg. 2 paragraph 2.1). As evidenced by Ward, RONOZYME ProAct is an acid stable protease, specifically the proteases according to the invention are acid stable serine proteases, as required by claim 1, obtained from bacteria of the order Actinomycetales, as required by claim 6 [0013], [0024], [0090]. Therefore, Cowieson as evidenced by Ward, teaches the protease is RONOZYME ProAct, which is an acid stable serine protease obtained or obtainable from the order Actinomycetales.
Cowieson does not teach the protease is derived from Nocardiopsis dassonvillei subsp. dassonvillei DSM 43235 (A1918L1), Nocardiopsis prasina DSM 15649 (NN018335L1), Nocardiopsis prasina (previously alba) DSM 14010 (NN18140Ll), Nocardiopsis sp. DSM 16424 (NN018704L2), Nocardiopsis alkaliphila DSM 44657 (NN019340L2) and Nocardiopsis lucentensis DSM 44048 (NN019002L2), as required by claim 1.
Lassen teaches adding proteases to animal feed to improve digestibility of the feed (Abstract; [0216]). Lassen discloses protease derived from Nocardiopsis dassonvillei subsp. dassonvillei DSM 43235, Nocardiopsis prasina DSM 15649, Nocardiopsis prasina DSM 14010, Nocardiopsis sp. DSM 16424, Nocardiopsis alkaliphila DSM 44657 and Nocardiopsis lucentensis DSM 44048, as required by claim 1 [0251-0253]; [0292-0293]; [0332-0333]; (Abstract). Lassen teaches the proteases are acid-stable serine proteases, as required by claim 1 and are obtained or obtainable from the order Actinomycetales, as required by claim 6 (Abstract), [0019-0024], [0052]. Lassen also discloses adding these proteases to improve the availability of proteins leading to improved digestibility and increased protein extraction, higher protein yields and improved protein utilization. This increases the nutritional value of the feed causing the growth rate, weight gain and feed conversion of the animal to be improved [0184], [0216].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified Cowieson in view of Vest, to have incorporated the teachings of Lassen to have at least one protease be an acid stable serine protease derived from Nocardiopsis dassonvillei subsp. dassonvillei DSM 43235, Nocardiopsis prasina DSM 15649, Nocardiopsis prasina DSM 14010, Nocardiopsis sp. DSM 16424, Nocardiopsis alkaliphila DSM 44657 and Nocardiopsis lucentensis DSM 44048, as required by claim 1, and obtained or obtainable from the order Actinomycetales, as required by claim 6, to increase the nutritional value of the animal feed causing the growth rate, weight gain and feed conversion of the animal to be improved, as recognized by Lassen [0184], [0216].
Cowieson teaches wherein the administering of the feed increases the standardized ileal digestibility of threonine, proline and cysteine (improving the ileal digestibility of all amino acids tested, which include threonine, proline and cysteine; Table 6; pg. 8, paragraph 1, lines 4-5) available in the feed, as required by claim 1. Table 6 of Cowieson shows the effect of adding protease (PROT) on apparent ileal digestibility on amino acids. The measured response for threonine (Thr), proline (Pro) and cysteine (Cys) increases when protease (PROT) is added (Table 6) to the diet. Cowieson further discloses the protease addition to the diet resulted in a significant increase in the digestibility of all amino acids (pg. 8, paragraph 1, lines 4-5).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cowieson et al., The effect of a mono-component exogenous protease, in view of Vest et al., Nutrition for the Backyard Flock, and Lassen et al. (US 20080286415) and as evidenced by Ward et al. (US 20140314910) as applied to claim 1 above, and as evidenced by European Food Safety Authority, Safety and efficacy of RONOZYME HiPhos as a feed additive for sows and fish and further evidenced by The European Commission, Commission Implementing Regulation (EU) No 837/2010. Hereinafter, European Food Safety and European Commission, respectively.
Please note the basis of the rejections below for European Food Safety and European Commission are based off the page and paragraph numbers added to the reference.
Regarding claim 5, Cowieson teaches the phytase is RONOZYME HiPhos (pg. 2 paragraph 2.1). As evidenced by European Food Safety, RONOZYME HiPhos is a preparation of 6-phytase produced by Aspergillus oryzae (DSM 22594), (pg. 1 Abstract; pg. 5 paragraph 1.2). In European Commission, it is stated 6-phytase produced by Aspergillus oryzae (DSM 22594), is EC 3.1.3.26 (pg. 1 [0005]). Therefore, Cowieson as evidenced by European Food Safety and European Commission, teaches phytase is RONOZYME HiPhos which is a phytase classified as belonging to the EC 3.1.3.26 group.
Response to Arguments
Applicant's arguments filed 05/27/2025, with respect to the 103 rejection of modified Cowieson, have been fully considered but they are not persuasive.
Rejection under 35 U.S.C. § 103
Applicant argues on pgs. 5-7 of their remarks that the claimed method is not obvious over the cited art because it provides unexpected advantage of a synergistic effect of the standardized ileal digestibility (SID) of threonine, proline and cysteine in the context of a specialized corn/soybean meal diet. The applicant observed this synergistic effect as surprising and believe that a skilled person considering the references would not have had a reason to expect the phytase and protease in the feed would have a synergistic effect on the SID of threonine, proline and cystine in the context of a corn/soybean meal diet. However, the Office disagrees for the following reasons.
The method of Cowieson in view of Vest and Lassen teaches a substantially identical method to the claimed method, as shown by the above rejection. Since modified Cowieson teaches a substantially identical method to the claimed method, the method of modified Cowieson is considered to have the same effects, specifically a synergistic effect of the standardized ileal digestibility of threonine, proline and cysteine in the context of a specialized corn/soybean meal diet. Thus, the method of modified Cowieson is considered to have the effects as claimed. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Additionally, Cowieson does teach wherein the administering of the feed increases the standardized ileal digestibility of threonine, proline and cysteine (improving the ileal digestibility of all amino acids tested, which include threonine, proline and cysteine; Table 6; pg. 8, paragraph 1, lines 4-5) available in the feed. While Cowieson teaches the feed is a mixed wheat and soybean meal feed (pg. 2 paragraph 2.1), it would have been obvious to a person of ordinary skill in the art to apply the same method used by Cowieson to a feed mixture of corn and soybean meal because this mixture results in a feed that approaches a good balance of necessary amino acids for the animal (chicken), as recognized by Vest (pg. 2 Protein paragraph 2). Thus, the method of modified Cowieson is expected to have substantially similar results on a mixed corn and soybean meal diet that provides a good balance of necessary amino acids for the animal as a mixed wheat and soybean meal feed, of having an improved ileal digestibility of all the amino acids tested, which include threonine, proline and cysteine.
Moreover, regarding Applicant’s arguments of unexpected advantage of a synergistic effect of the standardized ileal digestibility (SID) of threonine, proline and cysteine in the context of a specialized corn/soybean meal diet, Applicant has not shown any evidence that the unexpected advantage occurs over the entirety of the claimed ranges. Claim 1 states the protease activity in the feed is between 10,000-30,000 units/kg feed and the phytase activity is between 1,000-54,000 FYT/kg feed. However, as shown in the specification in Table 3 pgs. 17-18, the corn and soybean meal diet formulation with the phytase (RONOZYME HiPhos GT) and Protease (RONOZYME ProAct CT), were formulated to have a phytase activity of 3000 FYT/kg and protease activity of 15,000 FYT/kg feed, only one iteration within the broad claimed ranges of these two ingredients have been tested. Because Applicant only shows as evidence one formulation that have limited relative proportion ranges, Applicant does not provide an adequate basis for concluding that similar results would be obtained within the scope of the generic broad ranged claimed in claim 1. Thus, the results obtained are not commensurate in scope with the claimed invention. See MPEP 716.02(d).
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759