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 amendment filed January 29, 2026 is acknowledged. Claims 16-18, 23-26, and 28-33 are pending in the application. Claims 1-15, 19-22, and 27 have been cancelled.
Claim Objections
Claims 16 and 28 are objected to because of the following informalities:
In claim 16 at line 14, it is suggested to insert “optionally” after “the” and before “conditioned”.
In claim 28 at line 13, it is suggested to insert “optionally” after “the” and before “conditioned”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 29-30 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.
Claim 29 recites “selected from the group consisting of …; or is a mixture of at least two of the aforementioned compounds” at line 1-6. This claim recites improper Markush language and renders the scope of the claim indefinite. Applicant is reminded that claim language defined by a Markush grouping requires selection from a closed group "consisting of" the alternative members. Id. at 1280, 67 USPQ2d at 1196. See also Amgen Inc. v. Amneal Pharmaceuticals LLC, 945 F.3d 1368, 1376-78, 2020 USPQ2d 3197 (Fed. Cir. 2020) (stating that there is a strong presumption that a claim element set off with "consisting of" is closed to unrecited elements.). In a Markush grouping, alternatives may be set forth as "a material selected from the group consisting of A, B, AND C" (emphasis added). See MPEP 2111.03 and 2173.05.
For the purpose of the examination, the Markush language in claim 29 at lines 1-6 is interpreted as “selected from the group consisting of cis/trans-9,11-linoleic acid… and trans/trans-10,12-linoleic acid; or is a mixture of at least two of the aforementioned compounds” (emphasis added).
Claim 30 is not specifically discussed but is rejected due to its dependence on claim 29.
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.
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 16-18, 23-26, and 28-33 are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al. US 20040047894 (hereinafter “Kramer) in view of Luchini et al. US 20090105335 (hereinafter “Luchini”).
With respect to claim 16, Kramer teaches a method comprising the step of administering uncoated feed pellets to animals such as ruminants (paragraphs [0006], [0007], [0017], [0018], [0022], [0028], [0029], [0034], and [0036]).
Regarding the recitation of in pelleted form, a mixture of at least one solid particulate feed component with at least one rumen-labile constituent which has been added to the mixture, wherein the at least one rumen-labile constituent is at least one conjugated linolenic acid (CLA) in claim 16, Kramer teaches mixing conjugated linoleic acid (CLA) with customary feed constituents such as cereals, cereal brans, cereal flours, seed meals, beans, peas, fishmeal, and the like, and the preparation is in the form of pellets (paragraphs [0004], [0022], [0028], [0029], [0034], and [0036]).
Regarding the recitation of wherein the amount of added rumen-labile constituent is in the range of from 0.1% to 20% by weight, based on the total weight of the mixture to be pelleted in claim 16, Kramer teaches the preparation comprises 0.1 to 90% by weight of active compounds which includes 30% or more of CLA (at least 0.03% of CLA in the preparation) and overlaps with the presently claimed range (paragraphs [0004], [0027], [0028], [0034], and [0045]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the recitation of administering to a lactating ruminant in claim 16, Kramer does not expressly disclose the ruminant is lactating.
Luchini teaches supplementing the diet of ruminants, such as dairy cows, with CLAs to enrich the milk with CLAs (paragraphs [0009] and [0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Luchini, to select dairy cows as the ruminants in the method of Kramer with the expectation of success. One of ordinary skill in the art would have been motivated to do so because Kramer and Luchini similarly teach administering CLAs to ruminants, Kramer teaches dairy products of ruminant animals contains CLAs and CLAs have beneficial effects (paragraphs [0004]-[0007]), Luchini teaches the milk is enriched with CLAs as a result (paragraph [0010]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Regarding the recitation of wherein the uncoated pelleted ruminant feed is prepared by a process comprising: a) mixing at least one solid particulate feed component with the at least one rumen-labile constituent; b) optionally conditioning the resulting mixture with steam; c) compressing the optionally conditioned mixture in a pelleting, extruding or expanding device with the action of pressure at temperatures of 60⁰C to 100⁰C to give pellets; and d) cooling and/or drying the resulting pellets in claim 16, Kramer teaches mixing conjugated linoleic acid (CLA) with customary feed constituents such as cereals, cereal brans, cereal flours, seed meals, beans, peas, fishmeal, silage, and the like, and pelleting the preparation to form pellets (paragraphs [0004], [0022], [0028], [0029], [0034], [0036], and [0059]).
However, Kramer does not expressly disclose c) compressing the optionally conditioned mixture in a pelleting, extruding, or expanding device with the action of pressure at temperatures of 60⁰C to 100⁰C to give pellets, and d) cooling and/or drying the resulting pellets.
Luchini teaches supplementing the diet of ruminants, such as dairy cows, with CLAs. Pellets may be formed by blending the CLA with the feed formulation components (grains, silage, meals, and the like), extruding the mixture in an extruder, and drying the pellets (paragraphs [0009], [0010], [0037], [0054], [0079], [0082], [0084], [0089]-[0091], [0093], [0094], and [0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Luchini, to prepare pellets with an extruder and dry the pellets in the method of Kramer with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Kramer and Luchini similarly teach forming pellets with CLAs and feed components, Kramer is not limited to any specific examples of compression devices used, utilizing extruders to prepare pellets and drying pellets were well known in the art before the effective filing date of the claimed invention as shown in Luchini, and said combination would amount to the use of a known steps for their intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the extruding temperatures in the method of Kramer as modified by Luchini through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Luchini teaches the pellets are prepared in an extruder at elevated temperatures which is interpreted to include values above room temperature (paragraph [0110]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[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 II).
With respect to claim 17, modified Kramer is relied upon for the teaching of the method of claim 16.
Regarding the recitation of wherein the CLA is 10-trans, 12-cis-linoleic acid in claim 17, modified Kramer teaches this limitation since Kramer teaches the conjugated linoleic acid (CLA) may include trans-10, cis-12 CLA (paragraphs [0004] and [0028]).
With respect to claim 18, modified Kramer is relied upon for the teaching of the method of claim 16.
Regarding the recitation of wherein the CLA is present as a pure substance or as a natural or synthetic mixture of substances, comprising at least one of these CLAs in claim 18, modified Kramer teaches this limitation since Kramer teaches the CLAs may be prepared synthetically or obtained from natural sources (paragraphs [0004], [0005], [0027], [0028], and [0059]).
With respect to claim 23, modified Kramer is relied upon for the teaching of the method of claim 16.
Regarding the recitation of wherein the lactating ruminant is a cow, goat, or a sheep in claim 23, modified Kramer teaches this limitation since Kramer teaches the ruminants include cattle and sheep (paragraphs [0005], [0017], [0018], [0028], and [0029]).
With respect to claim 24, modified Kramer is relied upon for the teaching of the method of claim 16.
Regarding the recitation of wherein the amount of added rumen-labile constituent is in the range of from 3 to 15% by weight, based on the total weight of the mixture to be pelleted in claim 24, modified Kramer teaches this limitation since Kramer teaches the preparation comprises 0.1 to 90% by weight of active compounds which includes 30% or more of CLA (at least 0.03% of CLA in the preparation) and overlaps with the presently claimed range (paragraphs [0004], [0027], [0028], [0034], and [0045]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 25, modified Kramer is relied upon for the teaching of the method of claim 16.
Regarding the recitation of wherein the amount of added rumen-labile constituent is in the range of from 3 to 10% by weight, based on the total weight of the mixture to be pelleted in claim 25, modified Kramer teaches this limitation since Kramer teaches the preparation comprises 0.1 to 90% by weight of active compounds which includes 30% or more of CLA (at least 0.03% of CLA in the preparation) and overlaps with the presently claimed range (paragraphs [0004], [0027], [0028], [0034], and [0045]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 26, modified Kramer is relied upon for the teaching of the method of claim 16.
Regarding the recitation of wherein the amount of added rumen-labile constituent is in the range of from 3 to 5% by weight, based on the total weight of the mixture to be pelleted in claim 26, modified Kramer teaches this limitation since Kramer teaches the preparation comprises 0.1 to 90% by weight of active compounds which includes 30% or more of CLA (at least 0.03% of CLA in the preparation) and overlaps with the presently claimed range (paragraphs [0004], [0027], [0028], [0034], and [0045]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 28, Kramer teaches a method comprising the step of administering uncoated feed pellets to ruminants such as cattle and sheep (paragraphs [0005], [0006], [0007], [0017], [0018], [0022], [0028], [0029], [0034], and [0036]).
Regarding the recitation of comprising, in pelleted form, a mixture of at least one solid particulate feed component with at least one rumen-labile constituent which has been added to the mixture, wherein the at least one rumen-labile constituent is at least one conjugated linolenic acid (CLA) selected from 10-trans, 12-cis-linoleic acid in claim 28, Kramer teaches mixing conjugated linoleic acid (CLA), such as trans-10, cis-12 CLA, with customary feed constituents such as cereals, cereal brans, cereal flours, seed meals, beans, peas, fishmeal, and the like, and the preparation is in the form of pellets (paragraphs [0004], [0022], [0028], [0029], [0034], and [0036]).
Regarding the recitation of wherein the amount of added rumen-labile constituent is in the range of from 0.1 to 20% by weight, based on the total weight of the mixture to be pelleted in claim 28, Kramer teaches the preparation comprises 0.1 to 90% by weight of active compounds which includes 30% or more of CLA (at least 0.03% of CLA in the preparation) and overlaps with the presently claimed range (paragraphs [0004], [0027], [0028], [0034], and [0045]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the recitation of administering to a lactating sheep or goat in claim 28, Kramer does not expressly disclose the ruminant, such as sheep or cattle, is lactating.
Luchini teaches supplementing the diet of ruminants, such as dairy cows, with CLAs to enrich the milk with CLAs (paragraphs [0009] and [0010]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Luchini, to select dairy ruminants in the method of Kramer with the expectation of success. One of ordinary skill in the art would have been motivated to do so because Kramer and Luchini similarly teach administering CLAs to ruminants, Kramer teaches dairy products of ruminant animals contains CLAs and CLAs have beneficial effects (paragraphs [0004]-[0007]), Luchini teaches the milk is enriched with CLAs as a result (paragraph [0010]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. There would have been a reasonable expectation of success with said modification. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Regarding the recitation of wherein the uncoated pelleted ruminant feed is prepared by a process comprising: a) mixing at least one solid particulate feed component with the at least one rumen-labile constituent; b) optionally conditioning the resulting mixture with steam; c) compressing the optionally conditioned mixture in a pelleting, extruding or expanding device with the action of pressure at temperatures of 60⁰C to 100⁰C to give pellets; and d) cooling and/or drying the resulting pellets in claim 28, Kramer teaches mixing conjugated linoleic acid (CLA) with customary feed constituents such as cereals, cereal brans, cereal flours, seed meals, beans, peas, fishmeal, silage, and the like, and pelleting the preparation to form pellets (paragraphs [0004], [0022], [0028], [0029], [0034], [0036], and [0059]).
However, Kramer does not expressly disclose c) compressing the optionally conditioned mixture in a pelleting, extruding, or expanding device with the action of pressure at temperatures of 60⁰C to 100⁰C to give pellets, and d) cooling and/or drying the resulting pellets.
Luchini teaches supplementing the diet of ruminants, such as dairy cows, with CLAs. Pellets may be formed by blending the CLA with the feed formulation components (grains, silage, meals, and the like), extruding the mixture in an extruder, and drying the pellets (paragraphs [0009], [0010], [0037], [0054], [0079], [0082], [0084], [0089]-[0091], [0093], [0094], and [0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Luchini, to prepare pellets with an extruder and dry the pellets in the method of Kramer with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Kramer and Luchini similarly teach forming pellets with CLAs and feed components, Kramer is not limited to any specific examples of compression devices used, utilizing extruders to prepare pellets and drying pellets were well known in the art before the effective filing date of the claimed invention as shown in Luchini, and said combination would amount to the use of a known steps for their intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the extruding temperatures in the method of Kramer as modified by Luchini through routine experimentation with the expectation of successfully preparing a functional product. One of ordinary skill in the art would have been motivated to do so because Luchini teaches the pellets are prepared in an extruder at elevated temperatures which is interpreted to include values above room temperature (paragraph [0110]), and it is understood that, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. There would have been a reasonable expectation of success. “[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 II).
With respect to claim 29, modified Kramer is relied upon for the teaching of the method of claim 16.
Regarding wherein the at least one CLA is selected from the group consisting of cis/trans-9,11-linoleic acid, cis/trans-8,10-linoleic acid; cis/trans-11,13-linoleic acid; cis/trans-10,12-linoleic acid; cis/cis-9,11-linoleic acid; trans/trans-9,11-linoleic acid; cis/cis-8,10-linoleic acid; trans/trans-8,10-linoleic acid; cis/cis-11,13-linoleic acid; trans/trans-11,13-linoleic acid; cis/cis-10,12-linoleic acid; and trans/trans-10,12-linoleic acid; or is a mixture of at least two of the aforementioned compounds in claim 29, modified Kramer teaches this limitation since Kramer teaches the conjugated linoleic acid (CLA) may include cis/trans-9,11-linoleic acid, cis/trans-8,10-linoleic acid; cis/trans-10,12-linoleic acid; cis/cis-9,11-linoleic acid; trans/trans-9,11-linoleic acid; cis/cis-8,10-linoleic acid; trans/trans-8,10-linoleic acid; cis/cis-10,12-linoleic acid; or trans/trans-10,12-linoleic acid (paragraphs [0004] and [0028]).
With respect to claim 30, modified Kramer is relied upon for the teaching of the method of claim 29.
Regarding the recitation of wherein the at least one CLA is cis/trans-10, 12-linoleic acid in claim 30, modified Kramer teaches this limitation since Kramer teaches the conjugated linoleic acid (CLA) may include cis/trans-10, 12-linoleic acid (paragraphs [0004] and [0028]).
With respect to claim 31, modified Kramer is relied upon for the teaching of the method of claim 28.
Regarding the recitation of wherein the amount of added rumen-labile constituent is in the range of from 1 to 15% by weight, based on the total weight of the mixture to be pelleted in claim 31, modified Kramer teaches this limitation since Kramer teaches the preparation comprises 0.1 to 90% by weight of active compounds which includes 30% or more of CLA (at least 0.03% of CLA in the preparation) and overlaps with the presently claimed range (paragraphs [0004], [0027], [0028], [0034], and [0045]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 32, modified Kramer is relied upon for the teaching of the method of claim 31.
Regarding the recitation of wherein the amount of added rumen-labile constituent is in the range of from 2 to 10% by weight, based on the total weight of the mixture to be pelleted in claim 32, modified Kramer teaches this limitation since Kramer teaches the preparation comprises 0.1 to 90% by weight of active compounds which includes 30% or more of CLA (at least 0.03% of CLA in the preparation) and overlaps with the presently claimed range (paragraphs [0004], [0027], [0028], [0034], and [0045]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 33, modified Kramer is relied upon for the teaching of the method of claim 32.
Regarding the recitation of wherein the amount of added rumen-labile constituent is in the range of from 3 to 5% by weight, based on the total weight of the mixture to be pelleted in claim 33, modified Kramer teaches this limitation since Kramer teaches the preparation comprises 0.1 to 90% by weight of active compounds which includes 30% or more of CLA (at least 0.03% of CLA in the preparation) and overlaps with the presently claimed range (paragraphs [0004], [0027], [0028], [0034], and [0045]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant’s remarks filed January 29, 2026 have been fully considered.
Applicant’s arguments have been fully considered, but they are unpersuasive.
Applicant argues Kramer does not disclose administering CLAs to ruminants, nor provide any reason or rationale why one of ordinary skill would seek to do so, and Kramer provides no motivation or reason to look at Luchini. Kramer provides no motivation to apply the techniques discussed therein to the feeding of a lactating ruminant. Neither Kramer, nor Luchini, nor their combination teach or suggest the claimed pelleting procedure. Kramer does not teach or suggest that the pelleted feed should be prepared by compressing the conditioned mixture at 60-100⁰C, as required by the pending claims, or that such feed should be uncoated, or that such feed should be conditioned with steam. Even if one were to combine Luchini with Kramer, there is no prima facie rationale for doing so (P6-P11).
Examiner disagrees. The Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine Kramer and Luchini is found within the references themselves as well as in the knowledge generally available to one of ordinary skill in the art.
Kramer in view of Luchini teaches the claimed invention. As previously addressed, Kramer teaches mixing CLA with feed constituents and administering the uncoated feed pellets to animals such as ruminants (paragraphs [0004], [0006], [0007], [0017], [0018], [0022], [0028], [0029], [0034], and [0036]). While Kramer does not expressly disclose the ruminant is lactating, Luchini is relied upon for these teachings (paragraphs [0009] and [0010]). One of ordinary skill in the art would have been motivated to select dairy cows as the ruminants in the method of Kramer based on the teachings of Luchini with the expectation of success because Kramer and Luchini similarly teach administering CLAs to ruminants, Kramer teaches dairy products of ruminant animals contains CLAs and CLAs have beneficial effects (paragraphs [0004]-[0007]), Luchini teaches the milk is enriched with CLAs as a result (paragraph [0010]), and said combination would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected results. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Kramer also teaches mixing conjugated linoleic acid (CLA) with customary feed constituents such as cereals, cereal brans, cereal flours, seed meals, beans, peas, fishmeal, silage, and the like, and pelleting the preparation to form pellets (paragraphs [0004], [0022], [0028], [0029], [0034], [0036], and [0059]). Kramer does not expressly disclose compressing the optionally conditioned mixture in a pelleting, extruding, or expanding device with the action of pressure at temperatures of 60⁰C to 100⁰C to give pellets and cooling and/or drying the resulting pellets. However, Luchini is relied upon for these teachings since Luchini teaches supplementing the diet of ruminants, such as dairy cows, with CLAs. Pellets may be formed by blending the CLA with the feed formulation components (grains, silage, meals, and the like), extruding the mixture in an extruder, and drying the pellets (paragraphs [0009], [0010], [0037], [0054], [0079], [0082], [0084], [0089]-[0091], [0093], [0094], and [0110]). One of ordinary skill in the art would have been motivated to prepare pellets with an extruder and dry the pellets in the method of Kramer with the expectation of success because Kramer and Luchini similarly teach forming pellets with CLAs and feed components, Kramer is not limited to any specific examples of compression devices used, utilizing extruders to prepare pellets and drying pellets were well known in the art before the effective filing date of the claimed invention as shown in Luchini, and said combination would amount to the use of a known steps for their intended use in a known environment to accomplish entirely expected result. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007).
Additionally, one of ordinary skill in the art would have been motivated to optimize the extruding temperatures in the method of Kramer as modified by Luchini through routine experimentation with the expectation of success because Luchini teaches the pellets are prepared in an extruder at elevated temperatures which is interpreted to include values above room temperature (paragraph [0110]), and it is understood that, generally, differences in concentration or temperature 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 II).
Conclusion
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 TYNESHA L. MCCLAIN whose telephone number is (571)270-1153. The examiner can normally be reached Monday-Friday 10 AM - 6:30 PM ET.
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793