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 .
Claims 1-5, 11-14, 16-23 are pending and are currently under consideration.
Claims 6-10 and 15 are cancelled.
Claims 1, 3-5, 11, 12, 14, 18-21 are currently amended.
Withdrawn Rejections
The rejection of claim(s) 1-20 under 35 U.S.C. 102(a)(1) as being anticipated by Van den Bosch et al (WO 2016/090366) is withdrawn in view of Applicant’s cancellation of claims 6-10 and 15, as well as Applicant’s amendments to the independent claims.
The rejection of claim(s) 6-10 and 15 under 35 U.S.C. 103 as being unpatentable over Van den Bosch et al (WO 2016/090366) is withdrawn in view of Applicant’s cancellation of said claims.
The rejection of claim(s) 6-10 and 15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,547,126 is withdrawn in view of Applicant’s cancellation of said claims.
The rejection of claim(s) 6-10 and 15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,004,538 is withdrawn in view of Applicant’s cancellation of said claims.
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 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.
Claim(s) 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van den Bosch et al (WO 2016/090366) (IDS Reference).
Van den Bosch teaches an animal feed for monogastric animals, and specifically names sows (see entire document, for instance, [0008]). Van den Bosch teaches a standard diet comprising the composition of Table 1A (see entire document, for instance, [00045] and pages 15 and 16). The composition comprises 0.1% calcium nitrate, and specifically, Bolifor (see entire document, for instance, Table 1A), note that the instant specification indicates that Bolifor contains about 63% nitrate (see instant [00024] as well as Van den Bosch [00045]), which means the composition of Van den Bosch comprises 0.063% nitrate. Van den Bosch teaches that the method of Van den Bosch results in vasodilation benefits, but also has further additional benefits, such as color and meat quality (see entire document, for instance, [00034]). The pigs are taught as being at various stages, including piglets, barrows, gilts, boars, and sows (see entire document, for instance, [00037]). It is noted that the pigs can be fed the diet of Van den Bosch at least through farrowing (see entire document, for instance, claim 15).
Regarding claims 21-23, Applicant is reminded that the intended use of a product claim carries no patentable weight unless it imparts a structural limitation. See MPEP 2111.02. Therefore, since the intended use of the composition as improving the redness of meat is merely identifying that the composition can be used in such a way as to have said effect, and not imparting a structural limitation, it is the Examiner's position that the composition is capable of performing the intended use.
Response to Arguments
Applicant argues in the Remarks filed 05/26/2026 that Van den Bosch does not describe grower-finisher feed diet comprising the claimed elements. Applicant’s argument is not found persuasive. Specifically, claims 21-23 are directed to a product, wherein the intended use of the product does not materially change the structure of said product. Applicant has not established that there would be a structural difference between the composition of the instant claims and the composition of the prior art.
Rejections Maintained and Made Again in view of Applicant’s Amendments
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.
Claim(s) 1-5, 11-14, 16-23 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Van den Bosch et al (WO 2016/090366) (IDS Reference).
Van den Bosch teaches an animal feed for monogastric animals, and specifically names sows (see entire document, for instance, [0008]). Van den Bosch teaches a standard diet comprising the composition of Table 1A (see entire document, for instance, [00045] and pages 15 and 16). The composition comprises 0.1% calcium nitrate, and specifically, Bolifor (see entire document, for instance, Table 1A), note that the instant specification indicates that Bolifor contains about 63% nitrate (see instant [00024] as well as Van den Bosch [00045]), which means the composition of Van den Bosch comprises 0.063% nitrate. Van den Bosch teaches that the method of Van den Bosch results in vasodilation benefits, but also has further additional benefits, such as color and meat quality (see entire document, for instance, [00034]). The pigs are taught as being at various stages, including piglets, barrows, gilts, boars, and sows (see entire document, for instance, [00037]). It is noted that the pigs can be fed the diet of Van den Bosch at least through farrowing (see entire document, for instance, claim 15).
Van den Bosch, while teaching all of the instantly claimed components and the instantly claimed method, does not expressly articulate all of the claimed properties and comparisons of the composition to animals that have not undergone the instantly claimed method. Van den Bosch further, while teaching that the pigs are fed the diet at least through farrowing, does not exemplify feeding of the diet during the growing or finishing phases.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to follow the method as taught by Van den Bosch, and arrive at the instantly claimed invention. One would have been motivated to do so since Van den Bosch teaches the instantly claimed method steps utilizing the instantly claimed composition. It is noted that anticipation is the epitome of obviousness.
It further would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to continue feeding the pigs the diet after farrowing, through the growing and/or finishing phases. One would have been motivated to do so since Van den Bosch teaches that the diet results in other benefits, including feed intake, coping with heat stress, immunity, efficiency, meat quality, color, among others (see entire document, for instance, [0034]). These benefits would be desirable at any stage of the pig’s development, wherein Van den Bosch teaches that the animals are fed the diet at least through farrowing, this teaching of Van den Bosch indicates that the animals can be fed the diet after farrowing as well. One of ordinary skill in the art, desiring the benefits listen in Van den Bosch, would be motivated to feed the pigs the diet all the way through their development, growth, and finishing.
Applicant is reminded that the intended use of a product claim carries no patentable weight unless it imparts a structural limitation. See MPEP 2111.02. Therefore, since the intended use of the composition as improving the redness of meat is merely identifying that the composition can be used in such a way as to have said effect, and not imparting a structural limitation, it is the Examiner's position that the composition is capable of performing the intended use.
Response to Arguments
Applicant argues in the Remarks filed 05/26/2026 that the benefits listed in Van den Bosch are merely a general list of possible additional benefits. Applicant asserts that these benefits do not provide an articulated reason to modify Van den Bosch’s exemplified protocol. Applicant’s argument is not found persuasive. Specifically, the benefits are directly tied to the vasodilation from the nitrate in the supplement, therefore, one of ordinary skill in the art, desiring the benefits of the nitrate in the supplement throughout the grower or finisher phases of the pig would be motivated to utilize the supplement.
Regarding claims 21-23, Applicant is reminded that the intended use of a composition does not change the structure of a product claim, absent evidence to the contrary. Claims 21-23 are directed to a product, wherein the intended use of the product does not materially change the structure of said product. Applicant has not established that there would be a structural difference between the composition of the instant claims and the composition of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 11-14, 16-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,547,126. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to a method of improving meat quality in swine comprising feeding the pigs a diet comprising 0.01-1% nitrate, wherein the feeding is during one of the weaning phase, the growth phase, the finishing phase, or combinations of the phases, and wherein the nitrate is at least 0/06% of the daily diet, and wherein the nitrate is calcium nitrate (see claims 1-11).
Response to Arguments
Applicant argues in the Remarks filed 05/26/2026 that the result of the instant method, namely, the carcass yield, is not present in the patented claims. Applicant’s argument is not found persuasive since the effects of the method are necessarily tied to the composition and the active method steps which are taught in the patented claims. Therefore, the double patenting rejection is maintained.
Claims 1-5, 11-14, 16-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,004,538. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to a swine feed composition that is effective to increase the red color of the meat obtained when fed during the weaning phase, the growth phase, the finishing phase, or combinations of the phases. The diet comprising 0.02-0.07 nitrate, wherein the nitrate is selected from the group including calcium nitrate (see claims 1-8).
Response to Arguments
Applicant argues in the Remarks filed 05/26/2026 that the result of the instant method, namely, the carcass yield, is not present in the patented claims. Applicant’s argument is not found persuasive since the effects of the method are necessarily tied to the composition and the active method steps which are taught in the patented claims. Therefore, the double patenting rejection is maintained.
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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
