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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 23 June 2026 has been entered.
Status of the Claims
Claims 1-43, 45-48, 50, 53-54 and 57-58 have been cancelled.
Claims 55 and 56 have been withdrawn.
New claim 59 has been submitted.
Claims 44, 49, 51-52 and 59 are presented for examination on the merits.
NOTE: For purposes of examination the claims are given their broadest reasonable interpretation. The claims as currently drafted employ such open-ended language with minimal limiting value. For example, “performance” could apply to any horse. Likewise, the term “physical activity” could be anything regardless of intensity or duration. Also, the amount of time recovery covers is unlimited.
Thus, the claim is so broad as to include feeding malted dehulled oats to a horse that is or has performed minimal physical activity such that CK is unchanged.
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.
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) 44, 49, 51-52 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Collins et al. (US2012/082740) and Hansson et al. (US2007/0009575) and Ulgheri et al. (2010) and Koenig et al. (2014) and Johansson et al. (2019).
It is known from Collins et al. that dietary supplementation for 8 weeks with avenathramide contained in oat flour, reduces inflammatory markers due to downhill walking and potentially prevents muscle damage.
It is known from Hansson et al. that increasing the avenathramide content of oat seeds by dry heating at 30 to 40oC hulless oat seed and steeping at 4 to 40oC, and an oat bran comprising more than 750 ppm of avenanthramides.
It is known from Ulgheri et al. that polyphenols present in wheat and oat leachate have anti-inflammatory and induce anti-secretory factor activity in plasma.
It is known from Koenig et al. that anti-secretory factor protein improves cardiac output and heart function.
It is known from Johansson et al. that the use of anti-secretory protein for treating diseases like heart failure or muscle damage.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the instant Application to employ oats containing avenanthramides to improve cardiac and skeletal muscle function as suggested by the cited references. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Given the known beneficial effects of all types of avenanthramides, a skilled practitioner would be motivated to maximize their content in oats, such as by the technique disclosed by Hansson et al. in order to get the maximum effect.
Note: the claims are directed to a method which comprises a single positively recited step, i.e., “providing a performance horse with a consumable product feed comprising malted dehulled oats in an amount sufficient to …”. The mechanisms by which the effects are facilitated recited in dependent claims are a consequence of the positively recited step and do not effectively limit the claims as they would inherently result from said “providing” or administration/feeding. See Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F. 3d 1373 (Fed. Cir. 2003) (“clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”).
The adjustment of particular conventional working conditions (e.g., finding an appropriate effective amount/dosage depending on the response of the particular subject) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Accordingly, the instant claims, where no unexpected results are observed, (e.g., the criticality of specifically recited avenanthramides, such as avenathramide D being particularly effective) would have been obvious to one of ordinary skill having the above cited references before him/her.
Response to Arguments
Applicant asserts that the presently claimed invention arises from the inventors' recognition of the unexpected and novel effect of the SPC feed on high performance animals. With respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). In order to accord substantial weight to secondary considerations in an obviousness analysis, “the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)). “The patentee bears the burden of showing that a nexus exists.” WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999). “To determine whether the patentee has met that burden, we consider the correspondence between the objective evidence and the claim scope.” Henny Penny, 938 F.3d at 1332. Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
As the claims are not commensurate in scope with the evidence provided of unexpected results, the claims as drafted remain rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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