Ex Parte RemmereitDownload PDFPatent Trial and Appeal BoardApr 6, 201813463964 (P.T.A.B. Apr. 6, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. 13/463,964 72960 7590 Casimir Jones, S.C. FILING DATE 05/04/2012 04/10/2018 2275 Deming Way Ste 310 Middleton, WI 53562 FIRST NAMED INVENTOR Jan Remmereit UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. LSNAS-32001/US-2/0RD 4845 EXAMINER PROSSER, ALISSA J ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 04/10/2018 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es): docketing@casimirjones.com pto .correspondence@casimirjones.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAN REMMEREIT Appeal2017-005454 Application 13/463,964 1 Technology Center 1600 Before FRANCISCO C. PRATS, JEFFREY N. FRED MAN, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to methods of improving a performance parameter in a horse. The Examiner entered final rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellant identifies the real party in interest as "Life Science Nutrition AS." Br. 3. Appeal2017-005454 Application 13/463,964 STATEMENT OF THE CASE Background The Specification discloses that the economic industry relating to equines has an economic impact approaching $102 billion, that "substantial financial resources are devoted to ensuring the health and well being of horses ... , [that] the horse racing industry has a substantial economic impact ... [and, that] there is great need for supplements which enhance the performance of horses, as well as which improve the health and well being of horses." Spec. 1:26-33. The Specification discloses a "composition containing sialic acids or precursors, and their use to improve performance-related and social parameters in mammals, particularly humans and horses." Id. at 1 :9--11. Claims 15, 17-25, and 28-33 are pending and on appeal. Br. 3. Claim 15, the sole independent claim, is illustrative and reads as follows: 15. A method of improving a performance parameter in a horse comprising: administering to a horse in need thereof a composition comprising an effective amount of a sialic acid composition or sialic acid precursor composition sufficient to cause a positive effect on said performance parameter in said horse, wherein said performance parameter in said horse is selected from the group consisting of reduction in injuries, increase in oxygen uptake, reduction in lactic acid, increase in workload tolerance, improved joint and ligament health, increase in endurance, faster recuperation after workload, improved pulse parameters, improved appearance, improved muscularity, improved coat quality, and improved kidney function, and monitoring said horse for improvement in said performance parameter. Br. 19--20 (Claims Appendix). 2 Appeal2017-005454 Application 13/463,964 The following rejections are before us to review: I. Claims 15, 17-25, 28-31, and 33 are rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Remmereit, 2 Johnson, 3 Wikipedia, 4 and Sola-Penna. 5 II. Claim 32 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Remmereit, Johnson, Wikipedia, Sola-Penna, and Colarow. 6 III. Claims 15, 17, 18, 20-23, 28, 29, 31, and 32 are rejected underpre- AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell,7 Pugliese, 8 and Wang 1. 9 IV. Claim 19 is rejected underpre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wang 2. 10 2 U.S. 2009/0221526 Al, published September 3, 2009 ("Remmereit"). 3 Philip J. Johnson et al., Medical implications of obesity in horses - lessons for human obesity, 3(1) J. DIABETES SCIENCE AND TECHNOLOGY 163-174 (2009) ("Johnson"). 4 Wikipedia entry for "Horse," http://en.wikipedia.org/wiki/Horse, last modified February 4, 2015 ("Wikipedia"). 5 Mauro Sola-Penna, Metabolic regulation by lactate, 60(9) LIFE 605-608, (2008) ("Sola-Penna"). 6 WO 2010/052324 Al, published May 14, 2010 ("Colarow"). 7 WO 2007 /031725 Al, published March 22, 2007 ("Fretwell"). 8 Marco Pugliese et al., Severe cognitive impairment correlates with higher cerebrospinal fluid levels of lactate and pyruvate in a canine model of senile dementia, 29 PROGRESS INNEURO-PSYCHOPHARMACOLOGY & BIOLOGICAL PSYCHIATRY 603---610 (2005) ("Pugliese"). 9 Bing Wang et al., Dietary sialic acid supplementation improves learning and memory in piglets, 85 AMERICAN JOURNAL OF CLINICAL NUTRITION 561-569 (2007) ("Wang l"). 10 B. Wang and J. Brand-Miller, The role and potential of sialic acid in human nutrition, 57 EUROPEAN J. OF CLINICAL NUTRITION 1351-1369 (2003) ("Wang 2"). 3 Appeal2017-005454 Application 13/463,964 V. Claim 24 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Jensen. 11 VI. Claim 25 is rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and McMahon. 12 VII. Claims 30 and 33 are rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wassenaar. 13 Appellant has waived arguments based on Wang 2 for rejection IV, Jensen for rejection V, McMahon for rejection VI, and Wassenaar for rejection VII. Br. 15-17. See 37 C.F.R. § 41.37(c)(l)(iv) (Appeal Brief must contain "[ t ]he arguments of appellant with respect to each ground of rejection."); Hyatt v. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008) ("When the appellant fails to contest a ground of rejection to the Board, ... the Board may treat any argument with respect to that ground of rejection as waived."). Accordingly, the issues that are dispositive for rejection III are dispositive for rejections IV-VII. I The Examiner finds that Remmereit teaches "nutraceutical NGNA (n- glycolylneuraminic acid) compositions" (e.g., "a composition comprising an effective amount of a sialic acid composition or sialic acid precursor composition"), that NGNA "induces physiological responses such as alleviating (monitoring is implicit to alleviating) the symptoms of viral- induced obesity, alleviating the symptoms of colds, preventing the onset of 11 U.S. 5,064,675, issued November 12, 1991 ("Jensen"). 12 U.S. 2005/0096295 Al, published May 5, 2005 ("McMahon"). 13 U.S. 2007/0048354 Al, published March 1, 2007 ("Wassenaar"). 4 Appeal2017-005454 Application 13/463,964 colds, increasing energy and increasing the feeling of well-being in subjects," and that Remmereit includes "any animal, such as a mammal like a dog, cat, bird, livestock, and preferably a human" in its definition of a subject. Final Act. 3--4. The Examiner finds Remmereit describes monitoring subjects administered NGNA prior to exercise. Id. at 4. The Examiner further finds that NGNA can be isolated from a natural source, the sea cucumber (Holothuroidea Echinodermata), can be purchased from commercial sources, or can be synthesized at up to 99% purity. Id. The Examiner concludes that because the product is not 100% pure, at least some of the parent mannosamine compound would be present in the NGNA final synthesized product. Id. The Examiner further finds that Remmereit discloses ranges ofNGNA for use as a dietary supplement, which renders the claimed range obvious by overlap, and that the product may be administered in multiple forms, with inert ingredients and other supplements, and as a food product itself or included in animal feed. Id. at 5. The Examiner finds Remmereit does not teach "administering to a horse in need thereof and monitoring said horse for improvement in said performance parameter which is a reduction in lactic acid." Id. However, the Examiner finds that Johnson teaches that "obesity is common to many domestic animal species, including horses," and that"[ e ]quine health consequences of obesity include for example exercise intolerance (reduced athleticism)." Id. at 6. The Examiner finds Johnson teaches that study of the insulin resistance of a subject is used to characterize "the adverse medical consequences of obesity." Id. 5 Appeal2017-005454 Application 13/463,964 The Examiner finds that the Wikipedia entry for "horse" discloses that the range of horse weights can vary between 380 to 1000 kg. Id. The Examiner finds that Sola-Penna teaches that "lactate levels are chronically elevated in obese individuals, suggesting that elevated lactate decreases both insulin section and responsiveness to insulin (insulin resistance)." Id. The Examiner finds that, based on the teachings cited above, the skilled artisan would have found it obvious to administer the dietary supplement of Remmereit comprising NGNA (a sialic acid or sialic acid precursor) which induces physiological responses such as alleviating the symptoms of viral-induced obesity, alleviating the symptoms of colds, preventing the onset of colds, increasing energy and increasing the feeling of well-being in subjects specifically to horses because Johnson teach [sic] obesity is common to many domestic animal species, inclusive of horses, and the health consequences of equine obesity include for example exercise intolerance. Id. at 6-7. The Examiner finds the artisan would have reasonably expected that administration ofNGNA "would alleviate the symptoms of obesity and restore exercise tolerance," thereby improving the horse's performance parameters, including reducing lactic acid, because "the method of Remmereit in view of Johnson administers the same active (NGNA) in the same dose as required by the dependent claims to the same patient population (horses)." Id. at 7. The Examiner further concludes that because Sola-Penna teaches that lactate levels are chronically elevated in obese individuals, it would have been obvious to "specifically monitor the lactate levels for a reduction thereof' and that the artisan would have known to adjust dosing upwards as necessary for obese horses with respect to average horses. Id. at 7-8. 6 Appeal2017-005454 Application 13/463,964 Appellant contends that the claimed invention is not obvious because "the combined references do not teach each element of the claims, there is no reasonable expectation of success, and the combination is improper and not supported." Br. 9. The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner's conclusion that Remmereit, Johnson, Wikipedia, and Sola-Penna suggest the claimed method of improving a performance parameter in a horse. We select claim 15 as representative of the claims subject to this ground of rejection. 37 C.F.R. § 41.37(c)(l)(iv). As stated in Jn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden ... of presenting a prima facie case of unpatentability .... After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Here, Appellant does not persuade us that a preponderance of the evidence fails to support the Examiner's conclusion that the claimed method of improving a performance parameter in a horse would have been obvious to an ordinary artisan. Unless otherwise indicated herein, we adopt the Examiner's findings of fact, reasoning on scope and content of the claims and prior art, and conclusions set out in the Final Action and Answer. Final Act. 14 3-21; Ans. 2-10. Only those arguments made by Appellant in the Appeal Brief have been considered in this Decision. Arguments not presented in the Brief are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). 14 Examiner's Final Action, mailed December 16, 2015 ("Final Act."). 7 Appeal2017-005454 Application 13/463,964 We agree with the Examiner (see Final Act. 3-8; Ans. 6-8) that the skilled artisan would have found it obvious to combine the teachings of Remmereit, Johnson, Wikipedia, and Sola-Penna to practice the claimed method of improving a performance parameter in a horse. As found by the Examiner, Remmereit teaches administering nutraceutical NGNA compositions to mammals because of its ability to alleviate the symptoms of viral-induced obesity, treat and prevent colds, and increase the energy and feeling of well-being in subjects. Remmereit Abstract, i-fi-12, 7, 39, 46. The skilled artisan would also have learned that a mammal that was administered NGNA compositions, or a precursor composition, could be monitored for an increase of its performance based on the exercise study described by Remmereit. Id. i-fi-173-79, Figures 2a-f. The skilled artisan would also have learned from Remmereit the dose ranges, potential cofactors, and methods of administration for mammals given NGNA as a dietary product, and how to obtain NGNA from commercial and other sources. Id. i-fi-19, 42, 50-55, 57- 60, 63, 69, 71. We further agree with the Examiner that the skilled artisan would have learned by reading Johnson that horses are known to have obesity issues, that obese horses are less able to exercise, and that monitoring insulin resistance is a method used to characterize obesity in animals. Johnson 163, 166. The skilled artisan would have been informed by the Wikipedia entry (Wikipedia 1) of a general range of weights for horses and have been able to apply that information, along with the dosing information learned from Remmereit, to determine a dose range to administer to an obese horse. The skilled artisan would further have learned from Sola-Penna that obesity correlates to elevated lactate levels, and that insulin secretion and 8 Appeal2017-005454 Application 13/463,964 responsiveness to insulin both decrease in obese individual. Sola-Penna 606-7. We agree with the Examiner that the skilled artisan would have had a reasonable expectation of success in practicing the claimed method using the teachings of the cited references, in that the artisan would have been able to administer a sufficient dose ofNGNA to a horse to reduce its lactic acid and/ or increase its endurance and/ or improve its appearance and would have known to monitor the horse's reduction in lactic acid, which comprises measuring a parameter using a factor correlated to the performance aspect. It is obvious to those skilled in the art to substitute one known equivalent for another, as the Examiner has suggested here. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) ("[T]his court finds no ... error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another."). We conclude the combined teachings of the references as a whole would have suggested the claimed invention to the ordinarily skilled artisan. In re Keller, 642 F.2d 413, 425 (CCPA 1981) (The test for obviousness is what the combined teachings of the references, as a whole would have suggested to those of ordinary skill in the art). KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). We have considered Appellant's arguments but do not find them persuasive. Appellant argues that"[ n ]one of [the claimed] uses [i.e., performance parameters] are directed or related to treatment of obesity or colds, or indeed increased energy or well-being" and that "the combined references do not 9 Appeal2017-005454 Application 13/463,964 teach the claims element of a reduction in lactate following the administration of the identified compounds." Br. 9. We begin with claim construction, to determine the meaning of "performance parameter" to apply in our analysis. The Specification does not define "performance parameter." With regard to the use of sialic acid compositions to improve performance parameters, the Specification provides Examples 14 and 15. Spec. 22: 14--34. Both examples state that subjects (Group A) were administered "the sialic acid formulation" and a control group (Group B) administered a placebo. Id. The participants "maintain[ed] existing workout and exercise patterns." In both examples, the Specification states: At the end of the trial, Group A reports improvements, as compared to control Group B, in combinations of the following parameters: reduction in injuries, reduction in infectious disease, increase in lean muscle mass, increase in oxygen uptake, reduction in lactic acid, increase in workload tolerance, improved joint and ligament health, increase in endurance, faster recuperation after exercise, faster recuperation from disease, improved pulse parameters, improved gastric health, improved food utilization, improved appearance, improved muscularity, and improved kidney function. Id. Thus, the Specification does not state any of the metrics by which an ordinarily skilled artisan would "monitor" the claimed performance parameters. Accordingly, we apply the broadest reasonable construction in light of the Specification. See Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en bane) ("The Patent and Trademark Office ('PTO') determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction 'in light of the specification as it would be interpreted by one of 10 Appeal2017-005454 Application 13/463,964 ordinary skill in the art."' (quoting In re Am. A cad. of Sci. Tech Ctr., 3 67 F.3d 1359, 1364 (Fed. Cir. 2004))). With specific regard to the claimed performance parameters "reduction in injuries, increase in oxygen uptake, reduction in lactic acid, increase in workload tolerance, improved joint and ligament health, increase in endurance, faster recuperation after workload, improved pulse parameters, improved appearance, improved muscularity, improved coat quality, and improved kidney function," we find that these are characteristics of a horse that may improve or decline and that can be functionally measured by observation or testing. We further find that the skilled artisan would have understood that each of these parameters is subject to measurement, and that the measurement is objective in some cases (e.g., reduction in lactic acid) and subjective in others (e.g., improved appearance). For each parameter, we find the ordinarily skilled artisan would have found it reasonable to measure - and thereby monitor- the respective improvement in any given parameter using metrics customarily and reasonably associated with or applied to each parameter. For instance, "reduction in lactic acid" could be measured by chemical assessment of samples and "faster recuperation after workload" could reasonably be interpreted as shortening the time after which the horse is able to return to a subsequent task, whether improved by minutes, hours or days. We further find that a skilled artisan would reasonably have believed that a horse having "increased energy or well being" or having received treatment for a cold would be expected to recuperate more quickly after work; as such, the skilled artisan would reasonably have correlated "increased energy or well being" to either the "faster recuperation after 11 Appeal2017-005454 Application 13/463,964 workload" parameter or to "increase in workload tolerance." We further find that the skilled artisan would reasonably have believed that an obese horse would have a slimmer appearance and that "improved appearance" or "improved muscularity" could reasonably result from reducing the horse's obesity. Accordingly, we agree with the Examiner that treating obesity, providing increased energy, and increasing the well-being of a subject, each of which can be accomplished through administration ofNGNA, are each methods "to improve a performance parameter in a horse" as recited in claim 15 based on application of the broadest reasonable construction of those terms in light of the Specification. Appellant next argues that the Examiner's reasoning behind the prima facie case is flawed. Br. 11. According to Appellant, Remmereit does not teach that AD-36, which Remmereit indicates causes viral obesity in humans, "infects or causes obesity in horses or animals other than humans and no indication that administration ofNGNA reduces lactic acid in any animal, much less horses," "Johnson does not provide a nexus between reduced lactate in horses and treatment of obesity in horses," and Sola-Penna teaches "that lactate levels are increased in diabetic obese individuals, and contain[ s] no statement about non-diabetic, obese individuals in general." Id. Appellant argues that the Examiner's rationale is "clearly based on hindsight and is in error" and a 'jump from a teaching regarding obesity related to AD-36 infection in humans as taught in Remmereit, to conditions associated with obese diabetic humans as taught in Sola-Penna, [then tied] to obesity in horses." Id. The Examiner responds that Remmereit's teachings of use ofNGNA "include, but are not limited to, individuals suffering from viral obesity ... 12 Appeal2017-005454 Application 13/463,964 symptoms of viral-induced obesity include weight gain, weight loss and obesity." Ans. 7. The Examiner notes that Remmereit claims "alleviating symptoms and ... the administration of an antiviral" and "does not identify whether the test subjects were infected with AD-36." Id. We are not persuaded that the Examiner's rationale is error. We agree with the Examiner that Remmereit's teachings are not constrained to viral obesity caused by AD-36. Rather, Remmereit shows that NGNA can be used to address obesity as well as cold symptoms and to generally increase the well-being of subjects. Remmereit Abstract, i-fi-12, 7, 39, 46. "It is well settled that a prior art reference is relevant for all that it teaches to those of ordinary skill in the art." In re Fritch, 972 F.2d 1260, 1264 (Fed. Cir. 1992). Because, as discussed above, treating obesity, treating colds, providing increased energy, and increasing the well-being of a subject are each methods "to improve a performance parameter in a horse," we agree with the Examiner that Remmereit teaches this limitation of claim 15. Sola-Penna discloses that "lactate levels are chronically elevated in diabetic obese individuals" and that the elevation "is sustained by the augmented lactate production by adipocytes from obese subjects (29), can be found prior to diabetes onset (28), and may participate on this process. Lactate production by adipocytes is proportional to the volume of these cells (30) and thus to the degree of obesity." Sola-Penna 606 (emphasis in original). Accordingly, we find Sola-Penna's teachings correlate lactate production to general obesity and are not observations restricted to individuals having diabetes. The Examiner relied on Johnson for its teachings that horses are known to have obesity issues, that obese horses are less able to exercise, and that monitoring insulin resistance is a method used 13 Appeal2017-005454 Application 13/463,964 to characterize obesity in animals. Johnson 163, 166. Appellant's argument regarding the lack of demonstrated nexus is thus unpersuasive as the test for obviousness is what the combined teachings of the references, as a whole would have suggested to those of ordinary skill in the art. Keller, 642 F.2d at 425. The law does not require that the teachings of the reference be combined for the reason or advantage contemplated by the inventor, as long as some suggestion to combine the elements is provided by the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976). As discussed above, we find the suggestion to combine exists here and we discern no error in the Examiner's reasonable interpretation that, e.g., the performance parameter of "improved appearance" could have been achieved by the skilled artisan through targeting obesity, as taught by the references. We also acknowledge, but are unpersuaded by, Appellant's argument regarding "hindsight." Br. 11. Appellant points to no evidence that any of the Examiner's findings were beyond the level of ordinary skill at the time of the invention or could have been taken only from Appellant's Specification. See In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Conclusion of Law A preponderance of the evidence supports the Examiner's conclusion that Remmereit, Johnson, Wikipedia, and Sola-Penna suggest the claimed method of improving a performance parameter in a horse. Claims 17-25, 28-31, and 33 have not been argued separately and therefore fall with claim 15. 37 C.F.R. § 41.37(c)(l)(iv). 14 Appeal2017-005454 Application 13/463,964 II Claim 3 1 depends from independent claim 31 and recites that the "sialic acid or sialic acid precursor are derived from a natural source." Br. 21 (Claims App.) Claim 32 depends from claim 31 and recites that the "natural source is a non-animal or non-mammalian source." Id. The Examiner finds that Remmereit, Johnson, Wikipedia, and Sola- Penna do not teach "wherein the natural source is a non-animal or non- mammalian source" but finds that "Colarow teach sialic acid can be easily provided from bacterial sources (natural source, non-animal)." Final Act. 8- 9. The Examiner finds that "Remmereit and Colarow are analogous inventions in nutritional supplementation comprising sialic acids" and that the skilled artisan would have found it obvious to "use sialic acids provided from bacterial sources (non-animal natural source) as taught by Colarow in the NGNA compositions of Remmereit because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary." Id. at 9. We agree with the Examiner that, absent evidence to the contrary, substitution of sialic acid from a non-animal or non-mammalian source would be expected to be equivalent and would be obvious to the skilled artisan. "Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious." In re Fout, 675 F.2d 297, 301, (CCPA 1982); see also In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997) ("Because the applicants merely substituted one element known in the art for a known equivalent, this court affirms [the rejection for obviousness]."). 15 Appeal2017-005454 Application 13/463,964 Appellant argues that Colarow "does not cure the defects noted for the combination of Remmereit, Johnson, Wikipedia, and Sola-Penna noted above." Br. 12. Appellant argues that "Colarow teaches the following uses: treatment or prevention of neurodegeneration, improvement of cognitive performance, improvement of brain development, support of the immune system, boosting immunity and improving gut function," which Appellant argues are not the claimed uses (performance parameters). Id. We are not persuaded. As discussed with respect to the first rejection, Remmereit, Johnson, Wikipedia, and Sola-Penna suggest the claimed method of improving a performance parameter in a horse. The Examiner relies on Colarow for the teaching that sialic acid can be obtained from bacterial sources. Final Act. 9. Appellant has provided no evidence or persuasive argument why the ordinarily skilled artisan would not have successfully used Colarow's teachings to obtain sialic acid from bacterial sources. Attorney arguments and conclusory statements that are unsupported by factual evidence are entitled to little probative value. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). We affirm the rejection of claim 32. III The Examiner has rejected claims 15, 17, 18, 20-23, 28, 29, 31, and 32 under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, and Wang 1. The Examiner finds that Colarow teaches that "[ s ]ialic acids are a family of charged nine carbon mono saccharides derived from neuraminic acid" that can be used as "sialic acid enriched food products (oral administration) intended for humans or animals, in particular companion animals, pets, and/or livestock." Final Act. 10. The Examiner 16 Appeal2017-005454 Application 13/463,964 finds that food enriched with sialic acid can "promote healthy growth and aging and improve cognitive functioning, reduce low grade inflammations, [and] improve the gut barrier." Id. The Examiner finds that by virtue of teaching improving the gut barrier and reducing inflammation, that Colarow teaches monitoring the subject for the effect of the administration. Id. The Examiner finds that Colarow teaches N-acetylneuraminic acid as a preferred embodiment, along with natural sources of sialic acids, use of sialic acids to fortify foodstuffs, and ranges for sialic acid amounts in food products along with organic and inorganic carriers, vitamins, minerals, and protein/carbohydrate/lipid sources that can accompany sialic acid in foodstuffs. Id. at 10-11. The Examiner finds Colarow does not teach "administering specifically to animals that are horses in need thereof and monitoring said horse for improvement in said performance parameter which is a reduction in lactic acid as required by claim 15 and the elected embodiment thereof." Id. at 11. The Examiner finds Fretwell teaches "a food supplement and a method for improving the cognitive ability (functioning) of a companion animal including domestic animals such as cats, dogs and horses comprising the administration of leucine, isoleucine and valine." Id. The Examiner further finds Fretwell teaches that "[t]he ability of an animal to carry out a vital or required function depends on the cognitive ability and/or function of an animal" and that "improvement in cognitive ability results in an improvement in physical performance." Id. at 11-12. 17 Appeal2017-005454 Application 13/463,964 The Examiner finds Pugliese teaches that in a dog model "there is a parallel increase of lactate, pyruvate and potassium concentrations in [instances of] severe cognitive deficit." Id. at 12. The Examiner finds Wang teaches that "in animal models an exogenous source of sialic acid increased learning performance" and provided dose ranges for varying animals by weight. Id. The Examiner finds that, based on the teachings cited above, the skilled artisan would have found it obvious to administer the sialic acid enriched food products of Colarow intended for humans or animals, in particular companion animals, pets, and/or livestock for promoting healthy growth and aging, improving cognitive functioning, reducing low grade inflammations and improving the gut barrier to horses because Fretwell teach companion animals including domestic animals such as horses are in need of a food supplement for improving cognitive ability. Id. at 13. The Examiner further concludes the skilled artisan would have been motivated to combine the teachings of Colarow and Fretwell "because the ability of an animal to carry out a vital or required function depends on the cognitive ability and/or function of the animal and the improvement in cognitive ability results in an improvement in physical performance" and that the artisan would have had a reasonable expectation of success because "Colarow contemplate the administration of the sialic acid enriched food product in particular to companion animals, pets and/or livestock and Fretwell explicitly contemplate administration to companion animals including domestic animals such as horses." Id. The Examiner finds that Colarow' s teaching of improvement of certain parameters "implies the monitoring of said parameters." Id. Because Pugliese teaches that cognitive impairment correlates with higher levels of lactate in a dog model, the 18 Appeal2017-005454 Application 13/463,964 Examiner finds the skilled artisan would have further found it obvious "to specifically monitor the lactate levels for a reduction thereof." Id. The Examiner further finds that Wang would have provided the artisan with information necessary "to administer a daily dosage of the sialic acid enriched food product of Colarow such that the food is fortified" because Wang provides guidance on "the sialic acid content of a commercially available pig milk replacer and the maximum daily dosage of Wang is comparable to the amount of sialic acid naturally present in sow milk and the results of Wang show sialic supplementation enhances learning." Id. at 14. The Examiner finds the overlap in the claimed ranges of the rejected claims supports that the method would have been obvious. Id. Appellant argues "the references do not teach each element of the claims, do not provide a reasonable expectation of success, and are not properly combinable." Br. 13. Appellant argues that Colarow does not teach the claimed uses for improving performance parameters in a horse, but rather teaches the use of sialic acid to improve cognitive function. Br. 13. Appellant further argues that because "Fretwell, Pugliese and Wang likewise teach uses related to cognitive function" the combined references do not teach the claimed uses or support a prima facie case of obviousness because the references lack a "teaching or suggestion ... that administration sialic acid decreases lactate accumulation in horses (or any of the other claimed uses)." Id. at 13-14. Rather, Appellant argues, the Examiner has "jumped from use for treating cognitive impairment to use for reducing lactate accumulation while providing no scientifically sound support for that jump." Id. at 14. According to Appellant, Pugliese's "teach[ings] that cognitive impairment in dogs is associated with high levels of lactate is completely 19 Appeal2017-005454 Application 13/463,964 irrelevant to whether administration of sialic acid to a horse with reduce lactate accumulation" and that regardless of the mechanism "for the increased lactate in dogs observed by Pugliese, there is no evidence that that [sic] mechanism is any way related to lactate accumulation in horses." Id. at 15. Appellant contends the skilled artisan would not have combined the references as suggested, or, in doing so, have believed a reasonable expectation of success in practicing the claimed method. Id. The Examiner responds that inherency may supply a missing claim limitation in an obviousness analysis where the limitation is the natural result of the combination of prior art elements. Appellant's result to be achieved of a reduction in lactate is a necessary (inherent) consequence of the administration of sialic acid or a precursor thereof to a horse. Ans. 9. The Examiner further responds that the rejection provides a rationale for administering an amount within the claimed range of a sialic acid composition to a horse, and the reason for doing so, rendering the claimed method obvious. Id. The Examiner further responds that Pugliese is relied upon for its teachings that "cognitive impairment correlates with higher levels of lactate in a dog model," which would have taught the ordinary artisan that monitoring lactate levels for a reduction of lactate would be a means to measure cognitive impairment or fatigue associated with high lactate. Id. We are persuaded by Appellant's arguments that the Examiner's rejection is not supported by the weight of evidence. Claim 15 recites the following performance parameters subject to monitoring: "reduction in injuries, increase in oxygen uptake, reduction in lactic acid, increase in workload tolerance, improved joint and ligament health, increase in 20 Appeal2017-005454 Application 13/463,964 endurance, faster recuperation after workload, improved pulse parameters, improved appearance, improved muscularity, improved coat quality, and improved kidney function." Br. 19-20. Although we understand the Examiner's logic that an animal's ability to perform depends on its cognitive ability, we are mindful that the Federal Circuit has found, "obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention." Belden Inc. v. Berk-TekLLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Ultimately, therefore, "[i]n determining whether obviousness is established by combining the teachings of the prior art, 'the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art."' In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (citation omitted). In this regard, we are not persuaded that the skilled artisan, upon reading Colarow, Fretwell, Pugliese and Wang 1, would have been motivated to use the demonstrated benefits of sialic acid in improving cognition to improve the recited performance parameters in Appellant's claim 15. We agree with Appellant that a preponderance of the evidence does not support the Examiner's conclusion of obviousness over these references. We reverse the rejection of claims 15, 17, 18, 20-23, 28, 29, 31, and 32. IV-VII Claim 19 stands rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wang 2. Claim 24 stands rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Jensen. Claim 25 stands rejected under pre- 21 Appeal2017-005454 Application 13/463,964 AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and McMahon. Claims 30 and 33 stand rejected under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wassenaar. Appellant has waived arguments based on Wang 2, Jensen, McMahon, and Wassenaar. Br. 15-17. Each of these rejections depends on the findings of the Examiner with regard to Colarow, Fretwell, Pugliese, and Wang 1, and the Examiner does not advance additional findings that address the deficiency discussed above with regard to rejection III. See Final Act. 15, and 17-19. We therefore reverse the rejection of claims 19, 24, 25, 30, and 33 for the reasons discussed above. SUMMARY We affirm the rejection of claims 15, 17-25, 28-31, and 33 under pre- AIA 35 U.S.C. § 103(a) as obvious over Remmereit, Johnson, Wikipedia, and Sola-Penna. We affirm the rejection of claim 32 under pre-AIA 35 U.S.C. § 103(a) as obvious over Remmereit, Johnson, Wikipedia, Sola-Penna, and Colarow. We reverse the rejection of claims 15, 17, 18, 20-23, 28, 29, 31, and 32 under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, and Wang 1. We reverse the rejection of claim 19 under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wang 2. We reverse the rejection of claim 24 under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Jensen. We reverse the rejection of claim 25 under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and McMahon. 22 Appeal2017-005454 Application 13/463,964 We reverse the rejection of claims 30 and 33 under pre-AIA 35 U.S.C. § 103(a) as obvious over Colarow, Fretwell, Pugliese, Wang 1, and Wassenaar. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 23 Copy with citationCopy as parenthetical citation