Ex Parte Merchant et al

Patent Trial and Appeal BoardSep 14, 2018

11640421 (P.T.A.B. Sep. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/640,421 12/14/2006 29166 7590 09/18/2018 Jones Walker LLP 5th Floor, Four United Plaza 8555 United Plaza Boulevard Baton Rouge, LA 70809 FIRST NAMED INVENTOR Mark E. Merchant 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. 43345/120124-00 6274 EXAMINER LANDAU, SHARMILA GOLLAMUDI ART UNIT PAPER NUMBER 1653 NOTIFICATION DATE DELIVERY MODE 09/18/2018 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): j wpatents@j ones walker .com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARKE. MERCHANT and FREDERICK LEMIEUX, JR. Appeal2017-009634 1 Application 11/640,421 Technology Center 1600 Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and RYAN H. FLAX, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. Â§ 134(a) involves claims to a feed composition for a weanling pig or poultry hatchling, the feed composition containing a blood product from a crocodylian species. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. Â§ 6(b )(1 ). We reverse. STATEMENT OF THE CASE The following rejections are before us for review: (1) Claims 8, 9, 11, and 13-15, under 35 U.S.C. Â§ 103(a) as being 1 Appellants state that the real party in interest is McNeese State University. Appeal Br. 1. Appeal2017-009634 Application 11/640,421 unpatentable over CN '147, 2 Odmn, 3 and Kats4 (Final Act. 2-5); 5 (2) Claims 8, 9, 11, and 13-15, under 35 U.S.C. Â§ 103(a) as being unpatentable over Siruntawineti,6 CN '147, Odum, and Kats (id. at 5-7); (3) Claims 8, 9, 11, and 13-16, under 35 U.S.C. Â§ 103(a) as being unpatentable over CN '147, Odum, Kats, and Merchant7 (id. at 7-8); and (4) Claims 8, 9, 11, and 13-16, under 35 U.S.C. Â§ 103(a) as being unpatentable over Siruntawineti, CN '147, Odum, Kats, and Merchant (id. at 8-10). Claim 8 is the only independent claim on appeal, and reads as follows: 8. A feed composition for a weanling pig or poultry hatchling comprising: a commercial feed product digestible by said weanling pig or said poultry hatchling; and a feed supplement, said feed supplement is a blood product from at least one Crocodylian species in an amount 2 CN 1634147 A (published June 7, 2005). In citing to CN '147, we cite to the machine translation to which the Examiner and Appellants cite. 3 J. Odum, et al., Effect of Rodent Diets on the Sexual Development of the Rat, 61 TOXICOLOGICAL SCIENCES, 115-127 (2001). 4 , L.J. Kats et al., The Effects of Spray-Dried Blood Meal on Growth Performance of the Early-Weaned Pig, 72 J. ANIM. SCI. 2860-2869 (1994). 5 Final Action entered August 12, 2015. 6 Jindawan Siruntawineti et al., Crocodile Blood as Food Supplement: Its Effects on Hematological Values in Wistar Rats, 30th Congress on Science & Technology of Thailand (2004) (citation provided by Examiner). The copy of the Siruntawineti provided by the Examiner does not include page numbers. We cite to the first page as page 1, and the remaining pages as if numbered consecutively. 7 Mark E. Merchant et al., Comparisons of innate immune activity of all known living crocodylian species, 143 COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY, PART B 133-137 (2006). 2 Appeal2017-009634 Application 11/640,421 effective to increase weight gain of said pig or poultry hatchling being fed said feed composition; wherein the effective amount of the blood product to increase weight gain of the weanling pig or poultry hatchling is 0.5% to 1.0% by weight of the feed composition; and wherein said feed composition is palatable to said weanling pig or poultry hatchling. Appeal Br. 16. OBVIOUSNESS- CN '147, ODUM, AND KATS The Examiner's Prima Facie Case In rejecting claim 8 over CN '147, Odum, and Kats, the Examiner cited CN '14 7 as disclosing "a feed composition comprising a commercial feed product and a feed supplement, wherein the feed supplement is a blood product from at least one Crocodylian species (see translation, abstract, claim 1 ). " Final Act. 3. The Examiner found that CN '14 7 teaches that its feed composition "may be administered to rodents and that compositions comprising the blood product may be prepared to contain, for instance, 40 Âµg/ml or 1000 mg/L of the blood product, which is 4% or 0.1 % (see translation, p. 4, par. 3, p. 6, par. 3 and tables 3, 8)." Id. Therefore, the Examiner found, although CN ' 14 7 does not "specifically teach feed products comprising the use of 0.5 to 1 % [Crocodylian blood product as recited in Appellants' claim 8], the reference teaches that the blood products may be administered in compositions wherein the blood products are present at values near this range ( e.g., 0.1 % and 4%)." Id. 3 Appeal2017-009634 Application 11/640,421 The Examiner further found: Since the [ CN '14 7] reference also teaches that the compositions may be administered as food products, one of ordinary skill in the art would have been motivated to administer to the subjects a commercial feed product comprising the blood product within the claimed range in the course of routine experimentation and given the guidance of the prior art. This amount would inherently be effective to possess the characteristics recited in the claims (e.g., the increase in weight gain in a weanling pig or poultry hatchling). Final Act. 3--4. The Examiner found that CN ' 14 7 also differs from the feed composition of Appellants' claim 8 in that, "[a]lthough the reference does not specifically teach that the feed composition is digest[i]ble by and palatable to weanling pigs or poultry hatchlings, the reference teaches that the composition may be administered to rodents (see translation p. 3, par. 2)." Id. at 4. Despite that difference, the Examiner concluded that a feed composition palatable to a weanling pig or poultry hatchling as recited in Appellants' claim 8 would have been obvious: A commercial feed composition for rodents would be expected to be digest[i]ble by and palatable to weanling pigs, as evidenced by Odum, which teaches standard rodent feed containing, for instance, com, soybean meal and fish meal ( see abstract, p. 118, table 1 ), and Kats, which teaches that standard weanling pig feed may also contain com, soybean meal and fish meal (seep. 2864, table 5). Also, note the instant specification, page 2, first paragraph that teaches the use of the same the components to make a weanling pig food product. Thus, a feed composition prepared based on the teachings of [CN '147] would contain a commercial feed product that would be expected to be digest[i] ble by and palatable to weanling pigs. Final Act. 4. 4 Appeal2017-009634 Application 11/640,421 Analysis As stated in In 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. In KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the Supreme Court emphasized "an expansive and flexible approach" when analyzing the issue of obviousness, id. at 415, the Court also reaffirmed the importance of determining "whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue." Id. at 418. Ultimately, therefore, as our reviewing court has stated, "[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) (internal quotations omitted). Having carefully considered all of the arguments and evidence advanced by Appellants and the Examiner, Appellants persuade us that the preponderance of the evidence does not support the Examiner's determination of obviousness as to Appellants' claim 8. In particular, Appellants persuade us (see Appeal Br. 8-9; Reply Br. 2-3) that the Examiner has not shown by a preponderance of the evidence that the combination of CN '14 7, Odum, and Kats would have suggested preparing claim 8 's feed composition palatable to weanling piglets or poultry hatchlings, the feed composition containing 0.5% to 1.0% by weight of a 5 Appeal2017-009634 Application 11/640,421 crocodylian blood product. We acknowledge, as the Examiner found, that CN '14 7 discloses using "crocodile blood in preparation for the treatment of anti-tumor anti- viral drug to enhance immunity and health food applications." CN '14 7 at 1 ( claim 1 ). CN '147 explains that its objective in preparing foods containing crocodile blood is to address the increasing rate of cancer and viral diseases in humans. See id. at 2 ("China's current cancer patients [number] about 400 million people. Newly diagnosed each year 1.6 million cancer patients."); see also id. ("Meanwhile, the viral disease is harmful to human health a major killer, the number of infected is increasing every year, in order to cause great harm to society and human health.'). CN '14 7 discloses a broad oral dosage range of crocodile blood products to address these human disorders: Typically for oral use, of course, also possible to use other modes of administration, the manner of administration of different doses vary; the use of a solid oral dose per day is generally from about 0.001 to 100,000 mg, for adults the amount used is from 0.05 to 60,000 mg per day[.] The most commonly used dose of 5 to 5000 mg; once a day or several times to use. CN '147 at 2. As noted above, the Examiner relies on pages 4 and 6 of CN ' 14 7 as disclosing compositions administered orally to rodents, and reasons that, as required by Appellants' claim 8, the rodent-administered compositions would be palatable to weanling pigs and poultry hatchlings, as evidenced by Odum and Kats. Final Act 3--4. The Examiner finds, moreover, that the rodent-administered compositions described by CN '14 7 contain crocodile 6 Appeal2017-009634 Application 11/640,421 blood products at concentrations "near" the 0.5 to 1.0% by weight concentration range required by Appellants' claim 8. J d. at 3. The machine translation of CN '14 7 provided by the Examiner, including pages 4 and 6 cited by the Examiner, includes extensive passages which are grammatically confusing. In any event, the disclosures relied upon by the Examiner on page 4 of CN '14 7 appear to describe experiments in mice to show that oral administration of crocodile blood elicits anticancer effects, and the disclosures relied upon by the Examiner on page 6 of CN '14 7 appear to describe experiments in mice to show that oral administration of crocodile blood elicits antiviral effects. See CN '14 7 at 4, 6. Specifically, page 4 of CN '14 7 discloses that nasopharyngeal tumor tissue was "inoculated subcutaneously in nude mice ... to become human nasopharyngeal cancer nude mouse model." CN ' 14 7 at 4. Page 4 of CN ' 14 7 appears to disclose that different crocodile blood- containing products were administered orally, by "gavage," rather than as a supplement to the feed provided to the mice. Id. Page 4 of CN ' 14 7 also appears to disclose a number of different dosages of crocodile blood products, and the respective level of cancer inhibition elicited by those dosages. See id. ("the experimental results in ... Table 3 crocodile plasma lyophilized powder on HepG2 cells, inhibit cancer cell B16 dose rate (Âµg/mL) 900 400 150 60 40 inhibition rate ofHepG2 84.5 75.9 62.3 51.2 44.3 (%) B16 78.2 60.151.248.9 33.2."). Page 6 of CN '14 7, including paragraph 3 cited by the Examiner, appears to disclose the pneumonia-protecting effects in mice of a variety of different orally administered dosages of crocodile blood-containing compositions: 7 Appeal2017-009634 Application 11/640,421 Table 8 dose oral gavage for 10 consecutive days in each group Table 8 crocodile lyophilized plasma of mice infected with viral pneumonia caused by the protective effect of death (x Â± SD, n = 10) group N / only administered concentration (mg/ L) of death (n) Mortality(%) Average survival (d) the virus control group 10 5% PVP-K30 8 80 9.7 Â± 3.1 normal control group 10 5% PVP-K30 0 0 15.0 Â± 0.0 *** ribavirin group 10 1000 5 50 13.6 Â± 0.6 *** Crocodile plasma lyophilization 10 60 6 60 12.0 Â± 2.8 **powder administered group 10 120 3 30 13.7 Â± 2.4 *** 10 240 3 30 14.3 Â± 1.3 *** logic Lo crocodile plasma frozen 10 60 6 60 12.2 Â± 2.7 Li dry powder administered group 10 120 3 30 13.9 Â± 1.9 *** 10 240 2 20 14.7 Â± 0.7 *** Compared with the control group, L'iP> 0.05, * P <0.05, ** P <0.01, *** P <0.001. CN '147 at 6. The Examiner identifies no specific evidence in the record suggesting that the amounts of the crocodile blood products used in CN '14 7 to elicit its anticancer and antiviral effects in mice would overlap, or even be close to, the range recited in Appellants' claim 8, which recites an entirely different effect, and in different animals-increasing weight gain in weanling pigs or poultry hatchlings. Nor has the Examiner explained specifically why an ordinary artisan would have expected that optimizing the amount of crocodile blood to achieve the anticancer and antiviral effects CN '14 7 in mice would yield a concentration within the range of Appellants' claim 8, which recites an effect entirely different than the effects described in CN '14 7, in entirely different animals. In addition, as seen above, the crocodile blood products in CN '14 7 's mouse experiments were administered by gavage, as opposed to in the form of a feed product. Thus, even when viewed in light of the teachings in Odum and Kats regarding suitable rodent and weanling piglet feed 8 Appeal2017-009634 Application 11/640,421 compositions, we are not persuaded that the Examiner has explained sufficiently why the amounts of crocodile blood products allegedly described as being administered orally to mice on pages 4 and 6 of CN '14 7 for anticancer and antiviral effects, would have suggested a feed composition, palatable to weanling piglets or poultry hatchlings, having an amount of crocodile blood effective to increase the weight gain in weanling pigs or poultry hatchlings. The Examiner, moreover, provides no specific explanation as to the calculation (see Final Act. 3) used to determine that a composition containing 40 Âµg/ml of a crocodile blood product (i.e., 40 micrograms of crocodile blood product per gram of total weight), contains 4% by weight of the crocodile blood product (i.e., 40 milligrams crocodile blood product per gram of total weight). We are not persuaded, therefore, that the Examiner has explained sufficiently how or why the antiviral/anticancer amounts of crocodile blood product used in CN '14 7 would overlap, or even be close to, the concentration range of blood product recited in Appellants' claim 8. In response to Appellants' arguments regarding the cited references' failure to suggest the pig weanling/poultry hatchling feed having the claimed percentage of crocodylian species blood product, the Examiner contends that CN '14 7 includes a broad disclosure of suitable dosages of the crocodylian blood product, and based on that disclosure, urges that an ordinary artisan "could have arrived at the amount of crocodilian blood product recited in the claims in the course of routine experimentation, and could have done so with a reasonable expectation of success." Ans. 3 (citing CN '147); see also id. at 5---6 (reiterating routine experimentation argument). 9 Appeal2017-009634 Application 11/640,421 We are not persuaded that the preponderance of the evidence supports the Examiner's alternative rationale for holding the composition of Appellants' claim 8 obvious. We acknowledge CN 14 7 's disclosure, noted above, that crocodile blood products may be orally administered at a wide range of dosages to human subjects to elicit anticancer and antiviral effects. See CN '14 7 at 2 ("[T]he use of a solid oral dose per day is generally from about 0.001 to 100,000 mg, for adults the amount used is from 0.05 to 60,000 mg per day[.] The most commonly used dose of 5 to 5000 mg; once a day or several times to use."). That CN '14 7 discloses a broad range of dosages of crocodile blood suitable for oral administration to humans to provide an anticancer and/or antiviral effect does not persuade us that CN '14 7 would have suggested a feed composition, palatable to weanling piglets or poultry hatchlings, having an amount of crocodile blood effective to increase the weight gain in weanling pigs or poultry hatchlings, as recited in Appellants' claim 8. In particular, the Examiner identifies no specific evidence in the record suggesting that even the broadly disclosed amounts of the crocodile blood products described in CN '14 7 as eliciting its anticancer and antiviral effects in humans would overlap, or even be close to, the range recited in Appellants' claim 8, which elicits an entirely different effect in different animals-increasing weight gain in weanling pigs or poultry hatchlings. Nor has the Examiner explained specifically why an ordinary artisan would have expected that optimizing the amount of crocodile blood to achieve the anticancer and antiviral effects CN '14 7 in humans would yield a concentration within the range of Appellants' claim 8, which, again, recites an effect entirely different than the effects described in CN '14 7, in entirely 10 Appeal2017-009634 Application 11/640,421 different animals. The Examiner, moreover, fails to identify any specific evidence supporting the assertion (see Ans. 5) that a food composition for use in humans would necessarily be palatable to a weanling pig or poultry hatchling, as Appellants' claim 8 requires. In sum, for the reasons discussed, Appellants persuade us that the Examiner has not shown by a preponderance of the evidence that the feed composition of Appellants' claim 8 would have been obvious over CN '14 7, Odum, and Kats. We, therefore, reverse the Examiner's rejection of claim 8, and its dependent claims 9, 11, and 13-15, over CN '147, Odum, and Kats. OBVIOUSNESS- SIRUNTA WINETI, CN '147, ODUM, AND KATS The Examiner's Prima Facie Case In rejecting claim 8 over Siruntawineti, CN '14 7, Odum, and Kats, the Examiner cited Siruntawineti as disclosing "supplements for addition to feed for rats, wherein the feed supplement is a freeze-dried blood product (whole blood) from a Crocodylian, specifically Crocodylus siamensis (abstract)." Final Act. 5. The Examiner found that Siruntawineti differs from claim 8 in that the "reference does not teach the specific amounts in which the blood product is provided in the food or the formulation of the product for a weanling pig or poultry hatchling." Id. As evidence that the feed composition of Appellants' claim 8 would have been obvious despite that difference between claim 8 and Siruntawineti, the Examiner cited the disclosures in CN '14 7, discussed above, as evidence that it was known in the art to administer crocodile blood products to rodents at concentrations "near" the concentration range recited in claim 8. Id. at 6. 11 Appeal2017-009634 Application 11/640,421 In particular, the Examiner reasoned, "one of ordinary skill in the art would be motivated to use the amounts that are known to be useful for feed products based on the prior art, and would therefore have been motivated to use amounts of blood product similar to those of [ CN '14 7]." Id. The Examiner again cited Odum and Kats as evidence that rodent and weanling pig feeds contain ingredients in common, and that the rodent feed composition suggested by Siruntawineti and CN '14 7, therefore, would be palatable to weanling pigs, as required by Appellants' claim 8. J d. at 7. Analysis For reasons similar to those discussed above, we also reverse this rejection. We acknowledge Siruntawineti' s disclosure that, based on its reported antimicrobial activity, 300 Âµl of fresh crocodile blood or 50 mg of freeze- dried crocodile blood was administered to Wistar rats for 45 consecutive days "to determine whether the crocodile blood is safe to use as human food supplement by observing hematological changes in rat." Siruntawineti at 1. As to the results of its study, Siruntawineti discloses that its "data suggest the safety of crocodile blood as food supplement in animal." Id. As noted above, however, the Examiner relies entirely on the teachings in CN '14 7 to show that the concentration of blood product from crocodylian species recited in Appellants' claim 8 would have been an obvious component in a rodent feed. See Final Act. 6. As discussed above in relation to the previous rejection, the Examiner identifies no specific evidence in the record suggesting that the amounts of the crocodile blood products used in CN '147 to elicit its anticancer and antiviral effects in mice would overlap, or even be close to, the range recited 12 Appeal2017-009634 Application 11/640,421 in Appellants' claim 8, which recites an entirely different effect, in different animals-increasing weight gain in weanling pigs or poultry hatchlings. Nor has the Examiner explained specifically why an ordinary artisan would have expected that optimizing the amount of crocodile blood to achieve the anticancer and antiviral effects CN '14 7 in mice would yield a concentration within the range of Appellants' claim 8, which recites an effect entirely different than the effects described in CN '14 7, in entirely different animals. As also discussed above, we are not persuaded that the Examiner has adequately explained the calculations used to arrive at the finding that the amounts of crocodile blood products used in the mice experiments in CN '14 7 were close to the amounts recited in Appellants' claim 8. Moreover, although we note Siruntawineti's disclosure that crocodile blood has antimicrobial properties (Siruntawineti at 1 ), the Examiner does not identify any specific evidence suggesting that the amounts used by Siruntawineti as a food supplement for rats would be useful in a feed palatable to weanling pigs or poultry hatchlings, in an amount that increases weight gain in the weanling pigs or poultry hatchlings, as recited in Appellants' claim 8. Because we are not persuaded, for the reasons discussed, that the Examiner has shown by a preponderance of the evidence that the feed composition of Appellants' claim 8 would have been obvious over Siruntawineti, CN '147, Odum, and Kats, we reverse the Examiner's rejection of claim 8, and its dependent claims 9, 11, and 13-15, over Siruntawineti, CN '147, Odum, and Kats. REMAINING REJECTIONS In the remaining rejections, the Examiner rejected claims 8, 9, 11, and 13-16 over CN '147, Odum, Kats, and Merchant (Final Act. 7-8), and also 13 Appeal2017-009634 Application 11/640,421 rejected claims 8, 9, 11, and 13-16 over Siruntawineti, CN '147, Odum, Kats, and Merchant (id. at 8-10). In both of the remaining rejections, the Examiner relies on the previously discussed combination of either CN '14 7, Odum, and Kats, or Siruntawineti, CN '14 7, Odum, and Kats, and cites Merchant as evidence that it would have been obvious to use the blood product recited in Appellants' claim 16, which depends from claim 8, in the feed composition suggested by the other references. See id. at 7-8, 8-10. Because the Examiner does not explain, nor do we discern, how Merchant remedies the shortcomings of the other references in relation to claim 8, discussed above, we reverse these rejections as well. SUMMARY For the reason discussed, we reverse each of the Examiner's obviousness rejections. REVERSED 14