Ex Parte Destaillats et alDownload PDFPatent Trial and Appeal BoardOct 21, 201612935829 (P.T.A.B. Oct. 21, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/935,829 09/30/2010 29157 7590 K&L Gates LLP-Chicago P.O. Box 1135 CHICAGO, IL 60690 10/25/2016 FIRST NAMED INVENTOR Frederic Destaillats 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. 3712036-1181 7306 EXAMINER THAKOR, DEV ANG K ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 10/25/2016 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): USpatentmail@klgates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FREDERIC DESTAILLATS, JEAN-BAPTISTE BEZELGUES, FABIOLA DIONIS!, and CRISTINA CRUZ-HERNANDEZ1 Appeal2015-001427 Application 12/935,829 Technology Center 1600 Before ERIC B. GRIMES, JOHN G. NEW, and TIMOTHY G. MAJORS, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1Appellants state the real party-in-interest is Nestec S.A. App. Br. 2. Appeal2015-001427 Application 12/935,829 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner's Final Rejection of claims 1, 3, and 5-20.2 Specifically, claims 1, 3, 5-9, 16, and 19 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of Koss et al. (US 7,033,629 B2, April 25, 2006) ("Koss") and Ponroy (US 5,591,479, January 7, 1997) ("Ponroy"). Claim 17 stands rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of Koss and Ruxandra Bunea et al., Evaluation of the Effects of Neptune Krill Oil on the Clinical Course of Hyperlipidemia, 9(4) ALT. MED. REV. 420-28 ("2004") ("Farrah"). 3 Claims 10-15, 18, and 20 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination Ponroy, Farrah, Elswyk (US 2003/0060509 Al, March 27, 2003) ("Elswyk"), Pridmore- Merten (WO 2005/074719 Al, August 18, 2005) ("Pridmore-Merten"), and Viva Labs, Krill Oil Versus Fish Oil ("Viva Labs"). Claims 10-15, 18, and 20 also stand rejected as unpatentable under 35 U.S.C. § 103(a) as being obvious over the combination of Prosise (US 2005/0260302 Al, November 24, 2005) ("Prosise"), Ponroy, Farrah, Elswyk, and Viva Labs. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 2 Claims 2 and 4 are canceled. See Final Act. 2. 3 Although Dr. Bunea is the first author of this reference, both Appellants and the Examiner use another author's surname ("Farrah") to refer to this reference. We herein follow their practice to avoid confusion in the record. 2 Appeal2015-001427 Application 12/935,829 NATURE OF THE CLAIMED INVENTION Appellants' invention is directed to maternal food compositions comprising long-chain polyunsaturated fatty acids ("LC-PUPA"). Abstract. REPRESENTATIVE CLAIM Independent claim 1 is representative of the claims on appeal and recites: Claim 1: A maternal food composition comprising a source of lipids, wherein the source of lipids includes at least one LC-PUPA that is docosahexaenoic acid (DHA) in a form selected from the group consisting of phospholipids (PL) and their lyso derivatives, and wherein the maternal food composition is to be consumed during a pregnancy or a lactation period, the composition comprising a source of carbohydrates providing 40% to 80% of the total energy of the composition and a source of fat providing 20% to 30% of the total energy of the composition. App. Br. 39. FINDINGS OF FACT F. 1: Farrah teaches: Krill oil has a unique biomolecular profile of phospholipids naturally rich in omega-3 fatty acids and diverse antioxidants significantly different from the usual profile of fish oils. The association between phospholipids and long-chain omega-3 fatty acids highly facilitates the passage of fatty acid molecules through the intestinal wall, increasing bioavailability and ultimately improving the omega-3:omega-6 fatty acid ratio. Farrah 421 (footnotes omitted). F. 2: Example 1 of Appellants' Specification discloses that supplementation of the maternal diet with DHA-PL or DHA-TG has an 3 Appeal2015-001427 Application 12/935,829 influence on the level of DHA in the retina of newborn Sprague-Dawley rats. Spec. 15. F. 3: Example 1 of Appellants' Specification discloses that, at 14 days of life, DHA-PL shows a moderately superior effect than DHA-TG. However, at 21 days the opposite effect was observed. Spec. 15. F. 4: Example 1 of Appellants' Specification discloses that, after the weaning period, the animals received only a-linolenic acid as a source of n-3 fatty acids. Spec. 15. F. 5: Example 1 of Appellants' Specification discloses that, after 3 months under that diet, the analysis of the fatty acid composition of the retina revealed that the level of DHA is statistically higher in animals fed with the DHA-PL than those fed with DHA-TG or the control group. Spec. 15. F. 6: Example 1 of Appellants' Specification discloses that Flicker ERG experiments performed on newborns at day 21 show that DHA-PL treatment improves rod sensitivity. Spec. 15 (citing Spec. Fig. 6). ISSUES AND ANALYSES We agree with, and adopt, the Examiner's findings and conclusion that the appealed claims are prima facie obvious over the cited prior art references. We address below the arguments raised by Appellants. A. Claims 1, 3, 5, 8, 9, 16, and 19 Issue Appellants argue that, despite the Examiner's finding that the combined cited prior art teaches or suggests all of the limitations of the 4 Appeal2015-001427 Application 12/935,829 claims, the Examiner erred by ignoring the surprising and unexpected results disclosed in Appellants' Specification. App. Br. 8. Analysis Appellants do not dispute that the combined references teach or suggest all of the limitations in the claims at issue, nor do they dispute any motivation to combine the references. However, Appellants point to Example 1 of their Specification, which they argue discloses unexpected and surprising results. App. Br. 8. Appellants contend the data in Example 1 overcome the Examiner's prima facie case of obviousness for independent Claim 1. Id. Specifically, Appellants point to Example 1 of their Specification, which describes a study employing three different diets used for feeding rats during pregnancy and lactation. App. Br. 8 (see Spec. 12-14). Appellants state that the basic macronutrient distributions were the same in all these diets, however, the control diet did not contain docosahexaenoic acid ("DHA") or other long-chain polyunsaturated fatty acids ("LC-PUP As") whereas the DHA-TG and DHA-PL groups contained the same level of DHA added in these diets as triacylglycerols (TG) (fish oil) or phospholipids (PL) (krill oil) (Appellants note that Koss does not teach a specific form of DHA). App. Br. 8-9 (see F. 2--4). Appellants argue that their Specification also discloses that all neonates were euthanized after 14 or 21 days4 or three months thereafter. Id. at 9 (see Spec. 14; Fig. 3). Appellants assert that the neonates of those rats 4 The weaning period of Sprague-Dawley rats ends at 21 days. See Spec. 14. 5 Appeal2015-001427 Application 12/935,829 fed a DHA-containing diet exhibited enhanced incorporation ofn-3 PUPA, and especially of DHA, compared to those fed the control diet. Id. (see F. 2- 3). Appellants also observe that a significant increase in DHA level of retina and brain glial cells was observed in the DHA-PL group compared to other diets. Id. Appellants argue this demonstrates that supplementation of the maternal diet with DHA-PL is more efficient than DHA-TG in conferring elevated levels of DHA to the offspring. Id. Appellants argue that, at 21 days postpartum, opposite results were observed, with higher levels ofDHA-TG observed. App. Br. 9 (see F. 3). Finally, after weaning, the surviving rats of all test groups received only alpha-linolenic acid as a source of n-3 fatty acids in their diets and, after 3 months, analysis of the fatty acid composition of the retina revealed that the level of DHA was statistically higher in animals fed with DHA-PL than in the other groups (DHA-TG and control). Id. (see F. 5). These results, Appellants argue, demonstrate that the use of the DHA-PL as a supplement during the pregnancy and lactation period has a long-term effect on the DHA level in the retina. Id. Furthermore, Appellants argue that the flicker electroretinogram ("ERG") experiments performed on newborns at day 21 postpartum demonstrate that DHA-PL treatment improves rod sensitivity. App. Br. 9 (see F. 6). Finally, Appellants argue, both DHA diets significantly increased DHA levels in phosphatidylserine ("PS") purified from brain glial cells in male pups both at day 14 and weaning (p<0.0001). Id. Appellants summarize the results of the experiments disclosed in their Specification thus: administration of the maternal food composition of the 6 Appeal2015-001427 Application 12/935,829 claimed invention, rather than a standard maternal diet supplemented with D HA-PL from krill oil, ( 1) improves the level of D HA in the maternal milk, (2) improves the accretion of DHA in the neonatal retina, (3) accelerates the maturation of the neonatal retina, and ( 4) improves long term accretion of DHA in the brain glial cell PS. App. Br. 10. Therefore, Appellants argue, these results are new and unexpected in view of the prior art, and overcome the Examiner's primafacie case of obviousness over Koss and Ponroy. Appellants take issue with the Examiner's alleged reliance on the teachings of Farrah, which was not cited by the Examiner in the rejection of claim 1. App. Br. 10. According to Appellants, the Examiner stated, in the Advisory Action of December 2, 2013, "[a] comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." Id. (emphasis added by Appellants) (citing Adv. Act. 3 (quoting In re Merchant, 575 F.2d 865, 868 (CCPA 1978)); see also Manual of Patent Examining Procedure (MPEP) § 716.02(e) (9th ed., Rev. 07.2015, Nov. 2015)). However, Appellants argue, Farrah discloses only a study in which administration of krill oil to patients with hyperlipidemia reduced total cholesterol and LDL, and increased HDL. Id. Appellants assert that Farrah does not teach that the krill oil was consumed during a pregnancy or a lactation period, in a composition comprising a source of carbohydrates providing 40% to 80% of the total energy of the composition, or in a composition comprising a source of fat providing 20% to 30% of the total energy of the composition. Id. 7 Appeal2015-001427 Application 12/935,829 Therefore, Appellants contend, Farrah is not the closest prior art of record for independent Claim 1. Id. Appellants dispute the Examiner's finding that Farrah is the closest prior art of record because use of krill oil is the source of their unexpected results and, therefore, the claimed invention must be compared to a reference using krill oil as the LC-PUPA. App. Br. 10. According to Appellants, that finding is improper because it would require Appellants to "compare the results of the invention with the results of the invention." Id. (citing MPEP § 716.02(e)(III)). Furthermore, Appellants argue, the experimental comparison of the claimed invention to Farrah proposed by the Examiner would not be a reasonable comparison because administration of the claimed composition to infants via a pregnant or lactating mother would be compared with administration of krill oil to patients with hyperlipidemia as taught by Farrah. Id. at 10-11. Appellants also take issue with the Examiner's finding that a skilled artisan "would have reasonably expected that the use of the krill oil as the LC-PUPA source would result in increased beneficial effects." App. Br. 11. Appellants contend there is no basis for finding that unexpected results are only applicable when no benefit whatsoever is expected, and assert that the Examiner's finding that administration of DHA-PL would result in "increased beneficial effects" is too general to suggest to the skilled artisan the experimental results disclosed in the Specification. Id. Rather, Appellants argue, the inquiry for unexpected results is whether a greater than expected result, a superiority of a shared property, an unexpected property, or the absence of an expected property is achieved by the claimed invention. 8 Appeal2015-001427 Application 12/935,829 Id. (citing MPEP § 716.02(a)). Appellants assert that the experimental evidence demonstrates unexpected properties. The Examiner responds that it was never stated that Farrah was the closest prior art for comparison, but rather that "a comparison with Koss cannot constitute a comparison with the closest prior art for the purpose of establishing unexpected results because of the extent to which the comparison deviates from Koss." Ans. 4 (emphasis omitted). The Examiner finds Appellants "[have] not explained this deviation in the presentation of the alleged unexpected results." Id. (citing, inter alia, MPEP § 715.02) (emphasis omitted). Specifically, the Examiner finds the comparison made by Appellants is not identical with the disclosure of the reference "chosen as closest prior art" because the inventive composition used for the comparison includes DHA derived from krill oil (DHA-PL), whereas the closest prior art of Koss includes DHA derived from fish oil. Ans. 4. The Examiner finds DHA from fish oil is structurally different from the DHA from krill oil, and would therefore be expected to have a different effect. Id. at 4-5. The Examiner finds this expectation is supported by Appellants' results indicating that the observed increased benefit derived from the PL form of the DHA in krill oil, as opposed to the TG form of the DHA in fish oil. Id. at 5. The Examiner therefore finds that, even though the structure of DHA in krill oil was known at the time of invention to be different from DHA in fish oil (as taught by Farrah), Appellants fail to account for this difference when comparing the instant composition with that of Koss, particularly when making the comparison with Koss and Appellants' claimed composition. Ans. 5. More particularly, the Examiner finds, Appellants do 9 Appeal2015-001427 Application 12/935,829 not explain or account for the structural difference between the instant composition and the composition of the prior art considered to give rise to the allegedly unexpected results, as required by MPEP § 715.02. Under these circumstances, the Examiner finds§ 715.02 of the MPEP establishes that the burden is on Appellants to explain why, even with the defined structural difference, the results are still unexpected. Ans. 5-6. The Examiner also finds Farrah teaches that, at the time of invention, it was known in the art that the use of krill oil as a DHA source generally increases the bioavailability ofDHA. Ans. 6. This teaching is relevant to the alleged expectedness of Appellants' results, the Examiner finds, because it addresses the difference between the composition of the closest prior art (Koss) identified by Appellants and Appellants' composition. Id. In particular, finds the Examiner, krill oil would have been expected to provide the observed benefits based on the state of the art at the time of invention because it was known that DHA bioavailability is higher in krill oil than in fish oil based on the complexing of DHA with PL, compared to TG. Id. at 6-7 (citing Farrah 421 ). The Examiner finds a person of ordinary skill in the art would reasonably expect that the overall increase in the bioavailability of krill oil-based DHA could produce the benefits observed by Appellants when compared to fish oil. Id. at 7. The Examiner finds further that the alleged unexpected results of Appellants are not commensurate with the scope of the claims. Ans. 8. The Examiner finds the data disclosed by Appellants' Specification to support Appellants' claim of unexpected results were based on the benefits of employing krill oil instead of fish oil or no DHA. Id. However, the Examiner finds, the claims at issue do not limit the DHA source to krill oil. 10 Appeal2015-001427 Application 12/935,829 Id. The Examiner finds krill oil is only introduced in dependent claim 17, and that claims 1, 3, 5-9, 16, and 20 are drawn instead to DHA-PL. Id. Appellants have not shown that other sources of DHA-PL are superior to the fish oil described by Koss. Id. Therefore, the Examiner finds, there is no nexus between the alleged unexpected results and the claimed invention, which encompasses any DHA-PL. Id. We are not persuaded by Appellants' argument. As an initial matter, we agree with the Examiner that Appellants do not dispute the Examiner's findings that the claims at issue would have been obvious based on the combined cited prior art. See Ans. 3. The issue that confronts us, then, is whether the results disclosed in Example 1 of Appellants' Specification are sufficiently unexpected or surprising so as to overcome the Examiner's prima facie conclusion of obviousness. We conclude that they are not. We find Appellants' argument that the Examiner improperly relied upon Farrah to be without merit. See App. Br. 10. The claims at issue are directed to a composition, and Appellants do not dispute that the combined cited prior art (Koss and Ponroy) teach or suggest all of the limitations of the claimed compound. Rather, Appellants contend that the properties of the composition produce surprising and unexpected results when employed in the manner claimed in Appellants' method claims. However, we are not persuaded by Appellants' argument that the Examiner is thereby constrained to rely upon only those references cited as teaching the composition itself in rebutting Appellants' argument that the properties of the composition produce unexpected results. Indeed, the Examiner has explicitly relied upon Farrah in rejecting all of Appellants' method claims. See Final Act. 6, 7, 11. Furthermore, Appellants do not argue that Farrah is not art prior to their 11 Appeal2015-001427 Application 12/935,829 claimed invention but only that, because Farrah was not cited in the rejections of these composition claims, the Examiner may not use Farrah to overcome Appellants' rebuttal arguments. We disagree: the Examiner need not tum a blind eye to cited prior art, simply because that art was not cited as teaching the claimed composition, but was cited instead as teaching a portion of the method claims. We therefore reject Appellants' reasoning in this respect. Furthermore, we are not persuaded that Appellants have successfully demonstrated that the results disclosed in their Specification are sufficiently surprising or unexpected to overcome the Examiner's conclusion of obviousness. As an initial matter, we do not find it necessarily surprising or unexpected, nor do Appellants provide any evidence why we should, that a diet containing long-chain polyunsaturated DHA fatty acids (either PL- or TG-based) would result in increased DHA levels in postpartum rats when compared to those born to the control rats that were administered a diet containing no DHA at all (i.e., the control animals). This is particularly so when the differences in DHA in the control and experimental groups is of relatively minor magnitude (approximately <5% total). See Spec. Figs. 5, 7. The question, then, is whether it would have necessarily been surprising or unexpected to a person of ordinary skill that the test subject rats born to rats administered DHA-PL as part of their diet had statistically significantly more DHA in their bodies at 14 days postpartum (but not at 21 days) and at 3 months age than those born to rats administered DHA-TG in their diet. We find that it would not. 12 Appeal2015-001427 Application 12/935,829 Farrah teaches that krill oil has a unique biomolecular profile of phospholipids, rich in omega-3 fatty acids (e.g., DHA) and diverse antioxidants, that differs significantly from the usual profile of fish oils. See F. 1. Specifically, Farrah teaches: "[t]he association between phospholipids and long-chain omega-3 fatty acids highly facilitates the passage of fatty acid molecules through the intestinal wall, increasing bioavailability and ultimately improving the omega-3: omega-6 fatty acid ratio." Id. We agree with the Examiner's conclusion that it would therefore have been obvious to one of ordinary skill in the art to substitute DHA derived from krill oil, as taught by Farrah, for DHA derived from fish oil to increase the bioavailability of DHA in mammalian gestation and lactation. Furthermore, although differences between DHA-PL and DHA-TG disclosed by Appellants' Specification are, in some instances, statistically significant, they are nonetheless slight of magnitude, differing only by approximately two percent or less. See Spec. Figs. 5, 7. Given the teachings of Farrah with respect to the greater bioavailability of krill oil- derived DHA (see Farrah 421 ), we are not persuaded the data disclosed in the Specification would have been entirely unexpected or sufficiently different in kind as to overcome the Examiner's prima facie conclusion of obviousness. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1372 (Fed. Cir. 2007) (Unexpected results are required to show a difference in kind to overcome a primafacie conclusion of obviousness); see also Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 769 (Fed. Cir. 1988), cert. denied, 493 U.S. 814 (1989) (Although the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record may also 13 Appeal2015-001427 Application 12/935,829 establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness). We therefore conclude that Appellants have not adduced evidence sufficient to overcome the Examiner's prima facie conclusion of obviousness and we affirm the Examiner's rejection of claims 1, 3, 5, 8, 9, 16, and 19. Furthermore, because Appellants explicitly rely upon the same arguments with respect to claims 6, 7, and 18 (see App. Br. 11-12, 15), we similarly affirm the Examiner's rejection of those claims. B. Claims 17 Issue Claim 17 recites: "The maternal food composition according to claim 1, wherein the at least one LC-PUP A is in the form of krill oil." App. Br. 42. Appellants argue the Examiner erred because Farrah fails to teach or suggest the limitation of claim 1 requiring administering DHA to the infant through the mother. App. Br. 12. Analysis Appellants argue neither Koss nor Farrah teaches or suggests that administration of DHA-PL to the infant through the mother provides any benefit over DHA-TG, much less the alleged unexpected results disclosed in Appellants' Specification. App. Br. 12. Appellants dispute the Examiner's finding that Farrah teaches krill oil provides increased bioavailability of DHA and conclusion that the experimental results are not unexpected. Id. According to Appellants, Farrah teaches a study in which administration of krill oil to patients with hyperlipidemia reduced total cholesterol, LDL and 14 Appeal2015-001427 Application 12/935,829 increased HDL. Id. Appellants assert that the Examiner has provided no basis for extrapolating this teaching to infants indirectly receiving the DHA through the mother. Id. The Examiner responds that claim 17, like claim 1, is a composition claim and not a method claim. Ans. 14. The Examiner finds Appellants' argument, viz., the lack of teaching regarding administration to the mother, is irrelevant, as it is not necessary for Farrah or Koss to teach a method of administration of the compound to the mother. The Examiner finds administration to the mother is an intended use of the composition and therefore does not limit the structure of the composition. Id. We agree with the Examiner. Appellants do not dispute that the combined cited prior art would have made obvious the composition recited in claim 17, or claim 1 from which it depends. Rather, they argue, the combined references fail to teach the intended use of the composition, i.e., wherein the maternal food composition is to be consumed during a pregnancy or a lactation period. That intended use is not limiting on the composition of the claimed compound. In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969) ("A mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable"). Moreover, Farrah explicitly teaches that krill oil can be ingested as a foodstuff by people, and we find that this genus includes ingestion by pregnant and/or lactating females in the absence of any evidence to the contrary. See Farrah 422. We consequently affirm the Examiner's rejection of claim 1 7. 15 Appeal2015-001427 Application 12/935,829 C. Claims 10-15, 18, and 20 Analysis Appellants argue these claims separately, but provide identical arguments for each, so we address these arguments together. See App. Br. 13-37. Furthermore, Appellants rely upon the same arguments presented with respect to claims 1, 3, 5, 8, 9, 16, and 19 supra. See App. Br. 10-11. We have explained why we are not persuaded by Appellants' arguments with respect to the latter claims, and we incorporate by reference that explanation and apply it equally to these claims. We consequently affirm the Examiner's rejection of claims 10-15, 18, and 2 0. DECISION The Examiner's rejection of claims 1, 3, and 5-20 as unpatentable under 35 U.S.C. § 103(a) is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l.136(a)(l). See 37 C.F.R. § l.136(a)(l )(iv). AFFIRMED 16 Copy with citationCopy as parenthetical citation