David Rutenberg et al.Download PDFPatent Trials and Appeals BoardJul 25, 201915230494 - (D) (P.T.A.B. Jul. 25, 2019) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/230,494 08/08/2016 David Rutenberg 50508-6-05-CIP 9002 89602 7590 07/25/2019 FlashPoint IP Ltd. Rehov Rabban Gamliel 2 Elad, 4083201 ISRAEL EXAMINER SOROUSH, LAYLA ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 07/25/2019 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): FPIP-USPTO@FlashPointIP.com ydm@FlashPointIP.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte DAVID RUTENBERG and ILAN PERRY1 __________ Appeal 2019-002195 Application 15/230,494 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC B. GRIMES, and RICHARD M. LEBOVITZ, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of making phospholipid-enriched dairy products, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE “Phospholipids . . . have been used extensively in pharmaceutical compositions, nutritional compounds, and functional foods.” Spec. 1:19–21. The Specification states that “the importance of phosphatidylserine (PS) as a 1 Appellants identify the Real Party in Interest as Lipogen Ltd. Appeal Br. 3. Appeal 2019-002195 Application 15/230,494 2 functional ingredient is supported by the US FDA’s qualified health claims in which the usage of phosphatidylserine was related to the reduction of cognitive dysfunction and dementia in the elderly.” Id. at 1:21–24. The Specification describes “enzymatically-processed lecithin” as being a PS-calcium and/or -magnesium salt . . . produced via transphosphatidylation with lecithin and phospholipase D in the presence of L-serine and a calcium and/or magnesium salt . . . , which involves the exchange of the choline group in phosphatidylcholine for serine using phospholipase D as the active enzyme for the PS-production reaction to occur. Id. at 10:11–16. Claims 1–13 are on appeal. Claim 1 is the only independent claim and reads as follows (formatting added to step (a)): 1. A process for the preparation of phospholipid-enriched (PL- enriched) dairy products as nutraceuticals for the formulation of functional foods, the process comprising the steps of: (a) combining a non-dairy-based PL-containing material, having phosphatidylserine (PS) in said PL-containing material, wherein said PS is derived in part from an enzymatically-processed lecithin as a PS-calcium and/or -magnesium salt via transphosphatidylation with phospholipase D in the presence of L-serine and a calcium and/or magnesium salt, with water and an oil component to form a paste; (b) removing an excess amount of said water from said paste to form a PL-oil solution having a residual amount of said water; and (c) mixing said PL-oil solution with a dairy component, thereby obtaining a PL-enriched dairy product. Appeal 2019-002195 Application 15/230,494 3 The claims stand rejected as follows: Claims 1–13 under 35 U.S.C. § 103(a) as obvious based on Rutenberg2 and Szuhaj3 (Ans. 4) and Claims 1–13 for obviousness-type double patenting based on claims 1–6 of Rutenberg (Ans. 7). I The Examiner has rejected all of the claims on appeal as obvious based on Rutenberg and Szuhaj. The Examiner finds that Rutenberg teaches that lecithin (namely, phosphatidylcholine) selected from soy bean lecithin, rapeseed lecithin and egg yolk lecithin is subjected to the process of transphosphatidylation and hydrolysis with phospholipase-D in the presence of L-serine and water, thereby substituting the choline group with the serine group . . . , to produce the rearranged phosphatidyl-L-serine . . . . Ans. 4. The Examiner finds that Rutenberg suggests that the PS product can be blended into foods and beverages, but does not teach combining it with a dairy component as required by all the claims on appeal. Id. at 5. The Examiner finds that Szuhaj teaches that lecithin is used as an ingredient in, among other things, cheese products and dairy products. Id. The Examiner concludes that it would have been obvious to combine the phospholipid with a diary component. The motivation comes from the teaching of Szuhaj that lecithin containing the claimed phospholipids are useful as an ingredient in . . . cheese products, . . . [and] dairy and imitation dairy products, and dietary supplements; and further by 2 Rutenberg, US 6,410,522 B1, issued June 25, 2002. 3 B.F. Szuhaj, Lecithin Production and Utilization, 60 JAOCS 306 (1983). Appeal 2019-002195 Application 15/230,494 4 Ru[t]enberg that the phospholipid containing composition alleviates symptoms associated with depression and mental and emotional stress [and] may be blended into daily foods and beverages. Id. Appellants argue, among other things, that “the instant invention provides a novel and non-obvious process in which, inter alia, the removal of an excess amount of water [] from the paste to form the PL-oil solution having a residual amount of water (as recited in Step (b) of claim 1) is an essential aspect of the instant invention.” Appeal Br. 16. See also Reply Br. 5 (“These aspects (as cited in the Opening Brief), which form in part the basis of the instant invention, have been given short shrift by the Examiner when considering the relevance of the cited art.”). Appellants argue that certain dependent claims add further limitations to the PL-oil solution resulting from step (b) of the claimed method. Appeal Br. 16. Finally, Appellants point out that the Specification states that the basis of the effect of the residual water in the PL-oil solution “on the solubility of enzymatically-produced PS . . . in the PL-oil solution, and ultimately the PL-enriched dairy product” is unknown, but “it may be that such residual water in the PL-oil solution mitigates the hydrophilic/ hydrophobic properties of the enzymatically-produced PS . . . when combined with the water-based dairy component” and “mitigation of the hydrophilic/hydrophobic properties of the enzymatically-produced PS . . . containing a residual water component is likely the cause for the solubility, and hence the resulting, stable final product.” Id. at 16–17 (quoting Spec. 14:9–20). Appeal 2019-002195 Application 15/230,494 5 We agree with Appellants that the Examiner has not shown that a process meeting the limitations of claim 1, including “removing an excess amount of said water from said paste to form a PL-oil solution,” as recited in step (b), would have been obvious based on Rutenberg and Szuhaj. “An examiner bears the initial burden of presenting a prima facie case of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). “The test for obviousness is what the combined teachings of the references would have suggested to one of ordinary skill in the art,” In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991); i.e., “whether the teachings of the prior art, taken as a whole, would have made obvious the claimed invention.” In re Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991). Rutenberg discloses that “a complex of phosphatidyl-L-serine and phosphatidic acid produced by an enzymatic conversion utilizing phospholipase-D of at least one raw material lecithin” has antidepressant effects. Rutenberg 2:11–18. Rutenberg states that “lecithin (namely, phosphatidylcholine) . . . is subjected to the process of transphosphatidylation and hydrolysis with phospholipase-D in the presence of L-serine and water, thereby substituting the choline group with the serine group” to produce phosphatidylserine. Id. at 2:40–46. Rutenberg’s Example 1-1 states that soybean lecithin, soybean oil, ethyl acetate, L-serine (in sodium phosphate buffer), and phospholipase-D were combined and allowed to react. Id. at 3:1–9. The reaction solution was heated to inactivate the enzyme, then cooled to separate the solution into two layers; the “lower layer was extracted in chloroform, which was then dried.” Id. at 3:10–16. Rutenberg discloses that a product prepared as in Example Appeal 2019-002195 Application 15/230,494 6 1-1 was administered to “[f]ive volunteers with depression symptoms . . . [at] 200 mg. three times per day.” Id. at 3:45–50. Rutenberg does not describe a method of preparing a product that involves removing excess water from a paste to form a phospholipid-oil (PL-oil), as recited in claim 1. The only teaching in Szuhaj that the Examiner points to is its disclosure that lecithin is used as an ingredient in cheese products and dairy products, among other things. Ans. 5. We have reviewed Szuhaj but do not find a description of removing excess water from a PL-containing paste to form a PL-oil. Thus, regardless of whether Rutenberg’s product meets the limitations of the one recited in step (a) of the claims on appeal, we agree with Appellants that the Examiner has not shown that a process meeting all of the limitations of the claims would have been obvious to a person of ordinary skill in the art based on the teachings of Rutenberg and Szuhaj. We therefore reverse the rejection of claims 1–13 under 35 U.S.C. § 103(a). II The Examiner has rejected all of the claims on appeal for obviousness-type double patenting, on the basis that they are not patentably distinct from claims 1–6 of Rutenberg. The Examiner reasons that Rutenberg claims “a pharmaceutical or nutritional composition for treating depression . . . comprising Phosphatidyl-L-serine,” while “the claims herein are drawn to a nutraceutical and/or pharmaceutical preparation of phospholipid- enriched (PL-enriched) dairy products as nutraceuticals for the formulation of functional foods, the process comprising the steps of . . . .” Ans. 7–8. Appeal 2019-002195 Application 15/230,494 7 Appellants argue that “Claims 1–6 of Rutenberg ’522 relate to pharmaceutical or nutritional compositions for treating depression” while “[t]he instant invention . . . provides novel and nonobvious processes to obtain . . . enriched dairy formulations.” Appeal Br. 17. Appellants conclude that “the claims of the instant invention . . . are considered to be patentably distinct from claims 1–6 of Rutenberg ’522.” Id. at 18. We agree with Appellants that the Examiner has not persuasively shown that the instant claims are an obvious variant of those of Rutenberg. As Appellants have pointed out, Rutenberg’s claims are directed to a product, while the instant claims are directed to a method. The Examiner has not explained why the product claimed by Rutenberg would have made obvious a method comprising the steps (a), (b), and (c) of claim 1, particularly since, as discussed above, Rutenberg neither claims nor discloses a method that includes step (b) of the instantly claimed method. We therefore reverse the rejection of claims 1–13 for obviousness- type double patenting based on claims 1–6 of Rutenberg. SUMMARY We reverse both of the rejections on appeal. REVERSED Copy with citationCopy as parenthetical citation