Ex Parte PietrzkowskiDownload PDFPatent Trial and Appeal BoardMay 11, 201714118865 (P.T.A.B. May. 11, 2017) 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. 14/118,865 05/14/2014 Zbigniew Pietrzkowski 100700.0067US 5570 24392 7590 FISH & TS ANG LLP ROBERT D. FISH 2603 Main Street Suite 1000 Irvine, CA 92614-6232 05/15/2017 EXAMINER MAIER, LEIGH C ART UNIT PAPER NUMBER 1673 NOTIFICATION DATE DELIVERY MODE 05/15/2017 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): rfish @ fishiplaw. com patents @ fishiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ZBIGNIEW PIETRZKOWSKI Appeal 2016-006477 Application 14/118,8651 Technology Center 1600 Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a method of modulating the concentration of a protein associated with metabolic syndrome, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE “Metabolic syndrome, also known as insulin resistance syndrome, is a collection of disorders that, in combination, greatly increase an individual’s chances of developing diabetes and cardiovascular disease.” (Spec. 13.) 1 Appellant identifies the Real Party in Interest as VDF FutureCeuticals, Inc. (Appeal Br. 2.) Appeal 2016-006477 Application 14/118,665 “[AJspects of the syndrome, [include] for example, inflammation that is associated with atherosclerosis and cardiovascular disease.” {Id. 14.) Generally speaking, metabolic syndrome is characterized by obesity, difficulty in regulating glucose levels, elevated blood pressure, high serum triglyceride levels, and decreased HDL levels. Difficulties in regulating the body’s glucose levels include type II diabetes, which is characterized by a decrease in the body’s response to insulin. Biological markers for inflammation, such as C-reactive protein and YLK-40, may be present at elevated levels in affected individuals and are often associated with the development of atherosclerosis. (Id. f 3.) According to Appellant, “there remains a growing need for inexpensive and conveniently administered compounds that are effective in modulating endogenous substances related to metabolic syndrome.” {Id. 1 8.) Appellant’s invention is directed at “a method . . . that modulates the concentration and/or activity of an endogenous substance that is associated with metabolic syndrome (or related conditions) by administration of a boro- carbohydrate complex to a mammal, typically at an effective dosage and schedule.” {Id. 110.) Claims 1—20 are on appeal. Claims 1, 8, and 15 are representative and read as follows: 1. A method of modulating the concentration of a protein associated with metabolic syndrome comprising: identifying an individual as having a condition associated with metabolic syndrome; and administering to the individual a boro-carbohydrate complex at a dosage and schedule effective to reduce the concentration of under- carboxylated osteocalcin in blood. (Appeal Br. 18.) 2 Appeal 2016-006477 Application 14/118,665 8. A method comprising: identifying an individual as having a condition associated with metabolic syndrome; and administering to the individual a boron-carbohydrate complex at a dosage and schedule effective to increase the concentration of adiponectin in blood. (Appeal Br. 18—19.) 15. A method comprising: identifying an individual as having a condition associated with metabolic syndrome; and administering to the individual a boro-carbohydrate complex at a dosage and schedule effective to reduce the concentration of YKL-40 in blood. (Appeal Br. 19.) The following ground of rejection by the Examiner is before us on review: Claims 1—20 under 35 U.S.C. § 103 as unpatentable over Miljkovic,2 Gottlieb3 and Lopez Mas4. DISCUSSION The Examiner finds that “Gottlieb teaches that metabolic syndrome is an inflammatory state as evidenced by markers such as C-reactive protein and fibrinogen,” as well as including dyslipidemia. (Final Action 3.) The Examiner further finds that Gottlieb teaches treatment that mitigates chronic inflammation. (Id.) 2 Miljkovic et al., Calcium Fructoborate: Plant-Based Dietary Boron for Human Nutrition, 6 J. Dietary Supplements 211 (2009). 3 Gottlieb, M., US 2004/0186059 Al, published Sept. 23, 2004. 4 Lopez Mas et al., WO 2009/013596 A2, published Jan. 29, 2009. 3 Appeal 2016-006477 Application 14/118,665 The Examiner finds that “Lopez Mas teaches that metabolic syndrome comprises a cluster of risk factors, including dyslipidemia” and that patients with this syndrome have an increased risk of cardiovascular disease. (Id.) The Examiner further finds that Lopez Mas teaches treatment with products having antioxidant functionality. The Examiner finds that Miljkovic teaches that a diet enriched with calcium fructoborate “has a positive effect on lipid metabolism, causing a decrease in cholesterol levels.” (Id.) The Examiner further finds that Miljkovic teaches calcium fructoborate “is anti-inflammatory, causing a decrease in C-reactive protein and fibrinogen,” as well as having “value as an antioxidant.” (Id.) The Examiner additionally finds that Miljkovic “suggests the use of calcium fructoborate in metabolic disorders, generally.” (Id.) The Examiner also notes that Miljkovic discloses “the administration of 6 or 12 mg/day of [calcium fructoborate] to patients for 8 weeks in a method relying on the anti-inflammatory effect.” (Id. at 4.) In summary, the Examiner finds that it is known from Gottlieb and Lopez Mas that anti-inflammatory, antioxidant, and anti-dyslipidemic agents are useful in the treatment of metabolic syndrome and from Miljkovic that calcium fructoborate has anti-inflammatory, antioxidant, and anti- dyslipidemic effects, which are physiological activities shown to be beneficial in the treatment of metabolic syndrome. (Ans. 5, 8.) In light of these teachings of the prior art, the Examiner finds that it would have been obvious to one of ordinary skill in the art to administer calcium fructoborate to a person having metabolic syndrome, in the amounts taught to be administered by Miljkovic, with a reasonable expectation of success, and that, in so doing, one would reduce the concentration in the blood of the 4 Appeal 2016-006477 Application 14/118,665 patient of under-carboxylated osteocalcin and YKL-40, and increase the concentration in the blood of the patient of adiponectin as recited in the claims. (Final Action 4; Ans. 8.) The Examiner notes that it would be expected that one would reduce the concentration in the blood of the patient of under-carboxylated osteocalcin and YKL-40, and increase the concentration in the blood of the patient of adiponectin as recited in the claims because the dosage range taught for administration by Miljkovic overlaps with dosages recited in the claims (Ans. 6, 8), and that “it would be within the scope of the artisan to optimize the dosage for the treatment based on the antiinflammation and antioxidant effect through routine experimentation” (Final Action 4). We agree with the Examiner’s factual findings, which properly ascertained the scope and content of the prior art and the differences between the claimed invention and that prior art, contrary to Appellant’s allegation (Appeal Br. 7—10), and conclusion that the method of modulating the concentration of a protein associated with metabolic syndrome as recited in claims 1, 8, and 15 is rendered obvious by the art cited by the Examiner. Each of these claimed methods has two steps. One step is to identify an individual as having a condition associated with metabolic syndrome, and the other is to administer a “boro[n]-carbohydrate” complex to that individual. It is true that the administration has to effect a reduction or an increase in the concentration of a particular recited protein, however, it is the Examiner’s position that such a result is inherent in the obvious combination of Miljkovic, Gottlieb, and Lopez Mas for treating patients with metabolic syndrome with calcium fructoborate. 5 Appeal 2016-006477 Application 14/118,665 The Examiner provided well-founded reasons, premised on the level of ordinary skill in the art, which although not specifically delineated, was in evidence by the prior art (Appeal Br. 10—11), for combining the teachings of Miljkovic, Gottlieb, and Lopez Mas for treating patients with metabolic syndrome with calcium fructoborate. Gottlieb teaches that chronic inflammation, as evidenced by elevated C-reactive protein and serum fibrinogen, and dyslipidemia are components of metabolic syndrome, which is a syndrome that can progress to coronary artery disease and/or diabetes mellitus. (Gottlieb ]Hf 3, 5, 50, 51.) Gottlieb teaches controlling inflammation to defer progression of metabolic syndrome to diabetes mellitus and coronary heart disease. (Gottlieb Abs.) Lopez Mas also teaches that metabolic syndrome is associated with an increased risk of cardiovascular disease. (Lopez Mas 2.) And Lopez Mas teaches preventing or treating cardiovascular diseases and metabolic syndrome with the antioxidant phenolic compound, hydroxytyrosol. (Lopez Mas 9—10.) Miljkovic suggests that calcium fructoborate would be beneficial to treat metabolic disorders, such as dislipidemy, that result in an abnormal amount of lipids or fats in the blood. (Miljkovic 221—22.) Miljkovic also teaches that calcium fructoborate is an anti-inflammatory, including activity to reduce C reactive protein and fibrinogen, as well as having antioxidant properties, and would also be beneficial in treating cardiovascular disorders. (Miljkovic 218-220, 221-222.) Consequently, we agree with the Examiner, that Miljkovic teaches that calcium fructoborate has “physiological activities shown to be beneficial [in Gottlieb and Lopez Mas] in the treatment of metabolic syndrome.” (Ans. 5.) That is so regardless of Appellant’s point that “inflammation may be 6 Appeal 2016-006477 Application 14/118,665 related to hundreds of other conditions, diseases, or syndromes” besides metabolic syndrome (Reply Br. 6). The prior art (Gottlieb) links elevated C reactive protein and fibrinogen levels to chronic inflammation and a component of metabolic syndrome. And the prior art (Miljkovic 221—222) links calcium fructoborate with the ability to lower C reactive protein and fibrinogen levels and to that being anti-inflammatory activity. While it is true that the claims are not directed to treating metabolic syndrome (Reply Br. 4—5), they are directed at the patient population that has a “condition associated with metabolic syndrome,” which the prior art teaches includes cardiovascular disease, and/or diabetes (Lopez Mas 2, 9), and/or atherogenic dyslipidemia (Gottlieb 1 50, Lopez Mas 2). And, Miljkovic suggests that provision of calcium fructoborate will be beneficial to that patient population, as just discussed. In light of the combined teachings of the prior art, we also agree with the Examiner that there was ample reason from the prior art to treat a patient that has metabolic syndrome (including a condition associated with metabolic syndrome) with anywhere between 6 and 12 mg of calcium fructoborate, a dosage shown in Miljkovic to result in anti-inflammatory activity (Miljkovic 218), with a reasonable expectation of achieving therapeutic activity. “Obviousness does not require absolute predictability of success ... all that is required is a reasonable expectation of success.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009). The prior art teaches a number of physiological activities that could be targeted to ameliorate metabolic syndrome and resultant progression to other diseases such as cardiovascular disease, and dyslipidemia, and Miljkovic teaches calcium fructoborate has a number of those relevant activities (antioxidant, anti- 7 Appeal 2016-006477 Application 14/118,665 inflammatory, and lowering cholesterol levels), and even suggests use in “the diet of patients with cardiovascular and dislipidemy disorders.” (Miljkovic 222). We disagree with Appellant that the Examiner did not provide a factual finding “that modulation of under-carboxylated osteocalcin, adiponectin, or YKL-40 naturally or even necessarily flows from anti inflammatory effect of any drugs or treatment methods” (Reply Br. 6—7; see also Appeal Br. 7). The Examiner found that the effective result claimed would have inherently been achieved. (Ans. 8; See also Final Action 4.) We agree. “[Ijnherency may supply a missing claim limitation in an obviousness analysis . . . when the limitation at issue is the ‘natural result’ of the combination of prior art elements.” Par Pharm. v. TWI Pharms., Inc., 773 F.3d 1186, 1194 (Fed. Cir. 2014); see also Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012) (finding method of treating claims obvious from the prior art even though the claimed achievement of specific blood semm concentration levels was not disclosed in the prior art). Given that Miljkovic teaches a dosage range of calcium fructoborate to administer to achieve a beneficial effect for treating a condition associated with metabolic syndrome (6 mg to 12 mg) overlaps with the claimed amounts that are indicated to “reduce the concentration of under- carboxylated osteocalcin in blood,” i.e., at least 10 mg (claim 4), “to increase the concentration of adiponectin in blood,” i.e., at least 10 mg (claim 11), and “to reduce the concentration of YKF-40 in blood,” i.e., at least 0.01 mg (claim 18), whether or not recognized by the prior art, we agree with the Examiner that the effective result claimed would have inherently been 8 Appeal 2016-006477 Application 14/118,665 achieved. That is so because Appellant’s dependent claims instruct that the result of the dosage taught to be administered by Miljkovic is a result necessarily achieved by the administered amount; as such, it is both inherent and not an additional requirement imposed by the claims. See Alcon Research, Ltd. v. ApotexInc., 687 F.3d 1362, 1369 (Fed. Cir. 2012) (“As in In re Kubin, this claim language does not impose any additional requirement because the ’805 patent itself defines mast cell stabilization as a property that is necessarily present at those concentrations.”); In re Kubin, 561 F.3d 1351, 1357—58 (Fed. Cir. 2009) (“Even if no prior art of record explicitly discusses the [limitation], the ... application itself instructs that [the limitation] is not an additional requirement imposed by the claims on the [claimed invention], but rather a property necessarily present in the [claimed invention].”) For the foregoing reasons, we disagree with Appellant that the Examiner’s rejection “fail[s] to provide any logical link and explicit analysis in support of the combination rationale to combine the cited references” (Reply Br. 6; see also Appeal Br. 12—15). That the purpose for combining the references is different from Appellant’s (Reply Br. 4—5), does not render the Examiner’s rejection improper. Prima facie obviousness does not require prior art references to recognize or even suggest the problem that applicant attempted to solve. In re Beattie, 91A F.2d 1309, 1312 (Fed. Cir. 1992.) (“As long as some [reason,] motivation or suggestion to combine the references is provided by the prior art taken as a whole, the law does not require that the references be combined for the reasons contemplated by the inventor.”); In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir. 1996) (“Although the motivation to combine here 9 Appeal 2016-006477 Application 14/118,665 differs from that of the applicant, the motivation in the prior art to combine the references does not have to be identical to that of the applicant to establish obviousness.”) In other words, “[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls.” KSR Int 7 Co. v. Teleflex /«c., 550 U.S. 398,419 (2007). Appellant’s argument that “none of the references cited by the Examiner discloses any of [the] three proteins recited” and that “[wjithout teaching [the] modulation [of the proteins recited] in the cited art, the claimed subject matter cannot be taught or obvious” (Reply Br. 5) is also not persuasive. That Appellant recites the use of a boro-carbohydrate complex in the same patient population but for a different purpose to achieve a result not discussed in the prior art (Appeal Br. 16) does not render the claimed method nonobvious. SeeAlcon, 687 F.3d at 1369. The district court’s fact finding that the prior art did not teach that olopatadine would stabilize human conjunctival mast cells, and indeed taught away from using olopatadine for this purpose, is not clearly erroneous. It is, however, not the only motivation to arrive at the claimed invention. A person of ordinary skill in the art at the time of invention would have been motivated to use olopatadine to treat human eye allergies as claimed for its established antihistaminic efficacy. Given that the patent defines, and expressly claims, olopatadine concentrations that are “therapeutically effective” to stabilize conjunctival mast cells, Kamei’s disclosure of overlapping concentrations, even if for a different purpose, meets these claim limitations.); In reLintner, 458 F.2d 1013, 1016 (CCPA 1972) (“The fact that appellant uses sugar for a different purpose does not alter the conclusion that its use in a prior art composition would be prima facie obvious from the purpose 10 Appeal 2016-006477 Application 14/118,665 disclosed in the references.”) As just discussed, the Examiner provided the requisite motivation to establish prima facie obviousness of administering a boro-hydrate complex to an individual having a condition associated with metabolic syndrome, which we conclude would inherently result in the claimed reduction or increase of the specified proteins of the claims, given that the administration dosage suggested by the prior art overlaps with the specifically claimed amount recited in Appellant’s claims to achieve that purpose. Thus, the positive steps recited in Appellant’s claimed processes are rendered obvious by the prior art cited by the Examiner and would inherently achieve the claimed result. Claims 2—7, 11—14, and 16—20 have not been argued separately and therefore fall with claims 1, 8, and 15. 37 C.F.R. § 41.37(c)(l)(iv). SUMMARY We affirm the rejection of claims 1—20 under 35 U.S.C. § 103 as unpatentable over Miljkovic, Gottlieb and Lopez Mas. 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 11 Copy with citationCopy as parenthetical citation