Ex Parte WadhwaDownload PDFPatent Trial and Appeal BoardJan 26, 201813712328 (P.T.A.B. Jan. 26, 2018) 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. 13/712,328 12/12/2012 Manpreet S. Wadhwa 144673-00101 6998 64574 7590 01/30/2018 RT ANK ROME T T P EXAMINER Crystal J. Corsey DICUS, TAMRA ONE LOGAN SQUARE PHILADELPHIA, PA 19103 ART UNIT PAPER NUMBER 1791 NOTIFICATION DATE DELIVERY MODE 01/30/2018 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): corsey-c @ blankrome.com BRPhilaPatent@blankrome.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MANPREET S. WADHWA Appeal 2016-008424 Application 13/712,328 Technology Center 1700 Before GEORGE C. BEST, JULIA HEANEY, and MERRELL C. CASHION, JR., Administrative Patent Judges. BEST, Administrative Patent Judge. DECISION ON APPEAL The Examiner finally rejected claims 1—6, 10—17, and 21—24 of Application 13/712,328 under 35 U.S.C. § 103(a) as obvious. Final Act. (November 6, 2014). The Examiner also rejected claims 1—6 and 10—17 under 35 U.S.C. § 112,11 as failing to comply with the written description requirement and as lacking an enabling disclosure. Appellant1 seeks reversal of these rejections pursuant to 35 U.S.C. § 134(a). We have jurisdiction under 35 U.S.C. § 6. 1 Watermins, LLC is identified as applicant and the real party in interest. Appeal Br. 2. Appeal 2016-008424 Application 13/712,328 For the reasons set forth below, we affirm-in-part. BACKGROUND The ’328 Application describes liquid dietary supplement formulations that include water-soluble dietary minerals and, optionally, additional ingredients that are beneficial for health as well as methods for designing and producing such formulations. Spec. 1. In particular, the liquid dietary supplement formulations contain high levels of dissolved calcium and magnesium salts. Id. at 3^4. Claims 1 and 15 are representative of the ’328 Application’s claims and are reproduced below from the Claims Appendix of the Appeal Brief: 1. An aqueous composition, comprising: a. water; b. one or more fully dissolved calcium compound(s); and c. one or more fully dissolved magnesium compound(s); wherein the sum of the concentrations of the dissolved calcium compound(s) and dissolved magnesium compound(s) is from about 1.5 Molar to about 5 Molar; and wherein the molar ratio of calcium to magnesium is from about 0.1 to about 10. Appeal Br. 15 (Claims App.). 15. A method of fortifying a beverage or food comprising: adding to a beverage or food a composition according to claim 1 in an amount effective to increase the total concentration of calcium and magnesium by at least 1 ppm. Id. at 16. 2 Appeal 2016-008424 Application 13/712,328 REJECTIONS On appeal, the Examiner maintains the following rejections: 1. Claims 1—6 and 10—17 are rejected under 35 U.S.C. § 112,11 as failing to comply with the written description requirement. Final Act. 3. 2. Claims 1—6 and 10—17 are rejected under 35 U.S.C. § 112,11 because the Specification does not provide an enabling disclosure. Id. at 4. 3. Claims 1—6, 10-13, 15—17, 23, and 24 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Beeman2 and Paikin.3 Id. at 6. 4. Claims 15—17 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Beeman, Paikin, and Whittle.4 Id. at 9. 5. Claims 1—6, 10-17, 23, and 24 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Beeman, Paikin, and Sher.5 Id. at 11. 6. Claims 21 and 22 are rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Beeman, Paikin, and Gugger.6 Id. at 13. 2 US 2009/0011088 Al, published January 8, 2009. 3 US 2009/0142451 Al, published June 4, 2009. 4 WO 97/21356, published June 19, 1997. 5 US 6,261,610 Bl, issued July 17, 2001. 6 US 2005/0233007 Al, published October 20, 2005. 3 Appeal 2016-008424 Application 13/712,328 DISCUSSION Appellant argues preliminarily that “[t]he present application has undergone an unnecessarily and improperly protracted examination,†Appeal Br. 2, and describes two examples that are alleged to illustrate the unnecessary extension of the prosecution of the ’328 Application. Id. at 2—A. These arguments are irrelevant because questions regarding an examiner’s ex parte actions or requirements during prosecution of an application are addressed by means of petition to the Director. 37 C.F.R. § 1.181 (2013). Our authority is defined by statute and is limited to the review of adverse decisions by examiners which at least indirectly relate to matters involving the rejection of claims. In re Hengehold, 440 F.2d 1395, 1404, (CCPA 1971); see also 35 U.S.C. § 6(b) (defining the PTAB’s duties); 35 U.S.C. § 134 (granting applicant the right to appeal once any of the claims have been twice rejected). Rejections of claims involve examination for compliance with the statutory provisions of Title 35, United States Code, as set forth in §§ 100, 101, 102, 103, and 112. In re Harms eh, 631 F.2d716, 721 (CCPA 1980). Decisions an examiner makes during examination of a discretionary, procedural, or nonsubstantive nature not directly connected with the merits of issues involving rejections are reviewable by petition under 37 CFR § 1.181 to the Director, not by appeal. In re Berger, 279 F.3d 975, 984-85 (Fed. Cir. 2002). We now turn to Appellant’s arguments regarding the merits of each of the grounds of rejection asserted by the Examiner. Rejection 1. The Examiner rejected claims 1—6 and 10—17 for failing to comply with the written description requirement. Final Act. 3. In 4 Appeal 2016-008424 Application 13/712,328 particular, the Examiner found that “the claims recite a concentration of up to the higher limit of 5 Molar, which does not have the proper support in the original specification as filed because the specification does not provide any teaching or discussion on [sic, of] concentrations above 4.2 M.†Id. Appellant argues that these claims comply with the written description requirement for two reasons: (1) the Examiner has not successfully rebutted the presumption that an application satisfies the written description requirement, Appeal Br. 5 (“a description as filed is presumed to be adequate, unless or until sufficient evidence or reasoning to the contrary has been presented by the examiner to rebut the presumption†(citing In re Marzocchi, 439 F.2d 220, 224 (CCPA 1971))), and (2) the Examiner erred by finding that the ’328 Application’s Specification does not contain a sufficient written description, Appeal Br. 5. We are not persuaded by Appellant’s arguments. First, Appellant incorrectly relies upon Marzocchi as creating an enhanced burden for an examiner challenging the adequacy of the written description is misplaced. Marzocchi is an enablement case and does not concern the sufficiency of the written description to support a particular claim. Marzocchi, 439 F.2d at 223 (“Claims 6 and 12 . . . were criticized by the examiner as being based on a disclosure which was not enabling .... The board affirmed his rejection of those claims . . . .â€). In this case, the Examiner identified the claims subject to the written description rejection. The Examiner also provided a reasoned basis for the rejection. This is all the Examiner need do to give Appellant notice that the adequacy of the written description support for claims 1—6 and 10—17 was being challenged. 5 Appeal 2016-008424 Application 13/712,328 Second, the Examiner correctly determined that the ’328 Application does not contain sufficient written description to comply with 35 U.S.C. § H2,l 1. To comply with the written description requirement, an applicant’s specification must convey with reasonable clarity to a person of ordinary skill in the art that, as of the filing date, the applicant was in possession of the claimed invention. Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008). Appellant argues that the ’328 Application contains sufficient written description: Here, the as-filed application describes two formulations having total concentrations of about 4.2 Molar and about 4.7 [sic, 4.6] Molar for all dissolved compounds, and refers to these molar concentrations as “close to the point of saturationâ€. (See, Specification at pages 36-38). One skilled in the art armed with the data described in Example 3, and its accompanying description, would recognize that the above-mentioned compositions are close to, but not at, the point of saturation, which is clearly defined in the as-filed application as “the point at which water will not dissolve any more of a chemical in solutionâ€. (See, Specification at page 7). One skilled in the art would also recognize that a composition that is “close to saturationâ€, in the context of the present application, could still accommodate more solute; and they would have expected the invention to be enabled to at least 5 Molar, in view of the data described in the Specification as mentioned above, and in view of Example 3. Thus, the as-filed specification clearly demonstrates Appellant was in possession of the claimed invention at the time the application was filed. Further, the Declaration filed by the Appellant also demonstrates this fact, 6 Appeal 2016-008424 Application 13/712,328 by providing additional evidence that directly supports the scope of the claims. Appeal Br. 6. This argument is not persuasive. As Appellant concedes, the highest value for the sum of the concentrations of the calcium compound(s) and magnesium compound(s) described in the Specification is about 4.2 M. Spec. 36—38 (describing Example 3). As Appellant notes, the formulations described in Example 3 are close to saturation. Thus, a person of ordinary skill in the art at the time of the invention would have expected to be able to add some amount of a calcium compound and/or a magnesium compound to the solution. Thus, the Specification arguably provides written description support for claims in which the sum of the concentrations of the calcium and magnesium compounds is greater than 4.2 M. Neither the Specification nor Appellant, however, explains why a person of ordinary skill in the art would have understood that the inventor had possession of solutions in which the sum of the concentrations of the calcium and magnesium compounds could range as high as 5 M. In view of the foregoing, we affirm the rejection of claim 1. Claims 4 and 10—17 depend from claim 1 and contained the same limitation regarding the range of the total of the concentrations of the calcium and magnesium compounds. Thus, we also affirm the rejection of these claims. Claims 2, 3, 5, and 6, however, are directed to compositions in which the upper limit of the total concentrations of the calcium and magnesium compounds is 4.2 M. As the Examiner has conceded, the ’328 Application’s Specification does contain an adequate written description to support such claims. We, therefore, reverse the Examiner’s rejection of claims 2, 3, 5, and 6. 7 Appeal 2016-008424 Application 13/712,328 Rejection 2. The Examiner rejected claims 1—6 and 10—17 as failing to comply with the enablement requirement. Final Act. 4—6. The Examiner asserts that “the [Specification, while being enabling for up to 4.2 M, does not reasonably provide enablement for amounts over 4.2 M up to 5 M.†Id. at 4. At the above quoted passage makes clear, the Examiner has conceded that the ’328 Application’s Specification is enabling for compositions having total concentrations of calcium and magnesium compounds up to 4.2 M. Final Act. 4. Claims 2, 3, 5, and 6 are limited to compositions having a total concentration of calcium and magnesium compounds that is less than 4.2 M. We, therefore, summarily reverse the rejection of these claims as not enabled. Next, we consider whether the Examiner erred by rejecting claims 1, 4, and 10-17 as not enabled. A Specification complies with the 35 U.S.C. § 112,11 enablement requirement if it allows those of ordinary skill in the art to make and use the claimed invention without undue experimentation. See In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993); Adas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576 (Fed. Cir. 1984). Factors—which are illustrative, not mandatory, see Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991)—to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability of the art, and (8) the claims’ breadth. In re 8 Appeal 2016-008424 Application 13/712,328 Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Enablement is a question of law based upon underlying factual determinations. In re Swartz, 232 F.3d 862, 863 (Fed. Cir. 2000). The Examiner found that [t]he [Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to produce amounts over 4.2 M to make the invention commensurate in scope with these claims. The amounts over 4.2 M will not be fully dissolved as Applicant desires and may have components that don’t dissolve which the instant [Specification discusses as the Examiner has reason to believe the applied prior art teaches a saturated solution, in which no more could go into solution, it is not clear how Applicant [] would produce a concentrated solution up to 5 M, which is higher than the saturated solution of the prior art. See again pp. 25-26, instant [Specification. Answer 4. We are not persuaded by the Examiner’s analysis and reasoning. As demonstrated below, the vast majority of the Wands factors support a finding that the subject matter of claims 1, 4, and 10-17 are enabled. The solubility properties of the inorganic salts are well-known and predictable (Factors 5 and 7). Indeed, they frequently comprise a portion of first-year high school chemistry classes. Furthermore, the experiments to determine whether a particular combination of inorganic salts is soluble in a given amount of water are exceedingly simple (Factor 1). For example, the examples in the Specification use visual inspection to determine whether or not the combination of calcium compounds and magnesium compounds in each particular sample had dissolved completely (Factors 2 and 3). See, e.g., Spec. 33 (“All the formulations were visually clear, demonstrating full dissolution of the calcium and magnesium compounds.â€). 9 Appeal 2016-008424 Application 13/712,328 For the foregoing reasons, we reverse the rejection of claims 1—6 and 10-17 as not enabled. Rejection 3. The Examiner rejected claims 1—6, 10-13, 15—17, 23, and 24 as unpatentable over the combination of Beeman and Paikin. Final Act. 6—8. Appellant argues for reversal of this rejection without focusing on the limitations of any of the rejected claims. See Appeal Br. 9-12; see also generally Reply Brief. Accordingly, we select claim 1 is representative of the group of claims subject to this rejection. The remaining claims will stand or fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv) (2013). In rejecting claim 1, the Examiner found that Beeman describes or suggests a composition that meets each limitation set forth in claim 1 except for the requirement that the “molar ratio of calcium to magnesium is from about 0.1 to about 10.†Final Act. 6—7. The Examiner further found that Paikin describes a calcium- and magnesium-fortified beverage in which the calcium to magnesium ratio is 6.9. Id. at 7. The Examiner stated that it would have been obvious to a person having ordinary skill in the art to modify the ratio of calcium to magnesium in Beeman’s composition to achieve a ratio falling within the claimed range. Id. at 7—8. We reverse the Examiner’s rejection of claim 1 for the following reasons. First, the Examiner erred by finding that Beeman describes a solution comprising dissolved calcium and magnesium compounds in which the sum of the concentrations of the calcium and magnesium compounds is 3.2 M. For the purpose of rejections pursuant to § 102 and § 103, prior art references are presumptively enabled. In re Antor Media Corp., 689 F.3d 10 Appeal 2016-008424 Application 13/712,328 1282, 1287—88 (Fed. Cir. 2012). This presumption, however, maybe rebutted by an applicant. See In re Morsa, 713 F.3d 104, 110 (Fed. Cir. 2013) (“The presumption in Antor is a procedural one—designed to put the burden on the applicant in the first instance to challenge cited prior art... . Once an applicant makes a non-frivolous argument that cited prior art is not enabling, however, the examiner must address that challenge.â€). Here, Appellant points to the printed PCT counterpart to Beeman. Appeal Br. 9 (citing PCT/US/2007/004590). That application states that a concentrated batch formulation having the composition set forth in Beeman’s claim 3 may not be a completely clear solution. Rather, the PCT application states that the concentrated batch solution may contain precipitated calcium carbonate. Appellant explains why the concentrated batch formulation of Beeman’s claim 3 contain both precipitated calcium carbonate and magnesium carbonate. Id. at 9-10. Appellant also provided experimental evidence that Beeman’s claim 3 formulation does not dissolve completely. See Decl. of Manpreet S. Wadhwa (January 6, 2015). Appellant, therefore, has presented non-frivolous arguments and evidence showing that the Examiner’s calculations regarding the sum of the concentrations of the calcium and magnesium compounds in Beeman’s composition are incorrect. Because Appellant has done so, the Examiner now has the burden of addressing these arguments and evidence. Morsa, 713 F.3d at 110. The Examiner responds to Appellant’s evidence and arguments: Appellant argues the Declaration shows that Beeman’s composition is not fully dissolved; however[,] the Examiner points to published claims 3-5 that explicitly state the grams of minerals are dissolved and[,] thus[,] are fully dissolved as they are in solution. The Declaration is not commensurate in scope 11 Appeal 2016-008424 Application 13/712,328 with the claims as written. Appellant’s claims do not preclude precipitates[,] and the applied prior art does not teach the minerals precipitate out of solution. Beeman explicitly teaches the weights in solution equate to 3.2 Molar, which overlaps Appellant’s ranges. Answer 17. The Examiner further argues that, even if Appellant is right that a formulation having the composition set forth in Beeman’s claim 3 does not fully dissolve, this fact is irrelevant because Beeman is still available as prior art for all that it teaches. Id. at 16—17 (citing Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989); Symbol Techs. Inc. v. Opticonlnc., 935 F.2d 1569, 1578 (Fed. Cir. 1991)). The Examiner’s reasoning is not persuasive, and the analysis is erroneous. Neither Beckman Instruments nor Symbol Technologies are controlling because Appellant is not challenging the availability of Beeman as a reference. Rather, Appellant is questioning the accuracy of the portion of Beeman’s disclosure relied upon by the Examiner. The Appellant does so by pointing to evidence—the PCT publication and the experiment described in the Wadhwa Declaration—that suggest that Beeman’s description of its concentrated batch formulation is inaccurate. The Examiner does not address the substance of Appellant’s evidence that Beeman contained an inaccurate description. Instead, the Examiner ignored the PCT publication because it was not relied upon in in the rejection, and the evidence in the Wadhwa Declaration is deemed irrelevant because the declaration is not commensurate in scope with the ’328 Application’s claims. Neither of these facts is relevant to the reasons for which Appellant presents this evidence. Thus, the Examiner is not entitled to ignore the evidence. 12 Appeal 2016-008424 Application 13/712,328 Because the Examiner has not addressed the evidence presented by Appellant regarding the concentrated batch formulation described in Beeman’s claim 3, the Examiner has not established that all of the calcium and magnesium purportedly included in that composition is, in fact, in solution. Accordingly, the Examiner has not established that the total concentration of calcium and magnesium in Beeman’s concentrated batch formulation falls within the range set forth in claim 1 of the ’328 Application. Thus, the rejection of claim 1 of the ’328 Application cannot be affirmed. Second, the Examiner has not provided adequate reasoning to support the necessary conclusion that a person having ordinary skill in the art at the time of the invention would have been guided by Paikin’s disclosure to modify Beeman’s composition so as to arrive at a calcium to magnesium ratio within the scope of claim 1. Rather than provide definitive reasoning and a clear explanation, the Examiner merely cites a wide range of factors that may have led a person having ordinary skill in the art to change the particular composition described in Beeman’s claim 3. The Examiner then asserts that the inevitable result of such an optimization process would fall within the scope of claim number three. This is not sufficient. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.â€). Because we have reversed the rejection of claim 1 as obvious over the combination of Beeman and Paikin, we also reverse the rejection of claims 2—6, 10-13, 15—17, 23, and 24 on that basis. 13 Appeal 2016-008424 Application 13/712,328 Rejection 4. The Examiner rejected claims 15—17 as unpatentable over the combination of Beeman, Paikin, and Whittle. Final Act. 9. As discussed above, the Examiner did not properly address Appellant’s evidence that Beeman contains an inaccurate description of its concentrated batch formulation. In this rejection, the Examiner cites Whittle for reasons that do not remedy the failures that mandated reversal of Rejection 3. We, therefore, also reverse this rejection. Rejection 5. The Examiner rejected claims 1—6, 10-17, 23, and 24 as unpatentable over the combination of Beeman, Paikin, and Sher. Final Act. 11. As discussed above, the Examiner did not properly address Appellant’s evidence that Beeman contains an inaccurate description of its concentrated batch formulation. In this rejection, the Examiner cites Sher for reasons that do not remedy the failures that mandated reversal of Rejection 3. We, therefore, also reverse this rejection. Rejection 6. The Examiner rejected claims 21 and 22 as unpatentable over the accommodation of Beeman, Paikin, and Gugger. Final Act. 13. As discussed above, the Examiner did not properly address Appellant’s evidence that Beeman contains an inaccurate description of its concentrated batch formulation. In this rejection, the Examiner cites Gugger for reasons that do not remedy the failures that mandated reversal of Rejection 3. We, therefore, also reverse this rejection. CONCLUSION For the reasons set forth above, we affirm the rejection of claims 1, 4, and 10—17 as failing to comply with the written description requirement. 14 Appeal 2016-008424 Application 13/712,328 We reverse the rejection of claims 2, 3, 5, and 6 for failing to comply with the written description requirement. Furthermore, we reverse the rejection of claims 1—6 and 10—17 for failing to comply with the enablement requirement. We also reverse each of the § 103 rejections of claims 1—6, 10-17, and 21—24. 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-IN-PART 15 Copy with citationCopy as parenthetical citation