Ex Parte DaneshvariDownload PDFPatent Trial and Appeal BoardFeb 14, 201814391543 (P.T.A.B. Feb. 14, 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. 14/391,543 10/09/2014 Dana Daneshvari 212501-0002-US-517889 1024 123223 7590 02/16/2018 Drinker Biddle & Reath LLP (WM) 222 Delaware Avenue, Ste. 1410 Wilmington, DE 19801-1621 EXAMINER SONG, JIANFENG ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 02/16/2018 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): IPDocketWM @ dbr.com penelope. mongelluzzo @ dbr. com DB RIPDocket @ dbr. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DANA DANESHVARI1 Appeal 2016-008746 Application 14/391,543 Technology Center 1600 Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims directed to a wet granulation process comprising contacting a material to be granulated with a granulating liquid comprising Arabic gum. The Examiner’s rejection of claims 20, 22, 25—28, and 40-43 under 35 U.S.C. § 103 is appealed. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant identifies the Real Party in Interest as “ALPINA LAUDANUM INSTITUTE OF PHYTOPHARMACEUTICAL SCIENCES AG (IMPETUS IP LTD.).” Br. 2 (Appellant’s brief numbers every page as “3”; therefore, we cite herein to Appellant’s brief by counting its pages consecutively) Appeal 2016-008746 Application 14/391,543 STATEMENT OF THE CASE The Specification states, “[t]he present invention relates to a wet granulation process for producing granulate material comprising Arabic gum.” Spec. 1:13—14. The Specification states, “Arabic gum, also known as gum Arabic, acacia gum, chaar gund, char goond, or meska, is a natural gum made of hardened sap taken from acacia trees.” Id. at 1:18—19. Claim 20, reproduced below, is the sole independent claim and is representative: 20. A wet granulation process comprising contacting a material to be granulated with a granulating liquid, wherein the granulating liquid comprises Arabic gum and the concentration of Arabic gum in the granulating liquid is from about 5% to about 40% (w/v) and wherein the material to be granulated is Arabic gum or one or more metal salts where the metal is selected from the group consisting of potassium, sodium, lithium, calcium, magnesium, zinc, selenium, and iron, and wherein the counter ion of the metal salt is an organic counter ion selected from the group consisting of acetate, alginate, ascorbate, aspartate, amygdalate, benzoate, borogluconate, carbasalate, citrate, cyclamate, dinatriumtetra- lactate, dobesilate, ferro-phospholactate, folinate, formate, fumarate, glubionate, glucoheptonate, gluconate, glutamate, glycerophosphate, iopodate, ketoglutarate, lactate, lacto- gluconate, laevulinate, malate, methionate, orotate, oxalate, pangamate, pantothenate, phospholactate, phatalate, picrate, pidolate, propionate, resinate, saccharate (glucarate), saccharin, sorbate, and succinate. Br. 22 (Claims App’x) (paragraph formatting added for clarity). 2 Appeal 2016-008746 Application 14/391,543 The following rejection is appealed: Claims 20, 22, 25—28, and 40-43 stand rejected under 35 U.S.C. § 103(a) over Lang,2 Chawla,3 Cherukuri,4 and Adusumilli.5 Final Action 4. DISCUSSION Only those arguments made by Appellant in the Appeal Brief (no Reply Brief was submitted) have been considered in this Decision. Arguments not so presented in the Brief are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015); see also Ex parte Borden, 93 USPQ 2d 1473 (BPAI 2010) (informative) (“Any bases for asserting error, whether factual or legal, that are not raised in the principal brief are waived.”). “[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting a prima facie case of unpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). An applicant may rebut a prima facie case of obviousness by providing a “showing of facts supporting the opposite conclusion.” Such a showing dissipates the prima facie holding and requires the examiner to “consider all of the evidence anew.” In re Piasecki, 745 F.2d 1468, 1472 (Fed. Cir. 1984); In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976). In re Kumar, 418 F.3d 1361, 1368 (Fed. Cir. 2005). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” 2 US 7,807,125 B2 (issued Oct. 5, 2010) (“Lang”). 3 WO 2005/011666 A1 (pub. Feb. 10, 2005) (“Chawla”). 4 US 2009/0311317 A1 (pub. Dec. 17, 2009) (“Cherukuri”). 5 US 2005/0202084 A1 (pub. Sept. 15, 2005) (“Adusumilli”). 3 Appeal 2016-008746 Application 14/391,543 KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418. “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). “[T]he discovery of an optimum value of a variable in a known process is normally obvious.” Exceptions to this rule include (1) the results of optimizing a variable were unexpectedly good and (2) the parameter optimized was not recognized in the prior art as one that would affect the results. In re Antonie, 559 F.2d 618, 620 (CCPA 1977). In analyzing patentability in view of the prior art, “a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651 (CCPA 1972)). “[A] prior art publication cited by an Examiner is presumptively enabling barring any showing to the contrary by a patent applicant.” In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). We adopt the Examiner’s findings of fact, reasoning on scope and content of the claims and prior art, and conclusions set out in the Final Action and Answer. See Final Action 4—19 and Answer 3—25. The Examiner determined that Lang, directed to compactable granulated pharmaceutical formulations with calcium and sodium salts, Arabic gum, and binder components, and their manufacture, taught general methods of granulation using a granulating liquid. See Final Action 5, 8, 10—18; Answer 4 Appeal 2016-008746 Application 14/391,543 3—4, 7, 9-11, 13-15, 17, 20-21, 23-25; and Lang Abstract, 2:15-20, 4:6-8, 4:65—67, 5:61—6:2, 6:56—64, 7:7—8:23. The Examiner also determined that Chawla, directed to granulated pharmaceutical formulations with calcium salts, 3%-80% (e.g., at least 20% or at least 50%) Arabic gum, and binder components, and their manufacture, taught that in wet granulation the granulating liquid can include dissolved binder component. See Final Action 4—5, 8—10, 15—18; Answer 3—4, 7—8, 16—17, 20—24; and Chawla Abstract, H 12, 21, 33, 34. The Examiner also determined that Cherukuri, directed to granulated pharmaceutical formulations including a binder component, and their manufacture, taught that in wet granulation a non- aqueous solution or dispersion of binder component at 1 %—25%, which can be Arabic gum, can be used as a granulation liquid. See Final Action 4, 6, 8—9, 11, 17—18; Answer 3, 5, 7—8, 10, 17—24; and Cherukuri H 46, 51—55, 58. The Examiner also determined that Adusumilli, directed to granulated pharmaceutical formulations with calcium salts (e.g., calcium citrate and calcium lactate) and binding components and their manufacture, taught wet granulation using a granulation solution containing dissolved binder. See Final Action 4, 7—8, 14; Answer 3, 5—7, 19-25; and Adusumilli Abstract, 11 5, 45—47. Both Chawla and Cherukuri described amounts of Arabic gum which overlap or are encompassed by the claimed amounts. The Examiner determined that there would have been motivation to combine and a reasonable expectation of success in combining the cited references’ disclosures to achieve a wet granulation process comprising contacting a calcium salt (e.g., Ca-lactate) to be granulated with a granulating liquid including the binder component Arabic gum at 5%-40% 5 Appeal 2016-008746 Application 14/391,543 because such a combination amounts to mere substitution of known equivalent components in a predictable fashion and that any narrowing of the ranges for amounts of Arabic gum would be routine optimization because the prior art taught these amounts were results effective and optimizable variables. Final Action 8—10. Having considered the evidence before us, we conclude the Examiner’s determinations that the combination of the references’ teachings would have rendered claim 20, and also claims 22, 40, and 43, obvious are reasonable. Appellant has not persuasively established any error in the Examiner’s determinations. We address Appellant’s arguments below. To the extent Appellant argues the references individually, we do not find such arguments persuasive because the rejection is over a combination of prior art. “Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. [The references] must be read, not in isolation, but for what [they] fairly teach [] in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Appellant argues the Examiner’s combination of prior art required picking and choosing from the disclosed parameters without proper motivation as to a particular selection; Appellant urges this amounts to a hindsight reconstruction of the claimed invention. Br. 9—10. These arguments are not persuasive. We agree with the Examiner’s determination that the prior art references teach and suggest the components and steps claimed and that, without resort to hindsight reasoning, it would have been obvious to combine the art as determined by the Examiner. The picking and 6 Appeal 2016-008746 Application 14/391,543 choosing would not be unreasonable; the number of options is not so extreme and the references urge use of the components claimed, in the claimed amounts, for the same purposes. Appellant attacks Lang’s disclosure as directed to calcium carbonate as the component to be granulated and acknowledges that, while Lang teaches sodium chloride as a salt, it does not teach the claimed counter ion of the metal salt (e.g., lactate, citrate, acetate). Br. 10—11. Appellant argues Lang teaches “many different optional hydrocolloids” and acacia gum is taught to be one that is “particularly useful.” Id. at 11—12. Appellant argues that, because the examples set forth in Lang do not include Arabic gum, there were many different gums generally disclosed, and because Lang indicates a preference for acacia gum not Arabic gum, the claims are patentable over Lang. These arguments are not persuasive. As noted above, the rejection is over a combination of references, not just Lang (the Examiner provided express reason for modifying Lang to reach the limitations in the claim and Appellant has not persuasively identified error in this reasoning); therefore, attacking Lang individually is not persuasive. Also, while it is noted that Lang is focused on calcium carbonate, Lang teaches that other metal salts, such as calcium sulfate and ferrous sulfate and sodium chloride can be used in the formulation and, while Lang does not specify counter ions, other references do—Adusumilli specifically identifies calcium citrate and calcium lactate. It is immaterial whether or not Lang includes specific components in its examples because a reference’s teachings are not limited to its examples and, contrary to Appellant’s argument that Lang expresses a 7 Appeal 2016-008746 Application 14/391,543 preference for acacia gum over Arabic gum, Appellant’s Specification is explicit that these are synonymous terms for Arabic gum. See Spec 1:18—19 (“Arabic gum, also known as . . . acacia gum”). Appellant argues Chawla is directed to and requires gabapentin in its granulated pharmaceutical formulation, but gabapentin is not required in Appellant’s claimed process. Br. 12—13. Appellant further argues that, while Chawla discloses Arabic gum, Chawla does not disclose Arabic gum can be in the granulating liquid and in the material to be granulated, and that Chawla’s examples do not include Arabic gum. Id. at 13. These arguments are not persuasive. Again, attacking Chawla individually is not persuasive because the rejection is over a combination of art. The Examiner provided reasons for modifying Chawla, which Appellant has not persuasively shown to be error. Further, even if Chawla does not disclose Arabic gum in the granulation liquid, it teaches its inclusion in the granulation target material in the claimed amounts and other cited references teach to include it in the claimed amounts in the granulation liquid. That Chawla’s examples do not include Arabic gum is not determinative because is reference is not limited to its working examples. Mills, 470 F.2d at 651. Appellant argues Cherukuri, like the other references, teaches several choices for binders, one being Arabic gum, but provides no reason to select it from the group. Br. 14—15. Appellant argues Cherukuri teaches the granulating medium is water and does not suggest the amount of gum to be included in the water medium. Id. at 16. These arguments are not persuasive. Again, attacking Cherukuri individually is not persuasive because the rejection is over a combination of 8 Appeal 2016-008746 Application 14/391,543 art, which the Examiner provided reasons to combine. Each of Cherukuri’s disclosed binders for use in its ultimate formulation and for use as an agent in the granulating liquid of its manufacturing process is obvious in view of the reference’s disclosure, Arabic gum being one such listed component, thus establishing its suitability for the granulating process. Appellant’s argument that Cherukuri does not teach how much binder, e.g., Arabic gum, to include in the granulating solvent is inaccurate because Cherukuri teaches amounts which overlap with the claimed range of 5—40%, namely, “[t]he amount of this ‘binder’ may range from about 1% to about 25%” and teaches that Arabic gum is a binder agent. Cherukuri || 53, 55 (“the granulating solvent (whether aqueous or non-aqueous) may contain an excipient that serves as a binder. . . . The amount of this ‘binder’ may range from 1% to about 25%.”). Appellant argues Adusumilli discloses a pharmaceutical composition with alginic acid or salt thereof and a water-soluble carbonate, which is not required in the claimed invention. Br. 16. While Appellant concedes Adusumilli discloses including Arabic gum in its composition, Appellant argues it is not included in the examples of the reference. Id. These arguments are not persuasive. The fact that Adusumilli might include components not expressly recited in Appellant’s claims is not determinative; Appellant’s claims are “comprising” claims and can include other steps or materials, including any additional materials suggested by the prior art. Again, that Adusumilli does not include Arabic gum in an example is not determinative in view of the reference’s teachings as a whole. 9 Appeal 2016-008746 Application 14/391,543 Appellant concludes with an argument that the cited references are directed to different things and are not related and, so, would not have been combined by the skilled artisan. This argument is not persuasive. The references are each directed to producing a pharmaceutical formulation by granulation, they disclose similar components (e.g., calcium salts and Arabic gum binder), and they disclose similar manufacturing methods (e.g., wet granulation). These references are all in the same field of endeavor and pertinent to the same problem of wet granulation with which the Specification is concerned. In re Clay, 966 F.2d 656, 658—59 (Fed. Cir. 1992). It would have been reasonable for the skilled artisan to consult each of the cited references to develop a similar granulated pharmaceutical formulation or granulation manufacturing process because they are in the same endeavor as the claimed subject matter. As for claim 22, which recites “the material to be granulated comprises Arabic gum, in an amount of at least 20% (w/w),” and claim 40, which recites “wherein the material to be granulated comprises Arabic gum, in an amount of at least 50% (w/w),” these Arabic gum amounts overlap with the ranges disclosed by Chawla of Arabic gum as a polysaccharide component in the amount of about 3% to about 80%. In “cases involving overlapping ranges, [courts] have consistently held that even a slight overlap in range establishes a prima facie case of obviousness.” In re Peterson, 315 F.3d at 1329. Appellant’s arguments are not persuasive as the prior art combination teaches and suggests Arabic gum can be in the granulating liquid and in the material to be granulated. 10 Appeal 2016-008746 Application 14/391,543 As to claim 43, which recites “the material to be granulated does not include carbonate,” Appellant argues Lang and Adusumilli each requires carbonite and teaches away from this claim element. Br. 20. This argument is not persuasive. There is no requirement that the methods of either Lang or Adusumilli be incorporated whole-cloth into an ultimate method taught and suggested by the combined prior art. The prior art combination teaches and suggests compositions that include carbonate and also compositions that do not; either and both would have been obvious. There is no teaching in either reference that discourages, discredits, or criticizes exclusion of carbonate and disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971). SUMMARY The obviousness rejection is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 11 Copy with citationCopy as parenthetical citation