Ex Parte ChidambaramDownload PDFPatent Trial and Appeal BoardFeb 9, 201712716593 (P.T.A.B. Feb. 9, 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. 12/716,593 03/03/2010 Nachiappan Chidambaram 15660-177 (BLS 107USD1) 1037 129259 7590 02/09/2017 BGL/Banner Life Sciences c/o CPA Global P.O. Box 52050 Minneapolis, MN 55402 EXAMINER WESTERBERG, NISSA M ART UNIT PAPER NUMBER 1618 MAIL DATE DELIVERY MODE 02/09/2017 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte NACHIAPPAN CHIDAMBARAM1 __________ Appeal 2014-008741 Application 12/716,593 Technology Center 1600 __________ Before JOHN G. NEW, JACQUELINE T. HARLOW, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to an oral gastric resistant soft capsule shell, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part and enter new grounds of rejection. STATEMENT OF THE CASE Appellant discloses “an object of the invention [is] to provide a gastric resistant capsule shell, which can encapsulate a liquid, semi-solid, or solid fill, which contains a gastric resistant natural polymer at relatively low 1 Appellant identifies the Real Party in Interest as Banner Pharmacaps, Inc. (App. Br. 2.) Appeal 2014-008741 Application 12/716,593 2 concentrations.” (Spec. 3:1–3.) According to the Specification, “[e]xemplary gastric resistant natural polymers include pectin and pectin- like polymers.” (Id. at 4:25–26.) Claims 16, 18, 20, 21, 23–32, 36–40, and 64–66 are on appeal.2 Claim 16 is illustrative: 16. An oral gastric resistant soft capsule shell comprising (a) a gastric resistant natural polymer present in an amount less than 5% by weight of the capsule shell; (b) a film-forming natural polymer; and (c) a gelling agent. (App. Br. 17 (Claims App’x).) The claims stand rejected as follows: I. Claims 16, 18, 20, 21, 23–32, 37, 39, 40, and 65 under 35 U.S.C. § 103(a) over Scott3 (“Rejection I”). II. Claims 16, 18, 20, 21, 23, 24, 26–30, 39, 40, and 65 under 35 U.S.C. § 103(a) over Schurig4 (“Rejection II”). III. Claims 36–38 under 35 U.S.C. § 103(a) over Schurig and Andersen5 (“Rejection III”). IV. Claims 30–32, and 64 under 35 U.S.C. § 103(a) over Schurig and Opheim6 (“Rejection IV”) 2 Appellant indicates that claims 1–15, 17, 19, 22, 33, 41, and 42 have been cancelled, and that claims 34 and 43–63 are withdrawn. (App. Br. 2.) 3 Scott et al., US 2003/0175335 A1, published Sept. 18, 2003. 4 Schurig et al., US 5,484,598, issued Jan. 16, 1996. 5 Andersen et al., WO 03/084516 A1, published Oct. 16, 2003. 6 Opheim, US 2004/0037877 A1, published Feb. 26, 2004. Appeal 2014-008741 Application 12/716,593 3 V. Claim 25 under 35 U.S.C. § 103(a) over Schurig and Scott (“Rejection V”). VI. Claim 66 under 35 U.S.C. § 103(a) over Schurig, Scott, and Opheim (“Rejection VI”). REJECTION I Issue Has the Examiner established by a preponderance of the evidence that claims 16, 18, 20, 21, 23–32, 37, 39, 40, and 65 would have been obvious over Scott? Findings of Fact (FF) FF 1. The Examiner’s findings of fact and statement of Rejection I are provided at pages 2–3 and 7–9 of the Examiner’s Answer. (See also 3/13/13 Final Act. 2–5; 8/6/12 Non-Final Act. 4–5.) Except where otherwise stated, we adopt the Examiner’s findings in support of Rejection I and provide the following for emphasis. FF 2. Scott teaches “film-forming compositions containing pectin, at least one additional film-forming polymer and a setting system for use in pharmaceuticals, veterinary, food, cosmetic or other products . . ., preferably for predosed formulations like soft or hard capsules.” (Scott Abstract; see also id. at ¶ 1.) Scott teaches “[e]nteric materials have pH-dependent solubility. They are insoluble under gastric conditions . . . and readily soluble under intestinal conditions.” (Id. at ¶ 4.) Scott further teaches “enteric properties of pharmaceutical compositions are achieved by a coating process with enteric materials on e.g. granules, pellets, tablets or hard or soft capsules.” (Id. at ¶ 5.) Appeal 2014-008741 Application 12/716,593 4 FF 3. Scott teaches “[p]ectin has excellent enteric properties. A relatively low content of pectin from 5 to 25%, preferably 10 to 20% by weight in the composition, is sufficient to obtain capsule films with enteric properties.” (Id. at ¶ 12.) Scott further teaches “[t]he content of pectin is in the range of 5 to 60%, preferably 10 to 40%, and that of the second film- forming material in the range of 40 to 95%, preferably 50 to 85% by weight in the film composition.” (Id. at ¶ 17; see also id. ¶ 27 and claim 3.) Scott discloses that “[l]ow methoxyl pectins (LM pectins) . . . are especially preferred.” (Id. at ¶ 18.) FF 4. Scott teaches “[a] disadvantage of pectin is its brittleness like other enteric materials, if it is used in film-forming compositions alone or in high amounts. Surprisingly, we have found that this problem could be solved by the addition of at least one further film-forming material.” (Id. at ¶ 15.) Scott teaches “[s]uitable [film-forming materials] are for example gelatin; pullulan; polyvinyl alcohol” and other materials. (Id.) FF 5. Scott teaches “[s]urprisingly, we have found that pectin, besides its enteric properties, can provide sufficient setting behavior in the presence of divalent cations such as Ca++ or Mg++. . . . The setting behavior of the film-forming solution may be also achieved or altered by the addition of further gelling agents, preferably polysaccharides such as carrageenan or gellan.” (Id. at ¶¶ 20–21.) FF 6. The Specification discloses “[i]n one embodiment, the gastric resistant natural polymer is pectin. The gastric resistant natural polymer is present in an amount less than about 5% by weight of the composition.” (Spec. 5:16–17.) The Specification teaches that “[e]xemplary film-forming natural polymers include gelatin and gelatin-like polymers” (id. at 5:21–22) Appeal 2014-008741 Application 12/716,593 5 and “[e]xemplary gelling agents include divalent cations such as Ca2+ and Mg2+” (id. at 5:28–29). Principles of Law “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955); see also In re Peterson, 315 F.3d 1325, 1329–30 (Fed. Cir. 2003). “[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Analysis Appellant argues the patentability of the claims subject to Rejection I as a group. We select claim 16 as representative. See 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Scott discloses enteric-film formulations for hard or soft capsules that contain the ingredients encompassed by claim 16 — pectin as a gastric resistant polymer, gelatin as a film-forming polymer, and divalent calcium or magnesium cations as a gelling agent. (Ans. 2, 8.) The Examiner finds that Scott discloses “that pectin has excellent enteric properties with a relatively low content of pectin (5 - 25%) . . . but can be brittle if used alone or in high amounts.” (Ans. 2.) The Examiner acknowledges that the claimed concentration of pectin (“less than 5%”) and the ranges recited in Scott (e.g., 5–25% and 5–60%) do not directly overlap, but finds “[t]he range set forth in the body of the claim for the amount of pectin is so close . . . [to the edge of Scott’s ranges] that they are reasonably expected to have the same properties and therefore are Appeal 2014-008741 Application 12/716,593 6 prima facie obvious (see MPEP 2144.05).” (Ans. 9; see also id. at 3 (“Ranges that overlap or are otherwise so close that they touch are reasonably expected to have the same properties.”).) Further, according to the Examiner, the amount of pectin in the composition “is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize.” (Id.) The Examiner thus concludes, absent persuasive evidence of criticality or unexpected results related to the claimed range versus the prior art, claim 1 would have been obvious. (Id. at 9; Final Act. 2, 5.) Appellant argues “Scott does not disclose or suggest soft capsules containing the concentration of gastric resistant polymer recited in claim 16.” (App. Br. 7 (italics omitted); see also Reply Br. 3–4.) According to Appellant, Scott briefly mentions soft capsules, but provides no working examples or detailed description of soft-capsule production. (App. Br. 7–8.) Appellant argues the majority of Scott’s teachings and all its working examples focus on coating hard capsules and that Scott’s preferred embodiments and working examples employ greater amounts of pectin than what is claimed. (Id. (“Scott does not disclose or suggest any working examples of hard capsules having less than 10% pectin, let alone soft capsules containing less than 5%.”).) In support of its argument, Appellant also cites decisions of the Federal Circuit and Board concerning a different patent application allegedly owned by the assignee of the pending application. (Id. at 8 (citing In re Hassan, Appeal No. 2013-1287 (Fed. Cir. decided Aug. 2, 2013).) In that other matter, on joint motion, the Federal Circuit remanded to the Board stating: “We agree with the parties that the Board’s decision attributes to [prior art] Okajima a teaching of soft capsules without any analysis or Appeal 2014-008741 Application 12/716,593 7 discussion of Okajima’s repeated references to hard capsules.” In re Hassan, No. 2013-1287 at 1–2. The Board then reversed the claim rejections concluding “the Examiner has not clearly explained why Okajima’s disclosure of hard capsules would have suggested the [claimed] soft capsules.” Ex parte Hassan, Appeal No. 2011-013217 1, 4 (PTAB decided Sept. 18, 2013). According to Appellant here, “[t]he disclosure in Scott is limited to hard shell capsules” and thus “[t]he facts of In re Hassan are analogous to the present application.” (App. Br. 8.) Appellant next argues the behavior of soft capsules with less than 5% of the gastric resistant polymer is not predictable from Scott. (App. Br. 9.) Appellant contends pectin is brittle, that its use in a film decreases elasticity, and that having proper elasticity is important when preparing soft capsules. According to Appellant, the process of forming hard capsules is dip molding and “does not require an elastic film that can be run through a rotary die process . . . [and] [t]herefore hard capsule shells can tolerate much higher concentrations of pectin in the film forming composition.” (Id.) Appellant contends “Scott states explicitly that it was surprising that hard capsules prepared from dipping solution having a relatively low concentration of pectin would have sufficient enteric properties” and thus, according to Appellant, the skilled person “would not prepare soft capsules having an even lower amount of pectin.” (Id. at 10.) Finally, Appellant argues “the claimed capsule shells exhibit properties that were unexpected or not predictable from the teachings of Scott.” (Id. at 10.) Citing the December 10, 2012 Declaration of Qi Fang, Ph.D. (“Fang Decl.”), Appellant contends “the ability to use lower amounts of gastric resistant polymer” provides advantages: “less viscous gel mass” Appeal 2014-008741 Application 12/716,593 8 that “results in easier capsule manufacturing,” “lower manufacturing costs,” “clearer and more robust . . . capsules,” and “lower oxygen permeability . . . [for] better protection for oxygen-sensitive active agents.” (App. Br. 10.) We agree with the Examiner’s findings of fact, reasoning, and conclusion that claim 16 would have been obvious over Scott. Scott teaches pectin film compositions for coating pharmaceuticals and foods and expressly teaches these compositions are “preferably for predosed formulations like soft or hard capsules.” (FF 2 (emphasis added).) The fact that Scott illustrates its compositions further through working examples that are hard capsules does not mean that designing pectin film compositions for soft capsule production would have been nonobvious. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“[I]n a section 103 inquiry, the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered.”) (internal quotation marks omitted). As noted by the Examiner, “that soft capsules are not prepared in the examples does not teach away from the disclosure elsewhere that the compositions can be sued [sic used] for soft or hard shell capsules.” (Ans. 8.) Appellant’s contentions to the contrary are unpersuasive. We are also unpersuaded that decisions of the Federal Circuit and Board related to In re Hassan demonstrate error with the Examiner’s rejection in this appeal. (App. Br. 8.) To the contrary, as the Examiner pointed out, there is a critical difference between Scott and the Okajima reference in In re Hassan — “[t]he Okajima reference . . . makes absolutely no mention of soft shell capsules.” (Ans. 8.) Scott, on the other hand, teaches its compositions are “preferably for predosed formulations like soft Appeal 2014-008741 Application 12/716,593 9 or hard capsules.” (FF 2 (emphasis added).) In re Hassan and the Board’s reversal of the claim rejections in that case are thus inapplicable here. Although the claimed concentration of pectin encompassed by claim 16 and the range recited in Scott do not overlap, we agree with the Examiner that the concentrations are so close that they would reasonably be expected to have the same properties. (Ans. 9.) We further agree that the pectin in Scott is a results-effective variable — the concentration of which the skilled artisan would have predictably optimized to design an oral gastric resistant soft capsule with a concentration of pectin encompassed by claim 16. In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Overlap of ranges between the prior art and the claims is not always required to establish prima facie obviousness. As the Federal Circuit observed: “We have also held that a prima facie case of obviousness exists when the claimed range and the prior art range do not overlap but are close enough such that one skilled in the art would have expected them to have the same properties.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (discussing Titanium Metals Corp. v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985)). Here, the edge of the range expressly disclosed in Scott (e.g., 5– 25%) and the claimed “less than 5%” range are abutting. (FF 3.) Appellant provides no persuasive evidence of criticality to address this slight variation. (Ans. 8.) Absent such evidence, we are not persuaded the ordinarily skilled person would expect a material difference in the properties of a composition that included, for example, 5% pectin (as in Scott) and 4.99% pectin as within claim 16’s scope. (FF 3.) Appellant’s Specification lends support to the Examiner’s determination that compositions with pectin concentrations “so close that Appeal 2014-008741 Application 12/716,593 10 they touch” would be expected to share the same properties. (Ans. 3.) Indeed, the Specification describes the invention as encompassing concentrations of a gastric resistant polymer, including pectin, of “less than about 5%” — suggesting concentrations of 5% or slightly above also work for the inventive purpose. (FF 6 (emphasis added); see also Spec. 3:10–11, 5:16–17, 16:1–4.) We recognize Appellant’s argument that proximity of claimed and prior art ranges is not necessarily sufficient to demonstrate obviousness. (Reply Br. 2–3.) But based on the record before us, including the abutting ranges, the suggestion in Appellant’s Specification that concentrations of 5% or slightly above are workable, and the absence of persuasive evidence showing criticality to concentrations at any level below 5%, we agree that claim 16 is prima facie obvious over Scott. Appellant contends behavior of soft capsules with less than 5% pectin is unpredictable. We are unpersuaded. As noted above, the prior art and claimed range effectively touch, and the skilled artisan would have reasonably expected compositions with extremely minor variations in pectin concentration above or below 5% to have substantially the same properties. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (“[T]he expectation of success need only be reasonable, not absolute.”). In addition, Appellant’s contention that films for hard-capsule production tolerate higher pectin concentrations (App. Br. 9), would, if anything, point toward using lower pectin concentrations for soft-capsule production. To the extent pectin is brittle and decreases elasticity when used alone or in high amounts, Scott teaches to compensate for such brittleness by addition of film-forming gelatin (FF 3–4), and the skilled artisan would have predictably adjusted the concentrations of these materials to design a suitable soft-capsule film. Appeal 2014-008741 Application 12/716,593 11 We have considered Appellant’s evidence of secondary considerations but, like the Examiner, do not find it sufficiently persuasive to overcome the Examiner’s case for obviousness. As the Examiner observes, “the declaration only contains opinions and no data is presented.” (Final Act. 2.) Appellant’s declarant opines that “use of amounts of gastric resistant polymer less than about 5% by weight of the capsule shell, as defined in claim 1, provides several advantages . . . .” (Fang. Decl. ¶ 6 (emphasis added).)7 Examiner points out, however, that the alleged advantages would not have been unexpected. (Final Act. 2–3; Ans. 9.) For example, use of less of a viscous polymer would be expected to reduce material costs and produce a less viscous gel mass. Appellant’s declarant also emphasizes that mixtures of film-forming polymer and gastric resistant polymer “typically have higher oxygen permeability than capsules prepared from a film- forming polymer only.” (Fang Decl. ¶ 7.) Yet Scott does not teach forming capsules from a film-forming polymer alone, so this comparison elides the key issue: whether there is any critical difference or unexpected result in a compositions depending on whether the pectin concentration is just above or just below 5%. On this issue, Appellant’s use of general terminology — “higher amounts of pectin” and “lower amounts of a gastric resistant polymer” (id. at ¶¶ 7–8) — and the absence of any data or actual results fails to provide persuasive evidence of nonobviousness. (Id. passim.) 7 Appellant’s opinion evidence does not reflect the current claims, which require “less than 5%” of the gastric resistant natural polymer. The phrase “less than about 5%” encompasses a concentration of 5% and thus would overlap with the range of pectin recited in Scott. Appeal 2014-008741 Application 12/716,593 12 In the Reply Brief, Appellant argues “Scott does not render obvious the use of a gelling agent in a soft capsule.” (Reply Br. 4.) More specifically, Appellant contends the “divalent cations such as Mg2+ or Ca2+, or a gelling agent such as carrageenan or gellan, [are used in Scott] to impart sufficient setting ability to the hard gelatin capsules” and “Scott provides no instruction to include divalent cation or other gelling agent into the film forming composition intended for use in a soft capsule.” (Id.) This argument concerning the gelling agent of Scott is new and untimely. And the Board does not ordinarily consider new argument or evidence submitted for the first time in the Reply Brief. 37 C.F.R. § 41.41(b)(1) & (2). Ex parte Borden, 93 USPQ2d 1473, 1477 (BPAI 2010) (informative) (“Properly interpreted, the Rules do not require the Board to take up a belated argument that has not been addressed by the Examiner, absent a showing of good cause.”). Insofar as Appellant suggests Scott’s teachings are limited to hard capsules, we reject that argument for the reasons discussed above. (FF 2.) And, in any event, Scott suggests a setting system is used for soft capsules as well (FF 1), and absent persuasive evidence to the contrary, the skilled person would have predictably included the setting system/gelling agents disclosed in Scott (FF 5). See In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997) (argument by counsel cannot take the place of evidence). Conclusion of Law We conclude the Examiner established by a preponderance of the evidence that claim 16 would have been obvious over Scott. Claims 18, 20, 21, 23–32, 37, 39, 40, and 65 have not been argued separately and thus fall with claim 1. Appeal 2014-008741 Application 12/716,593 13 REJECTION II The Examiner rejected claims 16, 18, 20, 21, 23, 24, 26–30, 39, 40, and 65 as obvious over Schurig. Appellant argues the patentability of the claims as a group and we again select claim 16 as representative. The Examiner finds that Schurig discloses a gelatin capsule comprising starch as a gelling agent, and other optional ingredients such as thickening agents in the range 0.1–15% and gelatins in the range 0.1–40%. (Ans. 4.) The Examiner finds Schurig identifies pectin among a list of optional polysaccharide thickening agents, but that Schurig “does not prepare a composition with pectin.” (Id.) The Examiner, nevertheless, concludes it would have been obvious to design the capsule shell of claim 16 in light of Schurig’s teachings. (Id. at 4–5.) Appellant argues “Schurig discloses softgel capsules with gripping construction, such as knurled surfaces . . . to enhance gripping,” a “capsule [that] has a removable tab at one end” and “[t]he medicament encapsulated within the capsule is administered by removing the tab and expelling the medicament from the capsule.” (App. Br. 11.) Appellant thus contends the “purpose of Schurig is to modify conventional capsules to include structural features, such as knurls or ribs, on the surface to make it easier to manipulate the capsule by hand.” (Id.) In view of these teachings, Appellant argues, Schurig does not disclose or suggest (i) a shell containing a gelling agent and (ii) an oral gastric resistant softgel capsule. (Id. at 11–12.) Appellant has the better position. As an initial matter, the preamble of claim 16 does more than simply state an intended use of the invention. See Pitney Bowes Inc. v. Hewlett Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). It specifies an “oral Appeal 2014-008741 Application 12/716,593 14 gastric resistant soft capsule shell” and the body of the claim (element (a)) relies on the preamble for antecedent basis. Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003) (“When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.”). Moreover, as the claim preamble and body both specify inclusion of “gastric resistant” materials for the shell, an oral dosage form is implied. So, based on the record here, we agree with Appellant that the claim preamble “breathes life and meaning into the claim and therefore should be given patentable weight.” (App. Br. 12.) Turning to the prior art, as Appellant correctly observes, “Schurig makes no mention of gastric resistance since the capsules in Schurig are not swallowed.” (Id. at 12.) To the contrary, Schurig’s invention relates to gripping features such as knurled surfaces on capsules so the capsules are more easily manipulated, opened, and squeezed to expel the capsule’s medicament. (See, e.g., Schurig Fig. 1, 3:19–35.) We are not persuaded the skilled person would, absent hindsight supplied by Appellant’s disclosure, have predictably designed an oral gastric resistant soft capsule shell within the scope of claim 16 based on Schurig’s teachings. Such a modification runs counter to Schurig’s objective as discussed above. Indeed, removing the knurls and raised ribs — as well as likely modifying the overall shape to make tolerable for swallowing — would render Schurig’s capsules unsuitable for their intended purpose. See In re Sponnoble, 405 F.2d 578, 587 (CCPA 1969)). The Examiner asserts Schurig’s “capsules are capable of being inserted into the mouth and swallowed.” (Ans. 11.) But the Examiner has not supported this assertion Appeal 2014-008741 Application 12/716,593 15 with persuasive evidence or reasoning. Based on Schurig’s teachings (see, e.g., Schurig Figs. 1–5), we are not convinced the skilled person would reasonably consider Schurig’s capsules as suitable oral dosage forms. The Examiner has not established by a preponderance of the evidence that claim 16 would have been obvious over Schurig. We thus reverse. We reverse as to 18, 20, 21, 23, 24, 26–30, 39, and 40 for their dependency from claim 16. We also reverse as to 65, which includes limitations similar to claim 16 that we are not persuaded are taught or suggested in Schurig. REJECTIONS III–IV The Examiner rejected claims 36–38 as obvious over Schurig and Andersen. (Ans. 5.) The Examiner rejected claims 30–32 and 64 over Schurig and Opheim. (Id. at 5–6.) The Examiner relies on Andersen only for its teaching of various suitable pectins for film-formers in capsules (id. at 5), and Opheim only for its teaching of gelatin capsules with a fill material comprising fish oil (id. at 6). The Examiner has not shown that Andersen or Opheim make up for Schurig’s deficiencies. We thus reverse Rejections III and IV for the reasons discussed above with respect to Rejection II. REJECTIONS V–VI The Examiner rejected claim 25 over Schurig and Scott. (Ans. 6–7.) The Examiner rejected claim 66 over Schurig, Scott, and Opheim. (Ans. 7.) With respect to claim 25, Appellant essentially reprises the arguments concerning Scott and Schurig. (App. Br. 14–15.) We agree with Appellant as to Schurig, but conclude that Schurig is not necessary to show that claim 25 would have been obvious. For the reasons discussed above with respect to Rejection I, claim 25 would have been obvious over Scott alone. See Appeal 2014-008741 Application 12/716,593 16 generally, In re Bush, 296 F.2d 491, 496 (CCPA 1961) (the Board may rely on less than all of the references relied upon by Examiner). With respect to claim 66, we agree with and adopt the Examiner’s findings concerning the scope and content of Opheim. (Ans. 6–7.) Opheim discloses flavored gelatin capsules containing a fish oil. (Opheim ¶¶ 12–14.) The Examiner concludes it would have been obvious to fill the capsule of Scott and Schurig with fish oil because it is a known therapeutic and prophylactic agent. (Ans. 7.) We agree with the Examiner’s conclusion that it would have been obvious to use fish oil in the capsules of Scott. “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). We reject the combination with Schurig for the reasons discussed, but find that Schurig is unnecessary. In re Bush, 296 F.2d at 496. Scott, as discussed above concerning Rejection I, combined with Opheim would have produced the capsule of claim 66. Appellant reprises the arguments concerning Scott and Schurig, and argues “Opheim does not cure the deficiencies of Schurig and [Scott].” (App. Br. 15.) We agree with Appellant as to Schurig, but disagree that Scott is deficient. Inasmuch as Appellant contends “[t]here is no disclosure or suggestion in Opheim to include a gastric resistant polymer, let alone a gastric resistant polymer in the amount specified” in the claim (id. at 14), Examiner is not relying on Opheim for those teachings. In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be Appeal 2014-008741 Application 12/716,593 17 established by attacking references individually where the rejection is based upon the teachings of a combination of references.”) NEW GROUNDS OF REJECTION We enter new grounds of rejection: (i) claims 36 and 38 under § 103(a) over Scott and Andersen; and (ii) claim 64 over Scott and Opheim. Findings of Fact FF 7. We adopt the Examiner’s findings of fact concerning the scope and content of Andersen and Opheim (Ans. 5–6) and supplement as follows. FF 8. Andersen teaches seamless polysaccharide capsules suitable for pharmaceutical, veterinary, and food applications. (Andersen 1:2–5.) Andersen teaches film-forming agents may include “gelling or non-gelling polymers, and enteric polymers for example . . . pectins such as high methoxy (HM), low methoxy (LM), and amidated methoxy pectins . . . .” (Id. at 15:16–19.) FF 9. Opheim teaches “capsule formulations, medicinal and nutritive dose encapsulations and methods of manufacture of capsules.” (Opheim ¶ 3.) Opheim teaches fish oils include omega 3 fatty acids like EPA and DHA that are reported in medical literature to provide health benefits. (Id. at ¶¶ 5–9 (e.g., decreased blood pressure and improved central nervous function).) Opheim teaches “an additional object of the present invention [is] to optionally provide a flavored gelatin capsule containing a fish oil.” (Id. at ¶ 12; see also id. at ¶¶ 13–14.) Appeal 2014-008741 Application 12/716,593 18 Analysis Claims 36 and 38 Scott is discussed above concerning Rejection I. Scott discloses film formulations for hard or soft capsules that include pectin as an enteric agent. Scott teaches that “[p]ectin has excellent enteric properties.” (FF 3.) Scott teaches low methoxyl (LM) pectins are especially preferred. (Id.) Scott does not, however, expressly identify other types of pectins including high methoxy pectin or amidated pectin, such as encompassed by claims 36 and 38 respectively. Andersen teaches suitable enteric polymers include pectins, and identifies “high methoxy (HM), low methoxy (LM), and amidated methoxy pectins.” (FF 8.) It would have been obvious to the ordinarily skilled artisan at the time of invention to use low methoxy or amidated pectins in the film formulation of Scott. The skilled person would have had reason to make those modifications and would have reasonably expected success because these other pectins are art-recognized alternatives. KSR, 550 U.S. at 416. The substitution of one pectin for another, absent persuasive evidence to the contrary, would have been regarded as obvious because it was known, based at least on Andersen, that HM, LM, and amidated pectins are film-formers with enteric properties. (FF 8; see also Scott ¶ 4 (“[e]nteric materials have pH-dependent solubility . . . [and] are insoluble under gastric conditions.”) Claim 64 Claim 64 depends from claims 16, 30, and 32 and generally recites the shell of claim 16 with a therapeutic or prophylactic fill material of fish oil. Appeal 2014-008741 Application 12/716,593 19 Scott is discussed above. Scott does not disclose a fill material comprising fish oil. Opheim discloses capsules with fill materials that include a medicine or nutritional supplement. (FF 9.) A preferred fill material is fish oil. (Id.) It would have been obvious to the ordinarily skilled person at the time of the invention to prepare Scott’s capsules filled with the fish oil as taught in Opheim. The skilled person would have had a reason to make this combination to obtain the reported and expected benefits of fish oil as evidenced in Opheim. (FF 9.) Because Opheim expressly teaches including such oils in gelatin capsules (id.), the skilled person would have reasonably expected success in making the proposed combination. SUMMARY We affirm the rejection of claims 16, 18, 20, 21, 23–32,8 37, 39, 40, and 65 under 35 U.S.C. § 103(a) over Scott. We reverse the rejection of claims 16, 18, 20, 21, 23, 24, 26–30, 39, 40, and 65 under 35 U.S.C. § 103(a) over Schurig. We reverse the rejection of claims 36–38 under 35 U.S.C. § 103(a) over Schurig and Andersen. We reverse the rejection of claims 30–32 and 64 under 35 U.S.C. § 103(a) over Schurig and Opheim. We affirm the rejection of claim 66 under 35 U.S.C. § 103(a) over Scott and Opheim. We enter a new ground of rejection of claims 36 and 38 under 35 U.S.C. § 103(a) over Scott and Andersen. 8 Because we rely on Scott and not Schurig with respect to Rejection V, Rejection V is, in effect, encompassed by Rejection I. Appeal 2014-008741 Application 12/716,593 20 We enter a new ground of rejection of claim 64 under 35 U.S.C. § 103(a) over Scott and Opheim. TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new grounds of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the Examiner, in which event the proceeding will be remanded to the Examiner. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record. . . . Should the Appellant elect to prosecute further before the Examiner pursuant to 37 C.F.R. § 41.50(b)(l), in order to preserve the right to seek review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection, the effective date of the affirmance is deferred until conclusion of the prosecution before the Examiner unless, as a mere incident to the limited prosecution, the affirmed rejection is overcome. If the Appellant elects prosecution before the Examiner and this does not result in allowance of the application, abandonment or a second appeal, this case should be returned to the Patent Trial and Appeal Board for final Appeal 2014-008741 Application 12/716,593 21 action on the affirmed rejection, including any timely request for rehearing thereof. AFFIRMED-IN-PART, 37 C.F.R. § 41.50(b) Copy with citationCopy as parenthetical citation