Ex Parte Brady et alDownload PDFPatent Trial and Appeal BoardAug 29, 201412168619 (P.T.A.B. Aug. 29, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 12/168,619 07/07/2008 Scott P. Brady SCH054 P303 7810 277 7590 08/29/2014 PRICE HENEVELD LLP 695 KENMOOR SE P O BOX 2567 GRAND RAPIDS, MI 49501 EXAMINER TRAN, SUSAN T ART UNIT PAPER NUMBER 1615 MAIL DATE DELIVERY MODE 08/29/2014 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 SCOTT P. BRADY and ROBERT C. DOSTER1 ________________ Appeal 2012-005402 Application 12/168,619 Technology Center 1600 ________________ Before JEFFREY M. FREDMAN, ULRIKE W. JENKS, and ROBERT A. POLLOCK, Administrative Patent Judges. POLLOCK, Administrative Patent Judge. DECISION ON APPEAL Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s rejection of claims 1-16, 19, 20, 26, and 27. We have jurisdiction under 35 U.S.C. § 6(b). We affirm, and designate our affirmance as a New Ground of Rejection under 37 C.F.R. § 41.50(b). STATEMENT OF CASE Appellants’ invention is directed to tablet coating compositions suitable for orally-administered dietary supplements. 1 Appellants identify Enzyme Therapy, Inc. as the Real Party in Interest. (App. Br. 2). Appeal 2012-005402 Application 12/168,619 2 Exemplary independent claim 1 recites : 1. A tablet coating composition comprising: water; and at least one Certified Organic ingredient dispersed in the water, the composition being comprised entirely of water, Certified Organic ingredients, and at least one organic compliant ingredient. Independent claims 11 and 27 are further directed to a coated tablet comprising a tablet core and a coating layer. Claim 27, and the dedependent claims on appeal variously specify Certified Organic honey solids, Certified Organic soy lecithin, organic compliant vegetable glycerin, and organic compliant carrageenan. Claims 1, 2, 4, 6, 7, 9, 11-13, 15, 20, 26, and 27 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Vitamininformationpress (VIP)2, in view of Dalziel3 and Roman4. Claims 1-16, 19, 20, 26, and 27 stand rejected under 35 U.S.C. § 103(a) as unpatentable over VIP, in view of Dalziel, Roman, and Sue5. FINDINGS OF FACT The tablet coatings of Appellants’ invention “are made from Certified Organic ingredients and organic compliant ingredients.” (Spec. ¶ 12.) 2 “New Organic Products,” 9(4) Vitamininformationpress (April 2007). 3 Dalziel et al., US 2006/0068019, published March 30, 2006. 4 Roman et al., US 2008/0299258, published December 4, 2008. 5 Sue et al., US 2002/0192283, published December 19, 2002. Appeal 2012-005402 Application 12/168,619 3 The Specification defines “Certified Organic ingredients” as “ingredients that are certified ‘organic’ by the U.S.D.A. Accredited Certifying Agents for the National Organic Program established in accordance with the Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.).” (Id. ¶ 13.) “Organic compliant” ingredients are “non-agricultural substances (as listed under 7 U.S.C. §205. 605) that may be used in the production of products that may be labeled organic pursuant to 21 C.F.R. 01.22.” (Id. ¶ 17.) The Specification discloses preferred tablet coating compositions comprising “water, Certified Organic honey solids, and an organic compliant carrageenan. (Id. ¶ 20.) “Honey solids or honey powder is composed of sugars (predominantly fructose and glucose, but may also include maltose and sucrose), dextrins, minerals, diastase enzyme (which converts starch to maltose units), small amounts of lipids and proteins other than the diastase enzyme, and beeswax.” (Id. ¶ 21.) The Specification further states that coating compositions may also include organic compliant vegetable glycerin as a plasticizer (id. ¶ 24), and Certified Organic soy lecithin “to reduce the tackiness of the coating on the tablet cores.” (id. ¶ 25). The Specification states that “[c]oated tablets are well-known in the art” and have been employed for over 1,000 years. For example, it is reported that the mucilage of psyllium seeds was used to coat pills having an offending taste at least as early as the 9th century. Subsequently, it is reported that gold, silver, gelatin, and waxes have been employed as tablet coatings. Id. ¶ 3. Appeal 2012-005402 Application 12/168,619 4 The Specification discloses that tablet coatings perform a plurality of functions, stating: Unquestionably, a significant portion, if not most, pharmaceutical and/or nutriceutical solid dosage forms are provided with a coating that typically performs a plurality of functions. Tablet coatings are used for protecting the active ingredient in the tablet core from air, moisture and light to improve stability and extend useful shelf life of the tablet. Coatings are also used for masking unpleasant taste and odor; and for making the tablet easier to swallow. In addition, tablet coatings can be used to improve the appearance of the tablet, and to improve the mechanical integrity of the tablet by making it more resistant to abrasion, attrition and the like. (Id. ¶ 4.) Sue is directed to tablet coatings for masking the odor or taste of pharmaceutical preparations, in particular, dietary supplements derived from Valarian root extract. (Sue Abstract, ¶¶ 2, 5.) Sue teaches tablet coating compositions comprising, inter alia, a solvent such as water (id. ¶ 33), lecithin (id. ¶ 58), a plasticizer such as glycerin (id. ¶ 11), and a coating layer comprising “a sugar and at least one anti-tackiness agent” (id. ¶ 11). Sue further discloses that “[s]ugars increase the palatability of the preparation,” and that suitable sugars “include, but are not limited to, sucrose, dextrose, dextrin, maltose, glucose, fructose, mannose, sorbitol, lactose, mannitol, xylose and the like.” (Id. ¶ 25). Dalziel teaches coating compositions for pharmaceutical or nutritional supplements in particle form which may contain water as a solvent (Dalziel ¶ 75), along with soy protein (id. ¶ 83); lecithin (id. ¶¶ 74, 83); carrageenan (id. ¶¶ 83, 95); and a sweetening agent such as fructose, glucose, maltose, or sucrose (id. ¶¶ 83, 85). Appeal 2012-005402 Application 12/168,619 5 Roman teaches that raw organic honey as a sweetener. (Roman ¶ 52.) VIP is directed to “New Organic Products” including an “Organic Vitamin C 120 mg tablet.” (VIP 1.) VIP states that under USDA’s National Organic Program, 100% Organic means that “100% of the ingredients are organic; can use the USDA organic logo” and “Organic” means that “95% or more of ingredients are organic; can use the USDA organic logo.” (Id. 2). ANALYSIS Appellants contend that the Examiner errs in rejecting claims 1-16, 19, 20, 26, and 27 under 35 U.S.C. § 103(a) as unpatentable in view of Sue, Dalziel, Roman, and VIP. For the reasons set forth below, we are not persuaded. “Certified Organic” and “Organic Compliant” The claims on appeal recite a coating composition or coating layer “comprised entirely of” water, Certified Organic ingredients, and organic compliant ingredients. Invoking the language of independent claim 1, Appellants contend that “[n]one of the coating compositions specifically disclosed by Dalziel et al. is “comprised entirely of water, certified organic ingredients, and at least one organic compliant ingredient.” (Reply Br. 1.) Appellants further contend that the portions of Dalziel relied on by the Examiner “disclose a huge selection of choices without providing any teaching that would guide a person having ordinary skill in the art to the claimed coating composition comprised entirely of water, certified organic ingredients and at least one organic compliant ingredient.” (Id.) Appeal 2012-005402 Application 12/168,619 6 The claim terms at issue are, thus, “certified organic” and/or “organic compliant.” “Only when a claim is properly understood can a determination be made . . . whether the prior art anticipates and/or renders obvious the claimed invention.” Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1351 (Fed. Cir. 2001). “[T]he PTO gives a disputed claim term its “broadest reasonable interpretation consistent with the specification, and . . . claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art.” In re Bond, 910 F.2d 831, 8333 (Fed. Cir. 1990). The court recognizes the fairness of reading claims broadly “before a patent is granted [since] the claims are readily amended as part of the examination process.” Burlington Indus., Inc. v. Quigg, 822 F.2d 1581, 1583 (Fed. Cir. 1987). “Thus, a patent applicant has the opportunity and responsibility to remove any ambiguity in claim term meaning by amending the application.” In re Bigio, 381 F.3d 1320, 1324 (Fed. Cir. 2004). Applying the broadest reasonable interpretation to claims also “serves the public interest by reducing the possibility that claims, finally allowed, will be given broader scope than is justified.” In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). As defined in the Specification, “Certified Organic ingredients” are “ingredients that are certified ‘organic’ by the U.S.D.A. Accredited Certifying Agents for the National Organic Program established in accordance with the Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.).” (Spec. ¶ 13.) The Specification does not teach, and Appellants have not argued, that a “Certified Organic” certification results in any Appeal 2012-005402 Application 12/168,619 7 structural or functional difference as compared to the same material that has not been certified. The Specification similarly defines “organic compliant” ingredients as “non-agricultural substances (as listed under 7 U.S.C. §205.605) that may be used in the production of products that may be labeled organic pursuant to 21 C.F.R. 01.22.” (Id. ¶ 17.) Again, Appellants have presented no evidence that the statutory designation of an ingredient as one that may be used in products that may ultimately be labeled organic provides any structural or functional distinction over the same ingredient that has not been certified or identified on a list. Because there are no structural differences, we find that the “Certified Organic” and “organic compliant” designations are non-functional descriptive terms akin to printed matter. “All that the printed matter does is teach a new use for an existing product.” In re Ngai, 367 F.3d 1366, 1339 (Fed. Cir. 2004). And as our reviewing Court emphasizes, “‘[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.’” Id. (citing In re Gulack, 703 F.2d 1381, 1387 (Fed. Cir. 1983).) Thus, although we consider all claim limitations when determining patentability, Appellants’ non-functional descriptive designations are not entitled to weight in the analysis. Cf. In re Lowry, 32 F.3d 1579, 1584 (Fed. Cir. 1994) (“Lowry’s data structures are physical entities that provide increased efficiency in computer operation. They are not analogous to printed matter.”) Appeal 2012-005402 Application 12/168,619 8 Independent Claims 1 and 11 In light of our construction, Appellants’ claim 1 reduces to a tablet coating composition comprising at least two ingredients dispersed in water. Similarly, in claim 11, these at least two ingredients comprise a coating layer on the surface of a tablet core. Thus construed, we find claims 1 and 11 obvious under 35 U.S.C. § 103(a) in view of the cited references.6 In particular, Sue discloses tablet coating compositions comprising water as a solvent (id. ¶ 33), and multiple ingredients suitable for coating compositions, including lecithin (id. ¶ 58), glycerin (id. ¶ 11), and various sugars (id. ¶ 25). Sue further discloses the application of coatings to Valerian root tablet cores. Dalziel also discloses coating compositions comprising water as a solvent, and a selection of ingredients including soy protein (id. ¶ 83), lecithin (id. ¶¶ 74, 83), carrageenan (id. ¶¶ 83, 95), and sugars such as fructose, glucose, maltose and sucrose (id. ¶¶ 83, 85). VIP discloses organically-derived tablets and establishes that there is a market for such products. The cited art provides a reason to apply coating compositions to the surface of uncoated tablets. In particular, Sue teaches the coating of tablet cores mask odor or taste. (Sue Abstract, ¶¶ 2, 5). In addition, Appellants’ Specification admits that (1) “[c]oated tablets are well-known in the art” (Spec. ¶ 3), and “a significant portion, if not most, pharmaceutical and/or nutriceutical solid dosage forms are provided with a coating that typically 6 Although we affirm here the rejection under 35 U.S.C § 103(a), we are mindful of the well-settled axiom that “‘anticipation is the epitome of obviousness.’” In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (quoting Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). Appeal 2012-005402 Application 12/168,619 9 performs a plurality of functions” including “protecting the active ingredient in the tablet core from air, moisture and light . . . masking unpleasant taste and odor . . . making the tablet easier to swallow. . . . improve[ing] the appearance of the tablet, and [improving] the mechanical integrity of the tablet by making it more resistant to abrasion, attrition and the like.” In light of the above, one of ordinary skill in the art would have found it obvious to formulate a composition comprising water as a solvent and at least two coating ingredients as taught by Sue and/or Dalziel, and to further apply that composition to the surface of a tablet core with the reasonable expectation of achieving one or more of the benefits of coating taught by Sue, or admitted as known in Appellants’ Specification. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 401 (2007) (the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.”). Further, and to the extent the claim terms “Certified Organic” and “organic compliant” should be accorded functional weight, one of ordinary skill in the art would have found it obvious to select “Certified Organic” certified materials and “organic compliant” listed compounds from among those set forth in Sue and/or Dalziel in order to market coated tablets with the USDA logo and “100% Organic” or “Organic” designation as taught by VIP. (See VIP 2). See KSR at 421 (“When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”) Appeal 2012-005402 Application 12/168,619 10 Claims 2-10, 12-16, 19, 20, 26, and 27 Claims 2-10, 12-16, 19, 20, 26, and 27 further recite at least one of Certified Organic honey solids, Certified Organic soy lecithin, organic compliant vegetable glycerin, and organic compliant carrageenan. As above, we accord the terms “Certified Organic” and “organic compliant” no patentable weight. Each of these ingredients is taught or suggested by the cited references. Honey Solids Sue teaches a coating composition comprising “a sugar and at least one anti-tackiness agent” (id. ¶ 11) and states that “[s]ugars increase the palatability of the preparation.” Dalzeil similarly teaches sugars as sweetening agent (id. ¶¶ 83, 85). We agree with the Examiner that one of ordinary skill in the art would have found it obvious to substitute the sugars taught by Sue or Dalziel with the raw organic honey taught by Roman. (Ans. 5 (citing Roman ¶ 52)). Indeed, we note that whereas paragraph 21 of the Specification discloses that the sugars in honey solids or honey powder are “predominantly fructose and glucose, but may also include maltose and sucrose,” these sweeteners are expressly disclosed in Sue paragraph 25, and Dalziel paragraphs 83 and 85. Appellants admit that Roman discloses raw organic honey as a sweetening agent but argue that the required Certified Organic honey solids are different from the raw honey disclosed by Roman et al. First, the raw honey disclosed by Roman et al. is not necessarily certified organic. Further, raw honey is normally filtered, and does not contain honey solids, which are comprised predominantly of sugars, dextrins, minerals, diastase Appeal 2012-005402 Application 12/168,619 11 enzymes, and small amounts of lipids and proteins, and bees wax (see paragraph 21 of the specification). (App. Br. 9.) We are not persuaded. Again, we accord no patentable distinction to whether the material disclosed by Roman is “necessarily certified organic.” Nor have Appellants’ pointed to any evidence of record that Roman’s raw honey is functionally different from the claimed honey solids; that raw honey is “normally filtered;” or that filtering eliminates honey solids.7 Mere lawyer’s arguments and conclusory statements, unsupported by factual evidence, are entitled to little probative value. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997); In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Soy Lecithin Appellants’ Specification discloses the use of Certified Organic soy lecithin “to reduce the tackiness of the coating on the tablet cores.” (Spec. ¶ 25). Sue discloses a coating layer comprising “a sugar and at least one anti- tackiness agent.” (Sue ¶ 11.) Both Sue (id. ¶58) and Dalziel (Dalziel ¶¶ 74, 83) disclose lecithin as a coating ingredient. Dalziel also discloses the inclusion of soy protein (id. ¶ 83), further suggesting the use of soy lecithin in particular. Vegetable Glycerin Appellants’ Specification states that coating compositions may also include organic compliant vegetable glycerin as a plasticizer. (Spec. ¶ 24). The use of glycerin as a plasticizer is expressly taught in Sue paragraph 11. 7 Contrary to Appellants’ assertion, we note that a trade group, the “National Honey Board,” states that “While there is no official definition of “raw” honey, it generally means honey that has not been heated or filtered.” http://www.honey.com/faq/ (accessed August 25, 2014). Appeal 2012-005402 Application 12/168,619 12 Appellants have provided no evidence that glycerin derived from a vegetables is structurally or functionally different from glycerin derived from animal fat or chemically synthesized. Consequently we find that one of ordinary skill in the art would freely substitute one source for the other. Carrageenan Dalziel discloses the use of carrageenan in coatings at paragraphs 83 and 95. Appellants contend that the Examiner errs in citing Dalziel because the reference “does not teach a tablet with a coating” (App. Br. 8), but “is limited to coating particles that contain a polyunsaturated fatty acid or a liquid pharmaceutical material” (Reply Br. 3). We do not find this argument persuasive. In order for a reference to be proper for use in an obviousness rejection, it must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Analogous art need not be from the same field of endeavor as the claimed invention because “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). “Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” Bigio, 381 F.3d at 1325 (citations omitted). If Dalziel is analogous art, “any need or problem known in the field of endeavor at the time of the invention and addressed by Appeal 2012-005402 Application 12/168,619 13 [Appellant’s disclosure] can provide a reason for combining the elements in the manner claimed.” KSR, 550 U.S. at 420. We find that the cited references are analogous art under either test. First, Appellants’ invention, Dalziel is directed to coating compositions for pharmaceutical or nutritional supplements, albeit in particle form rather than larger tablets. As such, Dalziel is within the same general field of the invention. Second, we find that the coating of pharmaceuticals or nutritional supplements in particle form is reasonably pertinent to the coating of similar compositions in tablet format. Weight Percent We are mindful that claims 6-10, 12, 19, 20, and 27 recite express amounts of the various coating ingredients discussed above. Appellants have not, however, argued patentability on these bases. We, therefore, sustain the Examiner’s rejection under 35 U.S.C. §103(a) with respect to these elements. 37 C.F.R. § 41.37(c)(1)(vii). “[T]he Board [has] reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.” In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. July 22, 2011). DECISION The rejection of claims 1, 2, 4, 6, 7, 9, 11-13, 15, 20, 26, and 27 under 35 U.S.C. § 103(a) as unpatentable over Dalziel, Roman, and Vitamininformationpress (VIP) is affirmed. The rejection of claims 1-16, 19, 20, 26, and 27 as unpatentable under 35 U.S.C. § 103(a) in view of Sue, Dalziel, Roman, and VIP is affirmed. Appeal 2012-005402 Application 12/168,619 14 However, because our reasoning differs from that of the Examiner, we designate our affirmance a new ground of rejection under 37 C.F.R. § 41.50(b). TIME PERIOD FOR RESPONSE This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 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 the appellants, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground 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. . . . No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1). AFFIRMED; 37 C.F.R. § 41.50(b) sl Copy with citationCopy as parenthetical citation