Ex Parte RauDownload PDFPatent Trial and Appeal BoardApr 21, 201511234312 (P.T.A.B. Apr. 21, 2015) 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. 11/234,312 09/26/2005 Allen H. Rau PHYZ-0011-UT1 1054 80308 7590 04/22/2015 Steven B. Kelber Law Offices of Marc R. Labgold, P.C. 12007 Sunrise Valley Drive Suite 110 Reston, VA 20191 EXAMINER LOVE, TREVOR M ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 04/22/2015 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 ALLEN H. RAU __________ Appeal 2013-000004 Application 11/234,312 Technology Center 1600 __________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and ROBERT A. POLLOCK, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a composition comprising an effervescent combination of citric acid and sodium bicarbonate dissolved in water. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant identifies the Real Party in Interest as Tower Laboratories, Ltd. (see App. Br. 2). Appeal 2013-000004 Application 11/234,312 Statement of the Case Background “This application relates generally to oral care products and, in particular, to effervescent oral care compositions that include an effervescent acid and a carbonate salt and to the use of these compositions” (Spec. 1, ll. 11–13). The Claims Claims 1, 2, 8, and 10–17 are on appeal. Appellant does not separately argue dependent claims 2, 8, and 10–17. Therefore, these claims fall with claim 1. 37 C.F.R. § 41.37(c)(1). Independent claim 1 reads as follows: 1. A composition comprising an effervescent combination of citric acid and sodium bicarbonate dissolved in water, wherein the composition has an osmolality of 310 mOsm/kg of water or less. The issue The Examiner rejected claims 1, 2, 8, and 10–17 under 35 U.S.C. § 103(a) as obvious over Ammon,2 Sack,3 Alka-Seltzer Gold,4 and Rudnic5 (Ans. 3–6). 2 Ammon, Jr., et al., US 2004/0204496 A1, published Oct. 14, 2004. 3 Sack, D., US 5,741,680, issued Apr. 21, 1998. 4 Alka-Seltzer Gold, http://www.alka-seltzer.com/as/as_gold.html (accessed 4/20/2010). 5 Rudnic, E. and Schwartz, J., Oral Solid Dosage Forms, in Remington’s Pharmaceutical Sciences 1633–1665 (Alfonso R. Gennaro Ed. 1990). 2 Appeal 2013-000004 Application 11/234,312 The Examiner finds that “Ammon teaches a disinfecting solution . . . Said composition has a pH 4-9, and preferably 6-8 and an osmolality of preferably 175 to 320 mOsm/kg” (Ans. 3). The Examiner finds that “Ammon further teaches that suitable buffers for the composition include citric acid and sodium bicarbonate and combinations thereof” (Ans. 3). The Examiner finds that “Ammon, while teaching that sodium bicarbonate and citric acid can be present as buffers, fails to directly exemplify their use in combination” (Ans. 4). The Examiner finds that Sack teaches “that Alka-Seltzer is a commercially known buffering agent for oral compositions which comprises sodium bicarbonate, citric acid, and potassium bicarbonate” (Ans. 4). The Examiner finds the claims obvious because “Ammon teaches that the composition of Ammon is useful for oral delivery (see [0078])], wherein the buffer can comprise citric acid and sodium bicarbonate (see [0019]), wherein Sack identifies that Alka-Seltzer is a known oral buffering agent which comprises said citric acid and sodium bicarbonate” (Ans. 4). The Examiner notes that “[w]ith regard to the limitation that the composition has an osmolality of 310 or less, . . . Ammon teaches that the osmolality is most preferably 175-320 mOsm/kg” (Ans. 5). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Ammon, Sack, Alka-Seltzer Gold and Rudnic render the claims prima facie obvious? Findings of Fact 1. Ammon teaches “solutions effective for rapidly disinfecting bacterial endospore laden surfaces, air and/or water comprising bacterial 3 Appeal 2013-000004 Application 11/234,312 endosporicidally effective amounts of a biguanide or water-soluble salts thereof” (Ammon 1 ¶ 8). 2. Ammon teaches that the “pH of the subject solutions can range between 4.0 to 9.0 . . . . As mentioned above, one or more buffers may be employed to obtain the desired pH value” (Ammon 2 ¶ 19). 3. Ammon teaches that the “the subject solutions may include a ‘mixed buffer’ of tromethamine [TRIS] and one or more other buffer agents” (Ammon 2 ¶ 19). 4. Ammon teaches that: Other suitable buffers include for example but are not limited to borate buffers such as but not limited to boric acid, potassium tetraborate, potassium metaborate, sodium borate and mixtures thereof, phosphate buffers such as but not limited to Na2HPO4, NaH2PO4 , KH2PO4 and mixtures thereof, citrate buffers such as for example but not limited to sodium citrate, potassium citrate, citric acid and mixtures thereof, sodium bicarbonate, amino alcohol buffers and combinations thereof. (Ammon 2 ¶ 19; emphasis added). Ammon claims a disinfecting solution “wherein said solution includes one or more buffers selected from the group consisting of tromethamine, borate buffers, phosphate buffers, citrate buffers, Tris (hydroxymethyl)aminomethane, sodium bicarbonate and amino alcohol buffers” (Ammon 11, claim 15; emphasis added). 5. Ammon teaches that “[o]ne or more buffers are preferably added to solutions of the present invention in amounts ranging between approximately 0.01 to 2.0 weight percent by volume” (Ammon 2 ¶ 19). 4 Appeal 2013-000004 Application 11/234,312 6. Table I of Ammon is reproduced, in part, below: Table I shows four solutions, solutions 34, 35, 36, and 37, that include two buffering agents, either the combination of Na Borate (0.018%) and Boric acid (0.12%) or Na Phos. (m) (0.08%) and Na Phos. (di) (0.39%), but do not include a Tris buffering agent. 7. Ammon teaches that: Solutions of the present invention may be designed for a variety of osmolalities. Preferably, solutions in accordance with the present invention have an osmotic value of less than about 350 mOsm/kg, more preferably from about 175 to about 330 mOsmlkg, and most preferably from about 175 to about 320 mOsm/Kg. One or more osmolality adjusting agents may be employed in the subject solutions to obtain the desired final osmolality. (Ammon 2 ¶ 20). 8. Ammon teaches “examples of pharmaceutically acceptable forms of the subject solutions include . . . oral . . . or in any other form effective to deliver active components of the present invention to a site of microorganism infection” (Ammon 10 ¶ 78). 9. Sack teaches “a commercially available buffer (STANDARD BUFFER) Alka-Seltzer (registered Trademark)” (Sack, col. 6, ll. 39–41). 5 Appeal 2013-000004 Application 11/234,312 10. Alka-Seltzer Gold teaches that the active ingredients are effervescent and comprise anhydrous citric acid, potassium bicarbonate and sodium bicarbonate (Alka-Seltzer Gold). Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. “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) Analysis Ammon teaches disinfecting compositions (FF 1) that may be orally administered (FF 8). Ammon teaches that the compositions “have an osmotic value of less than about 350 mOsm/kg . . . most preferably from about 175 to about 320 mOsm/Kg” (FF 7), substantially overlapping the range recited in claim 1 “wherein the composition has an osmolality of 310 mOsm/kg of water or less.” Peterson, 315 F.3d at 1329. Ammon teaches a pH range of 4 to 9 and that “one or more buffers may be employed to obtain the desired pH value” (Ammon 2 ¶ 19; FF 2). Ammon teaches the use of a variety of buffers including citric acid and sodium bicarbonate and “combinations thereof” (FF 4), specifically teaching mixed buffers (FF 3). While many of Ammon’s exemplary compositions include mixed buffers with TRIS as one of the buffer constituents (FF 3), 6 Appeal 2013-000004 Application 11/234,312 Ammon does not require the use of TRIS in mixed buffers. Ammon specifically teaches four exemplary compositions, solutions 34–37, that do not include TRIS. Solutions 34 and 35 teach the combination of Na Borate and boric acid as the mixed buffers in combination (FF 4, 6). Solutions 36 and 37 teach the combination of Na2HPO4 and NaH2PO4 as the mixed buffers in combination (FF 4, 6). Sacks evidences that the combination of sodium bicarbonate and citric acid found in Alka-Seltzer is “a commercially available buffer” (FF 9) and Alka-Seltzer Gold confirms that the combination of sodium bicarbonate and citric acid is effervescent, as required by claim 1 (FF 10). Under these circumstances, we agree with the Examiner that it is fair to say that there were “a finite number of identified, predictable solutions” to the problem of finding physiological buffering agents for the biguanide solution of Ammon, and that the combination of sodium bicarbonate and citric acid as the buffer combination chosen was “the product not of innovation but of ordinary skill and common sense.” KSR, 550 U.S. at 421. That Ammon “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). We note that Appellant provides no evidence of any secondary consideration such as unexpected results. This result is consistent with the Wrigley, where the Federal Circuit found a “strong case of obviousness based on the prior art references of record. [The claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to 7 Appeal 2013-000004 Application 11/234,312 substitute one well-known . . . agent for another.” Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). The instant case is also factually similar to Wrigley. In Wrigley there was a single reference which taught a number of different cooling agent combinations as well as additional prior art teaching that the specific combination of cooling agents was also known. Id. at 1361, 1364. The Examiner’s rejection tracks this fact pattern, with Ammon suggesting a number of different buffers which may be used in combination (FF 2–6), Sacks teaching that the specific combination of sodium bicarbonate and citric acid was well known as Alka-Seltzer, a commercially available buffer (FF 9) and Alka-Seltzer Gold further establishing the effervescent nature of the buffer combination (FF 10). For these reasons, we adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 5–8; FF 1– 10) and agree that the claims are rendered obvious by Ammon, Sack, and Alka-Seltzer Gold. We address Appellant’s arguments below. Appellant contends that “Ammon is simply not directed to, or even close to, an oral care composition” (App. Br. 9). We find this argument unpersuasive because Ammon specifically teaches that “examples of pharmaceutically acceptable forms of the subject solutions include . . . oral . . . or in any other form effective to deliver active components of the present invention to a site of microorganism infection” (Ammon Jr. 10 ¶ 78; FF 8). In light of Ammon’s express teaching that the composition may be delivered orally, we find Appellant’s arguments, lacking supporting evidence, insufficient to rebut the express teaching of 8 Appeal 2013-000004 Application 11/234,312 Ammon. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“[A]ttorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness”). Appellant contends that “Sack suggests as a buffer a carbohydrate rich (high osmolality) buffer coupled with an electrolyte” (App. Br. 10). Appellant contends that “Rau specifically notes that one of skill in the art, using or starting with Alka-Seltzer Gold as a buffer, could not prepare a solution having an osmolality of 310 mOsm/kg or less, even if motivated to do so” (App. Br. 11). Appellant contends that “modifying Ammon to include Alka-Seltzer Gold as a buffer will give a solution of even higher osmolality, because at a minimum that solution must include the biguanide that is the central and essential ingredient of Ammon” (App. Br. 11). We find these arguments unpersuasive. Ammon specifically teaches that the osmolality of the solution is preferably within the range of 175 to 320 mOsm/Kg (FF 7). Ammon teaches, consistent with the knowledge of the ordinary artisan, that “[s]olutions of the present invention may be designed for a variety of osmolalities” (Ammon 2 ¶ 20; FF 7). The Examiner also points out that the Rau Declaration6 teaches that the ordinary artisan would minimally have an “undergraduate degree from a major University in chemistry or a similar discipline, and have experience in the measurement of osmolality. They would further be able to prepare solutions as directed, and consider the osmolality of various solutions so prepared.” (Rau Dec. 3 ¶ 5). 6 Declaration of Allen Rau, filed November 3, 2011. 9 Appeal 2013-000004 Application 11/234,312 Therefore, the evidence of record supports the Examiner’s position that the ordinary artisan, informed by Ammon that the desirable osmolality of the solution is within the range of 175 to 320 mOsm/Kg, would have been able to select amounts of buffers such as the combination of sodium bicarbonate and citric acid taught by Sack and Alka-Seltzer Gold, which when combined with biguanide and other desired components would have routinely modified to resulte in the desired osmolality. Ammon exemplifies solutions with osmolalities in the desired (and instantly claimed) range as shown by solutions 30 to 37 which have osmolalities ranging from 190 to 227 mOsm/kg (FF 6), well within the range required by claim 1. Indeed, the highest osmolality in the 50 solutions exemplified by Ammon was 234 mOsm/kg for solution 17 (see Ammon, table 1), which is also below the upper limit of 310 mOsm/kg specified in claim 1. Appellant contends that “there is no way to modify [Alka-Seltzer Gold] to arrive at Appellant’s claims. If one begins with Alka-Seltzer Gold - what can one add to it to reduce the osmolality? Nothing!” (App. Br. 12). Appellant contends that “one of skill in the art has nowhere to begin. The art assembled by the Examiner teaches a minimum osmolality of more than 310 mOsm/kg. Much more. There is no teaching in the art how to reduce that value and maintain a functional solution” (App. Br. 13). “‘Alka-Seltzer Gold®’ as relied upon by the Examiner . . . contains its own teaching away from dilution. This reference is specific - dissolve two tablets in four ounces of water. . . . there simply is no teaching anywhere to alter that value, to dilute the buffer, and doing so would run counter to common sense” (Reply Br. 3). 10 Appeal 2013-000004 Application 11/234,312 We are not persuaded. As we have already discussed above, modifying osmolality is within the skill level of the ordinary undergraduate chemistry student (see Rau Dec. 3 ¶ 5), who would know precisely where to begin such a modification, whether by dilution as discussed by the Examiner (Ans. 8) or ab initio by adding different amounts of the buffers to the composition as shown by Ammon (FF 6). Ammon teaches the addition of different amounts of buffers into solutions, exemplifying the use of 0.25 % TRIS in solutions 30 and 31, 0.14 % TRIS and 0.22 % Na Borate in solutions 32 and 33, 0.018% Na Borate and 0.12% Boric acid in solutions 34 and 35, and 0.08 % Na Phos. (m) and 0.39 % Na Phos. (di) in solutions 36 and 37, while maintaining the osmolality in a narrow range between 190 and 227 mOsm/kg (FF 6). We agree with the Examiner that there “would be a reasonable expectation of success since Ammon and Sack are both teaching the components as buffers, and further, wherein Ammon teaches that the buffer can comprise citric acid and sodium bicarbonate, which Sack identifies are the two primary ingredients of Alka-Seltzer” (Ans. 4). Conclusion of Law The evidence of record supports the Examiner’s conclusion that Ammon, Sack, Alka-Seltzer Gold and Rudnic render the claims prima facie obvious. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Ammon, Sack, Alka-Seltzer Gold, and Rudnic. 11 Appeal 2013-000004 Application 11/234,312 Pursuant to 37 C.F.R. § 41.37(c), claims 2, 8, and 10–17 fall with claim 1, as these claims were not argued separately. 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 tc 12 Copy with citationCopy as parenthetical citation