Ex Parte Collins et alDownload PDFPatent Trial and Appeal BoardDec 28, 201613574100 (P.T.A.B. Dec. 28, 2016) Copy Citation United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 13/574,100 07/19/2012 Michael Collins 8963-00-OC 3327 23909 7590 12/30/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER ROBERTS, LEZAH ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 12/30/2016 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): Paten t_Mail @ colpal. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL COLLINS, LINH FRUGE, BARBARA HEPLER, and KIMDRA SMITH-WEBSTER1 Appeal 2015-006999 Application 13/574,100 Technology Center 1600 Before ULRIKE W. JENKS, RYAN H. FLAX, and RACHEL H. TOWNSEND, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to an oral care composition. The Examiner rejects the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellants, the Real Party in Interest is Colgate-Palmolive Company. (App. Br. 3.) Appeal 2015-006999 Application 13/574,100 STATEMENT OF THE CASE The Specification provides that “fluoride and anionic surfactants are beneficial when used topically in an oral care composition, there are situations in which exposure to fluoride and anionic surfactants is not desired. For example, exposure to high amounts of fluoride may lead to fluorosis” (Spec. 14). “[MJicro efficacy of a fluoride free and anionic surfactant free oral care composition are maintained at a high level by using a humectant system comprising glycerin, propylene glycol, and sorbitol. The micro efficacy of a composition is the ability of the composition to withstand growth of microorganisms” {id. at 113). “The adverse effects of exposure to fluoride or anionic surfactants are particularly pronounced in children” {id. at 14). Claims 1, 5—15, and 17 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 1 and 13 are representative of the claims on appeal, and read as follows: 1. An oral care composition comprising: from 15% to 35% by weight glycerin; from 17% to 45% by weight propylene glycol; from 15% to 35% by weight sorbitol; and from 0.05% to 0.4% by weight citric acid; wherein the composition is free of anionic surfactants and a fluoride ion source. 13. An oral Care composition comprising: from 20% to 24% by weight glycerin; about 25% by weight propylene glycol; about 23% by weight sorbitol; about 0.1 % by weight citric acid; and wherein the composition is free of anionic surfactants and a fluoride ion source. (App. Br. 15 and 16, Claims Appendix.) 2 Appeal 2015-006999 Application 13/574,100 Appellants request review of the Examiner’s rejection of claims 1 and 6—12 under 35 USC § 102(b) as anticipated by Ulloa2, and claims 5, 13—15, and 17 under 35 USC § 103(a) as obvious over Ulloa. Anticipation and/ or Obviousness over Ulloa The Examiner finds that Ulloa: disclose[s] liquid pharmaceutical compositions comprising a mixture of glycerin (20%), propylene glycol (35%), sorbitol (22.5%) and citric acid (.064%). The compositions comprise no anionic surfactant or fluoride (paragraph 0014). The compositions also comprise glycerin (15% +/- 10% variation), propylene glycol (20% +/- 20% variation), sorbitol (44.8% +/- 20% variation) and citric acid (.04% +/- 10% variation). (Ans. 2.) Appellants contend that Ulloa does not disclose an oral care composition as recited in the claims (App. Br. 6), does not disclose a composition with the requisite range of ingredients (id. at 8), and that they have shown unexpected results for the addition of 0.1 wt% citric acid (id. at 14). The issue is: Does the preponderance of evidence of record support the Examiner’s finding that Ulloa either discloses or renders obvious a composition comprising the claimed components in the requisite amounts? Findings of Fact FF1. The Specification defines an ‘“oral care composition’ [a]s a composition that is suitable for administration or application to a human or animal subject for treating or preventing a condition of the 2 Ulloa et al., US 2003/0216423 Al, published Nov. 20, 2003 (“Ulloa”). 3 Appeal 2015-006999 Application 13/574,100 oral cavity, or improving the hygiene and/or appearance of the subject” (Spec. 110). FF2. Ulloa teaches a pharmaceutical liquid composition comprising glycerine, propylene glycol, sorbitol, and citric acid in addition to other ingredients. Paragraph 14 of Ulloa provides a table, reproduced below, containing the list of the ingredients: fttgredteni. mg/m! Loretadme 0.50 Pseadoepkdfine Sulfeie 6.00 Glycerin 200,00 Propylene Glycol 350.00 Sorbitol 70% Solu&oa 225,00 Sod asm Saccharin 0,40 Peach Flavor No. 609 2,50 Citric Acid. As&ydrous 0,64 Sodium Citrate 0.02 Puj Hied Water q,s. To make 1.00 mi The table above provides a list of ingredients for one of the pharmaceutical compositions (Ulloa 114). FF3. The Examiner finds: that based on the density of sorbitol, glycerin and propylene glycol, the amounts of each component is 0.17 ml of sorbitol (density 1.29 g/ml), 0.16 ml of glycerin (density 1.26 g/ml) and 0.337 ml of propylene glycol (1.04 g/ml). Therefore to arrive at 1 ml, 0.333 ml of water must be added. This would lead to 1118 mg of total composition. Therefore the percentage of sorbitol is 20%, glycerin is 18%, and propylene glycol is 31 % falling into the ranges recited by the instant claims. These percentages are based on paragraph [0014], The percent variation may be± 20%. Therefore Ulloa does disclose the amounts recited by the instant claims. (Ans. 9) 4 Appeal 2015-006999 Application 13/574,100 FF4. Ulloa teaches another oral liquid pharmaceutical composition having the following list of ingredients: Name of Ingredients CoaceatratiOB mg/mi Rationale % Mtmrioa Loratadin© 0.66 tu Art Active Dci&XO* n y WTOw.B IOTC IiSeudoepherine Sulfate am) HUivv Active Citric Acid 0,40 Baiter *10 Olvvt'i in Propylese Glycol OUajU 200.00 Solvent Solvent *20 Saccharin Sodium 0.40 Sweetener *10 Sorbitol soSulkm ?Q% 44&00 Solvent *20 Flavor 2.50 Flavor *10 Purified Water To make 3,00 ml Solvent ±20 (Ulloa 124.) FF5. Ulloa teaches that the “non-sedating antihistamine and expectorant formulated into a delivery system, i.e., tablet, capsule, oral gel, powder for constitution or suspension in association with inactive ingredients” (Ulloa 173). FF6. Ulloa teaches that it is important to maintain the pH in the system. “Typically suitable buffer systems include those capable of maintaining a pH in the range of 2.5 to 5.0, preferably about 2.9 to 4.3, more preferably 3.3-4.3. Preferred buffer systems include citric acid/sodium citrate; and acetic acid/sodium acetate. Use of sodium citrate/citric acid as the buffer system is preferred” (Ulloa 145). Principle of Law A prior art reference need only describe a single embodiment within the scope of that claim. Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001) 5 Appeal 2015-006999 Application 13/574,100 (“When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art.”); Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985) (“It is also an elementary principle of patent law that when, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art.”). Analysis We have reviewed Appellants’ contentions that the Examiner erred in rejecting claims 1 and 6—12 as anticipated by Ulloa, and claims 5, 13—15, and 17 as obvious over Ulloa. (App. Br. 6—14; Reply Br. 2—9.) We do not find Appellants’ contentions persuasive and adopt the findings concerning the scope and content of the prior art set forth in the Examiner’s Answer, the Final Office Action dated May 22, 2014, and the Advisory Action dated August 25, 2014. For emphasis, we highlight and address the following: Anticipation by Ulloa Appellants contend that it is “apparent from Ulloa that the oral gels, like its disclosed liquids, capsules, tablets, powders, etc., are merely various modes of delivering its actives through the oral cavity - and in no way implicate their use to treat conditions of the oral cavity” (App. Br. 8). We begin with claim construction of the phrase “oral care composition,” giving the claims their broadest reasonable interpretation consistent with the Specification. In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). The Specification provides that oral care compositions are “suitable for administration or application to a human or animal subject” and 6 Appeal 2015-006999 Application 13/574,100 the suitability is for treating or preventing a condition of the oral cavity or improving the hygiene and/or appearance of the subject (FF1). This definition in no way limits how the composition must be applied to the human or animal subject. It could be applied to the oral cavity as argued by Appellants, but it also permits achieving the purpose by ingestion. Moreover, as pointed out by the Examiner “[t]he definition also states ‘or improving the hygiene and /or appearance of the subject’” (Ans. 12; see FF1). In other words, the definition does not even require that the administration treats or prevents a condition of the oral cavity. Therefore, the broadest reasonable interpretation in light of the Specification is that an “oral care composition” includes any substance regardless of route of administration so long as there is either an effect on the oral cavity or an improvement in the hygiene and/or appearance to the subject. In addition, the Examiner also points out the limitation of “oral care composition” merely identifies the intended use of the composition (see Ans. 5). A claim preamble does not further limit claims if it merely states a purpose or intended use of subject matter. Preamble language is given effect if it is “necessary to give life, meaning, and vitality to the claims.” Kropa v. Robie, 187 F.2d 150, 157 (CCPA 1951) (“Where the structure is completely defined independently of the preamble of the claim and can be constructed from the description given, the preamble does not constitute a limitation upon structure but merely states a purpose or intended use of the structure”). We agree with the Examiner’s position that the preamble in claim 1 does not further limit the claim because it is not necessary to give life to the body of the claim, which merely recites a combination of ingredients and excludes other ingredients that make up the composition. 7 Appeal 2015-006999 Application 13/574,100 “‘Comprising’ is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). Accordingly, the broadest reasonable interpretation of the limitation of an “oral care composition comprising” in light of the Specification can include additional components, so long as the listed components are present and may be ingested or otherwise applied to the oral cavity. Thus, to anticipate the claim the art needs to encompass the listed components: glycerin, propylene glycol, sorbitol, and citric acid in the requisite ranges as well as not include anionic surfactants and fluoride. Based on our claim interpretation above, we are not persuaded by Appellants’ contention that Ulloa’s compositions “in no way implicate their use to treat conditions of the oral cavity” (App. Br. 8). As noted above, the claim does not require treating a condition of the oral cavity. It can include improving the hygiene or appearance of the subject. We agree with the Examiner that “[t]he compositions of Ulloa would improve the hygiene of a subject by relieving their allergies.” (Ans. 12;FF1.) Moreover, Ulloa identifies that its liquid pharmaceutical composition is intended to address “symptoms [such as] . . . sneezing, itching runny nose, nasal congestion, redness of the eye, tearing, itching of the ears or palate, and productive and non-productive coughs,” several of which are focused on the oral cavity. Ulloa | 5. We find that the Examiner has identified that Ulloa discloses compositions that contain the listed ingredients and explains that the ingredients are within the requisite ranges claimed and that they not only improve the hygiene of the subject, but also have a treating effect on the oral 8 Appeal 2015-006999 Application 13/574,100 cavity because they can relieve itching of the palate (see FF2—FF4; see Ans. 2 and 8—9). Appellants contend that the Examiner has not met the burden of explaining the reasoning for a finding of anticipation (App. Br. 9). Arguing that the “calculation of the weight per ml of the components, it is still not possible to calculate the weight percentage (i.e., w/w, used in Applicants’ specification and claims) from these data without knowing the exact amount of water, or the density of the solution” (App. Br. 9). Appellants contend that the Examiner’s calculation assumes that the volumes of the sorbitol, glycerin propylene glycol solutions are additive, and there is no evidence that this is the case. Rather, it is well known that mixing of defined amounts of different liquids almost never results in a solution volume that is additive . . . adding equal volumes of water and ethyl alcohol will result in only 1.92 volumes of mixture. (Reply Br. 5). We are not persuaded. In making the rejection, the Examiner relies on the disclosure that each of the components can be adjusted up or down by 20 percent (FF4). In the Answer, the Examiner provided a calculation that converts the individually listed weights of the components from Ulloa’s composition (FF2) to the corresponding volume of the liquid for each component (FF3). As pointed out by Appellants in the Reply Brief, the Examiner then took these calculated volumes to estimate the amount of water that would be necessary to arrive at the total volume of one milliliter. The Examiner then proceeded to calculate the total weight of that solution and used that number to determine the percentage of each component. We acknowledge, but are not persuaded by, Appellants’ contention that a solution volume is not necessarily additive (see Reply Br. 5). Appellants’ 9 Appeal 2015-006999 Application 13/574,100 point is that a combination of a liquid when mixed in equal volume with water to produce a mixture, the volume of the resulting mixture may not necessarily be additive. Here, the water component in Ulloa’s compositions is a much smaller component of the total volume so that any error would also be smaller than seen with the ethanol water mixture highlighted by Appellants. Appellants do not provide any information with respect to the behavior of liquids, such as glycerol, sorbitol, and propylene glycol when mixed with water that are the subject of the claims and those disclosed in Ulloa. Regardless if there is some adjustment necessary due to differences in the solubility between liquids, the fact that each of these components can be present in a wide range, varying by ± 20%, shows that the disclosure of Ulloa overlaps the claimed composition (FF4). On the record before us, we conclude the Examiner did not err in rejecting claim 1 under 35 U.S.C. § 102(b) as anticipated by Ulloa. As claims 6—12 under 35 USC § 102(b) have not been argued separately, they fall together with claim 1 as acknowledged by Appellants. 37 C.F.R. § 41.37(c)(l)(iv). Obviousness over Ulloa Appellants contend that Ulloa is non analogous art. They contend, “[ijndeed, there can be no reasonable dispute that Ulloa’s antihistamine and nasal decongestion/expectorant containing pharmaceutical compositions are not in the same field of endeavor as oral care compositions such as dentifrice” (App. Br. 10—11). We begin with claim interpretation of claim 13, as discussed above (see Anticipation), the “oral care composition” is reasonably interpreted by 10 Appeal 2015-006999 Application 13/574,100 the Examiner as an intended use recitation and merely identifies the application of the composition (see Ans. 11). See Kropa v. Robie, 187 F.2d at 157. We agree with the Examiner that the claim body is complete, and that the preamble language of “oral care composition” in claim 13 does not further limit the claim. Claim 13 contains the same components as recited in claim 1 and also requires that the composition is “free of anionic surfactants and a fluoride ion source.” The notable difference between the claims is that claim 13 narrows the range of glycerin in the composition, and recites the other components as single percentage values. We are not persuaded by Appellants’ contention that Ulloa is not analogous art. We agree with the Examiner that “Appellant’s definition of oral care compositions,. . . [encompasses] compositions [that] should be able to improve the hygiene of a subject. The compositions of Ulloa are suitable oral care compositions because they improve the hygiene of a subject” (Ans. 10; see FF1). As such, anything that improves oral health and/or hygiene would be considered a suitable oral care composition, treating allergies by administering an antihistamine would reasonably meet this limitation as discussed above. However, more importantly “[t]he Examiner submits that although Ulloa does not address the same problems, it comprises the same components. Appellant is arguing intended use” (Ans. 11). We agree with the Examiner that arguments with respect to intended use of the composition are not persuasive for the determination whether a reference is analogous art. Here, the claims are reasonably interpreted to comprise a composition, thus, any art that discloses similar compositions containing the same ingredients are reasonably pertinent art. “[T]he patentability of. . . composition claims depends on the claimed structure, not 11 Appeal 2015-006999 Application 13/574,100 on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). We also do not agree with Appellants’ contention that the Examiner disregarded the definition of oral care composition (App. Br 12). Here, the Examiner has explained that the limitation is an intended use limitation and as such is not necessary for the evaluation of the composition claim, but even if it were, the Ulloa composition meets the limitation, as discussed above. Appellants contend that “the Examiner has not established why one of ordinary skill in the art would have had a reasonable expectation of success in applying Ulloa to another field of endeavor” (App. Br. 13). “Optimizing the excipients and ranges in Ulloa to solve a problem not remotely addressed by Ulloa would not be obvious based on Ulloa” (id. at 14). We are not persuaded by Appellants’ contention that there is no reasonable expectation of success in applying Ulloa’s composition as an oral composition. As an initial matter, as discussed above we do not agree with Appellants’ contention that Ulloa’s subject matter is from a different field of endeavor. Even if the term “oral care composition” were interpreted to require treatment of the oral cavity, as the Examiner has demonstrated Ulloa’s composition is intended to achieve that result in that the application alleviates itching of the palate. The Examiner also finds that “[tjhese active ingredients may be used in oral care compositions. Further the amounts in the example are within the ranges recited by the instant claims. It is also noted that the compositions of Ulloa do not comprise anionic surfactants or fluorides” (Ans. 14). We agree with the Examiner’s position that there is no reason that Ulloa’s composition cannot be used as an “oral care composition,” i.e. one that has an effect on the oral cavity besides improving 12 Appeal 2015-006999 Application 13/574,100 the hygiene and/or appearance of the subject. Accordingly, we are not persuaded that Ulloa’s dosage forms are not effective for application as an “oral care composition” as claimed. With respect to optimizing Ulloa’s excipients to fall within the range as claimed, we agree with the Examiner’s position that there would have been a reasonable expectation of success that the compositions of Ulloa would be an oral care compositions and solve the problem of how to prepare an oral care composition free of anionic surfactants and fluoride because the compositions are pharmaceutical carriers with active ingredients. These active ingredients may be used in oral care compositions. Further the amounts in the example are within the ranges recited by the instant claims. It is also noted that the compositions of Ulloa do not comprise anionic surfactants or fluorides. Therefore the compositions of Ulloa may be used as oral care compositions. Further the amounts in recited by the instant claims are encompassed by the ranges disclosed by Ulloa. Therefore it would have been obvious to adjust the amounts of Ulloa because these are amounts suggested by Ulloa. (Ans. 14—15). We agree with the Examiner that it would have been obvious to adjust the amounts of the components in Ulloa’s composition because the reference discloses that a particular pH of the system is desired (FF6). We agree with the Examiner that Ulloa teaches adjusting any one of these components so long as the pH stays within the desired range and thereby Ulloa’s teaching provides a reasonable expectation of success in making adjustments to the components. Appellants contend that there are unexpected results for their oral care compositions (App. Br. 14). Appellants direct us to the Specification as showing unexpected results. The Specification shows the oral care 13 Appeal 2015-006999 Application 13/574,100 composition as claimed is able to kill a mixture of bacteria over time (Spec. 14) . “This test measures the rate of kill over time and the total kill over 24 hours. Results are calculated as Normalized Area Under the Curve (NAUC)” (Spec. 14). Appellants contend that the unexpected result lie with the observation that the “[t]he addition of citric acid [to Formula 4] unexpectedly raised the NAUC value from 61.31 to 133.31, more than doubling its value” (Spec. 134; App. Br. 14; Reply Br. 8—9). Formula 2 and Formula 4 are the same with the exception that formula 2 contains 0.1 wt% citric acid (Spec. 134). With regard to the unexpected results, we are not persuaded by Appellants contentions for the reasons set out by the Examiner (see Ans. 15) . The comparison in the Specification is comparing a composition containing citric acid and composition that does not contain citric acid. This is not a comparison with the closest prior art, Ulloa, which teaches compositions containing citric acid that overlap the claimed range. In other words, Appellants have not shown criticality with respect to the 0.1 wt% citric acid claimed. Ulloa teaches compositions comprising glycerin, sorbitol, propylene glycol, and citric acid among other ingredients and additionally teaches that these ingredients can vary within 20% for the glycerin, sorbitol, and propylene glycol components and within 10% for the citric acid component taught by Ulloa (FF4). What is missing form Appellants’ unexpected results is a showing that the concentration of the 0.1 wt% citric acid is critical for the ability of the composition to control bacterial growth. . 14 Appeal 2015-006999 Application 13/574,100 Appellants do not argue the claims separately, we focus our analysis on claim 13, and claims 5, 14, 15, and 17 stand or fall with that claim. 37 C.F.R. §41.37 (c)(l)(iv). SUMMARY We affirm the rejection of claims 1 and 6—12 under 35 USC § 102(b) as anticipated by Ulloa We affirm the rejection of claims 5, 13—15, and 17 under 35 USC § 103(1) as obvious over Ulloa. 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 15 Copy with citationCopy as parenthetical citation