Ex Parte Fei et alDownload PDFPatent Trial and Appeal BoardAug 11, 201613575671 (P.T.A.B. Aug. 11, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/575,671 07/27/2012 23909 7590 08/15/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 FIRST NAMED INVENTOR LinFei 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 8521-00-0C 4856 EXAMINER LIU, TRACY ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 08/15/2016 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): Patent_Mail@colpal.com uspto@thebellesgroup.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LIN PEI, RA VI SUBRAMANY AM, and GUOFENG XU Appeal2015-003320 Application 13/575,671 Technology Center 1600 Before DEMETRA J. MILLS, RICHARD J. SMITH, and RACHEL H. TOWNSEND, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal2015-003320 Application 13/575,671 STATEMENT OF CASE The following claims are representative. 1. An oral composition comprising: from about 0.05 to about 7% by weight propylene glycol; from about 0.05 to about 5% by weight of at least one or more active ingredients found in magnolia extract or a synthetic analogue thereof, selected from: 5,5'-di-n-butyl-biphenyl-2,2'- diol, isopropyl magnolol, isobutyl magnolol; and an orally acceptable carrier; wherein the amount of the propylene glycol in the composition is sufficient to enhance the solubility of the active ingredient therein. 8. The oral composition of claim 1, wherein at least one of the one or more active ingredients is 5,5'-di-n-butyl-biphenyl-2,2'-diol. Cited References Xu et al. Subramanyam et al. Zhu et al. Grounds of Rejection US 2006/0127329 Al June 15, 2006 ("Xu") US 2006/0140880 Al June 29, 2006 WO 01/82922 Al November 8, 2001 ("Zhu") 1. Claims 1-14 are rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Xu. 2. Claim 8 is rejected under pre-AIA 35 U.S.C. § 103(a) as being unpatentable over Xu in view of Subramanyam. 3. Claims 1-3 and 8-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 11 of copending Application No. 13/577621 in view of Zhu. 2 Appeal2015-003320 Application 13/575,671 FINDINGS OF FACT The Examiner's findings of fact are set forth in the Answer at pages 2-10. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). "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'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Where ... the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. ... Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). "From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing." In re Papesch, 315 F.2d 381, 391(CCPA1963). Applicants can rebut a prima facie case of obviousness based on overlapping ranges by showing the criticality of the claimed range. "The law is replete with cases in which the difference between the claimed invention 3 Appeal2015-003320 Application 13/575,671 and the prior art is some range or other variable within the claims .... In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990). Rejection 1 We agree with the Examiner's fact finding, statement of the rejection and responses to Appellants' arguments as set forth in the Answer. We find that the Examiner has provided evidence to support a prima facie case of obviousness. Appellants do not argue individual claims separately. We select claims 1 and 8 as representative claims. We provide the following additional comment to the Examiner's argument set forth in the Final Rejection and Answer. i\.ppellants contend that Xu does not teach or suggest 5,5'-di-n-butyl-biphenyl-2,2'diol, isopropyl magnolol and isobutyl magnolol as active ingredients. Specifically, claims 1 and 11 require that the one or more active ingredients found in magnolia extract, or a synthetic analogue thereof, are selected from 5,5'-di-n-butyl-biphenyl-2,2'diol, isopropyl magnolol and isobutyl magnolol. Further, since Xu does not teach or suggest the presence of polypropylene glycol in an amount that would enhance the solubility of the active ingredient, the claimed invention is distinguished from Xu. Xu merely suggests polypropylene glycol as a humectant. Br. 3. We are not persuaded. We agree with the Examiner that that given the teachings of Xu, one of ordinary skill in the art would have had little to no difficulty in in [sic] arriving at a composition comprising isobutyl magnolol, isopropyl magnolol 4 Appeal2015-003320 Application 13/575,671 and 5,5'-di-n-butylbiphenyl-2,2'-diol. Xu disclosed a composition comprising at least one active compound found in an extract of magnolia. Extract of magnolia is an extract from dried cortex, or bark, of a plant from the Magnoliaceae family. The active compound may be a synthetic or semi-synthetic equivalent of such an extract or an active component thereof (ii [00014 ]). In one embodiment, the magnolia extract is isolated by supercritical fluid extraction (SFE) using carbon dioxide (C02) (ii [00016]). The instant specification disclosed wherein 5,5'-di-n-butyl-biphenyl-2,2'-diol is an active ingredient found in magnolia extract and isopropyl magnolol and isobutyl magnolol are synthetic analogue of an active compound of magnolia extract (ii [0001 OJ). "Extract of magnolia" denotes an extract from dried cortex, or bark, of a plant from the Magnoliaceae family (ii [00018] of instant specification). The instant specification also disclosed wherein the magnolia extract is isolated by supercritical fluid extraction (SFE) using carbon dioxide (C02) (ii [00022]). Because Xu disclosed the same extract of magnolia and the same extraction process for that extract of magnolia as what is disclosed in the instant specification and wherein the active compound may be a synthetic equivalent of such extract or an active component thereof, the at least one active compound found in an extract of magnolia of Xu would also inherently include 5,5'-di-n-butyl- biphenyl-2,2'-diol, isopropyl magnolol and isobutyl magnolol. Ans. 3--4. Appellants have not shown that magnolia cortex extract of Xu obtained by supercritical fluid extraction (SFE) using carbon dioxide ( C02}-the same process by which Appellants' specification indicates the claimed active ingredients may be obtained---does not inherently include the claimed 5,5'-di-n-butyl-biphenyl-2,2'-diol. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Compare, Spec. ii 18-22. Appellants argue that Xu does not teach or suggest the presence of a polypropylene glycol in an amount that would enhance the solubility of the 5 Appeal2015-003320 Application 13/575,671 active ingredient. Xu merely suggests polypropylene glycol as a humectant. Appellants argue that the data [comparative Examples] provided by the instant patent application, at Example 5 (for magnolia extract), Example 6 (for magnolol) and Example 7 (for butyl magnolol) confirms that the claimed ranges represent a critical range of propylene glycol concentrations not taught or suggested by Xu for achieving a fully solubilized oral composition - where the appearance of a clear composition confirms that the components of the composition are fully solubilized. Br. 6. We are not persuaded. The Appellants motivation for combining the cited references does not have to be the same as that of the Examiner, and vice versa. The law does not require that the teachings of the reference be combined for the reason or advantage contemplated by the inventor, as long as some suggestion to combine the elements is provided by the prior art as a whole. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPi\. 1976). \Ve agree \vith the Examiner that Xu teaches that propylene glycol may be present from about 5 to about 40% by weight overlapping with the claimed amount of propylene glycol in an amount of from about 0.05 to about 7% by weight. Ans. 4. Appellants have not established the criticality of the claimed propylene glycol amounts. We are not convinced by Appellants' data or comparative examples in the Specification for the reasons given by the Examiner in the Answer, as reproduced below. The Examiner disagrees that the data provided in the instant specification confirms that the claimed ranges represent a critical range of propylene glycol concentrations. Examples 5-7 in the instant specification demonstrate the effect of propylene glycol on the 6 Appeal2015-003320 Application 13/575,671 solubility of magnolia extract, magnolol and butyl magnolol, respectively. None of the examples in the instant specification show the effect of propylene glycol on the solubility of the active ingredients recited in the instant claims. Also, Appellant claims from about 0.05 to about 7% by weight propylene glycol. Example 6 (Table 6) discloses wherein 5.28% propylene glycol has phase separation, while 8.18% propylene glycol is homogenous. Therefore, it appears that 8.18% propylene glycol, which is outside of the claimed range, is better than 5.28%, which is within the claimed range, at solubilizing the active ingredient. Example 7 (Table 7) discloses wherein 0%, 1.46% and 3.34% propylene glycol leads to a very cloudy or cloudy formulation, while 7% propylene glycol leads to a clear and transparent formulation. Therefore, it appears that 7% propylene glycol, which is outside of the claimed range, is better than 1.46% and 3.34% propylene glycol, which is within the claimed range, at solubilizing the active ingredient. Example 8 (Table 8) discloses wherein 1.46%, 3.35%, and 6.97% propylene glycol leads to a clear and transparent formulation. Therefore, it appears that the amount of propylene glycol does not affect the solubility of the active ingredient since 1 .46% and ~3.35% propylene glycol can lead to a cloudy or clear formulation. This is further evidenced by paragraph [00010] of the instant specification disclosing \~1herein the composition does not need to comprise propylene glycol. Ans. 6-7. Rejection 1 is affirmed for the reasons of record. Rejection 2- obviousness Appellants raise the same argument concerning the lack of disclosure of a 5,5'-dibutyl-2,2'dihydroxyl-1, 1 'biphenyl compound in Xu. For the reasons indicated with respect to this argument in rejection 1, we are not persuaded. Furthermore, Subramanyam discloses the use of 5,5'-dibutyl-2,2'- dihydroxy-l, 1 '-biphenyl compound from Magnolia officinalis, as an 7 Appeal2015-003320 Application 13/575,671 antibacterial and antiinflammatory ingredient of an oral composition. i-fi-1 5- 8. Rejection 2 is affirmed for the reasons of record. Rejection 3- Obviousness-type Double Patenting Appellants do not argue the merits of this rejection, therefore it is summarily affirmed. CONCLUSION OF LAW The cited references support the Examiner's obviousness rejections, and obviousness-type double patenting rejections, which are affirmed. All pending, rejected claims fall. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). 8 Copy with citationCopy as parenthetical citation