Ex Parte Shastry et alDownload PDFPatent Trial and Appeal BoardDec 11, 201711285871 (P.T.A.B. Dec. 11, 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. 11/285,871 11/23/2005 Ramachandra Shastry 7334-OO-US-Ol-OC 8826 23909 7590 12/18/2017 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 EXAMINER PACKARD, BENJAMIN J ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 12/18/2017 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 RAMACHANDRA SHASTRY, YELLOJI RAO MIRAJKAR, NAGARAJ DIXIT, RYAN CAMERON, QIN WANG, LYNETTE ZAIDEL, SUMAN K. CHOPRA, MICHAEL PRENCIPE Appeal 2017-003614 Application 11/285,8711 Technology Center 1600 Before DEMETRA J. MILLS, LORA M. GREEN, and ROBERT A. POLLOCK, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 The real party in interest is the Assignee, Colgate-Palmolive Company. App. Br. 2 Appeal 2017-003614 Application 11/285,871 STATEMENT OF CASE The claimed invention is directed to an oral care composition. The following claim is representative. 1. An oral care composition, comprising: (a) a peroxide composite comprising a peroxide compound and a porous cross-linked polymer forming a polymeric matrix in which the peroxide compound is sorbed, at a level of from 70% to 90% by weight of the peroxide compound to the crosslinked polymer, wherein the porous cross-linked polymer comprises a polymerized polyunsaturated monomer selected from the group consisting of polyacrylates, polymethacrylates, polyitaconates, and mixtures thereof, and wherein the peroxide composite is present in the composition in an amount of from 10% to 25% by weight of the oral care composition; and wherein the peroxide compound comprises hydrogen peroxide, urea peroxide, sodium percarbonate or a mixture of two or more thereof; and (b) an orally acceptable carrier, wherein the composition has a product form selected from the group consisting of a dentifrice, a rinse, a powder, a gel, a confectionary and a paint. Grounds of Rejection Claims 1, 3—7, 9-18 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Kuo (US 2003/0211440 Al; published Nov. 13, 2003) and Sojka (WO 00/41528; published July 20, 2000), as evidenced by Advanced Polymer Systems (Advanced Polymer Systems Asset Purchase Agreement, TechAgreements, http://www.techagreements.com/ agreement- preview. aspx?.num=41769 (1 of 11) (last visited 5/29/2008), Won (US 5,145,675; issued Sep. 8, 1992), and Piechota (US 4,582,701; issued Apr. 15, 1986). Final Act. 2. 2 Appeal 2017-003614 Application 11/285,871 FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Final Action at pages 2—10. The following facts are highlighted. 1. Kuo discloses an oral delivery composition for delivery of an agent to the oral environment. The agent may be a bleaching agent such as carbamide peroxide. Kuo 10, 11, 20. 2. In Kuo, the agent may be encapsulated or entrapped by a number of materials, including polyacrylic acids. Id. f 68. 3. In Kuo, the encapsulating material may be an ion exchange resin having a very high surface area and able to absorb a large quantity of agent. An exemplary resin is sold under the name of MICROSPONGE (Advanced Polymer Systems) as described in U.S. Pat. No. 5,145,675. Id. flO. 4. Kuo incorporates a bleaching material, such as 18—37% carbamide peroxide, which may be delivered to the oral environment in a resin material or a gel. Id. 120. The bleaching agent itself may be absorbed into the pores of the resin material, or the agent may be suspended in a carrier which is absorbed into the pores of the resin material. Id. 127. 5. Sojka teaches compositions comprising an adsorbent polymer, an active agent, and a release retardant which has improved ability to release active agent over an extended period of time. Sojka Abstract, page 1, lines 15—22, page 4, lines 8—10. Thus, the problem of premature release of an active agent from controlled release compositions is overcome (page 4, lines 8—10). 3 Appeal 2017-003614 Application 11/285,871 6. The adsorbent polymer microparticles of Sojka are highly porous in the form of spheres about 1—300 microns (id. at page 8, lines 27—33). The active agent is absorbed onto the adsorbent polymer (page 4, lines 21—26). 7. Sojka teaches that topically active agents such as antibacterial compounds are useful in the composition (page 16, line 33, page 17, lines 1—6). The amount of adsorbent polymer present in a controlled release composition is related to the amount of active agent in the composition. Page 16,11. 10-23. The amount of active agent required to perform its intended function is determined, then the amount of adsorbent polymer is determined based on considerations such as the identity of the adsorbent polymer and active agent, and the ability of the active agent to absorb the active agent. (Page 14, 1. 39—15, 1, 4.) Such a determination is easily performed by persons skilled in the art (page 14, line 29-page 15, line 6 and page 16, lines 18—23), i.e. the amount of device incorporated into a composition can be optimized by persons skilled in the art. 8. In Sojka, the microparticles are made by a suspension polymerization process of two polyunsaturated monomers, ethylene glycol dimethylacrylate and allyl methacrylate (page 9, lines 15—19). Sojka discloses that an adsorbent polymer Microsponge ® can alternately be used in the invention, i.e. the polymers produced by polymerization of ethylene glycol dimethylacrylate and allyl methacrylate, and Microsponge ® are functionally equivalent (Sojka, page 14, lines 22—25). To retard or 4 Appeal 2017-003614 Application 11/285,871 eliminate displacement of the active agent from the absorbent polymer, a release retardant is added; the release retardant can be added simultaneously with the active agent (page 27, lines 17—24). The active release retardants include mineral oil, waxes, silicone oils and block polymers of polyethylene oxide and polypropylene oxide (page 30, lines 7—15, lines 17—18, page 31, lines 13—16). 9. Sojka discloses that The only limitation on the adsorbent polymer is an ability at adsorb at least an equal weight amount of a solid or a liquid active agent, and preferably an ability to adsorb a greater than equal weight amount of an active agent. The adsorbent polymer typically adsorbs about 4 to about 5 times its weight of an active agent, and often about 10 times, and up to about 20 times, its weight of an active agent. Sojka, p. 14,11. 11-21. 10. Sojka discloses that The active agent is present in the controlled release composition in an amount to perform its intended function, typically in an amount of about 0.1% to about 30%, by weight, of the composition when in liquid form, and about 50% to about 95%, by weight, of the composition when in solid form. Semisolid forms of a controlled release composition contain about 0.1% to about 75%, by weight, of the active agent. Persons skilled in the art are aware of the amount of active agent needed to perform its intended function, and are capable of determining the amount active agent to incorporate into the composition based on the form, e.g., solid, semisolid, or liquid, of the composition. Sojka, p. 16,11. 10-24. 11. Sojka discloses that Preferably, the micro-particles of adsorbent polymer have a total sorption capacity for mineral oil of about 82-93% by weight, more preferably about 84% 5 Appeal 2017-003614 Application 11/285,871 by weight or greater, most preferably about 85-93% by weight or greater. Sojka, p. 16,11. 10-24. 12. Won ‘675 discloses the controlled release of an active substance from a polymeric delivery system which may be a bead or microsphere. Col. 1,11. 21—29, Col. 2, 11. 42—50.) The beads maybe made of polyenthyenically unsaturated monomers including ethylene glycol diacrylate and allyl acrylate. (Col. 6, 11. 32-40.) 13. Won ‘675, col. 7,11. 30-38, discloses that “[t]he impregnant [of the controlled release composition], whether it be pure active ingredient, a mixture of active ingredients or a solution of active ingredient, will generally comprise between approximately 5% and approximately 65% of the total weight of the impregnated beads.†14. Won ‘675 discloses that the The bead diameter is normally maintained in the range from about 5 microns to 100 microns, usually being about 10 microns to 50 microns, and the total pore volume is in the range from about 0.1 to 2.0 cc/g, usually being in the range from about 0.3 to 1.0 cc/g. The surface area of the beads will range from about 1 to 500 m2/ g, usually being in the range from about 20 to 200 m2/ g. The precise dimensions and characteristics of the beads are controlled by varying process parameters such as agitation speed and nature of the porogen. Col. 2, 1. 66—col. 3, 1. 8. (emphasis added). 15. Won discloses that the outward diffusion (release rate) of the impregnants is dependent upon the pore size. Abstract, col. 16,11. 33- 36. 16. Won discloses that the beads may be in the form of a microsponge. Col. 13,11. 19-38. 6 Appeal 2017-003614 Application 11/285,871 17. Won discloses a rigid cross-linked polymer beads having a total pore volume in the range from about 0.01 cc/g to about 4.0 cc/g. Won, claim 6. 18. Won discloses benzoyl peroxide, a bleaching agent, as the active inside the pores of porous solid particles or microspheres. Won, Claim 15. 19. The Specification, 113 discloses that, “[t]he peroxide composite preferably comprises a peroxide compound at a level of about 50% to about 95% optionally about 70 to about 90% by weight of the peroxide composite.†20. The Specification discloses that, “the polymer comprises porous particulates having a BET ... pore volume of about 0.05 to about 0.3cc/g, optionally about 0.1 to about 0.2 cc/g, optionally about 0.14 to about 0.16 cc/g.†Spec. 3 113. 21. The Specification page 8,125, discloses that Porous cross-linked polymers among those useful herein are disclosed in U.S. Patents 5,955,552; and 6,387,995, the contents of each of which are incorporated herein by reference. Such polymers include those commercially available as: MICROSPONGE® 5640, marketed by A.P. Pharma, Redwood City, California, U.S.A.; POLYTRAP® 6603 and POLYPORE ® 200 series, marketed by Amcol International Corp, Arlington Heights, Illinois, U.S.A.; and DSPCS®-12 series and SPCAT®-12 series, marketed by Kobo Products, Inc., South Plainfield, New Jersey, U.S.A. 22. Piechota discloses a dentifrice which includes bleaching agents, such as, sodium perborate, hydrogen peroxide, sodium percarbonate, and urea peroxide. Col. 4,11. 18—29. 7 Appeal 2017-003614 Application 11/285,871 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 Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). The meaning of the word “about†or “approximately†is dependent on the facts of a case, the nature of the invention, and the knowledge imparted by the totality of the earlier disclosure to those skilled in the art. Eiselstein v. Frank, 52 F.3d 1035, 1040 (Fed. Cir. 1995); see also, Ex parte Eastwood, Brindle and Kolb, 163 USPQ 316 (Bd. Pat. App. & Int. 1968) (The descriptive word “about†is not indefinite as argued by the examiner. . . . Rather, the term is clear but flexible and is deemed to be similar in meaning to terms such as “approximately†or “nearlyâ€.) Such broadening usages as ‘about’ [or ‘approximately’] must be given reasonable scope; they must be viewed by the decision maker as they would be understood by persons experienced in the field of the invention. Although it is rarely feasible to attach a precise limit to ‘about,’ [or ‘approximately’] the usage can usually be understood in light of the technology embodied in the invention. Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1554, (Fed. Cir. 1996) (internal citations omitted). In re Woodruff, 919 F.2d 1575, 1576 (Fed. Cir. 1990), held that, “the term ‘about 1-5%’ does allow for concentrations slightly above 5%.†8 Appeal 2017-003614 Application 11/285,871 Furthermore, “[precedent illustrates the fact-dependency of determinations of the technologic scope of ‘about’ and similar terms [such as approximately], depending on their contexts and the precision or significance of the measurements used.†Modine Mfg., 75 F.3d at 1554. Obviousness Rejection Claims 1, 3—7, 9-18 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Kuo and Sojka, as evidenced by Advanced Polymer Systems, Won, and Piechota. The Examiner finds that the cited references, in combination, support rejection of the pending claims. Particularly relevant is the disclosure of Won. Won ‘675 discloses a polymeric delivery system comprising impregnants inside the pores of porous solid particles or microspheres. (Abstract.) The polymer beads or micro spheres may be used alone or may be incorporated into a secondary carrier or vehicle composition. (Col. 2, lines 27-30.) Won ‘675, col. 7, lines 30-38, further discloses that, “[t]he impregnant [of the controlled release composition], whether it be pure active ingredient, a mixture of active ingredients or a solution of active ingredient, will generally comprise between approximately 5% and approximately 65% of the total weight of the impregnated beads.†Won ‘675 further teaches the use of the polymeric delivery system allows avoiding incompatibility of actives, such as chemical or physical interactions. (Col. 2, lines 24-41). Examiner considers the active ingredient of Won ‘675 which is “approximately 65%†of the total weight of the impregnated beads to read on the claimed 70% value where the range is close. Further, where the overall range is about 60%, the term “approximately†would be interpreted to be broader in scope than a narrower range, and as such, variance of 5% is reasonable. 9 Appeal 2017-003614 Application 11/285,871 Ans. 3. Appellants contend that Kuo discloses that many agents including carbamide peroxide may be releasably attached to the elastic repositioning appliance in a number of forms. Kuo also discloses many means for releasing an agent to the oral environment. Although Kuo makes a general statement that agents may be encapsulated or entrapped by a number of materials, including polyacrylic acid, and Kuo discloses Microsponge as an exemplary resin, Kuo does not disclose or teach peroxide composites comprising a peroxide compound and porous cross-linked polymers as specified in the present claims. Kuo also fails to teach that the peroxide should be sorbed to the polymer, or the specific amounts of peroxide suitable for use in such a system, or the specific amounts of the peroxide composite. This failure is not cured by the other cited references, none of which disclose or teach a peroxide compound sorbed to the crosslinked polymer as recited in the claims. Especially, with regard to claims 3, 5 and 18, Kuo does not disclose any polymer comprising polymethacrylate (as recited in claims 3 and 18) or comprising allyl methacrylates polymerized with ethylene glycol dimethacrylate (as recited in claim 5). App. Br. 6. Appellants further contend that, “[njeither Kuo nor the other cited references teach the range (70 to 90%) of a peroxide compound sorbed to the cross-linked polymer that is recited in the present claims.†App. Br. 7. Appellants argue that Moreover, if one were to accept the Examiner's argument, then the language “'approximately†would suggest that Won did not consider the range of 5-65% to be critical, or a result effective variable. As stated in MPEP 2144.05: A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges 10 Appeal 2017-003614 Application 11/285,871 of said variable might be characterized as routine experimentation. In re Antonie, 559F.2d618, 195 USPQ 6 (CCPA 1977)[.] Ap. Br. 9. ANALYSIS Individual claims are not separately argued in Appellants’ Brief, therefore we select claim 1 as representative claim. 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. We provide the following additional comment to the Examiner’s argument set forth in the Final Office Action and Answer. Claim Interpretation Claim 1 recites the limitation, “a peroxide composite comprising a peroxide compound and a porous cross-linked polymer forming a polymeric matrix in which the peroxide compound is absorbed, at a level of from 70% to 90% by weight of the peroxide compound to the crosslinked polymer.†The Specification, 113 discloses that, “[t]he peroxide composite preferably comprises a peroxide compound at a level of about 50% to about 95% optionally about 70 to about 90% by weight of the peroxide composite.†(Emphasis added). We interpret the claim 1 phrase “from 70% to 90% by weight of the peroxide compound†in the claim to read on the active ingredient, peroxide, amount of approximately 65% of the total weight of the impregnated beads, disclosed in Won. In addition, the Appellants’ Specification, 113 discloses that, “[t]he peroxide composite preferably comprises a peroxide compound 11 Appeal 2017-003614 Application 11/285,871 at a level of about 50% to about 95%,†indicating a lack of criticality within a range encompassing the approximately 65% disclosed in Won. Indeed, we do not discern any teaching in the Specification suggesting a criticality or difference in properties over the broadest disclosed range. We are not persuaded by Appellants’ arguments that the cited references, in combination, do not disclose the claimed range of a peroxide compound sorbed to the crosslinked polymer. The Specification, 113 discloses that, “[t]he peroxide composite preferably comprises a peroxide compound at a level of about 50% to about 95% optionally about 70 to about 90% by weight of the peroxide composite.†Thus the Specification contemplates a wide range of effective amounts of the active agent, peroxide, in the peroxide composite. Appellants do not establish criticality or unexpected results for the narrow range of peroxide amount claimed, in view of the broader range disclosed in the Specification 113. “The law is replete with cases in which the difference between the claimed invention 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, 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Appellants argue that The disclosure of Won cited by the Examiner only states that 5.3 parts/in 381 parts total; i.e. 1.4%, of a 70% active solution of benzoyl peroxide, is added to the mixture to initiate polymerization. That is, the “benzoyl peroxide at 70% active ingredient†that the Examiner refers to is not active ingredient in the Won composition, but merely the percentage of active 12 Appeal 2017-003614 Application 11/285,871 peroxide in the solution that is added to the Won polymerization mixture as catalyst. App. Br. 8. We are not persuaded by Appellants’ argument. Won discloses that, “[t]he impregnant [of the controlled release composition], whether it be pure active ingredient, a mixture of active ingredients or a solution of active ingredient, will generally comprise between approximately 5% and approximately 65% of the total weight of the impregnated beads.†FF15. Won discloses benzoyl peroxide, a bleaching agent, as the active. Won, Claim 15. FF18. It would have been obvious to include benzoyl peroxide in an amount of from 70% to 90% by weight of the peroxide compound to the crosslinked polymer as claimed, in view of Won’s disclosure of benzoyl peroxide as an active in impregnated beads or microsponge system, and that actives may be present in the controlled release microspheres in amount of approximately 65% (interpreted to include 70%). Appellants have provided no argument as to why the term “approximately 65%†in Won does not include 70%. Appellants have not established criticality of the 70% minimum amount of active by showing a difference in properties of the peroxide composites. In addition, Sojka’s improved controlled release composition includes an adsorbent polymer that typically adsorbs about 4 to about 5 times its weight of an active agent, and often about 10 times, and up to about 20 times, its weight of an active agent. FF10. Sojka discloses that the micro particles of adsorbent polymer have a total sorption capacity of about 82- 93% by weight, more preferably about 84% by weight or greater, most preferably about 85—93% by weight or greater. FF12. Moreover, Kuo (FF3), Won (FF18) and Sjoka (FF9) disclose absorbent polymers include 13 Appeal 2017-003614 Application 11/285,871 microsponge products similar to those disclosed in Appellants’ Specification (FF22). Thus it would have been obvious to one of ordinary skill in the art at the time of the invention that the absorptive, microsponge polymers of Sokja, and the cited references in combination, can absorb and deliver higher amounts of active agent, including active agent at a level of from 70% to 90% by weight of the peroxide compound to the cross-linked polymer. Appellants argue that the non-precedential and unpublished case, In Re Rajen M. Patel, 566 F. Appx. 1005 (Fed. Cir. 2014) (non-precedential) supports a finding of non-obviousness in the present case. App. Br. 9-10. We are not persuaded. In Patel, the court found that “[wjhere differences clearly exist and there is no evidence that they are either not meaningful or one of skill in the art would know to discard the limits set by the prior art, proximity alone is not enough to establish a prima facie case of obviousness.†Id. at 1010; App. Br. 10. In contrast, in the present case, for the reasons presented above, evidence has been presented that the range end points are not critical, that the cited art teaches higher amounts of active agent, and that and that the ordinary artisan would understand that the claimed amount of active agent is encompassed by the cited prior artespecially in view of the prior art teachings that absorbent polymers for incorporating the active agent that include microsponge products similar to those disclosed in Appellants’ Specification. Compare, Titanium Metals Corporation of America v. Banner, 778 F2d 775, 782 (Fed. Cir. 1985) (The alloy proportions between the prior art and that claimed are so close that prima facie one skilled in the art would have expected them to have the same properties. Appellee produced no evidence to rebut that prima facie case.) The obviousness rejection is affirmed for the reasons of record. 14 Appeal 2017-003614 Application 11/285,871 CONCLUSION OF LAW The cited references support the Examiner’s obviousness rejections, which are affirmed for the reasons of record. All pending, rejected claims fall. AFFIRMED 15 Copy with citationCopy as parenthetical citation