Ex Parte Robinson et alDownload PDFPatent Trial and Appeal BoardMay 2, 201612866663 (P.T.A.B. May. 2, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/866,663 08/06/2010 23909 7590 05/04/2016 COLGATE-PALMOLIVE COMPANY 909 RIVER ROAD PISCATAWAY, NJ 08855 FIRST NAMED INVENTOR Richard Scott Robinson 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. 8563-00-0C 3297 EXAMINER PARAD, DENNIS J ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 05/04/2016 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 PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte RICHARD SCOTT ROBINSON and RICHARD J. SULLIVAN Appeal2014-000701 Application 12/866,663 1 Technology Center 1600 Before LORA M. GREEN, FRANCISCO C. PRATS, and RY ANH. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims directed to oral care compositions comprising a peptide having basic amino acids and a protease for cleaving the peptide and releasing the basic amino acids in the mouth of a user. The Examiner rejects claims 1-27, 29- 40, 45, and 46 under 35 U.S.C. §§ 112, first paragraph, and 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse the rejections under§ 112, but affirm the rejections under § 103(a). 1 The Real Party in Interest is Colgate-Palmolive of New York, NY. Br. 3. Appeal2014-000701 Application 12/866,663 STATEMENT OF THE CASE Claims 1-27, 29--40, 45, and 462 are on appeal. These claims can be found in the Claims Appendix of the Appeal Brief. Claim 1 is the sole independent claim and reads as follows: 1. An oral care composition comprising: (i) an effective amount of a peptide or mix of peptides comprising basic amino acids wherein the peptide or mix of peptides has an average nitrogen content of at least about 1.25 nitrogen atoms per amino acid residue, and (ii) a protease which cleaves said peptide and releases a basic amino acid into an oral cavity when said composition is used in the oral cavity of a user. Br. 24, Claims Appendix. The Specification describes that arginine and other basic amino acids are believed to have benefits in combating cavity formation and tooth sensitivity and, so, are usefi1l in oral care. Spec.~ 2. Ho\i:1ever, the Specification also indicates that combining basic amino acids with minerals also having oral care benefits, e.g., fluoride and calcium, has been challenging. Spec. ,-i 3. The Specification describes compositions and methods to deliver basic amino acids to the oral cavity. Id. ,-i 4. The Specification describes the invention as a composition for oral care comprising an effective amount of a peptide comprising basic amino acids, e.g., arginine, and a protease which cleaves the peptide so that a basic amino acid is introduced into the oral 2 Claims 41--44 have been withdrawn from consideration. Final Action Summary Page. Claims 1-27, 29--40, 45, and 46 stand rejected. Id. Claim 28 was cancelled. Br. 28. 2 Appeal2014-000701 Application 12/866,663 cavity. Id. iii! 5, 9, 22-25. The Specification describes controlling the protease cleavage of the peptide using a protease inhibitor component in the composition so that the inhibition ceases once the composition is introduced into the user's oral cavity and is diluted. Id. iii! 17, 24, 25. The Specification describes that, in addition to the amino acids and protease (and protease inhibitor) discussed above, the composition can also include a source of calcium ions, phosphate ions, potassium ions, fluoride, polyol humectant, an abrasive or particulate, polymers, antibacterial agents, flavoring, gum, anti-inflammatories, antioxidants, whitening agents, water, foaming agents, vitamins, enzymes, thickeners, preservatives, fragrances, and/or colorings. Spec. iJ 7. The Specification describes that the composition can be incorporated into toothpastes, transparent pastes, gels, mouth rinses, sprays, and chewing gum. Id. iJ 52. The following grounds of rejection are on appeal: A. Claims 1-27, 29-40, 45, and 46 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement (Final Action 5-8); B. Claims 1-27, 29--40, 45, and 46 under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement (Final Action 8-10); 3 Appeal2014-000701 Application 12/866,663 C. Claims 1-27, 29-34, 36-40, 45, and 46 under 35 U.S.C. § 103(a) as being unpatentable over Sharma,3 Kuhner,4 Kleinberg, 5 Lowe,6 and Olsen7 (Final Action 10-15); D. Claim 35 under 35 U.S.C. § 103(a) as being unpatentable over Sharma, Kuhner, Kleinberg, Lowe, Olsen, and Sano8 (Final Action 10-15). FINDINGS OF FACT FF 1. The Appellants and Examiner agree that a person of ordinary skill in the art as of the time of the invention would include "a chemist, enzymologist, or biologist with advanced knowledge and experience in the art areas of, inter alia, oral care, dentifrice arts, short peptides, and corresponding enzymes" and such a person would have had "a firm understanding of the interrelationship between each of these disciplines and the functional and physical limitations of the claimed invention." Br. 10-11; see also Ans. 9 (in agreement with Appellants). 3 U.S. Patent Application Pub. No. 2007/0231277 Al, published Oct. 4, 2007) (hereinafter "Sharma"). 4 U.S. Patent Application Pub. No. 2003/0194445 Al, published Oct. 16, 2003) (hereinafter "Kuhner"). 5 U.S. Patent No. 6,217,851 Bl, issued Apr. 17, 2001) (hereinafter "Kleinberg"). 6 G. Lowe & Y. Yuthavong, Kinetic Specificity in Papain-Catalysed Hydrolyses, 124 BIOCHEM. J. 107-115 (1971) (hereinafter "Lowe"). 7 Olsen et al., Trypsin Cleaves Exclusively C-terminal to Arginine and Lysine Residues, 3 MOL. & CELL. PROTEOMICS 3.6 608-614 (2004) (hereinafter "Olsen"). 8 Sano et al., Effect of Chitosan Rinsing on Reduction of Dental Plaque Formation 44 BULL. TOKYO DENT. COLL. 9-16 (2003) (hereinafter "Sano"). 4 Appeal2014-000701 Application 12/866,663 FF2. The Specification describes, "[t]he invention thus comprises Composition 1.0, an oral care composition comprising an effective amount of a peptide comprising basic amino acids e.g., arginine, in free or salt form, and a protease which cleaves said peptide when said composition is used the oral cavity of a user." Spec. iJ 5. FF3. The Specification describes "[a ]dditional embodiments of the present invention also include the following methods ... wherein the protease hydrolyzes the peptide when introduced into the oral cavity." Spec. iii! 8-9, claim 4 2. FF4. The Specification describes an embodiment where "the protease inhibitor is inactivated or diluted when the composition is introduced into the oral cavity," thereby describing a means of restraining protease cleaving of the peptide in the composition until it is introduced into an oral cavity. Spec. iJ 9. FF5. The Specification describes that the composition can "comprise an effective amount of a peptide comprising basic amino acids" and "[a Jn effective amount is an amount effective to achieve the benefits of a basic amino acid, e.g., arginine, in the oral cavity following hydrolysis of the peptide by the protease" and "an effective amount of the peptide will be dependent on the amount of protease present in the composition." Spec. iii! 18 and 22. FF6. The Specification describes that the composition can "comprise an effective amount of a protease which hydrolyzes the peptide" and "an effective amount of the protease will be dependent on the amount of peptide present in the composition, and the particular protease selected" and 5 Appeal2014-000701 Application 12/866,663 "[i]n compositions comprising a peptide, protease, and protease inhibitor, the effective amount of the protease may be dependent upon the levels of peptide and the protease inhibitor." Spec. iii! 19 and 23. FF7. The Specification describes that the composition can "comprise an effective amount of a protease inhibitor which inhibits protease hydrolysis of the peptide until the composition is released in the oral cavity" and"[ e ]ffective amounts of the protease inhibitor will depend not only on the amounts of protease, but the type of protease, and the type of protease inhibitor." Spec. iii! 20 and 24. FF8. Sharma disclosed "multicomponent whitening compositions and containers" that include "a first chamber containing therein a first dentifrice composition" and "a second chamber containing therein a second dentifrice composition that includes ... a proteolytic enzyme," where the compositions can be provided, e.g., as toothpaste. Sharma title, Abstract, iii! 2, 3, 33; see also Final Action 11-12 (discussing Sharma), Non-Final (dated Mar. 30, 2012) 15-20 (discussing Sharma), and Ans. 12-17 (discussing Sharma). FF9. Sharma disclosed that a "zwitterionic stabilizer may be added to the first composition of the present invention to provide improved physical and/or chemical stability to the composition," that"[ s Jui table zwitterionic stabilizers include, but are not limited to, amino acids, short peptides, and their derivatives and such as glycine, di-glycine, tri-glycine, histidine, lysine, arginine, B-alanine, 4-amino butyric acid, and 6-amino hexanoic acid," and that "the amount of zwitterionic stabilizer may range from about 0.05% to about 5% ... by weight." Sharma iii! 25-26; see also 6 Appeal2014-000701 Application 12/866,663 Final Action 11-12 (discussing Sharma), Non-Final (dated Mar. 30, 2012) 15-20 (discussing Shanna), and Ans. 12-17 (discussing Shanna). FFlO. Sharma disclosed that "[p ]roteolytic enzymes that may be used in the present invention may be selected from the group consisting of bromelain, ficin, trypsin, actinidin and papain." Sharma ,-i 36; see also Final Action 11-12 (discussing Sharma), Non-Final 15-20 (discussing Sharma), and Ans. 12-17 (discussing Sharma). FFl 1. Kuhner disclosed "[p ]eptide compositions and methods for inhibiting and controlling the growth of microbes," that "[t]he peptides and compositions of the invention may be administered topically [and] orally," e.g., as mouthwash or toothpaste, and that "the most preferred amino acid [for inclusion in the peptides] is arginine." Kuhner Abstract, ,-i,-i 66, 285 (example 10, L, M, N), 198; see also Final Action 11-12 (discussing Kuhner), Non-Final (discussing Kuhner), and Ans. 15-17 (discussing Kuhner). FF12. Kuhner disclosed that "for peptides of four or five amino acids (n=4-5), at least two of the amino acids in positions X1 through Xs are preferably cationic amino acids such as Arg[inine ],"and that [f]or peptides of six to eight amino acids (n=6-8), it is preferred that at least three of the amino acids in positions X1 through Xs are cationic amino acids such as Arg[inine]." Kuhner 199-200; see also Final Action 11-12 (discussing Kuhner), Non-Final 17-19 (discussing Kuhner), and Ans. 15-17 (discussing Kuhner). FF13. Kleinberg disclosed that "the arginine component of the composition described herein attacks the first stage of the Miller process," 7 Appeal2014-000701 Application 12/866,663 by producing alkali compounds that neutralize acids produced by plaque bacteria. Kleinberg col. 2, 11. 45-61; see also Final Action 14-15 (discussing Kleinberg), Non-Final 19 (discussing Kleinberg), and Ans. 16 (discussing Kleinberg). FF14. There was motivation to combine Sharma and Kuhner because they are each directed to oral compositions (dentifrice products such as toothpastes and mouthwashes) that incorporate amino acids, e.g., arginine. See FF8-FF12, supra; see also Ans. 16 (discussion motivation to combine). Moreover, Kleinberg also taught that including arginine in an oral composition was safe and advantageous. Ans. 16. FF15. Sano disclosed a mouthrinse comprising chitosan that was "effective in reducing plaque formation and counts of salivary mutans streptococci after a 14-day rinsing period." Sano 9; see also Ans. 18-19 (discussing Sano). FF16. There was motivation to combine Sano with Sharma and Kuhner because Sano disclosed that chitosan is useful in dentifrice compositions to mitigate bacteria-related plaque formation and Sharma disclosed that an antibacterial agents can be incorporated into its compositions. Sano 9; Sharma ,-i 45; see also Ans. 18-19 (discussing Sano and its combination with the other prior art of record). CLAIM INTERPRETATION During examination, the PTO must interpret terms in a claim using "the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may 8 Appeal2014-000701 Application 12/866,663 be afforded by the written description contained in the applicant's specification." In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). We conclude that, when read in light of the Specification, the broadest reasonable interpretation of the claim language, "a protease which cleaves said peptide and releases a basic amino acid into an oral cavity when said composition is used in the oral cavity of a user," is "a protease which cleaves the peptide or a peptide of the mix of peptides of the composition so that a basic amino acid is released into an oral cavity when the composition is in the oral cavity of user." There are embodiments described in the Specification where the recited protease cleaves the peptide when the composition is used in the user's oral cavity. FF2 and FF3. In addition, the Specification also described means of controlling the peptide cleavage in the composition, e.g., with protease inhibitors. FF4, FF6, and FF7. DISCUSSION A. andB. The rejections of claim 1-27, 29-40, 45, and 46 under 35 U.S. C. § 112, first paragraph, as failing to comply with the written description and enablement requirements. The rejections under§ 112, first paragraph, are based on the same allegations and facts, and, therefore, we deal with these rejections together. Each is focused on whether the Specification sufficiently describes and enables a composition having both a peptide and a protease for cleaving that 9 Appeal2014-000701 Application 12/866,663 peptide and releasing a basic amino acid into an oral cavity when the composition is used. 9 The Examiner determined that, as to the§ 112, first paragraph, rejections and priority, "the pivotal issue ... is that the peptide would degrade in the presence of the protease and, thus, the composition as claimed would not cleave the peptide and release a basic amino acid into an oral cavity when the composition is used in the oral cavity." Final Action 9 (emphasis added). As support for the position that the protease would so degrade the peptide, the Examiner cited Sharma (iJ 18), which discloses a composition where peptides and proteases are also provided together, but kept isolated from one another in separate chambers until co-extrusion to maintain the integrity of incompatible ingredients. Final Action 7. The Examiner also cited to the references Svenson10 and Nguyen11 as evidence 9 Appellants also contest the Examiner's denial of priority to Provisional Application No. 61/027,584 (filed Feb. 11, 2008; hereinafter "the '584 provisional"). App. Br. 22-23. Appellants' asserted priority date per the '584 provisional is February 11, 2008. Spec. iJ 1. Each reference cited as prior art in the appealed§ 103(a) rejections predates this provisional filing date and any change in priority with respect to this provisional does not affect the§ 103(a) rejections. Because any change in priority with respect to the '5 84 provisional does not affect the prior art status of the references applied in the § 103 (a) rejections, we decline to issue an advisory opinion as to Appellants' priority claim to the '584 provisional. 10 Svenson et al., Antimicrobial Peptides with Stability Toward Tryptic Degradation, 47 BIOCHEM. 3777-3788 (2008) (hereinafter "Svenson"). 11 Nguyen et al., Serum Stabilities of Short Tryptophan- and Arginine-Rich Antimicrobial Peptide Analogs, 5 PLoS ONE 1-8 (Sep. 2010) (hereinafter "Nguyen"). 10 Appeal2014-000701 Application 12/866,663 that arginine-rich peptides would degrade rapidly in the presence of proteases. 12 Final Action 9. Appellants argue that the Examiner has imposed an unclaimed requirement of absolute stability of the claimed composition, i.e., the recited "peptide." Br. 7. Appellants challenge the Examiner's determinations because they "imply that it is essential for Applicants to show that the protease will not degrade the peptide at all in the formulation" and that "the Examiner has not explained why some degradation of the peptide" before oral delivery would "render the formulation non-functional." Br. 8-9. Appellants also argue that "while there could be some degradation in formulation, in a typical formulation, most of the degradation would still be expected to occur in the oral cavity" and"[ e ]ither by using a protease inhibitor, or by controlling the water and ion content of the formulation or the distribution of the peptide and protease, the specification makes clear that one of skill in the art can control this [protease cleavage] parameter if desired," but that "complete control is not essential to the invention." Br. 9- 10. Appellants' arguments are persuasive. A description adequate to satisfy 35 U.S.C. § 112, first paragraph, must "reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en 12 Neither Svenson nor Nguyen relate to topical oral compositions or proteolytic cleavage in a topical oral composition. See Br. 14. Svenson is directed to metabolic degradation of peptides in the gastrointestinal tract. Svenson Abstract. Nguyen is directed to proteolytic degradation in human serum. Nguyen Abstract. 11 Appeal2014-000701 Application 12/866,663 bane). Moreover, "the written description requirement does not demand either examples or an actual reduction to practice; a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement." Id. at 1352. Appellants point to the Specification ,-i,-i 22-25, which identify that an effective amount of a peptide achieves benefits (e.g., of arginine) in an oral cavity, that the effective amount of protease hydrolyzes the peptide, and that an effective amount of protease inhibitor will inhibit protease hydrolysis of the peptide until the composition is released into the oral cavity-effective amounts of each of these components depends upon the amounts of the others. Br. 7-8; see FF5-FF7. This disclosure in the Specification is commensurate with the subject matter and breadth of the claims and supports that Appellants were in intellectual possession of the subject matter of the claims. Therefore, we find that the Examiner has not established by a preponderance of the evidence that the claims are supported by a sufficient written description under 35 U.S.C. § 112, first paragraph. As to enablement, "[t]he specification need not explicitly teach those in the art to make and use the invention; the requirement is satisfied if, given what they already know, the specification teaches those in the art enough that they can make and use the invention without 'undue experimentation."' Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir. 2003). Appellants argue that it was within the skill and knowledge (of enzymology) of those of ordinary skill in the art at the time of the invention to engineer the claimed composition's protease and peptide components so that the degree to which the peptide is degraded in formulation versus upon 12 Appeal2014-000701 Application 12/866,663 administration in-mouth could be controlled (e.g., by using a protease inhibitor or by controlling water and ion content). Br. 9-10. Appellants and the Examiner agree on the level of skill in the art, which would have included "advanced knowledge and experience in the art areas of, inter alia, oral care, dentifrice arts, short peptides, and corresponding enzymes." See FF 1. We are persuaded it would have been within the skill set of such an artisan to, without undue experimentation, combine a peptide (e.g., rich in arginine), a protease that would cleave such a peptide, and a protease inhibitor (or other means of mitigating degradation) in a composition that would release a basic amino acid (e.g., arginine) when the composition is used in-mouth. Br. 9, 13-17. Therefore, we find that the Examiner has not established by a preponderance of the evidence that the claims are not enabled under 35 U.S.C. § 112, first paragraph. For these reasons, the rejections of claims 1-27, 29--40, 45, and 46 under 35 U.S.C. § 112, first paragraph, for lack of written description and for lack of enablement are each reversed. C. The rejection of claims 1-27, 29-34, 36--40, 45, and 46 under 35 U.S.C. § 103(a) as being unpatentable over Sharma, Kuhner, Kleinberg, Lowe, and Olsen. The Examiner determined that Sharma disclosed an oral care (tooth whitening toothpaste) composition comprising a protease and a zwitterionic stabilizer, which could include amino acids, short peptides, and their derivatives such as, inter alia, arginine. Final Action 11-12; Ans. 12 and 15 (citing Sharma Abstract, ,-i,-i 25 and 26). The Examiner determined that 13 Appeal2014-000701 Application 12/866,663 Kuhner disclosed compositions for oral administration, e.g., as toothpastes or mouthwash, comprising a short peptide of amino acids where the peptide is enriched with arginine. Ans. 15 (citing Kuhner Abstract, iii! 66, 122, 186- 201, 285). The Examiner determined that Sharma and Kuhner were readily combinable as each was directed to oral care compositions comprising arginine-derived, short peptides. Final Action 11-12; Ans. 16-17. Appellants argue that the Sharma-Kuhner combination would not have been made absent impermissible hindsight (Br. 17). However, motivation to combine could be found in the references themselves because they are directed to solving the same problem in the same technical field (topical oral-care compositions comprising arginine). FF14; Final Action 11-12; Ans. 16-17. Moreover, Kleinberg also taught that including arginine in an oral composition was safe and advantageous. FF 14; Ans. 16. Appellants argue that Sharma does not teach a formulated composition comprising both a peptide and a protease (Br. 19), but Sharma disclosed dual components, one with an arginine peptide and one with a protease, packaged in complementary compartments so that they are combined before or during introduction to a user's mouth. FF8; Ans. 36. Appellants also argue that Sharma fails to teach a peptide with an average nitrogen content of at least about 1.25 nitrogen atoms per amino acid (Br. 19), but Sharma taught its peptide is composed of arginine, which has 4 nitrogen atoms. FF9; Ans. 36. Finally, Appellants argue that Sharma's disclosed zwitterionic stabilizer (e.g., arginine) must be neutrally charged and Kuhner's disclosed peptides (e.g., arginine) have a net positive charge, therefore, the two references were not-combinable because doing so would have rendered 14 Appeal2014-000701 Application 12/866,663 Shanna unsatisfactory for its intended purpose. Br. 19-20. The Examiner explained, and we agree, that a proper reading of Sharma teaches that the disclosed zwitterionic stabilizer would not necessarily be a zwitterion, but a component that improves stability by affecting molecules or compounds with zwitterionic properties. Ans. 38. Moreover, Sharma itself expressly disclosed that its zwitterionic stabilizer can be a short peptide of arginine (FF9), which is Kuhner' s preferred amino acid. Sharma ,-i 26; Kuhner ,-i 198. Based on the above, we find that Appellants have not shown that the Examiner did not establish a prima facie case that the claims are obvious over Sharma, Kuhner, Kleinberg, Lowe, and Olsen. For these reasons, the rejection of claims 1-27, 29-34, 36--40, 45, and 46 under 35 U.S.C. § 103(a) is affirmed. D. The rejection of claim 35 under 35 U.S.C. § 103(a) as being unpatentable over Sharma, Kuhner, Kleinberg, Lowe, Olsen, and Sano. The rejection of claim 35 is based on the same reasoning as set forth by the Examiner for claim 1 (see above) from which it depends, but adds to the cited combination of references Sano' s disclosure of a chitosan component. Appellants argue that there would have been no motivation to combine Sano with the other references. Br. 21-22. We do not find this argument persuasive. The references suggest their combination because, inter alia, Sano discloses that chitosan is useful in dentifrice compositions to mitigate bacteria-related plaque formation, and Sharma disclosed that antibacterial agents could be incorporated into its compositions. Sano 9; Sharma ,-i 45; see also Ans. 18-19. 15 Appeal2014-000701 Application 12/866,663 For these reasons, the rejection of claim 35 under 35 U.S.C. § 103(a) over Sharma, Kuhner, Kleinberg, Lowe, Olsen, and Sano is affirmed. SUMMARY The rejection of claims 1-27, 29--40, 45, and 46 under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement is reversed. The rejection of claims 1-27, 29--40, 45, and 46 under 35 U.S.C. § 112, first paragraph, as failing to comply with the enablement requirement is reversed. The rejection of claims 1-27, 29-34, 36--40, 45, and 46 under 35 U.S.C. § 103(a) over Sharma, Kuhner, Kleinberg, Lowe, and Olsen is affirmed. The rejection of claim 35 under 35 U.S.C. § 103(a) over Sharma, Kuhner, Kleinberg, Lowe, Olsen, and Sano is affim1ed. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l.136(a). AFFIRMED 16 Copy with citationCopy as parenthetical citation