Ex Parte Walsh et alDownload PDFPatent Trials and Appeals BoardJun 5, 201914790404 - (D) (P.T.A.B. Jun. 5, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/790,404 07/02/2015 34395 7590 06/07/2019 OLYMPIC PA TENT WORKS PLLC P.O. BOX 4277 SEATTLE, WA 98104 FIRST NAMED INVENTOR Joseph F. Walsh 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. 35107.00lCl 6156 EXAMINER SIMMONS, CHRIS E ART UNIT PAPER NUMBER 1629 NOTIFICATION DATE DELIVERY MODE 06/07/2019 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): joanne@olympicpatentworks.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSEPH F. WALSH and SHARON KAY LASKA 1 Appeal2019-000792 Application 14/790,404 Technology Center 1600 Before RYAN H. FLAX, RACHEL H. TOWNSEND, and CYNTHIA M. HARDMAN, Administrative Patent Judges. HARDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving a claim to preparations that ameliorate and/or reverse human baldness. The Examiner rejected the claims as obvious over the prior art. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. STATEMENT OF THE CASE The Specification states that FDA-approved treatments for baldness "provide only a very modest, relatively short-term improvement for most 1 Appellants identify themselves as the real party in interest. Appeal Br. 1. Herein we reference the Specification filed July 2, 2015 ("Spec."); Final Office Action dated June 14, 2017 ("Final Act."); Appellants' Appeal Brief filed Feb. 23, 2018 ("Appeal Br."); Examiner's Answer dated Sept. 20, 2018 ("Ans."); and Appellants' Reply Brief filed Nov. 7, 2018 ("Reply Br."). Appeal2019-000792 Application 14/790,404 users." Spec. 2:3-5. The invention is directed to preparations that treat human hair loss by "render[ing] hair follicles accessible to treatment agents that remove blocking oil and cell remnants to allow additional treatment agents to enter the pilosebaceous units to kill or control microbes that disrupt hair growth by changing, inhibiting, or interrupting one or more biological functions of the pilosebaceous units." Id. at 2:11-15. Claim 2, the only claim on appeal, reads as follows: 2. A preparation that ameliorates and/or reverses human baldness, the preparation comprising: water; 3% or less ofbenzoyl peroxide; salicylic acid; and one or more additional substances selected from among D-limonene, minoxidil, thymol, carvacrol, pyrithione zinc, and selenium sulfate. Appeal Br. 23 (Claims Appendix). Claim 2 stands rejected under 35 U.S.C. § 103(a) as obvious over Niemiec2 and Martin. 3 Final Act. 3. 2 Niemiec et al., US 2002/0048558 Al, published Apr. 25, 2002 ("Niemiec"). 3 Martin et al., FR 2,685,638 Al, published July 2, 1993 ("Martin"). 2 Appeal2019-000792 Application 14/790,404 ANALYSIS The Examiner rejected claim 2 as obvious over Niemiec and Martin. Final Act. 3. The Examiner found that the preamble claim term "ameliorates and/or reverses human baldness" "is an intended use that does not provide patentable weight to the claimed preparation product," and stated that "if the prior art teaches or renders obvious the structural limitations of the composition, then the claimed invention is met." Id. at 3-4. The Examiner found that Niemiec teaches topical anti-acne formulations, which include the "benefit agents" salicylic acid (Ex. 1) and 2% benzoyl peroxide (Ex. 2, Ex. 3), among others. Id. at 5 ( citing Niemiec Table 6); Ans. 8-9. The Examiner stated: While Niemiec does not expressly teach 3 % or less of benzoyl peroxide together with salicylic acid, Niemiec further teaches that both salicylic acid and benzoyl peroxide are suitable anti-acne agents for the invention. Thus, one of ordinary skill in the art would have found it prima facie obvious to combine salicylic acid to either one of the anti-acne compositions (e.g., Ex 2, Ex 3, etc.) disclosed in Table 6, forming a composition containing benzoyl peroxide, salicylic acid and water. The artisan would have understood that the salicylic acid would provide anti-acne function to the anti-acne compositions disclose[ d] by Niemiec for treating acne. Additionally, the artisan would have found it obvious to combine Ex 1 with Ex 2 or Ex 3 because each are [sic] separately taught to be useful for treating acne. Id. at 6-7. The Examiner further found that while "Niemiec does not expressly teach zinc pyrithione," "Martin teaches the use of compositions comprising zinc pyrithione that are useful for treating acne." Id. at 7. The Examiner found that one of ordinary skill in the art "would have found it obvious to combine the compositions of Martin to the compositions 3 Appeal2019-000792 Application 14/790,404 suggested by Niemiec because each are separately taught to be useful for treating acne." Id. We adopt the Examiner's findings of fact, reasoning made in connection with the rejection, and responses to Appellants' arguments.4 See id. at 3-7; Ans. 4-11. We find that the Examiner has established that the claims would have been obvious over the prior art combination of Niemiec and Martin. Both Niemiec and Martin teach anti-acne compositions, and, as the Examiner indicated, the law is that "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose." In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980); see also Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 4 We disagree that it was improper or "clear error" for the Examiner to cite the MPEP. Appeal Br. 11, 14. The Examiner, while referencing the MPEP, is relying on the case law cited and discussed in the specified MPEP section to support the rejection. See e.g., Final Act. 4. We also find Appellants' argument that it "cannot" respond to the Examiner's position on the preamble recitations of Appellants' claim unpersuasive. Reply Br. 2. Whether or not the Examiner cited case law regarding claim interpretation, the Examiner clearly set forth his position that the preamble is given no patentable weight because it merely identifies an intended use of the otherwise fully-claimed composition, which is complete without reference to that intended use. Final Act. 3-4; Ans. 6. Consequently, Appellants were adequately put on notice of the Examiner's claim interpretation and the basis of the rejection under 35 U.S.C. § 103, as required by 35 U.S.C. § 132, such that they could rebut the Examiner's position. In re Jung, 637 F.3d 1356, 1363 (Fed. Cir. 2011) ("[A]ll that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner as to meet the notice requirement of§ 132."). 4 Appeal2019-000792 Application 14/790,404 804, 808 (Fed. Cir. 1989) ("Given the prior art teaching that both amiloride and hydrochlorothiazide are natriuretic, it is to be expected that their co- administration would induce more sodium excretion than would either diuretic alone"); In re Gee, 614 F. App'x 495,498 (Fed. Cir. 2015) (non- precedential) ("It would thus have been obvious to combine coffee grounds and honey, each of which is taught by the prior art to be useful for treating viral infections, to create a third composition which is also useful for treating viral infections."). Appellants' arguments have not persuaded us that the Examiner's determination of obviousness is incorrect. We address those arguments below. Many of Appellants' arguments flow from the premise that their claim requires a preparation for treating baldness, whereas the prior art compositions cited by the Examiner are directed to treating acne. See, e.g., Appeal Br. 8, 15-21; Reply Br. 2, 4-5. Thus, we begin, as the Examiner did, by addressing whether the claim term "ameliorates and/or reverses human baldness" is entitled to patentable weight. As noted above, the Examiner found that this claim term is not entitled to patentable weight. Final Act. 3. We agree. As our reviewing court has stated, "as a general rule preamble language is not treated as limiting." Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1327 (Fed. Cir. 2019) (citations omitted). Exceptions arise where, for example, the preamble recites "essential structure." Id. But "a preamble is not limiting 'where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention."' Id. at 13 2 8 ( quoting Catalina Mktg. Int 'l, 5 Appeal2019-000792 Application 14/790,404 Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). "[T]he rule against giving invention-defining effect to intended-use preamble language reflects a longstanding substantive aspect of the patent statute- specifically, the 'well settled' fundamental principle 'that the recitation of a new intended use for an old product does not make a claim to that old product patentable."' Arctic Cat, 919 F.3d at 1328 (quoting In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997)). Claim 2 is directed to certain preparations, i.e., compositions. It is not directed to a method of using those preparations in any fashion. The body of claim 2 recites the components required to be present in the claimed preparations, and we do not perceive, nor have Appellants explained, how stating that such a preparation "ameliorates or reverses human baldness" further limits the compositional elements required. See, e.g., Arctic Cat, 919 F.3d at 1328 (finding preamble language reciting "personal recreational vehicle" not limiting where it merely identified an intended use for the claimed power distribution module, and did not impose any structural requirement on the claimed module); cf In re Lemin, 326 F.2d 437,440 (CCP A 1964) (suggesting that an amount limitation could render an obvious composition patentable, if it differed from the amount used for the prior art purpose). As in Catalina, "deletion of the disputed phrase from the preamble ... [ would] not affect the structural definition ... of the [invention] itself." Catalina, 289 F.3d at 810. Thus, we conclude that the preamble does not further limit the scope of protection of the claimed preparations, and like the Examiner, do not give it patentable weight. For this reason, we are not persuaded by Appellants' arguments that rely on the 6 Appeal2019-000792 Application 14/790,404 purported lack of motivation or reasonable expectation of success in using the proposed prior art compositions or ingredients therein ( e.g. benzoyl peroxide) to treat hair loss. See, e.g., Appeal Br. 4-5, 8, 15-21; Reply Br. 2, 4-5. We next tum to Appellants' arguments that the prior art fails to adequately teach that benzoyl peroxide and salicylic acid, either by themselves or in combination together (without the other ingredients taught in Niemiec Table 6), are effective to treat acne. See, e.g., Appeal Br. 8-11, 14, 15-16, 18-19, 21; Reply Br. 3, 6. We are not persuaded by these arguments, because Niemiec identifies each of benzoyl peroxide and salicylic acid as "benefit agents" for the treatment of acne, and teaches that they can be used in combination. See, e.g., Niemiec ,-J 153 ("Examples of suitable anti-acne agents include ... salicylic acid; benzoyl peroxide ... and mixtures thereof."); claim 22. Additionally, we agree with the Examiner that a person of ordinary skill in the art would have found it obvious to combine salicylic acid or the formulation of Niemiec Example 1 with the formulation of Example 2 or 3 in Table 6. Final Act. 6-7; Ans. 5. In such a combination the resulting formulation would include not only salicylic acid and benzoyl peroxide, but the other ingredients in Table 6 as well. Claim 2 employs the transition term "comprising." "'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). Thus the presence of the additional ingredients in Table 6 in combining formulations would be within the scope of claim 2. 7 Appeal2019-000792 Application 14/790,404 To the extent Appellants are arguing that Niemie does not enable a composition of salicylic acid and benzoyl peroxide alone being effective to treat acne (Appeal Br. 9), "a prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant or patentee." In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012). While Niemiec suggests that the remainder of the formulation is useful for "enhancing the transmembrane penetration of benefit agents" (Niemiec at Abstract, emphasis added), it does not indicate that the benefit agents fail to work without the other ingredients. Appellants similarly argue that the prior art fails to adequately teach that zinc pyrithione, without piroctone olamine, is effective to treat acne. See, e.g., Appeal Br. 14; Reply Br. 3, 6, 8. We are also not persuaded by this argument because the Examiner's rationale for obviousness does not require that zinc pyrithione, without piroctone olamine, be effective against acne. Rather, the Examiner explained that a person of ordinary skill in the art would have found it obvious to combine Martin's entire formulation with the formulation of Example 2 or 3 in Niemiec's Table 6, such that the resulting formulation would include both zinc pyrithione and piroctone olamine. See, e.g., Final Act. 7; Ans. 5, 7. Appellants also argue that Martin teaches away from combining its formulations with those of Niemiec. Specifically, Appellants note that Martin's preferred embodiment includes an antioxidant, which they argue would neutralize free radicals, such as those generated the benzoyl peroxide in Niemiec's formulations. Appeal Br. 14-15; Reply Br. 8. We agree with the Examiner that this argument is not persuasive, because Martin teaches 8 Appeal2019-000792 Application 14/790,404 that the antioxidant is optional. Ans. 11; Martin at Abstract. Thus, to the extent a person of ordinary skill in the art would have expected that an antioxidant would render benzoyl peroxide ineffective (see Reply Br. 8), it would have been within the skill in the art to simply exclude the optional antioxidant from Martin's formulation. We next tum to Appellants' arguments directed to distinguishing In re Kerkhoven. Appellants argue that this case is distinguishable because it "involved claims to a process rather than claims to formulations." Appeal Br. 11. Appellants, however, do not explain how the difference between the type of claims (process versus composition claims) demands a different outcome here, particularly in view of the court's clear holding that "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose." In re Kerkhoven, 626 F.2d at 850 (emphasis added). Appellants also assert that In re Kerkhoven is distinguishable because the "simple detergents" at issue "lack any of the many complex types of interactions with biological molecules and physiological contexts, synergisms, antagonisms, bioavailability problems, including those discussed specifically by Niemiec, and other complexities that always accompany pharmaceutical preparations." Appeal Br. 12; see also Reply Br. 2-4. We address this argument together with Appellants' arguments based on the chemical differences between salicylic acid, benzoyl peroxide, and zinc pyrithione, and its arguments regarding whether the Examiner's proposed combination would be safe and effective to treat acne. Appeal Br. 9 Appeal2019-000792 Application 14/790,404 12-14; Reply Br. 3-4, 6-7. For example, Appellants argue that "[n]o one familiar with biochemistry or physiological chemistry would ever conclude that it would be obvious to mix compounds from entirely different chemical families together in order to derive a useful therapeutic composition unless the compounds were known to be effective and lacking in deleterious side effects when combined." Appeal Br. 12. Appellants additionally argue that "[t]he Examiner's assertions that the proposed combinations would have anti-acne properties are entirely conclusory and unsupported by any evidence that they would have any desirable biological effects." Reply Br. 4. We are not persuaded by these arguments. We agree with the Examiner that it would have been obvious to combine the anti-acne formulations taught by each of Niemiec and Martin, with a reasonable expectation that such a combination would also be an effective anti-acne formulation. Such a combination would be no more than "the predictable use of prior art elements according to their established functions." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,417 (2007); see also id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)) ("[W]hen a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious."). On this record, aside from the argument regarding the antioxidant, which we addressed above, Appellants have not pointed to persuasive evidence suggesting that the Niemiec or Martin formulations, either individually or in combination, would not treat acne, or that the chemical differences between salicylic acid, 10 Appeal2019-000792 Application 14/790,404 benzoyl peroxide, and zinc pyrithione would undercut the expected effects of the formulations as taught by those references. Attorney argument is "no substitute for evidence." See, e.g., Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). Finally, Appellants assert that there is a "long-felt but unresolved need for effective treatments for baldness as well as a rather spectacular number of failures of others." Appeal Br. 3, 20; see also Reply Br. 8-9. Even assuming that Appellants are correct about a long-felt need and failure of others, we determine that such factors do not overcome the prima facie case of obviousness here. It is not enough to merely point out a long-felt need or failure of others; Appellants must also demonstrate that their claimed invention satisfies the long-felt need and overcomes the failure of others. See, e.g., In re Cavanagh, 436 F.2d 491,496 (CCPA 1971) (noting that it is "incumbent upon appellant ... to bring forward evidence of his satisfaction of the need"). Appellants have not done so. For example, Appellants acknowledge that there are at least two known compounds that have "modest" efficacy in treating baldness. Appeal Br. 20; Spec. 2:3-5; see also Reply Br. 9. The record, however, contains no information as to whether the claimed preparations have better efficacy for baldness compared to the existing treatments so as to meet the long-felt, unmet need. Accordingly, on this record, Appellants' arguments on these secondary considerations of nonobviousness are insufficient to overcome the prima facie case of obviousness. 11 Appeal2019-000792 Application 14/790,404 SUMMARY We affirm the rejection of claim 2 under 35 U.S.C. § 103(a) as obvious over Niemiec and Martin. 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)(l )(iv). AFFIRMED 12 Copy with citationCopy as parenthetical citation