Ex Parte Tran et alDownload PDFPatent Trial and Appeal BoardFeb 14, 201912726326 (P.T.A.B. Feb. 14, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/726,326 03/17/2010 43734 7590 02/14/2019 RONALDJ. MEETIN, ATTORNEY AT LAW 210 CENTRAL A VENUE MOUNTAIN VIEW, CA 94043-4869 FIRST NAMED INVENTOR David Van Tran 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. R-0017 US 1003 EXAMINER BRANSON, DANIELL ART UNIT PAPER NUMBER 1616 MAIL DATE DELIVERY MODE 02/14/2019 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID VAN TRAN and DAVID NGUYEN TRAN Appeal 2018-001039 1, Application 12/726,326 Technology Center 1600 Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to methods for treating allergic rhinitis, hemorrhoids, toothache, dandruff, male itching, and bromhidrosis using a salt of peroxymonosulfuric acid. 2 The Examiner rejected the claims as containing new matter, as failing to comply with the enablement requirement, as indefinite, and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. 1 Appellants identify the Real Party in Interest as LuTran Industries, Inc. (see App. Br. 1 ). 2 We have considered and herein refer to the Specification of Mar. 1 7, 2010 ("Spec."); Non-Final Office Action of Nov. 30, 2016 ("Non-Final Act."); Appeal Brief of April 15, 2017 ("App. Br."); Examiner's Answer of Sept. 11, 2017 ("Ans."); and Reply Brief of Nov. 8, 2017 ("Reply Br."). Appeal2018-001039 Application 12/726,326 Statement of the Case Background "Peroxymonosulfates are generally strong oxidizing agents, i.e., they readily provide ( or release) oxygen under certain conditions at standard temperature (20-25°C) and standard pressure (760 torr)" (Spec. ,r 171). "The oxidizing capability of the peroxymonosulfate used in forming the medicinal drug of type I is believed to be a factor in the drug's effectiveness in combating bacterial, eukaryotic, prion, and viral pathogens that attack humans and in causing non-pathogenic-caused inflammation to be reduced in humans" (id. ,r 172). The Claims Claims 1-5, 8-12, 14--24, 26-30, and 61-94 are on appeal. 3 Independent claims 1 and 18 are representative below and read as follows: 1. A method comprising administering a medicinal drug to a person sufficiently to treat a medical condition of the person or/and to prevent the person from contracting the medical condition, the medicinal drug formed at least partially with salt of peroxymonosulfuric acid, the medical condition comprising at least one of allergic rhinitis, hemorrhoids, toothache, dandruff, male itching, and bromhidrosis. 18. A method comprising administering a medicinal drug non- topically to a person sufficiently to treat a virus-caused medical condition of the person or/and to prevent the person from contracting the medical condition, the medicinal drug formed at least partially with potassium hydrogen peroxymonosulfate. 3 The Examiner repeatedly recites "claims which depend therefrom" but fails to specifically list these claims in the statement of rejection (see, e.g., Non-Final Act. 4, 9). MPEP § 2103(I)(C) states "Examiners should begin claim analysis by identifying and evaluating each claim limitation." 2 Appeal2018-001039 Application 12/726,326 The Issues A. The Examiner rejected claims 1, 8, 22, 73, 79, and 85 under 35 U.S.C. § 112, first paragraph, new matter (Non-Final Act. 3--4). B. The Examiner rejected claims 1-5, 8-12, 14--24, and 26-30 under 35 U.S.C. § 112, first paragraph, scope of enablement (Non-Final Act. 4--8). C. The Examiner rejected claims 1-5, 8-12, 14--24, 26, and 61-94 under 35 U.S.C. § 112, second paragraph (Non-Final Act. 9-10). D. The Examiner rejected claims 1-5, 8-12, 14--24, 26-30, 72, 73, 78, 79, 84, and 85 under 35 U.S.C. § I03(a) as obvious over Bologna, 4 VirkonS, 5 VirkonS MSDS, 6 Martin, 7 Burkhart,8 Banerjee,9 and Weinstein 10 (Non-Final Act. 11-15). E. The Examiner rejected claims 61---68 under 35 U.S.C. § I03(a) as obvious over Weinfield 11 and Martin (Non-Final Act. 15-17). F. The Examiner rejected claims 1-5, 8-12, 14--24, 26-30, 72, 73, 78- 80, and 84--86 under 35 U.S.C. § I03(a) as obvious over Bologna, VirkonS, Martin, Burkhart, and Coleman 12 (Non-Final Act. 17-18). 4 Bologna et al., US 2003/0091644 Al, published May 15, 2003. 5 Virkon@S, The Ultimate Broad Spectrum Virucidal Disinfectant. 6 VirkonS, Virkon-S EPA Reg #62432-1, Material Safety Data Sheet Pharmacal Research Laboratories, Inc., www.pharmacal.com, revised Mar. 12, 2012, last visited Jan. 2019 ("VirkonS MSDS"). 7 Martin, US 2005/0062017 Al, published Mar. 24, 2005. 8 Burkhart et al., US 2007/0244195 Al, published Oct. 18, 2007. 9 Banerjee et al., Combined inhalational and oral supplementation of ascorbic acid may prevent influenza pandemic emergency: A hypothesis, 26 Nutrition 128-32 (2010). 10 Weinstein et al., Topical Treatment of Common Supeifzcial Tinea Infections, 65 Am. Family Physician 2095-102 (2002). 11 Weinfield, US 2010/0021530 Al, published Jan. 28, 2010. 12 Coleman, III, US 2003/0113349 Al, published June 19, 2003. 3 Appeal2018-001039 Application 12/726,326 G. The Examiner rejected claims 1-5, 8-12, 14--24, 26-30, 69, 71-73, 75, 77-79, 81, 83-85 and 87-94 under 35 U.S.C. § 103(a) as obvious over Bologna, VirkonS, Martin, Burkhart, and Ohmori 13 (Non-Final Act. 19-20). H. The Examiner rejected claims 1-5, 8-12, 14--24, 26-30, 70, 72, 73, 76, 78, 79, 82, 84, and 85 under 35 U.S.C. § 103(a) as obvious over Bologna, VirkonS, Martin, Burkhart, and Gallina14 (Non-Final Act. 20-22). A. 35 US.C. § 112,first paragraph, new matter The Examiner finds that claims "were amended or newly added to recite 'male itching[,]' but the [S]pecification does not provide support for differentiating between itching in one gender or the other" (Non-Final Act. 4). The Examiner finds that "in examples 41--43 where itching is treated, the itching is either located on the neck and back or involves itching over the whole body, itching which could affect males as well as females" (id.) Appellants contend: Using salt of peroxymonosulfuric acid to treat male itching is clearly disclosed in [S]pecification examples 41 - 43. Since the [S]pecification supports male itching, there is no need for the [S]pecification to differentiate between male itching and female itching. Whether salt of peroxymonosulfuric acid can be used to treat female itching is immaterial to the claims now limited to using salt of peroxymonosulfuric acid to treat male itching. (App. Br. 7). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner's finding that the Specification 13 Ohmori et al., US 5,135,952, issued Aug. 4, 1992. 14 Gallina, US 5,234,914, issued Aug. 10, 1993. 4 Appeal2018-001039 Application 12/726,326 fails to provide descriptive support for treatment of male itching using a salt of peroxymonosulfuric acid? Findings of Fact ("FF'') 1. Examples 41--43 of the Specification are reproduced below: Example 41 - itching: An adult male had extreme itching for 5 years. The male reported that he had tried many treatments for the itching without success. The Medicine was provided to the male as a 1 % solution for topical administration via complete-body immersion for 20 minutes 2 times a day for 2 weeks. The male reported that the itching had diminished by at least 50% on day 3 and that the itching was substantially gone at the end of the 2 weeks. The male reports that he now uses the Medicine twice a week as an itch preventative. Example 42 - itching: An adult male had itching throughout his body. The male stated that the itching was less at night than in the daytime. The male reported that he had tried many treatments, such as hydrocortisone, anti-histamines, and herbs, for the itching but without success. The Medicine was provided to the male as a 1 % topical administration via complete-body immersion for 10 minutes a day for 2 weeks. The male reported that he used the Medicine 3 times a week for 2 weeks and that the itching was substantially gone at the end of the 2 weeks. The male reports that he now uses the Medicine at an onset of the itching. Example 43 - itching: An adult male reported that he had red patches on his neck and back at birth, that the red patches began to itch as he reached middle age, and that he rubbed the red patches but did not scratch them for fear of tearing his skin. The male further reported that he had tried hydrocortisone and antihistamines to treat the itching but had little success. The Medicine was provided to the male as a 1 % solution for topical administration 3 times a day at 4-hour intervals for 2 weeks. The male reported that the itching was greatly reduced on day 5 and gone on day 10. The male reports that he now uses the Medicine once or twice a day for 2 days at an onset of the itching and that the itching then goes away. 5 Appeal2018-001039 Application 12/726,326 (Spec. ,r,r 289--291). Analysis In this case, the Specification provides express support for treatment of itching in males using a salt of peroxymonosulfuric acid (FF 1 ). We therefore agree with Appellants that the Specification provides support for treatment of "male itching." That this further limits the claim from itching in general is not an issue, because Appellants clearly have possession of a treatment of itching in males (FF 1 ). Conclusion of Law A preponderance of the evidence of record does not support the Examiner's finding that the Specification fails to provide descriptive support for treatment of male itching using a salt of peroxymonosulfuric acid. B. 35 US.C. § 112,first paragraph, scope of enablement The Examiner finds the [S]pecification, while being enabling for a method of treatment of allergic rhinitis, hemorrhoids, urticaria, toothache, tinea pedis, non-topical treatment of acute viral nasopharyngitis, dandruff, and bromhidrosis, it does not reasonably provide enablement for a method of prevention of hemorrhoids, all toothaches, allergic rhinitis and every virus- caused medical condition unlimited to any timeframe or treatment of every medical condition caused by a virus. (Non-Final Act. 4). Appellants contend there is sufficient information in the [S]pecification for medical doctors to develop medical prevention plans for administering medicinal drugs fanned respectively at least partially with salt of peroxymonosulfuric acid, potassium hydrogen peroxymonosulfate, and potassium monopersulfate triple salt 6 Appeal2018-001039 Application 12/726,326 composition to treat or/and prevent hemorrhoids, toothache, and allergic rhinitis of specific patients as well as virus-caused medical conditions of specific patients using topical administration. (App. Br. 12). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner's conclusion that the Specification does not enable the full scope of the claimed invention? Findings of Fact Breadth of Claims 2. Claims 14, 18, and 27 broadly encompass treatment or prevention of any "virus-caused medical condition" using potassium hydrogen peroxymonosulfate. 3. Claims 1, 8, and 22 broadly encompass treatment or prevention of, among other listed diseases, any allergic rhinitis, any hemorrhoids, any toothaches and any itching in men using any salt of peroxymonosulfuric acid. Presence of Working Examples 4. The Specification provides evidence in the form of short term treatment of patients with viral medical conditions including five patients with viral nasopharyngitis (Spec. ,r,r 276-280, (Examples 28-32)) and four patients with herpes simplex virus (Spec. ,r,r 281-284 (Examples 33-36)). 5. The Specification provides evidence in the form of short term treatment of five patients with allergic rhinitis (Spec. ,r,r 249-253 (Examples 1-5) ), four patients with hemorrhoids (Spec. ,r,r 263-266 (Examples 15- 18) ), three patients with toothaches (Spec. ,r,r 271-273 (Examples 22-24)), three patients with male itching (Spec. ,r,r 289-291 (Examples 41--43)). 7 Appeal2018-001039 Application 12/726,326 Amount of Direction or Guidance Presented 6. The Specification asserts: In accordance with the invention, people afflicted with diseases and other debilitating medical conditions caused by bacterial, eukaryotic, prion, and viral pathogens, again including fungal, spore-caused, and parasitic infections, and by nonpathogenic- caused inflammation are treated with a medicinal drug formed at least partially with water-soluble inorganic halide and an oxidizing agent reactable in water, typically aqueous solution, with the halide to generate hypohalite ions. (Spec. ,r 199). 7. The Specification teaches that "topical technique is often used to administer the medicinal drug of type I or II" and that "[ n ]on-topical techniques for administering the drug of type I or II include oral administration, intranasal administration, intraoptical administration, vaginal administration, rectal administration, urethral administration, and injection alternately referred to as infusion or parenteral administration" (Spec. ,r,r 233-234). 8. The Specification states the "dosages of the medicinal drug of type I or II varies depending upon the selected route of administration, the recipient's characteristics, including age, body weight, general state of health, desired therapeutic effect, the duration of the treatment, and the disease or other debilitating medical condition being treated" (Spec. ,r 242). 8 Appeal2018-001039 Application 12/726,326 Relative skill in the art 9. The Examiner finds the "relative skill of those in the pharmaceutical development and medical treatment arts is high, requiring advanced education and training" (Non-Final Act. 5). State of the Prior Art and Unpredictability of the Art 10. The Specification teaches that: "[m]edications to treat aspergilloma have not been shown to eradicate the fungi" (Spec. ,r 17); that "[ r ]esearch is ongoing to find safe and effective treatments for debilitating conditions produced by spore pathogens" (Spec. ,r 20); that "viruses are difficult to eliminate without killing the host cells" (Spec. ,r 29); that "vaccines do not guarantee complete protection from many diseases, particularly viral diseases" (Spec. ,r 34); and that "[t]here is currently no cure or treatment to eradicate herpes simplex 1 or 2 from the body at activations of HSV-1 or HSV-2" (Spec. i146). 11. The Specification teaches that "[ u ]rticaria, or hives, is a skin condition characterized by raised red skin welts," "is generally caused by direct contact with an allergenic substance or an immune response to food or some other allergen but can appear for other reasons," and "can be very difficult to treat" (Spec. ,r,r 66-67). The Specification teaches that "[i]tching can be related to anything from dry skin to cancer" (Spec. ,r 80). 12. Okeson teaches that toothache pain "may not be of dental origin" and that "[ n ]on-odontogenic toothaches are often difficult to identify and can challenge the diagnostic ability of the clinician" (Okeson, Abstract). 15 15 Okeson et al, Non-odontogenic toothache, 79 Northwest Dent. 37--44 (2000) Abstract only. 9 Appeal2018-001039 Application 12/726,326 13. Misra teaches "[ d]rugs can reduce oedema, relieve pain and help in thrombosis, but cannot definitively cure haemorrhoids" (Misra 1490, col. 1 ). 16 Quantity of Experimentation 14. The Examiner finds that it would require a "novel and extensive research program to show that the instant claimed compositions treat and eliminate the risk of developing every type of medical condition caused by a virus, allergic rhinitis, hemorrhoids and toothache, regardless of etiology" (Non-Final Act. 7-8). 15. The Specification teaches the "efforts of researchers in developing treatments for viral infections have been repeatedly frustrated by both the morphology and the metabolic nature of viruses. In brief, no efficient way for treating many viral diseases is currently available" (Spec. if 50). Principles of Law When rejecting a claim under the enablement requirement of section 112, the PTO bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the [S]pecification of the application. In re Wright, 999 F.2d 1557, 1561---62 (Fed. Cir. 1993). Factors to be considered in determining whether a disclosure would require undue experimentation ... include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state 16 Misra et al., Drug Treatment of Haemorrhoids, 65 Drugs 1481-91 (2005). 10 Appeal2018-001039 Application 12/726,326 of the prior art, ( 6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). Analysis In addressing the Wands factors, the Examiner has provided substantial evidence of unpredictability that relates to several different dimensions of claim scope. The scope of independent claims 14, 18, and 2 7 encompasses treatment of any virus whatsoever, but the evidence of record is drawn solely to nine patients, five with viral nasopharyngitis and four patients with herpes simplex virus (FF 4). The Specification itself recognizes that "viruses are difficult to eliminate without killing the host cells" (Spec. ,r 29); that "vaccines do not guarantee complete protection from many diseases, particularly viral diseases" (Spec. ,r 34 ); and that "[ t ]here is currently no cure or treatment to eradicate herpes simplex 1 or 2 from the body at activations ofHSV-1 or HSV-2" (Spec. ,r 46) (FF 10). The Specification further notes there is "no efficient way for treating many viral diseases is currently available" (FF 14 ). Other than generic treatment recitations (FF 8), the Specification does not provide evidence or reasoning that would predictably demonstrate that the claimed treatment would be expected to treat any viral infection in a patient, ranging from the flu virus and rhinovirus causing the common cold, to measles virus, HIV, and ebola viruses. Viruses differ in their surface proteins, in the presence or absence of a lipid bilayer, in whether their genome is DNA or RNA, whether their genome is double or single stranded, the cell tropism of infection, and many other parameters. 11 Appeal2018-001039 Application 12/726,326 Therefore, in light of the limited working examples and disclosure in the Specification, the large and unpredictable amount of experimentation necessary, and the very large breadth of claims 14, 18, and 27, we agree with the Examiner that the Specification does not enable the broad scope of claims 14, 18, and 27. Similarly, the scope of independent claims 1, 8, and 22 encompasses treatment of any type of itching in men in any location due to any cause ranging from infections such as impetigo or folliculitis to allergic reactions such as some types of dermatitis, agents such as poison ivy, and medication induced itching. These claims also encompass any type of toothache pain, whether caused by an abscess or infection, inflammation, tooth decay or a cracked tooth (see, e.g., Spec. ,r 70). There are working examples of only three patients with toothache and three with male itching (FF 5). All three of these toothache patients were individuals whose pain was due to tooth extraction and not due to abscess, infection, inflammation, tooth decay, cracked teeth, or other causes of toothache (see Spec. ,r,r 270-272). Thus, these working examples do not provide evidence commensurate with the scope of the claim. Similarly, the male itching patients are limited to three examples and are not commensurate with the scope of the claim (see Spec. i-fi-f 289--291). The Specification provides little guidance on specific clinical treatments that would address the full scope of these claims (FF 7, 8). The Specification itself demonstrates that treatment of conditions including itching is unpredictable (FF 11 ). Moreover, the Examiner cites Okeson to establish that toothache treatment can be difficult due to diagnostic concerns 12 Appeal2018-001039 Application 12/726,326 (FF 12) and cites Misra to establish some degree of unpredictability in hemorrhoid treatment (FF 13). Therefore, in light of the limited working examples and disclosure in the Specification, the large and unpredictable amount of experimentation necessary, and the large breadth of claims 1, 8, and 22, we agree with the Examiner that the Specification does not enable the broad scope of claims 1, 8, and 22. See In re Fisher, 427 F.2d 833, 839 (CCPA 1970) ("[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the [S]pecification to persons of ordinary skill in the art."). Appellants contend the disclosed information is sufficient for medical doctors to develop medical plans for administering medicinal drugs formed respectively at least partially with salt of peroxymonosulfuric acid, potassium hydrogen peroxymonosulfate, and potassium monopersulfate triple salt composition to prevent hemorrhoids, toothache, and allergic rhinitis of specific patients as well as virus-caused medical conditions of specific patients using topical administration. (App. Br. 13). We are not persuaded. Decisions by the Federal Circuit support the conclusion of undue experimentation. In Alza, the specific compound, methylphenidate, used for treating ADHD was known and the "enablement issue reduce[ d] to factual considerations with regard to whether undue experimentation is required to make oral dosage forms other than osmotic dosage forms that meet the limitations of the claims." Alza Corp. v. Andrx Pharm., LLC, 603 F.3d 935, 938 (Fed. Cir. 2010). In that much simpler situation, where the compound was known to be effective and alternative dosage forms were known to exist, Alza found that the "Wands factors weigh 13 Appeal2018-001039 Application 12/726,326 in favor of finding that the experimentation required to practice part of the claimed invention was not routine." Id. at 943-944. Here, where there are a variety of different medical conditions being treated and substantial evidence of unpredictability, the Wands factors also weigh in favor of a finding that the experimentation necessary to enable the rejected claims was not routine. Appellants also contend that It is certainly possible, perhaps even probable, that the methods recited in claims 1, 8, and 22 will not prevent hemorrhoids, toothache, and allergic rhinitis in all instances and that the topical-drug-administration methods recited in claims 14, 22, and 27 will not prevent virus-caused in all instances. However, this in itself is insufficient to find claims 1, 8, 14, 18, 22, and 27 and their dependent claims to lack enablement by the [S]pecification in light of all the dosage concentrations, drug administration intervals, drug administration procedures, and so on regarding medical treatment recited in the specification for treating and preventing hemorrhoids, toothache or allergic rhinitis. (Reply Br. 5). We find this argument unpersuasive because Enablement serves the dual function in the patent system of ensuring adequate disclosure of the claimed invention and of preventing claims broader than the disclosed invention .... This important doctrine prevents both inadequate disclosure of an invention and overbroad claiming that might otherwise attempt to cover more than was actually invented. Thus, a patentee chooses broad claim language at the peril of losing any claim that cannot be enabled across its full scope of coverage. MagSil Corp. v. Hitachi Global Storage Technologies, Inc., 687 F.3d 1377, 1380-1381 (Fed. Cir. 2012). Appellants did not identify credible evidence rebutting the evidence advanced by the Examiner that the claimed methods would not reliably or predictably treat the full scope of viral infections, 14 Appeal2018-001039 Application 12/726,326 toothaches, and itches encompassed by the claims. Accordingly, the Examiner had reasonable scientific basis to find the claims to be overbroad and not enabled for their full scope of coverage. Conclusion of Law A preponderance of the evidence of record supports the Examiner's conclusion that the Specification does not enable the full scope of the claimed invention. C. 35 US.C. § 112, second paragraph The Examiner finds that claims "recite 'male itching' yet no definition of this phrase is given in the specification. Itching has many different etiologies, most of which affect both females as well as males" (Non-Final Act. 9). The Examiner finds that "it is unclear if the claim is limited to only those causes of itching that can only affect males, such as fungal infection of male genitalia ('jock itch'), or if this recitation in the claim reads on other causes of itching which affect males, but can affect females as well" (id.). The Examiner also finds the phrase "medicinal drug formed at least partially with salt of peroxymonosulfuric acid" indefinite because "it would have been unclear what the metes and the bounds of the claims were and whether a peroxymonosulfate was actually required by the claim" (Non- Final Act. 9--10). Appellants contend "whether salt of peroxymonosulfuric acid can be used to treat female itching is immaterial to the claims now limited to using salt of peroxymonosulfuric acid to treat male itching" (App. Br. 14). Appellants also contend "there is no ambiguity as to what constitutes salt of peroxymonosulfuric acid" and a "claim recitation that a medicinal drug is 15 Appeal2018-001039 Application 12/726,326 'formed at least partially with salt of peroxymonosulfuric acid' necessarily requires that the medicinal drug be formed at least partially with the chemical composition known as salt of peroxymonosulfuric acid" (App. Br. 16). We agree with Appellants. The term "male itching" is not indefinite, but rather broad. That is, any itching experienced by a person identifying as male would constitute "male itching." While we agree with the Examiner that the breadth of the claim raises a scope of enablement issue as affirmed above, this unsupported breadth does not mean it is indefinite. In re Johnson, 558 F.2d 1008, 1016 n. 17 (CCPA 1977). Even "undue breadth is not indefiniteness." Id. As to the phrase "medicinal drug formed at least partially with salt of peroxymonosulfuric acid," we agree with Appellants that claim 1 necessarily includes some amount of a salt of peroxymonosulfuric acid as expressly recited. Again, the claim broadly encompasses situations where the drug is entirely composed of the salt of peroxymonosulfuric acid and situations where the drug has this salt as a relatively minor constituent, so long as the amount of peroxymonosulfuric acid functions to "treat a medical condition" and/or "to prevent the person from contracting the medical condition" as also required by claim 1. We therefore reverse the rejections of claims under 35 U.S.C. § 112, second paragraph as indefinite. 16 Appeal2018-001039 Application 12/726,326 D. 35 US.C. § 103(a) over Bologna, VirkonS, VirkonS MSDS, Martin, Burkhart, Bane,jee, and Weinstein The Examiner finds Bologna teaches the "use of unexpectedly low concentrations of peroxide over an extended period of time to treat or prevent infections without irritation" where the "peroxide source may be benzoyl peroxide or a salt of peroxomonosulfuric acid" (Non-Final Act. 11- 12). The Examiner acknowledges that Bologna does not "specifically teach the medical condition treated is one listed in either of claims 1 or 8 or is a viral infection" (id.). The Examiner finds that Virkon comprises potassium peroxymonosulfate and the Virkon S reference demonstrates that Virkon has been proven to have virucidal, bactericidal, sporicidal and fungicidal efficacy, including efficacy against the herpes simplex virus, corona virus, which Banerjee et al. evidences is one of the most likely causes of acute viral nasopharyngitis ... and the fungus trichophyton rubrum, which Weinstein evidences is the cause of most tineas, including tinea pedis as well as tinea cruris (IE jock itch). (Non-Final Act. 12). The Examiner finds Martin teaches a composition with minimal amounts of a "byproduct that is usually found in potassium monopersulfate salt compositions [and] is extremely irritating when it comes in contact with its users" (id. at 13). The Examiner finds Burkhart teaches a "composition comprising benzoyl peroxide to treat dandruff and jock itch" (id.). The Examiner finds it obvious to use a "salt of peroxymonosulfuric acid of Bologna et al. in a method of treating or preventing herpes simplex infection, acute viral nasopharyngitis, dandruff and male itching (IE jock itch) as Virkon teach that potassium peroxymonosulfuric acid is effective at 17 Appeal2018-001039 Application 12/726,326 killing the virus and fungus responsible for these conditions" (Non-Final Act. 13). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner's conclusion that the prior art renders the claims obvious? Findings of Fact 16. Bologna teaches "the use of unexpectedly low concentrations of peroxide over an extended period of time to provide a beneficial effect by treating or preventing vaginal infections without ... causing significant irritation of the sensitive tissues of the vagina" (Bologna ,r 19). 17. Bologna teaches the "peroxide source may be selected from a variety of sources, both organic and inorganic. Typical forms of peroxide sources are those used for treating mucosa and related epithelial tissue .... Preferably the peroxide source is one of the following forms ... benzoyl peroxide [or] peroxomonosulfuric acid and its salts)" (Bologna ,r 30). 18. VirkonS teaches a broad spectrum virucidal disinfectant that was safe "in the drinking water of broiler chicks" as well as safe for "spraying and fogging over broiler chicks" (VirkonS, 1 ). VirkonS teaches "[ c ]omplete control - aerial, surface, and water system disinfectant" (VirkonS, 2). 19. Virkon MSDS teaches that VirkonS is composed of 1 % potassium peroxymonosulfate and 99% water (see Virkon MSDS 1 ). 20. Banerjee teaches "acute viral nasopharyngitis, is a mild, self- limiting infectious disease that can be caused by more than 100 different viruses. Of these, rhinovirus and corona virus are responsible for approximately 50-70% of all common colds" (Banerjee 128, col. 1 ). 18 Appeal2018-001039 Application 12/726,326 21. Weinstein teaches "[ t ]richophyton rubrmn is the most common pathogen causing dermatomycoses, including tinea pedis, tinea corporis, and tinea cruris" (Weinstein 2096, col. 1; emphasis omitted). 22. Burkhardt teaches "[a]pplying the benzoyl peroxide in a gel (or cream) form in an alcohol base on top of the two sprays directly onto the skin surface .... We are finding this combination helpful in treating fungal infections (jock itch, athlete's foot, nail fungus)" (Burkhardt ,r,r 112-113). Principles of Law A prima facie case for obviousness "requires a suggestion of all limitations in a claim," CFMT, Inc. v. Yieldup International Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR International Co. v. Teleflex Inc., 550 U.S. 398,418 (2007). Analysis Claims 1, 8, and 22 We focus our analysis on "male itching" because each of these claims recites different types of medical conditions including "male itching". We interpret 'jock itch" and "athlete's foot" as types of "male itching" consistent with the Specification's teaching that "[a]n itch is a sensation felt on an area of skin which causes a person to scratch the area. Itching can be related to anything from dry skin to cancer" (Spec. ,r 80). We note the Board may rely on less than all of the references applied by the Examiner in an obviousness rationale without designating it as a new ground of rejection. In re Bush, 296 F.2d 491,496 (CCPA 1961). We also note that "where a rejection is predicated on two references each containing 19 Appeal2018-001039 Application 12/726,326 pertinent disclosure ... we deem it to be of no significance, but merely a matter of exposition, that the rejection is stated to be on A in view of B instead of on B in view of A, or to term one reference primary and the other secondary." Id. Burkhardt teaches administering benzoyl peroxide to a person for treatment of conditions including jock itch and athletes foot (FF 22). Burkhardt does not suggest the use of a salt of peroxymonosulfuric acid. Bologna teaches treatment of infections, including yeast infections, using peroxides (FF 16) and teaches "the peroxide source is one of the following forms ... benzoyl peroxide [or] peroxomonosulfuric acid and its salts)" (FF 17). The Examiner reasons that as Bologna et al. demonstrate that benzoyl peroxide and salts of peroxomonosulfuric acids are known equivalents in the art and as Burkhart et al. teach that the use of a composition comprising benzoyl peroxide to treat jock itch (IE male itching) ... it would have been obvious to one of ordinary skill in the art to utilize salts of peroxomonosulfuric acids to attempt to treat ... male itching. (Non-Final Act. 14). We agree with the Examiner that selecting such known equivalents would have been obvious. See KSR, 550 U.S. at 417 ("If a person of ordinary skill can implement a predictable variation, [section] 103 likely bars its patentability.") This result is also consistent with Wrigley, which found a "strong case of obviousness based on the prior art references of record. [The claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to 20 Appeal2018-001039 Application 12/726,326 substitute one well-known ... agent for another." Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). Here, where the substitution is selection of a different peroxide for treatment of jock itch where both peroxides were disclosed in a single reference as useful in the treatment of infections, including yeast (i.e. fungal) infections, we agree with the Examiner that the ordinary artisan would have had reason to substitute one well-known peroxide for another. Appellants respond that "[ n ]othing has been presented during the examination of this application to show that benzoyl peroxide is generally interchangeable with peroxymonosulfuric acid or its salts" (App. Br. 25). We find this argument unpersuasive because Bologna teaches treatment of fungal infections with peroxide sources (FF 16) and teaches the interchangeability of benzoyl peroxide and peroxymonosulfuric acid expressly, teaching "[p ]referably the peroxide source is one of the following forms ... benzoyl peroxide [or] peroxomonosulfuric acid and its salts)" (FF 17). Appellants contend "benzoyl peroxide ... is chemically structured very differently from both peroxymonosulfuric acid" and that "[ w ]hile benzoyl peroxide and (certain) salts of peroxomonosulfuric acid may serve as peroxide sources peroxide, this does not mean that benzoyl peroxide and (certain) salts ofperoxomonosulfuric acid are equivalents in the art" (App. Br. 25-26). We find this argument unpersuasive. At a minimum, Bologna suggests these two compounds are equivalent in function (FF 17). In any case of substituting equivalents, the structure will necessarily differ, or there would be no substitution, so this argument from structure is not persuasive. 21 Appeal2018-001039 Application 12/726,326 Moreover, to the question of whether benzoyl peroxide and salts of peroxomonosulfuric acid are equivalent in function, Appellants only provide attorney argument rather than evidence. However, "[a]ttorney's argument in a brief cannot take the place of evidence." In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Appellants contend that there would not have been a reasonable expectation of success because regarding treatment using substituted compounds, "[ s ]uch results are just too difficult to predict, especially here where benzoyl peroxide is chemically structured very differently from both peroxymonosulfuric acid and potassium hydrogen peroxymonosulfate" (App. Br. 26). We find this argument unpersuasive for several reasons. First, the efficacy of both of the compounds against fungi in Bologna along with the efficacy of benzoyl peroxide against jock itch in Burkhardt (FF 1 7, 22) supports a finding of a reasonable expectation of success in using a known effective fungal treatment agent against a known disease. "[O]bviousness does not require absolute predictability of success ... all that is required is a reasonable expectation of success." In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) ( emphasis omitted). Second, Appellants provide no rebuttal evidence, only attorney argument. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (Arguments and conclusions unsupported by factual evidence carry no evidentiary weight.) Third, as noted above, the structural differences between the compounds provides no support for Appellants' argument regarding efficacy because both compounds are peroxides and function due to the peroxide source (FF 17). 22 Appeal2018-001039 Application 12/726,326 Appellants point to a related case in which unpredictability was asserted by the Examiner (see App. Br. 27-28). We find this argument unpersuasive because "[ e Jach case must be decided on its own merits." In re Gyurik, 596 F.2d 1012, 1016 (CCPA 1979). Claims 14, 18, and 27 We note that these claims broadly recite treatment of viruses "non- topically" with the peroxymonosulfuric acid salt. Appellants contend "nothing in the Virkon S webpages or in the Virkon S MSDS indicates that any of the Virkon S testing on human- infecting pathogens was done in vivas, i.e., on living humans" (App. Br. 22). Appellants contend the "fact that a disinfectant successfully kills or otherwise neutralizes a pathogen in an in vitro environment does not mean that that the disinfectant will successfully kill or otherwise neutralize the pathogen when it is carried by a living human without causing significant injury to the human" (App. Br. 23). The Examiner responds one of ordinary skill in the art would have had a reasonable expectation of successfully treating the claimed conditions because the Virkon S reference demonstrates that this compound successfully combats the pathogens responsible for these conditions and because in vivo tests were conducted in Virkon S demonstrating that Virkon S is both safe and effective at treating conditions in vivo. (Ans. 9 (emphasis omitted)). We agree with Appellants because VirkonS is focused on a virucide that functions as an "aerial, surface, and water system disinfectant" (FF 18). The Examiner does not provide an adequate reason why a disinfectant would be used "non-topically" (i.e., internally) to treat viral infections of a patient 23 Appeal2018-001039 Application 12/726,326 as required by claims 14, 18, and 27. Just because VirkonS may demonstrate that the compound is safe if present in drinking water of broiler chicks in order to disinfect their water, does not suggest that the disinfectant was intended or would function to treat or prevent a viral infections occurring inside the chickens. Indeed, as our affirmance of the scope of enablement rejection above demonstrates, there is substantial unpredictability as to whether a salt of peroxymonosulfuric acid would function to treat viruses at all. The Examiner provides no evidence using this compound to treat or prevent virus infections with a non-topical mode of administration, nor does the Examiner provide a reasonable expectation of success for using a non-topical peroxide in treatment or prevention of viruses. Conclusion of Law A preponderance of the evidence of record support the Examiner's conclusion that the prior art renders claims 1, 8, and 22 obvious. A preponderance of the evidence of record does not support the Examiner's conclusion that the prior art renders claims 14, 18, and 27 obvious. E. 35 US.C. § 103(a) over Weinfield and Martin The Examiner finds that W einfield teaches topical application of "an anti-infective agent, such as potassium peroxymonosulfate" "to treat a fungal infection, such as onychomycosis" (Non-Final Act. 15). The Examiner finds that W einfield teaches "organisms which produce nail infections also produce a chronic type of tinea pedis" (id.). The Examiner finds the treatment agent would have "successfully treated the infection in 24 Appeal2018-001039 Application 12/726,326 skin of the foot (tinea pedis) as the infection is caused by the same fungus" (id.). The Examiner acknowledges that Weinfield doesn't teach "the specific salts that are used to treat or prevent the medical condition and that the disease treated is athlete's foot" (Non-Final Act. 16). The Examiner finds Martin teaches "a potassium monopersulfate triple salt composition" that lacks a byproduct that "is extremely irritating when it comes in contact with its users" (Non-Final Act. 16). The Examiner finds it obvious to "utilize the potassium monopersulfate triple salt of Martin in the method of W einfield because Martin teaches his salt is substantially free of the extremely irritating byproduct" (id.). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner's conclusion that the prior art renders claims 61---68 obvious? Findings of Fact 23. Weinfield teaches "a system and method for delivering an anti- infective agent through the nail of a subject having a nail infection such as, for example, onychomycosis" (Weinfield ,r 11 ). 24. Weinfield teaches "the anti-infective agent can comprise a multifunctional component that functions as an antifungal, antibacterial, surfactant, keratolytic, and drying agent. ... [T]he anti-infective agent comprises a component selected from the group consisting of ... potassium peroxymonosulfate" (Weinfield ,r 16). 25. Weinfield teaches a "subject having an onychomycosis diagnostic of a Trichophyton genus was treated .... The presence of fungal hyphae in the subject was consistent with Trichophyton Rubrum or 25 Appeal2018-001039 Application 12/726,326 Trichophyton Mentagrophytes. Nails infected with these organisms also produce a chronic type of tinea pedis" (Weinfield ,r 78). 26. Martin teaches a method of "production [ of] potassium monopersulfate having low oxodisulfate byproduct" (Martin ,r 2). Martin teaches the triple salt form "makes a good ... component in ... cleansing agents" but "is limited in its utility because of the presence of an irritating byproduct" that "can cause undesirable effects on humans" (Martin ,r,r 3--4). 27. Martin teaches production of a triple salt of potassium monopersulfate that "has an active oxygen content higher than 4.3 and has substantially no irritant" (Martin ,r 98). Analysis We agree with and adopt the Examiner's position with regard to this rejection (Non-Final Act. 15-17, FF 23-27). We address Appellants arguments below. Appellants contend "[n]owhere, as far as Applicants' Attorney can determine, does W einfield mention tinea pedis by that name or by either of its other common names athlete's foot and ringworm of the foot" (App. Br. 30). We note that this is incorrect because W einfield specifically teaches that tinea pedis is found in infected nails (FF 25), Weinfield teaches treatment of such nails with an anti-infective agent (FF 23), and Weinfield teaches that one such agent is potassium peroxymonosulfate (FF 24). Appellants contend that "Martin does not disclose that a medicinal drug formed at least partially with salt of peroxymonosulfuric acid is used to treat any debilitating human medical condition or to prevent a person from contracting any debilitating human medical condition" (App. Br. 30). 26 Appeal2018-001039 Application 12/726,326 We note that Weinfield teaches potassium peroxymonosulfate, a potassium salt, as well as the use of this compound for treatment of infections including tinea pedis and therefore renders claim 61 obvious alone (FF 23-25). The Examiner cited Martin to address the triple salt composition of claims 66-68. Martin teaches synthesis of a triple potassium salt as required by claims 66-68 (FF 26-27). We agree with the Examiner that the ordinary artisan, interested in using a salt form of peroxymonosulfuric acid, would have looked to Martin's formulation because Martin teaches that this formulation lacks an irritating byproduct "that can cause undesirable effects on humans" (FF 26). Thus, an ordinary artisan would have had reason to select Martin's formulation of the potassium peroxymonosulfate as that used in Weinfield's method of treating infective diseases such as tinea pedis in order to minimize irritation in the patients (FF 23-27). Appellants point to a related case in which unpredictability was asserted by the Examiner (see App. Br. 30-32). We find this argument unpersuasive because "[ e Jach case must be decided on its own merits." Gyurik, 596 F.2d at 1016. Conclusion of Law A preponderance of the evidence of record supports the Examiner's conclusion that the prior art renders claims 61---68 obvious. F.-H 35 US.C. § 103(a) rejections Appellants contend "[rr]othing in Coleman indicates that botulinum toxin reacts similarly to peroxymonosulfuric acid, potassium hydrogen peroxymonosulfate, or potassium monopersulfate triple salt composition. 27 Appeal2018-001039 Application 12/726,326 As far as Applicants' Attorney can determine, Coleman is totally irrelevant" (App. Br. 33-34). Appellants similarly contend that Ohmori "is totally irrelevant" and that "Gallina is totally irrelevant" (App. Br. 36-39). The Examiner responds that One of ordinary skill in the art would have found it obvious to utilize salts of peroxymonosulfuric acid as a preservative in the compositions taught by Coleman, Ohmori and Gallina for use in treating the selected medical conditions because each of these references teaches including a preservative and Virkon S demonstrates that salts of peroxymonosulfuric acid demonstrate excellent broad spectrum of antimicrobial properties characteristic of a preservative. (Ans. 14--15 (emphasis omitted)). We agree with Appellants. The Examiner does not provide any persuasive reason to select the components of Coleman, Ohmori, or Gallina for use with the peroxymonosulfuric acid and salts in Bologna or VirkonS. The use of a preservative in these references does not persuade us that the Examiner has established a prima facie case of obviousness. We therefore reverse these rejections. SUMMARY17 In summary, we reverse the rejection of claims 1, 8, 22, 73, 79, and 85 under 35 U.S.C. § 112, first paragraph, new matter. We affirm the rejection of claims 1-5, 8-12, 14--24, and 26-30 under 35 U.S.C. § 112, first paragraph, scope of enablement. We reverse the rejection of claims 1-5, 8-12, 14--24, 26, and 61-94 17 We note that claims 69-71, 74--77, 80-83, and 86-94 are not subject to any pending affirmed rejections. 28 Appeal2018-001039 Application 12/726,326 under 35 U.S.C. § 112, second paragraph. We affirm the rejection of claims 1, 8, and 22 under 35 U.S.C. § 103(a) as obvious over Bologna, VirkonS, VirkonS MSDS, Martin, Burkhart, Banerjee, and Weinstein. Claims 2-5, 9-12, 23, 24, 26, 72, 73, 78, 79, 84, and 85 fall with claims 1, 8, and 22. We reverse the rejection of claims 14, 18, and 27 under 35 U.S.C. § 103(a) as obvious over Bologna, VirkonS, VirkonS MSDS, Martin, Burkhart, Banerjee, and Weinstein. We also reverse the rejection of dependent claims 15-17, 19-21, and 28-30. We affirm the rejection of claims 61---68 under 35 U.S.C. § 103(a) as obvious over Weinfield and Martin. We reverse the rejection of claims 1-5, 8-12, 14--24, 26-30, 72, 73, 78-80, and 84--86 under 35 U.S.C. § 103(a) as obvious over Bologna, VirkonS, Martin, Burkhart, and Coleman. We reverse the rejection of claims 1-5, 8-12, 14--24, 26-30, 69, 71- 73, 75, 77-79, 81, 83-85 and 87-94 under 35 U.S.C. § 103(a) as obvious over Bologna, VirkonS, Martin, Burkhart, and Ohmori. We reverse the rejection of claims 1-5, 8-12, 14--24, 26-30, 70, 72, 73, 76, 78, 79, 82, 84, and 85 under 35 U.S.C. § 103(a) as obvious over Bologna, VirkonS, Martin, Burkhart, and Gallina. 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-IN-PART 29 Copy with citationCopy as parenthetical citation