Ex Parte ThorntonDownload PDFPatent Trial and Appeal BoardSep 9, 201613588910 (P.T.A.B. Sep. 9, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/588,910 08/17/2012 29747 7590 09/13/2016 GREENBERG TRAURIG (L V) 77 West Wacker Drive, Suite 3100 Intellectual Property Department Chicago, IL 60601 FIRST NAMED INVENTOR Joseph P. Thornton 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. 119095.010700 4241 EXAMINER GAR YU, LIANKO G ART UNIT PAPER NUMBER 1676 NOTIFICATION DATE DELIVERY MODE 09/13/2016 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): gtipmail@ gtlaw .com clairt@gtlaw.com rupickd@gtlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSEPH P. THORNTON Appeal2015-000456 Application 13/588,910 Technology Center 1600 Before FRANCISCO C. PRATS, JEFFREYN. FREDMAN, and JOHN G. NEW, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL r-T"I .. • • .. 1 .. ,..... ,_ TT r'1 I'\ l\ -1,..... Al • "1 • "1 • , "1"1 ims 1s an appear unaer j) u.~.L. s U4 mvo1vmg crnm1s to an orauy ingested tablet. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Statement of the Case Background "[T]here exists a need for natural treatment to more reliably and efficiently treating hemorrhoids" (Spec. i-f 3). "Accordingly, one embodiment of the present invention is a supplement tablet or pill including 1 Appellant identifies the Real Party in Interest as Nevada Medical Resources, LLC. (see Br. 1 ). Appeal2015-000456 Application 13/588,910 at least one or more anti-inflammatory agents and a laxative agent" (Spec. iT 4). The Claims Claim 1 is on appeal and reads as follows: 1. An orally ingested tablet comprising: Brome lain; an anti-inflammatory agent comprising Witch Hazel leaf and a laxative agent comprising Psyllium husk powder; and one or more of the following ingredients: Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid and/or Silicon Dioxide. The Issue The Examiner rejected claim 1under35 U.S.C. § 103(a) as obvious over Woods,2 Advanced Health Consultants,3 and Miller4 (Final Act. 3-5). The Examiner finds that "Woods teaches a formulation comprising bromelain and psyllium husk powder wherein the formulation is in the form of a tablet" but that Woods does not teach inclusion of "witch hazel leaf and one or more of the following ingredients: dicalcium phosphate, cellulose, croscarmellose sodium, steric acid, or silicon dioxide" (id. at 4). 2 Woods, C., US 2007/0065456 Al, published Mar. 22, 2007 ("Woods"). 3 Advanced Health Consultants, http://www.hemorrhoidtreatmentonline.com/How It Works.html (Accessed Oct. 29, 2012) (2008) ("Advanced Health Consultants"). 4 Miller, W., US 2007/0031398 Al, published Feb. 8, 2007 ("Miller"). 2 Appeal2015-000456 Application 13/588,910 The Examiner finds that "Advanced Health Consultants teach a composition for the treatment of hemorrhoids comprising psyllium and witch hazel leaf (an anti-inflammatory agent)" (id.). The Examiner finds that "Miller teaches a composition in the form of a tablet (an orally ingested tablet) comprising bromelain, microcrystalline cellulose, and silicon dioxide wherein silicon dioxide and microcrystalline cellulose are utilized as excipients" (id.). The Examiner finds it obvious to "combine bromelain and witch hazel together as a single formulation because each pharmaceutical agent was known and/or suggested to have the same therapeutic effect (i.e., anti- inflammatory) ... [and] with microcrystalline cellulose and silicon dioxide because microcrystalline cellulose and silicon dioxide are customary pharmaceutical excipients" (Final Act. 4--5). The issues with respect to this rejection are: (i) Does a preponderance of the evidence of record support the Examiner's conclusion that Woods, Advanced Health Consultants, and Miller render claim 1 obvious? (ii) If so, has Appellant presented evidence of secondary considerations, that when weighed with the evidence of obviousness, is sufficient to support a conclusion of non-obviousness? Findings of Fact 1. Woods teaches "a nutritional supplement formulation is available from Douglas Labs, Rocklin Calif., as 7594 DL Ultra D-Tox, which includes the following ingredients ... Psyllium Powder ... Bromelain" (Woods i-fi-122, 24, 36). 3 Appeal2015-000456 Application 13/588,910 2. Woods teaches that for "oral administration, soft gel capsules can be prepared by conventional means with pharmaceutically acceptable excipients such as binding agents, fillers, lubricants, disintegrants, or wetting agents" (Woods i-f 54). 3. Woods teaches that a "method of reducing inflammation described herein can include ingestion of one or more nutritional supplement formulations, e.g., by a human" (Woods i-f 61). 4. Advanced Health Consultants teaches that "[p ]harmacological studies have suggested that witch hazel strengthens veins and is anti- inflammatory" (Advanced Health Consultants 1 ). 5. Advanced Health Consultants teaches that "ClearMed ingredients are proven remedies for hemorrhoids" and specifically teaches that a serving comprises 800 mg Witch Hazel leaf and 100 mg Blonde Psyllium as well as excipients including microcrystalline cellulose and silicon dioxide (Advanced Health Consultants 1) (emphasis omitted). 6. Advanced Health Consultants teaches that "Blonde Psyllium helps with disorders in which easy bowel movements with a loose stool are desirable" (Advanced Health Consultants 1 ). 7. Miller teaches "customary pharmaceutical excipients. Among those used for this purpose are: microcrystalline cellulose ... colloidal silicon dioxide, stearic acid" (Miller i-f 87). 8. Miller teaches a dietary supplement composition comprising Bromelain, cellulose, silicon dioxide and stearic acid (Miller i-f 97). 4 Appeal2015-000456 Application 13/588,910 Principles of Law "It 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). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 3-5; FF 1-8) and agree that claim 1 is rendered obvious by Woods, Advanced Health Consultants, and Miller. We address Appellant's arguments below. Appellant contends that "[ w ]hile the ingredients are known, and were known at the time of filing of the subject patent application, the combination has not been disclosed, taught or suggested by any of the references" (Br. 4). We are not persuaded. "[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." KSR, 550 U.S. at 417. Appellant does not dispute that the prior art of Woods and Advanced Health Consultants teaches the individual use of Bromelain and Witch Hazel in anti-inflammatory compositions (FF 1, 3-5). We therefore agree with the Examiner that it would have been obvious to combine Bromelain and Witch Hazel, each of which is taught by 5 Appeal2015-000456 Application 13/588,910 the prior art to be useful as anti-inflammatory agents to create a third composition also useful as an anti-inflammatory. The use of the combination of Bromelain and Witch Hazel as anti-inflammatory compounds is nothing "more than the predictable use of prior art elements according to their established functions." KSR, 550 U.S. at 417. Appellant contends that "[i]t is the synergistic effect of the two anti- inflammatory agents that produces a more effective tablet" (Br. 4). Appellant contends that: The inventor has found the existence of a synergistic relationship between Witch Hazel and Bromelain such that the combination of the two anti-inflammatory agents is more effective tha[ n] either alone. Such was set forth in the application wherein it states "[T]able 1 details exemplary case studies. Advantageously, the results of utilizing the tablets in accordance with the embodiments of the present invention have dramatic synergistic effects over usage of the active ingredients individually. In addition, a high majority of the patients expressed that the tablets outperformed other over-the-counter medications such as common ointments" (paragraph [0017]). It is this synergistic effect that is not obvious to one skilled in the art and indeed one reason the prior art fails to disclose such a combination in an orally ingested tablet. (Br. 5). We are not persuaded. While Table 1 indicates that the subjective opinion of most patients was that tablets containing the claimed ingredients "treated hemorrhoids better than over-the-counter medications" (Spec. i-f 18), Table 1 does not compare results to the closest prior art of either Woods or Advanced Health Consultants that each contain two of three active ingredients required by claim 1 (FF 1, 5). See In re Baxter Travenol Labs., 6 Appeal2015-000456 Application 13/588,910 952 F.2d 388, 392 (Fed. Cir. 1991) ("[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art."). We also note that claim 1 broadly encompasses any amount of the active components of Bromelain, Witch Hazel, and Psyllium, while the composition tested in Table 1 "comprises 500 mg of Bromelain 1200 GDU 110, 100 mg of Witch Hazel leaf 120 and 100 mg of Psyllium husk powder 130" (Spec. i-f 14). Appellant does not address whether the amounts of the active ingredients impact efficacy or provide any ranges or other information to guide the scope of claim 1 that encompasses a composition with any amounts of these three active ingredients. See In re Harris, 409 F.3d 1339, 1344 (Fed. Cir. 2005) (Unexpected results must also be "commensurate in scope with the degree of protection sought by the claimed subject matter."). Conclusions of Law (i) The preponderance of evidence of record supports the Examiner's conclusion that Woods, Advanced Health Consultants, and Miller render claim 1 obvious. (ii) Appellant has not presented evidence of secondary considerations, that when weighed with the evidence of obviousness, is sufficient to support a conclusion of non-obviousness. SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as obvious over Woods, Advanced Health Consultants, and Miller. 7 Appeal2015-000456 Application 13/588,910 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 8 Copy with citationCopy as parenthetical citation