Ex Parte Marinello et al

Patent Trial and Appeal BoardSep 18, 2012

10662775 (P.T.A.B. Sep. 18, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 10/662,775 09/15/2003 Andrea Marinello 930071-2001 2185 20999 7590 09/18/2012 FROMMER LAWRENCE & HAUG 745 FIFTH AVENUE- 10TH FL. NEW YORK, NY 10151 EXAMINER GHALI, ISIS A D ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 09/18/2012 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 ANDREA MARINELLO and VITTORIA MARINELLO __________ Appeal 2011-005453 Application 10/662,775 Technology Center 1600 __________ Before DONALD E. ADAMS, DEMETRA J. MILLS, and FRANCISCO C. PRATS, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a device and process for treating sinusitis. The Examiner entered rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Appellants’ invention involves the transdermal delivery of “substances, known as revulsives,” to treat sinusitis (see Spec. 3). Thus, revulsives such as mustard and radish contain the active ingredient allyl isothiocyanate, which, when administered at the proper concentrations, can Appeal 2011-005453 Application 10/662,775 2 be delivered transdermally “to bones underlying the mucous membranes in the sinuses to reduce inflammation and infection without harmful side effects” (id. at 4). Claims 13-30 stand rejected and appealed (App. Br. 6). Claims 13 and 25, the independent claims, illustrate the appealed subject matter and read as follows: 13. A device comprising a facial mask accommodated to allow unobstructed respiratory function of the nostrils and the mouth, an inflatable elastic pad affixed to the facial mask and a compress fitted adjacent to said inflatable elastic pad, said compress comprising a revulsive or cress having an active ingredient, wherein the device promotes the absorption of the active ingredient through the skin to bones underlying mucous membranes in a sinus of a person in need thereof. 25. A method of treating sinusitis comprising the step of securing a device to a person’s head, the device comprising a facial mask accommodated to allow unobstructed respiratory function of the nostrils and the mouth, an inflatable elastic pad affixed to the facial mask and a compress fitted adjacent to said inflatable elastic pad, said compress comprising a revulsive or cress having an active ingredient wherein the device promotes the absorption of the active ingredient through the skin to bones underlying mucous membranes in a sinus of a person in need thereof. The following rejections are before us for review: (1) Claims 13, 14, 17-19, 21-26, and 30, under 35 U.S.C. § 103(a) as obvious over Marinello, 1 Ludwin, 2 and Smaldone 3 (Ans. 4-8); 1 GB 2 088 714 A (published June 16, 1982). 2 U.S. Patent No. 2,262,711 (issued November 11, 1941). 3 U.S. Patent No. 6,748,949 B2 (filed May 17, 2002). Appeal 2011-005453 Application 10/662,775 3 (2) Claims 15, 16, 27, and 28, under 35 U.S.C. § 103(a) as obvious over Marinello, Ludwin, Smaldone, and Depree 4 (Ans. 8-10); and (3) Claims 20 and 29, under 35 U.S.C. § 103(a) as obvious over Marinello, Ludwin, Smaldone, and Bracken 5 (Ans. 10-11). DISCUSSION The Examiner found that Marinello described the device and process as recited in independent claims 13 and 25, respectively, except that Marinello did not “explicitly teach the use of face mask as instantly claimed” (Ans. 5). To address that deficiency, the Examiner cited Ludwin as describing a medical nebulizer that included a face mask which promoted delivery of a vaporized drug into the small pores of a patient’s sinus tracts (id. at 5-6). The Examiner conceded, however, that Ludwin did not “explicitly teach that the face mask is unobstructive and covers the nose and mouth” (id. at 6). To address that deficiency, the Examiner cited Smaldone as disclosing a pressurized mask for delivering nebulized drugs, in which the “mask eliminates discomfort and potential harmful consequences that are associated with masks that leak to the perinasal area and eyes” (id. at 6). Based on the references’ teachings, the Examiner reasoned that an ordinary artisan would have considered it obvious to “treat sinusitis using mustard impregnated into a compress and using an inflatable elastic cushion to press the impregnated compress against the skin overlying the inflamed 4 J.A. Depree et al., Flavour and pharmaceutical properties of the volatile sulphur compounds of Wasabi (Wasabia japonica), 31 FOOD RESEARCH INTERNATIONAL 329-337 (1999). 5 U.S. Patent No 5,429,126 (issued July 4, 1995). Appeal 2011-005453 Application 10/662,775 4 sinuses as taught by Marinello, and further use a face mask and pressure taught by Ludwin to cover the impregnated compress of Marinello” (id. at 7). The Examiner further reasoned that an ordinary artisan would have been prompted to use Smaldone’s mask in such a process in view of Smaldone’s teaching that its mask “will reduce the inertia of the drug at the sites most at risk of facial damage and irritation which are the eyes to eliminate discomfort and potential harmful consequences that are associated with masks that leak to the perinasal area and eyes” (id. at 8) “In proceedings before the Patent and Trademark Office, the Examiner bears the burden of establishing a prima facie case of obviousness based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992). In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), while the Supreme Court emphasized “an expansive and flexible approach” to the obviousness question, it also reaffirmed the importance of determining “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. at 418 (emphasis added). Thus, “[o]bviousness requires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination.” Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). Instead, “[i]n determining whether obviousness is established by combining the teachings of the prior art, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted). Appeal 2011-005453 Application 10/662,775 5 Here, we agree with Appellants that the cited references would not have suggested the device and process, respectively, of independent claims 13 and 25 to an ordinary artisan. We acknowledge, as the Examiner argues (see, e.g. Ans. 17), that an ordinary artisan would have recognized that the masks of Ludwin and Smaldone had specific advantages when used to deliver nebulized drugs. We are not persuaded, however, that those advantages would have prompted an ordinary artisan to use those masks in Marinello’s process, which instead involves transdermal delivery of a revulsive agent: The use of vegetable oil solutions, as claimed, allows the solution to be maintained on the body for a longer period of time, thus allowing the revulsives to enter the dilated pores of the skin and cause reactions in the deep blood vessels of the body underlying the skin to which the solution is applied. (Marinello 2:109-115 (emphasis added); see also, id. at 5:11-26 (sinusitis treatment performed by application of revulsive to cheek, not by inhalation).) Thus, as we are not persuaded that an ordinary artisan would have been prompted to use the nebulized drug delivery masks of Ludwin and Smaldone in Marinello’s method of transdermally delivering revulsives, we agree with Appellants that the Examiner has not made out a prima facie case of obviousness as to independent claims 13 and 25. We therefore reverse the Examiner’s obviousness rejection of those claims, as well as their dependents, over Marinello, Ludwin, and Smaldone. As the Examiner points to no specific teachings in either Depree or Bracken that remedy the shortcomings discussed above as to the combination of Marinello, Ludwin, and Smaldone, we also reverse the Appeal 2011-005453 Application 10/662,775 6 Examiner’s rejection of claims 15, 16, 27, and 28 over Marinello, Ludwin, Smaldone, and Depree, as well as the rejection of claims 20 and 29 over Marinello, Ludwin, Smaldone, and Bracken. REVERSED alw