10176517 - (D) (P.T.A.B. Jun. 27, 2013)

Ex Parte Hansted et al

Patent Trials and Appeals BoardJun 27, 2013

10176517 - (D) (P.T.A.B. Jun. 27, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE 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. 10/176,517 06/21/2002 Kenneth W. Hansted 67005/GJG 1951 23432 7590 06/27/2013 COOPER & DUNHAM, LLP 30 Rockefeller Plaza 20th Floor NEW YORK, NY 10112 EXAMINER GHALI, ISIS A D ART UNIT PAPER NUMBER 1611 MAIL DATE DELIVERY MODE 06/27/2013 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 KENNETH W. HANSTED, DAVID SANDERS, and PHILIP WELSHER __________ Appeal 2009-002987 Application 10/176,517 Technology Center 1600 __________ Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a promotional insert and method for advertising a transdermal patch in a periodical. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 Appellants identify the Real Party in Interest as Graphic Productions, Inc. (see App. Br. 4). Appeal 2009-002987 Application 10/176,517 2 Statement of the Case Background “A transdermal patch is often used for percutaneous delivery of a pharmaceutical substance, i.e. drug delivery” (Spec. 1, ll. 13-14). According to the Specification, “print and broadcast advertising for transdermal patches has relied on photographic imagery or verbal descriptions of the patch product. . . . but no ability existed to allow the user a tactile experience” (Spec. 1, ll. 30-35). The Specification teaches “a promotional insert for advertising a transdermal patch to a reader of a periodical comprising a sample of the transdermal patch attached to the promotional insert” (Spec. 2, ll. 2-5). The Claims Claims 1-10, 14-20, and 35-48 are on appeal. Claim 1 is representative and reads as follows: 1. A promotional insert for advertising a transdermal patch to a reader of a periodical comprising a sample of the transdermal patch attached to the promotional insert, wherein the promotional insert contains a description of the sample of the transdermal patch attached thereto, wherein the promotional insert is suitable for inclusion into a periodical, and wherein the sample of the transdermal patch is attached to the insert by a first adhesive at a first portion, and by a second adhesive at a second portion, wherein the first adhesive is permanent and the second adhesive is resealable; attached to the insert by a pattern release coat under a portion of the patch, where only the portion attached by the pattern release coat is removable, or removable from the insert and affixable to the skin. Appeal 2009-002987 Application 10/176,517 3 The issue The Examiner rejected claims 1-10, 14-20, and 35-48 under 35 U.S.C. § 103(a) as obvious over Muchin2 (Ans. 3-4). The Examiner finds that Muchin teaches cosmetic samples “comprising the sample in a whole of film or absorbed onto an absorbent material and sandwiched between backing layer of polypropylene and release liner layer of polyester by adhesive, i.e. patch. The sample can be adhesively affixed to a carrier such as magazine page, coupon, or direct mailer” (Ans. 3). The Examiner finds that in some of Muchin’s embodiments “sufficient adhesive remain after removing the sampler to enable adhering the sample to skin. The adhesive used to affix layers together may be applied in a patterned manner” (Ans. 3). The Examiner finds it obvious to provide patch comprises backing layer, release liner and active agent in between that is affixed to magazine by adhesive as disclosed by [Muchin], and select the adhesive that can be re-adhered or alternatively select two adhesives of different adhesiveness to allow the sample to be adhered to another surface after removal from the carrier, motivated by the teaching of [Muchin] that adhesive is selected such that sufficient adhesive remain after removing the release liner to enable the sample to be adhered to skin, with reasonable expectation of having a patch sample attached to insert by two different adhesives wherein one of the adhesives is suitable for fixation to the skin after removal from the insert. (Ans. 4). 2 Muchin, J., US 5,161,688, issued Nov. 10, 1992. Appeal 2009-002987 Application 10/176,517 4 The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that Muchin renders claim 1 obvious? Findings of Fact 1. Muchin teaches “samplers and, in particular, cosmetic samplers and methods of making the same” (Muchin, col. 1, ll. 10-11). 2. Muchin teaches that the “sampler need not be limited to cosmetic samples but can be filled with other products such as suntan lotion and topical substances including benzoyl peroxide cream” (Muchin, col. 6, ll. 11-14). 3. Muchin teaches that “an adhesive is provided on the exterior surface of either the film ply or the closure ply, so that the sampler can be adhesively affixed to a carrier, such as the packaged product, magazine page, coupon, direct mailer, point of purchase display or the like” (Muchin, col. 2, ll. 16-21). 4. Muchin teaches where the cosmetic is a volatile liquid or only a small amount is desired, the sample is first absorbed onto an absorbent material (not shown), such as a die cut sponge, paper, cloth or molecular sieve and the absorbent material then placed into the retaining cavity. Once the sample is exposed, there is a controlled transpiration of the absorbed fragrance,-skin oil, etc. Such embodiments can also include a perforated ply over the opening of the retaining cavity to allow exposure or evaporation of the sample without direct contact of the sample with other surfaces. (Muchin, col. 4, ll. 50-61). 5. Muchin teaches that in “some embodiments, the base ply adhesive is chosen so that sufficient adhesive remains after the film ply has Appeal 2009-002987 Application 10/176,517 5 been removed to enable the samples to adhere to a surface, such as the skin of the user. Thus, the sampler may be used to directly contact the sample to the surface” (Muchin, col. 5, ll. 2-7). 6. Muchin teaches that a laminate sheet 50 is formed which includes a base ply 52, having applied on one side a base ply adhesive 54 and then a backing ply 56 covering the base ply adhesive 54 and on the opposite side having applied a liner adhesive 66 and then a liner ply 68 covering the liner ply adhesive. The backing ply 56 is preferably a non-porous, non-resilient backing with a smooth surface, most preferably the backing is a plastic film, such polypropylene film. (Muchin, col. 5, ll. 34-41). 7. The American Heritage Medical Dictionary3 defines “transdermal patch” as “A medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream” (American Heritage Medical Dictionary 548). 8. Benson4 teaches that “‘Transdermal’ means through the skin. Consequently, a transdermal product is applied to the skin for the purpose of delivering a drug to the bloodstream. This is in contrast to a topical product, which is intended to deliver drug to the skin rather than through the skin” (Benson, chapter 15). 3 The American Heritage® Medical Dictionary, Houghton Mifflin Company 548 (2008). 4 Benson et al., Eds., Topical and Transdermal Drug Delivery, John Wiley & Sons (2012). Appeal 2009-002987 Application 10/176,517 6 Principles of Law “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). “During examination, the patent application claims may be given their broadest interpretation consistent with the specification, in order to facilitate sharpening and clarifying the claims at the application stage.” In re Buszard, 504 F.3d 1364, 1366 (Fed. Cir. 2007). Analysis While Munchin teaches promotional advertising inserts (FF 1) where a perfume sample is attached by an adhesive to the insert (FF 3) and where the perfume sample may be removed from the insert and affixed to the skin (FF 5), Munchin does not teach the use of transdermal patches. The Examiner finds that the “term transdermal patch in its broadest reasonable interpretation to one having ordinary skill in the art is sheet or film that may contain active agent to be delivered when applied to the skin” (Ans. 5). We do not agree that the Examiner’s interpretation of the term “transdermal patch” is reasonable. The dictionary definition of “transdermal patch” is a “medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream” (American Heritage Medical Dictionary 548; FF 7). Benson makes it clear that delivery through the skin to the bloodstream is an essential element of the term “transdermal”, where delivery to the skin is termed “topical” delivery (FF 8). The Examiner provides no evidence or reasoning to support Appeal 2009-002987 Application 10/176,517 7 an interpretation of “transdermal patch” which would encompass “topical” treatment. Therefore, reading the claims using the broadest reasonable interpretation of the term “transdermal patch” in light of the art and the Specification, the Examiner provides no evidence to suggest that the perfume, fragrance, or cosmetic sampler of Muchin functions to deliver these components through the skin into the bloodstream as required by the limitation to a transdermal patch. Indeed, Muchin acknowledges that the “sampler need not be limited to cosmetic samples but can be filled with other products such as suntan lotion and topical substances including benzoyl peroxide cream” (Muchin, col. 6, ll. 11-14; FF 2). This is a teaching of topical administration, not a “transdermal patch” as required by each of independent claims 1, 16, and 20. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that Muchin renders claim 1 obvious. SUMMARY In summary, we reverse the rejection of claims 1-10, 14-20, and 35-48 under 35 U.S.C. § 103(a) as obvious over Muchin. REVERSED dm Notice of References Cited Application/Control No. 10/176,517 Applicant(s)/Patent Under Reexamination Appeal No. 2009-002987 Examiner BPAI Art Unit 1600 Page of U.S. PATENT DOCUMENTS * Document Number Country Code-Number-Kind Code Date MM-YYYY Name Classification A US- B US- C US- D US- E US- F US- G US- H US- I US- J US- K US- L US- M US- FOREIGN PATENT DOCUMENTS * Document Number Country Code-Number-Kind Code Date MM-YYYY Country Name Classification N O P Q R S T NON-PATENT DOCUMENTS * Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages) U The American Heritage® Medical Dictionary, Houghton Mifflin Company 548 (2008). V Benson et al., Eds., Topical and Transdermal Drug Delivery, John Wiley & Sons (2012). W X *A copy of this reference is not being furnished with this Office action. (See MPEP § 707.05(a).) Dates in MM-YYYY format are publication dates. Classifications may be US or foreign. U.S. Patent and Trademark Office PTO-892 (Rev. 01-2001) Notice of References Cited Part of Paper No.