Ex Parte Crowley et alDownload PDFPatent Trial and Appeal BoardDec 11, 201713903531 (P.T.A.B. Dec. 11, 2017) Copy Citation 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. 13/903,531 05/28/2013 Michael M. Crowley AUM-100US1 1040 23122 7590 12/18/2017 RATNFRPRFSTTA EXAMINER 2200 Renaissance Blvd WOLLSCHLAGER, JEFFREY MICHAEL Suite 350 King of Prussia, PA 19406 ART UNIT PAPER NUMBER 1742 NOTIFICATION DATE DELIVERY MODE 12/18/2017 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): PCorrespondence @ ratnerprestia.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL M. CROWLEY, JUSTIN M. KEEN, JOHN J. KOLENG, and FENG ZHANG Appeal 2017-004583 Application 13/903,531 Technology Center 1700 Before TERRY J. OWENS, BRIAN D. RANGE, and JANE E. INGLESE, Administrative Patent Judges. OWENS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE The Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’ rejection of claims 1—19. We have jurisdiction under 35 U.S.C. § 6(b). The Invention The Appellants claim an extruded laminate. Claim 1 is illustrative: 1. A bioadhesive bi-layered hot-melt extruded laminate comprising a hydrophilic bioadhesive reservoir layer and a hydrophobic backing layer, wherein a) the bioadhesive reservoir layer comprises an active agent; b) each of the bioadhesive reservoir layer and the backing layer comprises poly(ethylene) oxide (PEO); and Appeal 2017-004583 Application 13/903,531 c) the backing layer comprises a hydrophilic polymer in a sufficiently low amount such that the backing layer is hydrophobic. The References References relied upon by the Examiner Schiraldi US Re. 33,093 Oct. 17, 1989 US 5,095,619 Mar. 17, 1992 US 5,318,737 June 7, 1994 US 5,766,620 June 16, 1998 US 6,585,997 B2 July 1, 2003 US 2003/0141625 A1 July 31, 2003 US 2005/0100515 A1 May 12, 2005 US 8,465,759 B2 June 18, 2013 Davis Trabert Heiber Moro Shelby Sagel Crowley (Crowley ’759) Michael McDonald Crowley, Physiochemical and Mechanical Characterization of Hot-melt Extruded Dosage Forms, Doctor of Philosophy Dissertation - University of Texas at Austin (2003) (hereinafter the Crowley dissertation). Michael M. Crowley et al., Stability of polyethylene oxide in matrix tablets prepared by hot-melt extrusion, 23 Biomaterials 4241—48 (2002) (hereinafter the Crowley article). References relied upon by the Appellants US 6,375,963 B1 Apr. 23, 2002Repka A. Apicella. et al., Poly (Ethylene oxide) (PEO) and different molecular weight PEO blends monolithic devices for drug release, 14 Biomaterials 83— 90 (1993). The Rejections The claims stand rejected as follows: claims 1—19 on the ground of nonstatutory obviousness-type double patenting over claims 1—16 of 2 Appeal 2017-004583 Application 13/903,531 Crowley ’759,1 claims 1—3, 5—9, 11—13, and 19 under 35 U.S.C. § 102(b) or, in the alternative, under 35 U.S.C. § 103 over Schiraldi, claim 4 over Schiraldi in view of Shelby or Trabert, claim 10 over Schiraldi in view of Sagel, claims 14 and 15 over Schiraldi in view of Moro, claim 16 over Schiraldi in view of Heiber, and claim 17 over Schiraldi in view of Davis, the Crowley dissertation or the Crowley article. OPINION We affirm the obviousness-type double patenting rejection and the rejections under 35 U.S.C. § 103 and reverse the rejection under 35 U.S.C. § 102(b). Obviousness-type double patenting rejection The Appellants do not challenge the obviousness-type double patenting rejection but, rather, state that “Appellants avoid this rejection by concurrently filing a terminal disclaimer over U.S. Patent No. 8,465,759 with this Brief’ (App. Br. 4, 10). As pointed out by the Examiner (Ans. 8), no terminal disclaimer is of record. Accordingly, we summarily affirm the obviousness-type double patenting rejection. Rejection under 35 U.S.C. § 102(b) “Anticipation requires that every limitation of the claim in issue be disclosed, either expressly or under principles of inherency, in a single prior art reference.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1255—56 (Fed. Cir. 1989). We need address only the sole 1 The Examiner states that the rejection is “on the ground of nonstatutory double patenting” (Final Act. 3). As indicated by the Examiner’s acknowledgement that the claims on appeal and the claims in Crowley ’759 are not identical {id.), the rejection is on the ground of nonstatutory obviousness-type double patenting. See MPEP § 804. 3 Appeal 2017-004583 Application 13/903,531 independent claim, i.e., claim 1. That claim requires that each of a bioadhesive reservoir layer and a backing layer comprises PEO. Schiraldi discloses an extruded single- or multi-layered film which must have a hydroxypropyl cellulose and ethylene oxide homopolymer- containing water-soluble or water-swellable polymer matrix bioadhesive layer and may have an outer protective barrier membrane layer (col. 2, 11. 15—48, 57—60; col. 4,11. 2—7). The hydroxypropyl cellulose and ethylene oxide homopolymer are among the film-forming polymers which “are most useful in the bioadhesive layer of the film” (col. 3,11. 16—26). “Various non-soluble polymers may also be incorporated for modification of the film’s permeability properties, such as ethyl cellulose, propyl cellulose, polyethylene, polypropylene and carboxymethylcellulose (free acid)” (col. 3, 11. 26—30). The outer protective barrier membrane layer can consist essentially of “a polymer matrix of a major proportion of a non-water- soluble polymer selected from the group consisting of ethyl cellulose, propyl cellulose, polyethylene and polypropylene, and a minor portion of hydroxypropyl cellulose” (col. 10,11. 25—32). By varying the ratios of the polymers, “both the solubility and the adhesive properties of each layer of film may be controlled” (col. 3,11. 30-32). The Examiner finds that Schiraldi’s bioadhesive and outer protective membrane layers “share a common polymer (Example 5), including PEO (col. 3, lines 1-37)” (Final Act. 4). Example 5’s outer protective membrane layer does not include PEO, and the Examiner does not point to where Schiraldi discloses in relied-upon column 3, lines 1—37 an outer protective membrane layer including PEO. 4 Appeal 2017-004583 Application 13/903,531 Thus, the Examiner has not established a prima facie case of anticipation of the Appellants’ claimed laminate. Rejections under 35 U.S.C. § 103 The Appellants argue the claims as a group (App. Br. 5—10). Although additional references are applied in some dependent claim rejections the Appellants do not separately argue those claims (App. Br. 10). We therefore limit our discussion to one claim, i.e., claim 1. Claims 2—17 and 19 stand or fall with that claim. See 37 C.F.R. § 41.37(c)(l)(iv) (2012). The Appellants assert that “Schiraldi does not teach, suggest, or disclose that the PEO is present in any other layer than the bioadhesive layer” (App. Br. 5) and that Schiraldi “distinguishes water-soluble and/or water-swellable materials, such as PEO, from non-soluble polymers. In fact, Schiraldi places the water-soluble or swellable materials into a completely separate grouping, those that are ‘useful in the bioadhesive layer of the film, ’ from the non-soluble polymers” (App. Br. 7). Schiraldi’s disclosure that the hydroxypropyl cellulose and PEO are most useful in the bioadhesive layer indicates that they have some usefulness in other layers such as the outer protective membrane layer (col. 3,11. 16— 26). That usefulness is indicated further by Schiraldi’s disclosures that the outer protective membrane layer can contain a minor proportion of hydroxypropylcellulose (col. 10,11. 25—32) and that “[by] varying the ratios of the above polymers [including hydroxypropylcellulose, PEO and non-soluble polymers] both the solubility and the adhesive properties of each layer of film may be controlled” (col. 3,11. 30-32). The Appellants assert that Schiraldi’s Examples 1 and 5 and claims 8 and 9 expressly disclose that hydroxypropyl cellulose can be present in both 5 Appeal 2017-004583 Application 13/903,531 the adhesive layer and the outer protective membrane layer whereas PEO is limited to the bioadhesive layer (App. Br. 8).2 3 Schiraldi is not limited to its examples, see In re Fracalossi, 681 F.2d 792, 794 n.l (CCPA 1982); In re Mills, 470 F.2d 649, 651 (CCPA 1972), or to its claims 8 and 9. Instead, all disclosures therein must be evaluated for what they would have fairly suggested to one of ordinary skill in the art. See In re Boe, 355 F.2d 961, 965 (CCPA 1966). As set forth above, Schiraldi would have suggested to one of ordinary skill in the art that the outer protective membrane layer can contain a minor proportion of PEO. The Appellants assert that Schiraldi’s “outer layer is described as ‘consisting of’ non-adhesive and non-soluble polymers. See Id. at Col. 3, lines 12-15. PEO is both soluble and adhesive, having characteristics that would render it unsuitable for the durability and protection characteristics necessary in the outer layer” (App. Br. 6-1)? That assertion pertains to Schiraldi’s exemplification of an aphthous lesion-treating laminated two-layer film wherein benzocaine is incorporated into the adhesive layer and “[t]he outer layer would consist of non-soluble/- non-adhesive polymers that provide durability, protection and directs the delivery of benzocaine toward the lesion” (col. 3,11. 8—15). The Appellants 2 Repka’s Example 12’s film relied upon by the Appellants (App. Br. 9) includes hydroxypropyl cellulose in inner matrix and outer backing layers, but does not contain PEO in either layer. The inner matrix layer, however, contains polyethylene, which indicates that both a water-swellable or water-soluble polymer (hydroxypropylcellulose) and a non-soluble polymer (polyethylene) can be present in the same layer. 3 We do not consider the Appellants’ reliance upon Apicella in support of that assertion (App. Br. 7) because the record does not include a copy of that reference. 6 Appeal 2017-004583 Application 13/903,531 do not provide justification for interpreting Schiraldi’s term “consist of’ as though it is a claim transition term excluding non-recited components. Regardless, that term appears in an example, and Schiraldi is not limited to its examples. See Fracalossi, 681 F.2d at 794 n.l; Mills, 470 F.2d at 651. Furthermore, the Appellants do not provide evidence that PEO is unsuitable in an outer layer. The Appellants provide mere unsupported attorney argument, and arguments of counsel cannot take the place of evidence. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). The Appellants assert that Schiraldi’s hydroxypropylcellulose and PEO are not functionally equivalent (Reply Br. 2). Schiraldi’s hydroxypropylcellulose and PEO both function as a water-swellable or water-soluble polymer in Schiraldi’s layers (col. 3,11. 16— 32). Therefore, one of ordinary skill in the art, through no more than ordinary creativity, would have used not only hydroxypropylcellulose in the outer protective layer (col. 10,11. 25—32), but also would have used PEO in that layer. See KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (in making an obviousness determination one “can take account of the inferences and creative steps that a person of ordinary skill in the art would employ”). The Appellants argue (Reply Br. 3): In contrast to the functional and chemical characteristics of PEO, which is freely soluble in water, a person of ordinary skill in the art would recognize that the solubility of hydroxypropylcellulose decreases with increasing temperature, such that at the body temperatures in which Schiraldi’s devices would be used, hydroxypropylcellulose would not be expected to dissolve in a manner similar to PEO. Thus, a person of ordinary skill in the art would recognize that the chemical and functional characteristics of hydroxypropylcellulose render 7 Appeal 2017-004583 Application 13/903,531 hydroxypropylcellulose suitable for use in a layer designed for protection or durability, unlike the characteristics of PEO. That argument is not well taken because it is merely unsupported attorney argument, and arguments of counsel cannot take the place of evidence. See De Blauwe, 736 F.2d at 705. For the above reasons we are not persuaded of reversible error in the rejections under 35 U.S.C. § 103. DECISION/ORDER The rejection of claims 1—19 on the ground of nonstatutory obviousness-type double patenting over claims 1—16 of Crowley ’759 and the rejections under 35 U.S.C. § 103 of claims 1—3, 5—9, 11—13, and 19 over Schiraldi, claim 4 over Schiraldi in view of Shelby or Trabert, claim 10 over Schiraldi in view of Sagel, claims 14 and 15 over Schiraldi in view of Moro, claim 16 over Schiraldi in view of Heiber, and claim 17 over Schiraldi in view of Davis, the Crowley dissertation or the Crowley article are affirmed. The rejection of claims 1—3, 5—9, 11—13, and 19 under 35 U.S.C. § 102(b) is reversed. It is ordered that the Examiner’s decision is affirmed. 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