Ex Parte Huey et alDownload PDFBoard of Patent Appeals and InterferencesJan 18, 201211592477 (B.P.A.I. Jan. 18, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte RAYMOND J. HUEY and JEFFREY L. HORN __________ Appeal 2011-001121 Application 11/592,477 Technology Center 1600 __________ Before ERIC GRIMES, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to an apparatus for promoting blood clotting. The Examiner entered rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE Claims 1, 2 and 21-38 stand rejected and appealed (App. Br. 2). Claim 1, the only independent, is representative and reads as follows: 1. An apparatus for promoting the clotting of blood, comprising: a pouch closed on all sides, defined by a mesh on all sides, and a first blood clotting material in powder form incorporated Appeal 2011-001121 Application 11/592,477 2 into a material defining said mesh and captured therein so that at least a portion of said powder is exposed on an outer surface defined by said material; and a second blood clotting material in loose particulate form retained in said pouch; wherein the material defining the mesh comprises openings which are sufficiently large to allow at least a portion of the particulate blood clotting material to extend through the openings to allow contact with blood outside of the pouch. The following grounds of rejection are before us for review: (1) Claims 1, 2, 21-28, 30-34, and 38 under 35 U.S.C. § 103(a) as obvious over Hursey, 1 Watt „783, 2 and McCabe 3 (Ans. 3-8); (2) Claims 29 and 35, under 35 U.S.C. § 103(a) as obvious over Hursey, Watt „783, McCabe, and Wu 4 or Watt „842 5 (Non-Final Rejection 9-11 (entered June 18, 2009)); and (3) Claims 36 and 37, under 35 U.S.C. § 103(a) as obvious over Hursey, Watt „783, McCabe, Jensen, 6 and Bruder 7 (Non-Final Rejection 11- 13 (entered June 18, 2009)). 8 1 U.S. Patent Appl. Pub. No. 2003/0133990 A1 (published July 17, 2003). 2 EP 0 888 783 A1 (published January 7, 1999). 3 U.S. Patent No. 5,716,337 (issued February 10, 1998). 4 U.S. Patent No. 5,696,101 (issued December 9, 1997). 5 GB 2 314 842 A (published January 14, 1998). 6 EP 1 159 972 (published December 5, 2001). 7 U.S. Patent Appl. Pub. No. 2003/0208150 A1 (published November 6, 2003). 8 While Appellants do not list rejections 2 and 3 as being appealed, the Examiner‟s Answer explicitly states that “[e]very ground of rejection set forth in the Office action from which the appeal is taken (as modified by any advisory actions) is being maintained by the examiner except for the grounds of rejection (if any) listed under the subheading „WITHDRAWN Appeal 2011-001121 Application 11/592,477 3 DISCUSSION The Examiner cited Watt as disclosing a device for promoting wound healing that consisted essentially of an envelope or “„tea bag‟” made of a woven fabric that enclosed particles of a substance that promoted wound healing, such as zeolite (Ans. 4-5). The Examiner conceded: Watt does not teach the limitation wherein the apparatus (a) comprises of a first blood clotting agent and a second blood clotting agent in the said pouch wherein the first blood clotting agent is in the form of a powder (b) limitation that at least the said portion of said particulate molecular sieve material extend through the openings of the pouch to come into contact with the blood in the wound, (c) wherein the apparatus further comprises of a support/substrate for affixing the pouch to a bleeding area. (Id. at 5.) To address those deficiencies, the Examiner cited Hursey as teaching “a wound cover for retaining a hemostatic agent therein, the hemostatic agent comprising a first component (molecular sieve material) having hemostatic properties commingled with a second component (a clay material) having hemostatic property, at least a portion of the device being defined by a mesh (gauze), which has openings therein” (id. at 5-6). As further evidence of obviousness, the Examiner cited McCabe as disclosing a wound dressing composed of a perforated pouch containing wound exudate-absorbing alginate particles (id. at 6-7). The Examiner found that, given the dimensions of the device described in McCabe, McCabe‟s device inherently met the claim limitations requiring the enclosed particles to protrude at least partly through the mesh pouch (id. at 7). REJECTIONS.‟” (Ans. 2-3.) Notably, Appellants have listed the claims rejected in grounds 2 and 3 among those being appealed (App. Br. 2). Appeal 2011-001121 Application 11/592,477 4 Based on the references‟ combined teachings, the Examiner found that an ordinary artisan would have been prompted to apply McCabe‟s pouch teachings to the inventions of Watt and Hursey “so as to utilize the blood coagulating properties of the zeolite to its fullest extent[;] it would have been obvious to an ordinarily skilled artisan to utilize[] zeolite as both the first and second component in the apparatus of Hursey and Watt” (Ans. 7-8). We agree with Appellants that the Examiner has not shown that the cited references would have rendered the claimed apparatus prima facie obvious to an ordinary artisan. “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 Appeal 2011-001121 Application 11/592,477 5 in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted). Here, claim 1 recites an apparatus, in the form of a mesh pouch, for promoting blood clotting. Claim 1 requires blood clotting material to not only be in a loose particulate form retained inside the pouch, but also “in powder form incorporated into a material defining said mesh and captured therein so that at least a portion of said powder is exposed on an outer surface defined by said material” (App. Br. 11 (claim 1)). As the Specification explains, in certain embodiments encompassed by the claims, a blood clot-inducing “zeolite powder may be captured [in the mesh forming material] so as to protrude above the surface of the matrix material” (Spec. [0045]; see also Spec. [0046]; Figures 6-8). Thus, the blood coagulating material must be present not only inside the cavity formed by the claimed mesh pouch, but also incorporated into the material that forms the mesh itself. We acknowledge Hursey‟s disclosure of a wound dressing in the form of “an envelope or sock formed of a blood permeable fabric within which [a] blood coagulation accelerator is retained” (Hursey [0004]). We also acknowledge Hursey‟s disclosure that a “blood coagulation accelerator may be . . . used as a film, coating, or filler in the preparation of a wound cover or dressing” (id. (emphasis added)). We are not persuaded, however, that the Examiner has adequately explained how or why the cited references would have prompted an ordinary artisan to combine the pouch embodiments described in the references with the embodiments in which a powdered blood coagulation accelerator is used as a filler. Rather, on this record, the cited references at best suggest that Appeal 2011-001121 Application 11/592,477 6 blood permeable pouches containing blood clotting accelerators, and clot- accelerator-impregnated fabrics, are alternative embodiments. Thus, in Example 5, Hursey describes a zeolite-coated porous fabric useful as a wound dressing (Hursey [0078]-[0080]). In Example 6, Hursey separately describes preparing a wound dressing in the form of a permeable packet or sachet that contains loose blood coagulating material (id. at [0089]-[0094]). We agree with the Examiner that Watt „783 and McCabe describe enclosed blood permeable pouches that contain particulate wound-treating material (see Watt „783 at p. 2, ll. 53-58; McCabe, abstract). The Examiner has not, however, pointed to any teaching in any of the cited references, or anything in the knowledge generally available to an ordinary artisan, that would have suggested using a mesh material impregnated with a powdered clotting substance to form a pouch that itself contained loose particulate blood clotting material, as claim 1 requires. The Examiner argues that the claimed combination of pouch-enclosed and mesh-impregnating blood clotting materials is suggested by the prior art since Hursey “teaches co-mingling of the first component and a second component, both of which are blood coagulation accelerators which include zeolite, other clay material and inorganic oxide materials such as calcium oxide and teaches that powdered calcium oxide has good blood clotting properties which can be used in his invention” (Ans. 17). Thus, the Examiner reasons, since Hursey teaches impregnating fibrous material with blood clotting substances, and since Watt and McCabe both teach flexible porous bags that enclose blood-absorbing particulate materials Appeal 2011-001121 Application 11/592,477 7 choosing different blood coagulation accelerator or blood absorbing materials either in powder form which is fine particulate or in the form of larger particulates such as beads and developing a device for their delivery which involves incorporation of the powder form into the mesh which makes up a pouch and enclosing the bigger particulate form within the pouch for wound healing and hemostatic purposes would have been obvious to an ordinarily skilled artisan[ ] form [sic] the teachings of the prior art at the time of the invention. (Id.) We are not persuaded. We acknowledge Hursey‟s disclosure that its blood clotting accelerators can have different physical forms, including clays and molecular sieves, and that those different forms can be combined (see Hursey [0005]). In our view, however, that fact does not adequately explain why an ordinary artisan would have combined the prior art pouch embodiments with embodiments where a powdered clotting substance was incorporated into a porous material. We are also unconvinced that, without more, Hursey‟s disclosure of using blood clotting accelerators as fillers in wound dressing materials, as an alternative to pouch-enclosed clotting agents, suggests the claimed combination of pouch-enclosed and mesh-impregnating blood clotting materials with sufficient specificity. See Unigene v. Apotex, 655 F.3d at 1360; accord, Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA, Inc., 617 F.3d 1296, 1303 (Fed. Cir. 2010) (“[I]t is not enough to simply show that the references disclose the claim limitations; in addition, „it can be important to identify a reason that would have prompted a person of ordinary skill in the art to combine the elements as the new invention does.‟”) (quoting KSR, 550 U.S. at 401 (emphasis added)). Appeal 2011-001121 Application 11/592,477 8 Accordingly, we agree with Appellants that the Examiner did not make out a prima facie case of obviousness as to claim 1. We therefore reverse the Examiner‟s rejection of that claim, and its dependents, over Hursey, Watt „783, and McCabe. The Examiner also rejected claims 29 and 35 as obvious over Hursey, Watt „783, McCabe, and Wu or Watt „842 (Non-Final Rejection 9-11 (entered June 18, 2009)). The Examiner also rejected claims 36 and 37 as obvious over Hursey, Watt „783, McCabe, Jensen, and Bruder (Non-Final Rejection 11-13 (entered June 18, 2009)). Each of claims 29 and 35-37 depend directly or ultimately from claim 1, and the Examiner applied the Wu, Watt „842, Jensen, and Bruder references as evidence that additional limitations recited in those dependent claims would have been further obvious in view of Hursey, Watt „783, and McCabe, discussed above (see Non-Final Rejection 9-13 (entered June 18, 2009)). However, as the Examiner points to no teaching in any of Wu, Watt „842, Jensen, and Bruder that remedies the deficiencies as to claim 1 discussed above regarding Hursey, Watt „783, and McCabe, we reverse these rejections as well. SUMMARY We reverse the Examiner‟s obviousness rejection of claims 1, 2, 21- 28, 30-34, and 38 over Hursey, Watt „783, and McCabe. We also reverse the Examiner‟s obviousness rejection of claims 29 and 35 over Hursey, Watt „783, McCabe, and Wu or Watt „842. Appeal 2011-001121 Application 11/592,477 9 We also reverse the Examiner‟s obviousness rejection of claims 36 and 37 over Hursey, Watt „783, McCabe, Jensen, and Bruder. REVERSED cdc Copy with citationCopy as parenthetical citation