Ex Parte BOURGEOISDownload PDFPatent Trials and Appeals BoardMay 20, 201913686197 - (D) (P.T.A.B. May. 20, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/686,197 11/27/2012 21127 7590 POLSINELLI PC One International Place Suite 3900 BOSTON, MA 02110 05/22/2019 FIRST NAMED INVENTOR Philip BOURGEOIS 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. T012-7075USO 5540 EXAMINER BOSQUES, EDELMIRA ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 05/22/2019 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): mswannichols@polsinelli.com patentdocketing@polsinelli.com thendricks@polsinelli.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PHILIP BOURGEOIS Appeal2017-006265 Application 13/686, 197 Technology Center 3700 Before JOHN C. KERINS, MICHAEL L. HOELTER, and SEAN P. O'HANLON, Administrative Patent Judges. O'HANLON, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner's final decision rejecting claims 1-16 and 22-36. 2 Appellant's representative 1 Appellant is the Applicant, Tekni-Plex, Inc., which, according to the Appeal Brief, is the real party-in-interest. Appeal Br. 2. 2 Claims 17-21 are withdrawn. Final Act. 1; Appeal Br. 2. Appeal2017-006265 Application 13/686,197 presented oral argument on May 7, 2019. We have jurisdiction over this appeal under 35 U.S.C. § 6(b). We AFFIRM. In explaining our Decision, we refer to the Specification filed November 27, 2012 ("Spec."), the Final Office Action dated February 16, 2016 ("Final Act."), the Appeal Brief filed May 18, 2016 ("Appeal Br."), the Claims Appendix filed September 14, 2016 ("Claims App."), 3 the Examiner's Answer dated January 18, 2017 ("Ans."), and the Reply Brief filed March 7, 2017 ("Reply Br."). SUMMARY OF THE INVENTION Appellant's disclosure is directed to "polymeric tubing ... having multiple layers of different polymeric materials." Spec. ,r 2. Claims 1, 22, 27, 29, 30, 33, and 36 are independent. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A tube having a wall comprising an inner layer, an outer layer and a middle layer, wherein the inner layer comprises a thermoplastic polyurethane, the outer layer comprises a thermoplastic polyurethane and the middle layer comprises an ethylene ethyl acrylate copolymer or an ethylene methyl acrylate copolymer or an anhydride grafted ethylene methyl acrylate copolymer, a copolymer of two or more of said acrylates or a mixture of two or more of the foregoing. Claims App. 27. 3 In citing to the Claims Appendix, we refer to the pagination as provided therein. We note that the numbering begins with page 27, as an apparent continuation of the pagination of the Appeal Brief. 2 Appeal2017-006265 Application 13/686,197 REFERENCES The Examiner relies on the following prior art references in rejecting the claims on appeal: Ostoich Greenwood Helmus Mueller us 4,211,741 us 5,004,455 us 5,569,463 us 5,681,627 REJECTIONS July 8, 1980 Apr. 2, 1991 Oct. 29, 1996 Oct. 28, 1997 I. Claims 1, 2, 4--7, 10-16, 22-24, 27, 28, and 30-32 stand rejected under 35 U.S.C. § 102(b) as anticipated by Mueller or, in the alternative, under 35 U.S.C. § 103(a) as being unpatentable over Mueller and Ostoich. II. Claims 8, 9, 29, and 36 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Mueller and Ostoich. III. Claims 33-35 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Mueller, Ostoich, and Greenwood. IV. Claims 3, 25, and 26 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Mueller, Ostoich, and Helmus. ANALYSIS Rejection I The Examiner rejects claims 1, 2, 4--7, 10-16, 22-24, 27, 28, and 30- 32 as anticipated by or, in the alternative, as being unpatentable over Mueller and Ostoich. Final Act. 2-10. Each of these alternative rejections is discussed below. 3 Appeal2017-006265 Application 13/686,197 Anticipation The Examiner finds that Mueller discloses a tube as recited in independent claim 1, relying on the disclosure at column 10, lines 44--50 to disclose a tube. Id. at 3. Appellant argues that Mueller only discloses a cast film extrusion process, that Mueller rolls the film into a roll, and that a roll of film is not a tube. Appeal Br. 9--13. Mueller discloses a multilayer film. See, e.g., Mueller, 1:5. The film can be formed into a flexible medical pouch, such as an I.V. bag, ostomy pouch, or air-bladder portion of a compression device, by heat-sealing peripheral portions of the inner layer. Id. at 6:9--40. We agree with Appellant that Mueller's reference to a "tubular film" relied upon by the Examiner, taken in context with the totality of the Mueller disclosure, would not be regarded by a person of ordinary skill in the art as a tube as the term is used in the Appellant's Specification and claims. See, e.g., Spec. Fig. 1. As the Examiner has not explained adequately how each term of independent claim 1 is disclosed by Mueller, we do not sustain the rejection of claim 1 or its dependent claims as being anticipated by Mueller. As the Examiner relies on similar erroneous findings to reject independent claims 22, 27, and 30 (see Final Act. 6, 7-8, 9), we do not sustain the rejection of these claims or their dependent claims as being anticipated by Mueller. Obviousness Claims 1, 2, 4, 5, 10-16, 22, and 31 Appellant presents arguments contesting the rejection of claims 1, 2, 4, 5, 10-16, 22, and 31 collectively. We select claim 1 as representative, treating claims 2, 4, 5, 1 0-16, 22, and 3 1 as standing or falling with representative claim 1. See 37 C.F.R. § 4I.37(c)(l)(iv). 4 Appeal2017-006265 Application 13/686,197 The Examiner relies on Mueller to disclose a three-layer film having inner and outer layers comprising a thermoplastic polyurethane and a middle layer comprising an anhydride grafted ethylene methyl acrylate copolymer. Final Act. 3. The Examiner relies on Ostoich to teach a three-layer tube with inner and outer layers of polyurethane. Id. The Examiner reasons that it would have been obvious to a person having ordinary skill in the art to use the materials disclosed by Mueller to construct a medical tube, determining that Ostoich evidences that three layer medical tubes with inner and outer layers of polyurethane are well known in the art due to the flexibility, strength, and compatibility of the materials. Id. Appellant traverses, arguing first that Ostoich does not disclose a tube having an adhesive layer between inner and outer layers. Appeal Br. 13-15. Appellant characterizes this as a "teaching away" from an adhesive layer. Id. at 13. Mueller discloses that its middle layer, referred to as an "interior layer" (see Mueller, 5:22-24), is an adhesive. Id. at 7:58----67, 8:60----61. The Examiner relies on Ostoich to show that a tube having inner and outer polyurethane layers is well known, and relies on Mueller to disclose the materials used to make such a tube. Final Act. 3. Thus, we are note persuaded by Appellant's arguments. Nor are we persuaded that Ostoich teaches away from an adhesive layer. Appellant's arguments rely on the two-layer embodiment illustrated in Ostoich's Figure 2. Appeal Br. 14--15. However, the Examiner relies on the three-layer embodiment illustrated in Ostoich's Figure 4. See Final Act. 3 ( stating "Ostoich teaches a three layer tube" and referencing Ostoich, Fig. 4 ). Ostoich describes this embodiment as having a middle layer of 5 Appeal2017-006265 Application 13/686,197 "polyvinyl chloride or the like [that] is sandwiched between inner and outer polyurethane layers." Ostoich, 5:22-25. Appellant's attempt to differentiate the claimed tube from Ostoich's tube by the manufacturing process is unpersuasive as both Ostoich (see Ostoich, 4:21-23) and Appellant (see Spec. ,r 2) use a co-extrusion manufacturing process to form their respective tubes. As Appellant has failed to identify any criticism in Ostoich of an adhesive middle layer, Appellant has not shown persuasively any teaching away. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Appellant argues that the thicknesses of Ostoich's layers are "multiple times the thicknesses of the film layers of Mueller's films" and that the processing equipment used by the two references is "profoundly different." Appeal Br. 13. These arguments fail to apprise us of error, as the Examiner's rejection proposes to make a tube as disclosed by Ostoich using the materials disclosed by Mueller; the Examiner does not suggest using Mueller's equipment or films to form a tube. We additionally note that both Mueller and Ostoich disclose a three-layer medical device having inner and outer layers comprising polyurethane. See Mueller, 8:59---62; Ostoich, 5: 18-25. Additionally, Mueller and Ostoich disclose similar materials for the middle layer. See Mueller, 7:48-54 ("Suitable materials from which the interior layer may be selected include, without limitation, polymeric adhesive, ... polyvinylidene chloride, ... and mixtures of the foregoing materials."), 8:25-34 (explaining that a middle layer comprising polyvinylidene chloride acts as a gas barrier), 12:7-8 (explaining that SARAN is a polyvinyl chloride copolymer), 13:36-45 (disclosing an example embodiment using SARAN as the middle layer between two polyurethane layers); Ostoich, 3:52-54 ("a suitable inexpensive plastic such 6 Appeal2017-006265 Application 13/686,197 as polyvinyl chloride" (emphasis added)), 5:22-25 ("polyvinyl chloride or the like is sandwiched between inner and outer polyurethane layers" ( emphasis added)). As Mueller further discloses that its middle layer can be a polymeric adhesive such as anhydride-modified ethylene/methyl acrylate (EMA) copolymer (Mueller, 7:58-67), using Mueller's polymeric adhesive in place of Ostoich's polyvinyl chloride to form the middle layer amounts to the replacement of one known element by another known element, the results of which substitution would be predictable, as both the references use the materials as middle layers between polyurethane layers. See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results."). The obviousness of this substitution is buttressed by the fact that Appellant's Specification, Mueller, and Ostoich each recognize that polyurethane is relatively expensive and use a different material for the middle layer to reduce the cost of the end product. See Spec. ,r 9; Mueller, 7:44--47; Ostoich, 2:3-7. Next, Appellant notes that it has submitted, under 37 C.F.R. § 1.132, a declaration of Dr. Philip Bourgeois (the inventor), which Appellant argues "explains how and why the prior art cited by the [E]xaminer does not disclose or suggest the claimed tubular structures." Appeal Br. 19. Appellant asserts that the Bourgeois Declaration explains how "the Mueller and Ostoich disclosures teach away from a tube having an inner and outer polyurethane layer bound by an intermediate adhesive layer." Id. Appellant cites In re Sullivan, 498 F.3d 1345, 1350-51 (Fed. Cir. 2007) and In re Lueders, 111 F.3d 1569, 1574 (Fed. Cir. 1997) as supporting its contention that "the burden is on the [E]xaminer to cite to evidence that proves that the 7 Appeal2017-006265 Application 13/686,197 Mueller and Ostoich references can be modified as the [E]xaminer contends." Id. at 19--20. Appellant characterizes the Examiner's consideration of the Declaration as being a "singular explanation" of it being "not persuasive," and summarily asserts that such consideration "isn't good enough under In re Nuvasive[, Inc., 842 F.3d 1376 (Fed. Cir. 2016)]." Reply Br. 4. "[W]hen an applicant puts forth relevant rebuttal evidence, ... the Board must consider such evidence." Sullivan, 498 F.3d at 1354. "That is not to suggest that the Board's finding of obviousness must be overturned in light of the evidence; rather, the Board must give the declarations meaningful consideration before arriving at its conclusion." Id. The Bourgeois Declaration in large part parallels Appellant's arguments in the Appeal Brief. Compare Bourgeois Deel. ,r,r 6-13, with Appeal Br. 10-15. We have considered these arguments, which, as explained above, fail to apprise us of error in the Examiner's obviousness rejection. Lueders explains that the Board, when affirming a rejection "for different reasons" than those set forth by the Examiner, must identify evidentiary support, explicitly or implicitly, for its factual findings. Lueders, 111 F.3d at 1574. As such, the relevance of Lueders to this case is unclear. Nor do we agree that the Examiner summarily dismissed the Bourgeois Declaration as asserted by Appellant. We note that Appellant failed to address the Examiner's discussion of the Declaration at pages 17-19 of the Final Office Action and pages 18-19 of the Examiner's Answer. Additionally, for the reasons set forth above, we determine that the Examiner satisfactorily addresses both "the benefits that could have been obtained by combining the prior art references" and "the PHOSITA's 8 Appeal2017-006265 Application 13/686,197 motivation to combine at the time of the invention." See Nuvasive, 842 F.3d at 1384. Finally, Appellant argues that the Examiner's rejections are based on hindsight reasoning, citing six prior Board and federal district court cases purported as "dealing with multi-layer tubes or films." Appeal Br. 20-25. If the Examiner has articulated a reason having rational underpinnings for making a proposed combination of prior art teachings, and if the articulated reason and rational underpinnings have their genesis in the prior art, then that articulated reasoning demonstrates the combination is not based on hindsight. See In re Kahn, 441 F.3d 977,988 (Fed. Cir. 2006) (requiring "some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness") (cited with approval in KSR, 550 U.S. at 418). Here, the Examiner relies on Mueller's teachings regarding its interior layer as the basis for using that material as the middle layer of Ostoich' s three-layer tube: The interior layer is preferably formed from a material which does not detract from the flexibility imparted to the flexible film by the polyurethane-containing first exterior layer. Depending upon the particular application for which the multilayer film is to be used, the interior layer will preferably provide additional desired properties, e.g., oxygen-barrier functionality, strength, RF sea/ability, or melt strength. In addition, the core layer can serve to reduce the cost of the film by allowing less polyurethane (a relatively expensive material) to be used in the film structure. Mueller, 7:37--47 (emphases added); see also Final Act. 3 (noting Mueller's teachings of "flexibility, strength, and compatibility"). Having relied upon the express teachings of Mueller, and not on Appellant's disclosure, the 9 Appeal2017-006265 Application 13/686,197 Examiner's combination of Mueller and Ostoich is based on rational underpinnings and, therefore, is not based on improper hindsight reasoning. Furthermore, although Appellant reproduces selected quotations from the cited cases, Appellant does not explain how the facts of those cases are similar to the facts of this case or explain any differences. Thus, Appellant's citations, lacking any relevant analysis, fail to apprise us of any error in the Examiner's rejection. To the extent Appellant presented additional arguments in the oral hearing that are not addressed above, such new arguments are untimely and will not be considered. See 37 C.F.R. § 4I.47(e). Accordingly, for the foregoing reasons, we sustain the rejection of claims 1, 2, 4, 5, 10-16, 22, and 31 as being unpatentable over Mueller and Ostoich. Claims 6, 7, 23, 24, 27, 28, 30, and 32 Appellant presents additional arguments regarding dependent claims 6, 7, 23, 24, 27, 28, 30, and 32 collectively. We select claim 6 as representative per 37 C.F.R. § 4I.37(c)(l)(iv). Claim 6 depends directly from claim 1 and recites "wherein the inner and outer layers do not visually delaminate from the middle layer, at a stress up to of about 55 MPa and a strain up to about 900-950%." Claims App. 27. The Examiner finds that Mueller teaches this limitation, reasoning: [because] it would have been obvious to use the material of Mueller to create a medical tube, the tube would have the same structural limitations of the claimed tube, therefore the tube of Mueller does not visually delaminate from the middle layer, at a [stress] up to about 55 MPa and a strain up to about 900-950%. Final Act. 4. 10 Appeal2017-006265 Application 13/686,197 Appellant interprets the rejection as being based on inherency and argues that the Examiner has not properly shown, with extrinsic evidence, that the "theoretical tubes" taught by Mueller and Ostoich exhibit resistance to delamination. Appeal Br. 16-17; see also Reply Br. 4--5. In a case such as this where patentability rests upon a property of the claimed material not disclosed within the art, the PTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of the claimed product. In re Spada, 911 F .2d 705, 708 (Fed. Cir. 1990); In re Best, 562 F.2d 1252, 1254--55 (CCPA 1977). Here, as discussed above, Mueller discloses the recited materials and Ostoich discloses the recited structure of a tube and forming such a tube by a co-extrusion process. Appellant's Specification describes delamination resistance as being a material property. See, e.g., Spec. ,r,r 9 ("these materials provide good adhesion to a thermoplastic polyurethane elastomer (TPU) and maintain resistance to delamination of the tube under high stress and temperature conditions"), 12 (describing "three layer tubes manufactured by ... a co-extrusion process" in which the "TPU and ... EMA ... are melt extruded through a die head" as "act[ing] in a monolithic manner" and resisting delamination). Because the materials are the same, and the manufacturing process employed are effectively the same, the Examiner reasons that the tube taught by Mueller and Ostoich would exhibit 11 Appeal2017-006265 Application 13/686,197 a similar resistance to delamination as recited by Appellant. Appellant has not explained adequately why the tube set forth in the Office Action would not exhibit such delamination resistance, and, therefore, has failed to apprise us of error. Accordingly, for the foregoing reasons, we sustain the rejection of claims 6, 7, 23, 24, 27, 28, 30, and 32 as being unpatentable over Mueller and Ostoich. Rejection II The Examiner rejects claims 8, 9, 29, and 36 as being unpatentable over Mueller and Ostoich. Final Act. 10-14. Appellant does not advance arguments contesting the rejection of these claims separate from the arguments discussed above. For similar reasons as explained previously, we sustain the rejection of claims 8, 9, 29, and 36 as being unpatentable over Mueller and Ostoich. Rejection III The Examiner rejects claims 33-35 as being unpatentable over Mueller, Ostoich, and Greenwood. Final Act. 14--16. The Examiner relies on Mueller and Ostoich as discussed above with respect to claim 1, and further finds that Ostoich discloses a central fluid flow passage. Id. at 14-- 15. The Examiner relies on Greenwood to teach the use of a polyurethane catheter to deliver oxygen. Id. at 15. Appellant traverses, arguing that the Examiner uses improper hindsight reconstruction in combining the teachings of Greenwood with "the Mueller film reference and the no adhesive Ostoich reference." Appeal Br. 16. Appellant's conclusory arguments fail to address the Examiner's 12 Appeal2017-006265 Application 13/686,197 finding that Greenwood teaches oxygen delivery through a polyurethane catheter, and, thus, fail to apprise us of error. Appellant also cites three prior Board and federal district court decisions purported as prohibiting "a selective plucking of elements out-of- context from a multiplicity of references using the claims as a hindsight roadmap for the combination." Id. at 17-19. As explained above, the Examiner sets forth reasoning having rational underpinnings for forming a tube as disclosed by Ostoich using the materials disclosed by Mueller. The Examiner relies on Greenwood to teach delivering oxygen through a polyurethane tube. Appellant has not identified any improper "selective plucking of elements" in the Examiner's rejection, and, thus, has failed to apprise us of error. Furthermore, although Appellant reproduces selected quotations from the cited cases, Appellant does not explain how the facts of those cases are similar to the facts of this case or explain any differences. Thus, Appellant's citations, lacking any relevant analysis, fail to apprise us of any error in the Examiner's rejection. Accordingly, for the foregoing reasons, we sustain the rejection of claims 33-35 as being unpatentable over Mueller, Ostoich, and Greenwood. Rejection IV The Examiner rejects claims 3, 25, and 26 as being unpatentable over Mueller, Ostoich, and Helmus. Final Act. 16-17. The Examiner relies on Mueller and Ostoich as discussed above with respect to claim 1, and relies on Helmus to teach the use of polytetramethyleneglycol based polyurethane in a medical tube. Id. at 16. 13 Appeal2017-006265 Application 13/686,197 Appellant traverses, arguing that the portion of Helmus relied upon by the Examiner discloses a coating, not a tube layer. Appeal Br. 15. Appellant argues that Helmus does not disclose a tube using a polyurethane material. Id. We are not persuaded by Appellant's conclusory arguments. Initially, we note that Helmus mentions polyurethane repeatedly, for example "polyurethane catheter 10." See Helmus, 4:56-57. Appellant fails to apprise us why a catheter is not a tube. Nor does Appellant apprise us of a distinction between a tube "coating" and a tube "layer," especially given that Appellant and Helmus disclose overlapping thickness ranges. See Spec. ,r 46 ( disclosing the thicknesses of the inner and outer layers as being "between about .00025 inches and about .025 inches" (0.25-25 mils)); Helmus, 7:44--50 (disclosing the thickness of its coating as being 1-100, typically 2-3, mils). Appellant also cites three prior Board and federal district court decisions purported as prohibiting "a selective plucking of elements out-of- context from a multiplicity of references using the claims as a hindsight roadmap for the combination." Appeal Br. 17-19. This argument is unpersuasive for the reasons explained above regarding Rejection III. Accordingly, for the foregoing reasons, we sustain the rejection of claims 3, 25, and 26 as being unpatentable over Mueller, Ostoich, and Helmus. DECISION The Examiner's decision to reject claims 1, 2, 4--7, 10-16, 22-24, 27, 28, and 30-32 under 35 U.S.C. § 102(b) is reversed. 14 Appeal2017-006265 Application 13/686,197 The Examiner's decision to reject claims 1-16 and 22-36 under 35 U.S.C. § 103(a) 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)(l )(iv). AFFIRMED 15 Copy with citationCopy as parenthetical citation