Ex Parte Bourgeois et alDownload PDFPatent Trial and Appeal BoardNov 20, 201713354029 (P.T.A.B. Nov. 20, 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. 13/354,029 01/19/2012 Philip BOURGEOIS T012-7071US0 3940 21127 7590 11/22/2017 POT STNFT T T PC EXAMINER 100 Cambridge Street Suite 2101 LEE, WENG WAH BOSTON, MA 02114 ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 11/22/2017 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): thendricks @polsinelli. com athumann @polsinelli. com DC-IPDocketing@polsinelli.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PHILIP BOURGEOIS and MUNISH SHAH Appeal 2016-000924 Application 13/354,029 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 Philip Bourgeois and Munish Shah (Appellants)1 2appeal under 35 U.S.C. § 134(a) from the Examiner’s final decision rejecting claims 1-16. An oral hearing in accordance with 37 C.F.R. § 41.47 was held on 1 The Appeal Brief identifies Tekni-Plex, Inc. as the real party in interest. Appeal Br. 3. 2 Claims 17-20 are withdrawn. Final Act. 1; Appeal Br. 3. Appeal 2016-000924 Application 13/354,029 November 7, 2017. We have jurisdiction over this appeal under 35 U.S.C. § 6(b). SUMMARY OF THE DECISION We AFFIRM. SUMMARY OF THE INVENTION Appellants’ disclosure is directed to multilayer polymeric tubing in which the layers are successively adhered. Spec. ^ 1. Claim 1, reproduced below from page 28 (Claims Appendix) of the Appeal Brief, is illustrative of the claimed subject matter: 1. A tube comprising an inner layer, an outer layer and a middle layer, wherein the inner layer comprises a polyethylene, 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. REJECTIONS Claims 1, 4, and 7-15 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Samuelson (US 6,165,166, issued Dec. 26, 2000) and Julien (US 2009/0087606 Al, published Apr. 2, 2009). Claim 2 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Samuelson, Julien, and Fujieda (US 6,977,105 Bl, issued Dec. 20, 2005). 2 Appeal 2016-000924 Application 13/354,029 Claim 3 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Samuelson, Julien, Fujieda, and Penhasi (US 2003/0208259 Al, published Nov. 6, 2003). Claims 5 and 6 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Samuelson, Julien, and Penhasi.3 Claim 16 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Samuelson and Penhasi. ANALYSIS Obviousness Based on Samuelson and Julien Claims L 4. 7. 8. and 12 Appellants address claims 1, 4, 7, 8, and 12 collectively. Appeal Br. 8-26. We select independent claim 1 as representative, treating claims 4, 7, 8, and 12 as standing or falling with representative claim 1. See 37 C.F.R. § 41.37(c)(l)(iv). The Examiner finds that Samuelson discloses a tube substantially as recited in claim 1, including a polyethylene inner layer, an acrylate- containing polymer middle layer, and an outer layer that “can preferably [be] thermoplastic,” but “does not expressly disclose that the outer layer comprises a thermoplastic polyurethane.” Final Act. 3 (citing Samuelson 5:66-67, 6:42^46, 7:43-51, 7:65-67). The Examiner finds that Julien discloses a multilayer tubing including an inner layer, a middle layer, and an 3 Although the heading indicates that claim 16 is included in this rejection, claim 16 is not addressed in the body of the rejection. See Final Act. 11; Ans. 12. 3 Appeal 2016-000924 Application 13/354,029 outer layer “made of a thermoplastic polyurethane copolymer because it is widely used in medical devices and also provides high tensile strength among other characteristics.” Id. (citing Julien 68-69). The Examiner reasons that it would have been obvious to one of ordinary skill in the art to “modify the outer tube of Samuelson with the thermoplastic polyurethane copolymer as taught by Julien, since doing so would effectively provide high tensile strength for the tube.” Id. (citing Julien 69). Arguments Regarding Samuelson Appellants traverse, first arguing that “Samuelson explicitly teaches that a polyurethane material should ‘not’ be used as a material in the outer layer of Samuelson’s tube.” Appeal Br. 10-11; see also the Declaration under 37 C.F.R. § 1.132 of Dr. Philip Bourgeois dated December 8, 2014 (“Deck 3”) §§ 6-7. Appellants reproduce emphasized portions of Samuelson’s “Background of the Invention” disclosure, and conclude: This discussion of the prior art in the Background section of Samuelson purposely distinguishes the Samuelson tube structure from several prior art patents on the basis that... the use of polyurethane materials in the outer tubular layers of several cited prior art patents is not recommended for use in Samuelson’s invention because the materials used in the prior art outer layers are incompatible with a polyethylene inner layer. Appeal Br. 11 (referencing Deck 3 § 6). Continuing, Appellants reproduce portions of Samuelson column 6, lines 2-7 and assert: These choices of non-flexible, non-TPU [(thermoplastic polyurethane)] materials for Samuelson’s outer layer are purposely selected so as to provide Samuelson’s balloon catheter structure with a high enough stiffness that is capable of withstanding high pressures necessary to inflate a balloon as 4 Appeal 2016-000924 Application 13/354,029 well as to be compatible with the stiff inner PTFE or PVDF layer. Id. at 12 (referencing Decl. 3 § 7); see also Reply Br. 3—4. We are not persuaded by Appellants’ arguments, which misconstrue Samuelson’s disclosure. Rather, as correctly noted by the Examiner (see Ans. 15-16), Samuelson’s background section discusses problems associated with known two-layer medical tubing having an outer polyurethane layer and an inner polyethylene layer, including the tendency of layers formed of these materials to be subject to delamination. Samuelson 2:65-3:37. To solve this problem, Samuelson discloses a three-layer medical tubing adding an intermediate layer to bond the outer and inner layers “such that the layers resist delamination under operating conditions both normal and extreme.” Id. 3:47-61. Thus, a fair reading of Samuelson reveals that it discourages the direct bonding of a polyurethane layer to a polyethylene layer, but does not discourage the use of polyurethane or an outer layer comprising a thermoplastic polyurethane. Furthermore, we note that Samuelson discloses that outer layer 16 of its tubing 10 “is preferably comprise[d] of at least one polymer selected so as to be directly bondable to the [angioplasty] balloon by a technique such as fusion bonding.” Id. 5:62-65. Samuelson also discloses that “it is preferable that the outer surface of the tubing of the catheter be directly bondable to the balloon material, such as by fusion bonding, described in U.S. Pat. Nos. 5,501,759 [(the ’759 patent)] and 5,267,959 [(the ’959 patent)].” Id. at 2:18-21; see also id. at 9:28-31 (incorporating by reference the ’759 and ’959 patents). Finally, we note that both the ’759 patent and the ’959 patent disclose that thermoplastic polyurethanes are suitable 5 Appeal 2016-000924 Application 13/354,029 materials for fusion bonding. See the ’759 patent at 4:42-47; the ’959 patent at 4:43-49. Thus, Samuelson itself suggests to one of ordinary skill in the art the use of an outer tubing layer formed of a thermoplastic polyurethane, and is additional evidence that Samuelson does not teach away from the use of thermoplastic polyurethane. Appellants’ arguments to the contrary are not persuasive. Arguments Regarding Julien Appellants next argue that “Julien purposely specifies that Julien’s inner layer 10 and not Julien’s middle layer 15 may comprise some amount of acrylate in the form of a grafted long chain polyethylene molecule.” Appeal Br. 12. Appellants cite paragraph 80 of Julien’s Specification as disclosing that “the only adhesive polymers for use in Julien’s middle layer 15 are polyurethane adhesives or maleic anhydride modified polyolefins such as LLDPE. These adhesives are profoundly and purposely different from acrylate molecule structures and functions.” Id. at 13; see also the Declaration under 37 C.F.R. § 1.132 of Dr. Philip Bourgeois dated May 8, 2014 (“Decl. 2”) § 8; Decl. 3 § 8; and Reply Br. 3^1. The Examiner relies on Samuelson to disclose the middle and inner layers, and on Julien to teach a thermoplastic polyurethane outer layer. Final Act. 3. The Examiner does not rely on Julien’s middle layer. Thus, Appellants’ arguments fail to address the rejection as set forth by the Examiner, and, therefore, fail to apprise us of error in the Examiner’s findings or reasoning. Furthermore, we note that Appellants again misconstrue the disclosure of the cited references. Julien recites that its “adhesive tie layers are 6 Appeal 2016-000924 Application 13/354,029 typically polyurethane adhesives or maleic anhydride modified polyolefins such as LLDPE.” Julien 80 (emphasis added). This is a far cry from the exclusionary teaching advocated by Appellants. Hindsight Reasoning Appellants next argue that the Examiner’s combination of Samuelson and Julien is based on hindsight reasoning, citing six prior Board and federal district court cases purported as “dealing with erroneous obviousness rejections of multi-layer tubes or films.” Appeal Br. 16-21. 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 Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). Here, the Examiner relies on Julien’s teachings regarding thermoplastic polyurethane as the basis for forming Samuelson’s outer layer of this material: TPU copolymer is a widely accepted copolymer . . . used extensively in medical devices and is a good choice for the outer and outermost [tubing] layers due to its high tensile strength, rubber-like elasticity, transparency, exceptional structural memory, high resilience, adhesive properties, ease of processability, resistance to change during gamma (y) sterilization, and low temperature flexibility. In addition, TPU does not require plasticizers and can be formulated animal derived component free. 7 Appeal 2016-000924 Application 13/354,029 Julien 69; see also Final Act. 3 (citing Julien 69); and Ans. 18. Having relied upon the express teachings of Julien, and not on Appellants’ disclosure, the Examiner’s combination of Samuelson and Julien is based on rational underpinnings and, therefore, is not based on improper hindsight reasoning. Unexpected Results Finally, Appellants argue that: experimental data has been generated that shows the existence of an unexpected result by the use of an acrylate-containing polymer middle layer as compared to the use of an adhesive tie layer of a maleic anhydride modified polyolefin such as LDPE as specified by the Julien reference and ethyl vinyl acetate as suggested in DE202004000533U1 and EP244960A1 cited by the examiner in Europe. Appeal Br. 21 (citing the Declaration under 37 C.F.R. § 1.132 of Dr. Philip Bourgeois dated August 19, 2013 (“Decl. 1”) § 11). Although the Examiner states that the Declaration under 37 C.F.R. § 1.132 of Dr. Philip Bourgeois dated December 8, 2014 was “fully considered” (Final Act. 14), we agree with Appellants that the Examiner’s determination that “the affidavit is deficient under 37 CFR [§] 1.132 because the unexpected results were not disclosed in the originally filed [Specification” (see Reply Br. 1-2; Ans. 19) is improper, but, having carefully evaluated and weighed both the evidence relied upon by the Examiner and the objective evidence of nonobviousness provided by Appellants, we do not find Appellants’ assertion of unexpected results persuasive. 8 Appeal 2016-000924 Application 13/354,029 “[W]hen unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991) (citing In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)). The burden of demonstrating unexpected results rests on the party asserting them, and “it is not enough to show that results are obtained which differ from those obtained in the prior art; that difference must be shown to be an unexpected difference.” In reKlosak, 455 F.2d 1077, 1080 (CCPA 1972). Appellants have failed to satisfy these requirements. The experiments relied upon by Appellants purport to show “the existence of an unexpected result by the use of an acrylate-containing polymer middle layer” by showing comparisons to materials disclosed by Julien and two references cited by a European patent examiner. Decl. 1 §§ 11-21; Appeal Br. 21-25. As correctly found by the Examiner (which finding, we note, Appellants did not challenge), Samuelson discloses an acrylate-containing polymer middle layer. See, e.g., Samuelson 7:43-8:3; Final Act. 3. As Samuelson discloses the same adhesive layer material as recited in Appellants’ claims, Samuelson, not Julien or the references cited by the European patent examiner, is the closest prior art. Thus, Appellants’ experiments do not show an unexpected result compared with the closest prior art. Additionally, as Samuelson discloses an acrylate-containing polymer middle layer, Appellants have failed to establish that the results of their experiments are, in fact, unexpected. Finally, as the Examiner relies on Samuelson to disclose the recited middle layer, Appellant’s experiments and associated 9 Appeal 2016-000924 Application 13/354,029 arguments fail to address the rejection as set forth by the Examiner, and, therefore, fail to apprise us of error in the Examiner’s findings or reasoning. Conclusion Accordingly, for the foregoing reasons, we sustain the Examiner’s rejection of claims 1, 4, 7, 8, and 12 as being unpatentable over Samuelson and Julien. Claims 9-11 and 13-15 Claim 9 depends directly from claim 1 and further requires that “the tube does not visually delaminate when submersed in water at 60° C for 36 hours.” Appeal Br. 29 (Claims App.). Claim 10 depends directly from claim 1 and further requires, in relevant part, that “the outer and inner layers resisting delamination from each other at a stress of up to about 55 MPa and a strain of up to about 900-950 %.” Id. The Examiner determines that these recitations are statements of intended use that do not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Final Act. 5 (citing Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987)). The Examiner further determines that “the combination of the materials from the prior art would produce a structure that would inherently have the properties as claimed.” Ans. 5, 6, 18. Appellants address claims 9-11 and 13-15 collectively. Appeal Br. 14-16. We select claim independent 9 as representative, treating claims 10, 11, and 13-15 as standing or falling with representative claim 1. Appellants argue that Ex parte Masham is not applicable and that the subject recitations are “positive structural limitation on the claimed tube,” citing five U.S. patents purported as containing similar claim language. 10 Appeal 2016-000924 Application 13/354,029 Appeal Br. 14-16; see also Reply Br. 4. Appellants further assert that when making a determination of inherency, “the [Ejxaminer is required to point to extrinsic evidence that shows that the allegedly inherent properties or structures are ‘necessarily present’ in the thing described in the cited reference.” Reply Br. 2-3. Intended Use It is well established that “[a]n intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). We are persuaded that subject recitations regarding resistance to delamination are not statements of intended use. Rather than merely defining a context in which the recited tube operates, such recitations describe characteristics of the tube constructed from the claimed materials. Inherency A claim may be anticipated if an element, although not explicitly described, is inherent in a prior art disclosure. In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). “Inherency . . . may not be established by probabilities or possibilities.” In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 26 CCPA 937, 940 (1939)). When the Examiner relies upon a theory of inherency, the Patent Office must show a “reason to believe” that a property “asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent 11 Appeal 2016-000924 Application 13/354,029 characteristic of the prior art.” In re Swinehart, 439 F.2d 210, 213 (Fed. Cir. 1971); In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977). Although the Examiner’s explanation supporting the finding of inherency is brief, we are not persuaded that the determination was made in error. In a case such as this, where patentability rests upon a property of the claimed material not disclosed within the art, the Patent Office 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 Patent Office 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); Best, 562 F.2d at 1255. As discussed above, the Examiner found that the combination of Samuelson and Julien discloses a tube comprising a polyethylene inner layer, a thermoplastic polyurethane outer, and an acrylate-containing polymer middle layer as recited in Appellants’ claims.4 Final Act. 3. The Specification sets forth that the recited resistance to delamination is a result of using the recited tubing middle layer material. See Spec. ^ 5 (“the intermediate layer prevents delamination of the outer and inner layers from the intermediate layers under conditions of relatively low to moderate stress 4 We note that Appellants challenge the propriety of combining the reference teachings, but do not challenge the Examiner’s findings regarding the disclosure of the recited materials. Appeal Br. 8-26. 12 Appeal 2016-000924 Application 13/354,029 or strain”); see also id. 8, 15-17, 30, 36. Likewise, Dr. Bourgeois sets forth that it is the use of an acrylate-containing polymer middle layer that results in the recited delamination resistance. Decl. 1 §§ 11, 17-20. We additionally note that Samuelson and Julien both disclose manufacturing their medical tubing in the same manner as Appellants, namely by coextrusion. See, e.g., Samuelson 10:56-11:12; Julien 89-90; Spec. ^ 25. Given the Examiner’s conclusion that a tube made from the same materials as claimed would have been an obvious tube construction, and that Appellants have described the recited resistance to delamination as a mere characteristic of such materials as constructed into a tube, a preponderance of the evidence supports the Examiner’s conclusion that the recited delamination resistance is inherently disclosed by the relied upon prior art. We appreciate the fact that the Examiner first set forth the finding of inherency in the Examiner’s Answer, but note that Appellants decided to maintain the appeal rather than filing a petition pursuant to 37 C.F.R. § 41.40(a) seeking to reopen prosecution. Conclusion Accordingly, for the foregoing reasons, we sustain the Examiner’s rejection of claims 9-11 and 13-15 as being unpatentable over Samuelson and Julien. Obviousness Based on Samuelson, Julien, and Fujieda Appellants do not make any other substantive argument regarding the rejection of dependent claim 2 apart from its dependence from claim 1. See Appeal Br. 8-26. Therefore, we likewise sustain the rejection of claim 2 as being unpatentable over Samuelson, Julien, and Fujieda. 13 Appeal 2016-000924 Application 13/354,029 Obviousness Based on Samuelson, Julien, Fujieda, and Penhasi Appellants do not make any other substantive argument regarding the rejection of dependent claim 3 apart from its dependence from claim 1. See id. Therefore, we likewise sustain the rejection of claim 3 as being unpatentable over Samuelson, Julien, Fujieda, and Penhasi. Obviousness Based on Samuelson, Julien, and Penhasi Appellants do not make any other substantive argument regarding the rejection of dependent claims 5 and 6 apart from their dependence from claim 1. See id. Therefore, we likewise sustain the rejection of claims 5 and 6 as being unpatentable over Samuelson, Julien, and Penhasi. Obviousness Based on Samuelson and Penhasi Independent claim 16 recites a medical tube with limitations similar to those of claims 1, 9, and 10. Id. at 31 (Claims App.). Appellants do not contest the Examiner’s findings relative to the references, nor do Appellants challenge the propriety of the Examiner’s proposed combination. See id. at 8-26. Appellants do not make any substantive argument regarding the rejection of claim 16 apart from the arguments presented regarding the rejection of claim 9. See id. Therefore, we likewise sustain the rejection of claim 16 as being unpatentable over Samuelson and Penhasi. DECISION The Examiner’s decision to reject claims 1-16 is affirmed. 14 Appeal 2016-000924 Application 13/354,029 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