Ex Parte Xie et al

Patent Trial and Appeal BoardMar 28, 2019

14401266 (P.T.A.B. Mar. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/401,266 11/14/2014 59582 7590 04/01/2019 DICKINSON WRIGHT PLLC 2600 WEST BIG BEA VER ROAD SUITE 300 TROY, MI 48084-3312 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR JianXie 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. 29748-00025 5017 EXAMINER IWAMAYE, ANDREW MICHAEL ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 04/01/2019 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): D WPatents@dickinson-wright.com tgood@dickinsonwright.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JIAN XIE and ZHENG WEI 1 Appeal2018-005647 Application 14/401,266 Technology Center 3700 Before JENNIFER D. BAHR, MICHAEL J. FITZPATRICK, and LEE L. STEPINA, Administrative Patent Judges. BAHR, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. Â§ 134(a) from the Examiner's decision rejecting claims 1, 4, and 12-15. We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. 1 Puyi (Shanghai) Biotechnology Co., LTD (Appellant) is the applicant as provided in 37 C.F.R. Â§ 1.46 and is identified as the real party in interest. Appeal Br. 3. Appeal2018-005647 Application 14/401,266 THE CLAIMED SUBJECT MATTER Claim 1, reproduced below, is illustrative of the claimed subject matter. 1. A stent for treating sinusitis or allergic rhinitis, wherein the stent has a circumferentially extending one-layer wall extending about an axis between two open ends to form a closed tubular structure in the circumferential direction of a biodegradable polymer, and the wall is formed by monofilaments being woven with a plurality of interspaces between the monofilaments, wherein biodegradable fiber bundles independent from the monofilaments and containing drugs are interspersed in the interspaces, the fiber bundles are carried on the monofilaments and extend outwardly away from the monofilaments forming tentacles configured to extend axially from the wall to a free end located axially beyond one of the open ends for being scattered to locations of pathological changes of both axial sides of the stent, the monofilaments define a plurality of bending points at both ends of the wall and define positioning portions extending radially outwardly at both ends of the wall, the positioning portions having greater radial lengths than a radial length of an intermediate portion of the stent for sticking at locations of pathological changes; and wherein the wall extends an axial length between the two open ends and defines a maximum diameter that is longer than the axial length. THE REJECTION Claims 1, 4, and 12-15 stand rejected under 35 U.S.C. Â§ I03(a) as unpatentable over Ryan (US 2012/0083871 Al, published Apr. 5, 2012), Weber '588 (US 2009/0076588 Al, published Mar. 19, 2009), Weber '569 (US 2007/0244569 Al, published Oct. 18, 2007), and Brar (US 2004/0236412 Al, published Nov. 25, 2004). 2 Appeal2018-005647 Application 14/401,266 DISCUSSION Appellant does not present any separate arguments for dependent claims 4 and 12-15, apart from their dependency from claim 1. See Appeal Br. 6-10. Thus, we decide this appeal on the basis of claim 1, and claims 4 and 12-15 stand or fall with claim 1. See 37 C.F.R. Â§ 41.37(c)(l)(iv) (permitting the Board to select a single claim to decide the appeal as to a single ground of rejection of a group of claims argued together). The Examiner's findings and reasoning rejecting claim 1 are presented on pages 2--4 of the Final Action. The Examiner finds that Ryan fails to disclose biodegradable bundles as claimed, and a maximum wall diameter that is longer than the axial length of the wall. See Final Act. 2--4. The Examiner relies on Weber '588 and Weber '569 for a teaching to incorporate into Ryan's stent fiber bundles carrying therapeutic agent in the manner claimed, and relies on Brar for its teachings directed to radial length (diameter) and axial length of stents. See id. at 3--4. In particular, the Examiner determines it would have been obvious to modify Ryan's stent to have a maximum diameter that is longer than its axial length, in view of the teachings of Brar, because "it is a mere combination of prior art teachings and/or a mere change in size of prior art elements that produces predictable results of sizing the stent for a particular treatment and/or access site." Id. at 4 ( citing Brar ,r 57). Brar teaches, in pertinent part, that "[t]he size of [the stent] varies, depending on the particular treatment and access site" and "[t]he overall length, diameter[,] and wall thickness may vary depending on the treatment." Brar ,r 57. Brar also discloses a preferred embodiment of stent having "an inflated length between 1 and 10 cm" and "an inflated diameter 3 Appeal2018-005647 Application 14/401,266 between about 0.1 and 1.5 cm," but adds that "stents of any suitable dimension for the application may be used." Id. The Examiner finds that Brar' s disclosure of the preferred embodiment includes disclosure of a stent having an axial length of 1 cm and a maximum length of 1.1 cm-1.5 cm. Final Act. 4. Appellant contests the Examiner's finding that Brar teaches a stent having an axial length of 1 cm and a maximum length of 1.1 cm-1.5 cm because Brar "lacks sufficient specificity regarding either of the dimensions in the claimed relationship" and "lacks any disclosure regarding the specific combination of the dimensions as would be required to anticipate the claimed relationship." Appeal Br. 7. Appellant asserts that claim 1 recites "a result-effective combination of' a stent "wall defining a maximum diameter that is longer than the axial length for placement at a location of pathological changes in the sinus or in the ostium of the sinus" for treating sinusitis or allergic rhinitis with the fiber bundles, which are scattered on both axial sides of the stent, that provides "unexpected results." Id. at 7-8; see also id. at 10 ( asserting unexpected results from the combination of the fiber bundles extending outwardly from the monofilaments forming tentacles, and the maximum diameter being longer than the axial length). Thus, citing Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006) and Ex Parte Watanabe, No. 2011-000760, 2013 WL 5400511, *1 (PTAB Jan. 18, 2013), Appellant contends that Brar fails to disclose the relationship of the diameter to the axial length with sufficient specificity to anticipate the claim limitation that the maximum diameter is longer than the axial length. Id. at 7-8. 4 Appeal2018-005647 Application 14/401,266 Appellant does not provide any evidence to support the assertion of unexpected results. It is well settled that unexpected results must be established by factual evidence; mere argument or conclusory statements in the specification does not suffice. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (noting that arguments relying on factually unsupported assumptions "can hardly be considered factual evidence"). Appellant's Specification does not explicitly disclose that the stent wall diameter is longer than the axial length, much less attribute any criticality to such a relationship. See, e.g., Spec. ,r,r 66, 71, 80, 82, 85, 88 ( disclosing overlapping ranges for the radial length ( diameter) and the axial length). For example, the Specification discloses an Embodiment 6, illustrated in Figure 6, of "an implanted system for treating sinusitis or allergic rhinitis" in which the expanded radial length (diameter) of the implant is "2mm-30mm" and the "axial length is 2mm-60mm," thereby suggesting that implants having a diameter that is the same as or smaller than the axial length are within the scope of the invention and suitable for use in treating sinusitis or allergic rhinitis. Id. ,r,r 87-88. Moreover, even assuming that providing a stent with a diameter that is longer than its axial length affords the benefit, or advantage, that such a stent would fit well in the sinus, or the ostium of the sinus, as Appellant asserts, Appellant presents no evidence or technical explanation to show why such a result would have been unexpected to those of ordinary skill in the art. For these reasons, the present case is clearly distinguishable from Ex parte Watanabe, in which the appellants submitted "evidence that selection of an outer cover thickness smaller than the inner cover thickness might yield a different result than selection of equal outer 5 Appeal2018-005647 Application 14/401,266 cover and inner cover thicknesses." Ex parte Watanabe, 2013 WL 5400511, *2. Moreover, the propriety of the Examiner's determination that it would have been obvious to provide Ryan's stent with a diameter that is longer than the axial length does not tum on whether Brar anticipates a stent having a maximum diameter that is longer than the axial length ( e.g., an axial length of 1 cm and a maximum length of 1.1 cm-1.5 cm). The Examiner reasons that such a modification is "a mere change in size of prior art elements that produces predictable results of sizing the stent for a particular treatment and/or access site," consistent with the teachings of Brar. Final Act. 4; see Brar ,r 57 (teaching that stent size "varies, depending on the particular treatment and access site," and "stents of any suitable dimension for the application may be used"). Appellant does not persuasively attack this reasomng. Appellant also argues that it would not have been obvious to combine the elements of Weber '588, Weber '569, and Brar without changing the functions of these elements. Appeal Br. 9. In particular, Appellant contends that Brar' s stent "is inherently incompatible with the extending fiber bundles that are also required of claim 1" because "Brar is directed to arterial stents." Id. According to Appellant, persons of ordinary skill in the art would understand that if Brar's arterial stent included fiber bundles extending therefrom, those fiber bundles "would cause adverse results in the bloodstream, such as clots and/or particles which interrupt blood flow. Id. at 9-10. Appellant's argument is unavailing because the Examiner's rejection does not propose modifying Brar' s stent; rather, the rejection proposes 6 Appeal2018-005647 Application 14/401,266 modifying the dimensions of Ryan's stent as taught by Brar. Moreover, all of the references combined in the rejection (Ryan, Weber '588, Weber '569, and Brar) are directed to stents to be implanted in body passages in vascular systems (e.g., arteries). See Ryan ,r 3 (describing stents for body vessels in vascular systems); Weber '588 ,r 2 ( discussing tubular stents for implantation in body passageways, such as arteries); Weber '569 ,r,r 2, 48 ( discussing tubular stents for implantation in body passageways, such as arteries, as well as therapeutic agent-carrying fibers extending beyond the dimensions of the stent body); Brar ,r,r 4--10 (describing stents for arteries). Thus, Appellant's argument that Brar's teachings are incompatible with stents comprising extending fiber bundles is not persuasive. Further, Appellant argues that the combination of features recited in claim 1 provides unexpected results. Appeal Br. 10. As discussed above, unexpected results must be established by factual evidence, and Appellant does not provide any such evidence. For the above reasons, Appellant does not apprise us of error in the rejection of claim 1. Accordingly, we sustain the rejection of claim 1, as well as claims 4 and 12-15, which fall with claim 1. DECISION The Examiner's decision rejecting claims 1, 4, and 12-15 is AFFIRMED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). 7 Appeal2018-005647 Application 14/401,266 AFFIRMED 8