DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings were received on 01/02/2026. These drawings are acceptable.
Response to Arguments
Applicant's arguments filed 1/2/26 have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). First of all the examiner would like to make clear that Lye was not conceded for the adherent layer material not being disclosed as Lye in fact disclosed the generic type of materials poly (p-xylylene) stating parylene-C can be used on stents, see paragraph 229. Thus, Lye was just silent for the use of this material being used in one of the layers in the arrangement of layers as claimed. Applicant’s argument that the suggested use of the adherent layer of parylene-C by Hadley with the stent of Lye renders the stent of Lye inoperable is a misunderstanding of the rejection. What is interesting is first the argument suggests that the material suggested by Hadley would alter the porous layer of Lye and make it impermeable. The Examiner notes that the suggestion of using the material of Hadley was only to substitute material for the porous layer of Lye not to necessarily replace the porous layer or “etched adherent layer” as recited by Applicant and use as Hadley. The examiner only mentions that Hadley states advantages of the material and thus it was noted by the examiner such that the stent substrate of base stent graft would be protected by the material used by Hadley in all areas covered by the adherent layer of Lye.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 13,14,16,19,21,23 are rejected under 35 U.S.C. 103 as being unpatentable over Lye et al. (2006/0121080) in view of Hadley et al. (2014/0121750). The Examiner is entitled to give terms in a claim its plain meaning as interpreted by one of ordinary skill in the art. It is noted that the specification must clearly set forth the definition explicitly and with reasonable clarity, deliberateness, and precision. Exemplification is not an explicit definition. Even explicit definitions can be subject to varying interpretations. See Teleflex, Inc. V. Ficosa North America Corp., 63 USPQ2d 1374, 1381 (Fed. Cir. 2002), Rexnord Corp. V. Laitram Corp., 60 USPQ2d 1851,1854 (Fed. Cir. 2001) and MPEP 2111.01. It is noted that the terms "functionalized" and "marker" are generic terms and not given any special meaning. The surface of the stent graft has been disclosed in Lye to be treated and thus "functionalized" to provide an ability to bond. The material that is radiopaque for marking a site or disposed in the pores clearly functions as a marker as no specific material or configuration is limited by the use of the term. Lye et al. disclose a radiopaque stent graft comprising: a base stent graft (paragraph 97) having a functionalized surface (paragraphs 148,403-407); a tie layer surrounding a functionalized surface (paragraph 28). Lye et al. also disclose (paragraph 48) an etched adherent layer covering at least a portion of the tie layer. Lye et al. also disclose (paragraphs 10, 39) the etched adherent layer comprises a filled slot. Lye et al. further disclose (paragraph 51) the filled slot (paragraph 33) comprises a radiopaque marker material. It is noted that Lye et al. did disclose (paragraph 229) parylene C can be used as adherent layer on a base stent graft. However, Lye et al. did not disclose the etched adherent layer comprising a poly(p- xylylene), such as parylene C covers the tie layer. Hadley et al. teach (paragraph 100) that a polymer layer made of poly(p- xylylene) is advantageous with its barrier properties and cost effective material. Hadley et al. further (paragraph 101) teach that the polymer of poly(p-xylylene) can be for stents. It would have been obvious to one of ordinary skill in the art to select a known polymer such as poly(p-xylylene) and substitute the material as taught by Hadley et al. for the etched adherent layer on the stent of Lye et al. such that it has improved impermeability properties as the etched top layer to control fluid contact through the stent layers. It is also noted Hadley et al. teach (paragraphs 101,102) that the poly(p-xylylene) can be one of parylene C or parylene N. Thus the substitution of one material for another only involves routine skill in the art. With respect to claim 21, Lye et al. disclose (paragraphs 3,9,24) that the functionalized surface aids in bonding of the drug or radiopaque material. Regarding claim 14, Lye et al. also disclose (paragraphs 9,127,385) a sealant layer encapsulating the filled slot. Regarding claims 16,23 Lye et al. disclose (paragraphs 51,68) materials for coverings, coatings, grafts on the stent device can be polytetrafluoroethylene. Regarding claim 19, Lye et al. disclose one or more filled slots (paragraphs 17,33) comprises a radiopaque marker material.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lye et al. (2006/0121080) in view of Hadley et al. (2014/0121750) as applied to claim 14 above, and further in view of Dimatteo et al. (WO 00/59558). Lye et al. in view of Hadley et al. is explained supra. It is noted that Lye did disclose acrylates can be used as coating material, but, Lye et al. did not explicitly disclose the sealant layer comprises a flexible acrylate adhesive. Dimatteo et al. teach (Fig. 3A) that an adhesive 40 sealant layer is used on a stent 60 over the porous (page 7, lines 4-6) layer 21. Dimatteo et al. also disclose (page 8, lines 2,3) the adhesive can be an acrylate. It would have been obvious to one of ordinary skill in the art to utilize a flexible acrylate adhesive as taught by Dimatteo et al. as a sealant layer on the stent of Lye et al. as modified with Hadley et al. in order to provide a blood tight seal, page 12, lines 3,4 to eliminate any unwanted corrosion of the metal surface being covered.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799