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 .
Response to Arguments
Applicant's arguments filed 01/07/2026 have been fully considered but they are not persuasive. Applicant argues that the use of the term ”characterized” implies a certain feature “known by those of ordinary skill in the art” whereas other methods of coatings cause different characteristics to a surface. While the examiner agrees it is possible that an effect does happen to a surface when a coating process is applied thereon, it is not evident what that the result is because the substrate or parameters on which something may be treated/coated can vary. Thus, in other words it is not inherent or “known” without a doubt what these arbitrary characteristics are that Applicant suggests are present on the substrate surface of the marker. Limitations are not read into claims from the specification and Applicant did not even mention what “characteristics” are meant to be covered by the use of the term.
Applicant’s arguments, see page 5 of remarks (pg 11 of response), filed 1/7/26, with respect to the rejection(s) of claim(s) 11,13-17 under 35 U.S.C. 103 over Imran in view of MacGregor have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the teaching of Bayer as evidenced by Jing.
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) 11,13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (WO 99/30643) in view of Bayer (EP 2198898) as evidenced by Jing et al. (CN 101319342). Imran shows (Fig. 5) a disc- shaped marker element 37 for an implant, the marker element comprising: a bottom face forming a first surface; a top face forming a second surface; and at least one side face connecting said bottom face and said top face. Figs. 6,7 illustrate the marker of Imran has a top face forming an abluminal face once the marker element has been secured to a framework of the implant, see Fig. 1. Imran disclose (page 6, lines 5-9) the marker element being at least in part made of a radiopaque or radiodense material. However, Imran did not disclose said top face and said at least one side face being covered by a porous layer having the characteristics of having been generated by plasma electrolytic treatment coating, said bottom face not having a porous layer generated by plasma electrolytic treatment, and said porous layer being formed at least in part from the marker element material and being configured for ingrowth of the marker element into tissue when implanted. Please note that the recitation of "generated by plasma electrolytic treatment' is a product-by- process limitation. It must be understood that process limitations in a product claim do not limit or govern whether the process by which the marker was coated is patentable. See In re Klug, 333 F2d 905, 142 USPQ 161 (CCPA 1964). Thus, so long as the characteristics provided and the coating is the same, it can be said to render the feature obvious. Bayer teaches (page 5 of translation, 1st complete paragraph and last two paragraphs) that a metal marker substrate on an implant element is provided such that a resulting porous coating is created. Bayer also teaches that the porous coating is formed by a plasma electrolytic treatment to the material of the substrate, page 7 of translation, last complete paragraph. It would have been obvious to one of ordinary skill in the art to provide the substrate material with a porous coating as taught by Bayer on the marker of Imran such that the surfaces of the marker element has tissue ingrowth occur to provide a more secure attachment and stabilization of the device, see page 4 of translation, 2nd full paragraph. As best understood as to some surfaces coated with the porous coating, it is noted that Bayer meets the scope of the claim by stating (page 6 of translation) a "at least a portion of the body surface" (a substrate) is covered with the porous coating and thus the marker of Imran has at least the top and at least one side face coated per the modification with Bayer. Regarding the recitation of the porous layer being “dielectric” it is noted that Jing et al. state (paragraph 14) a plasma electrolytic treatment provides a dielectric layer when such a process is used. Thus, it is inherent that the porous layer applied on the marker of Imran per the teaching of Bayer results in a dielectric porous layer. Regarding claim 13,14 Imran did not disclose the porous coating having a porous layer with a pore diameter between 0.1 µm and 2 µm and/or a layer thickness between 0.3 µm and 10 µm or the thickness in the range of 0.5 µm and 4 µm. Bayer teaches (page 7 of translation, last paragraph) the porous layer is provided with a pore diameter within 0.1-2 µm and a layer thickness within 1-4 µm (page 5 of translation 3rd full paragraph). It would have been obvious to utilize a porous layer with a pore diameter between 0.1 µm and 2 µm and/or a layer thickness between 0.3 µm and 10 µm as taught by Bayer with the marker of Imran such that the appropriate value of thickness or pore sufficient for ingrowth is selected as such a modification only involves routine skill in the art.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Imran (WO 99/30643) in view of Bayer (EP 2198898) as applied to claim 11 above, and further in view of Li et al. (2005/0211680). Imran in view of Bayer is explained supra. However, Imran as modified by Bayer did not explicitly state the bottom face is formed with a groove-shaped pickling structure. Li et al. teach (paragraph 89) that a modified surface that is textured (please note the recitation of “groove-shaped pickling structure” is synonymous with textured or roughened surface) on a stent implant surface reduces scar tissue formation. It is also noted that Li et al. stated (paragraph 113) the grooved surfaces have reduced encapsulation or scar tissue formation and it must be noted that a bottom surface of the marker would be the luminal surface that is exposed to blood flow and cells passing therethrough. Thus, it would have been an obvious expedient for one of ordinary skill in the art to provide a groove-shaped pickling structure as taught by Li et al. on the bottom surface of the marker element of Imran as modified with Bayer such that it reduces scar tissue or tissue inflammation thereon and improve the implant structures acceptance, see paragraph 58 of Li et al.
Claim(s) 16,17 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (WO 99/30643) in view of Bayer (EP 2198898) as applied to claims 11,14 respectively above, and further in view of Allen et al. (2009/0204203). Imran in view of Bayer is explained supra. However, Imran as modified by Bayer did not disclose marker element being glued into an opening of the framework and a top face of said marker element forming an abluminal face. Allen et al. show (Fig. 2) a framework for the marker and the marker is glued (paragraph 65) into an opening 224 of the framework with a top face of the marker element forming an abluminal face. It would have been obvious to one of ordinary skill in the art to alternatively try and select another means of securing such as gluing a marker into an opening of the framework with a top face of the marker element forming an abluminal face as taught by Allen et al. and fasten the marker in the stent of Imran as modified with Bayer such that it provides a permanent type of fixation for preventing separation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Savage et al. (ES 2476594) teach that a stent can be masked such that abluminal and luminal surfaces can be provided with different surface features or properties via the use of masking.
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
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