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 request for reconsideration of the finality of the rejection of the last Office action in view of the Pre-Appeal Brief filed on 06/25/2025 is persuasive and, therefore, the finality of that action is withdrawn. PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references or any prior art of record, i.e. Imran, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Imran is modified in view of the newly discovered prior art to MacGregor to show porous coatings on metal surfaces of implanted devices has tissue ingrowth to stabilize the structure. Thus, it must be noted that the limitation at issue “porous layer of having been generated by plasma electrolytic treatment” is a product-by-process limitation and claims are not governed by this process. The prior art meets the scope if the structure is the same and the function can occur. In this instance MacGregor clearly teaches the same resulting product of the porous coating is made of the same material as the substrate and further it permits the same function of allowing tissue ingrowth. Thus the rejection to follow clearly establishes a prima facie case of obviousness.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11,13-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “characteristics” in claim 11 is a relative term which renders the claim indefinite. The term “characteristics” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “characteristics” can encompass many things or features, thus is it meant that the plasma treatment process causes porosity? Or can it mean hardness, elasticity, softness, roughness, etc. ? However, one does not know because no special definition uses the word in the written description to define what is meant by the term.
In claim 11, the recitation of “bottom face not having a porous layer generated by plasma electrolytic treatment” is unclear because while the bottom face may not be coated by plasma electrolytic treatment, it is not evident if it is to be coated or not. The scope of this limitation is just one type of exclusion, but not total exclusion of being coated.
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) 11,13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (WO 99/30643) in view of MacGregor (4101984). 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 a porous layer having the characteristics of having been generated by plasma electrolytic treatment coating said top face at least in part and said at least one side face, 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 said porous layer 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. MacGregor (col. 3, lines 6-8, 23-26) teaches that a metal substrate or implant element with blood engaging surfaces be provided with a porous coating. MacGregor also teaches that the porous coating is made of the same material as the substrate, col. 3, lines 62,63. 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 MacGregor 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 col. 7, lines 33-36,38-41. As best understood as to some surfaces coated with the porous coating, it is noted that Macgregor meets the scope of the claim by stating (col. 11, lines 23,24) a “substantial portion of the 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 MacGregor which is at least a substantial portion. 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. MacGregor teaches (col. 8, lines 15,16,25-27) the porous layer is provided with a pore diameter within 1-2 µm and a layer thickness within 1-2 µm. 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 MacGregor 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 and addresses the criticality or close tolerance conditions, see MacGregor, col.,8, lines 10-14,26,27. Regarding claim 15, Imran did not explicitly teach the bottom face is formed with a groove-shaped pickling structure. MacGregor teaches (col. 3, lines 58-60) that the surface of the substrate is roughened. It can be construed that a roughened surface provides a pickling structure. It would have been obvious to one of ordinary skill in the art to roughen the surface of the substrate to provide a picking structure as taught by MacGregor on the marker of Imran such that it enhances the tissue integration and porous coating interface, col. 3, lines 61,62.
Claim(s) 16,17 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (WO 99/30643) in view of MacGregor (4101984) as applied to claims 11,14 respectively above, and further in view of Allen et al. (2009/0204203). Imran in view of MacGregor is explained supra. However, Imran as modified by MacGregor 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 MacGregor such that it provides a permanent type of fixation for preventing separation.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799