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 .
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.
Claims 62-79 are rejected under 35 U.S.C. 103 as being unpatentable over Buckman, et al. (US 2011/0214785) in view of Mayer (US 5,628,787), and Scheuermann et al. (US 7,981,150).
Considering claim 62, Buckman teaches a method of forming a medical device (abstract) including providing a metal powder of rhenium and molybdenum (Paragraph 31) including embodiments of at least about 41 wt.% rhenium and at least about 50 wt.% molybdenum (Paragraph 18) where the metal powder is consolidated and pressed at about 400-700 MPa and sintered at about 2000-3000 °C in an oxygen reducing atmosphere to form a solid metal tube or rod (i.e. a blank) with an as-sintered average density of about 90-99% of minimum theoretical density (Paragraph 31). The rod or tube has its cross-sectional diameter reduced in a single step or series of steps (Paragraph 34), is subject to annealing in an oxygen reducing or inert environment at about 1200-1700 °C (Paragraph 37), where the rod may be drilled by gun drilling and cut by EDM (Paragraph 32) and is coated on the outer surface with one or more materials including one or more agents to prevent, inhibit, and/or treat one or more clinical or biological events and/or promote healing (Paragraph 42) and where this may be released in a controlled manner (Paragraph 43). The device may also be coated with mark material layers of metals including cobalt, chromium, titanium, etc. (Paragraph 51). However, Buckman does not teach the claimed swaging or coating material.
In a related field of endeavor, Mayer teaches a body compatible stent (abstract) formed by a method of providing a core and case which is annealed and mechanically worked in to a predetermined shape (Column 2 lines 34-63) and the outer diameter may be reduced by swaging or pultrusion in successive increments at a temperature in the annealing range (Column 3 lines 19-29).
In a related field of endeavor, Scheuermann teaches endoprosthesis with a reservoir of a drug material and an over coating (abstract). The coating enhances therapeutic performance and can advantageously control the release rate of the drug (Column 2 lines 40-48). The coating is formed by spraying a polymer layer and magnetron sputtering a metal layer of Ti, Cu, Au, etc. or an alloy thereof (Column 2 lines 21-39).
As Buckman, Mayer, and Scheuermann teach methods of forming medical devices they are considered analogous. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Buckman with the outer diameter reduction of swaging as taught by Mayer as this is considered a combination of prior art elements according to known methods to yield predictable results and one would have had a reasonable expectation of success and to further modify the coating of Buckman with the method of forming a control release drug coating with materials thereof taught by Scheuermann as this is known to enhance therapeutic performance and one would have had a reasonable expectation of success. Further, the Re and Mo content, pressure, sintering temperature, density, and annealing temperature taught by modified Buckman overlap those which are claimed and the courts have held that where claimed ranges overlap or lie inside of those disclosed in the prior art a prima facie case of obviousness exists. See MPEP 2144.05.
Considering claim 63, Buckman teaches where the medical device may be a hypotube (Paragraph 61).
Considering claims 64-65, Buckman teaches where the alloy comprises at least about 41 wt.% rhenium and at least about 50 wt.% molybdenum (Paragraph 18). See MPEP 2144.05.
Considering claims 66-67, Buckman teaches where the alloy comprises at least about 95% Re and Mo and one or more of titanium, etc. (Paragraph 19). See MPEP 2144.05.
Considering claims 68-69, Buckman teaches where the marker material comprises Ti, Co, Cr, stainless steel, etc. (Paragraph 51). Additionally, Scheuermann teaches where the coating comprises Cu, Ti, etc. (Column 2 lines 33-36).
Considering claims 70-71, Scheuermann teaches where the coating comprises ceramic (Column 2 lines 33-36).
Considering claims 72-73, Buckman teaches where an optional nitride layer is formed on the outer surface of the tube or rod by nitriding in the presence of nitrogen or a nitrogen mixture for at least about 1 minute at a temperature of at least about 400 °C (Paragraph 35). See MPEP 2144.05. This is a separate coating from the disclosed agent coating.
Considering claim 74, in addition to the disclosure as outlined in claim 62 above, Buckman teaches where the alloy comprises at least about 95% Re and Mo (Paragraph 19) and where the agent coating is separate from the nitride coating (Paragraphs 42-43). See MPEP 2144.05.
Considering claim 75, Scheuermann teaches where the coating comprises ceramic (Column 2 lines 33-36).
Considering claims 76-77, Buckman teaches where the medical device may be a stent or hypotube (Paragraph 61).
Considering claims 78-79, Buckman teaches where the nitride layer is formed on the outer surface of the tube or rod by nitriding in the presence of nitrogen or a nitrogen mixture for at least about 1 minute at a temperature of at least about 400 °C (Paragraph 35) and where the agent coating is separate from the nitride coating (Paragraphs 42-43). See MPEP 2144.05.
Response to Arguments
Applicant’s arguments, see remarks p.8, filed 19 January 2026, with respect to the rejection(s) of claim(s) 62-79 in view of Buckman and Mayer under 35 USC 103 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 Buckman, Mayer, and Scheuermann as outlined above.
Applicant’s arguments are addressed as considered relevant to the instant Office action. Applicant argues that claims 62 and 74 differentiate over Buckman in that the instant claim is not a nitriding layer. This is not persuasive as the instant claims do not recite the closed language transitional phrase “consisting of”, but rather the open-ended “comprising” which does not preclude the presence of a nitride layer. See MPEP 2111.03.
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.
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SETH DUMBRIS
Primary Examiner
Art Unit 1784
/SETH DUMBRIS/Primary Examiner, Art Unit 1784
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