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 Amendment
Applicant’s amendment filed 18 August 2026 are found to be supported at least in Paragraph 7 of the originally filed specification and figures 3-7 of US 7,488,444 incorporated by reference at Paragraph 104 of the originally filed specification. No new matter has been found.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
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Claims 68-69 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 68 and 69 recite “said coating material is selected from the group consisting of titanium, titanium alloy… and stainless steel” and claim 62 recites the closed language transitional phrase ‘consists of a metal alloy or ceramic material’ for the coating and the recitation of titanium separate from titanium alloy indicates this may be a singular metal alone from the alloy which is therefore not further limiting than the scope of claim 62. Further, stainless steel is not recited in the closed language of claim 62 and is therefore beyond the scope of the independent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 62-69, 72-74, 76, 78, and 81 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 Savage-Erickson et al. (US 2010/0262244).
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 fuse the metal powder and 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 for 2-200 minutes (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). The device is taught to also optionally be disclosed with an antibiotic material (Paragraph 42). 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, Savage-Erickson teaches a metal coated implant (abstract) having radiopaque properties to facilitate the visualization of the implant (Paragraph 1). The metal coating improves the visualization and may be Ti or Au (Paragraph 36) or other radiopaque metals of stainless steel, cobalt chrome, etc. and alloys of biocompatible metals thereof (Paragraphs 29 and 37) (e.g. a Ti-alloy).
As Buckman, Mayer, and Savage-Erickson 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 marking materials thereof taught by Savage-Erickson as this is known to facilitate visualization of the implant 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, Savage-Erickson teaches where the radiopaque metals may be stainless steel, cobalt chrome, etc. and alloys thereof (Paragraph 37) with a thickness of up to 100 µm (Paragraph 39) and is less than the wall thickness of 0.095” (i.e. ~24,130 µm) of the tube taught by Buckman (Paragraph 31). See MPEP 2144.05.
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). See MPEP 2144.05.
Considering claim 76, Buckman teaches where the medical device may be a stent or hypotube (Paragraph 61).
Considering claim 78, 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.
Considering claims 81, Savage-Erickson teaches where the radiopaque metals may be cobalt chrome, Ti, etc. and alloys thereof (Paragraphs 29 and 37).
Claims 62-67, 70-79, and 83-84 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 Guggenbichler et al. (US 2010/0057199).
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 fuse the metal powder and 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 for 2-200 minutes (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). The device is taught to also optionally be disclosed with an antibiotic material (Paragraph 42). 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, Guggenbichler teaches an antimicrobial substance comprising Mo (abstract) for use on implants (Paragraph 14) as well as catheters and tubes (Paragraph 15). The substance may be a molybdenum alloy (Paragraphs 38-39) or molybdenum oxide (Paragraph 34) (e.g. a ceramic). The antimicrobial is taught to be inexpensive and have high biocompatibility (Paragraph 17).
As Buckman, Mayer, and Guggenbichler 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 antibiotic materials thereof taught by Guggenbichler as this is known to be inexpensive and have high biocompatibility 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 70-71, Guggenbichler teaches where the antibacterial compound may be molybdenum oxide (Paragraph 34) (e.g. a ceramic) with a thickness of approximately 100 µm (Paragraph 144) and is less than the wall thickness of 0.095” (i.e. ~24,130 µm) of the tube taught by Buckman (Paragraph 31). See MPEP 2144.05.
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, Guggenbichler teaches where the antibacterial compound may be molybdenum oxide (Paragraph 34) (e.g. a ceramic).
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.
Considering claims 83-84, Guggenbichler teaches where the substance may be a molybdenum alloy (Paragraphs 38-39) or molybdenum oxide (Paragraph 34) (e.g. ceramic).
Allowable Subject Matter
Claim 82 is allowed.
The following is a statement of reasons for the indication of allowable subject matter: Please see the comments regarding allowability of claim 82 in the Office action set forth on 27 May 2026.
Response to Arguments
Applicant’s arguments, see remarks, filed p.10, with respect to 35 USC 112(a), and 35 USC 112(b) rejections have been fully considered and are persuasive. The rejections of claims 62-84 have been withdrawn. Applicant has amended the claims to remove the new matter, amended to recite “said sintered blank” to provide antecedent basis and dependency of claim 71.
Applicant's arguments filed 18 August 2026 regarding 35 USC 112(d) and 35 USC 103 rejections have been fully considered but they are not persuasive. Applicant’s arguments are addressed as follows:
Applicant argues that all claims are now proper pursuant to 35 USC 112 (remarks p.10, 35 USC 112 section). This is not persuasive as instant claims 68-69 still recite where the metal alloy is titanium or titanium alloy and stainless steel and the recitation of “titanium” alone is not further limiting than claims 62 and 67 where the coating is limited to where the coating consists of a coating metal alloy or ceramic material selected from the group consisting of titanium alloy, rhenium alloy, molybdenum alloy, and ceramic material. Stainless steel is not recited within the closed group either. Thus, the recitation of “titanium” alone and stainless steel are outside of the scope of the “group consisting of…” and is therefore not properly further limiting and therefore the prior rejection is maintained.
Applicant argues that Mayer does not teach a sintered blank and forming a tube therefrom and a cladding process of a core into a tube of metal and does not disclose the claimed coating (remarks p.11, 2nd full paragraph). This is not persuasive as ,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). Buckman teaches the claimed sintering of blank and tube formation and Savage-Erickson/Guggenbichler teach the claimed coatings. Mayer is only relied upon to teach where a method of swaging to reduce diameter of the material to be formed into a stent or prosthesis and as Buckman teaches a method of resizing a rod or tube by drawing through dies, etc. (Paragraph 34). As such, the combination of Mayer and Buckman is obvious to one of ordinary skill in the art.
Applicant argues that Savage-Erickson is limited to an intervertebral disc spacer and not a tube or sintered tube and is a polymer coated with metal which is fundamentally different from that which is claimed (remarks p.11, 3rd full paragraph). This is not persuasive as the instant rejection is not made in view of Savage-Erickson alone, but in combination with Buckman and Mayer. Savage-Erickson teaches medical devices, such as spinal intervertebral implants (Paragraph 1) where the implant is coated with a radiopaque metal to improve positioning and orienting the device (Paragraph 12). In addition to tubes and stents, Buckman also teaches where the medical device may be a spinal implant, etc. (Paragraph 81) indicating these articles are not fundamentally different as argued as the prior art recognizes where medical devices comprise both tubes/stents and spinal implants. Further, Buckman teaches where the device is optionally coated with a marking material layer designed to make the medical device visible to x-rays, e.g. radiopaque (Paragraph 51). As such, the combination of Buckman with Savage-Erickson is obvious to one of ordinary skill in the art.
Applicant argues that Savage-Erickson teaches single metals of Ti and Au for the metallic layer and not the claimed coating (p.11, 3rd full paragraph). This is not persuasive as Savage-Erickson teaches where the coating may comprise alloys of biocompatible metals (Paragraph 37) and where the biocompatible metals include Ti (Paragraph 29) and this renders obvious the use of a Ti-alloy.
Applicant argues that Guggenbichler teaches an antimicrobial substance comprising Mo to be coated on a plastic and is not directed to any type of medical device (remarks p.11 last paragraph – p.12 continuing paragraph). This is not persuasive as Guggenbichler teaches where the antimicrobial material is a molybdenum oxide (claim 1) (e.g. a ceramic material) and the antimicrobial layer may be deposited on metals, plastics, and ceramics (Paragraph 34) and is used with joint implants (Paragraph 14), catheter implants, tubes, etc. (Paragraph 15). As such, the teachings of Buckman and Mayer in combination with Guggenbichler is considered to render obvious the claimed ceramic coating.
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 SETH DUMBRIS whose telephone number is (571)272-5105. The examiner can normally be reached M-F 6:00 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Humera Sheikh can be reached at 571-272-0604. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SETH DUMBRIS
Primary Examiner
Art Unit 1784
/SETH DUMBRIS/Primary Examiner, Art Unit 1784
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