DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 May 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 62-84 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 62 and 74 recite in step c) sintering no more than 3000 °C. However, the only temperature range disclosed for sintering is found in Paragraph 57 of the originally filed specification and is 2000-3000 °C. As such, and all temperatures of 3000 °C and less is not supported and is considered new matter. Claims 63-73 and 75-84 are included in this rejection as they depend upon a rejected claim.
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.
Claims 62-84 are rejected under 35 U.S.C. 112(b) 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.
Claims 62 and 74 recite “annealing said tube” in step “e)” and this phrase lacks antecedent basis as no tube is recited in the method in steps a-d, only a blank. This may be overcome by amending to state where the blank is annealed. Claims 63-73 and 75-84 are included in this rejection as they depend upon a rejected claim.
Claims 63-64 recite “wherein said metal alloy” and it is unclear which alloy is being claimed as claim 62 recites “a sintered blank formed of a metal alloy” and “said coating material consists of a metal alloy…”. As such, the public is not appropriately appraised of the scope of the claims.
Claim 71 recites wherein said coating material is said ceramic material and this is considered to render the claim indefinite as claim 69 from which it depends recites where the coating is selected from the group consisting of Ti, Ti alloy, Co-Cr, and stainless steel. Accordingly, the scope of the claim is unclear as to how this can also encompass ceramic.
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.
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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 62-69, 72-74, 76, 78, and 80-81 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 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 thereof (Paragraph 37).
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).
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 80-81, Savage-Erickson teaches where the radiopaque metals may be cobalt chrome, Ti, etc. and alloys thereof (Paragraph 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 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) and is considered to meet the instant claims due to indefiniteness as outlined above.
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 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if amended to remove the new matter as outlined above and amended to remove indefiniteness as outlined above.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art to the instant claim is that of Buckman as outlined above. While Buckman teaches the use of Re as a marker material (Paragraph 51) it requires the use of a polymer in the marker material layer and therefore the marker layer does not consist of a Re alloy as claimed.
Response to Arguments
Applicant’s arguments, see remarks p.9, filed 12 May 2026, with respect to the rejection(s) of claim(s) 62-79 under 35 USC 103 rejections in view of Buckman, Mayer, and Scheuermann 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 Savage-Erickson/ Guggenbichler as outlined above. Applicant argues that Buckman does not teach the amended coating material consisting of Co-Cr, Ti-alloy, Re-alloy, Mo-alloy or ceramic. However, these materials are taught by Savage-Erickson and Guggenbichler as outlined above.
Conclusion
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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SETH DUMBRIS
Primary Examiner
Art Unit 1784
/SETH DUMBRIS/Primary Examiner, Art Unit 1784
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