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 .
Election/Restrictions
Claims 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected pultrusion device, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/04/2025.
Claim Objections
Claims 2-6 are objected to because of the following informalities: “MR-safe control cord” should be recited as --The MR-safe control cord--. Appropriate correction is required.
Claims 8-9 are objected to because of the following informalities: “Medical device” should be recited as --The medical device--. Appropriate correction is required.
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 2-5 and 8-9 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.
Regarding claims 2-5 and 8, the limitation “and/or” renders the claims indefinite. It is not clear if the associated limitations in the claims are inclusively required or merely recited in the alternative. For the sake of claim interpretation, it is assumed that the list is inclusive and has the same interpretation as “or”. Appropriate correction is required.
Claim 9 recites the limitation "the tubular jacket wall" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karmarkar et al. (US 2010/0198049 A1) in view of Storbeck et al. (US 2015/0290423 A1).
Regarding claim 1, Karmarkar et al. (‘049) teach an magnetic resonance imaging (MR) safe control cord for controlling a medical device (“catheter that can be safe and effective when used in an MRI environment” see [0012]), wherein the control cord can be arranged in a medical device (“pull wire 120” see [0045]), and wherein the control cord is structurally designed in such a way that the medical device can be controlled by displacing the control cord in and against an axial direction of a medical device (“pull wire 120 causes the deflectable tip section 115 to deflect as shown” see [0045]), or that a functional element of a medical device which can be coupled to the control cord can be controlled (“to carry out an injection” see [0046]), but fail to explicitly teach wherein the control cord is formed from a non-ferromagnetic matrix material. However, Storbeck et al. (‘423) from the same field of endeavor do teach a control cord formed from a non-ferromagnetic matrix material in which a reinforcing material is embedded (“braid of a suitable polymeric material” see [0066]). It would be obvious to one of ordinary skill in the art at the time of the invention to combine the invention of Karmarkar et al. with the features of Storbeck et al. for the benefit of a material that does not substantially distort the image and create substantial artifacts in MRI.
Regarding claim 2, Karmarkar et al. (‘049) in view of Storbeck et al. (‘423) teach the MR-safe control cord according to claim 1, wherein the control cord has at least one deflection section, the deflection section being formed with matrix materials having a lower stiffness and/or a higher flexibility than in the remaining region of the control cord (see Storbeck et al. [0066]).
Regarding claim 3, Karmarkar et al. (‘049) in view of Storbeck et al. (‘423) teach the MR-safe control cord according to claim 1, wherein the matrix material is doped with magnetic resonance imaging artifact-generating marker particles such that the medical device is visible in magnetic resonance imaging by these marker particles, whereas the magnetic resonance imaging artifact-generating marker particles are preferably arranged over substantially the entire length of the control cord such that the medical device is visible in magnetic resonance imaging over substantially its entire length and/or that the control cord comprises one or more X-ray markers (see Storbeck et al. [0070]).
Regarding claim 4, Karmarkar et al. (‘049) in view of Storbeck et al. (‘423) teach the MR-safe control cord according to claim 1, wherein the control cord is structurally designed in such a way that it can be arranged in one or more lumens in a sheath wall and/or in a central lumen of a tubular medical device, and has a diameter of 0.02 mm to 1 mm, i.e. of 1 mm, or smaller than 0.9 mm, or smaller than 0.8 mm, or smaller than 0.7 mm, or smaller than 0.6 mm, or smaller than 0.5 mm, or smaller than 0.4 mm, or smaller than 0.3 mm, or smaller than 0.2 mm, or smaller than 0.1 mm, or smaller than 0.05 mm (see Karmarkar et al. [0069]; and Storbeck et al. [0058]).
Regarding claim 5, Karmarkar et al. (‘049) in view of Storbeck et al. (‘423) teach the MR-safe control cord according to claim 1, wherein a structural design is achieved in that the matrix material is a duroplastic or a thermoplastic polymer, and/or that the reinforcing material comprises one or more reinforcing fibers which are formed as fibers, filaments, fiber bundles, filament bundles which preferably extend over approximately the entire length of the control cord, and/or in that the control cord has an elongation at break of 4% to 1%, which is a maximum of 4% or 3.5% or 3% or 2.5% or 2% or 1.5% or 1%, and/or that the control cord has an ultimate tensile strength of 3.5 to 6.0 GPa, which is at least 3.5 GPa or 4 GPa or 4.5 GPa or 5 GPa or 5.5 GPa and at most 6 GPa (see Storbeck et al. [0066]).
Regarding claim 6, Karmarkar et al. (‘049) in view of Storbeck et al. (‘423) teach the MR-safe control cord according to claim 1, wherein the control cord comprises a central section and a peripheral section extending in the axial direction of the control cord, the central section being centrally located with respect to a cross-section of the control cord and being radially surrounded by the peripheral section, and whereas both the central section and the peripheral section extend substantially over the entire length of the control cord, and the central section comprises at least one non-metallic reinforcing material embedded in a non-ferromagnetic matrix material, the matrix material being doped with MR marker particles, and the peripheral section comprises an undoped, non-ferromagnetic matrix material (see Storbeck et al. [0066]).
Regarding claim 7, Karmarkar et al. (‘049) in view of Storbeck et al. (‘423) teach a medical device having at least one MR safe control cord according to claim 1 (“catheter that can be safe and effective when used in an MRI environment” see [0012]).
Regarding claim 8, Karmarkar et al. (‘049) in view of Storbeck et al. (‘423) teach the medical device according to claim 7, wherein the medical device has a tubular jacket wall which delimits a lumen, in particular a central lumen, whereas in the central lumen and/or in at least one or more peripheral lumens formed in the jacket wall the control cord (“pull wire 320 is run through a polymeric tube 342” see Karmarkar et al. [0047]).
Regarding claim 9, Karmarkar et al. (‘049) in view of Storbeck et al. (‘423) teach the medical device according to claim 7, wherein the control cord has at least one fastening section at a distal end, via which the control cord is connected to a distal end of the tubular jacket wall (“pull wire 210 is connected to the distal end of the slotted tube at point D” see Karmarkar et al. [0046]).
Conclusion
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/MARK D REMALY/Primary Examiner, Art Unit 3797