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 .
Acknowledgement of Preliminary Amendments
For the record, acknowledgement is made of the applicant’s preliminary amendments to the claims under 37 CFR 1.115. Under examination are the newly amended claims, 1-17.
Drawings
The drawings are objected to because Figure 16 is incomplete as it lacks labels and has empty boxes. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 8-9 & 11-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Källbäck et al. (U.S. Patent Application 2019/0254607 A1).
Claim 1: Källbäck teaches –
A method of forming a medical device [The elongated substrate may be formed by numerous methods] (Para 0075) having MRI-compatible circuitry [Medical devices…are…navigated to the area of interest or disease using…MRI…for guidance] (Para 0002),
comprising:
providing a base surface [base layer] (Figure 8, Element 300); and
printing [Conductive traces 110…may be constructed by…conductive ink aerosol ink jet printing] (Para 0046) a first conducting layer [conductive layer] (Figure 8, Element 320) on the base surface [the adhesive layer 310 is needed as conductive layer 320 will not adhere well enough to the polyimide film 300 for a medical device] (Para 0076) using an ink [stencil conductive inks on to the base layer] (Para 0076) containing electrically conductive material [The conductive traces 110 (not shown in FIG. 8) are etched into this conductive layer 320] (Para 0076) to form circuitry [flexible circuit] (Para 0076 and Figure 8, Element 100) that is MRI-compatible [Medical devices…are…navigated to the area of interest or disease using…MRI…for guidance] (Para 0002) [aluminum] (Para 0076; aluminum is known to be a metal is compatible with MRI).
Claim 2/1: Källbäck teaches further comprising forming a first insulating layer [flexible substrate 105 utilizes an insulating material or a dielectric] (Para 0042) [three dielectric layers] (Para 0055) over at least a portion of the first conducting layer [two conductive trace layers] (Para 0055); and printing [Conductive traces 110…may be constructed by…conductive ink aerosol ink jet printing] (Para 0046) a second conducting layer [two conductive trace layers] (Para 0055) over at least a portion of the first insulating layer [three dielectric layers] (Para 0055). See Exhibit 1 for more detail.
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[AltContent: textbox (Exhibit 1 – Annotated Figure 2 of Källbäck)]Claim 3/1: Källbäck teaches wherein at least one of the first conducting layer and second conducting layer [two conductive trace layers] (Para 0055) is formed from discrete lengths (as shown in Figure 2) of differing types [trace layer can include a combination of the same or different metal or ions thereof] (Para 0008) of printed electrically conductive material [Conductive traces 110…may be constructed by…conductive ink aerosol ink jet printing] (Para 0046).
Claim 4/3/1: Källbäck teaches wherein the first conducting layer and second conducting layer [two conductive trace layers] (Para 0055) are formed from alternating lengths (stacked alternating as shown in Figure 2) of electrically conductive material that have different impedances [structure of the open lumen body varies over its length and diameter to fit specific needs of the designer, manufacturer, and user] (Para 0073).
Examiner’s Note: Varying the length and diameter of the structure will result in different impedances due to the varying of the structure itself.
Claim 8/1: Källbäck teaches wherein the portion of the surface of the base surface [base layer] (Figure 8, Element 300) upon which the first conductive layer is formed is an insulating material [different materials are suitable for base layers, such as polyester, Polyethylene terephthalate (PET), polyethylene napthalate (PEN)] (Para 0075; Para 0042 discloses that PEN is a dielectric/insulating layer).
Claim 9/1: Källbäck teaches further comprising depositing a layer of insulating material [adhesive layer] (Figure 8, Element 310 and Para 0075) over at least a portion of the surface of the base surface [base layer] (Figure 8, Element 300) prior to printing the first conductive layer [the adhesive layer 310 is needed as conductive layer 320 will not adhere well enough to the polyimide film 300 for a medical device] (Para 0076).
Examiner’s Note: Adhesives are understood to be insulators.
Claim 11/1: Källbäck teaches wherein the first conductive layer is electrically coupled to the second conductive layer at a location [via holes] (Figure 2, Element 140) where the first insulating layer is not present [Conductive traces 110 on opposite sides of the substrate 105 are electrically connected through the via holes 140] (Para 0047).
Claim 12/1: Källbäck teaches wherein the base surface includes an insulating sleeve [sheath] (Para 0064) configured to be fitted over at least a portion of a further device, and wherein the method further comprises disposing the insulating sleeve over the further device [one shaft and lumen of a multiple lumen catheter shaft, a sheath lumen, a guidewire lumen, a lumen forming part of an diagnostic or therapeutic assembly at the distal end of a device such as a catheter, or other medical device to be inserted into a patient] (Para 0064).
Claim 13/1: Källbäck teaches wherein the first conductive layer and second conductive layer [two conductive trace layers] (Para 0055) are printed [Conductive traces 110…may be constructed by… conductive ink aerosol ink jet printing] (Para 0046) onto the medical device using different materials [trace layer can include a combination of the same or different metal or ions thereof] (Para 0008).
Claim 14/1: Källbäck teaches wherein the first conductive layer and second conductive layer [two conductive trace layers] (Para 0055) are printed onto the medical device into configurations having different geometries [structure of the open lumen body varies over its length and diameter to fit specific needs of the designer, manufacturer, and user] (Para 0073).
Claim 15/1: Källbäck teaches wherein the first insulating layer [flexible substrate 105 utilizes an insulating material or a dielectric] (Para 0042) [three dielectric layers] (Para 0055) is printed onto the medical device [the substrate 105 is subjected to standard process steps used today by manufacturers of flexible printed wire boards] (Para 0106).
Claim 16/1: Källbäck teaches wherein the medical device is selected from the group consisting of an implant [therapy catheter] (Para 0064).
Claim 17/5/1: Källbäck teaches wherein the iMRI device is selected from the group consisting of a needle, a catheter, a delivery catheter, a guidewire, an endoscope, and a flexible device [a catheter] (Para 0032).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 5-6 & 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Källbäck et al. (U.S. Patent Application 2019/0254607 A1) as applied to claim(s) 1 above, and further in view of Karmarkar et al. (U.S. Patent Application 2014/0266207 A1).
Claim 5/1: Källbäck teaches wherein the medical device is an interventional MRI ("iMRI") medical device [Medical devices…are…navigated to the area of interest or disease using…MRI…for guidance] (Para 0002) and the first conducting layer and the second conducting layer [two conductive trace layers] (Para 0055). Källbäck fails to teach matching the anatomy. However, Karmarkar teaches further wherein one layer are selectively formed to each have an impedance that substantially matches anatomy along which the medical device is to be positioned [having a length to the diode via a proximal circuit board (which can hold the tuning circuit and/or a decoupling/matching circuit) sufficient to define a defined odd harmonic/multiple of a quarter wavelength at the operational frequency of the MRI Scanner 10S] (Para 0072) in order to help stabilize the tracking signal for more precise and speedy localization (Para 0072)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Källbäck to match the anatomy as taught by Karmarkar in order to help stabilize the tracking signal for more precise and speedy localization (Para 0072).
Claim 6/5/1: Källbäck teaches wherein the first conducting layer forms at least a portion of a first transmission line, and further wherein the second conducting layer forms at least a portion of a second transmission line (See Figure 2 as both layers are intended for transmission) [conductive trace layer are accessible from both sides for ease of connection to a sensor, electrode, or the like] (Para 0049).
Claim 10/1: Källbäck teaches further comprising printing at least one conductive layer on the medical device [two conductive trace layers] (Para 0055) and electrically coupling [Conductive traces 110 on opposite sides of the substrate 105 are electrically connected through the via holes 140] (Para 0047) the at least one conductive layer to at least one of the first conductive layer and the second conductive layer [two conductive trace layers] (Para 0055). Källbäck fails to teach windings. However, Karmarkar teaches windings [windings] (Para 0085) in order to have more flexibility in layer construction with windings/coils that can perform current suppression (Para 0085) to protect the patient from burns.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Källbäck to include windings as taught by Karmarkar in order to have more flexibility in layer construction with windings/coils that can perform current suppression (Para 0085) to protect the patient from burns.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Källbäck et al. (U.S. Patent Application 2019/0254607 A1) as applied to claim(s) 1 above, and further in view of Hoegh et al. (U.S. Patent Application 2005/0222658 A1) .
Claim 7/4/3/1: Källbäck teaches wherein the alternating lengths of electrically conductive material (stacked alternating as shown in Figure 2). Källbäck fails to teach the specifics regarding the length. However, Hoegh teaches wherein each have a length that is less than about one quarter of a wavelength of an applied RF signal [The length of each segment should not be substantially greater than one-quarter wavelength] (Para 0062) corresponding to the Larmor frequency of a nuclei of interest in a background magnetic field Bo of a MR scanner [The main or static magnetic field may typically vary between 0.2 and 3.0 Tesla] (Para 0011) in order to prevent the formation of standing waves (Para 0062-0063) which can create areas of high current along the device (Para 0053)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lengths of Källbäck with the lengths as taught by Hoegh in order to prevent the formation of standing waves (Para 0062-0063) which can create areas of high current along the device (Para 0053)
Examiner’s Note: Based on the Specification of the Applicant in Para 0060, the Examiner is interpreting background magnetic field to be the magnetic field of the MR scanner in Tesla.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Susil et al. (U.S. Patent Application 2003/0050557 A1) – Susil teaches a probe, including a first electrode disposed at least partially on the probe surface, a second electrode disposed at least partially on the probe surface, a first conductor electrically coupled to the first electrode, a second conductor electrically coupled to the second electrode, and a reactive element electrically coupling the first conductor and the second conductor
Zikorus et al. (U.S. Patent Application 2006/0085054 A1) – Zikorus teaches an apparatus for applying energy to a hollow anatomical structure having an inner wall. The apparatus comprises an elongate shaft having a distal end and a proximal end opposite the distal end; and a capacitive treatment element located near the distal end. The capacitive treatment element is sized for insertion into the hollow anatomical structure and placement near the inner wall. The capacitive treatment element is configured to create an electric field that extends at least partially into the inner wall. Other devices and methods for treatment of hollow anatomical structures are disclosed as well
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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