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 § 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 1-2, 7-14 and 21 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.
Claim 1 recites the limitation “such that the first coil structure at least partially conforms”. There is insufficient antecedent basis for the limitation in the claim. It is therefore unclear if the first coil structure is the same as the coil structure, the first non-helical coil or if this is a different/distinct element. For examination purposes, it has been interpreted to mean any first coil structure, however, clarification is required.
Claims 2 and 3 recite the limitation “the first coil”. It is unclear if the first coil is the same as the first non-helical coil, the first coil structure, or is a different first coil which has not been previously set forth. For examination purposes, it has been interpreted to mean any first coil, however, clarification is required.
Claim 7 recites the limitation “the first coil comprises a non-helical coil”. The limitation is first unclear as to whether the first coil is the same as the first non-helical coil, the first coil structure, or if this is a different first coil. It is further unclear if the non-helical coil is the same as or different from the first non-helical coil previously recited. For examination purposes, it has been interpreted to mean any first coil, however, clarification is required.
Claim 8 recites the limitation “a trace coil disposed on a flexible circuit board”. It is unclear if the trace coil and flexible circuit board are the same as the non-helical coil and substrate, respectively or if these are different elements of the coil structure. If they are different elements it is further unclear what the difference between the trace coil and the non-helical coil is and the difference between the flexible circuit board and the substrate. For examination purposes, it has been interpreted to mean any trace coil and flexible circuit board, however, clarification is required.
The term “near” in claim 11 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how close the at least one second coil must be to the elongate surface of the catheter to be considered “near” the elongate surface. For examination purposes, it has been interpreted that any use of a second coil is considered to be “near” the elongate surface of the catheter, however, clarification is required.
Claim 13 recites the limitation “an imaging device”. It is unclear if the imaging device is the same as or different from the tracked device. For examination purposes, it has been interpreted to mean any imaging device, however, clarification is required.
Claim 21 recites the limitation “a flexible circuit board”. It is unclear if the flexible circuit board is the same as or different from the substrate and further unclear what the difference between the flexible circuit board and the substrate is. For examination purposes, it has been interpreted to mean any flexible circuit board which may be the same as the substrate, however, clarification is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-13, 15-16, and 21-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Atalar by et al. (US 20020045816 A1), hereinafter Atalar.
Regarding claims 1 and 15,
Atalar discloses a trackable medical device, comprising:
A catheter (at least fig. 2 (202 and 216) and corresponding disclosure in at least [0091], where it is noted that the exterior surface and inner surface 216 are disclosed as being the same as described in fig. 1 which are part of tubular member 99 which is interpreted as a catheter since it is a tubular member that is dimensionally adapted for insertion into a body as disclosed in [0031]) configured to facilitate a medical procedure; and
A first coil structure (at least fig. 2 (224) and corresponding disclosure in at least [0091] See also at least fig. 4 (404) and corresponding disclosure in at least [0093]) comprising a first non-helical coil (see at least fig. 3 (332) and corresponding disclosure in at least [0092] see also [0091] disclosing a loop imaging coil and fig. 4 (407a) and corresponding disclosure in at least [0093]) on a substrate (at least fig. 3 (330) and corresponding disclosure in at least [0092]), the first coil structure disposed directly on an elongate surface of the catheter ([0074] which discloses the coil could be on the interior surface or the exterior surface of the tubular member) so that (i) the first coil structure at least partially conforms to a non-planar shape of a shaft of the catheter ([0092] which discloses the detector coil resides on a flexible circuit board. The detector coil may reside on any substrate. Examiner notes that in placing such a substate/flexible circuit board on the surface of the catheter (i.e. tubular member) that the first coil structure at least partially conforms to a non-planar shape of the shaft of the catheter) and surrounds only a portion of the perimeter or circumference of the catheter’s shaft (see at least fig. 2), (ii) the first non-helical coil (IC) has a center axis that is not a center axis of the device (see at least fig. 2), and (iii) the first non-helical coil is configured to receive a magnetic resonance signal from an imageable substance inside or outside the device during a medical procedure ([0091] which discloses loop imaging coil and [0037] which discloses a detector coil for imaging, using magnetic resonance imaging (MRI))
Regarding claims 2 and 16,
Atalar further discloses wherein the catheter comprises an internal space (see at least fig. 2 and 2A depicting an internal space) for receiving a fluid ([0080] which discloses the contrast agent is incorporated into the tubular member or the coil, for example, by applying a coating containing the contrast agent. Examiner further notes that for receiving a fluid is considered an intended use of the internal space where it is noted that the internal space is considered to be capable of receiving any other fluid and therefore reads on the claimed invention) and the first coil is configured to receive the magnetic resonance signal from the fluid ([0081] which discloses use of a contrast agent may be especially beneficial in this situation because the contrast material will generate a very intense signal in the MRI image. Furthermore it is noted that the coil configuration is considered an intended use of the coil without any specific structure recited as controlling the coil accordingly. It is therefore noted that since the coil structure is configured to receive magnetic resonance signals and is therefore considered to be considered to receive magnetic resonance signals from any substance including any fluid received in the internal space)
Regarding claim 3,
Atalar further discloses wherein the surface of the catheter to which the first coil is disposed comprises an internal surface of the catheter ([0074] which discloses the coil could be on the interior surface or the exterior surface of the tubular member)
Regarding claims 7 and 27,
Atalar further discloses wherein the first coil comprises a non-helical coil extending along an elongated length of the catheter configured to bend, deform, deflect, or otherwise change shape (see at least fig. 2 and 2A depicting the non-helical coil extending along an elongated length of the catheter)
Regarding claims 8 and 21,
Atalar further discloses wherein the disposing comprises affixing the coil structure to the elongate surface of the catheter, the coil structure comprising a trace coil disposed on a flexible circuit board (see at least fig. 3 and disclosure in [0092] which discloses the detector coil (i.e. trace coil resides on a flexible circuit board).
Regarding claim 9,
Atalar further discloses further comprising electrically connecting the first coil to an electronic component (at least fig. 3 (340) and corresponding disclosure in at least [0091] or at least fig. 4 (428a) and corresponding disclosure in at least [0093]) also disposed on the substrate (see at least fig. 3).
Regarding claim 10,
Atalar further discloses wherein the electronic component comprises a tuning and matching circuit ([0091] which discloses with tuning/matching capacitors can be distributed around the loop to improve performance, as for example depicted in the embodiment of FIG. 3 with a tuning/matching capacitor (340) at the distal end and [0093] which discloses the tuning/matching capacitors may similarly be incorporated into the quadrature loop embodiments)
Regarding claims 11 and 23,
Atalar further discloses further comprising at least one second coil (at least fig. 4 (407b) and corresponding disclosure in at least [0093]) disposed on or near the elongate surface of the catheter ([0093] which discloses tow substantially orthogonal loops are used to improve the homogeneity of the coil reception in a substantially quadrature mode)
Regarding claims 12 and 24,
Atalar further discloses wherein the at least one second coil is the same as or different than the first non-helical coil ([0093] which discloses two loop coils 407a and 407b)
Regarding claims 13 and 25,
Atalar further discloses wherein the first non-helical coil and the at least one second coil are arranged on the elongate surface of the catheter ([0074] which discloses the coil could be on the interior or exterior surface of the tubular member [0093] which discloses quadrature loops are described in Atalar '563. FIG. 4A is a cut-section through line AA of FIG. 4 and shows one arrangement of the two loop coils (407a, 407b) of the quadrature loop imaging coil (404)) to provide an array for an imaging device during the medical procedure ([0093] which discloses two substantially orthogonal loops are used to improve the homogeneity of the coil reception in a substantially quadrature mode. One skilled in the art would understand that the coils may also be situated at angles other than substantially orthogonal).
Regarding claim 22,
Atalar further discloses further comprising a tuning and matching circuit (at least fig. 3 (340) and corresponding disclosure in at least [0091] or at least fig. 4 (428a) and corresponding disclosure in at least [0093]) disposed on the substrate and electrically connected to the first non-helical coil (see at least figs. 3 and 4)
Regarding claim 26,
Atalar further discloses wherein the first non-helical coil is interchangeable with at least one other second coil (see at least figs. 1-5 depicting different embodiments of the coil where the first non-helical coil is considered interchangeable in its broadest reasonable interpretation with any of the disclosed embodiments)
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.
Claims 14 and 26 (alternatively) rejected under 35 U.S.C. 103 as being unpatentable over Atalar in view of Gilderdale et al. (US 5876338 A), hereinafter Gilderdale.
Regarding claims 14 and 26 (alternatively),
Atalar teaches the elements of claim 1 as previously stated. Atalar fails to explicitly teach further comprising removing the first coil structure from the shaft of the catheter and coupling a second coil structure to the shaft of the catheter to interchange the removed first coil structure with the second coil structure.
Gilderdale, in a similar field of endeavor involving probes with coils, teaches removing a first coil structure comprising a non-helical coil (at least fig. 2 (10) and corresponding disclosure in at least Col. 3 lines 23-50) from a shaft of a probe and coupling a second coil structure to the shaft of the catheter to interchange the removed first coil structure with the second coil structure (at least figs. 1 and 2 and corresponding disclosure in at least Cols. 2-3 describing the removable nature of the set of coils 8 and 10 and interchangeability with respect to an endoscope body and Abstract which discloses An MR compatible endoscope 1 has associated MR saddle coil 10 mounted on a removeable former 9. The tip 2 of the endoscope has the usual service channels for imaging. The coil 10 provides an additional MR signal. To avoid the need to plug the coil 10 in, it is inductively couples to a pick-up coil 13 and, to enable this to be removable as will from the endoscope, this may be located in one of the service channels 7 of the endoscope).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Atalar to include removing a first coil structure from the shaft of a probe and coupling a second coil structure to the shaft of the catheter as taught by Gilderdale in order to provide for different coil configurations provided to suit different applications (Gilderdale Col. 2) and different magnetic field strengths (Gilderdale Abstract). Furthermore, such a modification would allow for coil replacement or repair without disturbing the instrument (Gilderdale Col. 4 lines 17-24)
Examiner notes that Atalar, as modified, by GIlderdale further teaches an interchangeable coil.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Oppelt (US6317091B1) discloses a trackable medical device, comprising: A catheter (at least fig. 4 (40) and corresponding disclosure in at least Col. 5 lines 31-54) configured to facilitate a medical procedure; and A first coil structure (at least fig. 4 (46, 48, and 42) and corresponding disclosure in at least Col. 5 lines 31-54) comprising a first non-helical coil (46 and/or 48) on a substrate (42), the first coil structure disposed directly on an elongate surface of the catheter (see at least fig. 4) so that (i) the first coil structure at least partially conforms to a non-planar shape of a shaft of the catheter and surrounds only a portion of the perimeter or circumference of the catheter’s shaft (see at least fig. 4), (ii) the first non-helical coil (46 and/or 48) has a center axis that is not a center axis of the device (see at least fig. 4 in which the center axes of the coils 46 and 48 are not a center axis of the device (i.e. catheter 40), and (iii) the first non-helical coil is configured to receive a magnetic resonance signal from an imageable substance inside or outside the device during a medical procedure (Col. 5 lines 55-57 which discloses when the catheter 40 with the device for signal intensification is introduced into the body via blood vessels, the blood flowing through the vessels can be employed as an imaging substance in the magnetic resonance tomogram…Since the imaging areas of the resonant coil arrangements 44, 46, 48 are located within the cylindrical carrier 42, openings must be present in the carrier 42 through which the blood can flow into the interior)
Nevo (US 20030187347 A1) discloses a trackable medical device, comprising: a catheter (at least fig. 1 (8) and corresponding disclosure in at least [0054]) configured to facilitate a medical procedure; and a first coil structure (at least fig. 1 (6) and corresponding disclosure in at least [0054]) comprising a first non-helical coil (at least fig. 1 (ICx, ICy, or ICz) and corresponding disclosure in at least [0054] and/or at least fig. 4 (IC1, IC 3 or IC5) and corresponding disclosure in at least [0068]) on a substrate (at least fig. 4 (6) and corresponding disclosure in at least [0068]. See also fig. 5 (30) and corresponding disclosure in at least [0069]-[0070]), the first coil structure disposed directly on an elongate surface of the catheter (see at least fig. 1 in which the probe 6 is disposed directly on an elongate surface of the catheter 8 and [0054] which discloses the probe 6 is movable via catheter 8 through the body cavity or lumen to be examined. Examiner notes that in order to move such a probe that it must be disposed on an elongate surface of the catheter otherwise it would not move accordingly) so that (i) the first coil structure at least partially conforms to a non-planar shape of a shaft of the catheter and surrounds only a portion of the perimeter or circumference of the catheter’s shaft (see at least fig. 4), (ii) the first non-helical coil (IC) has a center axis that is not a center axis of the device (see at least fig. 4)
Nassar (“Wireless Double µ-Resonator for orientation free tracking of MR-Catheter during Interventional MRI) teaches a trackable medical device comprising a catheter (see fig. 8) and a coil structure comprising a first non-helical coil disposed on a substrate (see at least fig. 7) the coil structure disposed directly on an elongate surface of the catheter (see last sentence of pg. 81 disclosing the film with the completed saddle coil was rolled around a 5fr = 1.667 mm diameter catheter).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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