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 § 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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. (US 2014/0180127; hereinafter Meyer), in view of Kagawa et al. (US 5,163,433; hereinafter Kagawa).
Regarding claim 1, Meyer discloses a rotational ultrasound imaging catheter with extended catheter body telescope. Meyer shows an image diagnosis catheter (par. [0025] states “...the imaging catheter’ and “IVUS”) comprising: an outer tube (see 105 in fig. 3 and 4; par. [0038]); a support tube provided radially inside of the outer tube (see 102 in fig. 3 and 4; par. [0038]); an inner tube see 106 in fig. 4 and 7; par. [0035], [0036], [0038]) provided radially inside of the outer tube (fig. 3 shows that the proximal part of inner tube 106 is inside the outer tube 105; the examiner notes that the claim does not require that the whole portion of inner tube has to be inside the outer tube) and radially outside of the support tube (fig. 3 shows that the distal end of inner tube 106 is outside the support tube 102; the examiner notes that the claims does not require that whole portion of inner tube has to be outside the support tube), and the inner tube being configured to be movable relative to the outer tube (see fig. 3) and the support tube in an axial direction (see fig. 4, 5 and 7).
But, Meyer fails to explicitly state that a spacer extending in an axial direction between an outer circumferential surface of the support tube and an inner circumferential surface of the outer tube, and the spacer configured to connect the outer tube with the support tube, wherein the spacer is configured to form a communication passage between the outer tube and the support tube, the communication passage configured to communicate with an inside of the support tube.
Kagawa discloses an ultrasound type treatment apparatus. Kagawa teaches a spacer extending in an axial direction between an outer circumferential surface of the support tube and an inner circumferential surface of the outer tube (see 27 in fig. 1), wherein the spacer is configured to form a communication passage between the outer tube and support tube (see fig. 1; col. 6, lines 34-46), and the spacer forms a communication passage which is configured to communicate with an inside of the support tube (fig. 1 shows the spacers 27 forms a communication passage which is configured to communicate with an inside of support tube 22a).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a spacer configured to connect the outer tube with the support tube, wherein the spacer is configured to form a communication passage between the outer tube and the support tube, the communication passage configured to communicate with an inside of the support tube in the invention of Meyer, as taught by Kagawa, to be able to provide cooling water into the patient during treatment procedure.
Regarding claim 2 Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Meyer teaches a connector (see proximal end of the device shows in fig. 3-4), and Kagawa also teaches a connector configured to be joined to the outer tube (see 23 in fig. 1); the spacer is configured to be joined to the support tube (see fig. 1); and the spacer has a stopper positioned between the outer tube and the connector in the axial direction (see 24 in fig. 1). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the spacer is configured to be joined to the support tube; and the spacer has a stopper positioned between the outer tube and the connector in the axial direction in the invention of Meyer, as taught by Kagawa, to provide a water-tight seal connection.
Regarding claim 3, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches wherein the communication passage is defined by the spacer, the outer tube, and the connector (see fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the communication passage is defined by the spacer, the outer tube, and the connector in the invention of Meyer, as taught by Kagawa, to be able to provide cooling water into the patient during treatment procedure.
Regarding claim 4, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches wherein the spacer includes a spacer body positioned between an outer circumferential surface of the support tube and an inner circumferential surface of the outer tube (see 27 in fig. 1), and a protruding portion protruding from a distal end of the spacer body toward a distal end on a distal end side of the image diagnosis catheter with respect to a distal end surface of the outer tube (see 5 in fig. 1). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the spacer includes a spacer body positioned between an outer circumferential surface of the support tube and an inner circumferential surface of the outer tube, and a protruding portion protruding from a distal end of the spacer body toward a distal end on a distal end side of the image diagnosis catheter with respect to a distal end surface of the outer tube in the invention of Meyer, as taught by Kagawa, to provide a water supply which is able to provide cooling water into the patient during treatment procedure
Regarding claim 5, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches wherein the spacer body has a cylindrical shape (see fig. 1). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a cylindrical shape spacer body in the invention of Meyer, as taught by Kagawa, to provide a tube-like shape which will provide efficient fluid flow.
Regarding claim 6, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches an outer circumferential surface of the spacer body has two portions having a flat surface shape (see fig. 1), the two portions being separated from each other in a first direction along a radial direction and extending in the axial direction (see fig. 1).
Regarding claim 7, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Meyer shows a sheath configured to be inserted into a body cavity (see par. [0045]), the sheath being connected to a distal end of the outer tube (see fig. 3 and 4); and an imaging core (see par. [0048], and fig. 3), the imaging core including a drive shaft (see par. [0048]), a housing fixed to a distal end of the drive shaft (see fig. 3-4 and 7), and a signal transmitter and receiver that is accommodated in the housing and configured to transmit and receive a signal that an ultrasound wave (see par. [0048], [0053]), and wherein the imaging core is configured to move forward and backward in an axial direction with the inner tube and with respect to the sheath and the outer tube (see fig. 3-4).
Regarding claim 8, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Meyer shows a drive shaft (see par. [0048]); and a hub configured to be connected to the drive shaft (see proximal side of catheter in fig. 3, 4 and 7), the hub including: a hub body having a tubular shape coaxial with the inner tube and configured to be attachable to an external device (see fig. 7; par. [0036]); a port protruding radially outward from the hub body and communicating with the inside of the hub body (see fig. 7); a connection pipe attached to an outer circumferential surface of the drive shaft (see fig. 7); a bearing rotatably supporting the connection pipe (see par. [0027], [0047]); a seal member (see par. [0038], [0047], [0049]); and a connector portion provided with an electrical connector and an optical connector and configured to be attachable to the external device (see fig. 3, 4 and 7; par. [0011], [0053]), and wherein the connector portion is configured to be rotatable with the connection pipe and the drive shaft (see claim 1).
Regarding the limitations in claim 8, “configured to prevent the priming solution from leaking from a gap between the connection pipe and the bearing toward a proximal end side of the hub" directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Meyer and Kagawa is capable of performing the functions as set forth by applicant.
Regarding claim 9, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Meyer shows a locking portion provided at a distal end of the inner tube (see 107 in fig. 3), the locking portion configured to prevent disengagement of the inner tube from the outer tube (see fig. 3; par. [0038]); a connector, the connector includes a distal-end-side portion connector (see 103 in fig. 8) and a proximal-end-side portion connector detachably connected to the distal-end-side portion connector (see 104 in fig. 8).
Regarding the claim limitation in claim 9, “the locking portion... to be hooked at a predetermined position on an inner wall of the proximal-end-side portion connector of the connector when the inner tube is pulled out from the outer tube and the connector" directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Meyer and Kagawa is capable of performing the functions as set forth by applicant.
Regarding claim 10, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches wherein the spacer body has a cylindrical shape in which an axial groove extending in the axial direction is provided on the outer circumferential surface of the spacer body (see in fig. 1, 8, 10, 30, 35 and 36), the axial groove forming an axial flow passage extending in the axial direction between an outer circumferential surface of the spacer body and an inner circumferential surface of the outer tube (see in fig. 1, 8, 10, 30, 35 and 36). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the spacer body has a cylindrical shape in which an axial groove extending in the axial direction is provided on the outer circumferential surface of the spacer body, the axial groove forming an axial flow passage extending in the axial direction between an outer circumferential surface of the spacer body and an inner circumferential surface of the outer tube in the invention of Meyer, as taught by Kagawa, to provide a tube-like shape which will provide efficient fluid flow.
Regarding claim 11, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches wherein the protruding portion has a cylindrical shape (see in fig. 1, 8, 10, 30, 35 and 36), and a notch extending in the axial direction and connected to the axial groove of the spacer body (see in fig. 1, 8, 10, 30, 35 and 36), the distal end surface of the protruding portion being flush with a distal end surface of the support tube and an axial flow passage is defined by the axial groove provided on the outer circumferential surface of the spacer body and the inner circumferential surface of the outer tube (see in fig. 1, 8, 10, 30, 35 and 36). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of the protruding portion has a cylindrical shape, and a notch extending in the axial direction and connected to the axial groove of the spacer body, the distal end surface of the protruding portion being flush with a distal end surface of the support tube and an axial flow passage is defined by the axial groove provided on the outer circumferential surface of the spacer body and the inner circumferential surface of the outer tube in the invention of Meyer, as taught by Kagawa, to provide a tube-like shape which will provide efficient fluid flow.
Regarding claim 12, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches wherein the axial flow passage is defined by the axial groove provided on the inner circumferential surface of the spacer body and the outer circumferential surface of the support tube (see in fig. 1, 8, 10, 30, 35 and 36), and the notch of the protruding portion extends on the inner circumferential surface of the protruding portion over the entire length in the axial direction (see in fig. 1, 8, 10, 30, 35 and 36), and radially extends on the distal end surface of the protruding portion from the outer circumferential surface of the support tube to an outer circumferential edge of the protruding portion (see in fig. 1, 8, 10, 30, 35 and 36). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of wherein the axial flow passage is defined by the axial groove provided on the inner circumferential surface of the spacer body and the outer circumferential surface of the support tube, and the notch of the protruding portion extends on the inner circumferential surface of the protruding portion over the entire length in the axial direction, and radially extends on the distal end surface of the protruding portion from the outer circumferential surface of the support tube to an outer circumferential edge of the protruding portion in the invention of Meyer, as taught by Kagawa, to provide a tube-like shape which will provide efficient fluid flow.
Regarding claim 13, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches two or more through-holes axially penetrating a spacer body of the spacer (see fig. 1, 8, 10, 30, 35 and 36; col. 6, lines 34-46), the two or more through-holes forming an axial flow passage, and wherein a distal end of each of the two or more through-holes extend radially inward to an outer circumferential surface of the support tube (see fig. 1, 8, 10, 30, 35 and 36; col. 6, lines 34-46). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of two or more through-holes axially penetrating a spacer body of the spacer, the two or more through-holes forming an axial flow passage, and wherein a distal end of each of the two or more through-holes extend radially inward to an outer circumferential surface of the support tube in the invention of Meyer, as taught by Kagawa, to provide a tube-like shape which will provide efficient fluid flow.
Regarding claim 14, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches two or more through-holes axially penetrating a spacer body of the spacer (see fig. 1, 8, 10, 30, 35 and 36; col. 6, lines 34-46), and wherein the spacer body is formed of a porous member, and an axial flow passage is configured by a gap in the spacer (see fig. 1, 8, 10, 30, 35 and 36; col. 6, lines 34-46). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of two or more through-holes axially penetrating a spacer body of the spacer, and wherein the spacer body is formed of a porous member, and an axial flow passage is configured by a gap in the spacer in the invention of Meyer, as taught by Kagawa, to provide a tube-like shape which will provide efficient fluid flow.
Regarding claim 20, Meyer and Kagawa disclose the invention substantially as described in the 103 rejection above, furthermore, Kagawa teaches two or more through-holes axially penetrating a spacer body of the spacer (see fig. 1, 8, 10, 30, 35 and 36; col. 6, lines 34-46), the two or more through-holes froing an axial flow passage (see fig. 1, 8, 10, 30, 35 and 36; col. 6, lines 34-46), and wherein a distal end of each of the two or more through-holes extend radially inward to an outer circumferential surface of the support tube (see fig. 1, 8, 10, 30, 35 and 36; col. 6, lines 34-46). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching two or more through-holes axially penetrating a spacer body of the spacer, the two or more through-holes froing an axial flow passage, and wherein a distal end of each of the two or more through-holes extend radially inward to an outer circumferential surface of the support tube, as taught by Kagawa, to provide a tube-like shape which will provide efficient fluid flow.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kagawa et al. (US 5,163,433; hereinafter Kagawa), in view of Meyer et al. (US 2014/0180127; hereinafter Meyer).
Regarding claim 15, Kagawa discloses an ultrasound type treatment apparatus. Meyer shows an catheter (see fig. 1 and abstract) comprising: an outer tube (see 22 in fig. 1; see col. 5, lines 6-16); a support tube provided radially inside of the outer tube (see 22a in fig. 1; col. 5, lines 64-65); a spacer extending in an axial direction between an outer circumferential surface of the support tube and an inner circumferential surface of the outer tube, and the spacer (see 27 in fig. 1), wherein the spacer is configured to form a communication passage between the outer tube and support tube (see fig. 1; col. 6, lines 34-46), and the spacer forms a communication passage which is configured to communicate with an inside of the support tube (fig. 1 shows the spacers 27 forms a communication passage which is configured to communicate with an inside of support tube 22a).
configured to connect the outer tube with the support tube (see 27 in fig. 1; col. 6, lines 34-46), and the spacer configured to form a flow passage between the outer tube and the support tube (see fig. 1; col. 6, lines 34-46), the flow passage configured to be in communication with an inside of the support tube (see fig. 1; col. 6, lines 34-46); and wherein the spacer includes a spacer body positioned between an outer circumferential surface of the support tube and an inner circumferential surface of the outer tube (fig. 1 shows that the spacer 27 is positioned between an outer circumferential surface of the support tube 22a and an inner circumferential surface of outer tube 22), and a protruding portion protruding from a distal end of the spacer body toward a distal end on a distal end side of the catheter with respect to a distal end surface of the outer tube (see combination of elements 5 and 27 fig. 1, or 166/167 in fig. 30-33).
But, Kagawa fails to explicitly state the catheter is an image diagnosis catheter.
Meyer discloses a rotational ultrasound imaging catheter and teaches an image diagnosis catheter (see abstract and fig. 1). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have modified the catheter of Kagawa to incorporate an image diagnosis catheter, as taught by Meyer, to provide real-time imaging capability during treatment procedure and be able to diagnosis the region of interest to help with treatment.
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive.
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In response to Applicant’s arguments on pages 13-16, with respect to prior art rejection of independent claims 1 and 15, the examiner respectfully disagrees. Upon further consideration, the examiner maintains that prior art Kagawa does teach a spacer extending in an axial direction between an outer circumferential surface of the support tube and an inner circumferential surface of the outer tube (see 27 in fig. 1). See examiner annotated figure 1 of prior art Kagawa, the width of spacer does extend axially between an outer circumferential surface of the support tube and an inner circumferential surface of the outer tube.
Furthermore, the examiner maintains that Kagawa also teaches wherein the spacer is configured to form a communication passage between the outer tube and support tube (see fig. 1; col. 6, lines 34-46), and the spacer forms a communication passage which is configured to communicate with an inside of the support tube (fig. 1 shows the spacers 27 forms a communication passage which is configured to communicate with an inside of support tube 22a).
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 SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M 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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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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