DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed June 29th, 2026, has been entered. Claim 1 (see below claim objection) has been amended. Claims 2 & 15-16 are canceled. Claims 1 & 3-14 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1 & 3-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim “11” has been renumbered “1”; the independent claim (previously claim “1” has been numbered to be “11”; the examiner notes that the independent claim is being referred to as “independent claim 1” and not independent claim 11 in this office action.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-6, & 9-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Podmore et al. (previously presented-US 20070299437 A1), hereinafter “Podmore”, in view of Whitman (US 20020165444 A1), hereinafter “Whitman”.
Regarding claim 1, Podmore discloses a tissue modification device comprising: a rigid elongated member having a proximal end and a distal end dimensioned to be passed through a minimally invasive body opening ([0034] & [0036]; Figure 1—element 12); a visualization sensor integrated with the distal end of the rigid elongated member and including a cable ([0038] & [0039]; Figures 1 & 2—elements 28 & 32); a tissue modifier integrated with the distal end of the rigid elongated member ([0035]; Figures 1 & 2—element 18); and a controller configured to deliver ultrasound energy to a target tissue at a tissue site via the tissue modifier ([0035], [0037], [0052], & [0056]; Figure 1—element 26; connector 26 couples the device to a control system and an ablation energy delivery system such that the ultrasound energy can be delivered in a controlled manner); wherein the rigid elongated member has a length of 5-20 cm between the proximal end and the distal end ([0011] & [0052]; Podmore discloses that the tissue modifier 18 comprises a length of about 0.43 inch ([0052]; Figures 1-2, 13, & 14—elements 18), and although the drawings are not to scale it would appear that based on the proportion of the ultrasound transducer to the rigid elongated member 12, the rigid elongated member 12 would comprise a length of 5-20 cm; further Podmore discloses in [0011] that ablation devices for creating transmural lesions have been described in U.S. Pat. No. 6,971,394 to Sliwa et al. ("Sliwa"), which is incorporated by reference, Sliwa discloses in [Col. 11, lines 27-33], [Col. 12, lines 42-61], & [Col. 40, lines 37-63] that the elongated member has a length of 10-30 cm between the proximal end and the distal end).
Podmore does not disclose the cable carried in the rigid elongated member.
Whitman teaches a tissue modification device comprising an elongated member ([0062] & [0063]; Figure 9—element 170), a visualization sensor ([0059] & [0065]; Figure 9—element 905) comprising a cable ([0062]-[0063]; the visualization sensor may be connected to the processor via a wired connection), and a tissue modifier ([0059]; Figure 9—element 190); the cable carried in the elongated member ([0060], [0062], & [0063]; the wired connection between the visualization sensor and the remote device may comprise wires that are disposed within or external to the elongated member 170).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the visualization sensor cable, as disclosed by Podmore, to include the visualization sensor cable carried in the elongated member, as taught by Whitman, as both references and the claimed invention are directed toward tissue modification devices comprising visualization sensors. As disclosed by Podmore, the visualization sensor cable may be disposed laterally externally to the rigid elongated member and is configured to transmit images to a display device ([0039]-[0040]). As disclosed by Whitman, the visualization sensor cable may be disposed within or external to the elongated member and is configured to transmit image data to a remote device ([0060], [0062], & [0063]). 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 visualization sensor cable, as disclosed by Podmore, to include the visualization sensor cable carried in the elongated member, as taught by Whitman, as providing the visualization sensor cable within the elongated member is a known and suitable alternative to providing the visualization sensor cable external to the elongated member and would produce the predictable result of providing a wired connection between the visualization sensor and a remote device of a tissue modification device for transmitting image data.
Regarding claim 3, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore does not explicitly disclose wherein the visualization sensor further comprises an integrated light source.
Whitman further teaches wherein the visualization sensor further comprises an integrated light source ([0065]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention would have been motivated to modify the visualization sensor, as disclosed by Podmore, to include an integrated light source, as further taught by Whitman, as both references and the claimed invention are directed toward tissue modification devices comprising integrated visualization sensors. As disclosed by Whitman, the visualization sensor may include a light source for illuminating an object to be imaged (e.g. fiber optic light sources, light bulbs, LEDs, etc.) ([0065]). 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 visualization sensor, as disclosed by Podmore, to include an integrated light source, as taught by Whitman, as such a modification would aid in illuminating an object to be imaged by the visualization sensor.
Regarding claim 4, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore further discloses wherein the controller is configured to deliver the ultrasound energy preferentially to soft tissue ([0040] & [0049]).
Regarding claim 5, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore further discloses wherein the tissue modifier is configured to deflect at an angle from a longitudinal axis passing through the rigid elongated member ([0038]).
Regarding claim 6, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore further discloses further comprising a sensor positioned at the distal end of the rigid elongated member ([0011]; Podmore discloses in [0011] that ablation devices for creating transmural lesions have been described in U.S. Pat. No. 6,971,394 to Sliwa et al. ("Sliwa"), which is incorporated by reference, Sliwa discloses in [Col. 14, lines 22-34] & [Col. 40, lines 36-63] that the device may comprise a sensor (e.g. temperature sensor) positioned at the distal end of the rigid elongated member).
Regarding claim 9, Podmore in view of Whitman disclose all of the limitations of claim 6, as described above.
Podmore further discloses wherein the sensor comprises a physiological sensor configured to collect physiological data ([0011]; Podmore discloses in [0011] that ablation devices for creating transmural lesions have been described in U.S. Pat. No. 6,971,394 to Sliwa et al. ("Sliwa"), which is incorporated by reference, Sliwa discloses in [Col. 14, lines 22-34] & [Col. 40, lines 36-63] that the device may comprise a sensor wherein the sensor comprises a physiological sensor configured to collect physiological data (e.g. temperature sensor)).
Regarding claim 10, Podmore in view of Whitman disclose all of the limitations of claim 9, as described above.
Podmore further discloses wherein the controller is further configured to transmit the physiological data to an image display component, wherein the image display component is configured to provide the physiological data to a user ([0011]; Podmore discloses in [0011] that ablation devices for creating transmural lesions have been described in U.S. Pat. No. 6,971,394 to Sliwa et al. ("Sliwa"), which is incorporated by reference, Sliwa discloses in [Col. 14, lines 22-34], [Col. 26, lines 40-44], & [Col. 40, lines 36-63] that the device may comprise the sensor wherein the sensor comprises the physiological sensor configured to collect physiological data (e.g. temperature sensor), wherein the controller is further configured to transmit the physiological data to an image display component that configured to provide the physiological data to a user (the control system receives data from the sensors and comprises a temperature display)).
Regarding claim 11, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore further discloses an integrated articulation mechanism that imparts steerability to the distal end of the rigid elongated member ([0037]; Figure 1—element 24).
Regarding claim 12, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore further discloses wherein the distal end of the rigid elongated member is rotatable about its longitudinal axis ([0036]-[0038]; Figure 1—elements 12; it is the examiner position that the distal end of the rigid elongated member 12 would be capable of being rotatable about its longitudinal axis if a user rotated the device 10 about its longitudinal axis).
Regarding claim 13, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore further discloses wherein the rigid elongated member further comprises an irrigation lumen configured to provide fluid to the target tissue, the visualization sensor, or both ([0011] & [0037]; Figure 1—element 26; the connector 26 is configured to couple the device to a fluid delivery mechanism; Podmore discloses in [0011] that ablation devices for creating transmural lesions have been described in U.S. Pat. No. 6,971,394 to Sliwa et al. ("Sliwa"), which is incorporated by reference, Sliwa discloses in [Col. 3, lines 53-57], [Col. 13, lines 45-65], [Col. 16, lines 55-58], & [Col. 40, lines 36-63] that the fluid is provided to target tissue; the examiner notes the rest are in the alternative).
Regarding claim 14, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore further discloses wherein the rigid elongated member further comprises an aspiration lumen configured to remove tissue from the tissue site ([0011] & [0037]; Figure 1—element 26; the connector 26 is configured to couple the device to a fluid withdrawal mechanism; Podmore discloses in [0011] that ablation devices for creating transmural lesions have been described in U.S. Pat. No. 6,971,394 to Sliwa et al. ("Sliwa"), which is incorporated by reference, Sliwa discloses in [Col. 3, lines 53-57], [Col. 13, lines 45-65], [Col. 16, lines 55-58], & [Col. 40, lines 36-63] that the fluid withdrawal is configured to remove tissue from the tissue site).
Claims 6-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Podmore in view of Whitman and Hossack et al. (previously presented-US 6045508 A), hereinafter “Hossack”.
Regarding claims 6 & 7, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore does not disclose a sensor positioned at the distal end of the rigid elongated member (claim 6); wherein the sensor comprises an accelerometer (claim 7).
Hossack teaches an ultrasonic device for imaging ([Col. 3, lines 28-60]; Figure 1—element 10), comprising a rigid elongated member ([Col. 3, lines 28-51]; Figure 1—element 12), a sensor positioned at the distal end of the rigid elongated member (claim 6); wherein the sensor comprises an accelerometer (claim 7) ([Col. 9, lines 55-63]).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the distal end, as disclosed by Podmore, to include a sensor positioned at the distal end of the rigid elongated member, wherein the sensor comprises an accelerometer, as taught by Hossack, as both references and the claimed invention are directed toward tissue modifiers comprising ultrasonic probes. As disclosed by Hossack, the ultrasonic probe can include an absolute sensor incorporated in its distal end for position or orientation feedback, such as an accelerometer ([Col. 9, lines 55-63]). 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 distal end, as disclosed by Podmore, to include a sensor positioned at the distal end of the rigid elongated member, wherein the sensor comprises an accelerometer, as taught by Hossack, as such a modification would provide for a sensor that provides feedback regarding the position and orientation of the ultrasonic probe within tissue.
Claims 6 & 8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Podmore in view of Whitman and Law et al. (previously presented-US 5469853 A), hereinafter “Law”.
Regarding claims 6 & 8, Podmore in view of Whitman disclose all of the limitations of claim 1, as described above.
Podmore does not disclose a sensor positioned at the distal end of the rigid elongated member (claim 6); wherein the sensor comprises an optical encoder (claim 8).
Law teaches a tissue modification device comprising a rigid elongated member comprising a distal end ([Col. 28, line 66 – Col. 29, line 10] & [Col. 29, lines 34-51]; Figure 38—element 402 & 404), and comprising a sensor positioned at the distal end of the rigid elongated member (claim 6); wherein the sensor comprises an optical encoder (claim 8) ([Col. 31, line 49 – Col. 32, line 6]; Figure 45—element 470).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the distal end, as disclosed by Podmore, to include a sensor positioned at the distal end of the rigid elongated member, wherein the sensor comprises an optical encoder, as taught by Law, as both references and the claimed invention are directed toward tissue modifiers comprising ultrasonic probes with bendable distal ends. As disclosed by Law, the distal end of the ultrasonic probe can include an angle sensor, such as an optical encoder, to sense the angle of the bend of the distal end of the ultrasonic probe and provide feedback to assist the surgeon in performing the procedure ([Col. 31, line 49 – Col. 32, line 6]). 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 distal end, as disclosed by Podmore, to include a sensor positioned at the distal end of the rigid elongated member, wherein the sensor comprises an optical encoder, as taught by Law, as such a modification would provide for a sensor that provides feedback to a surgeon regarding the angle of the bend of the distal end of the device to further assist the surgeon in performing the surgical procedure.
Conclusion
Accordingly, claims 1 & 3-14 are rejected.
THIS ACTION IS MADE FINAL. 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 MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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