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.
Claim 15 is 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.
In claim 15, “no matter of a rotation” renders the claim indefinite, the scope of the limitation is unclear.
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.
Claim(s) 1 and 3-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 2019/0388133) in view of Eversull et al. (US 2007/0015964; hereinafter Eversull) and Abraham (US 2008/0183080).
Sharma shows a single-use catheter for performing a medical procedure in a patient’s gastrointestinal tract (Figs. 11A-11B), comprising: an elongated catheter with a catheter shaft with a central axis and configured for trans-esophageal introduction into a patient’s small intestine ([0293], [0372]); a first occlusion balloon and a second occlusion balloon both carried in the distal region of the elongated catheter ([0373]), wherein the first occlusion balloon and second occlusion balloon are spaced apart by from 5 cm to 30 cm ([0248]); at least one inflation channel in the catheter shaft for expanding the first occlusion balloon and the second occlusion balloon ([0374]); and a fluid media source having a fluid media and in communication with an inflow channel in the catheter shaft having an inflow port intermediate the first occlusion balloon and the second occlusion balloon ([0376]); a heating mechanism for converting a flow of the fluid media to a heated flow media ([0374]); and a negative pressure source in communication with an outflow channel in the catheter shaft having an outflow port intermediate the first occlusion balloon and the second occlusion balloon ([0336], [0374]; Figs. 11A-11B).
Sharma also shows an insufflation source in communication with at least one insufflation channel in the catheter shaft having an open termination distal to the first occlusion balloon and the second occlusion balloon ([0374]; Figs. 11A-11b; additionally, it is noted that the location of the open termination would be an obvious rearrangement of parts of the invention, involving only routine skill in the art, In re Japikse, 86 USPQ 70); wherein insufflation an insufflation channel in the catheter shaft has an open termination proximal to the first occlusion balloon and the second occlusion balloon ([0374]; Figs. 11A-11b; additionally, it is noted that the location of the open termination would be an obvious rearrangement of parts of the invention, involving only routine skill in the art, In re Japikse, 86 USPQ 70); a controller operatively coupled to the heating mechanism for controlling operating parameters thereof ([0376]); wherein the controller is operatively coupled to an inflation source for controlling inflation of the first occlusion balloon and the second occlusion balloon ([0376]); a control pad disposed on a handle for controlling at least one of actuation of a vapor source, activation of an inflation source, adjustment of parameters of the at least one light emitter, and operation of the image sensor ([0376], [0383]-[0385], [0391]-[0394]).
Sharma fails to show a plurality of pull-wires in the catheter shaft for adjusting a shape of a distal region of the catheter shaft; an image sensor positioned at a distal end of the catheter shaft; at least one light emitter at the distal end of the catheter shaft; at least one image sensor to view laterally to the central axis of the catheter shaft; wherein the at least one image sensor has an optical axis that is angled from 30o to 90o from the central axis of the catheter shaft; at least one LED adjacent each image sensor.
Sharma fails to show a plurality of lateral image sensors affixed on opposite sides of an exterior of the catheter shaft and configured to provide a plurality of signals for producing a lateral field of view extending 360 degrees around the catheter shaft. Also, wherein the plurality of lateral image sensors are positioned proximally and distally to the first occlusion balloon and to the second occlusion balloon; wherein the plurality of lateral image sensors are positioned between the first occlusion balloon and to the second occlusion balloon.
Eversull discloses apparatus and methods for internal imaging. Eversull teaches a plurality of pull-wires in the catheter shaft for adjusting a shape of a distal region of the catheter shaft ([0077]-[0083], [0112]); an image sensor positioned at a distal end of the catheter shaft ([0101], [0105]); at least one light emitter at the distal end of the catheter shaft ([0103]-[0104]); wherein the catheter shaft includes a proximal portion including rotatable grips for actuating at least one pull-wire to articulate the distal region of the elongated catheter ([0101]-[0105]); at least one image sensor to view laterally to the central axis of the catheter shaft ([0139]-[0142]; Fig. 15); wherein the at least one image sensor has an optical axis that is angled from 30o to 90o from the central axis of the catheter shaft ([0139]-[0142]; Fig. 15); at least one LED adjacent each image sensor ([0103]-[0104]).
Abraham discloses an image guided catheter with deployable balloons. Abraham teaches a plurality of lateral image sensors affixed on opposite sides of an exterior of the catheter shaft and configured to provide a plurality of signals for producing a lateral field of view extending 360 degrees around the catheter shaft ([0014]-[0017], [0058], [0061]-[0062], [0108]; Fig. 7B). Abraham also teaches wherein the plurality of lateral image sensors are positioned proximally and distally to the first occlusion balloon and to the second occlusion balloon (transducers mounted along the sides of the elongate body may be utilized to further image the vicinity immediately proximate the sides of the device such as a volumetric area for the deployment of locking and sealing balloons, [0014]-[0017], [0058], [0061]-[0062], [0108]; Fig. 7B); wherein the plurality of lateral image sensors are positioned between the first occlusion balloon and to the second occlusion balloon ([0014]-[0017], [0058], [0061]-[0062], [0108]; Fig. 7B).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Sharma to utilize pull-wires as taught by Eversull, in order to allow the user greater control over the direction of the catheter while navigating through the patient. Furthermore, it would have been obvious to have utilize an image sensor and light emitter positioned at the distal end of the catheter shaft as taught by Eversull, in order to obtain images of the region of interest from a position on the device near the tissue being treated, to aid in more accurately guiding the therapeutic procedure. Furthermore, it would have been obvious to provide an angled image sensor as taught by Eversull, in order to provide a wider viewing range, thereby allowing the operator to obtain a more accurate diagnosis.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma and Eversull to provide a plurality of lateral image sensors affixed on opposite sides of the catheter as taught by Abraham, as Abraham teaches that this allows for imaging of the balloons, allowing for the user to visualize the deployment of the balloons thereby providing more accurate guidance of the procedure ([0014]-[0015]).
Claim(s) 2 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US 2019/0388133) in view of Eversull et al. (US 2007/0015964; hereinafter Eversull) and Abraham (US 2008/0183080) as applied to claim 1 above, and further in view of Charles (US 2015/0272694).
Sharma fails to show at least one accelerometer carried in the distal region of the catheter shaft. Sharma also fails to show an image processor configured to stitch together the plurality of signals; wherein the at least one accelerometer provides an orientation signal to the image processor to provide an upright image on a display no matter of a rotation of a working end of the catheter shaft.
Charles discloses a surgical visualization system. Charles teaches at least one accelerometer carried in the distal region of the catheter shaft ([0279], [0293], [0300]). Charles also teaches an image processor configured to stitch together the plurality of signals ([0308], [0334], [0338]); wherein the at least one accelerometer provides an orientation signal to the image processor to provide an upright image on a display no matter of a rotation of a working end of the catheter shaft ([0343]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Sharma and Eversull, and Abraham to utilize an accelerometer as taught by Charles, as Charles teaches that an accelerometer provides orientation information which can be utilized by the image processor to stitch together multiple images to create a wider field of view or to reduce artifacts in the images ([0308]), or to allow for rotating/repositioning the images to provide a display in an upright orientation relative to the horizon ([0343]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
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 JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797