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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/27/2026 has been entered.
Status of Claims
Applicant’s amendments filed 06/16/2026 have been entered. Claims 1-8, 10-19, and 22 are pending and currently under consideration for patentability under 37 CFR 1.104. Previous rejections under 35 U.S.C. 112(a) have been withdrawn in light of Applicant’s amendments. New rejections and response to arguments found below,
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copies have been received.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the the imaging device comprises a housing that is stiffer than the catheter, said housing being shaped to function as a stylet to provide directional control for positioning the inflatable member (claim 22) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 § 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) 1-4, 6-8, and 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nave et al. (U.S. 2017/0232216) in view of Nakatate et al. (U.S. 2016/0030693)
With respect to claim 1, Nave et al. teaches a system with an inflatable member configured for being arranged in part of the patient's respiratory tract, comprising:
a catheter (101) carrying an inflatable member (104) to be arranged in the respiratory tract, wherein the catheter and the inflatable member form a unitary construction (FIG. 3C) said catheter being provided with a fluid line (111) for filling the inflatable member with a fluid (para [0104]);
said catheter having a first end (115) intended for being located outside of the patient's body and a second end (116) intended for being located in the patient's respiratory tract; and
an imaging device (102) attached to or integrated with the second end of the catheter (FIG. 3A, see also para [0096]);
said imaging device having a distal end positioned distally to the inflatable member (FIG. 3B,E).
With respect to claim 1, Nakatate et al. teaches an analogous system with an inflatable member configured for being arranged in part of the patient’s respiratory tract, comprising:
and said imaging device having a distal edge that is aligned with a distal edge of the catheter or wherein the distal edge of the imaging device is protruding distally from the distal edge of the catheter to form a leading portion of the catheter that functions as a guide for positioning the inflatable member (FIG. 3).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Nave et al. to have the distal edge of the imaging device is protruding distally from the distal edge of the catheter in the manner taught by Nakatate et al. in order to secure a wide field of view (para [0060]).
With respect to claim 2, Nave et al. teaches the imaging device comprises a light source (126).
With respect to claim 4, Nave et al. teaches the imaging device is configured and arranged such that the second end of the catheter functions as a guide for the positioning of the inflatable member (intended use).
With respect to claim 6, Nave et al. teaches the imaging device is configured or connected to transmit image data to a device outside the patient's body (para [0103], see also FIG. 3E).
With respect to claim 7, Nave et al. teaches the imaging device comprises a cylindrical housing aligned with a longitudinal axis of the catheter (FIG. 3A,B).
With respect to claim 10, Nave et al. teaches the imaging device comprises an active pixel sensor (para [0096]).
With respect to claim 11, Nave et al. teaches the imaging device comprises an active pixel sensor (para [0096]) and wherein the plurality of light emitting diodes is arranged around the active pixel sensor (FIG. 3A).
With respect to claim 12, Nakatate et al. teaches a lens arranged in front of the active pixel sensor and protruding out of the second end and wherein the lens forms the distal edge of the imaging device that is aligned with the distal edge of the catheter or wherein the lens forms the distal edge of the imaging device that is protruding distally from the distal edge of the catheter (para [0059]).
With respect to claim 13, Nave et al. teaches the imaging device has a field of view between 90 and 180 degrees (para [0100]).
With respect to claim 14, Nave et al. teaches the catheter comprises the fluid line (FIG. 1).
With respect to claim 15, Nave et al. teaches at least one electrical wire (109), arranged in the catheter, and configured for connecting the imaging device with a device outside the patient's body (FIG. 3E for example).
With respect to claim 16, Nave et al. teaches the catheter is made from a flexible material (para [0022]).
Claim(s) 3, 8, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nave et al. (U.S. 2017/0232216) in view of Nakatate et al. (U.S. 2016/0030693) as applied to claim 1 above and further in view of Chang (U.S. 2010/0185052).
Nave teaches a system as set forth above. However, Nave does not teach at least three LEDs.
With respect to claim 3, Chang teaches an imaging module with at lest three LEDs equally distributed (para [0037]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Nave to have at least three LEDs in the manner taught by Chang because Nave already teaches two LEDs. Adding a third LED would merely require a duplication of parts, which has been held to be within the level of one of ordinary skill in the art.
With respect to claim 8, Nave et al. teaches the cylindrical housing is arranged at least partially in the second end of the catheter (FIG. 3A,B)
However, Nave et al. does not teach specific dimension of the housing.
With respect to claim 8, Chang teaches an imaging module wherein the housing (40) has a diameter between 0.01 mm and 9 mm (para [0038]) and wherein a length of the housing is smaller than 10 mm (para [0039]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the imaging module of Nave et al. to utilize the dimensions taught by Chang in order to improve a moving range of the endoscopic device within the body organs (para [0005] of Chang).
With respect to claim 11, Nave et al. teaches the imaging device comprises an active pixel sensor (para [0096]) and wherein the plurality of light emitting diodes is arranged around the active pixel sensor (FIG. 3A).
Claim(s) 5 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nave et al. (U.S. 2017/0232216) in view of Nakatate et al. (U.S. 2016/0030693) as applied to claim 1 above and further in view of Nierich (WO 2018/106103).
Nave et al. teaches a system as set forth above. However, Nave et al. does not teach an ultrasonic imaging device.
With respect to claim 5, Nierich teaches a system comprising a catheter carrying an inflatable member and further comprising an ultrasonic imaging device configured to emit ultrasound waves through the inflatable member and receive reflected ultrasound waves (FIG. 8).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Nave et al. to further comprise an ultrasonic imaging device in the manner taught by Nierich in order to enable the imaging of an organ in a patient’s body, in particular the heart or the aorta (page 9, lines 12-14 of Nierich).
Nave et al. teaches a system as set forth above. However, Nave et al. is silent with respect to the volume and material of the inflatable member. Nave et al. further does not teach a pressure monitoring and control member.
With respect to claim 17, Nierich teaches the inflatable member, in the non-expanded state, has a volume between 20 ml and 60 ml (page 7, lines 6-9).
With respect to claim 18, Nierich teaches the material of the inflatable member is a thermoplastic elastomer (page 7, line 35-page 8 line 2).
With respect to claim 19, Nierich teaches a pressure monitoring and control member (24) to be arranged outside the patient's body, said pressure monitoring member being in fluid communication with the inflatable member and being configured to receive, during operation, fluid from the inflatable member when the pressure increases above a predetermined threshold pressure and to return said received fluid when the pressure decreases below said predetermined threshold pressure; and
wherein the pressure monitoring and control member is an elastically expandable balloon (24) made from a material which is configured to expand elastically when the pressure in the balloon increases above a predetermined threshold pressure and to contract when the pressure decreases below said predetermined threshold pressure.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Nave et al. to utilize the inflatable member and pressure monitoring control system as taught by Nierich in order to provide a system with an inflatable member for positioning in a part of the patient’s respiratory tract which allows for an improved pressure control such that damage can be avoided (page 2, lines 11-13 of Nierich).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nave et al. (U.S. 2017/0232216) in view of Nakatate et al. (U.S. 2016/0030693) as applied to claim 1 above and further in view of Chuda (U.S. 2008/0236575).
Nave et al. teaches a system as set forth above. However, Nave et al. does not teach the imaging device comprises a housing that is stiffer than the catheter, said housing being shaped to function as a stylet to provide directional control for positioning the inflatable member.
With respect to claim 22, Chuda teaches an imaging device integrated into a stylet (para [0056])
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the imaging device of Nave et al. to have stiff housing that functions as a stylet in the manner taught by Chuda in order to aid intubation procedures in the setting of anatomic or other difficult conditions which might prevent intubation from being successfully performed using routine equipment and methods (para [0005] of Chuda).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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ALEXANDRA L. SURGAN
Primary Examiner
Art Unit 3795
/ALEXANDRA L NEWTON/ Primary Examiner, Art Unit 3799
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