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 .
Status of Claims
Applicant’s amendments filed 01/09/2026 have been entered. Claims 1-8 and 10-19 are pending and currently under consideration for patentability under 37 CFR 1.104. Previous rejections under 35 U.S.C. 112(b) have been withdrawn in light of Applicant’s amendments.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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/09/2026 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and all dependent claims thereof are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite inter alia “wherein the catheter and the inflatable member form a unitary construction.” There is no support in the specification for this language.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 6-8, 10, 11, and 13-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nave et al. (U.S. 2017/0232216).
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, 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. 3B,E).
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 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) 1-3 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei et al. (U.S. 2019/0192811).
With respect to claim 1, Wei et al. teaches a system with an inflatable member configured for being arranged in part of the patient's respiratory tract, comprising:
a catheter (120) carrying an inflatable member (110) to be arranged in the respiratory tract, wherein the catheter and the inflatable member form a unitary construction (FIG. 11) said catheter being provided with a fluid line (850) for filling the inflatable member with a fluid (para [0056]);
said catheter having a first end intended for being located outside of the patient's body and a second end intended for being located in the patient's respiratory tract (FIG. 10); and
an imaging device (200) attached to or integrated with the second end of the catheter (FIG. 11);
said imaging device having a distal end positioned distally to the inflatable member (para [0075]), 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. 11).
With respect to claim 2, Wei teaches the imaging device comprises a light source (FIG. 4).
With respect to claim 3, Wei teaches at least three light emitting diodes equally distributed along a periphery of the second end of the catheter (FIG. 4).
With respect to claim 12, Wei et al. teaches a lens (220) 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 (FIG. 11).
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) 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 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 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).
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
On page 7, Applicant argues that in Nave, the visualization device is shown to be recessed within the tip of the endotracheal tube. This is not persuasive because the claim recites, “having a distal edge that is aligned with a distal edge of the catheter or…protruding distally from the distal edge of the catheter. As can be seen in the annotated FIG. 3B below:
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the distal edge of 102 indicated by the dashed line protrudes distally with respect to the upper edge of the catheter indicated by the arrow. Therefore Nave meets the broadest reasonable interpretation of the claim.
On page 9, Applicant argues that an insertable and removable device is, by definition, not “attached” or “integrated with” the structure it is inserted to. Examiner respectfully disagrees. To attach is to fasten, join, or connect (Cambridge Dictionary). The claim does not recite or require permanent attachment. Therefore Wei meets the plain meaning of the claim language.
On pages 10, Applicant argues Wei’s camera is for visualization only; there is no disclosure or suggestion that it provides any mechanical guiding function. This is not persuasive. There is nothing in the claim that requires a mechanical guiding function. Wei is capable of providing visual guidance, and thus meets the plain meaning of the claim.
On page 10, Applicant argues Wei’s lens 210 is part of the imaging device 200 which is fully contained within the transparent shell 192. This is not persuasive at least because Applicant is arguing with respect to FIG. 8 and not the embodiment of FIG. 11 upon which Examiner relies:
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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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799
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