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 09/24/2026 have been entered. Claims 1, 3-5, 9, 10, and 12-15 are pending and currently under consideration for patentability under 37 CFR 1.104
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 trocar (claim 10) 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 § 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 12 is 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 “the insertion depth sensor comprises a first light source positioned to emit first light onto a first portion of the endoscope body; [and] a first sensor positioned to receive light scattered or reflected off of the first portion of the endoscope body.” Claim 12 depends from claim 1 and recites inter alia, “the insertion depth sensor comprises a plurality of capacitive sensors disposed along the endoscope body.” There is no support in the specification for the insertion depth sensor to simultaneously be a first sensor positioned to receive light and a plurality of capacitive sensors disposed along the endoscope body. Therefore the claim is rejected for being directed to new matter.
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, 5, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (U.S. 2023/0015694) in view of Vecerina et al. (U.S. 2005/0075558).
With respect to claim 1, Lim et al. teaches a system comprising:
an endoscope comprising:
an endoscope body shaped to enter a portion of a body, the endoscope body defining a proximal end and a distal end opposite the proximal end (FIG. 1) and alternating markings disposed on the endoscope body, wherein the alternating markings are rotationally invariant about the endoscope body, wherein the alternating markings have equal widths along the longitudinal axis of the endoscope body (para [0053]);
an insertion depth sensor (70,72) configured to generate an insertion depth signal based on an insertion depth of the endoscope body within the portion of the body, wherein the insertion depth sensor comprises:
a first sensor (70) positioned to receive light scattered or reflected off of the first portion of the endoscope body (para [0054]);
and an inertial measurement unit (36,37, para [0046]) disposed at the distal end of the endoscope body, the inertial measurement unit configured to generate an orientation signal based upon an orientation of the inertial measurement unit (para [0066]); and
a controller (100) operatively coupled to the insertion depth sensor and the inertial measurement unit, the controller including logic that, when executed, causes the system to perform operations including:
generating positional information of the distal end of the endoscope body within the portion of the body based upon the insertion depth signal and the orientation signal (FIG. 5,7 for example).
However, Lim et al. does not teach the insertion depth sensor comprises a first light source, a slit shaped to allow the first light to pass through to the first portion of the endoscope body, or a light baffle.
With respect to claim 1, Vecerina et al. teaches an insertion depth sensor wherein the insertion depth sensor comprises:
a first light source (31) positioned to emit first light onto the first portion of the endoscope body,
wherein the insertion depth sensor defines a slit (11) shaped to allow the first light to pass through to the first portion of the endoscope body (FIG. 1); and
a light baffle (12) positioned between the first sensor and the first light source, wherein the light baffle is configured to block the first light from passing directly from the first light source to the first sensor.
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 Lim et al. to utilize the configuration of the insertion depth sensor in the manner taught by Vecerina et al. in order to allow the imaging element of the depth sensor to have a maximum field of vision of the endoscope as it passes through the insertion depth sensor (para [0027] of Vecerina et al.).
With respect to claim 4, Lim et al. teaches an analogous system wherein the insertion depth sensor comprises a quadrature encoder (para [0054]).
With respect to claim 5, Lim et al. teaches the insertion depth sensor comprises a second sensor is a second optical sensor (72) positioned to receive light scattered or reflected from the second portion of the endoscope body; and
wherein the alternating markings comprise:
a plurality of first bands having a first color (60); and
a plurality of second bands having a second color different than the first color (62), wherein second bands of the plurality of second bands are interspersed between first bands of the plurality of first bands (FIG. 3).
With respect to claim 13, Lim et al. teaches generating positional information of the distal end of the endoscope body within the portion of the body comprises generating a three-dimensional map of the portion of the body based on a path the distal end has travelled within the portion of the body (FIG. 8).
With respect to claim 14, Lim et al. teaches a user interface (110) configured to receive input from a user to annotate the three-dimensional map based on the input from the user (para [0022]-[0023]).
With respect to claim 15, Lim et al. teaches generating a marker signal when the distal end is located in a portion of the path corresponding to an annotated portion of the three-dimensional map (para [0022]-[0023]).
Claim(s) 3, 8, 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (U.S. 2023/0015694) in view of Vecerina et al. (U.S. 2005/0075558) as applied to claim 1 above and further in view of Whitin et al. (U.S. 2004/0176683).
Lim et al. teaches a system as set forth above. However, Lim et al. does not teach the insertion depth sensor defines an aperture shaped to receive the endoscope body. Lim et al. further does no teach a magnetic sensor. Finally Lim et al. does no teach capacitive sensing.
With respect to claim 3, Whitin et al. teaches an analogous system wherein the insertion depth sensor defines an aperture (100) shaped to receive the endoscope body.
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 Lim et al. utilize the structure of the external sensing device in the manner taught by Whitin et al. in order to provide a physical structure that can be positioned externally of the patient adjacent ot an opening into a body cavity (para [0078] of Whitin et al.).
With respect to claim 9, Whitin et al. teaches the insertion depth sensor is shaped to remain at an insertion point in the portion of the body and allow the endoscope body to pass through the aperture into and out of the portion of the portion of the body (FIG. 7B for example).
With respect to claim 12, Whitin et al. teaches the insertion depth sensor comprises a plurality of capacitive sensors disposed along the endoscope body. wherein a capacitive sensor of the plurality of capacitive sensors is configured to generate a capacitive insertion depth signal when the capacitive sensor is inserted within and in contact with the portion of the body (para [0066]-[0071]).
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 Lim et al. to utilize capacitive sensors in the manner taught by Whitin et al. because Whitin et al. teaches capacitive sensing is a known alternative to optical sensing (see para [0087] of Whitin et al. for example) such that one of ordinary skill in the art could substitute capacitive sensing for optical sensing and the results would have been predictable.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lim et al. (U.S. 2023/0015694) in view of Vecerina et al. (U.S. 2005/0075558) as applied to claim 1 above and further in view of Loo et al. (U.S. 2021/0378543).
Lim et al. teaches a system as set forth above. However, Lim et al. does not teach the insertion depth sensor is a trocar.
With respect to claim 10, Loo et al. teaches an analogous system wherein the insertion depth sensor is a trocar (FIG. 1A).
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 insertion depth sensor of Lim et al. to utilize a trocar in the manner taught by Loo et al. in order to fix the insertion depth sensor with respect to the patient (para [0040] of Loo et al.).
Response to Arguments
Applicant's arguments filed 09/24/2026 have been fully considered but they are not persuasive.
On page 7 Applicant argues the refractive optical element 12 of Vecerina does not function to block the first light from passing directly from the first light source to the first sensor. This is not persuasive. To be refractive is to bend light. It is obvious based on the disclosure of Vecerina that the angled surface of the element 12 functions to redirect light from the element 31 90 degrees down toward the instrument surface 13. If optical element 12 did not redirect light in this manner, and instead allowed light to pass through optical element 12 and directly into the transducer 32, the invention of Vecerina would not function.
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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/ALEXANDRA L NEWTON/Primary Examiner, Art Unit 3799
