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 .
Election/Restrictions
Applicant’s election without traverse of Species 5 (Multifunctional visualization instrument 48 of Fig. 28) and sub-species E (body port 60 shown in Fig. 21), in the reply filed on 12/17/2025 is acknowledged.
Applicant noted that “based on the election of Species 5, the listed sub-species no longer appear to be applicable and the claims pending herein seem to be generic to the listed subspecies.” It is noted that independent claims 41 and 52 include the recitation of “a hub to receive the proximal end of the introducer.” Accordingly, based on the claims, a sub-species election is required.
Claims 58-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. It is noted that elected Species 5 does not include a laryngoscope and therefore the recitation of operation in a multifunctional mode is not applicable to this species. As described in the specification, “the multifunctional mode permits simultaneous laryngoscope and endoscope functionality.” Slim elongate body 14 does not constitute a laryngoscope.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 62636534 and 62586231, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. It is noted that elected Species 5 is not disclosed in the 62636534 or 62586231 applications. The concept of a multifunctional visualization instrument body passing within the endotracheal tube is not discussed. The structure of the slim elongate body 14 (see Fig. 28) is not disclosed. Accordingly, the effective filing date for the claimed subject matter in the current application is 05/22/2018 and will be treated as such for examination purposes.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification does not disclose the location of the motor with respect to elected Species 5. The specification also fails to identify the claimed hub, and connector of elected Species 5.
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 motor must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Fig. 28 (elected species 5) does not illustrate the location of the motor, hub or connector.
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 Objections
Claims 41-57 are objected to because of the following informalities:
“A video laryngoscope” should be changed to --A multifunctional visualization instrument--. It is noted that elected Species 5 lacks a laryngoscope. Appropriate correction is required.
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.
Claims 50 and 51 are 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.
Claims 50 and 51 are directed to the location of the motor. The elected embodiment, shown in Fig. 28, lacks any identification of the motor location. The specification also fails to discuss the motor of the elected embodiment. It is further noted that the claimed electrical connectors and hub are not identified in the Drawings or Specification when discussing elected Species 5.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 41, 44-46, 52 and 57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gardner (U.S. 2018/0142833 A1).
Concerning claim 41, Gardner discloses a video laryngoscope system (see Figs. 20 and 21), comprising: an introducer (52), comprising: a proximal end; an articulating distal end (52a and see Fig. 6, element 52a and par. 01115); a display assembly (40) comprising a display screen; a body (350), detachable from the display assembly (see par. 0096), the body comprising: a hub (see Fig. 5, element 50b and Fig. 20, element 350) to receive the proximal end of the introducer (52); and
a connector for connecting the body to the display assembly (see par. 0096); and a motor (see par. 0115, i.e., the mechanism for moving a portion of the distal end 52a – mechanical or electrical) that controls articulation of the articulating distal end in response to receiving steering control signals.
Concerning claim 44, wherein, while the body is attached to the display assembly, the introducer is in communication with the display assembly via the body (see par. 0096).
Concerning claim 45, wherein the introducer further comprises an introducer camera (see Fig. 6, element 54 and see par. 0108, i.e., CMOS camera or fiber optic camera) positioned at the distal end, and signals from the introducer camera are communicated to the display assembly via the body (see par. 0096).
Concerning claim 46, wherein the introducer further comprises a sensor (see pars. 0005 and 0108, i.e., CMOS camera) positioned at the distal end, and signals from the sensor are communicated to the display assembly via the body (see par. 0096).
Concerning claims 52 and 57, as best understood from the elected Species illustrated below, Gardner discloses a video laryngoscope system, comprising: an introducer (52), comprising: a proximal end; an articulating distal end (52a and see Fig. 6, element 52a and par. 01115); an introducer camera (see Fig. 7, element 60 and par. 0108); and a first electrical connector (see below); a display assembly comprising a display screen (40); a body (350), detachable from the display assembly (see par. 0096), the body comprising: a hub (see Fig. 5, element 50b and Fig. 20, element 350) to receive the proximal end of the introducer; and a second electrical connector (see below) that electrically connects with the first electrical connector when the proximal end is inserted into the hub; a third electrical connector (see below) for connecting the body to the display assembly; and a motor (see par. 0115, i.e., the mechanism for moving a portion of the distal end 52a – mechanical or electrical) that controls articulation of the articulating distal end in response to receiving steering control signals. It is noted that the electrical connectors transmit image signals from the camera to the display (see pars. 0108, 0221 and 0248).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 42, 43, 53 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (U.S. 2018/0142833 A1) in view of Ohline et al. (U.S. 2003/0045778 A1).
Gardner discloses the invention substantially as described above. However, Gardner does not explicitly disclose that the motor drives a mechanical pull wire system to articulate the articulating distal end.
Ohline et al. disclose a steerable introducer comprising a motor that drives a mechanical pull wire system to articulate an articulating distal end of the introducer (see pars. 0007, 0013, 0021, 0050 and claim 8) in the same field of endeavor for the purpose of viewing internal body spaces with minimal impingement upon the walls of the body.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed inventio to incorporate a motor that drives a mechanical pull wire system to articulate the articulating distal end of Gardner’s introducer, the concept of which is disclosed by Ohline et al., in order to improve the precision and control and reduce operator fatigue. It is noted that pull-wire articulation systems in endoscopes are well-known, and motors for articulating mechanical systems are well-known. Accordingly, combining the motor to operate the pull-wire system would yield the predictable result of motorized articulation.
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (U.S. 2018/0142833 A1) in view of Sabczynski et al. (U.S. 2012/0089014 A1).
Gardner discloses the invention substantially as described above. However, Gardner does not explicitly disclose that the sensor includes an accelerometer.
Sabczynski et al. disclose an introducer comprising an accelerometer (see par. 0008) in the same field of endeavor for the purpose of communicating acceleration data to a remote processor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Gardner’s sensor to include an accelerometer, the concept of which is disclosed by Sabczynski et al., in order to track the orientation of the introducer tip and identify sudden movement or impact thereby providing spatial awareness that enhances control, safety, and diagnostic capability beyond visualization alone.
Claim(s) 48, 49 and 56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (U.S. 2018/0142833 A1) in view of Stewart et al. (U.S. 9,498,112 B1) and King et al. (U.S. 10,674,968 B2).
Gardner discloses the invention substantially as described above. However, Gardner does not explicitly disclose that one or more steering inputs are displayed on a touch screen, or that interactions with the steering inputs cause the steering control signals to be generated.
Stewart et al. teach a steering input for steering an introducer, displayed on a display screen
(see col. 2, lines 31-57 and col. 3, lines 9-36) which also displays an image of the patient captured by a
camera of the introducer in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date
of the claimed invention to modify Gardner’s introducer by incorporating steering capabilities to the
introducer and also including a steering input on the display screen for steering the introducer, the
concept of which is taught by Stewart et al., in order to enhance the viewing capabilities of the device by
displaying the images on one screen that the surgeon has in front of them during the surgical procedure
while also permitting steering of the device on that screen. The incorporation of steering capabilities would prevent puncture or damage to surrounding tissue, and the ability to control the steering on the display would allow the surgeon to focus on a single screen.
King et al. disclose the incorporation of a touch screen into a body image system in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Gardner’s system to include a touch screen, the concept of which is disclosed by King et al., in order to provide quick access to functions without reaching for physical controls, provide faster adjustments during procedures, to permit single-hand operation for functions, and permit pinch-to-zoom on live or captured images. The benefits and use of touch screens are widely known and accepted.
Claim(s) 50, 51 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (U.S. 2018/0142833 A1).
Gardner discloses the invention substantially as described above. However, Gardner does not explicitly disclose that the motor is positioned within the introducer or within the body.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to position the motor within the body in order to keep weight and bulk outside the patient, ease of maintenance or motor replacement, reduced biocompatibility concerns, sterilization ease, more space, and electrical connection ease. However, it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Accordingly, placement within the introducer would be obvious to one or ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773