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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/02/2026 has been entered.
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 wearable display device configured to depict the operating instructions, position and 3D anatomy structure 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 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 1-12 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. Claim 1 is rejected because it is unclear if the wearable display is part of the claimed device as it is inferentially set forth within the processor limitations. Accordingly all limitations directed to the wearable display device are indefinite as attempting to further define an unclaimed element. Claim 11 inherits Claim 1’s rejections. Claim 3 is rejected because it is unclear if “a display” is the wearable display now recited in Claim 1. Claim 4 inherits Claim 3’s rejection.
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.
Claim(s) 1-3, 5-13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0235716 to Hane et al. “Hane” in view of U.S. Publication No. 2017/0258295 to Kronman et al. “Kronman” and U.S. Publication No. 2021/0228282 to DiMaio et al. “DiMaio”.
As for Claims 1-2, 11, 13 and 15, Hane discloses a device for in-body navigation operations of a flexible endoscope, catheter or the like that is inserted into a lumen (Abstract; Paragraphs [0002], [0040] and [0200]-[0204]) including a storage (6 in Fig. 1 and corresponding descriptions) configured to store position data indicative of the current position of the tool tip inserted into the anatomy (Paragraphs [0006], [0056] and [0069]) and anatomical data including 3D images (Paragraphs [0061], [0065] and [0072]) and processor configured to determine the current location of the tool tip based on the current sensor information and a movement specification (e.g. instruction) to align the tip with a target location (Paragraphs [0056] and [0202]; Figs. 19-20 and corresponding descriptions). In one embodiment, Hane discloses wherein the system includes a handle with controls (Paragraph [0045]) and can include a head mounted display (e.g. wearable display; Paragraph [0171]) but Hane does not expressly disclose wherein the head mounted display overlays the operational instructions on a view of a control handle as now claimed.
Kronman teaches from within a similar field of endeavor with respect to displaying operating instructions for an intra-body device (Abstract) wherein the display instructions include a view of a control handle and indicators as to which way to manipulate the knobs/buttons to achieve the desired adjustment (Figs. 6A-B and corresponding descriptions).
However, such information is not displayed as augmented reality.
DiMaio teaches from within a similar field of endeavor with respect to display of operation adjustments in a medical procedure (Abstract) where a head mounted display (Fig. 3 and corresponding descriptions) may present instructions on how to adjust surgical components as “imagery overlaid in an environment” (e.g. augmented reality) (Figs. 1B, 7B and corresponding descriptions).
Accordingly, one skilled in the art would have been motivated to have modified Hane’s display instructions for the in-body instrument to reach a target location as imagery overlaid onto an environment such that control knob adjustments may be displayed on a view of the control handle as described by Kronman and DiMaio in order enhance the display of operational feedback and improve the accuracy of device adjustments. Such a modification also involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for Claim 3, the modified device would display the anatomy, current position of the tip in context with the anatomy and the operation instructions so that a user understands how to manipulate the device to reach the target location.
Regarding Claims 5-6, Hane explains wherein handle controls/knobs control bending and other movements (Paragraphs [0052]-[0053]). Kronman also depicts wherein controls adjust the movement (e.g. distal/proximal movement) of the device (Figs. 6A-B). Examiner notes the operation feedback displayed as augmented reality forms (e.g. arrows, directional cues, etc.) in the modified device as described above includes instructions for the user to manipulate controls on the device’s handle and would relate to movement of the tip, bending of the top and a movement vector of the tip in its broadest reasonable interpretation.
As for Claims 7-8, Examiner notes the handle controls are interfaced with the processing means (Hane; Fig. 2 and corresponding descriptions) so that any movements imparted via the controls and buttons are captured by the modified system and method in its broadest reasonable interpretation.
With respect to Claim 9, Examiner notes the operating instructions displayed over a view of the control handle are considered to be decoupled from other display interfaces which depict in-body navigation information.
Regarding Claim 12, Hane discloses wherein the device may include a shape sensor including a light source to emit detection light through an optical fiber and detects the detection light influenced by the detection portion so that the shape of the insertion unit is detected (Paragraph [0054]). Examiner notes the light source would be a laser light source as evidenced by U.S. Publication No. 2019/0250050 to Sanborn et al. which teaches an optical shape sensing system for use with a catheter including a tunable laser and shape sensing optical fiber (Paragraph [0020] and [0034]).
Claim(s) 4 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hane, Kronman and DiMaio as applied to claim 1 above, and further in view of U.S. Publication No. 2020/0078103 to Duindam et al. “Duindam”.
With respect to Claim 4, Hane, Kronman and DiMaio disclose a system and method to provide in-body navigation operation as described above. Hane depicts scope images (Fig. 22) (e.g. image acquisition device attached to tool tip region) in its broadest reasonable interpretation. However, it is not clear if the tool’s path is displayed on the endoscopic images.
Duindam teaches from within a similar field of endeavor with respect to displaying guidance information using a graphical user interface (Abstract) wherein anatomical images may be captured in real time with an endoscope (e.g. image acquisition device on at tool tip) (Paragraph [0035]) and wherein the tool path may be displayed on the endoscope image (Figs. 5 and 12 and corresponding descriptions).
Accordingly, one skilled in the art would have been motivated to have modified the endoscopic display described by Hane, Kronman and DiMaio to show data indicative of the tool tip’s position in the endoscopic images along a desired path as described by Duindam in order to enhance the accuracy of in-body navigation. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Alternatively regarding Claim 9, Examiner notes the operating instructions displayed over a view of the control handle are considered to be decoupled from other display interfaces which depict in-body navigation information.
Regarding Claim 10, Duindam’s Fig. 12 depicts various windows of different views of anatomy showing the tool tip in different views in its broadest reasonable interpretation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-13 and 15 have been considered but not persuasive. Regarding the drawing objections, Examiner maintains the drawings fail to depict the wearable display device configured to depict the operating instructions, position and 3D anatomy structure as claimed. Applicant argues Fig. 1 depicts a display 30 and its internal structure is not necessary for understanding the claimed invention (REMARKS, Pages 7-8). Examiner respectfully notes the internal structure of the display is not claimed and is not the basis of the objection. No figure depicts a wearable display that displays all of a current position, the anatomy structure and instructions as claimed. As for the 35 U.S.C. 112 rejections, Applicant argues the claims are reasonably clear in light of the specification (REMARKS, Pages 8-9). Examiner respectfully disagrees. Claim 1 is rejected because it is unclear if the wearable display is part of the claimed device because it is inferentially set forth within the processor limitations. Thus, all limitations directed to the display are indefinite for attempting to further define an unclaimed element. The issue is further compounded by Claim 3's limitation of the device further comprising a display". If Claim 1 includes the wearable display as a display, it is unclear if the display in Claim 3 is the same one or a different display. As for the prior art rejections, Applicant argues Hane does not provide the operating instructions as augmented reality to the user by overlaying the operation instructions on a view of the control handle via a wearable display device of the user ( REMARKS, Page 9), Kronman's display is not augmented reality displayed to a user via a wearable display device (REMARKS, Page 10) and DiMaio is directed to a wearable guidance system but fails to disclose displaying operating instructions as augmented reality on a view of a control handle via a wearable device" (REMARKS, Page 11). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner notes the combination of references teaches all the claimed limitations and the rejection above articulates why one skilled in the art would have been motivated to have combined the teachings. Thus, the rejections are maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Publication No. 2019/0371012 to Flexman et al. which discloses a hybrid operating room and catheter laboratory including an augmented reality system for providing contextual overlays that provide instructions for how to manipulate controls (Figs. 3 and corresponding descriptions).
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All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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