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 .
Response to Amendment
The cancellation of claims 6-7 and the amendments to claims 1-3, 8 and 10 in the response filed on 6 July, 2026 are acknowledged.
Claims 1-5 and 8-20 remain pending in the application.
Claims 14-20 are withdrawn.
Claims 6-7 are cancelled.
Claims 1-5 and 8-13 are examined.
Response to Arguments
Rejection under 35 USC 102 - Ludwig et al. Endoscopic Stone Measurement During Uretroscopy, Journal of Endourology, Vol.32, no.1, January, 2018, pp.34-39 (henceforth “Ludwig”).
Argument:
In regards to the amended claim 1, the applicant argues that Ludwig does not disclose a procedure where intraoperative image data is analyzed and displayed during a uretroscopic procedure [in the applicant's arguments dated 6 July, 2026, page 9 lines 21-28].
Response:
The examiner respectfully disagrees.
Ludwig suggests applying these steps during a uretroscopic proedure. See the abstract and introduction, and page 39, col. 1, lines 8-13.
As such, this argument is found to be unconvincing.
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.
The applicant's amendments to claims 1-3, 7-8 and 10 to overcome the 35 USC § 112 rejections of the previous action are acknowledged, and the rejections are withdrawn.
Claims 1-5 and 8-13 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 pre-AIA the applicant regards as the invention.
In regards to claim 1, the claim reads “an endoscopic probe” [line 3]. It is unclear if this is the “an endoscopic probe” of line 2 of claim 1. Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed that these are the same.
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.
Claims 1-6, 8 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Ludwig et al. Endoscopic Stone Measurement During Uretroscopy, Journal of Endourology, Vol.32, no.1, January, 2018, pp.34-39 (henceforth “Ludwig”).
In regards to Claim 1, Ludwig discloses a method of endoscopic imaging [abstract], comprising:
receiving calibration data [page 34, col.2 to page 35, col.2, sections “Geometric Model” and “Calibration”], for an endoscopic probe, the calibration data generated from imaging data taken from an endoscopic probe [section “Calibration”, also as this is not a positively claimed step, but one possible way for the calibration data to be generated] and comprising a plurality of camera parameters and a plurality of distortion parameters [page 35 col.1-2 sections “Geometric Model”, “Calibration” and “Measurement”: plural calibration coefficients could be labeled distortion parameters and camera parameters, further as the applicant has not set forth a strict definition for “camera parameters” and “distortion parameters”. If the applicant seeks to concretely claim multiple calibration paraments, name and define them. Otherwise, the applicant should delete this limitation.];
receiving, from the endoscopic probe while it is deployed within a patient during a ureteroscopic procedure [page 39, col.1, third paragraph: the suggestion is provided that this procedure be done during the operation. Also see the abstract and introduction (page 34), which clearly indicates that this is the only real goal of the procedure. Further note that receiving and analyzing data during an endoscopic procedure is routine in the art.], intraoperative imaging data that includes at least one image of a renal calculus [page 35 col.2 section “Measurement”, page 35 col.2- page 36 col.1, section “Study”; page 36 col.2 “discussion”, first paragraph.];
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applying the calibration data to the intraoperative imaging data to determine a size of the renal calculus [section “Measurement”] while the endoscopic probe remains deployed [page 39, col.1, lines 8-13: indication is provided that this procedure be done during the operation. Also see the abstract and introduction (page 34), which clearly indicates that this is the only real goal of the procedure. Further note that receiving and analyzing data during an endoscopic procedure is routine in the art.]; and
displaying the determined size [Figs.1b, 1d: also see Figs.1b, d provided hereinabove for illustrative purposes] to an operator during the uretroscopic procedure [page 39, col.1, third paragraph: the suggestion is provided that this procedure be done during the operation. Also see the abstract and introduction (page 34), which clearly indicates that providing this information to a practitioner during a uretroscopic procedure is the only real goal of the method. Further note that receiving image data, analyzing image data and presenting synthesized image data during an endoscopic procedure is routine in the art. Further note that providing relevant information to a medical practitioner is fundamental to the art.].
In regards to claim 2, Ludwig discloses the method of claim 1, wherein displaying the determined size comprises displaying the intraoperative imaging data with the determined size visually associated with the at least one image of the renal calculus [Figs.1b, 1d; note in particular the caption discussing parts of the image, also see Figs.1b and 1d provided hereinabove for illustrative purposes.]
In regards to claim 3, Ludwig discloses the method of claim 1, wherein displaying the determined size comprises displaying the image of the renal calculus labeled with the determined size [Figs.1b, d, also see Figs.1b, d provided hereinabove for illustrative purposes.].
In regards to claim 4, Ludwig discloses the method of claim 3, further comprising:
Displaying a shape overlaid on the image of the renal calculus, wherein the determined size is visually associated with the overlaid shape [the bar over the calculus next to the numerical size, Figs.1a, 1d].
In regards to claim 5, Ludwig discloses the method of claim 1, wherein the calibration data is generated from at least three images taken of one or more predetermined objects of known dimensions by the endoscopic probe [supplementary Fig.S2, also note generation of the calibration data is not a positively claimed method step].
In regards to claim 6, Ludwig discloses the method of claim 1, wherein the calibration data comprises a plurality of camera parameters and a plurality of distortion parameters [“Calibration”, page 39, col.1. As set forth here, this is mathematically indistinguishable from having an arbitrary number of parameters set forth which pertain to the camera and distortion. If the applicant seeks to concretely claim multiple calibration parameters, name and define them. This claim should otherwise be cancelled.].
In regards to claim 8, Ludwig discloses the method of claim 1,
wherein the intraoperative imaging data further includes at least one image of a surgical device component having one or more known dimensions [basket, Figs.1b, d, page 38 col.1], and
wherein determining the size of the renal calculus comprises determining a distance from the camera of the deployed endoscopic probe to the renal calculus based on the image and one or more known dimensions of the surgical device component [page 38, col.1-2: supplementatry Figs.S1-S2].
In regards to claim 10, Ludwig discloses the method of claim 1, wherein the steps of applying the calibration data to the intraoperative imaging data to determine a size of the renal calculus and displaying the determined size occur while the endoscopic probe is deployed [page 36, col.2 “discussion”, first paragraph- the measurement method is for use during flexible uteroscopy. And as “deployed” is an unusually broad term as set forth in this claim, this could be any time whatsoever].
In regards to claim 11, Ludwig discloses the method of claim 1, further comprising:
while the endoscopic probe is still deployed, receiving additional imaging data including at least one image of the renal calculus [this is repetition of the procedure- see below];
based on the additional imaging data, determining an updated size for the renal calculus [this is repetition of the procedure- see below]; and
displaying the updated size [page 38 col.2, “extraction would commence once all fragments were small enough to be effectively removed”, indicating repetition of the procedure during the same deployment. Also note “deployed” as set forth here is unusually broad and could refer to any time whatsoever.].
In regards to claim 12, Ludwig discloses the method of claim 1, wherein displaying the determined size further comprises:
comparing the determined size to at least one threshold value [Figs.1b, d: the numerical size displayed depends on the determined size, which is logically indistinguishable from comparison of the determined size with a threshold value];
selecting one or more display parameters based on the comparison of the determined size to the at least one threshold value [the number placed on the display]; and
displaying the determined size with the selected one or more display parameters [Figs.1b, 1d].
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ludwig et al. Endoscopic Stone Measurement During Uretroscopy, Journal of Endourology, Vol.32, no.1, January, 2018, pp.34-39 (henceforth “Ludwig”) in view of Ward (US 2006/0116692).
In regards to claim 9, Ludwig discloses the method of claim 8, wherein the surgical device component is a laser [page 38 col.1], however does not positively disclose wherein the surgical device component is a laser fiber.
Ludwig further discloses wherein the surgical device could be any ureteroscopic instrument [page 38 col.1].
Ward discloses that a laser fiber is a ureteroscopic instrument [para.4, 7, 64].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the method taught by Ludwig such that the surgical device is a laser fiber. This would be done as Ludwig indicates the surgical device may be any ureteroscopic instrument.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ludwig et al. Endoscopic Stone Measurement During Uretroscopy, Journal of Endourology, Vol.32, no.1, January, 2018, pp.34-39 (henceforth “Ludwig”) in view of Miyayashiki et al. (US 2012/0078043)
In regards to claim 13, Ludwig discloses the method of claim 12, however does not positively disclose wherein the selected one or more display parameters comprises a color selected from a plurality of colors each associated with a range of size values,
Ludwig further discloses wherein the selected one or more display parameters comprises a number selected from a plurality of numbers each associated with different ranges of size values to be indicated [Figs.1b, d].
Miyayashiki teaches a method of displaying endoscopic images [abstract, Figs.1-2, para.46-47] wherein display parameters include a color selected from a plurality of colors for different values of a variable to be indicated [Figs.1-2, para.45-47].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the selected one or more display parameters each associated with a range of size values taught by Ludwig such to comprise a color selected from a plurality of colors in accordance with the teaching of Miyayashiki. This would be done for the predictable result of readier communication with a user.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Carlson et al. (US 2008/0255505) discloses image processing to determine renal calculus size during a uretroscopic procedure.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action (ie. altered interpretation of the art). 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 AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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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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/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795
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