DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 05/14/2026. As indicated by the amendment: claims 1, 8, 10-11, 13, 16 and 18 have been amended and claims 4 and 9 have been cancelled. In response to the amendments of claims 8, 13 and 18, their rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn. Claims 1-3, 5-8 and 10-20 are presently pending in the application.
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 inertial sensor 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “44”. 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. 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 1-3, 5-7 and 16-20 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.
Amended independent claim 1 recites, in pertinent part, “the reflective element is cylindrically or conically shaped” and “wherein a shape of the reflective element is different in the collapsed position than in the extended position”. It is not clear in what position the reflective element is cylindrically or conically shaped, or if it is cylindrically or conically shaped in both the collapsed position and in the extended position. Accordingly, claim 1, and claims 2-3 and 5-7 depending therefrom, are rendered indefinite. Appropriate correction is required.
Claims 16-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the structural connection between the imaging device and the reflective element. Independent claim 16 recites, in pertinent part, “the reflective element surrounding a least a portion of an optical axis of the imaging device”. No other structural relationship between the reflective element and the imaging device is claimed. Is the reflective element connected to the imaging device? Is it a component of the imaging device? Is the reflective element separate from the imaging device? How does the reflective element extend and collapse while surrounding a portion of the optical axis of the imaging device? The claim language does not recite essential structural connections between the imaging device and the reflective element to ascertain the structural relationship, rendering the claim indefinite. Accordingly, claim 16, and claims 17-20 depending therefrom, a rendered indefinite. Appropriate correction is required.
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 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Themelis (US 2019/0278069 A1) in view of Kuthirummal et al. (US 2006/0050386 A1) in view of Hadani (US 2010/0010302 A1).
Regarding claim 1, Themelis discloses an imaging device (Fig. 1) for obtaining an image of an interior portion of a patient, the imaging device comprising: a body (10/22; Figs. 1-2; par. [0047] and [0050]) having a proximal end and a distal end configured to be inserted into the patient (Fig. 1); an optical system (8/16/12; Fig. 1; par. [0047]) including an image sensor (8; par. [0047]) and an optical lens (12; par. [0047]) configured to capture images along an optical axis (18; Fig. 1; par. [0052]) defined by a longitudinal axis of the body (22; Fig. 1); and a reflective element (20; Figs. 1-2; par.[0008] and [0050]-[0052]) surrounding at least a portion of the optical axis (18; Figs. 1-2; par. [0052]), and wherein the optical lens (12) is interposed between the image sensor (8) and the reflective element (20; Fig. 1) and configured to transmit light from the reflective element onto the image sensor (par. [0050]-[0051]).
Although Themelis discloses that the reflective element can have a variety of shapes such as convex, (hemi-) spherical, parabolic, hyperbolic, ellipsoid, or any other shape which allows the interior of the surgical cavity be surveyed (par. [0052] and [0063]), it does not specifically disclose wherein the reflective element is cylindrically or conically shaped. Kuthirummal teaches an analogous device (par. [0052] and [0130]-[0131]) wherein the reflective element (Figs. 1 and 9; par. [0052], [0080] and [0130]-[0131]) is cylindrically (par. [0052] and [0130]-[0131]) or conically shaped (par. [0080] and [0130]-[0131]). It would have been obvious to one having ordinary skill in the art to use a cylindrically or conically shaped reflective element, as taught by Kuthirummal, in the device of Themelis in order to view the interior of the surgical cavity, as Themelis teaches that the reflective element can be any shape that allows the interior of the surgical cavity be surveyed.
However, Themelis does not specifically disclose wherein the reflective element is configured to be moveable between a collapsed position and an extended position, wherein a shape of the reflective element is different in the collapsed position than in the extended position. Hadani teaches an analogous reflective element (260; Fig. 5A; par. [0081] and [0083]) that is configured to be moveable between a collapsed position and an extended position (par. [0081]), wherein a shape of the reflective element is different in the collapsed position than in the extended position (par. [0044] and [0081]). Hadani teaches collapsing the reflector to allow smooth movement of the body of the imaging device to a target location in the body (par. [0079]) and expanding the reflector when at the target location in the body (par. [0079]). It would have been obvious to one having ordinary skill in the art to make the reflective element of Themelis collapsible in order to allow smooth movement of the body of the imaging device to a target location in the body, as taught by Hadani.
Regarding claim 2, Themelis in view of Kuthirummal in view of Hadani disclose the imaging device of claim 1, wherein the reflective element (20) is attached to the distal end of the body (22; Figs. 1-2).
Regarding claim 3, Themelis in view of Kuthirummal in view of Hadani disclose the imaging device of claim 1, but does not specifically disclose wherein the reflective element is spaced apart from the distal end. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to space the reflective element apart from the distal end because Applicant has not disclosed that spacing the reflective element apart from the distal end provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant discloses a variety of configurations of the reflective element with respect to the distal end. One of ordinary skill in the art, furthermore, would have expected modified Themelis’s imaging device, and applicant’s invention, to perform equally well with either the reflective element configuration taught by modified Themelis or the claimed spacing between the reflective element and distal end because both attachment configurations would perform the same function of providing catadioptric imaging. Therefore, it would have been prima facie obvious to modify Themelis to obtain the invention as specified in claim 3 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Themelis.
Regarding claim 5, Themelis in view of Kuthirummal in view of Hadani disclose the imaging device of claim 1, but does not specifically disclose wherein the reflective element is at least partially disposed within the distal end. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to at least partially dispose the reflective element within the distal end because Applicant has not disclosed that at least partially disposing the reflective element within the distal end provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant discloses a variety of configurations of the reflective element with respect to the distal end. One of ordinary skill in the art, furthermore, would have expected modified Themelis’s imaging device, and applicant’s invention, to perform equally well with either the reflective element configuration taught by modified Themelis or the claimed at least partial disposal of the the reflective element within the distal end because both attachment configurations would perform the same function of providing catadioptric imaging. Therefore, it would have been prima facie obvious to modify Themelis to obtain the invention as specified in claim 5 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Themelis.
Regarding claim 6, Themelis in view of Kuthirummal in view of Hadani disclose the imaging device of claim 1, wherein the reflective element is a cylindrical mirror (Kuthirummal: par. [0052] and [0130]-[0131]).
Regarding claim 7, Themelis in view of Kuthirummal in view of Hadani disclose the imaging device of claim 1, wherein the reflective element is a conical mirror (Kuthirummal: par. [0080] and [0130]-[0131]).
Claim(s) 8 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuthirummal et al (US 2006/0050386 A1) in view of Kumada et al. (JP 3791899 B2) in view of Draxinger et al. (US 2007/0060792 A1).
Regarding claim 8, Kuthirummal discloses imaging system for obtaining images of an interior portion of a patient, the imaging system comprising: an imaging device (12; Fig. 22; par. [0130]-[0131]); an optical system (Figs. 22-23; par. [0130]-[0131]) including an image sensor (par. [0131] – camera) and an optical lens (12b; Fig. 23; par. [0131]) configured to capture images along an optical axis defined by a longitudinal axis (Fig. 1; z-axis); and a reflective element (12c; Fig. 22-23; par. [0131]) configured to surround the optical axis (Fig. 1), the reflective element (12c) being one of a cylindrical or conical shape (par. [0130]) so as to generate a plurality of images from a plurality of perspectives, the plurality of images captured by the image sensor (par. [0131] – camera); an image processor (13; par. [0129]; Fig. 22) configured to select at least one image among the image processor being further configured to generate a three-dimensional image corresponding to a pair of images, the pair of images being selected from among: (1) a central image (Fig. 8 – central view; par. [0076]-[0078]) and one image from the at least one image from among the plurality of images (Fig. 8 – right virtual view or left virtual view; par. [0076]-[0078]), or (2) two images from the at least one image with the at least one image including at least two images selected from among the plurality of images
Kuthirummal discloses that the camera can include a film-based camera, a digital camera, a video camera using a magnetic recording medium, a video camera using a digital recording medium, and variants thereof (par. [0131]), but does not specifically disclose the imaging device including: a body extending along a longitudinal axis, the body having a proximal end and a distal end configured to be inserted into the interior portion of the patient. Kumada is cited as one of several references that teach endoscopes comprising analogous optical systems and reflective elements disposed within its body (see Figs. 1-11). It would have been obvious to one having ordinary skill in the art to include the optical system and reflective element of Kuthirummal in a body of an endoscope for imaging the interior portion of a patient, as taught by Kumada.
Kuthirummal does not specifically disclose the imaging device comprising an inertial sensor configured to sense an angle of operation of the imaging device, the angle of operation defined by an angle of the longitudinal axis of the body with respect to the patient and the image processor configured to generate a three-dimensional image corresponding to the angle of operation. Draxinger teaches an analogous imaging device (Fig. 1) comprising an inertial sensor (32; par. [0059]-[0060]) configured to sense an angle of operation of the imaging device (par. [0059]-[0060]), the angle of operation defined by an angle of the longitudinal axis of the body with respect to the patient (par. [0060]). Draxinger teaches that the inertial sensor (32) and the position acquisition system (30) allows the position and orientation of the imaging device to be determined when images are captured (par.[0059]-[0060]). It would have been obvious to one having ordinary skill in the art to include an inertial sensor in the imaging device of modified Kuthirummal that senses the position and orientation of the imaging device, as taught by Draxinger, in order to ensure that the constructed three-dimensional images of the target site disclosed by Kuthirummal uses images that were captured at the same position and orientation of the imaging device, thereby ensuring proper three-dimensional viewing of the target site as the imaging device is moved in the bodily orifice.
Regarding claim 10, Kuthirummal in view of Kumada in view of Draxinger disclose the imaging system of claim 8, wherein the image processor is configured to set the angle of operation to select the at least one image according to a desired angle of operation of the imaging device, wherein the desired angle of operation is received by the image processor as an input (Draxinger: par. [0071]-[0073] – the position and orientation of the imaging device).
Regarding claim 11, Kuthirummal in view of Kumada in view of Draxinger disclose the imaging system of claim 8, further including an input for setting a desired perspective wherein the image processor is configured to at least one image using the desired perspective and the angle of operation (Draxinger: desired perspective from point 42; par. [0062] and [0069]).
Regarding claim 12, Kuthirummal in view of Kumada in view of Draxinger disclose the imaging system of claim 8, wherein the image processor is configured to process a difference in images between at least a pair of successive image frames to determine the pair of images corresponding to the angle of operation (Draxinger: par. [0071]-[0073]).
Regarding claim 13, Kuthirummal in view of Kumada in view of Draxinger disclose the imaging system of claim 8, wherein the image processor is configured to automatically perform stereoscopic image rotation using a desired horizon provided via a user input and then determining the pair of images that correspond to the desired horizon (Draxinger: image with the same orientation of the endoscope with respect to point 42; par. [0070]-[0073]).
Regarding claim 14, Kuthirummal in view of Kumada in view of Draxinger disclose the imaging system of claim 8, wherein the image processor is configured to extract dimensions of an object using triangulation (par. [0077]-[0078]; Draxinger: par. [0062]-[0063]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuthirummal in view of Kumada in view of Draxinger as applied to claim 8 above, and further in view of Kono et al. (US 2018/0114319).
Regarding claim 15, Kuthirummal in view of Kumada in view of Draxinger disclose the imaging system of claim 8, but does not specifically disclose wherein the image processor is further configured to detect an illumination in plurality of images and select the pair of images that do not have a specular reflection and correspond to the angle of operation. Kono teaches an analogous device and that it is known in the art to delete low-quality images containing blurring, specular reflection, and the likes in which these images are unnecessary for diagnosis, and therefore to improve image quality (par. [0004]). It would have been obvious to one having ordinary skill in the art to delete images containing specular reflection, such that they are not selected for image processing, in order to improve image quality.
Allowable Subject Matter
Claim 16 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The prior art of record does not specifically disclose or otherwise render obvious the method, as recited in claim 16, comprising, inter alia, the step of processing the orientation of the imaging device and selecting a left image and a right image from the plurality of images, wherein one of the left image and the right image corresponds to a central image and the other of the left image and the right image is one of the plurality of images corresponding to the orientation of the imaging device, in combination with the other steps of the method claim.
Response to Arguments
Applicant’s arguments, see claim amendments and remarks, filed 05/14/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hadani, as discussed above.
Regarding claim 8, Applicant's arguments filed 05/14/2026 have been fully considered but they are not persuasive. As discussed above, Draxinger teaches that the inertial sensor (32) and the position acquisition system (30) allow the position and orientation of the imaging device to be determined when images are captured (par.[0059]-[0060]). It would have been obvious to one having ordinary skill in the art to include an inertial sensor in the imaging device of modified Kuthirummal that senses the position and orientation of the imaging device when images are captured, as taught by Draxinger, in order to ensure that the constructed three-dimensional images of the target site disclosed by Kuthirummal uses images that were captured at the same position and orientation of the imaging device, thereby ensuring proper three-dimensional viewing of the target site as the imaging device is moved in the bodily orifice. Accordingly, the rejection is maintained.
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 RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/28/26
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