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 .
Claim Objections
Claim1 is objected to because of the following informalities: Claim 1, “the end of the insert” should read “the distal end of the insert”. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 07/23/2026 have been fully considered but they are not persuasive. Applicant argus that the off-center opening that forms the end of the insert is not an opening because Tingvatn states “a closed end 10” of the channel. The Office respectfully disagrees because ref. 10 is configured to hold another component, specifically a lens as disclosed in paragraph [0027], and therefore still an opening.
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) 1, 4, 5, 8 – 11, 13 , 16 and 18 - 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tingvatn (US 2020/0129047 A1).
Regarding claim 1, Tingvatn discloses a pelvic exam device comprising:
an insert (Fig. 6, refs. 2, 28), wherein the insert has a proximal end (located closest to the handle) and a distal end, and wherein the distal end of the insert has a dome shape (Fig. 6, see remarked Fig. 6 below);
a probe (refs. 24, 20, 22, 26, 21) that mounts to the insert (Fig. 5), wherein the probe includes a distal end that is positioned within the insert (Fig. 5); and
one or more cameras mounted to the distal end of the probe (paragraph [0032], ref. 24);
an opening in the dome shape that forms the end of the insert (ref. 10, Figs. 1 - 2), wherein the opening is off-center in the dome shape (ref. 10 is shown to be off-center, see Fig. 2).
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Regarding claim 4, Tingvatn discloses the device of claim 2, further comprising an instrument port formed in the insert, wherein the instrument port is sized to receive a tool to perform an operation or procedure (Figs. 1 – 2, ref. 6).
Regarding claim 5, Tingvatn discloses the device of claim 4, wherein the instrument port aligns with the opening such that the tool can access a patient into which the insert has been placed (Figs. 1 – 2).
Regarding claim 8, Tingvatn discloses the device of claim 1, further comprising one or more light sources mounted to the probe and configured to illuminate the insert (paragraph [0028], ref. 14).
Regarding claim 9, Tingvatn discloses the device of claim 1, further comprising one or more light sources mounted to the insert (paragraph [0028], ref. 14, Fig. 5).
Regarding claim 10, Tingvatn discloses the device of claim 9, wherein the one or more light sources include an edge light that illuminates a perimeter of the insert (Fig. 5 shows the light source located on an edge or perimeter of the insert).
Regarding claim 11, Tingvatn discloses the device of claim 1, further comprising a controller that controls a position of each of the one or more cameras within the insert (paragraphs [0013, 32] discloses a control unit).
Regarding claim 13, Tingvatn discloses a method of making a pelvic exam device (Abstract), the method comprising:
forming an insert that has a proximal end and a distal end, wherein the distal end of the insert is formed to have a dome shape (see remarked Fig. 6 below which shows the insert and therefor is formed);
forming a probe (refs. 24, 20, 22, 26, 21) that mounts to the insert, wherein the probe includes a distal end that is sized to fit within the insert (Fig. 5); and
mounting one or more cameras (ref. 24) mounted to the distal end of the probe (Fig. 5); and
forming an opening (ref. 10) in the dome shape that forms the distal end of the insert (Fig. 2), wherein the opening is formed off-center in the dome shape (Fig. 3).
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Regarding claim 16, Tingvatn discloses the method of claim 13, further comprising forming an instrument port (ref. 6) in the insert, wherein the instrument port is sized to receive a tool to perform an operation or procedure (Fig. 3).
Regarding claim 18, Tingvatn discloses the method of claim 13, further comprising mounting one or more light sources to the probe to illuminate the insert (paragraph [0028], ref. 14).
Regarding claim 19, Tingvatn discloses the method of claim 18, wherein the one or more light sources include an edge light that illuminates a perimeter of the insert (the light is shown to be mounted to a perimeter or edge wall of the insert).
Regarding claim 20, Tingvatn discloses the method of claim 13, further comprising mounting a controller to the probe that controls a position of each of the one or more cameras within the insert (paragraphs [0013, 32] discloses a control unit).
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) 6, 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tingvatn (US 2020/0129047 A1) in view of Levy et al. (US 2013/0172670 A1).
Regarding claim 6, Tingvatn discloses the device of claim 1, wherein the one or more cameras include a camera mounted to a tip of the distal end of the probe (ref. 24, Fig. 5) but is silent regarding a camera mounted to a side of the distal end of the probe.
Regarding claim 17, Tingvatn discloses the method of claim 13, wherein mounting the one or more cameras includes mounting a first camera to a tip of the distal end of the probe (ref. 24), but is silent regarding the step of mounting a second camera to a side of the distal end of the probe.
Levy teaches a removable tip endoscope and probe (Abstract) comprising a distal tip having one or more cameras (paragraph [0051], Fig. 3, ref. 304) and one or more cameras on a side end (paragraph [0056], Fig. 3, ref. 338). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the probe to include the one or more cameras on a side, as taught by Levy, for the purpose of broadening the field of the view of the probe (paragraph [0007]).
Regarding claim 7, Tingvatn discloses the device of claim 1, wherein the one or more cameras include a camera mounted to a tip of the distal end of the probe (ref. 24, Fig. 5), but is silent regarding six cameras mounted to sides of the distal end of the probe.
Levy teaches a removable tip endoscope and probe (Abstract) comprising a distal tip having one or more cameras (paragraph [0051], Fig. 3, ref. 304) and one or more cameras on a side end (paragraph [0056], Fig. 3, ref. 338). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the probe to include the one or more cameras on a side, as taught by Levy, for the purpose of broadening the field of the view of the probe (paragraph [0007]).
Tinvatn as modified by Levy discloses one or more side cameras and further states that there may be additional cameras (Levy, paragraph [0057]), but is silent regarding the number six. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the number of side cameras to be six, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tingvatn (US 2020/0129047 A1) in view of BAR-OR et al. (US 2020/0107714 A1).
Regarding claim 12, Tingvatn discloses the device of claim 11, except wherein the controller rotates the distal end of the probe to control the position of the one or more cameras.
BAR-OR teaches an analogous speculum device with a probe (Abstract), wherein the probe comprises a camera (paragraph [0059], ref. 1335) and controller (ref. 1320) to rotate the camera (paragraph [0059]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Tingvatn such that the controller may rotate the distal end of the probe and camera, for the purpose of rotating, tilting or panning the camera to gain better control of the field of view.
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/TESSA M MATTHEWS/Examiner, Art Unit 3773
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