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 .
Notice of Amendment
The Amendment filed 6/17/2026 has been entered. Claims 13-22 are pending in the application with claim 13 amended, claims 1-12 cancelled.
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.
Claims 13-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US Patent No. 4,254,762) in view of Henley et al. (US Patent Application Publication No. 2014/0288369, hereinafter Henley).
In regard to claim 13, Yoon discloses a tissue visualization device (Fig. 7), comprising:
an elongated body (40) extending along a longitudinal axis between a proximal end and a beveled tip (42) with a bevel angle between the longitudinal axis and a distalmost face of the elongate body (the bevel angle is 45°, Col 5, Lines 28-31), the beveled tip configured to pierce tissue (Col. 5, Lines 28-31); and
a visualization element (10) extending through the elongated body (Fig. 7).
wherein the elongated body and the visualization element are configured to slide longitudinally relative to each other to allow the visualization element to extend past the elongate body (Col. 5, Line 56 – Col. 6, Line 5), and are integrally connected such that the visualization element and the elongated body comprise a single integrated unit (Fig. 7),
wherein the visualization device is configured to provide a view along a viewing axis angled at a viewing angle from the longitudinal axis (the viewing axis is 35° from the longitudinal axis).
Yoon does not expressly teach the visualization element comprising a visualization sensor positioned at a distal end of the visualization element, wherein the bevel angle is equal to the viewing angle.
Henley teaches an analogous endoscope having a distal tip (136) including an image sensor (140), distal lens holder (148), prism (145) and outer window (151). The prism is used to change the direction of light received by the image sensor (Par. 31) and can have an exit angle matching the outer window, wherein the viewing angle can be any denomination of 5° between 0° and 90° (Par. 34).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the distal tip of Yoon to have an image sensor and prism in which the viewing angle can be 45° as taught by Henley as a matter of design choice since Henley teaches the viewing angle can be any denomination of 5° between 0° and 90° that can be useful for an endoscope procedure (Par. 34).
In regard to claim 14, Yoon teaches wherein the elongated body comprises a lumen configured to deliver a fluid to the distal end of the elongated body (via fluid port (49), Fig. 1).
In regard to claim 15, Yoon teaches wherein the lumen is further configured to aspirate fluid (via fluid port (49), Fig. 1).
In regard to claim 16, Yoon teaches further comprising a handpiece (24, 26), wherein the elongated body, the visualization element, and the handpiece are connectable to form a single unit (Fig. 1 illustrates elongated body, visualization element and handpiece are connectable to form a single unit via locking collar (26)).
In regard to claim 19, Yoon and Henley teaches wherein the bevel angle and viewing angle are no more than 45 degrees from the longitudinal axis (Yoon and Henley teach the bevel / viewing angle being 45°).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US Patent No. 4,254,762) in view of Henley et al. (US Patent Application Publication No. 2014/0288369, hereinafter Henley), as applied to claim 13, and further in view of Sanders et al. (US Patent Application Publication No. 2008/0108869, hereinafter Sanders).
In regard to claims 17 and 18, Yoon and Henley are silent with respect to further comprising a rotational sensor, the rotational sensor configured to determine a rotational orientation of the visualization sensor, wherein the rotational sensor communicates with a monitor to rotate an image such that a patient reference direction will always appear on a top of the image.
Sanders teaches of an optical surgical instrument (10) comprising a camera head (42) disposed in a distal end of the shaft (12) and a handle (22) attached to a proximal end of the shaft. The handle comprises an accelerometer (715) disposed therein for sensing rotation of the shaft to correct an image for display on a display device such that the image always appears right-side up (Par. 274).
It would’ve been obvious to one of ordinary skill in the art at the time of the invention to modify the handpiece of Yoon and Henley with the accelerometer (715) of Sanders ensuring an image is always displayed right-side up with respect to gravity during rotation of the image sensor (Par. 274).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US Patent No. 4,254,762) in view of Henley et al. (US Patent Application Publication No. 2014/0288369, hereinafter Henley), as applied to claim 13, and further in view of Steube (US Patent Application Publication No. 2009/0041924).
In regard to claim 20, Henley teaches the viewing angle can be any denomination in increments of 5 between 0° to 90° but Yoon and Henley fail to teach wherein the bevel angle and viewing angle are no more than about 10 degrees from the longitudinal axis, wherein the bevel angle and viewing angle are about 35 degrees from the longitudinal axis, wherein the bevel angle and viewing angle are between about 25 degrees and about 30 degrees from the longitudinal axis.
Steube teaches an analogous needle for penetrating tissue in which the tip of the needle can have a beveled tip (22) which can have a plurality of bevel surfaces having different bevel angles. A first surface (24) can have a bevel angle of 8-18 degrees, a second surfaces (28a, 28b) can have a bevel angle of 16-26 degrees and the sharpest bevel can have a bevel angle of 25 to 35 degrees (Par. 36-38).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the beveled tip of Henley with the beveled tip of Steube thereby providing a plurality of surface having a plurality of bevel angles for optimizing the needle for use in a plurality of applications (Par. 36-38).
Therefore, since Steube teaches a plurality of different bevel angles that can be anywhere from 8° to 35° on the cutting edge and Henley teaches the viewing angle of the endoscope can be 5°, 10°, 15°, 20°, 25°, 30°, 35°, the bevel angle and viewing angle are able to be the same angle.
Response to Arguments
Applicant’s arguments with respect to claims 13-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 August 6, 2026
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