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 .
Status of Claims
In the Non-Final Rejection mailed 05/20/2025, Examiner indicated claims 7 and 8 as allowable subject matter. In the response filed 11/20/2025, Applicant amended independent claim 1 and added new independent claim 29 to incorporate the subject matter that was indicated as allowable. After further search, Examiner has found prior art that reads on previously presented claims 7 and 8 (currently pending claims 1, 7, and 29). The previous indication of allowable subject matter is withdrawn and a second Non-Final Rejection is provided herein.
It is noted Examiner contacted Matthew Shaheen on 01/16/2026 to discuss the application and advance compact prosecution, however Examiner did not received a response.
Applicant’s amendments filed 11/20/2025 have been entered. Claims 1-7 and 9-30 are pending and currently under consideration for patentability under 37 CFR 1.104
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.
Claim(s) 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ringel et al.
With respect to claim 28, Ringel et al. teaches an endcap configured to be fitted on a distal end of an endoscope having a forward-looking camera and a forward-facing working port, the endcap comprising:
a body configured to fit onto the distal end of the endoscope, the body comprising a side opening providing access from an interior of the endcap to a lateral workspace exterior of the endcap, the workspace being lateral to both the endcap and the distal end of the endoscope;
a mirror supported in the interior of the endcap, the mirror comprising a reflective mirror surface in the field-of-view (FOV) of the forward-facing camera, the mirror surface being configured to place the lateral workspace within the FOV of the forward facing camera (see Figs, Methods).
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(s) 1-3 and 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ringel et al. in view of Gaonkar et al. (U.S. 2015/0274077).
With respect to claim 1, Ringel et al. teaches a system comprising an endcap configured to be fitted on a distal end of an endoscope having a forward-looking camera and a forward-facing working port, the endcap comprising a body configured to fit onto the distal end of the endoscope and a mirror supported by the body and comprising a reflective surface, the reflective surface being configured so that the forward-looking camera visualizes a workspace that is lateral of both the endcap and the distal end of the endoscope (see Figs).
However, Ringel et al. does not teach the reflective surface comprises a flattened central portion and convex spherical or aspherical edge portion configured to increase the field of view.
With respect to claim 1, Gaonkar et al. teaches a mirror comprising a reflective surface, wherein the reflective surface comprises a flattened central portion (18) and convex spherical or aspherical edge portion (FIG. 2) configured to increase the field of view.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the mirror of Ringel et al. to utilize a flattened central portion and convex spherical or aspherical edge portion in the manner taught by Gaonkar et al. in order to provide both true and undistorted reflections with good depth perception as well as compensating for the relatively narrow field of vision and the blind spots of the planar reflective surface (para [0006] of Gaonkar et al.).
With respect to claim 2, Ringel et al. teaches the reflective surface is positioned in an interior of the body, the body further comprising a side opening through which the forward-looking camera visualizes the lateral workspace (see Figs).
With respect to claim 3, Ringel et al. teaches the forward-looking camera is directed parallel to a central axis of the endoscope, wherein the reflective surface is angled with respect to the central axis so that the forward-looking camera views the lateral workspace via a reflection of the lateral workspace on the reflective surface (see Figs).
With respect to claim 29, Ringel et al. teaches a system comprising an endcap configured to be fitted on a distal end of an endoscope having a forward-looking camera and a forward-facing working port, the endcap comprising a body configured to fit onto the distal end of the endoscope and a reflective surface supported by the body, the reflective surface comprising a mirror configured so that the forward-looking camera visualizes a workspace that is lateral of both the endcap and the distal end of the endoscope (see Figs).
However, Ringel et al. does not teach the reflective surface comprises a flattened central portion and convex spherical or aspherical edge portion configured to increase the field of view.
With respect to claim 29, Gaonkar et al. teaches a reflective surface comprising a mirror, the reflective surface being convex and increasing the field-of-view (FOV), wherein the mirror has a length and a width, the length being greater than the width, wherein the convex reflective surface is aspherical, the radius of the convex reflective surface being larger across the length of the mirror, the radius of the convex reflective surface being smaller across the width of the mirror (FIG. 3, 4, para [0026]-[0029]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the mirror of Ringel et al. to utilize a flattened central portion and convex spherical or aspherical edge portion in the manner taught by Gaonkar et al. in order to provide both true and undistorted reflections with good depth perception as well as compensating for the relatively narrow field of vision and the blind spots of the planar reflective surface (para [0006] of Gaonkar et al.).
With respect to claim 30, Gaonkar et al. teaches the reflective surface comprises a flattened central portion (18) surrounded by spherical or aspherical edges (FIG. 1,2).
Claim(s) 9-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ringel et al. in view of Gaonkar et al. (U.S. 2015/0274077) as applied to claim 1 above and further in view of Riojas et al. (U.S. 2019/0133705).
With respect to claim 9, Ringel et al. teaches tools that can extend through the scope (see Methods).
However, Ringel et al. does not teach a steerable sheath configured to extend through the working port.
With respect to claim 9, Riojas et al. teaches a steerable sheath (FIG. 2B,C) configured to extend through the working port and exit the distal end of the endoscope (para [0080]), the steerable sheath having an inner lumen (226) through which one or more tools can extend.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the device of Ringel et al. to utilize the steerable sheath taught by Riojas et al. in order to aid the operation of the surgical instrument through actuation of the steerable sheath in concert with the instrument (para [0081] of Riojas et al.).
With respect to claim 10, Riojas et al. teaches the steerable sheath comprises a flexible tube having a steerable tip, the tip being actuatable to form a bend that enables the sheath to be steered outside the endcap in the lateral workspace (FIG. 2C for example).
With respect to claim 11, Ringel et al. teaches the endcap further comprises a redirecting surface configured to receive the steerable sheath and redirect the steerable sheath outside the endcap into the lateral workspace (see Figs).
With respect to claim 12, Ringel et al. teaches the redirecting surface comprises a portion of the reflective surface (see Figs).
With respect to claim 13, Ringel et al. teaches the redirecting surface is configured to enforce the lateral direction at which the steerable sheath exits the endcap into the lateral workspace (intended use).
With respect to claim 14, Riojas et al. teaches the steerable sheath comprises a concentric tube structure comprising nested concentric tubes, wherein actuation of the steerable tip is effectuated through applying an axial push-pull force to the concentric tubes (FIG. 2B,C).
With respect to claim 15, Riojas et al. teaches the concentric tubes are configured to have asymmetric elasticity along the portions of the tubes that extend along the steerable tip (FIG. 2B,C).
With respect to claim 16, Riojas et al. teaches the asymmetric elasticity of the tubes is created by cutout sections spaced lengthwise along the portions of the tubes that extend along the steerable tip (FIG. 2B,C).
With respect to claim 17, Ringel et al. teaches the tools comprise tools for performing an endoscopic retrograde cholangiopancreatography (ERCP) procedure (intended use).
With respect to claim 18, Riojas et al. teaches the tools comprise at least one of guidewires, cannulas, sphincterotomes, and baskets (para [0080]).
With respect to claim 19, Ringel et al. in view of Riojas et al. teaches an endoscope having a forward-looking camera and a forward-facing working port, wherein the endcap is fitted onto the endoscope and the steerable sheath passes through the working port into the interior of the endcap, wherein the endcap is configured to deflect the steerable sheath toward a side opening of the endcap into the lateral workspace, and the steerable sheath is configured to be steered to a position and orientation in the lateral workspace, under the visualization afforded by the camera via the reflective surface, to allow a tool to be advanced through the steerable sheath into the lateral workspace (Figs of Ringel et al., FIG. 2B,C of Riojas et al.).
With respect to claim 20, Ringel et al. teaches the endoscope comprises an illumination source and the reflective surface is configured to reflect light from the illumination source into the lateral workspace to illuminate the lateral workspace (see Figs).
With respect to claim 21, Ringel et al. teaches the endoscope comprises a fluid delivery channel and the endcap is configured so that fluids delivered via the fluid delivery channel wash the reflective surface (see Methods).
With respect to claim 22, Ringel et al. teaches the endcap body comprises a single piece of injection molded plastic (product by process) configured to receive and support the reflective surface (see Methods).
With respect to claim 23, Ringel et al. teaches the endcap body is free from moving parts (see Figs).
With respect to claim 24, Ringel et al. teaches the endcap body comprises a collar configured to be press-fitted onto the distal end of the endoscope tube (see Methods).
Claim(s) 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ringel et al. in view of Gaonkar et al. (U.S. 2015/0274077) as applied to claim 1 above and further in view of Ostrovsky et al. (U.S. 2019/0261835).
Ringel et al. teaches an endcap as set forth above. However, Ringel et al. does not teach flexible members.
With respect to claim 25, Ostrovsky et al. teaches an endcap wherein the body of the endcap comprises a tip portion comprising flexible members configured to deflect in response to engaging tissue in order to facilitate navigation of the endoscope with the tip affixed thereto (para [0066]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Ringel et al. to include the flexible members as taught by Ostrovsky in order to assist the clinician with attaching and removing the endcap (para [0066] of Ostrovsky et al.).
With respect to claim 26, Ostrovsky et al. teaches an outer soft layer such as silicone (para [0066]).
Modifying Ringel et al. to include an outer soft silicone layer would result in a separate tip component connectable with the body, wherein the tip has a domed configuration and is constructed of a material that is soft and flexible, the tip being configured to deflect in response to engaging tissue in order to facilitate navigation of the endoscope with the tip affixed thereto.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Ringel et al. to include a soft layer in the manner taught by Ostrovsky et la. in order to reduce the potential for injuries to a patient’s lumen (para [0066] of Ostrovsky et al.).
With respect to claim 27, Ostrovsky et al. teaches the endcap further comprises a basket, the basket comprising a plurality of loops and/or fingers that extend radially from the endcap body, wherein the loops and/or fingers are constructed of a material that is flexible and resilient so that the loops deflect toward the endcap body while the endoscope is advanced through tissue, the loops and/or fingers being configured to engage tissue and to deflect outward of the endcap (FIG. 4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the endcap of Ringel et al. to include the basket as taught by Ostrovsky et al. in order to in order to enlarge the body lumen in the region surrounding the endoscope (para [0061] of Ostrovsky et al.).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 29 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
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/ALEXANDRA L NEWTON/ Primary Examiner, Art Unit 3799