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 .
Election/Restrictions
Applicant’s election without traverse of Species C, embodied in Fig. 4C and directed to claims 1-6, 30, and 32-35 in the reply filed on 01/15/2026 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 03/31/2023 and 11/18/2025 have been considered by the Examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, 6, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Widenhouse et al (US 20100081995 A1).
Regarding claim 1, Widenhouse teaches a surgical robot calibration device (300) configured to be used when calibrating a surgical robotic system to perform a minimally invasive procedure through a natural orifice (see [0108]; the retractor can be placed in any opening within a patient’s body whether a natural orifice or an opening made by an incision),
the surgical robotic system comprising a surgical robotic arm and a surgical instrument having a rigid linear shaft (see Fig. 1B, [0120]; surgical instrument 116 having a shaft),
the surgical robot calibration device (300) comprising a resistive spacer (302) configurable to hold a calibration port (306) in a fixed position spaced from the natural orifice (see [0137]; surgical access device 300 having flexible deal base 302 and access ports 306 formed therethrough for receiving a surgical instrument),
such that when the calibration port is held in the resistive spacer (see [0138]; sealing ports 306 can be formed or disposed in the flexible base 302),
the surgical instrument is insertable into the natural orifice via the calibration port (see [0137]; ports 306 formed therethrough for receiving a surgical instrument) to enable a fulcrum (see [0030]; the flexible base allows each sealing port to selectively position instruments extending through the sealing element at converging and diverging positions relative to one another) about which the surgical instrument pivots whilst the surgical instrument is inserted into the calibration port (see Fig. 12A, [0105]; wherein unlabeled instruments are inserted through ports 306 in base 302 and can be manipulated within the target tissue via the axis as defined by the port) to be determined.
The preamble of claim 1 recites wherein the surgical robot calibration device is ‘configured to be used when calibrating a surgical robotic system to perform a minimally invasive procedure through a natural orifice, the surgical robotic system comprising a surgical robotic arm and a surgical instrument having a rigid linear shaft,’ which has been identified as functional language. The limitation has been carefully considered and does not impart further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device to be used in a surgical context for a minimally invasive procedure and therefore fulfills the structural limitations imparted by the claim.
In line 5, claim 1 recites the limitation ‘the surgical robot calibration device comprising a resistive spacer configurable to hold a calibration port in a fixed position spaced from the natural orifice,’ which has been identified as a statement of intended use of the claimed invention. The limitation has been carefully considered and does not impart further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device having a resistive spacer which holds a calibration port in a fixed position relative to the surgical opening, which may be a natural orifice, and therefore fulfills the structural limitations imparted by the claim.
Regarding claim 3, Widenhouse teaches a surgical robot calibration device as claimed in claim 1 wherein the resistive spacer (302) is configured to be received at one end in the natural orifice (see [0007]; a surgical access device can include a retractor having an opening extending throughout for forming a pathway through tissue into a body cavity, see Figs. 12A-B having retractor 334 at one end of the calibration device),
comprises an aperture at an opposing end (see annotated Fig. 12B below) for receiving the calibration port (306).
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The limitation ‘wherein the resistive spacer is configured to be received at one end in the natural orifice,’ has been identified as functional language. The limitation has been carefully considered and does not impart any further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device having an end which is configured to be received by a surgical opening, which may be a natural orifice, and therefore fulfills the structural limitations imparted by the claim.
Regarding claim 4, Widenhouse teaches a surgical robot calibration device as claimed in claim 1 wherein the resistive spacer (302) is configured to be received at one end in the natural orifice (see [0007]; a surgical access device can include a retractor having an opening extending throughout for forming a pathway through tissue into a body cavity, see Figs. 12A-B having retractor 334 at one end of the calibration device), and
comprises a surface spaced from that end having one or more apertures each configured to receive a calibration port (see Fig. 12A having a surface of base 302, spaced from the end of the calibration device comprising the retractor 334, including three apertures configured to receive a calibration port 306).
The limitation ‘wherein the resistive spacer is configured to be received at one end in the natural orifice,’ has been identified as functional language. The limitation has been carefully considered and does not impart any further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device having an end which is configured to be received by a surgical opening, which may be a natural orifice, and therefore fulfills the structural limitations imparted by the claim.
Regarding claim 6, Widenhouse teaches a surgical robot calibration device as claimed in claim 4 wherein the resistive spacer is curved so as to define a substantially domed three-dimensional shape (see Fig. 12A, [0137]; base 302 is generally dome shaped).
Regarding claim 30, Widenhouse teaches a surgical robot calibration device as claimed in claim 1, wherein the resistive spacer is capable of resisting external forces applied to the calibration port by the surgical instrument such that, in use, the calibration port is maintained in the fixed position. See Fig. 12A and paragraphs [0137-0140], where the resistive spacer comprises the seal base 302 extending from housing 304 where housing 304 is substantially rigid, whereby external forces applied to the calibration ports by the instrument may cause movement of the base 302, the calibration ports are maintained in a fixed position in relation to one another and laterally in relation to the orifice, at a distance defined by the spacer housing 304.
Claim(s) 1, 2, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Amson et al (US 20170049473 A1).
Regarding claim 1, Amson teaches a surgical robot calibration device (10) configured to be used when calibrating a surgical robotic system to perform a minimally invasive procedure through a natural orifice (see [0032]),
the surgical robotic system comprising a surgical robotic arm and a surgical instrument having a rigid linear shaft (see Fig. 6, [0054]; instrument 170 having a rigid shaft),
the surgical robot calibration device (10) comprising a resistive spacer (20) configurable to hold a calibration port (50) in a fixed position (see [0041]; using retaining means to securely maintain the position of the instrument docking port 50 when installed into the spacer 20) spaced from the natural orifice (see [0051]; device 10 having at least one retainer 40 to secure the device to the orifice, see Fig. 1 where calibration ports 50 are spaced away from retainer 40),
such that when the calibration port (50) is held in the resistive spacer (20), the surgical instrument (170) is insertable into the natural orifice via the calibration port (see [0051]; docking ports 50 are installed to provide access to endoscopic and laparoscopic surgical instruments into a surgical access port) to enable a fulcrum about which the surgical instrument pivots whilst the surgical instrument is inserted into the calibration port (see [0038]; the docking ports 50 allow for the insertion of surgical instruments 170 into the surgical access port to reach the target body cavity, it can be appreciated that the insertion point at port 50 acts as a fulcrum about which the instrument pivots due to the fixed nature of the port and the manipulatable nature of the instrument).
The preamble of claim 1 recites wherein the surgical robot calibration device is ‘configured to be used when calibrating a surgical robotic system to perform a minimally invasive procedure through a natural orifice, the surgical robotic system comprising a surgical robotic arm and a surgical instrument having a rigid linear shaft,’ which has been identified as functional language. The limitation has been carefully considered and does not impart further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device to be used in a surgical context for a minimally invasive procedure and therefore fulfills the structural limitations imparted by the claim.
In line 5, claim 1 recites the limitation ‘the surgical robot calibration device comprising a resistive spacer configurable to hold a calibration port in a fixed position spaced from the natural orifice,’ which has been identified as a statement of intended use of the claimed invention. The limitation has been carefully considered and does not impart further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device having a resistive spacer which holds a calibration port in a fixed position relative to the surgical opening, which may be a natural orifice, and therefore fulfills the structural limitations imparted by the claim.
Regarding claim 2, Amson teaches a surgical robot calibration device as claimed in claim 1, wherein the natural orifice is a mouth (see [0032]; referring to surgery performed through a natural orifice such as the oral cavity).
Regarding claim 5, Amson teaches a surgical robot calibration device as claimed in claim 1 wherein the resistive spacer (20) is configured to be received at one end in the natural orifice (see Fig. 1, [0051]; retainer 40 located at one end of the device 10 extending outwardly to secure the access of the device to the target site)
comprises a surface (20) spaced from that end (see Fig. 1 where ports 50 are located on an end opposite retainer 40) that is pierceable so as to receive a calibration port (see [0051-0052]; installation of ports 50 into the surface of dome 20 is achieved by forcibly inserting the port 50 into dome 20, effectively piercing the surface).
The limitation ‘wherein the resistive spacer is configured to be received at one end in the natural orifice,’ has been identified as functional language. The limitation has been carefully considered and does not impart any further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device having an end which is configured to be received by a surgical opening, which may be a natural orifice, and therefore fulfills the structural limitations imparted by the claim.
Claim(s) 1, 3, 4, 6, and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al (US 20090227843 A1).
Regarding claim 1, Smith teaches a surgical robot calibration device (10) configured to be used when calibrating a surgical robotic system to perform a minimally invasive procedure (see [0003-0004]; laparoscopic procedures and/or single port surgery procedures)
the surgical robotic system comprising a surgical robotic arm and a surgical instrument having a rigid linear shaft (see Fig. 15, [0059-0064]; instrument tubes 150a-c, formed of a material which provides sufficient rigidity, inserted into a body cavity via the access device),
the surgical robot calibration device (10) comprising a resistive spacer (14a) configurable to hold a calibration port (20a) in a fixed position spaced from the orifice (see [0055]; spacer 14a having wall 34c with openings 50a for securing ports 20a in a fixed position),
such that when the calibration port (20a) is held in the resistive spacer (14a), the surgical instrument (150) is insertable into the orifice via the calibration port to enable a fulcrum about which the surgical instrument pivots whilst the surgical instrument is inserted into the calibration port to be determined (see [0052]; when an instrument disposed in a port 20 imparts forces against the port in a direction transverse to the longitudinal axis of the part, preferential bending occurs along the junction 35 between the spacer and the port to avoid kinking of the port, which effectively establishes a fulcrum).
The preamble of claim 1 recites wherein the surgical robot calibration device is ‘configured to be used when calibrating a surgical robotic system to perform a minimally invasive procedure through a natural orifice, the surgical robotic system comprising a surgical robotic arm and a surgical instrument having a rigid linear shaft,’ which has been identified as functional language. The limitation has been carefully considered and does not impart further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device to be used in a surgical context for a minimally invasive procedure and therefore fulfills the structural limitations imparted by the claim.
In line 5, claim 1 recites the limitation ‘the surgical robot calibration device comprising a resistive spacer configurable to hold a calibration port in a fixed position spaced from the natural orifice,’ which has been identified as a statement of intended use of the claimed invention. The limitation has been carefully considered and does not impart further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device having a resistive spacer which holds a calibration port in a fixed position relative to the surgical opening, which may be a natural orifice, and therefore fulfills the structural limitations imparted by the claim.
Regarding claim 3, Smith teaches a surgical robot calibration device as claimed in claim 1 wherein the resistive spacer (14a) is configured to be received at one end in the natural orifice (see [0035]; device 10 includes base 12 positionable within an opening formed in a body wall), and
comprises an aperture (50a, 50b) at an opposing end for receiving the calibration port (20a, see Fig. 8a, [0055]; seal 14a having apertures 50a and 50b for receiving ports 20 on an opposite end to base 12 as seen in Fig. 1).
The limitation ‘wherein the resistive spacer is configured to be received at one end in the natural orifice,’ has been identified as functional language. The limitation has been carefully considered and does not impart any further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device having an end which is configured to be received by a surgical opening, which may be a natural orifice, and therefore fulfills the structural limitations imparted by the claim.
Regarding claim 4, Smith teaches a surgical robot calibration device as claimed in claim 1 wherein the resistive spacer (14a) is configured to be received at one end in the natural orifice (see [0035]; device 10 includes base 12 positionable within an opening formed in a body wall), and
comprises a surface (34c) spaced from that end having one or more apertures (50a, 50b) each configured to receive a calibration port (20a, see Fig. 8a, [0055]; seal 14a having apertures 50a and 50b for receiving ports 20 on an opposite end to base 12 as seen in Fig. 1).
The limitation ‘wherein the resistive spacer is configured to be received at one end in the natural orifice,’ has been identified as functional language. The limitation has been carefully considered and does not impart any further structural limitations to the surgical robot calibration device. The surgical robot calibration device as disclosed in the prior art teaches a calibration device having an end which is configured to be received by a surgical opening, which may be a natural orifice, and therefore fulfills the structural limitations imparted by the claim.
Regarding claim 6, Smith teaches a surgical robot calibration device as claimed in claim 4 wherein the resistive spacer is curved so as to define a substantially domed three-dimensional shape (see Fig. 8a, [0051]; domed wall 34).
Regarding claim 32, Smith teaches a method of calibrating a surgical robotic system to perform an invasive procedure via a natural orifice using the surgical robot calibration device as claimed in claim 1 and preceding claims 3, 4, and 6,
the surgical robotic system comprising a surgical robotic arm (150a-c) having a series of joints (154a-b) by which the configuration of the robotic arm can be altered (see [0061]; arms 150a-b having deflectable regions 154a-b to allow positioning and manipulation of the operative ends of the instruments),
the series of joints (154a-b) extending from a base (154a-b) at a proximal end of the surgical robotic arm to a surgical instrument having a rigid linear shaft attached at a distal end of the surgical robotic arm (see [0064]; tubes 150a-c may be formed of any material that will provide sufficient rigidity to prevent buckling during use), and
the method comprising determining a fulcrum about which the surgical instrument pivots when the configuration of the robotic arm is altered whilst the surgical instrument is inserted into the calibration port (see [0052]; when an instrument disposed in a port 20 imparts forces against the port in a direction transverse to the longitudinal axis of the part, preferential bending occurs along the junction 35 between the spacer and the port to avoid kinking of the port, which effectively establishes a fulcrum).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Widenhouse et al (US 20100081995 A1) in view of Rosenblood et al (US 20060063979 A1).
Regarding claims 33 and 34, Widenhouse teaches the surgical robot calibration device as claimed in claim 1 wherein the resistive spacer is configured to be received in a natural orifice (see Widenhouse [0108]) and comprises an attachment for a retractor (see Fig. 12A, [0141]; housing 304 can mate with a retractor 334 via threads 332 on the distal portion 330 of housing 304). The retractor (334) as taught by Widenhouse is detachable from the attachment portion, threads 332 on the distal portion 330 of housing 304.
Widenhouse is silent regarding wherein the natural orifice is a mouth and the resistive spacer comprises an attachment for a mouth retractor;
wherein the mouth retractor is detachable.
Rosenblood teaches a retracting device (10) for retracting at least a portion of a user’s mouth (Rosenblood, Abstract) where the retracting device may be inter-engaging with other dental tools or apparatuses (see Rosenblood [0057]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the calibration device having an attachment for a retractor as taught by Widenhouse with the mouth retractor as taught by Rosenblood for use when the natural orifice is a mouth. One of ordinary skill in the art would have been motivated to make this modification in order to retract the lips when performing an operation via an oral cavity in order to clear the area for examination and/or treatment by healthcare professionals (Rosenblood [0005]).
Claim(s) 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al (US 20090227843 A1) in view of Rosenblood et al (US 20060063979 A1).
Regarding claims 33-35, Smith teaches the surgical robot calibration device as claimed in claim 1 wherein the resistive spacer (14a) comprises an attachment for a retractor (see Fig. 2, [0042]; first engaging portion flange 26).
Smith is silent regarding wherein the natural orifice is a mouth and the retractor is a mouth retractor.
Regarding claims 33 and 34, Rosenblood teaches a retracting device (10) for retracting at least a portion of a user’s mouth (Rosenblood, Abstract) where the retracting device may be inter-engaging with other dental tools or apparatuses (see Rosenblood [0057]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the calibration device having an attachment for a retractor as taught by Smith with the mouth retractor as taught by Rosenblood for use when the natural orifice is a mouth. One of ordinary skill in the art would have been motivated to make this modification in order to retract the lips when performing an operation via an oral cavity in order to clear the area for examination and/or treatment by healthcare professionals (Rosenblood [0005]).
Regarding claim 35, Smith teaches wherein the attachment comprises a lip (flange 26), and the retractor is elastically deformable via clips 32 on the base 12a comprising retractor flange 16a. When the clips are in a first configuration as seen in Fig. 3C, the lip 26 attached the retractor base 12a; and
when the clips are in a second configuration as seen in Fig. 3B, the mouth retractor detaches from the resistive spacer (Smith [0042-0043]).
Smith is silent regarding wherein the resistive spacer is deformable such that with the resistive spacer in a first configuration, the lip attaches the mouth retractor to the resistive spacer; and
with the resistive spacer in a second, deformed, configuration, the mouth retractor can pass over the lip in order to detach the mouth retractor from the resistive spacer.
Rosenblood teaches a inter-engaging mouth retractor (see Rosenblood [0057]), which would be obvious to one of ordinary skill to use when the natural orifice is a mouth.
The prior art teaches the claimed invention except for where the resistive spacer is elastically deformable such that in a first configuration the mouth retractor is attached to the resistive spacer and in a second configuration the mouth retractor is released, rather disclosing an elastically deformable portion of the retractor, demonstrated by clips 32. Therefore, the difference between the prior art and the claimed invention is remedied by a rearrangement of parts where the elastically deformable clips are located on the resistive spacer instead of the retractor base. This rearrangement of parts would have no impact on the operation or function of the device, and it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04(VI)(C), In re Japikse, 86 USPQ 70.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792