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.
Response to Arguments
Applicant’s arguments, see Remarks filed 04/30/2026, with respect to the rejection of amended claim 1, which has been amended to incorporate the features of previous claims 33 and 34 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Gaiser et al (US 20020151871 A1) and Oyola et al (US 20140012287 A1).
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 03/31/2023 and 11/18/2025 have been considered by the Examiner.
Claim Objections
Claim 37 is objected because of improper dependence. Claim 37 currently depends upon itself which is improper. Examiner is interpreting the method claimed in claim 37 to depend upon the method of claim 36. Appropriate correction is required.
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 32, 36, and 37 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.
Claim 32 is unclear because in the preamble it claims ‘using the surgical robot calibration device as claimed in claim 1’ but then recites ‘the surgical system comprising a surgical robotic arm.’ This language is interpreted as referring to a new surgical robotic arm as it does not refer to the surgical robotic arm recited in claim 1. Examiner notes that any element present in claim 32, if referencing an element that depends upon claim 1, must be referred to as ‘the’ in order to establish proper antecedent basis.
Claim 32 is also unclear because of its passive recitation of the device of claim 1. The method claim itself does not contain any positive recitation of a step of inserting the device into the mouth, which then renders the limitations of ‘removing the surgical calibration device from the mouth’ in claims 36 and 37 as unclear.
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.
Claims 1, 3-6, 30, and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gaiser et al (US 20020151871 A1).
Regarding claim 1, Gaiser teaches a surgical robot calibration device (T) configured to be used when calibrating a surgical robotic system to perform a transoral surgery through a mouth of a patient (see [0093]; gripping tool T holds an instrument 15 in a fixed or stabilized position within the oral cavity),
the surgical robotic system comprising a surgical robotic arm and a surgical instrument (15) having a rigid linear shaft,
the surgical robot calibration device (T) comprising a resistive spacer (12) configurable to hold a calibration port in a fixed position spaced from the mouth (see Fig. 1, [0122]; the gripping element 17 consists of jaw assembly 18 carried by insert 12, where it can be appreciated that the jaw assembly 18 is configurable to hold a calibration port in a fixed position),
such that when the calibration port is held in the resistive spacer, the surgical instrument is insertable into the mouth 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 Figs. 4a-4e wherein the instrument 15 is insertable into the mouth via calibration port 20 to enable a fulcrum about which the instrument is pivoted),
wherein the resistive spacer comprises an attachment (16) for a mouth retractor (10), the mouth retractor being detachable from the attachment (see [0095]; the gripping tool T may be part of an insert 12 that is selectively attachable within the opening 11 of the bite block 10).
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 transoral surgery through a mouth of a patient, 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 transoral surgery 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 mouth of a patient, and therefore fulfills the structural limitations imparted by the claim.
Regarding claim 3, Gaiser teaches the surgical robot calibration device as claimed in claim 1, wherein the resistive spacer is configured to be received at one end in the mouth (see Fig. 2, [0095]; insert 12 is attachable within the opening 11 of bite block 10, wherein it can be appreciated that bite block 10 is positioned in a patient’s mouth), and
comprises an aperture (18) at an opposing end for receiving the calibration port (Fig. 2). See also annotated Fig. 1 which has been enlarged to focus on embodiment T1.
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Regarding claim 4, Gaiser teaches the surgical robot calibration device as claimed in claim 1, wherein the resistive spacer is configured to be received at one end in the mouth (see Fig. 2, [0095]; insert 12 is attachable within the opening 11 of bite block 10, wherein it can be appreciated that bite block 10 is positioned in a patient’s mouth), and
comprises a surface spaced (17) from that end having one or more apertures (18) each configured to receive a calibration port (Fig. 2). See also annotated Fig. 1 which has been enlarged to focus on embodiment T1.
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Regarding claim 5, Gaiser teaches the surgical robot calibration device as claimed in claim 1, wherein the resistive spacer is configured to be received at one end in the mouth (see Fig. 2, [0095]; insert 12 is attachable within the opening 11 of bite block 10, wherein it can be appreciated that bite block 10 is positioned in a patient’s mouth), and comprises a surface spaced from that end that is pierceable so as to receive a calibration port (see Figs. 6a-6e; where it can be appreciated that instrument/calibration port 15 may pierce through gripper 18 in order to be received by retention device T).
Regarding claim 6, Gaiser teaches the 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. 1 wherein the resistive spacer T is curved and substantially defines a domed three-dimensional shape).
Regarding claim 30, Gaiser teaches the 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 [0093-0094]; gripping tool T holds an instrument 15 in a fixed or stabilized position within the oral cavity during a procedure and assures that the instrument 15 will not inadvertently be moved during the procedure).
Regarding claim 35, Gaiser teaches the surgical robot calibration device as claimed in claim 1, wherein the resistive spacer is elastically deformable (see [0103]; the lips 16 of insert 12 have a plastic memory), and the attachment comprises a lip (16), such that:
with the resistive spacer in a first configuration, the lip attaches the mouth retractor to the resistive spacer (see [0103]; the lips 16 have a plastic memory so as to engage the rear edge of the bite block 10 in a snap fit when the insert 12 is properly positioned within the bite block opening 11); 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 (see Fig. 1, [0103]; where it can be appreciated that when the lips 16 are in a second deformed configuration wherein they are not in a snap fit configuration with the bite block 10, that the bite block 10 is able to move over the lip 16 and detach from the resistive spacer).
Claims 1 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oyola et al (US 20140012287 A1).
Regarding claim 1, Oyola teaches a surgical robot calibration device (300) configured to be used when calibrating a surgical robotic system (10) to perform a transoral surgery through a mouth of a patient (see [0006]; a system for performing a medical procedure such as a transoral robotic surgery procedure),
the surgical robotic system (100) comprising a surgical robotic arm (10) and a surgical instrument (200) having a rigid linear shaft (230),
the surgical robot calibration (300) device comprising a resistive spacer (320) configurable to hold a calibration port (310a) in a fixed position spaced from the mouth (see Fig. 8, [0176]; introducer 300 includes an upper shaft 310a, which is considered to be the calibration port, which is held in a fixed position in relation to the patient’s mouth via coupler 320 which comprises bracket 321 which attaches coupler 320 to a retractor placed in the patient’s mouth),
such that when the calibration port (310a) is held in the resistive spacer (320), the surgical instrument is insertable into the mouth 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 Fig. 8, [0177]; introducer 300 includes lumen 301 extending from its proximal end 311 to its distal end 312 wherein the lumen 301 is sized to slidingly receive a tool/tool support, [0180-0181]; probe 10 includes guide holes 37a and 37b through which tools 200a and 200b may be inserted),
wherein the resistive spacer (320) comprises an attachment (321) for a mouth retractor, the mouth retractor being detachable from the attachment (see Fig. 8, [0176]; coupler 320 comprises bracket 321 which includes slot 322 positioned and sized to fit over a device such as a retractor placed in the patient’s mouth).
Regarding claim 32, Oyola teaches a method of calibrating a surgical robotic system to perform transoral surgery via a mouth of a patient using the surgical robot calibration device as claimed in claim 1, the surgical robotic system comprising a surgical robotic arm (10) having a series of joints by which the configuration of the robotic arm can be altered (see [0163]; highly articulated probe 10 which is made of a plurality of links, see also Fig. 2 which shows probe 10 in an altered configuration via a plurality of links),
the series of joints extending from a base at a proximal end of the surgical robotic arm (see Fig. 1 where probe linked probe 10 extends from a base at a proximal end of the robotic arm) to a surgical instrument (200) having a rigid linear shaft attached at a distal end of the surgical robotic arm (see Fig. 4, [0169]; wherein distal link 31 includes an exit for one or more tool channels so that the working elements 220 of instrument 200, having rigid shaft 230, are attached at the distal end of the robotic arm), 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 (310a, see Fig. 8, [0177]; proximal end 311 of lumen 301 includes projections 313 which are sized and positioned to orient a tool support, [0178]; introducer 300 also includes two guide tubes 340a and 340b which may be locked in place in a desired position and orientation relative to the user).
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.
Claims 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Oyola et al (US 20140012287 A1) in view of Taraschi et al (US 20170105802 A1).
Regarding claims 36 and 37, Oyola teaches the method as claimed in claim 32. Oyola is silent regarding wherein the method comprises, subsequent to determining the fulcrum, removing the surgical calibration device from the mouth prior to performing a transoral surgery in the mouth.
Taraschi teaches a method for calibrating a surgical robotic system comprising determining a fulcrum about which the surgical instrument pivots (see Taraschi Fig. 12, [0095]; calibration device 900 is used for calibrating a surgical instrument so that respectively the tip and axis of the surgical sutting bit can be virtualized) when the configuration of the robotic arm is altered whilst the surgical instrument is inserted through the calibration port (see Taraschi Fig. 12, [0095]; the reference markers 805 connected to calibration device 900 can be used to determine the physical and axial orientation of the calibration device and especially the physical positions of the end points of probers 910 and 915 to which instruments or devices can be touched as part of the calibration process),
wherein, subsequent to determining the fulcrum (see Taraschi Fig. 5, [0082]; the calibration procedure may use a calibration tool 905 for facilitating pivoting the probe), removing the surgical calibration device prior to performing the surgery (see Taraschi Fig. 5, [0082]; step 322 after the calibration process is complete, an option is provided to select the tool which is physically mounted to the surgical instrument), and
accounting for spacing between the determined fulcrum and the mouth after the calibration device has been removed (see Taraschi Fig. 5, [0082]; step 320 where the user is able to navigate using the system so that the surgical instrument should be properly tracked in the physical world including its position and axial orientation).
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 Oyola’s surgical robotic calibration device with Taraschi’s method of calibration. One of ordinary skill in the art would have been motivated to make this modification in order to allow for preoperative planning which may increase the precision and safety of the procedure (Taraschi [0025-0026]).
Examiner notes that due to the rejections under 35 USC 112(b) as detailed above, Examiner is interpreting the claimed method to the best of their ability wherein the claimed method involves the use of a calibration device to determine a position and pivot point of a surgical instrument.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith et al (US 20080287743 A1) which teaches a medical retractor and stabilizing assembly and related methods of use.
Goudra et al (US 20150265792 A1) which teaches a ventilating bite block for use in endoscopic procedures.
Colman et al (US 20090275851 A1) which teaches an endoscopic bite block.
Tebbutt et al (US 20060112962 A1) which teaches a mouthpiece having a vestibular shield and opening allowing for controlled passage.
Reynolds II et al (US 8028704 B2) which teaches an endoscopic bite block for use with a cannula.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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