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
Claims 1-20 are pending in this application. Claims 2-4, 12-15, and 17-19 are withdrawn, and Claims 1, 5-11, 16, and 20 have been examined on the merits.
Interview Summary
A called was made to Nathan Smith on 04/01/2026 to discuss the Restriction requirements. Attorney agreed to the withdrawal of claims 2-4, 12, and 17-19, which reflect the nonelected claims in the Species restriction.
Election/Restrictions
Applicant’s election without traverse of claims 1-12 and 16-20 drawn to Invention I and species G from Group I in the reply filed on 02/05/26 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being
drawn to a nonelected Invention II drawn to an adapter for use with an instrument there being no allowable generic or linking claim. Claims 2-4, 12, and 17-19 are withdrawn as being drawn to the nonelected Species A-F and H as detailed in the Office Action dated 12/04/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “resilient member” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 objected to because of the following informalities:
In Claim 1, line 5 “the navigation sensor configured generate” should be “the navigation sensor configured to generate”.
In claim 16, line 6-7 “the navigation sensor configured generate” should be “the navigation sensor configured to generate”.
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 1, and 5-11 are 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 1 (and similarly claim 10) recites the limitation “instrument coupling arm configured to non-removably engage a portion of the instrument”. It is unclear what is meant by the coupling arm being non-removably engaged to a portion of the instrument, and whether this means that the coupling arm is a portion that cannot be removed, or if once attached, the instrument cannot be removed. For purposes of examination, the limitation will be construed as a coupling arm which is just a part of the device that cannot be removed. However, further clarification is required.
All remaining claims are rejected due to their dependency to the independent claim.
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.
Claims 1, 5,8-11, 16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tarke (US20220257093A1, disclosed in Applicant IDS).
Regarding Claim 1,
Tarke teaches an adapter for use with an instrument (corresponding disclosure in at least [0168], where there is an adapter used with an instrument “such an adapter may be readily coupled with an instrument”), the adapter comprising:
an adapter body extending between a proximal end and a distal end (Corresponding disclosure in at least [0170] and Figure 40, where there is a proximal and distal end “End effector (1022) is at the distal end of shaft assembly (1020)”);
PNG
media_image1.png
204
425
media_image1.png
Greyscale
Figure 40 of Tarke
an instrument coupling arm attached to the adapter body, the instrument coupling arm configured to non-removably engage a portion of the instrument (corresponding disclosure in at least [0174], where there is a coupling arm (the hub) which is attached to the adapter, which engages a portion of the instrument (tissue shaving instrument) “Hub (1110) of adapter sheath (1100) is configured to engage with hub (1010) of tissue shaving instrument (1000) to thereby removably secure adapter sheath (1100) relative to tissue shaving instrument (1000)”);
and a navigation sensor fixed to the adapter body, the navigation sensor configured generate signals indicating a position of at least a portion of the instrument in three-dimensional space (corresponding disclosure in at least [0174], where there is a navigation sensor “Proximal navigation sensor (1146) of adapter sheath (1100) is positioned further proximal from end effector (1022), such that proximal navigation sensor (1146) may readily indicate the real-time position of a corresponding proximal portion of shaft assembly” and further in [0159], where it is specified the instrument in 3D space is shown “defines a respective navigation sensor (650, 652, 653, 654, 656, 657) that is operable to generate signals indicative of the position of the respective navigation sensor (650, 652, 653, 654, 656, 657) and thereby indicative of the position of at least a portion (e.g., outer shaft (616)) of instrument (500) in three-dimensional space”).
Regarding Claim 5,
Tarke further teaches wherein the instrument coupling arm comprises a resilient member (corresponding disclosure in at least [0174], where there is a resilient member (there is a snap fit for the hub to fix the instrument in place) “Hub (1110) of adapter sheath (1100) is configured to engage with hub (1010) of tissue shaving instrument (1000) to thereby removably secure adapter sheath (1100) relative to tissue shaving instrument (1000). By way of example only, hub (1110) may provide a snap fit, and interference fit, or any other suitable kind of relationship with hub (1010). As shown in FIGS. 39 and 43, the length of shaft assembly (1120) is such that distal ends (1132, 1152) are just proximal to end effector (1022) when adapter sheath (1100) is fully seated on tissue shaving instrument”).
Regarding Claim 8,
Tarke further teaches wherein the resilient member defines an elongate slot (corresponding disclosure in at least disclosure in at least [0174] and Figure 39, where there is an elongate slot (the hub, which is the resilient member “hub (1110) may provide a snap fit, and interference fit, or any other suitable kind of relationship with hub (1010). As shown in FIGS. 39 and 43, the length of shaft assembly (1120) is such that distal ends (1132, 1152) are just proximal to end effector (1022) when adapter sheath (1100) is fully seated on tissue shaving instrument (1000)”).
PNG
media_image2.png
169
376
media_image2.png
Greyscale
Figure 39 of Tarke
Regarding Claim 9,
Tarke further teaches wherein the resilient member extends proximally from the distal end of the adapter body (corresponding disclosure in at least Figure 39, where the member extends proximally from the distal end (as the arrow shows, the member extends from a distal point to the proximal).
PNG
media_image2.png
169
376
media_image2.png
Greyscale
Figure 39 of Tarke
Regarding Claim 10,
Tarke further teaches wherein the instrument coupling arm is configured to non-removably engage a portion of the instrument, in a predetermined angular orientation with respect to an axis of the instrument (corresponding disclosure in at least [0169], where there is a knob which will rotate to the instrument to a specific orientation “Rotation control knob (1006) is rotatable relative to body (1002) to reorient shaft assembly (1020) about the longitudinal axis of shaft assembly (1020). Power connector (1008) is configured to couple with a power source to provide power to a motor (not shown) in body (1002). The motor is operable to drive a cutting shaft (not shown) of shaft assembly (1020) in a manner as is known in the art”).
Regarding Claim 11,
Tarke further teaches wherein the adapter body defines a through hole extending between the proximal end and the distal end (corresponding disclosure in at least [0103], where there is a hole between the proximal and distal end (the gap) “Tab (167) may be further positioned to leave a gap (not shown) between the proximal face of tab (167) and the distal end of conduit (164), and a similar gap may be left between the proximal face of tab (168) and the distal end of conduit (165). These gaps may be sized to allow liquid to escape from the distal ends of conduits (164, 165)”.
Regarding Claim 16,
Tarke teaches an adapter cuff for use with an instrument (corresponding disclosure in at least [0168], where there is an adapter used with an instrument “such an adapter may be readily coupled with an instrument”), the adapter cuff comprising:
an adapter body extending between a proximal end and a distal end, the adapter body defining an irrigation lumen extending from the distal end toward the proximal end (corresponding disclosure in at least Figure 2 and [0079], where the adapter body extends between a proximal and distal end, and there is an irrigation lumen at the distal end (the irrigation assembly “As best shown in FIG. 3, navigation, visualization, and irrigation assembly (106) is disposed within shaft assembly (104) and is operable to provide navigation capabilities to shaft assembly (104), and to provide visualization and irrigation at a target tissue site distal to distal end (120) of shaft assembly (104)”);
an irrigation nozzle located at the distal end of the adapter body and in fluid communication with the irrigation lumen (corresponding disclosure in at least Figure 2 and [0079], where there is an irrigation nozzle towards the end of the distal end “As best shown in FIG. 3, navigation, visualization, and irrigation assembly (106) is disposed within shaft assembly (104) and is operable to provide navigation capabilities to shaft assembly (104), and to provide visualization and irrigation at a target tissue site distal to distal end (120) of shaft assembly (104)” and further in [0100], where there is an irrigation nozzle and the irrigation lumen (the fluid conduits, which are connected to the body of the device, which is defined as the irrigation lumen according to [0092] of the present application to pick up fluids that pass through) “As best shown in FIG. 3, navigation, visualization, and irrigation assembly (106) is disposed within shaft assembly (104) and is operable to provide navigation capabilities to shaft assembly (104), and to provide visualization and irrigation at a target tissue site distal to distal end (120) of shaft assembly (104)”); and
a navigation sensor fixed to the adapter body, the navigation sensor being configured generate signals indicating a position of at least a portion of the instrument (corresponding disclosure in at least [0115], where there is a navigation sensor on the body which indicates the position of a portion of the instrument “defines a respective navigation sensor (250, 252, 254, 256) that is operable to generate signals indicative of the position of the respective navigation sensor (250, 252, 254, 256) and thereby indicative of the position of at least a portion (e.g., flexible portion (118) of shaft assembly (104)) of instrument (100) in three-dimensional space”).
Regarding Claim 20,
Tarke further teaches wherein the one or more navigation sensor comprises a non-concentric tri-axis sensor (Corresponding disclosure in at least [0115], where there is a tri-axis sensor “defines a respective navigation sensor (250, 252, 254, 256) that is operable to generate signals indicative of the position of the respective navigation sensor (250, 252, 254, 256) and thereby indicative of the position of at least a portion (e.g., flexible portion (118) of shaft assembly (104)) of instrument (100) in three-dimensional space” and further in Figure 15, where the sensor is non-concentric).
PNG
media_image3.png
309
324
media_image3.png
Greyscale
Figure 15 of Tarke
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 6 and 7 are rejected under 35 U.S.C. 103 as being obvious over Tarke (US20220257093A1, disclosed in Applicant IDS) in view of Amin (US20200188035A1)
Regarding Claim 6, Tarke teaches the limitations of Claim 5, and further teaches the instrument coupling arm comprising a complementary surface (corresponding disclosure in at least Figure 38, where there is a surface on the coupling arm)), but does not teach the recess defined by the portion of the instrument.
PNG
media_image4.png
363
628
media_image4.png
Greyscale
Figure 38 of Tarke
Amin, in a similar field of endeavor, teaches a similar concept (connectors to surgical instruments) of the recess defined by the portion of the instrument (corresponding disclosure in at least Figure 9, where there is a recess in the portion of the instrument).
PNG
media_image5.png
251
339
media_image5.png
Greyscale
Figure 9 of Amin
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a recess defined by the portion of the instrument as taught by Amin. One of the ordinary skill in the art would have been motivated to incorporate this because the recess provides a pocket or area to connect another instrument or tool to the instrument.
Regarding Claim 7, Tarke and Amin teaches the limitations of Claim 6, and Tarke further teaches wherein the complementary surface comprises an arched profile (corresponding disclosure in at least Figure 38 of Tarke, where the surface is an arched profile, as depicted in the Figure).
PNG
media_image4.png
363
628
media_image4.png
Greyscale
Figure 38 of Tarke
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Such prior arts include US20230380662A1 (surgical system with navigation sensors), US 20210236212 A1 (tracker in use with a surgical instrument, irrigation system, and adapter to engage with surgical instrument), and US 20190125375 A1 (IGS navigation system with instrument adapter).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN KIM whose telephone number is (571)272-1821. The examiner can normally be reached Monday-Friday 6-2 PST.
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, Anne Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797