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 Claims 5, 9, and 15 are canceled, Claims 2-4, 12-15, and 17-19 are withdrawn, Claims 21-23 are newly added, and Claims 1, 6-8, 10-11, 16, and 20-23 have been examined on the merits.
Claim Objections
Claim 1 objected to because of the following informalities:
In Claim 1, line 5 “the instrument arm” should be “the instrument coupling arm”.
In Claim 21, line 2, “the recess” should be “a recess”.
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.
Claim 22 is 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 22 recites the limitation “a fluid port of the recess”. It is unclear how there is a port in a recess, which is a hollow space. For purposes of examination, the limitation will be construed as a port that is located within a recess. However, further clarification is required.
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 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 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_image1.png
309
324
media_image1.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.
Claims 1, 10-11, and 21-23 are rejected under 35 U.S.C. 103 as being obvious over Tarke (US20220257093A1, disclosed in Applicant IDS) in view of Abramek (US20210386424A1)
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_image2.png
204
425
media_image2.png
Greyscale
Figure 40 of Tarke
an instrument coupling arm having a distal arm end attached to distal end of the adapter body, the instrument arm extending proximally to a proximal arm end configured to 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”).
Tarke does not teach wherein the instrument coupling arm is radially biased inward and configured to deflect radially outward as it engages the instrument.
Abramek, in a similar field of endeavor, teaches a similar concept (adapter assemblies) of wherein the instrument coupling arm is radially biased inward and configured to deflect radially outward as it engages the instrument (corresponding disclosure in at least [0053], where there is a coupling arm, or the adapter assembly, which is radially biased inwards “ Tubular body 212 a further includes a pair of tabs 212 f (see FIGS. 9 and 12) extending radially inward from an inner surface of tubular body 212” where the tabs are a part of the adapter assembly which are extending radially inward, and further where there is a part of the coupling arm that deflects radially outward, or the distal tooth, when it engages the instrument to secure the instrument, or the loading unit “ Tubular body 212 a further includes a distal tooth 212 g which functions as a rotational stop for lugs 110 e of adapter assembly 100 (see FIG. 8) and a retention feature that keeps loading unit connector housing 212 engaged with loading unit 2”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the instrument coupling arm to be radially biased inward and deflect radially outward when engaging with the instrument as taught by Abramek. One of the ordinary skill in the art would have been motivated to incorporate this because the initial extension of the coupling arm inward then having the deflection radially outwards when engaging the instrument keeps the instrument secured with the adapter.
Regarding Claim 10, Tarke and Abramek teach the limitations of Claim 1, and Tarke further teaches wherein the instrument coupling arm is configured to 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 and Abramek teach the limitations of Claim 1, and 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 21, Tarke and Abramek teach the limitations of Claim 1, and Abramek further teaches wherein the instrument coupling arm terminates at the proximal arm end in an engagement body configured to rest within the recess (corresponding disclosure in at least [0053] and Figure 3, where there is an engagement body, or the electrical connector assembly, which sits within a recess (notated in the Figure) “Loading unit 200 of elongated shaft assembly 14 supports a loading unit electrical connector assembly 210 between the pair of curved tines 204. Loading unit electrical connector assembly 210 extends distally through tubular shaft 202 for electrically coupling to sensors 308 supported within end effector 300, and 210 includes a loading unit connector housing 212 (wholly or partially non-conductive) having a tubular body”).
PNG
media_image3.png
289
710
media_image3.png
Greyscale
Figure 3 of Abramek
Regarding Claim 22, Tarke and Abramek teach the limitations of Claim 21, and
wherein the engagement body comprises a floor engagement surface configured to rest on an offset floor of the recess (corresponding disclosure in at least Figure 3 of Abramek, where the engagement body is on an offset floor of the recess, where the portion notated in the Figure is construed as the offset floor),
PNG
media_image4.png
333
536
media_image4.png
Greyscale
Figure 3 of Abramek
a port engagement surface configured to contact a fluid port of the recess (corresponding disclosure in at least Figure 3 of Tarke, where there is a fluid port, or the conduits notated in the Figure ,contacted by a surface notated in the Figure), and
PNG
media_image5.png
334
458
media_image5.png
Greyscale
Figure 3 of Tarke
a boundary engagement surface configured to contact a boundary surface of the recess (corresponding disclosure in at least Figure 3 of Tarke, where there is a boundary engagement surface, or a surface notated by the figure contacting a boundary surface of the recess, or the boundary notated in the figure)
PNG
media_image6.png
302
490
media_image6.png
Greyscale
Figure 3 of Tarke
Regarding Claim 23, Tarke and Abramek teach the limitations of Claim 21, and Abramek further teaches wherein the engagement body is configured to contact the recess to inhibit rotation of the adapter about a longitudinal axis of the instrument (corresponding disclosure in at least Figure 3 and [0053], where the engagement body or the connector assembly 210 is in contact with the recess “Loading unit 200 of elongated shaft assembly 14 supports a loading unit electrical connector assembly 210 between the pair of curved tines 204”) .
The limitation "to inhibit rotation of the adapter about a longitudinal axis of the instrument" is considered an intended use of the claimed invention. Examiner notes that limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The prior art structure must merely be capable of performing the intended use to meet the claim. Examiner notes that the structure of "inventor" (or modified structure in a 103) comprises the recited structural elements and would be capable of being used for "to inhibit rotation of the adapter about a longitudinal axis of the instrument".
Claim 6 and 7 are rejected under 35 U.S.C. 103 as being obvious over Tarke (US20220257093A1, disclosed in Applicant IDS) and Abramek (US20210386424A1) as applied in Claim 1 and in further 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_image7.png
363
628
media_image7.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_image8.png
251
339
media_image8.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_image7.png
363
628
media_image7.png
Greyscale
Figure 38 of Tarke
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over Tarke (US20220257093A1, disclosed in Applicant IDS) and Abramek (US20210386424A1) as applied in Claim 1 and in further view of Laby (US20210290310A1).
Regarding Claim 8, Tarke and Abramek teach the limitations of Claim 1, and Tarke further teaches wherein the instrument coupling arm 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_image9.png
169
376
media_image9.png
Greyscale
Figure 39 of Tarke
Tarke and Abramek do not teach a port engagement surface configured to contact a fluid port of the instrument.
Laby, in a similar field of endeavor, teaches a similar concept (surgical navigation tools) of a port engagement surface configured to contact a fluid port of the instrument (Corresponding disclosure in at least Figure 4 and [0094], where there is a port engagement surface, or the proximal housing that contacts a fluid port of the instrument, or the catheter, where fluid passes through between the catheter and the port, hence the fluid port “Sterile junction 76 releasably latches to lower housing 74 and includes a sterile barrier body that extends between catheter 12 and the driver contained within the sterile housing. Along with components that allow articulation fluid flow to pass through the sterile fluidic junction”).
PNG
media_image10.png
443
592
media_image10.png
Greyscale
Figure 4 of Laby
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a port engagement surface contacting a fluid port of an instrument as taught by Laby. One of the ordinary skill in the art would have been motivated to incorporate this because this allows for fluid to pass between the adapter and the instrument.
Response to Arguments
Applicant's arguments filed 07/08/2026 regarding the Drawing Objections have been fully considered and the objections are withdrawn in light of the amendments.
Applicant's arguments filed 07/08/2026 regarding the previously imposed Claim Objections have been fully considered and the objections are withdrawn in light of the amendments. However, a new objection has been added in light of the amendments (see above).
Applicant's arguments filed 07/08/2026 regarding the 35 U.S.C. 112b rejections have been fully considered and the rejections are withdrawn in light of the amendments.
Applicant’s arguments with respect to claims 1, 6-8, and 10-11 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.
Applicant's arguments filed 07/08/2026 regarding the 35 U.S.C. 102 and 103 rejections have been fully considered but they are not persuasive. Applicant argues that the irrigation assembly is not an element of the adapter sheath but rather of the instrument. However, [0171] provides further support regarding the adapter, where the adapter itself includes a shaft assembly, which is where the irrigation assembly is disposed ([0171] “As shown in FIG. 39-40, adapter sheath (1100) of the present example includes a hub (1110), a shaft assembly (1120) extending distally from hub”). Even in the instance where the irrigation nozzle is located on the instrument, Claim 16 only recites “an irrigation nozzle located at the distal end of the adapter body”. There is no further indication of where the instrument is located in the instant application, so the given example in the arguments (see page 9) where an instrument with an irrigation nozzle is attached at the distal end of the adapter body, it would still read on the claim because the irrigation nozzle would be at the distal end of the adapter body.
All other dependent claims are rejected due to their dependency to the rejected independent claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 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
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
Prosecution Insights