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 .
This Action is in response to Applicant’s amendment filed April 7, 2026.
Claims 1, 2, 6-8, 15, 16, and 19 are currently amended.
Claims 5 and 18 are cancelled.
Claims 21 and 22 are new.
Claims 1-4, 6-17, and 19-22 are being examined in this Office Action.
Claim Objections
Claim 15-22 is objected to because of the following informalities:
Claim 15 states the limitation “when the handle is connected to robotic arm”, this should read “when the handle is connected to a robotic arm”
Appropriate correction is required.
All remaining claims are objected to by virtue of their dependance on an objected claim
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 “wherein upon pressing down on the tab against the force, it is configured to cause the gear of the tab to disengage from the second gear of the first engagement member.” It is unclear what “it” is referring to, examiner interprets “it” to be the spring.
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, 6-17, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baez, JR. (Pub. No. US 20200060516 A1).
Regarding Claim 1, Baez, JR. discloses a robotically-controllable catheter assembly (Figs. 21A-22A) comprising:
an elongate shaft (203, Fig. 21 A) including a lumen and configured to couple to an aspiration system to provide aspiration to a target site via the lumen (“The elongated shaft 203 can include a working channel (not illustrated) through which additional instruments or tools can pass for delivery to the distal end 205” – Paragraph [0160], working channel capable of coupling to an aspiration system to provide aspiration); and
an instrument base (201) coupled to the elongate shaft (Fig. 21A) and configured to control actuation of the elongate shaft (Paragraph [0160]), the instrument base including a drive input assembly (227) configured to couple to a drive output assembly (304 of adapter 300) associated with a robotic arm when the instrument base is connected to the robotic arm (end of 306 configured to attach to a robotic arm in Fig. 22A, Paragraph [0181]),
a handheld instrument adapter (300, Fig. 22A) configured to receive manual input to control manipulation of the elongate shaft (203) when the handheld instrument adapter is connected to the instrument base (Paragraph [0181], Fig. 22A), the handheld instrument adapter including:
a coupler (304, Fig. 22A) configured to couple to the drive input assembly of the instrument base (“One or more of the robotic drive outputs 304 can engage the robotic drive inputs 227 (FIG. 21C) of the instrument handle 201” – Paragraph [0181]); and
a manual actuator (219) connected to the coupler (Fig. 22A) and configured to manipulate the coupler (Paragraph [0163]).
Regarding Claim 2, Baez, JR. discloses the robotically-controllable catheter assembly of claim 7, wherein the elongate shaft includes another lumen (“the pull wires can extend through lumens braided into or otherwise formed into the elongated shaft 203.” – Paragraph [0178]),
and the pull wire is slidably disposed in the other lumen and connected to a distal end of the elongate shaft (205), and wherein the drive input assembly is connected to the pull wire to control articulation of the elongate shaft (“pull wires can be included in or on the elongated shaft 203 to control articulation of the elongated shaft 203.” – Paragraph [0160], Paragraph [0163], Fig. 21A).
Regarding Claim 3, Baez, JR. discloses the robotically-controllable catheter assembly of claim 1, wherein the instrument base (201) includes a port (209) coupled to a proximal end of the elongate shaft (Fig. 21B) and configured to couple to the aspiration system (“The medical instrument 200 can include a working channel entry port 209 configured to allow access to the working channel” – Paragraph [0160], working channel able to couple to an aspiration system).
Regarding Claim 6, Baez, JR. discloses the robotically-controllable catheter assembly of claim 1, wherein the coupler includes a gear assembly (229 with keyed portions 247 and 245, Fig. 21E) engaged with the manual actuator and configured to engage with the drive input assembly (Fig. 21F, Paragraph [0174]).
Regarding Claim 7, Baez, JR. discloses the robotically-controllable catheter assembly of claim 6, further comprising: a pull wire (249, 251, 253, 255) configured to manipulate the elongate shaft (Paragraph [0178]); wherein the coupler includes a tensioning mechanism configured to disengage the manual actuator from manipulating the drive input assembly and configured to adjust tension of the pull wire (Paragraph [0178]).
Regarding Claim 8, Baez, JR. discloses a system (Figs. 21A-22A) comprising:
a robotically-controllable medical instrument (200, Paragraph [0159], Fig. 21A) including a drive input assembly (227, Figs. 21B-C) actuatable to articulate the robotically-controllable medical instrument (Paragraph [0165]), the drive input assembly is actuated by a drive output assembly of a robotic arm when the robotically-controllable medical instrument is connected to the robotic arm (“The robotic drive inputs 227 are configured to engage corresponding robotic drive outputs on an instrument drive mechanism when the instrument handle 201 is attached to the instrument drive mechanism” – Paragraph [0165], Fig. 22A);
a handheld instrument adapter (300, Fig. 22A) connectable to the robotically-controllable medical instrument (Fig. 22A), including:
a base (302, Fig. 22A);
a coupler rotatably supported in the base (304, Fig. 22A), the coupler configured to couple to the drive input assembly (Paragraph [0165]); and
a first manual actuator (219) operatively coupled to the coupler (Fig. 22A) and configured to manipulate the coupler to actuate the drive input assembly to articulate the robotically-controllable medical instrument to articulate when the handheld instrument adapter is connected to the robotically- controllable medical instrument (Paragraph [0161]).
Regarding Claim 9, Baez, JR. discloses the system of claim 8, wherein the coupler includes an engagement assembly (304) coupled to the first manual actuator (Figs. 21F, 22A) and configured to couple to the drive input assembly of the robotically-controllable medical instrument (“The distal face 302 can include robotic drive outputs 304 positioned thereon. One or more of the robotic drive outputs 304 can engage the robotic drive inputs 227 (FIG. 21C) of the instrument handle 201” – Paragraph [0181]).
Regarding Claim 10, Baez, JR. discloses the system of claim 9, wherein the engagement assembly includes (i) a first engagement member (239, side attached to manual drive input 219, Fig. 21F) to engage with the manual actuator (“the manual drive input 219 is attached to a shaft 239 of the first pulley assembly 229” – Paragraph [0172]), (ii) a second engagement member (239, side attached to robotic drive input 227) configured to engage with the drive input assembly (“one end of the shaft 239 can be connected to the first robotic drive input 227a” – Paragraph [0175]), and (iii) a disengagement mechanism (“The second pulley 243 can be configured to be removably attachable to the shaft 239” – Paragraph [0174]) configured to disengage a coupling of the first engagement member to the second engagement member (Paragraph [0174]).
Regarding Claim 11, Baez, JR. discloses the system of claim 10, wherein the disengagement mechanism includes a second manual actuator configured to receive manual input to disengage the coupling of the first engagement member to the second engagement member (“The manual interface can include one or more manual drive inputs that can be operated by hand. For example, the manual interface may couple manual drive inputs (e.g., levers, sliders, wheels, etc.), which are suitable for hand operation to the robotic drive inputs (e.g., spline-type rotational couplers)” – Paragraph [0214], Paragraph [0173]).
Regarding Claim 12, Baez, JR. discloses the system of claim 8, further comprising: the robotically-controllable medical instrument including (i) an elongate shaft (203, Fig. 21A) configured to couple to an aspiration system to provide aspiration to a target site (“The elongated shaft 203 can include a working channel (not illustrated) through which additional instruments or tools can pass for delivery to the distal end 205.” – Paragraph [0160], aspiration system being capable of entering working channel), and (ii) an instrument base (201) coupled to the elongate shaft (Fig. 21A) and configured to control actuation of the elongate shaft (Paragraph [0160]), the instrument base including the drive input assembly (227, Fig. 21C).
Regarding Claim 13, modified Baez, JR. discloses the system of claim 12, wherein the elongate shaft includes a lumen (“the pull wires can extend through lumens braided into or otherwise formed into the elongated shaft 203.” – Paragraph [0178]), and the robotically-controllable medical instrument further includes an elongate movement member slidably disposed in the lumen and connected to a distal end (205) of the elongate shaft (“pull wires can be included in or on the elongated shaft 203 to control articulation of the elongated shaft 203.” – Paragraph [0160]);
wherein the drive input assembly is connected to the elongate movement member to control articulation of the elongate shaft (Paragraph [0163], Fig. 21A).
Regarding Claim 14, modified Baez, JR. discloses the system of claim 13, wherein the coupler includes a tensioning mechanism (Paragraph [0178]) configured to disengage the first manual actuator from manipulating the drive input assembly (Paragraph [0187]) and configured to adjust tension of the elongate movement member (Paragraph [0178]).
Regarding Claim 15, Baez, JR. discloses a system (Figs. 21A-22A) comprising:
an elongate shaft (203, Fig. 21A) including a distal end portion (205), a proximal end portion (207), and a lumen (“working channel” – Paragraph [0160]), the elongate shaft being configured to couple to an aspiration system to provide aspiration via the lumen (“The elongated shaft 203 can include a working channel (not illustrated) through which additional instruments or tools can pass for delivery to the distal end 205” – Paragraph [0160], aspiration system capable of entering working channel, Fig. 21A); and
a handle (201) coupled to the elongate shaft (Fig. 21A) and configured to operate in:
a robotic mode in which the handle receives robotic input to control articulation of the elongate shaft when the handle is connected to robotic arm (Paragraph [0161], Fig. 22A); and
a manual mode in which the handle receives manual input to control articulation of the elongate shaft (Paragraph [0161]) when the handle is connected to a handheld adapter (300, Fig. 22A).
Regarding Claim 16, Baez, JR. discloses the system of claim 15, further comprising: the robotic arm (Fig. 22A) including a drive output assembly (304 of adapter 300) configured to provide the robotic input to the handle (Paragraph [0181]); wherein the handle is coupled to the drive output assembly of the robotic arm (Fig. 22A).
Regarding Claim 17, Baez, JR. discloses the system of claim 15, wherein the handle (201) includes a manual actuator (219) coupled to the elongate shaft (Fig. 21A) and configured to receive the manual input (Paragraph [0163]).
Regarding Claim 19, Baez, JR. discloses the system of claim 15, wherein the adapter includes a coupler (304 of adapter 300) configured to couple to a drive input assembly of the instrument base (Paragraph [0181]), the coupler including (i) a first engagement member (239 the side attached to the manual drive input, Fig. 21F) to engage with the manual actuator (“the manual drive input 219 is attached to a shaft 239 of the first pulley assembly 229” – Paragraph [0172]), (ii) a second engagement member (239, the side attached to the robotic drive input) configured to engage with the drive input assembly (“one end of the shaft 239 can be connected to the first robotic drive input 227a” – Paragraph [0175]), and (iii) a disengagement mechanism (“the second pulley 243 can be configured to be removably attachable to the shaft 239” – Paragraph [0174]) configured to disengage a coupling of the first engagement member to the second engagement member (Paragraph [0174]).
Regarding Claim 20, Baez, JR. discloses the system of claim 19, wherein the disengagement mechanism (Paragraph [0174]) includes another manual actuator (“a second manual drive input (not illustrated) can be rotationally coupled to the second pulley assembly 235 to further allow manual control of the elongated shaft” – Paragraph [0173]) configured to receive manual input to disengage the coupling of the first engagement member to the second engagement member (Paragraph [0174]).
Claim Rejections - 35 USC § 103
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 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baez, JR. in view of Graetzel et al. (Pub. No. US 20190000566 A1, herein Graetzel).
Regarding Claim 4, Baez, JR. discloses the robotically-controllable catheter assembly of claim 1.
Baez, JR. does not expressly disclose wherein the instrument base includes an identification element associated with an identifier for the robotically-controllable catheter assembly, the identification element including at least one of a radio-frequency identification tag, a Quick Response (QR) code, a bar code, or a magnet.
Graetzel teaches wherein the instrument base includes an identification element associated with an identifier for the robotically-controllable catheter assembly, the identification element including at least one of a radio-frequency identification tag, a Quick Response (QR) code, or a bar code (Paragraph [0158]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the robotically-controllable catheter assembly disclosed by Baez, JR. wherein the instrument base includes an identification element associated with an identifier for the robotically-controllable catheter assembly, the identification element including at least one of a radio-frequency identification tag, a Quick Response (QR) code, or a bar code as taught by Graetzel so that providers are able to retrieve computer readable mediums associated with the medical instrument (Graetzel, Paragraph [0157]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baez, JR.
Regarding Claim 21, Baez, JR. discloses the system of claim 15, wherein the adapter further includes: a first manual actuator (219, Fig. 21A) configured to receive a first manual input of the manual input (“the first manual drive input is configured to drive two-way deflection of the elongated shaft” – Paragraph [0015]); and a coupler (304 of adapter 300, Fig. 22A) configured to couple to a drive input assembly of the handle (Paragraph [0181]), the coupler including (i) a first engagement member to engage with the first manual actuator (239 the side attached to the manual drive input, Fig. 21F), (ii) a second engagement member (239 the side attached to the robotic drive input, Fig. 21F) configured to engage with the drive input assembly (“one end of the shaft 239 can be connected to the first robotic drive input 227a” – Paragraph [0175]), and (iii) a disengagement mechanism (“The second pulley 243 can be configured to be removably attachable to the shaft 239” – Paragraph [0174]) configured to disengage a coupling of the first engagement member to the second engagement member (Paragraph [0174]).
Baez, JR. does not express disclose the disengagement mechanism includes a second manual actuator configured to receive a second manual input to disengage the coupling of the first engagement member to the second engagement member, wherein once the coupling is disengaged, the second manual actuator is configured to be capable of actuating the second engagement member without actuating the first manual actuator.
However, in a differing embodiment, Baez, JR. teaches the disengagement mechanism includes a second manual actuator (“a second manual drive input (not illustrated) can be rotationally coupled to the second pulley assembly 235 to further allow manual control of the elongated shaft in, for example, the left and right directions.” – Paragraph [0173], Examiner interprets a second manual drive input would include a second manual drive actuator since a first manual drive input is actuated manually) configured to receive a second manual input to disengage the coupling of the first engagement member to the second engagement member (Examiner interprets that second manual actuator is capable of receiving input to disengage coupling of manual actuator 219 to the first engagement member), wherein once the coupling is disengaged, the second manual actuator is configured to be capable of actuating the second engagement member without actuating the first manual actuator (second manual actuator able to allow manual control in the left and right directions without engagement of shaft 239 attached to manual drive input 219, Paragraph [0173]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Baez, JR. wherein the disengagement mechanism includes a second manual actuator configured to receive a second manual input to disengage the coupling of the first engagement member to the second engagement member, wherein once the coupling is disengaged, the second manual actuator is configured to be capable of actuating the second engagement member without actuating the first manual actuator as taught by the differing embodiment so that the elongate shaft may further be controlled in the left and right directions (Paragraph [0173]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baez, JR. in view of Shelton, IV et al. (Pub. No. US 20190200998 A1, herein Shelton, IV).
Regarding Claim 22, modified Baez, JR. discloses the system of claim 21, wherein the first engagement member comprises a first gear (245) and a second gear (247 of the first pully assembly 227, Fig. 21E),
the second manual actuator attached to the second pulley assembly (235), being similar to the first pulley assembly (229, Paragraph [0174]) comprising a tab with a gear (similar to shaft 239 of first pulley assembly) mating engageable with the second gear of the first engagement member (Fig. 21D).
Baez, JR. does not expressly disclose when disposed in the handle, the second engagement member holds a spring configured to exert a force along the rotational axis on the tab to engage the gear of the tab with the second gear of the first engagement member, and wherein upon pressing down on the tab against the force, it is configured to cause the gear of the tab to disengage from the second gear of the first engagement member.
Shelton, IV teaches a rotary driver actuator (Fig. 25) holding a spring (201872) configured to exert a force along the rotational axis on the tab to engage the gear (201874) with the second gear (201878), and wherein upon pressing down on the tab against the force, it is configured to cause the gear of the tab to disengage from the second gear (“resilient member 201872 extends distally from rib 201828 of handle housing 201816 to a first gear 201874, which is unitarily secured to the distal end of motor housing 201818. When rotation knob 201812 is in the proximal position, resilient member 201872 compresses between first gear 201874 and rib 201828 to resiliently bias handle housing 201816 to the distal position.” – Paragraph [0493])
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Baez, JR. where when disposed in the handle, the second engagement member holds a spring configured to exert a force along the rotational axis on the tab to engage the gear of the tab with the second gear of the first engagement member, and wherein upon pressing down on the tab against the force, it is configured to cause the gear of the tab to disengage from the second gear of the first engagement member as taught by Shelton, IV in order to provide a biasing means for the manual actuator, e.g. allowing single hand articulation of the elongate shaft rather than two hand articulation.
Response to Arguments
Applicant’s arguments filed April 7, 2026 have been fully considered.
In regards to Applicant’s argument:
“Claims 1, 2, and 5-20 stand rejected under 35 U.S.C. § 102 over U.S. Patent Pub. 2020/0060516 to Baez. Office Action at pg. 2. Applicant respectfully disagrees and submits that the cited reference does not disclose each and every limitation of independent claim 1 as required to anticipate this claim under 35 U.S.C. § 102.”
This argument is persuasive and the 35 U.S.C. § 102 rejection for claims 1, 2 and 5-20 have been withdrawn, however, upon further consideration, a new ground of rejection is made in view of an alternate embodiment of Baez, JR.
In regards to Applicant’s argument:
“Dependent claim 3 stands rejected under 35 U.S.C. § 103 as being unpatentable over Baez. Office Action at pg. 10. Applicant respectfully disagrees.”
This argument is persuasive and the 35 U.S.C. § 103 rejection for claim 3 has been withdrawn, however, upon further consideration, a new ground of rejection is made in view of an alternate embodiment of Baez, JR.
In regards to Applicant’s argument that:
“Dependent claim 4 stands rejected under 35 U.S.C. § 103 as being unpatentable over Baez in view of U.S. Patent Pub. 2019/0000566 to Graetzel. Office Action at pg. 10. Applicant respectfully disagrees.”
This argument is persuasive and the 35 U.S.C. § 103 rejection for claim 4 has been withdrawn, however, upon further consideration, a new ground of rejection is made in view of an alternate embodiment of Baez, JR.
Conclusion
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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