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 with traverse of 5/26/2026 in the reply filed on 5/26/2026 is acknowledged. The traversal is on the ground(s) that the Examiner has not provide an explanation to support conclusions (a) and (b). This is not found persuasive because (a) the divergent subject matter is already apparent in the drawings and claimed subject matter (b) the divergent matter would require a different field of search, as differing species would require differing search terms. The Examiner’s rationale is supported.
The requirement is still deemed proper and is therefore made FINAL.
Claims 33, 43, 44, 47 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/26/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 31: “an instrument driver configured to operate the elongate body” is being interpreted as set forth in [0017] of the instant application as “robotic”.
Claims 45 and 50: “an insertion control member configured to … advance… to retract…” is being interpreted as set forth in [0037] as insert and retract buttons.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 32 is objected to because of the following informalities: the two instances of “the axis of rotation” should read “the axis of rotation defined by the support member”. 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 41 and 48 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.
Regarding Claims 41 and 48, the limitation “at least one of … or …” renders the claim indefinite as at least one of implies that two may be selected, but the “or” operator indicates that only one may be selected. For purposes of examination the indefinite limitation has been deemed to claim “at least one of … and …”.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 31, 38-42 and 50 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by US 20110166513 A1 to Cohen et al. (hereinafter, Cohen).
Regarding Claim 31, Cohen discloses a robotic system, comprising inter alia:
(a) an elongate body (catheter sheath 182) extending along a longitudinal axis, the elongate body being translatable along the longitudinal axis ([0218] “Catheter sheath 182 is physically attached to handle 172 so that movement of handle 172 forward or backward in direction arrow 192 or 194 causes catheter sheath 182, as well as distal end 188, to move similarly.”), the elongate body being rotatable about the longitudinal axis ([0218] “ Rotation or torquing of handle 172 in a clockwise or counterclockwise manner as is shown by arrows 196 and 198, will impart a similar rotation to catheter sheath 182.”);
(b) an instrument driver (motors 105, 148 and 209 on based 102/support base 114, with rotation assembly 152 handle controller 120/136) configured to operate the elongate body (Abstract “In one embodiment a first motor is connected through a drive screw to a handle controller to move the medical device forward and backward. A second motor is connected to drive wheels effective to rotate the medical device clockwise and counter-clockwise.”) ([0223] “Mounted to support base 114 is a rotation assembly 152, a motor 148 and terminal connectors 146.”) ([0225] “Motor 148 imparts rotation to drive wheels 164 to rotate handle 136.”); and
(c) an elongate body control device comprising:
(i) a rotary control member (rotation dial 246) that is configured to control rotation of the elongate body about the longitudinal axis ([0233] “A rotation dial 246 is connected to motor 148 (see FIG. 7) so that movement of dial 246 supplies power and a control signal to the motor and causes rotational movement of catheter 142.”), the rotary control member being coupled to a support member (remote control station 240) such that the rotary control member is configured to rotate about an axis of rotation defined by the support member (Rotation dial 246 is carried on the remote control station 240 and the dial rotates about the axis defined by its mount in station 240, a dial about the axis fixed by itself/own structure; [0233] “Remote control station 240 has a master switch 242 effective to supply power to each of the motors connected to remote control station 240. A forward/reverse dial 244 is connected to motor 105 (FIG. 2) so that movement of dial 244 supplies power and a control signal to motor 105 and imparts forward and backward movement of catheter 142. A forward/reverse power switch 250 selectively supplies power to dial 244.”), and
(ii) at least one insertion control member (forward/reverse dial 244) that is configured to control translation of the elongate body along the longitudinal axis ([0233] “A forward/reverse dial 244 is connected to motor 105 (FIG. 2) so that movement of dial 244 supplies power and a control signal to motor 105 and imparts forward and backward movement of catheter 142.”), the at least one insertion control member being coupled to the support member (Both dials sit on the one station and are therefore coupled to one another; [0233] “Remote control station 240 has a master switch 242… a forward/reverse dial 244… a rotation dial 246…”).
Regarding Claim 38, Cohen discloses the robotic system of claim 31, the at least one insertion control member (forward/reverse dial 244) including two insertion control members (dial 244 and switch 250)).
Regarding Claim 39, Cohen discloses the robotic system of claim 31, the at least one insertion control member (forward/reverse dial 244) being configured to selectively mechanically engage the rotary control member (rotation dial 246) (via the motor 105 that powers them).
Regarding Claim 40, Cohen discloses the robotic system of claim 31, the at least one insertion control member (forward/reverse dial 244) being configured to be selectively engaged by a digit of an operator (forward/reverse dial 244 is capable of being engaged by a digit of an operator).
Regarding Claim 41, Cohen discloses the robotic system of claim 31, the at least one insertion control member (forward/reverse dial 244) including at least one of a switch (switch 250).
Regarding Claim 42, Cohen discloses the robotic system of claim 31, the at least one insertion control member (forward/reverse dial 244) including at least one button (switch 250).
Regarding Claim 50, Cohen discloses a robotic system, comprising inter alia:
(a) an insertion control member (forward/reverse dial 244) configured to advance a guide wire in a forward direction and retract the guide wire in a reverse direction along a longitudinal axis of the guide wire ([0233] “A forward/reverse dial 244 is connected to motor 105 (FIG. 2) so that movement of dial 244 supplies power and a control signal to motor 105 and imparts forward and backward movement of catheter 142.”); and
(b) a rotary member (rotation dial 246) configured to roll the guide wire about the longitudinal axis ([0233] “A rotation dial 246 is connected to motor 148 (see FIG. 7) so that movement of dial 246 supplies power and a control signal to the motor and causes rotational movement of catheter 142.”), wherein the rotary member is coupled to a vertical support member (remote control station 240) on an axis of rotation extending along an axis of the vertical support member (Rotation dial 246 is carried on an “axis” of the remote control station 240 in a “vertical” manner and the dial rotates about the axis defined itself on the remote control station station 240 - a dial about the axis fixed by itself/own structure; [0233] “Remote control station 240 has a master switch 242 effective to supply power to each of the motors connected to remote control station 240. A forward/reverse dial 244 is connected to motor 105 (FIG. 2) so that movement of dial 244 supplies power and a control signal to motor 105 and imparts forward and backward movement of catheter 142. A forward/reverse power switch 250 selectively supplies power to dial 244.”), wherein the insertion control member includes:
(i) an insertion control (forward/reverse dial 244) coupled to the rotary member (rotation dial 246) and configured to provide commands for axial insertion control of the guide wire (Both dials sit on the one station and are therefore coupled to one another; [0233] “Remote control station 240 has a master switch 242… a forward/reverse dial 244… a rotation dial 246…”), and
(ii) a retraction control coupled to the rotary member and configured to provide commands for axial retraction control of the guide wire (the reverse (retraction) function of dial 244, likewise coupled to station 240; diam 244 “imparts forward and backward movement of catheter 142” – the backward command being axial retraction).
Allowable Subject Matter
Claims 32, 34-37 and are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 45 is allowable over the prior art of record. The closest prior art of US 20110166513 A1 to Cohen et al. fail to disclose, teach or fairly suggest, singly and in combination, a digital holder attached to a top face of the rotary member (Cohen et al. disclose roll control as a console dial and has no finger holder mounted on the face of the rotating roll member), a digit holder support at a location offset from a center of the rotary member (Cohen et al. do not disclose an offset mounting of a finger holder on the roll member), and the digit holder is configured to rotate about an axis of the digit holder support (Cohen et al. do not disclose a finger holder that idles/self-rotates on its own axis while the roll member turns).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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