DETAILED ACTION
The following Office Action is in response to the Non-Provisional Patent Application filed on July 11, 2024. Claims 1-20 are currently pending.
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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a torquer with a torque limiting actuator, classified in A61M 25/0113.
II. Claims 18-20, drawn to an EMD drive system, classified in A61B 2034/301.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination of Group II does not require the torquer to releasably secure the elongated medical device, or a body, a first pad, a biasing member, an actuator, and a knob of Group I. The subcombination has separate utility such as utilizing the torquer as a hand held device as opposed to being used in a robotic system.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The claims may be classed in separate subclasses and require diverging fields of search. The torquer of Group I requires a search in A61M 25/01 for catheter advancers and mechanical advancing means while the EMD drive system requires search primarily in A61B 34/30 in surgical robots.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Joshua Ryan on December 4, 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Claim Objections
Claim 16 is objected to because of the following informalities: Line 1 of the claim does not have a transition word at the end of the preamble. For the purposes of compact prosecution, the preamble will be interpreted as reading “A torquer for an elongated medical device comprising:”. 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 11 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. Lines 1-2 of the claim recite the limitation of “wherein the pusher includes a second pusher land surface coplanar to the first housing land surface”. However, claim 8, already states that the first pusher land surface is coplanar with the first housing land surface, therein making it indefinite as to whether the second pusher land surface is also intended to be coplanar with the first housing land surface, or if the limitation includes a typographical error and the second pusher land surface is intended to be coplanar with the second housing land surface. For the purposes of compact prosecution, the limitation will be interpreted as reading “wherein the pusher includes a second pusher land surface coplanar to the second housing land surface”.
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.
Claim(s) 1-7 and 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zirps et al. (US 2024/0207574, hereinafter Zirps ‘574).
Concerning claim 1, the Zirps ‘574 prior art reference teaches a device for manipulating an elongated medical device (Figure 1; 10) comprising: a torquer releasably securing an elongated medical device (EMD) thereto (Figure 4; 102); and a torque limiting actuator limiting a torque applied to the torquer (Figure 4; 104) in a fully open position (Figure 11; fully open position = opening of cover; cover 218 opens upon a torque applied to torquer that exceeds a predetermined torque, therein having the torque still being limited in a fully open position | [¶ 0094]).
Concerning claim 2, the Zirps ‘574 reference teaches the device of claim 1, wherein the torque limiting actuator limits a torque applied to the torquer in a fully closed position ([¶ 0094]; fully closed position = closed in-use position).
Concerning claim 3, the Zirps ‘574 reference teaches the device of claim 1, further including a shaft that is movably positioned within a torquer housing (Figure 5; 150) to a fixed position relative to the torquer housing (Figure 11; shaft movable distally to stop 216 which is at a fixed position) in the fully open position (Figure 11; shaft may be in said position when cover is in fully opened position).
Concerning claim 4, the Zirps ‘574 reference teaches the device of claim 1, further including a member (Figure 5; 124) having a proximal collar (Figure 5; 190) that is slidably received on a shaft (Figure 5; 190) that is movably positioned within a torquer housing (Figure 5; 108), the proximal collar prohibiting the member and a distal portion of the shaft from entering a threaded portion of the torquer housing (Figure 7; 176).
Concerning claim 5, the Zirps ‘574 reference teaches the device of claim 1, further including at least a first pad (Figure 9; 122) having a first post and a second post extending perpendicular to a longitudinal axis of the torquer (Figure 9; 226), the first pad being movable in a direction perpendicular to the longitudinal axis of the torquer to pinch the EMD, a pad biasing member (Figure 9; 124) includes a first arm (Figure 9; 212) having a first bearing surface (Figure 9; 224) that receives the first post of the first pad and a second arm (Figure 9; 214) having a second bearing surface that receives the second post of the first pad, the first arm and the second arm biasing the first pad in a direction away from the longitudinal axis of the torquer ([¶ 0078]).
Concerning claim 6, the Zirps ‘574 reference teaches the device of claim 1, further including at least a first pad (Figure 9; 122) movable toward and away from a longitudinal axis of the torquer to pinch and unpinch the EMD, the first pad including a first land portion spaced from and parallel to the longitudinal axis of the torquer (Figure 7; portion of 122 between 138 and 140) that contacts a torquer housing (Figure 7; 112) that maintains the first pad in a parallel orientation of the longitudinal axis in the fully open position (Figure 11).
Concerning claim 7, the Zirps ‘574 reference teaches the device of claim 1, wherein the torquer includes a torquer housing (Figure 7; 112) having a land surface (Figure 7; distalmost surface of 112), and a first pad (Figure 7; 122) including a first leveling surface (Figure 7; portion of 122 between 138 and 140) having a first portion in contact with the first housing land surface (Figure 11), the first housing land surface being spaced from and substantially parallel to a longitudinal axis of the torquer (Figure 11).
Concerning claim 12, the Zirps ‘574 reference teaches the device of claim 1, wherein the torque limiting actuator includes a shaft (Figure 7; 150) having a portion threadably secured to the housing of the torquer (Figure 7; 108) and a distal portion operatively moving a pad (Figure 7; 122) into engagement with the EMD upon rotation of the shaft relative to the torquer housing, the shaft travels to a fixed position within the torquer when the torquer (Figure 11; shaft movable distally to stop 216 which is at a fixed position) is in the fully open position (Figure 11; shaft may be in said position when cover is in fully opened position), a knob is releasably connected to the shaft upon an application of a predetermined torque when the torquer is in the fully open position ([¶ 0085]).
Concerning claim 13, the Zirps ‘574 reference teaches the device of claim 12, wherein the knob is releasably connected to the shaft upon the application of a predetermined torque when the torquer is in a fully closed position ([¶ 0085]).
Concerning claims 14 and 15, the Zirps ‘574 reference teaches the device of claim 1, wherein the torque limiting actuator is capable of limiting the torque applied to a torquer to a first predetermined torque in a fully closed position and to a second predetermined torque in the fully open position, wherein the first and second predetermined torques are equal and greater than zero.
Concerning claim 16, the Zirps ‘574 prior art reference teaches a torquer for an elongated medical device (Figure 4; 102), comprising: a body having a cavity defining a pathway (Figure 7; 110); a first pad movable within the cavity (figure 7; 122); a biasing member separate from the first pad biasing thee first pad relative to the body (Figure 7; 112); an actuator movable relative to the body moving the first pad (Figure 7; 104), wherein movement of the first pad pinches and/or unpinches the elongated medical device, with the first pad, within the pathway; and a knob (Figure 5; 160) releasably connected to a shaft of the actuator (Figure 5; 150) upon an application of a predetermined torque exceeding a predetermined value ([¶ 0085]) in a fully open position (Figure 11; fully open position = opening of cover; cover 218 opens upon a torque applied to torquer that exceeds a predetermined torque, therein having the torque still being limited in a fully open position | [¶ 0094]), wherein the shaft is movable to a fixed position relative to an actuator body in the fully open position (Figure 11; shaft movable distally to stop 216 which is at a fixed position).
Concerning claim 17, the Zirps ‘574 reference teaches the torquer of claim 16, wherein the first pad including a first land portion spaced from and parallel to the longitudinal axis of the torquer (Figure 7; portion of 122 between 138 and 140) that contacts a torquer housing (Figure 7; 112) that maintains the first pad in a parallel orientation of the longitudinal axis in the fully open position (Figure 11).
Claim(s) 1 and 7-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zirps et al. (US 2024/0024629, hereinafter Zirps ‘629).
Concerning claim 1, the Zirps ‘629 prior art reference teaches a device for manipulating an elongated medical device (Figure 1; 10) comprising: a torquer releasably securing an elongated medical device (EMD) thereto (Figure 4; 100); and a torque limiting actuator limiting a torque applied to the torquer (Figure 4; 106) in a fully open position ([¶ 0158], cassette 66 in which the torquer is disposed may include a cover, wherein the cover may be taken off to define a fully open position, wherein the torque limiting actuation may still limit the torque applied to the torquer when the cover is removed).
Concerning claim 7, the Zirps ‘629 reference teaches the device of claim 1, wherein the torquer includes a torquer housing (Figure 15; 206, 208) having a land surface (See OA Figure 1 below), and a first pad (Figure 15; 210) including a first leveling surface (See OA Figure 1 below) having a first portion in contact with the first housing land surface (See OA Figure 1 below), the first housing land surface being spaced from and substantially parallel to a longitudinal axis of the torquer.
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OA Figure 1
Concerning claim 8, the Zirps ‘629 reference teaches the device of claim 7, wherein the torquer includes a pusher movable within the torquer housing (Figure 15; inner surface of housing portion 206 may be interpreted as a pusher) to move the first pad in a direction perpendicular to the longitudinal axis of the torquer to pinch the EMD (Figures 15-17), the pusher includes at least a first pusher land surface coplanar to the first housing land surface (See OA Figure 1 below), the first leveling surface includes a second portion in contact with the first pusher land surface when the torquer is in the fully open position.
Concerning claim 9, the Zirps ‘629 reference teaches the device of claim 8, further including a second pad (Figure 15; 212) movable toward and away from the longitudinal axis of the torquer to pinch and unpinch the EMD between the first pad and the second pad, the second pad including a second land portion spaced from and parallel to the longitudinal axis of the torquer that contacts the torquer housing to maintain the second pad in a parallel orientation to the first pad and the longitudinal axis of the torquer in the fully open position (See OA Figure 1 below).
Concerning claim 10, the Zirps ‘629 reference teaches the device of claim 9, wherein the torquer housing includes a second housing land surface (See OA Figure 1 below), the second pad includes a second leveling surface having a first portion in contact with the second housing land surface, the second housing land surface being spaced from and substantially parallel to the longitudinal axis of the torquer (See OA Figure 1 below).
Concerning claim 11, the Zirps ‘629 reference teaches the device of claim 10, wherein the pusher includes a second pusher land surface coplanar to the second housing land surface (See OA Figure 1 below), the second leveling surface includes a second portion in contact with the second pusher land surface when the torquer is in the fully open position (See OA Figure 1 below).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Wenderow et al. reference (US 2013/0231678) and the Klem et al. reference (US 2022/0233264) both teach robotic catheter systems with wheel pads that may limit torque and a cover that may be in an open or closed position; and the Gill et al. reference (US 2020/0398031) and the Dolan et al. reference (US 2022/0395285) both teach torque limiting devices including first and second pads, a pusher, and a housing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN T TON/Examiner, Art Unit 3771 4/15/2026
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