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 .
For the purpose of examination, all references to the as-filed specification have been made using the USPGPub. version of the instant application.
Election/Restrictions
Applicant’s election of Species A-I and Species B-I (claims 1-15, and 17) in the reply filed on June 8, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 16 & 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species A-II and Species B-II, there being no allowable generic or linking 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.
Claims 3 and 13 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.
In claim 3, it is unclear if the limitation of “a proximal articulation control knob” is part of the medical device or that is responsible for controlling first or second actuator. Applicant is recommended to amend claim 3 to be consistent with the specification, which discloses a proximal articulation control knob being part of a second actuator ([0103]).
The term “desired” in claim 13 is a relative term which renders the claim indefinite. The term “desired” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The locking position of the distal articulation section has been rendered indefinite by the use of the relative term “desired”.
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 rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
Claims 1-3 & 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 2014/0276395 hereinafter Wilson).
Regarding claims 1-2 & 9, Wilson teaches a medical device (“a system and method of implanting a heart implant” in [0038]) comprising: a handle (102 in Fig 14, 214 in Fig. 20-24) comprising: a first actuator (218a in Fig. 20-24) mechanically coupled to a first set of articulation cables (220a in Fig. 20B), and a second actuator (218n in Fig. 20-24); a shaft coupled to the handle (96b in Fig. 14A & B220 in Fig. 20-24) the shaft comprising: a proximal distal articulation section (210 & 212 in Fig. 20-24) configured to bend with a distal articulation deflection angle and a distal articulation radius (“The first steerable device 210 may generally cause the shaft 206 to deflect … The second steerable device 212 may generally cause the shaft 206 to deflect and/or bend up to approximately 180 degrees … The radius of the curvature may be 1.0 inches to 2.0 inches” in [0086-0087]), wherein the distal articulation section is mechanically coupled to the first set of articulation cables (“wires 220 are coupled to the first and/or second steerable devices 210, 212” in [0081]), and wherein actuation of the first actuator is configured to induce the distal articulation deflection angle in the distal articulation section (The actuation devices 218a-n may… increase or decrease the tension placed on the wires 220. The tension in the wires 220 may asymmetrically urge/pull the first and/or second steerable devices” in [0081]); and a balloon disposed of adjacent to the distal articulation section of the shaft, wherein the balloon is configurable in a deflated state and an inflated state (114 in Fig. 14A (inflated) & Fig 14B (deflated) and “an expandable device 114 (such as, but not limited to a balloon or the like)” in [0065]), wherein the balloon is symmetric around the shaft (114 in Fig. 14C).
Regarding claim 3, Wilson teaches the medical device of claim 2, wherein actuation of a proximal articulation control knob is configured to induce the proximal articulation deflection angle in the proximal articulation section (The handle assembly 214 may also include one or more actuation devices 218a-218n (such as, but not limited to, knobs, sliders, or the like) coupled to the first and second steerable devices 210, 212. The actuation devices 218a-n may be configured to place the first and second steerable devices 210, 212 under tension, therefore causing the shaft 206 to deflect (e.g., curve or bend) in [0080]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-7, 13-15, & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Hsu et al. (US 2021/0045626, hereinafter Hsu).
Wilson teaches the medical device of claim 1.
Wilson does not teach further comprising a light fiber bundle disposed in the shaft, traversing from at least the handle to the distal articulation section, further comprising a light source disposed within the distal articulation section, wherein actuation of the first actuator is configured to bend the shaft in a first plane, and actuation of the second actuator is configured to bend the shaft in a second plane, wherein the first plane and the second plane are perpendicular, the handle further comprising a first articulation lock in mechanical communication with the first actuator, the first articulation lock configured to lock the distal articulation section in a desired position, the handle further comprising one or more proximal articulation drive nuts in mechanical communication with a second set of articulation cables, the handle further comprising one or more proximal articulation pulleys in mechanical communication with the second set of articulation cables, and further comprising a camera disposed on the shaft.
However, attention is drawn to the Hsu reference. Hsu teaches a medical device having multiple bending sections ([0002]) such as a steerable endoscope ([0041]) for uterine, GI, or bronchial procedures or a steerable catheter for vascular procedures ([0061]). Hsu explains that one of the challenges with ureteroscopy may be the inability to provide precise control near the distal tip or end of the ureteroscope, particularly after the ureteroscope has already been significantly bent or deflected to reach the desired target. This challenge is due in part to difficulty in finely and accurately articulating the distal section or end of the ureteroscope, in particular when the proximal section is already significantly deflected and difficulty in properly controlling the distal end without causing unpredictable behavior of the proximal or middle region of the flexible ureteroscope. To address this problem, Hsu teaches a flexible medical device that can be deflectable in one or two directions in each of two planes. It can be desirable for the at least the distal section to be deflectable in more than one plane to reach the desired area ([0116-0118])
Regarding claims 4-5 & 17, Hsu also teaches the inclusion of a camera (650 in Fig. 26B) and a light source (650 in Fig. 26B) in the tip of the device (further comprising a camera disposed on the shaft), either through an LED located at the tip portion (further comprising a light source disposed within the distal articulation section) or conveyed through fiber optic cables from the base (further comprising a light fiber bundle disposed in the shaft, traversing from at least the handle to the distal articulation section). The camera provides a frame of reference for navigating the articulation sections, and the light source illuminates target anatomy to facilitate visualization ([0125]).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to incorporate the light source, light fiber bundle, and camera of Wilson for the purpose of aiding visualization and providing a frame of reference for navigating the articulation sections of the catheter.
Regarding claims 6-7 & 13, Hsu teaches the device includes two pulleys within the housing of the endoscope base (1310a & 1310b Fig. 28A) ([0168]). Rotation of the first pulley 1310a can cause articulation of the elongate shaft within a first plane (first actuator is configured to bend the shaft in a first plane) in the first and third directions (such as in the up and down directions), and rotation of the second pulley 1310b can cause articulation of the elongate shaft within a second plane (second actuator is configured to bend the shaft in a second plane) in the second direction and fourth directions (such as in the left and right directions) that can be coupled to either a robotic or manual actuator ([0168-0170]). In some embodiments, the second plane is orthogonal or transverse to the first plane ([0136]) as illustrated in Fig. 26B (wherein the first plane and the second plane are perpendicular). These pulleys are connected to pull wires (260, 262, 264, 266 in Fig. 21) (one or more proximal articulation pulleys in mechanical communication with the second set of articulation cables.) through guide elements within the base ([0175]), with the pull wires being used to control articulation of the elongate shaft ([0159]). One or each of these pulleys can include a corresponding pulley ratchets (1314a & 1314b in Fig. 28B) and/or pulley lock mechanisms (1318a & 1318b in Fig 28B) (a first articulation lock in mechanical communication with the first actuator).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to incorporate the multiple perpendicular planes of deflection driven by a pulley system and/or drive nuts, guided by the camera and light source taught by Hsu into the steerable catheter of Wilson for the purpose of fine and accurate articulation of the catheter without causing unpredictable behavior of the proximal or middle region of the flexible catheter.
Regarding claims 14 & 15, Hsu teaches that the handle assembly of the device includes a deflection drive actuator (114 in Fig. 2) that is rotatable relative to a casing of handle assembly to thereby deflect end effector (140 in Fig. 2) and a distal portion of catheter away from a central longitudinal axis (LA) defined by a proximal portion of catheter (one or more proximal articulation drive nuts in mechanical communication with a second set of articulation cables). Various suitable components that may be coupled with deflection drive actuator and catheter to provide such functionality will be apparent to those skilled in the art in view of the teachings herein ([0030]). Fig.4 illustrates an embodiment in which the deflection is controlled by a rotary knob (214 in Fig. 4) at distal end of handle assembly. Rotary knob (214) is rotatable relative to casing, about the longitudinal axis (LA), to thereby actuate components that drive lateral deflection of open distal end of hollow shaft. By way of example only, such actuation components may include one or more pull wires, bands, or any other suitable structures as will be apparent to those skilled in the art in view of the teachings herein.
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to incorporate the multiple planes of deflection driven by a pulley system and/or drive nuts, as taught by Hsu into the steerable catheter of Wilson for the purpose of fine and accurate articulation of the catheter without causing unpredictable behavior of the proximal or middle region of the flexible catheter.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Planetta et al. US 2022/0151589, published May 19 2022, hereinafter Planetta)
Wilson teaches the medical device of claim 1.
Wilson does not teach wherein the balloon is asymmetric around the shaft.
However, attention is drawn to the Planetta reference. Planetta teaches an intracardiac delivery catheter with an asymmetric balloon (wherein the balloon is asymmetric around the shaft) having an asymmetric profile and portion to steer the delivery catheter, for example, into the right ventricle and into the pulmonary artery (abstract). The asymmetrical balloon (110A in Fig. 7A & 7B) enhances navigation and placement of the catheter ([0084)] by creating an off-set from the center of the elongated catheter body where blood flow or cardiac pressure provides a distributed force along a surface of the balloon. Unlike a symmetrical balloon, the force applied to the asymmetrical balloon defines a moment arm between the catheter shaft and the center of the balloon. This moment arm can be used to assist with steering and placement of the delivery catheter.
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to incorporate the asymmetrical balloon taught by Planetta into the steerable catheter taught by Wilson for the purpose of enhancing navigation and placement of the catheter.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Avitall et al. US 2018/0310978, hereinafter Avitall)
Wilson teaches the medical device of claim 1.
Wilson does not teach further comprising one or more impedance sensors disposed of at the distal articulation section of the shaft, wherein any of the one or more impedance sensors are disposed distally to the balloon, and wherein any of the one or more impedance sensors are disposed proximally to the balloon.
However, attention is drawn to the Avitall reference. Avitall teaches a treatment device that may be a treatment and mapping device. The device may include an elongate body passable through a patient's vasculature and/or proximate to a tissue region for diagnosis or treatment. For example, the device may be a catheter that is deliverable to the tissue region via a sheath or intravascular introducer ([0044]), including one or more actuation or control features that allow a user to control, deflect, steer, or otherwise manipulate a distal portion of the medical device ([0053]).
In the exemplary system embodiment shown in FIG. 1, the device includes an expandable treatment element (34 in Fig. 1), such as a cryoballoon ([0045]). The device further includes one or more electrodes (66a & 66b in Fig. 1) that are used for measuring impedance signals, referred to as impedance electrodes (one or more impedance sensors disposed of at the distal articulation section of the shaft.). These impedance electrodes may be used by the navigation system to visualize the device on a control unit display and/or navigation system display. For example, the device may include a first impedance electrode (66A) immediately adjacent and distal to the expandable portion (wherein any of the one or more impedance sensors are disposed distally to the balloon) of the treatment element (34) and a second impedance electrode (66B) immediately adjacent and proximal to the expandable portion (wherein any of the one or more impedance sensors are disposed proximally to the balloon) of the treatment element (34) ([0049]).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant application to incorporate the distal and proximal impedance sensors taught by Avitall into the steerable catheter taught by Wilson for the purpose of allowing the user to visualize the catheter device on a control unit display and/or navigation system display.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM P ADAMS whose telephone number is (571)270-0136. The examiner can normally be reached 9am-6pm M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.P.A./ Examiner, Art Unit 3792
/UNSU JUNG/ Supervisory Patent Examiner, Art Unit 3792
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