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 .
Response to Amendment
The claims filed on December 8th, 2025, have been entered. Claims 1-3 and 12-18 remain pending in the Application. The claim amendments overcome the previous 112(b) and 112(d) rejections.
Response to Arguments
Applicant's arguments filed December 8th, 2025, have been fully considered but they are not persuasive.
Applicant argues that Emmons et al. (Pub. No. 2014/0358140) in view of Chu et al. (Pub. No. 2018/0344397) does not disclose the newly added claim limitation that the expandable member is configured to grasp a wire “that has been advanced through a second percutaneous puncture so that a portion of the wire extends into” the metallic mesh of the expandable member because Chu et al. describes in [0141] and [0239] mechanisms to change the shape of antenna 104 instead of grasping a wire as claimed. Examiner respectfully disagrees. As pointed out in the Non-Final Rejection dated September 8th, 2025, the functional language “configured to” means that the claimed structure only needs to be capable of performing the claimed function. Chu et al. discloses in [0142] and [0163] that the antenna 104 is repositioned by engagement with meshes such as 140, where 140 is collapsed to be able to move 104, and that 104 is gripped hard enough that in [0141], 104 changes shape. By these disclosures, the mesh 140 is capable of grasping 104, and capable of doing so when 104 has been advanced through another percutaneous puncture so that part of 104 extends into 140 because 140 only grasps 104 when 104 is within 140.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3 and 12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Emmons et al. (Pub. No. 2014/0358140) in view of Chu et al. (Pub. No. 2018/0344397).
Regarding claim 1, Emmons et al. discloses a catheter device (110; [0089]; FIG. 1A) comprising:
a control mechanism (“control mechanism” is a term known in the art as the handle which an operator holds to control a manipulatable catheter and attached structure with other functions; [0308] the handle portion on the proximal end of the device) configured to be operated by a user exterior a patient ([0308] the user can use the handle portion to control the device from outside of the body of the patient);
an elongate catheter shaft (112) extending from the control mechanism and configured to be positioned within the patient ([0330] 112 is positioned near the pericardial region within the patient), wherein one or more portions of the catheter shaft are controllably deflectable using the control mechanism to steer the catheter shaft ([0101] 112 can be made of shape memory material to be manipulated by insertion and deployment);
a sharpened point ([0225] the distal end of 262/264 can have a sharp tip for puncturing tissue) attached to a distal tip portion of the catheter shaft (FIG. 1A: 262/264 are attached to the distal tip of 112), the sharpened point configured to cut or puncture a parietal pericardial layer surrounding a heart of the patient ([0330] the device can be used to puncture tissue in the pericardial region); and
an expandable member ([0335] a balloon can enclose a portion of the device in the distal end portion of 112) attached to the distal tip portion of the catheter shaft ([0335] the balloon can enclose any portion of the device, including the distal tip of 112), the expandable member being selectively expandable and collapsible using the control mechanism ([0308] the expandable balloons can be controlled by the handle portion),
wherein the expandable member is configured to grasp a wire that has been advanced through a second percutaneous puncture so that a portion of the wire extends into the expandable member (the balloon is capable of surrounding and then grasping a wire when the balloon has been deflated) when the expandable member is reconfigured from an expanded configuration ([0335] the balloon can have an inflated configuration) to a collapsed configuration attaching to the wire ([0335] the balloon can have a deflated configuration).
Emmons et al. does not disclose the expandable member is a metallic mesh with a shape-memory that biases the expandable member to seek the expanded configuration. However, Emmons et al. does disclose that the expandable member ([0335] a balloon can enclose a portion of the device) can comprise multiple other configurations, including pre-shaped tubular sheaths ([0308]).
Chu et al. teaches in the same field of endeavor of ablation devices (Abstract), and discloses a catheter device (100; FIGs. 9A-9C) comprising an expandable member (140; FIG. 9C) that is a metallic mesh ([0167] 140 can be made of shape memory material set to a default expanded state) and that is configured to grasp a wire ([0167] 140 presses against 104) when being reconfigured from an expanded configuration (FIG. 9C) to a collapsed configuration ([0167] 140 can be collapsed to a low-profile configuration).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the expandable member of Emmons et al. (balloon) for the expandable member of Chu et al. (metallic mesh) because both expandable members are disclosed as equivalent structures for anchoring the catheter device (Chu et al. [0167]), and substitution of one for the other would have resulted in the predictable result of allowing for expansion of the expandable member after deployment to the target site to keep the catheter device in place during the operation.
Regarding claim 2, Emmons et al. as modified by Chu et al. further discloses the metallic mesh comprises a shape-memory that biases the expandable member to seek the expanded configuration (Chu et al. [0167] 140 can be made of shape memory material set to a default expanded state).
Regarding claim 3, Emmons et al. as modified by Chu et al. further discloses one or more electrodes attached to the catheter device (Emmons et al. [0306] 110 can have electrodes attached to the device) and configured for detecting electrical signals (Emmons et al. [0306] the electrodes can be used to detect electrical signals).
Regarding claim 12, Emmons et al. as modified by Chu et al. further discloses the expandable member is a balloon (Chu et al. [0167] 140 can be a balloon).
Regarding claim 13, Emmons et al. as modified by Chu et al. further discloses the catheter device is comprised of a dielectric material (Emmons et al. [0094] 110 can be made of dielectric materials).
Regarding claim 14, Emmons et al. as modified by Chu et al. further discloses the dielectric material is plastic (Emmons et al. [0187] 110 can be made of plastic).
Regarding claim 15, Emmons et al. as modified by Chu et al. further discloses a cutting device that is the sharpened point at the distal tip portion of the catheter shaft (Emmons et al. [0225] the distal end of 262/264 can have a sharp tip for puncturing tissue).
Regarding claim 16, Emmons et al. as modified by Chu et al. further discloses the sharpened point at the distal tip portion of the catheter shaft includes an electrode (Emmons et al. [0107] electrodes can be put on different parts of the device) that can be energized to assist with puncturing tissue ([0107] the electrodes can assist in puncturing the tissues).
Regarding claim 17, Emmons et al. as modified by Chu et al. further discloses the catheter device is comprised of a dielectric material (Emmons et al. [0094] 110 can be made of dielectric materials).
Regarding claim 18, Emmons et al. as modified by Chu et al. further discloses the dielectric material is plastic (Emmons et al. [0187] 110 can be made of plastic).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JRM/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771