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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 23rd, 2026, has been entered.
Response to Amendment
The claims filed on June 23rd, 2026, have been entered. Claims 1-3 and 12-19 remain pending in the Application. Claim 19 has been added by the Applicant.
Response to Arguments
Applicant's arguments filed June 23rd, 2026, have been fully considered but they are not persuasive.
Applicant argues that the newly amended claim limitation “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 metallic mesh of the expandable member while the metallic mesh is in the expanded configuration, and wherein the metallic mesh is configured to grasp the wire when the expandable member is reconfigured from the expanded configuration to a collapsed configuration by collapsing to attach to the wire” is not disclosed by Emmons et al. (Pub. No. 2014/0358140) in view of Chu et al. (Pub. No. 2018/0344397) because Chu et al. does not disclose a metallic mesh that receives a wire into its structure while expanded nor grasping the wire by collapsing, and instead describes deploying a positioning element 140 to press an antenna 104 against a tissue wall, where the collapse of the positioning element 140 is only for withdrawal instead of for grasping the antenna 104. Since Chu et al. does not disclose the metallic mesh grasps the wire by collapsing to attach to the wire, Applicant argues that Chu et al. is not configured to perform the function. Examiner respectfully disagrees. Since the limitation uses the “configured to” language, the only structure that Chu et al. needs to disclose is the expandable member, so long as the expandable member is capable of performing the claimed function. Chu et al. discloses in [0142] and [0163] that the expandable metallic mesh 140 is capable of collapsing to be able to move antenna 104, and that this collapse can grip 104 so hard that in [0141], 104 is disclosed as changing shape. Therefore, prior to 140 collapsing onto 104, 140 is capable of having a potion of 104 extend into 140 while 140 is expanded, and 140 is capable of then grasping 104 when 140 goes from expanded to collapsed, which creates an attachment between 104 and 140.
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 1-3 and 12-19 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.
Claim 1 recites the limitation "the expanded configuration" in line 13. There is insufficient antecedent basis for this limitation in the claim. When Applicant amended claim 1, Applicant changed the previous introduction of the expanded configuration in line 15, but did not ensure that the expanded configuration was properly introduced in line 13. Applicant should amend line 13 to “an expanded configuration” to correct the antecedent basis issue. Claims 2-3 and 12-19 are rejected for their dependency on claim 1.
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 12-19 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 while the expandable member is in an expanded configuration (the balloon is capable of surrounding a wire while expanded), and wherein the expandable member is configured to grasp the wire when the expandable member is reconfigured from the expanded configuration ([0335] the balloon can have an inflated configuration) to a collapsed configuration by collapsing to attach to the wire ([0335] the balloon can have a deflated configuration, and the balloon is capable of grasping the wire when collapsed).
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).
Regarding claim 19, Emmons et al. as modified by Chu et al. further discloses the distal tip portion comprises multiple electrodes (Emmons et al. FIG. 1B and [0107] multiple electrodes 118 can be attached in the distal tip area near 262/264).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES R MCGINNITY/Examiner, Art Unit 3771
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