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 .
Specification
Applicant’s submitted amendment to the specification in response to the previously presented objection (now withdrawn) is acknowledged by Examiner.
Claim Rejections - 35 USC § 112
Examiner acknowledges Applicant’s amendment to claim 16 which overcomes the previously presented rejection (now withdrawn) with regard to claims 16-28.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Georges et al (WO 2020/198765 A2, hereinafter “Georges”; copy included in IFW from previous action).
The applied reference has a common assignee and inventor(s) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Georges discloses a transcatheterly implantable medical device (pars 41-43), comprising: a functional unit (pars 47-62); and an introducer unit having a distal end portion and a proximal end portion, the distal end portion of the introducer unit being configured for atraumatic introduction of the introducer unit in a subject’s body for implanting the functional unit therein (par 320), the proximal end portion of the introducer unit being configured to be operatively coupled to the functional unit for the functional unit to be operated in the subject’s body through the introducer unit (par 320).
Allowable Subject Matter
Claims 13-30 are allowed.
Claims 2-12 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.
Response to Arguments
Applicant's arguments filed 12/8/2025 have been fully considered but are only persuasive in-part.
Regarding claim 1, Applicant argues that paragraphs 0174 and 320 of Georges does not disclose the proximal end portion of the introducer unit being configured to be operatively coupled to the functional unit for the functional unit to be operated in the subject's body through the introducer unit. Examiner respectfully disagrees. The cited paragraphs of Georges discloses an introducer 1122 coupled to a loader 1128 into which the device 1010 has been loaded. The control cable 1039 is loaded in the cavity to navigate for delivery. In this configuration, the proximal end portion of the introducer unit is operatively coupled to the functional unit, where the functional unit is operated in the subject’s body through the introducer unit. The claim does not explicitly recite how the functional unit needs to be operated. Further, the functional unit is capable of operation in the subject's body through the introducer unit, as the claim as currently worded only recites an intended use of the functional unit.
However, Applicant’s arguments, as filed on 12/8/2025, with respect to claims 2-30 have been fully considered and are persuasive. The rejections of claims 2-30 have been withdrawn. The claims are now considered to be allowable (with claims 2-12 objected to as explained above) as listed under the section ‘Allowable Subject Matter’ in this action.
Conclusion
THIS ACTION IS MADE FINAL. 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 Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799