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
This action is in response to the amendment filed on 1/28/2026. In the amendment, claims 1-3, 9, & 10 have been amended and claim 20 has been cancelled. Claim 21 has been added.
Terminal Disclaimer
The terminal disclaimer filed on 1/28/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Pat. No. 12,048,625 has been reviewed and is accepted. The terminal disclaimer has been recorded. Therefore, the previous Double Patenting Rejection has been overcome.
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 16-18 & 21 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.
Claims 16 & 21 recites that the inner shaft is coupled to the knob and then later recites that the inner shaft is decouplable from the knob. It is unclear if this is during deconstruction of the instrument for sterilization purposes or if this is during use of the instrument. It is obvious that a threaded coupling as appears in both the application and the prior art Marsot et al. is capable of decoupling for deconstruction purposes. Further clarification is necessary to determine what is actually meant by the claim. If the intent is for deconstruction of the instrument after use, then the prior art would still apply, but if the intent for decoupling is during use of the instrument, then an amendment to clarify this over the prior art is necessary. It is also noted that this ‘decouplable’ language is not present in the specification, which is causing more confusion for the limitation since examiner cannot rely on the specification for further clarification of the limitation and its meaning. If an amendment to the claim is made, applicant must show where support for the amendment came from.
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.
Claims 1-4, 8-12, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marsot et al. (US Pub. No. 2017/0100250 A1).
Regarding claim 1, Marsot et al. disclose a delivery handle 314 (Figs. 34 & 47-48) for implanting a prosthetic device at one of a mitral, aortic, tricuspid, and pulmonary valve region of a human heart, the delivery handle 314 comprising: a housing 314 (Figs. 47-48); an actuation control mechanism comprising: a knob 305 (Figs. 47 & 48) rotatably coupled to the housing 314; wherein rotation of the knob 305 relative to the housing 314 rotates internal threads (paragraph [0165]); and an actuation tube 303 (actuator 303 includes ‘64’ & ‘332’; Figs. 34 & 47-48; paragraphs [0165]-[0169]) coupled to the knob 305 by external threads (paragraph [0165]; Fig. 47-48) such that rotation of the knob 305 in a first direction moves the actuation tube 303 (‘64’ & ‘332’) distally relative to the housing and rotation of the knob 305 in a second direction moves the actuation tube proximally relative to the housing (paragraphs [0165]-[0169]).
Regarding claim 2, Marsot et al. further disclose wherein the knob 305 includes the internal threads (Figs. 47 & 48).
Regarding claim 3, Marsot et al. further disclose wherein the actuation tube is coupled to the knob 305 by a drive screw that includes the external threads (paragraph [0165]; Figs. 47-48).
Regarding claim 4, Marsot et al. further disclose wherein external threads of the drive screw engaged by the internal threads of the knob 305 to couple the actuation tube 303 (303 includes ‘64’ & ‘332; Figs. 47-48) to the knob 305 (paragraph [0165]).
Regarding claim 8, Marsot et al. further disclose a pair of clasp control sutures 90 extending from a pair of clasps 16 to the housing 314 (shown throughout, best seen in Figs. 28 & 33).
Regarding claim 9, Marsot et al. disclose a system comprising: a prosthetic device 14 (Fig. 34; shown in detail in Figs. 25-27) configured to be implanted at a valve region of a human heart; an outer shaft 320 (Fig. 34) coupled to the prosthetic device 14; an inner shaft 303 (made up of ‘332’ & ‘64’; Fig. 34) disposed in the outer shaft 320 and coupled to the prosthetic device 14; wherein movement of the inner shaft 303 (made up of ‘332’ & ‘64’) relative to the outer shaft 320 moves a portion of the prosthetic device 14 (paragraphs [0165]-[0169]); a delivery handle 314 connected to the outer shaft 320, wherein the delivery handle 314 comprises: a housing 314 (Figs. 47-48); an actuation control mechanism comprising: a knob 305 (Figs. 47 & 48) rotatably coupled to the housing 314; and wherein the inner shaft 303 (made up of ‘332’ & ‘64’) is coupled to the knob 305 such that rotation of the knob in a first direction moves the inner shaft 303 (via ‘64’ end of ‘303’) distally relative to the housing 314 and rotation of the knob 305 in a second direction moves the inner shaft 303 proximally relative to the housing 314 (paragraphs [0165]-[0169]).
Regarding claim 10, Marsot et al. further disclose wherein the knob 305 includes internal threads (Figs. 47 & 48).
Regarding claim 11, Marsot et al. further disclose wherein the inner shaft 303 (made up of ‘332’ & ‘64’) is coupled to the knob 305 by an actuation tube and a drive screw that includes the external threads (paragraph [0165]; Figs. 47-48).
Regarding claim 12, Marsot et al. further disclose wherein external threads of the drive screw engaged by the internal threads of the knob 305 to couple the actuation tube 303 (303 includes ‘64’ & ‘332; Figs. 47-48) to the knob 305 (paragraph [0165]).
Regarding claim 19, Marsot et al. further disclose a pair of clasp control sutures 90 extending from a pair of clasps 16 to the housing 314 (shown throughout, best seen in Figs. 28 & 33).
Allowable Subject Matter
Claims 5-7 & 13-15 are 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to disclose, teach, or suggest wherein the drive screw is constrained to axial movement relative to the knob [claims 5 & 13]; wherein the actuation tube is releasably connected to the drive screw [claims 7 & 15].
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 ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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, 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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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 May 2, 2026
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