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 .
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 5, are rejected under 35 U.S.C. 103 as being obvious over Murad et al. 2021/0290387 in view of Ryan et al. 2009/0192591.
The applied reference has a common inventor 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).
MPEP 2114 states:
MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE
APPARATUS CLAIM FROM THE PRIOR ART
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-
Packard Co. V. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528
(Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to
the manner in which a claimed apparatus is intended to be employed does not
differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus
teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647
(Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was
"for mixing flowing developer material" and the body of the claim recited "means for
mixing said mixing means being stationary and completely submerged in the
developer material." The claim was rejected over a reference which taught all the
structural limitations of the claim for the intended use of mixing flowing developer.
However, the mixer was only partially submerged in the developer material. The Board
held that the amount of submersion is immaterial to the structure of the mixer and thus
the claim was properly rejected.).
Regarding claim 1 Murad et al. discloses a delivery apparatus (100, 110) comprising: a first shaft (i.e. the outer shaft see [0034]) configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align (this is functional language see MPEP 2114) a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implantation site;
a second shaft (i.e. the middle shaft 106) extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft; an inflatable balloon (see [0011]) coupled to the distal end portion of the first shaft; and
a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon, wherein the distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion such that the flared portion is disposed radially outward from an outer surface of the second shaft (see [0043] see fig. 3).
However, Murad does not specifically disclose that a radiopaque marker arranged on a distal shoulder of the delivery apparatus, or that wherein the marker is offset, in a circumferential direction relative to the central longitudinal axis, from a location of a selected commissure of the prosthetic heart valve.
Ryan et al. teaches that commissures post may have markers 34 on the heart valve (see [0042]) to aid with alignment. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Murad because radiopaque markers are already contemplated by Murad (see [0053]) and by placing the radiopaque marker on a distal shoulder of the delivery apparatus, wherein the marker is offset, in a circumferential direction relative to the central longitudinal axis, from a location of a selected commissure of the prosthetic heart valve in order to assist visually in the placement of the heart valve.
Regarding claim 2, “…wherein the flared portion of the distal shoulder comprises a plurality of wings that extend radially outward from the base portion, at an angle relative to the central longitudinal axis, wherein the wings of the plurality of wings are spaced circumferentially apart from one another, and wherein the radiopaque marker is centered on one of the wings.” See fig. 3 and elements (130 and 132).
Regarding claim 3 Murad et al. further discloses “…the base portion of the distal shoulder is arranged proximal and adjacent to a nose cone of the delivery apparatus, the nose cone mounted to the distal end portion of the second shaft, and wherein the distal shoulder is configured such that when the prosthetic valve is mounted on the balloon in a radially compressed state, the flared portion of the distal shoulder resists movement of the prosthetic valve relative to the balloon in an axial direction.” (see [0033] and nose cone 114).
Regarding claim 5, see [0010 and 0047].
This rejection under 35 U.S.C. 103 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); 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 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. See generally MPEP § 717.02.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 4, 6, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,171,655 (hereafter ‘655). Current claim 1 recites:
“A delivery apparatus comprising: a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implantation site;
a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft; an inflatable balloon coupled to the distal end portion of the first shaft; and a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon, wherein the distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion such that the flared portion is disposed radially outward from an outer surface of the second shaft, and wherein a radiopaque marker is mounted on or embedded within the flared portion of the distal shoulder.”
Patent ‘655 claims 1 and 3 recites:
“1. A medical assembly for replacing a native valve of a heart, comprising: a delivery apparatus comprising: a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft; an inflatable balloon coupled to the distal end portion of the first shaft; and a radiopaque marker arranged on a distal shoulder of the delivery apparatus, the distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon; and a prosthetic heart valve mounted in a radially compressed configuration onto and around the balloon, wherein the marker is offset, in a circumferential direction relative to the central longitudinal axis, from a location of a selected commissure of the prosthetic heart valve, wherein the first shaft is configured to rotate to rotationally align the marker at the native valve such that, after inflating the balloon to radially expand the prosthetic heart valve, the prosthetic heart valve is implanted with the selected commissure of the prosthetic heart valve circumferentially aligned with a target commissure of the native valve.”
“3. The medical assembly of claim 1, wherein the distal shoulder comprises a base portion and a flared portion that flares radially outward from the base portion, toward the prosthetic heart valve, and wherein the marker is mounted on or embedded within the flared portion such that the marker is spaced radially outward from an outer surface of the distal end portion of the second shaft.
Regarding claim 2, see pat. ‘655 claims 1 and 10
Regarding claim 4, see pat. ‘655 claim 11.
Regarding claim 6, see pat. ‘655 claims 6-7.
Regarding claim 9, see pat. ‘655 claim 8 and 15.
Allowable Subject Matter
Claims 7-8 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.
Claims 10-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art has been provided supra, however does not the recitations of claim 1 in combination with “…a first shaft having a proximal end portion that extends proximally from the handle to an adaptor, and further comprising a rotatable knob mounted on the proximal end portion of the first shaft, the knob configured to rotate the first shaft….further wherein the adaptor comprises a body coupled to the proximal end portion, a first port extending axially from the body, relative to the central longitudinal axis, and a second port extending at an angle from the body, relative to the central longitudinal axis, wherein the first port is coupled to an inner lumen of the second shaft and configured to receive a guidewire, and wherein the second port is fluidly coupled to an annular space defined between an outer surface of the second shaft and an inner surface of the first shaft.
The prior art further does not disclose the limitations of claim 16, specifically “…a first radiopaque marker arranged on a portion of the second shaft that is disposed inside the balloon; and a polymeric body mounted on the distal end portion of the second shaft and a second radiopaque marker mounted on or embedded within the polymeric body.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/ Primary Examiner, Art Unit 3774 September 14, 2026
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