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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-14, drawn to a prosthetic heart valve delivery system, classified in A61F2/2433.
II. Claims 15-20, drawn to a method implanting a prosthetic heart valve, classified in A61F2/9517.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product, for example in a procedure of delivering the heart valve to a mitral valve.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification.
The inventions have acquired a separate status in the art due to their recognized divergent subject matter.
The inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Stephen Lund on 08/12/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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.
Claim(s) 1-3, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Connell et al. (US 2018/0206989).
Regarding claim 1, O’Connell et al. discloses a prosthetic heart valve delivery system (100, FIG 3-5C, [0039], including the balloon arrangement of FIG 10A-10B, wherein [0097] discloses the embodiment of FIG 3 can incorporate the additionally taught elements of the disclosure) comprising: a handle (104); an outer catheter (114/1050) extending distally from the handle (FIG 3), a steering ring (138, FIG 4A, [0047]) being mounted to a distal end of the outer catheter (FIG 4A); an inner catheter (1058, FIG 10B, [0085]) extending distally from the handle through an interior of the outer catheter (FIG 10B); a nosecone (126) coupled to a distal end of the inner catheter (FIG 4B); a balloon coupled to a distal end of the delivery system ([0040]; for example balloon 1056, FIG 10B, [0084]), the balloon including (A) a proximal portion fixed to a distal end portion of the outer catheter (FIG 10B shows the proximal end fixed to 1050), (B) a distal portion fixed to either (i) the nosecone (FIG 10B shows the distal end fixed to nosecone 1026) or (ii) the distal end of the inner catheter, and (C) a center portion between the proximal portion and the distal portion (Center portion shown in FIG 10B); a prosthetic heart valve (101/1001) configured to be received over the center portion of the balloon (FIG 4A and 10B); and a steering wire (132, [0046-0047]) having a proximal end operably coupled to the handle ([0047]) and a distal end coupled to the steering ring ([0047], FIG 4B) to form a deflection point (Bend 125/115), the deflection point being positioned distal to a point at which the proximal portion of the balloon is fixed to the distal end portion of the outer catheter (FIG 3-5C shows the deflection point is distal to the proximal attachment point of the balloon).
Regarding claim 2, O’Connell et al. discloses a steering knob on the handle, the steering knob being operably coupled to the proximal end of the steering wire ([0047] discloses “extension of the elbow portion 124 may be permitted by loosening or slackening a tether device 130 attached to the arm portion 122 and deployable via remote actuation, e.g., via an actuator 108 (FIG. 3), such as a knob…carried by the handle component 104”).
Regarding claim 3, O’Connell et al. discloses rotation of the steering knob tensions the steering wire and causes the outer catheter to deflect at the deflection point ([0047] manipulation of the knob loosens steering wire 130/132 which allows for deflection of 114 at the deflection point, FIG 4A-4B).
Regarding claim 10, O’Connell et al. discloses a prosthetic heart valve delivery system (100, FIG 3-5C, [0039], including the balloon arrangement of FIG 10A-10B, wherein [0097] discloses the embodiment of FIG 3 can incorporate the additionally taught elements of the disclosure) comprising: a handle (104); an outer catheter (114/1050) extending distally from the handle (FIG 3); an inner catheter (1058, FIG 10B, [0085]) extending distally from the handle through an interior of the outer catheter (FIG 10B); a nosecone (126) coupled to a distal end of the inner catheter (FIG 4B); a steering ring (138, FIG 4A, [0047]) mounted to (i) a distal end of the inner catheter (FIG 4A-C); a balloon coupled to a distal end of the delivery system ([0040]; for example balloon 1056, FIG 10B, [0084]), the balloon including (A) a proximal portion fixed to a distal end portion of the outer catheter (FIG 10B shows the proximal end fixed to 1050), (B) a distal portion fixed to either (i) the nosecone (FIG 10B shows the distal end fixed to nosecone 1026) or (ii) the distal end of the inner catheter, and (C) a center portion between the proximal portion and the distal portion (Center portion shown in FIG 10B); a prosthetic heart valve (101/1001) configured to be received over the center portion of the balloon (FIG 4A and 10B); and a steering wire (132, [0046-0047]) having a proximal end operably coupled to the handle ([0047]) and a distal end coupled to the steering ring ([0047], FIG 4B) to form a deflection point (Bend 125/115).
Regarding claim 11, O’Connell et al. discloses the prosthetic heart valve is received on the center portion of the balloon (FIG 4B and 10B), the deflection point is positioned distal to an entirety of the prosthetic heart valve (FIGs 4A-4C and 10A shows the deflection point is distal to the entirety of the heart valve).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 4-9 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell et al. (US 2018/0206989) in view of Lee et al. (US 2020/0229921).
Regarding claim 4, O’Connell discloses the invention substantially as claimed, as set forth above for claim 1.
O’Connell fails to teach when the prosthetic heart valve is received over the center portion of the balloon, the proximal portion of the balloon forms a shoulder confronting an outflow end of the prosthetic heart valve, and the distal portion of the balloon forms a shoulder confronting an inflow end of the prosthetic heart valve.
However, Lee et al. teaches in the same field of endeavor of balloon expandable stent delivery (abstract ) a delivery device wherein a prosthetic heart valve (12, [0084]) is received over the center portion of the balloon (28, see positioning on the center portion in FIG 16), the proximal portion of the balloon forms a shoulder confronting an outflow end of the prosthetic heart valve (See shoulder created by the balloon at the proximal end, FIG 16), and the distal portion of the balloon forms a shoulder confronting an inflow end of the prosthetic heart valve (See shoulder created by the balloon at the distal end, FIG 16).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the balloon of O’Connell to be shaped in such a wat that during inflation, the proximal portion of the balloon forms a shoulder confronting an outflow end of the prosthetic heart valve, and the distal portion of the balloon forms a shoulder confronting an inflow end of the prosthetic heart valve, as taught by Lee et al., for the purpose of aiding in maintaining the position of the valve at the center of the ballon during expansion.
Regarding claim 5-7, O’Connell discloses the invention substantially as claimed, as set forth above for claim 1.
O’Connell fails to teach when the prosthetic heart valve is received over the center portion of the balloon, the outer catheter extends at about 100% of a length of the proximal portion of the balloon.
However, Lee et al. teaches in the same field of endeavor of balloon expandable stent delivery (abstract) a delivery device (600, FIGs 46-47A) wherein a prosthetic heart valve (12, [0084]) is received over the center portion of a balloon (612, [0145]), and the device has an outer catheter (608, including 614, FIG 47, [0145]), an inner catheter (610) extending through the outer catheter (FIG 47) and coupling to a nosecone (616) and wherein when the prosthetic heart valve is received over the center portion of the balloon (As shown in FIG 47A), the outer catheter extends at about 100% of a length of the proximal portion of the balloon (portion 614 of the outer shaft extends the full length of the proximal portion of the balloon, wherein the proximal portion is interpreted as the tapered segment in FIG 47).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the outer shaft of O’Connell to have a proximal stop member which extends into the balloon at least the length of the proximal portion of the balloon, as taught by Lee et al., for the purpose of aiding in maintaining the position of the valve at the center of the ballon during delivery ([0147]).
Regarding claim 8-9, O’Connell/Lee et al. discloses the invention substantially as claimed, as set forth above for claim 5. The device as modified by Lee further discloses at least one aperture is formed in a wall of the outer catheter at a location aligned with the proximal portion of the balloon ([0146] discloses “the proximal stop member 614 includes one or more openings 646 for inflation fluid formed in the annular wall between the outer surface of the inner shaft 610 and the inner surface of the outer shaft 608. The openings 646 allow inflation fluid to flow outwardly from the space between the inner shaft 610 and the outer shaft 608 into the balloon in the distal direction”) and wherein the at least one aperture defines an endpoint of an inflation lumen ([0146]) that extends into the handle and which is configured to receive inflation media therethrough (It is understood that the inflation fluid described as being delivered in [0146 and 01249] is originating from a fluid source at the handle of the device).
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell et al. (US 2018/0206989) in view of Murad (US 2024/0115381).
Regarding claims 12-13, O’Connell discloses the invention substantially as claimed, as set forth above for claim 10.
O’Connell is silent regarding the steering wire extends through a wall of the inner catheter and between an outer surface of the inner catheter and an inner surface of the balloon.
However, Murad teaches in the same field of endeavor a delivery system (500, FIG 16-17, which incorporates the steerable shaft 400, shown in FIG 15, [0089-0097]) for delivering a prosthetic valve (502, [0094]) delivered on a balloon (508), and further comprising a steering ring (210, FIG 15, [0089-0090]) coupled to the distal end of a steering wire (202, [0089-0092]), wherein the steering wire extends through a wall of the inner catheter (FIG 14-15 show the wire extending through a wall of the catheter) and between an outer surface of the inner catheter and an inner surface of the balloon (FIG 16, wherein 520 is a proximal portions of the balloon and the distal end of 400 comprising the steering ring and steering wire is positioning within the balloon end, therefore being within an inner surface of the balloon).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the steering ring and wire of O’Connell to be positioned in between the inner catheter and the balloon wall, as taught by Murad, for the purpose of utilizing a technique commonly known in the art for steering the distal end of a prosthetic heart valve delivery system and therefore achieving the predictable result of reliable controlling the positioning of the valve for deployment.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over O’Connell et al. (US 2018/0206989) in view of Stappenbeck et al. (US 2020/0360141).
Regarding claim 14, O’Connell discloses the invention substantially as claimed, as set forth above for claim 10.
O’Connell is silent regarding a second steering ring coupled to the distal end portion of the outer catheter; and a second steering wire having a proximal end operably coupled to the handle and a distal end coupled to the second steering ring.
However, Stappenbeck teaches in the same field of endeavor a delivery system for delivering a prosthetic valve (abstract, FIG 16) comprising a first and second steering ring (109, 111, FIG 16-17) coupled to the distal end of a first and second steering wire (110, 112, FIG 17, [0054, 0056, 0062-0063]), and positing at the distal end of a steerable catheter (FIG 16) and having a proximal end operably coupled to the handle (at actuators 113, 114, [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the outer catheter of O’Connell to further comprising a second steering ring coupled to the distal end portion of the outer catheter and a second steering wire having a proximal end operably coupled to the handle and a distal end coupled to the second steering ring, as taught by Stappenbeck, for the purpose of providing the ability to steer the distal end of the delivery system in multiple direction to better navigate the vasculature to the target treatment site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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