DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 9-12, 14, and 15 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Bourang et al. (2007/0088431).
Bourang discloses the following claimed limitations:
Claim 9: An assembly, comprising: a delivery apparatus comprising a handle (22, 26) (Fig. 1, 4, and 19), a first shaft (20) (Fig. 1-2 and 19 and [0042]) extending distally from the handle (Fig. 1-2 and 19 and [0042]), the first shaft having a distal end portion (Fig. 1 where the balloon is located), an inflatable balloon (18) (Fig. 1-2 and 19 and [0042]) mounted on the distal end portion of the first shaft (Fig. 1-2 and 19 and [0042]), a second shaft (72) extending distally from the handle at least partially over the first shaft (Fig. 4 and 19), the second shaft having a distal end portion (combination of 78 and 80 as seen in Fig. 4) (Fig. 4, 19, and 23a-d) comprising a plurality of longitudinally extending fingers (104) (Fig. 6a-b and [0049]) spaced apart from one another in a circumferential direction by a plurality of longitudinally extending slots (102) (Fig. 6a-b and [0049]), the distal end portion further comprising an end member (80) (Fig. 4 and 8 and [0051-52]) overlaying the plurality of longitudinal extending fingers (Fig. 4); and a prosthetic heart valve (16) (Fig. 1 and 4 and [0042]) that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration (Fig. 1, 4, and 23a-d and [0099-101]), wherein the prosthetic heart valve is mounted on the balloon in the radially compressed configuration (Fig. 1, 4, and 23a-d and [0099-101]); wherein the distal end portion of the second shaft extends at least partially over the balloon such that as the balloon is inflated from an uninflated state to an inflated state to expand the prosthetic heart valve (Fig. 23a-d and [0099-101]), the fingers deflect radially outward (Fig. 4 and 23a-d and [0099-101] where it is capable of performing this function).
It has been held that 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 satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Claim 10: wherein the slots extend longitudinally along the distal end portion of the second shaft and intersect a terminal distal end of the second shaft (Fig. 4, 19, and 23a-d).
Claim 11: wherein the fingers have distal ends that abut an adjacent end of the prosthetic heart valve (Fig. 4, 19, and 23a).
Claim 12: further comprising an introducer sheath (24) (Fig. 1 and [0042]) and wherein the fingers can deflect radially inward when inserted through the introducer sheath (Fig. 1 and [0042]).
Claim 14: wherein each of the plurality of longitudinally extending fingers flares from a first outer diameter at proximal ends of the fingers (Fig. 6a-b diameter at the proximal end of the fingers) to a second, lager, diameter at distal ends of the fingers (Fig. 6a-b where it flares at 108) when the balloon is in the uninflated state (Fig. 6a-b).
Claim 15: wherein the distal end portion of the second shaft has a first outer diameter proximal to the plurality of longitudinally extending fingers (Fig. 6a-b diameter at the proximal end of the fingers) and a second outer diameter at distal ends of the longitudinal extending fingers (Fig. 6a-b where it flares at 108), wherein the second outer diameter is greater than the first outer diameter when the balloon is in the uninflated state (Fig. 6a-b).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1, 6, 21, and 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bourang et al. (2007/0088431).
Claim 1:
Bourang discloses a delivery apparatus, comprising: a handle (22, 26) (Fig. 1 and 19); a first shaft (20) (Fig. 1-2 and 19 and [0042]) extending distally from the handle (Fig. 1-2 and 19 and [0042]); an inflatable balloon (18) (Fig. 1-2 and 19 and [0042]) disposed on a distal end portion of the first shaft (Fig. 1-2 and 19 and [0042]); a second shaft (72) extending distally from the handle over at least a portion of the first shaft (Fig. 4 and [0047]); and the second shaft comprising an expandable distal end portion (combination of 78 and 80 as seen in Fig. 4) (Fig. 4, 19, and 23a-d), extending over a portion of the balloon (Fig. 4, 19, and 23a-d); wherein the expandable distal end portion of the second shaft is configured to expand radially when the balloon is inflated from an uninflated state to an inflated state (Fig. 4, 19, and 23a-d); wherein the expandable distal end portion of the second shaft comprises a plurality of longitudinally extending slots (102) (Fig. 6a-b and [0049]) defining a plurality of circumferentially spaced deflectable sections (104) (Fig. 6a-b and [0049]) that can deflect radially outwardly from one another when the balloon is inflated (Fig. 4 and 23a-d where it is capable of performing this function); an end member (80) (Fig. 4 and 8 and [0051-52]) overlaying the plurality of circumferential spaced deflectable sections (Fig. 4).
It has been held that 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 satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Bourang discloses all the limitations discussed above including the end member (80) being made of a metal material ([0051]) however Bourang does not disclose that the circumferential spaced deflectable sections are metal.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the circumferential spaced deflectable section out of metal, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 6: Bourang discloses that the slots intersect a terminal distal end of the distal end portion the second shaft (Fig. 4, 19, and 23a-d).
Claim 21: Bourang discloses that that the end member forms an outer surface of the expandable distal end portion (Fig. 4), wherein the outer surface flares from a proximal end of the end member to a distal end of the end member (Fig. 4 and 8).
Claim 22: Bourang discloses that the end member comprises a plurality of circumferentially spaced sections (148) (Fig. 8 and [0051]) overlaying the plurality of circumferentially spaced deflectable sections (150) (Fig. 8 and [00515]).
Response to Arguments
Applicant's arguments filed 3/2/26 have been fully considered but they are not persuasive.
Applicant argues that Bourang does not disclose an end member that overlays the plurality of circumferential spaced deflectable sections as claimed.
The examiner disagrees, as seen in the rejection above, the end member as defined by the examiner is part 80 which is overlaying the plurality of circumferential spaced deflectable sections (104) as defined by the examiner and as best seen in Fig. 4.
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 DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 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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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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