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 Arguments
Applicant's arguments filed 01/02/26 have been fully considered but they are not persuasive.
On page 6 regarding specification objections, Applicant argues amendments cancel the new matter from the specification.
The Examiner respectfully notes no amendments to the specification canceling anything were submitted, and so the specification objection stands.
On page 7 regarding prior art rejections, Applicant argues Godin fails to teach both an outer shaft and a support tube, as well as the balloon being on the outer surface of the support tube.
The Examiner respectfully disagrees, noting as the rejection states, that the support tube and outer shaft form two halves of Goldin item 14, and figure 3 shows the balloon 4 on the outer surface of the support tube.
On page 8 Applicant argues further that the stopper 24 of Godin is not present on the outer surface of the support tube and states the stopper of Godin has a different intended use than Applicant’s stopper.
The Examiner respectfully disagrees and refers Applicant to figure 3 which shows the stopper 24 located on the outer surface of the support tube 14. As regards the intended use, the Examiner cannot determine what claim language Applicant argues is missing from the rejection of record which makes Applicant argue this.
On pages 9-10 Applicant appears to summarize the prior art of record.
On page 10 Applicant argues none of the prior art includes “three tubular structures of the delivery catheter” as the claims require. Applicant argues the prior art fails to teach a support tube with a balloon on its outer surface, the support tube having holes and stoppers, the support tube supporting the balloon during expansion and deflation of the valve, the distal opening and holes of the support tube ensuring uniform expansion of the balloon to allow uniform expansion of the valve, and the stopper maintaining the crimped position of the heart valve and allowing entry of inflation fluid inside the balloon to help it expand.
The Examiner respectfully disagrees. Regarding “three tubular structures of the delivery catheter”, the Examiner notes only one tube appears to be required by the claims (a “support tube”). As regards the support tube with a balloon on its outer surface, this is taught by Godin Figure 3, item 14, from the location the tubular member couples to the balloon and extends distally (right) only, with the balloon item 4, seen in Figure 3 to be on the outer surface of the support tube. As regards the support tube having holes and stoppers, this is taught by Godin which teaches one or more holes 16, and one or more stoppers 24. As regards the support tube supporting the balloon during expansion and deflation of the valve, the Examiner respectfully notes no mention of such a limitation being required by the claimed invention. As regards the distal opening and holes of the support tube ensuring uniform expansion of the balloon to allow uniform expansion of the valve, the Examiner again notes no mention of these limitations in the claims of record. As regards the stopper maintaining the crimped position of the heart valve and allowing entry of inflation fluid inside the balloon to help it expand, the Examiner again notes no requirement by the claim language for such limitations. Accordingly, all arguments are unpersuasive.
Specification
The amendment filed 04/30/25 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
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Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 4, 6, 12, 18 is/are rejected under 35 U.S.C. 103a as being unpatentable over Godin et al. (US 9352133 B2) hereinafter known as Godin in view of Winston et al. (US 20180126124 A10 hereinafter known as Winston.
Regarding claim 1 Godin discloses an assembly comprising:
(a) a prosthetic (Column 1 line 7 stent) mounted over a balloon (Figure 3 item 4) for deployment at a target location (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Godin was considered capable of performing the cited intended use), wherein the valve includes a predefined diameter and a predefined height corresponding to a diameter and height of a native valve (this does not appear to materially limit the claimed valve in any way, but rather appears to define the height/diameter of a valve into which the valve is intended to be implanted);
(b) a delivery catheter (Figure 3) which extends from a primary end ‘A’ to a secondary end ‘B’ (e.g. a proximal and distal end) which comprises:
an inner shaft (2) extending from an inner first end and an inner second end such that the inner first end is near the primary end ‘A’ and the inner second end is near the secondary end ‘B’ of the delivery catheter (Figure 3),
a support tube disposed on an outer surface of the inner shaft towards the secondary end ‘B’ (Figure 3 item 14, from the location the tubular member couples to the balloon and extends distally (right), only), the support tube comprising one or more holes (16) configured to pass inflation fluid (Column 4 lines 59-60), and the balloon is provided on the outer surface of the support tube (Figure 3),
an outer shaft (Figure 3 item 14, from the location the tubular member couples to the balloon and extends proximally (left), only) comprising an outer first end (at the location item 14 couples to the balloon 4), an outer second end (which extends proximally (left)), and a lumen (Figure 3), the outer shaft being disposed on the outer surface of the inner shaft such that the outer first end is coupled with a proximal end of the balloon (Figure 3) and the outer second end is positioned towards the primary end ‘A’ (proximally), and
one or more stoppers (24) on the outer surface of the support tube (Figure 3) and disposed within the balloon (Figure 3),
but is silent with regards to the assembly being a heart valve assembly which includes a heart valve, the valve being coupled to the catheter.
However, regarding claim 1 Winston teaches delivery catheters can deliver heart valves by coupling thereto (Figure 1; [0003]). Godin and Winston are involved in the same field of endeavor, namely endovascular delivery catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the item being delivered by the catheter so it is a heart valve as is taught by Winston since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B). In this case, the person of ordinary skill would have found it obvious to substitute a valve for a stent.
Regarding claim 2 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
wherein Winston further teaches a catheter which includes an outer shaft that includes or more layers (Figure 1 item 104), including an inner layer , a middle layer, and an outer layer, wherein the middle layer is braided over the inner layer ([0032] the middle layer is understood to be the braided layer 138, with the inner layer being one of the inner layers, and the outer layer being item 140).
Regarding claim 4 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
wherein Winston further teaches the outer shaft comprises a steerable mechanism ([0023]-[0024]).
Regarding claim 6 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regards to the valve being selected from a surface area from 280-900 mm2.
However, regarding claim 6 it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the selection of the valve to be from a surface area in the claimed range since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04 (IV)(A). Further, this difference in relative dimension is not critical in nature, and does not affect the function of the prior art. (The Examiner notes that the surface area of a structure depends on its dimensions.)
Regarding claim 12 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
wherein Godin further discloses the stopper has a first, conical-shaped portion (the part of the stopper 24 which is conical) and a second portion (e.g. the proximalmost (left) part of the stopper 24 which is cylindrical and joins to the support tube (distal part of item 14)).
Regarding claim 18 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
wherein Godin further teaches the hole is encapsulated by the balloon (Figure 3).
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Godin and Winston as is applied above, further in view of Tan et al. (US 20090182412 A1) hereinafter known as Tan.
Regarding claim 3 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regards to the outer shaft including a hub to pass the inflation fluid to expand the balloon.
However, regarding claim 3 Tan teaches catheter outer shafts (Figure 1 item 10) can include a hub (Figure 1 item 12) to pass inflation fluid to expand a balloon (this is stated as an “intended use” (see the explanation above). See also [0027]). Godin and Tan are involved in the same field of endeavor, namely catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Godin Perszyk Combination so that the outer shaft includes a hub to pass the inflation fluid to expand the balloon as is taught by Tan in order to ensure the fluid has a means for entry into the catheter for balloon inflation. The courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2143 (I)(C).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Godin and Winston as is applied above, further in view of Kim (US 6007544 A).
Regarding claim 5 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regards to the inner shaft having three layers, an intermediate layer of which having a braided configuration.
However, regarding claim 5 Kim teaches a catheter with an inner shaft that includes a first layer, an intermediate layer, and a second layer, wherein the intermediate layer has a braided configuration (Column 10 lines 53-61). Godin and Kim are involved in the same field of endeavor, namely catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the inner shaft of the Combination so that it includes multiple layers, the intermediate layer being braided, such as is taught by Kim as a known construction in the art for delivery catheters. The courts have held that it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, the use of a multi-layer material with a middle braid is an obvious material construction within the catheter arts in order to provide the necessary biocompatibility, strength, and flexibility a catheter must possess.
Claims 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Godin and Winston as is applied above, further in view of Spencer et al. (US 20030114913 A1) hereinafter known as Spencer.
Regarding claim 8 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regards to the valve being selected from a diameter from 18-34 mm.
However, regarding claim 8, Spencer teaches prosthetic valves can be selected with a diameter within the range of 18-34 mm ([0038] 19-25 mm). Godin and Spencer are involved in the same field of endeavor, namely balloon expandable valves and catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Combination so that the diameter is in the range of 18-34 mm as is taught by Spencer in order to ensure it will fit in a native human annulus.
Regarding claim 10, the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regards to the valve comprising a predefined height selected from a range of 14-28 mm.
However, regarding claim 10 Spencer teaches prosthetic valves can be selected with a height between 14-28 mm ([0237] 15 mm). Godin and Spencer are involved in the same field of endeavor, namely balloon expandable valves and catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Combination so that the height falls within the range of 14-28 mm as is taught by Spencer in order to ensure it will fit within a native human heart chamber.
Claim(s) 17 is/are rejected under 35 U.S.C. 103a as being unpatentable over Godin in view of Winston, and Spencer as is applied above, further in view of Zadno-Azizi (US 20060200191 A1).
Regarding claim 16 the Godin Winston Combination teaches the assembly of claim 1 substantially as is claimed,
but is silent with regards to the outer first end having a diameter greater than the second outer end.
However, regarding claim 16 Zadno-Azizi teaches an outer first end of an outer tubular member can have a diameter greater than the second outer end (Figure 2c shows the outer tubular body 44 with an outer first end near the balloon 12, which has a greater diameter than the more proximal end in light of its inclusion of an adhesive taper 72 which connects the outer member to the balloon). Godin and Zadno-Azizi are involved in the same field of endeavor, namely catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the assembly of the Combination so that the first outer end has a larger diameter than a second end as is taught by Zadno-Azizi in order to provide a mechanism to connect the outer member to the balloon in a transition region, since tapers are known to ensure a smooth and consistent connection between two concentric elements.
Claim(s) 17 is/are rejected under 35 U.S.C. 103a as being unpatentable over Godin in view of Winston, and Spencer as is applied above, further in view of Perszyk et al. (US 20190083261 A1) hereinafter known as Perszyk.
Regarding claim 17 the Godin Winston Spencer Combination teaches the assembly of claim 8 substantially as is claimed,
wherein Godin further teaches the stopper has a first portion (the part of the stopper 24 which is conical) and a second portion (the proximalmost (left) part of the stopper 24 which is cylindrical),
but is silent with regards to the second portion comprising a hole configured to attach the stopper to the support member.
However, regarding claim 17, Perszyk teaches the use of a hole and peg to attach two parts of a catheter together ([0042]). Godin and Perszyk are involved in the same field of endeavor, namely catheters. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of attaching the stoppers to the support tube so that it is done with a hole as is taught by Perszyk since the courts have held that the use of a known technique or method to improve a known device results in a prima facie case of obviousness. See MPEP 2148 (I)(C). In this case, utilizing any known attachment method would have been considered to be obvious.
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 01/22/26