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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeung et al (2020/0030094).
Yeung et al teaches a delivery device, comprising:
a catheter 52;
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and an inflatable balloon 50 coupled to the catheter, the inflatable balloon forming a leading pillow 64 and a trailing pillow 62 spaced from the leading pillow, the leading pillow and the trailing pillow defining a valve seat 60 therebetween to retain a prosthetic heart valve (20) during tracking of the delivery device (structured as claimed, thereby fully capable thereof).
Claim 2, further comprising a prosthetic heart valve comprising a stent 22 and a valve assembly 24.
Claim 3, further comprising an intermediate pillow 60 disposed between the leading pillow and the trailing pillow.
Claim 4, the delivery device of claim 3, wherein the intermediate pillow is shorter than at least one of the leading pillow and the trailing pillow in a radial direction; the intermediate pillow can be inflated from a very low pressure to a very high pressure, see claim 6. It is inherent that the intermediate pillow can have a shorter radial direction at a very low pressure when the leading and trailing pillows are inflated.
Claim 5, as shown above, the intermediate pillow is shorter than at least one of the leading pillow and the trailing pillow in an axial direction.
Claim 7, the intermediate pillow is disposed equidistant to the leading pillow and the trailing pillow at the inflection points.
Claim 8, the intermediate pillow is disposed closer to the leading pillow than the trailing pillow (at the maximum diameter). Per MPEP 2125, “the drawings must be evaluated for what the reasonably disclose and suggest to one of ordinary skill in the art.” In re Aslanain, 590 F.2d 911,200 USPQ 500 (CCPA 1979).
Claims 1-4 and 6-7, 10, 13-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Le et al (2022/0226115).
Referring to all embodiments, Le et al teaches a delivery device, comprising:
a catheter (see figure 6); and
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an inflatable balloon 108 coupled to the catheter, the inflatable balloon 108 forming a leading pillow (measured by D1) and a trailing pillow (measured by D2) spaced from the leading pillow, the leading pillow and the trailing pillow defining a valve seat 144 therebetween to retain a prosthetic heart valve 114 during tracking of the delivery device (structured as claimed, thereby fully capable thereof).
Claim 3, further comprising an intermediate pillow (portion 144 of 108) disposed between the leading pillow and the trailing pillow.
Claim 4, the intermediated pillow is radially shorter as shown in the figure above.
Claim 6, referring to figure 7 above, the leading pillow and intermediate pillow define a cavity to accept the majority of the valve assembly.
Claim 7, the intermediate pillow starts at the end of the leading pillow and trailing pillow begins at the end of the intermediate pillow. Therefore, the intermediate pillow is disposed equidistant to the leading pillow and trailing pillow.
Claim 10, the heart valve is tucked in a pocket 186 of the leading pillow and D2 of the trailing pillow is larger than D1 of the leading pillow, therefore, the leading pillow and the trailing pillow extend radially outward farther than the prosthetic heart valve.
Claim 13-14, the delivery device of claim 1, further comprising an inner shaft 106 extending through the balloon and having at least one rigid kink feature 130 disposed adjacent at least the trailing pillow. See figure 4.
Claim 15, an inner shaft 106 having at least one cage 160 disposed within the balloon.
Claim 16, the inner shaft comprises at least one of a helical tube and a braided tube; see par. 0143.
Claim 17, a method of delivering a prosthetic heart valve, the method comprising: providing a delivery device having a catheter (see at least figure 6) and an inflatable balloon 108 coupled to the catheter; forming a leading pillow (measured by D1) and a trailing pillow (measured by D2) from the leading pillow on the balloon, the leading pillow and the trailing pillow defining a valve seat 144; placing a prosthetic heart valve 114 on the valve seat; and advancing the delivery device to a native aortic valve (see at least par. 0346) of a patient while the prosthetic heart valve is disposed between the leading pillow and the trailing pillow of the delivery device ([0155]).
Claims 1, 3, 5-6, 8-9, 13-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Johnson (2004/0138731).
Referring to all embodiments, Papp et al teaches a delivery device, comprising:
a catheter 14; and
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an inflatable balloon 12 coupled to the catheter, the inflatable balloon forming a leading pillow (labelled 46) and a trailing pillow (labelled 44) spaced from the leading pillow, the leading pillow and the trailing pillow defining a valve seat therebetween (see Fig. 2) to retain a prosthetic heart valve during tracking of the delivery device (structured as claimed, thereby fully capable thereof).
Claim 3, intermediate pillows 50.
Claim 5, intermediate pillows 50 are axially shorter than 44 and 46 as shown.
Claim 6, the leading pillow (labelled 46) and a trailing pillow (labelled 44) forming a valve cavity therebetween (fully capable of the functional language).
Claim 7, the intermediate pillow 50 next to the leading pillow 46 is closer to the leading pillow than the trailing pillow.
Claim 8, the intermediate pillow 50 next to the trailing pillow 44 is closer to the trailing pillow than the leading pillow.
Claim 13-14, the inner shaft 22 has a circular shape which is a kink resistant feature adjacent to the trailing pillow.
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.
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Le et al (2022/0226115) in view of Yadav (6,645,174).
Le et al teaches a delivery device and heart valve as described above including the leading pillow overhangs edges of the stent of the valve; see figures 6-7, element 186. However, Le et al fails to teach the trailing pillow overhang edges of the stent of the prosthetic heart valve. Yadav teaches a stent wherein both the leading pillow and trailing pillow overhang a stent.
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It would have been obvious to one having ordinary skill in the art to have had the trailing overhang the stent as taught by Yadav on the catheter and heart valve system of Le et al to better secure the valve stent to the catheter.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Le et al (2022/0226115) in view of Goshgarian (2008/0154352).
Le et al teaches a delivery device and heart valve as described for claim 17 above, however, fails to teach heat setting the balloon prior to placing the prosthetic heart valve on the valve seat. Goshgarian teaches a ballon catheter and stent and heat setting the balloon prior to placing the stent on the seat; see par. 0043-0044.
It would have been obvious to one having ordinary skill in the art to have heat set the leading pillow and trailing pillow of Le et al prior to placing the prosthetic heart valve on the valve seat as taught by Goshgarian to increase burst the burst temperature of the balloon.
Claim 18, further comprising forming an intermediate pillow (portion 144 of 108) disposed between the leading pillow and the trailing pillow.
Claim 20, constraining a valve assembly of the prosthetic heart valve between the intermediate pillow and the leading pillow via a delivery sheath (see at least par. 0126) and/or pocket 186.
Allowable Subject Matter
Claim 12 is 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 an examiner’s statement of reasons for allowance: The examiner considers the closes prior art the references used in the rejections above. However, said reference fails to teach the combination of claims 1 and 2 and a loader sheath having a radially inward protruding ramp to retain the stent close to the balloon during a deairing process.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774
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