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 6/04/2026 have been fully considered. Regarding the rejection under 35 U.S.C. 102(a)(2) as being anticipated by Le et al (2022/0226115), the intermediate pillow is interpreted as 144 which has a second radial dimension smaller than the radial dimension at D1, D2.
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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 1-2, 5-7, 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 (radius measured at D1) and a trailing pillow (radius measured at 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).
The leading pillow and trailing pillow have the same first radial dimension when deflated; see par. 0151. The intermediate pillow (generally 144) having a second radial dimension when deflated within the delivery device, the second radial dimension being smaller than the first radial dimension.
Claim 2, see heart valve 10, 50, 114.
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 11, the heart valve is shorter than the intermediate pillow.
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 (10, 50, 114) 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 (radius measured by D1) and a trailing pillow (radius measured by D2) from the leading pillow on the balloon, and an intermediate pillow disposed between the leading pillow and the trailing pillow,
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].
The leading pillow and trailing pillow have the same first radial dimension when deflated; see par. 0151. The intermediate pillow (generally 144) having a second radial dimension when deflated within the delivery device, the second radial dimension being smaller than the first radial dimension.
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) 1, 5-9, 13-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Johnson (2004/0138731).
Referring to all embodiments, Johnson 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), a trailing pillow (labelled 44) and an intermediate pillow (one of 50) disposed between the leading pillow and trailing 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 and fully capable thereof).
Johnson teaches: [0071] Accordingly, the balloon also has a composite profile shape which varies at different pressures. The balloon initially is in a deflated state and has a deflated profile shape, as specifically illustrated in FIG. 2, having a central bed portion with a deflated bed diameter being flanked by a pair of proximal and distal shoulders 44 and 46 defining deflated shoulder diameters that are preferably larger than the deflated bed diameter. Also, see par. 0078.
Regarding the leading pillow and trailing pillow having the same first radial dimension when deflated: The MPEP states, “the description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 193 USPQ 332 (CCPA 1977)”. 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). It is the examiner’s position that one having ordinary skill in the art would reasonably conclude that the claimed dimensions are inherent or at least obvious in light of the drawings and specification to one having ordinary skill in the art.
Therefore, in view of at least par. 0071-0079, the leading pillow and trailing pillow have the same first radial dimension when deflated. The intermediate pillow having a second radial dimension when deflated within the delivery device, the second radial dimension being smaller than the first radial dimension.
Claim 5, the 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, see figure 6 having an intermediate pillow equidistant.
Claim 8, the intermediate pillow 50 next to the leading pillow 46 is closer to the leading pillow than the trailing pillow.
Claim 9, 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 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 allowed.
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 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.
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, 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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