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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/09/2026 has been entered.
Response to Arguments
Applicant's amendments and arguments filed 8/31/2026 have been fully considered and overcame the Le et al (2022/0226115) rejections. The examiner’s position regarding the rejection 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) is stated in the grounds of rejection below.
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.
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 46, a trailing pillow 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 and having a radial distance (see Fig. 2) to retain a prosthetic heart valve during tracking of the delivery device (fully capable thereof). The examiner notes applicant’s par. 0048 teaching a plurality of intermediate pillows and additionally shows the stent of the heart valve extends over an intermediate pillow).
Regarding the leading pillow and intermediate pillow defining a valve cavity configured and arranged to receive a valve assembly of the prosthetic heart, this is functional language which said leading pillow and one of the intermediate pillows define and art fully capable of.
Regarding the leading pillow and trailing pillow having the same first radial dimension when deflated: 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. 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, specification and intended use to contain a stent on the catheter; wherein the leading pillow and trailing pillow have the same first radial dimension when deflated would have been obvious to one having ordinary skill in the art to have tried with a reasonable expectation of success.
The intermediate pillow is portion of the valve seat (central bed portion in par. 0071) which is “preferably” smaller than the deflated shoulder diameters (leading and trailing pillows). Therefore, the intermediate pillow has a second radial diameter which is smaller than the first radial diameter. As shown, the radial distance of the intermediate pillow 50 is greater than the radial distance of the valve seat 48.
Further, see the teachings of par. 0075-0079.
Claim 5, the intermediate pillows 50 are axially shorter than 44 and 46 as shown above.
Claim 6, the valve cavity can be arbitrarily selected, to even include one of the pluralities of intermediate pillows, to fulfill the functional language. The valve assembly is not positively claimed and no defined measurements.
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.
Allowable Subject Matter
Claims 12, 17-18 and 20 are allowed.
Claims 2, 10-11 and 15-16 are 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.
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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