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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-20 and 30 is/are pending. Claim(s) 3 and 13 is/are withdrawn. Claim(s) 21-29 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 6/29/2026, with respect to the claim objection have been fully considered and are persuasive. The claim objection of claim 1 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments with respect to claim(s) 1-2, 4-12, 14-20, and 30 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 4-12, 14-20, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kung, et al (Kung) (US 6,626,821 B1).
Regarding Claim 1, Kung teaches an intravascular inflatable medical device (e.g. abstract, Figures 38-39), comprising:
a conduit including an inflatable wall (e.g. Figures 1, 34, 38-39), the inflatable wall defining a lumen therein (e.g. Figures 38-39, central opening),
the inflatable wall including an outer layer and an inner layer (e.g. annotated Figure 38 below), each layer extending continuously about a circumference of the inflatable wall (e.g. annotated Figure 38 below), and an intermediate layer that is disposed radially between the outer layer and the inner layer (e.g. annotated Figure 38 below; layer between the labeled inner layer and outer layer), the inner layer at least partially defining the lumen (e.g. annotated Figure 38 below),
the intermediate layer including, in a cross-section transverse to a longitudinal axis of the inflatable wall when inflated, an inflatable volume (e.g. column 16, lines 28-44) and a plurality of radial connectors extending between the outer layer and the inner layer (e.g. annotated Figure 38 below), such that when a fluid is delivered into the inflatable volume, a stiffness of the inflatable wall increases (e.g. Figures 38-39; the stiffness increases because the walls are held in the more open configuration, Figure 39, by the fluid pressure when inflated to that configuration).
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Annotated Figure 38, Fung
Regarding Claim 2, the inflatable wall is compliant when uninflated such that it is adapted to be folded for delivery (e.g. column 16, lines 28-44; the volumes are inflatable balloons and thus collapse when not inflated), wherein when folded it can have a different general configuration than when inflated (e.g. Figure 38 versus Figure 39).
Regarding Claim 5, the plurality of radial connectors are arranged within the intermediate layer such that a first portion of the inflatable wall has a first stiffness and a second portion spaced from the first portion has a second stiffness that is different than the first stiffness when the inflatable wall is inflated with the fluid (e.g. Figure 38, the location where adjacent radial connectors is located versus a location where there is no overlap; the thickness at the first location is greater than that at the second location and thus the stiffnesses differ in the configuration shown).
Regarding Claim 6, there is a fluid pathway extending proximally from the inflatable wall and in fluid communication therewith to facilitate fluid delivery through the fluid pathway and into the inflatable wall (e.g. Figure 37, #610; column 16, lines 6-22; where proximal is toward the bottom as shown in Figure 37).
Regarding Claim 7, each of the radial connectors extends from the outer layer at a location that is one or more of axially or circumferentially spaced from a location from which the respective radial connector extends from the inner member (e.g. Figure 38).
Regarding Claim 8, the plurality of radial connectors together create a wave pattern (e.g. Figure 38, as broadly claimed, the pattern is overlapping waves).
Regarding Claim 9, the inflatable volume comprises a first inflatable volume and a second inflatable volume, wherein the first and second inflatable volumes are not in direct fluid communication within the inflatable wall (e.g. Figures 37-38; each radial connector has its own volume).
Regarding Claim 10, the first and the second inflatable volumes are in fluid communication with first and second fluid inflation pathways, respectively (e.g. Figure 37, each volume has its own inflation pathway).
Regarding Claim 11, Kung teaches an intravascular inflatable medical device (discussed supra for claim 1), comprising:
a conduit including an inflatable wall, the inflatable wall defining a lumen therein (discussed supra for claim 1),
the inflatable wall including an outer layer and an inner layer (discussed supra for claim 1), each layer extending continuously about a circumference of the inflatable wall (discussed supra for claim 1), and an intermediate layer that is disposed radially between the outer layer and the inner layer (discussed supra for claim 1), the inner layer at least partially defining the lumen (discussed supra for claim 1),
the intermediate layer including, in a cross-section transverse to a longitudinal axis of the inflatable wall when inflated, an inflatable volume and a plurality of radial connectors extending between the outer layer and the inner layer (discussed supra for claim 1),
wherein the plurality of radial connectors each have a length from a first end that is coupled to the outer layer to a second end that is coupled to the inner layer (e.g. Figure 38),
wherein the lengths of the plurality of radial connectors are greater than a radial thickness of the outer layer and a radial thickness of the inner layer, the radial thickness measured in a radial direction transverse to the longitudinal axis of the inflatable wall (e.g. Figure 38).
Regarding Claim 12, the limitations of claim 12 are discussed supra for claim 2.
Regarding Claim 14, the limitations of claim 14 are discussed supra for claim 4.
Regarding Claim 15, the limitations of claim 15 are discussed supra for claim 5.
Regarding Claim 16, the limitations of claim 16 are discussed supra for claim 6.
Regarding Claim 17, the limitations of claim 17 are discussed supra for claim 7.
Regarding Claim 18, the limitations of claim 18 are discussed supra for claim 8.
Regarding Claim 19, the limitations of claim 19 are discussed supra for claim 9.
Regarding Claim 20, the limitations of claim 20 are discussed supra for claim 10.
Regarding Claim 30, Kung teaches an intravascular inflatable medical device (discussed supra for claim 1), comprising:
a conduit including an inflatable wall, the inflatable wall defining a lumen therein (discussed supra for claim 1),
the inflatable wall including an outer layer, an inner layer, and an intermediate layer that is disposed radially between the outer layer and the inner layer (discussed supra for claim 1), the inner layer at least partially defining the lumen (discussed supra for claim 1), wherein each of the outer layer, the inner layer, and the intermediate layer having radially inner and outer surfaces (these surfaces are inherently present), the intermediate layer outer surface facing the outer layer inner surface and the intermediate layer inner surface facing the inner layer outer surface (e.g. Figure 38; the claimed orientation is present in the shown configuration),
the intermediate layer including, in a cross-section transverse to a longitudinal axis of the inflatable wall when inflated, an inflatable volume and a plurality of radial connectors extending between the outer layer and the inner layer (discussed supra for claim 1), such that when a fluid is delivered into the inflatable volume, a stiffness of the inflatable wall increases (discussed supra for claim 1).
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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 8/19/2026
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