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.
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 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.
Status of the Claims
Claim(s) 1-20 is/are pending. Claim(s) 3 and 13 is/are withdrawn. Claim(s) 21-29 is/are canceled.
Election/Restrictions
Applicant’s election without traverse of Species 1-2 in the reply filed on 11/5/2025 is acknowledged.
Claims 2 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species 1-1, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/5/2025.
Information Disclosure Statement
The information disclosure statement filed see following list fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because see following list. Citation numbers are in the order they appeared in the documents rather than number order.
The 75 page IDS filed 3/9/2023
FOR documents not provided: numbers 1458, 1119, 1988, 2012, 2022, 2028, 2035, 2046, 2051, 1158, 1161, 1487, 1489, 1503, 2235
NPL documents not provided: numbers 2354, 2444, 2445, 2446, 2448, 2451
The 49 page IDS filed 3/10/2023
FOR documents not provided: numbers 1870, 1602, 1166, 2254
The 44 page IDS filed 3/10/2023
FOR documents not provided: numbers 1720, 1730, 1754, 1797, 1920, 1375, 1535, 1551, 1561, 1646, 2133
FOR documents having no English equivalent provided: numbers 1348, 1771, 1817, 1819, 1362
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
Claim Objections
Claims 10 and 19-20 are objected to because of the following informalities:
Claim 10, line 1 and claim 19, line 2 and claim 20, line 1 each recites “the first and second”, which should be “the first and the second”.
Appropriate correction is required.
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, and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rogers, et al (Rogers) (US 5,534,024 A).
Regarding Claim 1, Rogers teaches an intravascular inflatable medical device, comprising:
a conduit including an inflatable wall, the inflatable wall defining a lumen (e.g. Figures 1-3; column 2, lines 43-53) therein,
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 (e.g. annotated Figure 4 below; column 2, lines 22-32), the inner layer at least partially defining the lumen (e.g. Figure 2),
the intermediate layer including, in a cross-section transverse to a longitudinal axis of the inflatable wall when inflated (e.g. Figures 1-2), an inflatable volume (e.g. Figures 1-2, volume of #30) and a plurality of radial connectors extending between the outer layer and the inner layer (e.g. annotated Figure 4 below), such that when a fluid is delivered into the inflatable volume, a stiffness of the inflatable wall increases (e.g. column 2, lines 43-53; at least inflation from no fluid to the configuration shown in Figures 1-2 is an increase in stiffness because the walls are held in the open shape by the fluid pressure as opposed to collapsed).
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Annotated Figure 4, Rogers
Regarding Claim 2, the inflatable wall is compliant when uninflated such that it is adapted to be folded for delivery (e.g. column 2, lines 43-53), wherein when folded it can have a different general configuration than when inflated (e.g. Figure 5 versus Figure 6).
Regarding Claim 4, the plurality of radial connectors are arranged so as to have an irregular pattern along a length of the intermediate layer (e.g. Figure 2, at least the walls around opening #40/valve#42 will collapse differently that those of #30s without these elements; as seen in Figure 2 there is no regular pattern having #s 40/42, thus the overall pattern of the walls is irregular, when collapsed).
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 4, the first portion is considered the joint of the seam and the second portion is considered the inner and outer walls; since the first portion has double thickness relative the second thickness, at least the stiffness along the thicknesses are different from one another).
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 3, via opening #40/valve #42, from #44 into the volume of #30).
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. annotated Figure 2 below, the dotted line is a diameter through the example location on the outer wall; the solid line is a radial connector with circles at its two ends, which are circumferentially spaced apart from one another as shown).
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Annotated Figure 2, Rogers
Regarding Claim 8, the plurality of radial connectors together create a wave pattern (e.g. Figure 2).
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. Figure 2, each element #30 is separated from the other #30s as shown and thus fluid does not flow from one #30 to another #30).
Regarding Claim 10, the first and second inflatable volumes are in fluid communication with first and second fluid inflation pathways, respectively (e.g. annotated Figure 1 below, the dotted arrow is fluid into the system and each solid arrow is a flow path to a given chamber #30; all fluid paths are in communication with each other via the entry path and common annular channel adjacent the chambers #30).
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Annotated Figure 1, Rogers
Regarding Claim 11, 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),
the intermediate layer including, in a cross-section transverse to a longitudinal axis of the inflatable wall when inflated (discussed supra for claim 1), an inflatable volume (discussed supra for claim 1) 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. annotated Figure 2 above, length of the solid line),
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. annotated Figure 2 above, the length of the solid line is greater than each of the thicknesses of the inner and outer walls).
Regarding Claim 12, the inflatable wall is compliant when uninflated such that it is adapted to be folded for delivery, wherein when folded it can have a different general configuration than when inflated (discussed supra for claim 2).
Regarding Claim 14, the plurality of radial connectors are arranged so as to an irregular pattern along a length of the intermediate layer (discussed supra for claim 4).
Regarding Claim 15, 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 (discussed supra for claim 5).
Regarding Claim 16, 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 (discussed supra for claim 6).
Regarding Claim 17, 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 (discussed supra for claim 7).
Regarding Claim 18, the plurality of radial connectors together create a wave pattern (discussed supra for claim 8).
Regarding Claim 19, 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 (discussed supra for claim 9).
Regarding Claim 20, the first and second inflatable volumes are in fluid communication with first and second fluid inflation pathways, respectively (discussed supra for claim 10).
Relevant Prior Art
US 9,179,921 B1 to Morris teaches inflatable catheter (e.g. abstract, Figures 3-5).
US 5,330,528 to Lazim teaches an inflatable medical device (e.g. abstract, Figures 1, 5-7).
US 4,183,102 to Guiset teaches an inflatable prosthesis having walled chambers (e.g. translated abstract, Figures 1-2).
US 2012/0109179 A1 to Murphy, et al teaches an inflatable intravasculature device having walled chambers (e.g. abstract, Figure 1).
US 6,626,821 to Kung, et al teaches an inflatable medical device having walled chambers (e.g. abstract, Figures 1, 38-44).
US 2013/0103135 A1 to Vinluan teaches an inflatable medical device having walled chambers (e.g. abstract, Figure 1).
Conclusion
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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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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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 11/21/2025