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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 3, 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on June 3, 2026. As directed by the amendment: claims 1, 14 and 24 have been amended, no claims have been cancelled, and claims 25-27 have been added. Thus, claims 1-27 are presently pending in this application.
Declaration of Kenneth Mazzarese Under 37 C.F.R. §1.132
Examiner has reviewed the declaration which is directed to newly amended independent claims 1, 14 and 24 that further define the balloon as “compliant”. This declaration by Mr. Mazzarese is presented in anticipation of a §112(b) rejection to “compliant”, as well as to overcome the cited art Smith of the previous action. Applicant anticipates a §112(b) rejection to “compliant” because Applicant has amended the claims filed June 3, 2026 to include this limitation which was previously rejected in a non-final sent February 24, 2026. The arguments are summarized on page 2 of the Declaration, and they are directed to the term “compliant” and that Smith teaches a non-compliant balloon. The declaration is persuasive as to the term “compliant” and that Smith does not teach a compliant balloon.
Response to Arguments
Applicant’s arguments, see Remarks, filed June 3, 2026, with respect to the rejections of newly amended independent claims 1, 14 and 24 under 35 U.S.C. §103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view Kanai US 5,158,529, Wolvek et al. (Wolvek) US 5,716,373 and Milder et al. (Milder) US 5,116,305.
Pages 9-13 of the Remarks are related to the declaration by Mr. Mazzarese in anticipation of a §112(b) rejection. See above.
On pages 14-15 of the Remarks, Applicant argues the newly amended independent claims that further define the balloon as “compliant”, and that the balloon of Smith is non-compliant. In response, Examiner agrees that the newly amended independent claims overcome the cited art Smith of the previous action.
On page 16 of the Remarks, Applicant points to the declaration of Mr. Mazzarese regarding evidence that the balloon of Smith is non-compliant due to the method of manufacture and the resulting pre-formed, heat set longitudinally fluted configuration. In response, Examiner agrees that the newly amended independent claims overcome the cited art Smith of the previous action.
On page 17 of the Remarks, Applicant argues new claims 25-27. In response, Examiner points to the rejections below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 25-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claims 25-27 recite “…wherein the occlusion balloon is free of pre-formed longitudinal flutes in an uninflated configuration”, which is a negative limitation that is not supported by the written description. P0013 of the written description mentions flutes, and the relevant sentence from P0013 recites “The occlusion member may have…a fluted or corrugated shape with longitudinally oriented flutes or corrugations and valleys between adjacent flutes or corrugations when in its partially deployed state.” There is no mention in the written description regarding a lack of flutes in an uninflated condition as claimed.
On pages 17-18 of the Remarks (also see page 5 of the declaration), Applicant argues that the balloon of Smith having a heat set, pre-formed longitudinally fluted configuration is incompatible with a compliant balloon. Applicant builds on this argument for support in new claims 25-27, claiming that all compliant balloons are free of pre-formed longitudinal flutes in an uninflated configuration. It is not clear that all compliant balloons cannot have pre-formed longitudinal flutes, especially compliant balloons that are formed without a heat set process. For purposes of examination and to promote compact prosecution, a compliant balloon is interpreted to be free of pre-formed longitudinal flutes.
Claim Rejections - 35 USC § 103
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6-8, 12-13 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Kanai US 5,158,529 in view of Wolvek et al. (Wolvek) US 5,716,373 in view of Milder et al. (Milder) US 5,116,305.
Regarding claim 1, Kanai discloses an occlusion catheter system for partial or complete occlusion of the aorta (pumping device for operating an intra-aortic balloon comprising driver 3 and balloon pump/ballon catheter 4 as shown in Fig. 1 and described in c 2 ln 48-50), the occlusion catheter system comprising: a flow a valve having an open position (positive pressure opening/shut-off valve 313, c 3 ln 5-6) and an inflation device (positive pressure source 311, c 3 ln 4).
Kanai does not explicitly teach the balloon catheter having a proximal hub forming an internal inflation fluid pathway; the flow valve proximal to an inlet of the proximal hub, whereby an outlet of the flow valve is connected to the inlet of the proximal hub, the flow valve open position configured to fluidly communicate the inflation device with the inflation fluid pathway of the proximal hub; a proximal catheter member extending from the proximal hub; a distal catheter member; an intervening, occlusion balloon connected to the proximal catheter member and the distal catheter member, the occlusion balloon having a proximal neck, a distal neck and an intervening body portion; and a stiffener member having a proximal end and a distal end, the proximal end located within and fixedly coupled to the proximal hub, the stiffener member extending otherwise uncoupled within the proximal catheter member, and the stiffener member further extending into and beyond the body portion of the occlusion balloon.
However, Wolvek teaches an intra-aortic balloon catheter (intra-aortic balloon catheters, c 4 ln 6-7 and as shown in Fig. 3) having a proximal hub (fitting 10, c 3 ln 9) forming an internal inflation fluid pathway (the lumen of fitting 10); a proximal catheter member (catheter tube 2, c 3 ln 8) extending from the proximal hub; a distal catheter member (tip 3, c 3 ln 7); an intervening, occlusion balloon (balloon, see annotated Fig. 3 below) connected to the proximal catheter member and the distal catheter member, the occlusion balloon having a proximal neck, a distal neck and an intervening body portion (see annotated Fig. 3 below); and a stiffener member (support wire 12, c 3 ln 6) having a proximal end (at fitting 10) and a distal end (at tip 3), the proximal end located within and fixedly coupled to the proximal hub (support wire 12 ran into fitting 10, c 3 ln 6-9), the stiffener member extending otherwise uncoupled within the proximal catheter member (c 3 ln 5-9 and Fig. 3), and the stiffener member further extending into and beyond the body portion of the occlusion balloon (see annotated Fig. 3 below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute the balloon catheter of Kanai for the balloon catheter of Wolvek, wherein the flow valve is proximal to an inlet of the proximal hub, whereby an outlet of the flow valve is connected to the inlet of the proximal hub, the flow valve open position configured to fluidly communicate the inflation device with the inflation fluid pathway of the proximal hub, as a simple substitution of one known balloon catheter for another to obtain predictable results, MPEP 2143. Kanai contained a pumping device for operating an intra-aortic balloon which differed from the claimed device by the substitution of one intra-aortic balloon catheter for another. The substituted intra-aortic balloon catheter and their functions were well known as demonstrated by Wolvek. One of ordinary skill in the art could have substituted one known intra-aortic balloon catheter for another, and the results of the substitution would have been predictable because both are designed to pump blood within the aorta.
Wolvek does not explicitly teach that the occlusion balloon is compliant.
However, Milder teaches an intra-aortic balloon that is compliant c 3 ln 24-26.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the balloon of Wolvek to be compliant for the purpose of utilizing a balloon whose dimensions change as a function of pressure for pumping blood, Milder c 3 ln 24-26.
Regarding claim 2, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1, further comprising a lumen (Wolvek, lumen of catheter tube 2) originating from the proximal hub, in fluid communication with the inflation fluid pathway, and extending through the proximal catheter member and into communication with the occlusion balloon, and wherein the stiffener member is longitudinally solid (rod or wire, c 3 ln 12, wherein a wire lacks a lumen) throughout the extension thereof within the proximal catheter member, into and beyond the body portion of the occlusion balloon (Fig. 3).
Regarding claim 3, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1.
Kanai in view of Wolvek in view of Milder does not teach wherein the stiffener member defines an internal lumen.
However, it appears that the device of Wolvek would operate equally well with the claimed stiffener member that defines an internal lumen since the wire of Wolvek serves to impart rigidity, Wolvek c 2 ln 54-59. Further, Applicant has not disclosed that a stiffener member that defines an internal lumen solves any stated problem or is for any particular purpose, instead indicating that the stiffener is preferably a solid wire, instead of a tube with a lumen, see P0184 of the written description.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to cause the wire of Wolvek to define a lumen because it appears to be an arbitrary design consideration which fails to patentably distinguish over Wolvek.
Regarding claim 6, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1, wherein the distal end of the stiffener member is fixedly coupled to a proximal section of the distal catheter member (Wolvek, support wire 12 ran from the tip 3, c 3 ln 6-7 and Fig. 3).
Regarding claim 7, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1, wherein the flow valve is selectively actuatable between the open position and a closed position (Kanai, c 3 ln 3-41).
Regarding claim 8, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 7, wherein the flow valve is selectively actuatable between the open and closed positions with the stiffener member extending within the proximal catheter member (the support wire 12 of Wolvek is fixed within the catheter during use of the flow valve).
Regarding claim 12, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1, wherein the stiffener member is constructed of a metal (Wolvek, wire c 3 ln 12, wherein a wire is a metal, see attached definition).
Regarding claim 13, Kanai in view of Wolvek in view of Milder teaches an occlusion catheter assembly comprising: the occlusion catheter system of claim 1; and the inflation device being configured to fluidly connect with the inflation fluid pathway of the proximal hub via fluid flow through the flow valve located therebetween (Kanai, Fig. 1 and c 3 ln 3-15).
Regarding claim 25, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1, wherein the occlusion balloon is free of pre-formed longitudinal flutes in an uninflated configuration (Milder, the balloon is compliant).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Wolvek in view of Milder and further in view of Wolvek et al. (Wolvek ‘874) US 4,276,874.
Regarding claim 4, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1.
Kanai in view of Wolvek in view of Milder does not teach wherein the proximal end of the stiffener member is bonded to the proximal hub.
However, Wolvek ‘874 teaches a balloon catheter wherein the proximal end 48 of the stiffener member 46 is bonded to the proximal hub 26b, c 6 ln 48-50.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further secure the support wire 12 of Wolvek to the fitting 10 of Wolvek with adhesive as taught by Wolvek ‘874 for the purpose of permanent securement, Wolvek ‘874 c 6 ln 48-50.
Regarding claim 5, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 4, wherein the proximal end of the stiffener member is adhesively bonded to the proximal hub (Wolvek ‘874, adhesives, c 6 ln 48-50).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Wolvek in view of Milder and further in view of Valencia et al. (Valencia) US 2006/0030814 A1.
Regarding claim 9, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1.
Wolvek teaches that the balloon catheter could be inserted through the smallest possible introducer sheath, c 3 ln 16-17, but is silent as to wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 8 Fr or less in an uninflated configuration.
However, Valencia teaches an intra-aortic catheter wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 8 Fr or less in an uninflated configuration (P0177 teaches aortic catheters for use with introducer sheaths of about 6 to 8 Fr).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to size the balloon catheter of Wolvek as claimed to pass through a 6 to 8 Fr introducer sheath for the purpose of minimizing damage to the vasculature at the percutaneous entry point.
Regarding claim 10, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1.
Wolvek teaches that the balloon catheter could be inserted through the smallest possible introducer sheath, c 3 ln 16-17, but is silent as to wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 7 Fr or less in an uninflated configuration.
However, Valencia teaches an intra-aortic catheter wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 7 Fr or less in an uninflated configuration (P0177 teaches aortic catheters for use with introducer sheaths of about 6 to 8 Fr).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to size the balloon catheter of Wolvek as claimed to pass through a 6 to 8 Fr introducer sheath for the purpose of minimizing damage to the vasculature at the percutaneous entry point.
Regarding claim 11, Kanai in view of Wolvek in view of Milder teaches the occlusion catheter system of claim 1.
Wolvek teaches that the balloon catheter could be inserted through the smallest possible introducer sheath, c 3 ln 16-17, but is silent as to wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 6 Fr or less in an uninflated configuration.
However, Valencia teaches an intra-aortic catheter wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 6 Fr or less in an uninflated configuration (P0177 teaches aortic catheters for use with introducer sheaths of about 6 to 8 Fr).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to size the balloon catheter of Wolvek as claimed to pass through a 6 to 8 Fr introducer sheath for the purpose of minimizing damage to the vasculature at the percutaneous entry point.
Claims 14-18, 21-23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874.
Regarding claim 14, Kanai discloses an occlusion catheter system for partial or complete occlusion of the aorta to preserve blood flow to a heart and brain of a patient, the occlusion catheter system (MPEP 2111.02(II) recites that statements in the preamble reciting intended use must be evaluated to determine whether or not the intended use results in structural differences between the claimed invention and the prior art, and here the preamble does not result in a structural difference between the claimed invention and the prior art) comprising (claim limitations mapped as above for claim 1, unless otherwise noted below): a flow valve; wherein, in an open position of the flow valve, the flow valve is configured to fluidly communicate an inflation device with the balloon catheter, and in a closed position of the flow valve, the flow valve is configured to block fluid communication between the inflation device and the balloon catheter.
Kanai does not teach the balloon catheter having a proximal hub having a single inlet and forming an internal inflation fluid pathway; a proximal catheter member in fluid communication with the inflation fluid pathway; a distal catheter member; an intervening, occlusion balloon connecting the proximal catheter member with the distal catheter member; a lumen extending from the proximal hub through the proximal catheter member and into communication with the occlusion balloon; and a stiffener member having a proximal end and a distal end, the proximal end of the stiffener member (i) being located within the proximal hub and extending otherwise uncoupled within the lumen, and (ii) being spaced distally from the flow valve, the distal end of the stiffener member extending into the distal catheter member, the flow valve being selectively actuatable into each of the open and closed positions with the stiffener member extending distally from the proximal catheter member.
However, Wolvek teaches a balloon catheter (claim limitations mapped as above for claim 1, unless otherwise noted below) having a proximal hub having a single inlet (Fig. 3) and forming an internal inflation fluid pathway; a proximal catheter member in fluid communication with the inflation fluid pathway; a distal catheter member; an intervening, occlusion balloon connecting the proximal catheter member with the distal catheter member; a lumen extending from the proximal hub through the proximal catheter member and into communication with the occlusion balloon; and a stiffener member having a proximal end and a distal end, the proximal end of the stiffener member (i) being located within the proximal hub and extending otherwise uncoupled within the lumen, and (ii) being spaced distally from the flow valve, the distal end of the stiffener member extending into the distal catheter member, the flow valve being selectively actuatable into each of the open and closed positions with the stiffener member extending distally from the proximal catheter member.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Kanai with the balloon catheter of Wolvek wherein, in an open position of the flow valve, the flow valve is configured to fluidly communicate the inflation device with the inflation fluid pathway, via the single inlet, for occlusion balloon inflation, and in the closed position of the flow valve, the flow valve is configured to block fluid communication between the inflation device and the inflation fluid pathway, as a simple substitution of one known balloon catheter for another to obtain predictable results, MPEP 2143. Kanai contained a pumping device for operating an intra-aortic balloon which differed from the claimed device by the substitution of one intra-aortic balloon catheter for another. The substituted intra-aortic balloon catheter and their functions were well known as demonstrated by Wolvek. One of ordinary skill in the art could have substituted one known intra-aortic balloon catheter for another, and the results of the substitution would have been predictable because both are designed to pump blood within the aorta.
Wolvek does not explicitly teach that the occlusion balloon is compliant.
However, Milder teaches an intra-aortic balloon that is compliant c 3 ln 24-26.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the balloon of Wolvek to be compliant for the purpose of utilizing a balloon whose dimensions change as a function of pressure for pumping blood, Milder c 3 ln 24-26.
Wolvek does not teach wherein the stiffener member being bonded to the proximal hub
However, Wolvek ‘874 teaches a balloon catheter wherein the proximal end 48 of the stiffener member 46 is bonded to the proximal hub 26b, c 6 ln 48-50.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further secure the support wire 12 of Wolvek to the fitting 10 of Wolvek with adhesive as taught by Wolvek ‘874 for the purpose of permanent securement, Wolvek c 6 ln 48-50.
Regarding claim 15, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 14, wherein the proximal end of the stiffener member is adhesively bonded to the proximal hub (Wolvek ‘874, adhesives, c 6 ln 48-50).
Regarding claim 16, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 14.
The Fig. 3 embodiment of Wolvek is silent as to the distal end of the stiffener member is fixedly coupled to a lumen of the distal catheter member.
However, the embodiment of Fig. 4 Wolvek teaches the distal end of the stiffener member is fixedly coupled to a lumen of the distal catheter member (support member 30 is attached to tip 28 and Fig. 4 dashed lines at 46).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the tip 3 of the Fig. 3 embodiment of Wolvek as shown in the Fig. 4 embodiment of Wolvek for the purpose of securing the distal end of the support wire 12.
Regarding claim 17, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 14, wherein the stiffener member is longitudinally solid from the proximal end to the distal end thereof (rod or wire, c 3 ln 12, wherein a wire lacks a lumen).
Regarding claim 18, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 14.
Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 does not teach wherein the stiffener member defines an internal lumen therein.
However, it appears that the device of Wolvek would operate equally well with the claimed stiffener member that defines an internal lumen therein since the wire of Wolvek serves to impart rigidity, Wolvek c 2 ln 54-59. Further, Applicant has not disclosed that a stiffener member that defines an internal lumen solves any stated problem or is for any particular purpose, instead indicating that the stiffener is preferably a solid wire, instead of a tube with a lumen, see P0184 of the written description.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to cause the wire of Wolvek to define an internal lumen therein because it appears to be an arbitrary design consideration which fails to patentably distinguish over Wolvek.
Regarding claim 21, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 14, wherein the proximal catheter member and the distal catheter member are constructed of a polymeric material (Wolvek, polyurethane, c 4 ln 37-42), the occlusion balloon having a proximal balloon end (proximal neck, see annotated Fig. 3 below) and distal balloon end (distal neck, see annotated Fig. 3 below), the proximal balloon end attached to the proximal catheter member and the distal balloon end attached to the distal catheter member (see annotated Fig. 3 below).
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Regarding claim 22, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches an occlusion catheter assembly comprising: the occlusion catheter system of claim 14; and the inflation device being configured to fluidly connect with the inflation fluid pathway of the proximal hub via fluid flow through the flow valve located therebetween (Kanai, Fig. 1).
Regarding claim 23, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter assembly of claim 22, wherein the bond of the proximal end of the stiffener member with the proximal hub provides stiffness for the occlusion balloon catheter to resist pressure that builds against the catheter during occlusion of the aorta (the proximal end of the support wire 12 bonded to the fitting 10 as taught by Wolvek in view of Wolvek ‘874 provides rigidity, Wolvek c 2 ln 54 to c 3 ln 9, and is fully capable of resisting pressure that builds against the catheter during occlusion of the aorta).
Regarding claim 26, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 14, wherein the occlusion balloon is free of pre-formed longitudinal flutes in an uninflated configuration (Milder, the balloon is compliant).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 in view of Valencia.
Regarding claim 19, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 14, wherein the proximal catheter member is tubular (Wolvek, Fig. 3).
The embodiment of Fig. 3 Wolvek does not explicitly teach the distal catheter member is tubular.
However, the embodiment of Fig. 4 Wolvek teaches tip 28 is tubular for accepting support member 30, see Fig. 4.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the tip 3 of the Fig. 3 embodiment as shown in the Fig. 4 embodiment for the purpose of securing the distal end of the support wire 12.
Wolvek teaches that the balloon catheter could be inserted through the smallest possible introducer sheath, c 3 ln 16-17, but is silent as to wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 8 Fr or less in an uninflated configuration.
However, Valencia teaches an intra-aortic catheter wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 8 Fr or less in an uninflated configuration (P0177 teaches aortic catheters for use with introducer sheaths of about 6 to 8 Fr).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to size the balloon catheter of Wolvek as claimed to pass through a 6 to 8 Fr introducer sheath for the purpose of minimizing damage to the vasculature at the percutaneous entry point.
Regarding claim 20, Kanai in view of Wolvek in view of Milder in view of Wolvek ‘874 teaches the occlusion catheter system of claim 14, wherein the proximal catheter member is tubular.
The embodiment of Fig. 3 Wolvek does not explicitly teach the distal catheter member is tubular.
However, the embodiment of Fig. 4 Wolvek teaches tip 28 is tubular for accepting support member 30, see Fig. 4.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the tip 3 of the Fig. 3 embodiment as shown in the Fig. 4 embodiment for the purpose of securing the distal end of the support wire 12.
Wolvek teaches that the balloon catheter could be inserted through the smallest possible introducer sheath, c 3 ln 16-17, but is silent as to wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 6 Fr or less in an uninflated configuration.
However, Valencia teaches an intra-aortic catheter wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 6 Fr or less in an uninflated configuration (P0177 teaches aortic catheters for use with introducer sheaths of about 6 to 8 Fr).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to size the balloon catheter of Wolvek as claimed to pass through a 6 to 8 Fr introducer sheath for the purpose of minimizing damage to the vasculature at the percutaneous entry point.
Claims 24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Wolvek in view of Miller et al. (Miller) US 5,464,394 in view of Klocke et al. (Klocke) US 2019/0366046 A1 in view of Milder in view of Valencia.
Regarding claim 24, Wolvek discloses an occlusion catheter system for partial or complete occlusion of the aorta to occlude non-compressible hemorrhage in emergency or trauma environments where guidance imaging is typically not available, the occlusion catheter system (MPEP 2111.02(II) recites that statements in the preamble reciting intended use must be evaluated to determine whether or not the intended use results in structural differences between the claimed invention and the prior art, and here the preamble does not result in a structural difference between the claimed invention and the prior art) comprising (claim limitations mapped as claim 1 above, unless otherwise noted below): a proximal hub forming an internal inflation fluid pathway; a proximal catheter member extending from the proximal hub; a distal catheter member terminating in an atraumatic tip (tip 3 is rounded); an intervening, occlusion balloon connecting the proximal catheter member with the distal catheter member; an inflation lumen originating from the proximal hub, in fluid communication with the inflation fluid pathway, and extending through the proximal catheter member and into fluid communication with the occlusion balloon; and a stiffener member having a proximal end and a distal end, the stiffener member being longitudinally solid (wire 12) from the proximal end to the distal end, the stiffener member extending within the inflation lumen, the occlusion balloon and into the distal catheter member, the proximal end of the stiffener member being located within and fixedly coupled to the proximal hub and extending otherwise uncoupled within the inflation lumen, and the distal end of the stiffener member extending into the distal catheter member.
Wolvek does not teach a flow valve having an inlet and an outlet, whereby the outlet of the flow valve is connected to an inlet of the proximal hub, the flow valve having an open position configured to fluidly communicate a syringe with the inflation fluid pathway of the proximal hub.
However, Miller teaches a catheter having a flow valve (stop cock 20, c 4 ln 51 and as shown in Fig. 1) having an inlet and an outlet, the flow valve having an open position configured to fluidly communicate a syringe (Fig. 1) with the inflation fluid pathway of the proximal hub.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the balloon catheter of Wolvek with the flow valve and syringe of Miller whereby the outlet of the flow valve is connected to an inlet of the proximal hub for the purpose of performing a preloading process of the balloon prior to use.
Wolvek does not teach a length marking on an exterior of the proximal catheter section to indicate an insertion depth of the occlusion catheter.
However, Klocke teaches a catheter with markings having a length marking (marks 32, P0023) on an exterior of the proximal catheter section (Fig. 7A) to indicate an insertion depth of the occlusion catheter (P0024).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the occlusion catheter system of Wolvek with the marks of Klocke for the purpose of assessing the amount to which the catheter has been introduced to the treatment area, as taught by Klocke P0024.
Wolvek does not explicitly teach that the occlusion balloon is compliant.
However, Milder teaches an intra-aortic balloon that is compliant c 3 ln 24-26.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the balloon of Wolvek to be compliant for the purpose of utilizing a balloon whose dimensions change as a function of pressure for pumping blood, Milder c 3 ln 24-26.
Wolvek teaches that the balloon catheter could be inserted through the smallest possible introducer sheath, c 3 ln 16-17, but is silent as to wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 6 Fr or less in an uninflated configuration.
However, Valencia teaches an intra-aortic catheter wherein the proximal catheter member, the occlusion balloon and the distal catheter member have a greatest outer diameter of 6 Fr or less in an uninflated configuration (P0177 teaches aortic catheters for use with introducer sheaths of about 6 to 8 Fr).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to size the balloon catheter of Wolvek as claimed to pass through a 6 to 8 Fr introducer sheath for the purpose of minimizing damage to the vasculature at the percutaneous entry point.
Regarding claim 27, Wolvek in view of Miller in view of Klocke in view of Milder in view of Valencia teach the occlusion catheter system of claim 24, wherein the occlusion balloon is free of pre-formed longitudinal flutes in an uninflated configuration (Milder, the balloon is compliant).
Conclusion
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/J.A.D./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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