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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/15/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 4/15/26. The claims 1-20 are pending. Claims 1 and 20 have been amended.
Response to Arguments
Applicant’s arguments, filed 11/11/25 with respect to the rejections of claims 1-10, 13-18, and 20 under 103 as being unpatentable over Murad (WO2020/123230) in view of Dehdashtian (US2007/0112422) have been fully considered but they are not persuasive. Applicant argues the art does not teach “an inner tube attached to the proximal stop”, since the inner shaft (first shaft 104) of Murad passes through the proximal stop (proximal shoulder 110) of Murad. Examiner disagrees, where the inner tube (first shaft 104) of Murad extends to a proximal end and is attached to a handle ([033]). Where that handle is also attached to the proximal stop (proximal shoulder 110) via the second shaft 106 ([042]). Therefore the inner tube (first shaft 104) and the proximal stop (proximal shoulder 110) of Murad would be attached via the handle at least indirectly. It appears, Applicant’s argument is toward a limitation not claimed, of the proximal stop being directly and fixedly connected to the inner tube.
Applicant argues, the modification of Murad with Dehdastian, to substitute the inner tube of Dehdastian for the inner tube of Murad, since Murad fails to teach inflation fluid within the inner tube (first shaft 104). Examiner makes notice, the delivery system of Murad would work in the same manner when modified by Dehdastian. Furthermore, the inflation fluid through the inner tube and the inner tube defining an inflation lumen are functional recitations. Where the inner tube of Murad as modified by Dehdastian merely needs the capability of performing the claimed functions. A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. Applicant draws attention to a federal circuit case that found “in view of expectations of those of ordinary skill in the art, adding the subcoating would not have been expected to confer any particular desirable property on the final product. Rather, the final product obtained according to the proposed modification would merely have expected to have the same functional properties as the prior art product.” Where the modification proposed in the rejection is a simple substitution of one known element for another. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143. Where the substitution of an inner tube for an inner tube with openings would have the same predictable result of a tube through the delivery system having the capability of allowing fluid to flow through the tube.
Applicant further argues, that the limitation “at least some of the openings through the inner tube are position within the distal gap and some openings are positioned within the proximal gap” would not be an obvious matter of design choice. Examiner acquiesces to the argument; however, the rejection has been maintained since the combination of Murad/Dehdastian discloses the openings through the inner tube are positioned within the distal gap and some openings are positioned within the proximal gap because the inner tube (first shaft 104) is capable of being moved ([033]) so that the openings as taught by Dehdastian are positioned within the distal gap and the proximal gap.
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 of this title, 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.
Claims 1-10, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Murad (WO2020/123230 – cited in Applicant’s IDS) in view of Dehdashtian (US2007/0112422 – cited in Applicant’s IDS)
Regarding claim 1, Murad discloses a delivery system for an expandable medical device ([047]), comprising:
a catheter shaft (106);
a proximal stop (110) coupled to the catheter shaft ([042]);
an inner tube (104) attached to the proximal stop and extending distally therefrom (inner tube 104 is attached to the proximal stop 110 via the handle that is directly attached to the inner tube 104 and the second tube 106, [033], [042], see Fig. 3),
a distal stop (112) coupled to the inner tube, the distal stop having a lumen and at least one channel (slots 132) extending through a sidewall of the distal stop into the lumen (see Fig. 3); and an inflatable balloon (118) disposed over the distal stop, the inner tube, and the proximal stop [038];
wherein the distal stop is configured to allow inflation fluid to flow through the inner tube and the at least one channel into a distal end region of the balloon (distal region of balloon 118d is inflated by fluid through the slot 132, [047]).
Murad does not explicitly disclose the inner tube defining an inflation lumen and a plurality of openings extending through a sidewall of the inner tube to the inflation lumen. Dehdashtian teaches a balloon catheter having an inner tube 210 can be formed with small openings 298 to permit inflation of the balloon 52 and allow inflation fluid to flow outwardly into the space of the balloon 52 ([0083]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted the inner tube of Dehdashtian for the inner tube of Murad, since the substitution would have the same predictable result of allowing for inflation fluid to flow into the balloon ([0083] of Dehdashtian)
Regarding claim 2, Murad/Dehdastian makes obvious the delivery system of claim 1, Murad further discloses wherein each channel extends distally at an angle (portion 130 are flared outward and therefore the slots 132 would extend at an angle, [044]) from the lumen in the distal stop to an opening in an outer surface of the distal stop (opening is interpreted as open space at distalmost end of slot 132 of flared end portion 130, see Fig. 3).
Regarding claim 3, Murad/Dehdastian makes obvious the delivery system of claim 2, Murad further discloses wherein the opening is positioned under the distal end region of the balloon (see Fig. 3).
Regarding claim 4, Murad/Dehdastian makes obvious the delivery system of claim 1, Murad further discloses wherein a proximal end of the distal stop is flared outward (130) defining a distal gap between an outer surface of the inner tube and an inner surface of the distal stop ([043], see Fig. 3).
Regarding claim 5, Murad/Dehdastian makes obvious the delivery system of claim 4, Murad further discloses wherein the proximal end of the distal stop defines a plurality of spaced apart fingers (fingers are interpreted as the portions defined by the slots 132 that extend radially outward by the flared end portion 130; [043]; [044]; see Fig. 3) angled radially outward from a longitudinal axis of the distal stop.
Regarding claim 6, Murad/Dehdastian makes obvious the delivery system of claim 5, Dehdastian further teaches wherein the plurality of openings through the inner tube include proximal openings through a proximal end region of the inner tube, and distal openings through a distal end region of the inner tube (openings 298 are at proximal and distal regions, see Fig. 15).
Regarding claim 7, Murad/Dehdastian makes obvious the delivery system of claim 6, Dehdastian further teaches wherein a central region of the inner tube between the proximal end region and the distal end region is devoid of any openings (central region does not have openings; openings 298 are at proximal and distal regions, see Fig. 15).
Regarding claim 8, Murad/Dehdastian makes obvious the delivery system of claim 6, Murad further discloses wherein a distal end of the proximal stop is flared outward (128) defining a proximal gap between an outer surface of the inner tube and an inner surface of the proximal stop ([043], see Fig. 3).
Regarding claim 9, Murad/Dehdastian makes obvious the delivery system of claim 8, Murad further discloses wherein a distal end of the inner tube is adjacent the at least one channel (see Fig. 3).
Regarding claim 10, Murad/Dehdastian makes obvious the delivery system of claim 8, Murad/Dehdastian further teaches wherein at least some of the openings through the inner tube are positioned within the distal gap and some openings are positioned within the proximal gap (the inner tube is capable of being moved as stated in paragraph [033] of Murad, so that the openings as taught by Dehdastian are positioned within the distal gap and the proximal gap).
Regarding claim 13, Murad/Dehdastian makes obvious the delivery system of claim 1, Murad further discloses wherein a proximal waist of the balloon is fixed to the catheter shaft and a distal waist of the balloon is fixed to the distal stop, distal of the at least one channel ([038]).
Regarding claim 14, Murad/Dehdastian makes obvious the delivery system of claim 1, Murad further discloses further comprising a prosthetic heart valve (10) crimped over the balloon onto the inner tube between the proximal and distal stops ([058]).
Regarding claim 15, Murad discloses a delivery system for an expandable medical device ([047]), comprising:
a catheter shaft (106);
a proximal stop (110) attached to the catheter shaft ([042]);
an inner tube (104) having a proximal end coupled to the proximal stop (see Fig. 3), the inner tube defining an inflation lumen (inflation lumen defined by annular space 122, [039]);
a distal stop (112) coupled to a distal end of the inner tube (see Fig. 3), the distal stop having at least one channel (slots 132) extending through a sidewall of the distal stop (see Fig. 3), the at least one channel in fluid communication with the inflation lumen of the inner tube (the channel is in fluid communication with the balloon that is inflated by the annular space 122, [039]); and
an inflatable balloon (118) having a proximal end fixed to the catheter shaft and a distal end fixed to the distal stop, distal of the at least one channel ([038]);
wherein the proximal stop and the distal stop are configured to allow inflation fluid to flow from the inflation lumen, through a proximal region of inner tube and a distal region of inner tube (proximal and distal regions of inner tube 105 are within the balloon 118, see Fig. 3; where the proximal and distal stop 110/112 facilitate inflation fluid flow, [047]), and through the at least one channel ([047]), into proximal and distal regions of the balloon for uniform inflation of the balloon ([047] discusses facilitating even expansion of the balloon).
Murad does not explicitly disclose wherein the inner tube includes a plurality of openings through a sidewall of the inner tube, including proximal openings in a proximal end region of the inner tube, and distal openings in a distal end region of the inner tube. Dehdashtian teaches a balloon catheter having an inner tube 210 can be formed with small openings 298 at a proximal region and a distal region of the inner tube 210, to permit inflation of the balloon 52 and allow inflation fluid to flow outwardly into the space of the balloon 52 ([0083], see Fig. 15). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted the inner tube of Dehdashtian for the inner tube of Murad, since the substitution would have the same predictable result of allowing for inflation fluid to flow into the balloon ([0083] of Dehdashtian)
Murad as modified by Dehdashtian does not explicitly disclose the proximal openings at least partially covered by the proximal stop, and the distal openings at least partially covered by the distal stop. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the proximal openings at least partially covered by the proximal stop, and the distal openings at least partially covered by the distal stop because Applicant has not disclosed that having the proximal and distal openings partially covered by the proximal and distal stops provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, one of ordinary skill in the art would have expected the invention of Murad/Dehdashtain and Applicant’s invention to perform equally well with either the proximal and distal openings spaced in proximal and distal regions of the balloon as taught by Dehdashtian or the claimed proximal and distal openings partially covered by the proximal and distal stops because both configurations would perform the same result of inflating the proximal and distal regions of the balloon simultaneously, equally well considering the openings are spaced at both ends of the balloon and further Murad teaches this even inflation ([047]). Further Applicant’s specification does not state a particular purpose for the positioning of the openings (see page 10, lines 2-9)
Regarding claim 16, Murad/Dehdastian makes obvious the delivery system of claim 15, Murad further discloses wherein each channel extends distally at an angle (portion 130 are flared outward and therefore the slots 132 would extend at an angle, [044]) from an inner surface of the distal stop to an opening in an outer surface of the distal stop (opening is interpreted as open space at distalmost end of slot 132 of flared end portion 130, see Fig. 3).
Regarding claim 17, Murad/Dehdastian makes obvious the delivery system of claim 15, Murad further discloses wherein a proximal end of the distal stop is flared outward (flared end portion 130, see Fig. 3) defining a distal gap between an outer surface of the inner tube and an inner surface of the distal stop (see Fig. 3, [044]); yet, does not explicitly disclose wherein the distal openings in the inner tube are positioned within the distal gap. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the distal openings positioned within the distal gap because Applicant has not disclosed that having the distal openings being positioned within the distal gap provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, one of ordinary skill in the art would have expected the invention of Murad/Dehdashtain and Applicant’s invention to perform equally well with either the proximal and distal openings spaced in proximal and distal regions of the balloon as taught by Dehdashtian or the claimed distal openings positioned within the distal gap because both configurations would perform the same result of inflating the proximal and distal regions of the balloon simultaneously, equally well considering the openings are spaced at both ends of the balloon and further Murad teaches this even inflation ([047]). Further Applicant’s specification does not state a particular purpose for the positioning of the openings (see page 10, lines 2-9)
Regarding claim 18, Murad/Dehdastian makes obvious the delivery system of claim 17, Murad further discloses wherein a distal end of the proximal stop is flared outward (flared end portion 128, see Fig. 3) defining a proximal gap between an outer surface of the inner tube and an inner surface of the proximal stop (see Fig. 3, [044]); yet, does not explicitly disclose wherein the proximal openings in the inner tube are positioned within the proximal gap. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the proximal openings positioned within the proximal gap because Applicant has not disclosed that having the proximal openings being positioned within the proximal gap provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, one of ordinary skill in the art would have expected the invention of Murad/Dehdashtain and Applicant’s invention to perform equally well with either the proximal and distal openings spaced in proximal and distal regions of the balloon as taught by Dehdashtian or the claimed proximal openings positioned within the proximal gap because both configurations would perform the same result of inflating the proximal and distal regions of the balloon simultaneously, equally well considering the openings are spaced at both ends of the balloon and further Murad teaches this even inflation ([047]). Further Applicant’s specification does not state a particular purpose for the positioning of the openings (see page 10, lines 2-9)
Regarding claim 20, Murad discloses a delivery system for an expandable medical device ([047]), comprising:
a catheter shaft (106);
a proximal stop (110) attached to the catheter shaft ([042]);
an inner tube (104) coupled to the proximal stop (see Fig. 3);
a distal stop (112) having a lumen coupled to a distal end of the inner tube (see Fig. 3), the distal stop having at least one channel (slots 132) extending distally at an angle through a sidewall of the distal stop (portion 130 of 112 is flared outward and therefore the slots 132 would extend at an angle and slot 132 extends through a sidewall of 112, [044]);
an inflatable balloon (118) disposed over the distal stop, the inner tube, and the proximal stop ([038]);
wherein the distal stop is configured to allow inflation fluid to flow through the inner tube and the at least one channel into a distal end region of the balloon ([047], where fluid flow is allowed through the inner tube by being a hollow tube).
Murad does not explicitly disclose the inner tube defining an inflation lumen and having a plurality of proximal openings extending through a sidewall of the inner tube. Dehdashtian teaches a balloon catheter having an inner tube 210 can be formed with small openings 298 to permit inflation of the balloon 52 and allow inflation fluid to flow outwardly into the space of the balloon 52 ([0083]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted the inner tube of Dehdashtian for the inner tube of Murad, since the substitution would have the same predictable result of allowing for inflation fluid to flow into the balloon ([0083] of Dehdashtian)
Murad further discloses a proximal gap between an outer surface of the inner tube and an inner surface of the proximal stop (proximal gap defined by spacing between 128 and 104, see Fig. 3); however, Murad as modified by Dehdashtian does not explicitly disclose at least some of the proximal openings positioned under a distal end of the proximal stop in a proximal gap between an outer surface of the inner tube and an inner surface of the proximal stop. It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the invention to have the proximal openings positioned within the proximal gap because Applicant has not disclosed that having the proximal openings being positioned within the proximal gap provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, one of ordinary skill in the art would have expected the invention of Murad/Dehdashtain and Applicant’s invention to perform equally well with either the proximal and distal openings spaced in proximal and distal regions of the balloon as taught by Dehdashtian or the claimed proximal openings positioned within the proximal gap because both configurations would perform the same result of inflating the proximal and distal regions of the balloon simultaneously, equally well considering the openings are spaced at both ends of the balloon and further Murad teaches this even inflation ([047]). Further Applicant’s specification does not state a particular purpose for the positioning of the openings (see page 10, lines 2-9)
Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Murad (WO2020/123230) in view of Dehdashtian (US2007/0112422) as applied to claim 1 and 15, respectively; and further in view of Martin (US2020/0391009).
Regarding claim 11, Murad/Dehdastian makes obvious the delivery system of claim 1; yet, is silent regarding wherein an outer surface of the inner tube defines a raised helical coil. Martin teaches methods of forming a catheter made of polymer ([0101]). Where the catheter can include a helical strand that protrudes slightly from the surface of the tube (see Fig. 12C, [0101]). Where Martin further teaches any permutation of shapes, sizes, widths, heights, etc. can be combined to make a polymer layer ([0101]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner tube of Murad/Dehdashtian to be made of a polymer with a surface of a protruding strand ([0101]) in order to provide a medical tube with the requirements for navigating tortuous anatomy ([0003]).
Regarding claim 19, Murad/Dehdastian makes obvious the delivery system of claim 15; yet, is silent regarding wherein an outer surface of the inner tube defines a raised helical coil. Martin teaches methods of forming a catheter made of polymer ([0101]). Where the catheter can include a helical strand that protrudes slightly from the surface of the tube (see Fig. 12C, [0101]). Where Martin further teaches any permutation of shapes, sizes, widths, heights, etc. can be combined to make a polymer layer ([0101]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the inner tube of Murad/Dehdashtian to be made of a polymer with a surface of a protruding strand ([0101]) in order to provide a medical tube with the requirements for navigating tortuous anatomy ([0003]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Murad (WO2020/123230) in view of Dehdashtian (US2007/0112422) as applied to claim 1 above, and further in view of Ruflin (US1045326).
Regarding claim 12, Murad/Dehdastian makes obvious the delivery system of claim 1; yet, is silent regarding wherein an outer surface of the inner tube defines a plurality of longitudinal grooves. Ruflin teaches a catheter for irrigating passages and having return flow channels 5 (grooves) arranged on the outer surface of the catheter (C2:L10-11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the inner tube of Murad/Dehdashtian to have included longitudinal grooves in order to better direct flow along the outer surface of the inner tube (C2:L10-11)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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