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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/29/2026 has been entered.
Response to Amendments
The amendments filed 07/29/2026 has been entered.
Claims 1-15 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Final Office Action mailed 05/07/2026.
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 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Allex et al. (U.S. Publication No. 2010/0234875), hereinafter Allex, further in view of Todd et al. (U.S. Patent No. 5423745), hereinafter Todd, further in view Abela et al. (U.S. Patent No. 4860743), hereinafter Abela.
Regarding claim 1, Allex discloses a balloon (balloon 10) for a dilatation catheter, comprising, along an axial direction of the balloon:
a balloon body,
a balloon cone at each side of the balloon body; and
a balloon tip extending from the balloon cone and fixed to the dilatation catheter (see the Examiner annotated FIG. 1 below),
wherein the balloon body, the balloon cone, and the balloon tip are formed of a plurality of polymer layers (balloon 10 includes an inflation layer 20, a fiber layer 30, and a coating layer 40, see [0029]; compliant polymeric material of the coating layer 40 may be composed of the same material used to form the inflation layer 20, see [0045]) in a radial direction of the balloon,
a metal sleeve (radiopaque material disposed over substantially the entire length of the balloon, preferably the entire length, in or on the fiber layer, see [0016-0017; 0031; 0053]; radiopaque materials are well known and suitable for use with the present invention. Such materials include, but are not limited to barium, bismuth, tungsten, iridium, iodine, gold, iron, and platinum…radiopaque material or combination thereof may be used at the distal tip, see [0064]).
However, Allex does not expressly state wherein a metal sleeve separate from the plurality of polymer layers, wherein a plurality of notches are formed in the metal sleeve, and wherein the plurality of notches are distributed from an outer portion of the balloon tip toward the balloon cone, but terminate at an intermediate portion of the balloon tip between the outer end of the balloon tip and the balloon cone, with a portion of the metal sleeve between the plurality of notches and the balloon cone not including notches.
Todd teaches an expansive device in communication with a ballon catheter (Abstract) wherein a plurality of notches (outlets 66, see FIG. 6) are formed in the metal sleeve (tip 22), and wherein the plurality of notches are distributed from an outer portion of the balloon tip toward the balloon cone, but terminate at an intermediate portion of the balloon tip between the outer end of the balloon tip and the balloon cone, with a portion of the metal sleeve between the plurality of notches and the balloon cone not including notches. (See FIG. 6)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Allex to provide a plurality of notches formed on the metal balloon tip, and wherein the plurality of notches extend from an outer end of the balloon tip toward the balloon cone, but terminate at an intermediate portion of the balloon tip, with a portion of the balloon tip between the plurality of notches and the balloon cone not including notches. Doing so would modify fluid pressure of the flowing solution within the ballon chamber, as taught by Todd (Col 8 Line 57-Col 9 Line 18).
However, Allex in view of Todd does not expressly state a metal sleeve separate from the plurality of polymer layers.
Abela teaches a diffuser catheter for the ablation of electrical conduction tissue in the heart (Abstract) comprising a metal sleeve separate from the plurality of polymer layers (“a metal sleeve fixed to the catheter tip”, Col 6 Lines 38-52; “Alternatively, the catheter tip illustrated in FIG. 3 may be formed of plastic and fitted with a metal sleeve”, Col 6 Lines 7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the metal sleeve of Allex in view of Todd to a metal sleeve separate from the plurality of polymer layers. Doing so would absorb any scattered radiation and heat up, as taught by Abela (see Col 6 Lines 7-10).
Regarding claim 2, Allex in view of Todd in view of Abela teaches the claimed invention as discussed above concerning the rejection of claim 1, and Abela further teaches wherein the metal sleeve is a metal foil or metal tube (“the catheter tip may be formed of metal”, Col 6 lines 2-3; the Examiner notes metal sleeve would be tubular in shape to fit over the catheter end since the catheter end itself is tubular shaped; see FIGS. 3-4 ).
Regarding claim 15, Allex in view of Todd in view of Abela teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Allex in view of Todd in view of Abela does not expressly state wherein the plurality of notches have a diameter of from about 20 µm to about 50 µm.
It would have been an obvious matter of design choice to change the size of the plurality of notches to have a diameter of from about 20 µm to about 50 µm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.IV.A.
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date the invention to modify Allex in view of Todd in view of Abela to make the plurality of notches have a diameter of from about 20 µm to about 50 µm, because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Allex et al. (U.S. Publication No. 2010/0234875), hereinafter Allex, further in view of Todd et al. (U.S. Patent No. 5423745), hereinafter Todd, further in view Abela et al. (U.S. Patent No. 4860743), hereinafter Abela, and further in view of Eli et al. (U.S. Publication No. 2012/0232528), hereinafter Eli.
Regarding claim 3, Allex in view of Todd in view of Abela teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Allex in view of Todd in view of Abela does not expressly state wherein an outer surface of the balloon body includes printed scale marks capable of reflecting ultrasonic waves.
The Examiner notes Allex discloses that “radiopaque materials are well known and suitable for use with the present invention. Such materials include, but are not limited to barium, bismuth, tungsten, iridium, iodine, gold, iron, and platinum… radiopaque material or combination thereof may be used along the length of the balloon extending from the distal tip (B) to the proximal tip… balloon components, such as fibers, inks, adhesives and/or polymeric materials may be loaded with tungsten, see [0064]”.
Eli teaches a catheter delivery system that incorporates a series of radiopaque markers at discrete, intervals corresponding to units of measurement (see [0008]) wherein an outer surface of the balloon body includes printed scale marks capable of reflecting ultrasonic waves (radiopaque material that may be used to create the divisional markers can be selected from platinum-iridium alloys, barium sulfate, or other known materials, see [0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Allex in view of Todd in view of Abela to include printed scale marks capable of reflecting ultrasonic waves on the outer surface of the balloon. Doing so would establish indicators that can be seen using visual techniques, as taught by Eli (see [0021]).
Regarding claim 4, Allex in view of Todd in view of Abela in view of Eli teaches the claimed invention as discussed above concerning the rejection of claim 3, and Eli further teaches wherein a first scale mark and scale marks at an interval therefrom are different from other scale marks in shape (see first scale marks at the proximal and/or distal end in FIG. 5).
Regarding claim 5, Allex in view of Todd in view of Abela in view of Eli teaches the claimed invention as discussed above concerning the rejection of claim 4, and Eli further teaches wherein a starting position of the scale marks starts at a distal end of the balloon or at a distance from the balloon tip (see first scale marks at the distal end in FIG. 5).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Allex et al. (U.S. Publication No. 2010/0234875), hereinafter Allex, in view of Klisch et al. (U.S. Publication No. 2006/0182873), hereinafter Klisch.
Regarding claim 6, Allex discloses a balloon (balloon 10) for a dilatation catheter, comprising, along an axial direction of the balloon:
a balloon body,
a balloon cone at each side of the balloon body; and
a balloon tip extending from the balloon cone and fixed to the dilatation catheter (see the Examiner annotated FIG. 1 below),
wherein the balloon body and the balloon cone are formed of a plurality of polymer layers (balloon 10 includes an inflation layer 20, a fiber layer 30, and a coating layer 40, see [0029]; compliant polymeric material of the coating layer 40 may be composed of the same material used to form the inflation layer 20, see [0045]) in a radial direction of the balloon,
wherein the balloon tip comprises metal (radiopaque material disposed over substantially the entire length of the balloon, preferably the entire length, in or on the fiber layer, see [0016-0017; 0031; 0053]; radiopaque materials are well known and suitable for use with the present invention. Such materials include, but are not limited to barium, bismuth, tungsten, iridium, iodine, gold, iron, and platinum…radiopaque material or combination thereof may be used at the distal tip, see [0064]).
wherein the balloon tip, balloon body, and balloon cones are all formed of multiple polymer layers (balloon 10 includes an inflation layer 20, a fiber layer 30, and a coating layer 40, see [0029]; compliant polymeric material of the coating layer 40 may be composed of the same material used to form the inflation layer 20, see [0045]) in the radial direction of the balloon. However, Allex does not expressly state wherein the balloon tip is provided with a plurality of metal cuffs spaced apart in the axial direction and extending in a circumferential direction.
The Examiner notes Allex discloses “In one embodiment the radiopaque material may be disposed as radial bands spaced along the entire length of the balloon or any portion thereof, for example, one or multiple bands at one or each of the proximal and distal tips.” (see [0052]).
Still, Klisch teaches a medical balloon, formed by and/or manufactured by using laser ablation (see [0161]) wherein the balloon tip is provided with a plurality of metal cuffs (rings 707) spaced apart in the axial direction and extending in a circumferential direction (see FIG. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the radial bands and balloon tip of Allex, to be a plurality of metal cuffs spaced apart in the axial direction and extending in a circumferential direction. Doing so would form and/or modify other medical devices, such as medical catheters and would enhance the folding of the balloon as well as controlling rupture characteristics of the balloon, as taught by Klisch (see [0161-163]).
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Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to comprise cuffs made from metal, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 7-9 is rejected under 35 U.S.C. 103 as being unpatentable over Allex et al. (U.S. Publication No. 2010/0234875), hereinafter Allex, in view of Klisch et al. (U.S. Publication No. 2006/0182873), hereinafter Klisch, and further in view of Eli et al. (U.S. Publication No. 2012/0232528), hereinafter Eli.
Regarding claim 7, Allex in view of Klisch teaches the claimed invention as discussed above concerning the rejection of claim 6, however, Allex in view of Klisch does not expressly state wherein an outer surface of the balloon body includes printed scale marks capable of reflecting ultrasonic waves.
The Examiner notes Allex discloses that “radiopaque materials are well known and suitable for use with the present invention. Such materials include, but are not limited to barium, bismuth, tungsten, iridium, iodine, gold, iron, and platinum… radiopaque material or combination thereof may be used along the length of the balloon extending from the distal tip (B) to the proximal tip… balloon components, such as fibers, inks, adhesives and/or polymeric materials may be loaded with tungsten, see [0064]”.
Eli teaches a catheter delivery system that incorporates a series of radiopaque markers at discrete, intervals corresponding to units of measurement (see [0008]) wherein an outer surface of the balloon body includes printed scale marks capable of reflecting ultrasonic waves (radiopaque material that may be used to create the divisional markers can be selected from platinum-iridium alloys, barium sulfate, or other known materials, see [0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Allex to include printed scale marks capable of reflecting ultrasonic waves on the outer surface of the balloon. Doing so would establish indicators that can be seen using visual techniques, as taught by Eli (see [0021]).
Regarding claim 8, Allex in view of Klisch and further in view of Eli teaches the claimed invention as discussed above concerning the rejection of claim 7, and Eli further teaches wherein a first scale mark and scale marks at an interval therefrom are different from other scale marks in shape (see first scale marks at the proximal and/or distal end in FIG. 5).
Regarding claim 9, Allex in view of Klisch and further in view of Eli teaches the claimed invention as discussed above concerning the rejection of claim 8, and Eli further teaches wherein a starting position of the scale marks starts at a distal end of the balloon or at a distance from the balloon tip (see first scale marks at the distal end in FIG. 5).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Allex et al. (U.S. Publication No. 2010/0234875), hereinafter Allex, in view of Klisch et al. (U.S. Publication No. 2006/0182873), hereinafter Klisch, further in view Abela et al. (U.S. Patent No. 4860743), hereinafter Abela.
Regarding claim 10, Allex discloses a balloon (balloon 10) for a dilatation catheter, comprising, along an axial direction of the balloon:
a balloon body,
a balloon cone at each side of the balloon body; and
a balloon tip extending from the balloon cone and fixed to the dilatation catheter (see the Examiner annotated FIG. 1 below),
wherein the balloon body, the balloon cone, and the balloon tip are formed of a plurality of polymer layers (balloon 10 includes an inflation layer 20, a fiber layer 30, and a coating layer 40, see [0029]; compliant polymeric material of the coating layer 40 may be composed of the same material used to form the inflation layer 20, see [0045]) in a radial direction of the balloon,
a metal sleeve (radiopaque material disposed over substantially the entire length of the balloon, preferably the entire length, in or on the fiber layer, see [0016-0017; 0031; 0053]; radiopaque materials are well known and suitable for use with the present invention. Such materials include, but are not limited to barium, bismuth, tungsten, iridium, iodine, gold, iron, and platinum…radiopaque material or combination thereof may be used at the distal tip, see [0064]).
However, Allex does not expressly state wherein a surface of the metal of the metal sleeve is patterned to form a rectangular array, a triangular array, a hemispherical array, a diamond array, a cylindrical array, or a plurality of parallel grooves extending in a circumferential direction.
Klisch teaches a medical balloon, formed by and/or manufactured by using laser ablation (see [0161]) wherein a surface of the metal sleeve is patterned to form a rectangular array, a triangular array, a hemispherical array, a diamond array, a cylindrical array, or a plurality of parallel grooves (rings 707 and valleys in between) extending in a circumferential direction (see FIG. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to pattern the surface of the metal sleeve of the device of Allex to form a rectangular array, a triangular array, a hemispherical array, a diamond array, a cylindrical array, or a plurality of parallel grooves extending in a circumferential direction, as taught by Klisch. Doing so would form and/or modify other medical devices, such as medical catheters and would enhance the folding of the balloon as well as controlling rupture characteristics of the balloon, as taught by Klisch (see [0161-163]).
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However, Allex in view of Klisch does not expressly state a metal sleeve separate from the plurality of polymer layers.
Abela teaches a diffuser catheter for the ablation of electrical conduction tissue in the heart (Abstract) comprising a metal sleeve separate from the plurality of polymer layers (“a metal sleeve fixed to the catheter tip”, Col 6 Lines 38-52; “Alternatively, the catheter tip illustrated in FIG. 3 may be formed of plastic and fitted with a metal sleeve”, Col 6 Lines 7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the metal sleeve of Allex in view of Klisch to a metal sleeve separate from the plurality of polymer layers. Doing so would absorb any scattered radiation and heat up, as taught by Abela (see Col 6 Lines 7-10).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Allex et al. (U.S. Publication No. 2010/0234875), hereinafter Allex, in view of Klisch et al. (U.S. Publication No. 2006/0182873), hereinafter Klisch, further in view Abela et al. (U.S. Patent No. 4860743), hereinafter Abela, and further in view of Giasolli et al. (U.S. Publication No. 2018/0200491), hereinafter Giasolli.
Regarding claim 11, Allex in view of Klisch in view of Abela teaches the claimed invention as discussed above concerning the rejection of claim 10, however, Allex in view of Klisch in view of Abela does not expressly state wherein the patterned surface of the metal sleeve is covered with a heat-shrinkable polymer coating.
Giasolli teaches an angioplasty balloon with various cage embodiments to assist physicians with balloon positioning during procedure (see [0091-0093]) wherein the patterned surface of the metal sleeve is covered with a heat-shrinkable polymer coating (rings 12, 14 can be composed of a heat shrink material, see [0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to cover the patterned surface of the metal sleeve of the device of Allex and Klisch and Abela with a heat shrinkable polymer coating, as taught by Giasolli. Doing so would restrain the plurality of strips and prevent or limit the strips from moving, sliding, tilting or twisting at any point along the length of the strips but especially at either end of the balloon, as taught by Giasolli, (see [0116]).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Allex et al. (U.S. Publication No. 2010/0234875), hereinafter Allex, in view of Klisch et al. (U.S. Publication No. 2006/0182873), hereinafter Klisch, further in view Abela et al. (U.S. Patent No. 4860743), hereinafter Abela, and further in view of Eli et al. (U.S. Publication No. 2012/0232528), hereinafter Eli.
Regarding claim 12, Allex in view of Klisch in view of Abela teaches the claimed invention as discussed above concerning the rejection of claim 10, however, Allex in view of Klisch in view of Abela does not expressly state wherein an outer surface of the balloon body includes printed scale marks capable of reflecting ultrasonic waves.
The Examiner notes Allex discloses that “radiopaque materials are well known and suitable for use with the present invention. Such materials include, but are not limited to barium, bismuth, tungsten, iridium, iodine, gold, iron, and platinum… radiopaque material or combination thereof may be used along the length of the balloon extending from the distal tip (B) to the proximal tip… balloon components, such as fibers, inks, adhesives and/or polymeric materials may be loaded with tungsten, see [0064]”.
Eli teaches a catheter delivery system that incorporates a series of radiopaque markers at discrete, intervals corresponding to units of measurement (see [0008]) wherein an outer surface of the balloon body includes printed scale marks capable of reflecting ultrasonic waves (radiopaque material that may be used to create the divisional markers can be selected from platinum-iridium alloys, barium sulfate, or other known materials, see [0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Allex to include printed scale marks capable of reflecting ultrasonic waves on the outer surface of the balloon, as taught by Eli et al. Doing so would establish indicators that can be seen using visual techniques, as taught by Eli (see [0021]).
Regarding claim 13, Allex in view of Klisch in view of Abela in view of Eli teaches the claimed invention as discussed above concerning the rejection of claim 12, and Eli further teaches wherein a first scale mark and scale marks at an interval therefrom are different from other scale marks in shape (see first scale marks at the proximal and/or distal end in FIG. 5).
Regarding claim 14, Allex in view of Klisch in view of Abela in view of Eli teaches the claimed invention as discussed above concerning the rejection of claim 13, and Eli further teaches wherein a starting position of the scale marks starts at a distal end of the balloon or at a distance from the balloon tip (see first scale marks at the distal end in FIG. 5).
Response to Arguments
Applicant’s arguments, see Remarks filed 7/29/2026, with respect to the rejection(s) of claim(s) 1-5 and 10-15 under 35 U.S.C. 103 to Allex (U.S. Publication No. 2010/0234875) in view of Klisch (U.S. Publication No. 2006/0182873) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 to Allex (U.S. Publication No. 2010/0234875) in view of Klisch (U.S. Publication No. 2006/0182873) in view of Abela (U.S. Patent No. 4860743).
Applicant’s arguments, see Remarks, filed 07/29/2026, with respect to the rejection(s) of claim(s) 6-9 under 35 U.S.C. 103 to Allex (U.S. Publication No. 2010/0234875) in view of Klisch (U.S. Publication No. 2006/0182873) have been fully considered and are not persuasive.
In regards to the Applicant’s argument that “neither reference discloses the plurality of discrete, axially spaced metal cuffs that claim 6 requires, and the rejection of claim 6 should be withdrawn.”
This is not persuasive for the following reasons
While Allex does not expressly state wherein the balloon tip is provided with a plurality of metal cuffs spaced apart in the axial direction and extending in a circumferential direction, the Examiner notes Allex discloses “In one embodiment the radiopaque material may be disposed as radial bands spaced along the entire length of the balloon or any portion thereof, for example, one or multiple bands at one or each of the proximal and distal tips.” (see [0052]). Still, Klisch teaches a medical balloon, formed by and/or manufactured by using laser ablation (see [0161]) wherein the balloon tip is provided with a plurality of metal cuffs (rings 707) spaced apart in the axial direction and extending in a circumferential direction (see FIG. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the radial bands and balloon tip of Allex, to be a plurality of metal cuffs spaced apart in the axial direction and extending in a circumferential direction. Doing so would form and/or modify other medical devices, such as medical catheters and would enhance the folding of the balloon as well as controlling rupture characteristics of the balloon, as taught by Klisch (see [0161-163]).
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Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to comprise cuffs made from metal, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
08/07/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights