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 amendments filed 12/22/2025 has been entered.
Claims 1-15 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “intermediate portion” in claim 1 is a relative term which renders the claim indefinite. The term “intermediate portion” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2-5 and 15 are similarly rejected by virtue of their dependency upon claim 1.
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, 6, 10, and 15 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 Klisch et al. (U.S. Publication No. 2006/0182873), hereinafter Klisch.
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 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]).
However, Allex does not expressly state wherein a plurality of notches are 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.
Klisch teaches a medical balloon, formed by and/or manufactured by using laser ablation (see [0161]) wherein a plurality of notches are formed on the metal balloon tip (channels 108, see FIG. 1; ribs 407 and recessed panels 408, see FIG. 5), and wherein the plurality of notches extend from an outer end of the balloon tip toward the balloon cone (see FIG. 1a), but terminate at an intermediate portion (see portions 106 and 114 on outer surface 109 intermediate between notches 108) of the balloon tip, with a portion of the balloon tip between the plurality of notches and the balloon cone not including notches (see Examiner annotated FIG. 1b below).
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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 enhance the folding of the balloon as well as controlling rupture characteristics of the balloon, as taught by Klisch (see [0163]).
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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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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 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]).
However, Allex does not expressly state wherein a surface of the metal of the balloon tip 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 balloon tip 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 balloon tip 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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Regarding claim 15, Allex in view of Klisch teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Allex in view of Klisch 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 Klisch 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).
Claim 2 is 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 Klisch et al. (U.S. Publication No. 2006/0182873), hereinafter Klisch, further in view of Anderson et al. (U.S. Publication No. 2012/0209176), hereinafter Anderson.
Regarding claim 2, Allex in view of Klisch teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Allex in view of Klisch does not expressly state wherein the balloon tip is made entirely of metal.
Anderson teaches a wire balloon catheter (see [0023]) wherein the balloon tip is made entirely of metal (crossing tip member 38 may include a metal material or any other suitable material including those disclosed herein, see [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to make the entire balloon tip of the device of Allex from metal. Doing so would provide a suitable material for differential scanning calorimetry and dynamic metal thermal analysis, as taught by Anderson (see [0033; 0049]).
Claims 3-5, 7-9, and 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, further 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 3, Allex in view of Klisch teaches the claimed invention as discussed above concerning the rejection of claim 1, 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 4, Allex in view of Klisch and further 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 Klisch and further 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).
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).
Regarding claim 12, Allex in view of Klisch teaches the claimed invention as discussed above concerning the rejection of claim 10, 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, 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 and further 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 and further 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).
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, and further in view of Giasolli et al. (U.S. Publication No. 2018/0200491), hereinafter Giasolli.
Regarding claim 11, Allex in view of Klisch teaches the claimed invention as discussed above concerning the rejection of claim 10, however, Allex in view of Klisch does not expressly state wherein the patterned surface of the balloon tip 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 balloon tip 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 balloon tip of the device of Allex and Klisch 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]).
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed 12/22/2025, with respect to the rejection(s) of claim(s) 1-15 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 not persuasive.
In regards to Applicant’s argument that the combination of Allex with Klisch fails to disclose or render obvious every element of claim 1, particularly that Allex’s “channels 108, the ribs 407, and the recessed panels 408 extend along an entire length of the alleged "balloon tip" and do not terminate at any intermediate portion of the balloon tip with any portion of the length of the balloon tip not including the channels 108, the ribs 407, or the recessed panels 408, respectively”.
The Examiner notes that intermediate is broadly defined as simply being the middle or transitional position between two positions. Portions between channels 108 can be seen as being intermediate portions of the balloon tip. Therefor channels 108 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, as claimed in claim 1.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
04/29/2025
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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