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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 7/13/2026 is acknowledged. Claims 7 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species embodiments, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/13/2026. The requirement is deemed proper and is therefore made FINAL.
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.
Claim 6 and its dependent claims 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. Claim 6 states that the first segment comprises more circumferentially extending layers of the first material than the second material; however, the claims only describe the first segment as having the first material. Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-19, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tilson et al. (WO 2014/123983 A2; hereinafter “Tilson”).
Tilson discloses the following regarding claim 1: an inflatable balloon for a medical catheter, comprising: a first segment (balloon segments without reinforcing fibers) (e.g., Figs. 9A-9L) that has a first compliance (paras. 0148, 0208-0210, 0216, 0224-0226); and a second segment (balloon segments with reinforcing fibers) (e.g., Figs. 9A-9L) that has a second compliance (paras. 0148, 0208-0210, 0216, 0224-0226), the first compliance higher than the second compliance (paras. 0148, 0208-0210, 0216, 0224-0226), wherein the first segment and the second segment extend axially along a length of the balloon (Figs. 9A-9L; paras. 0202, 0212), and wherein the first segment is configured to rupture prior to the second segment in an axial direction under pressure from an inflation fluid introduced into the balloon (para. 0226).
Tilson discloses the following regarding claim 2: the balloon of claim 1, wherein the first segment and the second segment are circumferential segments of the balloon that each extend in a circumferential direction around different portions of a circumference of the balloon (Figs. 9A-9L; paras. 0202-0204).
Tilson discloses the following regarding claim 3: the balloon of claim 1, wherein the first segment comprises a first material (balloon material) having the first compliance and a first durometer (paras. 0148, 0169-0170, 0208-0210, 0216, 0224-0226, 0489), and wherein the second segment comprises the first material (balloon material) and a second material (reinforcing fibers) having a second durometer (para. 0309) that is greater than the first durometer (paras. 0169-0170, 0309, 0489).
Tilson discloses the following regarding claim 4: the balloon of claim 3, wherein the first segment comprises one or more circumferentially extending layers of the first material which extend across a thickness of the balloon (e.g., Figs. 9A-9L; paras. 0202-0204), and wherein the second segment comprises one or more circumferentially extending layers of the first material and one or more circumferentially extending layers of the second material (e.g., Figs. 9A-9L; paras. 0202-0204).
Tilson discloses the following regarding claim 5: the balloon of claim 4, wherein the second segment comprises one circumferentially extending layer of the second material disposed between multiple circumferentially extending layers of the first material (Figs. 9A-9L, as the second material of reinforcing fibers is located between alternating layers of the first material in the circumferential direction).
Tilson discloses the following regarding claim 6: the balloon of claim 3, wherein the first segment comprises more circumferentially extending layers of the first material than the second material, and wherein the second segment comprises more circumferentially extending layers of the second material than the first segment (Figs. 9A-9L, as best interpreted, the first segment does not comprise any of the second material; and therefore, the first segments has more layers of the first material than the second material and the second segment comprises more circumferentially extending layers of the second material than the first segment).
Tilson discloses the following regarding claim 8: the balloon claim 1, wherein the first segment comprises a first material having a first durometer embedded within a second material having a second durometer that is greater than the first durometer, and wherein the second segment comprises the second material (e.g., paras. 0263, 0284).
Tilson discloses the following regarding claim 9: the balloon of claim 1, wherein the balloon comprises a first circumferentially extending portion (circumferentially positioned balloon portions) comprising a first material having a first durometer (paras. 0148, 0169-0170, 0208-0210, 0216, 0224-0226, 0489) and a second circumferentially extending portion (circumferentially positioned reinforcing fiber portions) comprising a second material (reinforcing material) having a second durometer (para. 0309), the second durometer greater than the first durometer (paras. 0169-0170, 0309, 0489), and wherein the first segment is formed by a break (gaps formed in fibers) in the second circumferentially extending portion such that a discontinuity is formed in a circumferential direction (e.g., Figs. 9A-9L, 40C; paras. 0361-0365, 0383-0385, 0395-0396).
Tilson discloses the following regarding claim 10: the balloon of claim 1, wherein the medical catheter is a delivery apparatus for a radially expandable medical device (para. 0456).
Tilson discloses the following regarding claim 11: an inflatable balloon for a medical catheter, comprising: a first circumferential segment (circumferential balloon segments without reinforcing fibers) (e.g., Figs. 9A-9L) comprising one or more layers of a first material (balloon material) with a first durometer (paras. 0148, 0169-0170, 0208-0210, 0216, 0224-0226, 0489), the one or more layers extending across a thickness of the balloon (e.g., Figs. 9A-9L); and a second circumferential segment (circumferential balloon segments with reinforcing fibers) comprising one or more layers of the first material (e.g., Figs. 9A-9L) and one or more layers of a second material with a second durometer (para. 0309), the second durometer greater than the first durometer (paras. 0169-0170, 0309, 0489), and wherein the first circumferential segment is configured to form a rupture in an axial direction prior to the second circumferential segment under pressure from an inflation fluid introduced into the balloon (para. 0226).
Tilson discloses the following regarding claim 12: the balloon of claim 11, wherein the second circumferential segment comprises a layer of the second material disposed between two layers of the first material, in a radial direction, and wherein the first circumferential segment forms a break in the second material (e.g., paras. 0263, 0284).
Tilson discloses the following regarding claim 13: the balloon of claim 11, wherein an arc length of the second circumferential segment is longer than an arc length of the first circumferential segment (due to the breaks/gaps in the reinforcing fibers) (e.g., Figs. 9A-9L, 40C; paras. 0361-0365, 0383-0385, 0395-0396).
Tilson discloses the following regarding claim 14: the balloon of claim 11, wherein the first circumferential segment and the second circumferential segment both extend in an axial direction along a length of the balloon (e.g., Figs. 9A-9L).
Tilson discloses the following regarding claim 15: the balloon of claim 11, wherein the medical catheter is a delivery apparatus for a radially expandable medical device, and wherein the balloon is configured to be attached to a shaft (2000) of the delivery apparatus (para. 0456).
Tilson discloses the following regarding claim 16: a balloon catheter comprising: a shaft (2000) extending from a handle (where user holds the catheter) of the balloon catheter; and an inflatable balloon (e.g., Figs. 9A-9L) mounted to the shaft, the balloon comprising a plurality of axially extending circumferential segments segment (balloon segments without reinforcing fibers and the balloon segments with the reinforcing fibers) that have different compliances (paras. 0148, 0208-0210, 0216, 0224-0226), the plurality of segments configured such that a first segment having a higher compliance than a second segment is configured to rupture in an axial direction along the balloon before the second segment as the balloon is inflated with an inflation fluid (paras. 0148, 0208-0210, 0216, 0224-0226).
Tilson discloses the following regarding claim 17: the balloon catheter of claim 16, wherein the first segment and the second segment extend in a circumferential direction around different portions of a circumference of the balloon (e.g., Figs. 9A-9L).
Tilson discloses the following regarding claim 18: the balloon catheter of claim 16, wherein the first segment comprises a first material (balloon material) having a first durometer (paras. 0148, 0169-0170, 0208-0210, 0216, 0224-0226, 0489) and wherein the second segment comprises the first material and a second material (reinforcing fiber material) having a second durometer (para. 0309) that is greater than the first durometer (paras. 0169-0170, 0309, 0489).
Tilson discloses the following regarding claim 19: the balloon catheter of claim 18, wherein the first segment comprises a plurality of circumferentially extending layers of only the first material, and wherein the second segment comprises one or more circumferentially extending layers of the first material and one or more circumferentially extending layers of the second material (e.g., Figs. 9A-9L; e.g., paras. 0196-0197, 0263, 0284-0292).
Tilson discloses the following regarding claim 21: the balloon catheter of claim 16, wherein the balloon comprises a first circumferentially extending portion (circumferentially positioned balloon portions) comprising a first material (balloon material) having a first durometer (paras. 0148, 0169-0170, 0208-0210, 0216, 0224-0226, 0489) and a second circumferentially extending portion (circumferentially positioned reinforcing fiber portions) comprising a second material (reinforcing material) having a second durometer (para. 0309), the second durometer greater than the first durometer (paras. 0169-0170, 0309, 0489), and wherein the first segment is formed by a break (gaps formed in fibers) in the second circumferentially extending portion such that a discontinuity is formed in a circumferential direction (e.g., Figs. 9A-9L, 40C; paras. 0361-0365, 0383-0385, 0395-0396).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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