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 .
Response to Arguments
The previous objection of claim 1 due to minor informalities has been withdrawn in light of applicant’s amendments made 3/30/2026.
The previous rejection of claim(s) 2 and 8-9 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 2 and 8-9 on 3/30/2026.
Applicant's arguments filed 3/30/2026 have been fully considered but they are not persuasive. With respect to Halstead et al. (US 2020/0030577 A1) applicant argues that inasmuch as Halsted might disclose various stiffness relationships, the portion adjacent to the alleged first portion of Fig. 4C would be stiffer than the portion adjacent to the third portion such that Halsted would not teach or suggest, a fifth stiffness of a firth portion being larger than a further stiffness. Applicant’s arguments are solely based on the embodiment of Fig. 4C and do not extend to the other embodiments disclosed by Halstead. Accordingly, the applicant’s arguments over the embodiment of Fig. 4C are moot as the embodiment is no longer being applied to the rejection. Instead, the new rejection is based on the embodiment of Fig. 4E of Halsted.
Halsted teaches various embodiments of tips and the embodiment of Fig. 4E does disclose the amended claims, including a first portion F, a second portion A+D, a third portion A+C, a fourth portion E, and a fifth portion A+B, wherein the stiffness of the second portion is larger than the first portion, the third is larger than the second, and the fifth is larger than the fourth as each of the materials A, B, C, D, E, and F gets progressively softer, more flexible and has a lower durometer moving distally ([0041]).
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 6 recites “the at least one bending portions” in line 2 which should read “the at least one bending portion”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-3 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halstead et al. (US 2020/0030577 A1).
Regarding claim 1, Halstead discloses a balloon catheter (vascular catheter system 100; Fig. 1) comprising: a shaft body (including at least inner catheter 112 and distal tip segment 124; Figs. 1, 3A-3B) extending between a first tip end portion (distal end of 124) and a first base end portion (proximal end of 112; Fig. 1); and a balloon body (inflatable balloon 120/120’ herein referred to as 120) connected to the shaft body in the vicinity of the first tip end portion of the shaft body (Fig. 1) and including a second tip end portion (distal end of 120) and a second base end portion (proximal end of 120), the second tip end portion (distal end of 120) being connected to a first connection portion being a location of the shaft body separated to the side of the first base end portion with respect to the first tip end portion (as the distal end of the balloon 120 is fluidically sealed near the distal end of the inner catheter 112, which is closer to the first tip end portion within 124, thereby separated from the first base end portion; [0028]; Fig. 3A), the second base end portion (proximal end of 120) being connected to a second connection portion being a location of the shaft body separated to the side of the first base end portion with respect to the first connection portion (as the proximal end of the balloon 120 is fluidically sealed with the distal end of the outer catheter section 118 which is closer to the first connection portion i.e. at distal end of the balloon, thereby separated from the first base end portion; [0028]; Fig. 3A), and the balloon body (120) extending between the second tip end portion and the second base end portion (Fig. 3A), wherein the shaft body includes a bending region (bend portion of 124) including at least one bending portion at a section between the first tip end portion and the first connection portion (Fig. 3A), a stiffness of a first portion (F of Fig. 4E) of the balloon catheter is a first stiffness (the stiffness of F; each of the materials A, B, C, D, E, and F gets progressively softer, more flexible and has a lower durometer moving distally; [0041]), the first portion being a portion further to the side of the first tip end portion than the bending region (as the right side of Fig. 4E represents the distal end of the shaped tip 124; [0035]), in an extending direction (along the center axis of 112, 124), and the extending direction being a direction along a center of the shaft body (Fig. 3A), a stiffness of a second portion (A+D of Fig. 4E) of the balloon catheter is a second stiffness (the stiffness of A+D), the second portion being a portion overlapping the bending region in the extending direction (as the portion just proximal of W i.e., A+D in Fig. 4E is in the bending region; Figs. 3A, 3B, 5; [0043]), a stiffness of a third portion (A+C of Fig. 4E) of the balloon catheter is a third stiffness (the stiffness of A+C), the third portion being a portion further to the side of the first base end portion than the bending region in the extending direction (as A+C is proximal A+D, which is in the bending region), and the second stiffness is larger than the first stiffness (as the material of D has a larger durometer than the material of F; [0041]), and the third stiffness is larger than the second stiffness (as the material of C has a larger durometer than the material of D; [0041]), the second portion includes a fourth portion (E of Fig. 4E) positioned adjacent to the first portion (F; Fig. 4E), and a fifth portion (A+B of Fig. 4E) positioned adjacent to the third portion (A+C; Fig. 4E), a stiffness of the fourth portion is a fourth stiffness (the stiffness of E), a stiffness of the fifth portion is a fifth stiffness (the stiffness of A+B), and the fifth stiffness is larger than the fourth stiffness (as the material of B has a larger durometer than the material of E; [0041]).
Regarding claim 2, Halstead discloses wherein the shaft body includes a shaft main body portion (112 and at least a portion of 124) having a lumen (as the system 100 is tracked over a guidewire; therefore, 112, 124 has a lumen that extends over the guidewire; [0033]), and a tip (F; Fig. 4E) provided at an end portion, of the shaft main body portion, closest to the first tip end portion (Figs. 1, 3A), the tip having a smaller stiffness than that of the shaft main body portion (as the tip includes the material of tube F which is softer, more flexible and has a lower durometer than the material of tube A; [0041]), and the at least one bending portion is provided at the shaft main body portion (Figs. 3A-3B, 4E, 5).
Regarding claim 3, Halstead discloses a cover portion (portion of W covering A and/or D covering A; Fig. 4E) covering at least the bending region of the shaft body (Figs. 3A-3B, 4E, 5).
Regarding claim 6, Halstead discloses wherein the bending region includes two or more of the at least one bending portion (as the distal tip segment 124 of Figs. 3A and 3B may include two or more bends; see for example, Fig. 6; [0033]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halstead et al. (US 2020/0030577 A1) in view of Okamoto et al. (US 2021/0113820 A1).
Regarding claims 4-5, Halstead discloses wherein the balloon body includes a balloon (120/120’) configured to inflate and deflate ([0028]) but fails to disclose the balloon body including an element provided at the balloon, and a stiffness of the balloon body is larger than a stiffness of the balloon; wherein the element extends between the second tip end portion and the second base end portion.
However, Okamoto teaches a balloon catheter (balloon catheter 10; Figs. 2-3A) comprising a balloon body including a balloon (balloon 13) configured to inflate and deflate (Figs. 5A-5E), and an element (linear projections 30) provided at the balloon (Figs. 3A-3D), and a stiffness of the balloon body is larger than a stiffness of the balloon (as the balloon body includes both the balloon 13 and the linear projections 30, the stiffness of the balloon body is inherently larger than that of just the balloon 13), wherein the element (30) extends between a second tip end portion (distal end of balloon body) and the second base end portion (proximal end of balloon body; Fig. 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon body of Halstead to include an element between the second tip end portion and the second based end portion such that a stiffness of the balloon body is larger than a stiffness of the balloon as taught by Okamoto in order to provide a cutting/scoring balloon catheter that may be used to cut, break up, and treat a calcified lesion.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halstead et al. (US 2020/0030577 A1) in view of Sing et al. (US 2009/0318798 A1).
Regarding claim 7, Halstead fails to disclose wherein the first tip end portion of the shaft body is rounded.
However, Singh teaches a balloon catheter (instrument 10; Fig. 2) having a shaft body (body of flexible catheter 12) with a first tip end portion (Fig. 5A) that is rounded (outwardly convex; Fig. 5A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first tip end portion of Halstead to be rounded as taught by Singh in order to provide a blunt, less atraumatic tip thereby minimizing damage to surrounding tissue during delivery of the balloon catheter to the desired treatment site.
3. Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halstead et al. (US 2020/0030577 A1) in view of Tarunaga et al. (WO 2018/135533 A1).
Regarding claim 8, Halstead fails to disclose wherein a thickness of an outer side section of the at least one bending portion of the shaft body is thinner than a thickness of an inner side section of the at least one bending portion of the shaft body.
However, Tarunaga teaches a balloon catheter (balloon catheter 10; Fig. 1; abstract) comprising a shaft body (inside shaft 130; Fig. 2) and a balloon body (balloon 300), wherein the shaft body includes a bending portion (curved portion at tip member 200; Fig. 7) wherein a thickness of an outer side section (at 210b) of the bending portion of the shaft body is thinner than a thickness of an inner side section (at 210a) of the bending portion of the shaft body (Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one bending portion of Halstead such that a thickness of an outer side section of the at least bending portion of the shaft body is thinner than a thickness of an inner side section of the at least one bending portion of the shaft body as taught by Tarunaga in order to improve tracking of the balloon catheter over a guide wire in a curved state (abstract).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halstead et al. (US 2020/0030577 A1).
Regarding claim 9, Halstead discloses wherein a length of the shaft body in the extending direction from the first tip end portion to the at least one bending portion is about 8 mm (as the length of 124 is about 8 mm, which does not overlap the claimed range but is close and approaching 1 cm; [0030]) but fails to explicitly disclose the length is equal to or greater than 1 cm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the shaft body in the extending direction from the first tip end portion to the at least one bending portion of Halstead to be equal to or greater than 1 cm as applicant appears to have placed no criticality on the claimed range (see [0037] indicating the length “is not limited to being 1 cm”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights