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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/08/2026 has been entered.
Response to Arguments
The previous objection of claim 6 due to minor informalities has been withdrawn in light of applicant’s amendments made 9/08/2026.
Applicant's arguments filed 9/08/2026 have been fully considered but they are not persuasive. With respect to Halstead et al. (US 2020/0030577 A1) applicant argues the Office’s assertion that tube F corresponds to the claimed tip fails because neither tube D nor tube W (the alleged cover portion) nor any other element of Halstead covers any part of tube F; therefore, Halstead does not disclose “the cover portion covers at least the bending region of the shaft body and a second part of the tip” as recited by amended claim 1. While the examiner agrees with this assertation, upon further review, the interpretation of the tip of Halstead has been changed. For example, the tip is now being interpreted as the distal portion of A under W, A+E, E and F as shown in Fig. 4E. With this interpretation, W covers a distal portion of A i.e., “a second part of the tip”.
Applicant argues that alternatively, if the Office were to redefine the “tip” as a larger group of Figure 4E, the uncovered portion of such an enlarged tip would span multiple regions formed from materials that Halstead expressly describes as having different stiffness; therefore, any uncovered portion spanning more than one of these regions would not possess “a uniform stiffness in an extending direction” as recited by amended claim 1. However, the claims do not require the entirety of the uncovered portion of the tip to have a uniform stiffness. Instead, the claim recites “a first part of the tip, which is not covered by the cover portion, having a uniform stiffness in an extending direction.” It is the examiner’s position that F is considered the claimed first part of the tip, which is not covered by W and has a uniform stiffness. The claims do not preclude a third part of the tip between the first and second parts. Accordingly, Halstead does disclose the amended combination of a cover portion that covers both the bending region and a second part of the tip.
Applicant argues that the Office’s mapping does not satisfy the express requirement that the second portion includes both the fourth portion and the fifth portion as called for in claim 1 because E and A+B are separate regions from A+D. However, the claimed “second portion” is extremely broad and the claims do not require that all portions of the second portion necessarily have to be adjacent to one another. Instead, the claims require the second portion to include a fourth portion positioned adjacent to the first portion, and a fifth portion positioned adjacent to the third portion. Halstead does disclose these structural limitations as required by claim 1. Further, in the new rejection the third portion is interpreted as A+B while the fifth portion is interpreted as A+C so that the second portion includes A+C, A+D and E.
With respect to claim 9, applicant argues that Halstead’s distal tip segment length of about 8 mm does not overlap the claimed range; therefore, In re Wertheim, and in re Woodruff would not apply. However, as recited in 2144.05(I) of the MPEP a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, see for example, “Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions. It is the Office’s position that “about 8 mm” approaches 1 cm i.e., 10 mm and is so close that one skilled in the art would have expected the lengths to have the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) and Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997).
With respect to applicant’s argument that the proposed modification of the length of the shaft body from the first tip end portion to the at least one bending portion is equal to or greater than 1 cm would render Halstead unsatisfactory for its intended purpose, it is noted that Halstead discloses it is known in the prior art for tips to typically have lengths between about 1.5 and 3.0 cm ([0047]). While, the shorter tip of Halstead is preferred, it does not refute the fact that the prior art teaches it was known to have tips within the claimed range. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
Applicant’s arguments with respect to criticality of the claimed range are not found persuasive as applicant has not established unexpected results over the claimed range. In order to demonstrate criticality of a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
For at least the forgoing reasons, applicant’s arguments are not found persuasive.
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) 1-2 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), and a cover portion (W), wherein the shaft body (112, 124) includes a shaft main body portion (112, 124) having a lumen (Fig. 3A), a tip (interpreted as F, E, A+E and at least a distal portion of A+W; see annotated Fig. 4E below) provided at an end portion of the shaft main body portion that is closest to the first tip end portion (Fig. 4E), a first part of the tip (F), which is not covered by the cover portion (W), having a uniform stiffness (as F is a single material) in an extending direction, and the stiffness of the first part of the tip being smaller than a stiffness of the shaft main body portion (as F is softer and more flexible and has a lower durometer than A thru E; [0041]), and 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), the cover portion (W) covers at least the bending region of the shaft body (as the proximal end of W covers A at the bending region; see for example Fig. 5) and a second part (part of the tip under W) of the tip (Fig. 4E), 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 the 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 (including A+D, E, and A+C 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+B of Fig. 4E) of the balloon catheter is a third stiffness (the stiffness of A+B), 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+B 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 B 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+C of Fig. 4E) positioned adjacent to the third portion (A+B; 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+C), and the fifth stiffness is larger than the fourth stiffness (as the material of C has a larger durometer than the material of E; [0041]).
Regarding claim 2, Halstead discloses wherein the at least one bending portion is provided at the shaft main body portion (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. Halstead further teaches prior art shaped tips typically have lengths between about 1.5 and 3 cm ([0047]). While not preferred, Halstead teaches an inferior embodiment with tips having lengths up to 3 cm, in which a length of the shaft body in the extending direction from the first tip end portion to the at least one bending portion is equal or greater than 1 cm (as the bending portion is about at the half-way portion of the first tip end portion; thus a 3 cm length tip end portion would have a 1.5 cm length from the first tip end portion to the at least one bending portion).
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 a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Further, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Halstead, does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of dependent claim 10, which recites, inter alia “wherein a stiffness of the cover portion is larger than a stiffness of the shaft body”.
Halstead recites “the material of tube W is softer, more flexible and has a lower durometer than the material of tube A” ([0039]). Thus, the cover portion W has a lower stiffness than the shaft body, which includes tube A. It would not have been obvious to one of ordinary skill in the art to modify the stiffness of W to be larger than that of A as doing so would destroy the flexibility/rigidity gradient of the Fig. 4E. Further, W covers the bending portion; therefore, modifying W to be stiffer than A may prohibit bending of the bending region.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Willard et al. (US 4,846,174) is noted for teaching a shaft body with variable stiffness.
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.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
