DETAILED ACTION
Response to Amendment
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, 3, 6, 10, 12, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sugiura et al. (JP2012-143381; hereafter Sugiura).
In regard to claim 1, Sugiura discloses an apparatus (10) for crossing a lesion in a vessel and performing percutaneous transluminal angioplasty on the lesion , comprising: a shaft (11) including a guidewire lumen (31), an inflation lumen (21), and a tapered tip (36, 37) for being pushed into the lesion; and an inflatable balloon (13) mounted on the shaft and in communication with the inflation lumen (“The outer tube hole 21 of the outer tube 15 constitutes a fluid lumen that guides the compressed fluid supplied through the hub 12 into the balloon 13.”), the inflatable balloon (13) having a proximal portion (proximal cone of 13), a barrel portion having a working surface for compacting the lesion (barrel portion of 13), and a distal tapered portion (distal cone of 13) together with the tapered tip providing a distal end portion of the shaft with a substantially continuous transition (“Incidentally, the narrowed region 37 is formed including the junction region on the distal side of the balloon 13. Thereby, in a state in which the balloon 13 is in a deflated state and is wound around the axis with respect to the inner tube 16, a continuous tapered shape extends from the midway position of the balloon 13 to the distal end opening 35 from the midway position of the balloon 13. And passability is improved.”).
In regard to claim 3, Sugiura discloses wherein a taper of the distal tapered portion of the inflatable balloon and the tapered tip create a continuous sloping transition from a proximal end of the distal tapered portion to a distal end of the tapered tip (“Incidentally, the narrowed region 37 is formed including the junction region on the distal side of the balloon 13. Thereby, in a state in which the balloon 13 is in a deflated state and is wound around the axis with respect to the inner tube 16, a continuous tapered shape extends from the midway position of the balloon 13 to the distal end opening 35 from the midway position of the balloon 13. And passability is improved.”).
In regard to claim 6, Sugiura discloses wherein the tapered tip (36, 37) is elongated and extends to an end (35) having a circular cross-section adapted for receiving and surrounding a guidewire (31 is a guidewire lumen) (“In the configuration in which the strength of the distal end opening 35 is improved, when the balloon catheter 10 is used, a guide wire G having an outer diameter that hardly generates a gap with the distal end opening 35 is used ”.
In regard to claim 10, Sugiura discloses an apparatus (10) for crossing a lesion in a vessel and performing percutaneous transluminal angioplasty on the lesion, comprising: a shaft (11) including a guidewire lumen (31), an inflation lumen (21), and a tapered tip (36, 37) having an end for being advanced into the lesion; and an inflatable balloon (13) mounted on the shaft, the inflatable balloon attached to and forming a continuous sloping transition to the end of the tapered tip (“Incidentally, the narrowed region 37 is formed including the junction region on the distal side of the balloon 13. Thereby, in a state in which the balloon 13 is in a deflated state and is wound around the axis with respect to the inner tube 16, a continuous tapered shape extends from the midway position of the balloon 13 to the distal end opening 35 from the midway position of the balloon 13. And passability is improved.”).
In regard to claim 12, Sugiura discloses wherein the inflatable balloon (13) includes a proximal tapered portion (proximal cone of 13) and a distal tapered portion (distal cone of 13), a taper of the distal tapered portion and the tapered tip together forming the continuous sloping transition (“Incidentally, the narrowed region 37 is formed including the junction region on the distal side of the balloon 13. Thereby, in a state in which the balloon 13 is in a deflated state and is wound around the axis with respect to the inner tube 16, a continuous tapered shape extends from the midway position of the balloon 13 to the distal end opening 35 from the midway position of the balloon 13. And passability is improved.”).
In regard to claim 24, Sugiura discloses wherein the substantially continuous transition is from a distal end of the barrel portion of the inflatable balloon to a tip of the shaft (the balloon tapers from the beginning portion of 13 until the end of the distal tip; the taper is continuous even if the angle is not always constant; “Incidentally, the narrowed region 37 is formed including the junction region on the distal side of the balloon 13. Thereby, in a state in which the balloon 13 is in a deflated state and is wound around the axis with respect to the inner tube 16, a continuous tapered shape extends from the midway position of the balloon 13 to the distal end opening 35 from the midway position of the balloon 13. And passability is improved.”)..
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.
Claim(s) 2, 11, 15-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sugiura in view of Yribarren et al. (US 2009/0018501; hereafter Yribarren).
In regard to claim 2, Sugiura fails to expressly disclose wherein a portion of the shaft proximal of the balloon is braided.
In a similar art, Yribarren teaches a balloon catheter (100) with inner and outer shaft members (10, 20), wherein the material of the shaft can include braided materials (see par. [0048]-[0050]). The examiner notes that the inner and outer shaft members (10, 20) are proximal of the balloon (50).
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 device of Sugiura with the braided materials of Yribarren because such a material is demonstrated to be suitable for angioplasty balloon catheters and therefore such a modification is well within the skill of the ordinary artisan.
In regard to claim 11, substantially the same subject matter as claim 2 is recited.
In regard to claim 15, substantially the same subject matter as claim 2 is recited.
In regard to claim 16, wherein the distal tapered portion has a first taper corresponding to a second taper of the tapered tip so as to provide the catheter with a substantially uniform taper along a distal end portion thereof (“Incidentally, the narrowed region 37 is formed including the junction region on the distal side of the balloon 13. Thereby, in a state in which the balloon 13 is in a deflated state and is wound around the axis with respect to the inner tube 16, a continuous tapered shape extends from the midway position of the balloon 13 to the distal end opening 35 from the midway position of the balloon 13. And passability is improved.”).
In regard to claim 17, the tapered tip (36, 37) is tapered.
In regard to claim 18, the tapered tip is a unitary part of the shaft (see Figure 4-5).
In regard to claim 20, substantially the same subject matter as claim 2 is recited.
Claim(s) 4-5 and 13 rejected under 35 U.S.C. 103 as being unpatentable over Sugiura in view of Holman et al. (US 2006/0135909; hereafter Holman).
In regard to claims 4-5 and 13, Sugiura fails to expressly disclose wherein the distal tapered portion and the tapered tip each have a taper angle of less than about 20 degrees, and wherein the taper angle is 8-12 degrees. The instant disclosure describes the recited taper angles as being merely preferable, and does not describe the recited taper angles as contributing any unexpected results to the system. As such, parameters such as the recited taper angles are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the recited taper angle would be dependent on the actual application of the system and, thus would be a design choice based on the actual application. In a similar, Holman shows such a recited range (see par. [0018]) to be known in the art for using for the tapered distal portion of balloon catheters. Based on the design consideration feature and that such a feature is known in the art to be useful, it would have been obvious to use such a range if the application required it.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sugiura in view of Boyle et al. (US 2018/0185051; hereafter Boyle).
In regard to claim 7, Sugiura fails to expressly disclose further including one or more scoring wires extending alongside the balloon.
In a similar art, Boyle discloses a balloon catheter (100) with a balloon (115) and scoring wires (135) extending alongside the balloon (see Fig. 1a). The scoring wires allow for the scoring of a vascular lesion (see Abstract).
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 device of Sugiura with the scoring wires of Boyle in order to provide a scoring capability to the balloon catheter.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Sugiura in view of Miller et al. (US 4,821,722; hereafter Miller).
In regard to claim 8, Sugiura fails to expressly disclose wherein the shaft includes one or more radiopaque markers for identifying the working surface of the inflatable balloon when inflated.
In a similar art, Miller teaches a pair of radiopaque markers 27 formed of a suitable material such as gold or tungsten are positioned on the exterior of the inner tubular member 12 and are spaced apart so that they are near the proximal and distal extremities of the balloon to indicate the working length (the straight portion of the balloon). These radiopaque markers as shown are in the form of rings.
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 device of Sugiura with the features of Miller in order to provide a means for indicating the working length of a balloon.
Claim(s) 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sugiura in view of Bahmanyar et al. (US 2020/0306512; hereafter Bahmanyar).
In regard to claims 9 and 14, Sugiura fails to expressly disclose wherein the balloon is non-compliant.
In a similar art, Bahmanyar teaches that the balloon (1733) can be non-compliant. (see par. [0175]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Sugiura with the feature of Bahmanyar because such a feature is known in the art to be useful in similar applications.
Claim(s) 19 rejected under 35 U.S.C. 103 as being unpatentable over Sugiura and Yribarren in view of Bahmanyar et al. (US 2020/0306512; hereafter Bahmanyar).
In regard to claim 19, Sugiura and Yribarren fail to expressly disclose wherein the balloon is non-compliant.
In a similar art, Bahmanyar teaches that the balloon (1733) can be non-compliant. (see par. [0175]).
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 combination with the feature of Bahmanyar because such a feature is known in the art to be useful in similar applications.
Response to Arguments
Applicant's arguments filed 1/15/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Sugiura fails to disclose a distal tapered portion together with the tapered tip providing a distal end portion of the shaft with substantially continuous transition, the examiner respectfully disagrees. The applicant argues that Sugiura does not disclose a substantially continuous transition because there are two significant breaks, one from 13 to 13a and one from 13a to 36. This argument is not persuasive. The examiner notes that there is no special definition for “substantially continuous transition”. The broadest reasonable interpretation is a portion that continuously tapers which does not preclude different angles of tapering. Furthermore, the applicant is ignoring the disclosure cited in the rejection. See “a continuous tapered shape extends from the midway position of the balloon 13 to the distal end opening 35 from the midway position of the balloon 13.”
In regard to claim 3, the applicant argues that Sugiura fails to disclose “a taper of the distal tapered portion of the inflatable balloon and the tapered tip create a continuous sloping transition from a proximal end of the distal tapered portion to a distal end of the tapered tip. The applicant argues that the office action fails to account for the special definition for “continuous sloping transition”. The applicant reproduces the special definition found in par. [0028] of the pg-publication but does not include the entire special definition. The last clause of the special definition is “but does not mean the angle cannot vary by several degrees along the transition while still being continuously tapered.” The examiner’s position is that a change in the taper angle (of several degrees) would appear as what the applicant refers to as the “breaks” in Sugiura.
In regard to claim 6, the applicant contends that Sugiura does not disclose a circular opening. This is not persuasive. Sugiura discloses:
“In the configuration in which the strength of the distal end opening 35 is improved, when the balloon catheter 10 is used, a guide wire G having an outer diameter that hardly generates a gap with the distal end opening 35 is used (emphasis added by examiner). Therefore, if the above-described vertically long deformation does not occur, the entire tip region 36 follows the guide wire G, and the distal end opening 35 does not bulge in the radial direction (emphasis added by examiner). Therefore, the possibility that the peripheral edge of the distal end opening 35 is pressed against the inner wall of the blood vessel is low, and even if the strength of the tip region 36 is increased, the possibility of damaging the blood vessel is low. Further, since the degree of crystallinity is increased, the frictional resistance of the tip region 36 against the guide wire G is reduced. Therefore, the slidability of the guide wire G can be improved.”
In regard to claim 10, see the response above for claim 3 as the same issues are addressed.
In response to the applicant’s argument that there is no motivation to combine the teachings of Yribarren with Sugiura, the examiner respectfully disagrees. The applicant is ignoring the skill of the ordinary artisan in this field. The skill of the ordinary artisan is considered to be very high. The skilled artisan is designing devices to be inserted into the human body to treat various conditions, wherein the failure of these devices could result in patient injury and/or death. Choosing a generic catheter configuration such as “braided” is considered rudimentary in this field. Braided catheters are well-known and Sugiura shows that they a suitable material for angioplasty catheters. The ordinary skilled artisan would understand that the braided material would provide the necessary physical characteristics needed to access a patient’s vasculature.
In response to the applicant’s argument that the recited angles are not design considerations, the examiner respectfully disagrees. The applicant states the importance of the recited angle is to provide “a single catheter that can perform the dual functions of both crossing a lesion, such as a CTO, and then performing percutaneous transluminal angioplasty or atherectomy on it”. This is not found persuasive. There is nothing in the specification to support that the recited angles are needed to perform the dual functions or that the recited angles work to the exclusion of other angles. Holman teaches that an overlapping range is known in the art. Again, the applicant is ignoring the skill of the ordinary artisan and the ability of the artisan to choose a taper angle within a known taper range that is suitable for the purpose of the catheter.
In response to the applicant’s arguments over the rejections of claims 7-9, 14, and 19, the examiner respectfully disagrees. These claims recite well-known features in the angioplasty balloon art and each feature is taught by a reference. The ordinary skilled artisan is fully capable of employing these features in the Sugiura balloon system. The motivation is to provide the functionality of each feature, wherein the ordinary skilled artisan is fully capable of determining the need for the feature and has the ability to make the modification.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5681281 to Vigil
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WO-2014/018659-A2 to Clearstream Technologies LTD.
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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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783