DETAILED ACTION
Response to Amendment
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 13, 16, 18-25, and 30-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mitra (US 2024/0050714; effectively filed on 1/10/2021).
In regard to claim 13, Mitra discloses an apparatus (10) for performing angioplasty on a lesion and delivering a therapeutic agent thereto (italicized language is functional; see at least the Abstract), comprising: a catheter (12) including a first inflatable balloon (14 or 15) having a first degree of compliance (see par. [0043]; “balloons 14 and 15 may be made of… compliant materials”) and a second inflatable balloon (13) having a second degree of compliance less than the first degree of compliance (see par. [0043]; “balloon 13 may be made of non-compliant or semi-compliant materials”; the second balloon 13 has less compliance than the first balloon), wherein the second inflatable balloon (13) is proximal of the first inflatable balloon (15), and further including a third inflatable (14) balloon distal of the first inflatable balloon (14) (see Fig. 1).
In regard to claim 16, Mitra discloses wherein the catheter (12) includes at least one port (17 or 18) for delivering a therapeutic agent adjacent to the first inflatable balloon (see par. [0044]).
In regard to claim 18, Mitra discloses wherein the catheter (12) includes a first port (18) between the first inflatable balloon (15) and the second inflatable balloon (13) for delivering a therapeutic agent (see par. [0044]), and a second port (17) between the first inflatable balloon (15) and the third inflatable balloon (14) for delivering the therapeutic agent (see par. [0044]).
In regard to claim 19, Mitra discloses an apparatus (10) for performing angioplasty on a lesion in a vessel (italicized language is functional; see at least the Abstract), comprising: a catheter (12) including a proximal compliant balloon (15) adapted for sealing the vessel to prevent flow proximal of the lesion (32; see Fig. 7), a distal compliant balloon (14) adapted for sealing the vessel to prevent flow distal of the lesion (see Fig. 7), and an intermediate non-compliant balloon (13) adapted to compress the lesion when expanded (see Fig. 7).
In regard to claim 20, Mitra discloses wherein the catheter (12) further including at least one first port (17 or 18) for delivering a therapeutic agent to adjacent the lesion (see par. [0044]).
In regard to claim 21, Mitra discloses wherein the at least one first port (17) is located on the catheter (12) between the distal compliant balloon (14) and the intermediate non-compliant balloon (13) (see at least Figs. 5-7).
In regard to claim 22, Mitra discloses wherein the catheter (12) further including at least one second port (18) for delivering a therapeutic agent to adjacent the lesion (see par. [0044]).
In regard to claim 23, Mitra discloses wherein the at least one second port (18) is located on the catheter between the proximal compliant balloon (15) and the intermediate non-compliant balloon (13) (see at least Figs. 5-7).
In regard to claim 24, Mitra discloses wherein the at least one first port (17) and the at least one second port (18) are in fluid communication with a lumen of the catheter (see par. [0044]).
In regard to claim 25, Mitra discloses further including a vacuum source connected to the lumen (see par. [0044]-[0045] and [0053] and Fig. 10; the ports are for delivery and extraction).
In regard to claim 30, Mitra discloses a method of performing angioplasty on a lesion in a vessel (see Figs. 5-12), comprising: inflating a proximal compliant balloon (15) adapted for sealing the vessel to prevent flow proximal of the lesion (see Fig. 7); inflating a distal compliant balloon (14) adapted for sealing the vessel to prevent flow distal of the lesion (see Fig. 7); and inflating an intermediate non-compliant balloon (13) adapted to compress the lesion when expanded (see Figs. 6-7).
In regard to claim 31, Mitra discloses further including the steps of: deflating the intermediate non-compliant balloon (13) while the proximal compliant balloon (15) and distal compliant balloon (14) remain inflated for sealing the vessel (see Fig. 8); and delivering a therapeutic agent to adjacent the lesion (see Fig. 9).
In regard to claim 32, Mitra discloses further including the step of evacuating any residual therapeutic agent (see Fig. 10).
In regard to claim 33, Mitra discloses wherein, after the intermediate non-compliant balloon (13) compresses the lesion when expanded, the intermediate non-compliant balloon is at least partially deflated, the catheter is configured to be advanced to a location spaced to the site of the lesion and reinflated to block blood flow downstream temporarily, and thus form a plug, while the at least one first port proximal of the intermediate non-compliant balloon (13) is generally aligned with the compressed lesion for delivering the therapeutic agent (Mitra discloses all of the structure to perform these functional limitations).
Claim(s) 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boston Scientific Corporation (WO90/07352; hereafter Boston).
In regard to claim 27, Boston discloses a method of performing angioplasty on a lesion in a vessel and delivering a therapeutic agent thereto (see Figs. 2-2e and starting on page 8, line 12), comprising, in order: inflating a balloon (8) on a catheter (4) to compress the lesion (56; see Fig. 2b; see page 8, lines 21-29); deflating the balloon (see Fig. 2c; see page 8, lines 30-31); moving the catheter (4) to a location such that a port (12) in the catheter is adjacent to the lesion (see Fig. 2d; see page 8, line 31- page 9, line 2); inflating the balloon (see Fig. 2d; see page 9, lines 3-14); and delivering the therapeutic agent to the lesion (56) via the port (12) (see page 9, line 15-27).
In regard to claim 28, Boston discloses further including the step of evacuating any residual therapeutic agent via the port (see page 9, lines 27-31).
In regard to claim 29, Boston discloses wherein the moving step comprises advancing the catheter (see col. 8, line 30- col. 9, line 2).
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) 14-15 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Mitra in view of Beckham (US 2004/0082965).
In regard to claims 14 and 26, Mitra fails to expressly disclose that the second inflatable balloon (13) which is non-compliant balloon (see 112 rejection above) includes inelastic fibers. Beckham teaches at paragraph [0004] and [0006] that it is known in the art of non-compliant balloons to use the claimed material (inelastic fibers) to manufacture the non-compliant balloon. In view of the teaching of Beckham, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select inelastic fibers as the specific type of material from which to manufacture the non-compliant balloon (13) of Mitra, because it amounts to selection of a known material based on its known suitability for the purpose.
In regard to claim 15, Mitra further discloses that the first inflatable balloon (14 or 15) comprises a compliant or semi-compliant balloon (see par. [0043]) (see 112 rejection above).
Response to Arguments
Applicant's arguments filed 7/24/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Mitra fails to disclose the recited balloon relationship as is recited in claim 13, the examiner respectfully disagrees. In support of the argument, applicant references the disclosed instant apparatus 100 (Please see 2nd page of the Remarks starting at the 3rd full paragraph). Applicant references catheter 100 having balloons 112a, 112b, 112c, wherein the first and third balloons 112a and 112c are compliant and the second balloon 112b is non-compliant. The arrangement disclosed by Mitra and identified in the rejection above is identical to the applicant’s disclosed/recited embodiment with two compliant balloons flanking a non-compliant balloon. It is not consistent for the applicant to use apparatus 100 as support for the claimed limitations and also allege that the identically disclosed system of Mitra fails to anticipate the claimed limitations.
In response to the applicant’s argument that the provisional application does not provide support for the relied upon disclosure, the examiner respectfully disagrees. The provisional application provides identical Figures 1-15 and describes the systems in par. [034]-[051].
In response to the applicant’s argument that Boston fails to disclose the steps of method 27, the examiner respectfully disagrees. The applicant’s arguments are not well understood but it appears that the applicant is arguing that the inclusion of a second balloon (6) in the Boston system prevents the anticipation of the method. This is not correct. The claim does not prohibit the use a second balloon to create an enclosed treatment region. The use of “a balloon” and “the balloon” means that the same balloon must be referenced but this is totally consistent with the examiner’s interpretation. Only balloon 8 is referenced. The claim does not prohibit an anticipatory reference from using a second balloon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2008/0249461 to Foreman et al. reads on various claims.
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.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
