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 . Claims 1-20 are pending and examined below.
Response to Arguments
Applicant's arguments filed on 10/08/2025 have been fully considered but they are not persuasive. The applicant argues on pages 6-7, the art of record does not teach or suggest the amended claim language, however the examiner respectfully disagrees. The examiner notes, though the applicant amended the claims to describe structural features within a proximal section of the delivery device, the language does not limit the proximal section to “only” include the recited technical features, since the claims use the term “comprising” rather than “consisting”. Therefore, the examiner notes, though the art of record my include additional technical features within the proximal section of the delivery device, the technical features still read on the instant claims. In addition, see the 35 USC §102 and 35 USC §103 rejection below.
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.
(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.
Claims 1, 3-11, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by St. Germain et al (US 5,534,007)
Regarding claim 1, St. Germain et al discloses a delivery system comprising (abstract): an inner shaft (lumen (15), column 3, second and third paragraphs) comprising an inflatable balloon (an expansion balloon, column 3, second and third paragraphs); a stent disposed around the balloon and coupled to the inner shaft (Figs. 1-3: ballon expandable stent (35), column 3, third paragraph); a sheath extending circumferentially continuously around the stent and the inflatable balloon (Fig. 1: retractable distal sheath (40), column 3, third paragraph); and a sheath control wire coupled to a proximal end of the sheath and extending proximally from the sheath alongside the inner shaft (Fig. 1: retracting member (45), column 3, third paragraph), wherein, at a length of the delivery system that is defined by the sheath control wire (Fig. 6 shows a line (7) at a proximal portion of the device which includes a retracing member (45), column 6, second paragraph), and proximal to the sheath an outer cross-sectional dimension of the delivery system is defined by the inner shaft and the sheath control wire (Fig. 6 shows a line (7) at a proximal portion of the device which includes a retracing member (45) and lumen (15); column 6, second paragraph).
Regarding claim 3, St. Germain et al discloses the delivery system of claim 1, wherein the sheath has a length that is less than 200% of a length of the stent (Fig. 1: the retractable distal sheath (40) exactly covers and contains the stent (35), which implicitly teaches the sheath is the same length of the stent and therefore has a length that is less than 200% of the length of the stent, also see column 3, third paragraph)
Regarding claim 4, St. Germain et al discloses the delivery system of claim 1, wherein the sheath has a length that is no more than 10 cm greater than a length of the stent (Fig. 1: the retractable distal sheath (40) exactly covers and contains the stent (35), which implicitly teaches the sheath is the same length of the stent and therefore has a length that is no more than 10cm greater than the length of the stent, also see column 3, third paragraph).
Regarding claim 5, St. Germain et al discloses the delivery system of claim 1, wherein the delivery system has a cross-sectional dimension at the sheath control wire that is less than a cross-sectional dimension at the sheath (see annotated fig. 1 below, also see column 3, third paragraph) .
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Regarding claim 6, St. Germain et al discloses the delivery system of claim 1, further comprising a guidewire slidably disposed within the inner shaft (Fig. 1: guide wire (20), column 4, lines 53-55) .
Regarding claim 7, St. Germain et al discloses a delivery system comprising (abstract): an inner shaft (lumen (15), column 3, second and third paragraphs) comprising an inflatable balloon (an expansion balloon, column 3, second and third paragraphs); a stent extending about a portion of the inner shaft (Figs. 1-3: ballon expandable stent (35), column 3, third paragraph); a sheath covering an entirety of the stent (Fig. 1: retractable distal sheath (40), column 3, third paragraph), wherein the sheath has a length that is less than 200% of a length of the stent (Fig. 1: the retractable distal sheath (40) exactly covers and contains the stent (35), which implicitly teaches the sheath is the same length of the stent and therefore has a length that is less than 200% of the length of the stent, also see column 3, third paragraph); and a sheath control wire coupled to a proximal end of the sheath and extending alongside the inner shaft (Fig. 1: retracting member (45), column 3, third paragraph), wherein, at a length of the delivery system that is defined by the sheath control wire (Fig. 6 shows a line (7) at a proximal portion of the device which includes a retracing member (45), column 6, second paragraph), and proximal to the sheath, an outer cross-sectional dimension of the delivery system is defined by the inner shaft and the sheath control wire (Fig. 6 shows a line (7) at a proximal portion of the device which includes a retracing member (45) and lumen (15); column 6, second paragraph).
Regarding claim 8, St. Germain et al discloses the delivery system of claim 7, wherein the length of the sheath is no more than 10 cm greater than the length of the stent (Fig. 1: the retractable distal sheath (40) exactly covers and contains the stent (35), which implicitly teaches the sheath is the same length of the stent and therefore has a length that is no more than 10cm greater than the length of the stent, also see column 3, third paragraph).
Regarding claim 9, St. Germain et al discloses the delivery system of claim 7, wherein the sheath further covers an entirety of the balloon (Fig. 1: retractable distal sheath (40), column 3, third paragraph).
Regarding claim 10, St. Germain et al discloses the delivery system of claim 9, wherein the length of the sheath is less than 200% of a length of the balloon (Fig. 1: the retractable distal sheath (40) exactly covers and contains the stent (35), in addition to the balloon that expands the stent, which implicitly teaches the sheath is the same length of the stent and the balloon, therefore the sheath has a length that is less than 200% of the length of the stent, also see column 3, third and fourth paragraphs).
Regarding claim 11, St. Germain et al discloses the delivery system of claim 9, wherein the length of the sheath is no more than 10 cm greater than a length of the balloon (Fig. 1: the retractable distal sheath (40) exactly covers and contains the stent (35), in addition to the balloon that expands the stent, which implicitly teaches the sheath is the same length of the stent and the balloon, therefore the sheath has a length that is less than 10cm of the length of the stent, also see column 3, third and fourth paragraphs). .
Regarding claim 13, St. Germain et al discloses the delivery system of claim 7, wherein the delivery system has a cross-sectional dimension at the sheath control wire that is less than a cross-sectional dimension at the sheath (see annotated fig. 1 below, also see column 3, third paragraph).
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Regarding claim 14, St. Germain et al discloses the delivery system of claim 7, further comprising a guidewire slidably disposed within the inner shaft (Fig. 1: guide wire (20), column 4, lines 53-55).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 12, 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over St. Germain et al (US 5,534,007), in view of Jimenez, JR et al (US 2020/0107947 A1).
Regarding claim 2, St. Germain et al discloses the delivery system of claim 1, however doesn’t specifically disclose wherein the stent comprises a frame and protruding features.
Jimenez, JR et al discloses a delivery system for delivering expandable elements, such as a stent that has protruding features, where the delivery system can have a stent that is positioned over an inflatable balloon (abstract). Jimenez, JR et al further discloses a stent (Figs. 4-6: stent (190), paragraph 0054) comprises a frame (Figs. 4-6: frame (191), paragraph 0054) and protruding features configured to extend radially away from the frame when the stent is released from the sheath (Figs. 4-6: protruding features (194), paragraph 0054).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the stent taught by St. Germain et al with the above protruding features as taught by Jimenez, JR et al in order to have a stent that is able to penetrate target tissues and/or deliver drugs (paragraph 0038).
Regarding claim 12, St. Germain et al discloses the delivery system of claim 7, however doesn’t specifically disclose wherein the stent comprises a frame and protruding features.
Jimenez, JR et al discloses a delivery system for delivering expandable elements, such as a stent that has protruding features, where the delivery system can have a stent that is positioned over an inflatable balloon (abstract). Jimenez, JR et al further discloses a stent (Figs. 4-6: stent (190), paragraph 0054) comprises a frame (Figs. 4-6: frame (191), paragraph 0054) and protruding features configured to extend radially away from the frame when the stent is released from the sheath (Figs. 4-6: protruding features (194), paragraph 0054).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the stent taught by St. Germain et al with the above protruding features as taught by Jimenez, JR et al in order to have a stent that is able to penetrate target tissues and/or deliver drugs (paragraph 0038).
Regarding claim 15, St. Germain et al discloses a delivery system comprising (abstract): an inner shaft (lumen (15), column 3, second and third paragraphs) comprising an inflatable balloon (an expansion balloon, column 3, second and third paragraphs) and a sheath control wire coupled to a proximal end of the sheath and extending proximally from the sheath alongside the inner shaft (Fig. 1: retracting member (45), column 3, third paragraph); however doesn’t specifically disclose a stent control wire and a stent being axially adjacent to the balloon.
Jimenez, JR et al discloses a delivery system for delivering expandable elements, such as a stent that has protruding features, where the delivery system can have a stent that is positioned over an inflatable balloon (abstract). Jimenez, JR et al further discloses a stent control wire extending alongside a first radial side of the inner shaft (stabilizing wire, which is positioned within an inner shaft, paragraph 0102-0104), and a stent being axially adjacent to the balloon (the inflatable ballon can be distal to the stent or proximal to the stent, paragraph 0052).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the delivery device as taught by St. Germain et al to include a balloon being positioned adjacent to the stent and a stent control wire as taught by Jimenez, JR et al in order to reduce the space requirements of the catheter shaft (paragraph 0078) and having the capability to maintain the stents position (paragraph 0068).
Regarding claim 16, St. Germain et al discloses the delivery system of claim 15, however doesn’t specifically disclose wherein the stent and the sheath are proximal to the balloon.
Jimenez, JR et al discloses the stent and the sheath are proximal to the balloon (the inflatable ballon can be proximal to the stent, paragraphs 0052 and 0078).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the balloon placement within the delivery device as taught by St. Germain et al with the balloon being positioned adjacent to the stent as taught by Jimenez, JR et al in order to reduce the space requirements of the catheter shaft (paragraph 0078).
Regarding claim 17, St. Germain et al discloses the delivery system of claim 15, however doesn’t specifically disclose wherein the stent and the sheath are distal to the balloon.
Jimenez, JR et al discloses the stent and the sheath are distal to the balloon (the inflatable ballon can be distal to the stent, paragraphs 0052 and 0089).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the balloon placement within the delivery device as taught by St. Germain et al with the balloon being positioned adjacent to the stent as taught by Jimenez, JR et al in order to reduce the space requirements of the catheter shaft (paragraph 0089).
Regarding claim 18, St. Germain et al discloses the delivery system of claim 15, however doesn’t specifically disclose wherein the stent comprises a frame and protruding features.
Jimenez, JR et al discloses a delivery system for delivering expandable elements, such as a stent that has protruding features, where the delivery system can have a stent that is positioned over an inflatable balloon (abstract). Jimenez, JR et al further discloses a stent (Figs. 4-6: stent (190), paragraph 0054) comprises a frame (Figs. 4-6: frame (191), paragraph 0054) and protruding features configured to extend radially away from the frame when the stent is released from the sheath (Figs. 4-6: protruding features (194), paragraph 0054).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the stent taught by St. Germain et al with the above protruding features as taught by Jimenez, JR et al in order to have a stent that is able to penetrate target tissues and/or deliver drugs (paragraph 0038).
Regarding claim 19, St. Germain et al discloses the delivery system of claim 15, wherein the delivery system has a cross-sectional dimension at the sheath control wire that is less than a cross-sectional dimension at the sheath (see annotated fig. 1 below, also see column 3, third paragraph).
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Regarding claim 20, St. Germain et al discloses the delivery system of claim 15, further comprising a guidewire slidably disposed within the inner shaft (Fig. 1: guide wire (20), column 4, lines 53-55).
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 JOSE H TREVINO III whose telephone number is (703)756-4678. The examiner can normally be reached Monday - Friday: 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached 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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/J.H.T./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799