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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the tip” in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “the second internal lumen” in line 16. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-4, 6, 7, 10-12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2019/0076152) in view of Tremulis et al. (US 2007/0219466).
Regarding claims 1, 3, and 6, Franklin discloses a vascular occlusion catheter (FIGs 1A-1D, abstract, paragraph [0088]) for at least partial occlusion of a target vessel having an internal vessel wall (FIG 1E), the vascular occlusion catheter comprising: a proximal outer section (12b, FIG 1A-1D, paragraph [0088,0093]); a distal outer section (FIG 1C shows the distal portion of the outer shaft 12 which comprises 170); an occlusion balloon (140) connected to the proximal outer section (at 140c, FIG 1B) and the distal outer section (at 140d); the proximal outer section having a first internal lumen (13a, FIG 1B and 6, paragraph [0088-0090 and 0093]), the first internal lumen being in fluid communication with the occlusion balloon (Paragraph [0089]); the distal outer section having a distal internal lumen (FIG 3 shows the lumen which receives 12a. FIG 5 further shows a lumen in the distal end of 12); a hypotube (12a) extending through the first internal lumen (FIG 1B), through the occlusion balloon (FIG 1B) and into the distal internal lumen (FIG 3), the hypotube operating as the primary load-bearing chassis of the vascular occlusion catheter (Paragraph [0097]; 12a is a stiffener member providing load bearing properties); at least one of a first window formed in the proximal outer shaft (171 is shown as an opening in the proximal shaft, FIG 1B, and therefore is interpreted as a window, paragraph [0109]), and a proximal sensor being positioned within the second internal lumen facing the first window (Paragraph [0109] discloses proximal port 171 may be supplemented with electronic pressure sensors); or a second window formed in the distal outer shaft (170, FIG 1C), and a distal sensor being positioned within the distal internal lumen facing the second window (Paragraph [0093 and 0109] disclose 170 can be supplemented with a sensor). Franklin ‘152 further discloses a display hub (590’, FIG 1D) having a pump 591’ and a pressure sensor display positioned on the pump (Paragraph [0096]).
Franklin is silent regarding the display hub positioned along the proximal outer section, wherein the hypotube extends into the display hub, the display hub being electrically connected with at least one of the proximal sensor or the distal sensor.
However, Franklin discloses in the alternative embodiment of FIGs 36-42 (Paragraphs [0164-0179]) an occlusion catheter (1800/1900) having a display hub (1890/1990) positioned along a proximal outer section (1812b/1912b, FIGs 38-41), where a hypotube (1812/1912, paragraph [0180]) extend into the display hub (FIG 39 and 41), the display hub being electrically connected with a proximal sensor (1871, paragraphs [0165-0168]), and a distal sensor (1870, paragraphs [0165-0168]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the display hub of Franklin such that it comprises the display hub electrically connected to the proximal and distal sensors, as taught by the alternative embodiment, for the purpose of providing a user friendly interface for receiving the pressure readings obtained by the sensors in order to manage the occlusion with more precision and safety (Paragraph [0165]).
Franklin further teaches an atraumatic tip (450, FIGs 4-5, [0112-0117]) arranged at the distal end of the distal outer section (FIG 5) wherein an axis of the tip is radially offset from a central axis of the hypotube (FIG 5 shows 131 is the central axis of the hypotube and the central axis of the tip is radially offset therefrom (See FIGs 4-5 wherein the central axis of 453 of the tip is positioned below the axis 131, [0112]). However, the device is silent regarding a solid distal wire embedded in the distal outer section and extending toward the tip, the solid distal wire having a central axis that is radially offset from a central axis of the hypotube.
However, Tremulis et al. discloses in the same field of endeavor a catheter tip (18C, FIG 7A, [0041]) attachable to the distal end of a distal outer section of a catheter (12C), including a solid distal wire (70) embedded in a distal outer shaft (FIG 7A shows part of the wire 74 embedded in distal outer section) and extending toward the tip (FIG 7A shows the portions of 70 which extends into tip 18C), the solid distal wire having a central axis that is radially offset from a central axis of the distal outer section (FIG 7A shows that curved distal section 72 of the solid distal wire 70 extends below the central axis of 12C in a manner which is radially offset therefrom).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the distal outer shaft and the tip of Franklin to comprise a solid distal wire embedded in the distal outer shaft and extending toward the atraumatic tip, having a central axis that is radially offset from a central axis of the hypotube, as taught by Tremulis et al., for the purpose of creating a desired stiffness and curvature along the distal end of the device at both the distal outer shaft and the tip ([0041]; “to allow atraumatic tip 18C to bend or flex as is contacts, for example, an inner wall of a body lumen, while preventing the tip or the distal portion of elongated shaft 12C from bending”) and therefore achieving the predictable result of allowing the catheter to be navigated through a tortuous vasculature while minimizing trauma to the surrounding vessel wall and maintaining pushability.
Regarding claim 2, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 1. Franklin further discloses the hypotube includes an internal hypotube lumen (15).
Regarding claims 4 and 7, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 3 and 5. Franklin further discloses the proximal sensor is a pressure sensor configured to measure central aortic pressure downstream of the occlusion balloon and the distal sensor is a pressure sensor configured to measure central aortic pressure upstream of the occlusion balloon (Paragraph [0088 and 0097-0098] disclose the occlusion catheter is configured for use
in the aorta. Therefore, the proximal and distal pressure sensors are configured to measure aortic pressure downstream and upstream of the balloon).
Regarding claim 10, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 1. Franklin further discloses the display hub comprises an internal hub frame securing the hypotube and first internal lumen to the display hub (See FIG 41 below).
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Regarding claim 11, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 10. Franklin further discloses an inflation hub in fluid communication with the display hub via an inflation shaft (See annotated FIG 41 above), the internal hub frame securing the inflation shaft and fluidly connecting the inflation hub with the first internal lumen (See annotated FIG 41 above).
Regarding claim 12, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 11.
The device as modified fails to disclose the solid distal wire tapers from a proximal end thereof to a distal end thereof.
However, Tremulis teaches in the alternative embodiment of FIG 9 a catheter tip (18E, [0044-0046]) attachable to the distal end of a distal outer section of a catheter (12E), including a solid distal wire (74) embedded in a distal outer shaft (FIG 9 shows part of the wire 74 embedded in distal outer section) and extending toward the tip (FIG 9 shows the portions of 74 which extends into tip 18E), wherein the solid distal wire tapers from a proximal end thereof to a distal end thereof ([0046] discloses the portion of guide wire 74 within atraumatic tip 18E between proximal end 50E and distal end 52E may be tapered such that the diameter of guide wire 74 near coil region 80 is greater than the diameter of guide wire 74 near flange 76. As a result of tapering guide wire 74, atraumatic tip 18E may be more flexible toward distal end 52E and less flexible toward proximal end 50E).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the solid distal wire to taper from a proximal end thereof to a distal end thereof, as taught by the alternative embodiment of Tremulis, for the purpose of altering the stiffness such that the distal end is more flexible to be atraumatic and the proximal end is more stiff to be pushable.
Regarding claim 14, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the solid distal wire extends beyond a distal end of the hypotube by a distance greater than a greatest outer diameter of the catheter in an uninflated condition (In the device as modified, the solid distal wire extends through the length of the atraumatic tip distal to the hypotube, i.e. a straightened length of 450. As shown in FIG 1C, 1D, 4, and 5, it is understood that this length is greater than an uninflated diameter of the catheter).
Regarding claim 15, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the solid distal wire originates distally from a proximal-most end of a proximal neck of the occlusion balloon (The solid distal wire is only present in the distal outer section and the tip, which is distal to a proximal neck (140C, FIG 6) od the occlusion balloon).
Claim(s) 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2019/0076152) in view of Tremulis et al. (US 2007/0219466), further in view of Kornhaber et al. (US 2023/0010482).
Regarding claim 5 and 8, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claims 3 and 6.
Franklin is silent regarding the proximal and distal sensors are absolute sensors, and wherein the catheter further comprises a barometric transducer configured to convert absolute data to gauge-based data.
However, Kornhaber teaches a sensor for detecting fluid pressure changes in a body lumen (0012]) utilizing an absolute sensor which takes barometric pressure readings and further comprises a microprocessor to store and analyze the measured pressure ([0013]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the proximal and distal sensors to be absolute sensors with a transducer to convert the data to a readable form, as taught by Kornhaber, for the purpose of selecting a pressure sensor commonly known in the art for achieving the predictable result of determining a fluid pressure at the distal and proximal end of the device.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2019/0076152) in view of Tremulis et al. (US 2007/0219466), further in view of Layman et al. (US 2021/0282759).
Regarding claim 9, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 1.
The device as modified is silent regarding a portion of the solid distal wire overlapping with the hypotube is jacketed to the hypotube.
However, Layman et al. teaches a solid distal wire (522, FIG 8-9) embedded in an atraumatic tip (600, [0081]) and jacketed to an overlapping portion of a distal end of an elongated member (524 of 520, FIG 9 shows overlapping, wherein [0060 and 0064] disclose lamination of 522 to 524).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use jacketing as a means for connecting the hypotube and the solid distal wire of the device of Franklin/ Tremulis, for the purpose of selecting an attachment means commonly known in the art for allowing an appropriate amount of deflection of the distal tip without becoming detached form the distal outer section /hypotube to which the wire is attached.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Franklin et al. (US 2019/0076152) in view of Tremulis et al. (US 2007/0219466), further in view of Franklin et al. (US 2021/0290243).
Regarding claim 13, Franklin/ Tremulis disclose the invention substantially as claimed, as set forth above for claim 1.
The device as modified is silent regarding overall outer diameters of the uninflated device, specifically that the occlusion balloon, the proximal outer shaft and the distal outer shaft have a greatest outer diameter of seven French (7 Fr) or less in an uninflated condition.
However, Franklin ‘243 teaches an occlusion catheter (FIG 1C) having a balloon (84), a proximal outer shaft (81a) and a distal outer shaft (81c, paragraph [0073]) wherein a greatest outer diameter in an uninflated condition is seven French or less (Paragraph [0073]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select a diameter of the device to be seven French or less in the uninflated condition, as taught by Franklin ‘243, for the purpose of selecting a dimension capable of being inserted to the target treatment area with minimal trauma.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-4, 6, 7, 9, 10, 11, 12, 13, 14, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 1, 1, 2, 1, 1, 6, 10, 10, 11, 13, 12, and 20 respectively of U.S. Patent No. 12,102,330. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are more narrow and therefore anticipate the broader claims of the application.
Claim 1 of the ‘330 patent recites A vascular occlusion catheter for at least partial occlusion of a target vessel having an internal vessel wall, the vascular occlusion catheter comprising (Col 21 lines 60-62): a proximal outer section (Col 21 line 63); a distal outer section (Col 21 line 64); and an occlusion balloon connected to the proximal outer section and the distal outer section (Col 21 line 66-67); the proximal outer section having a first internal lumen, the first internal lumen being in fluid communication with the occlusion balloon (Col 22 lines 1-4);the distal outer section having a distal internal lumen (Col 22 line 5); a hypotube extending through the first internal lumen, through the occlusion balloon and into the distal internal lumen, the hypotube operating as the primary load-bearing chassis of the vascular occlusion catheter (Col 22 lines 6-11); a solid distal wire embedded in the distal outer section and extending toward the tip, the solid distal wire having a central axis that is radially offset from a central axis of the hypotube (Col 22 lines 12-15);at least one of: a first window formed in the proximal outer section, and a proximal sensor being positioned within the second internal lumen facing the first window (Col 22 lines 16-18); or a second window formed in the distal outer section, and a distal sensor being positioned within the distal internal lumen facing the second window (Col 22 lines 19-21); and a display hub positioned along the proximal outer section, wherein the hypotube extends into the display hub, the display hub being electrically connected with at least one of the proximal sensor or the distal sensor (Col 22 lines 22-28).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771