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 .
Response to Amendment
The amendments filed on 04/27/2026 have been entered. Claims 1-16 remain pending in the application. The amendments overcome the rejection under 35 USC 112(b) set forth in the previous office action dated 03/05/2026.
Response to Arguments
Applicant argues on page 8 that the double patenting rejection should be withdrawn in view of the concurrently filed Terminal Disclaimer. However, at the time of this office action, no TD has been received and therefore the double patenting rejection ahs been maintained.
Applicant’s arguments, see pages 5-7, filed 04/27/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Layman which teaches the overlapping portion of the solid distal wire and the hypotube. It is the examiners position that the limitations regarding the overlapping solid distal wire portion and the hypotube being radially offset is sufficiently met by the rejection below. The rejection does not rely on Tremulis to teach the solid distal wire being radially offset from the central axis of the hypotube. It is the examiners position that this feature is sufficiently taught in Franklin and in Layman.
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.
Claim 16 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 16 recites that the ”distal outer section extends… to the tip”, suggesting that the distal outer section is a separately defined element from the tip. However, claim 1 recites that a “distal outer section having a tip at the distal end”, suggesting that the distal outer section comprises the tip and therefore the tip is a component of the distal outer section. This contradiction renders the claim indefinite in terms of determining the scope of “extends distally beyond the solid distal wire”. It is unclear if the tip extending beyond the distal wire meet the limitation, since the tip is a part of the distal outer section as defined by claim 1, or if another segment of the distal outer section must extend distally beyond the solid distal wire. For the purpose of examination, the tip extending beyond the solid distal wire is interpreted as meeting the limitations because the tip is an element of the distal outer section.
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, 10-12, and 14-16 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 Layman et al. (US 2021/0282759).
Regarding claims 1, 3, 6, and 9, 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) having a tip at a distal end (450, FIGs 4-5, [0112-0117]); 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]) and a second internal lumen (“pressure sensor lumen”, [0109]), 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); 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) (Claim 3); 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]) (Claim 6).
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 the 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, a portion of the solid distal wire overlapping with the hypotube, such that a central axis of the solid distal wire is radially offset from a central axis of the hypotube along the overlapping portion.
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).
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, 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. In the device as modified, the solid distal wire is radially offset from a central axis of the hypotube because it would extend through the center of the tip of Franklin, which teaches the axis being offset from the central axis.
The device as modified is not specific regarding the arrangement of the solid distal wire relative to the hypotube, and specifically fails to disclose a portion of the solid distal wire overlapping with the hypotube and being jacketed thereto.
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 two overlapping portions 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. The device as modified meets the claimed limitation that the portion of the solid wire which overlaps the hypotube is radially offset from the central axis thereof because overlapping portions of the two elements requires a radial displacement of the respective axes.
Regarding claim 2, Franklin/ Tremulis/Layman 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 claim 4, Franklin/ Tremulis/Layman disclose the invention substantially as claimed, as set forth above for claim 3. Franklin further discloses the proximal sensor is a pressure sensor configured to measure central aortic pressure downstream 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/Layman 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/Layman 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/Layman 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/Layman 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/Layman 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) of the occlusion balloon).
Regarding claim 16, Franklin/ Tremulis/Layman disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the distal outer section extends distally beyond the solid distal wire, and to the tip (The curled tip 450 extends beyond the solid distal wire).
Claim(s) 5, 7 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 Layman et al. (US 2021/0282759), further in view of Kornhaber et al. (US 2023/0010482).
Regarding claim 5 and 8, Franklin/ Tremulis/Layman 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.
Regarding claim 7, Franklin/ Tremulis/Layman disclose the invention substantially as claimed, as set forth above for claim 5. Franklin further discloses 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).
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 Layman et al. (US 2021/0282759), further in view of Franklin et al. (US 2021/0290243).
Regarding claim 13, Franklin/ Tremulis/Layman 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 1-3, 6, 7, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 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 6 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 (Clo 22 line 12-13), a portion of the solid distal wire overlapping with the hypotube (Col 22 lines 48-50), such that the solid distal wire having a central axis that is radially offset from a central axis of the hypotube (Col 22 lines 13-15); 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
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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