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 Amendments
The Amendment filed 09/21/2026 has been entered.
Claims 13 and 14 were cancelled.
Claims 1-12 and 15-23 remain pending in the application.
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.
Claims 1, 2, 8-11, 12, 15, 16, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al. (US Patent No. 5431639), hereinafter Shaw, in further view of Dae et al. (US Patent No. 6866638), hereinafter Dae.
Regarding claim 1, Shaw discloses a device (device 2, see FIG. 1; the Examiner notes that all reference characters cited below refer to FIGS. 1-3 unless otherwise stated) configured to determine a depth of a puncture in a vessel relative to a skin surface of a patient (depth indicating system 22, see Col 6 Line 51 – Col 7 Line 3), the device comprising:
a flexible elongated body (body 4 surrounded by plug 14; “body 4, formed of a flexible, kink-resistant material”, Col 6 Lines 51-52) that extends along a central longitudinal axis (see FIG. 1), the flexible elongated body having
a proximal end (proximal end 24),
a distal end (distal end 26) spaced from the proximal end along the central longitudinal axis (see FIG. 1),
a first channel (lumen 12) that extends from the proximal end toward the distal end along the central longitudinal axis (see FIG. 1b),
a second channel (lumen 11) adjacent to the first channel and that extends from the proximal end toward the distal end along the central longitudinal axis (see FIG. 1b), the second channel including a) a proximal portion (lumen 5), and b) a distal portion (distal portion of lumen 11 adjacent to opening 15) opposite the proximal portion,
an orifice (opening 15) disposed at an end of the distal portion and that is open to the second channel (see FIG. 1b), and
a mandrel (distal end of guidewire 54) positioned along the distal portion and that is in communication with the orifice (see FIG. 2a); and
a movable shaft (shaft of guidewire 54) disposed inside the second channel and that extends from the proximal portion to the distal portion;
wherein the movable shaft is configured to actuate the mandrel between a first position where the mandrel is disposed inside the second channel and a second position where a distal end of the mandrel projects from the orifice (see FIGS. 2 and 2a),
However, Shaw does not expressly state the orifice extending through a side wall of the flexible elongated body, the mandrel being attached to the moveable shaft at an acute angle, the flexible elongated body includes a shaft curve formed in the flexible elongated body, the shaft curve curving from the distal end toward the proximal end along the central longitudinal axis such that the orifice is oriented proximally, and wherein the distal portion defines a straight shaft that extends from the orifice to the distal end.
Dae teaches a temperature sensing system (Abstract) having an orifice (opening 265) extending through a side wall (wall of sheath 250) of the flexible elongated body (sheath 250), the mandrel (wire 275) being attached to the moveable shaft at an acute angle (see FIGS. 11-12), the flexible elongated body includes a shaft curve (portion 270) formed in the flexible elongated body (see FIGS. 11-12), the shaft curve curving from the distal end toward the proximal end along the central longitudinal axis such that the orifice is oriented proximally (see FIGS. 11-12), and wherein the distal portion defines a straight shaft that extends from the orifice to the distal end (see FIGS. 11-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Shaw to have the orifice extending through a side wall of the flexible elongated body, the mandrel being attached to the moveable shaft at an acute angle, the flexible elongated body includes a shaft curve formed in the flexible elongated body, the shaft curve curving from the distal end toward the proximal end along the central longitudinal axis such that the orifice is oriented proximally, and wherein the distal portion defines a straight shaft that extends from the orifice to the distal end. Doing would provide retrograde positioning within the vessel lumen, as taught by Dae (see Col 15 Line 12 – Col 16 Line 6).
Regarding claim 2, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 1, and Shaw further teaches wherein the movable shaft (shaft of guidewire 54) advances the mandrel into the vessel in a downstream direction to a location downstream of the puncture (see FIGS. 2 and 2a).
Regarding claim 8, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 1, and Shaw further teaches wherein the flexible elongated body includes a plurality of markings (system 22 contains a series of marks 23, 25, 27, 29, and 31) spaced apart along a longitudinal direction that is parallel to the central longitudinal axis (see FIG. 1).
Regarding claim 9, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 8, and Shaw further teaches wherein the plurality of markings are etched into an outer surface of the flexible elongated body (see marks 23, 25, 27, 29, and 31 in FIG. 1).
Regarding claim 10, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 1, and Shaw further teaches wherein the flexible elongated body has a tapered portion (portion 8) that defines the distal end and a linear portion that extends from the tapered portion to the proximal end (“The taper makes the distal portion more flexible than proximal and alignment portions so that the distal portion will easily deflect when engaging a vessel wall to allow smooth axial motion”, Col 7 Lines 8-12), wherein the tapered portion tapers toward the central longitudinal axis (see FIG. 1).
Regarding claim 11, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Shaw in view of Dae doesn’t expressly state wherein the first channel and the second channel comprise between 65% and 80% of a distal diameter of the flexible elongated body.
It would have been an obvious matter of design choice to modify the diameter of the first and second channels of Shaw and Dae to be between 65% and 80% of a distal diameter of the flexible elongated body, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.IV.A.
Regarding claim 12, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 1, and Shaw further teaches wherein at least a part of the distal portion is offset with respect to the proximal portion (see FIG. 2c; the Examiner notes that during insertion in the vessel, the distal portion of lumen 11 is offset from the proximal end outside the body).
Regarding claim 15, Shaw discloses a device (device 2, see FIG. 1; the Examiner notes that all reference characters cited below refer to FIGS. 1-3 unless otherwise stated) configured to determine a depth of a puncture in a vessel relative to a skin surface of a patient (depth indicating system 22, see Col 6 Line 51 – Col 7 Line 3), the device comprising:
a flexible elongated body (body 4 surrounded by plug 14; “body 4, formed of a flexible, kink-resistant material”, Col 6 Lines 51-52) that extends along a central longitudinal axis (see FIG. 1), the flexible elongated body having
a proximal end (proximal end 24),
a distal end (distal end 26) spaced from the proximal end along the central longitudinal axis (see FIG. 1),
an inner channel (lumen 11) that extends from the proximal end toward the distal end along the central longitudinal axis (see FIG. 1b), the inner channel including a) a proximal portion (lumen 5), and b) a distal portion (distal portion of lumen 11 adjacent to opening 15),
an orifice (opening 15) disposed at an end of the distal portion (see FIG. 1b), and
a mandrel (distal end of guidewire 54) positioned along the distal portion and that is in communication with the orifice (see FIG. 2a); and
wherein the mandrel is actuatable between a first position where the mandrel is disposed inside the inner channel and a second position where a distal end of the mandrel projects from the orifice (see FIGS. 2 and 2a).
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However, Shaw does not expressly state the distal portion including a shaft curve formed in the flexible elongated body, the shaft curve curving from the distal end toward the proximal end along the central longitudinal axis, the distal portion further defining a straight shaft that extends from the orifice to the distal end, an orifice extending through a side wall of the flexible elongated body, and wherein the mandrel is attached at an acute angle to a shaft disposed within the inner channel.
Dae teaches a temperature sensing system (Abstract) having a distal portion including a shaft curve (portion 270) formed in the flexible elongated body (sheath 250), the shaft curve curving from the distal end toward the proximal end along the central longitudinal axis (see FIGS. 11-12), the distal portion further defining a straight shaft that extends from the orifice to the distal end (see FIGS. 11-12), an orifice (opening 265) extending through a side wall (wall of sheath 250) of the flexible elongated body, and wherein the mandrel (wire 275) is attached at an acute angle to a shaft disposed within the inner channel (see FIGS. 11-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Shaw to have the distal portion including a shaft curve formed in the flexible elongated body, the shaft curve curving from the distal end toward the proximal end along the central longitudinal axis, the distal portion further defining a straight shaft that extends from the orifice to the distal end, an orifice extending through a side wall of the flexible elongated body, and wherein the mandrel is attached at an acute angle to a shaft disposed within the inner channel. Doing would provide retrograde positioning within the vessel lumen, as taught by Dae (see Col 15 Line 12 – Col 16 Line 6).
Regarding claim 16, Shaw in view of Tartaglia teaches the claimed invention as discussed above concerning the rejection of claim 15, and Shaw further teaches wherein the mandrel (distal end of guidewire 54) is advanced into the vessel in a downstream direction to a location downstream of the puncture (see FIGS. 2 and 2a).
Regarding claim 20, Shaw in view of Tartaglia teaches the claimed invention as discussed above concerning the rejection of claim 15, and Shaw further teaches wherein the flexible elongated body includes a plurality of markings (system 22 contains a series of marks 23, 25, 27, 29, and 31) spaced apart along a longitudinal direction that is parallel to the central longitudinal axis (see FIG. 1).
Regarding claim 21, Shaw in view of Tartaglia teaches the claimed invention as discussed above concerning the rejection of claim 20, and Shaw further teaches wherein the plurality of markings are etched into an outer surface of the flexible elongated body (see marks 23, 25, 27, 29, and 31 in FIG. 1).
Regarding claim 22, Shaw in view of Tartaglia teaches the claimed invention as discussed above concerning the rejection of claim 15, and Shaw further teaches wherein the flexible elongated body has a tapered portion (portion 8) that defines the distal end and a linear portion that extends from the tapered portion to the proximal end (“The taper makes the distal portion more flexible than proximal and alignment portions so that the distal portion will easily deflect when engaging a vessel wall to allow smooth axial motion”, Col 7 Lines 8-12), wherein the tapered portion tapers toward the central longitudinal axis (see FIG. 1).
Regarding claim 23, Shaw in view of Tartaglia teaches the claimed invention as discussed above concerning the rejection of claim 15, however, Shaw in view of Tartaglia doesn’t expressly state wherein the inner channel comprises between 65% and 80% of a distal diameter of the flexible elongated body.
It would have been an obvious matter of design choice to modify the diameter of the inner channel of Shaw and Tartaglia to be between 65% and 80% of a distal diameter of the flexible elongated body, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04.IV.A.
Claims 3-7 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al. (US Patent No. 5431639), hereinafter Shaw, in further view of Dae et al. (US Patent No. 6866638), hereinafter Dae, further in view of Modesitt et al. (US Patent Pub. 20070027454), hereinafter Modesitt.
Regarding claim 3, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 2, however, Shaw in view of Tartaglia doesn’t expressly state wherein the mandrel engages with the puncture and prevents further proximal movement of the device when the device is pulled under tension.
Modesitt teaches devices and methods for accessing and closing vascular sites (Abstract) wherein the mandrel engages with the puncture and prevents further proximal movement of the device when the device is pulled under tension (“The anchor can be configured to hold the elongated member at a fixed angle with respect to the longitudinal lumen wall axis.”, [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the mandrel of Shaw and Tartaglia to engage with the puncture and prevent further proximal movement of the device when the device is pulled under tension. Doing would enable the mandrel the body in a fixed position with respect to the vessel wall, as taught by Modesitt (see [0009-0012]).
Regarding claim 4, Shaw in view of Dae further in view of Modesitt teaches the claimed invention as discussed above concerning the rejection of claim 3, and Modesitt further teaches wherein the distal portion (sections 16 and 18) further includes a cradle (delivery guide 4, see FIG. 3) proximal to the orifice (exit port 10), the cradle configured to provide a cross-sectional space for the mandrel to pass out of the orifice in a downstream direction without interfering with the vessel (see FIGS. 2-3).
Regarding claim 5, Shaw in view of Dae further in view of Modesitt teaches the claimed invention as discussed above concerning the rejection of claim 4, and Modesitt further teaches wherein the distal portion (sections 16 and 18) further includes an alignment member (wall retainer 56) that extends distally from the orifice (lumen 8), the alignment member configured to direct the mandrel in a downstream direction within the vessel and prevent the mandrel from extending proximally into the puncture when the movable shaft is placed under tension (“wall retainer 56 can be deployed through the entry wall retainer port 54. The entry wall retainer 56 can have a first retracted configuration (as shown in FIG. 13). The entry wall retainer 56 can have a second deployed configuration (as shown in FIG. 14).”, [0084]).
Regarding claim 6, Shaw in view of Dae further in view of Modesitt teaches the claimed invention as discussed above concerning the rejection of claim 3, and Shaw further discloses wherein said distal portion (distal portion of lumen 11 adjacent to opening 15) is configured to form a straight shaft and is configured to be in line with a blood vessel lumen (see FIG. 1b).
Regarding claim 7, Shaw in view of Dae further in view of Modesitt teaches the claimed invention as discussed above concerning the rejection of claim 3, and Dae further discloses wherein the shaft curve (portion 270) is at a location proximal to said orifice (opening 265; see FIGS. 11-12).
Regarding claim 17, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 16, however, Shaw in view of Dae doesn’t expressly state wherein the mandrel engages with the puncture and prevents further proximal movement of the device when the device is pulled under tension.
Modesitt teaches devices and methods for accessing and closing vascular sites (Abstract) wherein the mandrel engages with the puncture and prevents further proximal movement of the device when the device is pulled under tension (“The anchor can be configured to hold the elongated member at a fixed angle with respect to the longitudinal lumen wall axis.”, [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the mandrel of Shaw to engage with the puncture and prevent further proximal movement of the device when the device is pulled under tension. Doing would enable the mandrel the body in a fixed position with respect to the vessel wall, as taught by Modesitt (see [0009-0012]).
Regarding claim 18, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 15, however, Shaw in view of Dae doesn’t expressly state wherein the distal portion further includes a cradle proximal to the orifice, the cradle configured to provide a cross-sectional space for the mandrel to pass out of the orifice in a downstream direction without interfering with the vessel.
Modesitt teaches devices and methods for accessing and closing vascular sites (Abstract) wherein the distal portion (sections 16 and 18) further includes a cradle (delivery guide 4, see FIG. 3) proximal to the orifice (exit port 10), the cradle configured to provide a cross-sectional space for the mandrel to pass out of the orifice in a downstream direction without interfering with the vessel (see FIGS. 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the distal portion of Shaw to include a cradle proximal to the orifice, the cradle configured to provide a cross-sectional space for the mandrel to pass out of the orifice in a downstream direction without interfering with the vessel. Doing would provide a holding space for the lumen and anchor of the device, as taught by Modesitt (see [0009-0012]).
Regarding claim 19, Shaw in view of Dae teaches the claimed invention as discussed above concerning the rejection of claim 16, however, Shaw in view of Dae doesn’t expressly state wherein the distal portion further includes a tab proximal to the orifice, the tab configured to direct the mandrel in a downstream direction within the vessel and prevent the mandrel from extending proximally into the puncture.
Modesitt teaches devices and methods for accessing and closing vascular sites (Abstract) wherein the distal portion (sections 16 and 18) further includes a tab (wall retainer 56) proximal to the orifice (port 54), the tab configured to direct the mandrel in a downstream direction within the vessel and prevent the mandrel from extending proximally into the puncture (“wall retainer 56 can be deployed through the entry wall retainer port 54. The entry wall retainer 56 can have a first retracted configuration (as shown in FIG. 13). The entry wall retainer 56 can have a second deployed configuration (as shown in FIG. 14).”, [0084]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the distal portion of Shaw to include a tab proximal to the orifice, the tab configured to direct the mandrel in a downstream direction within the vessel and prevent the mandrel from extending proximally into the puncture. Doing would provide a retainer for the device to the luminal walls, as taught by Modesitt (see [0084]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 09/21/2026 , with respect to the rejection(s) of claim(s) 1-12 and 15-23 under 35 U.S.C. 102 and 103 to Shaw (US Patent No. 5431639) and Modesitt (US Patent Pub. 20070027454) and Tartaglia (US Patent No. 6102926) 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 view of 103 to Shaw, Modesitt, and Dae (US Patent No. 6866638).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
10/07/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
