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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 14th, 2026 has been entered.
Response to Amendment
The claims filed on August 14th, 2026 have been entered. Claims 1-2, 4- 10, 12- 17, and 19- 20 are pending in the application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-2, 4- 10, 12- 17, and 19- 20 under 35 U.S.C. 103 over Davis et al. (US 2004/0102730) in view of Rosen et al. (US 5,501,671), in view of Ashby et al. (US 7,695,492), and in view of Walters et al. (US 2014/0180332) in light of applicant’s amendments; specifically Davis does not teach moving the dilator along the guidewire in a distal direction until an inlet opening of the dilator is within the blood vessel or retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel.
Claim(s) 1- 2, 4- 10, 12- 17, and 19- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ashby et al. (US 7,695,492), in view of Davis et al. (US 2004/0102730), in view of Rosen et al. (US 5,501,671), and in view of Walters et al. (US 2014/0180332).
Regarding claim 1, Ashby (Ashby et al.) teaches a method for locating a puncture (420) in a blood vessel (406) of a patient (abstract; Column 2, Lines 56- 58 and Column 4, Lines 19- 21)(Figs. 4A- 4C), the method comprising:
inserting a distal end of a dilator over a proximal end of a guidewire (18) that extends out of the puncture in the blood vessel (see annotated Fig. 4A below)(Column 4, Lines 54- 55);
moving the dilator along the guidewire in a distal direction until an inlet opening (bleed back entrance port 402) of the dilator is within the blood vessel (see Fig. 4A)(Column 4, Lines 55- 58) and blood in the blood vessel flows into the inlet opening of the dilator and out of an outlet opening (bleed back exit port) defined by the dilator (Column 4, Lines 55- 58), generating a visual indication of presence of the inlet opening in the blood vessel (Column 4, Lines 19- 23; Column 4, Lines 55- 58),
retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel thereby ceasing the visual indication and noting when there is no more indication of presence of the inlet opening in the blood vessel (Column 4, Lines 58- 67).
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Ashby does not teach the outlet opening disposed between a proximal end of the dilator and the inlet opening and into an internal volume at least partially defined by a flexible barrier carried by the dilator overlying the outlet opening and an outer surface of the dilator, such that, the flexible barrier repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of a presence of the inlet opening in the blood vessel, wherein the dilator has a plurality of markings, retracting the dilator in a proximal direction along the guidewire until the flexible barrier no longer pulses thereby ceasing the visual and tactile indication; and noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a skin of the patient when the flexible barrier no longer pulses.
Davis (Davis et al.) teaches a method for locating a puncture in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058)(see annotated Fig. 2 below); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator, to an outlet opening defined by the dilator, wherein the dilator has an outer surface (see annotated Fig. 2 below) and into the lumen of the dilator (Paragraphs 0059- 0060), such that the dilator pulses in response to the pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (In Paragraph 0061, Davis teaches that the operator “can sometimes feel the pulse of the artery through the tract dilator”, as the dilator would physically move in order to replicate the pulse of the artery, an operator would have a visual indication of the presence of the inlet opening as well as a tactile indication. Furthermore, Davis teaches that bleed back is observed when the inlet opening is inserted, therefore there is another visual indication.); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062).
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It would have been obvious to one of ordinary skill in the art to modify the method as taught by Ashby to include a tactile indication that is the pulsing of the dilator barrier as taught by Davis since Davis teaches that the pulsing of the dilator barrier is one way to indicate that the device is in contact with the puncture wound and the vessel and allows the operator to control bleed back (Paragraph 0061). Furthermore, it would have been obvious to one of ordinary skill in the art to modify the dilator as taught by Ashby to have the marking as taught by Davis, since Davis teaches that the marking allows for the operator to measure the depth of the vessel (Paragraph 0062).
The combination does not teach the outlet opening disposed between a proximal end of the dilator and the inlet opening, and into an internal volume at least partially defined by a flexible barrier carried by the dilator and overlying the outlet opening and an outer surface of the dilator, such that, the flexible barrier repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel, retracting the dilator in a proximal direction along the guidewire until the flexible barrier no longer pulses, wherein the dilator has a plurality of markings, and noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a skin of the patient when the flexible barrier no longer pulses.
Rosen (Rosen et al.) teaches a method (abstract) for visualizing the entrance of a device (150)(Figs. 9- 10) into a blood vessel (Column 10, Lines 42- 44), the method comprising: having blood flow through an inlet opening (distal opening 160) of the device (Column 10, Lines 38- 44) and to an outlet opening defined by the device, the outlet opening disposed between a proximal end of the device and the inlet opening (see annotated Fig. 10 below), and into an internal volume at least partially defined by a flexible barrier (compliant intermediate member 154, Column 9, Lines 25- 27) carried by the device (Column 10, Lines 46- 54) and overlying the outlet opening and an outer surface of the dilator (see annotated Fig. 10 below), such that, the flexible barrier repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Column 9, Lines 25- 33 and Column 9, Lines 38- 42).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by Davis to have the elements of the device such as the visual and tactile indication through the flexible barrier as taught by Rosen, as Davis teaches that the method involves visual and tactile feedback (Paragraph 0061) and Rosen teaches that the device prevents contamination (Column 2, Lines 35- 36) and that the visual and tactile indication of the device is convenient when the device enters into a vessel (Column 2 Lines 31- 36) and that this indication is important (Column 1, Lines 50- 55).
Regarding the method step of retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel and the flexible barrier no longer pulses, thereby ceasing the visual and tactile indication, as the modified combination has the step of retracting the dilator until there is no more indication of presence of the inlet opening in the blood vessel through visual and tactile feedback (Ashby, Column 4, Lines 55-67; Davis, Paragraphs 0061 and 0062), and that the visual and tactile feedback is the pulsing of the flexible barrier (Rosen, Column 9, Lines 25- 33 and Column 9, Lines 38- 42), then within the combination the step of retracting the dilator would include this occurring until the flexible barrier no longer pulses.
The combination does not teach wherein the dilator has a plurality of markings, and further comprising noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a patient’s skin when the flexible barrier no longer pulses.
Walters (Walters et al.) teaches a similar method of locating a puncture site (12, Paragraph 0037) in a blood vessel of a patient (abstract)(Figs. 1A- 5C), the method comprising: inserting a dilator (110) over a guidewire (114, Paragraph 0048) into the puncture site (Paragraph 0055) and moving the dilator along the guidewire in a distal direction until there is an indication that an inlet opening (142) of the dilator is within the blood vessel (Paragraph 0055). Walters further teaches wherein the dilator has a plurality of markings (154, Paragraph 0050), and further comprising: using the plurality of markings to locate the puncture site (12) and noting a first visible marking when the puncture site is located (Paragraph 0050).
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It would have been obvious to one of ordinary skill in the art to modify the marking of the dilator and the marking of the access sheath as taught by the combination to be the plurality of markings of the dilator as taught by Walters since a plurality of markings would provide measurements for different depths depending on the puncture depth of different patients (Walters, Paragraphs 0050 and 0052).
Regarding the step of noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a patient’s skin when the flexible barrier no longer pulses, as the combination teaches the step of noting a first visible marking when the puncture site is located (Walters, Paragraph 0050), the step of locating the puncture site when the feedback on the dilator stops (Ashby, Column 4, Lines 1- 18), and that the feedback is the pulsing of the flexible barrier (Column 9, Lines 25- 33 and Column 9, Lines 38- 42), then the method of the combination includes the step of noting a marking of the plurality of markings when the flexible barrier no longer pulses.
Regarding claim 2, Ashby, Davis, Rosen, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
Ashby further teaches inserting the guidewire (18) through the puncture (420) into the blood vessel so that the distal end of the guidewire is inside of the blood vessel and the guidewire extends out of the puncture (see annotated Fig. 4A below)(Column 6, Lines 21- 23).
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Regarding claim 4, Ashby, Davis, Rosen, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
Ashby is silent to wherein the plurality of markings on the dilator are a first plurality of markings and the marking is a noted first marking, wherein the method further comprises: removing the dilator from the puncture along the guidewire; moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator; and further moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient.
Davis teaches a method for locating a puncture in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator (Paragraphs 0059- 0060), such that the dilator pulses in response to the pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Paragraph 0061); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062) and removing the dilator from the puncture along the guidewire (Paragraph 0064), threading the guidewire through the access sheath (Paragraph 0066), the access sheath defining a distal end, a proximal end, and a marking (52) disposed between the distal end and the proximal end of the access sheath (see annotated Fig. 11 below), the marking of the access sheath corresponding to the marking of the dilator (Paragraph 0065), and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until the second marking corresponds to the marking (depth indicator 30) on the dilator (10) (Paragraphs 0066 and 0067).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of the combination to have the steps of removing the dilator and moving an access sheath as taught by Davis, since Ashby teaches that the dilator can be used during any procedure (Column 3, Lines 32- 35) and Davis teaches a method of a procedure after a puncture has occurred (Paragraph 0037).
The combination does not teach wherein the plurality of markings on the dilator are a first plurality of markings, and the marking is a noted first marking, wherein the method further comprises: removing the dilator from the puncture along the guidewire, moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first visible marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient.
Walters (Walters et al.) teaches a similar method of locating a puncture site (12, Paragraph 0037) in a blood vessel of a patient (abstract)(Figs. 1A- 5C), the method comprising: inserting a dilator (110) over a guidewire (114, Paragraph 0048) into the puncture site (Paragraph 0055) and moving the dilator along the guidewire in a distal direction until there is an indication that an inlet opening (142) of the dilator is within the blood vessel (Paragraph 0055). Walters further teaches wherein the dilator has a plurality of markings (154, Paragraph 0050), and further comprising: using the plurality of markings to locate the puncture site (12) and noting a first visible marking when the puncture site is located (Paragraph 0050). Walters further teaches removing the dilator from the puncture along the guidewire, moving an access sheath (18) along the guidewire toward the puncture site (Paragraph 0056), the access sheath have a second plurality of markings (172) disposed between the distal end and the proximal end of the sheath (see annotated Fig. 4A below), with the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first visible marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient (Paragraph 0052).
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It would have been obvious to one of ordinary skill in the art to modify the marking of the dilator and the marking of the access sheath as taught by the combination to be the plurality of markings of the dilator and the plurality of markings of the access sheath as taught by Walters since a plurality of markings would provide measurements for different depths depending on the puncture depth of different patients (Walters, Paragraphs 0050 and 0052).
Regarding claim 5, Ashby, Davis, Rosen, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
Ashby is silent to the method step of after moving the dilator along the guidewire, a surgical procedure is performed.
Davis teaches a method for locating a puncture in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator (Paragraphs 0059- 0060), such that the dilator pulses in response to the pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Paragraph 0061); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062) and removing the dilator from the puncture along the guidewire (Paragraph 0064), threading the guidewire through the access sheath (Paragraph 0066, as only the dilator is taught by Davis to be removed from the puncture (Paragraph 0065), one of ordinary skill in the art would know that the guidewire can remain within the puncture, therefore when it is threaded through the access sheath, the sheath actually moves towards the puncture.), the access sheath defining a distal end, a proximal end, and a marking (52) disposed between the distal end and the proximal end of the access sheath (see annotated Fig. 11 below), the marking of the access sheath corresponding to the marking of the dilator (Paragraph 0065), and after moving the dilator along the guidewire, a surgical procedure is performed (Paragraphs 0058- 0067).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of the combination to have the step of performing a surgical procedure after moving the dilator as taught by Davis, since Ashby teaches that the dilator can be used before any procedure (Column 3, Lines 32- 35) and Davis teaches a method of a procedure after a puncture has occurred (Paragraph 0037).
Regarding claim 6, Ashby, Davis, Rosen, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 5.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of the combination to have the step of performing a surgical procedure after moving the dilator as taught by Davis, since Ashby teaches that the dilator can be used before any procedure (Column 3, Lines 32- 35) and Davis teaches a method of a procedure after a puncture has occurred (Paragraph 0037).
The combination further teaches the method comprising the steps of, prior to performing the surgical procedure in the blood vessel: inserting a procedural sheath (Davis, introducer 12) into the puncture (Davis, Paragraph 0067), inserting a surgical device (Davis, pusher 14) into the procedural sheath (Davis, Paragraph 0074), and removing the surgical device and procedural sheath from the blood vessel (Davis, Paragraph 0075).
Regarding claim 7, Ashby, Davis, Rosen, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
Ashby further teaches wherein the proximal end is spaced from the distal end along a central axis, and wherein the outer surface of the dilator defines an outer cross- sectional dimension that is substantially perpendicular to the central axis (see annotated Fig. 4A below).
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Ashby does not teach wherein the outer cross- sectional dimension is at least 2.50mm.
Davis teaches a method for locating a puncture in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator, to an outlet opening defined by the dilator and into the lumen of the dilator (Paragraphs 0059- 0060); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062) and removing the dilator from the puncture along the guidewire (Paragraph 0064), threading the guidewire through the access sheath (Paragraph 0066), the access sheath defining a distal end, a proximal end, and a marking (52), the marking of the access sheath corresponding to the marking of the dilator (Paragraph 0065), and wherein the proximal end is spaced from the distal end along a central axis, and wherein the outer surface of the dilator defines an outer cross-sectional dimension that is substantially perpendicular to the central axis (see annotated Fig. 2 below), wherein the outer cross-sectional dimension is about 12 French (Paragraph 0070; The diameter of the dilator is considered an outer cross-sectional dimension as it would be perpendicular to the central axis (see annotated Fig. 2 below).)(As 12 French is about 4 mm, and 4 mm is at least 2.5 mm as it is greater than 2.5 mm, Davis teaches the limitation of the outer cross-sectional dimension being at least 2.5 mm.).
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Since Ashby teaches a method for locating a puncture in a blood vessel of a patient (abstract; Column 3, Lines 63- 66) and Davis teaches a method for locating a puncture in a blood vessel of a patient (Paragraph 0053), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the outer cross-sectional dimension as taught by the combination to be at least 2.5 mm as taught by Davis.
Regarding claim 8, Ashby, Davis, Rosen, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
The combination further teaches wherein the pressure pulsations in the blood flow cause the flexible barrier (Rosen, compliant intermediate member 154) to pulse outwardly, thereby generating the visual and tactile indication of the presence of the inlet opening in the blood vessel (Rosen, Column 9, Lines 25- 33 and Column 9, Lines 38- 42).
Regarding claim 9, Ashby (Ashby et al.) teaches a method for locating a puncture (420) in a blood vessel (406) of a patient (abstract; Column 2, Lines 56- 58 and Column 4, Lines 19- 21)(Figs. 4A- 4C), the method comprising:
inserting a distal end of a dilator over a proximal end of a guidewire (18) that extends out of the puncture in the blood vessel (see annotated Fig. 4A below)(Column 4, Lines 54- 55);
moving the dilator along the guidewire in a distal direction until an inlet opening (bleed back entrance port 402) of the dilator is within the blood vessel (see Fig. 4A)(Column 4, Lines 55- 58) and blood in the blood vessel flows into the inlet opening of the dilator and out of an outlet opening (bleed back exit port) defined by the dilator (Column 4, Lines 55- 58), generating a visual indication of presence of the inlet opening in the blood vessel (Column 4, Lines 19- 23; Column 4, Lines 55- 58),
retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel thereby ceasing the visual indication and noting when there is no more indication of presence of the inlet opening in the blood vessel (Column 4, Lines 58- 67).
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Ashby does not teach the outlet opening disposed between a proximal end of the dilator and the inlet opening and into an internal volume at least partially defined by a flexible barrier carried by the dilator overlying the outlet opening and an outer surface of the dilator, such that, the flexible barrier repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of a presence of the inlet opening in the blood vessel, wherein the dilator has a plurality of markings, retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel and the flexible barrier no longer pulses thereby ceasing the visual and tactile indication; and noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a skin of the patient when the flexible barrier no longer pulses.
Davis (Davis et al.) teaches a method for locating a puncture (100) in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058)(see annotated Fig. 2 below); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator to an outlet opening defined by the dilator (see annotated Fig. 2 below) and into the lumen of the dilator (Paragraphs 0059- 0060), wherein the dilator has an outer surface (see annotated Fig. 2 below), such that the dilator pulses in response to the pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (In Paragraph 0061, Davis teaches that the operator “can sometimes feel the pulse of the artery through the tract dilator”, as the dilator would physically move in order to replicate the pulse of the artery, an operator would have a visual indication of the presence of the inlet opening as well as a tactile indication. Furthermore, Davis teaches that bleed back is observed when the inlet opening is inserted, therefore there is another visual indication.); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062).
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It would have been obvious to one of ordinary skill in the art to modify the method as taught by Ashby to include a tactile indication that is the pulsing of the dilator barrier as taught by Davis since Davis teaches that the pulsing of the dilator barrier is one way to indicate that the device is in contact with the puncture wound and the vessel and allows the operator to control bleed back (Paragraph 0061). Furthermore, it would have been obvious to one of ordinary skill in the art to modify the dilator as taught by Ashby to have the marking as taught by Davis, since Davis teaches that the marking allows for the operator to measure the depth of the vessel (Paragraph 0062).
The combination does not teach the internal volume at least partially defined by a blood pulsation indicator defined by a flexible barrier overlying the outlet opening and an outer surface of the dilator, whereby the blood pulsation indicator repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel, retracting the dilator in a proximal direction along the guidewire until the flexible barrier no longer pulses, wherein the dilator has a plurality of markings, noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a skin of the patient when the flexible barrier no longer pulses.
Rosen (Rosen et al.) teaches a method (abstract) for visualizing the entrance of a device (150)(Figs. 9- 10) into a blood vessel (Column 10, Lines 42- 44), the method comprising: having blood flow through an inlet opening (distal opening 160) of the device (Column 10, Lines 38- 44) to an outlet opening defined by the device, the outlet opening disposed between a proximal end of the device and the inlet opening (see annotated Fig. 10 below) and into an internal volume at least partially defined by a blood pulsation indicator (compliant intermediate member 154, Column 9, Lines 25- 27) defined in at least in part by a flexible barrier (raised dimples 168)(Column 9, Lines 34- 41) overlying the outlet opening and an outer surface of the dilator (see annotated Fig. 10 below), carried by the device (Column 10, Lines 46- 54), such that, the blood pulsation indicator repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Column 9, Lines 25- 33 and Column 9, Lines 38- 42).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by the combination to have the elements of the device such as the visual and tactile indication through the flexible barrier as taught by Rosen, as Davis teaches that the method involves visual and tactile feedback (Paragraph 0061) and Rosen teaches that the device prevents contamination (Column 2, Lines 35- 36) and that the visual and tactile indication of the device is convenient when the device enters into a vessel (Column 2 Lines 31- 36) and that this indication is important (Column 1, Lines 50- 55).
Regarding the method step of retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel and the flexible barrier no longer pulses, thereby ceasing the visual and tactile indication, as the modified combination has the step of retracting the dilator until there is no more indication of presence of the inlet opening in the blood vessel through visual and tactile feedback (Ashby, Column 4, Lines 55-67; Davis, Paragraphs 0061 and 0062), and that the visual and tactile feedback is the pulsing of the flexible barrier (Rosen, Column 9, Lines 25- 33 and Column 9, Lines 38- 42), then within the combination the step of retracting the dilator would include this occurring until the flexible barrier no longer pulses.
The combination does not teach wherein the dilator has a plurality of markings, and further comprising: noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a patient’s skin when the flexible barrier no longer pulses.
Walters (Walters et al.) teaches a similar method of locating a puncture site (12, Paragraph 0037) in a blood vessel of a patient (abstract)(Figs. 1A- 5C), the method comprising: inserting a dilator (110) over a guidewire (114, Paragraph 0048) into the puncture site (Paragraph 0055) and moving the dilator along the guidewire in a distal direction until there is an indication that an inlet opening (142) of the dilator is within the blood vessel (Paragraph 0055). Walters further teaches wherein the dilator has a plurality of markings (154, Paragraph 0050), and further comprising: using the plurality of markings to locate the puncture site (12) and noting a first visible marking when the puncture site is located (Paragraph 0050).
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It would have been obvious to one of ordinary skill in the art to modify the marking of the dilator and the marking of the access sheath as taught by the combination to be the plurality of markings of the dilator as taught by Walters since a plurality of markings would provide measurements for different depths depending on the puncture depth of different patients (Walters, Paragraphs 0050 and 0052).
Regarding the step of noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a patient’s skin when the flexible barrier no longer pulses, as the combination teaches the step of noting a first visible marking when the puncture site is located (Walters, Paragraph 0050), the step of locating the puncture site when the feedback on the dilator stops (Ashby, Column 4, Lines 1- 18), and that the feedback is the pulsing of the flexible barrier (Column 9, Lines 25- 33 and Column 9, Lines 38- 42), then the method of the combination includes the step of noting a marking of the plurality of markings when the flexible barrier no longer pulses.
Regarding claim 10, Ashby, Davis, Rosen, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
Ashby further teaches inserting the guidewire (18) through the puncture (420) into the blood vessel so that the distal end of the guidewire is inside of the blood vessel and the guidewire extends out of the puncture (see annotated Fig. 4A below)(Column 6, Lines 21- 23).
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Regarding claim 12, Ashby, Davis, Rosen, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
Ashby is silent to wherein the plurality of markings on the dilator are a first plurality of markings and the marking is a noted first marking, wherein the method further comprises: removing the dilator from the puncture along the guidewire; moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator; and further moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient.
Davis teaches a method for locating a puncture in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator (Paragraphs 0059- 0060), such that the dilator pulses in response to the pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Paragraph 0061); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062) and removing the dilator from the puncture along the guidewire (Paragraph 0064), threading the guidewire through the access sheath (Paragraph 0066), the access sheath defining a distal end, a proximal end, and a marking (52) disposed between the distal end and the proximal end of the access sheath (see annotated Fig. 11 below), the marking of the access sheath corresponding to the marking of the dilator (Paragraph 0065), and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until the second marking corresponds to the marking (depth indicator 30) on the dilator (10) (Paragraphs 0066 and 0067).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of the combination to have the steps of removing the dilator and moving an access sheath as taught by Davis, since Ashby teaches that the dilator can be used during any procedure (Column 3, Lines 32- 35) and Davis teaches a method of a procedure after a puncture has occurred (Paragraph 0037).
The combination does not teach wherein the plurality of markings on the dilator are a first plurality of markings, and the marking is a noted first marking, wherein the method further comprises: removing the dilator from the puncture along the guidewire, moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first visible marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient.
Walters (Walters et al.) teaches a similar method of locating a puncture site (12, Paragraph 0037) in a blood vessel of a patient (abstract)(Figs. 1A- 5C), the method comprising: inserting a dilator (110) over a guidewire (114, Paragraph 0048) into the puncture site (Paragraph 0055) and moving the dilator along the guidewire in a distal direction until there is an indication that an inlet opening (142) of the dilator is within the blood vessel (Paragraph 0055). Walters further teaches wherein the dilator has a plurality of markings (154, Paragraph 0050), and further comprising: using the plurality of markings to locate the puncture site (12) and noting a first visible marking when the puncture site is located (Paragraph 0050). Walters further teaches removing the dilator from the puncture along the guidewire, moving an access sheath (18) along the guidewire toward the puncture site (Paragraph 0056), the access sheath have a second plurality of markings (172) disposed between the distal end and the proximal end of the sheath (see annotated Fig. 4A below), with the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first visible marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient (Paragraph 0052).
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It would have been obvious to one of ordinary skill in the art to modify the marking of the dilator and the marking of the access sheath as taught by the combination to be the plurality of markings of the dilator and the plurality of markings of the access sheath as taught by Walters since a plurality of markings would provide measurements for different depths depending on the puncture depth of different patients (Walters, Paragraphs 0050 and 0052).
Regarding claim 13, Ashby, Davis, Rosen, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
Ashby is silent to the method step of after moving the dilator along the guidewire, a surgical procedure is performed.
Davis teaches a method for locating a puncture in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator (Paragraphs 0059- 0060), such that the dilator pulses in response to the pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Paragraph 0061); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062) and removing the dilator from the puncture along the guidewire (Paragraph 0064), threading the guidewire through the access sheath (Paragraph 0066), the access sheath defining a distal end, a proximal end, and a marking (52) disposed between the distal end and the proximal end of the access sheath (see annotated Fig. 11 below), the marking of the access sheath corresponding to the marking of the dilator (Paragraph 0065), and after moving the dilator along the guidewire, a surgical procedure is performed (Paragraphs 0058- 0067).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of the combination to have the step of performing a surgical procedure after moving the dilator as taught by Davis, since Ashby teaches that the dilator can be used before any procedure (Column 3, Lines 32- 35) and Davis teaches a method of a procedure after a puncture has occurred (Paragraph 0037).
Regarding claim 14, Ashby, Davis, Rosen, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 13.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of the combination to have the step of performing a surgical procedure after moving the dilator as taught by Davis, since Ashby teaches that the dilator can be used before any procedure (Column 3, Lines 32- 35) and Davis teaches a method of a procedure after a puncture has occurred (Paragraph 0037).
The combination further teaches the method comprising the steps of, prior to performing the surgical procedure in the blood vessel: inserting a procedural sheath (Davis, introducer 12) into the puncture (Davis, Paragraph 0067), inserting a surgical device (Davis, pusher 14) into the procedural sheath (Davis, Paragraph 0074), and removing the surgical device and procedural sheath from the blood vessel (Davis, Paragraph 0075).
Regarding claim 15, Ashby, Davis, Rosen, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
Ashby further teaches wherein the proximal end is spaced from the distal end along a central axis, and wherein the outer surface of the dilator defines an outer cross- sectional dimension that is substantially perpendicular to the central axis (see annotated Fig. 4A below).
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Ashby does not teach wherein the outer cross- sectional dimension is at least 2.50mm.
Davis teaches a method for locating a puncture in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator, to an outlet opening defined by the dilator and into the lumen of the dilator (Paragraphs 0059- 0060); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062) and removing the dilator from the puncture along the guidewire (Paragraph 0064), threading the guidewire through the access sheath (Paragraph 0066), the access sheath defining a distal end, a proximal end, and a marking (52), the marking of the access sheath corresponding to the marking of the dilator (Paragraph 0065), and wherein the proximal end is spaced from the distal end along a central axis, and wherein the outer surface of the dilator defines an outer cross-sectional dimension that is substantially perpendicular to the central axis (see annotated Fig. 2 below), wherein the outer cross-sectional dimension is about 12 French (Paragraph 0070; The diameter of the dilator is considered an outer cross-sectional dimension as it would be perpendicular to the central axis (see annotated Fig. 2 below).)(As 12 French is about 4 mm, and 4 mm is at least 2.5 mm as it is greater than 2.5 mm, Davis teaches the limitation of the outer cross-sectional dimension being at least 2.5 mm.).
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Since Ashby teaches a method for locating a puncture in a blood vessel of a patient (abstract; Column 3, Lines 63- 66) and Davis teaches a method for locating a puncture in a blood vessel of a patient (Paragraph 0053), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the outer cross-sectional dimension as taught by the combination to be at least 2.5 mm as taught by Davis.
Regarding claim 16, Ashby, Davis, Rosen, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
The combination further teaches wherein the pressure pulsations in the blood flow cause the flexible barrier (Rosen, compliant intermediate member 154) to pulse outwardly, thereby generating the visual and tactile indication of the presence of the inlet opening in the blood vessel (Rosen, Column 9, Lines 25- 33 and Column 9, Lines 38- 42).
Regarding claim 17, Ashby (Ashby et al.) teaches a method for locating a puncture (420) in a blood vessel (406) of a patient (abstract; Column 2, Lines 56- 58 and Column 4, Lines 19- 21)(Figs. 4A- 4C), the method comprising:
inserting a distal end of a dilator over a proximal end of a guidewire (18) that extends out of the puncture in the blood vessel (see annotated Fig. 4A below)(Column 4, Lines 54- 55);
moving the dilator along the guidewire in a distal direction until an inlet opening (bleed back entrance port 402) of the dilator is within the blood vessel (see Fig. 4A)(Column 4, Lines 55- 58) and blood in the blood vessel flows into the inlet opening of the dilator and out of an outlet opening (bleed back exit port) defined by the dilator (Column 4, Lines 55- 58), generating a visual indication of presence of the inlet opening in the blood vessel (Column 4, Lines 19- 23; Column 4, Lines 55- 58),
retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel thereby ceasing the visual indication and noting when there is no more indication of presence of the inlet opening in the blood vessel (Column 4, Lines 58- 67).
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Ashby does not teach the outlet opening disposed between a proximal end of the dilator and the inlet opening and into an internal volume at least partially defined by a flexible barrier carried by the dilator overlying the outlet opening and an outer surface of the dilator, such that, the flexible barrier repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of a presence of the inlet opening in the blood vessel, wherein the dilator has a plurality of markings, retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel and the flexible barrier no longer pulses thereby ceasing the visual and tactile indication; and noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a skin of the patient when the flexible barrier no longer pulses.
Davis (Davis et al.) teaches a method for locating a puncture (100) in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a guidewire (26) through the puncture into the blood vessel so that a distal end of the guidewire is inside the blood vessel and the guidewire extends out of the puncture (Paragraph 0057 and 0061)(see annotated Fig. 9 below); inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058)(see annotated Fig. 2 below); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator and to an outlet opening defined by the dilator (see annotated Fig. 2 below) and into the lumen of the dilator (Paragraphs 0059- 0060), wherein the dilator has an outer surface (see annotated Fig. 2 below), such that the dilator pulses in response to the pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (In Paragraph 0061, Davis teaches that the operator “can sometimes feel the pulse of the artery through the tract dilator”, as the dilator would physically move in order to replicate the pulse of the artery, an operator would have a visual indication of the presence of the inlet opening as well as a tactile indication. Furthermore, Davis teaches that bleed back is observed when the inlet opening is inserted, therefore there is another visual indication.); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062).
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It would have been obvious to one of ordinary skill in the art to modify the method as taught by Ashby to include a tactile indication that is the pulsing of the dilator barrier as taught by Davis since Davis teaches that the pulsing of the dilator barrier is one way to indicate that the device is in contact with the puncture wound and the vessel and allows the operator to control bleed back (Paragraph 0061). Furthermore, it would have been obvious to one of ordinary skill in the art to modify the dilator as taught by Ashby to have the marking as taught by Davis, since Davis teaches that the marking allows for the operator to measure the depth of the vessel (Paragraph 0062).
The combination does not teach the outlet opening disposed between a proximal end of the device and the inlet opening, or the internal volume at least partially defined by a blood pulsation indicator carried by the dilator and an outer surface of the dilator, the blood pulsation indicator defined by a flexible barrier overlying the outlet opening such that the blood pulsation indicator repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel.
Rosen (Rosen et al.) teaches a method (abstract) for visualizing the entrance of a device (150)(Figs. 9- 10) into a blood vessel (Column 10, Lines 42- 44), the method comprising: having blood flow through an inlet opening (distal opening 160) of the device (Column 10, Lines 38- 44) and to an outlet opening defined by the device, the outlet opening disposed between a proximal end of the device and the inlet opening (see annotated Fig. 10 below) and into an internal volume at least partially defined by a blood pulsation indicator (compliant intermediate member 154, Column 9, Lines 25- 27) carried by the device and an outer surface of the dilator (Column 10, Lines 46- 54), the blood pulsation indicator defined by a flexible barrier (raised dimples 168)(Column 9, Lines 34- 41) overlying the outlet opening (see annotated Fig. 10 below) such that, the blood pulsation indicator repeatedly pulses in response to pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Column 9, Lines 25- 33 and Column 9, Lines 38- 42).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by the combination to have the elements of the device such as the visual and tactile indication through the flexible barrier as taught by Rosen, as Davis teaches that the method involves visual and tactile feedback (Paragraph 0061) and Rosen teaches that the device prevents contamination (Column 2, Lines 35- 36) and that the visual and tactile indication of the device is convenient when the device enters into a vessel (Column 2 Lines 31- 36) and that this indication is important (Column 1, Lines 50- 55).
Regarding the method step of retracting the dilator in a proximal direction along the guidewire until the inlet opening is no longer within the blood vessel and the flexible barrier no longer pulses, thereby ceasing the visual and tactile indication, as the modified combination has the step of retracting the dilator until there is no more indication of presence of the inlet opening in the blood vessel through visual and tactile feedback (Ashby, Column 4, Lines 55-67; Davis, Paragraphs 0061 and 0062), and that the visual and tactile feedback is the pulsing of the flexible barrier (Rosen, Column 9, Lines 25- 33 and Column 9, Lines 38- 42), then within the combination the step of retracting the dilator would include this occurring until the flexible barrier no longer pulses.
The combination does not teach wherein the dilator has a plurality of markings, and further comprising: noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a patient’s skin when the flexible barrier no longer pulses.
Walters (Walters et al.) teaches a similar method of locating a puncture site (12, Paragraph 0037) in a blood vessel of a patient (abstract)(Figs. 1A- 5C), the method comprising: inserting a dilator (110) over a guidewire (114, Paragraph 0048) into the puncture site (Paragraph 0055) and moving the dilator along the guidewire in a distal direction until there is an indication that an inlet opening (142) of the dilator is within the blood vessel (Paragraph 0055). Walters further teaches wherein the dilator has a plurality of markings (154, Paragraph 0050), and further comprising: using the plurality of markings to locate the puncture site (12) and noting a first visible marking when the puncture site is located (Paragraph 0050).
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It would have been obvious to one of ordinary skill in the art to modify the marking of the dilator and the marking of the access sheath as taught by the combination to be the plurality of markings of the dilator as taught by Walters since a plurality of markings would provide measurements for different depths depending on the puncture depth of different patients (Walters, Paragraphs 0050 and 0052).
Regarding the step of noting a marking of the plurality of markings on the dilator that is adjacent to a surface of a patient’s skin when the flexible barrier no longer pulses, as the combination teaches the step of noting a first visible marking when the puncture site is located (Walters, Paragraph 0050), the step of locating the puncture site when the feedback on the dilator stops (Ashby, Column 4, Lines 1- 18), and that the feedback is the pulsing of the flexible barrier (Column 9, Lines 25- 33 and Column 9, Lines 38- 42), then the method of the combination includes the step of noting a marking of the plurality of markings when the flexible barrier no longer pulses.
Regarding claim 19, Ashby, Davis, Rosen, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 17.
Ashby is silent to wherein the plurality of markings on the dilator are a first plurality of markings and the marking is a noted first marking, wherein the method further comprises: removing the dilator from the puncture along the guidewire; moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator; and further moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient.
Davis teaches a method for locating a puncture in a blood vessel (102) of a patient (abstract)(Figs. 6- 10)(Paragraph 0053), the method comprising: inserting a distal end of a dilator (10) over a proximal end of a guidewire (26) that extends out of the puncture in the blood vessel (Paragraph 0057- 0058); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows through an inlet opening (opening of the lumen 24) of the dilator (Paragraphs 0059- 0060), such that the dilator pulses in response to the pressure pulsations of blood in the blood vessel, thereby generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Paragraph 0061); wherein the dilator has a marking (depth indicator 30), retracting the dilator in a proximal direction along the guidewire and moving the marking on the dilator until it is adjacent to a surface of the skin of a patient when a visual and tactile indication occurs (Paragraphs 0061 and 0062) and removing the dilator from the puncture along the guidewire (Paragraph 0064), threading the guidewire through the access sheath (Paragraph 0066), the access sheath defining a distal end, a proximal end, and a marking (52) disposed between the distal end and the proximal end of the access sheath (see annotated Fig. 11 below), the marking of the access sheath corresponding to the marking of the dilator (Paragraph 0065), and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until the second marking corresponds to the marking (depth indicator 30) on the dilator (10) (Paragraphs 0066 and 0067).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of the combination to have the steps of removing the dilator and moving an access sheath as taught by Davis, since Ashby teaches that the dilator can be used during any procedure (Column 3, Lines 32- 35) and Davis teaches a method of a procedure after a puncture has occurred (Paragraph 0037).
The combination does not teach wherein the plurality of markings on the dilator are a first plurality of markings, and the marking is a noted first marking, wherein the method further comprises: removing the dilator from the puncture along the guidewire, moving an access sheath along the guidewire toward the puncture, the access sheath defining a distal end, a proximal end, and a second plurality of markings disposed between the distal end and the proximal end of the access sheath, the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first visible marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient.
Walters (Walters et al.) teaches a similar method of locating a puncture site (12, Paragraph 0037) in a blood vessel of a patient (abstract)(Figs. 1A- 5C), the method comprising: inserting a dilator (110) over a guidewire (114, Paragraph 0048) into the puncture site (Paragraph 0055) and moving the dilator along the guidewire in a distal direction until there is an indication that an inlet opening (142) of the dilator is within the blood vessel (Paragraph 0055). Walters further teaches wherein the dilator has a plurality of markings (154, Paragraph 0050), and further comprising: using the plurality of markings to locate the puncture site (12) and noting a first visible marking when the puncture site is located (Paragraph 0050). Walters further teaches removing the dilator from the puncture along the guidewire, moving an access sheath (18) along the guidewire toward the puncture site (Paragraph 0056), the access sheath have a second plurality of markings (172) disposed between the distal end and the proximal end of the sheath (see annotated Fig. 4A below), with the second plurality of markings corresponding to the first plurality of markings of the dilator, and further moving the access sheath along the guidewire until the distal end of the access sheath enters the blood vessel and until a marking of the second plurality of markings on the access sheath that corresponds to the noted first visible marking on the dilator is a first visible marking of the access sheath that is adjacent to the surface of the skin of the patient (Paragraph 0052).
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It would have been obvious to one of ordinary skill in the art to modify the marking of the dilator and the marking of the access sheath as taught by the combination of Davis and Rosen to be the plurality of markings of the dilator and the plurality of markings of the access sheath as taught by Walters since a plurality of markings would provide measurements for different depths depending on the puncture depth of different patients (Walters, Paragraphs 0050 and 0052).
Regarding claim 20, Ashby, Davis, Rosen, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 19.
The combination further teaches wherein the pressure pulsations in the blood flow cause the flexible barrier (Rosen, compliant intermediate member 154) to pulse outwardly, thereby generating the visual and tactile indication of the presence of the inlet opening in the blood vessel (Rosen, Column 9, Lines 25- 33 and Column 9, Lines 38- 42).
Response to Arguments
Applicant’s arguments with respect to the rejection of claims 1-2, 4-10, 12-17, and 19-20 have been fully considered but are moot since, as discussed above, the previous prior art rejection was withdrawn in view of applicant’s amendments. However, it is noted that Davis, Ashby, Rosen and Walters are still relied upon for limitations not argued.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
