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
Claims filed on February 2nd, 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, 5-10 and 13- 17 under 35 U.S.C. 103 over Davis et al. (US 2004/0102730) in view of Rosen et al. (US 5,501,671) in light of applicant’s amendments, specifically Davis does not teach 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, or 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.
The rejection of claims 3-4, 11- 12, and 18-20 under 35 U.S.C. 103 over Davis et al. (US 2004/0102730) in view of Rosen et al. (US 5,501,671) in further view of Walters et al. (US 2014/0180332) in light of applicant’s amendments, specifically Davis does not teach 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 or 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.
Claim(s) 1- 2, 4- 10, 12- 17, and 19- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable 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).
Regarding claim 1, 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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Davis 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, 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, 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).
Davis and Rosen do not teach 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, 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.
Ashby (Ashby et al.) teaches a method for locating a puncture in a blood vessel (304) of a patient (abstract)(Fig. 3), 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. 3 below)(Column 3, Lines 63- 66); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows into an inlet opening (bleed back entrance port 300) of the dilator and out of an outlet opening (bleed back exit port 20) defined by the dilator (Column 3, Line 65- Column 4, Line 4), generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Column 3, Line 64- Column 4, Line 1), retracting the dilator in a proximal direction along the guidewire until there is no more indication of presence of the inlet opening in the blood vessel, and noting when there is no more indication of presence of the inlet opening in the blood vessel (Column 4, Lines 1- 18).
It would have been obvious to one of ordinary skill in the art to modify the method as taught by the combination to include the step of retracting the dilator until there is no more indication of presence of the inlet opening and noting when there is no more indication of presence as taught by Ashby, since Ashby teaches that this method “informs the user of the accurate location of the blood vessel puncture site” (Column 4, Lines 14- 18) and aids in “precisely locating an artery” (Column 3, Lines 32- 33).
Regarding the method step of retracting the dilator in a proximal direction along the guidewire until the flexible barrier no longer pulses, as the 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 a visual and tactile feedback (Ashby, Column 4, Lines 1- 18), and that the visual and tactile feedback is the pulsing of the flexible barrier (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, Davis, Rosen, Ashby, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
Davis further teaches inserting the guidewire (26) through the puncture (100) 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 (Paragraph 0057 and 0061)(see annotated Fig. 9 below).
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Regarding claim 4, Davis, Rosen, Ashby, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
Davis further teaches 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 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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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, Davis, Rosen, Ashby, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
Davis further teaches after moving the dilator along the guidewire, a surgical procedure is performed (Paragraphs 0058- 0067).
Regarding claim 6, Davis, Rosen, Ashby, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 5.
Davis further teaches the method comprising the steps of, prior to performing the surgical procedure in the blood vessel: inserting a procedural sheath (introducer 12) into the puncture (Paragraph 0067), inserting a surgical device (pusher 14) into the procedural sheath (Paragraph 0074), and removing the surgical device and procedural sheath from the blood vessel (Paragraph 0075).
Regarding claim 7, Davis, Rosen, Ashby, and Walters make obvious the method, including the flexible barrier of the dilator, as discussed above for claim 1.
Davis 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. 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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Regarding claim 8, Davis, Rosen, Ashby, 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, 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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Davis 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.
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 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).
Davis and Rosen do not teach 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, 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.
Ashby (Ashby et al.) teaches a method for locating a puncture in a blood vessel (304) of a patient (abstract)(Fig. 3), 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. 3 below)(Column 3, Lines 63- 66); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows into an inlet opening (bleed back entrance port 300) of the dilator and out of an outlet opening (bleed back exit port 20) defined by the dilator (Column 3, Line 65- Column 4, Line 4), generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Column 3, Line 64- Column 4, Line 1), retracting the dilator in a proximal direction along the guidewire until there is no more indication of presence of the inlet opening in the blood vessel, and noting when there is no more indication of presence of the inlet opening in the blood vessel (Column 4, Lines 1- 18).
It would have been obvious to one of ordinary skill in the art to modify the method as taught by the combination to include the step of retracting the dilator until there is no more indication of presence of the inlet opening and noting when there is no more indication of presence as taught by Ashby, since Ashby teaches that this method “informs the user of the accurate location of the blood vessel puncture site” (Column 4, Lines 14- 18) and aids in “precisely locating an artery” (Column 3, Lines 32- 33).
Regarding the method step of retracting the dilator in a proximal direction along the guidewire until the flexible barrier no longer pulses, as the 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 a visual and tactile feedback (Ashby, Column 4, Lines 1- 18), and that the visual and tactile feedback is the pulsing of the flexible barrier (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, Davis, Rosen, Ashby, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
Davis further teaches inserting the guidewire (26) through the puncture (100) 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 (Paragraph 0057 and 0061)(see annotated Fig. 9 below).
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Regarding claim 12, Davis, Rosen, Ashby, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
Davis further teaches wherein the method further comprises: 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 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 on the dilator (Paragraphs 0066 and 0067).
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Davis and Rosen do 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 13, Davis, Rosen, Ashby, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
Davis further teaches after moving the dilator along the guidewire, a surgical procedure is performed (Paragraphs 0058- 0067).
Regarding claim 14, Davis, Rosen, Ashby, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 13.
Davis further teaches the method comprising the steps of, prior to performing the surgical procedure in the blood vessel: inserting a procedural sheath (introducer 12) into the puncture (Paragraph 0067), inserting a surgical device (pusher 14) into the procedural sheath (Paragraph 0074), and removing the surgical device and procedural sheath from the blood vessel (Paragraph 0075).
Regarding claim 15, Davis, Rosen, Ashby, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 9.
Davis further teaches wherein the proximal end 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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Regarding claim 16, Davis, Rosen, Ashby, 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, 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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Davis 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 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).
Davis and Rosen do not teach 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, 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.
Ashby (Ashby et al.) teaches a method for locating a puncture in a blood vessel (304) of a patient (abstract)(Fig. 3), 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. 3 below)(Column 3, Lines 63- 66); moving the dilator along the guidewire in a distal direction until blood in the blood vessel flows into an inlet opening (bleed back entrance port 300) of the dilator and out of an outlet opening (bleed back exit port 20) defined by the dilator (Column 3, Line 65- Column 4, Line 4), generating a visual and tactile indication of presence of the inlet opening in the blood vessel (Column 3, Line 64- Column 4, Line 1), retracting the dilator in a proximal direction along the guidewire until there is no more indication of presence of the inlet opening in the blood vessel, and noting when there is no more indication of presence of the inlet opening in the blood vessel (Column 4, Lines 1- 18).
It would have been obvious to one of ordinary skill in the art to modify the method as taught by the combination to include the step of retracting the dilator until there is no more indication of presence of the inlet opening and noting when there is no more indication of presence as taught by Ashby, since Ashby teaches that this method “informs the user of the accurate location of the blood vessel puncture site” (Column 4, Lines 14- 18) and aids in “precisely locating an artery” (Column 3, Lines 32- 33).
Regarding the method step of retracting the dilator in a proximal direction along the guidewire until the flexible barrier no longer pulses, as the 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 a visual and tactile feedback (Ashby, Column 4, Lines 1- 18), and that the visual and tactile feedback is the pulsing of the flexible barrier (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, Davis, Rosen, Ashby, and Walters make obvious the method, including the blood pulsation indicator of the dilator, as discussed above for claim 17.
Davis further teaches wherein the method further comprises: 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 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 on the dilator (Paragraphs 0066 and 0067).
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Davis and Rosen do 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, Davis, Rosen, Ashby, 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, Rosen and Walters are still relied upon for limitations not argued.
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.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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