DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Beasley et al (US 2005/0273076) in view of Nance et al (US 2008/0243081) and Fischell (US 5,545,143).
Regarding Claim 1, Beasley teaches an indwelling venous cannula ([0059] and Fig. 18A, wherein the device (90) is a cannula for an infusion set (92), therefore is an indwelling venous cannula) for application to a living being;
comprising a venous catheter ([0059] wherein conduit tubing (102) is attached to a coil-reinforced cannula (94), thus (94, 102) together are a catheter);
at least one holding element (Fig. 18A, wherein the hub (104) may be held) configured for guiding the indwelling venous cannula (as seen in Fig. 18A) with one hand by a user for application of the indwelling venous cannula to the living being ([0059] and Fig. 18A, wherein (90) includes and infusion set (92) and is intended to be inserted into a body of a living being for the purpose of infusion); and
a fastening element configured to fix the indwelling venous cannula on the living being ([0059] wherein the hub (104) is designed to offer a large surface area to facilitate attachment to the skin of a patient by using tape or other adhesives. Therefore, a fastening element of tape/adhesive would be used with (104) to facilitate attachment/fixing of (104) on the skin of a living being),
wherein at least a part of the venous catheter (94) configured to remain in the living being is formed from a puncture-resistant material ([0003] wherein the infusion set is made of metal or plastic that perforates the epidermis of a patient. Metal is known in the art as a puncture resistant material), over its entire length or most of its length ([0003] wherein the entire length of the cannula can be metal, thus is puncture-resistant over its entire length),
wherein the venous catheter (94) has a spiral-shaped structure on an inner side of the venous catheter ([0052] wherein the helical (spiral-shaped) coil component is partially or completely internal to the tubing wall, therefore is on an inner side of the venous catheter (94)), wherein the spiral-shaped structure (within (94)) is formed from a puncture-resistant material ([0051] wherein the helically arranged coil component is continuous and can be closed (no spaces between the turns of the coil or individual coil components) along the entire length of the cannula. Further, the coil components may include metal or other rigid materials such as carbon fiber or wire. Metal is known in the art as a puncture resistant material),
wherein the at least one holding element (104) and the fastening element are combined in a single element ([0059] wherein the hub (104) is designed to offer a large surface area to facilitate attachment to the skin of a patient by using tape or other adhesives. Therefore, a fastening element of tape/adhesive would be used with (104) to facilitate attachment/fixing of (104) on the skin, and thus can be combined in a single element).
The embodiment of Beasley Figs 18-21 doesn’t explicitly teach a puncture needle having a sharp puncture tip for puncturing a vessel of the living being wherein the puncture needle is arranged in a longitudinally displaceable manner within the venous catheter and is guided longitudinally by the venous catheter when the puncture needle is longitudinally displaced, wherein the sharp puncture tip of the puncture needle is displaceable through and past an end of the venous catheter nearest the living being; nor explicitly teaches the venous catheter spiral shape structure is sized to be in contact with a side of the puncture needle when the puncture needle is guided by the venous catheter; nor explicitly teaches wherein the indwelling venous cannula is configured such that the venous catheter together with the puncture needle located within the venous catheter are insertable through skin and into the vessel of the living being to be catheterized, and for actual catheterization the venous catheter is advanceable over the puncture needle further into the vessel to be catheterized. Beasley also does not teach a least one pressure-sensitive valve configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being, nor an attachment element configured to permit attachment of an aspiration element to the indwelling venous cannula, wherein the attachment element comprises a filter which prevents entry of large particles, bacteria, and air into an interior of the indwelling venous cannula.
Another embodiment of Beasley, exemplified in [0063] and Figs 22-25, teaches a puncture needle (Fig. 22, (120)) having a sharp puncture tip for puncturing a vessel of the living being ([0063] wherein insertion needle (120) is for positioning the device in a desired location through the user’s (living being’s) skin. This would then be followed by puncturing a vessel such that infusion may occur), wherein the puncture needle (120) is arranged in a longitudinally displaceable manner within the venous catheter (seen in Fig. 25, wherein (120) is longitudinally displaced within (coil-reinforced cannula (112)) and is guided longitudinally by the venous catheter when the puncture needle is longitudinally displaced ([0052] teaches the coil component is a needle guide to assist in the insertion of a needle therethrough), wherein the sharp puncture tip of the puncture needle (120) is displaceable through and past an end of the venous catheter nearest the living being ([0063] wherein (120) is used to insert into a user’s skin, therefore the sharp puncture tip of (120) is displaced through and past a end of the venous catheter nearest the living being in order to be positioned through a user’s skin). Further, [0052] and seen in Fig. 25, longitudinally displacing the puncture needle (120) through the venous catheter spiral-shaped coil structure (112) to be a needle guide to assist insertion of a needle therethrough, implicitly teaches (120) will be in contact with said spiral-shaped coil structure during the guiding process. Fig. 25 illustrates how closely (112) may encircle (120) as it is longitudinally displaced therethrough. Therefore, during the process of longitudinal displacement of (120) through (112), (112) would be sized to be in contact with a side of the (120) when (120) is guided by the venous catheter (112), to facilitate guiding and assisting the insertion of the puncture needle (120). The indwelling venous cannula (112, 116, 118) is configured such that the venous catheter together with the puncture needle (120) located within the venous catheter (112), are insertable through skin and into the vessel of the living being to be catheterized ([0063] and Fig. 23, wherein insertion (puncture) needle (120) is disposed within (118) and (112), the entire device as (110) “thus being ready for insertion into a user”), and for actual catheterization the venous catheter is advanceable over the puncture needle further into the vessel to be catheterized ([0063] wherein (110) is inserted into a user, before (120) is withdrawn and (118) is adhered to the user’s skin. Therefore (112) and (118) are advanceable over (120), further into the vessel to be catheterized, before (120) is then removed).
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the indwelling venous cannula of the embodiment of Beasley Figs 18-21, to include a puncture needle having a sharp puncture tip for puncturing a vessel of the living being, guided by and displaceable through and past an end of the venous catheter nearest the living being; all as taught by the embodiment of Beasley Figs 22-25, for the motivation of positioning the device in a desired infusion location through the user’s skin ([0063]) and thus advantageously providing user comfort and ease of use ([0063]).
Nance discloses a catheter for use in the vascular system (especially the venous side - ¶13, ¶78). Nance includes a least one pressure-sensitive valve (¶23 – backflow check valve, such as a one-way or duckbill valve) configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being (¶23).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Beasley such that it includes a least one pressure-sensitive valve configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being as taught by Nance to prevent blood flow loss and flow of air into the circulatory system.
Fischell discloses an indwelling device which includes a bacterial filter 78 which is part of a mini-Luer lock fitting (Col.9 ll 21-27). Fischell discusses elsewhere that an object of the device is to provide an in-line bacterial filter that can prevent bacteria and/or air bubbles from passing into the patient (Col.4 ll 21-23). Such a filter will also prevent entry of particles larger than at least the bacteria and/or air bubbles.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Beasley such that it includes an attachment element configured to permit attachment of an aspiration element to the indwelling venous cannula, wherein the attachment element comprises a filter which prevents entry of large particles, bacteria, and air into an interior of the indwelling venous cannula as taught by Fischell to prevent contamination and/or air from causing damage to either the patient or the pump.
Regarding Claim 6, Beasley teaches the modified indwelling venous cannula as claimed in claim 1, wherein the venous catheter has an undulating surface ([0052] wherein the helical (spiral-shaped) coil component is helically wound, therefore would be an undulating surface).
Regarding Claim 11, Beasley teaches the indwelling venous cannula as claimed in claim 1. While [0052] teaches that, in some embodiments, the cannula (which comprises the coil component/spiral-shaped structure) includes perforations or apertures in select locations, which may be similarly or differently sized; the embodiment of Beasley Figs 18-21 doesn’t explicitly teach wherein the venous catheter has, at the end near the living being, recesses through the spiral-shaped structure which are distributed about a circumference and serve for homogeneous delivery of a fluid into the living being.
In another embodiment of Beasley, seen in Figs 7-11, Beasley [0056] teaches apertures/perforations (Fig. 11, (66)) through the spiral shaped structure (Fig. 11, (68)). These permit fluid delivery therethrough to enhance absorption of medication at the delivery site or increase indwelling time at a given delivery site ([0056]).
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the venous catheter of the embodiment of Beasley Figs 18-21, to include at the end near the living being, recesses through the spiral-shaped structure which are distributed about a circumference, as taught by the embodiment of Beasley Figs 7-11, for the motivation of enhancing absorption of medication at the delivery site (Beasley [0056]).
Claims 2-3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Beasley et al (US 2005/0273076), Fischell (US 5,545,143) and Nance et al (US 2008/0243081) as applied to Claim 1 above, further in view of Kline (US 3,757,768).
Regarding Claim 2, Beasley teaches the modified indwelling venous cannula as claimed in claim 1.
While Beasley [0063] teaches the device (infusion set) can be positioned in a desired location through a user’s skin, Beasley doesn’t explicitly teach wherein the indwelling venous cannula is a peripheral indwelling venous cannula.
In related prior art, Kline teaches an indwelling venous cannula (Figs 1 and 5-6) comprising a venous catheter (Fig. 6, (5)), wherein [Col. 2 lines 1-7] teaches the “venous cannula which is an indwelling cannula and can be used peripherally as well as to ‘intra-venous feeding’”.
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the indwelling venous cannula of Beasley, to be a peripheral indwelling venous cannula, as taught by Kline, for the motivation of versatile use as well as providing intra-venous feeding (Kline [Col. 2 lines 1-7]). This is further supported by Beasley [0063] teaching the device can be positioned in a desired location through a user’s skin, thus, can be a peripheral location of the user’s body.
Regarding Claim 3, Beasley in view of Kline teaches the modified indwelling venous cannula as claimed in claim 2. Beasley doesn’t explicitly teach wherein the venous catheter of the peripheral indwelling venous cannula has a piercing length of 10 mm to 200 mm.
Related prior art Kline [Col. 6 lines 1-2] teaches the venous cannula may be shortened to a length between 2.5 cm and 10 cm. Therefore, the indwelling venous cannula has a piercing length between 25 cm up to 1000 cm; this meets the required range of a piercing length of 10 mm to 200 mm).
Regarding Claim 13, Beasley teaches the modified indwelling venous cannula as claimed in claim 1. Beasley doesn’t explicitly teach wherein the puncture needle is a hollow needle.
In related prior art, Kline teaches an indwelling venous cannula (Figs 1 and 5-6) comprising a venous catheter (Fig. 6, (5)), wherein [Col. 1 lines 27-29] teaches a sharpened cannula (hollow needle) is inserted into the lumen of the Bessel prior to a wire guide being inserted therethrough to advance.
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the puncture needle of Beasley, to be a hollow needle, as taught by Kline, for the motivation of providing guiding means to advance therethrough (Kline [Col. 1, lines 27-29]) thus assisting in placement of the indwelling venous cannula ([Col. 5, lines 21-27] where the catheter is used for controlled catheterization (placement of an indwelling catheter)).
Claims 8-10, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Beasley et al (US 2005/0273076), Fischell (US 5,545,143) and Nance et al (US 2008/0243081) as applied to Claim 1 above, further in view of Turnlund et al (US 2009/0043283).
Regarding Claim 8, Beasley teaches the modified indwelling venous cannula as claimed in claim 6. Beasley doesn’t explicitly teach wherein the undulating surface is provided with a sealing coating.
In related prior art, Turnlund teaches a venous cannula ([0022] and Fig. 1, (10)), and further, [0060] teaches providing a sealing coating on the surfaces of the venous cannula.
It would be obvious to one of ordinary skill in the art, prior to the effective filing date, to modify the undulating surfaces of the venous cannula of Beasley, to include a sealing coating as taught by Turnlund, for the motivation of having added lubrication and protection to improve steerability and lesion crossing capability of a catheter (Turnlund [0060]).
Regarding Claim 9, Beasley and Turnlund teaches the modified indwelling venous cannula as claimed in claim 8, wherein Turnlund the sealing coating is a PTFE coating ([0060] wherein the sealing coating can include PTFE).
Regarding Claim 10, Beasley teaches the modified indwelling venous cannula as claimed in claim 1, but doesn’t explicitly teach wherein the venous catheter has, at an-the end nearest the living being, a dilation body for uniform widening of a punctured body part.
In related prior art, Turnlund [0022] teaches the venous catheter (Fig. 1, (10)), which can be a balloon catheter; therefore, the catheter would have a dilation member such as a balloon on the distal end.
It would be obvious to one of ordinary skill in the art, prior to the effective filing date, to modify the venous catheter of Beasley, to have a dilation body on the end near the living being, as taught by Turnlund, for the motivation of being applicable to a variety of different target locations in a patient, including blood vessels in various areas of the (patient’s) body periphery (Turnlund [0022]).
Regarding Claim 14, Beasley teaches the modified indwelling venous cannula as claimed in claim 1. Beasley doesn’t explicitly teach wherein an expansion body for fixing the position of the venous catheter in a punctured body part is arranged on the venous catheter.
In related prior art, Turnlund [0022] teaches the venous catheter (Fig. 1, (10)), which can be a balloon catheter; therefore, the catheter would have an expansion body such as a balloon on the distal end.
It would be obvious to one of ordinary skill in the art, prior to the effective filing date, to modify the venous catheter of Kline, to have a dilation body on the end near the living being, as taught by Turnlund, for the motivation of being applicable to a variety of different target locations in a patient, including blood vessels in various areas of the (patient’s) body periphery (Turnlund [0022]).
Regarding Claim 17, Beasley in view of Turnlund teaches the modified indwelling venous cannula as claimed in claim 8, wherein Turnlund teaches the sealing coating is a plastic coating ([0060] wherein polymers such as plastics can be used as coatings).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Beasley et al (US 2005/0273076), Fischell (US 5,545,143) and Nance et al (US 2008/0243081), as applied to Claim 1 above, and further in view of Tan et al (US 2015/0151085).
Regarding Claim 16, Beasley teaches the modified indwelling venous cannula as claimed in claim 1. Beasley doesn’t explicitly teach wherein the indwelling venous cannula has a safety mechanism which is configured to shield a tip of the puncture needle after the puncture needle has been removed from the venous catheter.
In related indwelling needle assembly prior art, Tan teaches an indwelling cannula (Fig. 2B, (106)) for use with a catheter ([0052] the indwelling needle assembly is used with a catheter), having a safety mechanism (Fig. 2B, (122)) configured to shield a tip (Fig. 2B, (142)) of the puncture needle after the puncture needle has been removed (as seen in [0050] and Fig. 2B, wherein the arms (138, 140) cover the needle when its removed).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date to modify the venous cannula of Beasley, to have a safety mechanism which is configured to shield a tip of the puncture needle after the puncture needle has been removed from the venous catheter; all as taught by Tan, for the motivation of preventing inadvertent needle sticks (Tan [0050]).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Beasley et al (US 2005/0273076) in view of Nance et al (US 2008/0243081).
Regarding Claim 18, Beasley teaches an indwelling venous cannula ([0059] and Fig. 18A, wherein the device (90) is a cannula for an infusion set (92), therefore is an indwelling venous cannula) for application to a living being,
comprising a venous catheter ([0059] wherein conduit tubing (102) is attached to a coil-reinforced cannula (94), thus (94, 102) together are a catheter);
at least one holding element (Fig. 18A, wherein the hub (104) may be held) configured for guiding the indwelling venous cannula (as seen in Fig. 18A) with one hand by a user for application of the indwelling venous cannula to the living being ([0059] and Fig. 18A, wherein (90) includes and infusion set (92) and is intended to be inserted into a body of a living being for the purpose of infusion);
a fastening element configured to fix the indwelling venous cannula on the living being ([0059] wherein the hub (104) is designed to offer a large surface area to facilitate attachment to the skin of a patient by using tape or other adhesives. Therefore, a fastening element of tape/adhesive would be used with (104) to facilitate attachment/fixing of (104) on the skin of a living being),
wherein at least a part of the venous catheter (94) configured to remain in the living being is formed from a puncture-resistant material ([0003] wherein the infusion set is made of metal or plastic that perforates the epidermis of a patient. Metal is known in the art as a puncture resistant material), over its entire length or most of its length ([0003] wherein the entire length of the cannula can be metal, thus is puncture-resistant over its entire length)
wherein the venous catheter (94) has a spiral-shaped structure on an inner side of the venous catheter ([0052] wherein the helical (spiral-shaped) coil component is partially or completely internal to the tubing wall, therefore is on an inner side of the venous catheter (94)), wherein the spiral-shaped structure (within (94)) is formed from a puncture-resistant material ([0051] wherein the helically arranged coil component is continuous and can be closed (no spaces between the turns of the coil or individual coil components) along the entire length of the cannula. Further, the coil components may include metal or other rigid materials such as carbon fiber or wire. Metal is known in the art as a puncture resistant material).
The embodiment of Beasley Figs 18-21 doesn’t explicitly teach a puncture needle having a sharp puncture tip for puncturing a vessel of the living being, wherein the puncture needle is arranged in a longitudinally displaceable manner within the venous catheter and is guided longitudinally by the venous catheter when the puncture needle is longitudinally displaced, wherein the sharp puncture tip of the puncture needle is displaceable through and past an end of the venous catheter nearest the living being; nor teaches wherein the indwelling venous cannula is configured such that the venous catheter together with the puncture needle located within the venous catheter are insertable through skin and into the vessel of the living being to be catheterized, and for actual catheterization the venous catheter is advanceable over the puncture needle further into the vessel to be catheterized. Beasley also does not teach a least one pressure-sensitive valve configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being.
Another embodiment of Beasley, exemplified in [0063] and Figs 22-25, teaches a puncture needle (Fig. 22, (120)) having a sharp puncture tip for puncturing a vessel of the living being ([0063] wherein insertion needle (120) is for positioning the device in a desired location through the user’s (living being’s) skin. This would then be followed by puncturing a vessel such that infusion may occur), wherein the puncture needle (120) is arranged in a longitudinally displaceable manner within the venous catheter (seen in Fig. 25, wherein (120) is longitudinally displaced within (coil-reinforced cannula (112)) and is guided longitudinally by the venous catheter when the puncture needle is longitudinally displaced ([0052] teaches the coil component is a needle guide to assist in the insertion of a needle therethrough), wherein the sharp puncture tip of the puncture needle (120) is displaceable through and past an end of the venous catheter nearest the living being ([0063] wherein (120) is used to insert into a user’s skin, therefore the sharp puncture tip of (120) is displaced through and past a end of the venous catheter nearest the living being in order to be positioned through a user’s skin). Further, [0052] and seen in Fig. 25, longitudinally displacing the puncture needle (120) through the venous catheter spiral-shaped coil structure (112) to be a needle guide to assist insertion of a needle therethrough, implicitly teaches (120) will be in contact with said spiral-shaped coil structure during the guiding process. Fig. 25 illustrates how closely (112) may encircle (120) as it is longitudinally displaced therethrough. Therefore, during the process of longitudinal displacement of (120) through (112), (112) would be sized to be in contact with a side of the (120) when (120) is guided by the venous catheter (112), to facilitate guiding and assisting the insertion of the puncture needle (120). The indwelling venous cannula (112, 116, 118) is configured such that the venous catheter together with the puncture needle (120) located within the venous catheter (112), are insertable through skin and into the vessel of the living being to be catheterized ([0063] and Fig. 23, wherein insertion (puncture) needle (120) is disposed within (118) and (112), the entire device as (110) “thus being ready for insertion into a user”), and for actual catheterization the venous catheter is advanceable over the puncture needle further into the vessel to be catheterized ([0063] wherein (110) is inserted into a user, before (120) is withdrawn and (118) is adhered to the user’s skin. Therefore (112) and (118) are advanceable over (120), further into the vessel to be catheterized, before (120) is then removed).
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the indwelling venous cannula of the embodiment of Beasley Figs 18-21, to include a puncture needle having a sharp puncture tip for puncturing a vessel of the living being, guided by and displaceable through and past an end of the venous catheter nearest the living being; all as taught by the embodiment of Beasley Figs 22-25, for the motivation of positioning the device in a desired infusion location through the user’s skin ([0063]) and thus advantageously providing user comfort and ease of use ([0063]).
Nance discloses a catheter for use in the vascular system (especially the venous side - ¶13, ¶78). Nance includes a least one pressure-sensitive valve (¶23 – backflow check valve, such as a one-way or duckbill valve) configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being (¶23).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Beasley such that it includes a least one pressure-sensitive valve configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being as taught by Nance to prevent blood flow loss and flow of air into the circulatory system.
Regarding Claim 19, Beasley teaches an indwelling venous cannula ([0059] and Fig. 18A, wherein the device (90) is a cannula for an infusion set (92), therefore is an indwelling venous cannula) for application to a living being;
comprising a venous catheter ([0059] wherein conduit tubing (102) is attached to a coil-reinforced cannula (94), thus (94, 102) together are a catheter);
at least one holding element (Fig. 18A, wherein the hub (104) may be held) configured for guiding the indwelling venous cannula (as seen in Fig. 18A) with one hand by a user for application of the indwelling venous cannula to the living being ([0059] and Fig. 18A, wherein (90) includes and infusion set (92) and is intended to be inserted into a body of a living being for the purpose of infusion); and
a fastening element configured to fix the indwelling venous cannula on the living being ([0059] wherein the hub (104) is designed to offer a large surface area to facilitate attachment to the skin of a patient by using tape or other adhesives. Therefore, a fastening element of tape/adhesive would be used with (104) to facilitate attachment/fixing of (104) on the skin of a living being),
wherein at least a part of the venous catheter (94) configured to remain in the living being is formed from a puncture-resistant material ([0003] wherein the infusion set is made of metal or plastic that perforates the epidermis of a patient. Metal is known in the art as a puncture resistant material), over its entire length or most of its length ([0003] wherein the entire length of the cannula can be metal, thus is puncture-resistant over its entire length),
wherein the at least one holding element (104) and the fastening element are combined in a single element ([0059] wherein the hub (104) is designed to offer a large surface area to facilitate attachment to the skin of a patient by using tape or other adhesives. Therefore, a fastening element of tape/adhesive would be used with (104) to facilitate attachment/fixing of (104) on the skin, and thus can be combined in a single element).
The embodiment of Beasley Figs 18-21 doesn’t explicitly teach a puncture needle having a sharp puncture tip for puncturing a vessel of the living being wherein the puncture needle is arranged in a longitudinally displaceable manner within the venous catheter and is guided longitudinally by the venous catheter when the puncture needle is longitudinally displaced, wherein the sharp puncture tip of the puncture needle is displaceable through and past an end of the venous catheter nearest the living being; nor explicitly teaches wherein the indwelling venous cannula is configured such that the venous catheter together with the puncture needle located within the venous catheter are insertable through skin and into the vessel of the living being to be catheterized, and for actual catheterization the venous catheter is advanceable over the puncture needle further into the vessel to be catheterized. Beasley also does not teach a least one pressure-sensitive valve configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being.
Another embodiment of Beasley, exemplified in [0063] and Figs 22-25, teaches a puncture needle (Fig. 22, (120)) having a sharp puncture tip for puncturing a vessel of the living being ([0063] wherein insertion needle (120) is for positioning the device in a desired location through the user’s (living being’s) skin. This would then be followed by puncturing a vessel such that infusion may occur), wherein the puncture needle (120) is arranged in a longitudinally displaceable manner within the venous catheter (seen in Fig. 25, wherein (120) is longitudinally displaced within (coil-reinforced cannula (112)) and is guided longitudinally by the venous catheter when the puncture needle is longitudinally displaced ([0052] teaches the coil component is a needle guide to assist in the insertion of a needle therethrough), wherein the sharp puncture tip of the puncture needle (120) is displaceable through and past an end of the venous catheter nearest the living being ([0063] wherein (120) is used to insert into a user’s skin, therefore the sharp puncture tip of (120) is displaced through and past a end of the venous catheter nearest the living being in order to be positioned through a user’s skin). The indwelling venous cannula (112, 116, 118) is configured such that the venous catheter together with the puncture needle (120) located within the venous catheter (112), are insertable through skin and into the vessel of the living being to be catheterized ([0063] and Fig. 23, wherein insertion (puncture) needle (120) is disposed within (118) and (112), the entire device as (110) “thus being ready for insertion into a user”), and for actual catheterization the venous catheter is advanceable over the puncture needle further into the vessel to be catheterized ([0063] wherein (110) is inserted into a user, before (120) is withdrawn and (118) is adhered to the user’s skin. Therefore (112) and (118) are advanceable over (120), further into the vessel to be catheterized, before (120) is then removed).
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the indwelling venous cannula of the embodiment of Beasley Figs 18-21, to include a puncture needle having a sharp puncture tip for puncturing a vessel of the living being, guided by and displaceable through and past an end of the venous catheter nearest the living being; all as taught by the embodiment of Beasley Figs 22-25, for the motivation of positioning the device in a desired infusion location through the user’s skin ([0063]) and thus advantageously providing user comfort and ease of use ([0063]).
Nance discloses a catheter for use in the vascular system (especially the venous side - ¶13, ¶78). Nance includes a least one pressure-sensitive valve (¶23 – backflow check valve, such as a one-way or duckbill valve) configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being (¶23).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Beasley such that it includes a least one pressure-sensitive valve configured to prevent a retrograde flow of liquids out of the living being and entry of air into the venous catheter and thus into the body of the living being as taught by Nance to prevent blood flow loss and flow of air into the circulatory system.
Response to Arguments
In response to Applicant's argument that Beasley and Nance teach away from claims 1, 18 and 19, it is noted that a teaching away requires a reference to actually criticize, discredit, or otherwise discourage investigation into the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). It has been further instructed that the Examiner will not read into a reference a teaching away from a process where no such language exists. See DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).
Moreover, in general, a reference will teach away if it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). However, the mere disclosure of alternatives does not teach away. In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012). Rather, teaching away requires “clear discouragement” from implementing a technical feature. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017).
Applicant argues on pages 7 and 8 the examiner overlooks the context in which Nance suggests a valve. However, similar to interpreting Applicant’s invention, references are not read in a vacuum but for what they teach one of ordinary skill in the art. Applicant argues the valve of Nance is not employed until after Nance’s sheath has been inserted into the circulatory system over a guidewire, and even then said valve is incorporated into a hub and there is no discussion of said hub or combination with a needle suited to puncture a vessel. Beasley already displays how its insertion needle and hub are envisioned as interacting in fig 25 (the needle avoids all but the most distal section of the hub). Thus placing a valve into the hub of Beasley will not be expected to physically interact with the valve at all and thus the references are not seen as teaching away from the combination.
Applicant argues on pages 9 and 10 that the references don’t teach the claimed filter. The examiner does not disagree the previous rejections did not address the newly introduced limitation regarding the filter. Reference Fischell is provided for said limitation.
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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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783