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 .
Claims, 1-2, 4-7, 9, 12-13, 15-16, 18-21, and 23-27 are examined in this office action.
Claims 1, 2, 4-7, 9, 12-13, 15-16, 18-19, 21, and 23-26 are currently amended.
Claim 27 is new.
Claims 1, 3, 8, 10, 11, 14, 17, 20, and 22 are canceled.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2, 4-7, 9, 13, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US Patent No. 4484914) in view of Peterson (US Patent No. 9155867 B2), Khalaj (WO 2015/079333 A1), and Glithero et al. (WO 2017/070013 A1).
Regarding claim 1, Brown in view of Peterson, Khalaj, and Glithero discloses a conduit securement device (Brown, catheter restraint 10, Fig. 1), for securing a flexible medical conduit (Brown, catheter 20, Fig. 2), the conduit securement device comprising:
a support portion (Brown, backing 12, Fig. 1);
a first strap (Brown, strip 14a, Fig. 2)(“ Brown, … flexible adhesive strips …” – Para [11]) coupled to the support portion (Brown, “The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12.” – Para [11]); a portion of the first strap being configured to be attached around a first region of the flexible medical conduit (Brown, "The catheter receptacle 20 is placed … between the strips 14a and 14b.” – Para [8], Fig. 2);
a second strap (Brown, strip 14b, Fig. 2) coupled to the support portion (Brown, “The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12.” – Para [11]); a portion of the second strap being configured to be attached around a longitudinally adjacent second region of said flexible medical conduit (Brown, "The catheter receptacle 20 is placed … between the strips 14a and 14b.” – Para [8], Fig. 2); and
a tertiary attachment (Brown, strip 14c, Fig. 2) for attaching a further region of said flexible medical conduit to the support portion (Brown, "A plurality of adhesive strips 14 emanate from or through the non-adhesive side of the backing 12 and may be attached thereto by pressure." - Para [3], Fig. 1) said further region being longitudinally adjacent the second region (Brown, Fig. 2) (Brown, “Additional strips may be added along either or both lines 16 and 18 …” – Para [4], Fig. 1);
wherein, when the first and second straps are attached around longitudinally adjacent first and second regions of the flexible medical conduit and secure the flexible medical conduit to the conduit securement device (Brown, “The catheter receptable 20 is placed … between the strips 14a and 14b.” – Para [8], Fig. 2), the flexible medical conduit is urged into a curved or convoluted pathway by the straps Brown, (“The tubing is then formed into a loop …’ – Para [9], Fig. 2).
The following limitation is a recitation of intended use:
“in use of the conduit securement device to secure said flexible medical conduit to a patient or a structure in a clinical setting, tension applied longitudinally to the flexible medical conduit secured to the conduit securement device acts to straighten the curved or convoluted pathway”
The MPEP (2114) states: It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.
However, Khalaj teaches that in use of the conduit securement device (catheter strain relief clip 10, Fig. 1) to secure said flexible medical conduit (catheter 48, Fig. 1) to a patient or a structure in a clinical setting, tension applied longitudinally to the flexible medical conduit (“… the catheter is subjected to a pulling force from only one direction.” – Para [0017]) secured to the conduit securement device acts to straighten the curved or convoluted pathway (“The cumulative effect of the various vertical deflections of the catheter 48 is beneficial in retaining the catheter and relieving axial stresses …” – Para [0041], Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include that in use of the conduit securement device to secure said flexible medical conduit to a patient or a structure in a clinical setting, tension applied longitudinally to the flexible medical conduit secured to the conduit securement device acts to straighten the curved or convoluted pathway as taught by Khalaj to retain the device at a target location (Khalaj, Para [0018])
Brown does not expressly disclose an elastically extendable first strap and an elastically extendable second strap and that tension applied longitudinally to the flexible medical conduit secured to the conduit securement device acts to … extend or further extend the first and/or second strap and increase a static friction with the flexible medical conduit.
Peterson teaches an elastically extendable first strap (adhesive strip 50, Figs. 1A and 1B, “Adhesive strip 50 may further include elastic properties which permit the strip to stretch and adhere itself to another surface.” – Col. 4 Line 39) and an elastically extendable second strap (adhesive strip 50, Figs. 1A and 1B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include an elastically extendable first strap and an elastically extendable second strap as taught by Peterson to maintain a desired position of catheter adapter 20 (Peterson, Col. 3, Line 65).
Peterson does not expressly disclose that tension applied longitudinally to the flexible medical conduit secured to the conduit securement device acts to … extend or further extend the first and/or second strap and increase a static friction with the flexible medical conduit.
Glithero teaches that tension applied longitudinally to the flexible medical conduit secured to the conduit securement device acts to … extend or further extend the first and/or second strap (“the tubing management member 150 is capable of being flexed or bent out of plane.” – Para [0024]) and increase a static friction with the flexible medical conduit (“… one or more of the first or second tube passages may be configured to increase a friction between the drainage tube and the tube passages.” – Para [0005])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include that tension applied longitudinally to the flexible medical conduit secured to the conduit securement device acts to … extend or further extend the first and/or second strap and increase a static friction with the flexible medical conduit as taught by Glithero in order to stabilize the tubing (Glithero, Para [0028]).
Regarding claim 2, Brown in view of Peterson, Khalaj, and Glithero discloses the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, wherein
the first strap and the second strap (Brown, strip 14a, Fig. 2) (Brown, strip 14b, Fig. 2) are configured to wrap around the flexible medical conduit, in opposite directions or senses (Brown, "The strips 14a and 14b are folded in opposite direction so that their adhesive surfaces cover both the receptacle and a portion of the non-adhesive surface of the backing 12. " - Para [8], Fig. 2).
Regarding claim 4, Brown in view of Peterson, Khalaj, and Glithero discloses the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, wherein
when a longitudinal force is applied along the flexible medical conduit (Brown, catheter 20, Fig. 2) proximal to or distal to the conduit securement device (Brown, "… a pulling force is applied to the catheter connecting tubing." - Para [8]), the first strap (Brown, strip 14a, Fig. 2) elastically extends or further extends and applies a first force to the flexible medical conduit (Brown, "The strips 14a and 14b are then folded in opposite directions so that their adhesive surfaces cover both the receptable and a portion of … the backing 12. In this way, force exerted against the catheter receptacle in either direction is prevented from dislodging the receptacle.” – Para [8], Fig. 2); and/or the second strap (Brown, strip 14b, Fig. 2) elastically extends or further extends and applies a second force to the flexible medical conduit;
wherein at least a component of the first and/or second force is applied normal to the longitudinal direction of the flexible medical conduit (Brown, See annotated Fig. 2).
PNG
media_image1.png
488
560
media_image1.png
Greyscale
Examiner interprets the folding of strips 14a and 14b around the catheter as the strips 14a and 14b being elastically extended.
Regarding claim 5, Brown in view of Peterson, Khalaj, and Glithero discloses the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, wherein
the conduit securement device comprises a first strap (Brown, strip 14a, Fig. 2) having a first fixed portion coupled to the support portion (Brown, "The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12." - Para [11], See annotated Fig. 1), a first intermediate portion (Brown, See annotated Fig. 1) and a first free end (Brown, See annotated Fig. 1) couplable to the support portion or another portion of the first strap (Brown, "The strips 14a and 14b are then folded in opposite directions so that their adhesive surfaces … cover a portion of the non-adhesive surface of the backing 12." - Para [8]) to form a first loop (Brown, See annotated Fig. 2); and
PNG
media_image2.png
270
528
media_image2.png
Greyscale
PNG
media_image3.png
480
472
media_image3.png
Greyscale
a second strap (Brown, strip 14b, Fig. 2) having a second fixed portion coupled to the support portion (Brown, "The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12." - Para [11], See annotated Fig. 1), a second intermediate portion (Brown, See annotated Fig. 1) and a second free end (Brown, See annotated Fig. 1) couplable to the support portion or another portion of the second strap (Brown, "The strips 14a and 14b are then folded in opposite directions so that their adhesive surfaces … cover a portion of the non-adhesive surface of the backing 12." - Para [8]) to form a second loop (Brown, See annotated Fig. 2);
PNG
media_image4.png
480
472
media_image4.png
Greyscale
first and second loops (Brown, See annotated Fig. 2) each defining a corresponding first and second channel (Brown, See annotated Fig. 2) therethrough;
wherein, when the straps are not elastically extended and the first and second channels are generally parallel to one another, the first and second channels are laterally offset from one another (Brown, “At least one additional strip 14 will be located along a second line 18 which is spaced apart from be generally parallel to the first line 16.” – Para [3]) and
wherein the first (Brown, strip 14c, Fig. 2) and second straps (Brown, strip 14d, Fig. 2) configured to define a curved or convoluted pathway (Brown, "The tubing is then formed into a loop …" - Para [9], Fig. 2) extending longitudinally across the support portion through the first and the second loops.
Brown does not expressly disclose an elastically extendable first intermediate portion and an elastically extendable second intermediate portion.
Peterson teaches an elastically extendable first strap (adhesive strip 50, Figs. 1A and 1B, “Adhesive strip 50 may further include elastic properties which permit the strip to stretch and adhere itself to another surface.” – Col. 4 Line 39) and an elastically extendable second strap (adhesive strip 50, Figs. 1A and 1B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include an elastically extendable first intermediate portion and an elastically extendable second intermediate portion as taught by Peterson to maintain a desired position of catheter adapter 20 (Peterson, Col. 3, Line 65).
PNG
media_image5.png
504
526
media_image5.png
Greyscale
Regarding claim 6, Brown in view of Peterson, Khalaj, and Glithero discloses the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, wherein the straps (Brown, strip 14a, Fig. 2) (Brown, strip 14b, Fig. 2) are positioned such that, in use the first channel extends generally continuously to the adjacent second channel (Brown, See annotated Fig. 2), when the flexible medical conduit (Brown, catheter 20, Fig. 2) is secured to the conduit securement device.
Regarding claim 7, Brown in view of Peterson, Khalaj, and Glithero discloses the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, wherein
the tertiary attachment (Brown, strip 14c, Fig. 2) is a further first strap (Brown, strips 14, Fig. 1) attachable around a further first portion of a conduit (Brown, "Strips 14c and 14d are then used to fix the tubing 22 into the loop …" - Para [9]) longitudinally adjacent the second portion (Brown, Fig. 2) (Brown, “Additional strips may be added along either or both lines 16 and 18 …” – Para [4], Fig. 1)
Examiner interprets strips 14b and 14c to be next to or very near to each other, making them adjacent to each other. Examiner also acknowledges the art of Brown allowing for the strips to placed anywhere along lines 16 and 18 as shown in Fig. 1, allowing for strips 14b and 14c to be placed even closer to each other.
Regarding claim 9, Brown in view of Peterson, Khalaj, and Glithero discloses the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, comprising
two first straps (Brown, strip 14a, Fig. 2) (Brown, strip 14c, Fig. 2) coupled to the support portion (Brown, "The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12." - Para [11]); a portion of each first strap being configured to be attached around a corresponding first region of the flexible medical conduit (Brown, "The catheter receptacle 20 is placed … between the strips 14a and 14b. The strips 14a and 14b … cover both the receptable and a portion of … the backing 12." - Para [8]) ("Strips 14c and 14d are then used to fix the tubing 22 into the loop …" - Para [9]); and a second strap (Brown, strip 14b, Fig. 2) coupled to the support portion (Brown, "The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12." - Para [11]); a portion of the second strap being configured to be attached around a second region of said flexible medical conduit (Brown, "The catheter receptacle 20 is placed … between the strips 14a and 14b. The strips 14a and 14b … cover both the receptable and a portion of … the backing 12." - Para [8]) that is between and longitudinally adjacent to the said first regions (Brown, Fig. 2) (Brown, “Additional strips may be added along either or both lines 16 and 18 …” – Para [4], Fig. 1)
Examiner interprets strips 14b and 14c to be next to or very near to each other, making them adjacent to each other. Examiner also acknowledges the art of Brown allowing for the strips to placed anywhere along lines 16 and 18 as shown in Fig. 1, allowing for strips 14b and 14c to be placed even closer to each other.
Brown does not expressly disclose two elastically extendable first straps and an elastically extendable second strap.
Peterson teaches two elastically extendable first straps (adhesive strip 50, Figs. 1A and 1B, “Adhesive strip 50 may further include elastic properties which permit the strip to stretch and adhere itself to another surface.” – Col. 4 Line 39) and an elastically extendable second strap (adhesive strip 50, Figs. 1A and 1B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include two elastically extendable first straps and an elastically extendable second strap as taught by Peterson to maintain a desired position of catheter adapter 20 (Peterson, Col. 3, Line 65).
Regarding claim 13, Brown in view of Peterson, Khalaj, and Glithero discloses the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, wherein
Brown does not expressly disclose that the securement device, or one or more parts thereof, is made from a wipe-clean material having a substantially non-porous surface; and/or wherein the securement device or one or more component parts thereof is provided with an antipathogenic coating, or impregnated with an antipathogenic component; and/or wherein the securement device or one or more component parts thereof is provided with a luminescent coating or impregnated with a luminescent pigment or dye.
Khalaj teaches that the conduit securement device, or one or more parts thereof, is made from a wipe-clean material having a substantially non-porous surface (Khalaj, “The body 12 can be made of any medical-grade material …” – Para [0029]); and/or wherein the conduit securement device or one or more component parts thereof is provided with an antipathogenic coating, or impregnated with an antipathogenic component; and/or wherein the conduit securement device or one or more component parts thereof is provided with a luminescent coating or impregnated with a luminescent pigment or dye.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the securement device of Brown to include that the conduit securement device, or one or more parts thereof, is made from a wipe-clean material having a substantially non-porous surface; and/or wherein the conduit securement device or one or more component parts thereof is provided with an antipathogenic coating, or impregnated with an antipathogenic component; and/or wherein the conduit securement device or one or more component parts thereof is provided with a luminescent coating or impregnated with a luminescent pigment or dye as taught by Khalaj to deliver or withdrawn fluids from a patient (Khalaj, Para [0005]).
Examiner interprets any medical-grade material to be inclusive of a wipe-clean material having a substantially non-porous surface.
Regarding claim 15, Brown in view of Peterson, Khalaj, and Glithero discloses a medical system (Brown, catheter tubing 22, catheter restraint 10, Fig. 1) comprising the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, and the flexible medical conduit secured to the conduit securement device,
wherein, when a longitudinal force is applied to the flexible medical conduit (Brown, "… a pulling force is applied to the catheter connecting tubing." - Para [8])
The following limitation is a recitation of intended use:
“in use of the securement device to secure said flexible medical conduit to a patient or a structure in a clinical setting, the first strap and/or the second strap elastically extend or further extend and increase the static friction with the flexible medical conduit.”
The MPEP (2114) states: It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.
However, Glithero teaches that in use of the securement device (tubing management member 150) to secure said flexible medical conduit (drainage tube and passage tube) to a patient or a structure in a clinical setting, the first strap and/or the second strap elastically extend or further extend (Glithero, "… the tubing management member 150 is capable of being flexed or bent out of plane." - Para [0024]) and increase the static friction with the flexible medical conduit (Glithero, "In some embodiments, one or more of the first or second tube passages may be configured to increase a friction between the drainage tube and the tube passages." - Para [0005])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include that when a longitudinal force is applied to the flexible medical conduit, the first strap and/or the second strap elastically extend or further extend and increase the static friction with the flexible medical conduit as taught by Glithero to stabilize the tubing (Glithero, Para [0028]).
Regarding claim 16, Brown in view of Peterson, Khalaj, and Glithero discloses the medical system (Brown, catheter tubing 22, catheter restraint 10, Fig. 1) as recited above, wherein
the flexible medical conduit is a fluid line (Brown, catheter tubing 22, Fig. 2) (Brown, "… the tubing may then be connected to the desired fluid …" - Para [9]), such or an electrical or optical conduit.
Regarding claim 27, Brown in view of Peterson, Khalaj, and Glithero discloses a conduit securement device (catheter restraint 10, Fig. 1), for securing a flexible conduit (catheter 20, Fig. 2), the conduit securement device comprising:
a support portion (backing 12, Fig. 1);
an elastically extendable first strap (strip 14a, Fig. 2)(“… flexible adhesive strips …” – Para [11]) coupled to the support portion (“The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12.” – Para [11]); a portion of the first strap being configured to be attached around a first region of the flexible medical conduit ("The catheter receptacle 20 is placed … between the strips 14a and 14b.” – Para [8], Fig. 2);
an elastically extendable second strap (strip 14b, Fig. 2) coupled to the support portion (“The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12.” – Para [11]); a portion of the second strap being configured to be attached around a longitudinally adjacent second region of said flexible medical conduit ("The catheter receptacle 20 is placed … between the strips 14a and 14b.” – Para [8], Fig. 2); and
a tertiary attachment (strip 14c, Fig. 2) for attaching a further region of said flexible conduit to the support portion ("A plurality of adhesive strips 14 emanate from or through the non-adhesive side of the backing 12 and may be attached thereto by pressure." - Para [3], Fig. 1) said further region being longitudinally adjacent the second region (Fig. 2) (“Additional strips may be added along either or both lines 16 and 18 …” – Para [4], Fig. 1);
wherein, when the first and second straps are attached around longitudinally adjacent first and second regions of the flexible conduit and secure the flexible conduit to the securement device (“The catheter receptable 20 is placed … between the strips 14a and 14b.” – Para [8], Fig. 2), the flexible medical conduit is urged into a curved or convoluted pathway by the straps (“The tubing is then formed into a loop …’ – Para [9], Fig. 2).
Brown does not expressly disclose an elastically extendable first strap and an elastically extendable second strap and that the support portion is less elastically extendable than the first and second straps and that in use of the device to secure said conduit, tension applied longitudinally to the flexible conduit secured to the device acts to straighten the curved or convoluted pathway and extend or further extend the first and/or second strap and increase as static friction with the flexible conduit.
Peterson teaches an elastically extendable first strap (adhesive strip 50, Figs. 1A and 1B, “Adhesive strip 50 may further include elastic properties which permit the strip to stretch and adhere itself to another surface.” – Col. 4 Line 39) and an elastically extendable second strap (adhesive strip 50, Figs. 1A and 1B) and that the support portion (catheter adapter 20, Fig. 1A) is less elastically extendable than the first and second straps (adhesive strips 50, Fig. 1B) (“The adhesive strap may comprise a flexible or elastic material thereby allowing the strap to be stretched …” – Col. 2, Line 34).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include an elastically extendable first strap and an elastically extendable second strap and that the support portion is less elastically extendable than the first and second straps as taught by Peterson to maintain a desired position of catheter adapter 20 (Peterson, Col. 3, Line 65).
Peterson does not expressly disclose that in use of the device to secure said conduit, tension applied longitudinally to the flexible conduit secured to the device acts to straighten the curved or convoluted pathway and extend or further extend the first and/or second strap and increase as static friction with the flexible conduit.
The limitation “in use of the conduit securement device to secure said flexible medical conduit to a patient or a structure in a clinical setting, tension applied longitudinally to the flexible medical conduit secured to the conduit securement device acts to straighten the curved or convoluted pathway” recited the intended use of the conduit securement device. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations.” MPEP 2114
However, Khalaj teaches that in use of the device (catheter strain relief clip 10, Fig. 1) to secure said flexible conduit (catheter 48, Fig. 1), tension applied longitudinally to the flexible conduit (“… the catheter is subjected to a pulling force from only one direction.” – Para [0017]) secured to the device acts to straighten the curved or convoluted pathway (“The cumulative effect of the various vertical deflections of the catheter 48 is beneficial in retaining the catheter and relieving axial stresses …” – Para [0041], Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include that in use of the device to secure said conduit, tension applied longitudinally to the flexible conduit secured to the device acts to straighten the curved or convoluted pathway as taught by Khalaj to retain the device at a target location (Khalaj, Para [0018])
Khalaj does not expressly disclose that tension applied longitudinally to the flexible conduit secured to the device acts to … extend or further extend the first and/or second strap and increase a static friction with the flexible conduit.
Glithero teaches that tension applied longitudinally to the flexible conduit secured to the device acts to … extend or further extend the first and/or second strap (“the tubing management member 150 is capable of being flexed or bent out of plane.” – Para [0024]) and increase a static friction with the flexible conduit (“… one or more of the first or second tube passages may be configured to increase a friction between the drainage tube and the tube passages.” – Para [0005])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include that tension applied longitudinally to the flexible conduit secured to the device acts to … extend or further extend the first and/or second strap and increase a static friction with the flexible conduit as taught by Glithero in order to stabilize the tubing (Glithero, Para [0028]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US Patent No. 4484914) in view of Peterson et al. (US Patent No. 9155867 B2), Khalaj (WO 2015/079333 A1), Glithero et al. (WO 2017/070013 A1, and in further view of Shesol et al. (US Patent No. 5,897,519) .
Regarding claim 12, Brown in view of Peterson, Khalaj, Glithero, and Shesol discloses the conduit securement device (Brown, catheter restraint 10, Fig. 1) as recited above, wherein
an external attachment (Brown, backing 12, Fig. 2), for attaching the conduit securement device to a patient (Brown, "… a patch or backing 12 having a pressure-sensitive adhesive on one surface thereof for binding to a patient's skin." - Para [2]),
Brown in view of Khalaj and Glithero does not disclose that the external attachment comprises a band for attachment around a patient's limb, or wherein the external attachment comprises a garment, or garment portion.
Shesol teaches that the external attachment comprises a band for attachment around a patient's limb (Shesol, wrap 12, Fig. 3), or wherein the external attachment comprises a garment, or garment portion.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the securement device of Brown in view of Khalaj and Glithero to include that the external attachment comprises a band for attachment around a patient's limb, or wherein the external attachment comprises a garment, or garment portion as taught by Brown for attaching the device 10 on various anatomic locations on the human body (Shesol, Para [3]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US Patent No. 4484914) in view of Peterson et al. (US Patent No. 9155867 B2), Khalaj (WO 2015/079333 A1), Glithero et al. (WO 2017/070013 A1), and in further view of Delk et al. (US Patent No. 5300037).
Regarding claim 18, Brown in view of Peterson, Khalaj, Glithero, and Delk discloses the medical system (Brown, catheter tubing 22, catheter restraint 10, Fig. 1) as recited above, comprising
conduits … secured to the conduit securement device along the curved or convoluted pathway (Brown, "The tubing is then formed into a loop …" - Para [9], Fig. 2) generally parallel to one another (Brown, “At least one additional strip 14 will be located along a second line 18 which is spaced apart from be generally parallel to the first line 16.” – Para [3]).
Brown in view of Khalaj and Glithero does not expressly disclose two or more conduits of the same or different types or diameters secured to the conduit securement device.
Delk teaches two or more conduits of the same or different types or diameters (Delk, "… an entire bundle comprising many different sizes and types of medical conduits could be enfolded as a unit and supported by the holder of this invention." - Para [2]) secured to the securement device (Delk, medical conduit holder 10, Fig. 1) (Delk, "… medical conduit holder 10 is shown holding a typical portion of a medical conduit C." - Para [2]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the medical system of Brown in view of Khalaj and Glithero to include disclose two or more conduits of the same or different types or diameters secured to the conduit securement device as taught by Delk to be adaptable to different sized or multiple tubing (Delk, Para [8]).
Claim(s) 19, 21, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US Patent No. 4484914) in view of Peterson (US Patent No. 9155867 B2).
Regarding claim 19, Brown in view of Peterson discloses a method (Brown, “… method for attaching a catheter to a patient …” – Para [6]) of securing a flexible medical conduit (Brown ,catheter 20, Fig. 2) comprising:
attaching a first strap (Brown ,strip 14a, Fig. 2) (Brown,"… flexible, adhesive strips …" - Para [11]) around a region of the flexible medical conduit (Brown ,"The catheter receptacle 20 is placed … between the strips 14a and 14b. The strips 14a and 14b … cover both the receptable and a portion of … the backing 12." - Para [8], Fig. 2);
attaching a second strap (Brown ,strip 14b, Fig. 2) around a longitudinally adjacent region of the flexible medical conduit;
attaching a tertiary attachment (Brown ,strip 14c, Fig. 2) to a tertiary region of the flexible medical conduit (Brown ,"Strips 14c and 14d are then used to fix the tubing 22 into the loop …" - Para [9], Fig. 2); and
urging the flexible medical conduit into a curved or convoluted pathway (Brown ,"The tubing is then formed into a loop …" - Para [9], Fig. 2) defined by the attachments between the flexible medical conduit and the first (Brown ,strip 14c, Fig. 2) and second straps (Brown ,strip 14d, Fig. 2) "Strips 14c and 14d are then used to fix the tubing 22 into the loop …" - Para [9], Fig. 2);
applying at least one of a first force to the first region of the flexible medical conduit by elastically extending the first strap, or a second force to the second region of the flexible medical conduit by elastically extending the second strap (Brown, "The strips 14a and 14b are then folded in opposite directions so that their adhesive surfaces cover both the receptable and a portion of … the backing 12. In this way, force exerted against the catheter receptacle in either direction is prevented from dislodging the receptacle.” – Para [8], Fig. 2).
Examiner interprets the folding of strips 14a and 14b around the catheter as the strips 14a and 14b being elastically extended.
Brown does not expressly disclose a first elastically extendable strap and a second elastically extendable strap.
Peterson teaches a first elastically extendable strap (adhesive strip 50, Figs. 1A and 1B, “Adhesive strip 50 may further include elastic properties which permit the strip to stretch and adhere itself to another surface.” – Col. 4 Line 39) and a second elastically extendable strap (adhesive strip 50, Figs. 1A and 1B).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the conduit securement device of Brown to include a first elastically extendable strap and a second elastically extendable strap as taught by Peterson to maintain a desired position of catheter adapter 20 (Peterson, Col. 3, Line 65).
Regarding claim 21, Brown in view of Peterson discloses the method (Brown, “… method for attaching a catheter to a patient …” – Para [6]) as recited above, wherein
PNG
media_image6.png
488
560
media_image6.png
Greyscale
when the first and second straps (Brown, strip 14a, Fig. 2) (Brown, strip 14b, Fig. 2) are elastically extended, at least a component of the second force opposes the first force (Brown, "The strips 14a and 14b are folded in opposite direction so that their adhesive surfaces cover both the receptacle and a portion of the non-adhesive surface of the backing 12. " - Para [8], See annotated Fig. 2)
Regarding claim 23, Brown in view of Peterson discloses the method (Brown, “… method for attaching a catheter to a patient …” – Para [6]) as recited above, comprising
wrapping the first and/or second strap (Brown, strip 14a, Fig. 2) (Brown, strip 14b, Fig. 2) around the flexible medical conduit, in opposite directions or senses (Brown, "The strips 14a and 14b are folded in opposite direction so that their adhesive surfaces cover both the receptacle and a portion of the non-adhesive surface of the backing 12. " - Para [8])
Regarding claim 24, Brown in view of Peterson discloses the method (Brown, “… method for attaching a catheter to a patient …” – Para [6]) as recited above, comprising
attaching two or more first (Brown, strip 14a, strip 14c, Fig. 2) and/or two or more second straps (Brown, strip 14b, 14d, Fig. 2) to the flexible medical conduit, whereby corresponding and adjacent first and second regions of the flexible medical conduit are alternately attached (Brown, See annotated Fig. 2)
PNG
media_image7.png
488
560
media_image7.png
Greyscale
Regarding claim 25, Brown in view of Peterson discloses the method (Brown, “… method for attaching a catheter to a patient …” – Para [6]) as recited above, wherein
the straps (Brown, strips 14, Fig. 1) form part of a securement device (Brown, "The adhesive strips 14 are secured directly to the upper surface of a single-layer backing 12." - Para [11]), wherein the securement device comprises an external attachment (Brown, backing 12, Fig. 2), wherein the method comprises attaching the external attachment to a patient or structure before or after securing the flexible medical conduit (Brown, "… a patch or backing 12 having a pressure-sensitive adhesive on one surface thereof for binding to a patient's skin." - Para [2]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US Patent No. 4484914) in view of Peterson et al. (US Patent No. 9155867 B2) and Delk et al. (US Patent No. 5300037).
Regarding claim 26, Brown in view of Peterson and Delk discloses the method (Brown, “… method for attaching a catheter to a patient …” – Para [6]) as recited above, comprising
Brown does not expressly disclose securing two or more flexible conduits to the securement device of the same or different types
Delk teaches securing two or more flexible conduits (Delk, "… an entire bundle comprising many different sizes and types of medical conduits could be enfolded as a unit and supported by the holder of this invention." - Para [2]) to the securement device (Delk, medical conduit holder 10, Fig. 1) (Delk, "… medical conduit holder 10 is shown holding a typical portion of a medical conduit C." - Para [2]) of the same or different types
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Brown to include securing two or more flexible conduits to the securement device of the same or different types as taught by Delk to be adaptable to different sized or multiple tubing (Delk, Para [8]).
Response to Arguments
Applicant’s arguments, see pages 2-6, filed 6/26/2206, with respect to the rejection(s) of claim(s) 1, 2, 4-7, 9, 11-13, 15, 16, 18-21, and 23-26 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Brown in view of Peterson.
102
Applicant argues that first Brown does not expressly disclose that the material of the strip 14 is "elastically extendable." Thus, the only basis by which the Examiner appears to support the assertion is that Brown inherently discloses the strip is "elastically extendable."
Secondly, Brown does not inherently disclose that the material of the strip 14 is "elastically extendable". In relying upon the theory of inherency, the Examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art. Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990) (emphasis in original). The Examiner has not made such a showing in the Office Action. Moreover, speculation as to the missing characteristic is insufficient. The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. In re Rijckaert, 9 F.3d 1531, 1534, 28 USPQ2d 1955, 1957 (Fed. Cir. 1993).
The Applicant submits that the Examiner's assertion that the "flexible" material of Brown is also necessarily "elastically extendable" is incorrect and based on insufficient speculation. The Applicant submits that a person of ordinary skill in the art would appreciate that a given material can independently be one or both of elastically extendable or flexible. There is no disclosure in Brown that in use in the clinical settings disclosed, the straps 14 necessarily elastically extend or further extend in any way or that the strip is otherwise elastically extendable.
At least for the foregoing reasons, the Applicant submits that Brown fails to disclose, expressly or inherently, all elements of amended claim 1. Therefore, the Applicant submits that claim 19 is not anticipated by Brown.
Claims 19, 21, and 23-25 depend from independent claim 19 discussed above, and, therefore, are submitted to be patentable for at least the same reasons.
103
Applicant argues that for at least the reasons noted above for claim 19, the Applicant submits that Brown fails to disclose at least the above-noted features of claim 1. Moreover, neither Khalaj nor Glithero remedies the deficiencies of Brown. Claims 2, 4-7, 9, 13, 15, and 16 depend from independent claim 1 discussed above, and, therefore, are submitted to be patentable for at least the same reasons. Claim 12 depends from independent claim 1 discussed above, and, therefore, is submitted to be patentable for at least the same reasons. Claim 18 depends from independent claim 1 discussed above, and, therefore, is submitted to be patentable for at least the same reasons. Claim 26 depends from independent claim 20 discussed above, and, therefore, is submitted to be patentable for at least the same reasons
Examiner interprets the argument above to overcome the previous prior art rejection. However, Peterson teaches the limitation “elastically extendable” as recited in the rejection above.
With respect to the applicants argument the rejection above teaches the claimed limitations. The rejection above is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights