DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/23/2026 has been entered.
Response to Amendments
The amendment filed 01/23/2026 has been entered. Claims 1, 6, 8-11, 14-26 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 06/26/2025.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6, 8-11, 14, 16, 17, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2011/0071469) in view of Patel (US 3,918,450) and further in view of Howell (US 2020/0330733) and further in view of Cameron (US 4,957,489).
Regarding claim 1, Wilson discloses a cannula arrangement (10, Fig 1) comprising a cannula support (16, Fig 2) with a distal end (20, Fig 2) and a proximal end (24, Fig 2), wherein a flow-through channel (interior lumen of cannula support 16, Best seen in Fig 4) extends within the cannula support between a distal end of the cannula support and a proximal end of the cannula support, and the flow-through channel defines a distal flow-through channel end section and a proximal flow-through channel end section (See Fig 4), - a cannula (18, Fig 1) with a distal end (26, Fig 2) and a proximal end (end opposite point 26, Fig 2), wherein a flow channel (interior lumen of needle, Best seen in Fig 4) extends within the cannula between a distal end of the cannula and a proximal end of the cannula (See Fig 4), a base body (12, Fig 1) with a distal end (46, Fig 2) and a proximal end (end near aperture 74, Fig 3), wherein a hole (hole that accommodates cannula support 16 and cannula 18, Best seen in Fig 4) extends in the base body between the distal end of the base body and the proximal end of the base body, and wherein at least the cannula support with the cannula held thereon is received in the hole and is adjustable in the axial direction in the hole (Para 0084, Para 0105),- a wing arrangement (100, Fig 2) with a tube-shaped retaining body (102, Fig 2) and wings (106, Fig 2) projecting from the retaining body on both sides, wherein the wings define a contact side (the underside of the wings, Fig 2) which can be positioned to face a patient, and- a coupling unit (108, 110, 112, Fig 2) arranged or formed between the retaining body and the base body, wherein the wing arrangement is held in a coupling position on the base body by the coupling unit (Para 0098 -Wilson), - wherein the proximal end of the cannula is received in the distal flow-through channel end section of the cannula support and is held on the cannula support (See Fig 4; Para 0086), and the cannula and the cannula support define a longitudinal axis (See Fig 1).
Wilson is silent regarding wherein as seen in axial section, the distal flow-through channel end section, starting from the distal end of the cannula support in the direction towards the proximal end of the cannula support, has a cross-sectional shape of stepped design with a first cross-sectional dimension and at least one further cross-sectional dimension, wherein each one of the cross-sectional dimensions defines an own receiving section for the respective cannula to be received therein, wherein the receiving sections are embodied so as to each have a hollow-cylindrical cross-section, wherein at least three receiving sections formed behind one another in the axial direction are provided, wherein each one of the receiving sections on a proximal end of each one of the receiving sections forms a planar, annular axial stop for the proximal end of the respective cannula received therein in each case, wherein the respective proximal end of the cannula is supported on the corresponding axial stop of the respective receiving section resting thereon in the direction towards the proximal end of the cannula support, wherein the cross-sectional dimension of each receiving section, starting from the distal end of the cannula support in the direction towards the proximal end of the cannula support, is in each case smaller than the cross-sectional dimension of the receiving section immediately upstream in the axial direction, and wherein each one of the cross-sectional dimensions of the receiving sections, which differ from one another, is embodied to receive the cannula with a corresponding cross-sectional cannula dimension in each case, and wherein an observation window is formed in the tube-shaped retaining body, said observation window being arranged on a side facing away from the contact side, and wherein in the coupling position, a protuberance projecting from the base body in the radial direction projects into the observation window, and - wherein the base body and the cannula support are made of a translucent or transparent material.
Patel teaches a cannula support (10, Fig 1), wherein a distal flow-through channel end section (14, Fig 1), starting from a distal end of the cannula support in the direction towards the proximal end of the cannula support, has a cross-sectional shape of stepped design with a first cross-sectional dimension (cross-sectional dimension of one of sections 16, Fig 1) and at least one further cross-sectional dimension (cross-sectional dimension of another one of sections 16, Fig 1), wherein each one of the cross-sectional dimensions defines an own receiving section (16, 17, Fig 1) for the respective cannula to be received therein, wherein the receiving sections (16, 17, Fig 1) are embodied so as to each have a hollow-cylindrical cross-section (Col 2, lines 14-16 ), wherein at least three, receiving sections (16, 17, Fig 1) formed behind one another in the axial direction are provided (See Fig 1), wherein each one of the recurving sections (16, 17, Fig 1) on its proximal end of the receiving section forms a planar, annular axial stop (17, Fig 1) for the proximal end of the respective cannula received therein in each case (Col 2, lines 46-52; See Fig 2), wherein the respective proximal end of the cannula is supported on the corresponding axial stop (17, Fig 1) of the respective receiving section (16, 17, Fig 1) resting thereon the direction towards the proximal end of the cannula support (Col 2, lines 46-63; See Fig 2), wherein the cross-sectional dimension of each receiving section, starting from the distal end of the cannula support in the direction towards the proximal end of the cannula support, is in each case smaller than the cross-sectional dimension of the receiving section immediately upstream in the axial direction, and wherein each one of the cross-sectional dimensions of the receiving sections, which differ from one another, is embodied to receive the cannula (52, Fig 2) with a corresponding cross-sectional cannula dimension in each case (Col 2, lines 46-59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula support disclosed by Wilson to comprise a stepped design as taught by Patel in order to have a cannula support that can accommodate various standard cannula sizes (Col 2, lines 46-59).
The modified invention of Wilson and Patel discloses a protuberance (108, Fig 2) projecting from the base body, however, is silent regarding an observation window is formed in the tube-shaped retaining body, said observation window being arranged on a side facing away from the contact side, and wherein in the coupling position, the protuberance projecting from the base body in the radial direction projects into the observation window and - wherein the base body and the cannula support are made of a translucent or transparent material.
Howell teaches an analogous cannula arrangement comprising a wing arrangement (200, Fig 2A) wherein a coupling unit (234,352, Fig 2G) is arranged or formed between the retaining body and the base body (300, Fig 1A) and wherein an observation window (234, Fig 2A) is formed in the tube-shaped retaining body, said observation window being arranged on a side facing away from the contact side, and wherein in the coupling position, a protuberance (352, Fig 2G) projecting from the base body in the radial direction projects into the observation window (Para 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the protuberance and retaining body disclosed by Wilson to be a retaining body with a window that engages with a protuberance as taught by Howell in order to provide additional anti-rotation feature as well as inhibit movement in a lateral direction, a longitudinal direction, or a combination thereof. This arrangement also provides tactile confirmation of correct seating of the two components. (Para 0062).
The modified invention of Wilson, Patel, and Howell discloses all of the elements of the invention as discussed above, however, is silent regarding the base body and the cannula support are made of a translucent or transparent material.
Cameron teaches an analogous base body (10, Fig 7) and cannula support (44, Fig 2c) that are made of a translucent or transparent material (Col 5, lines 35-49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base body and cannula support to be made of a translucent or transparent material in order for blood to be seen through the components to confirm placement in a blood vessel (Col 5, lines 35-49).
Regarding claim 6, the modified invention of Wilson, Patel, Howell, and Cameron discloses the cannula support (16, Fig 2 -Wilson) is formed by a component part of a safety cannula arrangement (See Fig 2 -Wilson).
Regarding claim 8, the modified invention of Wilson, Patel, Howell, and Cameron discloses an automatically acting adjusting element (52, Fig 2 -Wilson) is provided, said adjusting element being arranged acting between the base body and the cannula support (Para 0090 -Wilson), and the adjusting element displaces the cannula support together with the cannula held thereon from a first position, in which first position the cannula projects beyond the distal end of the base body, into a second position, in which second position at least the distal end of the cannula is covered by the base body (Para 0090; Para 0105 -Wilson).
Regarding claim 9, the modified invention of Wilson, Patel, Howell, and Cameron discloses a retaining device (30, 35, Fig 14 -Wilson) with multiple first retaining elements (35, Fig 14 -Wilson) and multiple second retaining elements (30, Fig 14 -Wilson) is provided, said retaining device defining the first position of the cannula support with respect to the base body in the mutually engaged position of the first and second retaining elements (Para 0104-0105 -Wilson), and wherein the first retaining elements are arranged in the region of the proximal end of the base body and the second retaining elements are arranged in the region of the proximal end of the cannula support (See Fig 14 -Wilson).
Regarding claim 10, the modified invention of Wilson, Patel, Howell, and Cameron discloses an arresting device (28, 66, Fig 4 -Wilson) with multiple first (66) and second (28) arresting elements (See Fig 4 -Wilson) is provided, said arresting device defining the second position of the cannula support with respect to the base body in the mutually engaged position of the first and second arresting elements (Para 0110-0112 -Wilson), and wherein the first arresting elements are arranged in the region of the proximal end of the base body and the second arresting elements are arranged in the region of the distal end of the cannula support (See Fig 4 -Wilson).
Regarding claim 11, the modified invention of Wilson, Patel, Howell, and Cameron discloses at least one relief recess (recess formed between protrusions 77 and 28, Figs 4-5 -Wilson) is arranged or formed in the cannula support (16, Fig 4 -Wilson), and wherein, when the cannula support is in the first position, the first arresting elements project into the at least one relief recess in their undeformed position (See Fig 4).
Regarding claim 14, the modified invention of Wilson, Patel, Howell, and Cameron discloses the coupling unit (108, 110, 112, Fig 2 -Wilson) further comprises an anti-rotation device with at least one first anti-rotation element (112, Fig 2 -Wilson) on or in the base body and at least one second anti-rotation element (110, Fig 2 -Wilson) cooperating therewith in or on the retaining body (Para 0098 -Wilson).
Regarding claim 15, the modified invention of Wilson, Patel, Howell, and Cameron discloses all of the elements of the invention as discussed, however, is silent regarding the at least one first anti-rotation element is embodied as a web and the at least one second anti-rotation element is embodied as a groove, and wherein the anti-rotation elements have a parallel longitudinal alignment with respect to the longitudinal axis.
Howell further teaches an analogous cannula arrangement comprising a wing arrangement (200, Fig 2A) wherein a coupling unit (228, 249, Fig 2H) is arranged or formed between the retaining body (220, Fig 2A) and the base body (300, Fig 1A) and wherein at least one first anti-rotation element (349A-B, Fig 2H) is embodied as a web and the at least one second anti-rotation element (228A-B, Fig 2H) is embodied as a groove, and wherein the anti-rotation elements have a parallel longitudinal alignment with respect to the longitudinal axis (Para 0062)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base body and retaining body 102 disclosed by Wilson to include retaining body with a first and second anti-rotational element as taught by Howell in order to provide additional anti-rotation feature as well as reduce rocking, pistoning, and/or kinking of the catheter (Para 0062).
Regarding claim 16, the modified invention of Wilson, Patel, Howell, and Cameron discloses the coupling unit (108, 110, 112, Fig 2 -Wilson) further comprises an axial securing device with at least one first axial securing element (108, Fig 2 -Wilson) on or in the base body and at least one second axial securing element (surface of 102 contacting element 108, Fig 1 -Wilson) cooperating therewith in or on the retaining body (Para 0098 -Wilson).
Regarding claim 17, the modified invention of Wilson, Patel, Howell, and Cameron discloses the axial securing elements (108, Fig 1-Wilson), as seen in axial section, are formed approximately with a triangular cross-section, wherein a first boundary line of the triangular cross-section, as viewed in the axial push-on direction of the wing arrangement onto the base body, defines a ramp formed to rise on the side facing away from the longitudinal axis , and a second boundary line of the triangular cross-section is oriented to run in a normal plane with respect to the longitudinal axis (See Fig 1 of Wilson wherein the resilient legs 108 have a ramped side and a normal side.).
Regarding claim 18, the modified invention of Wilson, Patel, Howell, and Cameron discloses a protective cover (76, Fig 2 -Wilson) is provided and the protective cover is arranged on the distal end of the base body and is detachably held thereon, wherein the cannula projecting from the base body in distal direction in the first position is covered by the protective cover (Para 0099).
Claims 19-21, 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2011/0071469) in view of Patel (US 3,918,450) and further in view of Howell (US 2020/0330733) and further in view of Cameron (US 4,957,489) and further in view of Rini (US 2021/0100960).
Regarding claim 19, the modified invention of Wilson, Patel, Howell, and Cameron discloses all of the elements of the invention as discussed, however, is silent regarding wherein at least two first longitudinal ribs and at least two second longitudinal ribs are arranged or formed distributed across the circumference on an internal surface of the protective cover facing the longitudinal axis, and wherein a first longitudinal rib and a second longitudinal rib are arranged alternately in the circumferential direction in each case.
Rini teaches an analogous protective cover (12, Fig 17) comprising at least two first longitudinal ribs (ribs 146 that don’t include element 154, Fig 18) and at least two second longitudinal ribs (154, Fig 18) are arranged or formed distributed across the circumference on an internal surface of the protective cover facing the longitudinal axis, and wherein a first longitudinal rib and a second longitudinal rib are arranged alternately in the circumferential direction in each case (See Fig 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify protective cover to include first and second longitudinal ribs as taught by Rini in order to improve coupling and alignment of the cap to the base body or needle hub as well as provide a stop to limit the depth that the base body protrudes into the cap cavity (0062-Para 0064).
Regarding claim 20, the modified invention of Wilson, Patel, Howell, Cameron and Rini discloses in the undeformed cross-section of the protective cover, first ends of the first longitudinal ribs (ribs 146 that don’t include element 154, Fig 18 -Rini) end at a first radial distance in front of the longitudinal axis and second ends of the second longitudinal ribs (154, Fig 18 -Rini) end at a second radial distance in front of the longitudinal axis, wherein the first radial distance is larger than the second radial distance (See Fig 18 of Rini wherein the second longitudinal ribs protrude further than the first longitudinal ribs).
Regarding claim 21, the modified invention of Wilson, Patel, Howell, Cameron and Rini discloses the first ends of the first longitudinal ribs are arranged on a first circular path and the second ends of the second longitudinal ribs are arranged on a second circular path and the two circular paths are arranged concentrically with respect to the longitudinal axis (See Fig 18 and 21 of Rini).
Regarding claim 23, the modified invention of Wilson, Patel, Howell, Cameron and Rini discloses wherein the total number of the first longitudinal ribs and the second longitudinal ribs is an even number and is selected from a total number of four, six, eight or ten (Para 0062 -Rini, there can be four detents and 4 stop members totaling 8).
Regarding claim 24, the modified invention of Wilson, Patel, Howell, Cameron and Rini discloses wherein the first longitudinal ribs (ribs 146 that don’t include element 154, Fig 18 -Rini), as seen in radial section, each have a wave shape (See Fig 19 -Rini).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2011/0071469) in view of Patel (US 3,918,450) and further in view of Howell (US 2020/0330733) and further in view of Cameron (US 4,957,489) and further in view of Rini (US 2021/0100960) and further in view of Pouget (US 2021/0379294).
Regarding claim 22, the modified invention of Wilson, Patel, Howell, Cameron and Rini discloses all of the element of the invention as discussed above, however, is silent regarding wherein a difference value of the first radial distance minus the second radial distance is in a difference value range the lower limit of which is 0.01 mm, preferably 0.04 mm, and the upper limit of which is 0.1 mm, preferably 0.06 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify height of the first longitudinal ribs (thereby changing the difference between the first radial distance and the second radial distance) since Pouget teaches that the height of a rib can be adjusted to adjust the pull force required to remove the cap (Para 0014-0015) and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 25-26 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson (US 2011/0071469) in view of Patel (US 3,918,450) and further in view of Howell (US 2020/0330733) and further in view of Cameron (US 4,957,489) and further in view of Shaw (US 2005/0131350)
Regarding claim 25, the modified invention of Wilson, Patel, Howell, and Cameron discloses a translucent or transparent material (Col 5, lines 35-49 -Cameron), however is silent regarding the material being a plastic material.
Shaw teaches a base body (12, Fig 1) made of a translucent or transparent material wherein the translucent or transparent material comprises a plastic material (Para 0018).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base body and cannula support to be made of a translucent or transparent plastic material as taught by Shaw in order to have material that is able to be injection molded for easier manufacturing while still being transparent and providing an easy viewing experience (Para 0018).
Regarding Claim 26, Wilson discloses an assembly (10, Fig 1) comprising - a cannula support (16, Fig 2) comprising a coupling part (24, Fig 2) with a distal end (20, Fig 2) and a proximal end (24, Fig 2), wherein a flow-through channel (interior lumen of cannula support 16, Best seen in Fig 4) extends within the cannula support between a distal end of the cannula support and a proximal end of the cannula support, and the flow-through channel defines a distal flow-through channel end section and a proximal flow-through channel end section (See Fig 4), - a cannula (18, Fig 1) held on the cannula support with a distal end (26, Fig 2) and a proximal end (end opposite point 26, Fig 2), wherein a flow channel (interior lumen of needle, Best seen in Fig 4) extends within the cannula between a distal end of the cannula and a proximal end of the cannula (See Fig 4), a base body (12, Fig 1) with a distal end (46, Fig 2) and a proximal end (end near aperture 74, Fig 3), wherein a hole (hole that accommodates cannula support 16 and cannula 18, Best seen in Fig 4) extends in the base body between the distal end of the base body and the proximal end of the base body, and wherein at least the cannula support with the cannula held thereon is received in the hole and is adjustable in the axial direction in the hole (Para 0084, Para 0105), - a wing arrangement (100, Fig 2) with a tube-shaped retaining body (102, Fig 2) and wings (106, Fig 2) projecting from the retaining body on both sides, wherein the wings define a contact side (the underside of the wings, Fig 2) which can be positioned to face a patient, and- a coupling unit (108, 110, 112, Fig 2) arranged or formed between the retaining body and the base body, wherein the wing arrangement is held in a coupling position on the base body by the coupling unit (Para 0098 -Wilson), - wherein the proximal end of the cannula is received in the distal flow-through channel end section of the cannula support and is held on the cannula support (See Fig 4; Para 0086), and the cannula and the cannula support define a longitudinal axis (See Fig 1).
Wilson is silent regarding cannula support comprising a female Luer coupling part; wherein as seen in axial section, the distal flow-through channel end section, starting from the distal end of the cannula support in the direction towards the proximal end of the cannula support, has a cross-sectional shape of stepped design with a first cross-sectional dimension and at least one further cross-sectional dimension, wherein each one of the cross-sectional dimensions defines an own receiving section for the respective cannula to be received therein, wherein the cross-sectional dimension of each receiving section, starting from the distal end of the cannula support in the direction towards the proximal end of the cannula support, is in each case smaller than the cross-sectional dimension of the receiving section immediately upstream in the axial direction, and wherein each one of the cross-sectional dimensions of the receiving sections, which differ from one another, is embodied to receive the cannula with a corresponding cross-sectional cannula dimension in each case, and wherein an observation window is formed in the tube-shaped retaining body, said observation window being arranged on a side facing away from the contact side, and wherein in the coupling position, a protuberance projecting from the base body in the radial direction projects into the observation window, and - wherein the base body and the cannula support are made of a translucent or transparent material.
Patel teaches a cannula support (10, Fig 1), wherein a distal flow-through channel end section (14, Fig 1), starting from a distal end of the cannula support in the direction towards the proximal end of the cannula support, has a cross-sectional shape of stepped design with a first cross-sectional dimension (cross-sectional dimension of one of sections 16, Fig 1) and at least one further cross-sectional dimension (cross-sectional dimension of another one of sections 16, Fig 1), wherein each one of the cross-sectional dimensions defines an own receiving section (16, 17, Fig 1) for the respective cannula to be received therein, wherein the receiving sections (16, 17, Fig 1) are embodied so as to each have a hollow-cylindrical cross-section (Col 2, lines 14-16 ), wherein at least three, receiving sections (16, 17, Fig 1) formed behind one another in the axial direction are provided (See Fig 1), wherein each one of the recurving sections (16, 17, Fig 1) on its proximal end of the receiving section forms a planar, annular axial stop (17, Fig 1) for the proximal end of the respective cannula received therein in each case (Col 2, lines 46-52; See Fig 2), wherein the respective proximal end of the cannula is supported on the corresponding axial stop (17, Fig 1) of the respective receiving section (16, 17, Fig 1) resting thereon the direction towards the proximal end of the cannula support (Col 2, lines 46-63; See Fig 2), wherein the cross-sectional dimension of each receiving section, starting from the distal end of the cannula support in the direction towards the proximal end of the cannula support, is in each case smaller than the cross-sectional dimension of the receiving section immediately upstream in the axial direction, and wherein each one of the cross-sectional dimensions of the receiving sections, which differ from one another, is embodied to receive the cannula (52, Fig 2) with a corresponding cross-sectional cannula dimension in each case (Col 2, lines 46-59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula support disclosed by Wilson to comprise a stepped design as taught by Patel in order to have a cannula support that can accommodate various standard cannula sizes (Col 2, lines 46-59).
The modified invention of Wilson and Patel discloses a protuberance (108, Fig 2) projecting from the base body, however, is silent regarding an observation window is formed in the tube-shaped retaining body, said observation window being arranged on a side facing away from the contact side, and wherein in the coupling position, the protuberance projecting from the base body in the radial direction projects into the observation window and - wherein the base body and the cannula support are made of a translucent or transparent material.
Howell teaches an analogous cannula arrangement comprising a wing arrangement (200, Fig 2A) wherein a coupling unit (234,352, Fig 2G) is arranged or formed between the retaining body and the base body (300, Fig 1A) and wherein an observation window (234, Fig 2A) is formed in the tube-shaped retaining body, said observation window being arranged on a side facing away from the contact side, and wherein in the coupling position, a protuberance (352, Fig 2G) projecting from the base body in the radial direction projects into the observation window (Para 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the protuberance and retaining body disclosed by Wilson to be a retaining body with a window that engages with a protuberance as taught by Howell in order to provide additional anti-rotation feature as well as inhibit movement in a lateral direction, a longitudinal direction, or a combination thereof. This arrangement also provides tactile confirmation of correct seating of the two components. (Para 0062).
The modified invention of Wilson, Patel, and Howell discloses all of the elements of the invention as discussed above, however, is silent regarding the base body and the cannula support are made of a translucent or transparent material.
Cameron teaches an analogous base body (10, Fig 7) and cannula support (44, Fig 2c) that are made of a translucent or transparent material (Col 5, lines 35-49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base body and cannula support to be made of a translucent or transparent material in order for blood to be seen through the components to confirm placement in a blood vessel (Col 5, lines 35-49).
The modified invention of Wilson, Patel, Howell, and Cameron discloses all of the elements of the invention as discussed, however, is silent regarding the cannula support comprising a female Luer coupling part
Jaquez teaches a cannula support (300, Fig 1B) comprising a female Luer coupling part (Para 306) (Para 0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling part to instead be a female Luer coupling part as taught by Jaquez in order to have a connector that can couple the cannula to various additional devices (Para 0027).
Response to Arguments
Applicant’s arguments filed 01/23/2026, on pages 13-14, regarding Patel not disclosing the use of the specific planar, annular stop surfaces within the context of a retractable safety housing have been fully considered but are not persuasive. While Patel does not disclose the stop surfaces within the context of a retractable safety housing, Patel is still analogous art. Patel is analogous at least because it is within the same field of endeavor as the instant invention and Patel are both classified under the A61M 5/00 heading directed to devices for bringing media into the body. Further, Patel addresses the same problem that the instant invention seeks to solve in that it provides a stepped surfaces to accommodate different sized of catheters. Therefore, one of ordinary skill in the art would look to Patel if they wanted to have a cannula support that can accommodate various standard cannula sizes (Col 2, lines 46-59)
Applicant’s arguments filed 01/23/2026, on page 14, regarding Howell’s window being used for mechanical coupling or anti-rotation rather than part of the multi-step cannula support have been fully considered but are not persuasive. Firstly, the claims only require that the observation window be a part of the retaining body (which Howell’s does), not part of the multi-stepped cannula support with defined stops. Further, the claimed observation window 46, shown in Fig 1, is structured such that it provides securement to a protuberance on the base body. This appears to provide the same function as the observation window 234 taught in Howell (securement to a protuberance 352 thereby inhibiting movement and rotation as detailed in Para 0062).
Applicant’s arguments filed 01/23/2026, on page 14, regarding Cameron failing to teach the stepped geometry with at least three axial stops support have been fully considered but are not persuasive. As detailed in the rejection above, Cameron is not relied upon to teach the axial steps. Cameron is only relied upon to teach why one of ordinary skill would make the base body and cannula support made of translucent or transparent material. That to allow blood to be seen through the components to confirm placement in a blood vessel (Col 5, lines 35-49).
Applicant’s arguments filed 01/23/2026, on page 15, regarding there being no motivation to combine Patel’s steps with Wilson’s safety hub in a manner that requires the precision of planar axial stops have been fully considered but is not persuasive. It is unclear to the Examiner what degree of precision Applicant is referring to. As detailed in the rejection of the independent claims above, Patel discloses steps and planar axial stops that receive different sized catheter (Col 2, lines 46-63).
Applicant’s arguments filed 01/23/2026, on pages 13 14, appear to be piecemeal criticisms of the references while disregarding the combination. Applicant is reminded that “one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)” (MPEP 2145(IV)).
Conclusion
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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