DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed December 08, 2025 has been entered. Claims 1-3, 6-10, 12-17, and 19-24 remain pending in the application. Claims 4-5, 11, and 18 were previously cancelled. Applicant’s amendments to the claims have overcome the rejections under 35 USC 101 previously set forth in the Non-Final Office Action mailed July 07, 2025.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21 and 22 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nowak et al. (USPN 4699616).
Regarding claim 21, Nowak discloses a stabilizer (catheter support structure 12: Figures 8-10) for an intraosseous device (catheter C) including a cannula and a hub (noted that the “intraosseous device”, “cannula”, and “hub” are not positively recited or claimed), the stabilizer comprising:
a first stabilizer member (clamping bar 125) including a first extension member (see annotated Figure 9 below), a second extension member (see annotated Figure 9 below) extending in an opposite direction from the first extension member (Figure 9), a first coupling surface (arcuate surface of clamping bar 125 having barbs 34) disposed between the first and second extension members (Figure 9), and a first connection portion (ratchet 130);
a second stabilizer member (clamping bar 126) including a third extension member (see annotated Figure 9 below), a fourth extension member (see annotated Figure 9 below) extending in an opposite direction from the third extension member (Figure 9), a second coupling surface (arcuate surface of clamping bar 126 having barbs 34) disposed between the third and fourth extension members (Figure 9), and a second connection portion (recess 131);
a first lower sidewall (right half of curved planar base 21 connected to right flexible support arm 24, see annotated Figure 9 below) and a second lower sidewall (left half of curved planar base 21 connected left flexible support arm 24, see annotated Figure 9 below), the first lower sidewall laterally extending from at least one of a bottom portion of the first extension member or the a bottom portion of the second extension member, and the second lower sidewall laterally extending from at least one of a bottom portion of the third extension member or the a bottom portion of the fourth extension member (Figure 8);
where the first connection portion of the first stabilizer member is releasably engageable with the second connection portion of the second stabilizer member (“bars 125, 126 are not permanently joined at one end but instead are provided with ratchet assemblies 130, 131 at both ends.” [Col 5, line 59]);
where the first extension member is configured to be proximate to the third extension member when the first connection portion engages the second connection portion (Figure 8, see Figure 7 for example of stabilizer in fully closed position), and the second extension member is configured to be proximate to the fourth extension member when the first connection portion engages the second connection portion (Figure 8, see Figure 7 for example of stabilizer in fully closed position);
where the first and second coupling surfaces cooperate to define an opening (see annotated Figure 9 below and Figure 8, opening extending from proximal-most surface of catheter support structure 12 to distal-most surface of catheter support structure at pad 11, wherein the arcuate surfaces of clamping bars 125, 126 define at least a proximal portion of the opening) configured to receive a portion of the intraosseous device (catheter C) when the first connection portion engages the second connection portion, the opening extending from a proximal end of the stabilizer to a distal-most end of the stabilizer (Figures 8 and 10), and wherein a diameter of the opening at the distal-most end is larger than a diameter of the opening at the proximal end (Figure 8 showing that the diameter at the distal-most end of the opening at pad 11 is larger than a diameter of the opening at the proximal-most surface of catheter support structure 12).
Regarding claim 22, Nowak discloses the stabilizer of claim 21, further comprising a first flexible tab (right half of barrier pad 11; “pad 11 is shown to be composed of a top layer 16 of resilient, flexible, fine-celled thermoplastic foam” [Col 3, lines 33-35]) coupled to the first lower sidewall (Figures 4 and 8; “base 21 is sealed adhesively…to the upper surface of pad 11” [Col 5, lines 52-54]); and a second flexible tab (left half of barrier pad 11; “pad 11 is shown to be composed of a top layer 16 of resilient, flexible, fine-celled thermoplastic foam” [Col 3, lines 33-35]) coupled to the second lower sidewall (Figures 4 and 8; “base 21 is sealed adhesively…to the upper surface of pad 11” [Col 5, lines 52-54]).
Claim 24 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Enns et al. (US 2006/0030825).
Regarding claim 24, Enns discloses a stabilizer (housing 16) for an intraosseous device including a cannula (needle 12) and a hub (sleeve 54 having flange 56; noted that the “intraosseous device”, “cannula”, and “hub” are not positively recited or claimed), the stabilizer comprising:
a first stabilizer member (first component 70) including a first extension member (right side of inner surface 78, see annotated Figure 5 below), a second extension member (left side of inner surface 78, see annotated Figure 5 below) extending in an opposite direction from the first extension member (Figure 5), a first coupling surface (sleeve-receiving cavity 82 and chamber 84) disposed between the first and second extension members (Figure 5), a first connection portion (pins 74), and a first lower sidewall (flat base 62 attached to first component 70), the first lower sidewall having a first portion (right side of base 62 attached to first component 70) directly connected to the first extension member (Figure 5) and laterally extending from the first extension member (Figure 5), and a second portion (left side of base 62 attached to first component 70) directly connected to the second extension member (Figure 5) and laterally extending from the second extension member (Figure 5);
a second stabilizer member (second component 72) including a third extension member (right side of inner surface 80 of second component 72, see annotated Figure 5), a fourth extension member (left side of inner surface 80 of second component 72, see annotated Figure 5) extending in an opposite direction from the third extension member, a second coupling surface (sleeve-receiving cavity 82 and chamber 84; “The inner surfaces 78, 80 of the respective components 70, 72 define a sleeve-receiving cavity 82, a chamber 84” [0030]) disposed between the third and fourth extension members, a second connection portion (recesses 76; “The components 70, 72 are coupled to one another by corresponding pins 74 and recesses 76 that are provided in the surfaces 78, 80.” [0029]) releasably engageable with the first connection portion of the first stabilizer member (Figure 5; “The components 70, 72 are coupled to one another by corresponding pins 74 and recesses 76 that are provided in the surfaces 78, 80. The pins 74 fit snugly into the recesses 76 to secure the components 70, 72 together. Male-female keys 75 are further provided in the surfaces 78, 80 to ensure that the components 70, 72 are properly aligned.” [0029]), and a second lower sidewall (flat base 62 attached to second component 72), the second lower sidewall having a first portion (right side of base 62 attached to first component 70) directly connected to the third extension member (Figure 5) and laterally extending from the third extension member (Figure 5), and a second portion (left side of base 62 attached to first component 70) directly connected to the fourth extension member (Figure 5) and laterally extending from the fourth extension member (Figure 5);
where the first extension member (right side of inner surface 78) is configured to be proximate to the third extension member (right side of inner surface 80) when the first connection portion engages the second connection portion, and the second extension member (left side of inner surface 78) is configured to be proximate to the fourth extension member (left side of inner surface 78) when the first connection portion engages the second connection portion (“The first component 70 includes an inner surface 78 that abuts an inner surface 80 of the second component 72, when the housing body 60 is assembled. The components 70, 72 are coupled to one another by corresponding pins 74 and recesses 76 that are provided in the surfaces 78, 80. The pins 74 fit snugly into the recesses 76 to secure the components 70, 72 together.” [0029]);
wherein the first and second coupling surfaces define an opening (“The inner surfaces 78, 80 of the respective components 70, 72 define a sleeve-receiving cavity 82, a chamber 84” [0030]) configured to receive a portion of the hub (sleeve 54 having flange 56) of the intraosseous device when the first connection portion engages the second connection portion (“The sleeve-receiving cavity 82 includes an aperture 88, which extends through a rear end 90 of the housing body 60, and a slot 92. The slot 92 includes a pair of arms 94 that are directed toward a lower surface 93 of the slot 92. The arms 94 act as a spring to bias the outwardly extending flange 56 of the sleeve 54 toward the lower surface 93.” [0030]; Figure 4),
wherein the opening extends from a proximal end of the stabilizer (at upper surface 90) to a distal end of the stabilizer (at forward end of housing body 60, Figure 4 showing that chamber 84 is at the distal end of the housing 16), the distal end of the stabilizer is configured to be proximate to an insertion site on a patient (Figure 4), and
wherein the first and second coupling surfaces (sleeve-receiving cavity 82 and chamber 84) are configured to receive a portion of the hub of the intraosseous device (sleeve 54 and extension 56) in a plurality of different positions relative to the insertion site on the patient (Figure 4), the plurality of different positions including a first position (position of extension 56) and a second position (position of sleeve 54), such that the first position is located closer to the distal end than the proximal end, and the second position is located closer to the proximal end than the distal end (Figure 4 showing extension 56 received in slot 92 of cavity 82 in a first position closer to the distal end and sleeve 54 received in aperture 88 of cavity 82 in more proximal, second position).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6-10, 12-13, 15-16, and 19-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Enns et al. (US 20060030825) in view of Wright (US 20060247577).
Regarding claim 1, Enns discloses a stabilizer (housing 16) for an intraosseous device including a cannula (needle 12) and a hub having a coupling portion (sleeve 54; noted that the “intraosseous device”, “cannula”, and “hub having a coupling portion” are not positively recited or claimed), the stabilizer comprising:
a first stabilizer member (first component 70) including a first extension member (right side of inner surface 78, see annotated Figure 5 below), a second extension member (left side of inner surface 78, see annotated Figure 5 below) extending in an opposite direction from the first extension member (Figure 5), a first coupling surface (sleeve-receiving cavity 82 and chamber 84) disposed between the first and second extension members (Figure 5), and a first connection portion (pins 74);
a second stabilizer member (second component 72) including a third extension member (right side of inner surface 80 of second component 72, see annotated Figure 5), a fourth extension member (left side of inner surface 80 of second component 72, see annotated Figure 5) extending in an opposite direction from the third extension member, a second coupling surface (sleeve-receiving cavity 82 and chamber 84; “The inner surfaces 78, 80 of the respective components 70, 72 define a sleeve-receiving cavity 82, a chamber 84” [0030]) disposed between the third and fourth extension members, and a second connection portion (recesses 76; “The components 70, 72 are coupled to one another by corresponding pins 74 and recesses 76 that are provided in the surfaces 78, 80.” [0029]);
a planar first lower sidewall (flat base 62 attached to first component 70; and
a planar second lower sidewall (flat base 62 attached to second component 72);
where the first connection portion of the first stabilizer member is releasably engageable with the second connection portion of the second stabilizer member (Figure 5; “The components 70, 72 are coupled to one another by corresponding pins 74 and recesses 76 that are provided in the surfaces 78, 80. The pins 74 fit snugly into the recesses 76 to secure the components 70, 72 together. Male-female keys 75 are further provided in the surfaces 78, 80 to ensure that the components 70, 72 are properly aligned.” [0029]);
where the first extension member is configured to be proximate to the third extension member when the first connection portion engages the second connection portion, and the second extension member is configured to be proximate to the fourth extension member when the first connection portion engages the second connection portion (“The first component 70 includes an inner surface 78 that abuts an inner surface 80 of the second component 72, when the housing body 60 is assembled. The components 70, 72 are coupled to one another by corresponding pins 74 and recesses 76 that are provided in the surfaces 78, 80. The pins 74 fit snugly into the recesses 76 to secure the components 70, 72 together.” [0029]);
where a first portion of the planar first lower sidewall (right side of flat base 62 attached to first component 70) is directly connected to a distal-most end of the first extension member (Figure 5), and a second portion of the planar first lower sidewall (left side of flat base 62 attached to first component 70) is directly connected to a distal-most end of the second extension member (Figure 5);
where a first portion of the planar second lower sidewall (right side of flat base 62 attached to second component 72) is directly connected to a distal-most end of the third extension member (Figure 5), and a second portion of the planar second lower sidewall (left side of flat base 62 attached to second component 72) is directly connected to a distal-most end of the fourth extension member (Figure 5);
where the first and second coupling surfaces cooperate to define an opening (“The inner surfaces 78, 80 of the respective components 70, 72 define a sleeve-receiving cavity 82, a chamber 84” [0030]) for receiving a portion of the intraosseous device (sleeve 54 and flange 56) when the first connection portion engages the second connection portion, the opening extending from a proximal end of the stabilizer to a distal end of the stabilizer (“The sleeve-receiving cavity 82 includes an aperture 88, which extends through a rear end 90 of the housing body 60, and a slot 92. The slot 92 includes a pair of arms 94 that are directed toward a lower surface 93 of the slot 92. The arms 94 act as a spring to bias the outwardly extending flange 56 of the sleeve 54 toward the lower surface 93.” [0030]; Figure 4);
where the first and second coupling surfaces are configured to grip the coupling portion of the hub of the intraosseous device (Figure 4); and
where the stabilizer is operable to keep the intraosseous device in a stable position relative to a patient when the first connection portion of the first stabilizer member engages the second connection portion of the second stabilizer member (Figure 4).
Enns fails to explicitly disclose a first flexible tab adhesively coupled to the planar first lower sidewall, and a second flexible tab adhesively coupled to the planar second lower sidewall.
Wright teaches a stabilizer (shielding device 10) having first and second stabilizer members (left and right sides of slotted securement 12; Figure 9), the first stabilizer member comprising a first flexible tab (wing 120A, Figure 26 showing the wings are flexible) adhesively coupled to a first lower sidewall (flange 22A), and a second flexible tab (wing 120B, Figure 26 showing the wings are flexible) adhesively coupled to a second lower sidewall (flange 22B; “As the cover 14 is dropped into the hole 106, the upper surface area of its flange 22A and 22B are secured by the adhesive layer 102A and 102B to the base wings 120A and 120B respectively.” [0057]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the stabilizer of Enns to include first and second flexible tabs adhesively coupled to the first and second flexible tabs based on the teachings of Wright to provide a means for securing the stabilizer to the skin of the patient for an extended period of time in a manner that protects the adhesive surfaces prior to use (Wright [0035-0036]).
Regarding claim 2, modified Enns discloses the stabilizer of claim 1, wherein a portion of the opening has a longitudinal axis disposed at a non-zero degree angle relative to a plane of a proximal surface of the first stabilizer member and a plane of a proximal surface of the second stabilizer member (Figures 4 and 5, showing that the longitudinal axis of the opening is perpendicular to the planar of a proximal surface).
Regarding claim 3, modified Enns discloses the stabilizer of claim 2, wherein the longitudinal axis of the opening is perpendicular to the plane of the proximal surface of the first stabilizer member and the plane of the proximal surface of the second stabilizer member (Figures 4 and 5 showing that the longitudinal axis of the opening is perpendicular to the planar of a proximal surface).
Regarding claim 6, modified Enns discloses the stabilizer of claim 1.
Enns fails to explicitly disclose an adhesive layer coupled to at least one of the first and second tabs for adhering the stabilizer to the patient.
Wright teaches a stabilizer to retain a fluid delivery device comprising first and second flexible tabs (wing 120A, 120B) and an adhesive layer (adhesive layer 136A, 136B; Figure 23) coupled to at least one of the first and second tabs for adhering the stabilizer to the patient (“pressing the adhesive layers 136A and 136B against the skin of the patient” [0036]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to have modified the stabilizer of Enns to include an adhesive layer coupled to at least one of the first and second tabs based on the teachings of Wright to provide a means to secure the apparatus to the skin of the patient for an extended period of time (Wright [0036]).
Regarding claim 7-10, modified Enns discloses the stabilizer of claim 1.
Modified Enns fails to explicitly teach wherein the first tab comprises a first double-sided adhesive layer having an upper side coupled to a lower surface of the first stabilizer member, and the second tab comprises a second double-sided adhesive layer having an upper side coupled to a lower surface of the second stabilizer member, as required by claim 7; wherein the first tab further comprises a first single-sided adhesive layer having a lower side coupled to an upper surface of the first stabilizer member and to a portion of the upper side of the first double-sided adhesive layer that is not coupled to the lower surface of the first stabilizer member; and the second tab further comprises a second single-sided adhesive layer having a lower side coupled to an upper surface of the second stabilizer member and to a portion of the upper side of the second double-sided adhesive layer that is not coupled to the lower surface of the second stabilizer member, as required by claim 8; wherein the first tab further comprises a first liner layer coupled to a lower side of the first double-sided adhesive layer, the first liner layer configured to be removable from the lower side of first double-sided adhesive layer such that the lower side of the first double-sided adhesive layer can be adhered to the skin of the patient; and the second tab further comprises a second liner layer coupled to a lower side of the second double-sided adhesive layer, the second liner layer configured to be removable from the lower side of second double-sided adhesive layer such that the lower side of the second double-sided adhesive layer can be adhered to the skin of the patient, as required by claim 9; and wherein the first liner layer includes a first tab portion extending beyond a peripheral edge of the first double-sided adhesive layer, and the second liner layer includes a second tab portion extending beyond a peripheral edge of the second double- sided adhesive layer, as required by claim 10.
Wright teaches a stabilizer (shielding device 10) having first and second stabilizer members (left and right sides of slotted securement 12 having flanges 22A, 22B; Figure 9), the first stabilizer member comprising a first tab and a second tab (two opposing wings 120A and 120B); wherein the first tab and second tab each comprises a double-sided adhesive layer (plastic material 130 of plug 160 having adhesive 132 and 136; Figure 23) having an upper side (adhesive 132) coupled to a lower surface of the respective stabilizer members (“The plug 160A and 160B is then again inverted as best seen in FIG. 19, and moved into overlaying engagement with the exposed flanges 22A and 22B of the cover 14 that was previously mounted to the base 120…the plug 160A and 160B is utilized to cover and secure the cover 14 to the base 120.” [0063]; Figures 19 and 23 showing that adhesive 132 in contact with the lower surface of the flanges 22A, 22B), as required by claim 7;
wherein the first and second tabs (wing 120A and 120B) each further comprises a single-sided adhesive layer (plastic layers 100A and 100B “each of the smooth plastic layers 100A and 100B is coated on its underside with a layer of non-skin irritating adhesive 102A and 102B respectively” [0035]) having a lower side coupled to an upper surface of the respective stabilizer member (“As the cover 14 is dropped into the hole 106, the upper surface area of its flange 22A and 22B are secured by the adhesive layer 102A and 102B to the base wings 120A and 120B respectively.” [0057]) and to a portion of the upper side of the double-sided adhesive layer (adhesive 132 of plastic material 130) that is not coupled to the lower surface of the respective stabilizer member (Figure 23, wherein the adhesive 132 is coupled to adhesive 102 outside boundary of the stabilizer members), as required by claim 8;
wherein the first and second tabs (wings 120A and 120B) each further comprise a liner layer (protective covers 17, 104A, 104B) coupled to a lower side of the double-sided adhesive layer (adhesive 136 of plastic material 130; Figures 22 and 23), the liner layer configured to be removable from the lower side of double-sided adhesive layer such that the lower side of the double-sided adhesive layer can be adhered to the skin of the patient (“The protective covers 17 and 104A and 104B are removable and are provided to protect the adhesive surfaces 136A and 136B and 102A and 102B respectively until such time as the securement 120 is ready to be utilized with a patient.” [0036]), as required by claim 9; and
wherein the liner layers (protective covers 17, 104A, 104B) each includes a tab portion extending beyond a peripheral edge of the double-sided adhesive layer (Figures 9 and 22 showing protective cover 17 extending beyond peripheral edge of adhesive 136 and “paper coverings 104A and 104B are each provided with a set of spaced apart lifting ears, such as the ears 212 and 214” [0066]), as required by claim 10.
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the first and second tabs of the stabilizer of Enns to each include a double-sided adhesive layer, a first single-sided adhesive layer, and a liner layer including a tab portion based on the teachings of Wright to provide a means for securing the stabilizer to the skin of the patient for an extended period of time in a manner that protects the adhesive surfaces prior to use (Wright [0035-0036]).
Regarding claim 12, modified Enns discloses the stabilizer of claim 2, wherein the first and second stabilizer members include a respective outer portion (outer surfaces of first and second components 70, 72; Figure 5) for gripping by a user.
Regarding claim 13, modified Enns discloses the stabilizer of claim 12, wherein the outer portion includes an arcuate shape (arcuate outer surfaces of first and second components 70, 72; Figure 5).
Regarding claim 15, modified Enns discloses the stabilizer of claim 12, wherein the outer portion includes an expanded or indented portion (arcuate outer surfaces of first and second components 70, 72; Figure 5).
Regarding claim 16, modified Enns discloses the stabilizer of claim 2, wherein the first connection portion (pins 74) of the first stabilizer member is configured as a male connection portion (Figure 5), and the second connection portion (recess 76) of the second stabilizer member is configured as a female connection portion (Figure 5), such that the female connection portion of the second stabilizer member is configured to receive the male connection portion of the first stabilizer member (“The components 70, 72 are coupled to one another by corresponding pins 74 and recesses 76 that are provided in the surfaces 78, 80. The pins 74 fit snugly into the recesses 76 to secure the components 70, 72 together.” [0029]).
Regarding claim 19, modified Enns discloses the stabilizer of claim 2, wherein the opening (“The inner surfaces 78, 80 of the respective components 70, 72 define a sleeve-receiving cavity 82, a chamber 84” [0030]) is configured to receive the portion of the intraosseous device (sleeve 54 and flange 56) in a first position (position of sleeve 54) relative to the proximal surface of the first stabilizer member and the proximal surface of the second stabilizer member (Figure 4 showing sleeve 54 received in aperture 88 of cavity 82 and extension 56 received in slot 92 of cavity 82 in a position distal of the position of sleeve 54).
Regarding claim 20, modified Enns discloses the stabilizer of claim 2, wherein the opening (“The inner surfaces 78, 80 of the respective components 70, 72 define a sleeve-receiving cavity 82, a chamber 84” [0030]) is configured to receive the portion of the intraosseous device (sleeve 54 and flange 56) in a second position (position of flange 56) relative to the proximal surface of the first stabilizer member and the proximal surface of the second stabilizer member (Figure 4 showing sleeve 54 received in aperture 88 of cavity 82 and extension 56 received in slot 92 of cavity 82 in a position distal of the position of sleeve 54).
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Enns et al. (US 2006/0030825) in view of Wright (US 2006/0247577) as applied in claim 12 above, and further in view of Roberts et al. (USPN 5372583).
Regarding claim 14, modified Enns discloses the stabilizer of claim 12.
Modified Enns fails to explicitly disclose wherein the outer portion includes a square shape.
Roberts teaches a stabilizer (fitting 26) for an intraosseous device (intraosseous cannula 24) including an outer portion including a square shape (shape formed between two adjacent indentations 78; Figures 3 and 4).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the respective outer portions of the first and second stabilizer members of Enns to include a square shape based on the teachings of Roberts to facilitate a firm grip on the stabilizer (Roberts [Col 4, lines 29-31]).
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Enns et al. (US 2006/0030825) in view of Wright (US 2006/0247577) as applied in claim 17 above, and further in view of Nowak et al. (USPN 4699616).
Regarding claim 17, modified Enns teaches the stabilizer of claim 16.
Modified Enns fails to explicitly teach wherein the female connection portion comprises a ledge, and the male connection portion of the first stabilizer member is configured to contact the ledge of the second stabilizer member to resist separation of the first and second stabilizer members, and the male connection portion of the first stabilizer member is configured to move past the ledge of the second stabilizer member and mechanically resist separation of the first and second stabilizer members.
Nowak teaches a stabilizer for maintaining a fluid delivery device (Figures 7-9) comprising a female connection portion (recess 131) comprises a ledge (edges forming recess 131), and a male connection portion (ratchet 130) of a first stabilizer member (clamping bar 125) is configured to contact the ledge of a second stabilizer member (clamping bar 126) to resist separation of the first and second stabilizer members (Figure 8; “The ratchet arm 30 of clamping bar 25 extends in the direction of the other bar 26, is receivable in aperture 31, and has a series of teeth 32 for holding the free ends of the clamping bars together in any of a variety of partially and fully closed positions.” [Col 4, line 32], for example), and the male connection portion (ratchet 130) of the first stabilizer member is configured to move past the ledge (edges forming recess 131) of the second stabilizer member and mechanically resist separation of the first and second stabilizer members (Figure 8; “The ratchet arm 30 of clamping bar 25 extends in the direction of the other bar 26, is receivable in aperture 31, and has a series of teeth 32 for holding the free ends of the clamping bars together in any of a variety of partially and fully closed positions.” [Col 4, line 32], for example).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the male and female connection portions of Enns such that the female connection portion comprises a ledge, and the male connection portion of the first stabilizer member is configured to contact and move past the ledge of the second stabilizer member to resist separation of the first and second stabilizer members based on the teachings of Nowak to ensure that the first and second stabilizer are not permanently joined and can be easily manipulated so as to allow selective repositioning of the intraosseous device relative to the user (Nowak [Col 1, line 55]).
Claim 23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nowak et al. (USPN 4699616) in view of Wright (US 20060247577).
Regarding claim 23, Nowak discloses the stabilizer of claim 22.
Nowak fails to explicitly disclose wherein the first flexible tab comprises a first double-sided tape layer having an adhesive upper side coupled to a lower surface of the first lower sidewall, and a first single-sided tape layer having an adhesive lower side coupled to an upper surface of the first lower sidewall and to a portion of an upper side of the first double-sided tape layer that is not coupled to the lower surface of the first lower sidewall; and wherein the second flexible tab comprises a second double-sided tape layer having an adhesive upper side coupled to a lower surface of the second lower sidewall, and a second single-sided tape layer having an adhesive lower side coupled to an upper surface of the second lower sidewall and to a portion of an upper side of the second double-sided tape layer that is not coupled to the lower surface of the second lower sidewall.
Wright teaches a stabilizer (shielding device 10) having first and second stabilizer members (left and right sides of slotted securement 12; Figure 9), the first stabilizer member comprising a first flexible tab (wing 120A) coupled to a first lower sidewall (flange 22A), and a second flexible tab (wing 120B) coupled to a second lower sidewall (flange 22B; “the upper surface area of its flange 22A and 22B are secured by the adhesive layer 102A and 102B to the base wings 120A and 120B respectively.” [0057]); wherein the first and second flexible tabs each comprises a double-sided tape layer (plastic material 130 of plug 160 having adhesive 132 and 136; Figure 23) having an adhesive upper side (adhesive 132) coupled to a lower surface of the respective sidewalls members (“The plug 160A and 160B is then again inverted as best seen in FIG. 19, and moved into overlaying engagement with the exposed flanges 22A and 22B of the cover 14 that was previously mounted to the base 120…the plug 160A and 160B is utilized to cover and secure the cover 14 to the base 120.” [0063]; Figures 19 and 23 showing that adhesive 132 in contact with the lower surface of the flanges 22A, 22B), and a single-sided tape layer (plastic layers 100A and 100B “each of the smooth plastic layers 100A and 100B is coated on its underside with a layer of non-skin irritating adhesive 102A and 102B respectively” [0035]) having an adhesive lower side (adhesive 102A, 102B) coupled to an upper surface of the lower sidewall (“As the cover 14 is dropped into the hole 106, the upper surface area of its flange 22A and 22B are secured by the adhesive layer 102A and 102B to the base wings 120A and 120B respectively.” [0057]) and to a portion of the upper side of the double-sided adhesive layer (adhesive 132 of plastic material 130) that is not coupled to the lower surface of the lower sidewall (Figure 23, wherein the adhesive 132 is coupled to adhesive 102 outside boundary of the stabilizer members).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the stabilizer of Nowak to include that the first and second flexible tabs each include a double-sided tape layer and a first single-sided tape layer based on the teachings of Wright to provide a means for securing the stabilizer to the skin of the patient for an extended period of time in a manner that protects the adhesive surfaces prior to use (Wright [0035-0036]).
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 6-10, 12-17, and 19-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding independent claim 1, the amendment of “a first portion of the planar first lower sidewall is directly connected to a distal-most end of the first extension member, and a second portion of the planar first lower sidewall is directly connected to a distal-most end of the second extension member; where a first portion of the planar second lower sidewall is directly connected to a distal-most end of the third extension member, and a second portion of the planar second lower sidewall is directly connected to a distal-most end of the fourth extension member” overcame the rejection of claim 1 in view of Nowak et al. (USPN 4699616) as presented in the Non-Final Rejection mailed 07/07/25. However, upon further search and consideration, claim 1 as currently presented is disclosed by the teachings of Enns et al. (US 20060030825) as detailed above.
Regarding independent claim 21, the amendment of “the opening extending from a proximal end of the stabilizer to a distal-most end of the stabilizer, and wherein a diameter of the opening at the distal-most end is larger than a diameter of the opening at the proximal end” overcame the rejection of claim 21 in view of Enns as presented in the Non-Final Rejection mailed 07/07/25. However, upon further search and consideration, claim 21 as currently presented is disclosed by the teachings of Nowak as detailed above.
Regarding independent claim 24 and the argument that “Enns does not disclose or suggest that the first and second coupling surfaces are configured to receive a portion of the hub of the intraosseous device in a plurality of different positions relative to the insertion site on the patient, the plurality of different positions including a first position and a second position, such that the first position is located closer to the distal end than the proximal end, and the second position is located closer to the proximal end than the distal end”, the examiner respectfully disagrees. As detailed above, Enns discloses that the first and second coupling surfaces (sleeve-receiving cavity 82 and chamber 84) are configured to receive a portion of the hub of the intraosseous device (sleeve 54 and extension 56) in a plurality of different positions including a first position (position of extension 56) and a second position (position of sleeve 54), such that the first position is located closer to the distal end than the proximal end, and the second position is located closer to the proximal end than the distal end (Figure 4 showing extension 56 received in slot 92 of cavity 82 in a first position closer to the distal end and sleeve 54 received in aperture 88 of cavity 82 in more proximal, second position). It is noted that the claims as currently presented do not require that the portion of the hub of the intraosseous device is configured to move distally or proximally between the plurality of positions.
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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/LEAH J SWANSON/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783