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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 19th 2025 has been entered.
Claim Objections
Claims 7, 24, and 26-27 are objected to because of the following informalities:
The status identifier of claim 7, in the new claim set filed December 19th 2025, is incorrect. The status identifier should read (Previously amended), not (Currently Amended), as the claim has not been amended. The underlined section appears to have already been previously amended in the claim set filed June 4th 2025.
The status identifier of claim 24, in the new claim set filed December 19th 2025, is incorrect. The status identifier should read (Currently Amended), not (Previously presented), as the dependency of claim 24 has changed from claim 1 to claim 28.
The status identifier of claim 27, in the new claim set filed December 19th 2025, is incorrect. The status identifier should read (Withdrawn - New), not (New), as new claim 27 is dependent on a withdrawn claim.
Regarding claim 26, claim 4, of which claim 26 depends on, has been cancelled, with its limitations now included in amended claim 1. This is being interpreted as a typographical error. For examination, claim 26 is being interpreted as dependent on claim 1.
Appropriate correction is required.
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.
Claims 1-2, 6-7, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Carrez (US 20120316536 A1) in view of Winsor (US 20100298782 A1), and further in view of Dikeman (US 20130012870 A1).
Regarding claims 1, Carrez discloses a coupler (coupler 210, [0087] & Fig. 4a) for a valve assembly (connector 200, [0087] & Fig. 4a) configured to couple to an infusion device (casing 220, [0087] & Fig. 4a), said coupler comprising: a proximal portion (right half of coupler 210, annotated as “PROXIMAL” in Fig. 4a below), a distal portion (left half of coupler 210, annotated as “DISTAL” in Fig. 4a below; the annotated yellow vertical line indicating the separation between distal and proximal portions), and a cylindrical central passage connecting the proximal portion and the distal portion (tubular chamber 211 connecting the proximal and distal portions of coupler 210, [0087] & Fig. 4a), said proximal portion comprising: a plurality of recessed segments configured to receive the infusion device (via multiple recessed segments on coupler 210 configured to engage casing 220 [0087], [0090] & annotated as “FIRST,” “SECOND,” and “THIRD” in Fig. 4a below), wherein a first recessed segment of the plurality of recessed segments is configured to engage a spring of the infusion device (coupler 210 having a recess segment designed to support spring 231, [0090] & Fig. 4a, also annotated as “FIRST” in Fig. 4a below), wherein a second recessed segment of the plurality of recessed segments is configured to engage a housing of the infusion device (coupler 210 having a recessed segment designed to engage a housing of casing 220, annotated as “SECOND” in Fig. 4a below), wherein a third recessed segment of the plurality of recessed segments is configured to engage a cannula of the infusion device (coupler 210 having a recessed segment to engage hollow tube 213, [0087] & annotated as “THIRD” in Fig. 4a below).
Carrez further discloses the distal portion of the coupler to include a connectable entry 212, which is disclosed as “luer-lock type” (see [0087] & Fig. 4b of Carrez).
However, Carrez fails to explicitly disclose the distal portion comprising: a central cavity defined by a valve flange, wherein the central cavity is configured to engage a flow control valve; wherein the valve flange comprises an exterior portion, an interior portion including a proximal face and a distal face, and an axial wall connecting the exterior portion to the interior portion of the valve flange, wherein the proximal face and a distal face are separated by a swage and a swage recess,
wherein the swage and the swage recess are configured to engage a luer lock fitting, and wherein the swage forms an angle between 35 and 55 degrees with the axial wall.
However, Winsor teaches an injection site 12 comprising a two-piece coupler that includes a support body 18, a luer lock fitting 22, and a flow control 24 therebetween. Additionally, the site includes a septum 64 provided to hold a cannula 16 ([0024], [0029], [0030] & Fig. 4 and 7). The septum 64 of Winsor being similar to the stopper 420 of the instant application. The specification of Winsor teaches that one of ordinary skill in the art would understand that a split septum, like septum 64, are typical in designs which utilize a blunt canula ([0024] of Winsor) and can be accompanied by a flow control valve.
Winsor teaches a coupler (abstract and [0021]) comprising a distal portion (support body 18, [0032] & Fig. 3 and 7) comprising: a central cavity defined by a valve flange (the socket formed by surfaces 56, 58, 60, and 62, which is being interpreted as the central cavity, is defined by valve seat 46 and sidewall 48, which is being interpreted as the valve flange, [0027] & Fig. 3 and 7), wherein the central cavity is configured to engage a flow control valve (the socket is configured to receive the flow control valve 24, [0027] & Fig. 3 and 7), and
wherein the valve flange comprises an exterior portion (sidewall 48 comprises an annular wall which includes an exterior surface, which is being interpreted as the exterior portion, see Fig. 7), an interior portion including a proximal face and a distal face, and an axial wall connecting the exterior portion to the interior portion of the valve flange, wherein the proximal face and a distal face are separated by a swage and a swage recess (“The sidewall 48 comprises an annular wall that presents interior, annular, proximal and distal axial surfaces 58, 60 that are joined by a shoulder 62 (see FIG. 7).”, [0027]; the bottommost surface of sidewall 48 is being interpreted as an axial wall, which connects the exterior surface of sidewall 48 with the interior, distal surface 60, see Fig. 7; interior, proximal surface 58 and interior, distal surface 60 are separated by shoulder 62, which is being interpreted as a swage, [0027] and [0032] & Fig. 7; shoulder 62 can be seen in Fig. 7 as protruding inwardly into the socket at an angle; the space between shoulder 62 and surface 60 is being interpreted as the swage recess – this space being between surface 58 and 60, see Fig. 7),
wherein the swage and the swage recess are configured to engage a luer lock fitting (shoulder 62 and the space between shoulder 62 and surface 60 are configured to engage luer lock fitting 22, [0027] & see Fig. 7; “surfaces 56,58,60,62 cooperatively form a socket that fluidly communicates with the passageway 54 and is configured to receive the flow control valve 24 and luer lock fitting 22.”, [0027]), and wherein the swage forms an angle with the axial wall (shoulder 62, as seen in Fig. 7, forms an angle with the bottommost surface of sidewall 48).
Winsor further teaches that “[t]he support body 18 and fitting 22 are further secured by attaching respective adjacent pairs of surfaces using a conventional ultrasonic welding process to form a hermetic seal between the support body 18 and fitting 22.” (see [0038] of Winsor). Shoulders 62 and 96 are taught to be adjacent surface configured to mate to interconnect fitting 22 and body 18 (see [0032] of Winsor).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the coupler of Carrez with Winsor to include the distal portion comprising a central cavity defined by a valve flange, wherein the central cavity is configured to engage a flow control valve, wherein the valve flange comprises an exterior portion, an interior portion including a proximal face and a distal face, and an axial wall connecting the exterior portion to the interior portion of the valve flange, wherein the proximal face and a distal face are separated by a swage and a swage recess,
wherein the swage and the swage recess are configured to engage a luer lock fitting, and wherein the swage forms an angle with the axial wall, since such a modification would provide structure to aid in controlling the flow of fluid through the coupler and provide structure to securely connect components of the coupler ([0027] and [0032] of Winsor). The modification provides predictable results pertaining to the prevention of fluid flow in unwanted directions through the coupler and selectively permitting aspiration and/or infusion fluid flow through the site 12 ([0034] of Winsor).
As combined, the connector of Carrez would be separated into two pieces, like the coupling piece of Winsor. The connector of Carrez would be separated to include the central cavity and valve flange of Winsor which would house the flow control valve of Winsor. The separation can occur along the annotated yellow line of Fig. 4a below. The central cavity can be included in the space where the longitudinal axis of connector 200 and the annotated yellow line splitting the distal and proximal portions intersect (annotated Fig. 4a below).
Further, Dikeman teaches a coupler (flow control valve assembly 10, [0034] & Fig. 2) wherein the swage (energy director 90, [0043] & Fig. 2) forms an angle between 35 and 55 degrees with the axial wall (“One of the steps 82 subtends an angle of less than 90 to form an energy director 90.”, [0043] & Fig. 2; an angle between 35 and 55 degrees falls within the range of less than 90 degrees).
Dikeman teaches that “[t]he energy director 90 serves to direct the ultrasonic melt, so that the surfaces of the mated steps 68 and 82 fuse and the valve flange 96 is captured between the stake 74 and the ring 88 in a generally S-shaped cross-sectional configuration as depicted in FIG. 2.” (see [0052] of Dikeman). Energy director 90 of Dikeman is a synonymous structure to shoulder 62 of Winsor.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the swage of Carrez, as modified by Winsor, with Dikeman to include the swage forming an angle between 35 and 55 degrees with the axial wall since Dikeman teaches this range to be an art effective range for a connection structure between a valve flange and a hub (see [0052] of Dikeman).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Carrez, as modified by Winsor, to have the swage form an angle between 35 and 55 degrees with the axial wall since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the shoulder 62 of Winsor would not operate differently having an angle within the claimed range considering the surface is illustrated as angled and intended to be ultrasonically welded to a corresponding surface to facilitate connection (see [0032], [0038], and citations to claim 26 below). The coupler would function appropriately having an angle within the claimed range.
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Regarding claim 2, Carrez, as modified, discloses all the limitations of claim 1. Carrez further discloses the coupler wherein the proximal portion further comprises an axial wall configured to engage the housing of the infusion device (the structure being interpreted as the axial wall is annotated as “AXIAL WALL” in Fig. 4a below; it is located on the proximal portion and engages the casing 220). The Examiner notes that the axial wall of claim 1, an axial wall of the valve flange, is not the same axial wall introduced in claim 2, an axial wall of the proximal portion.
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Regarding claim 6, Carrez, as modified, discloses all the limitations of claim 1. Carrez further discloses the coupler wherein the second recessed segment comprises an angled portion and a flat portion, said angled portion being radially angled outward at a proximal end of the second recessed segment; and said flat portion extending proximally from the angled portion (see annotated Figure. 4a below; the claimed angled portion of the second recessed segment is annotated as “ANGLED” and the claimed flat portion of the second recessed segment is annotated as “FLAT” below; the angled portion is radially angled outward at a proximal end of the second recessed segment and the flat portion extends proximally from the angled portion).
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Regarding claim 7, Carrez, as modified, discloses all the limitations of claim 1. Carrez further discloses the coupler wherein the third recessed segment comprises: a transverse groove and an angled wall proximal to the transverse groove, the angled wall tapering radially outward, wherein a center of the transverse groove defines a larger diameter than a diameter of the third recessed segment, and wherein the transverse groove and the angled wall mechanically engage the cannula of the infusion device (see annotated Figure 4a below; the claimed transverse groove is annotated as “TRANSVERSE GROOVE” and the claimed angled wall is annotated as “ANGLED WALL” below; the transverse groove tapering radially outward with the center having a larger diameter than the remainder of the third recessed segment; the angled wall is proximal to the transverse groove; the transverse groove and angled wall are seen engaging the hollow tube 213).
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Regarding claim 26, Carrez, as modified, discloses all the limitations of claim 1. However, Carrez fails to explicitly disclose the coupler wherein the coupler and the luer lock fitting are welded together. However, Winsor teaches the coupler wherein the coupler and the luer lock fitting are welded together (see [0032] and [0038]; shoulder 62 and 96 are adjacent pairs of surfaces that can be attached using ultrasonic welding). Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the coupler of Carrez with Winsor to include the coupler and the luer lock fitting welded together since such a modification would provide means to securely connect the luer lock fitting to the coupler ([0032] and [0038] of Winsor).
Additionally, with respect to the limitations of claim 26, Applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Carrez (US 20120316536 A1) in view of Winsor (US 20100298782 A1), further in view of Dikeman (US 20130012870 A1), and further in view of Nexus Medical (US 20140228776 A1).
Regarding claims 22 and 23, Carrez, as modified, discloses all the limitations of claim 1. Carrez, as modified, discloses the coupler wherein the central cavity comprises a valve wall configured to engage the flow control valve (in the modification of claim 1, the central cavity of Winsor, which is the socket formed by surfaces 56, 58, 60, and 62, is included in the coupler 210 of Carrez; flange-engaging face 56, which is being interpreted as the valve wall, engages flange wall 118 of valve 24 to firmly hold the valve 24, [0038]-[0039] & Fig. 7).
However, Carrez fails to explicitly disclose the distal portion further comprises a housing protrusion extending distally from the valve wall into the central cavity, wherein the housing protrusion engages the flow control valve; and wherein the third recessed segment extends through the housing protrusion. However, Nexus Medical teaches a housing protrusion extending distally from the valve wall into the central cavity (axially extending boss 62 extending distally from a valve seat 58 and flange-engaging face 72, [0036]-[0037] & Fig. 3), wherein the housing protrusion engages the flow control valve (“the boss extends axially, such that at least a portion of a distal end 84 of the boss 62 may contact at least a portion of the valve 18”, [0038] & Fig. 3); and wherein the third recessed segment extends through the housing protrusion (passageway 48b extends through channels 88, [0040] & Fig. 3; channels 88 are being interpreted as extensions of passageway 48b, which is synonymous to the third recessed segment of Carrez).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the central cavity of Carrez, as modified, with Nexus Medical to include a housing protrusion extending distally from the valve wall into the central cavity and wherein the third recessed segment extends through the housing protrusion since such a modification would prevent mechanical inversion of the valve, act as a back-stop, and/or aid in sealing the valve closed while permitting fluid flow in the desired direction and yield predictable results pertaining to desired valve functionality ([0052]-[0054] of Nexus Medical).
Claims 24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Carrez (US 20120316536 A1) in view of Winsor (US 20100298782 A1), further in view of Dikeman (US 20130012870 A1), and further in view of Johnson (US 20060196556 A1).
Regarding claims 24 and 28, Carrez, as modified, discloses all the limitations of claim 1. However, Carrez fails to explicitly disclose the coupler wherein the first recessed segment comprises a plurality of septum protrusions, wherein the plurality of septum protrusions comprises between two and five septum protrusions,
extending proximally from a distalmost area of the first recessed segment, wherein each septum protrusion is separated from an adjacent septum protrusion by an angle around the first recessed segment and is configured to engage the spring of the infusion device.
However, Johnson teaches a first recessed segment (space defined by support structure 34 and elongated body 26 forming a recessed area, see Fig. 7) comprising a plurality of septum protrusions, wherein the plurality of septum protrusions comprises between two and five septum protrusions (four shoulder portions 27a, [0031] & Fig. 5B), extending proximally from a distalmost area of the first recessed segment (shoulder portions 27a extending proximally from a distalmost area of the recessed segment, see Fig. 5B and 7), wherein each septum protrusion is separated from an adjacent septum protrusion by an angle around the first recessed segment (each shoulder portion 27a is separated from an adjacent shoulder portion by an angle around the first recessed segment, see Fig. 5B and 7) and is configured to engage the spring of the infusion device (shoulder potions 27a provide a surface for a biasing member 32, a spring, to be disposed about the elongated body, see [0031]-[0032] & Fig. 5B and 7).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the first recessed segment of Carrez, as modified, with Johnson to include a plurality of septum protrusions, wherein the plurality of septum protrusions comprises between two and five septum protrusions, extending proximally from a distalmost area of the first recessed segment, wherein each septum protrusion is separated from an adjacent septum protrusion by an angle around the first recessed segment and is configured to engage the spring of the infusion device, since such a modification would provide structure to help maintain the position of a spring about an elongated body and yield predictable results pertaining to spring engagement (see [0031] of Johnson).
Response to Arguments
Applicant's arguments filed December 19, 2025 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the shoulder is structurally incapable of providing the mechanical interlocking function achieved by Applicant’s angled swage, the Examiner finds that the claims do not include language regarding plastic deformation, upset material, or mechanical crimping. The claims simply limit the swage to be configured to engage a luer lock fitting, which shoulder 62 does (see [0027] and [0032] of Windsor). However, Windsor does explicitly teach that adjacent surfaces can be ultrasonically welded together (see [0038] of Winsor). Shoulder 62 and shoulder 96 are adjacent surfaces capable of being ultrasonically welded together. Dikeman teaches a similar relationship regarding director 90. Lastly, the Examiner notes that the claims do not include language limiting the swage to be ultrasonically welded. Shoulder 62 is explicitly taught as configured to facilitate connection between fitting 22 and body 18 (see [0032] of Winsor).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. plastic deformation, upset material, mechanical crimping, or mechanical locking) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s arguments that Windsor teaches away from modification and “modifying the perpendicular shoulder to an angled configuration would compromise this socket-defining function by creating a ramped, rather than flat, seating surface”, the Examiner finds that, firstly, the shoulder is not perpendicular. The shoulder 62 is clearly seen illustrated in Fig. 7 as angled and is cited as such above.
Secondly, the shoulder 62 functions to “define a socket” in [0027], as noted in the arguments, and functions to receive the flow control valve 24 and luer lock fitting 22: “surfaces 56,58,60,62 cooperatively form a socket that fluidly communicates with the passageway 54 and is configured to receive the flow control valve 24 and luer lock fitting 22.” ([0027]), and “The connection end 90 is designed to mate with the sidewall 48 so that respective surfaces 58,92, shoulders 62,96, and surfaces 60,94 engage one another to interconnect the fitting 22 and the support body 18 and secure the flow control valve 24…” ([0032]). The Examiner notes that a socket, or an artificial hollow into which something fits, and “socket-defining features” do not necessarily employ perpendicular geometries and that shoulder 62 is explicitly designed for ultrasonic welding (see [0032] and [0038]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783