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 .
Response to Amendment
The amendment filed 4/17/26 has been entered. Claims 1-2,6-8,10,13-15,17-20,22-24,26-27 and 29-31 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 1/27/26.
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, 24, 26-27, and 29-31 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), and further in view of Johnson (US 20060196556 A1).
Regarding claims 1, 24, 27, and 29-30, 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 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) the first recessed segment being located between a circumferential wall and a cannula flange (the recess segment designed to support spring 231 is located between a wall and a flange configured to hold a cannula, [0090] & annotated as “WALL” and “FLANGE” 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 first recessed segment comprises septum protrusions extending proximally from a distalmost area of the first recessed segment such that each of the septum protrusions is connected to the circumferential wall and the cannula flange, and 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, wherein the swage forms an angle between 35 and 55 degrees with the axial wall, and
wherein each of the septum protrusions is separated from an adjacent septum protrusion by an angle around the first recessed segment and wherein the septum protrusions are a part of a septum configured to operatively couple to the spring of the infusion device.
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 vertical line of Fig. 4a below. The central cavity can be included in the space where the longitudinal axis of connector 200 and the annotated vertical 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, 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.
Further, Johnson teaches a first recessed segment (space defined by support structure 34 and elongated body 26 forming a recessed area, see Fig. 7) wherein the first recessed segment comprises septum protrusions, wherein the septum protrusions comprise between two and five septum protrusions (four shoulder portions 27a, [0031] & Fig. 5B; “This configuration, however, is merely one embodiment, as other configurations can be employed, such as, but not limited to, more or fewer shoulder portions”, [0031]), extending proximally from a distalmost area of the first recessed segment such that each of the septum protrusions is connected to the cannula flange (shoulder portions 27a extending proximally from a distalmost area of the recessed segment and connected to elongated body 26, see Fig. 5B and 7 & [0030]-[0031]), wherein each of the septum protrusions 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 wherein the septum protrusions are a part of a septum configured to operatively couple to the spring of the infusion device (shoulder potions 27a, part of a septum (see Fig. 7), provide a surface for a biasing member 32, a spring, to be disposed about the elongated body, see [0031]-[0032] & Fig. 5B and 7; shoulder portions 27a couple to spring 32, [0031] & Fig. 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 the first recessed segment comprising septum protrusions, wherein the septum protrusions comprise between two and five septum protrusions, extending proximally from a distalmost area of the first recessed segment such that each of the septum protrusions is connected to the cannula flange, wherein each of the septum protrusions is separated from an adjacent septum protrusion by an angle around the first recessed segment, and wherein the septum protrusions are a part of a septum configured to operatively couple to 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).
As modified, shoulder portions 27a would be integrally formed with the coupler 210, like portions 27a being integrally formed with valve 20a of Johnson. Considering shoulder portions 27a are integrally formed with coupler 210, a bottom portion of shoulders 27a can be interpreted as “connected to the circumferential wall”, as the circumferential wall, the cannula flange, and shoulder portions 27a are all integrally formed.
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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.
Regarding claim 31, Carrez, as modified, discloses all the limitations of claim 1. Carrez, as modified, further discloses the coupler wherein the septum protrusions include three septum protrusions, wherein the three septum protrusions are separated from one another by approximately 120 degrees around the first recessed segment (“four shoulder portions are illustrated for shoulder portions 27a. This configuration, however, is merely one embodiment, as other configurations can be employed, such as, but not limited to, more or fewer shoulder portions.”, [0031] of Johnson; three shoulder portions 27a may be included in the first recess segment, see Fig. 3B and 5B of Johnson; three shoulder portions 27a would be equally spaced around body 26, like the four illustrated shoulder portions 27a, which would render the portions 27a separated by approximately 120 degrees).
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), in view of Dikeman (US 20130012870 A1), in view of Johnson (US 20060196556 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).
Response to Arguments
Applicant's arguments filed 4/17/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that Johnson does not teach septum protrusions as recited in amended claim 1, the Examiner finds that shoulder portions 27a would be integrally formed with coupler 210, like shoulder portions 27a integrally formed with valve 20A of Johnson. Since shoulder portions 27a and the circumferential wall are integrally formed, the bottom surface, or any surface between shoulders 27a and the circumferential wall, can be interpreted as “connected”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lammers (US-20040045607-A1) teaches three circumferentially spaced arms 50 connected to a rim 48 and a sleeve 46 spaced 120 degrees apart (see [0027]-[0028] & Fig. 9 of Lammers).
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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
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