DETAILED ACTION
Response to Amendment
The amendment filed March 31, 2026 has been entered. Claims 1, 9, and 19 have been amended. Claims 1-20 are currently pending in the application.
Response to Arguments
Applicant’s argument with respect to the rejection(s) of amended claim(s) 1 under have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below. Regarding Applicant’s arguments with respect to claims 8 and 19, the Examiner maintains that Sheffer teaches the biasing element does bias the inner body in a manner toward the first end of the housing and toward a first position. Sheffer teaches that the spring is positioned between flange 76 and locking collar 70 as in Figure 4. The collar is being biased against the open arms 78 so that when the connector 28 passes through the arms they will collapse over the flange of the connector and secure the two elements together. This is considered to meet the claim limitation as currently set forth. The rejection is maintained as set forth below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larkin (US 4,895,570) in view of Lopez (US 5,685,866).
Regarding claim 1, Larkin discloses (Figure 1) a coupling device for medical tubing (12), the coupling device comprising: a housing (lock ring 28) having an inner surface forming a cavity (Figure 2; it surrounds 22 and internal components formed within a cavity of the lumen of 28), a first opening into the cavity (covering segments 26; Figure 2), and a second opening into the cavity (opposing open side of 28 adjacent element 60 in Figure 2); and an inner body (collet 22 inside of 28) having a fluid passage (through pin 20, Figure 2; Col. 2, lines 62-63), extending through the inner body, and a coupling sleeve (formed as splayed segments 26), wherein the inner body is positioned within the cavity of the housing with the coupling sleeve extending toward the first opening of the housing such that the housing and the inner body are movable relative to each other (Figure 2; Col. 2, lines 62-64); wherein, in a first position of the inner body, biasing of at least a portion of the coupling sleeve in a direction that is radially outward is resisted by engagement of the coupling sleeve with the housing (Figure 3, segments 26, which are outwardly biased, are inside of lock ring 28 and are abutting an inner surface of ring 28); and wherein, in a second position of the inner body, the coupling sleeve is moved through the first opening in a direction that is away from the second opening of the housing such that the at least a portion of the coupling sleeve can be biased radially outward (Figure 2, segments 26 which form the coupling sleeve are moved toward the distal end, through the first opening of 28 so that the segments expand outwardly now that they’re unconstrained by the housing 28). Larkin fails to disclose the valve within the inner body and movable therein between open and closed positions.
Lopez teaches (Figures 1-5) a valve (seal 36) within an inner body of a connector element (12) which has a first, closed position (Figure 4) to resist movement of fluid therethrough, and a second, open position (Figure 5) to allow fluid to flow through the connector member (Col. 8, line 60-Col. 9, line 13).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connector member of Larkin to include the compressible valve assembly of Lopez to provide a means of preventing fluid flow through the inner body when the second connection element is not attached as taught by Lopez.
Regarding claim 2, Larkin further discloses wherein the inner body comprises at least one channel (elongated recesses 50 formed between splayed fingers 26) that extends through the coupling sleeve (forming the splayed end of the sleeve as depicted in Figures 1 and 4) in a direction from a first end of the inner body toward a second end of the inner body (it can be seen in Figure 1 that the splayed finger end of inner body 22 are formed with channels 50 therebetween and extend along the longitudinal axis of the inner body from a first end toward a second end as claimed; see also Col. 3, lines 39-45).
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Regarding claim 3, Larkin further discloses wherein the at least one channel (formed as recesses 50 between splayed portion 26) comprises a first channel and a second channel (the splayed fingers are formed via a plurality of recesses along the splayed end of body 22 as depicted in Figures 1 and 4; Col. 3, lines 39-45 disclose a plurality of splayed portions which would require a plurality of recesses therebetween), wherein the second channel is spaced apart from the first channel (by the width of a splayed portion 26), and wherein a first portion of the coupling sleeve between the first and second channels forms a first flexible finger (splayed portion 26 is formed between recesses 50), and a second portion of the coupling sleeve between the first and second channels forms a second flexible finger (the spacing of the inner body 22 between channels 50 forms the fingers as claimed and therefore any finger portion between first and second recesses 50 will be considered a flexible finger; in an embodiment with two splayed portions there would be two recesses or channels required to form the fingers as claimed and Larkin discloses a plurality of finger forming splayed portions).
Regarding claim 6, Larkin further discloses wherein the inner body (22) comprises a spline (thread 71) that extends from an outer surface of the inner body (Figure 4), in a direction that is radially away from an outer surface of the inner body (it has a thread depth and therefore the surfaces of the threads extend radially away from the outer surface of 22).
Regarding claim 7, Larkin further discloses wherein the spline (thread 71) is configured to be positioned within a groove (helical channel 73 on inner surface of 28) extending along the inner surface of the housing such that the housing and the inner body are rotationally coupled (Col. 5, lines 58-63; Figures 5-6).
Regarding claim 8, Larkin further discloses wherein the housing (28) and the inner body (22) are movable, relative to each other, along a length of the groove (73; Col. 5, lines 58-63).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larkin in view of Lopez, and further in view of Leinsing et al. (US 2003/0098430).
Regarding claim 4, Larkin/Lopez teach the claimed invention substantially as set forth above for claim 1, and further discloses a connection member (tip of pin 20 which engages with diaphragm 16 of tube 12), but does not explicitly disclose the inner body comprising a luer tip that extends within the coupling sleeve.
Leinsing et al. (henceforth Leinsing) teaches (Figure 7), a medical connector comprising a luer tip (male luer 34) for connecting to a corresponding medical device or fluid source (¶ [0038]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the piercing spike tip of the pin of Larkin with the luer connector of Leinsing so as to provide a means of creating a fluid-tight connection with a corresponding connector of a medical device as taught by Leinsing. One of ordinary skill in the art, looking to modify the device of Larkin to connect to a medical connector, which does not require the puncturing engagement of Larkin, would be motivated to utilize the luer connector of Leinsing, as it represents a well-known means of fluidly attaching two medical devices together in a fluid-tight manner as taught by Leinsing.
Claim(s) 5, 9, 10, 13-16, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larkin in view Lopez, and further in view of Sheffer et al. (US 2013/0167841).
Regarding claim 5, Larkin/Lopez teach the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose the claimed biasing element between the housing and the inner body.
Sheffer et al. (henceforth Sheffer) teaches (Figure 5) a housing (sleeve 70) and an inner body (collar 76 comprising fingers 72 which is set inside of sleeve 70); and wherein a biasing element is positioned between the housing and the inner body (¶ [0039] discloses a biasing element disposed between the collar 76 and the locking sleeve 70 to bias the locking sleeve 70 in the locked configuration by being pushed away from the collar 76).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connector of Larkin/Lopez to comprise a biasing member between the housing and inner member so as to provide an opening force on the inner member to require a user to overcome the bias in order to move the sleeve to the unlocked configuration to use the connector to engage a fluid source as taught by Sheffer (¶ [0039]).
Regarding claims 9 and 18, Larkin discloses a coupling device for medical tubing, the coupling device comprising: a housing (28) having a first end (adjacent segments 26), a second end (adjacent element 60 on sleeve 22), and an inner surface forming a cavity (Figure 2, element 28 forms a cavity for receiving collet 22), wherein the first end comprises a first opening into the cavity (Figure 2), and the second end comprises a second opening into the cavity (Figure 2); an inner body (22) having a first end portion (comprising segments 26), a second end portion (comprising 60), a fluid passage (within pin 20) extending through the first and second end portions of the inner body (Figure 2; the passage within pin 20 extends along element 22 from an end adjacent segments 26 to the second end of the inner body), the first end portion comprising a coupling sleeve (splayed segments 26) formed by a wall (they substantially enclose a portion of pin 20 and are therefore a wall as claimed) having an inner surface that extends around a longitudinal axis defined by the fluid passage to form a recess extending from a first end of the inner body toward the second end portion (it can be seen in Figure 2 that the splayed segments 26 encapsulate the end of the fluid path within pin 20 and back toward the second portion of the inner member 22), wherein the inner body is positioned within the cavity of the housing (Figure 2, the inner body 22 is surrounded by locking ring 28) such that the housing and the inner body are movable relative to each other (Figures 2-3, the locking ring moves relative to the inner body to lock the splayed segments around the connector); wherein, in a first position (Figure 2) of the inner body (22), the first end of the inner body (comprising segments 26) is longitudinally aligned with the first end of the housing (it can be seen in Figure 2 that at least a major portion of segments 26 are aligned with the first end of 28) such that biasing of at least a portion of the wall away from the longitudinal axis is resisted by the housing (the segments 26 still abut the housing when locking ring 28 has a second end in engagement with element 60 of collet 22; they are therefore still at least partially biased by the housing and the housing is therefore resisting the expansion as claimed), and in a second position of the inner body (Figure 3), the second end of the housing is moved away from the second end portion of the inner body (it can be seen that locking ring 28 has moved along collet 22 away from element 60) such that the first end of the inner body (comprising 26) is longitudinally spaced apart from the first end of the housing (the tips 58 of arms 26 are longitudinally spaced from the first opening of 28 as seen in Figure 3; they are inside of 28 but axially spaced relative to the first end terminal portion) and the at least a portion of the wall can be biased away from the longitudinal axis (the wall formed by segments 26 is still outwardly biased away from the longitudinal axis via their design; the fact that the outer housing 28 is constraining them to enclose the connector does not change the fact that they are biased away from the longitudinal axis; they are urged inwardly by the locking collar, but are biased outwardly; the limitation is not narrow enough to require the locking collar to move relative to the inner body toward a first end while removing a compression force to allow the wall to expand). Larkin does not explicitly disclose a biasing element positioned between the first end of the housing and the inner body.
Sheffer et al. (henceforth Sheffer) teaches (Figure 5) a housing (sleeve 70) and an inner body (collar 76 comprising fingers 72 which is set inside of sleeve 70); and wherein a biasing element (spring) is positioned between the housing and the inner body (¶ [0039] discloses a biasing element disposed between the collar 76 and the locking sleeve 70 to bias the locking sleeve 70 in the locked configuration by being pushed away from the collar 76); wherein the inner body is biased in a direction away from the first end of the housing and toward a first position (the spring biases locking sleeve 70 toward the first end so that when the fingers are deflected it allows the collar to move toward the element 28 to lock fingers 78 around the flange of the element 28).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connector of Larkin to comprise a biasing member between the housing and inner member so as to provide an opening force on the inner member to require a user to overcome the bias in order to move the sleeve to the unlocked configuration to use the connector to engage a fluid source as taught by Sheffer (¶ [0039]).
Regarding claim 10, Larkin further discloses wherein the inner body comprises at least one channel (between segments of 26 as seen in Figure 1) that extends through the coupling sleeve in a direction from a first end of the inner body toward a second end of the inner body (Figure 2).
Regarding claim 13, Larkin further discloses wherein the first opening of the housing (adjacent fingers 26) comprises a first cross-sectional width, and an outer surface of the wall of the inner body comprises a second cross-sectional width (width of splayed segmented section), and wherein the first cross-sectional width is equal to or greater than the second cross-sectional width (the outer housing has a larger diameter than the inner splayed member so that it can move within the outer housing between the first and second positions depicted in Figures 2-3), such that, the first end portion of the inner body is longitudinally movable between the first and second positions through the first opening (Figures 2-3).
Regarding claim 14, Larkin further disclose wherein the housing (28) comprises a ledge that extends radially inward from the inner surface of the cavity (see inwardly extending flange of 28 which abuts element 58 after locking the collar as depicted in Figure 3; it can be seen that the inner flange surface of 28 engages with the outer surface of 58 to maintain it in the locked configuration).
Regarding claim 15, Larkin further discloses wherein, in the first position, a portion of the inner body (22) is engaged against the ledge (see Figure 2, the splayed segmented portion of inner body 22 at least partially frictionally engage the inner ledge of 28 so that it can close the fingers to lock them in the locked configuration during movement of the locking collar relative to the inner member).
Regarding claim 16, Larkin further discloses wherein a distance from the first end of the inner body to a second end of the inner body is greater than a distance from the first end of the housing to a distal end of the cavity (Figure 2, the inner element 22 is longer than locking collar 28 which forms the cavity length).
Regarding claim 19, Larkin discloses a method for providing a coupling device for medical tubing (18), the method comprising: providing an inner body (22) in a cavity of a housing (locking collar 28) such that the housing and the inner body are movable relative to each other (Figures 2-3; Col. 2, lines 62-64), and a coupling sleeve (defined by splayed segments 26) defined by a proximal portion of the inner body (Figure 2) extends through a first opening (opening of 28 adjacent splayed segments 26) at a first end of the housing; providing a tubing (18) through a second opening at a second end of the housing (tubing 18 is connected adjacent the second end of 28 which is adjacent element 60 as depicted in Figure 2; the claim does not require the tubing to extend within the second opening of the housing) and couplable to a fluid passage (within spike 20) extending through the inner body (Figure 2); wherein, in a first position of the inner body, a first end of the inner body is longitudinally aligned with the first end of the housing such that biasing of at least a portion of coupling sleeve away from a longitudinal axis of the fluid passage of the inner body is resisted by the housing (Figure 3, segments 26, which are outwardly biased, are inside of lock ring 28 and are abutting an inner surface of ring 28), and in a second position of the inner body, the second end of the housing is moved away from the second end of the inner body such that the first end of the inner body is longitudinally spaced apart from the first end of the housing and the at least a portion of the coupling sleeve can be biased away from the longitudinal axis (Figure 2, segments 26 which form the coupling sleeve are moved toward the distal end, through the first opening of 28 so that the segments expand outwardly now that they’re unconstrained by the housing 28). Larkin fails to explicitly disclose providing a biasing element in the housing such that the biasing element is positioned between a first end of the housing and the inner body.
Sheffer et al. (henceforth Sheffer) teaches (Figure 5) a housing (sleeve 70) and an inner body (collar 76 comprising fingers 72 which is set inside of sleeve 70); and wherein a biasing element (spring) is positioned between the housing and the inner body (¶ [0039] discloses a biasing element disposed between the collar 76 and the locking sleeve 70 to bias the locking sleeve 70 in the locked configuration by being pushed away from the collar 76).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connector of Larkin to comprise a biasing member between the housing and inner member so as to provide an opening force on the inner member to require a user to overcome the bias in order to move the sleeve to the unlocked configuration to use the connector to engage a fluid source as taught by Sheffer (¶ [0039]).
Regarding claim 20, Larkin further discloses wherein when the inner body is in the second position (locked position of Figure 3) and a mating connector (12, 14), coupled to the coupling sleeve (via ends of 26 locking to flange 14 as depicted in Figure 3; Col. 4, lines 8-12) is moved in a direction away from the first end of the inner body (e.g., being pulled out of inner member 22), engagement of the mating connector with the coupling sleeve (via interaction of internal shoulder 56 on flange 14) directs at least a portion of the coupling sleeve away from the longitudinal axis (it can be seen that shoulder 56 on the splayed segment ends is angled and as such, if the connector 12, 14 were attempted to be removed from the locked configuration, at least a portion of the force would bias the ends of the splayed segments outwardly away from the longitudinal axis and against the inner surface of the locking collar 28).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larkin in view of Lopez in view of Sheffer, and further in view of Davis et al. (US 2017/0173321).
Regarding claim 11, Larkin/Lopez teach the claimed invention substantially as set forth above for claim 9, but fails to explicitly disclose a thread on an inner surface of the wall.
Davis et al. (henceforth Davis) teaches (Figure 1) a connector for a medical device comprising a coupling sleeve (via segments 42) formed by a wall having an inner surface (inner surface of segments 52) with a thread (46) that extends along the inner surface of the wall (Figure 1; ¶ [0048]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the splayed segments of Larkin/Lopez to comprise threads on an inner surface thereof for the purpose of providing a means of axial or rotational connection of the inner member of Larkin to a corresponding connector portion of a medical device as taught by Davis (as in ¶ [0048], the threaded split clip assembly provides for connection to a medical device via axial or rotational means). Such a modification to the device of Larkin would provide for a secure means of connecting to corresponding medical devices while comprising the original utility of using the lock sleeve to provide an additional securing means for holding the attached device after connection.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larkin in view of Lopez in view of Sheffer, and further in view of Leinsing et al. (US 2003/0098430).
Regarding claim 12, Larkin/Lopez teach the claimed invention substantially as set forth above for claim 1, and further discloses a connection member (tip of pin 20 which engages with diaphragm 16 of tube 12), but does not explicitly disclose the inner body comprising a luer tip that extends within the coupling sleeve.
Leinsing et al. (henceforth Leinsing) teaches (Figure 7), a medical connector comprising a luer tip (male luer 34) for connecting to a corresponding medical device or fluid source (¶ [0038]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the piercing spike tip of the pin of Larkin/Lopez with the luer connector of Leinsing so as to provide a means of creating a fluid-tight connection with a corresponding connector of a medical device as taught by Leinsing. One of ordinary skill in the art, looking to modify the device of Larkin to connect to a medical connector, which does not require the puncturing engagement of Larkin, would be motivated to utilize the luer connector of Leinsing, as it represents a well-known means of fluidly attaching two medical devices together in a fluid-tight manner as taught by Leinsing.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larkin in view of Lopez in view of Sheffer, and further in view of Racz (US 6,190,372).
Regarding claim 17, Larkin/Lopez/Sheffer teach the claimed invention substantially as set forth above for claim 9, but fail to explicitly disclose the cap assembly.
Racz teaches (Figure 1) a cap assembly (22 and including closed lumen 40; Col. 2, lines 45-50) for use in a medical device connector (comprising outer housing portion 24).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connector device of Larkin/Lopez/Sheffer to comprise a cap, such as that disclosed by Racz to provide a means of sealing the connection end of the connector when not in use as taught by Racz. In such a modification, the splayed fingers and locking ring of Larkin/Sheffer would be used to engage the interconnect member (50; Col. 2, lines 50-56) of the cap of Racz to provide a means of securing the cap to the connector in the method described by Larkin/Sheffer for engaging with a corresponding medical device. The cap extension (48) would surround the piercing end of the pin 20 of Larkin (via a similar diameter lumen 40 of Racz) to provide a means of covering the pin while maintaining sterility of the connector end when not in use.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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