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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 08/18/2023. Claims 1-25 are currently pending and being examined.
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 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.
Claim Objections
Claim 6 is objected to because of the following informalities : Claim 6 recites “the recess mirrors and outer profile”. Examiner suggests reciting “the recess mirrors an outer profile” . Appropriate correction is required.
Claim 18 is objected to because of the following informalities : Claim 18 recites “the recess mirrors and outer profile”. Examiner suggests reciting “the recess mirrors an outer profile” . Appropriate correction is required.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 9-13, 15-17, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lazzara (USPAP 2022/0032029) in view of Geppert (USPAP 2020/0179671).
In reference to independent claim 1, Lazzara discloses a coupling device (12, fig 1A-1C) for releasably securing a catheter (22, para 0068 discloses “tubing 22 can be connected, for example, to a catheter”) to a port (port of 30), comprising:
a stem receiving portion (18) configured to receive a stem (14) of the port (port of 30), the stem (14) receiving portion (18) comprising a lumen (17); and
an sleeve (36, fig 1A) coupled to an outside surface of the stem (14) receiving portion (18),
the sleeve (36) comprising:
a second configuration (pictured in fig 1B) extending away from the distal end of the stem receiving portion (left side of 12), however
Lazzara is silent to a first configuration extending toward a distal end of the stem receiving portion.
Geppert, a similar connector, teaches a first configuration wherein the securing mechanism (104, fig 3 & 4) is extending toward a distal end of the stem receiving portion (fig 4 shows the securing mechanism extending towards the distal end, the right in fig 4, the ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the locking position flexibility of Geppert in the device of Lazzara “to increase the effectiveness of the connection while minimizing leakage between the tubes and minimizing delay time when switching tubes” para 0004; Geppert. To be clear by inverting the elastomeric compressive sleeve in Lazzara the device can be assembled faster and tighter.
In reference to independent claim 15, Lazzara discloses a method of securing a port to a catheter (para 0068 “tubing 22 can be connected, for example, to a catheter”), comprising:
urging a stem (24 of a second non-pictured connector; para 0112 discloses “one or more features of any embodiment can be combined with one or more features of any other embodiment”, examiner is interpreting a secondary connector 10 connected to the left of 10, as can be interpreted based on para 0112) of a coupling device into a lumen (17 of a second non-pictured connector) of the catheter (connected to 22,);
urging a port stem (tip of 24) into a lumen (17) of the coupling device;
to a locked configuration (fig 1B), where the first surface (outside surface of 36) is faced outward and the second surface (inside surface of 36) is faced inward (shown in fig 1B); and engaging the second surface of the sleeve with a portion of the port (para 0075 discloses “As shown in FIG. 1B, the compression sleeve 36 engages the reusable connector 14 to secure and/or reinforce the connection between the single use connector 12 and the reusable connector 14”).
Lazzara is silent to inverting a sleeve of the coupling device from an unlocked configuration, where a first surface is faced radially inward and a second surface is faced radially outward.
Geppert, a similar connector, teaches inverting a securing mechanism (104, fig 4) of the coupling device from an unlocked configuration (shown in fig 4) to a locked configuration (shown in fig 3), where a first surface (bottom of 104 in fig 4) is faced radially inward and a second surface is faced radially outward (top of 104 in fig 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the locking position flexibility of Geppert in the device of Lazzara “to increase the effectiveness of the connection while minimizing leakage between the tubes and minimizing delay time when switching tubes” para 0004; Geppert. To be clear by inverting the elastomeric compressive sleeve in Lazzara the device can be assembled faster and tighter.
In reference to dependent claim 2, Lazzara in view of Geppert discloses the coupling device according to claim 1, Geppert discloses a connector wherein a rim portion of the invertible sleeve (distal portion of 104 fig 4, the sleeve equivalent portion (combined above) in Geppert, farthest from the pivot point) in the first configuration extends distally from the stem receiving portion to surround a portion of the stem receiving portion (pictured in fig 4 the sleeve equivalent portion is “inverted”, once combined the sleeve of Lazzara would surround a portion of the stem receiving portion).
In reference to dependent claim 3, Lazzara in view of Geppert discloses the coupling device according to claim 1, Lazzara further discloses a device wherein the invertible sleeve in the second configuration extends proximally to define a recess configured to receive a portion of the port therein (showed in fig 1B wherein the sleeve 36 surrounds the port of 30).
In reference to dependent claim 4, Lazzara in view of Geppert discloses the coupling device according to claim 3, Lazzara further discloses a device wherein the portion of the port is a sleeve bearing portion (external portion of the port of 30 bears on the sleeve 36, fig 1B).
In reference to dependent claim 5, Lazzara in view of Geppert discloses the coupling device according to claim 4, Lazzara further discloses a device wherein a diameter of the recess (formed by 36) is the same as, or less than, a diameter of the sleeve bearing portion of the port (para 0075 discloses “As shown in FIG. 1B, the compression sleeve 36 engages the reusable connector 14 to secure and/or reinforce the connection between the single use connector 12 and the reusable connector 14” because of the compression, the diameter of the recess is less than the sleeve bearing portion bearing portion of the port).
In reference to dependent claim 9, Lazzara in view of Geppert discloses the coupling device according to claim 1, Lazzara further discloses a device wherein the sleeve is formed of an elastic material selected from a group consisting of a plastic, polymer, elastomer (para 0075 discloses “the compression sleeve 36 can be formed from an elastomeric material configured to wrap around and at least partially cover the open proximal side 18 of the housing 16 when in the closed position”), silicone rubber, synthetic rubber, natural rubber, latex, or composite.
In reference to dependent claim 10, Lazzara in view of Geppert discloses the coupling device according to claim 1, Lazzara further discloses a device further including a stem extending distally from the stem receiving portion and configured to engage a lumen of a catheter (24 of a second non-pictured connector; para 0112 discloses “one or more features of any embodiment can be combined with one or more features of any other embodiment”, examiner is interpreting a secondary connector 10 connected to the left of 10, as can be interpreted based on para 0112, SEE ANNOTATED FIG 1B below).
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In reference to dependent claim 11, Lazzara in view of Geppert discloses the coupling device according to claim 10, Lazzara further discloses a device wherein an outer diameter of the stem (2nd, unpictured 28, see annotated fig 1B above) of the coupling device is the same or larger than an inner diameter of a lumen of a catheter to engage the catheter in a friction fit (fig 1A-1B shows how 28 can be inserted into 18 and the slope of 28 causes the diameter of 18 to be increased and create a friction fit).
In reference to dependent claim 12, Lazzara in view of Geppert discloses the coupling device according to claim 1, Lazzara further discloses a device wherein an outer diameter of the stem of the port is the same or slightly larger than an inner diameter of the lumen of the stem receiving portion (fig 1A-1B shows how 28 can be inserted into 18 and the slope of 28 causes the diameter of 18 to be increased, meaning the port is slightly larger than the lumen 17).
In reference to dependent claim 13, Lazzara in view of Geppert discloses the coupling device according to claim 1, Lazzara further discloses a device wherein the sleeve (36) in the second configuration (shown in fig 1B) is configured to create an air tight seal between a surface of the sleeve and a surface of the port to mitigate disengagement of the port from the coupling device (para 0075 discloses “As shown in FIG. 1B, the compression sleeve 36 engages the reusable connector 14 to secure and/or reinforce the connection between the single use connector 12 and the reusable connector 14” because of the compression examiner takes the position that the seal can be airtight, furthermore since the device is meant to be used with catheters an air leak into the catheter could actually threaten the life of the user, therefore examiner takes the position the coupling is air tight).
In reference to dependent claim 16, Lazzara in view of Geppert discloses the method according to claim 15, Lazzara further discloses a device wherein the sleeve (36) is formed of an elastic material selected from a group consisting of a plastic, polymer, elastomer (para 0075 discloses “the compression sleeve 36 can be formed from an elastomeric material configured to wrap around and at least partially cover the open proximal side 18 of the housing 16 when in the closed position”), silicone rubber, synthetic rubber, natural rubber, latex, or composite.
In reference to dependent claim 17, Lazzara in view of Geppert discloses the method according to claim 15, Lazzara further discloses a device wherein the sleeve (36) in the locked configuration defines a recess, a diameter of the recess (formed by 36) is the same as or less than a diameter of the portion of the port (para 0075 discloses “As shown in FIG. 1B, the compression sleeve 36 engages the reusable connector 14 to secure and/or reinforce the connection between the single use connector 12 and the reusable connector 14” because of the compression, the diameter of the recess is less than the sleeve bearing portion of the port).
In reference to dependent claim 21, Lazzara in view of Geppert discloses the method according to claim 15, Lazzara further discloses a device wherein an outer diameter of the stem (2nd, unpictured 28, see annotated fig 1B above) of the coupling device is the same or larger than an inner diameter of the lumen of the catheter (fig 1A-1B shows how 28 can be inserted into 18 and the slope of 28 causes the diameter of 18 to be increased and create a friction fit).
In reference to dependent claim 22, Lazzara in view of Geppert discloses the method according to claim 15, Lazzara further discloses a device wherein an outer diameter of the port stem is the same or slightly larger than an inner diameter of the lumen of the coupling device to engage the coupling device in a friction fit (fig 1A-1B shows how 28 can be inserted into 18 and the slope of 28 causes the diameter of 18 to be increased and create a friction fit) (fig 1A-1B shows how 28 can be inserted into 18 and the slope of 28 causes the diameter of 18 to be increased and create a friction fit).
In reference to dependent claim 23, Lazzara in view of Geppert discloses the method according to claim 15, Lazzara further discloses a device further including creating an air-tight seal between the second surface of the sleeve (inside surface of 36) and the portion of the port (para 0075 discloses “As shown in FIG. 1B, the compression sleeve 36 engages the reusable connector 14 to secure and/or reinforce the connection between the single use connector 12 and the reusable connector 14” because of the compression examiner takes the position that the seal can be airtight, furthermore since the device is meant to be used with catheters an air leak into the catheter could actually threaten the life of the user, examiner takes the position the coupling is air tight).
In reference to dependent claim 24, Lazzara in view of Geppert discloses the method according to claim 23, Lazzara further discloses a device wherein urging the port proximally creates a vacuum within the recess mitigating disengagement between the port and the coupling device (para 0075 discloses “As shown in FIG. 1B, the compression sleeve 36 engages the reusable connector 14 to secure and/or reinforce the connection between the single use connector 12 and the reusable connector 14” examiner takes the position that the compressive sleeve would result in a vacuum being produced).
Claims 6, 8, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lazzara (USPAP 2022/0032029) in view of Geppert (USPAP 2020/0179671) further in view of Pisula (USPAP 2010/0001516).
In reference to dependent claim 6, Lazzara in view of Geppert discloses the coupling device according to claim 4, however
Lazzara and Geppert do not teach an inner profile of the recess mirrors and outer profile of the sleeve bearing portion of the port.
Pisula, a similar medical connector, teaches an inner profile of the recess (recess formed by 340, fig 27) mirrors and outer profile of the connector (320) of the port.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the mating features of Pisula in the device of Lazzara and Geppert “provides for a smooth surface transition between the female 120 and male 140 portions of the latch assembly” para 0067; Pisula.
In reference to dependent claim 8, Lazzara in view of Geppert discloses the coupling device according to claim 1, however
Lazzara and Geppert do not teach an outer surface of the invertible sleeve in the second configuration and an outer surface of a body of the port forms a continuous outer profile.
Pisula, a similar medical connector, teaches an outer surface of the sleeve (320, fig 27) in the second configuration (shown in fig 27) and an outer surface of a body of the port forms a continuous outer profile (340 and 320 form a continuous profile, fig 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the mating features of Pisula in the device of Lazzara and Geppert “provides for a smooth surface transition between the female 120 and male 140 portions of the latch assembly” para 0067; Pisula.
In reference to dependent claim 18, Lazzara in view of Geppert discloses the method according to claim 17, however
Lazzara and Geppert do not teach an inner profile of the recess mirrors and outer profile of the portion of the port.
Pisula, a similar medical connector, teaches an inner profile of the recess (recess formed by 340, fig 27) mirrors and outer profile of the portion of the port (the portion of 320 mirrors 340).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the mating features of Pisula in the device of Lazzara and Geppert “provides for a smooth surface transition between the female 120 and male 140 portions of the latch assembly” para 0067; Pisula.
In reference to dependent claim 20, Lazzara in view of Geppert discloses the method according to claim 15, however
Lazzara and Geppert do not teach the first surface of the sleeve forms a continuous outer profile with a body of the port when the sleeve is in the locked configuration.
Pisula, a similar medical connector, teaches the first surface of the sleeve (surface of 320, fig 27) forms a continuous outer profile with a body of the port when the sleeve is in the locked configuration (340 and 320 form a continuous profile, fig 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the mating features of Pisula in the device of Lazzara and Geppert “provides for a smooth surface transition between the female 120 and male 140 portions of the latch assembly” para 0067; Pisula.
Claim 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lazzara (USPAP 2022/0032029) in view of Geppert (USPAP 2020/0179671) in reference to claim 3 above, and further in view of Schulte (USPAP 2005/0253389).
In reference to dependent claim 7, Lazzara in view of Geppert discloses the coupling device according to claim 3, however
Lazzara and Geppert do not teach an inner surface of the recess includes a ridge configured to engage a suture groove disposed on the port, when the invertible sleeve is in the second configuration.
Schulte, a similar tubing connector, teaches an inner surface of the recess includes a ridge (218, fig 5) configured to engage a groove (groove 122 can be used as a suture groove) disposed on the port, when the sleeve is in the second configuration (shown in fig 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the features taught in Schulte in the device of Lazzara in view of Geppert to “provide not only secure coupling of the mating components, but also strain relief to the catheter ends” para 0027; Schulte.
In reference to dependent claim 19, Lazzara in view of Geppert discloses the method according to claim 15, however
Lazzara and Geppert do not teach an engaging a ridge, disposed on the second surface of the sleeve, with a suture groove, disposed on the portion of the port, when the sleeve is in the locked configuration.
Schulte, a similar tubing connector, teaches an engaging a ridge (218, fig 5), disposed on the second surface of the sleeve (inside surface of sleeve 200), with a suture groove (groove 122 can be used as a suture groove), disposed on the portion of the port (100), when the sleeve is in the locked configuration (shown in fig 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the features taught in Schulte in the device of Lazzara in view of Geppert to “provide not only secure coupling of the mating components, but also strain relief to the catheter ends” para 0027; Schulte.
Claims 14 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lazzara (USPAP 2022/0032029) in view of Geppert (USPAP 2020/0179671) further in view of Schwartz (USPAP 2020/0054867).
In reference to dependent claim 14, Lazzara in view of Geppert discloses the coupling device according to claim 1, however
Lazzara and Geppert do not teach a coating configured to provide one of a leak-proof seal or to mitigate tissue ingrowth.
Schwartz, a similar medical device, teaches a coating configured to provide one of a leak-proof seal or to mitigate tissue ingrowth (para 0042 discloses “it preferably has a coating that prevents clotting or tissue ingrowth”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coating taught in Schwartz on the device of Lazzara in view of Geppert “prevents clotting or tissue ingrowth” para 0042; Schwartz.
In reference to dependent claim 25, Lazzara in view of Geppert discloses the method according to claim 24, further including creating a seal between the second surface and the portion of the port, however
Lazzara and Geppert do not teach the seal created by a coating disposed on the second surface, the seal mitigating one of leakage or tissue ingrowth.
Schwartz, a similar medical device, teaches a seal created by a coating disposed on the second surface (once combined the coating added to the connector would naturally act as a sealing surface), the seal mitigating one of leakage or tissue ingrowth (para 0042 discloses “it preferably has a coating that prevents clotting or tissue ingrowth”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coating taught in Schwartz on the device of Lazzara in view of Geppert “prevents clotting or tissue ingrowth” para 0042; Schwartz.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Brown (USPN 4,950,255) discloses a catheter connector.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783