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 .
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.
The factual inquiries 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.
Claim(s) 1, 13, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinger et al (8,551,067) in view of Roy et al (US 7,628,781).
Regarding claim 1, the limitation “configured for use with each of an infusion liquid container containing an infusion liquid and having a port for administering the infusion liquid, a medicament supply containing a medicament and having a male Luer, and an infusion set including an IV set spike” is interpreted to be an intended use limitation wherein those elements are not positively recited. Zinger discloses a closed-system liquid transfer device capable of being used with the fluid sources listed above (fig. 1), the device comprising: a body 13A (fig. 1); an IV set spike 22 at a first end of the body configured to be fluidly connected to the port of the infusion liquid container (fig. 2A; col. 2, line 53); a port 27 at a second end of the body to sealingly receive an IV set spike of an infusion set (fig. 2A; col. 1, line 66 – col. 2, line 1); and a female Luer 32 at a third end of the body configured to be fluidly connected to the male Luer of the medicament supply (col. 3, lines 1-3, 11-12; fig. 2A).
Claim 1 differs from Zinger in calling for the port to include a locking ring to resist a removal force applied to the port of the closed-system liquid transfer device or to the IV set spike of the infusion set. Roy teaches a body 110 having a port for receiving a spike 124 (fig. 2a), wherein the port includes a locking ring 112 to resist a removal force applied to the port of the spike (fig. 2a). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the port of Zinger to include a locking ring as taught by Roy to prevent the patient from accidentally dislodging their line from the fluid source.
Regarding claim 13, Zinger discloses a first lumen 31 fluidly connecting an opening of the female Luer with a first distally disposed opening of the IV set spike of the closed-system liquid transfer device, the first lumen being configured to provide fluid communication from the medicament supply via the female Luer to the infusion liquid container that is separated from the port of the closed-system liquid transfer device (fig. 2A; col. 2, lines 64-66); and a second lumen 26 fluidly connecting the port of the closed-system liquid transfer device with a second distally disposed opening of the IV set spike of the closed-system liquid transfer device (fig. 2A), the second lumen being configured to provide fluid communication from the infusion liquid container to the port of the closed-system liquid transfer device including liquid received from the medicament supply via the first lumen (col. 2, lines 57-59).
Regarding claim 22, Zinger in view of Roy teaches a kit comprising: the closed-system liquid transfer device of claim 1 (see claim 1 above); and Zinger further discloses the infusion liquid container 10; the medicament supply 19; and the infusion set (col. 4, lines 21-22).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Roy as applied to claim 1 above, and further in view of Nordgren et al (US 4,676,530).
Claim 2 differs from the teachings above in calling for the locking ring has a plurality of circumferential ridges on an inner surface of the locking ring, and the locking ring is provided within a recess of the port of the closed-system liquid transfer device. Nordgren teaches a locking ring having a plurality of circumferential ridges 15 on an inner surface of the locking ring (fig. 4), the locking ring 11 provided within a recess of the port (fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the locking ring of Zinger in view of Roy to be of the type taught by Nordgren including a ring having inner circumferential ridges, the ring located in a recess of the port to provide a secure connection between the spike and the port.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Roy as applied to claim 1 above, and further in view of Wong (US 2014/0339811).
Claim 7 differs from the teachings above in calling for the female Luer to comprise a plurality of protrusions that are configured to resist rotation of the male Luer in an opening direction. Wong teaches a female luer having protrusions 40a, 40b (fig. 2A) that are configured to resist rotation of the male Luer in an opening direction (page 3, para. 0040). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the female luer of Zinger to include protrusions that resist rotation of the male luer in an opening direction as taught by Wong to prevent accidental separate of the connectors.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Roy as applied to claim 1 above, and further in view of Shriver et al (US 10,159,788).
Claim 9 differs from the teachings above in calling for the IV set spike of the closed-system liquid transfer device to comprise a restrainer having an outwardly projecting trailing edge defining a plurality of barbs. Shriver teaches a spike having a plurality of barbs 128h (fig. 9A) to prevent withdrawal of the spike from the connector (col. 12, lines 59-67). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spike of Zinger to include barbs as taught by Shriver to provide resistance to removal to ensure that the spike remains securely attached to the connector.
Claim(s) 24, 25, 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Wong.
Regarding claim 24, the limitation “configured for use with each of an infusion liquid container containing an infusion liquid and having a port for administering the infusion liquid, a medicament supply containing a medicament and having a male Luer, and an infusion set including an IV set spike” is interpreted to be an intended use limitation wherein those elements are not positively recited. Zinger discloses a closed-system liquid transfer device capable of being used with the fluid sources listed above (fig. 1), the device comprising: a body 13A (fig. 1); an IV set spike 22 at a first end of the body configured to be fluidly connected to the port of the infusion liquid container (fig. 2A; col. 2, line 53); a port 27 at a second end of the body to sealingly receive an IV set spike of an infusion set (fig. 2A; col. 1, line 66 – col. 2, line 1); and a female Luer 32 at a third end of the body configured to be fluidly connected to the male Luer of the medicament supply (col. 3, lines 1-3, 11-12; fig. 2A).
Claim 24 differs from the teachings above in calling for the female Luer to comprise a plurality of protrusions that are configured to resist rotation of the male Luer in an opening direction. Wong teaches a female luer having protrusions 40a, 40b (fig. 2A) that are configured to resist rotation of the male Luer in an opening direction (page 3, para. 0040). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the female luer of Zinger to include protrusions that resist rotation of the male luer in an opening direction as taught by Wong to prevent accidental separate of the connectors.
Regarding claim 25, Wong further teaches that the plurality of protrusions are arranged in a circumferential thread (fig. 2A).
Regarding claim 32, Zinger in view of Wong teaches a kit comprising: the closed-system liquid transfer device of claim 24 (see claim 24 above); and Zinger further discloses the infusion liquid container 10; the medicament supply 19; and the infusion set (col. 4, lines 21-22).
Claim(s) 27, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zinger in view of Wong as applied to claim 24 above, and further in view of Shriver.
Claim 27 differs from the teachings above in calling for the IV set spike of the closed-system liquid transfer device to comprise a restrainer having an outwardly projecting trailing edge defining a plurality of barbs. Shriver teaches a spike having a plurality of barbs 128h (fig. 9A) to prevent withdrawal of the spike from the connector (col. 12, lines 59-67). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spike of Zinger to include barbs as taught by Shriver to provide resistance to removal to ensure that the spike remains securely attached to the connector.
Regarding claim 31, Zinger discloses a first lumen 31 fluidly connecting an opening of the female Luer with a first distally disposed opening of the IV set spike of the closed-system liquid transfer device (fig. 2A), the first lumen being configured to provide fluid communication from the medicament supply via the female Luer to the infusion liquid container that is separated from the port of the closed- system liquid transfer device (col. 2, lines 64-66); and a second lumen 26 fluidly connecting the port of the closed-system liquid transfer device with a second distally disposed opening of the IV set spike of the closed-system liquid transfer device, the second lumen being configured to provide fluid communication from the infusion liquid container to the port of the closed-system liquid transfer device including liquid received from the medicament supply via the first lumen (col. 2, lines 57-59).
Allowable Subject Matter
Claims 4, 11, 12, 14, 15, 18, 20, 29, 30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter of the claims listed above could not be found in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
Prosecution Insights