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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Burkholz et al. (US 2019/0321590) hereinafter Burkholz.
Regarding claim 1, Burkholz teaches a liquid medicine administration device comprising:
a catheter (55/12) configured to be inserted into and left in place in a living body;
a catheter hub (52/54) that holds a proximal end of the catheter;
a device body (10, Figure 4A-B) that is separate from the catheter (38) and capable to deliver a liquid medicine from a distal portion of the device body (refer to paragraph [0060]);
a tube (66) held by the catheter hub, the tube being connected to the catheter and configured to allow the liquid medicine to flow toward the catheter;
a connector (72/49) to which the device body is attached, the connector being located at a proximal end of the tube;
a valve body (37) that has a disk shape (39) in a flow path between the catheter hub and a proximal end of the connector, the valve body having an opening and closing hole that has a slit shape (Refer to paragraph [0067]) and that opens during delivery of the liquid medicine, the valve body allowing the device body to communicate with the tube via the opening and closing hole.
Regarding claim 2, Burkholz teaches wherein: the valve body is disposed between a proximal end of the tube and the connector (See Figure 5A).
Regarding claim 3, Burkholz teaches the connector is selectively connectable to a priming solution delivery tool configured to deliver a priming solution from a distal portion of the priming solution delivery tool; the connector has a valve seat having an annular shape (see Annotate Figure 5A), disposed on a side of the tube with respect to the valve body, and protruding toward the valve body; and the valve seat is in contact with the valve body on a radially outer side of the opening and closing hole, and the valve body is held between the valve seat and a proximal end face of the connector (See Figure 5A).
Regarding claim 4, Burkholz teaches wherein: the opening and closing hole is formed to have a straight line shape or a cross shape at a central part of the valve body (Refer to paragraph [0067], See Figure 5A).
Regarding claim 5, Burkholz teaches an opening pressure of the valve body for opening the opening and closing hole is lower than a pressure applied to the valve body by a driving force when the device body is driven (since the valve 37 opens when the delivery device is driven towards it).
Regarding claim 6 , Burkholz teaches a liquid medicine administration device comprising:
a catheter (55/12) configured to be inserted into and left in place in a living body;
a catheter hub (52/54) that holds a proximal end of the catheter;
a tube (66) held by the catheter hub, the tube being connected to the catheter and configured to allow the liquid medicine to flow toward the catheter;
a connector (49/72) to which a device body is attachable, the connector being located at a proximal end of the tube;
and a valve body (37) that has a disk shape (39) in a flow path between the catheter hub and a proximal end of the connector, the valve body having an opening and closing hole that has a slit shape (see paragraph [0067]) and that opens during delivery of the liquid medicine, the valve body allowing the device body to communicate with the tube via the opening and closing hole (See paragraph [0060]).
Regarding claim 7, Burkholz teaches the valve body (37/39, See Figure 5A) is disposed between a proximal end of the tube and the connector (49).
Regarding claim 8, Burkholz teaches wherein: the connector is selectively connectable to a priming solution delivery tool (10) configured to deliver a priming solution from a distal portion of the priming solution delivery tool;
the connector has a valve seat having an annular shape (see Annotated Figure 5A), disposed on a side of the tube with respect to the valve body, and protruding toward the valve body; and the valve seat is in contact with the valve body on a radially outer side of the opening and closing hole, and the valve body is held between the valve seat and a proximal end face of the connector (see Figure 5A).
Regarding claim 9, Burkholz teaches the opening and closing hole is formed to have a straight line (slit, see paragraph [0067]) shape or a cross shape at a central part of the valve body.
Regarding claim 10, Burkholz teaches an opening pressure of the valve body for opening the opening and closing hole is lower than a pressure applied to the valve body by a driving force when the device body is driven (since the valve 37 opens when the delivery device is driven towards it).
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) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Abitabilo et al. (US 2017/0239443) hereinafter Abitabilo.
Regarding claim 11, Burkholz teaches a method comprising:
providing a device body configured to deliver a fluid from a distal portion of the device body (See paragraph 0007);
providing a fluid administration device comprising:
a catheter (55/12) configured to be inserted into and left in place in a living body;
a catheter hub (52/54) that holds a proximal end of the catheter;
a tube (66) held by the catheter hub, the tube being connected to the catheter and configured to allow the liquid medicine to flow toward the catheter;
a connector (49/72) to which the device body is attached, the connector being located at a proximal end of the tube;
and a valve body (39/37) that has a disk shape in a flow path between the catheter hub and a proximal end of the connector, the valve body having an opening and closing hole that has a slit shape (Refer to paragraph [0067]);
and delivering the fluid from the device body to the tube, during which the opening and closing hole opens and allows the device body to communicate with the tube via the opening and closing hole (refer to paragraphs [0045, 47, and 0060]).
Burkholz fails to explicitly teach the fluid is a liquid medicine.
Abitabilo teaches a fluid administration device (See figure 4a) comprising, a catheter (106/108), a hub (110), a tube (100), and a connector (118), and the delivery of a medical fluid to a patient (refer to paragraph [003]), using a device body for IV fluid (refer to paragraph 162, 182, ) or medications delivery to a patient.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the device of Burkholz as taught by Abitabilo, to deliver a fluid medication to a patient, to maintain fluid, nutrients and electrolyte balance in a patient.
Conclusion
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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