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 –
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, 3-5 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mescher et al (US 2005/0238506) hereinafter Mescher.
Regarding claim 1, Mescher teaches a pressure switch comprising:
an upper plate (top of 380, Fig. 7);
a baseplate (360), opposite the upper plate, having an opening therein in communication with a fluid path (327/328);
an elastic membrane (325, Refer to paragraph 65) sealing the opening in a baseplate, wherein the elastic membrane is deformable by pressure from fluid within the fluid path;
a plunger (388) disposed between the upper plate and the membrane and moveable along an axis extending between the upper plate and the membrane;
and a spring (366/395) biasing the plunger toward the membrane;
wherein a threshold pressure on the elastic membrane from the fluid within the fluid path moves the plunger toward the upper plate (Refer to paragraphs 65, 73).
Regarding claim 3, Mescher teaches a compression standoff (370) disposed between the upper plate and the baseplate and configured to maintain a predetermined spacing between the upper plate and the baseplate (See Figure 7).
Regarding claim 4, Mescher teaches the compression standoff forms a seal between the fluid path and the plunger (Refer to paragraph [0073], when a magnetic force is generated in 370, the plunger moves downward, and the membrane deflects, sealing the fluid pathway and restricting flow).
Regarding claim 5, Mescher teaches the compression standoff maintains the plunger (388, See Fig. 7) within a space defined within the compression standoff.
Regarding claim 7, Mescher teaches the spring (376) comprises one of metal and plastic (Refer to paragraph [0073]).
Regarding claim 8, Mescher teaches the elastic membrane comprises an elastomer (Refer to paragraphs [0050 and 0065]).
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hills et al. (US 20120203173) hereinafter Hills.
Regarding claim 1, Hills teaches a pressure switch comprising:
an upper plate (56, Fig 2);
a baseplate (36), opposite the upper plate, having an opening therein in communication with a fluid path (path within 44);
an elastic membrane (sidewalls 48) sealing the opening in a baseplate, wherein the elastic membrane is deformable by pressure from fluid within the fluid path;
a plunger (28) disposed between the upper plate and the membrane and moveable along an axis extending between the upper plate and the membrane;
and a spring (68) biasing the plunger toward the membrane;
wherein a threshold pressure on the elastic membrane from the fluid within the fluid path moves the plunger toward the upper plate (Refer to paragraph [0038]).
Regarding claim 2, Hills teaches the upper plate comprises a printed circuit board (56);
and the pressure switch further comprises:
at least one first conductive element (24) disposed on an upper face of the plunger,
and at least one second conductive element (metal pad in the circuit board) disposed on a lower face of the printed circuit board, such that the threshold pressure on the elastic membrane moves the plunger toward the upper plate such that the at least one first conductive element contacts the at least one second conductive element, closing an electrical circuit.
Regarding claim 3, Hills teaches a compression standoff (32) disposed between the upper plate and the baseplate and configured to maintain a predetermined spacing between the upper plate and the baseplate (See Figure 2).
Regarding claim 4, Hills teaches the compression standoff forms a seal between the fluid path and the plunger (See Figs. 2-3).
Regarding claim 5, Hills teaches the compression standoff maintains the plunger (See Fig. 2, Refer to paragraph [0032]) within a space defined within the compression standoff.
Regarding claim 7, Hills teaches the spring (68) comprises one of metal and plastic (Refer to paragraph [0041]).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hills et al. (US 20120203173) hereinafter Hills in view of Blakely (US 8704115)
Regarding claim 6, Hills teaches the at least one first conductive element (24, See Figure 2) comprises a conductive layer disposed on the upper face of the plunger, and the at least one second conductive element comprises a contact pad
disposed on the lower face of the printed circuit board.
Hills fails to explicitly disclose the conductive element comprises a contact pad, disposed on the lower face of the printed circuit board
Blakey teaches a pressure switch (500, col. 4, line 14), comprising a contact pad (302, Fig. 5), disposed on the lower face of the printed circuit board (300, Fig. 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to have a contact pad in the printer circuit board of Hills as taught by Blakely for better transmission of electricity to the PCB.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hills et al. (US 20120203173) hereinafter Hills in view of Siddhamali et al (US 9334984) hereinafter Siddhamali.
Regarding claim 8, Hills fails to explicitly teach the elastic membrane comprises an elastomer. Siddhamalii teaches a medical tubing comprising an elastomer (300, Fig. 3; Col. 7, line 37).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to use an elastomer as the material of the sidewalls of the tube of Hills as taught by Siddhamalii to allow for compression and expansion of the tubing.
Claim(s) 9-13, 15 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Straessler et al hereinafter Straessler in view of Hills et al. (US 20120203173) hereinafter Hills.
Regarding claim 9, Straessler teaches an insulin delivery device comprising:
a power and control system (38, paragraph [0069]),
and a pumping system (22, 22’ paragraph [0065] controlled by the power and control system, the pumping system comprising:
a fill port (inlet arrow seen in Fig. 1a) configured to receive a fluid medication from an external source, a reservoir (reservoir 20 within 22) configured to receive the fluid medication from the fill port and store the fluid medication therein,
a cannula (4, See paragraph [0061]) configured to deliver the fluid medication to a patient,
a pump (22, paragraph [0065]) configured to move the fluid medication from the reservoir to the cannula, and a pressure switch disposed on a fluid path (17) between the fill port and the cannula (3, See Fig. 1a, Paragraph 0085). Straessler fails to explicitly disclose the details of the pressure switch, the switch comprising: an upper plate;
a baseplate, opposite the upper plate, having an opening therein in communication with the fluid path;
an elastic membrane sealing the opening in a baseplate, wherein the elastic membrane is deformable by pressure from the fluid medication within the fluid path;
a plunger disposed between the upper plate and the membrane and moveable along an axis extending between the upper plate and the membrane; and a spring biasing the plunger toward the membrane; wherein a threshold pressure on the elastic membrane from the fluid medication within the fluid path moves the plunger toward the upper plate.
Hills teaches a pressure switch used with a medical pump 52, comprising:
an upper plate (56, Fig 2);
a baseplate (36), opposite the upper plate, having an opening therein in communication with a fluid path (path within 44);
an elastic membrane (sidewalls 48) sealing the opening in a baseplate, wherein the elastic membrane is deformable by pressure from fluid within the fluid path;
a plunger (28) disposed between the upper plate and the membrane and moveable along an axis extending between the upper plate and the membrane;
and a spring (68) biasing the plunger toward the membrane;
wherein a threshold pressure on the elastic membrane from the fluid within the fluid path moves the plunger toward the upper plate (Refer to paragraph [0038]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to include the details of the pressure switch taught by Hills, in the pump system of Straessler to detect occlusions in the fluid path of the medication.
Regarding claim 10, modified Straessler teaches the upper plate comprises a printed circuit board (56, Hills); and the pressure switch further comprises:
at least one first conductive element (24, Hills) disposed on an upper face of the plunger,
and at least one second conductive element (metal pad in the circuit board) disposed on a lower face of the printed circuit board, such that the threshold pressure on the elastic membrane moves the plunger toward the upper plate such that the at least one first conductive element contacts the at least one second conductive element, closing an electrical circuit (See paragraph [0038], Hills).
Regarding claim 11, modified Straessler teaches the pressure switch further comprises: a compression standoff (32, Fig. 2, Hills) disposed between the upper plate and the baseplate and configured to maintain a predetermined spacing between the upper plate and the baseplate.
Regarding claim 12, modified Straessler teaches the compression standoff forms a seal between the fluid path and the plunger (see figs. 2-3, Hills).
Regarding claim 13, modified Straessler teaches the compression standoff maintains the plunger within a space defined within the compression standoff (See Fig. 2, Refer to paragraph [0032], Hills).
Regarding claim 15, modified Straessler teaches the spring (68) comprises one of metal and plastic (Refer to paragraph [0041], Hills).
Regarding claim 17 modified Straessler fails to explicitly teach the pressure switch is located on the fluid path between the fill port and the reservoir. It would be obvious to try for a person of ordinary skill at the time the invention was filed, as there is a finite number of possible positionings of the pressure switch, to have placed the pressure switch on the fluid path between the fill port and the reservoir, as doing so would result in determining flow resistance and occlusions in that area. (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.)
Regarding claim 18, modified Straessler fails to explicitly teach the pressure switch is located on the fluid path at the reservoir.
It would be obvious to try for a person of ordinary skill at the time the invention was filed, as there is a finite number of possible positionings of the pressure switch, to have placed the pressure switch on the fluid path at the reservoir, as doing so would result in determining flow resistance and occlusions in the reservoir. (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.)
Regarding claim 19, modified Straessler teaches the pressure switch is located on the fluid path between the pump (22) and the cannula (4).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Straessler et al hereinafter Straessler in view of Hills et al. (US 20120203173) hereinafter Hills as applied to claim 9 and further in view of Blakely (US 8704115).
Regarding claim 14, modified Straessler teaches the at least one first conductive element comprises a conductive layer disposed on the upper face of the plunger, and the at least one second conductive element comprises a contact pad disposed on the lower face of the printed circuit board. Modified Straessler fails to explicitly disclose the conductive element comprises a contact pad, disposed on the lower face of the printed circuit board
Blakey teaches a pressure switch (500, col. 4, line 14), comprising a contact pad (302, Fig. 5), disposed on the lower face of the printed circuit board (300, Fig. 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to have a contact pad in the printer circuit board of modified Straessler as taught by Blakely for better transmission of electricity to the PCB.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Straessler et al hereinafter Straessler in view of Hills et al. (US 20120203173) hereinafter Hills as applied to claim 9 and further in view of Siddhamali et al (US 9334984) hereinafter Siddhamali.
Regarding claim 16, modified Straessler fails to explicitly teach the elastic membrane comprises an elastomer. Siddhamalii teaches a medical tubing comprising an elastomer (300, Fig. 3; Col. 7, line 37).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to use an elastomer as the material of the sidewalls of the tube on modified Straessler as taught by Siddhamalii to allow for compression and expansion of the tubing.
Conclusion
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772