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 § 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) 1-6 and 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lanier, JR. et al. (hereinafter “Lanier”, US 2017/0246383).
Regarding claim 1, Lanier discloses a user-wearable infusion pump (Abstract, ¶[0031]-[0033]), comprising:
a housing (Fig. 1, 102);
a reservoir (Fig. 4, 118) configured to contain a medicament disposed in the housing (¶[0219]);
a delivery mechanism (Fig. 3, 104) configured to deliver medicament from the reservoir to a user (¶[0217]);
an actuation wire (Fig. 3, 112) configured to be energized to actuate the delivery mechanism to deliver medicament from the reservoir to a user (¶[0217]).
Regarding claim 2, Lanier discloses the user-wearable infusion pump of claim 1, wherein the actuation wire defines two electrical paths that are separately energizable (¶[0219], where the actuation wire is not limited to a single pathway and multiple are expressed as a possible configuration for the device).
Regarding claim 3, Lanier discloses the user-wearable infusion pump of claim 2, wherein the two electrical paths are configured to provide two different predetermined medicament dispense sizes with the delivery mechanism (¶[0375], [0382]-[0385], the device of Lanier is described as having at least one actuation wire and is expressed as having the capability for different doses that send and use different signals to produce the configured doses).
Regarding claim 4, Lanier discloses the user-wearable infusion pump of claim 2, wherein each electrical path is defined by corresponding electrical contacts that are energized to actuate the delivery mechanism.
Regarding claim 4, Lanier discloses the user-wearable infusion pump of claim 2, wherein the actuation wire is a single continuous wire (Fig. 3, 112).
Regarding claim 6, Lanier discloses the user-wearable infusion pump of claim 1, wherein the actuation wire comprises a shape memory material such that energization of the actuation wire causes the actuation wire to shorten to actuate the delivery mechanism (¶[0217]).
Regarding claim 11, Lanier discloses user-wearable infusion pump (Abstract, ¶[0031]-[0033]), comprising:
a housing (Fig. 1, 102);
a reservoir (Fig. 4, 118) configured to contain a medicament disposed in the housing (¶[0217]); and
a delivery mechanism (Fig. 3, 104) configured to deliver medicament from the reservoir to a user, wherein the delivery mechanism is configured to provide two different predetermined medicament dispense sizes (¶[0217]).
Regarding claim 12, Lanier discloses he user-wearable infusion pump of claim 11, further comprising an actuation wire (Fig. 3, 112) configured to be energized to actuate the delivery mechanism to deliver medicament from the reservoir to a user (¶[0217]).
Regarding claim 13, The user-wearable infusion pump of claim 12, wherein the actuation wire defines two electrical paths corresponding to the two different predetermined medicament dispense sizes (¶[0375], [0382]-[0385], the device of Lanier is described as having at least one actuation wire and is expressed as having the capability for different doses that send and use different signals to produce the configured doses).
Regarding claim 14, The user-wearable infusion pump of claim 13, wherein each electrical path is defined by corresponding electrical contacts that are energized to actuate the delivery mechanism.
Regarding claim 15, Lanier discloses the user-wearable infusion pump of claim 12, wherein the actuation wire is a single continuous wire (Fig. 3, 112).
Regarding claim 16, Lanier discloses the user-wearable infusion pump of claim 12, wherein the actuation wire comprises a shape memory material such that energization of the actuation wire causes the actuation wire to shorten to actuate the delivery mechanism (¶[0217]).
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) 7-10 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lanier, JR. et al. (hereinafter “Lanier”, US 2017/0246383) in view of Menroe (US 2007/0276329).
Regarding claim 7, Lanier discloses the user-wearable infusion pump of claim 1, Lanier does not specifically teach wherein the delivery mechanism comprises a drive gear configured to be rotated to actuate the delivery mechanism.
Menroe teaches a disposable dispensing device with a driving mechanism for fluid delivery. Menroe teaches wherein the delivery mechanism comprises a drive gear configured to be rotated to actuate the delivery mechanism (¶[0143]). By modifying the device of Lanier to use a driving gear mechanism to drive the actuation and the delivery of the medicine, it would allow for more accurate dosing and reduce the risk of malfunction which can include overdosing (¶[0144] from Menroe).
Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Lanier to use a gear driving mechanism (¶[0143] from Menroe).
Regarding claim 8, the combined device of Lanier and Menroe teaches the user-wearable infusion pump of claim 7, Menroe further teaches wherein the delivery mechanism further comprises a frame disposed around the drive gear (Fig. 5d, 72), the frame including a flexible member having a drive tooth configured to interface with the drive gear to rotate the drive gear (Fig. 5a, 40).
Regarding claim 9, the combined device of Lanier and Menroe teaches the user-wearable infusion pump of claim 8, Menroe further teaches wherein the actuation wire is configured to pull the flexible member down to causes the drive tooth to rotate the drive gear a predetermined amount (¶[0153], where the wire 186 pulls on the plate to cause the actuation of the driving mechanism to occur).
Regarding claim 10, the combined device of Lanier and Menroe teaches the user-wearable infusion pump of claim 7, Menroe further teaches wherein the delivery mechanism further includes an encoder having a plurality of teeth that is rotated when the drive gear rotates to track accuracy of medicament delivery (¶[0144], where the purpose of the gear and wheel during mechanism is to have a reliable way to track dosing and have accurate dosing measurements for delivery).
Regarding claim 17, Lanier discloses the user-wearable infusion pump of claim 11, Lanier does not specifically teach wherein the delivery mechanism comprises a drive gear configured to be rotated to actuate the delivery mechanism.
Menroe teaches a disposable dispensing device with a driving mechanism for fluid delivery. Menroe teaches wherein the delivery mechanism comprises a drive gear configured to be rotated to actuate the delivery mechanism (¶[0143]). By modifying the device of Lanier to use a driving gear mechanism to drive the actuation and the delivery of the medicine it would allow for more accurate dosing and reduce the risk of malfunction which can include overdosing (¶[0144] from Menroe).
Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Lanier to use a gear driving mechanism (¶[0143] from Menroe).
Regarding claim 18, the combined device of Lanier and Menroe teaches the user-wearable infusion pump of claim 17, Menroe further teaches wherein the delivery mechanism further comprises a frame disposed around the drive gear (Fig. 5d, 72), the frame including a flexible member having a drive tooth configured to interface with the drive gear to rotate the drive gear (Fig. 5a, 40).
Regarding claim 19, the combined device of Lanier and Menroe teaches the user-wearable infusion pump of claim 18, Menroe further teaches wherein the actuation wire is configured to pull the flexible member down to causes the drive tooth to rotate the drive gear a predetermined amount (¶[0153], where the wire 186 pulls on the plate to cause the actuation of the driving mechanism to occur).
Regarding claim 20, the combined device of Lanier and Menroe teaches the user-wearable infusion pump of claim 17, Menroe further teaches wherein the delivery mechanism further includes an encoder having a plurality of teeth that is rotated when the drive gear rotates to track accuracy of medicament delivery (¶[0144], where the purpose of the gear and wheel during mechanism is to have a reliable way to track dosing and have accurate dosing measurements for delivery).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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