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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 14, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on March 18, 2024. These drawings are acceptable.
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.
Claims 1-8, 13-15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (US 20230381407), hereinafter Yu, in view of Pizzochero et al. (US 20180272058), hereinafter Pizzochero.
Regarding claim 1, Yu discloses a transcutaneous drug delivery system (Fig. 1, patch pump 1) receiving a reservoir containing a liquid (Fig. 3 and [0039], pump 1 may receive reservoir 4 containing liquid insulin) comprising: a pump housing attachable to skin of a patient (Fig. 2 and [0046], housing components 2 and 9, wherein bottom housing 9 comprises an adhesive pad 34 for attaching to skin) and supporting a peristaltic pump providing actuating finger elements (Fig. 2-9 and [0039, 0053-0056], housing contains/supports pump 3 which may peristaltic pump provided by cam assembly 60, wherein cams 64, 66, 68 are the actuating finger elements); an IV line Fig. 4 and [0048-0052], fluid channel 44 and conduit 58 together form an IV line through the pump mechanism 36) coupled to the reservoir (Fig. 4 and [0052], conduit 58 couples to reservoir 4) and communicating with the peristaltic finger elements to provide undulating movement along the IV line (Fig. 4-9 and [0056-0058], fluid channel 44 communicates with cams 64, 66, 68 via its membrane 50 for providing undulating movement along fluid channel 44); and an IV line connector providing a leak-free connection between the IV line and the IV line connector (Fig. 4 and [0051], conduit 54 with coupling 52 for providing fluid tight connection between fluid channel 44 and conduit 54) and coupled to a hypothermic needle to fluidly communicate the liquid to the patient through the hypothermic needle (Fig. 3-4 and [0013, 0051], conduit 54 then connects to cannula 32, which may be a hollow steel cannula/infusion needle).
Yu fails to disclose wherein the reservoir is an intravenous (IV) bag. However, Pizzochero discloses wherein the reservoir is an intravenous (IV) bag (Fig, 23-24 and [0107-0109], reservoir 104 is a flexible bag (IV-type bag), which engages with a conduit tubing/fluid channel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu to incorporate the teachings of Pizzochero and modify the reservoir to be an intravenous (IV) bag. Doing so would allow the reservoir to fill voids within the patch pump, thus aiding in reducing the dimensions of the patch pump (Pizzochero, [0059]).
Regarding claim 2 and Yu, in view of Pizzochero, Yu further discloses the transcutaneous drug delivery system of claim 1 wherein the housing includes a first compartment receiving the IV bag (Fig. 3-4 and [0042-0045], housings 2/20 and 9 can form two compartments (internal spaces 26 and 28), wherein internal space 28 can receive at least part of reservoir 4) and a second compartment releasably supporting the peristaltic pump (Fig. 3 and [0042-0045], internal space 26 may comprise the pump mechanism 36).
Regarding claim 3 and Yu, in view of Pizzochero, Yu further discloses the transcutaneous drug delivery system of claim 2 wherein the IV line passes from the first compartment to the second compartment (Fig. 3-4 and [0052], fluid channel 44 passes under barrier wall 24 from internal space 28 (where reservoir and conduit 58 are located) to internal space 26 where (pump mechanism 36 is located)).
Regarding claim 4 and Yu, in view of Pizzochero, Yu further discloses the transcutaneous drug delivery system of claim 3 wherein the first compartment and second compartment are separated by a false bottom (Fig. 3 and [0042], barrier wall 24 creates a false bottom wall which separates the internal space 28 from the internal space 26).
Regarding claim 5 and Yu, in view of Pizzochero, Yu further discloses the transcutaneous drug delivery system of claim 1 wherein the housing includes a guide channel (Fig. 3-4 and [0047], base 22 which may be part of the bottom surface housing of device, comprises guide recess 42) holding the IV line against a retaining wall (Fig. 4 and [0047-0048], recess 42 forms the guide channel with membrane 50, and allows form the guide channel to be against a retaining side/bottom wall of recess 42).
Regarding claim 6 and Yu, in view of Pizzochero, Yu further discloses the transcutaneous drug delivery system of claim 5 wherein the peristaltic finger elements are positioned to undulate towards the retaining wall (Fig. 7-9 and [0058], cams64,66,68 are positioned to undulate towards retaining wall of recess 42).
Regarding claim 7 and Yu, in view of Pizzochero, Yu further discloses the transcutaneous drug delivery system of claim 6 wherein the peristaltic pump comprises a motor (Fig. 4 and [0053, 0056], pump mechanism 36 comprises motor 71) configured to rotate a pump crank (Fig. 4 and [0053], drive motor 71 rotates drive shaft 69).
Regarding claim 8 and Yu, in view of Pizzochero, Yu further discloses the transcutaneous drug delivery system of claim 1 further comprising an adhesive sheet attached to the pump housing permitting attachment of the pump housing to the skin of the patient (Fig. 1 and [0046], bottom surface of housing may comprise an adhesive pad 34 for attaching bottom surface of pump housing to skin).
Regarding claim 13, Yu, in view of Pizzochero, discloses the transcutaneous drug delivery system of claim 1, as explained above. Yu is silent to wherein the pump housing is rigid. However, Pizzochero further discloses wherein the pump housing is rigid (Fig. 8-9 and [0067], at least base 9 of pump housing is made of a stiff/rigid material).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero, to further incorporate the teachings of Pizzochero and modify the base housing to be rigid. Doing so would provide a base made of a material which can support and be configured with the various components of the pump (Pizzochero, [0067]).
Regarding claim 14, Yu, in view of Pizzochero, discloses the transcutaneous drug delivery system of claim 13, as explained above. As noted above, Yu fails to disclose wherein the pump housing is rigid and is thus silent to wherein the pump housing is manufactured of a thermoplastic material (Fig. 8-9 and [0067], base 9 of pump housing is made of a thermoplastic resin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero, to further incorporate the teachings of Pizzochero and modify the base housing to be manufactured of a thermoplastic material. Doing so would provide a base made of a material which can support and be configured with the various components of the pump (Pizzochero, [0067]).
Regarding claim 15, Yu, in view of Pizzochero, discloses the transcutaneous drug delivery system of claim 1.
However, Yu, in view of Pizzochero, does not expressly disclose wherein the pump housing is one inch by one and one half inches in size or smaller.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yu, in view of Pizzochero, to have a pump housing which is one inch by one and one half inches in size or smaller. since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified device of Yu would not operate differently with the housing size range and Yu discloses in Fig. 2-3 and [0010, 0012] that the pump and fluid path design of the device is constructed for use in a limited space environment, such as a patch pump, to thus minimize the overall size and complexity of the device. Therefore, the device would function appropriately having the claimed pump housing dimension range. Further , it appears that the applicant places no criticality on the range claimed, indicating simply that the pump housing "may be" or "for example, is" one inch by one and one half inches in size or smaller (instant specification [0023, 0038]).
Regarding claim 17, Yu discloses a method of transcutaneously delivering a liquid drug from a reservoir containing the liquid drug (Fig. 1, method of delivering a drug from patch pump 1) comprising: attaching a pump housing to skin of a patient (Fig. 2 and [0046], attaching bottom housing 9 (pump housing comprises top housing 2 and bottom housing 9), which comprises an adhesive pad 34, to skin), the pump housing supporting a peristaltic pump (Fig. 2-9 and [0039, 0053-0056], housing contains/supports pump 3 which may peristaltic pump), the peristaltic pump having finger elements (Fig. 2-9 and [0039, 0053-0056], peristaltic pump provided by cam assembly 60, wherein cams 64, 66, 68 are the actuating finger elements) providing undulating movement of the liquid through the IV line (Fig. 4-9 and [0056-0058], fluid channel 44 communicates with cams 64, 66, 68 via its membrane 50 for providing undulating movement along fluid channel 44), and an IV line connector providing a leak-free connection between the IV line and the IV line connector (Fig. 4 and [0051], conduit 54 with coupling 52 for providing fluid tight connection between fluid channel 44 and conduit 54) and couplable to a hypothermic needle to fluidly communicate the liquid drug to the patient (Fig. 3-4 and [0013, 0051], conduit 54 then connects to cannula 32, which may be a hollow steel cannula/infusion needle); connecting the IV line connector to the hypothermic needle (Fig. 3-4 and [0013, 0051], conduit 54 connects fluid channel 44 to cannula/infusion needle 32); operating the peristaltic pump to undulate the peristaltic finger elements to provide movement of the liquid through the IV line (Fig. 7-9 and [0058], cam assembly 60 is operated to move fluid through fluid channel 44); and expelling the liquid from the reservoir through the IV line and IV line connector into the skin of the patient (Fig. 3-4 and [0051, 0063], pump operates to expel fluid from reservoir 4 to cannula 36, via fluid channel 44, for delivery into patient).
Yu fails to disclose wherein the reservoir is an intravenous (IV) bag. However, Pizzochero discloses wherein the reservoir is an intravenous (IV) bag (Fig, 23-24 and [0107-0109], reservoir 104 is a flexible bag (IV-type bag), which engages with a conduit tubing/fluid channel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu to incorporate the teachings of Pizzochero and modify the reservoir to be an intravenous (IV) bag. Doing so would allow the reservoir to fill voids within the patch pump, thus aiding in reducing the dimensions of the patch pump (Pizzochero, [0059]).
Regarding claim 18 and Yu, in view of Pizzochero, Yu further discloses the method of claim 17 further comprising filling the IV bag with the liquid drug through the IV line prior to attaching the pump housing to the skin of the patient ([0045-0046], prior to use (prior to attachment of the device to patient skin) the reservoir 4 may be filled via a fill port, which may include a conduit portion that serves as part as the fluid channel 44 for flow exiting reservoir 4).
Regarding claim 19 and Yu, in view of Pizzochero, Yu further discloses the method of claim 17 further comprising controlling a flow rate of the liquid from the IV bag (Fig. 4 and [0063], pump 36 is configured to delivering fluid from the reservoir 4 at a controlled rate).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 20230381407), in view of Pizzochero (US 20180272058), as applied to claim 8 above, and further in view of Levinson et al. (US 20100249560), hereinafter Levinson.
Regarding claim 9, Yu, in view of Pizzochero, discloses the transcutaneous drug delivery system of claim 8.
Yu, in view of Pizzochero, fails to disclose wherein the adhesive sheet is oxygen permeable. However, Levinson discloses wherein the adhesive sheet is oxygen permeable (Fig. 1 and [0036], adhesive layer 11 may be oxygen permeable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero, to incorporate the teachings of Levinson and modify the adhesive sheet to be oxygen permeable. Doing so provides an adhesive layer which does not present a significant transport barrier to oxygen, as generally the composition of the adhesive layer is inherently at least partially oxygen permeable. Additionally, said skin adhesives include those produced by 3M, which Yu also discloses as an example skin adhesive to use with device (Levinson, [0036, 0060, 0159] and Yu, [0046]).
Claims 10-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 20230381407), in view of Pizzochero (US 20180272058), as applied to claims 1 and 17 above, and further in view of Rorvig (US 20110259774).
Regarding claim 10 and Yu, in view of Pizzochero, Yu further discloses the transcutaneous drug delivery system of claim 1 wherein the peristaltic pump is supported on a support board (Fig. 4 and [0054], peristaltic pump cam assembly 60 is mounted on support 72).
Yu, in view of Pizzochero, fails to disclose wherein the pump housing further comprises retention elements permitting the support board to be removably released from the pump housing. However, Rorvig discloses wherein the pump housing further comprises retention elements permitting the support board to be removably released from the pump housing (Fig. 1-2 and [0039, 0040], housing 200 comprises latch 525 for releasably engaging an indentation tab 125 on a bottom support surface of pump assembly 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero, to incorporate the teachings of Rorvig and modify the pump housing to further comprise retention elements permitting the support board to be removably released from the pump housing. Doing so would allow for removal of the pump assembly from the housing when not in use, but also ensures effective locking of the pump assembly when within housing to prevent undesired movement between the components during handling (Rorvig, [0040, 0044]).
Regarding claim 11, Yu, in view of Pizzochero and Rorvig, discloses the transcutaneous drug delivery system of claim 10, as explained above. As noted above, Yu, in view of Pizzochero, fails to disclose the retention elements and is thus silent to wherein the retention elements comprise a latch and tab interlockable to releasably secure the support board to the pump housing. However, Rorvig further discloses wherein the retention elements comprise a latch and tab interlockable to releasably secure the support board to the pump housing (Fig. 1-2 and [0039, 0040], retention elements comprise the latch 525 on housing 200 for releasably engaging the indentation tab 125 on a bottom support surface of pump assembly 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero and Rorvig, to further incorporate the teachings of Rorvig and modify the retention elements to comprise a latch and tab interlockable to releasably secure the support board to the pump housing. Doing so would allow for removal of the pump assembly from the housing when not in use, but also ensures effective locking of the pump assembly when within housing to prevent undesired movement between the components during handling (Rorvig, [0040, 0044]).
Regarding claim 20 and Yu, in view of Pizzochero, Yu further discloses the method of claim 17 wherein the peristaltic pump is supported on a support board (Fig. 4 and [0054], peristaltic pump cam assembly 60 is mounted on support 72).
Yu, in view of Pizzochero, fails to disclose the method further comprising removing the support board and peristaltic pump from the pump housing following drug delivery. However, Rorvig discloses removing the support board and peristaltic pump from the pump housing following drug delivery (Fig. 11 and [0040, 0049], pump assembly 120, which comprises a support base surface (see Fig. 1) may be removed from the pump housing after use).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero, to incorporate the teachings of Rorvig and modify the method to include removing the support board and peristaltic pump from the pump housing following drug delivery. Doing so would allow for removal of the pump assembly from the housing when not in use, but also ensures effective locking of the pump assembly when within housing to prevent undesired movement between the components during handling (Rorvig, [0040, 0044]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 20230381407), in view of Pizzochero (US 20180272058), as applied to claim 1 above, and further in view of Chiu et al. (US 20180318550), hereinafter Chiu, and Zhu (US 20210268254).
Regarding claim 12, Yu, in view of Pizzochero, discloses the transcutaneous drug delivery system of claim 1.
Yu, in view of Pizzochero, fails to disclose wherein the IV line connector is a Luer-Lock connector. However, Chiu discloses wherein the IV line connector is a Luer-Lock connector (Fig. 26 and [0153], tube 128, which connects further tubing 130 with cannula 10 for delivery of fluid, may comprise a Luer-lock connector).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero, to incorporate the teachings of Chiu and modify the IV line connector to be a Luer-Lock connector. Doing so would provide an in-line coupling device that seals to tubing/cannula with the further IV tubing (Chiu, [0153]).
Yu, in view of Pizzochero and Chiu, fails to disclose wherein the Luer-Lock connector provides a plug. However, Zhu discloses wherein the Luer-Lock connector provides a plug (Fig. 3 and [0025], Luer-lock connector may be provided with a cap 135 to plug fluid flow through).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero and Chiu, to incorporate the teachings of Zhu and modify the Luer-Lock connector to provide a plug. Doing so would plug the fluid channel lumen when luer is not connected to other flow components (Zhu, [0025, 0027, 0031]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Yu (US 20230381407), in view of Pizzochero (US 20180272058), as applied to claim 1 above, and further in view of Slaby et al. (US 20210361860), hereinafter Slaby.
Regarding claim 16, Yu, in view of Pizzochero, discloses the transcutaneous drug delivery system of claim 1.
Yu, in view of Pizzochero, fails to disclose wherein the IV line is at least partially manufactured of a silicone material. However, Slaby further discloses wherein the IV line is at least partially manufactured of a silicone material (Fig. 1A-B and [0057], pumping conduit comprises a flexible membrane made of silicone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Yu, in view of Pizzochero, to incorporate the teachings of Slaby and modify the IV line to be at least partially manufactured of a silicone material. Doing so would provide an IV line comprised of a flexible material which may be deformed/occluded by the fingers of the pump to cause fluid movement through the line (Slaby, [0056-0057]).
Conclusion
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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