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.
Claims 1-9 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (CN Publication No. 112843380), hereinafter Zhou, in view of Zhou (CN Patent No. 217854059), hereinafter, Zhou ‘059.
Regarding claim 1, Zhou discloses an integrated balanced paste-type medicine infusion system (liquid medicine conveying device comprising medicine storage tank 1, driving host machine 2, remaining needle 3, and transfusion hose 4 in fig. 1), comprising an injection device (remaining needle 3 comprising base 31, liquid guide cavity 311, soft indwelling transfusion needle 312, flexible sealing member 313; upper cover 32, liquid inlet interface 321, and hard needle tube 322 in figs. 1 and 12-13), a medicine delivery device (medicine storage tank 1 comprising injection cylinder 11 and mounting base 12 in figs. 1 and 4-8), a baseplate (bottom plate 22 in fig. 10), an adhesive member (bottom surface of bottom plate 22 is used for adhering on the surface of the skin of the patient; page 9, paragraph 2; claim 6), a main body shell (driving host machine 2 comprising main machine box 21 in fig. 2-5) and a controlling device (key 21a and plurality of indicator light 21b in figs. 1-5; page 7, paragraph 3);
the controlling device is mounted in the main body shell (key 21a and indicator light 21b are mounted in main machine box 21 of driving host machine 2 in figs. 1-5); the medicine delivery device and the main body shell are mounted on the baseplate (medicine storage tank 1 and driving host machine 2 are mounted on bottom plate 22; page 7, paragraph 1); the adhesive member is fixedly provided on a side of the baseplate distal to the main body shell; then the adhesive member is used to attach the baseplate to skin (bottom surface of bottom plate 22 is used for adhering on the surface of the skin of the patient; page 9, paragraph 2; claim 6);
the medicine delivery device is used to store medicinal liquid (medicine storage tank 1 comprising injection cylinder 11 and mounting base 12 in figs. 1 and 4-8); an output end of the medicine delivery device is connected to an input end of the injection device (transfusion hose 4 connects medicine storage tank 1 to remaining needle 3 in fig. 1); the controlling device is used to control the medicine delivery device to output the medicinal liquid to the injection device (key 21a and plurality of indicator light 21b in figs. 1-5; page 7, paragraph 3);
Zhou does not, however, disclose that the injection device is mounted on the baseplate.
Zhou also does not disclose that the main body shell is provided with a first avoidance hole penetratingly; the output end of the medicine delivery device is mounted on the first avoidance hole.
Zhou also does not disclose that the baseplate is provided with a second avoidance hole penetratingly; the injection device is mounted on the second avoidance hole; and the second avoidance hole is in communication with the first avoidance hole.
Zhou ‘059 teaches the injection device is mounted on the baseplate (vertical indwelling needle 2 and liquid inlet interface 21, serving as the claimed injection device, is mounted to application surface 11 and mounting part 12a, serving as the claimed baseplate, in figs. 1-3)
Zhou ‘059 also teaches that the main body shell is provided with a first avoidance hole penetratingly (Zhou ‘059: avoidance groove 32b in the insertion portion of inserting part 32a in fig. 6; pages 5-6, paragraph 7; claim 8); the output end of the medicine delivery device is mounted on the first avoidance hole (Zhou ‘059: liquid outlet interface 31b mounts to avoidance groove 32b of inserting part 32a in figs. 5-6);
Zhou ‘059 also teaches that the baseplate is provided with a second avoidance hole penetratingly (Zhou ‘059: installation face of bottom plate 1 which aligns with central liquid inlet interface 21 in figs. 1-3; page 4, paragraph 11); the injection device is mounted on the second avoidance hole; and the second avoidance hole is in communication with the first avoidance hole (Zhou ‘059: liquid inlet interface 21 seals to delivery port through avoidance groove 32b of main machine set 3 and creates aligned avoidance path in figs. 1-3 and 5-6).
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 liquid conveying device of Zhou to include the central balanced mounting of the indwelling needle through aligned first and second avoidance holes in the main body shell and baseplate, at taught by Zhou ‘059, in order to minimize displacement of the indwelling needle cause by patient movement and reduce the risk of increasing the patient’s skin wound surface.
Regarding claim 2, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 1, wherein the second avoidance hole is provided in a central predetermined area of the baseplate, so that the injection device is provided in a central position of the entire integrated balanced paste-type medicine infusion system (Zhou ‘059: installation face of bottom plate 1 which aligns with central liquid inlet interface 21 is centrally located in figs. 1-3; page 4, paragraph 11).
Regarding claim 3, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 1, but fails disclose that the output end of the medicine delivery device is inserted into the first avoidance hole from a side of the main body shell distal to the baseplate; the injection device is mounted in the second avoidance hole of the baseplate; and the injection device is inserted into the first avoidance hole from a side of the main body shell proximal to the baseplate.
Zhou 059’ teaches that the output end of the medicine delivery device is inserted into the first avoidance hole from a side of the main body shell distal to the baseplate (Zhou ‘059: liquid outlet interface 31b mounts to avoidance groove 32b of inserting part 32a located on the distal side of bottom plate 1 in figs. 5-6); the injection device is mounted in the second avoidance hole of the baseplate (Zhou ‘059: vertical indwelling needle 2 is mounted/aligned in the central inlet area of bottom plate 1 in figs. 1-3); and the injection device is inserted into the first avoidance hole from a side of the main body shell proximal to the baseplate (Zhou ‘059: needle liquid inlet interface 21 receives bottom plate 1 connection from the proximal side in figs. 2-3).
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 connection path in modified Zhou such that the output end of the medicine delivery device is inserted into the first avoidance hole from the distal side of the main body shell and the injection device is inserted from the proximal side, as taught by Zhou ‘059, in order to achieve a compact, sealed, through-shell fluid path while maintaining the central balanced placement that minimizes needle displacement and skin trauma during patient activity.
Regarding claim 4, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 3, wherein the injection device comprises an indwelling needle and a needle holder, but fails to disclose that the needle holder is used to mount the indwelling needle to the baseplate.
Zhou ‘059 teaches that the needle holder is used to mount the indwelling needle to the baseplate (Zhou ‘059: vertical remaining indwelling needle 2 is formed with a liquid inlet interface 21 connected with the top inlet of the remaining needle tube on the mounting surface 12 and formed with a mounting part 12a in figs. 1-3; page 2, paragraphs 4-5).
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 injection device of modified Zhou to include a dedicated needle holder for mounting the indwelling needle to the baseplate, as taught by Zhou ‘059, in order to securely position the needle in the central balanced location and further reduce skin wound risk from patient movement.
Regarding claim 5, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 4, but fails to disclose that the main body shell is provided with a mounting buckle in the first avoidance hole, and the mounting buckle is used to snap-fit the output end of the medicine delivery device with the body shell.
Zhou ‘059 teaches that the main body shell is provided with a mounting buckle in the first avoidance hole, and the mounting buckle is used to snap-fit the output end of the medicine delivery device with the body shell (Zhou ‘059: inserting groove 31a and inserting part 32a, which is further formed with drug delivery device 31b and indwelling needle 2 mounted to bottom plate 1, can be fixed by clamping; page 5, paragraph 6 – page 6, paragraph 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 shell connection of modified Zhou to include a mounting buckle in the first avoidance hole for snap-fitting the output end of the medicine delivery device, as taught by Zhou ‘059, in order to provide a secure, detachable attachment while preserving the aligned avoidance path for the balanced central design.
Regarding claim 6, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 1, but fails to disclose that the main body shell is provided with a slot; and
the slot is snap-fitted with the elastic fixing buckle so that the main body shell is mounted on the baseplate.
Zhou 059’ teaches that the main body shell is provided with a slot (Zhou ‘059: inserting groove 31a on host machine set 3 in fig. 4-5); the baseplate is provided with an elastic fixing buckle (Zhou ‘059: bottom plate 1 with mounting surface 12 with mounting part 12a has first buckle, which can be an elastic clamping tongue in figs. 1-3; page 2, paragraph 6-7); and
the slot is snap-fitted with the elastic fixing buckle so that the main body shell is mounted on the baseplate (Zhou ‘059: inserting groove 31a and inserting part 32a, which is further formed with drug delivery device 31b and indwelling needle 2 mounted to bottom plate 1, can be fixed by clamping; page 5, paragraph 6 – page 6, paragraph 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 mounting between the main body shell and baseplate of modified Zhou to use a slot on the shell and elastic fixing buckle on the baseplate, as taught by Zhou ‘059, in order to enable easy detachable assembly of the modular patch system while maintaining the central balanced needle placement that reduces skin trauma.
Regarding claim 7, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 6, wherein the adhesive member is fixed to the baseplate by adhesive or ultrasonic welding (bottom surface of bottom plate 22 is used for adhering on the surface of the skin of the patient; page 9, paragraph 2; claim 6).
Regarding claim 8, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 1 wherein the medicine delivery device is detachably connected to the main body shell (pushing end of injection cylinder 11 is detachably connected to connection port on box wall of main machine box 21 in figs. 1-5; pages 6-7, paragraph 4).
Regarding claim 9, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 8, wherein the medicine delivery device is provided with a medicine reservoir (medicine storage tank 1 with injection cylinder 11 in figs. 1-8), a connecting tube (transfusion tube 4 in fig. 1) and a connecting needle (remaining needle 3 in fig. 1) sequentially;
the controlling device (driving main machine 2 in fig. 1) is used to pump out the medicinal liquid within the medicine reservoir so that the medicinal liquid flows from the medicine reservoir through the connecting tube to the connecting needle (liquid medicine conveying device comprising medicine storage tank 1, driving host machine 2, remaining needle 3, and transfusion hose 4 drive medicinal liquid to patient in figs. 1-5; page 5, paragraphs 6-7); the connecting needle is mounted on the first avoidance hole; and the connecting needle passes through the first avoidance hole to connect the injection device (Zhou ‘059: vertical remaining indwelling needle 2 on liquid outlet interface 31b mounts to avoidance groove 32b of inserting part 32a located on the distal side of bottom plate 1 in figs. 5-6).
Regarding claim 11, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 2, wherein the output end of the medicine delivery device is inserted into the first avoidance hole from a side of the main body shell distal to the baseplate (Zhou ‘059: liquid inlet interface 21 seals to delivery port through avoidance groove 32b of main machine set 3 and creates aligned avoidance path in figs. 1-3 and 5-6); the injection device is mounted in the second avoidance hole of the baseplate (Zhou ‘059: vertical indwelling needle 2 is mounted in the central area of bottom plate 1 in figs. 2-3); and the injection device is inserted into the first avoidance hole from a side of the main body shell proximal to the baseplate (Zhou ‘059: needle liquid inlet interface 21 receives bottom plate 1 connection from the proximal side in figs. 2-3).
Regarding claim 12, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 2, wherein the main body shell is provided with a slot (Zhou ‘059: inserting groove 31a on host machine set 3 in fig. 4-5); the baseplate is provided with an elastic fixing buckle (Zhou ‘059: bottom plate 1 comprises mounting part 12a, which can be elastic clamping tongue fixing buckle in figs. 1-3; page 5, paragraphs 1-2; claims 2 and 3); and
the slot is snap-fitted with the elastic fixing buckle so that the main body shell is mounted on the baseplate (Zhou ‘059: inserting groove 31a and inserting part 32a, which is further formed with drug delivery device 31b and indwelling needle 2 mounted to bottom plate 1, can be fixed by clamping; page 5, paragraph 6 – page 6, paragraph 1).
Regarding claim 13, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 4, wherein the main body shell is provided with a slot (Zhou ‘059: inserting groove 31a on host machine set 3 in fig. 4-5); the baseplate is provided with an elastic fixing buckle (Zhou ‘059: bottom plate 1 with mounting surface 12 with mounting part 12a has first buckle, which can be an elastic clamping tongue in figs. 1-3; page 2, paragraph 6-7); and
the slot is snap-fitted with the elastic fixing buckle so that the main body shell is mounted on the baseplate (Zhou ‘059: inserting groove 31a and inserting part 32a, which is further formed with drug delivery device 31b and indwelling needle 2 mounted to bottom plate 1, can be fixed by clamping; page 5, paragraph 6 – page 6, paragraph 1).
Regarding claim 14, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 5, wherein the main body shell is provided with a slot (Zhou ‘059: inserting groove 31a on host machine set 3 in fig. 4-5); the baseplate is provided with an elastic fixing buckle (Zhou ‘059: bottom plate 1 with mounting surface 12 with mounting part 12a has first buckle, which can be an elastic clamping tongue in figs. 1-3; page 2, paragraph 6-7); and
the slot is snap-fitted with the elastic fixing buckle so that the main body shell is mounted on the baseplate (Zhou ‘059: inserting groove 31a and inserting part 32a, which is further formed with drug delivery device 31b and indwelling needle 2 mounted to bottom plate 1, can be fixed by clamping; page 5, paragraph 6 – page 6, paragraph 1).
Regarding claim 15, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 2, wherein the medicine delivery device is detachably connected to the main body shell (pushing end of injection cylinder 11 is detachably connected to connection port on box wall of main machine box 21 in figs. 1-5; pages 6-7, paragraph 4).
Regarding claim 16, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 4, wherein the medicine delivery device is detachably connected to the main body shell (pushing end of injection cylinder 11 is detachably connected to connection port on box wall of main machine box 21 in figs. 1-5; pages 6-7, paragraph 4).
Regarding claim 17, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 5, wherein the medicine delivery device is detachably connected to the main body shell (pushing end of injection cylinder 11 is detachably connected to connection port on box wall of main machine box 21 in figs. 1-5; pages 6-7, paragraph 4).
Regarding claim 18, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 7, wherein the medicine delivery device is detachably connected to the main body shell (pushing end of injection cylinder 11 is detachably connected to connection port on box wall of main machine box 21 in figs. 1-5; pages 6-7, paragraph 4).
Claims 10, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Zhou ‘059, as applied to claim 1 above, and further in view of Duhamel (US Publication No. 2023/0277762), hereinafter, Duhamel.
Regarding claim 10, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 1 comprising a controlling device (driving main machine 2 in fig. 1).
Modified Zhou fails, however, to disclose that the integrated balanced paste-type medicine infusion system according to claim 1 comprises a blood glucose meter; the blood glucose meter is communicatively connected to the controlling device; and the controlling device is used to control the medicine delivery device to output the medicinal liquid according to blood glucose data sent by the blood glucose meter.
Duhamel teaches that the integrated balanced paste-type medicine infusion system according to claim 1 comprising a blood glucose meter (Duhamel: analyte sensors 108/109 in fig. 1, para [0076]); the blood glucose meter is communicatively connected to the controlling device; and the controlling device is used to control the medicine delivery device to output the medicinal liquid according to blood glucose data sent by the blood glucose meter (Duhamel: drug delivery system 102 delivers doses of drugs, such as insulin, to a user in accordance with sensor data from analyte sensors 108/109 may be controllable by medication delivery algorithm (MDA) 129 stored in memory 123 and execute by controller 121 in fig. 1, para [0075-0077]).
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 controlling device of modified Zhou to include a blood glucose meter communicatively connected to the controlling device, as taught by Duhamel, in order to allow the controlling device to automatically analyze glucose levels and adjust the output of medicinal liquid accordingly, thereby providing more precise and responsive diabetes management as sought by the present invention.
Regarding claim 19, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 1 comprising a blood glucose meter (Duhamel: analyte sensors 108/109 in fig. 1, para [0076]); the blood glucose meter is communicatively connected to the controlling device (driving main machine 2 in fig. 1); and the controlling device is used to control the medicine delivery device to output the medicinal liquid according to blood glucose data sent by the blood glucose meter (Duhamel: drug delivery system 102 delivers doses of drugs, such as insulin, to a user in accordance with sensor data from analyte sensors 108/109 may be controllable by medication delivery algorithm (MDA) 129 stored in memory 123 and execute by controller 121 in fig. 1, para [0075-0077]).
Regarding claim 20, modified Zhou discloses the integrated balanced paste-type medicine infusion system according to claim 1 comprising a blood glucose meter (Duhamel: analyte sensors 108/109 in fig. 1, para [0076]); the blood glucose meter is communicatively connected to the controlling device (driving main machine 2 in fig. 1); and the controlling device is used to control the medicine delivery device to output the medicinal liquid according to blood glucose data sent by the blood glucose meter (Duhamel: drug delivery system 102 delivers doses of drugs, such as insulin, to a user in accordance with sensor data from analyte sensors 108/109 may be controllable by medication delivery algorithm (MDA) 129 stored in memory 123 and execute by controller 121 in fig. 1, para [0075-0077]).
Conclusion
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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