DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 20, 2026 has been entered.
Claims 1, 5-12, 16-23, and 27 remain pending in the application. Claims 2-4, 13-15, and 24-26 have been cancelled.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5-7, 9-12, and 16-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gabel et al. (US 20030187395) in view of Shermer et al. (US 20040138612) in further view of Kingsford (US 20050118388) and in further view of Burbank et al. (US 20060015144).
Regarding claim 1, Gabel discloses a medical system (delivery device 10) comprising:
a reservoir (cartridge 14 having internal reservoir 72) partially collapsible (Figures 7-9; “Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly” [0056]) for containing an infusible fluid (“reservoir 72 for containing the substance to be delivered to the patient.” [0051]), the reservoir comprising an integral septum (seal member 96; Figure 7);
a fluid path (from reservoir 72 through fluid channel 76 and out axial passages 82) fluidly connected to the reservoir (Figure 9; “Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly to dispense the contents of reservoir 72 through fluid channel 76 and skin penetrating members 80” [0056]; and
a plurality of microneedles (skin penetrating members 80; “the skin penetrating members can be microneedles” [0063]) fluidly connected to the reservoir by the fluid path (“Skin penetrating members 80 are mounted in apertures 86 in outer wall 74 so that axial passages 82 are in fluid communication with fluid channel 76.” [0054]), each microneedle having a body portion forming a fluid passages (axial passages 82; Figure 10), wherein the body portion is not dissolvable (“skin penetrating members 80 are stainless steel hollow needles” [0063], wherein stainless steel is not dissolvable),
wherein the reservoir is fluidly connected to the fluid path by a needle (piercing member 110) penetrating the septum on the reservoir (“Plunger 108 can be forced inwardly through sleeve 100 so that tip 112 of piercing member 110 pierces seal member 96 to provide fluid communication between reservoir 72 and fluid channel 76.” [0055]).
Gabel fails to explicitly disclose each microneedle having two appendages not forming the fluid passage, wherein the appendages are dissolvable, and wherein the fluid path passes through the needle.
Shermer teaches a medical system (infusion device 1000) comprising: a reservoir (reservoir subassembly 100) comprising an integral septum (septum 160); a fluid path (flexible tubing 350) fluidly connected to the reservoir (“a second fluid path comprised of the septum needle 330, septum needle manifold 322, and tube 350…creates a sterile flow path between the reservoir and the patient needles 222.” [093]); and a plurality of microneedles (microneedles 222) fluidly connected to the reservoir by the fluid path (“A flexible tube 350 can be used to connect the septum needle 330 and/or septum needle manifold 322 to the patient needle manifold 220” [0128]), wherein the reservoir is fluidly connected to the fluid path by a needle (septum needle 330) penetrating the septum on the reservoir, wherein the fluid path passes through the needle (“Depending upon the sequence desired, prior to, concurrent with, or slightly after the septum needle 330 penetrates the septum 160, the patient needle manifold 220 is released and bottoms out against the skin surface, seating the patient needles 222 and thereby initiating flow of energized fluid from the reservoir, through the septum needle and septum needle manifold, through the flexible tubing attached to the septum needle manifold, and to the patient needles of the patient needle manifold” [0126]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the medical system of Gabel to include that the fluid path passes through the needle based on the teachings of Shermer to provide greater flow within the fluid path and form a direct, sterile fluid path from the reservoir to guide the infusible fluid to the plurality of microneedles (Shermer [0093-0094], [0126-0127]).
Modified Gabel fails to explicitly disclose each microneedle having two appendages not forming the fluid passage, wherein the appendages are dissolvable.
Kingsford teaches a medical system (member 10) comprising: a plurality of microneedles (skin-penetrating elements 14; “A patch with an array of microneedles” [0002]), each microneedle having a body portion (cone-shaped body 18) and two appendages (two discrete barbs 20a, 20b) not forming a fluid passage (Figure 3A).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the microneedles of the medical system of Gabel to comprise two appendages not forming the fluid passage based on the teachings of Kingsford to secure the medical system to the skin without causing pain and discomfort (Kingsford [0003-0004]).
Modified Gabel fails to explicitly disclose the appendages are dissolvable.
Burbank teaches a medical system (staple 10) having a plurality of penetrating members (legs 12, 13), each penetrating member comprising a body portion (body of legs 12, 13; Figure 1) and two appendages (barbs 14, 15); wherein the body portion of each needle is not dissolvable (“The uterine artery staple…may be made from…metals such as stainless steel” [0046], see all of [0046]) and the appendages are dissolvable (“FIG. 1 illustrates a uterine artery staple 10 which has a pressure applying occlusion bar 11 which extends between two tissue penetrating legs 12 and 13. The legs 12 and 13 are provided with a plurality of protuberances or barbs 14 and 15 respectively which help to retain the legs of staple 10 in tissue after placement therein. At least part of the staple 10, illustrated at locations 16-19, is formed of a bioabsorbable material such as polylactic acid, polyglycolic acid or copolymers or blends thereof…Alternatively, the protuberances 14 and 15 may be formed of bioabsorbable material, which when the material thereof is bio-absorbed, the entire staple may be easily removed.” [0035])
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the microneedles of the medical system of Gabel in view of Kingsford to include the appendages are dissolvable based on the teachings of Burbank to allow for disintegration of the appendages and therefore easy removal of the medical system after use (Burbank [0035]).
Regarding claim 5, modified Gabel teaches the medical system of claim 1.
Modified Gabel fails to explicitly teach wherein the appendages provide for microneedle retention.
Kingsford teaches a medical system (member 10) comprising: a plurality of microneedles (skin-penetrating elements 14; “A patch with an array of microneedles” [0002]), each microneedle having a body portion (cone-shaped body 18) and two appendages (two discrete barbs 20a, 20b; Figure 3A) that provide for microneedle retention (“The barbs are configured to cooperate to resist removal of the skin attachment member from skin.” [0004]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the microneedles of the medical system of Gabel to comprise two appendages for microneedle retention based on the teachings of Kingsford to secure the medical system to the skin without causing pain and discomfort (Kingsford [0003-0004]).
Regarding claim 6, modified Gabel teaches the medical system of claim 1 wherein the reservoir (reservoir 72) is non-pressurized (Figure 7 showing reservoir 72 non-compressed and non-pressurized).
Regarding claim 7, modified Gabel teaches the medical system of claim 1 wherein the fluid path extends through one of the microneedles (Figure 10; “Skin penetrating members 80 are mounted in apertures 86 in outer wall 74 so that axial passages 82 are in fluid communication with fluid channel 76.” [0054]).
Regarding claim 9, modified Gabel teaches the medical system of claim 1 wherein the reservoir (reservoir 72) is contained within a housing (housing 12; Figures 3-5).
Regarding claim 10, modified Gabel teaches the medical system of claim 9 wherein the housing (housing 12) is a wearable housing (“The delivery device 10 includes a housing 12 and a cartridge 14 for delivering a substance intradermally to a patient. In a preferred embodiment of the invention, the device 10 is a small compact device adapted to be attached to the surface of the skin during delivery of the substance. Typically, the device 10 will have dimensions suitable for attachment to the wrist or arm of the patient.” [0042]).
Regarding claim 11, modified Gabel teaches the medical system of claim 10 wherein the housing (housing 12 having cover 32) is an infusion pump (“The cover 32 functions to cause a fluid substance within the cartridge to be dispensed when the cover is closed.” [0048], wherein the housing functions as an infusion pump because it delivers fluid via pressure).
Regarding claim 12, Gabel discloses a medical infusion system (delivery device 10) comprising:
a wearable housing (housing 12; “The delivery device 10 includes a housing 12 and a cartridge 14 for delivering a substance intradermally to a patient. In a preferred embodiment of the invention, the device 10 is a small compact device adapted to be attached to the surface of the skin during delivery of the substance. Typically, the device 10 will have dimensions suitable for attachment to the wrist or arm of the patient.” [0042]);
a reservoir (cartridge 14 having internal reservoir 72) contained within the housing (Figures 3-5) and collapsible (Figures 7-9; “Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly” [0056]) for containing a fluid (“reservoir 72 for containing the substance to be delivered to the patient.” [0051]), the reservoir comprising an integral septum (seal member 96; Figure 7);
a fluid path (from reservoir 72 through fluid channel 76 and out axial passages 82) fluidly connected to the reservoir (Figure 9; “Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly to dispense the contents of reservoir 72 through fluid channel 76 and skin penetrating members 80” [0056]; and
a plurality of microneedles (skin penetrating members 80; “the skin penetrating members can be microneedles” [0063]), each microneedle having a body portion (Figure 10 having axial passages 82), wherein the body portion is not dissolvable (“skin penetrating members 80 are stainless steel hollow needles” [0063], wherein stainless steel is not dissolvable), the plurality of microneedles fluidly connected to the reservoir by the fluid path (“Skin penetrating members 80 are mounted in apertures 86 in outer wall 74 so that axial passages 82 are in fluid communication with fluid channel 76.” [0054]), wherein the fluid path extends through the body portion of one of the microneedles (Figure 10; “Skin penetrating members 80 are mounted in apertures 86 in outer wall 74 so that axial passages 82 are in fluid communication with fluid channel 76.” [0054]),
wherein the reservoir is fluidly connected to the fluid path by a needle (piercing member 110) penetrating the septum on the reservoir (“Plunger 108 can be forced inwardly through sleeve 100 so that tip 112 of piercing member 110 pierces seal member 96 to provide fluid communication between reservoir 72 and fluid channel 76.” [0055]).
Gabel fails to explicitly disclose each microneedle having at least two appendages not forming the fluid path, wherein the appendages are dissolvable, and wherein the fluid path passes through the needle.
Shermer teaches a medical infusion system (infusion device 1000) comprising: a housing (housing subassembly 200); a reservoir (reservoir subassembly 100) comprising an integral septum (septum 160); a fluid path (flexible tubing 350) fluidly connected to the reservoir (“a second fluid path comprised of the septum needle 330, septum needle manifold 322, and tube 350…creates a sterile flow path between the reservoir and the patient needles 222.” [093]); and a plurality of microneedles (microneedles 222) fluidly connected to the reservoir by the fluid path (“A flexible tube 350 can be used to connect the septum needle 330 and/or septum needle manifold 322 to the patient needle manifold 220” [0128]), wherein the reservoir is fluidly connected to the fluid path by a needle (septum needle 330) penetrating the septum on the reservoir, wherein the fluid path passes through the needle (“Depending upon the sequence desired, prior to, concurrent with, or slightly after the septum needle 330 penetrates the septum 160, the patient needle manifold 220 is released and bottoms out against the skin surface, seating the patient needles 222 and thereby initiating flow of energized fluid from the reservoir, through the septum needle and septum needle manifold, through the flexible tubing attached to the septum needle manifold, and to the patient needles of the patient needle manifold” [0126]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the medical infusion system of Gabel to include that the fluid path passes through the needle based on the teachings of Shermer to provide greater flow within the fluid path and form a direct, sterile fluid path from the reservoir to guide the infusible fluid to the plurality of microneedles (Shermer [0093-0094], [0126-0127]).
Modified Gabel fails to explicitly disclose each microneedle having at least two appendages not forming the fluid path, wherein the appendages are dissolvable.
Kingsford teaches a medical infusion system (member 10; “The penetration of elements 14 into the epidermis facilitates the delivery of drugs through the epidermis” [0038]) comprising: a plurality of microneedles (skin-penetrating elements 14; “A patch with an array of microneedles” [0002]), each microneedle having a body portion (cone-shaped body 18) and at least two appendages (two discrete barbs 20a, 20b) not forming a fluid path (Figure 3A).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the microneedles of the medical infusion system of Gabel to comprise at least two appendages not forming the fluid path based on the teachings of Kingsford to secure the medical system to the skin without causing pain and discomfort (Kingsford [0003-0004]).
Modified Gabel fails to explicitly disclose the appendages are dissolvable.
Burbank teaches a medical system (staple 10) having a plurality of penetrating members (legs 12, 13), each penetrating member comprising a body portion (body of legs 12, 13; Figure 1) and two appendages (barbs 14, 15); wherein the body portion of each needle is not dissolvable (“The uterine artery staple…may be made from…metals such as stainless steel” [0046], see all of [0046]) and the appendages are dissolvable (“FIG. 1 illustrates a uterine artery staple 10 which has a pressure applying occlusion bar 11 which extends between two tissue penetrating legs 12 and 13. The legs 12 and 13 are provided with a plurality of protuberances or barbs 14 and 15 respectively which help to retain the legs of staple 10 in tissue after placement therein. At least part of the staple 10, illustrated at locations 16-19, is formed of a bioabsorbable material such as polylactic acid, polyglycolic acid or copolymers or blends thereof…Alternatively, the protuberances 14 and 15 may be formed of bioabsorbable material, which when the material thereof is bio-absorbed, the entire staple may be easily removed.” [0035])
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the microneedles of the medical system of Gabel in view of Kingsford to include the body portion of each microneedle is not dissolvable and the appendages are dissolvable based on the teachings of Burbank to allow for disintegration of the appendages and therefore easy removal of the medical system after use (Burbank [0035]).
Regarding claim 16, modified Gabel teaches the medical infusion system of claim 16.
Modified Gabel fails to explicitly teach wherein the appendages provide for microneedle retention.
Kingsford teaches a medical infusion system (member 10) comprising: a plurality of microneedles (skin-penetrating elements 14; “A patch with an array of microneedles” [0002]), each microneedle having a body portion (cone-shaped body 18) and two appendages (two discrete barbs 20a, 20b; Figure 3A) that provide for microneedle retention (“The barbs are configured to cooperate to resist removal of the skin attachment member from skin.” [0004]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the microneedles of the medical system of Gabel to comprise two appendages for microneedle retention based on the teachings of Kingsford to secure the medical system to the skin without causing pain and discomfort (Kingsford [0003-0004]).
Regarding claim 17, modified Gabel teaches the medical infusion system of claim 12 wherein the reservoir (reservoir 72) is non-pressurized (Figure 7 showing reservoir 72 non-compressed and non-pressurized).
Claims 8 and 18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gabel et al. (US 20030187395) in view of Shermer et al. (US 20040138612) in further view of Kingsford (US 20050118388) and in further view of Burbank et al. (US 20060015144) as applied in claims 1 and 12 above, and in further view of Prausnitz et al. (USPN 7344499).
Regarding claim 8, modified Gabel teaches the medical system of claim 1.
Modified Gabel fails to explicitly teach wherein one of the microneedles is an analyte sensor.
Prausnitz teaches a medical system (“the microneedle device may include an integrated sensor…The unit can be constructed to function as a closed loop drug delivery unit, including drug delivery means, analyte recovery means, sensing means to measure the analyte, and control means to provide a signal to the drug delivery means.” [Col 6, lines 56-63]) comprising a plurality of microneedles (microneedles 14) fluidly connected to a reservoir (chamber 16), wherein one of the microneedles (microneedle 32) is an analyte sensor (“the microneedle is adapted to be the sensing element…See FIG. 3 which illustrates a cross sectional view of a preferred embodiment of a microneedle device 30 including microneedle 32, attached to substrate 34 and having hollow bore 36. In FIG. 3a, sensor material 38 is coated on the external surface of microneedle 32. In FIG. 3b, sensor material 38 is coated on the internal surface of hollow bore 36. In FIG. 3c, sensor material 38 is located within the pores of a porous microneedle 32.” [Col 7, lines 25-37]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the medical system of Gabel to include that one of the microneedles is an analyte sensor based on the teachings of Prausnitz to provide a closed loop drug delivery unit including fluid delivery in response to analyte measurement (Prausnitz [Col 6, lines 56-63]).
Regarding claim 18, modified Gabel teaches the medical infusion system of claim 12.
Modified Gabel fails to explicitly teach wherein one of the microneedles is an analyte sensor.
Prausnitz teaches a medical infusion system (“the microneedle device may include an integrated sensor…The unit can be constructed to function as a closed loop drug delivery unit, including drug delivery means, analyte recovery means, sensing means to measure the analyte, and control means to provide a signal to the drug delivery means.” [Col 6, lines 56-63]) comprising a plurality of microneedles (microneedles 14) fluidly connected to a reservoir (chamber 16), wherein one of the microneedles (microneedle 32) is an analyte sensor (“the microneedle is adapted to be the sensing element…See FIG. 3 which illustrates a cross sectional view of a preferred embodiment of a microneedle device 30 including microneedle 32, attached to substrate 34 and having hollow bore 36. In FIG. 3a, sensor material 38 is coated on the external surface of microneedle 32. In FIG. 3b, sensor material 38 is coated on the internal surface of hollow bore 36. In FIG. 3c, sensor material 38 is located within the pores of a porous microneedle 32.” [Col 7, lines 25-37]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the medical infusion system of Gabel to include that one of the microneedles is an analyte sensor based on the teachings of Prausnitz to provide a closed loop drug delivery unit including fluid delivery in response to analyte measurement (Prausnitz [Col 6, lines 56-63]).
Claims 19-23 and 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gabel et al. (US 20030187395) in view of Shermer et al. (US 20040138612) in further view of Kingsford (US 20050118388) in further view of Burbank et al. (US 20060015144) and in further view of Prausnitz et al. (USPN 7344499).
Regarding claim 19, Gabel discloses a medical infusion and sensing system (delivery device 10) comprising:
a wearable housing (housing 12 and cartridge 14; “The delivery device 10 includes a housing 12 and a cartridge 14 for delivering a substance intradermally to a patient. In a preferred embodiment of the invention, the device 10 is a small compact device adapted to be attached to the surface of the skin during delivery of the substance. Typically, the device 10 will have dimensions suitable for attachment to the wrist or arm of the patient.” [0042]);
a reservoir (internal reservoir 72) for containing a fluid (“reservoir 72 for containing the substance to be delivered to the patient.” [0051]), the reservoir collapsible (Figures 7-9; “Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly” [0056]) and contained within the housing (Figures 3-5), the reservoir comprising an integral septum (seal member 96; Figure 7);
a fluid path (from reservoir 72 through fluid channel 76 and out axial passages 82) fluidly connected to the reservoir (Figure 9; “Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly to dispense the contents of reservoir 72 through fluid channel 76 and skin penetrating members 80” [0056]; and
a plurality of microneedles (skin penetrating members 80; “the skin penetrating members can be microneedles” [0063]) fluidly connected to the reservoir by the fluid path (“Skin penetrating members 80 are mounted in apertures 86 in outer wall 74 so that axial passages 82 are in fluid communication with fluid channel 76.” [0054]) wherein the fluid path extends through one of the microneedles (Figure 10; “Skin penetrating members 80 are mounted in apertures 86 in outer wall 74 so that axial passages 82 are in fluid communication with fluid channel 76.” [0054]) having a body portion forming the fluid path (via axial passages 82; Figure 10), wherein the body portion is not dissolvable (“skin penetrating members 80 are stainless steel hollow needles” [0063], wherein stainless steel is not dissolvable); and
wherein the reservoir is fluidly connected to the fluid path by a needle (piercing member 110) penetrating the septum on the reservoir (“Plunger 108 can be forced inwardly through sleeve 100 so that tip 112 of piercing member 110 pierces seal member 96 to provide fluid communication between reservoir 72 and fluid channel 76.” [0055]).
Gabel fails to explicitly disclose the microneedle having at least two appendages not forming the fluid path, wherein the appendages are dissolvable; and one of the microneedles is an analyte sensor attached to a path, the path attached to the housing, and wherein the fluid path passes through the needle.
Shermer teaches a medical infusion system (infusion device 1000) comprising: a reservoir (reservoir subassembly 100) comprising an integral septum (septum 160); a fluid path (flexible tubing 350) fluidly connected to the reservoir (“a second fluid path comprised of the septum needle 330, septum needle manifold 322, and tube 350…creates a sterile flow path between the reservoir and the patient needles 222.” [093]); and a plurality of microneedles (microneedles 222) fluidly connected to the reservoir by the fluid path (“A flexible tube 350 can be used to connect the septum needle 330 and/or septum needle manifold 322 to the patient needle manifold 220” [0128]), wherein the reservoir is fluidly connected to the fluid path by a needle (septum needle 330) penetrating the septum on the reservoir, wherein the fluid path passes through the needle (“Depending upon the sequence desired, prior to, concurrent with, or slightly after the septum needle 330 penetrates the septum 160, the patient needle manifold 220 is released and bottoms out against the skin surface, seating the patient needles 222 and thereby initiating flow of energized fluid from the reservoir, through the septum needle and septum needle manifold, through the flexible tubing attached to the septum needle manifold, and to the patient needles of the patient needle manifold” [0126]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the medical infusion and sensing system of Gabel to include that the fluid path passes through the needle based on the teachings of Shermer to provide greater flow within the fluid path and form a direct, sterile fluid path from the reservoir to guide the infusible fluid to the plurality of microneedles (Shermer [0093-0094], [0126-0127]).
Modified Gabel fails to explicitly disclose the microneedle having at least two appendages not forming the fluid path, wherein the appendages are dissolvable; and one of the microneedles is an analyte sensor attached to a path, the path attached to the housing.
Kingsford teaches a medical infusion system (member 10; “The penetration of elements 14 into the epidermis facilitates the delivery of drugs through the epidermis” [0038]) comprising: a plurality of microneedles (skin-penetrating elements 14; “A patch with an array of microneedles” [0002]) having a body portion (cone-shaped body 18) and at least two appendages (two discrete barbs 20a, 20b) not forming a fluid path (Figure 3A).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the microneedles of the medical infusion and sensing system of Gabel to comprise at least two appendages not forming the fluid path based on the teachings of Kingsford to secure the medical system to the skin without causing pain and discomfort (Kingsford [0003-0004]).
Modified Gabel fails to explicitly disclose the appendages are dissolvable; and one of the microneedles is an analyte sensor attached to a path, the path attached to the housing.
Burbank teaches a medical system (staple 10) having a plurality of penetrating members (legs 12, 13), each penetrating member comprising a body portion (body of legs 12, 13; Figure 1) and two appendages (barbs 14, 15); wherein the body portion of each needle is not dissolvable (“The uterine artery staple…may be made from…metals such as stainless steel” [0046], see all of [0046]) and the appendages are dissolvable (“FIG. 1 illustrates a uterine artery staple 10 which has a pressure applying occlusion bar 11 which extends between two tissue penetrating legs 12 and 13. The legs 12 and 13 are provided with a plurality of protuberances or barbs 14 and 15 respectively which help to retain the legs of staple 10 in tissue after placement therein. At least part of the staple 10, illustrated at locations 16-19, is formed of a bioabsorbable material such as polylactic acid, polyglycolic acid or copolymers or blends thereof…Alternatively, the protuberances 14 and 15 may be formed of bioabsorbable material, which when the material thereof is bio-absorbed, the entire staple may be easily removed.” [0035])
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the microneedles of the medical infusion and sensing system of Gabel in view of Kingsford to include the appendages are dissolvable based on the teachings of Burbank to allow for disintegration of the appendages and therefore easy removal of the medical system after use (Burbank [0035]).
Modified Gabel fails to explicitly disclose the appendages are dissolvable; and one of the microneedles is an analyte sensor attached to a path, the path attached to the housing.
Prausnitz teaches a medical infusion and sensing system (“the microneedle device may include an integrated sensor…The unit can be constructed to function as a closed loop drug delivery unit, including drug delivery means, analyte recovery means, sensing means to measure the analyte, and control means to provide a signal to the drug delivery means.” [Col 6, lines 56-63]) comprising a plurality of microneedles (microneedles 14) fluidly connected to a reservoir (chamber 16), wherein one of the microneedles (microneedle 32) is an analyte sensor (“the microneedle is adapted to be the sensing element…See FIG. 3 which illustrates a cross sectional view of a preferred embodiment of a microneedle device 30 including microneedle 32, attached to substrate 34 and having hollow bore 36. In FIG. 3a, sensor material 38 is coated on the external surface of microneedle 32. In FIG. 3b, sensor material 38 is coated on the internal surface of hollow bore 36. In FIG. 3c, sensor material 38 is located within the pores of a porous microneedle 32.” [Col 7, lines 25-37]) attached to a path (hollow bore 36), the path attached to a housing (substrate 34).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to further modify the medical infusion and sensing system of Gabel to include that one of the microneedles is an analyte sensor attached to a path that is attached to the housing based on the teachings of Prausnitz to provide a closed loop drug delivery unit including fluid delivery in response to analyte measurement (Prausnitz [Col 6, lines 56-63]).
Regarding claim 20, modified Gabel teaches the medical infusion and sensing system of claim 19 wherein the wearable housing (housing 12 and cartridge 14) comprising a reusable portion (housing 12; “At the end of the delivery step, cover 32 can be opened and cartridge 14 removed and discarded. The spent cartridge can be replaced with a fresh cartridge for delivering a substance to the patient by repeating the process.” [0060]) and a disposable portion (cartridge 14; “Cartridge 14 is typically constructed and manufactured as a single use disposable member.” [0061]).
Regarding claim 21, modified Gabel teaches the medical infusion and sensing system of claim 19 wherein the reservoir comprises at least one flexible portion (“Top wall 66 of cartridge 14 is made from a flexible material so that top wall 66 can be depressed inwardly to dispense the contents of reservoir 72 through fluid channel 76 and skin penetrating members 80.” [0056]).
Regarding claim 22, modified Gabel teaches the medical infusion and sensing system of claim 19 further comprising a pumping mechanism (cover 32 with spring 48) for pumping fluid from the reservoir through the fluid path (“The cover 32 functions to cause a fluid substance within the cartridge to be dispensed when the cover is closed. The cover includes a spring 48 to apply pressure to cartridge 14” [0048]; “Spring 48 provides a substantially constant and uniform pressure against top wall 66, thereby providing a dispensing pressure to the fluid in reservoir 72” [0060]; wherein the cover 32 with spring 48 is a pumping mechanism because it delivers the fluid via pressure).
Regarding claim 23, modified Gabel teaches the medical infusion and sensing system of claim 19 wherein the pumping mechanism is actuated using at least one shape memory actuator (spring 48: “As shown in FIG. 14, reservoir 72 of body 64 is initially filled with a fluid to be delivered to the patient so that top wall 66 bulges outwardly from body 64. Spring 48 contacting top wall 66 is initially flattened such that second end 54 and second tab 56 of spring 48 slide away from the fixed end of spring 48 radially outward with respect to cover 32 toward hinge 34.” [0059]; “As shown in FIG. 15, spring 48 eventually resumes its original shape” [0060], wherein the spring 48 is a shape memory actuator because it returns to its original shape after applying a force to the top wall 66 of reservoir 72).
Regarding claim 27, modified Gabel teaches the medical infusion and sensing system of claim 19.
Modified Gabel fails to explicitly teach wherein the appendages provide for microneedle retention.
Kingsford teaches a medical infusion system (member 10) comprising: a plurality of microneedles (skin-penetrating elements 14; “A patch with an array of microneedles” [0002]), each microneedle having a body portion (cone-shaped body 18) and two appendages (two discrete barbs 20a, 20b; Figure 3A) that provide for microneedle retention (“The barbs are configured to cooperate to resist removal of the skin attachment member from skin.” [0004]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the microneedles of the medical infusion and sensing system of Gabel to comprise two appendages for microneedle retention based on the teachings of Kingsford to secure the medical system to the skin without causing pain and discomfort (Kingsford [0003-0004]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 5-12, 16-23, and 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to applicant's argument that Burbank et al. (US 20060015144) is nonanalogous art (Remarks, page 6-9), it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Burbank is reasonably pertinent to the particular problem. The present specification states that one particular problem with which the inventor was concerned is ensuring the medical system remains secured to the patient for the desired treatment time while also being removable (“The appendage then prevents the microneedle from unwontedly being pulled from the patient and after the passage of a predetermined period of time, the appendages dissolve or disintegrate facilitating the removal of the microneedles from the patient.” [0031]). Burbank is reasonably pertinent to this same problem of securing a medical device for the desired treatment time period and then allowing the medical device to be easily removed. Burbank solves this problem using dissolvable appendages on a penetrating body (see Burbank [0011], [0035]).
Regarding the argument that Burbank fails to teach or suggest the “appendages not forming the fluid path” as required by independent claims 1, 12, and 19 (Remarks, page 6-9), the rejections as detailed above does not rely on the disclosure of Burbank for a teaching of the limitation “appendages not forming the fluid path”. This limitation is disclosed by Kingsford (US 20050118388). The modification as detailed in the rejections of claims 1, 12, and 19 above is to modify the microneedles of Gabel to include the appendages not forming the fluid path as taught by Kingsford to secure the medical system to the skin without causing pain and discomfort (Kingsford [0003-0004]) and to further modify those appendages to be dissolvable as taught by Burbank to allow for disintegration of the appendages and therefore easy removal of the medical system after use (Burbank [0035]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783