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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/9/2026 has been entered.
Response to Amendment
The amendment filed 3/9/2026 has been entered. Claims 1-4 and 6-15 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed 12/22/2025.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 7, 9-11, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaufmann (US 20130253431 A1).
Regarding claims 1, 7, 9, and 15, Kaufmann discloses a drug delivery device (abstract and [0002]) comprising: a housing; a reservoir positioned within the housing and configured to receive a fluid (cannula assembly 1, [0170]-[0173] & Fig. 1 and 14A-14B; fluid connector 440, which is filled with insulin before connection to hub 150, [0169] and [0174] & Fig. 14A-14B); a fluid path in fluid communication with the reservoir (the path from connector 440 to the lateral opening 121 in cannula 120 is being interpreted as the fluid path, [0180] & Fig. 14A-14B); a delivery sub-system configured to deliver the fluid from the reservoir to the fluid path (“a fluid connector of a fluid source or infusion pump may be connected or attached to the inserter module.”, [0081]; an infusion pump is employed to deliver fluid from connector 440, [0091]; also see [0146], [0160], [0169], and [0173]-[0175]);
an insertion mechanism comprising a cannula in fluid communication with the fluid path, the insertion mechanism configured to move the cannula from a retracted position where the cannula is positioned within the housing to an extended position where at least a portion of the cannula is positioned outside of the housing (inserter module 200 comprising cannula 120 in fluid communication with the fluid path, [0169]-[0175] & Fig. 14A-14B; “The inserter module 200 may be disposable and comprise a biased spring 220. The biased spring 220 can be integrated into the inserter module 200. In the embodiments described herein, the biased spring 220 may be in tension or compression. Furthermore, the energy stores described herein, (e.g., biased spring 220) may be energized and/or discharged automatically and/or manually.”, [0158]; also see [0170]-[0171]; module 200 is configured to move cannula 120 from a position inside assembly 1 to an extended position where cannula 120 is positioned outside assembly 1, Fig. 14A-14B);
an activation member in fluid communication with the fluid path (“the cannula assembly 1 is triggered by a fluid acting on the activation mechanism”, [0170]; activation mechanism including spongy element 330 and biased elastic element 320, [0170], [0172], and [0176]& Fig. 14A-14B); and an energy storage member, wherein the energy storage member comprises a spring, connected to the activation member, the energy storage member having a stored state when the cannula is in the retracted position and a released state when the cannula is in the extended position (biased spring 220 connected to spongy element 330 and having a compressed and released state, [0174] and [0176] & see Fig. 14A-14B),
wherein the energy storage member is triggered to transition from the stored state to the released state in response to wetting of the activation member by the fluid from the reservoir (biased spring 220 transitions from a compressed state to a released state in response to spongy element 330 being wetted by insulin from connector 440, [0172], [0174], and [0176] & Fig. 14A-14B).
Regarding claims 2 and 10, Kaufmann discloses all the limitations of claims 1 and 9. Kaufmann further discloses the insertion mechanism wherein the activation member is configured to seal after coming into contact with the fluid from the reservoir (“When fluid such as insulin is supplied, the fluid acts on the spongy element 330. The spongy element 330 becomes soft and a biased elastic element 320 such as, for example, a flexible seal made of a material such as silicone rubber, is inverted.”, [0172]).
Regarding claims 3 and 11, Kaufmann discloses all the limitations of claims 1 and 9. Kaufmann further discloses the insertion mechanism wherein the activation member comprises a hydrophilic material (“the spongy element 330 wetted and the insertion of the cannula 120 triggered.“, [0174]; spongy element 330 is configured to be wetted), the hydrophilic material having a first tensile strength when dry and a second tensile strength when wet, and wherein the first tensile strength is greater than the second tensile strength (“When insulin flows into the fluid connector 440 of the cannula module 100, the spongy element 330 is structurally weakened such that it can no longer support the biased elastic element 320.”, [0176] & Fig. 14A-14B; element 330 has a first strength before being wetted that is greater than a second strength after being wetted).
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) 1-2, 7-10, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US 20150190588 A1), in view of Locke (US 20200179575 A1).
Regarding claims 1 and 7-8, Hanson discloses an insertion mechanism for a drug delivery device (insertion mechanism 200 for drug delivery pump 10, Fig. 1B and 6B), the insertion mechanism comprising: a fluid path configured to be in fluid communication with a reservoir (fluid conduit 30 connected to reservoir 50, see [0037] & Fig. 1A-1B and 5A-B); an activation member in fluid communication with the fluid path (membrane 233, along with its associated pressure sensor, is being interpreted as the activation member, [0058] and [0064] & Fig. 6A; pressure sensor not illustrated); and an energy storage member connected to the activation member (insertion biasing member 210, a spring, operatively connected to membrane 233 and the pressure sensor, [0058] and [0063]-[0065] & Fig. 6A-6D; the expulsion of gaseous fluid through membrane 233 from conduit 30 and manifold 240 initiating mechanism 200 to move needle 214), the energy storage member having a stored state and a released state (Fig. 6A-6C illustrating the first position in which biasing member 210 is in a stored state, see [0064] and Fig. 6D illustrating the second position in which biasing member 210 is in a released state, see [0066]),
wherein the energy storage member transitions from the stored state to the released state when a fluid from the reservoir contacts and wets the activation member (biasing member 210 expanding and inserting needle 214 and cannula 234 once the pressure sensor has identified that the gaseous fluid has been substantially entirely expelled from the fluid pathway and manifold, [0064]-[0065]; this occurs once liquid drug fills the manifold – substantially contacting membrane 233 and covering membrane 233 with liquid, or wetting, see Fig. 6C and [0063]).
However, Hanson fails to explicitly disclose an insertion mechanism for a drug delivery device wherein the energy storage member is triggered to transition from the stored state to the released state in response to wetting of the activation member by a fluid from the reservoir and wherein the activation member comprises a dissolvable material configured to disintegrate when in contact with the fluid.
However, Locke teaches a medical fluid container 112 having a port 220 defining a flow path 222, containing a hydrophobic filter 230, to an external environment to selectively allow for gas evacuation from container 112 ([0038], [0043], and [0046] & Fig. 2). Locke teaches an activation member (stopple 210, Fig. 2) comprising a dissolvable material (stopple 210 being a liquid-degradable component which “may comprise a hydrophilic coating”, see [0043]-[0046] & Fig. 2) configured to disintegrate when in contact with the fluid (“…contact between the liquid within the liquid reservoir 202 and the liquid-degradable component may cause the liquid-degradable component to begin to erode, dissolve, disintegrate, or otherwise degrade. Upon the liquid-degradable component degrading and losing structural integrity, gas communication between the liquid reservoir 202 and the external environment may be allowed, such as via the first flowpath 222.”, [0057]).
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 activation member of Hanson with Locke to include a dissolvable material configured to disintegrate when in contact with the fluid, since such a modification would restrict gas communication between the manifold and the external environment prior to liquid entering the manifold which would help prevent gas from undesirably entering the manifold and yield the same predictable results pertaining to controlled gas expulsion (see [0006], [0046], [0048], and [0057] of Locke).
As modified, stopple 210 of Locke can be included in manifold 240 of Hanson. Membrane 233 of Hanson and stopple 210 of Locke are both being interpreted as part of the claimed activation member. As combined, biasing member 210 is triggered to expand in response to stopple 210 being wetted. Gas cannot fully escape manifold 240 until stopple 210 is wetted and beings to disintegrate. Therefore, biasing member 210 may be interpreted as triggered to expand in response to the wetting of stopple 210 since the step of expansion of biasing member 210 cannot occur until stopple 210 is wetted. In other words, the disintegration of stopple 210 initiates the step of member 210 expanding.
Regarding claims 9, 13, and 15, Hanson discloses a drug delivery device (drug delivery pump 10, Fig. 1A and abstract) comprising: a housing (pump housing 12, [0037] & Fig. 1A); a reservoir positioned within the housing and configured to receive a fluid (drug container 50, [0037] & Fig. 1B); a fluid path in fluid communication with the reservoir (fluid conduit 30 fluidly connected to container 50 through connection 300, [0037] and [0044] & Fig. 1B-1C); a delivery sub-system configured to deliver a fluid from the reservoir to the fluid path (drive mechanism 100, [0047] and [0052] & Fig. 1B); an insertion mechanism comprising a cannula in fluid communication with the fluid path (insertion mechanism 200 having a cannula 234 in fluid communication with conduit 30, [0057] & Fig. 6A and 6F), the insertion mechanism configured to move the cannula from a retracted position where the cannula is positioned within the housing to an extended position where at least a portion of the cannula is positioned outside of the housing (mechanism 200 configured to move cannula 234 from a first, retracted, position, Fig. 6A, to a second, extended, position where cannula 234 is positioned outside the housing, Fig. 6D, see [0063]); an activation member in fluid communication with the fluid path (membrane 233, along with its associated pressure sensor, is being interpreted as the activation member, [0058] and [0064] & Fig. 6A; pressure sensor not illustrated); and an energy storage member connected to the activation member (insertion biasing member 210, a spring, operatively connected to membrane 233 and the pressure sensor, [0058] and [0063]-[0065] & Fig. 6A-6D; the expulsion of gaseous fluid through membrane 233 from conduit 30 and manifold 240 initiating mechanism 200 to move needle 214 and cannula 234), the energy storage member having a stored state when the cannula is in the retracted position and a released state when the cannula is in the extended position (Fig. 6A-6C illustrating the first position in which biasing member 210 is in a stored state, see [0064], and Fig. 6D illustrating the second position in which biasing member 210 is in a released state, see [0066]),
wherein the energy storage member transitions from the stored state to the released state when a fluid from the reservoir contacts and wets the activation member (biasing member 210 expanding and inserting needle 214 and cannula 234 once the pressure sensor has identified that the gaseous fluid has been substantially entirely expelled from the fluid pathway and manifold, [0064]-[0065]; this occurs once liquid drug fills the manifold – substantially contacting membrane 233 and covering membrane 233 with liquid, or wetting, see Fig. 6C and [0063]).
However, Hanson fails to explicitly disclose an insertion mechanism for a drug delivery device wherein the energy storage member is triggered to transition from the stored state to the released state in response to wetting of the activation member by a fluid from the reservoir and wherein the activation member comprises a dissolvable material configured to disintegrate when in contact with the fluid.
However, Locke teaches a medical fluid container 112 having a port 220 defining a flow path 222, containing a hydrophobic filter 230, to an external environment to selectively allow for gas evacuation from container 112 ([0038], [0043], and [0046] & Fig. 2). Locke teaches an activation member (stopple 210, Fig. 2) comprising a dissolvable material (stopple 210 being a liquid-degradable component which “may comprise a hydrophilic coating”, see [0043]-[0046] & Fig. 2) configured to disintegrate when in contact with the fluid (“…contact between the liquid within the liquid reservoir 202 and the liquid-degradable component may cause the liquid-degradable component to begin to erode, dissolve, disintegrate, or otherwise degrade. Upon the liquid-degradable component degrading and losing structural integrity, gas communication between the liquid reservoir 202 and the external environment may be allowed, such as via the first flowpath 222.”, [0057]).
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 activation member of Hanson with Locke to include a dissolvable material configured to disintegrate when in contact with the fluid, since such a modification would restrict gas communication between the manifold and the external environment prior to liquid entering the manifold which would help prevent gas from undesirably entering the manifold and yield the same predictable results pertaining to controlled gas expulsion (see [0006], [0046], [0048], and [0057] of Locke).
As modified, stopple 210 of Locke can be included in manifold 240 of Hanson. Membrane 233 of Hanson and stopple 210 of Locke are both being interpreted as part of the claimed activation member. As combined, biasing member 210 is triggered to expand in response to stopple 210 being wetted. Gas cannot fully escape manifold 240 until stopple 210 is wetted and beings to disintegrate. Therefore, biasing member 210 may be interpreted as triggered to expand in response to the wetting of stopple 210 since the step of expansion of biasing member 210 cannot occur until stopple 210 is wetted. In other words, the disintegration of stopple 210 initiates the step of member 210 expanding.
Regarding claims 2 and 10, Hanson discloses all the limitations of claims 1 and 9. Hanson further discloses the insertion mechanism wherein the activation member is configured to seal after coming into contact with the fluid from the reservoir (membrane 233 sealing manifold 240 and the liquid drug from the external environment in which the gaseous fluid is expelled, [0063] & Fig. 6A-6D).
Claim(s) 3-4 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hanson (US 20150190588 A1), in view of Locke (US 20200179575 A1), in view of Hooven (US 20200214625 A1), and further in view of Ward (US 5428123 A).
Regarding claims 3 and 11, Hanson discloses all the limitations of claims 1 and 9. Hanson discloses that “membrane 233 may be any number of permeable or semi-permeable membranes which are capable of permitting passage of gaseous fluids while prohibiting passage through the membrane 233 of liquid fluids. In at least one embodiment of the present invention, this is accomplished by utilizing a permeable membrane, such as a hydrophobic permeable membrane, that is permeable to a gaseous fluid but not a liquid fluid, such as the liquid drug treatment. In at least one embodiment of the present invention, it may be beneficial to utilize a permeable membrane that is also a sterile barrier. For example, the membrane 233 may be a polymeric filter made of polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE), a number of types of styrene, and/or a high-density polyethylene fiber (such as that sold under the trade name TYVEK by DuPont), among many other types of suitable medical-grade gas filtering membranes.”, [0062]. Polymeric filters and PET in many circumstances being hydrophilic in nature, as is well known in the art.
However, Hanson fails to explicitly disclose the insertion mechanism wherein the activation member comprises a hydrophilic material, the hydrophilic material having a first tensile strength when dry and a second tensile strength when wet, and wherein the first tensile strength is greater than the second tensile strength.
However, Hooven teaches an insertion mechanism (injector 7, [0162] & Fig. 17-18) wherein the activation member comprises a hydrophilic material (air remover filter 123 which may be configured with a hydrophobic filter or a combination of hydrophobic and hydrophilic filters, [0162] & Fig. 17-18).
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 membrane of Hanson, as modified, with Hooven to include the activation member comprising a hydrophilic material since Hooven teaches an air removal filter 123, a structure synonymous to membrane 233 of Hanson, including hydrophobic and hydrophilic materials to be an art effective configuration for a filter designed to remove air from a fluid pathway (see [0162] of Hooven). As modified, membrane 233 of Hanson can include a hydrophilic material.
Further, Ward teaches a hydrophilic material (abstract) having a first tensile strength when dry and a second tensile strength when wet, and wherein the first tensile strength is greater than the second tensile strength (“FIG. 2 shows the correlation of membrane tensile strength vs. hydrophilic content of the polymers of the present invention. In every case the tensile strength of the hydrated membrane is lower than that of the dry membrane.” Col 6 lines 50-56).
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 Hanson, as modified, with Ward to include the hydrophilic material having a first tensile strength when dry and a second tensile strength when wet, and wherein the first tensile strength is greater than the second tensile strength since such a modification would allow for the hydrophilic material to maintain some degree of tensile strength even when hydrated (Col 6 lines 50-56 and Fig. 2 of Ward).
Regarding claims 4 and 12, Hanson, as modified, discloses all the limitations of claims 3 and 11. Hanson, as modified, further discloses the insertion mechanism wherein the hydrophilic material prevents fluid from passing through the activation member once the hydrophilic material is fully saturated by fluid (as modified, once the hydrophilic material of membrane 233 becomes saturated with fluid, no more fluid will be able to pass into, or through, membrane 233, see Fig. 6A-6B).
Response to Arguments
Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that the secondary references do not teach or suggest the triggering relationship as claimed, the Examiner finds that, as rejected above, the causal activation mechanism is found to be taught by Hanson in view of Locke and anticipated by Kaufmann.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783
/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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