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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/18/2025 has been entered. Claims 161-162, 164-175 and 206-211 are currently pending and under examination.
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) 161-162, 164-175 and 206-211 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0202366 to Mitchell et al. (Mitchell) (previously cited) in view of US 2019/0076069 to Lin et al. (Lin) (cited by applicant).
In reference to at least claim 161
Mitchell discloses an on-skin wearable medical device system (e.g. sensor applicator 150) comprising: a transcutaneous analyte sensor having an insertion portion for being disposed with skin of a host and a coupling portion (e.g. sensor 9112 includes a portion for insertion and a coupling portion with housing 9104, Figs. 31A-32B); an insertion element for inserting the transcutaneous analyte sensor into the skin of the host (e.g. sharp 9114); a housing including an outer perimeter and (e.g. electronics housing 706/9104 contains an outer perimeter), an insertion channel for the insertion element to pass through (e.g. channel within housing 706 and 9104 in which the sharp 9114 passes through, “Corresponding portions of the sensor 9112 and the sharp 9114 extend distally from the bottom of the electronics housing 9104 (e.g., the mount 9108). A sharp hub 9116 may be overmolded onto the sharp 9114 and configured to secure and carry the sharp 9114. As best seen in FIG. 31A, the sharp hub 9116 may include or otherwise define a mating member 9118. In assembling the sharp 9114 to the sensor control device 9102, the sharp 9114 may be advanced axially through the electronics housing 9104 until the sharp hub 9116 engages an upper surface of the electronics housing 9104 or an internal component thereof and the mating member 9118 extends distally from the bottom of the mount 9108.”, para. [0382]), a distal surface configured to face towards the skin (e.g. distal end of electronics housing 706 faces skin, para. [0193]), and a cavity in the distal surface for receiving the coupling portion of the transcutaneous analyte sensor (e.g. cavity present on the distal surface within the mount portion 9108 of the housing 1904 which receives a coupling portion of the sensor 9112, Figs. 31A-32B, 41); a patch coupled to the housing and including a first surface for engaging the skin (e.g. adhesive patch 9110), the patch positioned distal of the housing (e.g. adhesive patch 9110 is distal of housing 9104); and one or more moisture passageways extending along the cavity (e.g. channels 10130 and/or holes 10600, Figs. 40A-C, 41) and configured for removal of moisture that is positioned distal of the housing (e.g. fluid can evaporate, para. [0438], [0443]) in a direction towards the outer perimeter of the housing (e.g. channels 10130 and/or holes 10600 drain fluid in a direction towards an outer perimeter of the housing, para. [0438], [0443]).
Mitchell further discloses wherein the patch includes a plurality of layers (e.g. patch 9110 can include multiple layers, Fig. 42A-C) including a first layer (e.g. first layer includes 10300 and/or 10400) in which one or more of the transcutaneous analyte sensor or an insertion element for the transcutaneous analyte sensor pass through (e.g. aperture 10150 within layer 10300 and 10400 allow an insertion element to pass through, Fig. 41).
Mitchell does not explicitly teach a puncture layer positioned distal of the housing, and wherein the transcutaneous analyte sensor and the insertion element both extend through the puncture layer and the puncture layer stabilizes the transcutaneous analyte sensor relative to the insertion element.
Lin discloses an on-skin wearable medical device system (e.g. CGM 100, para. [0027], biosensor 400, para. [0038], biosensor 500, para. [0040]) comprising: a transcutaneous analyte sensor having an insertion portion for being disposed within skin of a host and a coupling portion (e.g. sensor wire 120 extends out of housing 110, para. [0027]); an insertion element for inserting the transcutaneous analyte sensor into the skin of the host (e.g. hollow insertion needle 130,1220, 1320, para. [0026]); a housing including an outer perimeter and including an insertion channel for the insertion element to pass through (e.g. any of housings 110, 850, 1030, 1210, 1310 which has an outer perimeter and includes a channel for the hollow insertion need to pass through, Figs. 1A,8B,9B,10B,12A-12B,13A-13B and associated paras. [0027], [0051], [0057], [0062], [0068] and [0071]), a distal surface configured to face towards the skin (e.g. any of housings 110, 850, 1030, 1210, 1310 has a distal surface that faces towards the skin, Figs. 1A,8B,9B,10B,12A-12B,13A-13B), and a cavity in the distal surface for receiving the coupling portion of the transcutaneous analyte sensor (e.g. sensor wire and needle have an exit point within the housing, the exit point is being interpreted as the claimed cavity, para. [0052]); a patch coupled to the housing and including a first surface for engaging the skin, the patch positioned distal of the housing (e.g. pad(s) that engage the skin and are coupled with the retention features are being interpreted as the claimed patch including any of the following recited pad(s): retention feature 220 can include a pad or backing material, para. [0033]; retention feature 420 coupled to a pad 410, para. [0039], retention feature 520 or 610 coupled to pad 510, para. [0040], [0043], retention feature 854 coupled with pad 856, para. [0051], and/or retention feature 1244 coupled to pad 1242, para. [0068]), a puncture layer positioned distal of the housing (e.g. retention feature 140, 310,420,520,610,854, 1244 is positioned distal of the housing Figs. 1E, 2B, 3-6,8B and 12 and associated paras. [0031], [0036], [0038], [0040], [0043], [0051], [0068]), and wherein the transcutaneous analyte sensor and the insertion element both extend through the puncture layer (e.g. retention feature 140, 210,420,520 has an extendable portion 142, 230, 422a-b,522a-b in which hollow insertion needle with biosensor wire extend through, Figs. 1E, 2B, 3-5) and the puncture layer stabilizes the transcutaneous analyte sensor relative to the insertion element (e.g. retention feature 140, 210,420,520 has an extendable portion 142, 230, 422a-b,522a-b that has a co-axial alignment between the hollow insertion needle with biosensor wire that helps to prevent the sensor wire from dislodging from within the cross-section of the hollow insertion needle while not affecting the insertion procedure, Figs. 1E, 2B, 3-5, para. [0031]).
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 system of Mitchell to include a retention feature as a puncture layer positioned distal of the housing, wherein the transcutaneous analyte sensor and the insertion element both extend through the puncture layer and the puncture layer stabilizes the transcutaneous analyte sensor relative to the insertion element, as taught by Lin, in order to provide a layer that helps to prevent the sensor wire from dislodging from within the hollow insertion needle while not affecting the insertion procedure (‘069, para. [0031]).
In reference to at least claim 162
Mitchell modified by Lin renders obvious a system according to claim 161. Mitchell further discloses wherein the one or more moisture passageways are configured for removal of moisture positioned proximate an insertion site of the transcutaneous analyte sensor into the skin (e.g. fluid in an area of the skin underneath the adhesive patch can evaporate, para. [0438], [0443]).
In reference to at least claim 164
Mitchell modified by Lin renders obvious a system according to claim 161. Mitchell further discloses wherein the one or more moisture passageways are configured for removal of moisture positioned between the patch and the distal surface of the housing (e.g. channels 10130 and/or holes 10600 drain fluid in a direction towards an outer perimeter of the housing, para. [0438], [0443]-[0444]).
In reference to at least claim 165
Mitchell modified by Lin renders obvious a system according to claim 161. Mitchell further discloses wherein the distal surface of the housing includes at least one channel forming at least a portion of the one or more moisture passageways (e.g. distal surface of housing may include vents 10302 which aid in moisture removal through holes 10600,para. [0444]).
In reference to at least claim 166
Mitchell modified by Lin renders obvious a system according to claim 161. Mitchell further discloses wherein the patch includes at least one channel forming at least a portion of the one or more moisture passageways (e.g. channels 10130 and/or holes 10600 are formed in adhesive patch 9110).
In reference to at least claim 167
Mitchell modified by Lin renders obvious a system according to claim 166. Mitchell further discloses the at least one channel extends in a direction from a region of the patch proximate an insertion site of the transcutaneous analyte sensor into the skin towards the outer perimeter (e.g. channels 10130 form a region proximate an insertion site at opening 10350 into the skin towards the outer perimeter, Figs. 40A-B).
In reference to at least claim 168
Mitchell modified by Lin renders obvious a system according to claim 161. Mitchell further discloses wherein the patch includes a plurality of layers (e.g. patch 9110 can include multiple layers, Fig. 42A-C) and a first layer of the plurality of layers spaces a second layer of the plurality of layers from the distal surface of the housing to form the one or more moisture passageways (e.g. first layer includes 10300 and/or 10400 which spaces second layer 10400 and/or 10500 from a distal surface of housing 9104, Figs. 42A-C, para. [0443]; layer 10400 can include holes 10600 for liquid breathability or evaporation which can vent through 10302, para. [0444]-[0445]).
In reference to at least claim 169
Mitchell modified by Lin renders obvious a system according to claim 168. Mitchell further discloses wherein the first layer includes one or more elongate arms spacing the second layer from the distal surface of the housing to form the one or more moisture passageways (e.g. thread “elongate arms” 10301 form vents 10302 which form part of the passageway for moisture evaporation, para. [00444]-[00445]).
In reference to at least claim 170
Mitchell modified by Lin renders obvious a system according to claim 169. Mitchell further discloses wherein the housing includes an outer perimeter (e.g. housing 1094 includes an outer perimeter), and at least one of the one or more elongate arms extends in a direction from a region of the patch proximate an insertion site of the transcutaneous analyte sensor into the skin towards the outer perimeter (e.g. threads 10301 extend from a region proximate the insertion site shown my opening 10350 to an outer perimeter, Figs. 41, 42A).
In reference to at least claim 171
Mitchell modified by Lin renders obvious a system according to claim 169. Mitchell further discloses wherein the one or more elongate arms include at least two of the elongate arms that intersect (e.g. threads 1031 intersect, Figs. 42A).
In reference to at least claim 172
Mitchell modified by Lin renders obvious a system according to claim 168. Mitchell further discloses wherein at least a portion of the first layer includes a V-shape (e.g. threads 10301 form a V-shape Fig. 42A).
In reference to at least claim 173
Mitchell modified by Lin renders obvious a system according to claim 168. Mitchell further discloses a first layer includes that includes 10300 and/or 10400 (e.g. 10300 and/or 10400 which spaces second layer 10400 and/or 10500 from a distal surface of housing 9104, Figs. 42A-C, para. [0443]; layer 10400 can include holes 10600 for liquid breathability or evaporation which can vent through 10302, para. [0444]-[0445]). Lin discloses the retention feature(s) which is being interpreted as the puncture layer being coupled with a pad, therefore the modified system of Mitchell in view of Lin places the puncture layer distal of the housing coupled with a first layer of the patch.
In reference to at least claim 174
Mitchell modified by Lin renders obvious a system according to claim 168. Mitchell further discloses wherein the patch includes a third layer, the third layer including the first surface (e.g. layer 10500 has a surface that engages the skin, Figs. 41,42A-C).
In reference to at least claim 175
Mitchell modified by Lin renders obvious a system according to claim 161. Mitchell further discloses wherein the one or more moisture passageways are configured for wicking moisture positioned distal of the housing (e.g. channels 10130 or holes 10600 drain and/or evaporate fluid distal of housing 9104, para. [0438], [0443]-[0444]).
In reference to at least claim 206
Mitchell modified by Lin renders obvious a system according to claim 161. Mitchell further discloses one or more elongate arms overlapping the cavity and forming the one or more moisture passageways (e.g. thread “elongate arms” 10301 form vents 10302 which form part of the passageway for moisture evaporation and slightly overlap the cavity of housing 9104, Figs. 41-42A, para. [00444]-[00445]).
In reference to at least claim 207
Mitchell modified by Lin renders obvious a system according to claim 206. The modified system of Mitchell in view of Lin placing a puncture layer distal of the housing, see rejection of claim 161 above, would provide the one or more elongate arms extending from the puncture layer to the outer perimeter of the housing (e.g. thread “elongate arms” 10301 form vents 10302 which form part of the passageway for moisture evaporation and would extend from the puncture layer of the modified system of Mitchell in view of Lin, Figs. 41-42A, para. [00444]-[00445]).
In reference to at least claim 208
Mitchell modified by Lin renders obvious a system according to claim 206. Mitchell further discloses wherein the one or more elongate arms protrude from the outer perimeter of the housing (e.g. thread “elongate arms” 10301 form vents 10302 which form part of the passageway for moisture evaporation protrude from the outer perimeter of housing 9104, Figs. 41-42A, para. [00444]-[00445]).
In reference to at least claim 209
Mitchell modified by Lin renders obvious a system according to claim 206. Mitchell further discloses the one or more elongate arms extend along a longitudinal axis of the cavity (e.g. thread “elongate arms” 10301 form vents 10302 which form part of the passageway for moisture evaporation extend along a longitudinal axis of the cavity within housing 9104, Figs. 41-42A, para. [00444]-[00445]).
In reference to at least claim 210
Mitchell modified by Lin renders obvious a system according to claim 206. Lin discloses the retention feature(s) which is being interpreted as the puncture layer being coupled with a pad, therefore the modified system of Mitchell in view of Lin places the puncture layer distal of the housing coupled with the patch, see rejection of claim 161 above, which would provide the one or more elongate arms extending from the puncture layer to the outer perimeter of the housing (e.g. thread “elongate arms” 10301 form vents 10302 which form part of the passageway for moisture evaporation and would extend from the puncture layer of the modified system of Mitchell in view of Lin, Figs. 41-42A, para. [00444]-[00445]). Additionally, 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 system of Mitchell modified by Lin to include the elongate arms being integral with the puncture layer since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art, see MPEP 2144.04.
In reference to at least claim 211
Mitchell modified by Lin renders obvious a system according to claim 161. Mitchell further discloses wherein the cavity extends laterally on the distal surface from the insertion channel (e.g. cavity present on the distal surface within the mount portion 9108 of the housing 1904 which receives a coupling portion of the sensor 9112 extends laterally on the distal surface from the insertion channel of housing 9104, Figs. 31A-32B, 41);
Response to Arguments
Applicant’s arguments with respect to claim(s) 161 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. It is noted that the rejections have been updated to include reference US 2019/0076069 to Lin et al. in view of the claim amendments, see rejection above.
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796