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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Claims Accounting
Applicant' s arguments, filed 02/20/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/20/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claim 116 has been amended.
Claim 129 has been canceled.
Claim 211 is newly presented.
Claims 116-128, 130-135, and 211 are the current claims hereby 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.
Claims 116-128, 131, 133-135, and 211 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2020/0337608 by Garai et al. – previously cited, hereinafter “Garai” in view of US Patent Publication 2013/0150691 by Pace et al. – previously cited, hereinafter “Pace”.
Regarding claim 116, Figs. 34-36 of Garai teaches an on-skin wearable medical device ([0196]; physiological characteristic sensor assembly 700, which includes components that are similar or the same as the physiological characteristic sensor assembly 10 discussed with regard to FIGS. 1-9) configured to be deployed to a skin of a host ([0197]; sensor assembly 700 couples to the skin of the user), the on-skin wearable medical device comprising: a housing (top housing 702 and bottom housing 16) configured to be worn on the skin and configured to couple to a transcutaneous analyte sensor (sensor 38 is coupled to the housing by being assembled therein), the housing including a wall comprising a film layer ([0196-0197]; the lower housing 16 and the top housing 702 can be considered a wall and may comprise a thin film layer), a through-hole in the housing for the transcutaneous analyte sensor to extend through; ([0202]; bore comprising of needle bore 706 and sensor bore 79 aligned comprise a through-hole for the analyte sensor to extend through).
Figs. 34-36 of Garai does not teach the on-skin wearable medical device comprising a socket coupled to the housing, the socket including an opening positioned on an outer surface of the housing, the socket being configured to couple to corresponding structure of the transcutaneous analyte sensor.
Figs. 23-27 of Pace teaches a two piece configuration of an on-skin wearable device. The sensor electronics are contained in the on-body device 2502 (See Figs. 25-27). The sensor assembly 2300 includes the analyte sensor and electrical connectors to interface with the circuit board. The on-body wearable device 2502 comprises housing 2404 with snap features (i.e. couple to corresponding structure of the analyte sensor) for receiving the sensor assembly 2300 of Figs. 22-23 (the recess of housing 2404 configured to receive the sensor assembly can be considered a socket with an opening on the outer surface of the housing, as it receives the sensor assembly from the outside and holds the sensor assembly) ([0125-0127]). This two piece configuration can be advantageous as the sensor assembly can be sealed to avoid leakage, avoiding contamination and/or current leakage due to fluid intrusion ([0125]). It is noted that the configuration not only seals the sensor, but may also include gasket 2604 that can ensure sealing in critical circuit connection areas ([0126]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the on-skin wearable medical device of Garai to comprise a two piece configuration such that the on-skin wearable medical device comprises a socket coupled to the housing, the socket including an opening positioned on an outer surface of the housing, the socket being configured to couple to corresponding structure of the transcutaneous analyte sensor, in order to seal the sensor and electrical connection areas, avoiding contamination and/or current leakage due to fluid intrusion, as taught by Pace ([0125-0126]).
It is noted that the housing 2404 and gasket 2604 of Pace comprise a hole (i.e., through hole) for the analyte sensor to pass through, and therefore the combination of Garai and Pace comprises both a through hole and a socket. It is further noted that the device taught by the combination is configured to couple to the transcutaneous analyte sensor through the coupling of the sensor subassembly of Pace with the on-skin device via the socket (i.e., housing 2404).
Regarding claim 117, Garai in view of Pace teaches the on-skin wearable medical device of claim 116, wherein the housing includes a bottom portion configured to be positioned proximate the skin (Garai, [0202]; the adhesive patch is coupled to the lower housing and affixes the sensor to the skin) and a top portion configured to be raised above the bottom portion (Garai; top housing 702 is shown to be raised above the bottom housing in as the components between them have a thickness), at least a portion of the top portion comprising the film layer (Garai, [0197]; the top portion may be composed of a thin film of a biocompatible polymer).
Regarding claim 118, Garai in view of Pace teaches the on-skin wearable medical device of claim 116, wherein the outer surface of the housing includes an outer top surface configured to face away from the skin, at least a portion of the outer top surface comprising the film layer (Garai; the exterior of top housing 702 comprises an outer top surface. This surface is facing opposite the bottom surface of the bottom housing, which faces the skin. [0197]; top housing may be composed of a thin film).
Regarding claim 119, Garai in view of Pace teaches the on-skin wearable medical device of claim 116, wherein the housing includes a bottom portion configured to be positioned proximate the skin (Garai; lower housing 16 in configured to be coupled to the skin via the adhesive), at least a portion of the bottom portion comprising the film layer (Garai, [0196]; the lower housing 16 and may comprise a thin film layer).
Regarding claim 120, Garai in view of Pace teaches the on-skin wearable medical device of claim 116, wherein the housing includes a bottom surface configured to face towards the skin (Garai; the bottom side of bottom housing 16 faces the skin), at least a portion of the bottom surface comprising the film layer (Garai, [0196]; the lower housing 16 and may comprise a thin film layer).
Regarding claim 121, Garai in view of Pace teaches the on-skin wearable medical device of claim 116, wherein the housing includes a bottom portion configured to be positioned proximate the skin and a top portion configured to be raised above the bottom portion (See the rejection of claim 117), wherein the bottom portion includes the film layer (Garai, [0196]; the lower housing 16 and may comprise a thin film layer) and the top portion includes the film layer (Garai, [0197]; top housing may be composed of a thin film), the film layer of the bottom portion being coupled to the film layer of the top portion (Garai, [0202]; the top housing 702 is coupled to the lower housing 16, via thermal welding for example).
Regarding claim 122, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, wherein the film layer of the bottom portion couples to the film layer of the top portion to form a seal of an interior cavity of the housing (Garai, [0202]; The coupling of the top housing to the bottom housing using a process such as thermal welding creates a seal and defines the interior cavity of sensor assembly 700 that houses the sensor electronics).
Regarding claim 123, Garai in view of Pace teaches the on-skin wearable medical device of claim 122, wherein the film layer of the bottom portion couples to the film layer of the top portion about a periphery of the housing (Garai, Fig. 34; The electrical components are contained in the middle of bottom housing 16, therefore the coupling must occur around the periphery).
Regarding claim 124, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, wherein the film layer of the bottom portion couples to the socket (In the combination of Garai and Pace, the socket would be positioned where the sensor bore and needle bore is. The housing of Pace is located on the PCB 2402, and therefore the socket would be positioned on the flexible printed circuit board 714 of Garai. The flexible circuit board 714 is coupled to the bottom layer 16, and therefore the socket is coupled to the bottom layer via the flexible PCB 714.) and the film layer of the top portion couples to the socket (The socket abuts the top housing of the on-skin medical device in order to be able to receive the sensor assembly. Therefore, the socket must be coupled to the top layer (i.e., film layer)).
Regarding claim 125, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, further comprising a patch coupled to the housing and configured to couple the housing to the skin (Garai, [0202]; adhesive patch 18 may be coupled to the lower housing 16 for affixing the lower housing 16, and thus, the physiological characteristic sensor assembly 700, to the skin of the user.).
Regarding claim 126, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, wherein the housing is flexible (Garai, [0196-0197]; sensor assembly 700 is flexible and the top housing 702 is flexible).
Regarding claim 127, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, wherein the housing has a length (Garai; along the axis connecting the battery 50 and antenna 712), a width (the dimension perpendicular to the length and not vertical), and a height (vertical dimension), with the length and the width each being greater than the height. The sensor subassembly 700 is low profile (Garai, [0196]). It can be seen from the exploded view of Figs. 34-36 that the length and width of the assembly are greater than the height.
Regarding claim 128, Garai in view of Pace teaches the on-skin wearable medical device of claim 127, wherein the opening of the socket (Opening of the housing 2404 of Pace) is configured for receiving a plug coupled to the transcutaneous analyte sensor to be inserted through to be received by the socket (The opening of the housing 2404 (i.e., socket) is configured for receiving the sensor assembly 2300 (which can be considered a plug coupled to the transcutaneous analyte sensor). Fig. 25A of Pace shows the sensor subassembly prior to being inserted through the opening of the socket.)).
Regarding claim 131, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, but does not teach wherein the housing has a rectangular shape. It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the shape of the housing taught by Garai to be rectangular. Regarding the shape of housing, the courts have held that a change in shape alone, without demonstration of the criticality of a specific limitation, may be considered obvious to a person of ordinary skill in the art. See MPEP 2144.04-IV-B.
Regarding claim 133, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, further comprising one or more electrical components positioned within an interior cavity of the housing (Garai; the top housing and bottom housing couple to form a cavity, where electrical components are housed).
Regarding claim 134, Garai in view of Pace teaches the on-skin wearable medical device of claim 133, wherein the one or more electrical components comprise one or more of a transmitter (Garai; antenna 712), a battery (Garai; battery 50), or contacts for the transcutaneous analyte sensor (Garai; [0200]; sensor contacts 86. It is noted that in the combination of Garai and Pace, the sensor subassembly 2300 contains electrical contacts for connection with the printed circuit board (Pace, [0125])).
Regarding claim 135, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, further comprising a filler positioned within an interior cavity of the housing (Garai, Shim 718 can be considered a filler).
Regarding claim 211, Garai in view of Pace (as applied to claim 116) teaches an on-skin wearable medical device configured to be deployed to a skin of a host (See the rejection of claim 116), the on-skin wearable medical device comprising: a housing configured to be worn on the skin and configured to couple to a transcutaneous analyte sensor (See the rejection of claim 116), the housing including a wall comprising a film layer (See the rejection of claim 116); and a socket coupled to the housing, the socket including an opening positioned on an outer surface of the housing (See the rejection of claim 116), the socket including coupling features configured to couple to corresponding coupling features of a plug for the transcutaneous analyte sensor (The sensor subassembly 2300 of Pace can be considered a plug for the transcutaneous analyte sensor as the subassembly fills the socket and contains the transcutaneous sensor. The housing 2404 (i.e., socket) has snap features (i.e., coupling features) for receiving the sensor subassembly (Pace, [0126]). The part of the sensor subassembly that is retained by the snap features can be considered corresponding coupling features).
Claim 130 is rejected under 35 U.S.C. 103 as being unpatentable over Garai in view of Pace, as applied to claim 28, in view of US Patent Publication 2018/0368774 by Gray et al. – previously cited, hereinafter “Gray”.
Garai in view of Pace teaches the on-skin wearable medical device of claim 128, wherein the length (the length can be defined as along the axis from battery 50 to antenna 712) is greater than the width (the dimension along the length axis is greater than the dimension across the device as can be seen in Figs. 34-36), wherein the socket has an oblong shape (the shape of housing 2404 is oblong), but does not teach the socket having a long dimension extending along the width of the housing.
Fig. 91 of Gray teaches an on skin sensor 9160 with a length greater than its width. The on skin sensor features a bore 9296 and an aperture 9294 to engage with an anti-rotational feature (i.e., alignment feature) of the applicator ([0179]). The aperture (i.e., corresponding alignment feature of the housing) extends along the shorter dimension of its housing (i.e., width of the housing).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the socket of Garai in view of Pace such that the socket has a long dimension extending along the width of the housing, as taught by Gray. This combination merely comprises combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A. It is noted that the Pace teaches that the socket contains snap features to ensure retention and alignment of the sensor subassembly. Therefore, the modification to the orientation of socket comprises a modification to the orientation of the alignment features.
Claim 132 is rejected under 35 U.S.C. 103 as being unpatentable over Garai in view of Pace, as applied to claim 121, in view of US Patent Publication 2017/0027514 by Biederman et al. – previously cited, hereinafter “Biederman”.
Regarding claim 132, Garai in view of Pace teaches the on-skin wearable medical device of claim 121, but does not teach the device further comprising a cover layer forming an outer surface of the housing and positioned over the film layer.
Biederman teaches an on skin medical device that may be covered by a conformal sealant layer one or both sides of the device. The conformal sealant layer may conformally coat and adhere to exposed surfaces of the device. The conformal sealant layer can seal all voids or volumes that water vapor or another material can be deposited, condense, or otherwise accumulate ([0159]), protecting the internal electronics of the sensor.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Garai in view of Pace to include a cover layer forming an outer surface of the housing and positioned over the film layer, as taught by Biederman ([0159]) to further protect the internal electronics of the sensor.
Response to Arguments
Applicant’s arguments, filed 02/20/2026 have been fully considered.
Applicant’s assertions regarding the rejections of independent claims 116 and 211 under 35 U.S.C. 102 and 103 are acknowledged. These assertions are moot as they are based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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