DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
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, 4-9, 12, 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durand (US 20090048556) in view of Perez et al. (US 20170080207 hereinafter “Perez”).
Regarding Claim 1, Durand teaches (Fig 1) A drug delivery device for delivering a drug to a user, comprising:
one or more housings (layers 28, 30);
a storage (24) for storing the drug (See [0037]);
a pump for pumping the drug from the storage for delivery to the user (see [0076] teaching how the device is attached to a charge pump);
a capacitive coupling arrangement for wireless transmission and reception via body channel communication for a drug delivery device (see [0038] teaching how this device has
wireless capability for communication with external devices and can receive signals through capacitive coupling for the drug delivery device), comprising:
an electrically conductive surface (electrode 22; see [0037] and Fig 1) on an exterior face or an interior face of a housing surface (see [0040]; electrode 22 is on an exterior face of layer 26 since release layer 34 will be peeled off) for the drug delivery device;
an electrically conductive patch (electrode 20; see [0037]) secured to or embedded in an adhesive patch (flexible layer 26 that has the high-tack adhesive 30 on the outer layer; [0037]) secured to a bottom surface of the one or more housings (see Fig 1; bottom surface of housing is face of layer 26 that has the adhesive 30 and electrode 20 on it), wherein:
the adhesive patch is for securing the drug delivery device to skin of the user (see Fig 2 and [0039] teaching that there are adhesives placed on both sides of layer 26 with the high-tack adhesive for placing system 10 to the skin of the patient).
Durand does not specify a wireless transceiver for transmitting and receiving wireless communications; the electrically conductive patch is electrically connected to the wireless transceiver in the drug delivery device; and the electrically conductive patch is configured for transmitting a signal from the wireless transceiver via a body of the user using body channel communication to another on-body medical device attached to the user
Perez teaches (Fig 1a) a drug delivery device for delivering a drug to a user, comprising:
one or more housings (111);
a storage for storing the drug (See [0872] teaching how the device of Fig 1a could be used with an insulin pump used to deliver insulin based on users glucose levels detected by sensors 135; it is interpreted that the insulin would be necessarily be in a 'storage' in this embodiment described in [0872]));
a pump for pumping the drug from the storage for delivery to the user (See [0872] teaching how the device of Fig 1a could be used with an insulin pump used to deliver insulin based on users glucose levels detected by sensors 135; it is interpreted that the insulin pump is connected to the 'storage' holding the insulin that would be delivered as described in [0872]);
a wireless transceiver (114) for transmitting and receiving wireless communications ([0525] teaches wireless communications);
and an electrically conductive patch (see [0545] teaching 110 is an electrically conductive patch) is electrically connected to the wireless transceiver (see Fig 1a, 110 is connected to wireless transceiver 114) in the drug delivery device; and the electrically conductive patch is configured for transmitting a signal from the wireless transceiver via a body of the user using body channel communication to another on-body medical device attached to the user (See [0542-543] teaching how the transceiver communicates with other devices such as sensor pods, watches, phones or second electrodes; this is interpreted to be another on-body medical device attached to the user).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug delivery device of Durand such that it includes a wireless transceiver for transmitting and receiving wireless communications; the electrically conductive patch is electrically connected to the wireless transceiver in the drug delivery device; and the electrically conductive patch is configured for transmitting a signal from the wireless transceiver via a body of the user using body channel communication to another on-body medical device attached to the user as taught by Perez. One of ordinary skill in the art would have been motivated to do so in order to allow for a user to receive communication through a companion device (Perez [0524]) and generate feedback related to the health management application of the specific treatment (Perez [0534]).
Regarding Claim 4, the combination of Durand and Perez teaches all elements of claim 1 as described above Durand further teaches the drug delivery device wherein the electrically conductive patch is a copper foil, aluminum foil or a silver foil (see [0066] "electrodes 20 and 22 are formed of silver or silver chloride" also see [0046] "silver loaded isotropic conductive cement" teaching that silver can be sued to provide the electrical and mechanical connection).
Regarding Claim 5, the combination of Durand and Perez teaches all elements of claim 1 as described above Durand further teaches the drug delivery device wherein the electrically conductive surface (electrode 22, see [0046] teaching "one or both electrodes 20 and 22 are made of Ag/AgCI printable conductive ink coating").
Regarding Claim 6, the combination of Durand and Perez teaches all elements of claim 1 as described above Durand further teaches the drug delivery device wherein the electrically conductive surface (electrode 22, Fig. 1) is another conductive patch (electrode 20 is another electrode, [0037], Fig.1) that is secured to the exterior face or the interior face of the surface of the one or more housings (electrode 20 and 22 are on layer 26, Fig.1).
Regarding Claim 7, the combination of Durand and Perez teaches all elements of claim 1 as described above Durand further teaches the drug delivery device wherein the electrically conductive patch is sufficiently flexible to conform to a curvature of the skin surface of the user when secured to the user (electrodes 20 and 22 are contained in flexible layer 26; see [0043] teaching how 26 conforms to the application area of the patient’s body, this is considered to meet the limitation of ‘sufficiently flexible to conform to a curvature of the skin surface of the user when secured to the user’ ).
Regarding Claim 8, Durand teaches (Figs 1-2) a drug delivery device, comprising:
a top housing (layer 28 with battery 14, antenna 16, and printed flexible wiring 18; see [0037] and Fig. 1) having an electrically conductive surface (battery 14, antenna 16, and flexible wiring 18) on an exterior face or an interior face of the top housing (side of layer 28 that attaches to battery 14 and printed flexible wiring 18; see [0037], Fig. 1);
a bottom housing (layer 26 with microprocessor controller 12, Fig.1) that forms a complete housing when interconnected with the top housing (layer 28 combines with layer 26; see [0037] "Layer 26 and layer 28 are bonded together to seal"; Fig.1);
an adhesive patch secured to a bottom face of the bottom housing (high-tack adhesive 30 on layer 26; see [0039] and Fig.1), the adhesive patch having an adhesive for securing the drug delivery device to a skin surface of a user (high-tack adhesive for placing system 10 to the skin of the patient [0039], Fig.2);
an electrically conductive patch secured to or embedded in the adhesive patch on a bottom face of the bottom housing (electrodes 20 secured to high-tack adhesive on layer 26, Fig. 1, [0037]) for electrically coupling the drug delivery device with a body of the user (electrodes 20 drive the charged drug molecules to the drug reservoir that functions as a conductive medium [0041] ), wherein the electrically conductive patch (electrodes 20, Fig. 1) is electrically connected to the and the electrically conductive patch (electrodes 20, Fig. 1) and the electrically conductive surface (battery 14, antenna 16, and flexible wiring 18, Fig. 1) on the exterior or interior face of the top housing (layer 28 with battery 14, antenna 16, and printed flexible wiring 18; see [0037], Fig. 1) form a capacitive coupling arrangement (flexible circuit couples the battery 14, antenna 16, and flexible wiring 18 with electrode 20, see [0008] and antenna 16 can receive signals from an outside device through capacitive coupling ; see [0038]) for wireless transmission and reception body channel communication for the drug delivery device (see [0038] teaching "antenna 16 provides a wireless capability for system 10 to communicate with other external devices" as well as antenna 16 can receive signals from an outside device).
Durand does not specify a wireless transceiver for transmitting and receiving wireless communications; the electrically conductive patch is electrically connected to the wireless transceiver in the drug delivery device.
Perez teaches (Fig 1a) a drug delivery device for delivering a drug to a user, comprising:
one or more housings (111);
a storage for storing the drug (See [0872] teaching how the device of Fig 1a could be used with an insulin pump used to deliver insulin based on users glucose levels detected by sensors 135; it is interpreted that the insulin would be necessarily be in a 'storage' in this embodiment described in [0872]));
a pump for pumping the drug from the storage for delivery to the user (See [0872] teaching how the device of Fig 1a could be used with an insulin pump used to deliver insulin based on users glucose levels detected by sensors 135; it is interpreted that the insulin pump is connected to the 'storage' holding the insulin that would be delivered as described in [0872]);
a wireless transceiver (114) for transmitting and receiving wireless communications ([0525] teaches wireless communications);
and an electrically conductive patch (see [0545] teaching 110 is an electrically conductive patch) is electrically connected to the wireless transceiver (see Fig 1a, 110 is connected to wireless transceiver 114) in the drug delivery device.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drug delivery device of Durand such that it includes a wireless transceiver for transmitting and receiving wireless communications; the electrically conductive patch is electrically connected to the wireless transceiver in the drug delivery device as taught by Perez. One of ordinary skill in the art would have been motivated to do so in order to allow for a user to receive communication through a companion device (Perez [0524]) and generate feedback related to the health management application of the specific treatment (Perez [0534]).
Regarding Claim 9, the combination of Durand and Perez teaches all elements of claim 8 as described above. Durand further teaches the drug delivery device wherein the drug delivery device is an insulin pump, glucagon pump, a therapeutic agent pump or a combination thereof (see [0045] "system 10 may be configured to deliver multiple types of charged drug molecules"; this is interpreted to be a ‘therapeutic agent pump’; furthermore, the pump in Perez [0872] is an insulin]).
Regarding Claim 12, the combination of Durand and Perez teaches all elements of claim 8 as described above. Durand further teaches the drug delivery device wherein the electrically conductive patch is a copper foil, aluminum foil or a silver foil (see [0066] teaching "electrodes 20 and 22 are formed of silver or silver chloride"; also see [0046] teaching "silver loaded isotropic conductive cement" may be used to provide the electrical and mechanical connection).
Regarding Claim 14, the combination of Durand and Perez teaches all elements of claim 8 as described above. Durand further teaches the drug delivery device wherein the electrically conductive surface (electrode 22, Fig.1) is a conductive coating (see [0046] "one or both electrodes 20 and 22 are made of Ag/AgCl printable conductive ink coating").
Regarding Claim 15, the combination of Durand and Perez teaches all elements of claim 8 as described above. Durand further teaches the drug delivery device wherein the electrically conductive surface (electrode 22, Fig. 1) is another conductive patch (electrode 20 is another electrode; see [0037], Fig. 1) that is secured to the exterior face or the interior face of the housing surface (electrode 20 and 22 are on layer 26, Fig. 1).
Regarding Claim 16, the combination of Durand and Perez teaches all elements of claim 8 as described above. Durand further teaches the drug delivery device wherein the electrically conductive patch is sufficiently flexible to conform to a curvature of the skin surface of the user when secured to the user (see [0043] teaching how electrodes 20 and 22 are contained in flexible layer 26 that conform to the application area of the patient’s body; this is interpreted to meet the limitation of ‘sufficiently flexible to conform to a curvature of the skin surface of the user when secured to the user’).
Regarding Claim 17, Durand discloses that a method, comprising:
providing an electronic component in a drug delivery device that is configured to be worn on a body of a user (see [0041], electrodes 20 and 22 drive the charged drug molecules into the skin of the patient; Fig.1);
creating an electrically conductive surface (electrode 22) on an exterior face (side of layer 26 attaching to layer 34, Fig. 1) or an interior face of a housing of the drug delivery device (electrode 22 creates a conductive surface on the exterior face of layer 26, Fig. 1);
securing an electrically conductive patch (electrode 20, Fig. 1, [0037]) over a bottom face of the housing (face of layer 26 towards layer 34, Fig.1) of the drug delivery device for electrically coupling the drug delivery device with the body of the user (electrode 20 is on the side layer 26 that layer 34 attaches to and antenna 16 and microprocessor controller 12, Fig. 1).
Durand does not specify a wireless transceiver for transmitting and receiving wireless communications; the electrically conductive patch is electrically connected to the wireless transceiver in the drug delivery device; and the electrically conductive patch is configured for transmitting a signal from the wireless transceiver via a body of the user using body channel communication to another on-body medical device attached to the user
Perez teaches (Fig 1a) a drug delivery device for delivering a drug to a user, comprising:
one or more housings (111);
a storage for storing the drug (See [0872] teaching how the device of Fig 1a could be used with an insulin pump used to deliver insulin based on users glucose levels detected by sensors 135; it is interpreted that the insulin would be necessarily be in a 'storage' in this embodiment described in [0872]));
a pump for pumping the drug from the storage for delivery to the user (See [0872] teaching how the device of Fig 1a could be used with an insulin pump used to deliver insulin based on users glucose levels detected by sensors 135; it is interpreted that the insulin pump is connected to the 'storage' holding the insulin that would be delivered as described in [0872]);
a wireless transceiver (114) for transmitting and receiving wireless communications ([0525] teaches wireless communications);
and an electrically conductive patch (see [0545] teaching 110 is an electrically conductive patch) is electrically connected to the wireless transceiver (see Fig 1a, 110 is connected to wireless transceiver 114) in the drug delivery device; and the electrically conductive patch is configured for transmitting a signal from the wireless transceiver via a body of the user using body channel communication to another on-body medical device attached to the user (See [0542-543] teaching how the transceiver communicates with other devices such as sensor pods, watches, phones or second electrodes; this is interpreted to be another on-body medical device attached to the user).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Durand such that it includes a wireless transceiver for transmitting and receiving wireless communications; the electrically conductive patch is electrically connected to the wireless transceiver in the drug delivery device; and the electrically conductive patch is configured for transmitting a signal from the wireless transceiver via a body of the user using body channel communication to another on-body medical device attached to the user as taught by Perez. One of ordinary skill in the art would have been motivated to do so in order to allow for a user to receive communication through a companion device (Perez [0524]) and generate feedback related to the health management application of the specific treatment (Perez [0534]).
Regarding Claim 18, the combination of Durand and Perez teaches all elements of claim 17 as described above. Durand further teaches the method wherein the securing an electrically conductive patch (electrode 22, Fig. 1) over a bottom face of the housing (layer 26 that has electrode 22 on it, Fig.1) of the drug delivery device (system 10, Fig. comprises embedding the electrically conductive patch in an adhesive patch (electrode 22 is embedded in adhesive 30, Fig.1; see [0039]) and securing the adhesive patch to the body of the user (adhesive patch goes on skin; see [0039]).
Regarding Claim 19, the combination of Durand and Perez teaches all elements of claim 17 as described above. Durand further teaches the method wherein the securing an electrically conductive patch (electrode 22, Fig. over a bottom face of the housing (layer 26 that has electrode 22 on it, Fig. 1) of the drug delivery device (system 10, Fig. 1) comprises securing the electrically conductive patch to an adhesive patch (see [0039] teaching electrode 22 is embedded in adhesive 30) and securing the adhesive patch to the body of the user (see [0039] teaching adhesive patch goes on skin).
Claim(s) 2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durand and Perez as applied to claims 1 and 8 above, and further in view of Streit (US 20210393871).
Regarding Claim 2, the combination of Durand and Perez teaches all elements of claim 1 as described above. Durand does not specify the drug delivery device wherein the electrically conductive patch is a sheet of metal.
Streit teaches [0209] that the electrically conductive patch is a sheet of metal (see [0209] "connector members 271a-271d may be stamped out of a metal sheet").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrically conductive patch of Durand to include a sheet of metal as taught by Streit. One of ordinary skill in the art would have been motivated to do since it is beneficial that the metal sheets can bend to form electrical contact [0209] and thereby establish an electrical connection. Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Regarding Claim 11, the combination of Durand and Perez teaches all elements of claim 8 as described above. Durand does not specify the drug delivery device wherein the electrically conductive patch is a sheet of metal.
Streit teaches [0209] that the electrically conductive patch is a sheet of metal (see [0209] "connector members 271a-271d may be stamped out of a metal sheet").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrically conductive patch of Durand to include a sheet of metal as taught by Streit. One of ordinary skill in the art would have been motivated to do since it is beneficial that the metal sheets can bend to form electrical contact [0209] and thereby establish an electrical connection. Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07)
.
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durand and Perez as applied to claims 1 and 8 above, and further in view of Klapper (US 11570891).
Regarding Claim 3, the combination of Durand and Perez teaches all elements of claim 1 as described above. Durand does not specify the drug delivery device wherein the electrically conductive patch is a woven sheet.
Klapper teaches (Col 5 lines 45-59) that the electrically conductive patch is a woven sheet (see Col 5 lines 45-59 teaching conductive element 31, 32 can be a fiber coated in an electrically conductive manner in a woven or knitted fabric).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrically conductive patch of Durand to include a woven sheet as taught by Klapper. One of ordinary skill in the art would have been motivated to do so because composite materials can be used for an electrically conductive element (Klapper Col 5 lines 44-45]). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Regarding Claim 13, the combination of Durand and Perez teaches all elements of claim 8 as described above. Durand does not specify the drug delivery device wherein the electrically conductive patch is a woven sheet.
Klapper teaches (Col 5 lines 45-59) that the electrically conductive patch is a woven sheet (see Col 5 lines 45-59 teaching conductive element 31, 32 can be a fiber coated in an electrically conductive manner in a woven or knitted fabric).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrically conductive patch of Durand to include a woven sheet as taught by Klapper. One of ordinary skill in the art would have been motivated to do so because composite materials can be used for an electrically conductive element (Klapper Col 5 lines 44-45]). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Durand and Perez as applied to claim 17 above, and further in view of Gannon (US 20160183794).
Regarding Claim 20, the combination of Durand and Perez teaches all elements of claim 17 as described above. Durand does not specify the method wherein the creating an electrically conductive surface on the exterior face or the interior face of a housing of the drug delivery device comprises securing a metal foil to the exterior or interior face of the housing.
Gannon teaches of creating an electrically conductive surface on the exterior face or
the interior face of a housing (part of adhesive 20 layer; [0071], Fig.3) of the drug delivery device
comprises securing a metal foil to the exterior or interior face of the housing (see [0071 teaching that the reflector can be made up of a metallized layer or a metal foil layer, and which reflector can be "incorporated at part of the adhesive 20 layer" that or the reflector can be "located between the upper flexible single sided adhesive 20 layer and the temperature sensor 39", Fig.3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrically conductive surface as described by Durand to include that that it comprises a metal foil as taught by Gannon. One of ordinary skill in the art would have been motivated to do so because the metal sheet provides a conductive surface to concentrate the radiated heat from the patient's skin more directly onto the temperature sensor (Gannon [0071]). Additionally, it has been held to be within the level of ordinary skill in the art to select a known material based on its suitability for its intended purpose (see MPEP 2144.07).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 8 and 17 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 7/23/2025.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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