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 .
Response to Amendment
This office action is responsive to the amendment filed 16 December 2025. As directed by the amendment: claim 4 is cancelled. Claims 1-3, 5-7, 13-16 and 20-26 are presently pending.
Response to Arguments
Applicant’s arguments with respect to claim(s) 4-5 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.
Applicant’s arguments, see pages 8-9, filed 16 December 2025, with respect to the rejection(s) of claim(s) 13-16 and 20-26 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Novo Nordisk A/S (WO 2006/067217) and Amgen Inc. (WO 2019/089178).
Claim Rejections - 35 USC § 102
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.
Claim(s) 20-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Novo Nordisk A/S (hereinafter “Nordisk”, WO 2006/067217).
Regarding claim 20, Nordisk discloses a drug delivery device (Fig. 10, 100) comprising:
a hub operably coupled to a needle insertion mechanism (Fig. 10, 140, where 140 is connected to a cannula for insertion to a patient);
a drug delivery member (110) fixed to the hub and having a proximal opening and a distal opening (Fig. 10, where the transcutaneous device has a distal opening allowing fluid to flow out and a proximal end associated with 140), the proximal opening disposed within the hub and in communication with the distal opening (Fig. 10, where 110 is associated with the hub and has an L-shape for interaction with the patient);
a light source oriented to project light through the hub, into the proximal opening of the drug delivery member, out of the distal opening of the drug delivery member, and into the tissue of a patient with the drug delivery member in an injection position (p. 7, lines 1-17 & p. 20, lines 10-20, where the light source can be in multiple locations including but not limited to the cannula and the reservoir, this would include 140 and can project light through 140);
a photodiode oriented to receive light radiating through the tissue of the patient adjacent to the drug delivery member when the drug delivery member is in the injection position; and a controller in communication with the photodiode to receive data associated with the light received (p. 7, lines 1-17 & p. 20, lines 10-20, where the light source can be in multiple locations including but not limited to the cannula and the reservoir, this would include 140 and can project light through 140).
Regarding claim 21, Nordisk discloses the drug delivery device of claim 20, wherein the controller is configured to correlate the data to a depth that the drug delivery member has been inserted into the tissue of the patient (Pg. 7, lines 11-17).
Regarding claim 22, Nordisk discloses he drug delivery device of claim 20, further comprising:
a housing (Fig. 1, 20, where figures 9-15 show another view of the device, but still have technical features of figures 1-9);
a primary container disposed within the housing (Fig. 10, 142); and
a flow path fluidly coupling the primary container to the drug delivery member (Fig. 10, 141);
wherein the drug delivery member extends through the hub, the drug delivery member including a bend disposed within the hub with the proximal opening extending therethrough and a distal end extending from the bend through a bottom surface of the hub (Fig. 10, where 110 has an L-Shape and is contained within the overall hub 140 and the bend extends after towards a distal end of 110).
Regarding claim 23, The drug delivery device of claim 20, further comprising:
a housing (Fig. 1, 20, where figures 9-15 show another view of the device, but still have technical features of figures 1-9);
a primary container disposed within the housing (Fig. 10, 142);
a flow path fluidly coupled to the primary container (Fig. 10, 141); and
an inlet conduit mounted to hub (Fig. 10, where the proximal end of 110 has at least a portion that is connected to the hub);
wherein the hub includes an internal cavity, the inlet conduit fluidly couples the flow path to the internal cavity of the hub, and the drug delivery member extends from the internal cavity through a bottom surface of the hub, the proximal opening of the drug delivery member fluidly coupling the drug delivery member to the internal cavity (Fig. 10, where the fluid path 141 is connected to the proximal connection portion of 110 and is associated with a cavity like space that exists within the pathway 141 and the overall hub 140)
Regarding claim 24, Nordisk discloses he drug delivery device of claim 22, wherein the photodiode is mounted to an upper surface of the hub (Pg. 7, lines 11-17 and Pg. 20, lines 16-20).
Regarding claim 25, Nordisk discloses he drug delivery device of claim 22, wherein the photodiode is mounted to a bottom wall of the housing adjacent to a drug delivery member opening extending therethrough (Pg. 7, lines 11-17 and Pg. 20, lines 16-20).
Regarding claim 26, Nordisk discloses he drug delivery device of claim 20, further comprising a primary container (Fig. 10, 141), and wherein the drug delivery member comprises a needle (Fig. 10, where the transcutaneous member 110 can have a needle associated with it), the hub is fixedly mounted to a distal end of the primary container (Fig. 10, 140, 141), the light source comprises an array of light sources carried by the hub; and the photodiode comprises an array of photodiodes extending around and adjacent to the distal end of the primary container, the array of light sources and the array of photodiodes being non-aligned to provide generally unobstructed paths toward a distal end of the needle (Pg. 7, lines 11-17).
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) 1-3, 5-7, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Amgen Inc. (hereinafter “Amgen”, WO 2019/089178) in view of Novo Nordisk A/S (hereinafter “Nordisk”, WO 2006/067217) and Cefai et al. (US 2011/0316562).
Regarding claim 1, Amgen discloses a drug delivery device (Fig. 1-7, 50, 600) comprising:
a housing (52, 610);
a primary container (62, 612) disposed within the housing;
a drug delivery member (54, 614) fluidly coupled to the primary container, the drug delivery member movable between a retracted position disposed in the housing and an injection position at least partly extending out of the housing (¶[0039]);
a wire having a first end and a second end, the second end electrically connected at a connection point adjacent to the drug delivery member, the connection point fixed against movement relative to the housing (¶[0041], [0062], where the connection of 54 can include a wire with a first and second end that allows for movement of the injection portion during operation); and
a controller (60, 660) in communication with the first end of the wire, the controller configured to receive from the wire capacitance information associated with the drug delivery member in the injection position (¶[0043], [0072]).
Amgen does not specifically discloses further comprising a pair of capacitor plates disposed entirely within the housing and spaced from the drug delivery member, the drug delivery member extending between the pair of capacitor plates; and wherein the connection point is located on the pair of capacitor plates, and the controller is in communication with the capacitor plates to receive capacitance information associated with the drug delivery member in the injection position.
Nordisk teaches a skin mountable device that utilizes a controller and sensors with a retraction and insertion mechanism. Nordisk teaches further comprising a pair of capacitor plates disposed within the housing and spaced from the drug delivery member (Fig. 10, 120), the drug delivery member extending between the pair of capacitor plates (pg. 11, line 27-pg. 13, lines 27); and wherein the connection point is located on the pair of capacitor plates, and the controller is in communication with the capacitor plates to receive capacitance information associated with the drug delivery member in the injection position (pg. 11, line 27-pg. 13, line 27, where the capacitor plates 120 and the “second” plate are located within the housing are in communication with a connection point to communicate with a controller).
Cefai teaches at least two capacitor plates spaced apart within a housing for the detection of displacement (¶[0020]). This modification would be advantageous as it allows the capacitor plates to be stationary which simplifies and makes the transducer more robust while improving signal output reliability (¶[0020]). By combining Nordisk and Cefai with Amgen it would allow for two capacitor plates for detection to be used within a housing that do not need to contact each other and also leave room for the drug delivery member.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the device of Amgen to include a pair of capacitor plates that are in communication with the controller because modifying the device of Amgen to include a pair of capacitor plates that connect with a controller would allow the device to more accurately determine the position and proper placement of the device (pg. 11, line 27-pg. 13, line 27 from Nordisk & ¶[0020] from Cefai).
Regarding claim 2, Amgen discloses the drug delivery device of claim 1, wherein the controller is further configured to correlate the capacitance information to a depth that the drug delivery member has been inserted into a patient (¶[0043], [0072], where the controller 60 is configured to measure impedance, resistance or capacitance values based on the depth of insertion).
Regarding claim 3, Amgen discloses the drug delivery device of claim 1, further comprising a needle insertion mechanism (Fig. 2, 56); and
wherein the drug delivery member has an elongate configuration with a proximal end extending from the primary container and being fixed against movement with respect to the housing, an intermediate bend, and a distal end, the needle insertion mechanism configured to move at least a portion of the distal end between the retracted position and the injection position (Fig. 2, 54, 56, ¶[0039], where the insertion portion has a proximal end within the housing and a distal end for insertion, 54 also has an intermediate bend as shown in Figure 2. As stated in para. 0039 there is a retracted state and an inserted state for the injection portion of the device).
Regarding claim 5, Amgen, Nordisk and Cefai teach the drug delivery device of claim 1, Nordisk further teaches further comprising one or more dielectric members disposed between the capacitor plates and the drug delivery member, the one or more dielectric members spaced outwardly from the drug delivery member (pg. 11, line 27-pg. 12, line 12 from Nordisk & ¶[0020] from Cefai).
Regarding claim 6, Amgen discloses the drug delivery device of claim 1, wherein the drug delivery member comprises a cannula having a conductive portion (¶[0041], [0062], where the cannula 54 has a conductive portion and the connection point within the housing is near the cannula 54 which has the conductive property).
Regarding claim 7, Amgen discloses the drug delivery device of claim 6, wherein the conductive portion of the cannula comprises a conductive coating extending over at least a portion of an outer surface of the cannula (¶[0041], [0062], where the cannula 54 has a conductive coating that can be used).
Regarding claim 13, Amgen discloses a drug delivery device (Fig. 1-7, 50, 600) comprising:
a housing (52, 610);
a hub movably (150) disposed within the housing;
a drug delivery member (54, 614) having a portion extending through and connected to the hub (Fig. 2, where 54 extends through and is connected to 150);
a needle insertion mechanism (56) operably coupled to the hub and configured to move the hub to drive the drug delivery member between a retracted position disposed in the housing and an injection position at least partly extending out of the housing (¶[0039], where there is a retracted and injection position that operates through 56 with controller 60);
a wire with a first end and a second end, at least a portion of the second end of the wire fixed to the hub and electrically connected to the portion of the drug delivery member extending through the hub (¶[0041], [0062], where the connection of 54 can include a wire with a first and second end that allows for movement of the injection portion during operation); and
a controller (60, 66) in communication with the wire to receive capacitance information associated with the drug delivery member in the injection position (¶[0043], [0072]).
Regarding claim 14, Amgen discloses he drug delivery device of claim 13, wherein the controller is configured to correlate the capacitance information to a depth that the drug delivery member has been inserted into a patient (¶[0043], [0072], where the controller 60 is configured to measure impedance, resistance or capacitance values based on the depth of insertion).
Regarding claim 15, Amgen discloses he drug delivery device of claim 13, wherein the drug delivery member comprises a cannula having a conductive portion and the wire is electrically connected to the conductive portion of the cannula (¶[0041], [0062], where the cannula 54 has a conductive portion where a wire used to electrically connect the cannula 54 for the circuit used).
Regarding claim 16, Amgen discloses he drug delivery device of claim 15, wherein the conductive portion of the cannula comprises a conductive coating extending over at least a portion of an outer surface of the cannula (¶[0041], [0062], where the cannula 54 has a conductive coating).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783