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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 28 January 2026 has been entered.
Response to Amendment
This Office Action is in response to the Applicant’s amendment filed 28 January 2026 wherein Claims 1, 4, 10, and 13 are amended, Claims 3 and 12 are cancelled, and no claims are withdrawn or added. Therefore, Claims 1, 2, 4 – 11, 13 – 19 are currently pending within the Application.
The Applicant’s amendments to the Specification and Drawings dated 28 January 2026 have been fully considered. The Applicant’s amendments to the Specification and Drawings have overcome each Drawing and Specification Objection set forth in the Final Rejection dated 25 September 2025 (hereinafter referred to as the “Final Rejection”). Therefore, each Drawing and Specification Objection set forth in the Final Rejection is withdrawn.
The Applicant’s amendments to the Claims dated 28 January 2026 have been fully considered. The Applicant’s amendments to the Claims have overcome each Claim Rejection under 35 U.S.C. § 112(b) as set forth in the Final Rejection. Therefore, each Claim Rejection under 35 U.S.C. § 112(b) set forth in the Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 11 – 12, filed 28 January 2026, with respect to the rejection(s) of independent claim(s) 1 and 10 and their respective dependent claims under 35 U.S.C. § 103 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 Therefore, the rejection has been withdrawn.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 Aoki et al. (US 2016/0287815 A1) and Duchon et al. (US 2003/0028145 A1).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 5, 9, 10, 13, 14, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aoki et al. (US 2016/0287815 A1) (hereinafter referred to as “Aoki”) and Duchon et al. (US 2003/0028145 A1) (hereinafter referred to as “Duchon”).
With regards to claim 1, Aoki discloses a drug delivery device (see Fig. 1 an [0043]) comprising:
a reservoir (9) (see [0047]) configured to contain a drug (see [0071]) and having a first end (see top end of 9 in Fig. 2) and a second end (see the bottom end of 9 near B in Fig. 2);
a plunger (41) disposed within the reservoir at the first end thereof (see [0073] and Fig. 12), the plunger slidingly movable within the reservoir (see [0076]);
a plunger rod (10) configured to engage the plunger (see [0076]);
a motor (13) (see [0049]) operably coupled to the plunger rod (see [0049] and [0072]) and configured to drive the plunger rod to thereby slide the plunger from the first end of the reservoir to the second end of the reservoir (see [0072] and [0076]);
an encoder (28) (see [0094]) operably coupled to the motor (see [0094] “An encoder 28 that senses position information about the piston 10 is connected to the motor 13”); and
a controller (25, 250) (see [0093] “the CPU 250 of the controller 25” and [0094]) configured for
(i) receiving signals from the encoder (see Fig. 22 and [0094] “An encoder 28 that senses position information about the piston 10 is connected to the motor 13, and outputs pulses corresponding to the rotation of the motor 13 to the CPU 250. The CPU 250 counts the pulses outputted by the encoder 28, and calculates the amount of movement by the piston 10.”), wherein a count of the received signals indicates a current position of the plunger rod and the controller is configured to sample the position of the plunger rod by determining a current count of the signals (see [0094] “the CPU 250 uses the output of the encoder 28 and the output of the origin sensor 23 to recognize the current piston position”);
(ii) determining a position and/or movement of the plunger within the reservoir based on the current count of the received signals (see [0073], [0094], [0116], [0185], [0186], and [0187]), and
(iii) determining whether to stop operation of the motor based on the position and/or movement of the plunger (see [0187] “Once the value is reached, the controller 25 clears the count on the encoder 28 and stops the motor 13 (S417, S418, S419, and S420 in Fig. 22)”).
However, Aoki is silent with regards to the controller being configured to sample the position of the plunger rod at set intervals by determining a current count of the signals.
Nonetheless Duchon, which is within the analogous art of injector systems (see abstract and title), teaches the controller being configured to sample the position of the plunger rod at set intervals by determining a current count of the signals (see [0166] “ for each millimeter of contrast material injected 1,317 counts are received from the encoder 463. As the piston moves during an injection, the embedded processor looks at the current position of the ram or piston every ten milliseconds.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the controller of the drug delivery device of Aoki in view of a teaching of Duchon such that the controller is configured to sample the position of the plunger rod at set intervals by determining a current count of the signals. One of ordinary skill in the art would have been motivated to make this modification because sampling the position of the plunger rod at set intervals by determining a current count of the signals provides for a precise determination of the amount of material injected. See [0166] of Duchon. Here, sampling the position of the plunger rod at set intervals of ten milliseconds by determining a current count of the signals would increase the accuracy, precision, and system reliability of the drug delivery device. The plunger’s position directly controls how much medication is injected. If the plunger’s movement is not tracked closely, small deviations can cause over or under injection. Sampling every ten milliseconds provides high temporal resolution to detect and correct any positional changes in real time.
The drug delivery device of Aoki modified in view of a teaching of Duchon will hereinafter be referred to as the drug delivery device of Aoki and Duchon.
With regards to claim 4, the drug delivery device of Aoki and Duchon teaches the claimed invention of claim 1, and Aoki further teaches wherein the controller (25, 250) (see [0093] “the CPU 250 of the controller 25” and [0094]) determining whether to stop operation of the motor based on the position and/or movement of the plunger (41) further comprises the controller determining whether the signals indicate that the plunger has moved within a predetermined number of samples of the signals (see Fig. 22, [0073], [0094], [0116], [0185], [0186], and [0187] “to determine whether or not the count has reached the injection amount (EP) set as the current injection amount. Once the value is reached, the controller 25 clears the count on the encoder 28 and stops the motor 13 (S417, S418, S419, and S420 in Fig. 22).” Here the predetermined number of samples of the signals is the injection amount (EP) set as the current injection amount.).
With regards to claim 5, the drug delivery device of Aoki and Duchon teaches the claimed invention of claim 4, and Aoki further teaches wherein the controller (25, 250) (see [0093] “the CPU 250 of the controller 25” and [0094]) is configured to compare the current count to an expected endpoint count corresponding to the plunger (41) being driven to the second end of the reservoir (see Fig. 22, [0073], [0094], [0116], [0185], [0186], and [0187] “The controller 25 uses this amount of forward movement to confirm whether or not the pharmaceutical cartridge 9 has been emptied of pharmaceutical, and to determine whether or not the count has reached the injection amount (EP) set as the current injection amount. Once this value is reached, the controller 25 clears the count on the encoder 28 and stops the motor 13 (S417, S418, S419, and S420 in FIG. 22).” When the pharmaceutical cartridge 9 has been emptied of the pharmaceutical then the plunger 41 has been driven to the second end of the reservoir as shown in Fig. 12.).
With regards to claim 9, the drug delivery device of Aoki and Duchon teaches the claimed invention of claim 1, and Aoki further teaches wherein the drug delivery device comprises an autoinjector (see [0178] – [0189] where the injection operation of the drug delivery device is described).
With regards to claim 10, Aoki discloses a method for operating a drug delivery device (see Fig. 1 and [0043]), the method comprising:
receiving signals at a controller (25, 250) (see [0093] “the CPU 250 of the controller 25” and [0094]) from an encoder (28) (see [0094]) coupled to a motor (13) (see [0049]) of the drug delivery device, the motor operably coupled to a plunger rod (10) (see [0049] and [0072]) configured to engage and drive a plunger (41) (see [0073]) within a reservoir (9) (see [0047] and Fig. 12), wherein a count of the received signals indicates a current position of the plunger rod (see Fig. 22 and [0094] “An encoder 28 that senses position information about the piston 10 is connected to the motor 13, and outputs pulses corresponding to the rotation of the motor 13 to the CPU 250. The CPU 250 counts the pulses outputted by the encoder 28, and calculates the amount of movement by the piston 10.”) and the controller is configured to sample the position of the plunger rod by determining a current count of the signals (see [0094] “the CPU 250 uses the output of the encoder 28 and the output of the origin sensor 23 to recognize the current piston position”);
determining, by the controller, a position and/or movement of the plunger within the reservoir based on the current count of the received signals (see [0073], [0094], [0116], [0185], [0186], and [0187]), and
determining, by the controller, whether to stop operation of the motor based on the position and/or movement of the plunger (see [0187] “Once the value is reached, the controller 25 clears the count on the encoder 28 and stops the motor 13 (S417, S418, S419, and S420 in Fig. 22)”).
However, the method of Aoki is silent with regards to the controller being configured to sample the position of the plunger rod at set intervals by determining a current count of the signals.
Nonetheless Duchon, which is within the analogous art of injector systems (see abstract and title), teaches the controller being configured to sample the position of the plunger rod at set intervals by determining a current count of the signals (see [0166] “ for each millimeter of contrast material injected 1,317 counts are received from the encoder 463. As the piston moves during an injection, the embedded processor looks at the current position of the ram or piston every ten milliseconds.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the controller of the drug delivery device of the method of Aoki in view of a teaching of Duchon such that the controller is configured to sample the position of the plunger rod at set intervals by determining a current count of the signals. One of ordinary skill in the art would have been motivated to make this modification because sampling the position of the plunger rod at set intervals by determining a current count of the signals provides for a precise determination of the amount of material injected. See [0166] of Duchon. Here, sampling the position of the plunger rod at set intervals of ten milliseconds by determining a current count of the signals would increase the accuracy, precision, and system reliability of the drug delivery device. The plunger’s position directly controls how much medication is injected. If the plunger’s movement is not tracked closely, small deviations can cause over or under injection. Sampling every ten milliseconds provides high temporal resolution to detect and correct any positional changes in real time.
The method of Aoki modified in view of a teaching of Duchon will hereinafter be referred to as the method of Aoki and Duchon.
With regards to claim 13, the method of Aoki and Duchon teaches the claimed invention of claim 10, and Aoki further teaches wherein determining whether to stop operation of the motor (13) based on the position and/or movement of the plunger (41) comprises determining, by the controller (25, 250) (see [0093] “the CPU 250 of the controller 25” and [0094]), whether the signals indicate that the plunger has moved within a predetermined number of samples of the signals (see Fig. 22, [0073], [0094], [0116], [0185], [0186], and [0187] “to determine whether or not the count has reached the injection amount (EP) set as the current injection amount. Once the value is reached, the controller 25 clears the count on the encoder 28 and stops the motor 13 (S417, S418, S419, and S420 in Fig. 22).” Here the predetermined number of samples of the signals is the injection amount (EP) set as the current injection amount.).
With regards to claim 14, the method of Aoki and Duchon teaches the claimed invention of claim 13, and Aoki further teaches further comprising comparing the current count to an expected endpoint count corresponding to the plunger (41) being driven to a second end of the reservoir (9) (see Fig. 22, [0073], [0094], [0116], [0185], [0186], and [0187] “The controller 25 uses this amount of forward movement to confirm whether or not the pharmaceutical cartridge 9 has been emptied of pharmaceutical, and to determine whether or not the count has reached the injection amount (EP) set as the current injection amount. Once this value is reached, the controller 25 clears the count on the encoder 28 and stops the motor 13 (S417, S418, S419, and S420 in FIG. 22).” When the pharmaceutical cartridge 9 has been emptied of the pharmaceutical then the plunger 41 has been driven to the second end of the reservoir as shown in Fig. 12.).
With regards to claim 18, the method of Aoki and Duchon teaches the claimed invention of claim 10, and Aoki further teaches wherein the drug delivery device comprises an autoinjector (see [0178] – [0189] where the injection operation of the drug delivery device is described).
Claim(s) 2, 8, 11, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aoki and Duchon as applied to claims 1 and 10 above, and further in view of Jennings et al. (US 2013/0274655 A1) (hereinafter referred to as “Jennings”).
With regards to claim 2, the drug delivery device of Aoki and Duchon teaches the claimed invention of claim 1, however, Aoki is silent with regards to wherein the encoder includes a disk having one or more discernible portions and an optical sensor configured to detect the one or more discernible portions and send a signal in response to the detection.
Nonetheless Jennings, which is within the analogous art of auto-injectors (see abstract and title), teaches (Figs. 1A – 1B and 9A – 9B) wherein the encoder (3.12; see [0105] “An encoder sensor 3.12”) includes a disk (“wheel”; see [0036] “The encoder sensor may be arranged as a slotted encoder wheel” and Claim 24) having one or more discernible portions (slots in the slotted encoder wheel) and an optical sensor (sensor of an optical coupler”; see [0036] and Claim 24) configured to detect the one or more discernible portions and send a signal in response to the detection (see [0035] – [0036], [0105], and Claim 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the encoder of the drug delivery device of Aoki and Duchon in view of a teaching of Jennings such that the encoder includes a disk having one or more discernible portions and an optical sensor configured to detect the one or more discernible portions and send a signal in response to the detection. One of ordinary skill in the art would have been motivated to make this modification because Aoki does not describe the structure of the encoder 28. Therefore, a person having ordinary skill in the art would refer to the teaching of Jennings to determine a structure of an encoder. See [0035], [0036], [0105], and Claim 24 of Jennings. Here, Jennings teaches that it is well known to use an encoder includes a disk having one or more discernible portions and an optical sensor configured to detect the one or more discernible portions and send a signal in response to the detection to track the displacement of a plunger. See [0035], [0036], [0105], and Claim 24 of Jennings.
With regards to claim 8, the drug delivery device of Aoki and Duchon teaches the claimed invention of claim 1, however, Aoki is silent with regards to the drug delivery device further comprising a needle and a needle insertion mechanism, and wherein the controller is configured for causing the needle insertion mechanism to retract the needle in response to determining to stop operation of the motor.
Nonetheless Jennings, which is within the analogous art of auto-injectors (see abstract and title), teaches (Figs. 1A – 1B and 9A – 9B) the drug delivery device further comprising a needle (2.2; see [0069] “an injection needle 2.2”) and a needle insertion mechanism (see [0095] “such as activating and de-activating the electric motor 3.5 that axially translates the plunger 3.2 to insert and/or retract the injection needle 2.2” and [0104] – [0105]) wherein the controller (3.11; see [0103] “An electric control unit 3.11”) is configured for causing the needle insertion mechanism to retract the needle in response to determining to stop operation of the motor (see [0034], [0095], [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of Aoki and Duchon in view of a teaching of Jennings such that the drug delivery device further comprising a needle and a needle insertion mechanism, and wherein the controller is configured for causing the needle insertion mechanism to retract the needle in response to determining to stop operation of the motor. One of ordinary skill in the art would have been motivated to make this modification because Jennings teaches that including a needle, needle insertion mechanism, and needle retraction mechanism reduces the risk of an accidental needle stick. See [0032], [0070], and [0102] of Jennings.
With regards to claim 11, the method of Aoki and Duchon teaches the claimed invention of claim 10, however, Aoki is silent with regards to the method further comprising detecting a discernible portion of a disk of the encoder with an optical sensor; and sending a signal in response to the detection.
Nonetheless Jennings, which is within the analogous art of auto-injectors (see abstract and title), further teaches that the method further comprises:
detecting a discernible portion (slots in the slotted encoder wheel) of a disk (“wheel”; s see [0036] “The encoder sensor may be arranged as a slotted encoder wheel” and Claim 24) of the encoder (3.12; see [0105] “An encoder sensor 3.12”) with an optical sensor (“sensor of an optical coupler”; see [0036] and Claim 24); and
sending a signal in response to the detection (see [0035] – [0036], [0105] and Claim 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the encoder of the drug delivery device of the method of Aoki and Duchon in view of a teaching of Jennings such that the method further comprising detecting a discernible portion of a disk of the encoder with an optical sensor; and sending a signal in response to the detection. One of ordinary skill in the art would have been motivated to make this modification because Aoki does not describe the structure of the encoder 28. Therefore, a person having ordinary skill in the art would refer to the teaching of Jennings to determine a structure of an encoder. See [0035], [0036], [0105], and Claim 24 of Jennings. Here, Jennings teaches that it is well known to use an encoder includes a disk having one or more discernible portions and an optical sensor configured to detect the one or more discernible portions and send a signal in response to the detection to track the displacement of a plunger. See [0035], [0036], [0105], and Claim 24 of Jennings.
With regards to claim 17, the method of Aoki and Duchon teaches the claimed invention of claim 10, however, Aoki is silent with regards to the method further comprising retracting a needle of the drug delivery device with a needle insertion mechanism in response to the controller determining to stop operation of the motor.
Nonetheless Jennings, which is within the analogous art of auto-injectors (see abstract and title), further teaches (Figs. 1A – 1B and 9A – 9B) that the method further comprises retracting a needle (2.2; see [0069] “an injection needle 2.2”) of the drug delivery device (A; see [0094] “Figures 9A and 9B show sectional views of the assembled auto-injector A”) with a needle insertion mechanism (see [0095] “such as activating and de-activating the electric motor 3.5 that axially translates the plunger 3.2 to insert and/or retract the injection needle 2.2” and [0104] – [0105]) in response to the controller (3.11; see [0103] “An electric control unit 3.11”) determining to stop operation of the motor (see [0034], [0095], and [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug delivery device of the method of Aoki and Duchon in view of a teaching of Jennings such that the method further comprising retracting a needle of the drug delivery device with a needle insertion mechanism in response to the controller determining to stop operation of the motor. One of ordinary skill in the art would have been motivated to make this modification because Jennings teaches that including a needle, needle insertion mechanism, and needle retraction mechanism reduces the risk of an accidental needle stick. See [0032], [0070], and [0102] of Jennings.
Claim(s) 6, 7, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aoki and Duchon as applied to claims 5 and 14 above, and further in view of Hanson et al. (US 2011/0160666 A1) (hereinafter referred to as “Hanson”).
With regards to claim 6, the drug delivery device of Aoki and Duchon teaches the claimed invention of claim 5, however, Aoki is silent with regards to wherein the controller is configured to revise the predetermined number of samples of the signals in response to determining that the current count is less than the expected endpoint count.
Nonetheless Hanson, which is within the analogous art of engagement and sensing systems and methods (see abstract), teaches the controller (422; see [0159] “the processor 422 (or the circuitry 420)”) is configured to revise the predetermined number of samples of the signals (pre-stored values; see [0140], [0147] and see [0172] which discusses the adjusting or compensating of the measurements in response to output shift) in response to determining that the current count (current signal showing the location of the plunger 165, see [0160] – [0163]) is less than the expected endpoint count (expected amount of movement of the plunger 165, see [0160] – [0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the controller of the drug delivery device of Aoki and Duchon in view of a further teaching of Hanson such that the controller is configured to revise the predetermined number of samples of the signals in response to determining that the current count is less than the expected endpoint count. One of ordinary skill in the art would have been motivated to make this modification because Hanson teaches the measurements can be adjusted or otherwise compensated to correct output shift of the sensor caused by environmental conditions (see [0172] of Hanson).
With regards to claim 7, the drug delivery device of Aoki and Duchon teaches the claimed invention of claim 5, however, Aoki is silent with regards to wherein the controller is configured to determine that the plunger has stalled in response to determining that the current count is less than the expected endpoint count.
Nonetheless Hanson, which is within the analogous art of engagement and sensing systems and methods (see abstract), further teaches the controller (422; see [0159] “the processor 422 (or the circuitry 420)”) is configured to determine that the plunger (165; see [0116] “a plunger arm 160 (e.g., FIG. 7) having a plunger head 165”) has stalled in response to determining that the current count (current signal showing the location of the plunger 165, see [0160] “such a condition may result if the motor 184 is not moved (an expected amount, if at all)”, [0161], [0162], and [0163] wherein if the motor is stalled so too is the plunger) is less than the expected endpoint count (expected amount of movement of the plunger 165, see [0160] – [0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the controller of the drug delivery device of Aoki and Duchon in view of a further teaching of Hanson such that the controller is configured to determine that the plunger has stalled in response to determining that the current count is less than the expected endpoint count. One of ordinary skill in the art would have been motivated to make this modification because Hanson further teaches that the controller is capable of determining if a malfunction of the motor has occurred (see [0161] of Hanson).
With regards to claim 15, the method of Aoki and Duchon teaches the claimed invention of Claim 14, however, Aoki is silent with regards to the method further comprising revising, by the controller, the predetermined number of samples of the signals in response to determining that the current count is less than the expected endpoint count.
Nonetheless Hanson, which is within the analogous art of engagement and sensing systems and methods (see abstract), further teaches the method further comprising revising, by the controller (422) (see [0140]), the predetermined number of samples of the signals (pre-stored values; see [0140], [0147] and see [0172] which discusses the adjusting or compensating of the measurements in response to output shift) in response to determining that the current count (current signal showing the location of the plunger 165, see [0160] – [0163]) is less than the expected endpoint count (expected amount of movement of the plunger 165, see [0160] – [0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Aoki and Duchon in view of a further teaching of Hanson such that the method further comprising revising, by the controller, the predetermined number of samples of the signals in response to determining that the current count is less than the expected endpoint count. One of ordinary skill in the art would have been motivated to make this modification because Hanson teaches the measurements can be adjusted or otherwise compensated to correct output shift of the sensor caused by environmental conditions (see [0172] of Hanson).
With regards to claim 16, the method of Aoki and Duchon teaches the claimed invention of Claim 14, however, Aoki is silent with regards to the method further comprising determining, by the controller, that the plunger has stalled before being driven to the second end of the reservoir in response to determining that the current count is less than the expected endpoint count.
Nonetheless Hanson, which is within the analogous art of engagement and sensing systems and methods (see abstract), determining, by the controller (422)(see [0140]) that the plunger (165; see [0116] “a plunger arm 160 (e.g., FIG. 7) having a plunger head 165”) has stalled before being driven to the second end of the reservoir (40; see [0074] “a reservoir system 40”) in response to determining that the current count (current signal showing the location of the plunger 165, see [0160] “such a condition may result if the motor 184 is not moved (an expected amount, if at all)”, [0161], [0162], and [0163] wherein if the motor is stalled then so too is the plunger) is less than the expected endpoint count (expected amount of movement of the plunger 165, see [0160] – [0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the method of Aoki and Duchon in view of a further teaching of Hanson such that the method further comprising determining, by the controller, that the plunger has stalled before being driven to the second end of the reservoir in response to determining that the current count is less than the expected endpoint count. One of ordinary skill in the art would have been motivated to make this modification because Hanson further teaches that the controller is capable of determining if a malfunction of the motor has occurred (see [0161] of Hanson).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aoki and Duchon as applied to claim 1 above, and further in view of Denzer et al. (US 2015/0045729 A1; hereinafter referred to as “Denzer”).
With regards to claim 19, the drug delivery device of Aoki and Duchon teaches the claimed invention of claim 1, and Aoki further teaches the drug delivery device further comprising a drug (see [0071]) in the reservoir (9).
However, Aoki is silent with regards to the drug comprises etanercept.
Nonetheless Denzer, which is within the analogous art of autoinjector apparatuses (see abstract), teaches a drug in the reservoir, wherein the drug comprises etanercept (see [0120] “the syringe 260 of the cassette 200 may also be prefilled with other products. Examples of other pharmaceutical products that may be used may comprise, but are not limited to, therapeutics such as a biological (e.g., Enbrel® (etanercept…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the drug within the reservoir of the drug delivery device of Aoki and Duchon in view of a teaching of Denzer such that the drug comprises etanercept. One of ordinary skill in the art would have been motivated to make this modification because Denzer teaches that other products such as etanercept may be prefilled within the cassette of the syringe in order to treat a variety of diseases or disorders (see [0120] of Denzer).
Conclusion
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/15/2026
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