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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/30/2025 has been entered.
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 1-6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Harrington (USPGPub 2021/0069427) in view of Uber et al. (USPGPub 2017/0165427).
Re Claim 1, Harrington teaches a drug delivery device (1, 2, 3) (Harrington Fig. 1) comprising: a housing (30) comprising a window (32) (Harrington ¶ 0043); and a syringe (11, 40a, 40b) contained in the housing (30) (Harrington Fig. 1; ¶ 0046), the syringe (11, 40a, 40b) comprising: a container (40a, 40b) containing a liquid medicament, the container (40a, 40b) comprising an aperture (12) at a distal end thereof and through which the liquid medicament can be dispensed (Harrington ¶ 0046); a stopper (43a, 43b) within the container (40a, 40b) (Harrington ¶ 0058), the stopper (43a, 43b) moveable between a first longitudinal position and a second longitudinal position relative to the container (40a, 40b) to cause dispensing of the liquid medicament through the aperture (12) (Harrington ¶ 0058). However, Harrington fails to teach at least one identifier identifying the liquid medicament, the at least one identifier arranged on a circumferential surface of the stopper and visible through the window.
Uber teaches a syringe (200) comprising at least one identifier (210, 220) for identifying a liquid medicament (Uber ¶ 0054, 0057), the at least one identifier (210, 220) arranged on a circumferential surface of the stopper (204) (Uber ¶ 0054-0057), the configuration for properly identifying syringe contents and other identifying information about the syringe, such as instructions for using the syringe (Uber ¶ 0016). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the syringe barrel of Harrington include at least one identifier identifying the liquid medicament, the at least one identifier arranged on a circumferential surface of the stopper as disclosed by Uber, the configuration for properly identifying syringe contents and other identifying information about the syringe, such as instructions for using the syringe (Uber ¶ 0016). Such a modification of Harrington would result in the identifier, as disclosed by Uber, being visible in the window (32) of Harrington for properly identifying syringe contents and other identifying information about the syringe, such as instructions for using the syringe (Uber ¶ 0016). Furthermore, Harrington encourages a user of the device to inspect the cartridge contents through the window (32) (Harrington ¶ 0043).
Re Claim 2, Harrington in view of Uber teach all of the limitations of Claim 1. Harrington fails to teach wherein the at least one identifier is arranged at a distal end of the syringe. It is noted here that the identifier in Uber is arranged on a circumferential surface of the stopper (Uber ¶ 0054-0057). Therefore, as the stopper is depressed within the syringe, the at least one identifier (210, 220) is arranged at a distal end of the syringe (220), the configuration for properly identifying syringe contents and other identifying information about the syringe, such as instructions for using the syringe (Uber ¶ 0016). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the at least one identifier of Harrington in view of Uber be arranged at the distal end of the syringe as disclosed by Uber, wherein the at least one identifier being arranged on the stopper naturally would result in the identifier being arranged at a distal end of the syringe as disclosed by Uber, wherein the identifier configured to be on a circumferential surface of the stopper is for properly identifying syringe contents and other identifying information about the syringe, such as instructions for using the syringe (Uber ¶ 0016).
Re Claims 3 and 4, Harrington in view of Uber teach all of the limitations of Claim 1. Harrington further teaches wherein the syringe (11, 40a, 40b) further comprises a needle shield (20) comprising a hole (22) through which the liquid medicament is to be dispensed (Harrington Figs. 1 and 20-21 - wherein needle shield 20 has a bore 22 therethrough which accommodates needle 12), wherein the outer surface of the needle shield comprises a front face (21), and wherein the hole (22) is arranged on the front face (21) (as seen below in Harrington Annotated Fig. 21; ¶ 0047).
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Re Claim 5, Harrington in view of Uber teach all of the limitations of Claim 1. Harrington fails to teach wherein the at least one identifier comprises a printed surface. Uber teaches the at least one identifier (210, 220) comprising a printed surface for a user to identify the concentration of the medicament or a characteristic of the syringe (Uber ¶ 0052, 0054, 0057). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the at least one identifier of Harrington in view of Uber to comprise a printed surface as disclosed by Uber for a user to identify the concentration of the medicament or a characteristic of the syringe (Uber ¶ 0052, 0054, 0057). Furthermore, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill. KSR Int'l Co. V. Teleflex, Inc., 550 U.S. 398 (2007). In the present case, the technique of printing to a surface is well within the ordinary skill of the art based on the teachings of Uber (Uber ¶ 0052, 0054, 0057).
Re Claim 6, Harrington in view of Uber teach all of the limitations of Claim 1. Harrington fails to teach wherein the at least one identifier comprises a laser marked surface. Uber teaches the at least one identifier (210, 220) comprising a laser marked surface for a user to identify the concentration of the medicament or a characteristic of the syringe (Uber ¶ 0054). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the at least one identifier of Harrington in view of Uber to comprise a laser marked surface as disclosed by Uber for a user to identify the concentration of the medicament or a characteristic of the syringe (Uber ¶ 0054). Furthermore, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill. KSR Int'l Co. V. Teleflex, Inc., 550 U.S. 398 (2007). In the present case, the technique of laser marking a surface is well within the ordinary skill of the art based on the teachings of Uber (Uber ¶ 0054).
Re Claim 15, Harrington teaches a method comprising: disposing a syringe (11, 40a, 40b) in a housing (30) of a drug delivery device (1, 2, 3) (Harrington Fig. 1), the syringe (11, 40a, 40b) comprising a container (40a, 40b) containing a liquid medicament, the container (40a, 40b) comprising an aperture (12) at a distal end thereof and through which the liquid medicament can be dispensed (Harrington ¶ 0046), and a stopper (43a, 43b) within the container (40a, 40b), the stopper (43a, 43b) moveable between a first longitudinal position and a second longitudinal position relative to the container (40a, 40b) to cause dispensing of the liquid medicament through the aperture (12) (Harrington ¶ 0058), and the housing (30) further comprising a window (32) (Harrington ¶ 0043). However, Harrington fails to teach at least one identifier identifying the liquid medicament, the at least one identifier arranged on a circumferential surface of the stopper and visible through the window.
Uber teaches a syringe (200) comprising at least one identifier (210, 220) for identifying a liquid medicament (Uber ¶ 0054, 0057), the at least one identifier (210, 220) arranged on a circumferential surface of the stopper (204) (Uber ¶ 0054-0057), the configuration for properly identifying syringe contents and other identifying information about the syringe, such as instructions for using the syringe (Uber ¶ 0016). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the syringe barrel of Harrington include at least one identifier identifying the liquid medicament, the at least one identifier arranged on a circumferential surface of the stopper as disclosed by Uber, the configuration for properly identifying syringe contents and other identifying information about the syringe, such as instructions for using the syringe (Uber ¶ 0016). Such a modification of Harrington would result in the identifier, as disclosed by Uber, being visible in the window (32) of Harrington for properly identifying syringe contents and other identifying information about the syringe, such as instructions for using the syringe (Uber ¶ 0016). Furthermore, Harrington encourages a user of the device to inspect the cartridge contents through the window (32) (Harrington ¶ 0043).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Harrington (USPGPub 2021/0069427) in view of Uber et al. (USPGPub 2017/0165427) as applied to Claims 1 or 15 respectively above, and further in view of Sharp et al. (USPGPub 2007/0088285).
Re Claims 21 and 22, Harrington in view of Uber teach all of the limitations of Claims 1 and 15 respectively. Harrington in view of Uber fail to teach wherein the at least one identifier is positioned between at least two sealing surfaces of the stopper. Sharp teaches a stopper (50) (Sharp Fig. 8) having at least two sealing surfaces, one at a distal most surface of the stopper and the other at a proximal most surface of the stopper (as seen in Sharp Fig. 8), the two sealing surfaces for aligning the stopper with markings on the syringe (Sharp ¶ 0004). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the stopper of Harrington in view of Uber to have at least two sealing surfaces at a proximal end and distal end of the stopper as disclosed by Sharp for aligning the stopper with markings on the syringe (Sharp ¶ 0004). Furthermore, where the stopper of Harrington in view of Uber is modified as such, the at least one identifier of Harrington in view of Uber would be positioned between the at least two sealing surfaces of the stopper where the at least two sealing surfaces are arranged at a distal most and proximal most surface of the stopper (as seen in Sharp Fig. 8).
Response to Arguments
Applicant’s arguments with respect to Claims 1-6, 15 and 21-22 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. Examiner concedes that the prior art in the rejection dated 05/30/2025 fails to teach “at least one identifier identifying the liquid medicament, the at least one identifier arranged on a circumferential surface of the stopper and visible through the window.” To obviate said limitation, examiner now relies upon secondary reference Uber.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783