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.
Claims 1-5, 15 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over
Harrington (USPGPub 2021/0069427) in view of Pommereau et al. (USPGPub 2012/0268741) above, and further in view of Sudo (USPGPub 2013/0316110).
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 the stopper comprising at least one identifier identifying the liquid medicament, the at least one identifier arranged on a circumferential surface of the stopper, readable from the stopper, and visible through the window. Pommereau teaches a syringe (1) comprising a stopper (4) (Pommereau ¶ 0057; Fig. 1), wherein the stopper (4) comprises at least one identifier (6.1) (Pommereau Fig. 2), the at least one identifier (6.1) arranged on a circumferential surface of the stopper (4) and readable from the stopper (4) (Pommereau ¶ 0058), the configuration for detecting a longitudinal position of the visual marker such that a remaining quantity of the medicament in the syringe can be calculated for a given geometry of the syringe and a given longitudinal position of the identifier (Pommereau ¶ 0058).
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 stopper of Harrington comprise at least one identifier identifying the liquid medicament, the at least one identifier arranged on a circumferential surface of the stopper and readable from the stopper, as disclosed by Pommereau, the configuration for detecting a longitudinal position of the visual marker such that a remaining quantity of the medicament in the syringe can be calculated for a given geometry of the syringe and a given longitudinal position of the identifier (Pommereau ¶ 0058).
Harrington in view of Pommereau fail to teach the at least one identifier identifying the liquid medicament. Sudo teaches a stopper (1) with at least one identifier (4) identifying a liquid medicament for preventing fatal medical errors (Sudo ¶ 0029). 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 Pommereau identify a liquid medicament as disclosed by Sudo for preventing fatal medical errors (Sudo ¶ 0029). Such a modification of Harrington would result in the identifier of Pommereau above and further in view of Sudo being visible in the window (32) of Harrington for properly identifying syringe contents and other identifying information about the syringe (Sudo ¶ 0029). 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 Pommereau above and further in view of Sudo 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 Pommereau is arranged on a circumferential surface of the stopper (Pommereau ¶ 0058). Therefore, as the stopper is depressed within the syringe, the at least one identifier (6.1) is arranged at a distal end of the syringe (1), the configuration for detecting a longitudinal position of the visual marker such that a remaining quantity of the medicament in the syringe can be calculated for a given geometry of the syringe and a given longitudinal position of the identifier (Pommereau ¶ 0058). 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 Pommereau above, and further in view of Sudo be arranged at the distal end of the syringe as disclosed by Pommereau, 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 Pommereau, wherein the identifier is configured to be on a circumferential surface of the stopper for detecting a longitudinal position of the visual marker such that a remaining quantity of the medicament in the syringe can be calculated for a given geometry of the syringe and a given longitudinal position of the identifier (Pommereau ¶ 0058).
Re Claims 3 and 4, Harrington in view of Pommereau above, and further in view of Sudo 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 Pommereau above, and further in view of Sudo teach all of the limitations of Claim 1. Harrington fails to teach wherein the at least one identifier comprises a printed surface. Pommereau teaches the at least one identifier (6.1) comprising a printed surface (Pommereau ¶ 0061). Where 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 Pommereau (Pommereau ¶ 0061). 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 Pommereau above, and further in view of Sudo to comprise a printed surface as disclosed by Pommereau where the technique of printing to a surface is well within the ordinary skill of the art based on the teachings of Pommereau (Pommereau ¶ 0061; see also KSR Int'l Co. V. Teleflex, Inc., 550 U.S. 398 (2007)).
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 the syringe comprising at least one identifier identifying the liquid medicament contained in the container such that an entirety of the at least one identifier is arranged on a circumferential surface of the stopper and visible through a window of the housing. Pommereau teaches a syringe (1) comprising a stopper (4) (Pommereau ¶ 0057; Fig. 1), wherein the stopper (4) comprises at least one identifier (6.1) (Pommereau Fig. 2) such that an entirety of the at least one identifier (6.1) is arranged on a circumferential surface of the stopper (4) (Pommereau ¶ 0058), the configuration for detecting a longitudinal position of the visual marker such that a remaining quantity of the medicament in the syringe can be calculated for a given geometry of the syringe and a given longitudinal position of the identifier (Pommereau ¶ 0058).
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 stopper of Harrington comprise at least one identifier such that an entirety of the at least one identifier is arranged on a circumferential surface of the stopper as disclosed by Pommereau for detecting a longitudinal position of the visual marker such that a remaining quantity of the medicament in the syringe can be calculated for a given geometry of the syringe and a given longitudinal position of the identifier (Pommereau ¶ 0058).
Harrington in view of Pommereau fail to teach the at least one identifier identifying the liquid medicament. Sudo teaches a stopper (1) with at least one identifier (4) identifying a liquid medicament for preventing fatal medical errors (Sudo ¶ 0029). 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 Pommereau identify a liquid medicament as disclosed by Sudo for preventing fatal medical errors (Sudo ¶ 0029). Such a modification of Harrington would result in the identifier of Pommereau above and further in view of Sudo being visible in the window (32) of Harrington for properly identifying syringe contents and other identifying information about the syringe (Sudo ¶ 0029). Furthermore, Harrington encourages a user of the device to inspect the cartridge contents through the window (32) (Harrington ¶ 0043).
Re Claims 21 and 22, Harrington in view of Pommereau above, and further in view of Sudo teach all of the limitations of Claims 1 and 15 respectively. Harrington fails to teach wherein the at least one identifier is positioned between at least two sealing surfaces of the stopper. Pommereau teaches a stopper (4) (Pommereau Figs. 1-2) having at least two sealing surfaces, one at a distal most surface of the stopper (4) and the other at a proximal most surface of the stopper (as seen in Pommereau Fig. 2; ¶ 0058), the configuration for detecting a longitudinal position of the visual marker such that a remaining quantity of the medicament in the syringe can be calculated for a given geometry of the syringe and a given longitudinal position of the identifier (Pommereau ¶ 0058).
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 Pommereau above, and further in view of Sudo to have at least two sealing surfaces at a proximal end and distal end of the stopper as disclosed by Pommereau for detecting a longitudinal position of the visual marker such that a remaining quantity of the medicament in the syringe can be calculated for a given geometry of the syringe and a given longitudinal position of the identifier (Pommereau ¶ 0058).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Harrington (USPGPub 2021/0069427) in view of Pommereau et al. (USPGPub 2012/0268741) above, and further in view of Sudo (USPGPub 2013/0316110) as applied to Claim 1 above, and further in view of Uber et al. (USPGPub 2017/0165427).
Re Claim 6, Harrington in view of Pommereau above, and further in view of Sudo teach all of the limitations of Claim 1. Harrington in view of Pommereau above, and further in view of Sudo fail 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 Pommereau above, and further in view of Sudo 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).
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.
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 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 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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