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) 1-2, 4-9, 11, 12, 23-29, 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graf et al. (US 2008/0103435 A1) in view of Edwards et al. (US 8,627,816 B2).
With regard to claim 1 and 23, Graf discloses A syringe device (Fig. 1) for administration of a therapeutic, the syringe device comprising: a syringe (Fig. 1) including comprising a barrel (2) that defines an internal volume containing a therapeutic dose ([0042]), and a stopper (element K in Fig. 1) slidably disposed within the barrel, the stopper configured to be advanced within the barrel to eject the therapeutic dose from the syringe; and a plunger assembly (see all elements housed within element 1) operatively connected to the stopper, the plunger assembly comprising: a plunger rod (8) attached to the stopper; an actuator (10) disposed about and engaged with the plunger rod, the actuator including channels (at 11, the protrusion forms a channel to hold onto the teeth of the plunger rod) configured to receive protrusions (9) on the plunger rod to secure the actuator at selectable positions along the plunger rod ([0047]): and a spacer (5) mounted on the plunger rod between the actuator and the stopper, the spacer defining a predetermined stroke length for movement of the actuator ([0052]) and an encasement housing (1 and 3) the syringe and the plunger assembly, the encasement configured to prevent removal or retraction of the plunger rod from the stopper and to restrict access to the syringe (see at 14, the encasement retains the plunger assembly and syringe together into a single unit), the actuator and the spacer are secured around the plunger rod to define a start position and an end position of the stopper (start position at 12 and end position at 5), such that actuation of the actuator advances the stopper the predetermined stroke length through the barrel to eject the therapeutic dose ([0052]), and wherein the plunger assembly and the encasement cooperate to prevent retraction or tampering with the plunger rod after movement of the actuator (the encasement necessarily prevents tampering since it is a housing that surrounds the plunger rod, further definition of tampering would need to be defined in order to overcome the rejection).
However, Graf does not disclose an opioid antagonist.
Edwards teaches a delivery device for delivery of at least one opioid antagonist (Col 4, lines 53-55). Naloxone is known to prevent and/or reverse the effects of opioids, such as respiratory depression from an opioid toxicity (col 1, line 1-16).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device of Graf to deliver an opioid antagonist as taught by Edwards because the substitute of one medication for another is well-known in the art and the use of naloxone is known to reverse the effects of opioids and treat respiratory depression (Col 1, lines 13-23).
With regard to claim 2 and 30, Graf discloses wherein the plunger assembly is configured to provide substantially identical doses of the at least one opioid antagonist even if more or less therapeutic is provided in the syringe by moving the stopper the predetermined stroke length ([0015]).
However, Graf does not disclose an opioid antagonist.
Edwards teaches a delivery device for delivery of at least one opioid antagonist (Col 4, lines 53-55). Naloxone is known to prevent and/or reverse the effects of opioids, such as respiratory depression from an opioid toxicity (col 1, line 1-16).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device of Graf to deliver an opioid antagonist as taught by Edwards because the substitute of one medication for another is well-known in the art and the use of naloxone is known to reverse the effects of opioids and treat respiratory depression (Col 1, lines 13-23).
With regard to claim 4 and 24, Graf discloses wherein the encasement includes a window ([0011], [0053]) configured to allow the user to view viewing of the at least one opioid antagonist in the syringe through the window.
With regard to claim 5 and 25, Graf discloses wherein the encasement includes a needle guard configured to allow the user to cover a needle associated with the syringe after use (P in Fig. 1).
With regard to claim 6-9 and 27, Graf discloses the claimed invention except for at least one opioid antagonist.
Edwards teaches a delivery device for delivery of at least one opioid antagonist including naloxone (Col 4, lines 53-55). Naloxone is known to prevent and/or reverse the effects of opioids, such as respiratory depression from an opioid toxicity (col 1, line 1-16). While Edwards does not explicitly teach the specific amount, it would be prima facie obvious to optimize the amount delivered to be about 5mg or 15mg as doing so would not alter the overall function of the device.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery device of Graf to deliver an opioid antagonist as taught by Edwards because the substitute of one medication for another is well-known in the art and the use of naloxone is known to reverse the effects of opioids and treat respiratory depression (Col 1, lines 13-23).
With regard claim 8,9, 28, Graf discloses wherein the syringe device is configured to deliver about 5 mg of naloxone or a salt thereof (the claim language recites “configured to” indicating functional language and the device would only need to be capable of performing the recited function. Thus the syringe of Graff would be able to deliver 5 or 15 mg of a therapeutic and thus teaches the claims).
With regard to claim 11, Graf discloses a finger depression location (19).
With regard to claim 12, Graf discloses configured for use in an opioid overdose (“configured to” language implies a functional limitation and the device of Graf would be capable of being used for opioid overdose).
With regard to claim 26, Graf discloses wherein the actuator includes a force application surface comprising a finger depression location (19).
With regard to claim 29, Graf discloses wherein the actuator and the spacer are keyed to the encasement to prevent rotation of the plunger assembly relative to the syringe once assembled ([0009], [0019]).
With regard to claim 31, Graf discloses wherein the syringe device is configured for single use and locks the plunger rod from movement after actuation to prevent multiple uses ([0045] piston cannot be moved proximally therefore preventing re-use of the device).
With regard to claim 32, Graf discloses wherein the spacer comprises a top stop (15) and a bottom stop (5), a distance between the top stop and the bottom stop defining the predetermined stroke length, and the bottom stop comprises a locking mechanism operably couplable to the plunger rod to prevent movement of the plunger rod relative to the barrel when the locking mechanism interacts with the plunger rod (4).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-9, 11-12 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 LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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