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 .
Information Disclosure Statement
The information disclosure statement filed 03/20/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. No copy of AU 2013203107 was included.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-5, 8-11, and 13-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 4,681,566 to Fenton, Jr. et al. (“Fenton”).
Regarding claim 1, Fenton teaches an auto-injector for receiving and operating a syringe (Figs. 1-2), the auto-injector comprising a housing for receiving the syringe, the housing comprising a main body (12) and a door (14) operable into a first position (Fig. 2) and a second position (Fig. 1), wherein the syringe is receivable within the housing when the door is in the first position (Fig. 2), wherein the door is configured to couple to: (i) a first plunger driver (51) for priming thereof on a first movement of the door (It is noted that Dictionary.com defines “priming” as “to prepare or make ready for a particular purpose or operation,” in the instant case, maximum displacement or reset of the spring puller members, which are attached to at least one of the springs, is considered “priming” since it is a necessary operation for subsequent syringe operation, column 5, lines 48-52 & Fig. 7, given the broadest reasonable interpretation), the first plunger driver comprising a first spring (51), and (ii) a second plunger driver (52) for priming thereof on a second movement of the door (column 3, lines 2-5, upon closing of the door, the plunger is biased by the spring, which includes the second spring in the embodiment where both springs are used, the combination of the closing of door and the biasing of the second spring biases or “prepares” the device for actuation as interpreted above, since the closing of the door and biasing are required for the device to operate), the second plunger driver comprising a second spring (52), the first and second plunger drivers being configured on activation of the auto-injector to drive a plunger forward within the auto-injector to operate the syringe received within the auto-injector (column 8, lines 48-50), wherein the second position of the door is the closed position (Fig. 1), wherein the first movement of the door is an opening movement, and wherein the second movement of the door is a closing movement (previously shown above).
Regarding claim 3, Fenton teaches an auto-injector according to claim 2 as shown above, Fenton further teaching at least the second spring comprising a tension spring (spring 52 provides tension).
Regarding claim 4, Fenton teaches an auto-injector according to claim 1 as shown above, Fenton further teaching the syringe is receivable within the main body of the housing when the hinged door is in the first position (Fig. 2).
Regarding claim 5, Fenton teaches an auto-injector according to claim 1 as shown above, Fenton further teaching the main body and the door are connected by a hinge (at 24, Fig. 2), and the auto-injector is provided with a charging link (42/43) between the main body and the door, wherein the connection of the charging link to the main body and/or the connection of the charging link to the door is a slidable connection configured to slide when the door moves between the first and second positions (Figs. 7 and 9), the charging link being configured to couple to the first and second plunger drivers for priming thereof on the respective first and second movements of the door (Figs. 7 and 9, 42 is coupled to springs 51/52).
Regarding claim 8, Fenton teaches an auto-injector according to claim 5 as shown above, Fenton further teaching the connection of the charging link to the door is fixed (42/43 are fixed to 14, Fig. 2) and the connection of the charging link to the main body is slidable (Figs. 7 and 9).
Regarding claim 9, Fenton teaches an auto-injector according to claim 5 as shown above, Fenton further teaching the connection of the charging link to the door is positioned at a point up to a half, up to a third, or up to a quarter of the length of the door from the hinge of the door (Fig. 2).
Regarding claim 10, Fenton teaches an auto-injector according to claim 5 as shown above, Fenton further teaching the main body and the connection of the charging link to the door are configured such that a maximum angle between the plane of the main body and the charging link during: (i) the first movement of the hinged door; and(ii) the second movement of the hinged door is up to 45 degrees (the angle of 42/43 relative to the main body 12 is approximately 45 degrees as shown in Fig. 2).
Regarding claim 11, Fenton teaches an auto-injector according to claim 1 as shown above, Fenton further teaching the force required for priming of the first plunger driver is less than the force required for priming of the second plunger driver (given that the first driver 51 is smaller, it would require less force to prime).
Regarding claim 13, Fenton teaches an auto-injector according to claim 5 as shown above, Fenton further teaching the charging link comprising a shuttle (100/102) configured to travel along a shuttle guide (elongated cavity 22) to provide a slidable connection of the charging link to the main body.
Regarding claim 14, Fenton teaches an auto-injector according to claim 13 as shown above, Fenton further teaching the shuttle comprising a first priming portion (100) coupled to the first plunger driver and configured to travel along the shuttle guide in a first direction on the first movement of the door for priming the first plunger driver (upon opening of the door, 100/40 is maximally displaced from opening 30 in a first direction, column 5, lines 48-52).
Regarding claim 15, Fenton teaches an auto-injector according to claim 14 as shown above, Fenton further teaching the main body and/or the first priming portion comprises a latch (112, Fig. 7 and 9) configured to retain the first priming portion in position after the first movement of the door (112 is capable of maintaining 100 once the door is opening as shown in Fig. 7).
Regarding claim 16, Fenton teaches an auto-injector according to claim 14 as shown above, Fenton further teaching the first plunger driver is primed under compression (51 is in a relatively compressed state in Fig. 7) and is connected between the main body (via 53) and the first priming portion (100).
Regarding claim 17, Fenton teaches an auto-injector according to claim 14 as shown above, Fenton further teaching the shuttle comprising a second priming portion (102) configured to travel along the shuttle guide in a second direction opposite the first direction on the second movement of the door for priming the second plunger driver (upon closure 102 moves in a second direction, Fig. 9).
Regarding claim 18, Fenton teaches an auto-injector according to claim 17 as shown above, Fenton further teaching the charging link is configured to retain the second priming portion in position after the second movement of the door (42 retains 100/102 upon door closure, Fig. 9).
Regarding claim 19, Fenton teaches an auto-injector according to claim 17 as shown above, Fenton further teaching the second plunger driver is primed under tension (52 is under tension in Fig. 9). and is connected alongside (see 112 rejection above for interpretation) the first priming portion and the second priming portion (at least a portion of 42 is position alongside 100 and 102 in Fig. 9).
Regarding claim 20, Fenton teaches an auto-injector according to claim 17 as shown above, Fenton further teaching the charging link (42) is connected to the second priming portion (102 via 112 in Fig. 9).
Regarding claim 21, Fenton teaches an auto-injector according to claim 19 as shown above, Fenton further teaching the first (100) and second (102) priming portions are configured to travel together along the shuttle guide on the first movement of the door (to the position in Fig. 7), and are separable such that the second priming portion separates from the first priming portion and travels along the shuttle guide on the second movement of the door (100 and 102 are capable of being separated as shown in Fig. 8).
Regarding claim 22, Fenton teaches an auto-injector according to claim 13 as shown above, Fenton further teaches the shuttle guide (40/100/102) is coupled to the first (51) and second (52) plunger drivers such that movement of the first and second plunger drivers follows a path determined by the shuttle guide (Fig. 9, 100/102 follow the same path).
Regarding claim 23, Fenton teaches an auto-injector according to claim 21 as shown above, Fenton further teaching the shuttle guide comprising a rod (51b) passing through the first plunger driver and passing through an aperture in the shuttle (screw fastener 51b passes through 51 and into an aperture on 100).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fenton alone.
Regarding claim 12, Fenton teaches an auto-injector according to claim 1 as shown above, but is silent regarding the driving force.
Fenton discloses that in certain embodiments, both springs 51 and 52 are used to drive plunger 18 instead of just one spring in order to accommodate larger sized syringes which require a greater force to be applied. The range of the combined driving force is a result effective variable in that changing the driving force is necessary to provide smooth plunger operation that may vary according to plunger size and the viscosity of the medicament. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Fenton to provide a driving force within the claimed range, as it involves only adjusting the type of spring or stretched distance which would require adjustment based on the aforementioned factors. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined driving force of the first and second plunger drivers to be in the range from 30-50 Newtons as a matter of routing optimization since it has been held that “[W]here the general conditions of a claims are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Allowable Subject Matter
Claim 24 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art, Fenton does not teach or suggest a ratchet operable during the second movement of the hinged door to prevent movement of the door in the direction of the first position by a force exerted by the second plunger in combination with all the limitations of claim 1. It is noted that the ratchet is not shown in the drawings as set forth above.
Response to Arguments
The drawings were received on 11/24/2025. These drawings are acceptable.
Applicant’s arguments and amendments with respect to drawing objections have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments and amendments with respect to claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant's arguments amendments with respect to art rejections have been fully considered but they are not persuasive. Applicant argues that Fenton fails to teach the priming of the autoinjector being split into two stages, i.e., opening the auto injector primes the first plunger driver/spring and the closing the door primes the second plunger driver/spring. Examiner respectfully disagrees. First, as indicated by Applicant, Fenton’s leaf spring are both primed together during the opening of the cover member. This at least teaches the first plunger driver/spring being primed during the opening of the cover member, and as claimed, claim 1 does not exclude priming of the second plunger driver/spring. Second, as also indicated by Applicant, when the pivoting actuation cover is closed, a pre-loaded spring is coupled to the plunger applying a constant force to the plunger. Given the interpretation of the term “priming” above as “to prepare or make ready for a particular purpose,” even if a force is applied to the plunger once the door is closed, the act of closing the door and the coupling or biasing of the spring (including the second spring) to the plunger “prepares” the device for actuation, since apart from closing the door and the associated biasing, the device would not be actuated. Examiner also notes that as claimed, activation of the device upon closing of the door is not excluded. Applicant also argues that no loading force is applied on the closing of the cover, however such a limitation is not claimed. The rejection stands.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783