DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-4, 7-12 and 14-16 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Hommann et al. (PG PUB 2005/0203466).
Re claim 1, Hommann discloses an injection device (as seen in Fig 1-7; it is noted that all reference characters cited below refer to Fig 1-7 unless otherwise noted) comprising: a housing 5 enclosing a product container 7 connected to an injection needle 10 and having a longitudinal axis (extending vertically in Fig 1), the product container and the injection needle being non-axially movable relative to the housing (as seen in Fig 1-7, the proximal flange of syringe 7 always resides on flange 6 of the housing 5); a piston rod 12 configured to act on a piston in a delivery direction for product delivery (piston rod 12 acts upon rod 9 which acts upon piston 8, Para 26,32; it is noted that “a piston” is only functionally recited and, therefore, not a part of the claimed invention); a delivery spring 14 biasing the piston rod (Para 32), wherein prior to the product delivery, the piston rod is in a blocking connection preventing the piston rod from moving in the delivery direction by the biased delivery spring (Para 31,32); a needle protecting sleeve 4 comprising an activating element (the sleeve 4 itself), the needle protecting sleeve shiftable along the longitudinal axis relative to the housing from an initial position (seen in Fig 2) in which the needle protecting sleeve protrudes beyond a distal end of the housing (as seen in Fig 2) to a proximal position (seen in Fig 3) during manual insertion of the injection needle and prior to release of the blocking connection (Para 31); a restoring spring 22 for shifting the activating element distally from the proximal position to an end position (seen in Fig 7) (Para 34); a triggering element 13 comprising a button (triggering element 13 is pressed distally upon by ring 28, as described in Para 32 and, therefore, it considered a “button”) at an exterior of a proximal end of the housing (as seen in Fig 1, wherein the entire space proximal to proximal end 6 of the housing 5 is considered “an exterior” of the proximal end 6 of the housing 5), wherein the button is configured to be movable along the longitudinal axis relative to the housing by being pressed in a distal direction to release the blocking connection in order to trigger the injection device (Para 32); and a releasing member 11 comprising a protrusion (seen in the Figures, but not labeled; labeled in Fig A below) directed radially inward and configured to engage with an outer surface of the piston rod in an engagement to prevent the piston rod from moving in the distal direction relative to the product container (Para 31), wherein the releasing member is prevented from disengaging from the engagement by a surface of a supporting element 2 directed radially inward and preventing the releasing member from moving radially outward transverse to the longitudinal axis (as seen in Fig 1, the inner surface of supporting element 2 radially surrounds the outer surface of the releasing member 11 and, therefore, prevents the releasing member from moving radially outward), and wherein by shifting the supporting element along the longitudinal axis, the releasing member is permitted to disengage from the engagement to thereby release the piston rod for distal movement relative to the product container in the product delivery direction by the biased delivery spring (Para 32).
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Re claim 2, Hommann discloses that the triggering element causes the releasing member to shift (when the triggering element 13 is compressed, as seen in Fig 4, it moves distally past the releasing member 11, as seen in Fig 5; this movement involves the triggering element 13 and the releasing member 11 to shift relative to each other (as seen in comparison of Fig 4 to Fig 5); it is noted that the claim does not specify what the releasing member shifts relative to and, therefore, the claim only requires that the releasing member shift relative to something).
Re claim 3, Hommann discloses that, in the initial position, the triggering element is prevented from undergoing a triggering movement (as seen in Fig 2; Para 31 sets forth that the triggering element is not permitted to undergo a triggering movement until the needle protecting sleeve is in the proximal position).
Re claim 4, Hommann discloses that, in the proximal position, the triggering element is permitted to undergo the triggering movement (as seen in Fig 3; Para 31).
Re claim 7, Hommann discloses that, in the end position, the needle protecting sleeve covers a distal end of the injection needle (as seen in Fig 7; Para 35).
Re claim 8, Hommann discloses that, in the initial position, the needle protecting sleeve covers a distal end of the injection needle (as seen in Fig 2; Para 30).
Re claim 9, Hommann discloses that, in the initial position, the triggering element is prevented from undergoing a triggering movement, and in the proximal position, the triggering element is permitted to undergo the triggering movement (Para 31).
Re claim 10, Hommann discloses that, in the end position, the needle protecting sleeve is blocked from shifting axially in a proximal direction relative to the housing (Para 35).
Re claim 11, Hommann discloses an injection device (as seen in Fig 1-7; it is noted that all reference characters cited below refer to Fig 1-7 unless otherwise noted) comprising: a housing 5 configured to enclose a product container 7 connected to an injection needle 10 and having a longitudinal axis (extending vertically in Fig 1), the product container being non-axially movable relative to the housing (it is noted that “a product container” and “an injection needle” are only functionally recited and, therefore, not a part of the claimed invention; this limitation is met in view of Fig 1-7 that show the proximal flange of syringe 7 always resides on flange 6 of the housing 5); a piston rod 12 configured to act on a piston in a delivery direction for product delivery (piston rod 12 acts upon rod 9 which acts upon piston 8, Para 26,32; it is noted that “a piston” is only functionally recited and, therefore, not a part of the claimed invention); a delivery spring 14 biasing the piston rod (Para 32); a needle protecting sleeve 4 comprising an activating element (the sleeve 4 itself), the needle protecting sleeve shiftable along the longitudinal axis relative to the housing from an initial position (seen in Fig 2) in which the needle protecting sleeve protrudes beyond a distal end of the housing (as seen in Fig 2) to a proximal position (seen in Fig 3) in which the needle protecting sleeve is shifted into the housing and the injection needle protrudes from a distal end of the needle protecting sleeve for manual insertion (Para 31); a restoring spring 22 for shifting the activating element distally from the proximal position to an end position (seen in Fig 7) in which the needle protecting sleeve protrudes beyond a distal end of the injection needle (as seen in Fig 7, Para 34); a triggering element 13 at a proximal end of the housing (as seen in Fig 1), the triggering element comprising a button (triggering element 13 is pressed distally upon by ring 28, as described in Para 32 and, therefore, it considered a “button”) at an exterior of the housing (as seen in Fig 1, wherein the entire space proximal to proximal end 6 of the housing 5 is considered “an exterior” of the housing 5), wherein the button is configured to be movable along the longitudinal axis relative to the housing by being pressed in a distal direction to release a blocking connection of the piston rod in which the piston rod is prevented from moving in the delivery direction by the biased spring in order to trigger the injection device (Para 32); and a releasing member 11 configured to form an engagement with an outer surface of the piston rod (via the protrusion labeled in Fig A above) to prevent the piston rod from moving in the distal direction relative to the product container (Para 31), wherein the releasing member and the piston rod are held in the engagement by a supporting element 2, the supporting element blocking the releasing member from disengaging from the engagement with the piston (as seen in Fig 1, the inner surface of supporting element 2 radially surrounds the outer surface of the releasing member 11 and, therefore, prevents the releasing member from disengaging from the engagement) wherein the supporting element is shiftable relative to the releasing member (as seen in Fig 3 vs Fig 4; Para 32), and after shifting, the supporting element no longer blocks the releasing member from disengaging from the engagement (Para 32), and wherein, in the initial position, the triggering element is prevented from releasing the blocking connection (Para 30), and in the proximal position, the triggering element is permitted to release the blocking connection (Para 31).
Re claim 12, Hommann discloses that the triggering element causes the releasing member to shift (when the triggering element 13 is compressed, as seen in Fig 4, it moves distally past the releasing member 11, as seen in Fig 5; this movement involves the triggering element 13 and the releasing member 11 to shift relative to each other (as seen in comparison of Fig 4 to Fig 5); it is noted that the claim does not specify what the releasing member shifts relative to and, therefore, the claim only requires that the releasing member shift relative to something).
Re claim 14, Hommann discloses that, in the end position, the needle protecting sleeve is blocked from shifting proximally relative to the housing (Para 35).
Re claim 15, Hommann discloses that the releasing member comprises a protrusion (labeled in Fig A above)) directed radially inward and engages with an outer surface of the piston rod in the engagement (as seen in Fig 2), and wherein the releasing member is held in the engagement by a surface of the supporting element directed radially inward (as seen in Fig 1, the inner surface of supporting element 2 radially surrounds the outer surface of the releasing member 11 and, therefore, holds the releasing member 11 in engagement by the inner surface of the supporting element 2).
Re claim 16, Hommann discloses that upon releasing the engagement, the releasing member moves radially outward transverse to the longitudinal axis (relative to the triggering element, as seen in comparison of Fig 3 and 4).
Response to Arguments
Applicant’s arguments filed 10/28/2025 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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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