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 Objections
Claims 19-22, 30, 33, 35, 69-72, 79-80 are objected to because of the following informalities:
Regarding claims 19-21, 30, 33, 35, 69-72, 79-80, only claim status (withdrawn) is shown. No claim text is presented. It is unclear if Applicant intends to cancel the claim or if it is simply Withdrawn. If claims are withdrawn the claim text should still be present in the claim set.
In regards to claim 22, the claim is missing. For purposes of examination claim 22 is being interpreted as being cancelled.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaufmann et al. (EP 2739329 B1).
Regarding claim 1, Kaufmann discloses an automatic injection device (Fig 1) for use with a syringe (piston 102 + needle 95+ piston rod (1000, Annotated Fig 1)+ drug container 110, Fig 2-3) including at least one syringe piston (plunger 102, Fig 3) and a needle (needle 95, Fig 2) coupled to a forward end thereof (forward end of drug container 110 of syringe, Fig 2), comprising: a housing element (housing 70, Fig 1) arranged along a longitudinal axis (L, Fig 1) and having a forward end (1001, Annotated Fig 1) and a rearward end (1002, Annotated Fig 1); at least one resilient element (drive means 60, Fig 1; [0018]: helical spring) arranged to be located within said housing element (70) (Fig 2-3 shows drive means 60 within housing 70); a needle shield (needle guard 10, Fig 1) selectably positionable with respect to said housing element (70) ([0018]); and a control unit (drive device 50, Fig 1) adapted, when actuated, to be driven by said at least one resilient element (60)([0018]) for initially displacing said syringe (piston rod 1000 of syringe, Annotated Fig 1; piston rod is displaced by resilient element 60) relative to said housing element (70) from a non-penetration position (rest position before injection) to a penetration position (position where medicament is injected) and thereafter displacing said at least one syringe piston (102) in said syringe (102+95+1000+110) to effect drug delivery, and wherein said control unit (50) is configured to be actuated upon axial rearward displacement of said needle shield (10) with respect to said housing element (70) ([0032]), also comprising a locking element (40) operative for selectable displacement relative to said housing element (70) and being operatively engageable with said needle shield (10) and wherein upon axial rearward displacement of said needle shield (10) with respect to said housing element (70), said locking element (40) is permitted to rotate about said longitudinal axis (L) under the urge of said at least one resilient element (60) ([0032]) and wherein said locking element (40) is axially fixed relative to said housing element (70) ([0022]: “ (…) The rotary sleeve 40 is held axially relative to the housing by means of cams 49 in the holding slot 71 and is rotatably movable.”).
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Regarding claim 3, Kaufmann discloses the automatic injection device, according to claim 1, and wherein said locking element (40) is selectably operatively engaged with said control unit (50) and wherein said control unit (50) is operative for causing rotation of said locking element (40) under the urge of said at least one resilient element (60) upon axial rearward displacement of said needle shield (10) with respect to said housing element (70) ([0032]: “The torque applied by the gear (by means of the profiles 41 and 51) rotates the rotating sleeve 40” (…) “The drive device 50 is unlocked and can be driven in the dispensing direction by means of the drive means 60,”; proximal movement of the needle protection device 10 allow rotational movement of the sleeve 40 and torque of gear with drive device 50 under action of drive means 60 rotates the sleeve 40).
Regarding claim 4, Kaufmann discloses the automatic injection device, according to claim 1, also comprising a plunger rod (1000, Annotated Fig 1), operative to selectably drive said at least one syringe piston (102) in axial motion relative to said housing element (70); said plunger rod (1000, Annotated Fig 1) is operative to be displaced together with said control unit (50) from said actuation of said control unit (50) up to said penetration position of said syringe (position in which the medication is dispensed (102+95+1000+110)) ([0021]).
Regarding claim 10, Kaufmann discloses the automatic injection device, according to claim 1, and wherein said locking element (40) is permitted to be rotated in a single rotational direction ([0032]; rotatory sleeve 40 rotates in a single rotation from the first position to the second position).
Regarding claim 11, Kaufmann discloses the automatic injection device, according to claim 1, and wherein said locking element (40) is selectably positioned in one of a locked orientation (first position; locked orientation before dispensing, [0032]) and an unlocked orientation (second position; unlock orientation, [0032]) relative to said control unit (50); and wherein when said locking element (40) is positioned in said unlocked orientation (unlock orientation; [0032]), said at least one resilient element (60) is permitted to drive said control unit (50) axially forwardly relative to said housing element (70)([0032]).
Regarding claim 12, Kaufmann discloses the automatic injection device, according to claim 11, and wherein said locking element (40) has a rotation enabling element (first profile 41, [0029]) and said control unit (50) has a counter rotation enabling element (second profile 51, [0029]), which engages said rotation enabling element (41) when said locking element (40) is disposed in said locked orientation (first position, [0029]).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kaufmann et al. (EP 2739329 B1) in view of Hommann et al. (US20180078713A1).
Regarding claim 8, Kaufmann discloses the automatic injection device, according to claim1, also comprising a needle cover remover (needle protection cap 100, Fig 1) configured to be removably attached to said housing element (70)(Fig 3; [0020]), operative for protecting said needle (95).
Kaufmann is silent wherein said needle shield is prevented from axial rearward displacement with respect to said housing element when said needle shield remover is attached to said housing element.
Hommann teaches an automatic injection device (Fig 1) wherein a needle shield (needle protecting tube 4, Fig 1) is prevented from axial rearward displacement with respect to said housing element (front casing part 1, Fig 1) when said needle shield remover (needle protecting cap 15, Fig 1) is attached to said housing element (1) (Fig 1)([0027]: “the attached needle protecting cap 15 also secures the auto-injector against being intentionally or unintentionally triggered, by preventing the needle protecting tube 4 from being touched or shifted”).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Kaufmann with similar needle cap as taught by Hommann for the purpose of preventing unintentional trigger of device ([0027]).
Response to Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive. Applicant submits that Kauffman does not teach “said locking element is permitted to rotate about said longitudinal axis under the urge of said at least one resilient element”. Applicant indicates that Claim 1, as amended, requires that the locking element is allowed to be rotated under the urge of a resilient element, rather than urged to rotate due to engagement of other surfaces such as second profile 51 as taught in Kauffman para. [0026] and [0027].
Examiner respectfully disagrees. Claim limitation “ (…) said locking element is permitted to rotate about said longitudinal axis under the urge of said at least one resilient element” includes both direct and indirect urging through the presence of intermediary structure. Examiner recommends to include further details regarding the structural relationship between the components or provide additional details regarding how rotation is achieved under the urge of the resilient member.
Amended claim limitation does not overcome the prior art of record. Please see relevant section of Claim 1, and rationale below:
(…) and wherein said locking element (40) is axially fixed relative to said housing element (70) ([0022]: “ (…) The rotary sleeve 40 is held axially relative to the housing by means of cams 49 in the holding slot 71 and is rotatably movable.”).
References from Kauffman specification, provided by applicant in the submission, relates to different embodiments of device of Kauffman. The rejection does not rely on the embodiments of (Figs 23-25; and Fig 26-36), please see [0022].
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/
Primary Examiner, Art Unit 3783