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 .
Response to Arguments
Applicant's arguments filed 5/22/2026 have been fully considered.
Regarding claim 16, Applicant argues that Rekaya discloses that the projection/groove provides an orientation, anti-rotation, and sliding-guide arrangement, btu does not disclose a mechanical coding defined by a combination of a longitudinal position of a coding feature and an extent of the coding feature, nor does Rekaya disclose a coded/non-coded pairing architecture in which non-matching mechanical coding and counter coding prevents engagement of the fasting element and counter fastening element. This argument is not convincing. The shape and size of the projection 120 and groove 130 of Rekaya are such that the connection is formed only when these two specifically sized and shaped elements are engaged. Therefore, these elements form a coding and counter coding element. The limitation “the mechanical coding and the mechanical counter coding being operable o prevent an engagement of the fastening element with the counter fastening element when the mechanical coding does not match the mechanical counter coding” is interpreted to be a functional limitation. The mechanical coding and mechanical counter coding of Rekaya are sized and shaped such that elements having different sizes and/or shapes could not engage with each other. Rekaya need not specifically call these element coding and counter coding elements to teach the claimed invention when it is clear from the disclosure of Rekaya that this is how the elements operated based on their configuration. The fastening element 24 can only engage the counter fastening element 34 when they are sized and shaped in a corresponding manner. A fastener 24 located closer or further from the proximal end would not engage the corresponding element 34. Applicant argues that the instant disclosure shows the mismatched configurations, however, these specific configurations are not claimed, rather the non-matching coding and counter coding are recited only functionally.
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.
Claim(s) 16-24, 27-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rekaya et al (US 2019/0269855).
Regarding claim 16, Rekaya discloses a housing of a drug delivery device, the housing comprising: a first housing component 20 configured to accommodate a cartridge 50 filled with a medicament and comprising a first connecting end 23 (fig. 4; page 7, para. 0121), a second housing component 30 configured to accommodate a drive mechanism 5 of the drug delivery device and comprising a second connecting end 33 (fig. 3; page 7, para. 0123), an insert 21 provided on one of the first connecting end or the second connecting end (page 7, para. 0125), a receptacle 31 provided on the other one of the first connecting end or the second connecting end (page 7, para. 0125), wherein the insert is insertable into the receptacle along a longitudinal direction for mutually fastening the first housing component and the second housing component (fig. 2), a fastening element 24 provided on the insert (page 7, para. 0127; fig. 4), a counter fastening element 34 complementary shaped to the fastening element and provided in the receptacle (fig. 3; page 7, para. 0127), a mechanical coding 120 provided on the insert and comprising a coding feature (fig. 4; page 7, para. 0125), a mechanical counter coding 130 provided in the receptacle and comprising a counter coding feature (fig. 3; page 7, para. 0125), the mechanical coding and the mechanical counter coding being operable to prevent an engagement of the fastening element with the counter fastening element when the mechanical coding does not match the mechanical counter coding (figs. 3, 4: if the mechanical coding 120 and counter coding 130 are not complementary, the housings cannot be engaged such that fastening elements engage), wherein the mechanical coding is defined by a combination of a position of the coding feature with regard to the longitudinal direction and an extent of the coding feature in at least one of the longitudinal direction or a transverse direction (fig. 4: the coding defines a length and a radial position).
Regarding claim 17, Rekaya discloses that the coding feature 120 and the counter coding feature 130 comprise: a radial protrusion 120 on the insert (fig. 4); and a radial recess 130 on the receptacle (fig. 3).
Regarding claim 18. Rekaya discloses that when the mechanical coding matches the mechanical counter coding, the radial protrusion fits into the radial recess (fig. 2).
Regarding claim 19, the mechanical coding and counting coding of Rekaya are arranged such that when the mechanical coding does not match the mechanical counter coding, the radial protrusion does not fit into the radial recess because there is a very small clearance between the elements to allow for improper fit (fig. 2).
Regarding claim 20, the coding feature 120 is a longitudinal position versus a longitudinal extent of one of the radial protrusion or the radial recess on an outside surface of the insert (fig. 4).
Regarding claim 21, the coding feature 120 is a longitudinal position versus a transverse extent of one of the radial protrusion or the radial recess on an outside surface of the insert (fig. 4: the coding feature has a length and a radial position).
Regarding claim 22, as discussed above, the coding feature and counter coding feature of Rekaya have a particular configuration and therefore necessarily distinguish from a second coding feature and counter coding feature having a different configuration. The second coding feature and counter coding feature and not positively recited.
Regarding claim 23, Rekaya discloses a groove 130 provided on receptacle, the groove extending along the longitudinal direction (fig. 3), and a protrusion 120 provided on the insert (fig. 4), the receptacle configured to slide along the groove upon insertion of the insert into the receptacle to rotationally lock the first housing component relative to the second housing component (fig. 5; page 7, para. 0125).
Regarding claim 24, Rekaya discloses that the radial recess 130 comprises a coded groove (page 7, para. 0125), and wherein: the coded groove is provided on an inside surface of a sidewall of the receptacle (fig. 3) and adjoins a longitudinal end face of the second connecting end (fig. 3).
Regarding claim 27, Rekaya discloses that the fastening element 24 comprises a snap element and the counter fastening element 34 comprises a counter snap element having a complementary shape to the snap element (figs. 3, 4), and wherein the snap element is configured to engage with the counter snap element to interlock the first and second housing components against a relative movement in the longitudinal direction or the circumferential direction (page 7, para. 0129).
Regarding claim 28, Rekaya discloses that the mechanical coding is integrated into the snap element and is defined by a longitudinal position and one of a longitudinal extent or a transverse extent of the snap element on the insert (figs. 3, 4).
Regarding claim 29, Rekaya discloses that the mechanical counter coding is integrated into the counter snap element and is defined by a longitudinal position and one of a longitudinal extent or a transverse extent of the counter snap element in the receptacle (fig. 3).
Regarding claim 30, Rekaya discloses a groove 130 provided on the receptacle (fig. 3), the groove extending along the longitudinal direction, and a protrusion 120 provided on the insert (fig. 4), the receptacle configured to slide along the groove upon insertion of the insert into the receptacle to rotationally lock the first housing component relative to the second housing component (page 7, para. 0125).
Regarding claim 31, Rekaya discloses an injection device for injecting a dose of a medicament, the injection device comprising: a housing comprising: a first housing component configured 20 to accommodate a cartridge 50 filled with a medicament and comprising a first connecting end 23 (figs. 2, 4; page 7, para. 0121), a second housing component 30 configured to accommodate a drive mechanism 5 of the drug delivery device and comprising a second connecting end 33 (figs. 2, 3; page 7, para. 0122), an insert 21 provided the first connecting end (fig. 4), a receptacle 31 provided on the second connecting end (fig. 3), wherein the insert is insertable into the receptacle along a longitudinal direction for mutually fastening the first housing component and the second housing component (fig. 2), a fastening element 24 provided on the insert (fig. 4), a counter fastening element 34 complementary shaped to the fastening element and provided in the receptacle (fig. 3), a mechanical coding 120 provided on the insert and comprising a coding feature (fig. 4), a mechanical counter coding 130 provided in the receptacle and comprising a counter coding feature (fig. 3), the mechanical coding and the mechanical counter coding being operable to prevent an engagement of the fastening element with the counter fastening element when the mechanical coding does not match the mechanical counter coding (figs. 2-4: when the coding 120 cannot engage groove 130, the fastening elements 24/34 cannot engage), wherein the mechanical coding is defined by a combination of a position of the coding feature with regard to the longitudinal direction and an extent of the coding feature in at least one of the longitudinal direction or a transverse direction (fig. 2); and the cartridge 50 arranged inside the housing (fig. 2), the cartridge comprising a barrel 51 filled with the medicament 53 and sealed in a proximal longitudinal direction by a movable bung 54 (page 7, para. 0121; fig. 2), and the drive mechanism 5 arranged inside the housing, the drive mechanism comprising a piston rod 110 operable to exert a distally directed dispensing force onto the bung of the cartridge (page 7, para. 0122; fig. 1).
Allowable Subject Matter
Claim 32 is allowed.
Claims 25, 26 are 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: see prior office action.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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