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 § 102
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.
Claim(s) 1, 3-5, 7-13, 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alexandersson (EP 3,320,932 A1).
With regard to claim 1, Alexandersson discloses a subassembly (Fig. 2, elements 1-7, 9) for a drug delivery device comprising: a housing (2); a displaceable needle cover (3, see it assembled with housing in Fig. 15) comprising a distal end comprising a flange (Fig. 4, element 33), the needle cover (3) received within the housing (portion 37 is within housing 2, as shown in in Fig. 4 and 15) and configured to have a pre-use position in which the needle cover (as shown in Fig. 15) extends from the housing and a use position in which the needle cover ([0023]) is at least partially displaced into the housing, wherein displacement of the needle cover into the housing actuates the drug delivery device through interaction with a drive mechanism ([0023]); and a cap assembly (5, 7, 9, 4) comprising: a cap remover (7) configured to be grasped by a user; a retainer (9) received within the cap remover (fig. 12b) and configured to engage the flange (Fig. 12b, flange 33 engaged with retainer 9 via 912 and 916) of the needle cover (3) of the drug delivery device; and a push back element (52) operatively received within the retainer (best seen in Fig. 10, showing push back element 5 located within retainer 9, can be seen at connection point 514 and 98),wherein the push back element (52) is configured to push the retainer in a proximal direction (see between Fig. 10, where pushback element 52 and retainer are at its most distal position, and Fig. 13, showing the pushback element which has moved proximally by length W and in turn via its connection with the retainer moves the retainer proximally. [0036] The entirety of the pushback member is located within the retainer). Further this limitation is functional due to the use of the “configured to” language, therefore the pushback member must only be capable of moving the retainer element proximally which is described in [0036]).
With regard to claim 3, Alexandersson discloses wherein the push back element (52) is removably held in the retainer (52, can be seen as a separate component in Fig. 2 and is thus considered removable relative to the retainer if desired).
With regard to claim 4 and 8, Alexandersson discloses wherein the push back element (52) comprises a tab (see annotated drawing below) that covers an opening defined in the cap remover (see Fig. 10, showing element 52 that covers part of the opening formed by element 931).
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With regard to claim 5, Alexandersson discloses wherein the push back element (52) comprises the extension member (see annotated drawing above) configured to be received in the retainer (see Fig. 10), wherein at least a portion of the retainer (9) defines an opening with a cross-sectional shape that corresponds to a cross-sectional shape of the extension member (see Fig. 10 showing the extension member fitting into corresponding members of the retaining such as 98, the extension members fit into the opening formed in the distal end of retainer 9 into corresponding latch opening such as 98. The term corresponding is broad and the element 52 with the extension is designed to fit within an opening of the retainer and therefore is considered to “correspond” to the opening of the retainer).
With regard to claim 7, Alexandersson discloses wherein a proximal surface (proximal portion of 52) of the push back element is configured to push the retainer in the proximal direction.
With regard to claim 9, Alexandersson discloses a drug delivery device (fig. 2) comprising: a housing (2); a syringe (8) comprising a needle (81) and received at least partially within the housing; a needle cover (3, see it assembled with housing in Fig. 15) comprising a distal end comprising a flange (Fig. 4, element 33), the needle cover (3) received within the housing (portion 37 is within housing 2, as shown in in Fig. 4 and 15) and configured to have a pre-use position in which the needle cover (as shown in Fig. 15) extends from the housing and a use position in which the needle cover ([0023]) is at least partially displaced into the housing, wherein displacement of the needle cover into the housing actuates the drug delivery device through interaction with a drive mechanism ([0023]); and a cap assembly (5, 7, 9, 4) comprising: a cap remover (7) configured to be grasped by a user; a retainer (9) received within the cap remover (fig. 12b) and configured to engage the flange (Fig. 12b, flange 33 engaged with retainer 9 via 912 and 916) of the needle cover (3) of the drug delivery device; and a push back element (52) wherein an entirety of the push pack element is received within the retainer (best seen in Fig. 10, showing push back element 52 located within retainer 9),wherein the push back element (52) is configured to push the retainer in a proximal direction (see between Fig. 10, where pushback element 52 and retainer are at its most distal position, and Fig. 13, showing the pushback element which has moved proximally by length W and in turn via its connection with the retainer moves the retainer proximally. [0036]. Further this limitation is functional due to the use of the “configured to” language, therefore the pushback member must only be capable of moving the retainer element proximally which is described in [0036]).
With regard to claim 10, Alexandersson discloses wherein the push back element (52) comprises a tab (see annotated drawing above) and an extension member (see annotated drawing above) that extends from the tab.
With regard to claim 11, Alexandersson discloses wherein the push back element (52) is removably held in the retainer (52, can be seen as a separate component in Fig. 2 and is thus considered removable relative to the retainer if desired).
With regard to claim 12, Alexandersson discloses wherein the push back element (52) comprises a tab (see annotated drawing aove is considered the tab portion because it covers over the opening of the needle cap remover 7, this is generally where label 52 is show in Fig. 8a and 10).
With regard to claim 13, Alexandersson discloses wherein the push back element (52) comprises the extension member (see annotated drawing above) configured to be received in the retainer (9, see Fig. 8a and Fig. 9/10), wherein at least a portion of the retainer (9) defines an opening with a cross-sectional shape that corresponds to a cross-sectional shape of the extension member (see Fig. 10 showing the extension member fitting into corresponding members of the retaining such as 98, the extension members fit into the opening formed in the distal end of retainer 9 into corresponding latch opening such as 98).
With regard to claim 15, Alexandersson discloses a cap assembly (Fig. 2, elements 5, 7, 9, 4) for a drug delivery device, the cap assembly (5, 7, 9, 4) comprising: a cap remover (7) configured to be grasped by a user; a retainer (9) received within the cap remover (fig. 12b) and configured to engage the flange (Fig. 12b, flange 33 engaged with retainer 9 via 912 and 916) of the needle cover (3) of the drug delivery device; and a push back element (52) operatively received within the retainer (best seen in Fig. 10, showing push back element 52 located within retainer 9, can be seen at connection point 514 and 98),wherein the push back element (52) is configured to push the retainer in a proximal direction (see between Fig. 10, where pushback element 5 and retainer are at its most distal position, and Fig. 13, showing the pushback element which has moved proximally by length W and in turn via its connection with the retainer moves the retainer proximally. [0036]. Further this limitation is functional due to the use of the “configured to” language, therefore the pushback member must only be capable of moving the retainer element proximally which is described in [0036]).
With regard to claim 16, Alexandersson discloses wherein the push back element (52) comprises a tab (see annotated drawing above is considered the tab portion because it covers over the opening of the needle cap remover 7, this is generally where label 5 is show in Fig. 8a) and an extension member (see annotated drawing) that extends from the tab.
With regard to claim 17, Alexandersson discloses wherein the push back element (52) is removably held in the retainer (52, can be seen as a separate component in Fig. 2 and is thus considered removable relative to the retainer if desired).
With regard to claim 18, Alexandersson discloses wherein the push back element (52) comprises a tab (see annotated drawing above is considered the tab portion because it covers over the opening of the needle cap remover 7, this is generally where label 52 is show in Fig. 8a).
With regard to claim 19, Alexandersson discloses wherein the push back element (52) comprises the extension member (see annotated drawing above) configured to be received in the retainer (9, see Fig. 8a and Fig. 9/10), wherein at least a portion of the retainer (9) defines an opening with a cross-sectional shape that corresponds to a cross-sectional shape of the extension member (see Fig. 10 showing the extension member fitting into corresponding members of the retaining such as 98, the extension members fit into the opening formed in the distal end of retainer 9 into corresponding latch opening such as 98).
Claim(s) 6, 14, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alexandersson (EP 3,320,932 A1) in view of Cucarouge (WO 2020/173997 A1).
With regard to claim 6, 14, 20, Alexandersson discloses the claimed invention except for the material of the push back element.
Ducarouge teaches a similar overall cap assembly (fig. 3, element 100) that includes a needle remover (150), a retainer (110 within the needle remover) and a pushback member (120). All the elements can be made with medical-grade plastic ([0040]).
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 material of the push back member of Alexandersson with the medical-grade plastic as taught by Ducarouge because the substitution of one well-known material with another is well-known in the art and does not alter the overall function of the device ([0040]), and further provides a rigid material for a user to firmly grip the cap remover ([0040]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-20 have been considered but are moot because the new ground of rejection applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Element 52 is now considered the push back element instead of element 5 in order to read on the amended claims that the entirety of the push back element is received within the retainer. Because it appears the claims focus on the push back element, it is suggested that the claims be amended to provide additional structure to the push back element in order to overcome the current rejection. Examiner is open to an interview to discuss possible amendments.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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