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 on 12/08/2025 have been fully considered but they are not persuasive.
With regards to the arguments that the reference cited fail to teach “the grip latching member having a disk defining a base having an opening and at least one- axially-extending resilient finger member”, examiner respectfully disagrees.
Gentz et al disclose further including a grip latching member (locking mechanism, para 0045, locking mechanism includes rings 24d and 24e which are configured to be lock together, see para 0047) disposed on the grip shell (see fig 1B and 2), the grip latching member having a disk (guide 24e) defining a base having an opening (see fig 2 and para 0047) and at least one axially-extending resilient finger member (button 24c).
The limitations of the claim require that the grip member to have a disk defining a base and at least one axially-extending resilient finger member but this limitation does not clearly clarify that the at one axially-extending resilient finger member is directly attached to the disk. It is the examiner opinion that the grip latching member is defined as rings 24d and 24e when locked together to become an unitary structure comprising a base (guide 24e) and at least one axially-extending resilient finger member (button 24c).
With regards to the arguments that “the Gentz reference does not disclose attachment to a fully assembled injector without requiring disassembly as recited by claims 1 and 13”, examiner respectfully disagrees. Applicant is reminded that the cap 12 is a separate component of the injector 1 and it mounted to the injector to protect user against needle stick. It is the opinion of the examiner that a fully assembled injector is an injector having a body and cover sleeve 11 and the injector is assembled to be removably attach to the accessory 2 as seen in figure 1C.
Thus the rejections of claims 1 and 13 are maintained.
By virtue of dependency, claims 2-12 and 14-19 are also maintained.
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.
Claims 1-5 and 7-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gentz et al (US 20190217022 A1).
Regarding claim 1, Gentz et al disclose a drug delivery device (see fig 1A, injection device 1) comprising an injector (device 1) including an injector housing (housing 10) defining a housing body (body 10) having a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end thereof (see fig 1A, 3a-f); a needle assembly (needle 13b) at least partially disposed within the injector housing at the proximal end thereof (see fig 3a-f), the needle assembly comprising a syringe barrel (syringe 13a) containing a medicament and a needle or a cannula (para 0052); a drive assembly (injection spring 16) at least partially disposed within the housing and operably coupled to the needle assembly to urge the medicament through the needle or cannula (see fig 3a-f, para 0053); the housing body of the injector housing being graspable by a user upon fully assembling the injector to administer the medicament (see fig 3a-f, device 1 is fully assembled and can be used to administer drug, para 0052); and an accessory grip (see fig 1B, module 2 and para 0023) defining a grip shell (housing 20) having a proximal end, a distal end, and a body extending between the proximal end and the distal end thereof (see fig 1B), the proximal end of the grip shell including a first opening dimensioned to receive a first portion of the injector housing, the distal end of the grip shell including a second opening dimensioned to receive a second portion of the injector housing (see fig 1C and para 0024), the accessory grip further including a grip latching member (locking mechanism, para 0045) disposed on the grip shell (see fig 1B and 2), the grip latching member having a disk (guide 24e) defining a base having an opening (see fig 2 and para 0047) and at least one axially-extending resilient finger member (button 24c), wherein the accessory grip is adapted to be removably attached to the injector housing upon assembling the injector to increase a graspable surface area of the injector (para 0023 and 0044).
Regarding claim 2, Gentz et al disclose the drug delivery device of claim 1, further comprising: an injector housing latching member (opening 10a) disposed on the housing body (see fig 1A), wherein the grip latching member (locking mechanism) secures to the injector housing latching member to secure the injector housing to the accessory grip (see fig 1C and para 0045 and 0047).
Regarding claim 3, Gentz et al disclose the drug delivery device of claim 2, wherein the injector housing latching member comprises at least one depression formed on the housing body (see fig 1A, opening 10a), and wherein the at least one axially-extending resilient finger member (button 24c) is configured to be inserted into the at least one depression (see fig 1C, button is inserted through opening 10a when device 10 is inserted into module 2).
Regarding claim 4, Gentz et al disclose the drug delivery device of claim 3, wherein the at least one depression (window 10a) forms a dosage window on the injector housing (para 0044).
Regarding claim 5, Gentz et al disclose the drug delivery device of claim 4, wherein the accessory grip (module 2) further includes at least one viewing window (window 20a) that is aligned with the dosage window (para 0044).
Regarding claim 7, Gentz et al disclose the drug delivery device of claim 1, wherein the accessory grip (module 2) further comprises at least one electronic device at least partially disposed within the grip shell (sensor 21 and para 0020, para 0045-46).
Regarding claim 8, Gentz et al disclose the drug delivery device of claim 7, wherein the at least one electronic device comprises at least one of: a display; a lighting system; a skin sensor; a communications module; a motion sensor; or an electromechanical feedback mechanism (para 0045-46).
Regarding claim 9, Gentz et al disclose the drug delivery device of claim 8, wherein the at least one electronic device is adapted to communicate with the injector (para 0045-46).
Regarding claim 10, Gentz et al disclose the drug delivery device of claim 1, wherein the accessory grip comprises a tubular clamshell that extends in a direction along the longitudinal axis of the injector housing (see fig 1B).
Regarding claim 11, Gentz et al disclose the drug delivery device of claim 1, wherein the accessory grip comprises an elongated dome-shaped clamshell having a curved upper gripping surface (see fig 1B, upper portion of module 2).
Regarding claim 12, Gentz et al disclose the drug delivery device of claim 1, wherein the proximal end of the grip shell further comprises a planar contact surface (see 1B).
Regarding claim 13, Gentz et al disclose an accessory grip (module 2) for a drug delivery device (device 1), the accessory grip comprising: a grip shell (module housing 20) having a proximal end, a distal end, and a body extending between the proximal end and the distal end (see fig 1B); a first opening formed at the proximal end of the grip shell, the first opening dimensioned to receive a first portion of a fully assembled drug delivery device (see fig 1C, para 0044-47); a second opening formed at the distal end of the grip shell, the second opening dimensioned to receive a second portion of the fully assembled drug delivery device (see fig 1C, para 0044-47), the first opening and the second opening being in communication with each other via a throughbore extending therebetween (see fig 1B); and a grip latching member (locking mechanism, para 0045) disposed on the grip shell (see fig 1B and 2), the grip latching member including a disk (guide 24e) defining a base having an opening (see fig 2 and para 0047) and at least one axially-extending resilient finger member (button 24c), wherein the grip latching member is adapted to couple to an outermost housing of the fully assembled drug delivery device to secure the accessory grip to the fully assembled drug delivery device without requiring disassembly thereof (see fig 1C and para 0022 and 0045 and 0047).
Regarding claim 14, Gentz et al disclose the accessory grip of claim 13, further comprising at least one viewing window (window 20a) disposed on the body of the grip shell (see fig 1B).
Regarding claim 15, Gentz et al disclose the accessory grip of claim 13, further comprising at least one electronic device at least partially disposed within the grip shell (sensor 21 and para 0020, para 0045-46).
Regarding claim 16, Gentz et al disclose the accessory grip of claim 15, wherein the at least one electronic device comprises at least one of: a display; a lighting system; a skin sensor; a communications module; a motion sensor; an electromechanical feedback mechanism (para 0045-46).
Regarding claim 17, Gentz et al disclose the accessory grip of claim 13, wherein the grip shell comprises a tubular clamshell that extends in a direction along a longitudinal axis (see fig 1B).
Regarding claim 18, Gentz et al disclose the accessory grip of claim 13, wherein the grip shell comprises an elongated dome-shaped clamshell having a curved upper gripping surface (see fig 1B, upper portion of module 2).
Regarding claim 19, Gentz et al disclose the accessory grip of claim 13, wherein the proximal end of the grip shell further comprises a planar contact surface (see fig 1B).
Claim Rejections - 35 USC § 103
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 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 6 is rejected under 35 U.S.C. 103 as being unpatentable over (US 20190217022 A1) in view of Martin et al (US 20170332969 A1).
Regarding claim 6, Gentz et al disclose the limitations of claim 1 and further teach the drug delivery device of claim 1, wherein the grip shell (module 2) further defines a throughbore (opening of module 2) extending between the first opening and the second opening thereof (see fig 2), the throughbore being dimensioned to receive the injector (device 1) such that the proximal end of the injector housing is exposed through the first opening of the grip shell (see fig 1c) but fail to teach the distal end of the injector housing is exposed through the second opening of the grip shell.
However, Martin et al disclose a drug delivery system (abstract, see fig 2) comprising an injector (device 100) and a grip accessory (cover 190) wherein the distal end of the injector housing is exposed through the second opening of the grip shell (see fig 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Gentz et al and incorporate the teachings of Martin et al to have the distal end of the injector housing is exposed through the second opening of the grip shell. This would provide the benefit of allowing a user to access the distal end of said injector for activation when it is ready for use (see para 0023).
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 FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783