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)(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.
Claim(s) 1-2, 8-10, 12-16, 18, 22, 25, 27-30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McLusky et al. (US 2021/0290855 A1).
With regard to claim 1, McLusky discloses A drug delivery device assembly comprising: an injector (Fig. 1a and 1b, element 100) including: an injector housing (120) having a body with a proximal end (at 102, note that proximal and distal are being used opposite to their normal meaning of the word), a distal end (175), and a longitudinal axis extending between the proximal end and the distal end (inherent); a needle assembly (130/110) at least partially disposed within the body adjacent to the proximal end (see needle 130 that extends into the proximal end of the syringe, Fig. 1b), the needle assembly comprising a syringe barrel (110) containing a medicament and a needle or a cannula (130); a drive assembly (170) at least partially disposed within the body and operably coupled with the needle assembly, wherein the drive assembly is configured to, when actuated, automatically urge (claims state that the injection is automated after actuated. The actuation is done manually by pushing the plunger rod [0007], once pushed the injection is considered to be automatic as the agent is then delivered. Claims would need to clarify the actuation mechanism or structure in order to overcome the current rejection) the medicament through the needle or cannula ([0063]); and an accessory (fig. 4, element 310) defining a shell having a proximal end (generally at 365), a distal end (generally at 380), and a longitudinal axis extending between the proximal end and the distal end (inherent), the proximal end of the shell including a first opening sized to receive a portion of the injector (as shown in Fig. 3 and 4), the distal end of the shell including a second opening (at where 355 is pointing); wherein the longitudinal axis of the body is generally aligned with the longitudinal axis of the shell and the body of the injector housing extends through the second opening of the shell when the shell is coupled with the body of the injector housing (see Fig. 4); wherein an axial end surface of the proximal end of the shell is free from contact with any other component of the drug delivery device assembly before and during use (surface 367 as shown in Fig. 3 and 4 considered to be the axial surface at the proximal end is not in contact with any other component of the drug delivery device before and during use).
With regard to claim 2, McLusky discloses wherein the body includes an outer surface and a knob (155 are the flanges of the injector and are considered to be knobs) projecting from the outer surface, and wherein the accessory includes a debossed feature (352) disposed on an interior surface of the shell, the debossed feature being shaped to slidably receive the knob of the body [0067], also see Fig. 4).
With regard to claim 8, McLusky discloses wherein the accessory includes a plurality of fins extending radially outward from the proximal end of the shell (365).
With regard to claim 9, McLusky discloses wherein the first opening (at 355) is larger than the second opening (at 320) (the accessory at 300 becomes larger in diameter than at 340, thus the first opening at 355 is larger than the second opening at 320), the second opening (320) adjacent to the proximal end of the shell and sized to permit the needle or cannula to pass through (see Fig. 3).
With regard to claim 10, McLusky discloses wherein the shell includes a ledge (670, Fig. 7) adjacent to the second opening (the distal end opening near plunger 270), the ledge extending radially inward relative to the longitudinal axis of the shell (see Fig. 7), wherein when the accessory is coupled with the injector, the ledge of the shell is optionally adjacent to a planar surface of the proximal end of the injector (this limitation is optional and therefore not required to be taught by the prior art).
With regard to claim 12, McLusky discloses wherein the accessory includes a flange (365) extending radially outward relative to the longitudinal axis, the flange disposed at the proximal end of the shell.
With regard to claim 13, McLusky discloses A drug delivery device assembly comprising: an injector body (Fig. 1a and 1b) with a proximal end (generally at 102), a distal end (generally at 180), and an outer surface 100); a needle assembly (110/1030) at least partially disposed within the injector body, the needle assembly including a syringe barrel (110) containing a medicament and a needle or a cannula (130); a drive assembly (170) at least partially disposed within the injector body and operably coupled with the needle assembly wherein the drive assembly is configured to, when actuated, automatically urge (claims state that the injection is automated after actuated. The actuation is done manually by pushing the plunger rod [0007], once pushed the injection is considered to be automatic as the agent is then delivered. Claims would need to clarify the actuation mechanism or structure in order to overcome the current rejection) to urge the medicament through the needle or cannula ([0063]); an accessory (310) defining a shell with a proximal end, a distal end, a first opening (generally at 320) at the proximal end sized to receive at least a portion of the injector body (see Fig. 3), a second opening (generally at 355) at the distal end, and a cut-out (352) and/or an indention formed in the shell and configured to secure the accessory and the injector body (via flange 155 [0067]); wherein the body of the injector housing extends through the second opening of the shell when the shell is coupled with the body of the injector housing (see in Fig. 4, where body of injector 370 is extending through 320); an wherein an axial end surface (367) of the proximal end of the shell is free from contact with any other component of the druq delivery device assembly before and during use (surface 367 as shown in Fig. 3 and 4 considered to be the axial surface at the proximal end is not in contact with any other component of the drug delivery device before and during use).
With regard to claim 14, McLusky discloses further comprising the indentation (670 form fins such that the space between fins are considered indentations), the indentation formed on an interior surface of the shell, the indentation shaped to slidably receive a knob (280) projecting from an outer surface of the injector body (]0088] fins and indentations guide the movement and prevent lateral movement of 280).
With regard to claim 15, McLusky discloses wherein the indentation of the shell optionally extends from an edge of the proximal end of the shell to a notch formed at a location spaced from the edge of the proximal end of the shell (claim language uses the term “optionally” and therefore is not required to be taught by the prior art. Only the indentations need to be taught which are explained above in rejection to claim 14).
With regard to claim 16, McLusky discloses further comprising the cut-out (352), wherein the notch (the notch is not required to be taught by the prior art because it was only optionally introduced in claim 15 from which claim 16 depends) is at least one of (a) sized to receive the knob of the injector body to couple the injector body with the shell by a snap-fit connection, and/or (b) spaced away from the cut-out.
With regard to claim 18, McLusky discloses wherein the indentation is at least partially defined by an angled wall (670), wherein the angled wall is optionally arranged to guide a portion projecting from an outer surface of the injector body into a notch formed at a location spaced from an edge of the proximal end of the shell (use of the term “optionally” indicates that the limitation is not required to be taught by the prior art).
With regard to claim 22, McLusky discloses An accessory (Fig. 4) for a drug delivery device, the assembly comprising: a drug delivery device ((Fig. 1a and 1b) comprising a container (110) and a drive assembly (170) configured to, when actuated, automatically urge (claims state that the injection is automated after actuated. The actuation is done manually by pushing the plunger rod [0007], once pushed the injection is considered to be automatic as the agent is then delivered. Claims would need to clarify the actuation mechanism or structure in order to overcome the current rejection) and an accessory comprising: a shell (310) with a proximal end (generally at 320), a distal end (generally at 300), and a longitudinal axis extending between the proximal end and distal end (inherent); a first opening at the proximal end (320); a second opening at the distal end (355); a throughbore connecting the first opening and the second opening (see Fig. 4), the throughbore sized to receive at least a first portion of the drug delivery device (see Fig. 4, showing injection device within the shell); at least one of (a) and (b), (a) a plurality of fins extending radially outward from the proximal end (not required to be taught by the prior art since only one of (a) or (b) is needed), and (b) a cut-out (352) formed in the shell and disposed between the first opening and the second opening; wherein the second opening is configured such that at least a second portion of the drug delivery device extends through the second opening when the first portion of the drug delivery device is received in the throughbore (second portion fo the drug delivery device can be considered the plunger 270 which extends out of the second opening 355 as shown in Fig. 4); and wherein an axial end surface (367) of the proximal end of the shell is configured to be free from contact with any component of the drug delivery device before and during use (367 does not contact any other component before or during use).
With regard to claim 25, McLusky discloses wherein the shell includes (a) a ledge (670) extending radially inward relative to the longitudinal axis of the shelf and defining the second opening (see fig. 7). Rest of the limitation are not required to be taught by the prior art because they are part of an “or” clause.
With regard to claim 27, McLusky discloses wherein the accessory includes a flange (365) extending radially outward relative to the longitudinal axis, the flange disposed at the proximal end of the shell (see Fig. 3 and 4).
With regard to claim 28-30, McLusky discloses wherein at least a portion of the drug delivery device extends through the first opening beyond the axial end surface of the proximal end of the shell of the accessory such that the at least a portion of the drug delivery device is disposed outside of the shell of the accessory (see Fig. 5c when the entire device is in-use. A portion (portion 101 shown in Fig. 1a) of the injector body can be seen extending proximal from the shell).
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(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLusky et al. (US 2021/0290855 A1) in view of Rekaya et al. (US 2016/0008546 A1).
With regard to claim 3, McLusky discloses a notch (352) that is sized to receive the knob (155) of the injector.
However, McLusky does not teach a debossed feature that extends from the proximal edge up to the notch.
Rekaya teaches an accessory comprising a shell (Fig. 27) showing a debossed feature (49) that extends from a proximal edge to a notch formed in the interior surface of the shell .
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 device of McLusky to have the debossed feature at the proximal edge as taught by Rekaya for the purpose of aiding in orienting the fixation features ([0174]).
With regard to claim 4, McLusky/Rekaya discloses the deposed feature (Reyaka rejection above of claim 3). However, Rekaya does not explicitly disclose the shape of the deposed featuring being narrowing. However, it would be a simple design choice to change the shape of the deposed feature of Chang as doing so would not alter the overall function of the device.
With regard to claim 5, McLusky discloses wherein the notch (352) is sized to receive the knob (155) of the body of in the inejcotr housing to couple the injector housing with the shell.
With regard to claim 6, McLusky discloses wherein the shell further includes (a) at least one cut-out (395, Fig. 4) that is aligned with a dosage window of the injector, and/or (b) a corrugated outer surface (this limitation is not required to be taught because it follows an “or” clause).
Claim(s) 20, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLusky et al. (US 2021/0290855 A1) in view of Chang et al. (US 2017/0007769 A1).
With regard to claim 20 and 23, McLusky discloses the cut- out (352) formed in the shell.
However, Holmqvist does not teach an indentation and cut out.
Chang teaches further comprising a cut-out (118) formed in the shell and at least partially surrounded by the indentation (116) formed in the interior surface of the shell (see Fig. 10), wherein optionally the cut-out or indentation is generally triangular to help guide a portion of the injector body to a notch adjacent to the cut-out or indentation (limitation is not required to be taught by the prior art due to the term “optionally”). Thus an indentation can be added to the cutout already formed in Mclusky to help guide the fixation knob 152.
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 device of McLusky with the indentation and cutout as taught by Chang for the purpose of providing directed contact surfaces to guide the fixation elements ([0049]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 8-10, 12-16, 18, 20, 22-23, 25, 27-30 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.
Claims would need to further define the actuation mechanism or motion in order to overcome the current rejection.
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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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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