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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/08/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 01/07/2026. As directed by the amendment, claim 1 has been amended, claims 3, 4, 7, 13, 17, 19-23, 25 and 26 have been previously withdrawn and claims 5, 9, 14-16, 18, 24 and 27 have been cancelled.
Thus, claims 1-4, 6-8, 10-13, 17, 19-23, 25, and 26 are pending in this application with claims 3, 4, 7, 13, 17, 19-23, 25, and 26 being withdrawn.
Applicant’s amendments to the claims have overcome each and every 112(a) claim rejection previously set forth in the Non-final Office Action mailed on 10/21/2025.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 1 recites the limitations “a corner surface connected to the topmost surface and terminating at an exterior edge immediately upon bending to be perpendicular to the plane” that have been added and are supported but are not disclosed in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 6, 8, 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the tapered surface extends from the upper surface to the second portion and the tapered surface tapers inwardly continuously from the exterior edge at the end of the drug delivery device to the second portion”. Claim 1 requires the tapered surface to taper inwardly continuously from the exterior edge at the end of the drug delivery device to the second portion, however, the handle of the drug delivery device comprising a first portion, a tapered surface and a second portion wherein the first portion is being wider than the second portion and the examiner is unsure whether the first portion is the upper surface or the first portion of the handle is a part of the tapered surface. Until this is clarified, the examiner is interpreting the limitation as “the tapered surface extends from the first portion to the second portion and the tapered surface tapers inwardly continuously from the first portion of the drug delivery device to the second portion”.
By virtue of dependency, claims 2, 6, 8, 10-12 are also rejected.
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.
Claims 1, 2, 6, 8, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over McLoughlin et al (US 20170239419 A1) in view of Tsals et al (US 20030229308 A1).
Regarding claim 1, McLoughlin et al disclose a drug delivery device (see fig 1, device 1), comprising: a syringe assembly (syringe 10, see fig 3A) including a needle (needle 14); a handle (housing 20, 22) adapted to house at least a portion of the syringe assembly (see figures), the handle including a first portion (see annotated figure below), a second portion (second annotated figure below), a tapered surface (part 24), and a window (viewing port 2), the first portion being wider than the second portion (see annotated figure below), the needle of the syringe assembly adapted to extend from adjacent the second portion during an injection procedure (see fig 2 and 8C, para 0112), the window positioned between the first portion and the second portion (see annotated figure below) and adapted to allow contents of the drug delivery device to be viewed (para 0093); wherein the drug delivery device is arranged along a longitudinal axis and includes an upper surface (plug 42, see fig 8A) at an end of the drug delivery device (see fig 8A), the upper surface including a topmost surface (see annotated figure below) positioned within a plane that is perpendicular to the longitudinal axis and is topmost of the drug delivery device along the longitudinal axis during an injection procedure (fig 3B) and a corner surface (see annotated figure below) connected to the topmost surface (fig 3B) and terminating at an exterior edge immediately upon bending to be perpendicular to the plane (see annotated figure below), and the tapered surface extends from the first portion to the second portion and the tapered surface tapers inwardly continuously from the first portion of the drug delivery device to the second portion (see annotated figure below).
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McLoughlin et al fail to teach a base positioned adjacent the second portion of the handle during at least the injection procedure, the base being wider than the second portion of the handle and adapted to increase stability of the drug delivery device during the injection procedure.
However, Tsals et al disclose a drug delivery device (see fig 3) comprising an injector (device 10), a base (base portion 22), a first portion (upper part of injection device 10) and second portion (lower part of injection device 10), the base being wider than the second portion (see fig 4) and adapted to increase stability of the drug delivery device during the injection procedure (para 0040).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of McLoughlin et al and incorporates the teachings of Tsals et al to have a base positioned adjacent the second portion of the handle during at least the injection procedure, the base being wider than the second portion of the handle and adapted to increase stability of the drug delivery device during the injection procedure. The modification would provide the benefit of making sure said delivery device is securely coupled to said base during injection without the need for an user to hold said device during injection, thereby preventing any needle movements in the tissue during injection (see para 0040).
Regarding claim 2, McLoughlin et al in view of Tsals et al disclose the limitations of claim 1,
Tsals et al further disclose wherein the base (base 22) includes a flange (see fig 1, base 22) that extends outwardly from the second portion of the handle (see fig 4, base 22 extends radially from said second portion).
Regarding claim 6, McLoughlin et al in view of Tsals et al disclose the limitations of claim 2,
Tsals et al further disclose the base (base 22) includes a seal (liner 27C) positioned between portions of the flange (see fig 2A), the seal being at least one of pierceable by the needle of the syringe assembly during the injection procedure or removable prior to the injection procedure taking place (see para 0037, liner 27C is released by pull tab 32 prior to injection).
Regarding claim 8, McLoughlin et al in view of Tsals et al disclose the limitation of claim 1,
Tsals et al further disclose the base (base 22) includes a cradle (receiving portion 24) comprising a collar and a flange (body portion 24 and flange 22), the collar defining a bore (see fig 1, opening of portion 24) adapted to receive the second portion of the handle during the injection procedure (see figs 3 and 4).
Regarding claim 10, f McLoughlin et al in view of Tsals et al disclose the limitations of claim 8,
Tsals et al further disclose the cradle comprises a seal (see fig 1, flange 22 with liner 27C) that defines a portion of the bore (flange 22 defines a portion of said opening).
Regarding claim 11, McLoughlin et al in view of Tsals et al disclose the limitations of claim 10,
Tsals et al further disclose the seal is at least one of pierceable by the needle of the syringe assembly during the injection procedure or removable prior to the injection procedure taking place (see para 0037, liner 27C is released by pull tab 32 prior to injection).
Regarding claim 12, McLoughlin et al in view of Tsals et al disclose the limitations of claim 1,
McLoughlin et al further disclose wherein the second portion of the handle comprises a needle guard (see fig 8B, forward housing part 26, para 0109, head part 26 covers the needle until actuated).
Response to Arguments
Applicant’s arguments, see remarks, filed on 01/07/2026 with respect to the rejections of claims 1, 2, 6, 8, 10-12 have been fully considered but are not persuasive.
With regard to the arguments that McLoughlin et al fail to teach a tapered surface that tapers inwardly continuously from the exterior edge of an upper surface to a second portion, where the upper surface terminates at the exterior edge immediately upon a corner surface of the upper surface bending to be perpendicular, examiner is unsure whether the first portion is the upper surface or the first portion of the handle is a part of the tapered surface. The examiner is interpreting the limitation as “the tapered surface extends from the first portion to the second portion and the tapered surface tapers inwardly continuously from the first portion of the drug delivery device to the second portion”, McLoughlin et al disclose the tapered surface extends from the first portion to the second portion and the tapered surface tapers inwardly continuously from the first portion of the drug delivery device to the second portion (see annotated figure above).
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.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783