DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Final Office Action is in Reply to the arguments/amendment after non-final rejection (hereinafter “Response”) dated 08/20/2026. Claim(s) 16-30 are presently pending. Claim(s) 16, 20, 24, and 27-29 is/are amended.
Response to Amendment and Arguments
The rejections of claim(s) 16-30 under 35 U.S.C. 112(b) is/are withdrawn in light of the submitted amendment to the claims, applicant(s) amendment having addressed the issues identified in these rejections, however, applicant(s) amendment has introduced new issues of indefiniteness and new matter, as described below. Therefore, these claims are rejected under 35 U.S.C. 112(b) according to new grounds of rejection as caused by applicant(s) amendments.
The rejection of claims 16-19 and 22-24 under 35 U.S.C. 102 as being anticipated by Holmqvist (U.S. Pat. Pub. No. 2013/0324934 A1) is/are withdrawn in light of the submitted amendment to the claims and in view of applicant(s) arguments. No present rejection of these claims over the prior art is presented due to the matters of indefiniteness described below.
The rejection of claims 16-19 and 22-25 under 35 U.S.C. 102 as being anticipated by Holmqvist ‘905 (U.S. Pat. Pub. No. 2013/0237905 A1) is/are withdrawn in light of the submitted amendment to the claims and in view of applicant(s) arguments. No present rejection of these claims over the prior art is presented due to the matters of indefiniteness described below.
The rejection of claims 26-30 under 35 U.S.C. 103 as being obvious over Holmqvist in view of Olson (U.S. Pat. Pub. No. 2013/0131590 A1) is/are withdrawn in light of the submitted amendment to the claims and in view of applicant(s) arguments. No present rejection of these claims over the prior art is presented due to the matters of indefiniteness described below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 16-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 16 recites “a plurality of proximally directed surfaces on the delivery member guard.” The original disclosure does not describe proximally directed surfaces provided on the delivery member guard. Instead, the specification describes the plurality of proximally directed surfaces as being part of the body of the delivery member guard locking member (see Fig. 4, 7A, and 13A-13B, pg. 8, ln 25 – pg.9, ln 7, pg. 10, ln 22 – pg.11, ln 10, and pg. 14, ln 12 – pg. 15, ln 4, which blocks the guard adapter by abutting the guard adapter’s distally directed surface (pg. 14, ln 29 – pg. 15, ln 4). When found within the specification, the delivery member guard is described either as not part of the sub-assembly (pg. 13, ln 6-17) or as being the guard adapter itself (pg. 13, ln 18 – pg. 14, ln 7). The cited limitation is thus new matter. Appropriate correction or removal is required.
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.
Claims 16-30 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 16 recites the limitation “the delivery guard member.” There is insufficient antecedent basis for this limitation, because the claim recites only “a delivery guard locking member.” It is thus unclear whether the delivery guard locking member is a required component of the claimed sub-assembly or not. Further complicating the issue, the specification does discuss “a delivery guard locking member”, but within the specification the delivery member guard is described either as not part of the sub-assembly (pg. 13, ln 6-17) or as being the guard adapter itself (pg. 13, ln 18 – pg. 14, ln 7). It is thus unclear whether the delivery member guard is a required element of the sub-assembly or how it relates to the guard adapter. Appropriate clarification or correction is required.
Claim 16 also recites that the locking member moves relative to the guard adapter between an unlocked position and a locked position, defined (at least in part) by whether the guard adapter’s distally directed surface is aligned/overlapped with “a plurality of proximally directed surfaces on the delivery member guard.” Because no structural relationship is established between the locking member and those surfaces within the claim, it is unclear how movement of the locking member causes changes in the alignment or overlap. Looking to the specification further complicates matters, since the delivery member guard is described within the specification either as not part of the sub-assembly (pg. 13, ln 6-17) or as being the guard adapter itself (pg. 13, ln 18 – pg. 14, ln 7). Neither interpretation remedies the deep uncertainty created by the cited limitation or explains how movement of the locking member is in any way related to the alignment or misalignment of the guard adapter’s distally directed surface with respect to “a plurality of proximally directed surfaces”, such a feature being provided either on a component that is not part of the claimed apparatus at all (pg. 13, ln 6-17), or else being provided on the guard adapter itself (pg. 13, ln 18 – pg. 14, ln 7), a logical impossibility. This deep uncertainty in meaning creates significant uncertainty in the scope of the claim, rendering claim 16 and all claims dependent therefrom (claims 17-30) indefinite. Appropriate clarification and/or correction is required. For examination purposes, no reasonable interpretation of the scope of the claims could be made in view of the deep uncertainties described herein, both in regards 35 U.S.C. 103 and in re 35 U.S.C. 102. Thus, no rejection of the claims 16-30 over the prior art are presented in this office action, however, such should not be taken as an indication of allowability.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. This art includes
Holmqvist (U.S. Pat. Pub. No. 2013/0324934 A1) (already of record) discloses subject matter relevant to claims 16-19 and 22-24 (see prior Non-Final rejection, para. 16), and teaches a plurality of proximally directed surfaces (proximally facing surfaces on the circumferentially extending portion 144 of each of the two flexible arms 142 of the rotator barrel 132) provided on the delivery member guard locking member (rotator barrel 132) (see prior Non-Final rejection, para. 16). Holmqvist, however, fails to teach that the plurality of proximally directed surfaces extend radially outward relative to the longitudinal axis of the housing.
Steffanov (U.S. Pat. Pub. No. 2018/0296773 A1), relevant at least to claims 16, 17, and 22, teaches a subassembly of a medicament delivery device similar to that of Holmqvist, comprising a housing (housing 10) within which a delivery member guard/adapter (guard 64) and delivery member guard locking member (rotator 82) similar to those of Holmqvist are provided (see Fig. 1 and 5-6, and [0019-0022]). The delivery member guard/adapter of Steffanov further comprises two distally directed surfaces/arms upon which protrusions 78 are provided (see Fig. 6). As the delivery member guard/adapter is pressed distally towards the locking member, protrusions 78 ride inclined ridges 80i of the locking member, and thereby cause it to rotate from an unlocked starting position to a locked position wherein the protrusions become aligned with and pass over protrusions 86 of the locking member and are trapped in place (see Fig. 6, [0029], and [0031]). There being two protrusions 86 (corresponding to two protrusions 78 of the delivery member guard/adapter), and these surfaces being oriented (directed) in the manner of proximally and radially outwardly climbing ramps, it follows that the two protrusions 86 of Steffanov may be considered a plurality of proximally directed surfaces whose surfaces extend radially outward relative to the longitudinal axis of the housing (see Fig. 6, [0022], and [0031]). It is likely that one of ordinary skill in the art, having seen Steffanov, would consider it an obvious matter of routine substitution to exchange the circumferentially active delivery member guard locking arrangement in Holmqvist to instead comprise the that the delivery member guard comprises radially inwardly extending delivery member protrusions provided on the distally directed surfaces, the locking member comprises guide surfaces provided on the radially outer surface thereof, and the locking member further comprise a plurality of radially outwardly extending proximally directed surfaces configured to engage and trap the delivery member protrusions as the delivery member is pressed distally towards the locking member, as taught by Steffanov.
Olson (U.S. Pat. Pub. No. 2013/0131590 A1), relevant at least to claims 26-30, teaches a subassembly of a medicament delivery device similar to that of Holmqvist, comprising a housing (110) within which a delivery member guard (needle shield 114) and delivery member guard locking member (rotator 126) similar to those of Holmqvist are provided (see Fig. 7-12 and [0053-0056). Olsen teaches that the advancement and subsequent locking of the delivery member guard may be controlled by the use of a well-known variety of engagement features/configurations. One such engagement configuration is to provide a delivery member guard locking member with ratchet-like ledges 42, which may face radially outward/inward (see Fig. 6c) to engage with a portion of the delivery member guard for limiting its advancement to only one direction when the portion and ledges are aligned (see Fig. 6a-6c and [0046]). Such a reference may be used to further modify a radially outwardly directed of proximally directed surface, such as each of those in Steffanov, to instead be embodied as a plurality of rachet-like ledges, thereby creating a graduated locking process wherein the delivery member guard is allowed to advance proximally in graduated steps and prevented at each step from retraction in the distal direction. Such may have the advantageous effect of ensuring that the delivery member guard is not accidentally withdrawn and the needle exposed after injection due to user error (fumbling of the device) or malfunction which may prevent the delivery member guard from fully extending.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
