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 Objections
Claim 42 is objected to because of the following informalities: in the last line “at least one holder interface feature” should be “the at least one holder interface feature”. Appropriate correction is required.
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.
Claim 58 is 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 58 recites “the gripper holder comprises a radially extending recess or a radial opening” this feature is already recited in claim 42 and it is not clear if this is the same or a different opening. For purposes of the rejection, it is taken as the same opening.
The term “sensitive” in claim 58 second to last line is a relative term which renders the claim indefinite. The term “sensitive” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the characteristic of the region is rendered indefinite. Further, there is insufficient antecedent basis for the limitation “the at least one sensitive region” in the claim. For purposes of the rejection it is considered as the plane surface region or less bent surface region.
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) 42-59 and 61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schader et al. (WO 2019/086575 A1).
With regard to claims 42, 45-47, and 51, Schader et al. teach a needle shield removal assembly for a drug delivery device, the needle shield removal assembly comprising: a needle shield gripper configured to operatively engage a needle shield and to interlock with the needle shield (Fig. 18 member 12.1); and a gripper holder (Fig. 13 member 12), wherein the needle shield gripper is secured to the gripper holder via a connection interface established between the gripper holder and the needle shield gripper, wherein the connection interface is formed by at least one holder interface feature of the gripper holder engaging at least one gripper interface feature of the needle shield gripper (Fig. 15 holder interface inwardly deflecting arms 12.5.1 incline 12.5.1.3, gripper interface 12.1.2); wherein the gripper holder has a holder opening, the holder opening being configured and dimensioned to receive the needle shield gripper and/or the needle shield, wherein the at least one holder interface feature is offset from the holder opening (Fig. 13 opening of 12 opposite 12.6); wherein the gripper holder defines a receiving space within which the needle shield gripper is received (Fig. 13 space within 12); wherein the receiving space has an axial extension directed away from the holder opening (Fig. 13 in the direction toward 12.6); wherein the gripper holder has a radial recess or a radial opening in a section of the gripper holder which is axially angularly offset from the at least one holder interface feature (Fig. 13 space around 12.5.1, see Reference Figure 1 below); and wherein a first axial end of the radial recess or radial opening which faces towards the holder opening is axially offset from the holder opening, and wherein the radial recess or radial opening overlaps axially with at least one holder interface feature (Fig. 13, see Reference Figure 1 below, the opening is offset in an angular direction from the interface and overlaps with the interface along an axis perpendicular to the longitudinal axis of the holder, the first end is axially offset from the opening along the longitudinal axis of the holder).
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With regard to claims 43 and 44, see the walls of 12.5 (Fig. 13).
With regard to claim 48, 12.5.1.3 is angled creating an opening with an angular radial width that varies (Fig. 13).
With regard to claim 49, the second end is offset from the holder interface in an axial direction perpendicular to the longitudinal axis of the holder and is away from the holder opening as it is in a plane below the holder opening.
With regard to claim 50, at least the second axial end is an open axial end.
With regard to claims 52 and 53, the bent region above 12.1.2 overlaps with the opening, the width of the opening is greater due to 12.5.1.3 (Figs. 13 and 18).
With regard to claims 54-56, 12.1 is fixed to 12 (Pg. 9 line 17), 12.1.1 abuts surface in 12.4.
With regard to claim 57, see at least the interlock features which are not numbered but are flexed inward (Fig. 18).
With regard to claim 58, see Fig. 18 there are non-numbered portions where there are protrusions which are bent inward on either side of region which are planer/less bent.
With regard to claim 59, Schader et al. teach a drug delivery device comprising the needle shield removal assembly of claim 42 (see the rejection above) and a reservoir, the reservoir comprising a drug (Fig. 1A member 24, Pg. 9 line 11), wherein the drug delivery device further comprises a needle (Fig. 1B member 17) and a needle shield, the needle being at least partly covered by the needle shield, wherein the needle shield gripper engages the needle shield such that the needle shield can be removed from the needle using the needle shield removal assembly, and wherein the needle shield removal assembly is a cap assembly of the drug delivery device (Fig. 11 inner shield).
With regard to claim 61, Schader et al. teach a drug delivery device comprising the needle shield removal assembly of claim 42 (see the rejection above), wherein the needle shield gripper and the gripper holder are adjusted to one another to prevent mechanical contact of a) the gripper holder and a bent or kinked region of the needle shield gripper (Fig. 18 in the area of 12.1.2) and/or of b) the gripper holder and an edge or corner of the needle shield gripper during insertion of the needle shield gripper into the receiving space via the opening in at least one region of the gripper holder which is angularly offset from the at least one holder interface feature.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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. Applicant argues 12.5.1 does not secure a needle shield gripper or engage at least one gripper interface features. The Examiner maintains that Fig. 15 shows 12.5.1 engaged with 12.1. 12.5 is in contact with 12.1. The rejection to the radial recess ore opening has been modified in light of the 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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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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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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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