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 § 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 58 and 61 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 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 claims 58 and 61 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. The term “reduce” in claims 58 and 61 is a relative term which renders the claim indefinite. The term “reduce” 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 amount of contact is indefinite. There is no initial value of contact which is ascertained to which the reduction is compared.
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) 42-61 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, 51, 58, 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 12.5); wherein the gripper holder defines a receiving space within which the needle shield gripper is received (Fig. 13 space within 12.5); wherein the receiving space has an axial extension directed away from the holder opening (Fig. 13 in the direction toward 12.6); and wherein the gripper holder has a radial recess or a radial opening in a section of the gripper holder which is axially and/or angularly offset from the at least one holder interface feature (Fig. 13 space above 12.5.1, considered to be in a sensitive region).
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 claims 49 and 50, the first end is in the area of 12.5.1 (is at least associated with an axial position of the holder interface), the second end is the area on either side of where 12.5.1 pivots (Fig. 13).
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 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 60, 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 12.5.1, 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 (Fig. 13 opening of 12.5); wherein the holder interface feature is arranged to block movement of the needle shield gripper towards the holder opening by a blocking portion of the needle shield gripper abutting a surface of the holder interface feature facing away from the opening (12.1 is fixed to 12 (Pg. 9 line 17), 12.1.1 abuts surface in 12.4); and wherein the blocking portion of the needle shield gripper is arranged in a region between an end surface of the needle shield gripper and an axially oriented portion of the needle shield gripper (Fig. 11).
With regard to claim 61, 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 12.5.1, gripper interface 12.1.2); wherein the gripper holder has an opening, the 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 opening (Fig. 13 opening of 12.5); wherein the gripper holder defines a receiving space within which the needle shield gripper is received, wherein the receiving space has an axial extension directed away from the opening (Fig. 13 space within 12.5); and wherein the needle shield gripper and the gripper holder are adjusted to one another to reduce or 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 sensitive region of the gripper holder which is angularly offset from the at least one holder interface feature.
Conclusion
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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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783