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 appl icant regards as his invention. Claim(s) 14 is/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. Regarding Claim 14, Applicant recites “A medicament delivery device (13) comprising a needle shield remove r (1) as claimed in claim 1.” However, this limitation creates confusion as it is unclear exactly what structural components beyond the needle shield remover are actually required by the claim. Specifically, the “medicament delivery device” is found only in the preamble of the claim and not assigned any hardware other than the “needle shield remover”. Claim 1, on which Claim 14 is dependent, recites “A needle shield remover (1) for removing a needle shield (11g) covering a needle (11c) of a medicament delivery device (13)…” It is unclear if Claim 14, by positively requiring the claim to be directed toward “a medicament delivery device”, is also requiring those components functionally recited as part of “a medicament delivery device” in Claim 1, i.e. a needle shield covering a needle, but not explicitly recited as part of the “a medicament delivery device” in Claim 14. For the sake of prosecution it will be presumed that Claim 14 merely requires the needle shield remover to be provided in association with ANY medicament delivery device and not necessarily a specific medicament delivery device comprising the needle shield and needle functionally recited in Claim 1. 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) 1, 5-8, 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/115508 (“Habeshaw”) in view of EP 3409312 (“Grunthut”) and U.S. Publication No. 2003/0181859 (“Brunel”). Regarding Claim s 1 and 14 , Habeshaw discloses a needle shield remover ( Fig. 7 ) for removing a needle shield ( 120 ) covering a needle ( 118 ) of a medicament delivery device (1 14 ), the needle shield remover comprising: - a body having a proximal end (see the closed end – Fig. 9 ) and a distal end ( see the open end receiving the syringe shield – Fig. 9 ), comprising: an outer cap structure ( 130 ) having a distal end opening configured to receive a proximal end of a medicament delivery device ( Fig. 9 ), an inner cap structure ( not labeled; see generally 162 extending “proximally” to the closed end ) arranged radially inwards of and concentrically with the outer cap structure ( see Fig. 9 ), the inner cap structure having a central channel ( see Fig. 9 ); and - a frustoconical (after deformation – see Pg. 5) grabber ( 160 ) arranged in the central channel (see Fig. 9) with the grabber being configured to receive a proximal end of the needle shield (see Fig. 9), wherein the grabber is provided with a plurality of sharp edges (re: “castellations”) configured to engage with and prevent the needle shield from rotating in a first direction relative to the grabber (Pg. 5 – re: the castellations “cut” into the boot thereby anchoring the castellations within the material of the boot which will thereby prevent rotation). In the instant case Habeshaw fails to disclose a distinct top and base, rather the grabber is only shown as disc shaped. While discussion is made by Habeshaw as to frustoconical deformation of the grabber , this configuration is not clearly shown. However, Grunhut discloses a substantially similar grabber ( 23) which can be constructed in various frustoconical configurations (see e.g. Fig. 12) wherein the grabber is arranged within a central channel of a cap body (4) to receive and gasp a needle shield (116) inserted therein (see generally Fig. 5), the grabber having a top (see generally 26 – specifically the common surface from which laminas 26 depend) and a base (31), the grabber being arranged in the central channel (see 144, 146 corresponding with the frustoconical geometry) with the base facing the distal end of the body ( see Fig. 13) , the grabber being configured to receive a proximal end of the needle shield ( see generally Fig. 5 ), wherein the top is provided with a plurality of sharp edges ( 26 ) configured to engage with and prevent the needle shield from rotating in a first direction relative to the grabber (see Col. 2 , Col. 5 ). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the grabber of Habeshaw to have a non-deformed frustoconical shape such that it can be locked into the inner cap via corresponding locking hardware , as disclosed by Grunhut, in order to ensure that the securing shape is consistently maintained (not relying upon inconsistent deformation to assume a frustocontical retaining shape) and adequately affixed to the cap body to prevent accidental separation of the components. It has been held that such mere changes in shape which affect only predictable and expected results are obvious, particularly when such a shape is explicitly known to the art to be a suitable alternative to an existing shape, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966 and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Should Examiner’s argument that recitation toward the teeth of the grippers of Habeshaw and Grunhut which “cut” into the needle shield thereby establishes a clear preventi on of rotation of the shield not b r found persuasive the following is presented. Brunel discloses related grabber teeth (12) which grip a received needle shield (8), whereby the teeth grip into a corresponding surface of the shield to prevent both rotation and longitudinal translation of the shield with respect to the grabber to explicitly ensure that the components remain locked together (Par. 22 , 39, 62). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the device of Habeshaw to rotationally lock the grabber teeth and needle shield together, as disclosed by Brunel, in order to minimize any movement therebetween which might be manipulated to cause the two components to shift or move with respect to one another defeating the engagement. Regarding Claim 5, Habeshaw, as modified, discloses the inner cap structure has a distal ledge ( 34, 142 - Grunhut ) extending radially inwards in the inner channel ( see Fig. 12, 13 – Grunhut) , and wherein the grabber has a slot ( see the lip formed at 31 - Grunhut ) configured to engage with the ledge to restrict axial movement of the grabber towards the proximal end of the body. Regarding Claim 6, Habeshaw, as modified, discloses the sharp edges (28 - Grunhut ) point towards the proximal end of the body ( see Fig. 13) and provide a ratchet function on the needle shield ( i.e. because the teeth are unidirectional the teeth will slide/deflect over the needle shield when inserted in a first direction, but will resist pull-out when a removal force is attempted to be applied to the needle shield body ). Regarding Claim 7, Habeshaw, as modified, discloses the grabber is mechanically flexible and configured to flex radially outwards by pressure provided by the needle shield ( see Col. 2 - Grunhut ). Regarding Claim 8, Habeshaw and Grunhut both disclose the grabber comprises metal (see Col. 2, Grunhut; Pg. 5, Habeshaw) . Regarding Claim 10, Habeshaw discloses the inner cap structure has a shorter axial extension in a direction from the proximal end to the distal end than the outer cap structure ( see Fig. 9 ). Regarding Claim 11, Habeshaw discloses the central channel is cylindrical (see Fig. 7) . Regarding Claim 12, Habeshaw, as modified, discloses the frustoconical grabber is configured to engage with and cut into the needle shield ( Pg. 5 – Habeshaw; Col. 2, Grunhut ) when the needle shield remover is pulled from a medicament delivery device, so that removal of the needle shield remover from the medicament delivery device thus also removes the needle shield . Regarding Claim 13, Habeshaw, as modified, discloses the plurality of sharp edges are configured to engage with and prevent the needle shiel d from rotating in a first direction relative to the grabber by cutting into an external surface of the needle shield when the needle shield remover is rotated in the first direction relative to a medicament delivery device containing a syringe with the needle shield, and/or when the needle shield remover is pulled from the medicament delivery device ( Pg. 5, Habehsaw; Col. 2, Grunhut; Par. Par. 22, 39, 62, Brunel ). Claim (s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/115508 (“Habeshaw”) in view of EP 3409312 (“Grunthut”) and U.S. Publication No. 2003/0181859 (“Brunel”) as applied above, and further in view of WO 2019/101613 (“Dasbach”) . Regarding Claim 2, Habeshaw, as modified by Grunhut, discloses the central channel has an inner surface provided with an axially extending rib ( see 142 - Grunhut ) and the grabber has a cooperative geometry for engaging the rib (sere Fig. 12) to lock the frustoconical grabber in place within the cap body. However, Grunthut fails to disclose that the grabber has a “slit” which prevents “rotation of the grabber relative to the inner cap structure”. Dasbach discloses a similar grabber (10) and inner cap (22, circa 24 – see Fig. 4)) wherein the inner surface of the inner cap comprises a rib (24) which engages with a corresponding slit (21) of the grabber to prevent not only relative longitudinal movement of the grabber with respect the cap, but also rotational movement (Pg. 12). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the grabber of modified Habeshaw to have a plurality of circumferentially offset windows corresponding to the circumferential offset of the ribs (see 142 – Grunhut), as disclosed by Dasbach, in order to ensure that the cap and grabber are circumferentially and axially locked to thereby prevent relative rotation and potential misalignment, which might disrupt the seating between the two components leading to improper interaction between the grabber and shield. Regarding Claim 3, Habeshaw, as modified, discloses the inner cap structure is provided with a mounting stop ( 34 – see Grunhut ) extending radially inwards relative to an inner surface of the central channel, the mounting stop being configured to prevent the grabber from moving out axially from the central channel in a direction towards the distal end of the body ( see Fig. 3 – Grunhut). Regarding Claim 4, Habeshaw, as modified, discloses the mounting stop (7b) is arranged axially aligned with the rib (see Fig. 12 – Grunhut). Claim (s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/115508 (“Habeshaw”) in view of EP 3409312 (“Grunthut”) and U.S. Publication No. 2003/0181859 (“Brunel”) as applied above, and further in view of WO 2017/223354 (“Newton”) . Regarding Claim 9, Habeshaw, as modified, discloses the invention substantially as claimed except that that the central channel defines a proximal opening at the proximal end of the body. Rather Habeshaw illustrates a closed proximal end (see Fig. 9). However, Newton discloses a related needle shield remover comprising a central channel which defines a proximal opening at the proximal end of the body ( see Fig. 3 ). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the central channel of Habeshaw to have an open proximal end, as disclosed by Newton, in order to reduce the risks of the cap as a choking hazard should it accidentally be swallowed, particularly by a child mishandling the device. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT WILLIAM R CARPENTER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3637 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT) . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT KEVIN SIRMONS can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-4965 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783 03/11/2026