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 § 102 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 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) 1 -2, 4-5, 8 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Tsals US 5,858,001 . Regarding claim 1, Tsals discloses a needle shield remover for a wearable injector , Tsals discloses a cartridge based drug delivery device having a needle 102 that is capable of functioning as a needle shield remover comprising: a first portion 106 comprising a cam member , labeled cam , the first portion having a top surface F1S and a bottom surface F2S positioned opposite to the top surface; and a second portion 95 connected to the first portion , via hinge 107 , the second portion having a top surface S1S and a bottom surface S2S positioned opposite to the top surface, the second portion comprising a device connector 92 configured to secure the second portion of the needle shield remover to the wearable injector, wherein the first portion is moveable relative to the second portion between a first po sition where the cam member is aligned with the top surface of the second portion and a second position where the cam member protrudes from the top surface of the second portion, and wherein the cam member is configured to contact a housing of the wearable injector when the first portion is in the second position. Referring to figs. 13-15, in the first po si tion shown partially in fig. 15, where the mounting lever 106 is capable of laying flat/aligned with the second portion 95, and concentric with the S1S, and a second position where the cam member protrudes from the top surface of the second portion, as seen in fig. 13 , where the cam portion is capable of contacting a housing of the wearable injector . The Examiner notes that the claim only recites a needle shield remover with the recited claims and not the components of the wearable injector , where the cam element, the first and second portions can be arranged on a wearable injector to remove a needle shield. Regarding claim 2, Tsals discloses the first portion is connected to the second portion via a hinge. See element 107 . Regarding claim 4, Tsals discloses the first portion is moveable from 0 to 90 degrees relative to the second portion. See fig. 15 where the first portion is shown at almost 0 degrees and fig. 13 where the first portion is at 90 degrees. Regarding claim 5, Tsals discloses the cam member is parallel to the top surfaces of the first portion and the second portion when the first portion is in the first position. Referring to fig. 15, Tsals shows the surface 106 would be parallel to S1S and F1S when fully locked down. Figure 15 shows the condition when the system is almost fully engaged. Regarding claim 8, Tsals discloses the first portion comprises a handle. See annotated figure above labeled handle . 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . Claim (s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsals in view of Wickham US 2017/0281878 . Regarding claim 3, Tsals discloses all elements except for the hinge is a living hinge. Rather Tsals teaches that the hinges are pins. Wickham teaches that a hinged structure may be living hinges or pins passing through securing holes. See para. [0120] . It would have been obvious to an ordinary skilled worker to substitute the pin hinges of Tsals with a living hinge as taught by Wickam as part of an obvious substitution of known elements, in this case a pin hinge for a living hinge, to achieve predictable results. See KSR; MPEP 2141 III B . Additionally Wickam states that pin hinges and living hinges are obvious variants of each other. See para. [0120] . Allowable Subject Matter Claim s 9-16 are allowed. Claim s 6-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding claim 9, the prior art does not teach a wearable injector having a housing as claimed, a needle as claimed, a needle shield remover… where the cam member is aligned with the top surface of the second portion in a first position and the cam member protrudes from the top surface of the second portion… and configured to contact a housing of the wearable injector in combination with the remaining elements claimed. Regarding claim 6, the limitation “a needle shield comprising a body defining an opening configured to receive a needle of the wearable injector” in combination with the remaining elements as claimed. The closest prior art of record is clearly Clasen US 2022/0313925 which shows a substantially identical wearable injector shown in figs. 1-17 including a needle shield remover shown in figs. 18-21, the needle shield remover has a first portion 212 and a second portion 208 with a needle shield 218. In operation the portion 212 is bent up to 90 degrees from fig. 18 about hinge 216 and the user pulls the needle shield remover off. However, the device does not provide a cam member as claimed. Levered devices are known in the art. See WO 2018/222636 showing a levered needle shield 10, however, the element downstream of the hinge 53 connected to spring 64 does not operate as a cam as claimed or configured to be operable as a cam as claimed . Similarly, Dhami US 2015/0182689 teaches a cam 48 on a levered device, see fig. 7b . However, the cam isn’t aligned or protruding as claimed. The Examiner notes that absent structure drawn to the needle shield or wearable injector, numerous references showing a levered structure would appear to anticipate claim 1. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT GERALD LUTHER SUNG whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3765 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 9-5 PST . 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /GERALD L SUNG/ Primary Examiner, Art Unit 3741