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. Information Disclosure Statement The information disclosure statement (IDS), submitted on 11/17/2023, has been considered by the examiner. 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. Claims 2, 4, 7, 9-12, and 15, 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 2] The claim recites the limitation of “the cannula” in the 19 th line of the claim. There is a lack of antecedent basis for this limitation in the claims. Further more , the examiner is unable to determine the metes and bounds of the claim, since it is unclear if “the cannula” is intended to be rigid or flexible “extending from the hub,” thus introducing ambiguity into what direction is considered to be parallel. For purposes of examination, it is interpreted that “a direction away from the hub parallel to the cannula extending from the hub” is proximally directed and parallel with the longitudinal axis of the hub. [Claim 4] The claim is rejected based upon its dependency from claim 2. [Claim 7] The claim recites the limitation of “the same inclination angle” in the 4 th line of the claim. There is a lack of antecedent basis for this limitation in the claim. [Claims 9 and 10] The claim recites the limitation of “the angular displacement” in the 2 nd lines of the claim. There is a lack of antecedent basis for these limitations in the claims. [Claim 11] The claim recites the limitation of “a protector removable engageable” in the 2 nd line of the claim. The examiner is unable to determine the metes and bounds of the claim, since the phrase is grammatically incorrect. For purposes of examination, it is interpreted the phrase should recite “a protector removably engageable.” [Claim 12] The claim recites the limitation of “the sheath comprises bridge elements arranged in the receiving space which bridge elements support on the protector in the starting position of the sheath.” The examiner is unable to determine the metes and bounds of the claim, since the phrasing appears to be grammatically incorrect. For purposes of examination, it is interpreted that the limitation should recite “the sheath comprises bridge elements arranged in the receiving space which are configured to be supported by a protector in the starting position of the sheath.” [Claim 12] The claim recites the limitation of “the protector ” in the 3 rd line of the claim. There is a lack of antecedent basis for this limitation in the claim. [Claim 15] The claim recites the limitation of “ a hard case comprising a cap and a case in which case the safety needle assembly is inserted when the sheath is in the starting position.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear what is intended to be encompassed by the term “hard case.” Specifically, it is unclear how the “case” is to be differentiated from the overall “hard case” which also comprises a “cap.” Furthermore, the phrasing of “in which case” adds unnecessary confusion into the claim limitation. For purposes of examination, it is interpreted the limitation recites “a hard case comprising a cap and a body wherein the safety needle assembly is inserted when the sheath is in the starting position.” 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, 3, 5-7, and 10-1 7 , are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Crawford et al. (PGPub 2002/0161336) . [Claim 1] Crawford teaches a safety needle assembly (figure 1) comprising: a hub (figure 2, items 60/90) having a proximal end for connecting with a syringe (the examiner notes the “syringe” is not a positively recited claim limitation) extending in a proximal area of the hub (figure 9) ; a needle (figure 2, item 40) longitudinally extending from a distal end of the hub (figure 2, item s 60 /90 ) in a distal area of the hub (figure 2) ; a sheath (figure 2, item 140) pivotally connected (via items 182/114) to the hub (figure 2, items 60/90) (paragraph [0064]) , the sheath (figure 2, item 140) having two side walls (figure 3a, items 162) connected by a back wall (figure 3a, items 174/188) defining a receiving space (figure 3a, item s 160 /192 ) therebetween for receiving the needle (figure 2, item 40) ; wherein the sheath (figure 2, item 140) is adjustable between a starting position (figure s 1 and 7 ) in which the sheath (figure 2, item 140) is substantially positioned in the distal area of the hub (figure 2, items 60/90) , between a use position (figures 9-11) in which the sheath (figure 2, item 140) is substantially positioned in the proximal area of the hub (figure 2, items 60/90) , and between a locked position (figure 13) in which the sheath (figure 2, item 140) is locked to secure the needle (figure 2, item 40) into the receiving space (figure 3a, item s 160 /192 ) ; wherein in the starting position (figures 1 and 7) the sheath (figure 2, item 140) is longitudinally extending from the hub (figure 2, items 60/90) , wherein the hub (figure 2, items 60/90) is provided with at least one first cooperating element (figure 15a, items 118/120) and the sheath (figure 2, item 140) is provided with at least one second cooperating element (figure 15a, item 194) , wherein, in the locked position (figure 13) of the sheath (figure 2, item 140) , the first (figure 15a, items 118/120) and the second (figure 15a, item 194) cooperating elements are engaged to each other for locking the sheath (figure 2, item 140) (figure 15a; paragraph [0067]) , wherein, in the starting position (figures 1 and 7) , the first (figure 15a, items 118/120) and second (figure 15a, item 194) cooperating elements are in contact with each other (the examiner notes the two elements are always “in contact” with each other) for defining the starting position (figures 1 and 7) of the sheath (figure 2, item 140) . [Claim 3] Crawford teaches the limitations of claim 1, upon which claim 3 depends. In addition, Crawford discloses the at least one first cooperating element (figure 15a, items 118/120) longitudinally extends (figure 15a) from the distal end of the hub (figure 2, items 60/90) . [Claim 5] Crawford teaches the limitations of claim 1, upon which claim 5 depends. Crawford also teaches the at least one second cooperating element (figure 15a, item 194) protrudes from the back wall (figure 3a, items 174/188) of the sheath (figure 2, item 140) into the receiving space (figure 3a, items 160/192) (figures 15a/15b) , and/or, wherein the at least one second cooperating element (figure 15a, item 194) is at least one opening in the sheath (figure 2, item 140) . [Claim 6] Crawford teaches the limitations of claim 1, upon which claim 6 depends. Crawford further discloses at least one of the first (figure 15a, items 118/120) and second (figure 15a, item 194) cooperating elements is provided as a snap fit element (figures 15a/15b) that engages in a snap-fit connection in the locked position of the sheath (figure 2, item 140) (paragraph [0060]) . [Claim 7] Crawford teaches the limitations of claim 1, upon which claim 7 depends. Crawford also discloses the first (figure 15a, items 118/120) and second (figure 15a, item 194) cooperating elements each are provided with inclined contact surfaces (figures 15a/15b , items 122/195 ) that are configured for contacting each other ( again, the examiner notes the two elements are always “in contact” with each other) in the starting position (figures 1 and 7) of the sheath (figure 2, item 140) , the contact surfaces (figures 15a/15b, items 122/195) having the same inclination angle (figure 15b) . [Claim 10] Crawford teaches the limitations of claim 1, upon which claim 10 depends. In addition, Crawford teaches an angular displacement of the sheath (figure 2, item 140) between the starting position (figures 1 and 7) and the use position (figures 9-11) is more than 90 degrees (as best shown in figure 10) . [Claim 11] Crawford teaches the limitations of claim 1, upon which claim 11 depends. Crawford further discloses a protector (figure 1, item 50) removably engageable to the distal end of the hub (figure 2, items 60/90) for protecting the needle (figure 2, item 40) when the sheath (figure 2, item 140) is in the starting position (figures 1 and 7) (paragraph [0053]) . [Claim 12] Crawford teaches the limitations of claim 1, upon which claim 12 depends. Crawford also teaches the sheath (figure 2, item 140) comprises bridge elements (figures 3a and 6, item 192) arranged in the receiving space (figure 3a, items 160/192) which are configured to be supported by a protector (figure 1, item 50) in the starting position (figures 1 and 7) of the sheath (figure 2, item 140) . [Claim 13] Crawford teaches the limitations of claim 1, upon which claim 1 3 depends. Crawford also discloses the sheath (figure 2, item 140) further is provided with an additional cooperating element (figure 13, item 167) for engaging with a distal end of the needle (figure 2, item 40) in the locked position (figure 13) of the sheath (figure 2, item 140) (figure 13; paragraph [0058]) . [Claim 14] Crawford teaches the limitations of claim 1, upon which claim 14 depends. Crawford further discloses the sheath (figure 2, item 140) comprises a recess region (figure 1, area of item 163) to engage with a finger of a user (figure 8) , such that the user can pivot the sheath (figure 2, item 140) between the starting position (figures 1 and 7) , the use position (figures 9-11) and/or the locked position (figure 13) . [Claims 15-17] Crawford teaches the limitations of claim 1, upon which claims 15-17 depend. In addition, Crawford teaches a hard case (figure 2, items 50/52) comprising a hard cap (figure 2, item 52) and a body (figure 2, item 50) wherein the safety needle assembly is inserted when the sheath (figure 2, item 140) is in the starting position (figures 1 and 7) (figure 1; paragraph [0053]) . Claim s 1-4, 6-10, and 14, are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sweeney et al. (USPN 5,746,726) . [Claims 1, 2, and 4] Sweeney teaches a safety needle assembly (figure 1, item 10) comprising: a hub (figure 4, item 22) having a proximal end (figure 4, item 24) for connecting with a syringe (figure 5, item 12) (the examiner notes the “syringe” is not a positively recited claim limitation) extending in a proximal area of the hub (figure 4, item 22) (figure 5) ; a needle (figure 4, item 14) longitudinally extending from a distal end (figure 4, item 26) of the hub (figure 4, item 22) in a distal area of the hub (figure 4) ; a sheath (figure 1, item 36) pivotally connected to the hub (figure 4, item 22) (figures 5-8) , the sheath (figure 1, item 36) having two side walls (figure 3, item 42) connected by a back wall (figure 3, item 38) defining a receiving space (figure 3, item 44) therebetween for receiving the needle (figure 4, item 14) ; wherein the sheath (figure 1, item 36) is adjustable between a starting position (figure 5) in which the sheath (figure 1, item 36) is substantially positioned in the distal area of the hub (figure 4, item 22) (figure 5) , between a use position (figure 7) in which the sheath (figure 1, item 36) is substantially positioned in the proximal area of the hub (figure 4, item 22) (figure 7) , and between a locked position ( figure 5, via figure 8 ) in which the sheath (figure 1, item 36) is locked to secure the needle (figure 4, item 14) into the receiving space (figure 3, item 44) (figure 5) ; wherein in the starting position (figure 5) the sheath (figure 1, item 36) is longitudinally extending from the hub (figure 4, item 22) , wherein the hub (figure 4, item 22) is provided with at least one first cooperating element ( figure 6, items 58/60 ) and the sheath (figure 1, item 36) is provided with at least one second cooperating element (figure 6, item 56) , wherein, in the locked position (figure 5, via figure 8 ; the examiner notes that the claim language does not preclude the “starting position” and the “locked position” from being identical ) of the sheath (figure 1, item 36) , the first (figure 6, items 58/60) and the second (figure 6, item 56) cooperating elements are engaged to each other for locking the sheath (figure 1, item 36) (figure 5) ; wherein, in the starting position (figure 5) , the first (figure 6, items 58/60) and second (figure 6, item 56) cooperating elements are in contact /engage with each other for defining the starting position (figure 5) of the sheath (figure 1, item 36) by abutting to each other (figure 5) ; wherein, the first cooperating element (figure 6, items 58/60) protrudes in a direction away (the examiner notes the element protrudes away in both the proximal and distal direction) from the hub (figure 4, item 22) parallel to the cannula extending from the hub (figure 4, item 22) (figure 5) and the second cooperating element (figure 6, item 56) protrudes from the back wall (figure 3, item 38) of the sheath (figure 1, item 36) in a direction approximately parallel (figure 3) to the side walls (figure 3, item 42) into the receiving space (figure 3, item 4 4 ) (figures 3 and 5) . [Claim 3] Sweeney teaches the limitations of claim 1, upon which claim 3 depends. In addition, Sweeney discloses the at least one first cooperating element (figure 6, items 58/60) longitudinally extends ( again, the examiner notes the element protrudes away in both the proximal and distal direction) from the distal end of the hub (figure 4, item 22) (figure 5) . [Claim 6] Sweeney teaches the limitations of claim 1, upon which claim 6 depends. Sweeney further discloses at least one of the first (figure 6, items 58/60) and second (figure 6, item 56) cooperating elements is provided as a snap fit element that engages (figure 5, via figure 8) in a snap-fit connection in the locked position ( figure 5, via figure 8 ) of the sheath (figure 1, item 36) . [Claims 7 and 8] Sweeney teaches the limitations of claim 1, upon which claim s 7 and 8 depend. Sweeney also discloses the first (figure 6, items 58/60) and second (figure 6, item 56) cooperating elements each are provided with inclined contact surfaces (see annotated figure below) that are configured for contacting each other in the starting position (figure 5) of the sheath (figure 1, item 36) , the contact surfaces (see annotated figure below) having the same inclination angle (the examiner notes that any point of direct contact between two surfaces can be considered to have the same inclination angle) ; wherein the first (figure 6, items 58/60) and second (figure 6, item 56) cooperating elements further are provided with further contact surfaces (see annotated figure below) , at a different angle than the inclined contact surfaces (see annotated figure below) , wherein the further contact surfaces (see annotated figure below) are configured for contacting each other in the locked position ( figure 5, via figure 8 ) of the sheath (figure 1, item 36) . [Claims 9 and 10] Sweeney teaches the limitations of claim 1, upon which claims 9 and 10 depend. In addition, Sweeney teaches an angular displacement of the sheath (figure 1, item 36) between the starting position (figure 5) and the locked position ( figure 5, via figure 8 ) of the sheath (figure 1, item 36) is less than 20 degrees (figure 5; again, the examiner notes that the claim language does not preclude the “starting position” and the “locked position” from being identical) and an angular displacement of the sheath (figure 1, item 36) between the starting position (figure 5) and the use position (figure 7) is more than 90 degrees (figures 5 and 7) . [Claim 14] Sweeney teaches the limitations of claim 1, upon which claim 14 depends. Sweeney further discloses the sheath (figure 1, item 36) comprises a recess region (as best shown in figure 8) to engage with a finger of a user (figure 8) , such that the user can pivot the sheath (figure 1, item 36) between the starting position (figure 5) , the use position (figure 7) and/or the locked position ( figure 5, via figure 8 ) . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JASON E FLICK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7024 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 7 a.m.-3 p.m. Eastern Time . 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 Bhisma Mehta can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-3383 . 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. /JASON E FLICK/ Primary Examiner, Art Unit 3783 03/09/2026