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 .
Acknowledgments
In the reply, filed on May 11, 2026, Applicant amended claims 22, 27-29, 31, 33, 35-39, and 41.
Applicant added new claim 42.
In the non-final rejection of February 11, 2026, Examiner objected to claims 22, 28, 39, and 41. Applicant amended claims 22, 28, 39, and 41; however, Applicant did not address all of the objections. Objection is maintained.
Examiner rejected claims 27, 29-31, and 35-41 under 35 U.S.C. 112(b). Applicant amended claims 27, 29, 31, 33, and 35-38. Rejection is withdrawn.
Examiner rejected claims 22-25, 28, 32-34, and 38 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 19, and 22 of U.S. Patent No. 11,801,345. Applicant argued: Applicant respectfully traverses the rejection to the extent the claims are not patentably indistinct. However, solely to expedite favorable conclusion of the examination and without conceding that the pending claims are unpatentably distinct, Applicant states that, in the event the pending claims are otherwise found to be allowable, Applicant will submit a terminal disclaimer to obviate the non-statutory double patenting rejection (Remarks, page 6). Rejection is maintained.
Claim Objections
Claims 22, 27, and 39 are objected to because of the following informalities:
In regards to claim 22, line 3, “the injector device the reservoir” should be changed to “the injector device, the reservoir”.
In regards to claim 27, line 2, “the injection device” should be changed to “the injector device”.
In regards to claim 39, line 1, “the step of moving” should be changed to “the moving”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 22-25, 28, 32-34, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 19, and 22 of U.S. Patent No. 11,801,345.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the application claims and the patent claims at least recite a needle unit, a needle, an inner part, a slot engagement portion, an outer part, an injector device, a housing, a cartridge, a reservoir, a slot, a method of using an injector device, moving the outer part of the needle unit relative to the housing (rotating the outer part of the needle unit relative to the housing), and moving the needle unit into engagement with the cartridge such that the needle is placed in fluid communication with the reservoir.
The table below shows application claims 22-25, 28, 32-34, and 38 corresponding to claims 1-4, 6, 19, and 22 of U.S. Patent No. 11,801,345:
Application claims
U.S. Patent No. 11,801,345 claims
22
1, 22
23
2
24
1
25
2-4
28
2, 6
32
19
33
1
34
2, 6
38
22
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.
Claims 22-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GB 836,278.
In regards to claim 22, GB 836,278 teaches a needle unit (Figures 6-8) for an injector device, wherein the injector device comprises a housing and a cartridge mounted in the housing, wherein the cartridge has a reservoir for a medicament, wherein prior to use of the injector device the reservoir is sealed from a needle of the needle unit, the needle unit comprising:
the needle (20)
an inner part (labeled in Figure 6 below) to which the needle is mounted
a slot engagement portion (423) to engage with a slot and that is guided by the slot, wherein the slot is configured to restrict a movement of the needle unit relative to the slot
an outer part (421) disposed externally of the slot, radially outside the slot and overlapping at least with a portion of the slot
wherein a rotation of the outer part relative to the slot is configured to move the slot engagement portion in a longitudinal direction to place the needle in fluid communication with the reservoir (Figures 6-7)(page 3, lines 56-63)
PNG
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509
208
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Greyscale
In regards to claim 23, GB 836,278 teaches wherein the slot comprises a movement portion that permits the needle to move towards the cartridge (Figures 6-8).
In regards to claim 24, GB 836,278 teaches wherein the slot comprises a locking portion, which when engaged with the slot engagement portion, is configured to lock a position of the needle (Figures 6-8).
In regards to claim 25, GB 836,278 teaches wherein the slot comprises a movement portion adjoining the locking portion, and wherein the locking portion is angled with respect to the movement portion (Figure 8).
In regards to claim 26, GB 836,278 teaches wherein the injector device has a longitudinal axis, and wherein the cartridge and the needle are aligned with the longitudinal axis such that the needle is axially spaced from the cartridge (Figure 6).
In regards to claim 27, GB 836,278 teaches wherein the movement portion of the slot extends along or parallel to a longitudinal axis of the injection device (Figure 8).
In regards to claim 28, GB 836,278 teaches a needle sleeve (25) longitudinally slidable relative to the needle (page 3, lines 66-67) and relative to the housing (Figures 6-7) and configured to protrude from a distal end of the housing of the injector device (Figures 6-7).
In regards to claim 29, GB 836,278 teaches wherein the needle sleeve is movable in a proximal direction and permits the needle to extend from a distal region of the housing (Figures 6-7).
In regards to claim 30, GB 836,278 teaches wherein one of the housing and the needle sleeve comprises the slot, and wherein the slot engagement portion engages the slot (Figures 6-7).
In regards to claim 31, GB 836,278 teaches wherein the needle sleeve is configured to push the needle in a proximal direction into an engagement with the cartridge (Figures 6-7).
In regards to claim 32, GB 836,278 teaches wherein the reservoir contains the medicament (page 3, lines 50-51)(page 3, line 92).
In regards to claim 33, GB 836,278 teaches an injector device (Figures 6-8) comprising:
a housing (411, 10)(page 3, lines 68-70)
a cartridge (1) mounted in the housing (Figures 6-7)( page 3, lines 68-70), the cartridge having a reservoir (1) filled with a medicament (page 3, lines 50-51)(page 3, line 92)
a needle unit comprising a needle (20), an inner part (labeled in Figure 6 above), and an outer part (421), wherein the needle is mounted to the inner part (Figures 6-7)
a slot (414) configured to restrict a movement of the needle relative to the slot (Figures 6-7)
a slot engagement portion (423) of the needle unit to engage with the slot and that is guided by the slot (Figures 6-7)
wherein the outer part is disposed externally of the slot, radially outside the slot and overlaps at least with a portion of the slot (Figures 6-7)
wherein a rotation of the outer part relative to the slot is configured to move the slot engagement portion in a longitudinal direction to place the needle in fluid communication with the reservoir (Figures 6-7)(page 3, lines 56-63)
In regards to claim 34, GB 836,278 teaches a needle sleeve (25) longitudinally slidable relative to the needle (page 3, lines 66-67) and relative to the housing (Figures 6-7) and configured to protrude from a distal end of the housing (Figures 6-7).
In regards to claim 35, GB 836,278 teaches wherein the needle sleeve is movable in a proximal direction and permits the needle to extend from a distal region of the housing (Figures 6-7).
In regards to claim 36, GB 836,278 teaches wherein one of the housing and the needle sleeve comprises the slot (Figures 6-8).
In regards to claim 37, GB 836,278 teaches wherein a needle sleeve (25) is configured to push the needle in a proximal direction into an engagement with the cartridge (Figures 6-7).
In regards to claim 38, GB 836,278 teaches a method of using an injector device (Figures 6-8), the injector device comprising a housing (411, 10)(page 3, lines 68-70), a cartridge (1) mounted in the housing (Figures 6-7)( page 3, lines 68-70), a needle unit (Figures 6-7) and a slot (414) configured to restrict a movement of the needle unit (Figures 6-7); wherein the needle unit comprises a needle (20), an inner part (labeled in Figure 6 above), and an outer part (421); wherein the needle is mounted to the inner part (Figures 6-7), wherein the outer part is disposed externally of the slot, radially outside the slot and overlaps at least with a portion of the slot (Figures 6-7); and wherein prior to use of the injector device, a reservoir (1) is sealed from the needle (Figure 6), the method comprising:
moving the outer part of the needle unit relative to the housing (Figures 6-7)(page 3, lines 56-63)
moving the needle unit into engagement with the cartridge such that the needle is placed in fluid communication with the reservoir (Figures 6-7)
In regards to claim 39, GB 836,278 teaches wherein the step of moving the outer part includes rotating the outer part and moving the outer part relative to the slot in a longitudinal direction (Figures 6-7)(page 3, lines 56-63).
In regards to claim 40, GB 836,278 teaches wherein the injector device comprises a needle sleeve (25) longitudinally slidable relative to the needle (page 3, lines 66-67) and relative to the housing (Figures 6-7) and configured to protrude from a distal end of the housing (Figures 6-7), and wherein the needle sleeve is moved in a longitudinal proximal direction to permit the needle to extend from a distal region of the housing (Figures 6-7).
In regards to claim 41, GB 836,278 teaches wherein the needle sleeve is moved in the longitudinal proximal direction to push the needle into an engagement with the cartridge (Figures 6-7).
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 42 is rejected under 35 U.S.C. 103 as being unpatentable over GB 836,278, as applied to claim 36 above, and further in view of Millerd (US 8,382,719).
In regards to claim 42, GB 836,278 does not teach wherein the slot engagement portion of the needle unit engages the slot of the needle sleeve, as GB 836,278 instead teaches wherein the slot engagement portion (423) of the needle unit engages the slot (414) of the housing (411) (Figures 6-7). Millerd teaches an injector device (Figures 1A-5) wherein a slot engagement portion (26) of a needle unit (12/22) engages a slot (24) of a needle sleeve (18). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the slot engagement portion of the needle unit, of the device of GB 836,278, to engage the slot of the needle sleeve, as taught by Millerd, as such will allow for protecting the needle after an injection (column 1, lines 44-47) in order to prevent accidental needle stick injuries to healthcare workers who are at risk of being stuck with a contaminated needle (column 1, lines 24-36).
Response to Arguments
Applicant's arguments filed May 11, 2026, have been fully considered but they are not persuasive:
In regards to claims 22, 33, and 38, Applicant argued: However, even under that mapping, GB278 does not disclose the amended spatial relationship. As shown in GB278's Figures 6-8, the knurled distal portion of needle hub 421 is longitudinally offset from groove 414. In particular, Figure 7 shows the knurled portion of hub 421 in abutment with the upper or distal end of ferrule 411, rather than radially outside and overlapping any portion of groove 414. The groove 414 is positioned in ferrule 411 to receive and guide pins 423, while the knurled portion relied upon as the alleged outer part remains axially displaced from that groove. Accordingly, GB278 may disclose pins 423 engaging groove 414 and movement of the needle hub by cooperation of those structures, but it does not disclose an outer part that is both radially outside the slot and overlapping at least a portion of the slot, as now required by independent claims 22, 33, and 38. The examiner's mapping in the Office action therefore relies on two different longitudinal regions of GB278's needle hub 421: the pins 423 at the groove 414, and the knurled distal portion spaced from the groove 414. That arrangement does not meet the amended claim language because the alleged outer part is not in the claimed overlapping relationship with the slot (Remarks, pages 7-8). Examiner disagrees. GB 836,278 teaches an outer part (421) disposed externally of the slot (414), radially outside the slot and overlapping at least with a portion of the slot (Figures 6-7).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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