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 .
Status of the Claims
Claims 1-6 and 9-10 are currently pending. Claims 1-6 and 9-10 are currently rejected. Claims 7-8 have been cancelled.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/09/2026, with respect to the rejection(s) of claim(s) 1 as amended under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Smith (US 5807338 A).
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 1-6 and 9-10 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 1 recites the limitation "the two cantilever arms" in lines 2-3 of the second paragraph. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to read “two cantilever arms” instead of “the two cantilever arms”.
Claim 1 recites the limitation "the execution sleeve" in line 2 of the second paragraph. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to read “an execution sleeve” instead of “the execution sleeve”.
Claim 1 recites the limitation "the axis" in line 6 of the second paragraph. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to read “an axis” instead of “the axis”.
Claim 1 recites the limitation “an execution sleeve” in the first line of the third paragraph. The limitation “execution sleeve” is introduced earlier in claim 1, thus making it unclear whether this instance of “an execution sleeve” is meant to refer back to the earlier introduced element or introduce a new, separate element. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 recites the limitation “two cantilever arms” in the second line of the third paragraph. The limitation “two cantilever arms” is introduced earlier in claim 1, thus making it unclear whether this instance of “two cantilever arms” is meant to refer back to the earlier introduced element or introduce a new, separate element. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 recites the limitation “an axis” in the first line of the third paragraph. The limitation “axis” is introduced earlier in claim 1, thus making it unclear whether this instance of “axis” is meant to refer back to the earlier introduced element or introduce a new, separate element. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 2 recites the limitation “a protruding part” in line 2. Claim 1, from which claim 2 depends, already introduced the limitation “a protruding part” in lines 2-3 of paragraph 4. Thus, it is unclear whether this instance of “a protruding part” is meant to refer back to the earlier introduced element or introduce a new, separate element. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 2-6 and 9-10 are rejected at least for depending upon an indefinite claim, since dependent claims inherit the deficiencies of those claims from which they depend.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Appy et al (US-20210196900-A1; hereafter Appy) in view of Wang (CN-112933346-A; hereafter Wang) and further in view of Smith et al (US 5807338 A; hereafter Smith) Text reference is made to the previously included pdf English translation of Wang.
Regarding claim 1, Appy discloses an actuation assembly (subassemblies 100, 200, and 300, noted in [0328], including syringe subassembly 200) of an auto-injector (automatic drug delivery device 10, fig. 1), which is used for combining a container assembly with a vial (glass body 204, fig. 1), comprising:
an actuation sleeve (trigger element 302, fig. 4), which includes a channel (tube-shaped hollow body 360, [0360]);
the two cantilever arms (see 112b interpretation above) (flexible arms 474, fig. 39 and fig. 40, [0368]) of the execution sleeve (see 112b interpretation above) (retainer 312 and shield retention indicator inner element 314, fig. 4, [0334]), and each of the two cantilever arms (flexible arms 474, fig. 40) further includes an outer expansion portion (chamfered radial outward projection 478, fig. 40) corresponding to at least one stopper structure (guiding ribs 386, fig. 32 and arch-like connecting rib 388, fig. 33; [0386] outward projections 478 contact inner circumferential surface of trigger element 302);
an execution sleeve (see 112b interpretation above) (retainer 312 and shield retention indicator inner element 314, fig. 4, [0334]), which is movably threaded ([0401] actuation sleeve/trigger element 302 moves beyond projections 478 shown in fig. 39 as part of execution sleeve 312/314, this means that the execution sleeve 312/314 is slidably located within actuation sleeve 302) through the channel (tube-shaped hollow body 360, [0360] 360 is part of actuation sleeve/trigger element 302) along an axis (see 112b interpretation above), the execution sleeve (312/314) includes two cantilever arms (see 112b interpretation above) (flexible arms 474, fig. 39, [0368]) that are symmetrical to each other, and each of the two cantilever arms includes a clamping part (radial inward projections 480 of cantilever/flexible arms 474, fig. 41, [0386]);
a first elastic element (trigger spring 304, fig. 4, [0334]), one end of the first elastic element abuts against a protruding part (circumferential rib 380, fig. 31, [0382]) of the actuation sleeve (302) ([0382] end of first elastic element 304 abuts against protruding portion 380) and the other end abuts against a plurality of abutting portions (portions of element 314 of execution sleeve 312/314 including: [0366] longitudinal arms 446, first portion 448, execution sleeve portion 314, hollow cylindrical portion 444 and end plate 456, fig. 38) of the execution sleeve ([0382] distal end of first elastic element 304 presses against plate 456 of execution sleeve portion 314, fig. 38);
a rear cover (distal end cap 316, fig. 4, [0334]), coupled to an end of the execution sleeve ([0411] rear cover/end cap 316 makes contact with shield retention indicator inner element 314, which is part of execution sleeve 312/314);
a push rod (plunger 308, fig. 4, [0334]), which is movably threaded through the execution sleeve ([0401] push rod/plunger 308 moves within execution sleeve 312/314) along the axis ([0386] plunger 308 is held in its axial position against the drive force of the main spring 310 due to engagement between the cantilever/flexible arms 474 of execution sleeve 312/314 which engage into the through holes 430 provided in the plunger 308), the push rod includes two grooves (through holes 430); and
a second elastic element (drive spring 310), two ends (see 112b interpretation) of the second elastic element abuts the rear cover and the push rod respectively ([0386] second elastic element/drive spring 310 presses against the proximal end of push rod/plunger 308; distal end of the spring 310 supported against distal end of retainer 312, Examiner notes that the retainer is noted element 312 in [0384] and [0385], and that the retainer is part of the execution sleeve 312/314);
wherein, when each of the two cantilever arms (flexible arms 474) of the execution sleeve (312/314) is confined within the channel (360) of the actuation sleeve, the clamping part ([0386] radial inward projections 480 of cantilever/flexible arms 474, fig. 41) of each of the two cantilever arms (flexible arms 474, fig. 39, [0368]) is clipped respectively into each of the two grooves (through holes 430; see fig. 48c which shows the symmetrical construction with the projections 480 each engaged in a through hole 430) of the push rod to restrict the movement of the push rod ([0386] radial inward projections 480 of cantilever/flexible arms 474 engage with grooves/through holes 430 of push rod/plunger 308; this limits the movement of the push rod/plunger 308); when the actuation sleeve (302) moves along the axis direction relative to the execution sleeve (312/314), the first elastic element (304) is gradually compressed ([0401] actuation sleeve/trigger element 302 moves relative to execution sleeve 312/314 during compression of the first elastic element 304), so that the clamping part (radial inward projections 480) of each of the two cantilever arms (flexible arms 474) of the execution sleeve (312/314) is disengaged ([0401] due to the relative movement of the execution sleeve 312/314 and actuation sleeve 302, the cantilever 474 flexes outward and releases push rod 308) from the groove (through hole 430) of the push rod (plunger 308), and the push rod (plunger 308) is actuated ([0401] push rod 308 moved in axial proximal direction under the action of the second resilient element 310; Abstract states that proximal direction is toward the dispensing site) toward the vial (glass body 204) by the second elastic element (main spring 310) which has been compressed ([0386] push rod 308 retains second resilient element 310 in a compressed state prior to movement).
The first embodiment of Appy relied on above is silent to the rear cover including a locating element and the second elastic element threading through the locating element of the rear cover to abut against the rear cover.
A second embodiment of Appy teaches wherein the rear cover (distal end cap 1316 and rotary click element 1314, fig. 83b, fig. 84b, [0494], [0493]) includes a locating element (cylindrical pole member 1454, fig. 83b, fig. 84b, [0494]); and the second elastic element (main spring 1304, fig. 84b) threads through the locating element of the rear cover ([0494] as can be seen in fig. 84b on the right side, the cylindrical pole member 1454 extends in proximal direction into the hollow interior of the main spring 1304 and acts as an axial guiding element for the compressed main spring 1304) to abut against the rear cover ([0493] the distal end of the main spring 1304 protrudes out of the plunger 1302 and is received within the hollow interior of the rotary click element 1314).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the first embodiment of Appy with the teachings of the second embodiment of Appy so that the rear cover included the locating element/cylindrical pole element 1314. One would have been motivated to make the modification because the addition of the cylindrical pole member would provide the main spring of Appy with more stability and predictable, controlled movement, thus increasing the reliability of the device and reducing the chance that the spring would become incorrectly arranged within the device.
Both embodiments of Appy are silent to an auxiliary mounting hole passing through the outer surface of the actuation sleeve.
Wang, directed to an axial propelling mechanism for an autoinjector, teaches wherein the actuation sleeve (release sleeve 6, fig. 4b, [0088] second paragraph on pg. 30 of 37, “release sleeve 6 is provided with a release window 61, a reset channel 62, an activation channel 64, and a limit slot 65”) which includes at least one auxiliary mounting hole (release window 61, fig. 4a/b), the at least one auxiliary mounting hole passes through the outer surface of the actuation sleeve to the channel (reset channel 62, see fig. 4b), and is located between one end of the actuation sleeve (6) adjacent to a rear cover (bottom cover 11, see fig. 2b, [0088] second paragraph on pg. 28 of 37, “Pre-filled syringe 5, release sleeve 6, toothed sleeve 8, and push rod 9 are located in the cavity formed by head end protective cap 1, outer shell 3, and bottom cover 11”) and at least one stopper structure (limiting slot 65, fig. 4a; see assembled arrangement of actuation sleeve 6 with rear cover 11 in fig. 11) (Appy guiding ribs 386, fig. 32 and arch-like connecting rib 388, fig. 33, [0361]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the actuation sleeve of Appy to have an auxiliary mounting hole/release window 61 between the stopper structure and the end of the actuation sleeve by the rear cover as taught by Wang since both references deal with autoinjectors. One would have been motivated to make this modification because the auxiliary mounting hole/release window 61 would allow the person assembling the device to verify visually and/or mechanically that the execution sleeve is correctly positioned within the actuation sleeve. Additionally, if the components of the device are improperly assembled and become stuck, the release window may facilitate separating parts with minimal damage.
Appy as modified is silent to the at least one auxiliary mounting hole being radially aligned with the two cantilever arms of the execution sleeve, such that an external tool radially passes through the at least one auxiliary mounting hole to abut against the two cantilever arms, thereby compressing the two cantilever arms toward the axis to enter the channel.
Smith, in the art of trocars with multiple sleeved elements, teaches the at least one auxiliary mounting hole (opposing longitudinal openings 196, fig. 7A, col. 8 ln. 14-20) radially aligned with the two cantilever arms (stops 190, fig. 7A, col. 8 ln. 14-20) of the execution sleeve (knife rod 180, fig. 6, col. 8 ln. 14-20), such that an external tool (forceps-type tool noted in col. 8 ln. 14-20) radially passes through the at least one auxiliary mounting hole to abut against the two cantilever arms, thereby compressing the two cantilever arms toward the axis (see 112b interpretation above) to enter the channel (col. 8 ln. 14-20 describes jaws of tool entering through at least one auxiliary mounting hole 196 to compress the opposing portions of the knife rod 180 which form the cantilever arms “such that stops 190 are compressed to a smaller dimension than shelf 192 to permit stops 190 to pass distally below shelf 192”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Appy as modified so that the auxiliary mounting holes of Appy modified by Wang align with the two cantilever arms as described by Smith such that the cantilever arms can be compressed for assembly/disassembly via an external tool, as taught by Smith, since all three references deal with medical devices with interacting cylindrical components and stops. One would have been motivated to make the modification because, as taught by Smith, having the opposing auxiliary mounting holes aligned with flexible compressible arms allows for the arms to be compressed and facilitates the movement of the internal structure to the desired location within the surrounding structure, thus improving user ease of assembly or disassembly of the device.
Appy as modified discloses the claimed device except for wherein the auxiliary mounting hole is radially aligned with the cantilever arms. It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to rotate the cantilever arms (190 in Smith fig. 7A) 90 degrees relative to the holes (196 in Smith fig. 7A), thereby yielding predictable results without change to inventive function. Furthermore, having the cantilever arms aligned with the mounting holes would be obvious to try by beneficially providing the forceps-type tool better leverage for compressing the cantilever arms. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Appy as modified would still work appropriately.
Regarding claim 2, Appy modified by Wang and Smith as applied to claim 1 above discloses the actuation assembly of the auto-injector of claim 1. Appy further discloses wherein the actuation sleeve (302) includes a protruding part (see 112b interpretation above) (circumferential rib 380, fig. 31, [0382]), which is disposed on the outer surface of the actuation sleeve (see fig. 31).
Regarding claim 3, Appy modified by Wang and Smith as applied to claim 2 above discloses the actuation assembly of the auto-injector of claim 2. Appy further discloses wherein the actuation sleeve (302) further comprises a plurality of grooves (circumferential space between guiding ribs 386 seen in fig. 30, ribs describe in [0361]), and the plurality of abutting portions of the execution sleeve pass through the plurality of grooves (circumferential space between guiding ribs 386) to protrude from the outer surface of the actuation sleeve (fig. 44b shows portions of element 314 extending beyond the outer surface of actuation sleeve 302), when the actuation sleeve moves relative ([0381] actuation sleeve 302 is fixed to housing 104; [0372-0373] end cap 316 is also fixed to housing 104; [0411] element 314 moves relative to end cap 316; Examiner notes that element 314 must move relative to actuation sleeve 302) to the execution sleeve, the plurality of abutting portions (portions making up element 314, fig. 38) move along the plurality of grooves (circumferential space between guiding ribs 386 seen in fig. 30).
Regarding claim 4, Appy modified by Wang and Smith as applied to claim 1 above discloses the actuation assembly of the auto-injector of claim 1. Appy further discloses wherein the execution sleeve (312/314) further comprises a plurality of buckle parts (parts of outer circumferential groove 500), and the rear cover (distal end cap 316) further comprises a plurality of fasteners (parts of inner circumferential projection of hollow cylindrical body 530), and wherein the plurality of fasteners are correspondingly fastened to the plurality of buckle parts ([0384] retainer 312 is fixedly held within the distal end cap 316 by the hollow cylindrical body 530 gripping with an inner circumferential projection into the outer circumferential groove 500 of the retainer in a form-fitting manner.).
Regarding claim 5, Appy modified by Wang and Smith as applied to claim 1 above discloses the actuation assembly of the auto-injector of claim 1. Appy further discloses wherein the rear cover (316) includes a plurality of guide elements ([0371] distal end cap has a cross-sectional profile which is rounded with an extension, fig. 42, Examiner interprets the circular portion and the extension portion to be guide elements), and the execution sleeve (312/314) further includes a plurality of corresponding guide elements ([0367] distal portion of shield retention indicator inner element 314 has end plate 456 has a cross-sectional profile which is rounded with an extension, fig. 38, Examiner interprets the rounded portion and the extension portion to be guide elements); when the rear cover moves relative to the execution sleeve, the rear cover is moved relative to the execution sleeve along the axis with the cooperation between the guide elements and the corresponding guide elements ([0411] when moving distally, the endplate 456 of the shield retention indicator inner element 314 hits the inner bottom surface 532 of the distal end cap 316; Examiner notes that the similarly shaped cross-sections would ensure that this sliding occurs without rotation.).
Regarding claim 6, Appy modified by Wang and Smith as applied to claim 1 above discloses the actuation assembly of the auto-injector of claim 1. Appy further discloses wherein the at least one stopper structure (guiding ribs 386, fig. 32 and arch-like connecting rib 388, fig. 33), protrudes from a surface of the channel ([0361] ribs 386 and 388 are located along the inner circumferential surface of the tubular hollow body 360).
Regarding claim 9, Appy discloses an auto-injector, which is used for mounting and injecting a vial, comprising: the actuation assembly according to any of claim 1 (see rejection of claim 1 above, Appy modified by Wang and Smith); and
an accommodating component (proximal subassembly 100, [0332]), coupled to one end of the actuation assembly (syringe subassembly 200 and power-pack subassembly 300), comprising:
an outer housing (longitudinal housing 104, fig. 2);
a vial sleeve (syringe holder 106, fig. 3), which is coupled to the outer housing (housing 104) for mounting the vial ([0352] vial sleeve/syringe holder 106 receives and holds vial/prefilled syringe 204 within the housing 104); and
a needle cap (safety shield 102, fig. 2, [0332]), which is threaded through and partially exposed to the outer housing and can move relative to the outer housing ([0391] needle cap/safety shield 102 moves relative to housing 104 to cover the needle) and the vial sleeve ([0349] double-ring structure 230 is part of housing 104, see fig. 20; [0354] vial sleeve/syringe holder 106 is held in position by engagement with double-ring structure 230);
wherein, when the needle cap (102) is moved toward ([0401] needle cap 102 is moved toward housing 104) the outer housing (104) by an external force, the needle cap (102) pushes against ([0401] movement of needle cap 102 causes movement of actuation sleeve 302) the actuation sleeve (302) of the actuation assembly, causing the clamping part (480) of each of the two cantilever arms (474) of the execution sleeve to disengage ([0401] due to the relative movement of the execution sleeve 312/314 and actuation sleeve 302, the cantilever 474 flexes outward and releases push rod 308) the groove (430) of the push rod (308), which in turn actuates the push rod (308) through the second elastic element (310) which has been compressed, thereby actuating the push rod (308) to move toward the vial (204) to complete the injection ([0401] push rod 308 moved in axial proximal direction under the action of the second resilient element 310; Abstract states that proximal direction is toward the dispensing site).
Regarding claim 10, Appy modified by Wang and Smith as applied to claim 9 above discloses the auto-injector of claim 9. Appy further discloses wherein the accommodating component (subassembly 100) further comprises a backing ring (stopper 210, fig. 3), which is disposed ([0403] push rod/plunger 308 engages backing ring/stopper 210) at an end of the actuation assembly (syringe subassembly 200 and power-pack subassembly 300) adjacent to the vial sleeve (syringe holder 106).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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, Michael Tsai can be reached at (571) 270-5246. 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.
/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 04/30/2026
Prosecution Insights