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 § 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.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Crossman et al. (USPN 5,300,030).
Re Claim 1, Crossman teaches a sub-assembly of a medicament delivery device (Crossman Figs. 1-4), the sub-assembly comprising: a plunger rod (26); a main body (7, 15) extending longitudinally to partially surround the outer surface of the plunger rod (26), where the plunger rod (26) comprises a flexible arm (8, 9) that is directly and releasably connected to the inner surface of the main body (7, 15) (Crossman Col. 2 Lines 25-37 and Col. 3 Lines 3-19); and a coupling member (3) axially fixed, partially surrounding, and rotatable relative to an outside surface of the main body (7, 15) such that the outside surface of the main body (7, 15) is between the outer surface of the plunger rod (26) and an inner surface of the coupling member (3) (as seen in Crossman Fig. 1, cap 3 surrounds largest diameter portion 7) when the coupling member (3) rotates from a first position (position of Crossman Fig. 1) to a second position (position in Crossman Fig. 2), where the inner surface of the coupling member (3) confines the flexible arm (8, 9) in a locking engagement with the inner surface of the main body (7, 15) to prevent axial movement of the plunger rod (26) when the coupling member (3) is in the first position (Crossman Col. 3 Lines 3-19).
Crossman further teaches wherein the plunger rod (26) comprises a first locking element (12) and the coupling member (3) comprises a second locking element (4), the first locking element (12) having a protrusion having a ramp-shaped first surface (12-1) and a wall-shaped second surface (12-2) extending orthogonally radially inward from a surface of the coupling member (3) (Crossman Annotated Fig. 1 below), wherein rotation of the coupling member (3) from the first position causes the second locking element (4) to engage with the ramp-shaped first surface (12-1) of the protrusion (protruding annulus 4) to bend the first locking element (12) radially inward such that the second locking element (4) and first locking element (12) are releasably engaged with each other (Crossman Figs. 1-2) such that the coupling member (3) is prevented from rotating to the second position (position in Crossman Fig. 2), and wherein movement of the coupling member (3) to the second position allows the flexible arm (8, 9) to disengage from and unlock the plunger rod (26) (Crossman Col. 2 Lines 16-37; Col. 3 Lines 3-19).
In the present case, Crossman discloses the claimed invention except for the main body comprising a flexible arm (as opposed to the plunger rod comprising the flexible arm as in Crossman) that is directly and releasably connected to the outer surface of the biased plunger rod (as opposed to connection to the inner surface of the main body as in Crossman), where the inner surface of the coupling member confines the flexible arm in a locking engagement with the outer surface of the plunger rod (as opposed to locking engagement with the inner surface of the main body as in Crossman), wherein the main body (as opposed to the plunger rod as in Crossman) comprises a first locking element and the coupling member comprises a second locking element having a protrusion having a ramp-shaped first surface and a wall-shaped second surface extending orthogonally radially inward from a surface of the coupling member, wherein rotation of the coupling member from the first position causes the first locking element to engage with the ramp-shaped first surface of the protrusion to bend the first locking element radially inward.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present case to reverse the roles of the main body and plunger rod with first locking element of Crossman wherein the main body comprising a flexible arm that is directly and releasably connected to the outer surface of the biased plunger rod, where the inner surface of the coupling member confines the flexible arm in a locking engagement with the outer surface of the plunger rod, wherein the main body comprises a first locking element, and the coupling member comprises a second locking element having a protrusion having a ramp-shaped first surface and a wall-shaped second surface extending orthogonally radially inward from a surface of the coupling member, wherein rotation of the coupling member from the first position causes the first locking element to engage with the ramp-shaped first surface of the protrusion to bend the first locking element radially inward, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
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Re Claim 2, Crossman teaches wherein the first locking element (12) is a longitudinal tab (as seen in Crossman Fig. 2) extending in the distal direction. It is noted here that the roles of the main body and plunger rod with first locking element of Crossman are reversed from that of the present case, and thus, the longitudinal tab extends in the distal direction as opposed to the proximal direction.
Re Claim 3, Crossman teaches wherein the tab comprises a proximal half (8) that extends radially outward and then inward (portion 9) to form an arch (Crossman Fig. 2).
Re Claim 4, Crossman teaches wherein a distance between the arch of the proximal half (8) and the central longitudinal axis is larger than the distance between all other portions of the tab and the central longitudinal axis (Crossman Fig. 2).
Re Claim 5, Crossman teaches wherein the first locking element (12) comprises two longitudinal tabs extending in the distal direction and that are oppositely arranged relative to a central longitudinal axis of the main body (as seen in Crossman Fig. 2). It is noted here that the roles of the main body and plunger rod with first locking element of Crossman are reversed from that of the present case, and thus, the longitudinal tabs extend in the distal direction as opposed to the proximal direction.
Re Claim 7, Crossman teaches wherein the surface of the coupling member (3) is part of a circumferential recess (annulus 4).
Re Claim 8, Crossman teaches wherein the first locking element (12) comprises a longitudinal tab extending in the distal direction and having a distal end rotatably positioned within the circumferential recess (annulus 4, as seen in Crossman Fig. 1, wherein beveled surfaces 12 rotate radially inward). It is noted here that the roles of the main body and plunger rod with first locking element of Crossman are reversed from that of the present case, and thus, the longitudinal tab extends in the distal direction and has a distal end that is rotatable as opposed to the longitudinal tab extending in the proximal direction and having a proximal end that is rotatable.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Crossman et al. (USPN 5,300,030) in view of Gabrielsson (USPGPub 2016/0193413).
Re Claim 6, Crossman teaches all of the limitations of Claim 1. Crossman further teaches where the biasing member surrounds the distal end of the plunger rod (26) to bias the plunger rod in the proximal direction. However, Crossman fails to teach wherein the plunger rod comprises an outer surface, an open distal end and a closed proximal end, where a biasing member extends into the open distal end to bias the plunger rod in a proximal direction. Gabrielsson teaches a medicament delivery device (Gabrielsson Fig. 2) comprising a plunger rod (72), wherein the plunger rod (72) comprises an outer surface, an open distal end and a closed proximal end, where a biasing member (78) extends into the open distal end to bias the plunger (72) rod in a proximal direction (Gabrielsson ¶ 0039), the configuration for protecting the biasing member.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the plunger rod and biasing member of Gabrielsson such that the plunger rod comprises an outer surface, an open distal end and a closed proximal end, where a biasing member extends into the open distal end to bias the plunger rod in a proximal direction as disclosed by Gabrielsson, the configuration for protecting the biasing member (Gabrielsson ¶ 0039).
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claim 1 of USPN 11,690,956, hereinafter patent '956. Although the claims at issue are not identical, they are not patentably distinct from each other because where Claim 1 of the present case is more broad than that of patent '956.
Response to Arguments
Applicant’s arguments filed 06/25/2026 with respect to claim objections have been fully considered and are persuasive. Examiner thanks applicant for clarifying amendments. Due to clarifying amendments, all claim objections are hereinafter withdrawn.
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive. Applicant’s claims as amended still represent a mere reversal of working parts of prior art Crossman. However, applicant’s ramp-shaped first surface and second wall-shaped surface, as seen in applicant’s Fig. 5B, clearly comprise a different structural configuration to that of Crossman. Applicant’s ramp-shaped first surface and second wall-shaped surface are defined by an interior surface of an outer wall of the coupling member. Prior art Crossman comprises no such feature, nor could it be modified as such. Examiner is available for interview at applicant’s leisure.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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