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
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 30-44 and 55-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alexandersson (USPGPub 2021/0196896).
Re Claim 30, Alexandersson teaches an injector (1) (Alexandersson Fig. 1) comprising: a housing (10) having a proximal end (11) and a distal end (12) (Alexandersson Fig. 2); a shell (30, 60) within the housing (10) and having a cavity to receive at least a portion of a medicament chamber (32) (Alexandersson ¶ 0058), the shell (30, 60) moveable with respect to the housing (10) from an initial position (Alexandersson Fig. 1) to an injecting position (Alexandersson ¶ 0060-0063); a ram (70) movable with respect to the shell (30, 60) in the injecting position (Alexandersson ¶ 0058); a plunger (36) moveable with respect to the medicament chamber (32) (Alexandersson ¶ 0058).
Alexandersson further teaches a needle guard (20) moveable between an extended position and a retracted position (Alexandersson ¶ 0062-0066); a first member (40) within the housing (10) (as seen in Alexandersson Fig. 1); and an actuation assembly (62, 72 and 42 - first, second and third energy accumulating members) coupled to the housing (10) and the shell (30, 60) (as seen in Alexanderson Fig. 1); wherein the needle guard (20) moves the first member (40) with respect to the housing (10) as the needle guard (20) moves from the extended position to the retracted position (Alexandersson ¶ 0064 - wherein the needle cover 20 is operationally coupled with the actuation sleeve 40), wherein the actuation assembly moves the shell (30, 60) from the initial position to the injecting position when the first member (40) moves with respect to the housing (10) (Alexandersson ¶ 0062-0069), wherein a position of the ram (70) is fixed relative to the medicament chamber (32) when the shell (30, 60) is moved from the initial position to the injecting position, and wherein the ram (70) moves the plunger (36) with respect to the medicament chamber (32) when the shell (30, 60) is in the injecting position (Alexandersson ¶ 0062-0069).
Re Claim 31, Alexandersson teaches all of the limitations of Claim 30. Alexandersson also teaches wherein proximal movement of the needle guard (20) moves the first member (40) proximally with respect to the housing (10) (Alexandersson ¶ 0064 - when needle shield 20 is pressed against a delivery site, needle shield moves in the proximal direction).
Re Claim 32, Alexandersson teaches all of the limitations of Claim 30. Alexandersson teaches wherein the shell (30, 60) moves with respect to the housing (10) in response to movement of the needle guard (20) (Alexandersson ¶ 0064-0065).
Re Claim 33, Alexandersson teaches all of the limitations of Claim 31. Alexandersson teaches wherein the shell (30, 60) moves distally with respect to the housing (10) when the first member (40) moves proximally with respect to the housing (10) (Alexandersson ¶ 0064-0065).
Re Claim 34, Alexandersson teaches all of the limitations of Claim 30. Alexandersson teaches wherein the first member (40) includes a detent (46) moveable from a first position to a second position (wherein engagement members 46 are deflectable), wherein the detent engages the housing (10) (wherein engagement members 46 are connected to housing via holding component 50 connected to plunger holder 60) to prevent movement of the first member (40) when the detent (46) is in the first position and wherein the detent (46) is disengaged from the housing (10) when the detent (46) is in the second position (Alexandersson Fig. 11; ¶ 0076).
Re Claim 35, Alexandersson teaches all of the limitations of Claim 34. Alexandersson teaches wherein the needle guard (20) prevents movement of the detent (46) from the first position to the second position when the needle guard (20) is in the extended position (Alexandersson Fig. 11; ¶ 0076 wherein engagement member 46 is configured to be released and/or opened by the distal movement of the needle cover 20 distally).
Re Claim 36, Alexandersson teaches all of the limitations of Claim 30. Alexandersson teaches a second member (80) fixed to the housing (Alexandersson ¶ 0057, 0074; Figs. 2 and 3), the second member (80) including a catch (82) engageable with the shell (30, 60) to prevent movement of the shell (30, 60) with respect to the housing (10) (Alexandersson ¶ 0063 wherein locking rod 82 prevents actuation).
Re Claim 37, Alexandersson teaches all of the limitations of Claim 36. Alexandersson teaches wherein the second member (80) at least partially encircles the shell (30, 60) (Alexandersson Figs. 1 and 3 wherein collar 84 encircles proximal end of shell).
Re Claims 38-39, Alexandersson teaches all of the limitations of Claim 36. Alexandersson teaches wherein the shell (30, 60) includes a recess (lumen through plunger rod 70) and the catch (82) is positioned within the recess when the catch (82) is in a first position (as seen in Alexanderson Fig. 4); and wherein the catch (82) moves out of the recess (lumen through plunger rod 70) when first member (40) moves with respect to the housing (10) (Alexandersson ¶ 0060-0076; Figs. 4-5).
Re Claims 40-41, Alexandersson teaches all of the limitations of Claim 30. Alexandersson teaches wherein the actuation assembly includes a first biasing element (62) operatively associated with the housing (10) and the shell (30, 60), wherein the first biasing element (62) moves the shell (30, 60) relative to the housing (10) from the initial position to the injecting position when the first member (40) moves with respect to the housing (10) (Alexandersson ¶ 0060, 0067-0068); wherein the actuation assembly includes a second biasing element (72) operatively as sociated with the shell (30, 60) and the plunger (70), wherein the second biasing element (72) moves the plunger (70) with respect to the shell (30, 60) when the shell is in the injecting position (Alexandersson ¶ 0061, 0069-0070).
Re Claims 42-43, Alexandersson teaches all of the limitations of Claim 41. Alexandersson teaches wherein the shell (30, 60) includes an engagement member (74) moveable from an engaged position wherein the engagement member (74) prevents movement of the ram (70) to a disengaged position wherein the ram (70) can move with respect to the shell (30, 60) (Alexandersson ¶ 0061, 0063, 0069-0070); and wherein the engagement member (74) is in the engaged position when the shell (30, 60) is in the initial position and the engagement member (74) is in the disengaged position when the shell (30, 60) is in the injecting position (Alexandersson ¶ 0061, 0063, 0069-0070).
Re Claim 44, Alexandersson teaches all of the limitations of Claim 42. Alexandersson teaches a second member (80) fixed to the housing (10) (Alexandersson ¶ 0057, 0074; Figs. 2 and 3), the second member (80) including a catch (82) engageable with the shell (30, 60) to prevent movement of the shell (30, 60) with respect to the housing (10) (Alexandersson ¶ 0063 wherein locking rod 82 prevents actuation), wherein the second member blocks movement of the flexible arm (74) from the engaged position to the disengaged position when the shell (30, 60) is in the initial position (Alexandersson ¶ 0061, 0063, 0069-0070).
Re Claim 55, Alexandersson teaches all of the limitations of Claim 30. Alexandersson also teaches wherein the needle guard (20) is moveable to a lockout position and the needle guard (20) includes a needle guard lock (26) that engages a lockout surface (as seen in Alexandersson Annotated Fig. 8 below) to prevent proximal movement of the needle guard (20) when the needle guard is in the lockout position (Alexandersson ¶ 0072).
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Re Claim 56, Alexandersson teaches all of the limitations of Claim 55. Alexandersson further teaches wherein the needle guard lock (26) includes a lockout arm that flexes radially outwardly to engage the lockout surface when the needle guard is in the lockout position (as described in Alexandersson ¶ 0072; Annotated Fig. 8 above).
Re Claim 57, Alexandersson teaches all of the limitations of Claim 55. Alexandersson further teaches a collar coupled to the housing, the collar including the lockout surface (Alexandersson Annotated Fig. 8 above - where the lockout surface as annotated above, shows a protrusion or a rim coupled to the housing 10 that includes the lockout surface).
Re Claim 58, Alexandersson teaches all of the limitations of Claim 57. Alexandersson further teaches a biasing element (42) coupled to the collar and the needle guard (20),
the biasing element (42) biasing the needle guard (20) toward the extended position
(Alexandersson ¶ 0064-0065, 0071).
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 45-54 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersson (USPGPub 2021/0196896) in view of Bechmann et al. (USPGPub 2016/0001005).
Re Claim 45, Alexandersson teaches all of the limitations of Claim 30. Alexandersson further discloses a syringe (32) (medicament chamber of Claim 30); and a syringe holder (30) having a first end, a second end, a longitudinal axis extending from the first end (A) to the second end (B), and a sidewall (C) extending from the first end (A) toward the second end (B), the sidewall (C) defining a receiving area for the syringe (32) (as seen in Alexandersson Annotate Fig. 4 below). Alexandersson fails to disclose wherein the sidewall includes a sidewall opening such that the syringe can be loaded into the syringe holder from a side of the syringe holder. Bechmann teaches a syringe holder (800) (Bechmann Annotated Fig. 14 below) and a syringe (900), the syringe holder (800) having a sidewall defining a receiving area therein for the syringe (900), such that the syringe (900) can be loaded into the syringe holder (800) from a side of the syringe holder (800) for ease of syringe placement during assembly (Bechmann ¶ 0165 and Bechmann Annotated Fig. 14 below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to have configured the sidewall of Alexandersson to include a sidewall opening such that the syringe can be loaded into the syringe holder from a side of the syringe holder as disclosed by Bechmann for ease of syringe placement during assembly (Bechmann ¶ 0165).
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Re Claim 46, Alexandersson in view of Bechmann teach all of the limitations of Claim 45. Alexandersson fails to disclose wherein the syringe is loaded into the syringe holder without moving axially through a rear opening of the syringe holder. However, Bechmann discloses the syringe which can be loaded from a side of the syringe holder (800) without moving axially (Bechmann Fig. 14 - wherein a portion of the wall of the syringe tube 800 is missing along the length of the syringe tube 800 permits side loading of the syringe 900) for ease of syringe placement during assembly (Bechmann ¶ 0165). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the prese application to have configured the sidewall of Alexandersson in view of Bechmann wherein the syringe is loaded into the syringe holder without moving axially through a rear opening of the syringe holder as disclosed by Bechmann for ease of syringe placement during assembly (Bechmann ¶ 0165).
Re Claim 47, Alexandersson in view of Bechmann teach all of the limitations of Claim 45. Alexandersson fails to disclose wherein a needle shield is coupled to the syringe and the syringe is loaded into the syringe holder without passing the needle shield through the syringe holder. However, Bechmann discloses wherein a needle shield (300) is coupled to the syringe (900) and the syringe (900) is loaded into the syringe holder (800) without passing the needle shield (300) through the syringe holder (800) for ease of syringe placement during assembly (Bechmann Fig. 1 and 5A-5C; ¶ 0132-0137). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to have configured the syringe holder and syringe of Alexandersson in view of Bechmann such that a needle shield is coupled to the syringe and the syringe is loaded into the syringe holder without passing the needle shield through the syringe holder as disclosed by Bechmann for ease of syringe placement during assembly (Bechmann Fig. 1 and 5A-5C; ¶ 0132-0137).
Re Claim 48, Alexandersson in view of Bechmann teach all of the limitations of Claim 45. Alexandersson fails to disclose wherein the sidewall opening extends from the first end to the second end. Bechmann discloses wherein the sidewall opening extends from the first end to the second end (Bechmann Fig. 14 and element 4 of embodiment of Fig. 15) for ease of syringe placemen during assembly. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to have configured the sidewall of Alexandersson in view of Bechmann to extend from the first end to the second end as disclosed by Bechmann for ease of syringe placement during assembly (Bechmann Figs. 14-15).
Re Claims 49-50, Alexandersson in view of Bechmann teach all of the limitations of Claim 45. Alexandersson further discloses wherein the syringe (32) includes a body defining a medicament chamber (Alexandersson ¶ 0058), a needle (34) fluidly coupled to the medicament chamber, and a needle shield (5) that receives the needle (34) (Alexandersson Fig. 1), the needle shield (5) having a needle shield diameter, and wherein the syringe holder (30) includes an end wall having an end wall opening with an end wall opening diameter that is smaller than the needle shield diameter (as seen in Alexandersson Fig. 1); and wherein the syringe includes a syringe flange (as seen in Annotated Alexandersson figure below) at a proximal end of the syringe (32), wherein a distal end of the syringe (32) engages the end wall and the syringe flange is spaced from the second end of the sidewall when the syringe is coupled to the syringe holder (As annotated in the figure below, distal end of the syringe engages the end wall and the syringe flange is spaced (grey area) from the second end of the sidewall when the syringe is coupled to the syringe holder).
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Re Claim 51, Alexandersson in view of Bechmann teach all of the limitations of Claim 49. Alexandersson discloses a needle shield remover (6) having a projection positioned between a proximal end of the needle shield (5) and the distal end of the syringe (32) (Alexandersson ¶ 0058; Fig. 1).
Re Claim 52, Alexandersson in view of Bechmann teach all of the limitations of Claim 51. Alexandersson discloses a cap (3) coupled to the housing (10), the needle shield remover (6) coupled to the cap (3) such that the needle shield (5) is removed when the cap (3) is decoupled from the housing (10) (Alexandersson ¶ 0058; Fig. 1).
Re Claim 53, Alexandersson in view of Bechmann teach all of the limitations of Claim 52. Alexandersson discloses wherein the cap (3) at least temporarily maintains the needle guard (20) in the extended position (Alexandersson ¶ 0058; Fig. 1).
Re Claim 54, Alexandersson in view of Bechmann teach all of the limitations of Claim 49. Alexandersson further discloses wherein movement of the plunger (70) expels medicament from the medicament chamber through the needle (Alexandersson ¶ 0059).
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 30-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-29 of USPN 11,850,401, hereinafter Patent ‘401. Although the claims at issue are not identical, they are not patentably distinct from each other because where independent Claim 30 of the present case is more broad than independent Claim 1 of Patent ‘401.
Terminal Disclaimer
A terminal disclaimer may be effective to overcome a nonstatutory double patenting rejection over a reference patent (37 CFR 1.321(b) and (c)). 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. 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/PatentForms. The filing date of the application will determine what form 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/TerminalDisclaimer.
Conclusion
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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