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.
Claim(s) 1-8, 10-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grimard et al. (US 7,100,768) in view of Barrelle et al. (US 8,016,795).
Regarding claim 1, Grimard et al. (henceforth Grimard) discloses (Figure 1) a package comprising: a tray (6) having a plurality of openings (formed by 6a); wherein a barrel extends through each of the plurality of openings (barrels 10 extend through the openings). Grimard fails to explicitly disclose the barrel covers as claimed.
Barrelle et al. (henceforth Barrelle) teaches (Figures 1-3 and 13-14) a syringe assembly (2) comprising a barrel cover (3) overlaying the syringe barrel.
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the holding tray assembly of Grimard to retain a plurality of the injector assemblies of Barrelle so as to maintain sterility of the syringes of Barrelle after sterilization as taught by Grimard (Col. 4, lines 5-16). In the cited combination, the barrel covering portion (3) of Barrelle would be retained within the shafts 6a of the support tray 6.
Regarding claim 2, Grimard/Barrelle further teach a plurality of syringe bodies (Figure 1 of Grimard, the tray is configured to carry a number of syringe devices), where each of the syringe bodies is inserted into one of the plurality of barrel covers through a corresponding opening (Col. 6, line 65-Col. 7, line 4 discloses the insertion of syringe 2 into body 3 to form the combined syringe device).
Regarding claim 3, Grimard/Barrelle further teach a plurality of syringe caps (depicted covering the needle assemblies of all retained syringes in Figure 1; see also cap 46 in Figure 13 of Barrelle which would be attached to the retained syringe assembly) configured to seal a distal portion of one of the plurality of syringe bodies when the plurality of syringe bodies are inserted into the plurality of barrel covers through the plurality of openings (Figure 13 of Barrelle discloses the assembled device which would be retained in the opening; see also Figure 1 of Grimard showing all retained syringes are capped after insertion).
Regarding claim 4, Barrelle further teaches each of the plurality of syringe bodies (2) includes a flange (8, 12; Figures 2 and 4) at a proximal end of the syringe body, and each of the plurality of barrel covers (3) includes a plurality of ridges (holding surfaces within fixing means 21, Figures 1 and 16; the syringe flange is retained between transverse platform 22 and rim 23 after connection which are considered to be ridges as claimed).
Regarding claim 5, Grimard further discloses wherein the plurality of syringe bodies are empty when inserted into the barrel covers (Grimard discloses in Col. 4, lines 5-8 that the barrels within the tub are intended to be sterilized; Grimard further depicts open syringe barrels for being sterilized in Figure 1; Grimard further discloses in Col. 2, lines 17-20 that the general method of use of the device is to provide syringes intended to be filled with a drug after sterilizing). Therefore, Grimard is considered to disclose, for the cited combination, a disclosure of mounting the syringe and barrel cover combination of Barrelle within the tray in an empty configuration so as to sterilize these components before being filled for use.
Regarding claim 6, Grimard/Barrelle further teach wherein the syringe bodies are made of glass (e.g., Col. 2, lines 38-39 of Grimard disclose the known use of glass syringes; Col. 4, lines 65 and Col. 10, lines 17-24 of Barrelle also disclose the use of glass for the syringe material).
Regarding claim 7, Barrelle further teaches (Figures 1 and 14) wherein each of the plurality of barrel covers (3) has a proximal opening (the plunger extends therethrough) and a distal opening (for the cap 10 to extend there through after removal of the barrel cover cap as depicted in Figures 1 and 14), and each of the plurality of syringe bodies extends distal of the distal opening of each of the plurality of barrel covers (Figures 1 and 14, it can be seen that the cap 10 extends beyond the distal end of the barrel cover distal end as claimed).
Regarding claim 8, Grimard/Barrelle further teach a plurality of tamper evident device (frangible cap 46, Figures 13-14 of Barrelle) including a collar (portion of bridge 47 connected to body 3; seen still attached after cap removal in Figure 14), a tamper evident cap (46), and a frangible connection (47) between the collar and tamper evident cap, wherein each of the plurality of tamper evident devices is attached to one of the plurality of barrel covers (Col. 9, lines 7-11; in the cited combination, each syringe assembly would comprise the tamper evident cap assembly). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the tamper evident cap assembly on the barrel cover so as to provide a means of alerting a user of the device that the syringe has been opened before use as taught by Barrelle.
Regarding claim 10, Grimard/Barrelle further teach wherein the tray (6) has a plurality of tube members (6a) extending from an upper surface of the tray, each of the plurality of tube members defining one of the plurality of openings (Figure 1), and each of the plurality of barrel covers being supported by one of the plurality of tube members (in the cited combination, the barrel covers 3 of Barrelle would be extending through the opening formed by tubes 6a).
Regarding claim 11, Grimard further discloses a tub (2) including a shoulder portion (4) configured to support the tray (Figure 1; Col. 4, lines 5-11).
Regarding claim 12, Grimard further discloses a sheet (film 18; Figure 1) adhered to a rim of the tub and covering the tray, wherein the sheet is permeable to sterilizing gas and/or vapor (Col. 4, lines 25-29; it allows for the passage of a thermal sterilizing fluid).
Regarding claim 14, Grimard discloses a package comprising a tray (6) having a plurality of tube members (6a) extending from an upper surface, each of the plurality of tube members defining an opening (for receiving a syringe therein; Figure 1); a tub (2) receiving the tray (Figure 1). Grimard fails to explicitly disclose the barrel covers, syringe bodies in the barrel covers, or the tamper evident devices.
Barrelle et al. (henceforth Barrelle) teaches (Figures 1-3 and 13-14) a syringe assembly (2) comprising a barrel cover (3) overlaying the syringe barrel; and a plurality of tamper evident devices (frangible cap 46, Figures 13-14 of Barrelle) including a collar (portion of bridge 47 connected to body 3; seen still attached after cap removal in Figure 14), a tamper evident cap (46), and a frangible connection (47) between the collar and tamper evident cap, wherein each of the plurality of tamper evident devices is attached to one of the plurality of barrel covers (Col. 9, lines 7-11; in the cited combination, each syringe assembly would comprise the tamper evident cap assembly).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the holding tray assembly of Grimard to retain a plurality of the injector assemblies of Barrelle so as to maintain sterility of the syringes of Barrelle after sterilization as taught by Grimard (Col. 4, lines 5-16). In the cited combination, the barrel covering portion (3) of Barrelle would be retained within the shafts 6a of the support tray 6.
In addition, it would have been obvious to one of ordinary skill in the art at the time of filing to provide the tamper evident cap assembly on the barrel cover so as to provide a means of alerting a user of the device that the syringe has been opened before use as taught by Barrelle.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grimard in view of Barrelle, and further in view of Sugita (US 8,348,902).
Regarding claim 9, Grimard/Barrelle teach the claimed invention substantially as set forth above for claim 1, but fail to explicitly disclose wherein the barrel cover is translucent or transparent.
Sugita teaches a syringe barrel (11) and barrel cover (21) assembly and further wherein the barrel cover is transparent (Col. 9, lines 24-28).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the barrel cover of the device of Grimard/Barrelle to be transparent so as to allow a user to view the syringe and its contents inside during use as taught by Sugita (Col. 9, lines 24-28).
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grimard in view of Barrelle, and further in view of Kerboul et al. (US 2015/0122682).
Regarding claims 13 and 15, Grimard/Barrelle teach the claimed invention substantially as set forth above for claim 1, but do not explicitly disclose how the barrel cover is fit into the tray.
Kerboul et al. (henceforth Kerboul) teaches a tray (11) for holding medical articles (Figures 1-2) wherein the tray comprises a means(15) for frictionally receiving a medical device member therein (¶ [0032] discloses that the holes are designed so as to frictionally engage the medical device inserted therethrough so as maintain the device within the opening).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of Grimard/Barrelle to receive the barrel cover in a frictional engagement within the tube members so as to provide a means of securing the injection devices relative to the tray after insertion as taught by Kerboul.
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grimard in view of Beauvais et al. (US 5,876,379), and further in view of Meseke et al. (US 5,007,535).
Regarding claim 16, Grimard discloses a method of packaging a plurality of syringe bodies, the method comprising: inserting the plurality of syringe bodies (10) into a plurality of openings in a tray 6, and inserting the tray into a tub (2; Figure 1; the syringes are placed within tray 6 before being inserted into tub 2 as per Col. 4, lines 8-11). Grimard fails to explicitly disclose that the syringes are within barrel covers and that the barrel covers are in the tray prior to insertion of the syringe bodies.
Beauvais et al. (henceforth Beauvais) teaches (Figures 1-3 and 13-14) a syringe assembly (26) comprising a barrel cover (12) overlaying the syringe barrel (Figures 1-3).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the holding tray assembly of Grimard to retain a plurality of the injector assemblies of Beauvais to be retained therein so as to maintain sterility of the syringes of Beauvais after sterilization as taught by Grimard (Col. 4, lines 5-16). In the cited combination, the barrel covering portion (3) of Barrelle would be retained within the shafts 6a of the support tray 6. As above, Grimard/Barrelle still fail to disclose the barrel covers in the tray before insertion of the syringe into the barrel cover, and finally the insertion of the tray into the tub.
Meseke et al. (henceforth Meseke) teaches a tray (1) for holding syringe elements (e.g., cap 8) and inserting another portion of a syringe therein (needle and hub; Figure 1).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging method of Grimard/Beauvais to place the barrel cover within the tray first so as to stabilize the barrel cover prior to insertion of the injection device therein as taught by Meseke. Based upon the structure of the injection device of Beauvais, it would not alter the function of attaching the support 12 to the syringe 26 as it is inserted axially and fixed to the syringe via the flange member and could readily be attached at any point before use. In this manner, the barrel cover and syringe barrel could be sterilized in the manner taught by Grimard.
Regarding claim 17, as above, Grimard discloses placing the barrel assemblies into the openings and Meseke provides support for positioning a portion of a syringe device within a tray prior to attaching a syringe element to said portion. As such, the cited combination teaches the method of inserting the barrel cover of Beauvais into the tray openings of Grimard, prior to insertion of the syringe bodies, as claimed.
Regarding claim 18, Grimard further discloses sealing the tub (2) by attaching a sheet (18) to an upper flange (14) of the tub, wherein the sheet is permeable to sterilizing gas and/or vapor (Col. 4, lines 25-29; it allows for the passage of a thermal sterilizing fluid).
Regarding claim 19, Grimard further discloses wherein the plurality of syringe bodies are empty when inserted into the barrel covers (Grimard discloses in Col. 4, lines 5-8 that the barrels within the tub are intended to be sterilized; Grimard further depicts open syringe barrels for being sterilized in Figure 1; Grimard further discloses in Col. 2, lines 17-20 that the general method of use of the device is to provide syringes intended to be filled with a drug after sterilizing). Therefore, Grimard is considered to disclose, for the cited combination, a method of providing the syringe and barrel combination of Beauvais within the tray in an empty configuration so as to sterilize these components before being filled for use.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grimard in view of Beauvais in view of Meseke, and further in view of Kerboul.
Regarding claim 20, Grimard/Beauvais/Meseke teach the claimed method substantially as set forth above for claim 16, but fail to explicitly disclose the attachment of the barrel covers to the tray.
Kerboul et al. (henceforth Kerboul) teaches a tray (11) for holding medical articles (Figures 1-2) wherein the tray comprises a means(15) for frictionally receiving a medical device member therein (¶ [0032] discloses that the holes are designed so as to frictionally engage the medical device inserted therethrough so as maintain the device within the opening).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the packaging of Grimard/Barrelle to receive the barrel cover in a frictional engagement within the tube members so as to provide a means of securing the injection devices relative to the tray after insertion as taught by Kerboul.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783