DETAILED ACTION
Response to Amendment
The amendment filed April 8, 2026 has been entered. Claims 1-5, 8, 10-12, 14, 16, and 20 have been amended. Claims 21-26 have been newly added, and claims 6, 7, 9, 17, and 18 have been cancelled. Claims 1-5, 8, 10-16, and 19-26 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are not persuasive. Regarding Applicant’s arguments with respect to amended claim 1, the Examiner believes Barrelle clearly teaches an anti-rotation feature formed as a plurality of breakable bridges (47, Figures 13-14). While they are meant to allow for breakage, they will at least prevent relative rotation between the cap 46 and the cover. The claim does not require that the anti-rotation features completely prevent rotation or the like. In addition, with respect to Applicant’s arguments in response to the rejection of amended claim 14, Barrelle clearly teaches the use of the cover comprising cover flanges for receiving syringe flanges (e.g., Figure 1, syringe flange 12 is received in slots in cover portion 21). Regarding Applicant’s arguments as to amended claim 16, the arguments are considered persuasive and therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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) 1-5, 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 as well as the plurality of barrel covers including an anti-rotation feature at a distal portion of the barrel cover.
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. Barrelle further teaches wherein the barrel cover (3) includes an anti-rotation feature (breakable bridges 47 will prevent rotation between cap 46 and the cover 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 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 utilize the anti-rotation features of Barrelle to provide a means for providing tamper-proofing means to alert a user as to the sterility of the device as taught by Barrelle (Col. 9, lines 7-11).
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). However, Grimard fails to explicitly disclose a syringe flange engaging with a corresponding cover flange of the barrel cover.
Barrelle teaches (seen in Figure 1) wherein the barrel cover (3) comprises cover flanges (in 21 for receiving flange 12 of the syringe) such that each syringe flange rests over a corresponding cover flange of the one of the plurality of barrel covers (Figure 1).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the syringe cover of Grimard to comprise cover flanges for engaging with syringe flanges on the syringes to provide a means for securing the cover to the syringe during use as taught by Barrelle (Col. 7, lines 5-15).
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 cover flange (receiving portion 21 with slots for holding syringe flange 12) at a proximal end of the syringe body, and each cover flange (receiving portion 21 with slots for holding flange 12) 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 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) when the tray is inserted into the tub.
Regarding claim 12, Grimard further discloses a sheet (film 18; Figure 1) adhered to a rim of the tub and covering the tray when the tray is inserted into 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).
Claim(s) 8, 14, and 21-25 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), and further in view of Jansen et al. (US 6,520,935).
Regarding claims 8, 14, and 23, Grimard discloses (also as set forth above with respect to claim 3) a package comprising a tray (6) having a plurality of tube members (6a) extending from an upper surface of the tray, 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, each of the plurality of barrel covers including a cover flange (21 for receiving flange 12 of syringe) at a proximal portion of the barrel cover (Figure 1) for providing a space in which the syringe flange of the syringe body can rest over a corresponding cover flange (Figure 1, syringe flange 12 has two sides which rest in corresponding slots in the cover 3); 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.
Grimard/Barrelle also fail to disclose the collar includes an anti-rotation feature on a distal end thereof which is configured to mate with an anti-rotation feature on the collar as claimed.
Jansen et al. (henceforth Jansen) teaches a tamper evident device (Figures 1-5) formed from a collar portion (44) connected to the syringe (12) which engages with a tamper evident cap (56, 58), and wherein the collar includes an anti-rotation feature which engages with an anti-rotation feature on the cap (Col. 6, lines 35-42 disclose that the outer cap comprises ribs 84 which engage with the surface of 44 to prevent relative rotation of the outer cap relative to the collar; this applies to claim 23 as well which provides for the same connection between the cover and collar).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the assembly of Grimard/Barrelle to comprise the tamper evident cap of Jansen so as to provide a means of determining when the device has been used via the separation of the outer cap elements as taught by Jansen. In this combination, the frangible cap of Barrelle would be replaced to place the collar of Jansen on the distal end of the cover of Barrelle which teaches that any syringe-type device can have such a cover on a distal end thereof. This would then mate with the outer cap to provide a secure means of accessing the syringe via the frangible tamper-evident connection.
Regarding claim 21, Barrelle further teaches wherein each tamper evident cap (46) is spaced in an entirety from each tip cap (10) of the syringe body when inserted in the barrel cover (Figures 13-14, the cap 46 surrounds, but does not contact syringe cap 10).
Regarding claim 22, in the cited combination, the syringe cap (10) of Barrelle would be maintained and surrounded by the tamper evident cap and collar assembly of Jansen to maintain sterility of the syringe while providing the tamper-evident benefits of the cap of Jansen.
Regarding claims 24 and 25, Jansen further teaches wherein the anti-rotation feature at the distal portion of the barrel cover is a plurality of teeth or a plurality of grooves, and the second anti-rotation feature at the collar is a plurality of teeth or a plurality of grooves (Figure 3 depicts collar 44 as having grooved features on an external surface, and Figure 4 depicts the outer cap 58 comprising inner teeth or ribs 84 for engaging with the outer surface of the collar 44).
Claim(s) 13 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 claim 13, 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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grimard in view of Barrelle in view of Jansen, and further in view of Kerboul et al. (US 2015/0122682).
Regarding claim 15, Grimard/Barrelle/Jansen 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/Jansen 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, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grimard in view of Barrelle in view of Jansen, 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); 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), and sterilizing the tub (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). 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, or the anti-rotation features of tamper evident devices.
Barrelle teaches (Figures 1 and 13-14) a syringe assembly (2) comprising a barrel cover (3) overlaying the syringe barrel (Figures 1-2).
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 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.
As above, Grimard/Barelle/Meseke fail to teach the use of first and second anti-rotation features on the barrel cover and tamper-evident cap.
Jansen et al. (henceforth Jansen) teaches a tamper evident device (Figures 1-5) formed from a collar portion (44) connected to the syringe (12) which engages with a tamper evident cap (56, 58), and wherein the collar includes an anti-rotation feature which engages with an anti-rotation feature on the cap (Col. 6, lines 35-42 disclose that the outer cap comprises ribs 84 which engage with the surface of 44 to prevent relative rotation of the outer cap relative to the collar).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the assembly of Grimard/Barrelle to comprise the tamper evident cap of Jansen so as to provide a means of determining when the device has been used via the separation of the outer cap elements as taught by Jansen. In this combination, the frangible cap of Barrelle would be replaced to place the collar of Jansen on the distal end of the cover of Barrelle which teaches that any syringe-type device can have such a cover on a distal end thereof. This would then mate with the outer cap to provide a secure means of accessing the syringe via the frangible tamper-evident connection.
Regarding claim 19, Grimard further discloses wherein the plurality of syringe bodies are empty when inserted into the barrel covers (Col. 2, lines 17-32).
Regarding claim 26, as set forth above, Barrelle teaches a tip cap (10) for a syringe configured to seal a distal portion of one of the plurality of syringe bodies; Barrelle as modified by Jansen teaches the collar (44), tamper evident cap (58), and that the syringe cap is spaced from the syringe cap after installation (the relationship between the syringe tip cap and tamper evident cap 46 of Barrelle would be maintained in the cited combination wherein they are spaced from each other as claimed).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grimard in view of Barelle in view of Jansen in view of Meseke, and further in view of Kerboul.
Regarding claim 20, Grimard/Barrelle/Jansen/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/Jansen/Meseke 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
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 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
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