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 .
Response to Arguments
Applicant's arguments filed 30 October 2025 regarding claims 10 and 14-16 have been fully considered but they are not persuasive. Regarding claims 10 and 14-16, applicant argues that: (a) McCarthy does not have a plunger seal with barbs, instead having a pawl of a guide element that is not part of the plunger, and (b) the flexture arms of Maffetone cannot anticipate the mutually exclusive features of claims 14-16. However, (a) the plunger of McCarthy is interpreted as a combination of the stem (20) and the guide (30) and as such the pawl of the guide (30) can be interpreted as a seal of the plunger to anticipate the claimed structure of claim 10. In addition, (b) the arms (84) of Maffetone can be interpreted as a spring clip because the arms are resilient and move back to a compressed position, an internal ring clip because the arms are part of a ring (80) and are internal to the barrel (30), and an external ring clip because the arms are part of a ring (80) and are external to the rod (45). The different clips have no special definition nor are known by a person of ordinary skill in the art to be exclusive structures and can therefore be interpreted broadly.
Applicant’s arguments, see pages 10,11, and 13-18, filed 30 October 2025, with respect to claims 8, 9, 11, 13, 17, and 19 have been fully considered and are persuasive. The rejections of claims 8, 9, 11, 13, 17, and 19 have been withdrawn.
Examiner notes that no arguments were made for any of the other claims and as such the art and double patenting rejections are maintained as detailed below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 6, 10 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCarthy (US 4995869).
Regarding claim 1, McCarthy discloses:
A system (Figs. 1, 2) comprising: a syringe (10) comprising: a barrel (12) configured to hold a fluid; and a plunger (20, 30) configured to draw the fluid into the barrel (12) when the plunger is pulled backward through the barrel (12) (Fig. 2), the syringe (10) being configured to inhibit forward movement of the plunger (20, 30) (ridges 52 of the syringe 10 are fully capable of inhibiting movement of the plunger portion 30 because skirt portion 50 abuts each ridge 52 and hinders its movement).
Regarding claim 2, McCarthy discloses:
The system of claim 1, further comprising one or more mating pockets (44) configured to engage one or more barbs (50) to inhibit forward movement of the plunger (20, 30).
Regarding claim 3, McCarthy discloses:
The system of claim 2, wherein the one or more mating pockets (44) are integrated into the barrel (12) and the one or more barbs (50) are integrated into the plunger (30).
Regarding claim 6, McCarthy discloses:
The system of claim 2, wherein the one or more barbs (50) and the one or more mating pockets (44) are arranged to enable a predetermined draw volume (Col. 4:28-34 – each section 44 is a fixed equal size to allow a predetermined draw of fluid).
Regarding claim 10, McCarthy discloses:
The system of claim 1, wherein the plunger (20, 30) includes a plunger seal (30) having one or more barbs (50), the one or more barbs (50) configured to inhibit forward movement of the plunger (ridges 52 of the syringe 10 are fully capable of inhibiting movement of the plunger portion 30 because skirt portion 50 abuts each ridge 52 and hinders its movement).
Regarding claim 18, McCarthy discloses:
The system of claim 1, wherein the barrel (12) includes an inner ridge (52), the inner ridge (52) having a ramp (sides of pocket 44) that inclines towards the proximal end (24) to a vertical wall, the ramp permitting backward movement of the plunger (20, 30) over the ramp and the vertical wall inhibiting forward movement of the plunger (ridges 52 of the syringe 10 are fully capable of inhibiting movement of the plunger portion 30 because skirt portion 50 abuts each ridge 52 and hinders its movement).
Claims 1-2 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bazell et al (US 4370987).
Regarding claim 1, Bazell discloses:
A system (Fig. 5) comprising: a syringe (10) comprising: a barrel (20) configured to hold a fluid (Fig. 5); a plunger (50) configured to draw the fluid into the barrel (20) when the plunger (50) is pulled backward through the barrel (20), the syringe (10) being configured to inhibit forward movement of the plunger (50) (Fig. 4 – the engagement of projections 54 and locking member 28 prevent movement between the plunger 50 and the barrel 20).
Regarding claim 2, Bazell discloses:
The system of claim 1, further comprising one or more mating pockets (pockets between ridges 54) configured to engage one or more barbs (28) to inhibit forward movement of the plunger (Fig. 4 – the engagement of projections 54 and locking member 28 prevent movement between the plunger 50 and the barrel 20).
Regarding claim 4, Bazell discloses:
The system of claim 2, wherein the one or more mating pockets (pockets between ridges 54) are integrated into the plunger (50) and the one or more barbs (28) are integrated into the barrel (20).
Claims 1-2, 5, 12, and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maffetone (US 5084017).
Regarding claim 1, Maffetone discloses:
A system (Fig. 1) comprising: a syringe (10) comprising: a barrel (30; Fig. 5) configured to hold a fluid (S); and a plunger (45) configured to draw the fluid (S) into the barrel (30) when the plunger (45) is pulled backward through the barrel (30), the syringe (10) being configured to inhibit forward movement of the plunger (45) (Col. 7:66-68, Col. 8:1-2).
Regarding claim 2, Maffetone discloses:
The system of claim 1, further comprising one or more mating pockets (pockets of arms 84; Fig. 18) configured to engage one or more barbs (70) to inhibit forward movement of the plunger (Col. 7:66-68, Col. 8:1-2).
Regarding claim 5, Maffetone discloses:
The system of claim 2, wherein the one or more mating pockets (pockets of arms 84) are integrated into a clip (80) configured to be removably attached at least partially around the plunger (45).
Regarding claim 12, Maffetone discloses:
The system of claim 1, further comprising: a clip (80) configured to attach to the barrel (30) and to securely engage the plunger (45) and inhibit forward movement of the plunger (45) when the clip (80) engages the barrel (30) (Col. 7:66-68, Col. 8:1-2).
Regarding claim 14, Maffetone discloses:
The system of claim 1, wherein the plunger (45) includes one or more spring clips (84) configured to contact the barrel (30) of the syringe (10) (Fig. 18) and to inhibit forward movement of the plunger (45) (Col. 7:66-68, Col. 8:1-2).
Regarding claim 15, Maffetone discloses:
The system of claim 1, wherein the plunger (45) includes one or more internal ring clips (84) configured to contact the barrel (30) of the syringe (10) (Fig. 18) and to inhibit forward movement of the plunger (45) (Col. 7:66-68, Col. 8:1-2).
Regarding claim 16, Maffetone discloses:
The system of claim 1, wherein the barrel (30) includes one or more external ring clips (84) configured to contact the plunger (45) (Fig. 7) and to inhibit forward movement of the plunger (45) (Col. 7:66-68, Col. 8:1-2).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ellgass (US 5037393).
Regarding claim 1, Ellgass discloses:
A system (Figs. 3a-5b) comprising: a syringe (Fig. 3A) comprising: a barrel (32) configured to hold a fluid (70; Fig. 6); and a plunger (42) configured to draw the fluid into the barrel (32) when the plunger (42) is pulled backward through the barrel (32), the syringe being configured to inhibit forward movement of the plunger (42) (Fig. 1; Col. 1:61-65).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McCarthy in view of Brannon (US 6013037).
Regarding claim 7, McCarthy discloses the system of claim 2 but is silent regarding “wherein the plunger includes an interface having an open-ended cylinder with a collection needle and a sampling channel through the plunger.” However, Brannon teaches an injection system (Fig. 1) with a plunger (20) includes an interface having an open-ended cylinder (25) with a collection needle (56) and a sampling channel (32) through the plunger (20). Such a plunger and interface are used to sterilely collect blood samples during use of the device (Col. 4:27-35). It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have provided the system of McCarthy to incorporate a plunger with a collection needle and sampling channel as taught by Brannon in order to sterilely collect blood during use of the device, as recognized by Brannon.
Double Patenting
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,390,596 as detailed in the Non-Final Office Action mailed 08 September 2025.
Allowable Subject Matter
Claims 8, 9, 11, 13, 17, and 19-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783