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 § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention . Claim 1 is rejected under 35 U.S.C. § 112(b) as failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. Specifically, claim 1 recites the positional terms "a first position" and "a second position" three separate times within the same claim, each time in reference to a different structural element: (1) the first shaft relative to the first barrel; (2) the second shaft relative to the second barrel; and (3) the piercing member relative to the second barrel. The repeated use of identical positional terminology to describe different structural elements creates ambiguity as to whether these positions are the same or different, and whether the subsequent recitation of "a first position" and "a second position" with respect to the piercing member refers to the same positions previously introduced for the first shaft and second shaft, or to entirely new positions. This ambiguity renders the metes and bounds of claim 1 unclear. See MPEP § 2173.05(e). Applicant is invited to amend claim 1 to use distinct positional terms for each structural element (e.g., "a first shaft position and a second shaft position," "a first needle position and a second needle position") to clearly distinguish the positions of the first shaft, the second shaft, and the piercing member. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. Clai m 1 is rejected under 35 U.S.C. 103 as being unpatentable over Zivkovic et al. (US2012/0022464 A1 ; hereinafter “Zivkovic” ) in view of Shaw et al. (US 2010/0168674 A1 ; hereinafter “Shaw” ) . In relation to independent claim 1 , Zivkovic discloses a sy ringe assembly (Abstract; ¶ [0011]), the syringe assembly comprising: a first barrel : Zivkovic discloses a fluid barrel 110 including a sidewall having an inside surface defining a fluid chamber 115 for retaining fluid (¶ [0055]: "the retractable syringe assembly includes a dual syringe barrel 101 that includes fluid barrel 110 and a retraction barrel 120"). a second barrel : Zivkovic discloses a retraction barrel 120 disposed adjacent to the sidewall of the fluid barrel 110, the retraction barrel including a wall having an interior surface defining a needle chamber 125 (¶ [0055]; ¶ [0058]: "The retraction barrel 120 is disposed adjacent to the sidewall 112 of the fluid barrel 110 . . . The retraction barrel 120 is configured to house a needle hub assembly 140 therein and the retraction feature"). a plunger comprising a first shaft and a second shaft, wherein the first shaft is slidably coupled inside at least a portion of the first barrel between a first position and a second position, and the second shaft is slidably coupled inside at least a portion of the second barrel between a first position and a second position : Zivkovic discloses a plunger rod 160 (first shaft) disposed within the fluid chamber of the fluid barrel 110 (¶ [0067]: "A plunger rod 160 is disposed within the fluid chamber 125 . . . The plunger rod 160 includes a distal end 161 and a proximal end 169"). The plunger rod 160 is slidable between a proximal position (after aspiration, FIG. 7) and a distal position (after injection, FIG. 9) (¶ [0082]: "the user applies p roximal force to the plunger rod until a predetermined or desired amount of liquid is aspirated or drawn into the syringe"). Zivkovic further discloses a trigger element 190 (second shaft) that is "moveable with the plunger rod 160 but extends into the needle chamber 125 of the retraction barrel 120" (¶ [0073]: "The retractable syringe assembly 100 also includes a trigger element 190 . . . The trigger element 190 is moveable with the plunger rod 160 but extends into the needle chamber 125 of the retraction barrel 120"). The trigger element 190 is slidably coupled inside at least a portion of the retraction barrel 120 and moves between a first position (prior to activation) and a second position (after activation, when the trigger force is applied) (¶ [0073]; ¶ [0074]). a piercing member coupled to the second shaft, the piercing member movable from a first position in which a distal tip of the piercing member extends from a distal portion of the second barrel to a second position in which the distal tip is retracted into the second barrel: Zivkovic discloses a needle cannula 150 (piercing member) attached to the needle hub 142 and disposed within the retraction barrel 120 (¶ [0062]: "The needle hub assembly 140 is disposed within the retraction barrel 120 and includes a needle hub 142 and a needle cannula 150 attached to the needle hub 142"). The needle cannula 150 is positioned so it "extends beyond the open distal end 121 of the retraction barrel in a first position" (¶ [0065]). The needle cannula 150 is biased to move in the proximal direction and, upon activation of the trigger element 190, the needle cannula 150 "retracts and is housed into the retraction barrel" in a second position (¶ [0063]; ¶ [0074]: "The trigger element 190 is sized, shaped and positioned to provide a trigger force on the needle hub 142 to disengage the supporting element 134 and the latch portion 145 so the needle cannula 150 retracts and is housed into the retraction barrel"). While the needle cannula 150 is not directly mechanically coupled to the trigger element 190 (second shaft), the trigger element 190 provides the trigger force that causes the needle cannula 150 to retract into the retraction barrel 120. The needle cannula 150 is thus operationally coupled to the trigger element 190 (second shaft) through the retraction mechanism. a first reservoir located inside of the first barrel such that sliding the first shaft proximally relative to the first barrel increases a volume of the first reservoir: Zivkovic discloses that the fluid barrel 110 includes a fluid chamber 115 for retaining fluid (¶ [0055]). When the user applies proximal force to the plunger rod 160, liquid is "aspirated or drawn into the syringe" (¶ [0082]: "the user applies proximal force to the plunger rod until a predetermined or desired amount of liquid is aspirated or drawn into the syringe. During the aspiration step, the plunger rod and the stopper body move in the proximal direction together to draw medication into the syringe"). Thus, sliding the plunger rod 160 (first shaft) proximally relative to the fluid barrel 110 (first barrel) increases the volume of the fluid chamber 115 (first reservoir). Zivkovic does not disclose that the syringe assembly is " a vascular access system for placement of a catheter within a patient's blood vessel. " Zivkovic is directed to a retractable syringe assembly for injection and aspiration of fluids, and does not disclose the use of the dual-barrel syringe assembly in combination with a catheter for vascular access. Shaw discloses an IV catheter introducer that is "a medical device, optionally having a retractable needle, that is used to insert a catheter into a patient's body, especially for the intravenous delivery of a fluid" (¶ [0003]). Shaw further discloses that "Intravenous ("IV") catheter insertion devices are well known. When a catheter is inserted into a patient for the intravenous delivery of a fluid, a disposable needle passing through the catheter is utilized to puncture a vein to permit entry of the catheter" (¶ [0005]). Shaw discloses a specific embodiment (FIGS. 7-14) in which an IV catheter introducer 210 comprises a plunger assembly 212, a housing 214, a retractable needle assembly 218 with a needle 246, and an IV catheter assembly 216 with a catheter 274 (¶ [0046]). Shaw discloses that "needle 246 and the forwardly extending tip of catheter 274 are desirably inserted into a vein" and that "Once needle 246 has punctured the vein and catheter 274 is properly positioned inside the vein" the needle is retracted (¶ [0055]). Shaw thus discloses a vascular access system for placement of a catheter within a patient's blood vessel using a retractable needle. In view of the above comments, i t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dual-barrel retractable syringe assembly of Zivkovic to be used as a vascular access system for placement of a catheter within a patient's blood vessel, as taught by Shaw. One of ordinary skill in the art would have been motivated to make this combination because Shaw teaches that retractable needle devices are well known and d esirable for inserting catheters into a patient's vein for intravenous delivery of fluid (Shaw, ¶ [0003]; ¶ [0005]), and because Zivkovic's dual-barrel retractable syringe assembly already includes the key structural features needed for such a vascular access system, namely a retractable needle cannula housed in a separate retraction barrel that isolates the retraction feature from the fluid path (Zivkovic, ¶ [0054]). The combination of Zivkovic's dual-barrel structure with Shaw's catheter placement functionality would yield the predictable result of a vascular access system having a dual-barrel configuration with a retractable needle for safe catheter placement, while providing the additional benefit of isolating the retraction feature from the fluid path to reduce the risk of premature activation (Zivkovic, ¶ [0076]). Examiner’s Comment PCT/US15/14240 includes a rejection of claim 1 of this application made by the U.S. Patent and Trademark Office as the international searching authority (ISA) that complies with all the requirements of section 103. According to the record, it appears that there is no response to this international office action. Therefore, the rejection has been included in the following section of this office action to provide Applicant the opportunity to formally respond to the rejection and clarify the record. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Shaw et al. (US 2014/0012206A1; hereinafter “Shaw”) in view of Glynn (US 2010/0137833) . In relation to independent claim 1 , Regarding claim 1, Shaw discloses a vascular access system for placement of a catheter within a patient's blood vessel, the vascular access system (abstract; IV-catheter insertion device, para. 0016) comprising: a first barrel (barrel 106, fig. 11); a second barrel (retraction chamber 42, fig. 15); wherein the first shaft is slidably coupled inside at least a portion of the first barrel between a first position and a second position (syringe 104), wherein the first shaft is slidably coupled inside at least a portion of the first barrel between a first position and a second position (plunger 108 cooperates with barrel 106 to define a variable-volume fluid chamber 110 inside the syringe that can supply a fluid to needle 38 through the fluid pathway, para. 0080, fig. 11); and the second shaft is slidably coupled inside at least a portion of the second barrel between a first position and a second position (entry of needle holder 72 and retraction spring 80 into retraction cavity 58 during needle retraction, para. 0073); a piercing member coupled to the second shaft (needle 38, fig. 15), the piercing member movable from a first position in which a distal tip of the piercing member extends from a distal portion of the second barrel to a second position in which the distal tip is retracted into the second barrel (first position in which syringe 108 is aligned with needle 38 to a second position in which the needle retraction cavity of connector housing 32 is aligned with needle 38, para. 0082; pre - injection position, para. 0080, fig. 11; needle retraction is desirably achieved in medical device 30 by repositioning connector housing 32 relative to frontal attachment 34 so that needle retraction chamber 42 is moved into coaxial alignment with needle 38, para. 0082, fig. 15) ; an d a first reservoir located inside of the first barrel (variable-volume fluid chamber 110 inside the syringe, para. 0080), and further discloses a plunger comprising a second shaft (plunger 108) but fails to disclose a plunger comprising a first shaft and a second shaft, and a first reservoir located inside of the first barrel such that sliding the first shaft proximally relative to the first barrel increases a volume of the first reservoir. Glynn is in the field of drug delivery devices (abstract) and discloses a plunger comprising a first shaft and a second shaft (plunger 33, drug vial-receiving adapter 73, main housing 3, fig. 2), and a first reservoir located inside of the first barrel such that sliding the first shaft proximally relative to the first barrel increases a volume of the first reservoir (reservoir 5, fig. 3; plunger being partially and slideably located in the proximal end of the shaft, the plunger having sufficient length to be moved from a first plunger position to a second plunger position, plunger is moved from the first position to the second position, the liquid drug will be drained from the vial through the one-way valve and through the inlet conduit into the drug holding reservoir, para. 0051) It would have been obvious to one of ordinary skill in the art to use the plunger of Glynn as the plunger of Shaw. The motivation would have been to move the fluid from one area to another vial movement of the plunger. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MANUEL A MENDEZ whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-4962 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 7:00 AM-5:00 PM . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Bhisma Mehta can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-3383 . 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