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 .
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 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,349,924.
Regarding claim 19, patent claim 1 discloses a dual syringe assembly (Col. 8, line 8) compromising: a first syringe having an open top end, a bottom end opposite said open top end and a longitudinal sidewall wherein said longitudinal sidewall defines a cavity within said syringe (Col. 8, lines 9-13 disclose first syringe structure as the patent claims defines a bottom wall which is a specific example of a bottom end which forms a cavity with the sidewall portion as claimed) ; a plunger inserted into said cavity of said first syringe through said open end (Col. 8, lines 19-20); a first port at said bottom end of said first syringe creating a fluid pathway into said cavity of said first syringe (Col. 8, lines 14-16); a second port at said bottom of end of said first syringe creating a fluid pathway between said cavity of said first syringe and a cavity of a second syringe (Col. 8, lines 17-18 and 27-28 disclose the first syringe second port creates a fluid pathway with the cavity and then the second syringe port fluidly connects the cavity to the second syringe as claimed); said second syringe having an open top end, a bottom end opposite said open top end and a longitudinal cylindrical sidewall wherein said cylindrical sidewall defines a cavity within said second syringe (Col. 8, lines 21-26); a plunger inserted into said cavity of said second syringe through said open top end (Col. 8, lines 29-30); a port at said bottom end of said second syringe creating said fluid pathway between said cavity of said second syringe and said cavity of said first syringe (Col. 8, lines 27-34 disclose fluid flow from the cavity through the second syringe port); and a longitudinal groove in the exterior surface of said sidewall of said first syringe wherein at least a portion of said cylindrical sidewall of second syringe is positioned within said groove (Col. 8, lines 35-38).
Regarding claim 20, the subject matter is known from claim 2 of the patent which places the first port above the second port as claimed.
Claims 1-6 and 15-18 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 9, and 10 of U.S. Patent No. 10,349,924 in view of Bailey (US 3,978,846). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the patent discloses a dual syringe assembly (Col. 8, line 8) comprising: a first syringe having an open top end, a longitudinal sidewall, a bottom end opposite said open top end wherein said sidewall of said first syringe defines a cavity within said first syringe (the patent claims defines a bottom wall which is a specific example of a bottom end which forms a cavity with the sidewall portion as claimed); a first port positioned at said bottom end (Col. 8, lines 14-16 set forth the first port formed in the bottom wall which is at the bottom end as claimed) and a second port positioned at said bottom end below said first port (claim 1 sets forth the second port in the bottom wall and claim 2 sets forth that the second port is below the first port as claimed); a plunger inserted into said cavity of said first syringe through said open top end (Col. 8, lines 29-30); a second syringe having an open top end, a longitudinal sidewall, a bottom end opposite said open top end wherein said sidewall of said second syringe defines a cavity within said second syringe (Col. 8, lines 21-26 disclose the syringe assembly and cavity); a port positioned at said bottom end of said second syringe (Col. 8, lines 27-28); a plunger inserted into said cavity of said second syringe through said top open end (Col. 8, lines 29-30); said first port of said first syringe creating a fluid pathway between said cavity of said first syringe and a needle hub attached to said first syringe; and said second port of said first syringe creating a fluid pathway between said cavity of said first syringe and said port of said second syringe. The patent fails to explicitly disclose the needle hub attached to the first syringe.
Bailey teaches (Figures 1-2) a dual syringe assembly comprising a first syringe (22) having a bottom end (needle attachment end) and having a first port (44) attached to a needle hub (cylindrical attachment portion of needle 46 with extension 42 of the distal end of syringe 22).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent device to comprise the needle and hub assembly of Bailey attached to the first port so as to allow a user to draw fluid into the chamber at the bottom of the first syringe during a blood drawing procedure as taught by Bailey (Col. 4, lines 1-43).
Regarding claim 2, the subject matter is known from claim 1 which sets forth that the second syringe sidewall is positioned within a longitudinal groove on the exterior surface of the first syringe sidewall.
Regarding claim 3, the subject matter is known from claim 1 of the patent which sets forth that the first and second ports of the first syringe extend through a bottom wall opposite the open top end of the first syringe as claimed (Col. 8, lines 14-18).
Regarding claim 4, the subject matter is known from claim 9 of the patent which sets forth that the bottom wall is sloped away from the top end from the first port to the second port as claimed.
Regarding claim 5, the subject matter is known from claim 10 of the patent.
Regarding claim 6, the patent fails to explicitly disclose the needle hub structure, however, Bailey teaches the needle hub comprising a syringe attachment member (e.g., cylindrical feature of hub for engaging with extension 42 of the first syringe); a cannula attachment member (portion of hub attached to needle cannula member); and a hollow needle (46) extending from said cannula attachment member and creating a fluid pathway between said first port of said first syringe and said needle (for drawing blood into the distal cavity of the syringe).
Regarding claim 15, patent claim 1 discloses a dual syringe assembly comprising: a first syringe having an open top end, a longitudinal sidewall, and a bottom wall opposite said open top end wherein said sidewall and said bottom wall define a cavity within said first syringe (the patent claims defines a bottom wall of the first syringe which forms a cavity with the sidewall portion as claimed); a first port (Col. 8, lines 14-16 set forth the first port formed in the bottom wall which is at the bottom end as claimed) and a second port extending through said bottom wall of said first syringe (Col. 8, lines 17-18 disclose the second port in the bottom wall); a plunger inserted into said cavity of said first syringe through said open end (Col. 8, lines 19-20); a second syringe having an open top end, a longitudinal sidewall, and a bottom end opposite said open top end wherein said longitudinal sidewall defines a cavity within said second syringe (Col. 8, lines 21-26 disclose the cylindrical side wall and bottom wall form a cavity in the second syringe; the bottom wall is the bottom end of the second syringe); a port at said bottom end of said second syringe (Col. 8, lines 27-28 disclose the port in the bottom wall of the second syringe); a plunger inserted into said cavity of said second syringe through said open end (Col. 8, line 29-30); and said second port of said first syringe creating a fluid pathway between said cavity of said first syringe and said port of said second syringe (Col. 8, lines 31-34 disclose the fluid pathway formed between the second port of the first syringe through the port of the second syringe as claimed. The patent fails to explicitly disclose the fluid pathway between the first port of the first syringe and a needle attachment.
Bailey teaches (Figures 1-2) a dual syringe assembly comprising a first syringe (22) having a bottom end (needle attachment end) and having a first port (44) attached to a needle assembly (cylindrical attachment portion of needle 46 with extension 42 of the distal end of syringe 22); wherein the first syringe creates a fluid pathway from the cavity of the first syringe through the first port to the needle attachment (fluid flows from the needle assembly through 44 and into the cavity 40 as claimed).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent device to comprise the needle and hub assembly of Bailey attached to the first port so as to allow a user to draw fluid into the chamber at the bottom of the first syringe during a blood drawing procedure as taught by Bailey (Col. 4, lines 1-43).
Regarding claim 16, the subject matter is known from claim 2 of the patent.
Regarding claim 17, the subject matter is known from claim 1 of the patent which discloses the second syringe has a cylindrically shaped sidewall positioned within a longitudinal groove on the exterior surface of the longitudinal sidewall of the first syringe.
Regarding claim 18, the subject matter is known from claim 9 of the patent.
Claims 6-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 10,349,924 in view of Eisenberg (US 3,312,220).
Regarding claim 6, the patent fails to explicitly disclose the needle hub structure, however, Eisenberg teaches the needle hub comprising a syringe attachment member (e.g., proximal cylindrical feature of hub 4 for engaging with extension 42 of the first syringe); a cannula attachment member (portion of hub attached to needle cannula member 3 as in Figure 4); and a hollow needle (4) extending from said cannula attachment member and creating a fluid pathway between said first port of said first syringe and said needle (for passing fluid from the syringe into the injection space; Figure 4 discloses the combined needle/cannula assembly). It would have been obvious to one of ordinary skill in the art at the time of filing to modify the dual syringe system of the patent to comprise a needle/cannula assembly at the distal end so as to allow for a means of utilizing the device to insert a cannula at the target space as taught by Eisenberg (Col. 2, lines 28-38).
Regarding claim 7, Eisenberg further teaches a cannula (1) having an opening on one end (adjacent needle tip 5) and an attachment member (3) on the opposing end; wherein said attachment member of said cannula is connected to said cannula attachment member (e.g., distal end of needle attachment member 4) and said needle is positioned within said cannula and extends through said opening of said cannula (Figure 4, the tip extends beyond the distal end of the cannula); and wherein said syringe attachment member is attachable to and detachable from said first syringe (via proximal end of hub 4 which attaches to a syringe or the first injector of the patent).
Regarding claim 8, Eisenberg further teaches wherein the cannula (1) is removable from the needle hub (4; Col. 2, lines 21-38).
Regarding claim 9, Eisenberg further teaches at least one port (drainage hole 9; Col. 3, lines 8-9) along the longitudinal axis (Figure 4).
Regarding claim 10, Eisenberg further teaches wherein said cannula tapers to said opening of said cannula (at tapered tip 2; Col. 3, line 1).
Regarding claims 11 and 12, Eisenberg further teaches wherein the cannula is attachable and detachable from a syringe (via connection of the cannula with the needle which is attached to the syringe (Col. 3, lines 25-49 disclose the placement of the cannula and the attachment to the syringe via the needle or after insertion using the hub 3), the cannula having an attachment member (3) on an opposing end wherein said attachment member of said cannula is attachable from said first syringe (e.g., through the combined needle cannula assembly of Figure 4, or as set forth above, after insertion, via hub 3 connected directly to a syringe); and a fluid pathway is between said cannula and said first port of said first syringe (as the needle/cannula is connected to a syringe it will engage with the first port of the syringe to fluidly couple the syringe to the cannula).
Regarding claim 13, Eisenberg further teaches at least one port (drainage hole 9; Col. 3, lines 8-9) along the longitudinal axis (Figure 4).
Regarding claim 14, Eisenberg further teaches wherein said cannula tapers to said opening of said cannula (at tapered tip 2; Col. 3, line 1).
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bailey (US 3,978,846).
Regarding claim 15, Bailey discloses a dual syringe (22, 28) assembly comprising: a first syringe (22) having an open top end (34a for receiving plunger 24), a longitudinal sidewall, and a bottom wall (formed by leading end 34b opposite said open top end) opposite said open top end wherein said sidewall and said bottom wall define a cavity within said first syringe (formed by the barrel of 22 and the leading end 34b); a first port (44) and a second port (50) extending through said bottom wall of said first syringe (formed in leading end 34b; Figure 2); a plunger (24) inserted into said cavity of said first syringe through said open end (Figure 2); a second syringe (28) having an open top end (28a), a longitudinal sidewall, and a bottom end (adjacent 56) opposite said open top end (28a) wherein said longitudinal sidewall defines a cavity within said second syringe (Figure 2, the syringe is formed by the cylindrical sidewall and the bottom plate 56); a port (58) at said bottom end of said second syringe (Figure 2); a plunger (30) inserted into said cavity of said second syringe through said open end (28a); said first port of said first syringe creating a fluid pathway between said cavity of said first syringe and a needle attachment (extension 42; 48 and portion of needle hub engaging extension 42 to retain the needle on the inlet port of the first syringe); and said second port (50) of said first syringe creating a fluid pathway between said cavity of said first syringe and said port of said second syringe (Figure 2, the fluid flows from the opening cavity 40 through port 50 and is fluidly connected through port 58 to the second syringe; Col. 4, lines 1-43 disclose the use and fluid flow through the pathway as claimed).
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) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey in view of Andersson (US 2007/0219506).
Regarding claim 17, Bailey discloses the claimed invention substantially as set forth above for claim 15, but fails to explicitly disclose a cylindrical sidewall portion of the second syringe is removably positioned within a longitudinal groove on the exterior surface of the longitudinal sidewall of the first syringe.
Andersson teaches (Figures 1-2) a first syringe (2) comprising a longitudinal groove (9) located on its sidewall (Figure 1) which receives a cylindrical portion of a second element (10) of a second body (3) attached thereto so as to removably couple the second element to the syringe while preventing lateral movement between the two elements when connected (¶ [0039]; the first and second elements are cylindrical as are the groove and extension which is considered to read on the claim as currently set forth as they are part of the barrel assemblies).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connection means between the first and second syringe members of Bailey to comprise the groove/extension connection means of Andersson so as to provide for a removable second syringe element which could be attached and removed from the first syringe as needed and as taught by Andersson.
Regarding claim 19, Baily discloses a dual syringe assembly (22, 28) compromising: a first syringe (22) having an open top end (34a), a bottom end (formed by 34b) opposite said open top end and a longitudinal sidewall (Figure 2) wherein said longitudinal sidewall defines a cavity within said syringe (Figure 2) ; a plunger (24) inserted into said cavity of said first syringe through said open end (Figure 2); a first port (44) at said bottom end of said first syringe creating a fluid pathway into said cavity of said first syringe (from the needle into space 40); a second port (50) at said bottom of end of said first syringe creating a fluid pathway between said cavity of said first syringe and a cavity of a second syringe (50 creates a fluid path between cavity 40 and the syringe chamber 60); said second syringe having an open top end (28a), a bottom end (at plate 56) opposite said open top end and a longitudinal cylindrical sidewall wherein said cylindrical sidewall defines a cavity within said second syringe (Figure 2); a plunger (30) inserted into said cavity of said second syringe through said open top end (Figure 2); a port (58) at said bottom end of said second syringe creating said fluid pathway between said cavity of said second syringe and said cavity of said first syringe (Col. 3, lines 39-49). Bailey fails to explicitly disclose a longitudinal groove in the exterior surface of said sidewall of said first syringe wherein at least a portion of said cylindrical sidewall of second syringe is positioned within said groove.
Andersson teaches (Figures 1-2) a first syringe (2) comprising a longitudinal groove (9) located on its sidewall (Figure 1) which receives a cylindrical portion of a second element (10) of a second body (3) attached thereto so as to removably couple the second element to the syringe while preventing lateral movement between the two elements (¶ [0039]; the first and second elements are cylindrical as are the groove and extension which is considered to read on the claim as currently set forth as they are part of the barrel assemblies).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connection means between the first and second syringe members of Bailey to comprise the groove/extension connection means of Andersson so as to provide for a removable second syringe element which could be attached and removed from the first syringe as needed and as taught by Andersson.
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