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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,414,899. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims are merely broader than the patent claims.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-11, 13-15 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eliuk (2006/0259195).
In re claim 7, Eliuk discloses a robotic system (at least figs.15a-c, 52a-b, and 53a-d) operable for transfer of fluid between a container (vial or IV bags shown in figs.52a-b) and a fluid transfer assembly (syringe with luer lock needle connector shown in figs.46 and 52a-53d) comprising a fluid transfer unit (syringe barrel and plunger shown in figs.46, 52a-53d) accessible via a fluid transfer connector (luer lock needle connector shown in figs. 46, 52a-53d), said fluid transfer connector being configured to facilitate connection of the fluid transfer assembly with the container for said transfer of fluid (paras.450-462), the robotic system comprising:
a controller (at least paras.76, and 179-180); and
a manipulator (at least one of the manipulators shown in figs.15a-c, 52a-b, or 53a-d) controllable by the controller and configured to hold and manipulate the fluid transfer assembly, said manipulator being configured to hold the fluid transfer assembly at the fluid transfer connector (best shown in figs.52a-b and 53a-d and described in paras.450-462).
In re claim 8, Eliuk discloses the robotic system according to claim 7, wherein the manipulator comprises a gripping arm (“fingers” para.451) having at least one gripper element (“notch” para.451) configured to grip a gripping portion of the fluid transfer connector.
In re claim 9, Eliuk discloses the robotic system according to claim 7, wherein the manipulator comprises an engaging arm (“fingers” para.451) configured to engage an engaging portion of the fluid transfer connector.
In re claim 10, Eliuk discloses the robotic system according to claim 7, wherein the manipulator is configured to manipulate the fluid transfer assembly while maintaining the fluid transfer unit free of hold by the manipulator (has all of the structure required to meet the claim, paras.450-462).
In re claim 11, Eliuk discloses the robotic system according to claim 7, wherein the manipulator is configured to manipulate the fluid transfer assembly while holding the fluid transfer assembly at a portion distant from the fluid transfer unit (has all of the structure required to meet the claim, paras.450-462, figs.15a-c, 52a-b, and 53a-d).
In re claim 13, Eliuk discloses the robotic system according to claim 7, further comprising a fluid transfer connector (luer lock needle connector shown in figs. 46 and 52a- 53d) configured to connect to a fluid transfer unit of the fluid transfer assembly and to facilitate connection of the fluid transfer unit with the container for said transfer of fluid, wherein the manipulator comprises a gripping arm (“fingers” para.451) having at least one gripper element (“notch” para.451) configured to grip a gripping portion of the fluid transfer connector.
In re claim 14, Eliuk discloses the robotic system according to claim 13, wherein the fluid transfer connector comprises the gripping portion (needle portion of the luer lock needle connector and/or the cap removed by the gripper) configured to be gripped by the gripping arm of the manipulator.
In re claim 15, Eliuk discloses the robotic system according to claim 14, wherein the gripping portion comprises at least one grip-able element (gripping portion of the cap removed) configured to be gripped by the gripper element of the gripping arm.
In re claim 1, Eliuk discloses a method for transferring fluid between a syringe assembly and a container, see the rejection of claim 7, below. The method is anticipated by the normal use of the robotic system. The robotic system merely uses broader terminology for the syringe assembly, syringe, and syringe connector.
In re claim 2, the method is anticipated by the normal use of the device as rejected in claim 8.
In re claim 3, the method is anticipated by the normal use of the device as rejected in claim 9
In re claim 5, the method is anticipated by the normal use of the device as rejected in claim 13.
In re claim 6, the method is anticipated by the normal use of the device as rejected in claim 14.
In re claim 19, see the rejection of claim 7 above.
In re claim 20, see the rejection of claim 7 above.
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.
Claim(s) 4, 12, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eliuk in view of Kriheli (8,196,614).
In re claim 4, Eliuk discloses the container comprises a container septum (septum of vial/IV bag) and wherein the manipulator manipulates the syringe assembly to secure contact between the syringe connect and the container-septum of the container while holding the syringe assembly at the syringe connector (paras.450-462). However, Eliuk fails to explicitly disclose the sheathed needle syringe with the protective septum for the needle.
Kriheli teaches another grippable syringe with a needle and septum (figs.8-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the teachings of Kriheli in Eliuk as an obvious engineering design choice for swapping two known equivalent items. It has been held that “reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle”. See MPEP 2144.06 and 2144.07. Additionally, Kriheli teaches the benefit form utilizing such a connector is the safer transfer of hazardous drugs.
In re claims 12 and 18, see the rejection of claim 4 above.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eliuk in view of Perazzo (9,466,088)
In re claim 16, Eliuk discloses the robotic system according to claim 15, wherein the gripper element comprises a corresponding recess (“notch” para.451) configured to receive therein, at least partially, said protrusion. However, Eliuk fails to explicitly disclose he at least one grip-able element comprises a protrusion.
Perazzo teaches corresponding protrusions on items gripped (col.26 ln.51-58, figs.5 and 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to utilize the teachings of Perazzo in Eliuk for the purpose of ensuring a more secure grip.
In re claim 17, see the rejection of claim 16 above. Modified Eliuk discloses all the limitations of the claims, except for the notch and protrusion are swapped. It would have been obvious to one of ordinary skill in the art at the time the invention was made to switch the location of the notch/protrusion, since it has been held that rearranging parts of a prior art structure involves only routine skill in the art. See MPEP 2144.04. Regardless, Perazzo teaches the grooves and ridges, see, e.g. col.26 ln.51-58.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Timothy P. Kelly whose telephone number is (571)270-7615. The examiner can normally be reached from 8:30 a.m. to 4:30 p.m. (ET) on Monday, Thursday, and Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Craig M Schneider can be reached at (571) 272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Timothy P. Kelly/Primary Examiner, Art Unit 3753
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