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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-17 in the reply filed on 22 April 2026 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 April 2026.
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over: claims 1-8 of U.S. Patent No. 11,559,468; and claims 1-7 of 11,844,750. 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. See, e.g., In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993).
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) 1-4, 6-8, 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Capone (2014/0228762).
In re claim 1, Capone discloses a compounder system for reconstituting, mixing, and delivering a drug from a vial to a receiving container, comprising:
a cartridge (10) having:
a plurality of controllable fluid pathways (channel of the manifold which connect 126, 272, 270 and the pump together) fluidly coupled to at least one diluent port (126), a waste port (272) and a receiving container port (270);
a syringe pump (104, 200); and
a plurality of valves (114, 300) operable to selectively couple the syringe pump to one or more of the plurality of controllable fluid pathways.
In re claim 2, Capone discloses the compounder system of claim 1, further comprising a common housing for the syringe pump and at least one syringe valve, the common housing comprising a fluid pathway between the syringe pump and the at least one syringe valve (fig.6).
In re claim 3, Capone discloses the compounder system of claim 1, wherein the plurality of valves comprises at least one rotary valve (valves 300, fig.6).
In re claim 4, Capone discloses the compounder system of claim 3, further comprising a pump head assembly (102), wherein each rotary valve comprises an external valve handle (304).
In re claim 6, Capone discloses the compounder system of claim 3, wherein the at least one rotary valve comprises a stopcock rotary valve includes a plurality of openings disposed around a perimeter of a cylindrical internal valve member that is rotatable by a valve handle (fig.6, paras. 120-123).
In re claim 7, Capone discloses the compounder system of claim 6, wherein the rotating valve handle rotates positions of the openings relative to one or more of the plurality of controllable fluid pathways to open and close the stopcock rotary valve (fig.6, paras.120-123).
In re claim 8, Capone discloses the compounder system of claim 1, wherein the syringe pump and the plurality of valves consist of a syringe pump/syringe valve apparatus (22) comprising:
a housing (body shown best in figs.2-8) having a syringe pump cylinder (104) with a syringe pump plunger (200);
a plurality of syringe valve cylinders (114); and
a fluid flow pathway (path between, shown in at least fig.6) between the syringe pump cylinder and the plurality of syringe valve cylinders.
In re claim 15, Capone discloses the compounder system of Claim 8, wherein the fluid flow pathway is coupled to each of the syringe valve cylinders by a corresponding coupling cylinder (122, 124, 126) in the housing (figs.2-6).
In re claim 16, Capone discloses the compounder system of Claim 15, wherein each of the coupling cylinders extends from a corresponding one of the plurality of syringe valve cylinders in a first direction (figs.2-6).
In re claim 17, Capone discloses the compounder system of Claim 16, wherein the port of each of the syringe valve cylinders extends from that syringe valve cylinder in a second direction that is perpendicular to the first direction (figs.2-6).
Allowable Subject Matter
Claims 5, and 9-14 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.
The following is a statement of reasons for the indication of allowable subject matter: none of the prior art of record, alone or in combination, discloses or fairly suggests:
“each of the syringe valve cylinders comprises a port and a syringe plunger actuatable to open and close the port”, in the combination as claimed. Capone discloses a rotary valve within a cylinder. This rotary valve cannot be reasonably construed to be a “syringe plunger” as a syringe plunger requires reciprocation or “plunging” movement, which Capone is incapable of performing in its intended use; or
“the pump head assembly is configured to actuate a syringe and to rotate one or more external valve handles to control motion of the one or more fluids through the controllable fluid pathways” in the combination as claimed.
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.
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, 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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