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 .
This action is in response to the preliminary amendment received on May 19, 2025.
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by THORNE, JR et al. (US 10,322,235).
In reference to claims 1, THORNE, JR et al. discloses a mixing syringe apparatus having a chamber enclosing a free piston 100’, the free piston comprising: a first piston part 110’ that communicates with a distal chamber 152’ and a second (separately formed; figures 17 & 18) piston part 120’in communication with a proximal chamber 154’, the piston parts being nested together (via valve stem 140’) to form the free piston 100’; each of the piston parts 110’, 120’ having a wiping ring (see Diagram I below) sized and shaped to engage an inner surface of the mixing syringe chamber; the first piston 110’ including a normally closed, one-way valve 200 for keeping the proximal chamber contents isolated from the distal chamber contents (column 15 lines 8-17) until actuated to an open state as a result of actuation of a pressure disposed in the second piston part 120’ for displacement of fluid from the proximal chamber into the distal chamber for mixing (column 15 lines 25-43).
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Diagram I
Regarding claim 2, column 15 lines 39-47 of THORNE, JR further disclose the one-way valve 200 disposed to permit flow toward the distal chamber when a proximal source of fluid pressure is provided by displacement 260 of a plunger rod 50 such that activation of the pressure actuated valve exceeds pressure toward the first (distal) piston part 110’ opening the one-way valve 200 to provide diluent flow of liquid disposed in the proximal chamber into the distal chamber for mixing.
With respect to claim 3, figure 14 of THORNE, JR discloses the one-way valve 200 as a dome valve (see Diagram I 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 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by THORNE, JR et al. (US 10,322,235 hereinafter ‘235) in view of THORNE, JR et al. (US 9,289,562 hereinafter ‘562).
In reference to claim 4, THORNE, JR et al. ‘235 discloses a free piston defined by a first piston part nested with a second nested part as required in claim 1, but does not disclose a medically disposed piston part configured to filter the fluid of the proximal chamber as required in claim 4.
THORNE, JR et al. ‘562 teaches a mixing syringe apparatus 10 having a chamber 30 enclosing a free piston, the free piston comprising: a first piston part 402 that communicates with a distal chamber 120’ and a second (separately formed; figure 30) piston part 410 in communication with a proximal chamber 430, the piston parts being nested together (figure 31; see Diagram II below) to form the free piston; each of the piston parts 402, 410 having a wiping ring sized and shaped to engage an inner surface of the chamber 30; the first piston 402 including a normally closed, one-way valve for keeping the proximal chamber contents isolated from the distal chamber contents (column 15 lines 42-50) until actuated to an open state as a result of actuation of a pressure disposed in the second piston part 410 for displacement of fluid from the proximal chamber into the distal chamber for mixing (column 15 lines 51-58); and a medically disposed piston part 330 between the valve of the first (distal) piston part (figure 16), the medically disposed piston part 330 comprising a filter (column 15 lines 5-26). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the distal piston part of THORN, JR et al. ‘235 to include a medically disposed piston part since column 15 lines 14-of THORN, JR et al. ‘562 state such a modification allows gas to be vented from the syringe for the purpose of effectively mixing the fluid within the barrel of the syringe.
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Diagram I
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to the attached PTO-892 for a notice of references cited and recommended for consideration based on their disclosure of limitations related to the claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GLORIA R WEEKS whose telephone number is (571)272-4473. The examiner can normally be reached M-F 8am-2pm & 5pm-7pm EST.
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/GLORIA R WEEKS/Primary Examiner, Art Unit 3731
February 2, 2026
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