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
Claims 7 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 31 December 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, 8-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (WO2015/020374).
Regarding claim 1, Lee discloses intravenous drug dispensing kit comprising:
a cylinder cartridge (200, figure 9) for introducing and discharging external fluids through changes in the volume of a cylinder occurring when a pair of first and second pistons (256, 230, figure 8) disposed therein is fixed and rotates relatively to each other ([0050]);
a first tube (20, figure 9) connected to an outlet tube (216) of the cylinder cartridge;
a three-way valve (40 and 42, [0080]) having a first introducing flow path (path formed by 16), a second introducing flow path (path formed by 18), and a discharge flow path (path formed by 14) connected to any one of the first introducing flow path and the second introducing flow path (figure 9);
a second tube (tube 14) for connecting the discharge flow path of the three-way valve to an inlet tube (214) of the cylinder cartridge;
a third tube (16) connected to the first introducing flow path of the three-way valve (figure 9); and
a fourth tube (18) connected to the second introducing flow path of the three-way valve (figure 9).
Regarding claims 2-3, Lee discloses wherein the first tube and the third tube are connected to an infusion pack ([0002-0004], [0026]), and the fourth tube is connected to a medical liquid container ([0002-0004], [0026]) and wherein the fourth tube and the medical liquid container are connected to each other by means of an adapter having an air introducing function ([0080], syringe is capable of introducing air).
Regarding claim 8, Lee discloses wherein the cylinder cartridge comprises an upper rotation member (244) and a lower rotation member (220, figure 4) freely rotating with respect each other, while forming a circular cylinder space (space between the members) between the upper rotation member and the lower rotation member, and the first piston is coupled to the upper rotation member to rotate along the cylinder space, while the second piston is coupled to the lower rotation member to rotate along the cylinder space (figure 4, [0063-0065]).
Regarding claim 9, Lee discloses the limitations of claim 1 and additionally discloses a cylinder pump (shafts 112 and 114 on the driving device 100) for mounting the cylinder cartridge of the intravenous drug dispensing kit thereon to drive the pair of first and second pistons disposed inside the cylinder cartridge independently of each other ([0049-0050]).
Regarding claim 10, Lee discloses wherein the cylinder pump comprises a cylinder driving part (114 and 112 of 100) for driving the pair of first and second pistons disposed inside the cylinder cartridge independently of each other ([0050]) and a controller ([0028]) for controlling the cylinder driving part, and the controller controls amounts and flow rates of the liquids introduced and discharged through the cylinder cartridge, with preset values ([0028]).
Regarding claim 11, Lee discloses wherein the controller of the cylinder pump is capable of performing the intended use of controls the cylinder driving part to allow the medical liquid of the medical liquid container connected to the fourth tube to be introduced by the preset amount and then discharged to the infusion pack connected to the first tube. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Lee discloses the features of the controller, pump, lines, infusion pack and container ([0028], [0050], [0080]) and thus is capable of performing the above cited use.
Regarding claim 12, Lee discloses wherein on the three-way valve, the second introducing flow path connected to the fourth tube and the discharge flow path connected to the second tube are open ([0080], three way valve can be adjusted for desired movement including the configuration claimed).
Regarding claim 13, Lee discloses wherein the cylinder driving part comprises a first driving part (114) for operating the upper rotation member of the cylinder cartridge and a second driving part (112) for operating the lower rotation member of the cylinder cartridge, the cylinder driving part having a structure of a double shaft in which a second driving shaft of the second driving part is inserted into a first driving shaft of the first driving part (internal shaft 114 is inside external drive shaft 112, [0049-0050]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lee.
Regarding claims 4-6, Lee does not disclose at least one or more additional three-way valves, each additional three-way valve having a first introducing flow path and a discharge flow path connected to any one of the second tube, the third tube, and the fourth tube (claim 4) wherein the additional three-way valve has a second introducing flow path connected to an additional medical liquid container (claim 5), and wherein the additional three-way valve has a second introducing flow path connected to the infusion pack, the first tube and the third tube are connected to an empty infusion pack, and the fourth tube is connected to the medical liquid container (claim 6).
However, it has been held that duplication of parts has no patentable significance unless a new and unexpected result is produced. In this case, the duplication of the three way valve on the other pathways does not lead to a new and unexpected result since Lee already discloses the use of the valve in order to control movement of fluid ([0080]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lee to include additional three way valves on the flow paths of any one of the tubes and connected to different containers since Lee already teaches the connections to containers and blood packs and the use of the valves to control movement of fluid in the infusion system.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Thompson (US 4710116).
Regarding claim 14, Lee does not disclose wherein the first driving part and the second driving part have worm gear structures.
Thompson discloses an infusions system using a drive shaft (178) and teaches the drive part (178) utilizes threads/worm (figure 4, col 6, lines 34-37).
Thompson provides drive threads in order to enable the drive to translate power to the rotation (col 6, lines 34-50). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Lee by substituting the pattern of Lee with the threaded structure of the shaft in order to translate power. Both are functionally equivalent ways to mate the shaft with the nut.
Allowable Subject Matter
Claims 15-22 are allowed.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach or reasonably suggest either alone or in combination a fourth step of opening the second introducing flow path connected to the fourth tube and the discharge flow path connected to the second tube, on the three-way valve; and a fifth step of operating the cylinder pump to introduce the medical liquid in the medical liquid container into the infusion pack by a set amount. While Lee discloses the use of the three way valve to move and infuse material there is no explicit teaching/disclosure of the steps as recited of a fourth step of opening the second introducing flow path connected to the fourth tube and the discharge flow path connected to the second tube, on the three-way valve; and a fifth step of operating the cylinder pump to introduce the medical liquid in the medical liquid container into the infusion pack by a set amount. Lee only arbitrarily mentions the usage in an infusion manner but fails to explicitly teach the exact connections and valve state to achieve this. Yu (US 2007/0156089) while teaching connections for infusion fails to cure the deficiencies of Lee since Yu cannot appear to be combinable with Lee to arrive at the instant invention without significant redesign of Lee. Similarly Spohn (US 2005/0234407) also cannot be combined with Lee in a reasonable manner to arrive at the instant invention. Thus, claims 15-22 are allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
KAI H. WENG
Primary Examiner
Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781