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 .
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) 1-3, 5-11 and 14-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burbank et al (US 2014/0018727).
Regarding claim 1, Burbank discloses a peritoneal dialysis system comprising: a source of water made suitable for peritoneal dialysis (“WFPD”) (¶102); at least one source of concentrate 910/912; a cycler including a control unit 907 and a pump actuator 943 under control of the control unit; and a disposable set operable with the cycler and in fluid communication with the source of water and the at least one source of concentrate, the disposable set including: a pumping cassette including a pump chamber 944 configured to be actuated by the pump actuator (fig 8A), and a mixing container 606/908 in fluid communication with the pumping cassette, wherein the control unit is programmed to mix the WFPD and the at least one concentrate to form mixed WFPD by causing (i) the pump actuator to operate the pump chamber to pump a first amount of the WFPD to the mixing container (¶104 – according to dialysis solution prescription), (ii) the pump actuator to operate the pump chamber to pump a prescribed amount of the at least one concentrate from the at least one concentrate source to the mixing container (¶104 – according to dialysis solution prescription), and (iii) the pump actuator to operate the pump chamber to pump a second amount of the WFPD to the mixing container (¶80, if measured conductivity is not what is expected, pump additional water to achieve desired conductivity).
Regarding claim 2, wherein the control unit is further configured to cause a sample of the mixed WFPD to undergo a test using a sensor 628 (¶82).
Regarding claim 3, wherein at least one of prior to or after the test, the sensor is bypassed or used for a different purpose (sensor is in the drain line, thus any other fluids that drain and are not tested bypass the sensor; also, fluids that have that are used for treatment will bypass the sensor).
Regarding claim 5, wherein the test includes comparing a measured property of the sample to a setpoint for the property (setpoint that is correct conductivity - ¶82).
Regarding claim 6, further comprising a plural sources of concentrate 910/912, and wherein in (ii) the pump actuator operates the pump chamber to pump prescribed amounts of each concentrate from its concentrate source to the mixing container (¶104).
Regarding claim 7, wherein the prescribed amount of the at least one concentrate is a total amount needed for the at least one concentrate (¶80).
Regarding claim 8, wherein the first and second amounts of the WFPD add to a total amount needed for the WFPD (¶80, first amount when tested shows incorrect concentration, second amount is added water which brings it to proper concentration).
Regarding claim 9, wherein the water is made suitable for peritoneal dialysis, at least in part, at the source of water (¶102, using water purification system 901).
Regarding claim 10, wherein the control unit is programmed to cause (i) to (iii) to be repeated at least one time (¶74 – at least one fill cycle, meaning there may be more than one and thus device is programmed to cause i-iii to happen at least one more time).
Regarding claim 11, wherein the mixing container is a heater/mixing bag (¶105; ¶74 – batch/mixing container is 606).
Regarding claim 14, wherein the control unit is further configured to cause a sample of the mixed WFPD and the at least one concentrate to undergo a test using a sensor 628 (¶82).
Regarding claim 15, wherein the test includes comparing a measured property of the sample and the at least one concentrate to a setpoint for the property (setpoint that is correct conductivity - ¶82).
Regarding claim 16, Burbank discloses a peritoneal dialysis system comprising: a cycler including a control unit 907 and a pump actuator 943 under control of the control unit; and a disposable set operable with the cycler (fig 8A, ¶101) and in fluid communication with a source of water made suitable for peritoneal dialysis (“WFPD”) (¶102) and at least one source of concentrate 910/912, the disposable set including: a pumping cassette including a pump chamber 944 configured to be actuated by the pump actuator (fig 8A), and a mixing container 606/908 in fluid communication with the pumping cassette, wherein the control unit is programmed to mix the WFPD and the at least one concentrate to form mixed WFPD by causing (i) the pump actuator to operate the pump chamber to pump a first amount of the WFPD to the mixing container (¶104 – according to dialysis solution prescription), (ii) the pump actuator to operate the pump chamber to pump a prescribed amount of the at least one concentrate from the at least one concentrate source to the mixing container (¶104 – according to dialysis solution prescription), and (iii) the pump actuator to operate the pump chamber to pump a second amount of the WFPD to the mixing container (¶80, if measured conductivity is not what is expected, pump additional water to achieve desired conductivity).
Regarding claim 17, wherein the control unit is programmed to cause (i) to (iii) to be repeated at least one time (¶74 – at least one fill cycle, meaning there may be more than one and thus device is programmed to cause i-iii to happen at least one more time).
18. The peritoneal dialysis system of Claim 16, wherein the mixing container is a heater/mixing bag (¶105; ¶74 – batch/mixing container is 606).
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) 12, 13, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burbank et al (US 2014/0018727) in view of Steck et al (US 2009/0012460).
Regarding claims 12, 13, 19 and 20, wherein the pump actuator is a first pump actuator 943 and the pump chamber is a first pump chamber 944.
While Burbank substantially discloses the invention as claimed, it does not disclose wherein the cycler includes a second pump actuator under control of the control unit, wherein the pumping cassette has a second pump chamber configured to be actuated by the second pump actuator, and wherein the control unit is programmed to form the mixed WFPD by causing (i) the first and second pump actuators to operate the first and second pump chambers to pump the first amount of the WFPD to the mixing container, (ii) the first and second pump actuators to operate the first and second pump chambers to pump the prescribed amount of the at least one concentrate from the at least one concentrate source to the mixing container, and (iii) the first and second pump actuators to operate the first and second pump chambers to pump the second amount of the WFPD to the mixing container, nor wherein the control unit is programmed to cause the first and second pump actuators to simultaneously operate.
Steck discloses two pumping chambers and two actuators (see fig 7A with identical chambers 100 and identical inlets and outlets). This allows faster pumping as one pump may be dispensing while the other is filling. This suggests to one of ordinary skill in the art an additional pump and actuator allows for pumping of a fluid while the single pump is used for a different of the fluids.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Burbank such that the cycler includes a second pump actuator under control of the control unit, wherein the pumping cassette has a second pump chamber configured to be actuated by the second pump actuator, and wherein the control unit is programmed to form the mixed WFPD by causing (i) the first and second pump actuators to operate the first and second pump chambers to pump the first amount of the WFPD to the mixing container, (ii) the first and second pump actuators to operate the first and second pump chambers to pump the prescribed amount of the at least one concentrate from the at least one concentrate source to the mixing container, and (iii) the first and second pump actuators to operate the first and second pump chambers to pump the second amount of the WFPD to the mixing container, and wherein the control unit is programmed to cause the first and second pump actuators to simultaneously operate as suggested by Steck to achieve faster mixing in the device of Burbank.
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 8-12 of U.S. Patent No. 10,828,412. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally broader versions of the patented claims. The dependent claims not in the ptent are obvious in view of Burbank et al (US 2014/0018727).
Claim 4 is rejected under double patenting only.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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