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 claims corresponding to species Group 1 (drawn to a filter body with first and second membrane modules and a fluidic spacer configured for series or parallel flow) in the reply filed on July 20, 2026 is acknowledged.
Status of Claims
This action is in response to Applicant’s response to restriction requirement.
Claims 1-20 are pending.
Claims 1-7 and 16-20 are currently under examination.
Claims 8-15 are withdrawn from consideration as they are drawn to un-elected species.
Claim 8 requires that the first and second membrane modules include a plurality of inlets, passageways or lumens that are positioned and arranged to cause arrangements (i) and (ii), and that a portion of those inlets, passageways or lumens are plugged to select (i) or (ii).
In the un-elected species to which claim 8 is drawn, the membrane modules have only the limited number of openings required for normal inlet and outlet flow. Plugging any of those openings simply blocks flow through the module and renders it non-functional; there is no excess plurality of independently pluggable inlets, passageways or lumens on the modules that can be selectively closed to reconfigure the system between series and parallel operation. Because the claim requires a structural feature (a plurality of pluggable lumens on the modules themselves that can be used to select arrangements (i) or (ii) that cannot be practiced in the un-elected species without disabling the modules, claim 8 and claims 9-13 are withdrawn.
Claim 14 requires that the first and second membrane modules are stacked together and that the filter body further includes an inlet cover and an outlet cover, at least one of the modules or covers being configurable to cause arrangements (i) or (ii).
The elected species uses side-by-side membrane modules with a fluidic spacer between them. It does not employ stacked modules or inlet/outlet covers that are themselves configurable to select series or parallel flow. Because claim 14 requires a stacked-module structure with configurable covers that is structurally distinct from the elected spacer embodiment, claim 14 and its dependent claim 15 are withdrawn.
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.
Claims 1 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peabody (US Publication No.2002/0162778), hereinafter, Peabody.
Regarding claim 1, Peabody discloses a peritoneal dialysis ("PD") system (10) (automated peritoneal dialysis system “A” in figs. 1, 1A–1B; para [0034]) comprising:
a PD machine (20) (control system 16 together with automated peritoneal dialysis system “A”, dialysate preparation component “B”, and sterilization/delivery/drain component “C”, filter test component “D” in figs. 1 – 1C; para [0034] and [0037]);
a patient line (50) extending from the PD machine (20) (segment L4 leads to a catheter inserted into the peritoneal cavity in figs. 1B; para [0042]); and
a filter set (100) (sterilization/fill/drain component C includes an in-line dialysate sterilization unit 12 which preferably includes a primary sterilization filter assembly E and a secondary sterilization filter assembly F for sterilizing the dialysate delivered from mixing vessel 28 in figs. 1, 1B; para [0040]) in fluid communication with the patient line (50) (sterilization unit 12 is in fluid communication with fluid segment L4 that leads to peritoneal cavity in figs. 1, 1B; para [0040]), the filter set (100) including a filter body (110, 150, 190) (sterilization unit 12 in fig.1, 1B; para [0040]) housing first and second filter membranes (112a, 112b) (primary sterilization filter assembly “E” and a secondary sterilization filter assembly “F” for sterilizing the dialysate in figs. 1, 1B), the filter body (110, 150, 190) configured to be placed in different arrangements such that fresh PD fluid (i) flows through the first filter membrane (112a) and then through the second filter membrane (112b) (dialysate flows through primary sterilization filter assembly “E”, is accumulated in vessel 42, then flows through secondary sterilization filter assembly “F” in a series arrangement in fig. 1; para [0045]) or (ii) splits and flows through the first and second filter membranes (112a, 112b) in parallel (alternative embodiment shows first and second sterilization filter assemblies E’ and F’ arranged to operate in parallel with 3-way valves 220/222 selectively direct flow so that assemblies can be used in parallel or in isolation in fig. 6; para [0048]; a similar arrangement is shown in another embodiment in fig. 7; para [0047]).
Regarding claim 17, Peabody discloses the PD system (10) according to Claim 1, wherein the filter set (100) (sterilization/fill/drain component C includes an in-line dialysate sterilization unit 12 which preferably includes a primary sterilization filter assembly E and a secondary sterilization filter assembly F for sterilizing the dialysate delivered from mixing vessel 28 in figs. 1, 1B; para [0040]) is configured to connect directly to a patient's transfer set, or wherein the filter set (100) includes a flexible tube (108) configured to connect to the patient's transfer set (quick disconnect peritoneal port 154 is provided to connect a plug 155 of fluid line segment L4 to a catheter inserted in the peritoneal cavity of the patient in fig. 1B; para [0042]).
Regarding claim 18, Peabody discloses the PD system (10) according to Claim 1, wherein the PD machine (20) (control system 16 together with automated peritoneal dialysis system “A”, dialysate preparation component “B”, and sterilization/delivery/drain component “C”, filter test component “D” in figs. 1 – 1C; para [0034] and [0037]) includes a pressure sensor (28b) (pressure sensor 60 in fig. 1C; para [0042]) positioned and arranged to sense a pressure of fresh PD fluid downstream from the filter membrane (112) during a patient fill (pressure sensor 60 is located directly after valve 148 and monitors the pressure of fluid delivered to the peritoneal cavity to prevent over extension of the cavity in fig. 1C; para [0042]; located downstream of primary sterilization filter assembly “E” and a secondary sterilization filter assembly “F” for sterilizing the dialysate in figs. 1, 1B).
Regarding claim 19, Peabody discloses the PD system (10) according to Claim 1, wherein the first and second filter membranes are sterilizing grade or bacteria reduction filter membranes (112a, 112b) (primary sterilization filter assembly “E” and a secondary sterilization filter assembly “F” for sterilizing the dialysate in figs. 1, 1B; para [0040]; filter passages create a semipermeable membrane for trapping bacterial and other contaminants as fluid is passed through the tubes; para [0044]).
Regarding claim 20, Peabody discloses a peritoneal dialysis ("PD") system (10) (automated peritoneal dialysis system “A” in figs. 1, 1A–1B; para [0034]) comprising:
a PD machine (20) (control system 16 together with automated peritoneal dialysis system “A”, dialysate preparation component “B”, and sterilization/delivery/drain component “C”, filter test component “D” in figs. 1 – 1C; para [0034] and [0037]);
a patient line (50) extending from the PD machine (20) (segment L4 to a catheter inserted into the peritoneal cavity in figs. 1B; para [0042]); and
a filter set (100) (sterilization/fill/drain component C includes an in-line dialysate sterilization unit 12 which preferably includes a primary sterilization filter assembly E and a secondary sterilization filter assembly F for sterilizing the dialysate delivered from mixing vessel 28 in figs. 1, 1B; para [0040]) in fluid communication with the patient line (50) (sterilization unit 12 is in fluid communication with fluid segment L4 that leads to peritoneal cavity in figs. 1, 1B; para [0040]), the filter set (100) including a filter body (110, 150, 190) (sterilization unit 12 in fig.1, 1B; para [0040]) and at least one of a first membrane (112a) or a second filter membrane (112b) (primary sterilization filter assembly “E” and a secondary sterilization filter assembly “F” for sterilizing the dialysate in figs. 1, 1B), the filter body (110, 150, 190) configured to be placed in different arrangements such that fresh PD fluid (i) flows through the first filter membrane (112a) and then through the second filter membrane (112b) (dialysate flows through primary sterilization filter assembly “E”, is accumulated in vessel 42, then flows through secondary sterilization filter assembly “F” in a series arrangement in fig. 1; para [0045]), (ii) splits and flows through first and second filter membranes (112a, 112b) in parallel (3-way valves 220/222 selectively direct flow so that assemblies can be used in parallel or in isolation in fig. 6; para [0048]; a similar arrangement is shown in another embodiment in fig. 7; para [0047-0049]), or (iii) flows through the first filter membrane (112a) (one unit may be used alone while the other is down for replacement or other maintenance; para [0014]) only.
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.
Claims 2-5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Peabody, as applied to claim 1 above, in view of Baird (US Patent No. 11,072,540), hereinafter, Baird.
Regarding claim 2, Peabody discloses the PD system (10) according to Claim 1, wherein the filter body (110) (sterilization unit 12 in fig.1, 1B; para [0040]) includes a first membrane module (120a) (tubular housing 200 in figs. 2-5, para [0044]) housing the first filter membrane (112a) (primary sterilization filter assembly “E” for sterilizing the dialysate in figs. 1, 1B; each sterilization filter assembly E and F may comprise a tubular housing 200 which encloses a bundle of hollow fiber tubes 202 in figs. 2-5; para [0044]), a second membrane module (120b) (tubular housing 200 in figs. 2-5, para [0044]) housing the second filter membrane (112b) (secondary sterilization filter assembly “F” for sterilizing the dialysate in figs. 1, 1B).
Peabody fails, however, to disclose a fluidic spacer (130a, 130b) in fluid communication with the first and second membrane modules (120a, 120b), the fluidic spacer (130a, 130b) configured to cause (i) or (ii).
Baird teaches a fluidic spacer (130a, 130b) (Baird: connecting structure of manifold heads 10a-10c that places the filters/membranes in fluid communication in fig. 4) in fluid communication with the first and second membrane modules (120a, 120b), the fluidic spacer (130a, 130b) configured to cause (i) or (ii) (Baird: for the series connection of fig. 4, the first fitting 30 of one manifold head 10 is in fluid communication with the second fitting 34 of a different manifold head or for the parallel connection of fig. 5, all of the first fluid passages 30 are connected to a common first fluid passage and all of the second fluid passages are connected to a different but common fluid passage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connecting structure between the first and second membrane modules of Peabody to include a discrete fluidic spacer (manifold-style structure) in fluid communication with the first and second membrane modules, as taught by Baird, in order to provide a modular, reconfigurable flow path that can selectively direct fluid in series or parallel through the filter modules while maintaining a compact and easily serviceable filter set.
Regarding claim 3, modified Peabody discloses the PD system (10) according to Claim 2, wherein the first membrane module (120a) is formed the same as the second membrane module (120b) (primary sterilization filter assembly “E” and secondary sterilization assembly “F” are constructed identically, each having the same tubular housing 200 that encloses the same type of membrane bundle 202 in figs. 2-5; para [0044]).
Regarding claim 4, modified Peabody discloses the PD system (10) according to Claim 2, wherein for (i) the fluidic spacer (130a) (Baird: connecting structure of manifold heads 10a-10c that places the filters/membranes in fluid communication in fig. 4) is configured such that fresh PD fluid flows from the fluidic spacer (130a) through the first filter membrane (112a) (primary sterilization filter assembly “E” in figs. 1, 1B) of the first membrane module (120a) (tubular housing 200 in figs. 2-5, para [0044]), flows into the second membrane module (120b) (tubular housing 200 in figs. 2-5, para [0044]), flows through the second filter membrane (112b) (secondary sterilization filter assembly “F” for sterilizing the dialysate in figs. 1, 1B), and flows back into the fluidic spacer (130a) before flowing to a patient (Baird: for the series connection of fig. 4, the first fitting 30 of one manifold head 10 is in fluid communication with the second fitting 34 of a different manifold head. Thus, the second fitting 34a of manifold head 10a is connected to tube 18a by second coupling 114a, while the first fitting 30a is connected to a different tube 18b by first coupling 110a. The tube 118b is connected to second fitting 34b of different manifold head 10b by second coupling 114b. The first fitting 30b of manifold head 10b is connected to first coupling 110b and tube 118c. The tube 118c is connected to the second fitting 34c of manifold head 10c. The first fitting 30c of manifold head 10c is connected to first coupling 110c and tube 118d. Thus, fluid flows through all the manifold heads 10a, 10b, 10c in series through the couplings 114 and tubes 118; col. 21, line 60 – col. 22, line 8).
Regarding claim 5, modified Peabody discloses the PD system (10) according to Claim 2, wherein for (ii) the fluidic spacer (130b) (Baird: connecting structure of manifold heads 10a-10c that places the filters/membranes in fluid communication in fig. 5) is configured such that fresh PD fluid splits from the fluidic spacer (130a) into the first and second membrane modules (120a, 120b) (tubular housing 200 for each of sterilization filter assembly “E” and “F” in figs. 2-5, para [0044]), is filtered through the first and second filter membranes (112a, 112b) (primary sterilization filter assembly “E” and secondary sterilization filter assembly “F” in figs. 1, 1B) in parallel, and flows back into the fluidic spacer (130b) before flowing to a patient (Baird: for the parallel connection of fig. 5, all of the first fluid passages 30 are connected to a common first fluid passage and all of the second fluid passages are connected to a different but common fluid passage. Thus, the first fittings 30 are connected by a first coupling 110 to a first tube 112 which connects to each first coupling 110. The depicted coupling 110 is an elbow coupling having a first coupler connected to and axially aligned with a distal end of the first fitting 30 while the while other end of the coupling 110 has another coupler connecting to another tube (here series tube 118). The second fittings 34 are connected by a second coupling 114 which connects to a second tube 116 in a manner similar to the first coupling 110, the description of which is not repeated; col. 21, lines 24-38).
Regarding claim 7, modified Peabody discloses the PD system (10) according to Claim 2, wherein the fluidic spacer (130a, 130b) (Baird: connecting structure of manifold heads 10a-10c that places the filters/membranes in fluid communication in fig. 4) includes a blind fresh PD fluid inlet (132) (Baird: intake port of manifold heads 10a in figs. 4-5) that accepts fresh PD fluid from the patient line (50) (segment L1 is the corresponding upstream segment of the patient line which supplies unsterilized dialysate into the sterilization filter assemblies “E” and “F” in figs. 1B; para [0041]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Peabody in view of Baird, as applied to claims 1 and 2 above, and further in view of Blatter (US Publication No. 2016/0375190), hereinafter, Blatter.
Regarding claim 6, modified Peabody discloses the PD system (10) according to Claim 2, wherein the fluidic spacer (130a, 130b) (Baird: connecting structure of manifold heads 10a-10c that places the filters/membranes in fluid communication in fig. 4).
Modified Peabody fails, however, to explicitly disclose that the fluidic spacer includes a patient lumen (134) that allows filtered fresh PD fluid to flow to a patient and used PD fluid to flow from the patient.
Blatter teaches a patient lumen (134) that allows filtered fresh PD fluid to flow to a patient and used PD fluid to flow from the patient (Blatter: certain embodiments of PD systems operate with a dual lumen PD catheter, with one lumen for uptake from the peritoneal space and a second lumen for returning reconstituted fluid to the peritoneal space; uptake segment 2 and return segment 3 in fig. 1; para [0024] and [0029]; this dual lumen catheter can be applied to the patient-side port of Baird’s manifold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manifold-style fluidic spacer of modified Peabody to include a patient lumen that allows filtered fresh PD fluid to flow to a patient and used PD fluid to flow from the patient, as taught by Blatter, in order to enable bidirectional fluid communication between the filter set and the patient through a single dual-lumen patient connection, thereby simplifying the patient interface while still permitting simultaneous or sequential delivery of fresh dialysate and removal of used dialysate.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Peabody, as applied to claim 1 above, in view of Blatter.
Regarding claim 16, Peabody discloses the PD system (10) according to Claim 1, wherein the patient line (50) (segment L4 leads to a catheter inserted into the peritoneal cavity in figs. 1B; para [0042]) includes a fresh PD fluid lumen (52) (segment L4 comes from component C and sterilization unit 12 to deliver sterilized dialysate to the patient in fig. 1B; para [0041-0042]) placed in fluid communication with a fresh PD fluid port (104f) (outlet port 136 in fig. 1B; para [0042]) of the filter set (100) (sterilization/fill/drain component C includes an in-line dialysate sterilization unit 12 which preferably includes a primary sterilization filter assembly E and a secondary sterilization filter assembly F for sterilizing the dialysate delivered from mixing vessel 28 in figs. 1, 1B; para [0040]) and a used PD fluid port (104u) (outlet ports 112 and 140 of the sterilization filter assemblies “E” and ”F” carry used dialysis fluids through line segment D1/L5 into drain vessel 52 in fig. 1C; para [0013] and [0043]) of the filter set (100).
Peabody fails, however, to disclose that the patient line (50) is a dual lumen patient line, the dual lumen patient line (50) further including a used PD fluid lumen (54) placed in fluid communication with a used PD fluid port (104u) of the filter set (100).
Blatter teaches that the patient line (50) is a dual lumen patient line (Blatter: certain embodiments of PD systems operate with a dual lumen PD catheter, with one lumen for uptake from the peritoneal space and a second lumen for returning reconstituted fluid to the peritoneal space in fig. 1; para [0024] and [0029]), the dual lumen patient line (50) further including a used PD fluid lumen (54) (Blatter: uptake segment 2 in fig. 1; para [0024] and [0029]) placed in fluid communication with a used PD fluid port (104u) of the filter set (100).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient line of Peabody to be a dual lumen patient line including a fresh PD fluid lumen placed in fluid communication with a fresh PD fluid port of the filter set and a used PD fluid lumen placed in fluid communication with a used PD fluid port of the filter set, as taught by Blatter, in order to provide separate dedicated pathways for the simultaneous or sequential delivery of fresh sterilized dialysate to the patient and the removal of used dialysate from the patient through a single patient-line connection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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, Michael Tsai can be reached at (571) 270-5246. 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.
/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights