Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/13/2026 has been entered. Claims 1-16, 21-24 are pending in the application. The 112(b) rejections previously set forth are withdrawn in view of the amendment and remarks.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims 1, 21, 24 and the new limitations have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16, 21-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 21, 24 recite the limitations "wherein a blood urea nitrogen (BUN) of the subject is configured to be maintained to be less than 30 mg/dl when use of the attachable urea removal module does not exceed 10 hours in a given one-week period,” this language is unclear, it is unclear how the BUN of the subject is configured, while a controller can be configured to provide a specific function, the BUN of the subject would be an intended result, absent clarification of what is required, or what structure performs the function of configuring the BUN of the subject.
Applicant cited paragraphs 0194-0196 of the instant specification disclose the average blood urea nitrogen (BUN) of a subject is maintained to be less than about 30 mg/dL through use of the urea removal module and in certain embodiments, a subject is attached to the urea removal module for a total time that does not exceed more than about 10 hours in any one week period, and that a controller is used to control infusate addition to maintain ion concentration (0021), control the rate of a filtrate pump or a control pump 0026, 0041-0044, compare conductivity and calculate the amount of urea absorbed and signal an alert if the conduvity between two sensors are substantially equal (0059-0060) controller 801 can signal the subject or another individual when a sufficient amount of urea has been removed to allow return to use of the portable treatment module 100. (0272)
, wherein the controller is configured to alert the subject that a sufficient amount of urea has been removed and that use of the portable treatment module is permitted”
Additional claims are rejected as dependent on a rejected claim.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3, 7-10, 16, 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Fulkerson (US PG Pub 2009/0120864), in view of Elahi (US PG Pub 2015/0224243), alternatively in view of Sanford (US PG Pub 2010/0114012) and Ward (US 5,032,615).
With respect to claims 1, 21, 24, Fulkerson teaches a portable continuous dialysis system configured as a wearable belt in fluid communication with a separate unit in the form of a bag or case, a highly portable dialysis system comprising a relatively lightweight wearable unit, in fluid communication with an easy to carry yet sturdy portable unit, the wearable belt unit with a dialyzer and a pump, the portable unit comprising a dialysate regeneration system, (abstract, 0002-0017, 0026-0027), the belt comprising a dialyzer and pump (0016) a blood circuit in the form of a belt 105, 205, 605 (0029, 0032, 0063), (a system comprising: an extracorporeal module), dialyzer with a membrane, 106, 315, 530 (0029, 0043, 0058), with dialysate ports 112/113, 323/325, 334/535 (031-0032, 0046-0049, 0061, a dialyzer including a dialysate inlet and a single dialysate outlet), dialysate circuit 110/115, 210, 320, 510 (Figures), the belt units connect to the portable units with couplings (0012, 0018, 0028, 0032-0034, Fig. 2, one or more first connectors for connecting, disconnecting, and reconnecting the modules to, and from, the dialysate inlet and the dialysate outlet of the dialyzer), in an embodiment pump 321 in dialysate circuit 320 (0046, Fig. 3, a unit including the first dialysate pump), the portable unit which can be configured in the form of any one of a fanny pack, a case with a handle, or a pack wearable around the shoulder (0002, 0010, 0017, 0029, the portable units attachable modules), an electronic control unit 120/controller 351 (0015, 0052, a controller), in the embodiment of figure 3, the dialysate circuit comprises dialysate module 330 with a plurality of sorbent cartridges (0047), in an embodiment, each sorbent cartridge is a miniaturized cartridge containing a distinct sorbent. For example, a system of five sorbent cartridges may be used wherein each cartridge separately contains urease, zirconium phosphate, hydrous zirconium oxide and activated carbon, and that persons of ordinary skill in the art would appreciate that urease, zirconium phosphate, hydrous zirconium oxide and activated carbon are not the only chemicals that could be used as sorbents in the present invention, in fact, any number of additional or alternative sorbents could be employed without departing from the scope of the present invention (0037).
While Fulkerson does not explicitly teach two units, Fulterson teaches units that can be coupled to a wearable belt, duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.01 VI. B), such that it would have been obvious to one of ordinary skill in the art before the invention was made to provide a second unit, each of which would be alternately connectable to the belt, in order to provide alternative treatment options depending on patient need. Fulkerson teaches placement of components can be varied between the portable unit and the wearable belt unit, depending upon factors such as comparative weight and size of the belt and portable units, the ease of operation of the dialysis system by the patient, the overall length of the tubing system and the safety of operation of the overall system (abstract, 0042), keeping the relatively bulkier dialysate regeneration and waste collection system separate from the light wearable unit (0027-0029), the two units are detachable from each other to allow flexibility and mobility to the patient, and a wearable belt; units comprising sorbent cartridges in the form of packs, cases, which can vary in portability as discussed above, and that the selection of sorbent would be within the skill of persons of ordinary skill in the art, and the use of sorbents including activated carbon (a sorbent that does not contain a material that converts urea into a different chemical form), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have both wearable and less wearable or not portable units depending on the desired treatment and mobility requirements of the patient (0008, 0032), and to vary the sorbent cartridges to units/modules depending on patient need.
Applicant amended to require: wherein a blood urea nitrogen (BUN) of the subject is configured to be maintained to be less than 30 mg/dl when use of the attachable urea removal module does not exceed 10 hours in a given one-week period; wherein the controller is configured to alert the subject that a sufficient amount of urea has been removed and that use of the portable treatment module is permitted.
Fulkerson teaches a control unit in communication with a plurality of sensing probes, and the control unit monitors thresholds to determine alarm situations and monitoring various aspects of the dialysis system that are known to persons of ordinary skill in the art (0015-0016, 0040-0052), after a predetermined amount of time, the microprocessor signals an alarm/alert to the patient conveying that the patient needs to connect the belt unit to the portable unit (the controller configured to alert the subject to change the connection between a portable unit and a wearable unit), alarms which can be audio and/or visual via suitable buzzers and/or LEDs as would be evident to persons of ordinary skill in the art (0034), but does not explicitly teach the amount of time indicates a sufficient amount of urea has been removed, or the recited BUN limitations.
Elahi teaches a communication apparatus for dialysis including a processor that determines a dialysis dwell time for at least one cycle of a dialysis therapy, achieving a urea removal level and an output interface providing an indication to the patient of a completion of the dialysis dwell time (abstract),
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention the Fulkerson’s taught predetermined time would be a time to achieve a urea removal level, or such that a sufficient amount of urea has been removed as Fulkerson teaches the control unit monitors thresholds to determine alarm situations and monitoring various aspects of the dialysis system that are known to persons of ordinary skill in the art, and alarm/notifications to that urea removal has been achieved are known in the art as shown by Elhadi.
See 112(b) rejection above, with respect to the limitations concerning BUN. The maintenance of the recited BUN values appears to be directed to an intended use of the apparatus, absent clarification of what structure is required to perform the recited function, examiner notes intended use of the apparatus is not accorded patentable weight where the statement of intended use does not distinguish over the prior art apparatus (see MPEP 2114). Alternatively, in the interest of compact prosecution, Sanford teaches portable dialysis systems (abstract), Figures 8, 10, 12 providing graphs of BUN as a function of time, Ward teaches a method of preventing clotting during dialysis (abstract), where BUN is monitored (C4/L35-58) and BUN levels consistently maintained below 60 (C6/L12-23). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to maintain patient BUN over the course of treatment, depending on patient needs.
With respect to claim 2, the system of claim 1 is taught above. As noted above, Fulkerson teaches the selection of sorbent is within the skill of one of ordinary skill in the art such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the attachable portable treatment module does not contain a sorbent cartridge containing urease.
With respect to claims 3, 10, 16, the system of claim 1 is taught above. Fulkerson teaches an electronic control unit (a controller), to control the operation of all the components of said system, the microprocessor in the electronic control unit 120 determines the rate and amount of fluid removal through volumetric pump 155, excess fluid is removed from the spent dialysate in the spent dialysate tube through the volumetric pump 130 and into the waste collection bag (0035), volumetric pumps first and second control pumps, flow meters measure blood and dialysate flow and are used in ways known to persons of ordinary skill in the art (0041) rates, and control of the pumps to provide increased clearance by convective mass transfer and the use of changing convective gradients (0053), the controller controls an efflux rate of a first control pump.
With respect to claim 7, the system of claim 1 is taught above. Fulkerson teaches cartridges where sorbent comprises zirconium phosphate and urease (0037, the second sorbent cartridge in the attachable urea removal module contains urease and zirconium phosphate).
With respect to claim 8, the system of claim 1 is taught above. Fulkerson teaches additive micropumps for infusion 125, 334/336, and infusate reservoirs 126, 337 (0039, 0047, the attachable urea removal module further comprises an infusate pump and an infusate reservoir).
With respect to claim 9, the system of claim 8 is taught above. Fulkerson teaches infusate pumps and reservoirs as discussed above and the infusate pump and infusate reservoir are connected to the dialysis circuit downstream of the sorbent cartridge (Figs. 1-4).
With respect to claims 22, 23, the system of claim 1 is taught above. Fulkerson teaches leak tight couplings and a disconnect sensor, the signal of goes to the microprocessor which disables dialysate pumping when the belt is decoupled (0032-0034, Fig. 2, connectors configured to stop the fluid from flowing when disconnected by a user, the controller is configured to detect a connection state of the one or more first connectors and the one or more second connectors).
Claims 3-5, 13, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Fulkerson (US PG Pub 2009/0120864), in view of Elahi (US PG Pub 2015/0224243), alternatively in view of Sanford (US PG Pub 2010/0114012) and Ward (US 5,032,615), in view of Graf (US 6,860,866).
With respect to claims 3-6, 10-13, 16, the system of claims 1 and 9 is taught above. See 112(b) above, Fulkerson teaches an electronic control unit (a controller), to control the operation of all the components of said system, the microprocessor in the electronic control unit 120 determines the rate and amount of fluid removal through volumetric pump 155, excess fluid is removed from the spent dialysate in the spent dialysate tube through the volumetric pump 130 and into the waste collection bag (0035), flow meters measure blood and dialysate flow and are used in ways known to persons of ordinary skill in the art (0041) rates, and control of the pumps to provide increased clearance by convective mass transfer and the use of changing convective gradients (0053), the controller controls an efflux rate of a first control pump.
Graf teaches clearance and/or dialysance can be determined as a function of dialysis fluid rate (C3/Ll-60), and a controller determines dialysance or clearance for a pump (claim 6), It would have been obvious to one of ordinary skill in the art before the invention was made to control pump Fulkerson's pumps based a set patient removal rate and a set convective clearance, as described by Graf in order to monitor the efficiency of a dialyzer during a dialysis treatment without any delay (Graf C2/L62-67), and as it has been held that "[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR, 550 U.S. at 415-16. Furthermore, "if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill." KSR, 550 U.S. at 417. Absent evidence of unexpected results, a ratio of the first set period of time and the second set-period of time is set based on the set patient fluid removal rate and a set convective clearance, is considered inherent.
With respect to claim 13, the system of claim 12 is taught above. Updyke teaches microprocessor 70 controls pump flow rates and timing and sequencing of the components of the module ([0105]) the controller controls a ratio of the pump rates of the first control pump and second control pump to achieve the set patient fluid removal rate and the set convective clearance.
Claims 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fulkerson (US PG Pub 2009/0120864), in view of Elahi (US PG Pub 2015/0224243), alternatively in view of Sanford (US PG Pub 2010/0114012) and Ward (US 5,032,615), in view of Orhan (US PG Pub 2012/0273354).
With respect to claim 14, the system of claim 1 is taught above. Fulkerson teaches an electronic control unit (a controller), to control the operation of all the components of said system, the microprocessor in the electronic control unit 120 determines the rate and amount of fluid removal through volumetric pump 155, excess fluid is removed from the spent dialysate in the spent dialysate tube through the volumetric pump 130 flow meters measure blood and dialysate flow and are used in ways known to persons of ordinary skill in the art (0041) rates, and control of the pumps to provide increased clearance by convective mass transfer and the use of changing convective gradients (0053), the controller adjusts patient removal rate,a plurality of sensors enable continuous monitoring of various aspects for a safe and efficient functioning of the system and such probes and the use thereof for monitoring various aspects of the dialysis system are known to persons of ordinary skill in the art and are not described (0041), but does not teach sensing of hematocrit or hemoglobin, or adjusting removal rate based on hematocrit level. Orhan teaches a wearable dialysis fluid removal device (abstract, 0035, 0055), measuring of hematocrit or hemoglobin with a sensor (0032-0033, 0322). It would have been obvious to one of ordinary skill in the art before the invention was made to incorporate a hematocrit or hemoglobin sensor, as described by Orhan in order to determine the change in hematocrit due to the treatment, and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
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 1-16, 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 of U.S. Patent No. 10,857,277, in view of the rejections above. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims require substantially the same components, instant claims 1, 21, and 24 are analogous to claim extracorporeal module comprising a blood pump, attachments to a dialyzer, attachable portable treatment module, and urea removal modules comprising: sorbent cartridges, with an without urease, each with a dialysis circuit with a pump, a control pump, controlled compliant, and at least one controller, additional details are provided in the rejections above.
Claims 1-16, 20-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 30 of copending Application No. 19/028/634 in view of the rejections above. Reference claim 1 requires a dialyzer, an extracorporeal module, attachment modules, quick connectors, reference claim 30 requires a urea removal module, analogous to instant claims 1, 21, and 24, in view of the rejections above.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gura conductivity sensor US 7854718, Gura US 2006/0241543.
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/JEANNIE MCDERMOTT/Examiner, Art Unit 1776
/BRADLEY R SPIES/ Primary Examiner, Art Unit 1776
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