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 .
Status of Claims
As directed by the amendment filed on 15 April 2026: claim(s) 1, 14, and 26 have been amended, claim(s) 40 has been added. Thus, claims 1, 3, 6-8, 10, 13-14, 16-18, 21, 23-24, 26, 28-29, 31-32, and 40 are pending.
Response to Arguments
Applicant's arguments filed 15 April 2026 have been fully considered but they are not persuasive.
Regarding the argument Remarks that “Nanko and Nosrati, whether taken alone or together, do not disclose, teach, or suggest "a hydrogel configured to absorb and adsorb one or more toxins from the process fluid without use of a dialysate to purify the process fluid, wherein one of said one or more toxins is urea," as recited in amended claim 1”, Nanko discloses the hydrogel ("hydrogel of C-cellulose as adsorbent"; [0149] & [0153]; FIG. 1) and the hydrogel being used without a dialysis circuit (“can be used not only singly in the above-mentioned extracorporeal circulation circuit but also in a combination with other extracorporeal circulation therapy system. As examples of such combination, there are a combination with an artificial dialysis circuit, and the like, and the device can be used in a combination with dialysis therapy” ([0166]). Furthermore, Nosrati teaches that one of said one or more toxins is urea (“Urease” [0264]; NOTE: urease is an enzyme that breaks down urea).
Nanko discloses claim 40 as discussed below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 6, 7, 17, 21, 23-24, 26, 31-32, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nanko et al. (US 20040226874 A1) in view of Nosrati (US 20170252701 A1).
Regarding Claim 1, Nanko discloses a sorbent cartridge for use in a portable wearable renal therapy system ([0148], [0170]), the sorbent cartridge comprising:
an inlet 1 and an outlet 2 ("1 denotes an inlet for body fluid, 2 denotes an outlet for body fluid"; [0149]; FIG. 1), the inlet configured to receive process fluid from the renal therapy system and the outlet configured to discharge treated process fluid ([0146]; FIG. 1);
a hydrogel 3 ("hydrogel of C-cellulose as adsorbent"; [0149] & [0153]; FIG. 1) configured to absorb and adsorb one or more toxins from the process fluid ([0069]) without use of a dialysate to purify the process fluid ("does not need an additional fluid replacement"; [0170]);
wherein the inlet and the outlet are each configured to couple to the renal therapy system (see FIG. 3);
said sorbent cartridge further comprising: a temperature sensor ([0283]), and at least one of a heating element and/or a cooling element ([0044]), the temperature sensor configured to send a temperature signal to a controller ("sensor control board"; [0270]), and the at least one of a heating element and/or a cooling element configured to receive an output signal from a controller ([0048]-[0059]).
Nanko fails to specify that the inlet and the outlet are each configured to releasably couple to the renal therapy system for removing the sorbent cartridge. However, the court has held that it would be obvious to make an element removable “if it were considered desirable for any reason”. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Furthermore, Nanko shows the inlet 13 and outlet 15 as friction-fit spikes (FIG. 2). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Nanko’s device as a matter of obvious engineering choice, such that the inlet and the outlet are each configured to releasably couple to the renal therapy system for removing the sorbent cartridge, to switch out a cartridge for another containing a different sorbent to suitably adjust the absorbing ability of the renal therapy system ([0078]).
Nanko discloses the ability to absorb and adsorb one or more toxins from the process fluid (“This invention relates to an adsorbent for removing substances related to malady in body fluid such as blood, especially small molecular weight proteins including .beta.2-microglobulin and chemokines, etc.” ([0002]) but fails to specify one of said one or more toxins is urea and said sorbent cartridge further comprising: a temperature sensor, and at least one of a heating element and/or a cooling element, the temperature sensor configured to send a temperature signal to a controller, and the at least one of a heating element and/or a cooling element configured to receive an output signal from a controller. However, Nosrati teaches a modular biomimetic microfluidic modules for combining into “medical devices such as dialysis, bioreactors and organ support devices” (see Abstract) with a sorbent cartridge ([0264]) wherein one of said one or more toxins is urea (“Urease” [0264]; NOTE: urease is an enzyme that breaks down urea) and comprising: a temperature sensor ("enables operation of the device and monitoring of blood temperature" [0147]), and at least one of a heating element and/or a cooling element ("heating and cooling elements" [0044]), the temperature sensor configured to send a temperature signal to a controller ("sensor control board"; [0270]), and the at least one of a heating element and/or a cooling element configured to receive an output signal from a controller ([0048]-[0059]). Therefore, it would have been obvious to modify Nanko’s device to incorporate the claimed features as taught by Nosrati to filter out targeted toxin ([0263-0264]) and "to motivate faster permeation, diffusion and convection" and improve device operation efficiency ([0048]-[0073]).
Regarding Claim 6, Nanko discloses the hydrogel is formed as a plurality of beads ("shape of hydrogel particles contained in a device for blood purification is spherical"; [0134]), the plurality of beads position in a reservoir of the sorbent cartridge configured to receive process fluid flowing through the sorbent cartridge ([0149]-[0150]; FIG. 1), the sorbent cartridge comprising a filter 5 to prevent passage of the plurality of beads into circulation of the process fluid ("5 denote a filter through which body fluid and ingredients contained in body fluid can pass but the adsorbent cannot pass"; [0149]; FIG. 1).
Regarding Claim 7, Nanko discloses the sorbent cartridge is configured such that the hydrogel is in direct contact with the process fluid ([0167]).
Regarding Claim 21, Nanko discloses a renal therapy system comprising the sorbent cartridge of claim 1 (see rejection for Claim 1), wherein the renal therapy system is at least one of a hemodialysis system ([0168]) or a hemoperfusion system ([0167]).
Regarding Claim 26, Nanko discloses a method for removing one or more toxins from process fluid, the method comprising:
providing the sorbent cartridge of claim 1 ([0002]);
moving process fluid through the sorbent cartridge in communication with the hydrogel ("body fluid is flowed through the container"; [0146]), the process fluid comprising one or more toxins ("substances related to malady, especially β2-microglobulin or chemokines"; [0144]); and
absorbing or adsorbing the one or more toxins from the process fluid into the hydrogel to provide treated process fluid ([0076]);
Nanko fails to specify one of said one or more toxins is urea and receiving a temperature input from a temperature sensor on the sorbent cartridge and determining that a temperature gradient must be created across a portion of the sorbent cartridge; and causing a cooling element to create the temperature gradient. However, Nosrati teaches a modular biomimetic microfluidic modules for combining into “medical devices such as dialysis, bioreactors and organ support devices” (see Abstract) with a sorbent cartridge ([0264]) wherein one of said one or more toxins is urea (“Urease” [0264]; NOTE: urease is an enzyme that breaks down urea) and comprising receiving a temperature input from a temperature sensor on the sorbent cartridge ("enables operation of the device and monitoring of blood temperature" [0147]) and determining that a temperature gradient must be created across a portion of the sorbent cartridge ([0048] & [0269] & [0373]); and causing a cooling element to create the temperature gradient ([0269]). Therefore, it would have been obvious to modify Nanko’s device to incorporate the claimed features as taught by Nosrati to filter out targeted toxin ([0263-0264]) and "to motivate faster permeation, diffusion and convection" and improve device operation efficiency ([0048]-[0073]).
Regarding Claims 17, 23-24, and 31-32, Nanko discloses the hydrogel as a sorbent but fails to specify a vibration element configured to vibrate the hydrogel; a cooling element to create a temperature gradient along a length of the hydrogel; vibrating the hydrogel; and cooling the hydrogel to create a temperature gradient along a length of the hydrogel. However, Nosrati teaches modular biomimetic microfluidic modules for combining into “medical devices such as dialysis, bioreactors and organ support devices” (see Abstract); a vibration element configured to vibrate the hydrogel ([0060]); a cooling element to create a temperature gradient along a length of the hydrogel ([0048]-[0059]); vibrating the hydrogel ([0060]); and cooling the hydrogel to create a temperature gradient along a length of the hydrogel ([0048]-[0059]). Therefore, it would have been obvious to modify Nanko’s device to incorporate the claimed features "to motivate faster permeation, diffusion and convection" and improve device operation efficiency ([0048]-[0073]).
Regarding Claim 40, Nanko discloses the hydrogel is a polyacrylamide hydrogel (“cross-linked polyacrylamide” [0097]) or a PEG functionalized polyacrylamide hydrogel ([0100]).
Claim(s) 3 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nanko/Nosrati in view of Tanabe et al. (US 4734097 A).
Regarding Claim 3, Nanko discloses the hydrogel as the sorbent but fails to specify that the hydrogel is configured to release to the process fluid at least one of an electrolyte, a buffer, a mineral, a vitamin, or an anti-coagulant. However, Tanabe teaches “a medical material comprising a molded hydrogel” (see Abstract) wherein the hydrogel is configured to release to the process fluid an anti-coagulant (col. 3 ln. 19-27). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Nanko/Nosrati’s device to incorporate the claimed features "to improve the antithrombosis" ability of the medical device (col. 2 ln. 18-21).
Regarding Claim 29, Nanko discloses the hydrogel as the sorbent but fails to specify releasing at least one of an electrolyte, a buffer, a mineral, a vitamin, or anti-coagulant from the hydrogel to the process fluid. However, Tanabe teaches “a medical material comprising a molded hydrogel” (see Abstract) that releases anti-coagulant from the hydrogel to the process fluid (col. 3 ln. 19-27). Therefore, it would have been obvious to modify Nanko/Nosrati’s device to incorporate the claimed features "to improve the antithrombosis" ability of the medical device (col. 2 ln. 18-21).
Claim(s) 8, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nanko/Nosrati in view of Shettigar et al. (US 5211850 A).
Regarding Claim 8, Nanko discloses the sorbent cartridge but fails to specify the sorbent cartridge is configured such that the hydrogel is in indirect communication with the process fluid across a membrane. However, Shettigar teaches a system for “selective removal of plasma components using sorbents” (col. 3 ln. 3-4) wherein the sorbent cartridge ("container 31"; col. 7 ln. 2-3; FIG. 3) is configured such that the hydrogel ("sorbents 33"; col. 7 ln. 4; FIG. 3) is in indirect communication with the process fluid across a membrane ("filter 30"; col. 7 ln. 1-14; FIG. 3). Therefore, it would have been obvious to modify Nanko/Nosrati’s device to incorporate the claimed features to achieve extracorporeal blood filtration without using any plasma pump or transmembrane pressure controls (col. 1 ln. 7-14).
Regarding Claim 14, Nanko discloses the hydrogel and the sorbent cartridge but fails to specify the hydrogel is cast in place over the membrane in said sorbent cartridge, and wherein the membrane is a hollow fiber membrane. However, Shettigar teaches a system for “selective removal of plasma components using sorbents” (col. 3 ln. 3-4) wherein the hydrogel (“sorbent 14”) is cast in place over the membrane in said sorbent cartridge (col. 4 ln. 65 thru col. 5 ln. 25; FIG. 1), and wherein the membrane is a hollow fiber membrane ("hollow fiber membrane 10"; col. 4 ln. 66; FIG. 1). Therefore, it would have been obvious to modify Nanko/Nosrati’s device to incorporate the claimed features to achieve extracorporeal blood filtration without using any plasma pump or transmembrane pressure controls (col. 1 ln. 7-14).
Regarding Claim 16, Nanko/Shettigar discloses the membrane but fails to specify a conductive member configured to couple with a cooling element to create a temperature gradient along a distance between the conductive member and the membrane. However, Nosrati teaches modular biomimetic microfluidic modules for combining into “medical devices such as dialysis, bioreactors and organ support devices” (see Abstract) comprising a conductive member ("heatsink"; [0044]) configured to couple with a cooling element (“cooling elements”; [0048]) to create a temperature gradient along a distance between the conductive member and the membrane ([0048]-[0059]). Therefore, it would have been obvious to modify Nanko/Shettigar’s device to incorporate the claimed features "to motivate faster permeation, diffusion and convection" and improve device operation efficiency ([0048]-[0073]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nanko/Nosrati in view of Shettigar et al. and further in view of Grossman (US 3742946 A).
Regarding Claim 13, Nanko/Nosrati/Shettigar discloses the sorbent cartridge but fails to specify the sorbent cartridge comprises a first compartment and a second compartment, the first compartment comprising the membrane configured to remove water from the process fluid, and the second compartment comprising the membrane configured to toxin removal. However, Grossman teaches an “apparatus for the in vivo treatment of blood containing harmful components” (col. 1 ln. 5-6) comprising a sorbent cartridge ("blood treating unit indicated generally by the numeral 12"; col. 2 ln. 43; FIG. 1) wherein the sorbent cartridge 12 comprises a first compartment and a second compartment (see FIG. 2), the first compartment comprising the membrane ("semi-permeable membrane 14"; col. 3 ln. 41; FIG. 2) configured to remove water from the process fluid (col. 4 ln. 14-20), and the second compartment comprising the membrane configured to toxin removal ("migration of the undesirable small molecules from tube 14 into the solid packing surrounding the tube"; col. 4 ln. 31-33; FIG. 2). Therefore, it would have been obvious to modify Nanko/Nosrati/Shettigar’s device to incorporate the claimed features to provide “a lightweight, portable, blood-purifying apparatus which does not involve hemo-dialysis, which does not require attachment to plumbing, which is relatively inexpensive and which may be made widely available to persons afflicted with kidney disease” (col. 1 ln. 33-37).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nanko/Nosrati in view of O'Loughlin et al. (US 20050123529 A1).
Regarding Claim 10, Nanko discloses the hydrogel as a sorbent but fails to specify the hydrogel is configured to absorb 1 gram to 100 grams of urea in 24 hours from the process fluid without altering electrolyte levels outside of a physiological range that would cause harm a user of the renal therapy system. However, O'Loughlin teaches a system for “the treatment of uremic toxins” with a sorbent (see Abstract) wherein the treatment is designed to eliminate toxins similarly to the kidney, which is configured to absorb 1 gram to 100 grams of urea in 24 hours from the process fluid without altering electrolyte levels outside of a physiological range that would cause harm a user of the renal therapy system ([0002]). Therefore, it would have been obvious to modify Nanko/Nosrati’s device to incorporate the claimed features to avoid uremia or uremic toxicity ([0002]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nanko/Nosrati in view of Kudo et al. (US 20160272806 A1).
Regarding Claim 18, Nanko discloses the hydrogel as a sorbent but fails to specify the hydrogel forms a hydrogel layer having a thickness of greater than or equal to about 1 mm. However, Kudo teaches an organic/inorganic composite hydrogel (see Abstract) for medical use ([0117]) wherein the hydrogel forms a hydrogel layer having a thickness of greater than or equal to about 1 mm. Therefore, it would have been obvious to modify Nanko/Nosrati’s device to suitably form a self-supporting hydrogel having high modulus of elasticity that allows a shape to be retained in water (see Abstract).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nanko/Nosrati in view of Grossman.
Regarding Claim 28, Nanko discloses the method of Claim 26 but fails to specify absorbing water from the process fluid into the hydrogel. However, Grossman teaches an “apparatus for the in vivo treatment of blood containing harmful components” (col. 1 ln. 5-6) comprising absorbing water from the process fluid into the hydrogel (“a proportion of the water is removed by the desiccant”; col. 2 ln. 7-8). Therefore, it would have been obvious to modify Nanko/Nosrati’s device to incorporate the claimed features to “to extend the time between treatments” (col. 4 ln. 58).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. 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.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights