DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
1. Claims 83-102 are pending and currently under consideration for patentability.
Claims 1-82 are cancelled as of the January 3, 2024 preliminary amendment.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 1, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
4. Claims 97-102 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.
Claim 97 recites the limitation "dialysis pump" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, this limitation will be treated as ---dialysate pump---.
Claims 98-102 are rejected due to their dependency.
Claim Rejections - 35 USC § 103
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).
5. Claim 83-86, 88-97 and 99-102 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kamen et al. (US PGPUB 2009/0101549 A1) in view of Henley et al. (US PGPUB 2007/0233022 A1).
6. With regard to claims 83 and 97, Kamen discloses a hemodialysis system (Figs. 1, 2, 8; abstract; [0060]) comprising: a dialysis unit (dialysis system, 5; Figs. 1, 2) configured to perform hemodialysis, the dialysis unit (5) comprising: a dialyzer (14); a pneumatically driven blood pump (blood flow pump, 13) configured to pump blood through the dialyzer (14; [0012-0014]; [0067]); and a balancing circuit (143; Figs. 2, 4) including a pneumatically driven dialysate pump (two dialysate pumps, 15) to control a flow of dialysate through the dialyzer (14; [0065]; [0067]; [0074-0075]), wherein flow of blood and dialysate through the dialysis unit (5) is controlled by a plurality of pneumatically actuated valves (pneumatically operated valves 211, 212, 213, 241, 242; Fig. 4; [0075]); a power unit (power module, 52) configured to provide pneumatic power for actuating the blood pump (13), dialysate pump (15) and the plurality of valves (211, 212, 213, 241, 242; [0094]), the power unit (52) comprising: a housing (Figs. 7, 8); a first positive pressure tank (“positive pressure reservoir”); a negative pressure tank (“vacuum or negative pressure reservoir”); a compressor (“two independent compressors”) fluidly connected to the first positive pressure tank ([0096]); and a dehumidifier (“cold section”) downstream of the compressor, fluidly connected between the compressor and the first positive pressure tank ([0101]), the dehumidifier comprising: a tubing circuit (“circulation system”) fluidly connected to the compressor ([0101]); and a chiller (“fan” for “cold box,” “insulated from hot section”) that cools the tubing circuit ([0101]); wherein the pressure tanks reside in the housing (Figs. 7, 8) and the housing is detachably connected to the dialysis unit (5), the power unit (52) having a power conduit and at least two pneumatic lines (“conduits”) configured to connect to the dialysis unit (5; Fig. 7; [0094-0096]).
While Kamen discloses a tubing circuit (“circulation system”) fluidly connected to the compressor ([0101]); and a chiller (“fan” for “cold box,” “insulated from hot section”) that cools the tubing circuit, Kamen fails to explicitly disclose that the tubing circuit is comprised of metal tubes.
However, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the dehumidifier tubing disclosed by Kamen to be metal tubing, since it is well-known in the art that metal is a high thermal conductor, and utilizing tubing with high thermal conductivity within the dehumidifier would be considered as merely an obvious selection having a reasonable expectation of success.
Furthermore, Kamen is silent in regard to the dehumidifier comprising: a water trap fluidly connected to the metal tube downstream of the compressor and upstream of a first positive pressure tank.
Within the same field of endeavor of extracorporeal fluid circuits using compressors, Henley discloses a wound treatment apparatus (10; Figs. 1-3; abstract) comprising: a medicinal fluid supply (15), a drainage system (19) and temperature control system (17; Fig. 1; [0051]); wherein the drainage system (19) includes a compressor (52) fluidly connected to a first positive pressure tank (nebulizer, 26); and a water trap (68) fluidly connected to tubing downstream of the compressor (52) and upstream of the first positive pressure tank (26; Figs. 2-3).
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the dehumidifier disclosed by Kamen to include a water trap, similar to that disclosed by Henley, in order to trap particulate matter and water droplets from the compressed air output from compressor, as suggested by Henley in paragraph [0066]. Additionally, it is common general knowledge that both heating and cooling mechanisms result in vaporization/condensation, and one having ordinary skill in the art would look to implement a water trap as a mere workshop improvement to improve the longevity of electrical componentry of the system.
7. With regard to claims 84 and 99, Kamen discloses that the power unit (52) further comprises: a vacuum pump ([0094-0095]; [0098]]) fluidly connected to the negative pressure tank (“vacuum or negative pressure reservoir”).
8. With regard to claim 85, Kamen discloses that the power unit (52) further comprises: a first control system (“devices to control flow of pneumatic power in the power unit 52, as well as a controller having suitable components, such as a programmed general purpose data processor, memory, sensors (e.g., to detect pressure, temperature, etc.), relays, actuators, and so on”) to control the compressor to achieve a predetermined first positive pressure in the first positive pressure tank ([0094]); and a second control system to control the vacuum pump to achieve a predetermined negative pressure in the negative pressure tank ([0094]; [0096-0098]).
9. With regard to claims 86 and 100, Kamen discloses that the power unit (52) further comprises: a positive pressure regulator (“bang-bang controller”) fluidly connected to the first positive pressure tank ([0096]), the positive pressure regulator set to a second positive pressure, the second positive pressure less than the first positive pressure ([0095-0096]); and a second positive pressure tank (“one or more supply tanks”) fluidly connected to the first positive pressure tank via the positive pressure regulator ([0096]); wherein the power unit (52) inherently comprises at least three pneumatic lines configured to connect to the dialysis unit (5; [0094-0096]; [0100]).
10. With regard to claims 88-91, Kamen discloses that the first positive pressure is in the range of 700 to 850 mmHg ([0095]); and that the negative pressure is -400 to -450 mmHg ([0095]).
However, while Kamen suggests a second positive pressure higher than the set first positive pressure ([0096]), Kamen and Henley fail to explicitly disclose a second positive pressure in the range of 1000-1100 mmHg pressure.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the invention being made to have specified the second positive pressure disclosed by Kamen in view of Henley to be in the range of 1000-1100 mmHg pressure, since it has been held that since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In the instant case, one having ordinary skill in the art would be motivated to optimize the second positive pressure range in order to tailor flow through the system.
11. With regard to claim 92, Kamen discloses that the first control system comprises a pressure sensor fluidly connected to the first positive pressure tank and a relay to control the compressor (“devices to control flow of pneumatic power in the power unit 52, as well as a controller having suitable components, such as a programmed general purpose data processor, memory, sensors (e.g., to detect pressure, temperature, etc.; [0094]), the first control system controlling a pressure in the first positive pressure tank ([0094-0096]).
12. With regard to claim 93, Kamen discloses that the first control system turns the compressor on when a pressure measured by the pressure sensor is a predetermined value below the first positive pressure and turns the compressor off when a pressure measured by the pressure sensor is a predetermined value above the first positive pressure ([0096]).
13. With regard to claim 94, Kamen discloses that the first control system drives the compressor with a pulse-width-modulated signal and controls the compressor with a proportional-integral-derivative controller ([0097]).
14. With regard to claims 95-96 and 101-102, Kamen discloses that the housing (Figs. 7, 8) is detachably connected to the dialysis unit (5) by operation of a single handle (521; [0011-0012]; [0099]); wherein the handle (521) is a manually operable connection handle ([0011-0012]; [0099]).
15. Claim 87 and 98 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kamen in view of Henley, as applied to claims 83 and 97 above, and further in view of Walz (US 3,399,536).
16. With regard to claims 87 and 98, while Kamen discloses that the chiller (“cold box”) comprises a heat exchanger (“grid to allow air to flow in and out of the cold box”) and a fan ([0101]), Kamen and Henley are silent in regard to the heat exchanger being finned and the chiller further comprising a Peltier cooler.
However, within the same field of endeavor of controlling blood temperatures, Walz discloses a device for varying the temperature of blood (abstract; Figs. 1-3), wherein the device includes a chiller (Fig. 1) comprising a Peltier cooler (a Peltier block formed of p and n-conductive semiconductor members, 1), a finned heat exchanger (cooling fins, 10) and a fan (11; col. 1, lines 28-35; col. 3, line 47 – col. 4, line 9).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the invention being made to have modified the chiller disclosed by Kamen in view of Henley to include a Peltier cooler, a finned heat exchanger and a fan, similar to that disclosed by Walz, in order to provide sufficient flow-through space for an effective heat exchanging chiller which avoids the possibility of obstruction of the blood and resulting coagulation thereof, as suggested by Walz in column 2, lines 44-63.
Conclusion
17. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fleming (US 4,666,425) discloses a device for perfusing an animal head.
Tracey et al. (US PGPUB 2005/0095154) discloses a bezel assembly for pneumatic control.
Wilt et al. (US PGPUB 2009/0008331) discloses hemodialysis systems.
Frugier et al. (US PGPUB 2010/0168643) discloses an infusion site for improved fluid mixing.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
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