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 the Claims
The amendment filed 10/09/2024 has been entered. Claims 1-24 are pending and under consideration.
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 6, 9, 10, 20 and 23 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 6, 10, 20 and 23 recite “in its compressed configuration” in line 2, there is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution, the limitation is being interpreted as “in the compressed configuration”
Claim 9 recites “a first position” and “a second position”, there is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution, the limitation is being interpreted as “the first position” and “the second position” respectively.
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, 4, 13, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12138373 (hereinafter ‘373) in view of Lockhart (WO 2006076732 A1)
Regarding claim 1, ‘373 substantially claims applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A dialysate container, comprising:
a reservoir (claim 1, a reservoir) arranged and configured to store dialysate;
an exit port (claim 1, an exit port) arranged and configured in fluid communication with the reservoir and arranged and configured to couple to tubing so that dialysate can flow from the reservoir to the tubing; and
a thermal protection system (claim 1, a circular hollow ring) arranged and configured in operative communication with the exit port, the thermal protection system arranged and configured so that when the dialysate container is subjected to a temperature greater than a predetermined temperature, the thermal protection system is arranged and configured to prevent the dialysate from flowing through the exit port and into the tubing;
wherein the thermal protection system comprises a spring-loaded plunger arranged and configured to block the exit port when the dialysate container is subjected to a temperature greater than the predetermined temperature (claim 1, “when the dialysate container is subjected to a temperature greater than a predetermined temperature, the circular hollow ring melts upon reaching the predetermined temperature to block a borehole of the circular hollow ring to prevent the dialysate from flowing through the exit port and into the tubing.”).
‘373 does not claim wherein the thermal protection system comprises a spring-loaded plunger.
Lockhart teaches a temperature-controlled valve, which relatively pertinent to the problem posed by the applicant of thermal protection system, wherein the thermal protection system comprises a spring-loaded plunger (abstract and figure 2, valve 100 comprises a spring 238 and piston 220).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘373 to incorporate the teachings of Lockhart and provides the thermal protection system as claimed for the purpose of providing reopenable valve that prevent overheated dialysate from flowing through the exit port and into the tubing, as taught by Lockhart (page 2), thereby protecting the patient from exposure to overheated dialysate
Regarding claim 4, ‘373, as modified by Lockhart, teaches the dialysate container of claim 1.
The combination further teaches wherein the spring-loaded plunger is vertically displaceable from a first position (Lockhart; page 5 and figure 2a, the piston 220 at position 220(a), allows fluid flow indicated by flow line 250) enabling the dialysate to flow through the exit port and into the tubing to a second position blocking the dialysate from flowing through the exit port and into the tubing (Lockhart; page 5 and figure 2a, the position at position 220(b) blocks and stopping flow of water).
Regarding claim 13, ‘373 claims a dialysate container, comprising:
a reservoir (Claim 1, reservoir) arranged and configured to store dialysate;
an exit port (claim 1, an exit port) arranged and configured in fluid communication with the reservoir and arranged and configured to couple to tubing so that dialysate can flow from the reservoir to the tubing; and
a spring-loaded plunger system arranged and configured in operative communication with the exit port, the spring-loaded plunger system moveable between a first configuration and a second configuration; wherein:
in the first configuration, dialysate is permitted to flow from the reservoir through the exit port and into tubing; in the second configuration, dialysate is prevented from flowing from the reservoir through the exit port and into tubing; and
the spring-loaded plunger system transitions from the first configuration to the second configuration when the dialysate container is subjected to a temperature greater than a predetermined temperature.
‘373 does not claim the dialysate container comprising
a spring-loaded plunger system arranged and configured in operative communication with the exit port, the spring-loaded plunger system moveable between a first configuration and a second configuration; wherein:
in the first configuration, dialysate is permitted to flow from the reservoir through the exit port and into tubing; in the second configuration, dialysate is prevented from flowing from the reservoir through the exit port and into tubing; and
the spring-loaded plunger system transitions from the first configuration to the second configuration when the dialysate container is subjected to a temperature greater than a predetermined temperature.
Lockhart teaches a temperature-controlled valve, which relatively pertinent to the problem posed by the applicant of providing thermal protection for a dialysate container, a spring-loaded plunger system (figure 2, valve 100) arranged and configured in operative communication with the exit port, the spring-loaded plunger system moveable between a first configuration and a second configuration (figure 2 and page 5, position 220(a) and 220(b)); wherein:
in the first configuration, dialysate is permitted to flow from the reservoir through the exit port and into tubing; in the second configuration, dialysate is prevented from flowing from the reservoir through the exit port and into tubing (figure 2 and page 5, piston 220 in position 220(a), the valve allows the fluid to flow ); and
the spring-loaded plunger system transitions from the first configuration to the second configuration when the dialysate container is subjected to a temperature greater than a predetermined temperature (figure 2 and page 5, the piston 220 transitions from the position 220(a) to position 220(b) when the T>Tth piston 220 extend and mate with surface 220, thereby stopping flow of water).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘373 to incorporate the teachings of Lockhart and provides the thermal protection system as claimed for the purpose of providing reopenable valve that prevent overheated dialysate from flowing through the exit port and into the tubing, as taught by Lockhart (page 2), thereby protecting the patient from exposure to overheated dialysate
Regarding claim 14, ‘373, as modified by Lockhart, teaches the dialysate container of claim 13.
The combination further teaches wherein the spring-loaded plunger system is arranged and configured to block the exit port when the dialysate container is subjected to a temperature greater than the predetermined temperature (Lockhart; page 5).
Regarding claim 17, ‘373, as modified by Lockhart, teaches the dialysate container of claim 14.
The combination further teaches wherein the spring-loaded plunger system is vertically displaceable from a first position (Lockhart; page 5 and figure 2a, the piston 220, at position 220(a), allows fluid flow) when in the first configuration thereby enabling the dialysate to flow through the exit port and into the tubing to a second position when in the second configuration to block the dialysate from flowing through the exit port and into the tubing (Lockhart; page 5 and figure 2a, the position at position 220(b) blocks and stopping flow of water).
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.
Claims 1, 4 13, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Barone et al (US 20150045763 A1) in view of Lockhart (WO 2006076732 A1).
Regarding claim 1, Barone substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A dialysate container, comprising:
a reservoir (figure 1, dialysis solution bag 20) arranged and configured to store dialysate;
an exit port (figure 1, drainage port 46) arranged and configured in fluid communication with the reservoir and arranged and configured to couple to tubing so that dialysate can flow from the reservoir to the tubing; and
a thermal protection system arranged and configured in operative communication with the exit port, the thermal protection system arranged and configured so that when the dialysate container is subjected to a temperature greater than a predetermined temperature, the thermal protection system is arranged and configured to prevent the dialysate from flowing through the exit port and into the tubing;
wherein the thermal protection system comprises a spring-loaded plunger arranged and configured to block the exit port when the dialysate container is subjected to a temperature greater than the predetermined temperature.
Barone does not teach the container comprising
a thermal protection system arranged and configured in operative communication with the exit port, the thermal protection system arranged and configured so that when the dialysate container is subjected to a temperature greater than a predetermined temperature, the thermal protection system is arranged and configured to prevent the dialysate from flowing through the exit port and into the tubing;
wherein the thermal protection system comprises a spring-loaded plunger arranged and configured to block the exit port when the dialysate container is subjected to a temperature greater than the predetermined temperature.
Lockhart teaches a temperature-controlled valve, which relatively pertinent to the problem posed by the applicant of thermal protection system, a thermal protection system (abstract and figure 2, valve 100 comprising a spring 238 and piston 220 configured to terminate the fluid flowing through the device reaches a specific temperature) arranged and configured in operative communication with the exit port, the thermal protection system arranged and configured so that when the dialysate container is subjected to a temperature greater than a predetermined temperature, the thermal protection system is arranged and configured to prevent the dialysate from flowing through the exit port and into the tubing;
wherein the thermal protection system comprises a spring-loaded plunger (figure 2, valve 100 comprising spring 238 and piston 200) arranged and configured to block the exit port when the dialysate container is subjected to a temperature greater than the predetermined temperature.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barone to incorporate the teachings of Lockhart and provides the thermal protection system as claimed for the purpose of preventing overheated dialysate from flowing through the exit port and into the tubing, as taught by Lockhart (page 2), thereby protecting the patient from exposure to overheated dialysate
Regarding claim 4, Barone, as modified by Lockhart, teaches the dialysate container of claim 1.
The combination further teaches wherein the spring-loaded plunger is vertically displaceable from a first position (Lockhart; page 5 and figure 2a, the piston 220 is displaceable along the longitudinal axis of the valve from a first position, 220(a), which permits fluid flow therethrough) enabling the dialysate to flow through the exit port and into the tubing to a second position blocking the dialysate from flowing through the exit port and into the tubing (Lockhart; page 5 and figure 2a, in second position, 220(b), blocks the fluid pathway and prevent fluid flow).
Regarding claim 13, Barone teaches a dialysate container, comprising:
a reservoir (figure 1, dialysis solution bag 20) arranged and configured to store dialysate;
an exit port (figure 1, drainage port 46) arranged and configured in fluid communication with the reservoir and arranged and configured to couple to tubing so that dialysate can flow from the reservoir to the tubing; and
a spring-loaded plunger system arranged and configured in operative communication with the exit port, the spring-loaded plunger system moveable between a first configuration and a second configuration; wherein:
in the first configuration, dialysate is permitted to flow from the reservoir through the exit port and into tubing; in the second configuration, dialysate is prevented from flowing from the reservoir through the exit port and into tubing; and
the spring-loaded plunger system transitions from the first configuration to the second configuration when the dialysate container is subjected to a temperature greater than a predetermined temperature.
Barone does not teach the dialysate container comprising:
a spring-loaded plunger system arranged and configured in operative communication with the exit port, the spring-loaded plunger system moveable between a first configuration and a second configuration; wherein:
in the first configuration, dialysate is permitted to flow from the reservoir through the exit port and into tubing; in the second configuration, dialysate is prevented from flowing from the reservoir through the exit port and into tubing; and
the spring-loaded plunger system transitions from the first configuration to the second configuration when the dialysate container is subjected to a temperature greater than a predetermined temperature.
Lockhart teaches a temperature-controlled valve, which relatively pertinent to the problem posed by the applicant of thermal protection system, a spring-loaded plunger system (abstract page 5 and figure 2, valve 100 comprising a spring 238 and piston 220 moveable between a first configuration 220(a) and a second configuration 220(b)) arranged and configured in operative communication with the exit port, the spring-loaded plunger system moveable between a first configuration and a second configuration; wherein:
in the first configuration, dialysate is permitted to flow from the reservoir through the exit port and into tubing (page 5 and figure 2a, in the first configuration, the valve allows fluid flow therethrough);
in the second configuration, dialysate is prevented from flowing from the reservoir through the exit port and into tubing (figure 5 and figure 2a, in the second configuration, the valve blocks the fluid pathway and prevent the fluid flow); and
the spring-loaded plunger system transitions from the first configuration to the second configuration when the dialysate container is subjected to a temperature greater than a predetermined temperature (abstract and figure 2, valve 100 comprising a spring 238 and piston 220 configured to terminate the fluid flowing through the device reaches a specific temperature).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barone to incorporate the teachings of Lockhart and provides the spring-loaded plunger system as claimed for the purpose of preventing overheated dialysate from flowing through the exit port and into the tubing, as taught by Lockhart (page 2), thereby protecting the patient from exposure to overheated dialysate.
Regarding claim 14, Barbon, as modified by Lockhart, teaches the dialysate container of claim 13.
The combination further teaches wherein the spring-loaded plunger system is arranged and configured to block the exit port when the dialysate container is subjected to a temperature greater than the predetermined temperature (Lockhart; page 5).
Regarding claim 17, Barbon, as modified by Lockhart, teaches the dialysate container of claim 13.
The combination further teaches wherein the spring-loaded plunger system is vertically displaceable from a first position when in the first configuration thereby enabling the dialysate to flow through the exit port and into the tubing to a second position when in the second configuration to block the dialysate from flowing through the exit port and into the tubing (Lockhart; Lockhart; page 5 and figure 2a, the piston 220 is displaceable along the longitudinal axis of the valve from a first position, 220(a), which permits fluid flow therethrough to a second position, 220(b), blocks the fluid pathway and prevent fluid flow).
Allowable Subject Matter
Claims 2, 3, 5-12, 15, 16 and 18-24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, overcomes 112(b) rejections and double patent rejection as discussed supra.
The following is a statement of reasons for the indication of allowable subject matter: No prior art, alone or in combination, could be found to teach (Claim 2) wherein the spring-load plunger comprises a plunger member, a spring, and a holding member, the holding member being arranged and configured to melt upon reaching the predetermined temperature and, upon melting, the holding member releasing the spring causing the plunger member to block the dialysate from flowing through the exit port and into the tubing.
The closest prior art Lockhart teaches the spring-load plunger comprises a plunger member (figure 2, piston 220), a spring (figure 2, spring 238), and a holding member (figure 2, expanding medium 224), however Lockhart fails teach, upon melting, the holding member releasing the spring causing the plunger member to block the dialysate from flowing through the exit port and into the tubing, as Lockhart teaches the expanding medium is configured to be melt and expand upon heating, thereby pushing against and compressing the spring, which is the opposite of the claimed operation.
Furthermore, Schultze (US 5477877 A) teaches the spring-loaded plunger shut-off mechanism including a holding member that melts to release a spring as claimed (figure 1, soler pallet 17), however, Schultze teaches the valve is intended for sue in a gas pipeline, and the holding member is intended to melt in response to the high temperatures generated by gas ignition or fire, rather than in response to the abnormal temperature of liquid, i.e., dialysate or water, and therefore it would not function within the abnormal temperature range of the claim and Lockhart.
Similar, Claim 5 recites “in the second position, the spring is released thereby moving the ball into abutting contacting with an internal wall to prevent the dialysate from flowing through the exit port and into the tubing.”;
Claim 9 recites “in a second position, the spring is released thereby moving the plate into abutting contacting with an internal wall to prevent the dialysate from flowing through the exit port and into the tubing.” ;
Claim 15 recites “upon melting, the holding member releasing the spring causing the plunger member to block the dialysate from flowing through the exit port and into the tubing.”;
Claim 18 recites “in the second position, the spring is released thereby transitioning the spring-loaded plunger system to the second configuration.”; and
Claim 22 recites “in the second configuration, the spring is released thereby moving the plate into abutting contacting with an internal wall to block the dialysate from flowing through the exit port and into the tubing.”. Accordingly the claims and dependent claims are allowable over the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bennett (US 4480784 A), McMath (US 3720220 A) and Sidney (US 2707965 A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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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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/SETH HAN/ Examiner, Art Unit 3781
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