DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 6 is objected to because of the following informalities: “a conveying rate of the second pump” should be “the conveying rate of the second pump.” Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the claim must end in a period. Appropriate correction is required.
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 2-10 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.
Regarding claim 2, the limitation “preferably” renders the claim indefinite. Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. See MPEP 2173.05(d). In this case, the term “preferably” leads to confusion over the intended scope of a claim, as it is unclear whether that following “preferably” is required. If “preferably” was changed to “optionally,” there would be no 35 USC 112, second paragraph issue. For examination purposes, the limitation regarding “may preferably” is interpreted as an optional limitation.
Additionally, regarding claim 2, the limitation “the controller” in the last line of claim 2 renders the claim indefinite, as it is unclear whether this is the same or different than the “at least one controller” in line 13.
Claims 3-10 are rejected as dependents of claim 2.
Regarding claim 3, the limitation “the controller” renders the claim indefinite as, like with claim 2, it is unclear whether this is the same or different than the “at least one controller” in line 13 of claim 2.
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 2 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,592,332, hereinafter ‘332. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 2, claim 1 of ‘332 discloses all limitations required by claim 2 of the current application. As the quantity of the at least one liquid is predetermined by the structure conveying the liquid and speed of the operating second pump, claim 1 of ‘332 discloses “a predetermined quantity of the at least one liquid is introduced into the extracorporeal blood circuit by operating the second pump.”
Regarding claim 5, claim 3 of ‘332 discloses all limitations required by claim 5 of the current application.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘332 in view of Utterberg et al. (US 2007/0010779).
Regarding claim 3, claim 1 of ‘332 discloses al limitations required by claim 3 except further comprising an air recognition detector into which the arterial conduit portion may be inserted, wherein the controller is configured to emit a warning or an alarm and/or halt blood conveyance and/or close the arterial patient tube clamp upon recognition of air in the arterial conduit portion.
Utterberg discloses a treatment apparatus comprising at least one extracorporeal blood circuit comprising an arterial conduit portion 14 having a conduit interior and a patient tube clamp; a venous conduit portion 34 having a conduit interior and a venous patient tube clamp; an arterial needle 12; and a venous needle 36 (see Fig. 1). Utterberg also discloses an air recognition detector 16 into which the arterial conduit portion may be inserted (see Fig. 1), wherein the controller is configured to emit a warning or an alarm (see par. 32, 42, and 47) so that a patient is protected (see par. 47). It would have been obvious to a person having ordinary skill in the art before the date of invention to have the apparatus of claim 1 of ‘826 further include an air recognition detector as disclosed by Utterberg in order to help protect the patient undergoing treatment.
Claims 4 and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘332 in view of Berunto (JP H06197958).
Regarding claim 4, claim 1 of ‘332 discloses limitations of claim 4 except for a substituate conduit external to the extracorporeal blood circuit, where no blood flows through the substituate conduit.
Berunto discloses an extracorporeal blood circuit in a treatment apparatus (see Figs. 1 and 20), the circuit having an arterial line 100 and a venous line 120, with a blood pump 140 arranged on the circuit and at least one second pump 210, 220 adapted to pump at least one liquid 150, 170 into the circuit (see Fig. 1), further comprising a substituate conduit 160, 180 external to the circuit, wherein no blood flows through the substituate conduit as each substituate conduit is for pumping the at least one liquid into the circuit (see Fig. 1). It would have been obvious to a person having ordinary skill in the art before the date of invention to further include a substituate conduit as disclosed by Berunto in order to help with the pumping of the at least one liquid into the circuit.
Regarding claim 8, claim 1 of ‘332 discloses limitations of claim 8 except for the at least one liquid is added through a pre-dilution site.
Berunto discloses an extracorporeal blood circuit in a treatment apparatus (see Figs. 1 and 20), the circuit having an arterial line 100 and a venous line 120, with a blood pump 140 arranged on the circuit and at least one second pump 210, 220 adapted to pump at least one liquid 150, 170 into the circuit (see Fig. 1), the at least one liquid is added through a pre-dilution site (see Fig. 1). It would have been obvious to a person having ordinary skill in the art before the date of invention to have the at least one liquid added through a pre-dilution site, such a position disclosed by Berunto and predictably resulting in the second pump pumping liquid into the circuit, which is shown as desirable by claim 1 of ‘826.
Regarding claim 9, claim 1 of ‘332 discloses limitations of claim 9 except for the predetermined quantity is conveyed through at least a portion of the arterial conduit portion and at least a portion of the venous conduit portion.
Berunto discloses an extracorporeal blood circuit in a treatment apparatus (see Figs. 1 and 20), the circuit having an arterial line 100 and a venous line 120, with a blood pump 140 arranged on the circuit and at least one second pump 210, 220 adapted to pump at least one liquid 150, 170 into the circuit (see Fig. 1), the at least one liquid is added through a pre-dilution site (see Fig. 1), therefore having ap redetermined quantity of the at least one liquid introduced into the circuit by the second pump (see Fig. 1). Berento further discloses the predetermined quantity is conveyed through at least a portion of the arterial conduit portion and at least a portion of the venous conduit portion (see Fig. 1, Abstract) due to its position in entering the circuit. It would have been obvious to a person having ordinary skill in the art before the date of invention to have the at least one liquid added through a pre-dilution site, such a position disclosed by Berunto and predictably resulting in the second pump pumping liquid into the circuit, which is shown as desirable by claim 1 of ‘826, and would result in the predetermined quantity conveyed through at least a portion of the arterial conduit portion and at least a portion of the venous conduit portion.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘332 in view of Bissler et al. (US 6,780,322)
Regarding claim 7, claim 9 of ‘332 discloses limitations of claim 7 except blood conveyance by means of the blood pump is temporarily stopped and is restarted.
Bissler discloses a treatment apparatus (see Fig. 1) comprising an extracorporeal blood circuit with an arterial conduit portion 14 and venous conduit portion 30 and a blood pump 16 for conveying blood (see Fig. 1), wherein blood conveyance by means of the blood pump is temporarily stopped and is restarted so that that the system can be continued later without losing previously measured and computed data (see col. 11, lines 59-67). It would have been obvious to a person having ordinary skill in the art before the date of invention to have blood conveyance by means of the blood pump temporarily stopped and restarted so that that the system can be continued later without losing previously measured and computed data, as disclosed by Bissler.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘332 in view of Yamagami et al. (US 4,372,846).
Regarding claim 10, claim 1 of ‘332 discloses all limitations except that at least one controller is configured to stop the second pump when the predetermined quantity of the liquid has been introduced into the at least one conveyor using the second pump.
Yamagami discloses a controller controlling a metering pump to supply fluid and based on the volume of the supply, the unit controls the pump to control the volume discharged (see col. 7, lines 29-36). It would have been obvious to a person having ordinary skill in the art before the time of invention to have the controller control the pump to control the volume discharged, as disclosed by Yamagami, in order to automatically have the system run, making it easier on the user. As the predetermined quantity of the liquid is the liquid that was introduced via the pump, this would be what is controlled as it is the volume discharged. Additionally, as there is a set volume, it would have to stop when the set volume is done.
Claim 2, 4-6, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,957,826, hereinafter ‘826. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 2, both claims 1 and 15, individually, of ‘826 discloses all limitations required by claim 2 of the current application. As the quantity of the at least one liquid is predetermined by the structure conveying the liquid and speed of the operating second pump, claims 1 and 15 of ‘826 disclose “a predetermined quantity of the at least one liquid is introduced into the extracorporeal blood circuit by operating the second pump.”
Regarding claim 4, claim 15 of ‘826 discloses all limitations required by claim 4 of the current application.
Regarding claim 5, claim 9 of ‘826 discloses all limitations required by claim 5 of the current application.
Regarding claim 6, claim 18 of ‘826 discloses all limitations required by claim 6 of the current application.
Regarding claim 10, claim 6 of ‘826 discloses all limitations required by claim 10 of the current application.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘826 in view of Utterberg et al. (US 2007/0010779).
Regarding claim 3, claim 1 of ‘826 discloses al limitations required by claim 3 except further comprising an air recognition detector into which the arterial conduit portion may be inserted, wherein the controller is configured to emit a warning or an alarm and/or halt blood conveyance and/or close the arterial patient tube clamp upon recognition of air in the arterial conduit portion.
Utterberg discloses a treatment apparatus comprising at least one extracorporeal blood circuit comprising an arterial conduit portion 14 having a conduit interior and a patient tube clamp; a venous conduit portion 34 having a conduit interior and a venous patient tube clamp; an arterial needle 12; and a venous needle 36 (see Fig. 1). Utterberg also discloses an air recognition detector 16 into which the arterial conduit portion may be inserted (see Fig. 1), wherein the controller is configured to emit a warning or an alarm (see par. 32, 42, and 47) so that a patient is protected (see par. 47). It would have been obvious to a person having ordinary skill in the art before the date of invention to have the apparatus of claim 1 of ‘826 further include an air recognition detector as disclosed by Utterberg in order to help protect the patient undergoing treatment.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘826 in view of Bissler et al. (US 6,780,322)
Regarding claim 7, claim 9 of ‘826 discloses limitations of claim 7 except blood conveyance by means of the blood pump is temporarily stopped and is restarted.
Bissler discloses a treatment apparatus (see Fig. 1) comprising an extracorporeal blood circuit with an arterial conduit portion 14 and venous conduit portion 30 and a blood pump 16 for conveying blood (see Fig. 1), wherein blood conveyance by means of the blood pump is temporarily stopped and is restarted so that that the system can be continued later without losing previously measured and computed data (see col. 11, lines 59-67). It would have been obvious to a person having ordinary skill in the art before the date of invention to have blood conveyance by means of the blood pump temporarily stopped and restarted so that that the system can be continued later without losing previously measured and computed data, as disclosed by Bissler.
Claims 8 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of ‘826 in view of Berunto (JP H06197958).
Regarding claim 8, claim 1 of ‘826 discloses limitations of claim 8 except for the at least one liquid is added through a pre-dilution site.
Berunto discloses an extracorporeal blood circuit in a treatment apparatus (see Figs. 1 and 20), the circuit having an arterial line 100 and a venous line 120, with a blood pump 140 arranged on the circuit and at least one second pump 210, 220 adapted to pump at least one liquid 150, 170 into the circuit (see Fig. 1), the at least one liquid is added through a pre-dilution site (see Fig. 1). It would have been obvious to a person having ordinary skill in the art before the date of invention to have the at least one liquid added through a pre-dilution site, such a position disclosed by Berunto and predictably resulting in the second pump pumping liquid into the circuit, which is shown as desirable by claim 1 of ‘826.
Regarding claim 9, claim 1 of ‘826 discloses limitations of claim 9 except for the predetermined quantity is conveyed through at least a portion of the arterial conduit portion and at least a portion of the venous conduit portion.
Berunto discloses an extracorporeal blood circuit in a treatment apparatus (see Figs. 1 and 20), the circuit having an arterial line 100 and a venous line 120, with a blood pump 140 arranged on the circuit and at least one second pump 210, 220 adapted to pump at least one liquid 150, 170 into the circuit (see Fig. 1), the at least one liquid is added through a pre-dilution site (see Fig. 1), therefore having ap redetermined quantity of the at least one liquid introduced into the circuit by the second pump (see Fig. 1). Berento further discloses the predetermined quantity is conveyed through at least a portion of the arterial conduit portion and at least a portion of the venous conduit portion (see Fig. 1, Abstract) due to its position in entering the circuit. It would have been obvious to a person having ordinary skill in the art before the date of invention to have the at least one liquid added through a pre-dilution site, such a position disclosed by Berunto and predictably resulting in the second pump pumping liquid into the circuit, which is shown as desirable by claim 1 of ‘826, and would result in the predetermined quantity conveyed through at least a portion of the arterial conduit portion and at least a portion of the venous conduit portion.
Examiner Comment
The closest prior art found was Kopperschmidt (US 2006/0254982) and Sternby (US 2004/0168969), which do not disclose the removal of blood via substituate/at least one liquid from both the arterial conduit portion and from the venous conduit portion of the extracorporeal blood circuit and towards the arterial needle and the venous needle, as this requires flow in opposite directions (towards the arterial needle and towards the venous needle) while the combination
of Kopperschmidt and Sternby discloses flow in the same direction (away from the arterial needle and
towards the venous needle). Ueda et al. (US 2007/0118064) similarly does not disclose the required removal of blood from both the arterial conduit portion and the venous conduit portion towards the arterial needle and the venous needle, respectively, as Ueda discloses flow away from both needles (see par. 16-17), with that in the venous conduit being driven via the ultrafiltration pump and that in the arterial conduit being driven via the blood pump, or flow only towards the venous needle (see par. 32, replacement saline during dialysis treatment).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781