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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 16, 2026 has been entered.
Response to Arguments
Applicant's arguments filed May 23, 2025 have been fully considered but they are not persuasive. Amendments to the current set of claims have changed the scope of the claimed invention, resulting in a modification of the previous prior art rejection, using a new embodiment from a previous secondary reference Furuhashi et al., (“Furuhashi”, US 2014/0158589) and combining another newly found secondary reference Kim et al., (“Kim”, US 2005/0230314).
On pages 7-8 of the Remarks section, Applicant discusses the previous interview held, the amendment to the Specification, and the previous prior art rejections.
Applicant argues against the previous 103 prior art rejections regarding independent Claims 1 & 13, arguing that primary reference Toyoda et al., (“Toyoda”, US 2017/0361003), and secondary references Furuhashi et al., (“Furuhashi”, US 2014/0158589), Demers et al., (“Demers”, US 2009/0095679), and Kelly et al., (“Kelly”, US 2005/0131332), do not disclose the added claim limitations to either claim. However, the Examiner has found that Furuhashi discloses the structural features of the claimed rehydration line, (Air is introduced via Air Pump 18 via any of lines Lg, Lf and Lc/Lg into Arterial or Venous Lines 1 & 2, See Figure 1 & 5, See paragraph [0072]), and Kim discloses the act of adding back more liquid or inherently water by doing so, (See paragraph [0007], [0052], [0063]). Applicant also argues that Demers only uses its compressed air to return blood to the patient when there is no power. The Examiner notes here that it is not required in the claim under what conditions or circumstances the air can operate to return blood to the patient. The Examiner finds this remark unpersuasive. No further substantial arguments have been provided, so the remainder of the remarks are considered moot.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). However, the Examiner notes that the certified copy submitted appears have its pages in reverse order.
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) 1-4, 9-11 & 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyoda et al., (“Toyoda”, US 2017/0361003), in view of Furuhashi et al., (“Furuhashi”, US 2014/0158589), in further view of Demers et al., (“Demers”, US 2009/0095679), in further view of Kelly et al., (“Kelly”, US 2005/0131332), and Kim et al., (“Kim”, US 2005/0230314).
Claims 1-4 & 9-11 are directed to a blood purification apparatus, an apparatus type invention group.
Regarding Claims 1-4 & 9-11, Toyoda discloses a blood purification apparatus, (See Abstract), comprising: a blood circuit which is coupled with a puncture needle punctured into a patient and through which blood from the patient flows, (Arterial Blood Circuit 1a of Blood Circuit 1, and Arterial Puncture Needle (a), See Figure 1, See paragraphs [0028] & [0029]); a blood pump that is provided to the blood circuit and delivers liquid in the blood circuit by being driven, (Blood Pump 3 on Blood Circuit 1, See Figure 1, See paragraphs [0028]-[0030]); a needle removal detector that detects removal of the puncture needle from the patient, (See paragraph [0038] & [0059]); a controller that starts a blood return process to return the blood in the blood circuit to the patient and puts the blood pump in a non-active state in response to determination that the blood return process ends, (See paragraph [0030], [0048], [0049], [0051]), and having a priming process carried out before the blood return process, (See paragraph [0049], Toyoda).
Toyoda does not disclose a dialysate introduction circuit that introduces dialysate into the blood circuit in the blood return process; and an air introducer that pushes out the dialysate introduced in the blood circuit by introducing air into the blood circuit in the blood return process; wherein the dialysate introduction circuit includes a priming liquid line, and the priming liquid line introduces the dialysate into the blood circuit and fills the blood circuit with the dialysate in the priming process; wherein the controller determines whether to end a dialysate introduction stage to introduce the dialysate into the blood circuit based on an amount of returned blood and/or elapsed time, and starts an air introduction stage to introduce the air into the blood circuit in response to a determination that the dialysate introduction stage ends, and wherein the air introducer is coupled to the dialysate introduction circuit and introduces the air into the blood circuit through the dialysate introduction circuit, and wherein the air introducer further includes an on-off valve or a rehydration line coupled to the air introducer to introduce the air from the air introducer into the blood circuit through the rehydration line so that the dialysate is introduced into the blood circuit to rehydrate the blood.
Furuhashi discloses a dialysate introduction circuit that introduces dialysate into the blood circuit in the blood return process, (See paragraph [0070]-[0076], Furuhashi); and an air introducer that pushes out the dialysate introduced in the blood circuit by introducing air into the blood circuit in the blood return process, (See paragraphs [0072]-[0079]); wherein the controller determines whether to end a dialysate introduction stage to introduce the dialysate into the blood circuit based on an amount of returned blood and/or elapsed time, (See paragraph [0073]), and starts an air introduction stage to introduce the air into the blood circuit in response to determination that the dialysate introduction stage ends, (See paragraphs [0072]-[0079], particularly [0074]), wherein the air introducer further includes an on-off valve, (V4 or V5 on Lines Le or Lf open and close on air circulation line where Air Pump 18 resides, See Figure 1, See paragraphs [0047]-[0049]), and a rehydration line coupled to the air introducer to introduce the air from the air introducer into the blood circuit through the rehydration line, (Air is introduced via Air Pump 18 via any of lines Lg, Lf and Lc/Lg into Arterial or Venous Lines 1 & 2, See Figure 1 & 5See paragraph [0072]), so that the dialysate is introduced into the blood circuit, (See paragraph [0072], [0074] & [0076]; The air pump is working in unison with the pump 14 and blood pump 4 to pull dialysate into the blood circuit and substitute the blood with dialysate, which inherently contains water).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood purification apparatus of Toyoda by incorporating a dialysate introduction circuit that introduces dialysate into the blood circuit in the blood return process; and an air introducer that pushes out the dialysate introduced in the blood circuit by introducing air into the blood circuit in the blood return process; wherein the controller determines whether to end a dialysate introduction stage to introduce the dialysate into the blood circuit based on an amount of returned blood and/or elapsed time, and starts an air introduction stage to introduce the air into the blood circuit in response to determination that the dialysate introduction stage ends wherein the air introducer further includes an on-off valve and a rehydration line coupled to the air introducer to introduce the air from the air introducer into the blood circuit through the rehydration line so that the dialysate is introduced into the blood circuit as in Furuhashi because “in practice, the substitution solution with the extracorporeally circulating amount [of blood] or more is needed” during “return of the blood after treatment”, (See paragraph [0006], Furuhashi), so providing “an air circulation line”, (See paragraph [0009], Furuhashi), results in “a blood purification apparatus that can reliably substitute blood during returning of the blood and can suppress a supply amount of the substitution solution”, (See paragraph [0008], Furuhashi).
Modified Toyoda does not disclose wherein the dialysate introduction circuit includes a priming liquid line, and the priming liquid line introduces the dialysate into the blood circuit and fills the blood circuit with the dialysate in the priming process or wherein the air introducer is coupled to the dialysate introduction circuit and introduces the air into the blood circuit through the dialysate introduction circuit.
Demers discloses a blood purification apparatus, (See Abstract, Demers), wherein the air introducer is coupled to the dialysate introduction circuit and introduces the air into the blood circuit through the dialysate introduction circuit, (See paragraphs [0434]-[0443], Demers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood purification apparatus of modified Toyoda by incorporating wherein the air introducer is coupled to the dialysate introduction circuit and introduces the air into the blood circuit through the dialysate introduction circuit as in Demers when “compressed air is provided as an accessory to the dialysis machine” and “if the treatment is terminated early due to a power failure or system failure of the dialysis machine”, (See paragraph [0437], Demers), it “may be desirable to return as much blood to the patient as possible” so it “takes advantage of this compressed gas to use it in case of [said] power failure”, (See paragraph [0434], Demers).
Modified Toyoda does not disclose wherein the dialysate introduction circuit includes a priming liquid line, and the priming liquid line introduces the dialysate into the blood circuit and fills the blood circuit with the dialysate in the priming process.
Kelly discloses a blood purification apparatus wherein the dialysate introduction circuit includes a priming liquid line, and the priming liquid line introduces the dialysate into the blood circuit and fills the blood circuit with the dialysate in the priming process, (See paragraph [0245], Kelly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood purification apparatus of modified Toyoda by incorporating wherein the dialysate introduction circuit includes a priming liquid line, and the priming liquid line introduces the dialysate into the blood circuit and fills the blood circuit with the dialysate in the priming process as in Kelly because “it is necessary to prime the extracorporeal circuits…with sterile solution prior to connecting [access lines] to the patient”, (See paragraph [0245], Kelly), “to allow for a safe treatment for the patient and reliable operation of the system” by removing air, (See paragraph [0013], Kelly).
Kim discloses to rehydrate the blood, (See paragraph [0007], [0052], [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood purification apparatus of modified Toyoda by incorporating to rehydrate the blood as in Kim in order to provide “emergency treatment means to cope with a blood pressure drop of the patient, or the like” since “it is the purpose to increase the amount of blood circulation in the patient”, (See paragraph [0063], Kim).
Additional Disclosures Included:
Claim 2: The blood purification apparatus according to claim 1, wherein the controller puts the blood pump in an active state in response to detection of needle removal, (See paragraph [0047], Toyoda).
Claim 3: The blood purification apparatus according to claim 1, wherein the controller determines that the blood return process ends based on a returned blood flow rate and/or an elapsed time, (See paragraph [0050], Toyoda).
Claim 4: The blood purification apparatus according to claim 1, wherein the controller determines that the blood return process ends based on detection of no blood flowing in the blood circuit and/or detection of bubbles in the blood circuit, (See paragraph [0074], Furuhashi).
Claim 9: The blood purification apparatus according to claim 1, wherein the air introducer is coupled to the blood circuit and introduces the air into the blood circuit, (See paragraphs [0072]-[0079], Furuhashi).
Claim 10: The blood purification apparatus according to claim 9, further comprising: a chamber that is provided to the blood circuit and stores the blood in the blood circuit, wherein the air introducer is coupled to the chamber and adjusts a liquid level in the chamber by feeding the chamber with the air in a treatment other than the blood return process, (Air Trap Chamber 5/6, Air Pump 18, See Figure 1, See paragraphs [0072]-[0079], Furuhashi).
Claim 11: The blood purification apparatus according to claim 9, further comprising: a chamber that is provided to the blood circuit and stores the blood in the blood circuit, wherein the blood pump is coupled to the chamber and introduces the air into the chamber as the air introducer in the blood return process, (Air Trap Chamber 5/6, Blood Pump 4, See Figure 1, See paragraphs [0072]-[0079], Furuhashi; Blood pump 4 is also in operation moving the dialysate and air along).
Claims 13-15 are directed to a method, a method type invention group.
Regarding Claims 13-15, Toyoda discloses a method executed by a blood purification apparatus, (See Abstract), including a blood circuit which is coupled with a puncture needle punctured into a patient and through which blood from the patient flows, (Arterial Blood Circuit 1a of Blood Circuit 1, and Arterial Puncture Needle (a), See Figure 1, See paragraphs [0028] & [0029]), a blood pump that is provided to the blood circuit and delivers liquid in the blood circuit by being driven, (Blood Pump 3 on Blood Circuit 1, See Figure 1, See paragraphs [0028]-[0030]), a needle removal detector that detects removal of the puncture needle from the patient, (See paragraph [0038] & [0059]), detecting removal of the puncture needle, (See paragraph [0038] & [0059]); starting a blood return process to return the blood in the blood circuit to the patient, (See paragraph [0030], [0048], [0049], [0051]), and a priming process carried out before the blood return process, (See paragraph [0049], Toyoda).
Toyoda does not disclose a dialysate introduction circuit that introduces dialysate into the blood circuit in the blood return process, and an air introducer that pushes out the dialysate introduced in the blood circuit by introducing air into the blood circuit in the blood return process, the method comprising the steps of: determining whether to end a dialysate introduction stage to introduce the dialysate into the blood circuit based on an amount of returned blood and/or elapsed time; starting an air introduction stage to introduce the air into the blood circuit in response to determination that the dialysate introduction stage ends; and putting the blood pump in a non-active state in response to determination that the blood return process ends, and wherein the air introducer further includes an on-off valve or a rehydration line coupled to the air introducer to introduce the air from the air introducer into the blood circuit through the rehydration line so that the dialysate is introduced into the blood circuit to rehydrate the blood.
Furuhashi discloses a dialysate introduction circuit that introduces dialysate into the blood circuit in the blood return process, (See paragraph [0070]-[0076], Furuhashi); and an air introducer that pushes out the dialysate introduced in the blood circuit by introducing air into the blood circuit in the blood return process, (See paragraphs [0072]-[0079]); the method comprising the steps of: determining whether to end a dialysate introduction stage to introduce the dialysate into the blood circuit based on an amount of returned blood and/or elapsed time, (See paragraph [0073]), starting an air introduction stage to introduce the air into the blood circuit in response to determination that the dialysate introduction stage ends; and putting the blood pump in a non-active state in response to determination that the blood return process ends, (See paragraphs [0072]-[0079], particularly [0074]), wherein the air introducer further includes an on-off valve, (V4 or V5 on Lines Le or Lf open and close on air circulation line where Air Pump 18 resides, See Figure 1, See paragraphs [0047]-[0049]), and a rehydration line coupled to the air introducer to introduce the air from the air introducer into the blood circuit through the rehydration line, (Air is introduced via Air Pump 18 via any of lines Lg, Lf and Lc/Lg into Arterial or Venous Lines 1 & 2, See Figure 1 & 5See paragraph [0072]), so that the dialysate is introduced into the blood circuit, (See paragraph [0072], [0074] & [0076]; The air pump is working in unison with the pump 14 and blood pump 4 to pull dialysate into the blood circuit and substitute the blood with dialysate, which inherently contains water).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Toyoda by incorporating a dialysate introduction circuit that introduces dialysate into the blood circuit in the blood return process, and an air introducer that pushes out the dialysate introduced in the blood circuit by introducing air into the blood circuit in the blood return process, the method comprising the steps of: determining whether to end a dialysate introduction stage to introduce the dialysate into the blood circuit based on an amount of returned blood and/or elapsed time; starting an air introduction stage to introduce the air into the blood circuit in response to determination that the dialysate introduction stage ends; and putting the blood pump in a non-active state in response to determination that the blood return process ends wherein the air introducer further includes an on-off valve and a rehydration line coupled to the air introducer to introduce the air from the air introducer into the blood circuit through the rehydration line so that the dialysate is introduced into the blood circuit as in Furuhashi because “in practice, the substitution solution with the extracorporeally circulating amount [of blood] or more is needed” during “return of the blood after treatment”, (See paragraph [0006], Furuhashi), so providing “an air circulation line”, (See paragraph [0009], Furuhashi), results in “a blood purification apparatus that can reliably substitute blood during returning of the blood and can suppress a supply amount of the substitution solution”, (See paragraph [0008], Furuhashi).
Modified Toyoda does not disclose wherein the dialysate introduction circuit includes a priming liquid line, introducing the dialysate via a priming line of the dialysate introduction circuit by filling the blood circuit with the dialysate in the priming process or wherein the air introducer is coupled to the dialysate introduction circuit and introduces the air into the blood circuit through the dialysate introduction circuit.
Demers discloses a method, (See Abstract, Demers), wherein the air introducer is coupled to the dialysate introduction circuit and introduces the air into the blood circuit through the dialysate introduction circuit, (See paragraphs [0434]-[0443], Demers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Toyoda by incorporating wherein the air introducer is coupled to the dialysate introduction circuit and introduces the air into the blood circuit through the dialysate introduction circuit as in Demers when “compressed air is provided as an accessory to the dialysis machine” and “if the treatment is terminated early due to a power failure or system failure of the dialysis machine”, (See paragraph [0437], Demers), it “may be desirable to return as much blood to the patient as possible” so it “takes advantage of this compressed gas to use it in case of [said] power failure”, (See paragraph [0434], Demers).
Modified Toyoda does not disclose wherein the dialysate introduction circuit includes a priming liquid line, introducing the dialysate via a priming line of the dialysate introduction circuit by filling the blood circuit with the dialysate in the priming process.
Kelly discloses a method wherein the dialysate introduction circuit includes a priming liquid line, introducing the dialysate via a priming line of the dialysate introduction circuit by filling the blood circuit with the dialysate in the priming process, (See paragraph [0245], Kelly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of modified Toyoda by incorporating wherein the dialysate introduction circuit includes a priming liquid line, and the priming liquid line introduces the dialysate into the blood circuit and fills the blood circuit with the dialysate in the priming process as in Kelly because “it is necessary to prime the extracorporeal circuits…with sterile solution prior to connecting [access lines] to the patient”, (See paragraph [0245], Kelly), “to allow for a safe treatment for the patient and reliable operation of the system” by removing air, (See paragraph [0013], Kelly).
Kim discloses to rehydrate the blood, (See paragraph [0007], [0052], [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood purification apparatus of modified Toyoda by incorporating to rehydrate the blood as in Kim in order to provide “emergency treatment means to cope with a blood pressure drop of the patient, or the like” since “it is the purpose to increase the amount of blood circulation in the patient”, (See paragraph [0063], Kim).
Claim 14: The method according to claim 13, further comprising changing the blood pump to an active state with a controller in response to detection of needle removal, (See paragraph [0047], Toyoda).
Claim 15: The method according to claim 13, determining, via a controller that the blood return process ends based on a returned blood flow rate and/or an elapsed time, (See paragraph [0050], Toyoda).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toyoda et al., (“Toyoda”, US 2017/0361003), in view of Furuhashi et al., (“Furuhashi”, US 2014/0158589), in further view of Demers et al., (“Demers”, US 2009/0095679), in further view of Kelly et al., (“Kelly”, US 2005/0131332), in further view of Kim et al., (“Kim”, US 2005/0230314), in further view of Toyoda et al., JP2007020801A, (“Toyoda 2”, “Machine Translation of JP2007020801A”, Toyoda et al., JP2007020801A, published 2007, 22 total pages).
Claim 12 is directed to a blood purification apparatus, an apparatus or device type invention group.
Regarding Claim 12, modified Toyoda discloses the blood purification apparatus according to claim 1, but does not explicitly disclose wherein the needle removal detector includes a touch sensor integrally formed with the puncture needle and detects the removal of the puncture needle with the touch sensor detecting whether or not the puncture needle is in contact with a body surface of the patient.
Toyoda 2 discloses wherein the needle removal detector includes a touch sensor integrally formed with the puncture needle and detects the removal of the puncture needle with the touch sensor detecting whether or not the puncture needle is in contact with a body surface of the patient, (See paragraph [0008]-[0010], Toyoda 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the blood purification apparatus of Toyoda by incorporating wherein the needle removal detector includes a touch sensor integrally formed with the puncture needle and detects the removal of the puncture needle with the touch sensor detecting whether or not the puncture needle is in contact with a body surface of the patient as in Toyoda 2 in order to provide “a puncture site monitoring device that can predict the removal of the puncture needle due to the patient’s own needle removal, and can reliably avoid the adverse effects of the puncture needle being removed”, (See paragraph [0008], Toyoda 2).
Conclusion
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779