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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 5, 2026 has been entered.
Response to Arguments
Applicant's arguments filed February 5, 2026 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 newly found secondary reference Kelly et al., (“Kelly ‘675”, US 2009/0088675).
On page 9 of the Remarks section, as indicated by the page number at the bottom of each page, Applicant discusses the status of the claims, and also discusses the amendments made to obviate the previous 112 rejections. In response, the Examiner has withdrawn these rejections.
On pages 9-10, Applicant argues against the previous prior art rejection regarding presently amended independent Claims 1 & 9. Here, Applicant summarizes the amendments to independent Claims 1 & 9, as well as the addition of new dependent Claims 15 & 16. Applicant then argues that previous primary reference Kelly et al., (“Kelly ‘332”, US 2005/0131332), does not disclose “sequential phases” using a common container for providing saline in the first rinsing phase and collecting dialysate in the second air elimination phase. Applicant argues that in Kelly ‘332, the saline priming and dialysate priming used are alternative modes, not sequential phases that use a same container. Here, the Examiner notes however that Kelly ‘332 describes using two different priming methods using either dialysate or saline, in paragraphs [0245]-[0246] and [0247]-[0248], and also discloses using two different rinseback methods as in paragraph [0249] & [0250] and then in paragraphs [0251]-[0253], Kelly ‘332 states that each of these priming methods may be also adapted for blood rinseback at the end of the therapy. The Examiner notes that performing a saline priming method as in paragraph [0247]-[0248] and then modifying it to perform a blood rinseback where dialysate is pumped through the dialyzer into the blood circuit as in paragraph [0251] would read upon the claimed invention in this manner in the sequential phase as argued by Applicant. For this reason, the Examiner finds this portion of Applicant’s argument unpersuasive.
Applicant also argues that Kelly ‘332 does not explicitly disclose this sequence of circulation such that the same first container is used such that dialysate is driven back into the first container from which saline was pulled. The Examiner notes here that newly found secondary reference Kelly et al., (“Kelly ‘675”, US 2009/0088675), discloses this feature instead as detailed in the prior art rejection section below, in combination with original primary reference Kelly ‘332. Thus, the Examiner finds Applicant’s remark here moot.
On pages 11-12, Applicant argues that Kelly ‘332 merely discloses the forward and reverse operation of pumps. However, as detailed above, each paragraph [0246]-[0253] of Kelly ‘332 demonstrates various priming and/or rinseback operations using both of saline and dialysate. The Examiner finds this remark unpersuasive.
On pages 12-13, Applicant argues that secondary reference Brugger does not disclose the above discussed claim features. The Examiner notes that Brugger is no longer used to disclose the features in Claims 1 & 9, thus these remarks are considered moot. The remainder of Applicant’s remarks do not present any other specific arguments, so they are also considered moot.
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 1, 4, 10, 11, and their dependent claims 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 1 recites the limitation “the closure” on line 35 & 36. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation “the rinsing phase”. It is not clear if this limitation is the same as “an extracorporeal circuit rinsing phase” as in Claim 1, or something different.
Claim 10 recites the limitation “the rinsing phase” as in Claim 9. It is not clear if this limitation is the same as “an extracorporeal circuit rinsing phase”, or something different.
Claim 11 recites the limitation “the connected state” on lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
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, 3, 4, 7, 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al., (“Kelly ‘332”, US 2005/0131332), as evidenced by “Priming, Connecting and Disconnecting”, (Chapter 6, “Priming, Connecting and Disconnecting”, Indian Journal of Nephrology, Volume 30, Supplement 1, July 2020, 3 total pages), in view of Folden et al., (“Folden”, US 2009/0076433), in further view of Kelly et al., (“Kelly ‘675”, US 2009/0088675).
Claims 1, 3, 4, 7, 8 are directed to a dialysis machine, an apparatus or device type invention group.
Regarding Claims 1, 3, 4, 7, 8, Kelly ‘332 discloses a dialysis machine for treating a bodily fluid, including blood or plasma, (See Abstract), said machine comprising: - a dialyzer having an enclosure, (Dialyzer 20,30, See Figure 26, See paragraph [0253]), which includes: - a blood compartment, (See paragraph [0003], two portions of dialyzer are formed when membrane separates blood and dialysate), which has a bodily fluid inlet, and a bodily fluid outlet, (Inlet and Outlet of Dialyzer 20,30 attached to Lines 44a/44b, See Figure 26, See paragraph [0245]), and a dialysate compartment, (See paragraph [0003], two portions of dialyzer are formed when membrane separates blood and dialysate), which has a dialysate inlet and a dialysate outlet, (Inlet and Outlet of Dialyzer 20,30 attached to Lines 314/328, See Figure 26); - a membrane system between the blood compartment and the dialysate compartment, (See paragraph [0003] & [0007]); - an arterial line connected to the bodily fluid inlet of the blood compartment of the dialyzer, (Line 44a, See Figure 26, See paragraph [0245]); the arterial line having an end to which a first container, of physiological saline is connectable, (Saline Bag 368 connected to Arterial Access Line 44a, See Figure 26, See paragraph [0245]); - a venous line connected to the bodily fluid outlet of the blood compartment of the dialyzer, (Venous Access Line 44b, See Figure 26, See paragraph [0245]); the venous line having an end to which a second container is connectable, (Drip Chamber 52, See Figure 26, See paragraph [0245]); - a blood pump, configured to allow a fluid to circulate back and forth in the arterial line, (Blood Pump 48, See Figure 26, See paragraph [0245]); - a dialysate feed system having: - a dialysate feed line which is connected to the dialysate inlet of the dialysate compartment, (Dialysate Line 314, See Figure 26, See paragraph [0176]; This line is present in Figure 26 also delivering dialysate to Dialyzer 20,30), and - a dialysate delivery system which is connected to the dialysate feed line and to which a dialysate supply source is connectable, (Dialysate Bags/Containers 14, 16, 18 connected to Line 330 connected to Line 314, See Figure 26, See paragraph [0080] and more); - a dialysate discharge system having a dialysate discharge line which is connected to the dialysate outlet of the dialysate compartment, (Spent Dialysate/Effluent Line 328, See Figure 26, See paragraph [0232]); a control unit, (See paragraph [0242], [0276]), being configured such that, in a connected state of the first container to the arterial line, of the second container to the venous line, and of the dialysate supply source to the dialysate delivery system, (Saline Bag 318 connected to Arterial Access Line 44a, Drip Chamber 52 connected to Venous Line 44b, Dialysate Bags 14-18 connected to Lines 330/314, See Figure 26), wherein said control unit is configured to implement a first saline circulation phase for extracorporeal circuit rinsing, which comprises a step of control of an operation of the blood pump so as to cause part of the physiological saline, contained in the first container, to circulate through the blood compartment into the second container which collects said part of physiological saline and residues entrained by said part of the physiological saline, (“saline for rinsing the blood compartment…is done to eliminate all the air and residual sterilant from the dialyzer, blood lines” etc, “Priming, Connecting and Disconnecting”), during the circulation of said part of the physiological saline, (Saline Bag 368 connected to Arterial Access Line 44a and saline circulated into Dialyzer 20,30 into Venous Line 44b and Drip Chamber 52, See Figure 26, See paragraph [0247] & [0248]; also see paragraphs [0245] & [0250]; which show that operating in the normal direction causes fluid to travel through the dialyzer towards the venous line); a second dialysate circulation phase for air elimination from the dialyzer, (See paragraph [0249]), which comprises the following steps:- controlling a closure of circulation in the venous line, (See paragraph [0252]); - controlling a closure of circulation in the discharge line of the dialysate discharge system, (See paragraph [0252] & [0253]); - controlling an operation of the dialysate delivery system in order to cause dialysate to circulate from the dialysate supply source through the blood compartment and the arterial line, (Dialysate on dialysate side circulated via Dialysate Pumps 370/390, See Figure 26, See paragraph [0252] or [0253]), the first container which contains physiological saline and which has been partially emptied during the first saline circulation phase, (Saline Bag 368 connected to Arterial Access Line 44a and saline circulated into Dialyzer 20,30 into Venous Line 44b and Drip Chamber 52, See Figure 26, See paragraph [0247] & [0248]).
Kelly ‘332 does not disclose executing the steps before connecting a patient connection device to the venous line in place of the second container, or following said first saline circulation phase for extracorporeal circuit rinsing and causing the dialysate to circulate into the first container.
Folden discloses executing steps before connecting a patient connection device to the venous line in place of the second container, (Bag 285 or Coupler 220 are disconnected after priming and system is connected to patient, See Figure 1, See paragraph [0048]).
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 dialysis machine of Kelly ‘332 by incorporating executing the steps before connecting a patient connection device to the venous line in place of the second container as in Folden so that “any air that is in the circuit ought to escape through the “chamber [or container]”, (See paragraph [0051], Folden), while it will “allow for flexibility in priming the circuit”, (See paragraph [0026], Folden).
Kelly ‘675 discloses following said first saline circulation phase for extracorporeal circuit rinsing and causing the dialysate to circulate into the first container, (See Figure 13, See paragraph [0068] & [0073], Kelly ‘675).
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 dialysis machine of modified Kelly ‘332 by incorporating following said first saline circulation phase for extracorporeal circuit rinsing and causing the dialysate to circulate into the first container as in Kelly ‘675 because “the pressurization of the circuit blood loss can occur if the tubing is not closed properly after withdrawing air and there is also the risk of blood contamination during the manual procedure” so this incorporated feature “eliminates these risks because the level control mechanism does not require the operator to make any connections”, (See paragraph [0014], Kelly ‘675).
Additional Disclosures Included:
Claim 3: The dialysis machine as claimed in claim 1, in which the venous line is provided with a clamp system, controllable by the control unit, to permit closing or opening of the circulation inside the venous line, (Clamp 54, See Figure 26, See paragraph [0253], Kelly ‘332).
Claim 4: The dialysis machine as claimed in claim 1, in which, for execution of the second dialysate circulation phase for air elimination, the control unit is configured to control the operation of the blood pump, in a direction opposite to a direction of operation used during first saline circulation phase for extracorporeal circuit rinsing, in parallel with said step of controlling the operation of the dialysate delivery system, (Pump 48 running in reverse, See Figure 26, See paragraph [0253], Kelly ‘332).
Claim 7: The dialysis machine as claimed in claim 1, in which said dialysate delivery system comprises at least one flexible bag, called a ventricle bag, intended to contain the dialysate, and means for pressurizing the ventricle bag, (Balance Chambers 340a/b, See Figure 26, See paragraph [0202], [0211], [0245], Kelly ‘332).
Claim 8: The dialysis machine as claimed in claim 1, wherein the control unit is configured to determine a volume of physiological saline displaced by the blood pump into the second container, (See paragraph [0252], Kelly ‘332), and to stop operation of said blood pump when the volume of physiological saline displaced has reached a predefined value, (See paragraph [0252], Kelly ‘332).
Regarding Claims 9 & 10, Kelly ‘332 discloses a method of rinsing and eliminating air from a dialysis machine, said dialysis machine having: - a dialyzer having an enclosure (Dialyzer 20,30, See Figure 26, See paragraph [0253], Kelly ‘332), which includes:- a blood compartment, (See paragraph [0003], Kelly ‘332, two portions of dialyzer are formed when membrane separates blood and dialysate), which has a bodily fluid inlet, and a bodily fluid outlet, (Inlet and Outlet of Dialyzer 20,30 attached to Lines 44a/44b, See Figure 26, See paragraph [0245], Kelly ‘332), and - a dialysate compartment, (See paragraph [0003], Kelly ‘332, two portions of dialyzer are formed when membrane separates blood and dialysate), which has a dialysate inlet and a dialysate outlet, (Inlet and Outlet of Dialyzer 20,30 attached to Lines 314/328, See Figure 26, Kelly ‘332); - a membrane system between the blood compartment and the dialysate compartment, (See paragraph [0003] & [0007], Kelly ‘332); - an arterial line connected to the bodily fluid inlet of the blood compartment of the dialyzer, (Line 44a, See Figure 26, See paragraph [0245], Kelly ‘332); the arterial line having an end to which a first container of physiological saline is connectable, (Saline Bag 368 connected to Arterial Access Line 44a, See Figure 26, See paragraph [0245], Kelly ‘332); - a venous line connected to the bodily fluid outlet of the blood compartment of the dialyzer, (Venous Access Line 44b, See Figure 26, See paragraph [0245]); the venous line having an end to which a second container, is connectable, (Drip Chamber 52, See Figure 26, See paragraph [0245]); - a blood pump, configured to allow a fluid to circulate back and forth in the arterial line, (Blood Pump 48, See Figure 26, See paragraph [0245]); - a dialysate feed system having: - a dialysate feed line which is connected to the dialysate inlet of the dialysate compartment, (Dialysate Line 314, See Figure 26, See paragraph [0176]; This line is present in Figure 26 also delivering dialysate to Dialyzer 20,30), and - a dialysate delivery system which is connected to the dialysate feed line and to which a dialysate supply source is connectable, (Dialysate Bags/Containers 14, 16, 18 connected to Line 330 connected to Line 314, See Figure 26, See paragraph [0080] and more); - a dialysate discharge system having a dialysate discharge line which is connected to the dialysate outlet of the dialysate compartment, (Spent Dialysate/Effluent Line 328, See Figure 26, See paragraph [0232]), said method comprising the steps of: a first saline circulation phase for extracorporeal circuit rinsing, which comprises a step of control of an operation of the blood pump so as to cause part of the physiological saline, contained in the first container, to circulate through the blood compartment into the second container which collects said part of physiological saline and residues entrained by said part of the physiological saline, (“saline for rinsing the blood compartment…is done to eliminate all the air and residual sterilant from the dialyzer, blood lines” etc, “Priming, Connecting and Disconnecting”), during the circulation of said part of the physiological saline, (Saline Bag 368 connected to Arterial Access Line 44a and saline circulated into Dialyzer 20,30 into Venous Line 44b and Drip Chamber 52, See Figure 26, See paragraph [0247] & [0248]; also see paragraphs [0245] & [0250]; which show that operating in the normal direction causes fluid to travel through the dialyzer towards the venous line); a second dialysate circulation phase for air elimination from the dialyzer, (See paragraph [0249]), which comprises the following steps:- controlling a closure of circulation in the venous line, (See paragraph [0252]); - controlling a closure of circulation in the discharge line of the dialysate discharge system, (See paragraph [0252] & [0253]); - controlling an operation of the dialysate delivery system in order to cause dialysate to circulate from the dialysate supply source through the blood compartment and the arterial line, (Dialysate on dialysate side circulated via Dialysate Pumps 370/390, See Figure 26, See paragraph [0252] or [0253]), the first container which contains physiological saline and which has been partially emptied during the first saline circulation phase, (Saline Bag 368 connected to Arterial Access Line 44a and saline circulated into Dialyzer 20,30 into Venous Line 44b and Drip Chamber 52, See Figure 26, See paragraph [0247] & [0248]).
Kelly ‘332 does not disclose executing the steps before connecting a patient connection device to the venous line in place of the second container, or following said first saline circulation phase for extracorporeal circuit rinsing and causing the dialysate to circulate into the first container.
Folden discloses executing steps before connecting a patient connection device to the venous line in place of the second container, (Bag 285 or Coupler 220 are disconnected after priming and system is connected to patient, See Figure 1, See paragraph [0048]).
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 dialysis machine of Kelly ‘332 by incorporating executing the steps before connecting a patient connection device to the venous line in place of the second container as in Folden so that “any air that is in the circuit ought to escape through the “chamber [or container]”, (See paragraph [0051], Folden), while it will “allow for flexibility in priming the circuit”, (See paragraph [0026], Folden).
Kelly ‘675 discloses following said first saline circulation phase for extracorporeal circuit rinsing and causing the dialysate to circulate into the first container, (See Figure 13, See paragraph [0068] & [0073], Kelly ‘675).
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 dialysis machine of modified Kelly ‘332 by incorporating following said first saline circulation phase for extracorporeal circuit rinsing and causing the dialysate to circulate into the first container as in Kelly ‘675 because “the pressurization of the circuit blood loss can occur if the tubing is not closed properly after withdrawing air and there is also the risk of blood contamination during the manual procedure” so this incorporated feature “eliminates these risks because the level control mechanism does not require the operator to make any connections”, (See paragraph [0014], Kelly ‘675).
Additional Disclosures Included:
Claim 10: The method as claimed in claim 9, in which the second dialysate circulation phase for air elimination comprises operation of the blood pump, in a direction opposite direction to a direction of operation used during the first saline circulation phase for extracorporeal circuit rinsing, in parallel with said step of operating the dialysate delivery system, (Dialysate on dialysate side circulated via Dialysate Pumps 370/390, Blood Pump 48 operates in normal direction, See Figure 26, See paragraph [0253], Kelly ‘332).
Regarding Claim 11, Kelly ‘332 discloses a non-transient computer program product comprising program code instructions, (See paragraph [0242], Kelly ‘332; and See paragraph [0009] & [0048], Folden), with a method as claimed in claim 9, when said program is executed by a processor of a control unit being configured such that, (See paragraph [0242], [0276], [0287], Kelly ‘332; and See paragraph [0009] & [0048], Folden), and in which the system performs in the connected state of the first container to the arterial line, of the second container to the venous line, and of the dialysate supply source to the dialysate delivery system, (Saline Bag 318 connected to Arterial Access Line 44a, Drip Chamber 52 connected to Venous Line 44b, Dialysate Bags 14-18 connected to Lines 330/314, See Figure 26, Kelly ‘332), said control unit implements the first saline circulation phase for extracorporeal circuit rinsing, which comprises the step of control of the operation of the blood pump so as to cause part of the physiological saline, contained in the first container, to circulate through the blood compartment into the second container which collects said part of physiological saline and residues entrained by said part of the physiological saline during the circulation of said part of the physiological saline, (Saline Bag 368 connected to Arterial Access Line 44a and saline circulated into Dialyzer 20,30 into Venous Line 44b and Drip Chamber 52, See Figure 26, See paragraph [0247] & [0248], Kelly ‘332); wherein, following said first saline circulation phase for extracorporeal circuit rinsing, the control unit is configured to implement the second dialysate circulation phase for air elimination from the dialyzer, which comprises the following steps executed before connecting the patient connection device to the venous line in place of the second container, (Bag 285 or Coupler 220 are disconnected after priming and system is connected to patient, See Figure 1, See paragraph [0048], Folden):- controlling the closure of circulation in the venous line:- controlling a closure of circulation in the discharge line of the dialysate discharge system, (See paragraph [0252] & [0253], Kelly ‘332);- controlling the operation of the dialysate delivery system in order to cause the dialysate to circulate from the dialysate supply source through the blood compartment and the arterial line, (Dialysate on dialysate side circulated via Dialysate Pumps 370/390, See Figure 26, See paragraph [0252] or [0253], Kelly ‘332), causing the dialysate to circulate into the first container, (See Figure 13, See paragraph [0068] & [0073], Kelly ‘675), which contains physiological saline, (Saline Bag 368 connected to Arterial Access Line 44a and saline circulated into Dialyzer 20,30 into Venous Line 44b and Drip Chamber 52, See Figure 26, See paragraph [0247] & [0248], Kelly ‘332).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al., (“Kelly”, US 2005/0131332), as evidenced by “Priming, Connecting and Disconnecting”, (Chapter 6, “Priming, Connecting and Disconnecting”, Indian Journal of Nephrology, Volume 30, Supplement 1, July 2020, 3 total pages), in view of Folden et al., (“Folden”, US 2009/0076433), in further view of Kelly et al., (“Kelly ‘675”, US 2009/0088675), in further view of Brugger et al., (“Brugger”, US 5,650,071),
Regarding Claim 2, modified Kelly ‘332 discloses the dialysis machine as claimed in claim 1, but does not explicitly disclose in which the bodily fluid inlet of the dialyzer is situated above the bodily fluid outlet.
Brugger discloses a dialysis machine in which the bodily fluid inlet of the dialyzer is situated above the bodily fluid outlet, (Inlet 53 is above Outlet 61 for Dialyzer 54, See Figure 1, See column 5, lines 30-55, Brugger).
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 dialysis machine of modified Kelly ‘332 by incorporating in which the bodily fluid inlet of the dialyzer is situated above the bodily fluid outlet as in Brugger in order to help “ensure that a reused dialyzer is properly cleansed before it is connected to a patient”, (See column 9, lines 61-64, Brugger).
Claim(s) 5 & 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al., (“Kelly”, US 2005/0131332), as evidenced by “Priming, Connecting and Disconnecting”, (Chapter 6, “Priming, Connecting and Disconnecting”, Indian Journal of Nephrology, Volume 30, Supplement 1, July 2020, 3 total pages), in view of Folden et al., (“Folden”, US 2009/0076433), in further view of Kelly et al., (“Kelly ‘675”, US 2009/0088675), in further view of Kenley et al., (“Kenley”, US 5,591,344).
Claims 5 & 6 are directed to a dialysis machine, an apparatus or device type invention group.
Regarding Claim 5, modified Kelly ‘332 discloses the dialysis machine as claimed in claim 1, in which, with the dialysis machine comprising a pressure sensor arranged to measure a pressure in a dialysate circulation circuit formed between the blood pump and the dialysate delivery system, (Pressure Sensor 46, See Figure 26, See paragraph [0111], [0152], Kelly ‘332), but does not explicitly disclose the control unit is configured to control aspeed of operation of the pump as a function of the pressure measured so as to maintain said pressure within a predefined value range.
Kenley discloses a dialysis machine where the control unit is configured to control the speed of operation of the pump as a function of the pressure measured so as to maintain said pressure within a predefined value range, (See column 33, lines 13-35, Kenley).
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 dialysis machine of modified Kelly ‘332 by incorporating the control unit is configured to control the speed of operation of the pump as a function of the pressure measured so as to maintain said pressure within a predefined value range as in Kenley in order to “bring the pressure to acceptable limits”, (See column 33, lines 12-13, Kenley), that is “safe”, (See column 33, lines 17-19, Kenley).
Regarding Claim 6, modified Kelly ‘332 discloses the dialysis machine as claimed in claim 1, in which the control unit is configured such that, in the first saline circulation phase for extracorporeal circuit rinsing, and or in the second dialysate circulation phase for air elimination from the dialyzer, said control unit varies a speed of operation of the blood pump, (See paragraph [0080], See Figure 26, Kelly ‘332), but does not disclose doing so in order to generate jolts.
Kenley discloses a dialysis machine that generates jolts with the blood pump, (See column 42, lines 18-31, Kenley).
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 dialysis machine of modified Kelly ‘332 by incorporating generating jolts as in Kenley in order to “shear any remaining bubbles from the fibers of the dialyzer”, during priming, (See column 33, lines 21-24, Kenley).
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al., (“Kelly”, US 2005/0131332), as evidenced by “Priming, Connecting and Disconnecting”, (Chapter 6, “Priming, Connecting and Disconnecting”, Indian Journal of Nephrology, Volume 30, Supplement 1, July 2020, 3 total pages), in view of Folden et al., (“Folden”, US 2009/0076433), in further view of Kelly et al., (“Kelly ‘675”, US 2009/0088675), in further view of Tamari, (US 2001/0010802).
Claims 12 & 13 are directed to a dialysis machine, an apparatus or device type invention group.
Regarding Claim 12, modified Kelly ‘332 discloses the dialysis machine as claimed in claim 1, wherein said first container is a bag, (Saline Bag 368, See Figure 26, Kelly ‘332), but does not disclose that the second container is a bag.
Tamari discloses that the second container is a bag, (See paragraph [0098], See Abstract and paragraph [0006], Tamari).
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 dialysis machine of modified Kelly ‘332 by incorporating that the second container is a bag as in Tamari since “a venous bag is used because it provides significant safety features” since “if the bag empties, it collapses, thereby preventing gross air from being pumped to the patient”, (See paragraph [0007], Tamari). Additionally, it “allows the user to adjust the “atmospheric” pressure about the external walls of the soft-shell reservoir” and it will “improve gas bubble removal”, (See Abstract, Tamari).
Regarding Claim 13, modified Kelly ‘332 discloses the dialysis machine as claimed in claim 8, but does not disclose wherein said predefined value is between 600 and 1800 ml.
Tamari discloses a machine wherein said predefined value is between 600 and 1800 ml, (See paragraph [0110], [0112], See Abstract, See paragraph [0006], Tamari; A venous bag may accept ml volumes such as 1400 ml anticipating the claimed range at that value).
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 dialysis machine of modified Kelly ‘332 by incorporating wherein said predefined value is between 600 and 1800 ml as in Tamari since it provides “a path for gas bubbles entering the inlet to move unhindered up to the gas purge port”, (See paragraph [0025], Tamari), and “providing a more volumetrically effective gas purge, and one that is less traumatic to the blood”, (See paragraph [0031], Tamari), thus it will “improve gas bubble removal”, (See Abstract, Tamari).
Claim 14 is directed to a method, a method type invention group.
Regarding Claim 14, modified Kelly ‘332 discloses the method as claimed in claim 9, wherein said first containers are bags, (Saline Bag 368, See Figure 26, Kelly), but does not disclose that the second container is a bag.
Tamari discloses that the second container is a bag, (See paragraph [0098], See Abstract and paragraph [0006], Tamari).
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 Kelly ‘332 by incorporating that the second container is a bag as in Tamari since “a venous bag is used because it provides significant safety features” since “if the bag empties, it collapses, thereby preventing gross air from being pumped to the patient”, (See paragraph [0007], Tamari). Additionally, it “allows the user to adjust the “atmospheric” pressure about the external walls of the soft-shell reservoir” and it will “improve gas bubble removal”, (See Abstract, Tamari).
Claims 15 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al., (“Kelly”, US 2005/0131332), as evidenced by “Priming, Connecting and Disconnecting”, (Chapter 6, “Priming, Connecting and Disconnecting”, Indian Journal of Nephrology, Volume 30, Supplement 1, July 2020, 3 total pages), in view of Folden et al., (“Folden”, US 2009/0076433), in further view of Kelly et al., (“Kelly ‘675”, US 2009/0088675), in further view of Vecten et al., (“Vecten”, WO 2019/087103).
Regarding Claim 15, modified Kelly ‘332 discloses the dialysis machine as claimed in claim 1, wherein the control unit is configured to determine a level during the first saline circulation phase, and the control unit is configured to determine when the level is reached and to carry out the second dialysate circulation phase for air elimination from the dialyzer, (See paragraph [0070], Kelly ‘675).
Modified Kelly ‘332 does not disclose that the level detected is the volume of said saline that has passed during the first saline circulation phase.
Vecten discloses a dialysis machine where the level detected is the volume of said saline that has passed during the first saline circulation phase, (See page 59, lines 7-39, page 60, lines 1-38, page 61, lines 1-34, Vecten).
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 dialysis machine of modified Kelly ‘332 by incorporating where the level detected is the volume of said saline that has passed during the first saline circulation phase as in Vecten so it “allows the automation of some operations in order to make possible a safe home treatment or to facilitate the treatment process for example the priming and/or the blood return process” which results in “hemodialysis preparation to treatment completion safely, reliably and speedily, and to significantly reduce the labor and supply costs”, (See page 2, lines 37-39, page 3, lines 1-6, Vecten).
Regarding Claim 16, modified Kelly ‘332 discloses the machine as claimed in claim 1, but does not explicitly disclose wherein the control unit is configured to determine said volume of physiological saline to be used for the first saline circulation phase so that, at an end of the first saline circulation phase and of the second dialysate circulation phase for air elimination from the dialyzer, a given volume of physiological saline and dialysate remains in the first container, in order to be able to ensure a return step, (See paragraph [0070], Kelly ‘675).
Modified Kelly ‘332 does not disclose wherein the control unit is configured to determine said volume of physiological saline to be used for the first saline circulation phase so that, at an end of the first saline circulation phase and of the second dialysate circulation phase for air elimination from the dialyzer, a given volume of physiological saline and dialysate remains in the first container, in order to be able to ensure a return step.
Vecten discloses a dialysis machine wherein the control unit is configured to determine said volume of physiological saline to be used for the first saline circulation phase so that, at an end of the first saline circulation phase and of the second dialysate circulation phase for air elimination from the dialyzer, a given volume of physiological saline and dialysate remains in the first container, in order to be able to ensure a return step,, (See page 59, lines 7-39, page 60, lines 1-38, page 61, lines 1-34, Vecten; and See page 62, lines 12-19, Vecten).
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 dialysis machine of modified Kelly ‘332 by incorporating wherein the control unit is configured to determine said volume of physiological saline to be used for the first saline circulation phase so that, at an end of the first saline circulation phase and of the second dialysate circulation phase for air elimination from the dialyzer, a given volume of physiological saline and dialysate remains in the first container, in order to be able to ensure a return step as in Vecten so that “enough volume remains…for the priming of the remaining components”, (See page 62, lines 15-17, Vecten), so it “allows the automation of some operations in order to make possible a safe home treatment or to facilitate the treatment process for example the priming and/or the blood return process” which results in “hemodialysis preparation to treatment completion safely, reliably and speedily, and to significantly reduce the labor and supply costs”, (See page 2, lines 37-39, page 3, lines 1-6, Vecten).
Conclusion
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779