DETAILED ACTION
This detailed action is in response to the amendments and arguments filed on 12/19/2025, and any subsequent filings.
Notations “C_”, “L_” and “Pr_” are used to mean “column_”, “line_” and “paragraph_”.
Claims 19-21 are canceled. Claims 1-5, 7, 9 and 11-18 are pending.
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 .
Response to Arguments
Claim Rejections - 35 USC § 103
The Applicant argues that the Examiner “made up” a flushing phase of reference Kenley (pg. 7). This argument is unpersuasive because Kenley teaches a backflushing (C8/L55-61).
In response to applicant's argument that modifying Kenley using Shaldon and other cited references would not result in the presently claimed dialysis machine (pg. 8-9), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's argument that the examiner has combined an excessive number of references (pg. 8), reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references (pg. 8-9), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, all of the cited references concern dialysis (Kenley/abstract, Kelly/abstract, Abaci/abstract and Shaldon/abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the blood in Kenley would be thickened in the dialyzer, as demonstrated by Kelly, because blood thickens when fluid is withdrawn (Kelly, C30, L17-24). It would have been obvious that the pressure differences are reduced over the length of the dialyzer of Kenley, as demonstrated by Abaci, because radial velocity reaches a maximum at the dialyzer inlet and decreases along the fiber as the dialyzer outlet is approached (Abaci, pg. 3358). It would have also been obvious that a uniform deposition of proteins is achieved on the dialysis membrane of Kenley, as demonstrated by Abaci, because as the operation times increases, a uniform thickness is achieved when equilibrium protein adsorption capacity of the surface is reached (Abaci, pg. 3359, right column, Pr1). It would have also been obvious to have the flushing phase of Kenley to immediately follow the conditioning phase, as demonstrated by Shaldon, to clean and sterilize the dialysis machine after use (Shaldon, C1, L11-18 and C1, L25-32).
Response to Amendment
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.
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.
Claims 1-5, 7, 9 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication US5932103A (‘Kenley’) in view of U.S. Publication US9039648B2 (‘Kelly’) and in further view of Publication Modeling of Hemodialysis Operation, Annals of Biomedical Engineering, Vol. 38, No. 11, November 2010 (‘Abaci’) and in further view of U.S. Publication US20050230314A1 (‘Kim’).
The Applicant’s claims are directed towards an apparatus.
Regarding Claims 1-5, 7, 9 and 11-18, Kenley teaches a dialysis machine (dialysis machine 10, C3, L48-54, Fig. 1) comprising an extracorporeal blood circuit (extracorporeal circuit 24, C3, L58-59, Figs. 1-2), a control unit (computer control system, C3, L5-15), a dialyzer (dialyzer 46, C4, L32-35, Fig. 2), a dialysate circuit (dialysate circuit 72, C4, L35-39, Fig. 2), and a substitution line (Fig. 2, C8, L47-61, priming fluid is drawn through the dialyzer and may then enter lines 82/88), wherein
the extracorporeal blood circuit has a blood pump (blood pump 44, C4, L30-35, Fig. 2) arranged therein, and comprises a venous line (Fig. 2, C4, L35-39, venous line 40),
the substitution line leads into the venous line (Fig. 2, C8, L47-61, priming fluid is drawn through the dialyzer and may then enter lines 82/88. The fluid entering those lines may further return to the patient (i.e. to the venous line)) and is configured to carry substitution fluid into the venous line,
the blood pump is arranged to convey blood through the dialyzer at a blood flow rate (C6, L67-C7, L3 and C7, L10-26, blood pump flow rate (BPF)),
the dialyzer has a length and a dialysis membrane (membrane 45, C4, L35-39, Fig. 2) that separates the dialyzer into a blood side and a dialysate side (Fig. 2, C4, L30-55),
the control unit is configured to carry out a conditioning cycle during a blood treatment (C6/L5-21), after the extracorporeal blood circuit has been completely filled with blood (C6, L12-21, blood from the patient is introduced into both the arterial and venous lines 42 and 40, so as to substantially fill the arterial and venous lines with blood as the priming fluid is transported across the dialyzer membrane. C7, L10-25, arterial and venous lines substantially filling with blood completely), the conditioning cycle including a conditioning phase in which
an ultrafiltration occurs at an ultrafiltration flow rate (C6, L65-C7, L3, ultrafiltration pump 86 rate),
the ultrafiltration flow rate exceeds the blood flow rate through the blood side of the dialyzer (Table 1 indicated that the BLP rate is lower than the ultrafiltration pump (UFP) rate) such that liquid is withdrawn from the blood in the dialyzer and the blood is thickened in the dialyzer (C6, L22-50, ultrafiltration pump 86 creates negative pressure in line 78, drawing fluid across membrane 45 into line 78),
a fluid volume of between 20% and 70% of the total blood volume is withdrawn from the blood on the blood side of the dialyzer through the dialysis membrane during the conditioning phase (Table 1), and
the conditioning cycle further includes a flushing phase (C8, L55-61) that follows the conditioning phase (fluid drawn by ultrafiltration pump 86 can be used to backflush the dialyzer membrane, C8, L47-61),
the control unit is configured (C3, L2-15, computer control system controls the blood pump and dialysate pump) to carry out the flushing phase whereby the blood pump is controlled to generate a blood flow rate through the dialyzer that exceeds the ultrafiltration flow rate (C8, L47-61, backflushing the fluid across the dialyzer), and
the control unit is configured to at least partially substitute the liquid that is withdrawn from the blood side of the dialyzer during the conditioning phase, with substitution fluid carried through the substitution line (fluid drawn by the ultrafiltration pump (which is controlled by a computer control system, see Kenley, C2, L66-C3, L15).
Kenley does not teach that the blood is thickened in the dialyzer, that pressure differences are reduced over the length of the dialyzer to achieve a uniform deposition of proteins on the dialysis membrane, that the flushing phase immediately follows the conditioning phase, and that the control unit is configured to at least partially substitute the liquid that is withdrawn from the blood side of the dialyzer after the conditioning phase and during the flushing phase.
Kelly also relates to dialysis (abstract), wherein the blood is thickened in the dialyzer (blood thickens when fluid is withdrawn, C30, L17-24).
Abaci also relates to dialysis (abstract), where pressure differences are reduced over the length of the dialyzer (radial velocity reaches a maximum at the dialyzer inlet and decreases along the fiber as the dialyzer outlet is approached (pg. 3358) and radial velocity directly influences the rate of protein transfer and consequently the rate of protein adsorption on the surface of the membrane (pg. 3358, right column). Protein layer thickness decreases as the dialyzer outlet is approached due to lower protein transport toward the membrane surface (pg. 3359, right column, first paragraph), low protein transport near the dialyzer outlet is due to low radial velocity, see pg. 3358, and in turn a reduced pressure difference, see pg. 3358, left column) to achieve a uniform deposition of proteins on the dialysis membrane (pg. 3359, right column, first paragraph).
Kim also relates to a dialysis machine (abstract), wherein the conditioning cycle during a blood treatment further includes a flushing phase that immediately follows the conditioning phase ([0022]), and
the control unit (Fig. 2, [0114], control means G may be a hemodialyzing console (0104)) is configured to at least partially substitute the liquid that is withdrawn from the blood side of the dialyzer after the conditioning phase and during the flushing phase ([0031-0034] and [0117], replenishing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the blood in Kenley would be thickened in the dialyzer, as demonstrated by Kelly, because blood thickens when fluid is withdrawn (Kelly, C30, L17-24). It would have been obvious that the pressure differences are reduced over the length of the dialyzer of Kenley, as demonstrated by Abaci, because radial velocity reaches a maximum at the dialyzer inlet and decreases along the fiber as the dialyzer outlet is approached (Abaci, pg. 3358). It would have also been obvious that a uniform deposition of proteins is achieved on the dialysis membrane of Kenley, as demonstrated by Abaci, because as the operation times increases, a uniform thickness is achieved when equilibrium protein adsorption capacity of the surface is reached (Abaci, pg. 3359, right column, Pr1). It would have been obvious for the conditioning cycle of Kenley to be during a blood treatment and further include a flushing phase that immediately follows the conditioning phase, as demonstrated by Kim, to cancel negative pressure from during priming, allowing to maintain the inside of the blood line to be positive pressure (Kim, [0046]). It would have been obvious for the control unit of Kenley to be configured at least partially substitute the liquid that is withdrawn from the blood side of the dialyzer after the conditioning phase and during the flushing phase to cancel negative pressure from during priming, allowing to maintain the inside of the blood line to be positive pressure (Kim, [0046]) and to increase blood circulation in the patient (Kim, [0069]).
Additional Disclosures Included:
Claim 2: the control unit (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) is further configured to carry out the conditioning cycle at the start of the treatment (Kenley, C2, L1-18 and C2, L29-35).
Claim 3: the ratio of the ultrafiltration rate to the blood flow rate amounts to between 1.5 to 1 and 2.5 to 1 (the ultrafiltration pump rate (UFP) is 150 mL/min while the blood pump flow rate (BLP) is between 75 mL/min and 110.29 mL/min (Kenley, Table 1). This gives rise to a ratio of the ultrafiltration rate to the blood flow rate caused by the blood pump of between 1.36 to 1 and 2 to 1.).
Claim 4: the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to ensure that no dialysate flows into the dialysate side of the dialyzer during the conditioning phase (at the end of the priming process, the extracorporeal circuit 24 is filled completely with the priming fluid (Kenley, C5, L27-31). The patient is connected to the arterial and venous lines of the extracorporeal circuit and dialysate solution is prepared in the dialysate preparation module 25 and circulated through the dialysate circuit 72 to the dialyzer 46 (Kenley, C5, L27-34)).
Claim 5: the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to cause the duration of the conditioning phase to amount to 15 to 120 seconds (the priming phase lasts between 43.2 to 81.6 seconds (Kenley, Table 1)).
Claim 7: the control unit is configured to repeat the conditioning cycle (Kelly, pump 48 (Fig. 2) runs in its operational direction and reverse direction, this priming method cycles back and forth until the extracorporeal circuit is completely filled (C40, L63-C41, L13). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the control unit of the combination of Kenley, Kelly, Abaci and Kim to repeat the conditioning cycle, as demonstrated by Kelly, in order to remove air and residual contaminants prior to dialysis (Kenley, C1, L35-54)).
Claim 9: the blood side of the dialyzer has a volume (Kenley, Table 1) and the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to flow a blood volume during the flushing phase, to flush the blood side of the dialyzer amounts to, in an amount of from 0.5 to 5 times the volume of the blood side (see calculation in previous office action).
Claim 11: the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to control the ratio of the ultrafiltration flow rate to the blood flow rate to amount to between 1.8 to 1 and 2.2 to 1 (the ultrafiltration pump rate (UFP) is 150 mL/min while the blood pump flow rate (BLP) is between 75 mL/min and 110.29 mL/min (Kenley, Table 1). This gives rise to a ratio of the ultrafiltration rate to the blood flow rate caused by the blood pump of between 1.36 to 1 and 2 to 1.).
Claim 12: the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to control the ratio of the ultrafiltration flow rate to the blood flow rate caused by the blood pump amounts to approximately 2 to 1 ((the ultrafiltration pump rate (UFP) is 150 mL/min while the blood pump flow rate (BLP) is between 75 mL/min and 110.29 mL/min (Kenley, Table 1). This gives rise to a ratio of the ultrafiltration rate to the blood flow rate caused by the blood pump of between 1.36 to 1 and 2 to 1.).
Claim 13: the control unit (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) is configured to control a duration of the conditioning phase to be between 30 to 60 seconds (the priming phase lasts between 43.2 to 81.6 seconds (Kenley, Table 1)).
Claim 14: the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to cause a fluid volume of between 30% and 60% of a total volume of the blood side of the dialyzer to be withdrawn through the dialysis membrane during the conditioning phase (During dialysis, the fluid removed from the patient is pumped by the ultrafiltration pump from the dialysate circuit (Kenley, C4, L51-C5, L3) and the difference between the blood pump flow rate (BLP) and the ultrafiltration pump rate (UFP) is in the range of from about 40 mL/min to 75 mL/min (Kenley, Table 1). This difference between the blood pump flow rate (BLP) and the ultrafiltration pump rate (UFP) is being interpreted as the amount of liquid being pulled from the blood per minute (see Kenley, C8, L47-61), as the blood pump flow rate was between 75 mL/min to about 110 mL/min (Kenley, Table 1)).
Claims 15 and 17: the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to repeat the conditioning cycle at least three times to provide a first conditioning cycle, a second conditioning cycle, and a third conditioning cycle, and between three times and six times (the priming method of Kelly includes fluid passing through the venous line 44 and its venous drip chamber 52 four times (C40, L57-C41, L9)).
Claim 16: the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to carry out the second conditioning directly following the first conditioning cycle, and to carry out the third conditioning cycle directly following the second conditioning cycle (Kelly, C40, L57-C41, L9).
Claim 18: the blood side of the dialyzer has a volume (Kenley, Table 1), and the control unit is configured (Kenley, C3, L5-15, computer control unit controls the blood pump and the pump in the dialysate circuit) to cause a blood volume used in the flushing phase, to flush the blood side of the dialyzer, that is between 1 to 2 times the volume of the blood side (fluid drawn by the ultrafiltration pump is directed into an ultrafiltration tank 90 and the fluid may be used for backflushing (Kenley, C8, L47-61). Using the information from row 1 of Table 1, the volume of the blood side of the dialyzer is 110 mL and the amount of fluid drawn by the ultrafiltration pump was 150 mL/min x 81.6 sec = 204 mL, giving 1.85 times the volume of the blood side.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BOI-LIEN THI NGUYEN whose telephone number is (703)756-4613. The examiner can normally be reached Monday to Friday, 8 am to 6 pm.
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/BOI-LIEN THI NGUYEN/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779