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 .
Response to Arguments
Applicant's arguments filed September 22, 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.
On page 7 of the Remarks section as indicated by the page number at the bottom of each page, Applicant discusses the previous claim objection and 112 rejections, stating that amendments have bene made in response. The Examiner has withdrawn the objection and all but one 112 rejection as a result.
On pages 7-9, Applicant argues against the previous 103 prior art rejection using primary reference Kelly et al., (“Kelly”, US 2005/0131332), and secondary reference Weiss et al., (“Weiss”, US 4,828,543). Applicant summarizes on pages 7-9 that previous dependent Claims 11, 16 & 17 have been incorporated into independent Claim 10, and then on page 9, argues that neither Kelly or Weiss disclose these features. However, the Examiner notes that Kelly explicitly discloses to “modulate a pump speed of the blood pump by increasing a flow rate of the blood pump from a first flow rate to a second flow rate”, (See paragraph [0246], Kelly; Examiner interprets moving from a reverse or negative flow rate to a normal/forward or positive flowrate to increase the flow rate), and “opening or releasing the second clamping mechanism due to prior extended clamping of the fluid delivery line”, (One of Valve V11 or V12 is opened, See Figure 26, See paragraphs [0247], [0248], [0253], Kelly). The Examiner also notes that Weiss discloses that “the electronic controller operates the blood pump to increase a fluid pressure within the dialysis tubing set when the blood pump flow rate is modulated,” (See column 8, lines 44-59, See column 3, lines 17-21, See column 24, lines 37-40, Weiss). The Examiner notes that neither Kelly or Weiss discloses the feature that “wherein a portion of the fluid delivery line remains occluded or partially occluded after opening or releasing a second clamping mechanism due to prior extended clamping of the fluid delivery line and pressure propagates to the portion of the fluid delivery line that remains occluded or partially occluded and forces the portion to un-occlude the fluid delivery line”, but previously used secondary reference Childers et al., (“Childers”, US 8,105,266), discloses this feature instead, (). While Applicant argues that Kelly does not ‘module the pump speed in the same operating direction to increase pressure’, the Examiner notes that Weiss discloses this feature instead, (See column 8, lines 44-59, See column 3, lines 17-21, See column 24, lines 37-40, Weiss). Such a statement is considered piecemeal analysis and is thus unpersuasive.
On page 9, Applicant then argues that Childers only discloses pushing additional dialysate through the line if there is a clog or clot, not for priming the circuit. The Examiner notes however that Childers explicitly discloses in the cited portion, (See column 38, lines 50-55), that the line may remain partially occluded or closed and then pushes more dialysate through the line to address and open it. The Examiner notes that Kelly already discloses using a priming process and that Childers teaches pushing more dialysate through a line in the event of partial or full occlusion to open the line. The Examiner also notes that Childers remarks multiple times throughout the reference that valves and clamps occlude the lines as well, (See column 30, lines 52-56, Childers). The Examiner does not rely upon Childers to disclose priming. For these reasons, the Examiner finds Applicant’s remarks unpersuasive.
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.
Claim 10 and its 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 10 recites the limitation “the dialysis tubing” on line 15. 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) 10, 13, 15 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al., (“Kelly”, US 2005/0131332), in view of Weiss et al., (“Weiss”, US 4,828,543), in further view of Childers et al., (“Childers”, US 8,105,266).
Claims 10, 13, 15 & 18 are directed to a dialysis system, an apparatus or device type invention group.
Regarding Claims 10, 13, 15 & 18, Kelly discloses a dialysis system, (See Abstract), comprising: a fluid source, (Saline Bag 368, See Figure 26, See paragraph [0245]); a dialysis tubing set that includes at least an arterial line, (Arterial Access 44a, See Figure 26, See paragraph [0245], Kelly), a blood pump portion, (Portion of Access 44a extending through Blood Pump 48, See Figure 26, See paragraph [0245], Kelly), and a fluid delivery line that connects the fluid source to the dialysis tubing set, (Saline Line 372, See Figure 26, See paragraph [0247]); a blood pump configured to interface with the blood pump portion of the dialysis tubing set, (Blood Pump 48, See Figure 26, See paragraph [0245], Kelly); a first clamping mechanism configured to interface with the arterial line, (Clamp 54, See Figures 6 & 7, See paragraph [0252]); a second clamping mechanism configured to interface with the fluid delivery line, (V11 or V12 on Line 372, See Figure 26, See paragraph [0247]); wherein, during a priming sequence, the system is configured to: close or occlude the first clamping mechanism, (Clamp 54 is closed, See Figure 26, See paragraph [0252]); open or un-occlude the second clamping mechanism, (Valve V11 or V12 is opened, See Figure 26, See paragraphs [0247], [0248], [0253]); modulate a pump speed of the blood pump by increasing a flow rate of the blood pump from a first flow rate to a second flow rate, (See paragraph [0246], Kelly; Examiner interprets moving from a reverse or negative flow rate to a normal/forward or positive flowrate to increase the flow rate), to deliver fluid into the dialysis tubing from the fluid source through the fluid delivery line, (See paragraph [0245]), and opening or releasing the second clamping mechanism due to prior extended clamping of the fluid delivery line, (One of Valve V11 or V12 is opened, See Figure 26, See paragraphs [0247], [0248], [0253], Kelly).
Kelly does not explicitly disclose in this embodiment an electronic controller configured to control operation of the blood pump, the first clamping mechanism, and the second clamping mechanism or that the electronic controller operates the blood pump to increase a fluid pressure within the dialysis tubing set, or wherein a portion of the fluid delivery line remains occluded or partially occluded after opening or releasing a the second clamping mechanism due to prior extended clamping of the fluid delivery line in which the pressure propagates to the portion of the fluid delivery line that remains occluded or partially occluded and forces the portion to un-occlude the fluid delivery line.
Weiss discloses a system with an electronic controller configured to control operation of the blood pump, (See Abstract), the first clamping mechanism, and the second clamping mechanism, (See column 12, lines 24-40; and/or See column 20, lines 67-68, column 21, lines 1-12, Weiss), and also that the electronic controller operates the blood pump to increase a fluid pressure within the dialysis tubing set when the blood pump flow rate is modulated, (See column 8, lines 44-59, See column 3, lines 17-21, See column 24, lines 37-40, Weiss).
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 system of Kelly by incorporating an electronic controller configured to control operation of the blood pump, the first clamping mechanism, and the second clamping mechanism or that the electronic controller operates the first and second clamping mechanisms and pump to increase a fluid pressure within the dialysis tubing set when the blood pump flow rate is modulated as in Weiss so that “the central processor regulates the arterial pump speed as necessary to achieve the desired transmembrane pressure”, (See Abstract, Weiss), for “effecting changes in the flowing fluid as dictated by the medical treatment needs”, (See column 8, lines 60-62, Weiss), and “causes faster filtration”, (See column 3, lines 14-17, Weiss).
Childers discloses a system wherein a portion of the fluid delivery line remains occluded or partially occluded after opening or releasing a second clamping mechanism due to prior extended clamping of the fluid delivery line and pressure propagates to the portion of the fluid delivery line that remains occluded or partially occluded and forces the portion to un-occlude the fluid delivery line, (See column 38, lines 50-55, Childers).
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 system of modified Kelly by incorporating wherein a portion of the fluid delivery line remains occluded or partially occluded after opening or releasing the second clamping mechanism due to prior extended clamping of the fluid delivery line and pressure propagates to the portion of the fluid delivery line that remains occluded or partially occluded and forces the portion to un-occlude the fluid delivery line as in Childers to “attempt to clear the line pushing [fluid]”, if ‘the flowrate has remained between the intermediate and high-end thresholds for longer then the preset time”, (See column 38, lines 52-54, Childers).
Additional Disclosures Included:
Claim 13: The system of claim 10, wherein the electronic controller is configured to modulate the pump speed of the blood pump by pulsing a flow rate of the blood pump, (See paragraph [0246], Kelly; Examiner interprets moving from a normal/forward or positive flow rate to a reverse or negative flowrate and moving back to a normal/forward or positive flow rate to read upon pulsing the flow rate back and forth).
Claim 15: The system of claim 10, wherein the electronic controller is configured to automatically perform the close, open, and modulate steps periodically during dialysis therapy, (See paragraph [0249] & [0250], Kelly; Examiner interprets that these steps are occurring during blood rinseback during the end of dialysis therapy to read upon performing during dialysis therapy).
Claim 18: The system of claim 10, wherein the electronic controller is further configured to: un-occlude the arterial line; close or compress the second clamping mechanism that interfaces with the fluid delivery line; and initiate dialysis therapy, (See paragraph [0249] & [0250], Kelly; Examiner interprets that these steps then occur during blood rinseback during the end of dialysis therapy to read upon performing during dialysis therapy).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al., (“Kelly”, US 2005/0131332), in view of Weiss et al., (“Weiss”, US 4,828,543), in further view of Childers et al., (“Childers”, US 8,105,266), in further view of Tullis et al., (“Tullis”, US 2011/0009796).
Claim 14 is directed to a dialysis system, an apparatus or device type invention group.
Regarding Claim 14, modified Kelly discloses the system of claim 10, wherein the electronic controller is configured to modulate the pump speed of the blood pump by decreasing a flow rate of the blood pump from a first rate to a second rate, (See paragraph [0246], Kelly; Examiner interprets moving from a normal/forward or positive flow rate to a reverse or negative flowrate to decrease the flow rate).
Modified Kelly does not disclose a first rate of approximately 320 ml/min and a second rate of approximately 180 ml/min.
Tullis discloses a first rate of approximately 320 ml/min and a second rate of approximately 180 ml/min, (See paragraph [0042], Tullis; The flow rate may be about 320 and/or 180, or a range defined by any two of these values).
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 system of modified Kelly by incorporating a first rate of approximately 320 ml/min and a second rate of approximately 180 ml/min as in Tullis in order to select a flow rate “to increase a clearance rate of the apparatus”, (See paragraph [0007], Tullis).
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 JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779