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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 26, 2026 has been entered.
Response to Arguments
Applicant's arguments filed with the After-Final Response on August 26, 2026 have been fully considered. 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 Stuva et al., (“Stuva”, US 2015/0335809).
Examiner reproduces the response to the previous After-Final Response from the Advisory Action mailed September 11, 2026. On pages 6-12 of the Remarks section, Applicant discussed the previous 112 rejections and 103 prior art rejection of the claims. Applicant stated that the proposed amendments would obviate the previous 112 rejections. Examiner agreed that these 112 rejections would be withdrawn in response. Regarding the 103 prior art rejections, Applicant argued that neither primary reference Schnell, (US 2007/0179422), or secondary reference Wallace, (US 2015/0027951), disclosed the newly added limitation "to prevent the flexible diaphragm from forming a seal over the pressure sensor port" when "elastically dimpling the flexible diaphragm away from the pressure sensor port". The Examiner notes that while secondary reference Wallace discloses "elastically dimpling the flexible diaphragm away from the pressure sensor port", it does not do so while it "prevent(s) the flexible diaphragm from forming a seal over the pressure sensor port". Thus, these amendments changed the scope of the claimed invention in such a way that requires further searching and/or consideration. The remaining remarks are considered moot.
Newly found secondary reference Stuva et al., (“Stuva”, US 2015/0335809), discloses the limitation discussed above instead of Wallace.
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, 5-9, 12, 13, & 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schnell et al., (“Schnell”, US 2007/0179422), in view of Stuva et al., (“Stuva”, US 2015/0335809).
Regarding Claims 1-3, 5-9, & 12, Schnell discloses a pressure output device (POD) for sensing fluid pressure in a blood line set, (See Abstract and See Figures 7-11, See paragraphs [0065], [0066]), the POD comprising: a base comprising an inlet port and an outlet port, (Lower Compartment 22a and Flow Ports 30a/32a, See Figure 9, See paragraph [0071], [0073]), the inlet port and outlet port being connectable to the blood line set, (See paragraph [0057]-[0059], See Figures 1 & 2); a cap coupled to the base to form an interior chamber of the POD, (Upper Compartment 24a sealed with Lower Compartment 22a with Volume 92, See Figure 8, See paragraph [0071], [0073]), the cap comprising: an outer shell, (Upper Compartment 24a forms a shell, See Figure 8, See paragraph [0071], [0073]); a pressure sensor port extending from the outer shell and configured to transmit fluid pressure from within the POD, (Sealed Port 116, See Figure 8, See paragraph [0073], [0076]; See paragraph [0013] and Pressure Sensor 43 and Connector 41 inserted into end of Pressure Tube 42 leading to Port 40 of POD 12, See Figure 1, See paragraphs [0059] & [0060]); and a tab extending inwardly from an inner surface of the outer shell and away from the pressure sensor port, (Partition 120 within interior surface of Lower Compartment 92 and extending within interior of Port 116, See Figure 8, See paragraph [0073]); a flexible diaphragm coupled to the cap and positioned over the base to divide the interior chamber into a fluid chamber and a pressure sensing chamber, (Diaphragm 26a coupled to Upper/Lower Compartments 22a/24a, See Figure 8, paragraph [0071], [0079]), the tab configured to deform a portion of the flexible diaphragm, (See paragraph [0024], [0014]; when tab is moved by breaking the seal, the diaphragm is then movable).
Schnell does not explicitly disclose elastically dimpling the flexible diaphragm away from the pressure sensor port to prevent the flexible diaphragm from forming a seal over the pressure sensor port.
Stuva discloses elastically dimpling the flexible diaphragm away from the pressure sensor port to prevent the flexible diaphragm from forming a seal over the pressure sensor port, (Diaphragm 114 dimpled towards/away in configuration between Positions 118 & 119 both of which do not demonstrate full sealing on Connection Apparatus 84 which juts up around the port formed by 152, See Figure 4, See paragraph [0067], Stuva).
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 POD for sensing fluid pressure in a blood line set of Schnell by incorporating elastically dimpling the flexible diaphragm away from the pressure sensor port to prevent the flexible diaphragm from forming a seal over the pressure sensor port as in Stuva in order to provide a diaphragm that is “flexible and oversized to ensure none of the force exerted by the pressure on the diaphragm in the extracorporeal blood circuit is lost to the tension or compression of the diaphragm”, (See paragraph [0003], Stuva), and the “diaphragm bulge may be placed in a particular direction giving a larger range in the pressure range of interest (e.g. either positive or negative)”, (See paragraph [0077], Stuva).
Additional Disclosures Included:
Claim 2: The POD of claim 1, wherein the tab is positioned beneath the pressure sensor port, (Partition 120 located at bottom of Sealed Port 116, See Figure 8, See paragraph [0073], Schnell).
Claim 3: The POD of claim 1, wherein the tab is configured to prevent the flexible diaphragm from covering an opening of the pressure sensor port, (Partition 120 located between bottom edge of Port 116 and top edge of Diaphragm 26a, See Figure 8, 11, See paragraph [0077] Schnell).
Claim 5: The POD of claim 1, wherein the tab comprises: a first portion configured to contact the flexible diaphragm, (Section 102 of Partition 120 is moved downwards when Portion 98 breaks open, See Figure 8, 9, 11, See paragraph [0077]); and a second portion configured to bend to adjust a position of the first portion, (Portion 100/Section 104 of Partition 120 acts as hinge, See Figure 8, 9, 11, See paragraph [0076], [0077] Schnell).
Claim 6: The POD of claim 5, wherein a width of the first portion is larger than a width of the second portion, (First Section 102 is wider in diameter direction than Section 104/Portion 100, See Figure 8, 9, See paragraph [0076], [0077] Schnell).
Claim 7: The POD of claim 5, wherein a thickness of the first portion is larger than a thickness of the second portion, (First Section 102 is thicker in vertical direction than Section 104/Portion 100, See Figure 8, 9, See paragraph [0076], [0077] Schnell).
Claim 8: The POD of claim 5, wherein the first portion has a cross-sectional shape that is circular, rectangular, elliptical, or square, (Section 102 is semi-circular or elliptical, See Figure 8, 9, See paragraph [0075], [0077] Schnell).
Claim 12: The POD of claim 1, wherein the tab is configured to be bent into a bent position prior to a blood treatment performed using the blood line set, (See paragraph [0076], [0077] and then see paragraphs [0025]-[0028] Schnell describe fitting together the diaphragm and sealed port and tab first before priming/hemodialysis).
Regarding Claims 17-21, Schnell discloses a blood treatment system, comprising: a blood treatment machine, (See paragraph [0012], [0061], [0079]); a blood line set configured to be connected to the blood treatment machine, (Set 60, Tubing 70, Tubing 84, See Figure 7, See paragraph [0061], [0079]); and a pressure output device (POD) for sensing fluid pressure in the blood line set, the POD comprising: a base comprising an inlet port and an outlet port, the inlet port and outlet port being connectable to the blood line set, (Lower Compartment 22a and Flow Ports 30a/32a, See Figure 9, See paragraph [0071], [0073]; and See paragraph [0057]-[0059], See Figures 1 & 2); a cap coupled to the base to form an interior chamber of the POD, the cap comprising: an outer shell, (Upper Compartment 24a sealed with Lower Compartment 22a with Volume 92, See Figure 8, See paragraph [0071], [0073]); a pressure sensor port extending from the outer shell, (Sealed Port 116, See Figure 8, See paragraph [0073], [0076]; See paragraph [0013]), the pressure sensor port configured to transmit a fluid pressure from within the POD, (Pressure Sensor 43 and Connector 41 inserted into end of Pressure Tube 42 leading to Port 40 of POD 12, See Figure 1, See paragraphs [0059] & [0060]); and a tab extending inwardly from an inner surface of the outer shell and away from the pressure sensor port, (Partition 120 within interior surface of Lower Compartment 92 and extending within interior of Port 116, See Figure 8, See paragraph [0073]); a flexible diaphragm coupled to the cap and positioned over the base to divide the interior chamber into a fluid chamber and a pressure sensing chamber, (Diaphragm 26a coupled to Upper/Lower Compartments 22a/24a, See Figure 8, paragraph [0071], [0079]), the tab configured to deform a portion of the flexible diaphragm, (See paragraph [0024], [0014]).
Schnell does not explicitly disclose elastically dimpling the flexible diaphragm away from the pressure sensor port to prevent the flexible diaphragm from forming a seal over the pressure sensor port.
Stuva discloses elastically dimpling the flexible diaphragm away from the pressure sensor port to prevent the flexible diaphragm from forming a seal over the pressure sensor port, (Diaphragm 114 dimpled towards/away in configuration between Positions 118 & 119 both of which do not demonstrate full sealing on Connection Apparatus 84 which juts up around the port formed by 152, See Figure 4, See paragraph [0067], Stuva).
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 POD for sensing fluid pressure in a blood line set of Schnell by incorporating elastically dimpling the flexible diaphragm away from the pressure sensor port to prevent the flexible diaphragm from forming a seal over the pressure sensor port as in Stuva in order to provide a diaphragm that is “flexible and oversized to ensure none of the force exerted by the pressure on the diaphragm in the extracorporeal blood circuit is lost to the tension or compression of the diaphragm”, (See paragraph [0003], Stuva), and the “diaphragm bulge may be placed in a particular direction giving a larger range in the pressure range of interest (e.g. either positive or negative)”, (See paragraph [0077], Stuva).
Additional Disclosures Included:
Claim 18: The blood treatment system of claim 17, wherein the blood treatment machine is a dialysis machine, (See paragraph [0012] Schnell).
Claim 19: The blood treatment system of claim 18, wherein: the blood treatment machine is a hemodialysis machine, (See paragraph [0012], [0021] Schnell); and the blood treatment system further comprises a dialyzer, (Dialyzer 76, See Figure 7, See paragraph [0066], Schnell).
Claim 20: The blood treatment system of claim 17, wherein the blood line set comprises at least one of an arterial line and a venous line, (Arterial Line Set 60, See Figure 7, See paragraph [0066] Schnell).
Claim 21: The blood treatment system of claim 17, wherein the tab is configured to be bent into a bent position by a pin of the blood treatment machine that extends through the pressure sensor port and contacts the tab when the POD is coupled to the blood treatment machine, (Luer Connector 106 inserted in Port 116 and contacts Partition 120 which is then bent, See Figure 11, See paragraphs [0077], [0079], Schnell).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schnell et al., (“Schnell”, US 2007/0179422), in view of Stuva et al., (“Stuva”, US 2015/0335809), in further view of Robinson et al., (“Robinson”, US 2009/0173682).
Regarding Claim 4, Schnell discloses the POD of claim 1, but does not disclose wherein the cap and the flexible diaphragm are formed using a two shot molding process.
Robinson discloses wherein the cap and the flexible diaphragm are formed using a two shot molding process, (See paragraph [0100], Robinson).
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 POD of Schnell by incorporating wherein the cap and the flexible diaphragm are formed using a two shot molding process as in Robinson because it “would remove the need to individually assemble these parts into the manifold therefore reducing labor costs and improve quality of the manifold assembly”, (See paragraph [0100], Robinson).
Claim(s) 9, 13, 15 & 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schnell et al., (“Schnell”, US 2007/0179422), in view of Stuva et al., (“Stuva”, US 2015/0335809), and in view of Siekmann, (US 4,303,376).
Regarding Claim 9, modified Schnell discloses the POD of claim 1, where the tab is an element and the bent position is an extended position, but does not disclose wherein the element elastically dimples the flexible diaphragm when the element is in a bent position and the flexible diaphragm contacts the element.
Siekmann discloses wherein the element elastically dimples the flexible diaphragm when the element is in the extended position and the flexible diaphragm contacts the element, (Valving Pins 47/48 elastically dimple the Diaphragm 27, See Figure 5a-d, See column 6, lines 24-34, and/or Arm 73 pivots, See column 9, lines 62-68, column 10, lines 1-24, Siekmann).
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 POD of modified Schnell by incorporating wherein the element elastically dimples the flexible diaphragm when the element is in the extended position and the flexible diaphragm contacts the element as in Siekmann “to provide an appropriate fluid seal thereat”, (See column 6, lines 31-32, Siekmann), and “control the flow of fluid …during sequencing of pressure”, (See column 6, lines 13-15, Siekmann).
Regarding Claims 13, 15 & 16, Schnell discloses a method of assembling a pressure output device (POD), the method comprising: bending a tab which is an element of a first portion of the POD into a bent configuration, (Portion 100/Section 104 of Partition 120 acts as hinge for Section 102 of Partition 120, See Figure 8, 9, 11, See paragraph [0076], [0077]), the portion of the flexible diaphragm being positioned below a pressure sensor outlet of the POD, (Top edge of Diaphragm 26a is located below bottom edge of Port 116, See Figure 8, 11, See paragraph [0077]); and connecting the first portion of the POD, the flexible diaphragm, and a second portion of the POD, (Diaphragm 26a coupled to Upper/Lower Compartments 22a/24a, See Figure 8, paragraph [0071], [0079]), a pressure sensor within the pressure sensor outlet being configured to transmit fluid pressure from within the POD, (Pressure Sensor 43 and Connector 41 inserted into end of Pressure Tube 42 leading to Port 40 of POD 12, See Figure 1, See paragraphs [0059] & [0060]).
Schnell does not disclose in which the element is configured to form a dimple in a portion of a flexible diaphragm when the flexible diaphragm is in contact with the element, thereby forming the dimple away from the pressure sensor outlet.
Siekmann discloses the element is configured to form a dimple in a portion of a flexible diaphragm when the flexible diaphragm is in contact with the element, (Valving Pins 47/48 elastically dimple the Diaphragm 27, See Figure 5a-d, See column 6, lines 24-34, and/or Arm 73 pivots, See column 9, lines 62-68, column 10, lines 1-24, Siekmann).
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 POD of Schnell by incorporating wherein the element is configured to form a dimple in a portion of a flexible diaphragm when the flexible diaphragm is in contact with the element as in Siekmann “to provide an appropriate fluid seal thereat”, (See column 6, lines 31-32, Siekmann), and “control the flow of fluid …during sequencing of pressure”, (See column 6, lines 13-15, Siekmann).
Wallace discloses thereby elastically dimpling the flexible diaphragm away from the pressure sensor port, (Flexible Film 50 deflects (dimples) in multiple directions (towards and away) from Wall 60 and other walls defining ports in valve, See Figure 8, See paragraph [0077], Wallace).
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 POD for sensing fluid pressure in a blood line set of modified Schnell by incorporating thereby elastically dimpling the flexible diaphragm away from the pressure sensor port as in Wallace “thus creating a barrier between the inlet…and outlet”, (See paragraph [0077], Wallace), and “controlling the predetermined pumping pressure in order to achieve a predetermined valve closure pressure…upon closure of the valve”, (See paragraph [0042], Wallace).
Additional Disclosures Included:
Claim 15: The method of claim 13, wherein bending the tab comprises bending the tab along a first portion of the tab that is thinner or has a smaller width than a second portion of the tab, (First Section 102 is thicker in vertical direction than Section 104/Portion 100, See Figure 8, 9, See paragraph [0076], [0077], Schnell).
Claim 16: The method of claim 13, wherein bending the tab comprises bending the tab by inserting a rod through a port of the POD and applying a force to the tab, (Luer Connector 106 inserted in Port 116 and contacts Partition 120 which is then bent, See Figure 11, See paragraphs [0077], [0079], Schnell).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schnell et al., (“Schnell”, US 2007/0179422), in view of Stuva et al., (“Stuva”, US 2015/0335809), in further view of Lichtenstein, (US 4,370,983).
Regarding Claim 10, Schnell discloses the POD of claim 1, but does not disclose wherein the base and the outer shell of the cap are semi-rigid.
Lichtenstein discloses wherein the base and the outer shell of the cap are semi-rigid, (See column 33, lines 43-56 and lines 57-68, column 34, lines 1-16, Lichtenstein).
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 POD of Schnell by incorporating wherein the base and the outer shell of the cap are semi-rigid as in Lichtenstein because “the grooved walls surrounding the ….flow paths…form a rigid, at least partially enclosing structure supporting the spatial organization of flow paths”, (See column 33, lines 43-46, Lichtenstein), in which “the use of tubing, rigid or semi-rigid structures” can “facilitate integration with the appropriate hardware sensors and controllers” and “be prepared for reuse”, (See column 33, lines 67-69, column 34, lines 1-5, Lichtenstein).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schnell et al., (“Schnell”, US 2007/0179422), in view of Stuva et al., (“Stuva”, US 2015/0335809), in further view of Borsanyi, (US 3,863,504).
Regarding Claim 11, Schnell discloses the POD of claim 1, but does not disclose wherein the base and the outer shell of the cap are translucent.
Borsanyi discloses wherein the base and the outer shell of the cap are translucent, (See column 2, lines 39-43, Borsanyi).
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 POD of Schnell by incorporating wherein the base and the outer shell of the cap are translucent as in Borsanyi because it is “advantageous to mold both the base and the cover from transparent plastic”, (See column 2, lines 41-43, Borsanyi), “to permit the position of the diaphragm to be observed from outside of the casing”, (See column 2, lines 39-41, Borsanyi).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schnell et al., (“Schnell”, US 2007/0179422), in view of Siekmann, (US 4,303,376), in view of in view of Stuva et al., (“Stuva”, US 2015/0335809), in further view of Robinson et al., (“Robinson”, US 2009/0173682).
Regarding Claim 14, modified Schnell discloses the method of claim 13, but does not disclose further comprising forming the first portion using a first shot of a two-shot molding process, and forming the flexible diaphragm using a second shot of the two-shot molding process.
Robinson discloses further comprising forming the first portion using a first shot of a two-shot molding process, and forming the flexible diaphragm using a second shot of the two-shot molding process, (See paragraph [0100], Robinson).
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 POD of Schnell by incorporating further comprising forming the first portion using a first shot of a two-shot molding process, and forming the flexible diaphragm using a second shot of the two-shot molding process as in Robinson because it “would remove the need to individually assemble these parts into the manifold therefore reducing labor costs and improve quality of the manifold assembly”, (See paragraph [0100], Robinson).
Conclusion
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
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