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 .
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 1 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 1 recites in the preamble “A pressure output device (POD) for sensing fluid pressure in a blood line set”, but the body of the claim does not demonstrate how this device generates “pressure output”, or how the “fluid pressure” that is sensed is within or associated with “a blood line set”, since no “pressure output” is shown in the body of the claim, and no “blood line set” is defined in relation to the rest of the claimed invention in the body of the claim. For these reasons, the Examiner considers these limitations in the preamble indefinite.
Claim 13 recites in the preamble “A method of assembling a pressure output device (POD)”, but the body of the claim does not demonstrate how this device generates “pressure output”, since no “pressure output” is shown in the body of the claim. For these reasons, the Examiner considers this limitation in the preamble indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-9, 12, 13, & 15-21 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Schnell et al., (“Schnell”, US 2007/0179422).
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]); 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, (Sealed Port 116, See Figure 8, See paragraph [0073], [0076]; See paragraph [0013]); and a tab extending inwardly from an inner surface of the outer shell, (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).
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]).
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]).
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]).
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]).
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]).
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]).
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] 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 (Lower Compartment 22a and Flow Ports 30a/32a, See Figure 9, See paragraph [0071], [0073]); 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]); and a tab extending inwardly from an inner surface of the outer shell, (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]).
Additional Disclosures Included:
Claim 18: The blood treatment system of claim 17, wherein the blood treatment machine is a dialysis machine, (See paragraph [0012]).
Claim 19: The blood treatment system of claim 18, wherein: the blood treatment machine is a hemodialysis machine, (See paragraph [0012], [0021]); 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]).
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 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schnell et al., (“Schnell”, US 2007/0179422), in 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 Siekmann, (US 4,303,376).
Regarding Claim 9, 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 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]).
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.
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).
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 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 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 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