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 .
Specification
The disclosure is objected to because of the following informalities: please also insert the WIPO publication number and date into the Cross-Reference section.
Appropriate correction is required.
Claim Objections
Claim 24 is objected to because of the following informalities: the phrase “their joint or mutual connection” on line 3 should be rewritten to exclude language such as “their”. Appropriate correction is required.
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 18, 20, 21, 27, 30-36, 38 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 18 recites in the preamble, “A valve device for connecting to an outlet tap, the outlet tap comprising an actuator being arranged in or on an effluent outlet line or an attachment therefor, associated with an effluent outlet opening of an effluent bag for receiving effluents resulting from a blood treatment, wherein the actuator of the outlet tap has a first setting, in which the flow from the effluent outlet opening along the effluent outlet line is blocked, and a second setting, in which the flow is released form the effluent outlet opening along the effluent outlet line and out of the effluent bag”. It is not clear if all of these recited features are part of the claimed invention or not, since the invention is directed towards “a valve device”, yet all of the structure in the preamble here is directed to “an outlet tap” which does not appear to be part of the valve device at all. It is also not clear how these recited limitations are expressed in the body of the claim, where it would demonstrate how the valve device and outlet tap interact in a structural manner such that they are part of the claimed invention.
Claim 18 recites the limitation “the flow” on line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation “flow” on line 16. It is not clear if this limitation is the same as “flow” on line 14 or not.
Claim 20 recites the limitation “and/or vice versa” on lines 4-5. It is not clear what action is meant to occur when the phrase “vice versa” is invoked. It is not precise enough in the preceding claim language to know what would be intended by “vice versa”.
Claim 21 recites the limitation “a position” on line 3. It is not clear if this limitation is the same as “a/the first position” as already recited in Claim 18 or 20, or if this is an entirely new position. Examiner interprets it to be the same as the “first position”.
Claim 27 recites the limitation “an effluent bag” on line 3. It is not clear if this limitation is the same as “an effluent bag” as already recited in Claim 18 or not.
Claim 30 recites the limitation “flow” and “the first time” on lines 7 & 8, respectively. It is not clear if the limitation “flow” is the same as “the flow” on line 5 of Claim 18, or not. The limitation “the first time” also appears to lack antecedent basis.
Claim 31 recites the limitations “an effluent bag”, “an effluent outlet opening”, “an outlet tap”, “an actuator”, “an effluent outlet line”, “a first setting”, “the flow”, and “a second setting”. It is not clear if these limitations are the same limitations as already recited in Claim 18, or if they are all new and different limitations. Examiner interprets them to be the same.
Claim 32 recites the limitation “a second fluid line” on line 1. It is not clear if this limitation is the same as the limitation already recited in Claim 18, or not. Examiner interprets them to be the same.
Claim 33 recites the limitations “an effluent bag”, “effluents”, “a blood treatment”, “an effluent outlet opening”, and “an outlet tap”. It is not clear if these limitations are the same limitations as already recited in Claim 18, or if they are all new and different limitations. Examiner interprets them to be the same.
Claim 34 recites the limitations “an effluent bag”, “effluents”, “a blood treatment”, and “an outlet tap”. It is not clear if these limitations are the same limitations as already recited in Claim 18, or if they are all new and different limitations. Examiner interprets them to be the same.
Claim 34 recites the limitations “the effluent inlet line”, “the effluent inlet opening”. There is no insufficient antecedent basis for these limitations in the claim.
Claim 35 recites the limitation “an effluent bag”. It is not clear if this limitation is the same limitation as already recited in Claim 18, or if it is a new and different limitation. Examiner interprets them to be the same.
Claim 36 recites limitations “the effluent inlet line”, “the effluent inlet opening”. There is no insufficient antecedent basis for these limitations in the claim.
Claim 38 recites limitations “the effluent inlet line”, “the effluent inlet opening”. There is no insufficient antecedent basis for these limitations 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) 18-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beisser et al., (“Beisser”, US 2020/0230301; An earlier publication date using parent publication WO 2019/016145 of 01/24/2019 is relied upon), in view of Peret et al., (“Peret”, US 2013/0310990).
Claims 18 is directed to a valve device, an apparatus type invention group.
Regarding Claim 18, Beisser discloses a valve device for connecting to an outlet tap, (Tap 401, See Figure 4, paragraph [0120]), the outlet tap comprising an actuator being arranged in or on an effluent outlet line or an attachment therefor, (Tap 401 next to or on Effluent Outlet Line 403, See Figure 4, See paragraph [0122]), associated with an effluent outlet opening of an effluent bag for receiving effluents resulting from a blood treatment, (Effluent Bag 400 and Connection Line 407, See Figure 4, See paragraph [0119] & [0120]), wherein the actuator of the outlet tap has a first setting, in which the flow from the effluent outlet opening along the effluent outlet line is blocked, (See paragraph [0108]), and a second setting, in which the flow is released from the effluent outlet opening along the effluent outlet line and out of the effluent bag, (See paragraph [0116]), but does not disclose wherein the valve device comprises: a holding section for holding the valve device at or on the outlet tap; an insert section for inserting a second fluid line into the valve device; and a blocking element which can be switched between at least a first position and a second position; wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the second fluid line to block flow along the second fluid line, and when the blocking element is arranged in the second position, the blocking element allows flow along the second fluid line.
Peret discloses wherein the valve device comprises: a holding section for holding the valve device at or on the outlet tap, (Valve 340 held onto Actuator 341 via Frame 349, See Figure 50A or 50B, See paragraph [0573], Peret); an insert section for inserting a second fluid line into the valve device, (Tube 335 in Inner/Outer Supporting Members 342, See Figure 50A or 50B, See paragraph [0573]); and a blocking element which can be switched between at least a first position and a second position, (Barrel Nut 334/Screw 347 move towards/away Hooks 348/Frame 349, See paragraph [0573]); wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the second fluid line to block flow along the second fluid line, and when the blocking element is arranged in the second position, the blocking element allows flow along the second fluid line, (See paragraphs [0573], [0574], [0138], Peret; flow is blocked in another position versus the original position).
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 valve device of Beisser by incorporating wherein the valve device comprises: a holding section for holding the valve device at or on the outlet tap; an insert section for inserting a second fluid line into the valve device; and a blocking element which can be switched between at least a first position and a second position; wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the second fluid line to block flow along the second fluid line, and when the blocking element is arranged in the second position, the blocking element allows flow along the second fluid line as in Peret in order to “monitor, regulate and/or control the use of fluid associated with the patient”, (See paragraph [0129], Peret), to “provide feedback” and “instruct a valve to stop fluid flow when a…parameter related to fluid flow is…outside of a predetermined range”, (See paragraph [0131], Peret).
Additional Disclosures Included:
Claim 19: The valve device according to claim 18, wherein when the blocking element is arranged in the first position, the blocking element interrupts an electrically conductive liquid column in the second fluid line in an electrically insulating manner, (See paragraph [0026]-[0028], [0109], [0117], Beisser; the tap 401 is in different positions blocking flow from one line to another while the tap itself is electrically insulating).
Claim 20: The valve device according to claim 18, wherein the blocking element is arranged such that, as the actuator is being moved into the first setting, (See paragraph [0108], Beisser), the blocking element is forcibly being moved into the second position, and as the actuator is being moved to the second setting, (See paragraph [0116], Beisser), the blocking element is forcibly being moved to the first position, and/or vice versa, (See paragraphs [0108], [0116], Beisser).
Claim 21: The valve device according to claim 20, wherein the blocking element is arranged such that, when the actuator is moved into the second setting, (See paragraph [0116], Beisser), the blocking element maintains a position in which the flow along the second fluid line is or remains prevented, (See paragraph [0117], Beisser).
Claim 22: The valve device according to claim 21, wherein an electrically conductive liquid column in the second fluid line is interrupted in an electrically insulating manner before the actuator assumes the second setting, (See paragraph [0026]-[0028], [0109], [0117], Beisser; the tap 401 is in different positions blocking flow from one line to another while the tap itself is electrically insulating).
Claim 23: The valve device according to claim 18, wherein the holding section comprises a rotary bolt with a cover, (Threaded Rod/Screw 347 in Receiving Portion 351, See Figure 50A/B, 51A/B, See paragraph [0573], Peret), wherein the cover is movable between a first, open cover-setting for inserting or removing the outlet tap from the holding section or the rotary bolt and a second cover-setting for force-fitting and/or form-fitting of the outlet tap in the holding section, (Threaded Rod/Screw 347 snapped into Receiving Portion 351, See Figure 50A/B, 51A/B, See paragraph [0582], Peret).
Claim 24: The valve device according to claim 18, wherein the holding section has a rotary bolt for receiving the outlet tap or a section thereof and a cover, wherein the rotary bolt and/or cover are designed with a snap or click system for their joint or mutual connection and/or for at least partially closing the rotary bolt using the cover, (Threaded Rod/Screw 347 snapped into Receiving Portion 351, See Figure 50A/B, 51A/B, See paragraph [0582], Peret).
Claim 25: A valve device according to claim 18, wherein the second fluid line or a section thereof is arranged in the insert section, (Tube 335 in Inner/Outer Supporting Members 342, See Figure 50A or 50B, See paragraph [0573], Peret).
Claim 26: The valve device according to claim 18, wherein the outlet tap, or a section thereof, is arranged in the holding section, or wherein the holding section is connected to the outlet tap, (Frame 349 connected to Actuator 341, See Figures 50A/B, See paragraph [0573], Peret).
Claim 27: The valve device according to claim 26, wherein the second fluid line comprises a first free end for connecting it to an effluent inlet line and a second free end for connecting the second fluid line to an effluent inlet opening of an effluent bag or a fluid line connected thereto, (Line 102 connected to Line 305 via Dialyzer 303, See Figure 4, See paragraph [0088], Beisser).
Claim 28: The valve device according to claim 18, further comprising a switching element, arranged for manual switching of the blocking element from the first position to the second position, (Knob 363 on Shaft 362 and Barrel 361 which actuate Valve 352, See Figure 51A/B, See paragraph [0581], [0582], [0132], Peret).
Claim 29: The valve device according to claim 28, wherein the switching element is arranged such that in manual switching of the blocking element from the first position to the second position, the actuator or a connecting section for connecting the switching element to the actuator is moved from the second setting to the first setting, (Knob 363 on Shaft 362 and Barrel 361 which actuate Valve 352 via Actuator, See Figure 51A/B, See paragraph [0581], [0582], [0132], Peret; knob is both actuated and manually operated).
Claim 30: The valve device according to claim 18, wherein when the blocking element rotates through a first angle, the blocking element is arranged to be moved between the second position, in which the second fluid line is completely released from the blocking element, and the first position in which the second fluid line is completely closed by the blocking element, (Support Members 342/343 are not capable of bending more than touching from top to bottom, in which each of the top or bottom edge would not move more than halfway so no more than 90o, See Figure 50A/B, See paragraph [0573], [0574], Peret), wherein when the actuator rotates through a second angle, the actuator is arranged to be moved between the first setting, in which the effluent outlet line is completely closed by the actuator, into the second setting, in which flow is allowed for the first time in the effluent outlet line via the actuator, (Demonstration of interior of Tap 401 in Figures 2 & 3 show that it moves 90o, when applied to Figure 4, Beisser), wherein the first angle is smaller than the second angle, (Support Members 342/343 are not capable of bending more than touching from top to bottom, in which each of the top or bottom edge would not move more than halfway so no more than 90o, See Figure 50A/B, See paragraph [0573], [0574], Peret; which overlaps up to 90o with 90o for Beisser).
Regarding Claim 31, modified Beisser discloses an effluent bag for receiving effluent resulting from a blood treatment, (Effluent Bag 400, See Figure 4, See paragraph [0119], Beisser), the effluent bag comprising: an effluent inlet opening, (Entrance opening on Effluent Bag 400 leading to Connection Line 407 from Line 102, See Figure 4, See paragraph [0120], Beisser; also see paragraph [0106]); an effluent outlet opening, (Exit opening on Effluent Bag 400 leading to Line 403, See Figure 4, See paragraph [0122], Beisser; also see paragraph [0106]); an outlet tap connected to the effluent outlet opening, the outlet tap comprising an actuator and arranged in or at an effluent outlet line, (Tap 401 next to or on Effluent Outlet Line 403, See Figure 4, See paragraph [0122], Beisser), wherein the actuator of the outlet tap has a first setting, in which the flow from the effluent outlet opening along the effluent outlet line is blocked, (See paragraph [0108], Beisser), and a second setting in which the flow is released from the effluent outlet opening along the effluent outlet line and out of the effluent bag, (See paragraph [0116], Beisser); and a valve device according to claim 18, (See rejection of Claim 18 above).
Regarding Claims 32 & 33, modified Beisser discloses a set having a valve device according to claim 18 and a second fluid line for inserting into the insert section of the valve device, (Line 102 inserting into Tap 401, See Figure 4, See paragraph [0122], Beisser).
Additional Disclosures Included:
Claim 33: The set according to claim 32, further comprising an effluent bag for receiving effluents resulting from a blood treatment, the effluent bag comprising an effluent inlet opening, (Entrance opening on Effluent Bag 400 leading to Connection Line 407 from Line 102, See Figure 4, See paragraph [0120], Beisser; also see paragraph [0106]), and an effluent outlet opening, (Exit opening on Effluent Bag 400 leading to Line 403, See Figure 4, See paragraph [0122], Beisser; also see paragraph [0106]), as well as an outlet tap for closing the effluent outlet opening or comprises an attachment therefor, (Tap 401 next to or on Effluent Outlet Line 403, See Figure 4, See paragraph [0122], Beisser).
Regarding Claim 34, modified Beisser discloses a method for preparing an effluent bag for receiving effluents resulting from a blood treatment, (See Abstract, Beisser), the method comprising: providing the set according to claim 32; connecting the second fluid line to both the effluent inlet line and also to the effluent inlet opening using suitable connectors at free ends of the second fluid line, (Line 102 connected to Line 305 via Dialyzer 303, and connected to Tap 401 which connects to Line 407 and to Bag 400, See Figure 4, See paragraph [0088], Beisser); inserting the second fluid line in the insert section of the valve device; and connecting the valve device to the outlet tap using the holding section, (Valve 340 held onto Actuator 341 via Frame 349, Tube 335 in Inner/Outer Supporting Members 342, See Figure 50A or 50B, See paragraph [0573]).
Regarding Claims 35 & 36, modified Beisser discloses a method for emptying an effluent bag, the method comprising: providing the set according to claim 32; and actuating the switching element of the valve device in such a way that a fluid connection is established between the interior of the effluent bag and the interior of the effluent outlet line, (See paragraphs [0108], [0116], [0117], Beisser; and Barrel Nut 334/Screw 347 move towards/away Hooks 348/Frame 349, See paragraph [0573]).
Additional Disclosures Included:
Claim 36: The method of claim 35, wherein providing the set comprises: connecting the second fluid line to both the effluent inlet line and also to the effluent inlet opening using suitable connectors at free ends of the second fluid line, (Line 102 connected to Line 305 via Dialyzer 303, and connected to Tap 401 which connects to Line 407 and to Bag 400, See Figure 4, See paragraph [0088], Beisser); inserting the second fluid line in the insert section of the valve device; and connecting the valve device to the outlet tap using the holding section, (Valve 340 held onto Actuator 341 via Frame 349, Tube 335 in Inner/Outer Supporting Members 342, See Figure 50A or 50B, See paragraph [0573]).
Regarding Claims 37-40, modified Beisser discloses a blood treatment apparatus connected to the set according to claim 32, (Blood Treatment Apparatus 100, See Figure 4, See paragraph [0039], [0119], Beisser).
Additional Disclosures Included:
Claim 38: The blood treatment apparatus of claim 37, wherein the set is prepared by a method comprising: connecting the second fluid line to both the effluent inlet line and also to the effluent inlet opening, (Line 102 connected to Line 407 (and Bag 400) via Tap 401, See paragraph [0019], [0120], Beisser), using suitable connectors at free ends of the second fluid line, (Line 102 connected to Line 305 via Dialyzer 303, and connected to Tap 401 which connects to Line 407 and to Bag 400, See Figure 4, See paragraph [0088], Beisser); inserting the second fluid line in the insert section of the valve device, and connecting the valve device to the outlet tap using the holding section, (Valve 340 held onto Actuator 341 via Frame 349, Tube 335 in Inner/Outer Supporting Members 342, See Figure 50A or 50B, See paragraph [0573]).
Claim 39: The blood treatment apparatus according to claim 37, comprising a hemodialysis apparatus, hemofiltration apparatus or hemodiafiltration apparatus, (Blood Treatment Apparatus 100, See Figure 4, See paragraph [0039], [0119], Beisser).
Claim 40: The blood treatment apparatus according to claim 39, comprising an apparatus for acute and chronic renal replacement therapy or for continuous renal replacement therapy (CRRT), (Blood Treatment Apparatus 100, See Figure 4, See paragraph [0039], [0119], Beisser).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at 571-270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779
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