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 July 7, 2026 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 using newly found secondary reference Burbank et al., (“Burbank”, US 2008/0230450).
On page 8, Applicant discusses the previous objections, 112 rejections and amendments to the claims. The Examiner has withdrawn the objections and most 112 rejections, and has made new 112 rejections in response to the amendments made.
On pages 8-11, Applicant argues against the previous 103 prior art rejection involving primary reference Beisser et al., (“Beisser”, US 2020/0230301; An earlier publication date using parent publication WO 2019/016145 of 01/24/2019 is relied upon), and secondary reference Peret et al., (“Peret”, US 2013/0310990). Here, Applicant argues that these references do not disclose the added limitations “the effluent outlet opening of the effluent bag being separate from and in addition to an effluent inlet opening, the tubing section connected to the effluent inlet opening”. The Examiner notes that newly found secondary reference Burbank et al., (“Burbank”, US 2008/0230450), discloses these features in combination with the other references as demonstrated in the prior art rejection section below. Applicant also argues that Beisser and Peret do not disclose the limitations associated the actuator and blocking element. The Examiner takes the position that the actuator as disclosed in Beisser carries out the same functions as claimed in which the flow is changed between different lines using different positions of the three-way valve mechanism located within the actuator. The Examiner also notes that secondary reference Peret adds the blocking element to said actuator to carry out the same function when the actuator’s three-way valve mechanism is in the different positions and changing the flow between the connected lines. For these reasons, the Examiner finds Applicant’s arguments here 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.
Claims 18, 34, 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 “flow” on line 20. It is not clear if this limitation is the same as “flow” on line 24 or not.
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 38 recites the limitation “an effluent inlet opening”. It is not clear if this limitation is the same limitation as “an effluent inlet opening” as in Claim 1, or not. Examiner interprets it to be the same.
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.
Claim(s) 18 & 23-26, 28-33 & 37-40 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), in further view of Burbank et al., (“Burbank”, US 2008/0230450).
Claims 18, 23-26 & 28-30 are directed to a valve device, an apparatus type invention group.
Regarding Claims 18, 23-26 & 28-30, 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]), wherein the actuator includes an arrangement that is arranged such that, as the actuator is being moved into the first setting, (See paragraph [0108], Beisser), the arrangement is forcibly being moved into the second position, and as the actuator is being moved to the second setting, (See paragraph [0116], Beisser), the arrangement is forcibly being moved to the first position, (See paragraphs [0108], [0116], Beisser), wherein, when the arrangement is in the first position, (See paragraph [0117], Beisser), and the actuator is moved into the second setting, (See paragraph [0116], Beisser), the arrangement stays in the first position, (See paragraph [0117], Beisser), the actuator operates to interrupt an electrically conductive liquid column in the tubing section 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), but does not disclose wherein the effluent outlet opening of the effluent bag being separate from and in addition to an effluent inlet opening, the tubing section connected to the effluent inlet opening and the valve device comprises: a holding section for holding the valve device at or on the outlet tap; an insert section for inserting a tubing section into the valve device; and the arrangement includes a blocking element which can be switched between at least the first position and the second position; when the actuator is moved into the first setting, the blocking element is forcibly being moved into the first position, wherein, when the blocking element is in the first position, the blocking element can stay in the first position, wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the tubing section to block flow along the tubing section, and when the blocking element is arranged in the second position, the blocking element allows flow along the tubing section.
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 tubing section into the valve device, (Tube 335 in Inner/Outer Supporting Members 342, See Figure 50A or 50B, See paragraph [0573]); and the arrangement includes a blocking element which can be switched between at least the first position and the second position, (Barrel Nut 334/Screw 347 move towards/away Hooks 348/Frame 349, See paragraph [0573]); blocking element which can be switched between at least a first position and a second position; when the actuator is moved into the first setting, the blocking element is forcibly being moved into the first position, wherein, when the blocking element is in the first position, the blocking element can stay in the first position, wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the tubing section to block flow along the tubing section, and when the blocking element is arranged in the second position, the blocking element allows flow along the tubing section, (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 tubing section into the valve device; and the arrangement includes a blocking element which can be switched between at least a first position and a second position; when the actuator is moved into the first setting, the blocking element is forcibly being moved into the first position, wherein, when the blocking element is in the first position, the blocking element can stay in the first position, wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the tubing section to block flow along the tubing section, and when the blocking element is arranged in the second position, the blocking element allows flow along the tubing section 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).
Modified Beisser does not disclose the effluent outlet opening of the effluent bag being separate from and in addition to an effluent inlet opening, the tubing section connected to the effluent inlet opening.
Burbank discloses the effluent outlet opening of the effluent bag being separate from an in addition to an effluent inlet opening, (Batch Bag 1444 connected to Path Selector (valve device) 1499 with Line 1460 and Line 1462 carrying fluid into/out of Bag 1444, See Figure 22, See paragraph [0156], [0160], Burbank), the tubing section connected to the effluent inlet opening, (Path Selector 1499 connected using multiple valves 1412/1414/1416/1418 in which Lines 1460 and 1462 are connected together to Path Selector 1499, [0156], [0160], Burbank).
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 modified Beisser by incorporating the effluent outlet opening of the effluent bag being separate from an in addition to an effluent inlet opening and the tubing section connected to the effluent inlet opening as in Burbank in order to use multiple connectors such that the “inlet line…may be disconnected” and “this prevents any incursion of contaminants back into the fluid circuit or batch bag”, (See paragraph [0160], Burbank).
Additional Disclosures Included:
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 the cover are designed with a snap or click system for joint or mutual connection of the rotary bolt and the cover 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 tubing section 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 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 tubing section is completely released from the blocking element, and the first position in which the tubing section 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 the flow in the effluent outlet line is allowed for a first time 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); wherein the actuator includes an arrangement that is arranged such that, as the actuator is being moved into the first setting, (See paragraph [0108], Beisser), the arrangement is forcibly being moved into the second position, and as the actuator is being moved to the second setting, (See paragraph [0116], Beisser), the arrangement is forcibly being moved to the first position, (See paragraphs [0108], [0116], Beisser), wherein, when the arrangement is in the first position, (See paragraph [0117], Beisser), and the actuator is moved into the second setting, (See paragraph [0116], Beisser), the arrangement stays in the first position, (See paragraph [0117], Beisser), the actuator operates to interrupt an electrically conductive liquid column in the tubing section 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), 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 tubing section into the valve device; and the arrangement includes a blocking element which can be switched between at least the first position and the second position; when the actuator is moved into the first setting, the blocking element is forcibly being moved into the first position, wherein, when the blocking element is in the first position, the blocking element can stay in the first position, wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the tubing section to block flow along the tubing section, and when the blocking element is arranged in the second position, the blocking element allows flow along the tubing section.
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 tubing section into the valve device, (Tube 335 in Inner/Outer Supporting Members 342, See Figure 50A or 50B, See paragraph [0573]); and the arrangement includes a blocking element which can be switched between at least the first position and the second position, (Barrel Nut 334/Screw 347 move towards/away Hooks 348/Frame 349, See paragraph [0573]); blocking element which can be switched between at least a first position and a second position; when the actuator is moved into the first setting, the blocking element is forcibly being moved into the first position, wherein, when the blocking element is in the first position, the blocking element can stay in the first position, wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the tubing section to block flow along the tubing section, and when the blocking element is arranged in the second position, the blocking element allows flow along the tubing section, (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 tubing section into the valve device; and the arrangement includes a blocking element which can be switched between at least a first position and a second position; when the actuator is moved into the first setting, the blocking element is forcibly being moved into the first position, wherein, when the blocking element is in the first position, the blocking element can stay in the first position, wherein, when the blocking element is arranged in the first position, the blocking element acts directly or indirectly on the tubing section to block flow along the tubing section, and when the blocking element is arranged in the second position, the blocking element allows flow along the tubing section 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).
Regarding Claims 32 & 33, modified Beisser discloses a set having the valve device according to claim 18 and the tubing section 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 the effluent bag for receiving effluents resulting from a blood treatment, the effluent bag comprising the 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 the 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 the 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 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 tubing section to both an effluent inlet line and also to an 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
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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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
