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 .
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a system for flushing a port valve in a medical device, classified in A61M 1/288.
II. Claims 18-29, drawn to a method to flush a valve, classified in A61M 1/281.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process for using the product as claimed can be practiced with another materially different product such as a product comprising mechanical means such as valves to operate the device instead of using a controller controlling the operation of the device.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) The inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(b) The inventions require a different field of search (for example, searchingdifferent classes/subclasses or electronic resources, or employing different search queries);
(c) The prior art applicable to one invention would not likely be applicable to another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Michael Norris on 3/17/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action. Claim 18-29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “12” has been used to designate two features with different structures in figure 1. The same reference character could be used if applicant intended to refer to same thing i.e. dialysate delivery set. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The reference characters “15” on page 44, line 8 and “14” on page 44, line 1 are both referring to “membrane”.
The reference character “172” has been used to refer to “manifold” on page 31, line 6, “control chamber” on page 74, line 5 and “control chamber wall” on page 74, line 11.
The reference character “185” has been used to refer to “liquid” on page 115, line 8 and “valve wells” on page 21, line 21.
Appropriate correction is required.
Claim Objections
Claims 1, 3, 9-11, 13, 15, 16 and 17 are objected to because of the following informalities:
Regarding claim 1, line 16, the term “throught” appears to be amended to recite “through” to correct the spelling error.
Regarding claim 1, line 19, the recitation “liquid” appears to be amended to recite “the liquid” in order to refer to “liquid” recited in claim 1, line 17.
Claim 3 recites the limitation “the first predetermined period of time” in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner acknowledges the recitation of “a first period of time” in claim 1, line 18 however, if applicant intended to refer previously recited time, then applicant is requested to amend claim 3 to recite “the first period of time” or amend claim 1 to recite “a first predetermined period of time”.
Claim 3 recites the limitation “the second predetermined period of time” in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner acknowledges the recitation of “a second period of time” in claim 1, last line however, if applicant intended to refer previously recited time, then applicant is requested to amend claim 3 to recite “the second period of time” or amend claim 1 to recite “a second predetermined period of time”.
Regarding claims 9 and 10, the term “valve” is repeated two times in reciting “valve valve”. It appears that one instance of “valve” needs to be deleted to correct grammatical error.
Regarding claim 11, line 3, the limitation “a first pump chamber” appears to be amended to recite “the first pump chamber” in order to refer to “a first pump chamber” recited in claim 11, lines 1-2.
Regarding claim 11, lines 3 and 5, the recitation “liquid” appears to be amended to recite “the liquid” in order to refer to “liquid” recited in claim 1, line 17.
Regarding claim 11, line 4, the recitation “an open position” appears to be amended to recite “the open position” in order to refer to “an open position” recited in claim 1, line 18.
Regarding claim 11, line 4, the recitation “negative pressure” appears to be amended to recite “the negative pressure” in order to refer to “negative pneumatic pressure” recited in claim 1, line 19.
Claim 13 recites the limitation “the pump actuator” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “the application of positive pressure” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “the application negative pressure” in line 3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the grammatical error appears to be present in the recited limitation. The grammatical error could be corrected by adding “of” between “application” and “negative”.
Claim 16 recites the limitation “the steps” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the application negative pressure” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the grammatical error appears to be present in the recited limitation. The grammatical error could be corrected by adding “of” between “application” and “negative”.
Regarding claim 16, line 1, the recitation “the valve flush” appears to be amended to recite “the valve flush procedure” in order to refer to same limitation consistently in all the claims.
Regarding claim 17, the recitation “the steps of steps” in line 1 appears to be amended to recite “steps of the steps” to refer to steps recited in claim 16.
Regarding claim 17, line 3, grammatical error appears to be present in recitation “application negative pressure”. The grammatical error could be resolved by reciting “application of negative pressure”.
Appropriate correction is required.
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.
Claims 1, 3-5 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Scarpaci et al. (US 2013/0165847 A1) in view of Wilt et al. (US 2017/0326282 A1).
Regarding claim 1, Scarpaci discloses a system 10 (figure 1) for flushing a port valve in a medical device comprising:
a liquid pumping cassette 24 comprising:
at least one pump chamber 181;
a port valve 184 fluidly connected to a patient port 154 on a port side (side of element 184 towards element 154) of the valve and fluidly connected to the at least one pump chamber 181 on the cassette side (side of element 184 towards element 181) of the port valve; and
a patient line (one of lines 26, 28, 34 connected to element 154) fluidly connected to the patient port; and
a reusable medical device 14 comprising:
an occluder 147 (figure 38) configured to occlude at least the patient line;
a portion 142 to receive the liquid pumping cassette;
an actuation chamber (paragraph 0772, “actuation chamber”) to apply pneumatic pressure to the at least one pumping chamber, wherein the pneumatic pressure may be selectively varied (paragraph 0367, lines 1-5, paragraph 0063, lines 1-14);
a valve actuator 312 (fig. 45A, paragraph 0364, lines 14-18) to close and open the port valve; and
a controller 16 to control the pneumatic pressure and the valve actuator but is silent regarding wherein the controller is configured to occlude the patient line before flushing the valve, the controller is configured to flush the valve through an application of positive pneumatic pressure to the at least one pump chamber to push liquid toward the port valve in an open position for a first period of time, followed by an application of negative pneumatic pressure to the least one pump chamber to pull liquid from the port valve for a second period of time.
However, Wilt teaches a design of a dialysis system comprising a controller (paragraph 1055, “controller”) wherein the controller is configured to occlude the patient line (paragraph 1055, lines 4-11) before flushing the valve, the controller is configured to flush the valve through an application of positive pneumatic pressure to the at least one pump chamber to push liquid toward the port valve in an open position for a first period of time, followed by an application of negative pneumatic pressure to the least one pump chamber to pull liquid from the port valve for a second period of time (paragraph 1055, lines 11-42, paragraph 1053, lines 22-24) for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4). While Wilt teaches that the approach could be applied to any portion of the desired fluid path by properly opening and closing valve, one of ordinary skill in the art when modifying the system of Scarpaci and desiring to clear the fluid path until the occluder would leave element 147 of Scarpaci open.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of Scarpaci to incorporate wherein the controller is configured to occlude the patient line before flushing the valve, the controller is configured to flush the valve through an application of positive pneumatic pressure to the at least one pump chamber to push liquid toward the port valve in an open position for a first period of time, followed by an application of negative pneumatic pressure to the least one pump chamber to pull liquid from the port valve for a second period of time as taught by Wilt for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Regarding claim 3, Scarpaci is silent regarding where the first predetermined period of time is equal to the second predetermined period of time.
However, Wilt teaches where the first predetermined period of time is equal to the second predetermined period of time (paragraph 1055, “one second”) for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in th art before the effective filing of the claimed invention to modify the controller of Scarpaci to incorporate wherein the first predetermined period of time is equal to the second predetermined period of time as taught by Wilt for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Regarding claims 4 and 5, Scarpaci is silent regarding where the first predetermined period of time is 0.2 seconds or is less than 1 second.
While, Wilt teaches the first predetermined period of time is 1 second (paragraph 1055, “one second”), Wilt does not expressly disclose where the first predetermined period of time is 0.2 seconds or is less than 1 second as required by the claim. Wilt discloses (paragraph 1053) that the first predetermined period of time needs to be optimized to allow the “swishing” procedure thereby “improve the dislodgment of debris”. It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Wilt time period to have the first predetermined period of time being 0.2 seconds or less than 1 second as it only involves programming the controller. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Wilt time period to have the first predetermined period of time within the claimed range, as it involves only adjusting the time period. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Wilt time period by making the first predetermined period of time as 0.2 seconds or less than 1 second as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 9 and 10, Scarpaci is silent regarding wherein the controller flushes the valve two or more times or 5 times.
While, Wilt teaches the controller flushing the path (which will be valve when Scarpaci is modified in view of Wilt) several times (paragraph 1055, lines 41-42), Wilt does not explicitly recite flushing two or more times or 5 times. Wilt discloses that the number of flushes needs to be optimized to ensure “a through washing of path”. It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the number of flushes of Wilt to have the flushes two or more times or 5 times as it only involves programming the controller. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the number of flushes of Wilt to have the flushes two or more times or 5 times. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing of the claimed invention to modify the number of flushes to two or more times or 5 times as a matter of routine optimization since it has been held “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 11, Scarpaci discloses wherein at least one pump chamber comprises a first pump chamber (one of the two elements 181 in figure 4) and a second pump chamber (second of two elements 181 in figure 4) but is silent regarding wherein the controller is configured to supply the positive pressure to a first pump chamber that pushes liquid toward the port valve in an open position and configured to supply negative pressure to the second pump chamber that pulls liquid from the port valve.
However, Wilt teaches wherein the controller (paragraph 1055) is configured to supply the positive pressure to a first pump chamber that pushes liquid toward the path in an open position and configured to supply negative pressure to the second pump chamber that pulls liquid from the path for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
While Wilt teaches the cleaning of a path 400 as an example, Wilt teaches that same cleaning approach could be used to clean any path. Therefore, if one of ordinary skill in the art would be interested in cleaning the fluid path including the port valve of Wilt will modify the controller of Scarpaci to incorporate wherein the controller is configured to supply the positive pressure to a first pump chamber that pushes liquid toward the port valve in an open position and configured to supply negative pressure to the second pump chamber that pulls liquid from the port valve.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of Scapraci to incorporate wherein the controller is configured to supply the positive pressure to a first pump chamber that pushes liquid toward the port valve in an open position and configured to supply negative pressure to the second pump chamber that pulls liquid from the port valve as taught by Wilt for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Regarding claim 12, Scarpaci discloses wherein the valve actuator 312 (paragraph 0368, lines 5-11, “pneumatic control valves” would indicate actuator is pneumatic actuator) is a pneumatic actuator.
Regarding claim 13, Scarpaci discloses wherein the valve actuator 312 is driven by the same pressure driving the pump actuator (paragraph 0512, lines 6-19).
Claims 6, 7 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Scarpaci et al. (US 2013/0165847 A1) in view of Wilt et al. (US 2017/0326282 A1) and further in view of Egley et al. (US 2014/0261717 A1).
Regarding claim 6, Scarpaci/Wilt (hereinafter referred as “modified Scarpaci”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Wilt further discloses wherein the controller ends the flushing cycle after the application of negative pressure to the at least one pump chamber to pull liquid form the port valve (paragraph 1055). However, modified Scarpaci is silent regarding wherein the controller tests the port valve for leakage after the application of negative pressure to the at least one pump chamber to pull liquid from the port valve.
However, Egley teaches a design of a port valve 20 (figure 1) wherein the controller 94 tests the port valve for leakage after the application of valve flush procedure (paragraph 0024, lines 9-11) for the purpose of self-resolving the leakage caused in the valve due to foreign particle contamination and then resume the normal device operation (paragraph 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of modified Scarpaci to incorporate wherein the controller tests the port valve after the application of valve flush procedure as taught by Egley for the purpose of self-resolving the leakage caused in the valve due to foreign particle contamination and then resume the normal device operation (paragraph 0024).
Modified Scarpaci in view of Egley will result in wherein the controller tests the port valve for leakage after the application of negative pressure to the at least one pump chamber to pull liquid from the port valve.
Regarding claim 7, modified Scarpaci discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Scarpaci is silent regarding wherein the controller tests the port valve for leakage after flushing the valve.
However, Egely teaches a design of a port valve 20 (figure 1) wherein the controller 94 tests the port valve for leakage after flushing the valve (paragraph 0024, lines 9-11) for the purpose of self-resolving the leakage caused in the valve due to foreign particle contamination and then resume the normal device operation (paragraph 0024).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the controller of modified Scarpaci to incorporate wherein the controller tests the port valve for leakage after flushing the valve as taught by Egely for the purpose of self-resolving the leakage caused in the valve due to foreign particle contamination and then resume the normal device operation (paragraph 0024).
Regarding claim 14, Scarpaci discloses a system 10 (figure 1) for flushing a port valve in a medical device comprising:
a liquid pumping cassette 24 comprising:
at least one pump chamber 181;
a port valve 184 fluidly connected to a patient port 154 on a port side (side of element 184 towards element 154) of the valve and fluidly connected to the at least one pump chamber 181 on the cassette side (side of element 184 towards element 181) of the port valve; and
a patient line (one of lines 26, 28, 34 connected to element 154) fluidly connected to the patient port; and
a reusable medical device 14 comprising:
an occluder 147 (figure 38) configured to occlude at least the patient line;
a portion 142 to receive the liquid pumping cassette;
an actuation chamber (paragraph 0772, “actuation chamber”) to apply pressure to actuate each of the at least one pumping chamber;
an actuator 312 (fig. 45A, paragraph 0364, lines 14-18) to close and open the port valve;
a user interface 302 (figure 45) configured to display visual information (paragraph 0595, lines 4-13);
a controller 16 to control the pressure and the valve actuator but is silent regarding the controller is configured to execute a valve flush procedure on the port valve when the controller determines that the port valve leaks.
However, Egley teaches a design of a dialysis control valve 20 (figure 1A) with self-cleaning mode wherein the controller 94 (figure 2) is configured to execute a valve flush procedure (paragraph 0041, lines 34-48) on the port valve when the controller determines that the port valve leaks for the purpose of fixing the leakage caused by foreign particle contamination (paragraph 0024, lines 1-5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of Scarpaci to incorporate wherein the controller is configured to execute a valve flush procedure on the port valve when the controller determines that the port valve leaks as taught by Egley for the purpose of fixing the leakage caused by foreign particle contamination (paragraph 0024, lines 1-5).
Scarpaci further discloses wherein the controller issue an alert to the user interface when the controller determines an issue with system, therapy conditions or system operating conditions (paragraph 0613) but is silent regarding wherein the controller issue an alert to the user interface when the controller determines that the port valve leaks after the completion of the valve flush procedure.
However, Wilt teaches wherein the controller issue an alert to the user interface when the controller determines that the port leaks (paragraph 1232, lines 6-10) for the purpose of alerting the user regarding the leakage situation (paragraph 1232, lines 6-10).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the controller to incorporate wherein the controller issue an alert to the user interface when the controller determines that the port leaks (paragraph 1232, lines 6-10) for the purpose of alerting the user regarding the leakage situation (paragraph 1232, lines 6-10).
Furthermore, Egley teaches avoiding the alarm when the leakage can be fixed using flush procedure (paragraph 0049). Therefore, one of ordinary skill in the art when combining Scarpaci, Egley and Wilt will design a modified controller wherein the controller issues an alert to the user interface when the controller determines that the port valve leaks after the completion of the valve flush procedure.
Regarding claim 15, Scarpaci is silent regarding wherein the valve flush procedure includes an occlusion of the patient line before the application of positive pressure to the at least one pump chamber to push liquid to an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port valve.
However, Wilt teaches wherein the valve flush procedure includes an occlusion of the patient line (paragraph 1055) before the application of positive pressure to the at least one pump chamber to push liquid to an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port valve for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the flush procedure of Scarpaci (and Egley) to incorporate wherein the valve flush procedure includes an occlusion of the patient line before the application of positive pressure to the at least one pump chamber to push liquid to an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port valve as taught by Wilt for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Examiner acknowledges that examiner relies on Egley for teaching the flush procedure but using the steps outlined by Wilt because Egley teaches the flush procedure use to dislodge the foreign particle (paragraph 0024, lines 6-9) and Wilt also outlines flush procedure using different steps to perform the same output i.e. dislodge the foreign particle. Therefore, the combination of Scarpaci/Egley/Wilt teaches the claimed invention.
Regarding claim 16, Scarpaci is silent regarding wherein the valve flush includes putting the patient line in an occluded state before repeating the steps of application of positive pressure to the at least one pump chamber to push liquid toward an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port.
However, Wilt teaches wherein the valve flush (paragraph 1055) includes putting the patient line in an occluded state before repeating the steps of application of positive pressure to the at least one pump chamber to push liquid toward an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the valve flush of Scarpaci (and Egley) to incorporate wherein the valve flush includes putting the patient line in an occluded state before repeating the steps of application of positive pressure to the at least one pump chamber to push liquid toward an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port as taught by Wilt for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Regarding claim 17, Scarpaci is silent regarding wherein the steps of steps of application of positive pressure to the at least one pump chamber to push liquid toward an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port are repeated two or more times.
However, Wilt teaches wherein the steps of steps of application of positive pressure to the at least one pump chamber to push liquid toward an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port are repeated two or more times (paragraph 1055, lines 41-42, “several times” indicate two or more times) for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the valve flush procedure of Scarpaci (and Egley) to incorporate wherein the steps of steps of application of positive pressure to the at least one pump chamber to push liquid toward an open port valve, then the application negative pressure to the at least one pump chamber to pull liquid from the port are repeated two or more times as taught by Wilt for the purpose of improving dislodgement of debris from the fluid path (paragraph 1053, lines 1-4).
Allowable Subject Matter
Claims 2 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record, Scarpaci et al. (US 2013/0165847 A1) in view of Wilt et al. (US 2017/0326282 A1) is silent regarding wherein the controller directs the actuator to close the port valve before actuating the at least one pump chamber to pull liquid form the port valve in combination with other claimed limitations of claim 2.
The closest prior art of record, Scarpaci et al. (US 2013/0165847 A1) in view of Wilt et al. (US 2017/0326282 A1) is silent regarding wherein the controller retracts the occluder before testing the port valve for leakage after flushing the valve in combination with other claimed limitations of claim 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
Prosecution Insights