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 Objections
Claim 15 is objected to because of the following informalities: Line 20 on page 60 recites “and” that is followed by another “and”. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Puppini et al. (US 2009/0151470A1).
Regarding claim 1, Puppini teaches a method for testing an integrity of a semipermeable membrane of a filter (fig. 1 discloses two filters 4 and 13) of an extracorporeal blood treatment apparatus (1), the extracorporeal treatment apparatus comprising:
a supply line including an inlet end connected to a source of treatment liquid (refer dialysate source 2) and an outlet end connected to an inlet port of a blood treatment device (refer device 8), wherein the filter is inserted in the supply line and the semipermeable membrane divides the filter into a first chamber (6 or 15) and a second chamber (7 or 16), the filter including a first port connecting a first tract of the supply line to the first chamber, and a second port connecting the second chamber to a second tract of the supply line (refer fig. 1);
a waste line (refer line connecting to drain 18) including an inlet end connected to an outlet port of the blood treatment device (8) and an outlet end connected to a discharge of used treatment liquid (refer drain 18);
an air inlet line (25) connected to the first chamber of the filter or to the first tract of the supply line (refer fig. 1);
at least one waste pump (17) located on the waste line; and
at least one pressure sensor configured to detect a pressure in one of: the second chamber of the filter, the second tract of the supply line, or the waste line (refer pressure sensor P2),
wherein the method comprises:
filling the first chamber of the filter with air through the air inlet line (refer [0058] and [0046] disclosing pumping air into the first chamber and draining fluid from the first chamber), verifying when, while the waste pump is running (refer [0058] disclosing pump 17 running), the pressure sensed by the at least one pressure sensor reaches a set negative pressure threshold (Pt), and determining that the filter semipermeable membrane has a multi-fiber break when the sensed pressure does not reach the set negative pressure threshold (Pt) within a set time interval (T) (refer [0062]), the pressure being considered relative to atmospheric pressure present in a location where the extracorporeal blood treatment apparatus operates (this is inherent and evident since the pressure in the second chamber is influenced by the liquid in the second chamber).
Puppini does not disclose that the filters 4 and 13 are ultrafilters, however, Puppini disclosed in [0011] and [0012] that use of ultrafilters in similar systems is known in the art and therefore would have been obvious to one of ordinary skill in the art to apply the method of Puppini to system comprising ultrafilters.
Regarding claim 2, Puppini teaches limitations of claim 1 as set forth above. Puppini teaches after filling the first chamber with air, the waste pump is operated to make pressure in the second chamber more negative or to create a negative pressure in the second chamber (refer [0060]-[0062]).
Regarding claim 3, Puppini teaches limitations of claim 1 as set forth above. Puppini teaches after filling the first chamber with air, the waste pump is operated to make pressure in the second chamber more negative or to create a negative pressure in the second chamber (refer [0060]-[0062] disclosing monitoring pressure P2 over a time period and comparing with a threshold).
Regarding claim 4, Puppini teaches limitations of claim 1 as set forth above. Puppini teaches wherein verifying the measured pressure does not reach the set negative pressure threshold (Pt) comprises detecting pressure by the pressure sensor and measuring an actual time interval at which the negative pressure threshold (Pt) is reached.
Regarding claim 5, Puppini teaches limitations of claim 1 as set forth above. Puppini teaches wherein filling the first chamber with air comprises operating an air pump (19) located on the air inlet line (25).
Regarding claim 6, Puppini teaches limitations of claim 1 as set forth above. Puppini teaches wherein the semipermeable membrane separates the ultrafilter into a first and a second chamber (Refer membrane 5 separating chambers 6 and 7; or membrane 14 separating chambers 15 and 16),
the method comprising: emptying the first chamber of the ultrafilter from liquid and filling the first chamber with air (refer [0046], [0058]);
after the first chamber has been filled with air, extracting or continuing to extract liquid from the second chamber of the ultrafilter (refer [0058] disclosing keeping open communication between the second chambers of the filter with pump 17 and keeping second chambers in depression by pump 17 which continues to work);
verifying, while extracting liquid from the second chamber of the ultrafilter, when the pressure in the second chamber of the ultrafilter reaches a set negative pressure threshold (Pt) (refer [0059] disclosing monitoring pressure over time);
determining that the semipermeable membrane has a multi- fiber break when the pressure in the second chamber during the step of extracting liquid does not reach the set negative pressure threshold (Pt) within a set time interval (T) (Refer [0062]), wherein the pressure in the second chamber is considered relative to atmospheric pressure present in a location where the ultrafilter operates (this is inherent and evident since the pressure in the second chamber is influenced by the liquid in the second chamber).
Regarding claim 7, Puppini teaches a method for testing an integrity of a semipermeable membrane of a filter (Puppini discloses filters 4 and 13 having semipermeable membranes 5 and14 respectively), wherein the semipermeable membrane separates the filter into a first and a second chamber, the method comprising:
emptying the first chamber of the filter from liquid and filling the first chamber with air (refer [0058] and [0046] disclosing draining fluid from first chamber by pumping air into the first chamber and draining fluid from the first chamber);
after the first chamber has been filled with air, extracting or continuing to extract liquid from the second chamber of the filter (refer [0058] disclosing keeping open communication between the second chambers of the filter with pump 17 and keeping second chambers in depression by pump 17 which continues to work);
verifying, while extracting liquid from the second chamber of the filter, when the pressure in the second chamber of the filter reaches a set negative pressure threshold (Pt) (refer [0059] disclosing monitoring pressure over time);
determining that the semipermeable membrane has a multi- fiber break when the pressure in the second chamber during the step of extracting liquid does not reach the set negative pressure threshold (Pt) within a set time interval (T) (refer [0062]), wherein the pressure in the second chamber is considered relative to atmospheric pressure present in a location where the filter operates (this is inherent and evident since the pressure in the second chamber is influenced by the liquid in the second chamber).
Puppini does not disclose that the filters 4 and 13 are ultrafilters, however, Puppini disclosed in [0011] and [0012] that use of ultrafilters in similar systems is known in the art and therefore would have been obvious to one of ordinary skill in the art to apply the method of Puppini to system comprising ultrafilters.
Regarding claims 8 and 9, Puppini teaches limitations of claim 7 as set forth above. Puppini teaches monitoring pressure P2 in the second chambers of the filters.
Regarding claim 10, Puppini teaches limitations of claim 7 as set forth above. Puppini teaches wherein an air inlet line is connected to the first chamber of the ultrafilter, and wherein the steps of emptying the first chamber of the ultrafilter from liquid and filling the first chamber with air comprise opening an air valve or operating an air pump located on the air inlet line (refer air inlet line 25 connected to an air pump 19, also refer [0046] and [0058]).
Regarding claim 11, Puppini teaches limitations of claim 7 as set forth above. Puppini teaches wherein extracting or continuing to extract liquid from the second chamber of the ultrafilter after filling the first chamber with air makes pressure in the second chamber more negative or creates a negative pressure in the second chamber (this is evident in fig. 3 of Puppini because drain pump 17 is active which creates a suction pressure on 2nd chambers of the filters).
Regarding claim 12, Puppini teaches limitations of claim 7 as set forth above. Puppini teaches the ultrafilter is inserted in a supply line including an inlet end connected to a source of treatment liquid (refer filter 4 connected to dialysate source 2) and an outlet end connected to an inlet port of a blood treatment device (blood treatment device 8 is connected to filter 4), the ultrafilter having a first port connecting a first tract of the supply line to the first chamber of the same ultrafilter, and a second port connecting the second chamber of the ultrafilter to a second tract of the supply line (refer fig. 1 disclosing 2nd chamber in fluid communication with the dialysate source);
a waste line (refer line connected to drain 18) including an inlet end is connected to an outlet port of the blood treatment device (8) and an outlet end is connected to a discharge of used treatment liquid;
a waste pump (17) is positioned on the waste line; and
an air inlet line (25) is connected to the first chamber of the ultrafilter, wherein said step of extracting liquid from the second chamber is achieved by operating the waste pump, and wherein said step of verifying takes place while the waste pump is running (Refer [0058] – [0062]).
Regarding claim 13, Puppini teaches a method for testing an integrity of a semipermeable membrane of a filter of an extracorporeal blood treatment apparatus (1), the extracorporeal treatment apparatus comprising:
a supply line including an inlet end connected to a source of treatment liquid (dialysate source 2) and an outlet end connected to an inlet port of a blood treatment device (device 8), wherein the filter (4 or 13) is inserted in the supply line and the semipermeable membrane divides the filter into a first chamber and a second chamber (refer membrane 5 dividing chambers 6 and 7; or membrane 14 dividing chambers 15 and 16), the filter including a first port connecting a first tract of the supply line to the first chamber, and a second port connecting the second chamber to a second tract of the supply line (refer fig. 1);
a waste line (connected to drain 18) including an inlet end connected to an outlet port of the blood treatment device (8) and an outlet end connected to a discharge of used treatment liquid; and
a waste pump (17) located on the waste line,
the method comprising the following steps:
emptying the first chamber of the filter from liquid and filling the first chamber with air (refer [0058] and [0046] disclosing draining fluid from first chamber by pumping air into the first chamber and draining fluid from the first chamber),
operating the waste pump to extract or to continue extracting liquid from the second chamber of the filter (refer [0058] disclosing pump 17 running),
verifying, while the waste pump is operating, when the pressure in the second chamber of the filter reaches a set negative pressure threshold (Pt), and determining that the semipermeable membrane has a fiber break when, while operating the waste pump, the pressure in the second chamber does not reach the set negative pressure threshold (Pt) within a set time interval (T) (refer [0062]), the pressure being considered relative to atmospheric pressure present in a location where the extracorporeal blood treatment apparatus operates (this is inherent and evident since the pressure in the second chamber is influenced by the liquid in the second chamber).
Puppini does not disclose that the filters 4 and 13 are ultrafilters, however, Puppini disclosed in [0011] and [0012] that use of ultrafilters in similar systems is known in the art and therefore would have been obvious to one of ordinary skill in the art to apply the method of Puppini to system comprising ultrafilters.
Regarding claim 14, Puppini teaches limitations of claim 13 as set forth above. Puppini teaches wherein verifying the measured pressure does not reach the set negative pressure threshold (Pt) comprises detecting the pressure in the second chamber of the ultrafilter after expiration of the set time interval (T) (refer [0060]-[0062] disclosing monitoring pressure P2 over a time period).
Regarding claim 15, Puppini teaches limitations of claim 13 as set forth above. Puppini teaches wherein verifying the measured pressure does not reach the set negative pressure threshold (Pt) comprises detecting pressure the second chamber of the ultrafilter, or a line connected to the second chamber of the ultrafilter; and measuring an actual time interval at which the negative pressure threshold (Pt) is reached (refer [0060]-[0062] disclosing monitoring pressure P2 over a time period and determining status of fibers based on pressure change).
Regarding claim 16, Puppini teaches limitations of claim 13 as set forth above. Puppini teaches wherein an air inlet line (refer 25) is connected to the first chamber (6 or 15) of the ultrafilter, and wherein the steps of emptying the first chamber of the ultrafilter from liquid and filling the first chamber with air comprise operating an air pump (19) located on the air inlet line.
Regarding claim 17, Puppini teaches limitations of claim 13 as set forth above. Puppini teaches wherein operating the waste pump (17) to extract or to continue extracting liquid from the second chamber of the ultrafilter takes place until after the first chamber has been filled with air (Refer [0058]-[0062]).
Regarding claim 18, Puppini teaches limitations of claim 17 as set forth above. Puppini teaches wherein operating the waste pump after filling the first chamber with air makes pressure in the second chamber more negative or creates a negative pressure in the second chamber (this is evident in fig. 3 of Puppini because drain pump 17 is active which creates a suction pressure on 2nd chambers of the filters).
Regarding claim 19, Puppini teaches limitations of claim 16 as set forth above. Puppini teaches wherein the method further includes:
while filling the first chamber of the ultrafilter with air, operating the waste pump (17) based on a first set negative pressure value, which is a desired set value to be reached by the pressure sensed by the at least one pressure sensor (refer [0058]-[0062] disclosing operating pump 17 while monitoring pressure value from sensor P2); and
after the step of filling the first chamber of the ultrafilter with air, once the first chamber has been emptied from liquid and filled with air, operating the waste pump based on a second set negative pressure value, which is a desired set value to be reached by the pressure sensed by the at least one pressure sensor and which is more negative than the first pressure value, wherein the set negative pressure threshold, which is checked during the verifying step, has a negative value intermediate between the first set pressure value and the second set pressure value (refer [0058]-[0062] disclosing operating pump 17 while monitoring pressure value from sensor P2 and monitoring pressure difference over a period of time to determine whether the fibers are intact or not).
Regarding claim 20, Puppini teaches limitations of claim 19 as set forth above. The limitations regarding setting the pressure values would have been obvious to one of ordinary skill in the art because "[W]here 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).
Conclusion
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/PRANAV N PATEL/ Primary Examiner, Art Unit 1777