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 Interpretation
Regarding limitations recited in Claim 57, which are directed to a manner of operating disclosed apparatus, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Claim 57 recites “wherein the priming fluid is the same fluid that is used during production for diluting a dialysis concentrate, and wherein the priming fluid is water or used dialysis solution”. Said limitation does not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.
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 41, 50, 57 and 58 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 41 recites “which is positioned and arranged to evacuate gas from the gas collection chamber while providing priming fluid to the gas collection chamber”. Claim 41 is deemed indefinite because it is unclear what component of the claimed apparatus “is positioned and arranged”. As-originally filed specification discloses “the apparatus is positioned and arranged to evacuate gas from the gas collection chamber while providing priming fluid to the gas collection chamber” (see as-originally filed specification page 5).
Claim 50 recites “providing fluid”. Claim 50 is deemed indefinite because it is unclear if “fluid” is a dialysis fluid, a priming fluid or some other fluid. For the sake of compact prosecution, claim 50 is understood as being open to either of these interpretations.
Claim 58 recites “method for priming a forward osmosis (FO-) unit configured to be used for diluting a dialysis concentrate in a process for producing a dialysis fluid”. Claim 58 is deemed indefinite. First, it is unclear if “configured to be used for diluting a dialysis concentrate in a process for producing a dialysis fluid” is a method step of the claimed method. Second, the claimed “used” limitation is indefinite. Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 39 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by DE 102020106751 B4 (hereinafter DE 751) (DE 751 was published on 09-23-2021. DE 751 is available as prior art under 102(a)(1).). (US 2023/0146806 A1 (hereinafter US 806) is herein cited as the English language translation).
Regarding claim 39, US 806 discloses an apparatus for producing fluid for dialysis (see US 806 abstract, figures 1 & 3 and paragraphs 0005 and 0039-0043).
US 806 discloses a forward osmosis (FO-) unit configured for diluting a dialysis concentrate in a process for producing a dialysis fluid, the FO-unit including a FO-membrane that separates a first side from a second side of the FO-unit (see US 806 figures 1 & 3; pars. [0040], [0048]-[0049], [0075]-[0078]).
US 806 discloses a first flow path including the first side of the FO-unit (see US 806 figures 1 & 3 and paragraphs 0038, 0040-0041, 0048-0049, 0075-0078).
US 806 discloses a control arrangement configured to provide priming fluid from a priming fluid source to the first flow path (see US 806 paragraphs 0020, 0042, 0063, 0067, 0089-0098).
US 806 discloses a return path fluidly connecting an inlet port of the first side to an outlet port of the first side of the FO-unit, the return path allowing priming fluid expelled from the outlet port to circulate to the inlet port via the return path (see US 806 figures 1 & 3, flow path including 11, 14, 13b, 11a; and paragraph 0042, 0045).
US 806 discloses gas collection chamber arranged in the first flow path between the first side and the return path, wherein the gas collection chamber is configured to receive gas removed from the first flow path (see US 806 figures 1 & 3 and paragraphs 0044).
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.
Claims 39-58 are rejected under 35 U.S.C. 103 as being unpatentable over JP2021010696, machine translation (hereinafer JP 696) in view of US 20170065762 A1 (hereinafter US 762).
Regarding claim 39, JP696 discloses apparatus for producing fluid for dialysis (see JP 696 figures 1-3 and paragraphs 0001, 0004-0005, 0007-0014, 0020).
Statements in the preamble reciting the purpose or intended use of the claimed invention which do not result in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art do not limit the claim and do not distinguish over the prior art apparatus (or process). See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) and cases cited therein, as it has been held that the recitation of a new intended use for an old product does not make a claim to that old product patentable. In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997). See also MPEP § 2111.02, §2112.02 and 2114-2115.
JP696 discloses a first chamber and a second chamber (see JP 696 figures 1-3 and paragraphs 0010-0013, 0019, 0020). JP 696 does not disclose a forward osmosis (FO-) unit configured for diluting a dialysis concentrate in a process for producing a dialysis fluid, the FO-unit including a FO-membrane that separates a first side from a second side of the FO-unit.
US 762 discloses a forward osmosis (FO) unit for recycling a portion of the waste/spent dialysis fluid from the outlet of a dialyzer (see US 762 abstract, figures 1-5E, claim 1, and paragraphs 0001, 0007). US 762 discloses “a forward osmosis (FO) unit (102) comprising a forward osmosis membrane (103) having a feed side (104) and a draw side (105), wherein the feed side is in fluid communication with filtrate waste fluid or spent fluid from a patient undergoing a renal replacement therapy; and wherein the draw side is in fluid communication with either a supply of dialysis concentrate, a supply of electrolyte replacement concentrate, or a flow of concentrated blood having undergone hemofiltration (106) or a combination of one or more of such sources, and where said forward osmosis membrane has an active layer which comprises nanoporous water channels such as aquaporin water channels” (see US 762 paragraph 0008). US 762 discloses “Re-using pure water obtained through FO extraction according to the invention herein adds additional benefits to the production of fresh dialysis fluids, because of elimination of the energy use necessary for the usual reverse osmosis and ultrafiltration processes in addition to other benefits, such as reduced dangers of toxic substance contamination etc” (see US 762 paragraph 0162).
US 762 is considered to be analogous to the claimed invention because it is in the same field of endeavor, i.e. a process and system for forming dialysis fluid for a dialyzer and/or dialysis system.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify JP 696 by incorporating a forward osmosis (FO) unit, as disclosed in US 762, for each of the first and second dialysate chambers, as disclosed in the system of JP 696, because it would assist with regenerating dialysis fluid from spent dialysis fluid.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify JP 696 by incorporating a forward osmosis (FO) unit, as disclosed in US 762, for each of the first and second dialysate chambers, as disclosed in the system of JP 696, and reasonably expect the resulting apparatus to work as the prior art intended, i.e. form dialysis fluid.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify JP 696 by incorporating a forward osmosis (FO) unit, as disclosed in US 762, for each of the first and second dialysate chambers, as disclosed in the system of JP 696, because the FO unit, as a chamber, in the system of JP 696 assists with achieving “additional benefits to the production of fresh dialysis fluids, because of elimination of the energy use necessary for the usual reverse osmosis and ultrafiltration processes in addition to other benefits, such as reduced dangers of toxic substance contamination etc” (see US 762 paragraph 0162).
Hence, JP 696 in view of US 762 is deemed to disclose an apparatus for producing fluid for dialysis, the apparatus comprising a forward osmosis (FO-) unit configured for diluting a dialysis concentrate in a process for producing a dialysis fluid, the FO-unit including a FO-membrane that separates a first side from a second side of the FO-unit.
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed forward osmosis (FO-) unit of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of diluting a dialysis concentrate in a process for producing a dialysis fluid, the FO-unit including a FO-membrane that separates a first side from a second side of the FO-unit.
JP 696 in view of US 762 discloses a first flow path including the first side of the FO-unit (see JP 696 figures 1-3; see annotated figure 1 below).
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JP 696 in view of US 762 discloses a control arrangement configured to provide priming fluid from a priming fluid source to the first flow path (see JP 696 figures 1-3).
It is noted that priming fluid and a priming fluid source are not elements of the claimed apparatus.
JP 696 in view of US 762 does not disclose a return path fluidly connecting an inlet port of the first side to an outlet port of the first side of the FO-unit, the return path allowing priming fluid expelled from the outlet port to circulate to the inlet port via the return path.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system of JP 696 in view of US 762 by forming a return path line between the inlet and the outlet of the first side of the FO unit because it would assist with increasing the priming of the FO unit and/or because it would assist with reusing/recycling the priming solution, which would assist with minimizing cost of materials and/or because it would assist with preparing/priming the membrane of the FO unit.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system of JP 696 in view of US 762 by forming a return path line between the inlet and the outlet of the first side of the FO unit and reasonably expect the resulting apparatus to work as the prior art intended, i.e. assist with transporting fluid from one point to another.
Hence, JP 696 in view of US 762 is deemed to disclose a return path fluidly connecting an inlet port of the first side to an outlet port of the first side of the FO-unit, the return path allowing priming fluid expelled from the outlet port to circulate to the inlet port via the return path.
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed return path of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of allowing priming fluid expelled from the outlet port to circulate to the inlet port via the return path.
JP 696 in view of US 762 discloses a gas collection chamber arranged in the first flow path between the first side and the return path, wherein the gas collection chamber is configured to receive gas removed from the first flow path (see JP 696 figures 1-3 degassing tank 31 and paragraphs 0011, 0017, 0025, 0027).
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed gas collection chamber of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of receiving gas removed from the first flow path.
Regarding claim 58, JP 696 discloses a method for priming a unit configured to be used for diluting a dialysis concentrate in a process for producing a dialysis fluid (see JP 696 paragraphs 0001, 0009-0010, 0022). That is, JP696 discloses a first chamber and a second chamber (see JP 696 figures 1-3 and paragraphs 0010-0013, 0019, 0020), but JP 696 does not disclose a forward osmosis (FO-) unit, wherein the FO-unit includes a FO-membrane that separates a first side from a second side of the FO-unit.
US 762 discloses a forward osmosis (FO) unit for recycling a portion of the waste/spent dialysis fluid from the outlet of a dialyzer (see US 762 abstract, figures 1-5E, claim 1, and paragraphs 0001, 0007; see also US 762 paragraphs 0007-0008, 0021, 0033, 0036). US 762 discloses “a forward osmosis (FO) unit (102) comprising a forward osmosis membrane (103) having a feed side (104) and a draw side (105), wherein the feed side is in fluid communication with filtrate waste fluid or spent fluid from a patient undergoing a renal replacement therapy; and wherein the draw side is in fluid communication with either a supply of dialysis concentrate, a supply of electrolyte replacement concentrate, or a flow of concentrated blood having undergone hemofiltration (106) or a combination of one or more of such sources, and where said forward osmosis membrane has an active layer which comprises nanoporous water channels such as aquaporin water channels” (see US 762 paragraph 0008). US 762 discloses “Re-using pure water obtained through FO extraction according to the invention herein adds additional benefits to the production of fresh dialysis fluids, because of elimination of the energy use necessary for the usual reverse osmosis and ultrafiltration processes in addition to other benefits, such as reduced dangers of toxic substance contamination etc” (see US 762 paragraph 0162).
US 762 is considered to be analogous to the claimed invention because it is in the same field of endeavor, i.e. a process and system for forming dialysis fluid for a dialyzer and/or dialysis system.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify JP 696 by incorporating a forward osmosis (FO) unit, as disclosed in US 762, for each of the first and second dialysate chambers, as disclosed in the system of JP 696, because it would assist with regenerating dialysis fluid from spent dialysis fluid.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify JP 696 by incorporating a forward osmosis (FO) unit, as disclosed in US 762, for each of the first and second dialysate chambers, as disclosed in the system of JP 696, and reasonably expect the resulting apparatus to work as the prior art intended, i.e. form dialysis fluid.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify JP 696 by incorporating a forward osmosis (FO) unit, as disclosed in US 762, for each of the first and second dialysate chambers, as disclosed in the system of JP 696, because the FO unit, as a chamber, in the system of JP 696 assists with achieving “additional benefits to the production of fresh dialysis fluids, because of elimination of the energy use necessary for the usual reverse osmosis and ultrafiltration processes in addition to other benefits, such as reduced dangers of toxic substance contamination etc” (see US 762 paragraph 0162).
Hence, JP 696 in view of US 762 is deemed to disclose a method for priming a forward osmosis (FO-) unit configured to be used for diluting a dialysis concentrate in a process for producing a dialysis fluid, the FO-unit including a FO-membrane that separates a first side from a second side of the FO-unit.
JP 696 in view of US 762 discloses providing priming fluid to a first flow path comprising the first side and a gas collection chamber configured to receive gas removed from the first flow path (see JP 696 figures 1-3; see annotated figure 1, reproduced below).
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).
JP 696 in view of US 762 discloses circulating the provided priming fluid in a recirculation path comprising the first side and the gas collection chamber (see annotated figure 1 above; see also US 762 figures 1-5E, claim 1, and paragraphs 0001, 0007-0008).
JP 696 in view of US 762 does not disclose priming fluid in a recirculation path comprising the first side, a return path and the gas collection chamber, wherein the return path fluidly connects an inlet port of the first side to an outlet port of the first side of the FO-unit. However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system of JP 696 in view of US 762 by forming a return path, wherein the return path fluidly connects an inlet port of the first side to an outlet port of the first side of the FO-unit because it would assist with increasing the priming of the FO unit and/or because it would assist with reusing/recycling the priming solution, which would assist with minimizing cost of materials and/or because it would assist with preparing/priming the membrane of the FO unit.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the system of JP 696 in view of US 762 by forming a return pat, wherein the return path fluidly connects an inlet port of the first side to an outlet port of the first side of the FO-unit and reasonably expect the resulting apparatus to work as the prior art intended, i.e. assist with transporting fluid from one point to another.
Hence, JP 696 in view of US 762 is deemed to disclose a method for priming a forward osmosis (FO-) unit configured to be used for diluting a dialysis concentrate in a process for producing a dialysis fluid, the FO-unit including a FO-membrane that separates a first side from a second side of the FO-unit, the method comprising providing priming fluid to a first flow path comprising the first side and a gas collection chamber configured to receive gas removed from the first flow path, and circulating the provided priming fluid in a recirculation path comprising the first side, a return path and the gas collection chamber, wherein the return path fluidly connects an inlet port of the first side to an outlet port of the first side of the FO-unit.
Regarding claim 40, JP 696 in view of US 762 discloses the invention as discussed above in claim 39. Further, JP 696 in view of US 762 discloses the control arrangement is configured to monitor a level of priming fluid in the gas collection chamber and to provide priming fluid to the gas collection chamber until the level of priming fluid in the gas collection chamber has reached a predetermined level (see rejection of claim 39; see JP 696 paragraphs 0023-0025).
It is understood that “a predetermined level” may be any level. Herein, there must necessarily be a value within the prior art. . “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112, II.
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of receiving gas removed from the first flow path.
Regarding claim 41, JP 696 in view of US 762 discloses the invention as discussed above in claim 40.
As noted above, claim 41 is deemed indefinite. the as-originally filed specification discloses “the apparatus is positioned and arranged to evacuate gas from the gas collection chamber while providing priming fluid to the gas collection chamber” (see as-originally filed specification page 5).
Claim 41, being understood as the apparatus is positioned and arranged, is deemed rendered obvious by JP 696 in view of US 762. JP 696 in view of US 762 is deemed to disclose an apparatus capable of evacuating gas from the gas from the gas collection chamber while providing priming fluid to the gas collection chamber (see rejection of claim 39; see JP 696 figures 1-3).
Claim 41, being understood as the control arrangement being positioned and arranged, is deemed rendered obvious by JP 696 in view of US 762. JP 696 in view of US 762 is deemed to disclose a control means capable of evacuating gas from the gas from the gas collection chamber while providing priming fluid to the gas collection chamber (see rejection of claim 39; see JP 696 paragraphs 0023, 0024).
Regarding claim 42, JP 696 in view of US 762 discloses the invention as discussed above in claim 39. Further, JP 696 in view of US 762 discloses the gas collection chamber comprises a gas outlet port for evacuating gas from the gas collection chamber (see rejection of claim 39; see JP 696 figures 1-3 and paragraphs 0017, 0025).
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed gas outlet port of the claimed gas collection chamber of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of evacuating gas from the gas collection chamber.
Regarding claim 43, JP 696 in view of US 762 discloses the invention as discussed above in claim 42. Further, JP 696 in view of US 762 discloses a gas collection path fluidly connecting the gas outlet port of the gas collection chamber to a drain (see rejection of claim 39; see JP 696 figures 1-3 and paragraphs 0017, 0025).
Regarding claim 44, JP 696 in view of US 762 discloses the invention as discussed above in claim 39. Further, JP 696 in view of US 762 discloses the control arrangement is configured to provide priming fluid from the priming fluid source to the first side of the FO-unit via the first flow path and the gas collection chamber to fill the first side with priming fluid (see rejection of claim 39; see JP 696 figures 1-3 and paragraphs 0023-0025).
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of providing priming fluid from the priming fluid source to the first side of the FO-unit via the first flow path and the gas collection chamber to fill the first side with priming fluid.
Regarding claim 45, JP 696 in view of US 762 discloses the invention as discussed above in claim 44. Further, JP 696 in view of US 762 discloses the control arrangement is configured to provide priming fluid from the priming fluid source to the first side of the FO-unit via the first flow path and the gas collection chamber, upon the level of priming fluid in the gas collection chamber reaching a predetermined level (see rejection of claim 39; see JP 696 figures 1-3 and paragraphs 0023-0025).
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of providing priming fluid from the priming fluid source to the first side of the FO-unit via the first flow path and the gas collection chamber, upon the level of priming fluid in the gas collection chamber reaching a predetermined level.
Regarding claim 46, JP 696 in view of US 762 discloses the invention as discussed above in claim 39. Further, JP 696 in view of US 762 discloses the control arrangement is configured to stop flow via the return path while priming fluid is provided to the first flow path from the priming fluid source (see rejection of claim 39; see JP 696 figures 1-3 and paragraphs 0023-0025).
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of stopping flow via the return path while priming fluid is provided to the first flow path from the priming fluid source.
Regarding claim 47, JP 696 in view of US 762 discloses the invention as discussed above in claim 44. Further, JP 696 in view of US 762 discloses the control arrangement is configured to circulate the priming fluid provided to the first side in a first direction in a recirculation path, the recirculation path comprising the first side, the return path and the gas collection chamber (see rejection of claim 39; see JP 696 figures 1-3 and paragraphs 0023-0025).
It is noted that the priming fluid and the recirculation path are not elements of the claimed apparatus.
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of circulating the priming fluid provided to the first side in a first direction in a recirculation path, the recirculation path comprising the first side, the return path and the gas collection chamber.
Regarding claim 48, JP 696 in view of US 762 discloses the invention as discussed above in claim 47. Further, JP 696 in view of US 762 discloses the control arrangement is configured to circulate the priming fluid in a second direction in the recirculation path (see rejection of claim 39; see JP 696 figures 1-3 and paragraphs 0023-0025).
It is noted that the priming fluid and the recirculation path are not elements of the claimed apparatus.
It is noted that the “first direction” and the “second direction” of priming fluid throughout the apparatus does not recite a structural feature of the claimed apparatus. The direction of the flow of a fluid through a conduit in dependent upon the pressure placed upon said fluid with the assistance from a device, such as a pump and/or valve.
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of circulating the priming fluid provided to the first side in a first direction in a recirculation path, the recirculation path comprising the first side, the return path and the gas collection chamber.
Regarding claim 49, JP 696 in view of US 762 discloses the invention as discussed above in claim 48. Further, JP 696 in view of US 762 discloses the control arrangement is configured to repeat (i) circulation of the priming fluid in the first direction in the recirculation path, and (ii) circulation of the priming fluid in the second direction in the recirculation path, at least one time until one or more predetermined priming criteria is/are fulfilled (see rejection of claims 39, 40, 47, 48).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to repeat the flow of fluid, such as priming fluid, throughout the apparatus, in either the first direction and second direction, more than once, because it would assist with priming the FO unit.
Regarding claim 50, JP 696 in view of US 762 discloses the invention as discussed above in claim 48. Further, JP 696 in view of US 762 discloses a second flow path for providing fluid to the second side, wherein the control arrangement is configured, upon fulfilling the one or more predetermined priming criteria for the first side, to provide fluid from a solution source via the second flow path to an inlet port to the second side, the inlet port arranged below an outlet port of the second side (see rejection of claim 39; see annotated figure 2 below; see JP 696 figures 1-3 and paragraphs 0012, 0019, 0023-0025).
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Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed a) second flow path and the claimed b) control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of a) providing fluid to the second side and b) upon fulfilling the one or more predetermined priming criteria for the first side, to provide fluid from a solution source via the second flow path to an inlet port to the second side, the inlet port arranged below an outlet port of the second side.
It is understood that “predetermined priming criteria” may be any criteria. Herein, there must necessarily be a value within the prior art. . “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112, II.
It is noted that the fluid and the solution source are not elements of the claimed apparatus.
Regarding claim 51, JP 696 in view of US 762 discloses the invention as discussed above in claim 49. Further, JP 696 in view of US 762 discloses the control arrangement is configured to circulate the priming fluid in the first direction at a first flow rate and to circulate the priming fluid in the second direction at a second flow rate (see rejection of claims 47-49). Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the control means, valve and/or pump elements to control the flow of fluid through the apparatus of JP 696 in view of US 762 because one of ordinary skill in the art would want to be able to control the flow of fluid throughout the system.
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of circulating the priming fluid in the first direction at a first flow rate and to circulate the priming fluid in the second direction at a second flow rate.
Thus, JP 696 in view of US 762 discloses the flow rate of the priming solution through the apparatus.
JP 696 in view of US 762 does not disclose the first flow rate is different from the second flow rate. However, achieving different flow rates for the first flow rate and the second flow rate is not a structural element of the claimed apparatus. Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of achieving a first flow rate that is different from the second flow rate.
Regarding claim 52, JP 696 in view of US 762 discloses the invention as discussed above in claim 51. Further, JP 696 in view of US 762 discloses the first flow rate is greater than the second flow rate (see rejection of claim 51).
Regarding claim 53, JP 696 in view of US 762 discloses the invention as discussed above in claim 49. Further, JP 696 in view of US 762 discloses the control arrangement is configured to circulate the priming fluid in the first direction in the recirculation path for a predetermined first time period and to circulate the priming fluid in the second direction in the recirculation path for a second time period (see rejection of claim 51).
It is understood that “a predetermined first time period” may be any time period. Herein, there must necessarily be a value within the prior art. . “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.” See MPEP 2112, II.
JP 696 in view of US 762 does not disclose the first time period and the second time period have different lengths. However, achieving different time periods for the first priming direction and the second priming direction is not a structural element of the claimed apparatus. Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed control arrangement of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of achieving the first time period and the second time period being different lengths.
Regarding claim 54, JP 696 in view of US 762 discloses the invention as discussed above in claim 39. Further, JP 696 in view of US 762 discloses the control arrangement comprises at least one pump (see JP 696 figures 1-3, pumps P1-P6, and paragraphs 0005-0006).
Regarding claim 55, JP 696 in view of US 762 discloses the invention as discussed above in claim 54. Further, JP 696 in view of US 762 discloses the at least one pump comprises a first pump arranged to provide the priming fluid to the first path from the priming fluid source (see JP 696 figures 1-3, pumps P1, P4, & P5, and paragraphs 0005-0006, 0011, 0015, 0023).
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed pump of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of providing the priming fluid to the first path from the priming fluid source.
Regarding claim 56, JP 696 in view of US 762 discloses the invention as discussed above in claim 55. Further, JP 696 in view of US 762 discloses the at least one pump comprises a second pump arranged to circulate the priming fluid in the recirculation path (see JP 696 figures 1-3, pumps P1, P4, & P5, and paragraphs 0005-0006, 0011, 0015, 0023).
Additionally, regarding product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. The Courts have held that it is well settled that where there is a reason to believe that a functional characteristic would be inherent in the prior art, the burden of proof then shifts to the applicant to provide objective evidence to the contrary. See In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1478, 44 USPQ2d at 1432 (Fed. Cir. 1997) (see MPEP § 2112.01, I.). Herein, the structure of JP 696 in view of US 762 is substantially identical to the claimed pump of the present application, and therefore, the structure of JP 696 in view of US 762 is presumed inherently capable of circulating the priming fluid in the recirculation path.
Regarding claim 57, JP 696 in view of US 762 discloses the invention as discussed above in claim 39. Further, JP 696 in view of US 762 discloses the priming fluid is the same fluid that is used during production for diluting a dialysis concentrate, and wherein the priming fluid is water or used dialysis solution (see rejection of claim 39; see JP 696 figures 1-3).
Related Prior Art
Prior art made of record and not relied upon is considered pertinent to applicants’ disclosure:
US 2021/0299341 (hereinafter US 341) discloses a method and to an apparatus for preparing a dialysis solution that uses a hollow fiber module in a RO (reverse osmosis) or FO (forward osmosis) process (see US 341 abstract, figures and paragraphs 0028). US 341 discloses “wherein the first circuit has a container (10) for receiving the consumed dialysis solution or fresh water or another fluid, the primary side (21) of a filter (20) connected downstream of the container (10), and a return line (30) from the primary side (21) of the filter (20) into the container (10), wherein the filter (20) is configured to prepare purified water from the consumed dialysis solution or from fresh water or from another fluid, and wherein the second circuit has the secondary side (22) of the filter (20), the dialyzate side of a dialyzer (100), a reservoir (200), a line (K) that leads from the reservoir (200) to the secondary side (22) of the filter and by means of which dialyzate or a dialyzate concentrate can be supplied to the secondary side (22) of the filter (20), and a filtrate line (F) that leads away from the secondary side (22) of the filter (20)” (see US 341 claim 1).
Other Applicable Prior Art
All other art cited not detailed above in a rejection is considered relevant to at least some portion or feature of the current application and is cited for possible future use for reference. Applicant may find it useful to be familiar with all cited art for possible future rejections or discussion.
Conclusion
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/BERNADETTE KAREN MCGANN/Examiner, Art Unit 1773
/BENJAMIN L LEBRON/Supervisory Patent Examiner, Art Unit 1773