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 .
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 34-36 and 39-41 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 34 recites the limitation "the vertical flow channel" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets this limitation as "a vertical flow channel".
Claim 34 recites the limitation "the vertical wall" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets this limitation as "a vertical wall ".
Claim 34 recites the limitation "the vertical fluid chamber" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets this limitation as "a vertical fluid chamber".
Claim 35 recites the limitation "the vertical fluid chamber" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner will be examining claim 35 as a dependent claim of claim 34.
Claim 36 recites the limitation "the vertical flow channel" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner will be examining claim 36 as a dependent claim of claim 34.
Claim 39 recites the limitation "the vertical flow channel" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets this limitation as "a vertical flow channel".
Claim 39 recites the limitation "the vertical fluid chamber" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the examiner interprets this limitation as "a vertical fluid chamber".
Claim 39 recites the limitation "the vertical fluid chamber " in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 40 recites the limitation "the vertical flow channel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 40 recites the limitation "the vertical fluid chamber " in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "a vertical fluid chamber " in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 is dependent off of claim 50, making claim 41 an orphan claim. In other words, claim 41 is rendered indefinite under 35 U.S.C. 112(b) for being dependent from a claim not in the application. For purposes of examination, claim 41 is being treated as being dependent off claim 40.
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.
Claims 22-23, 26 and 28-29 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Grant et al. (US Pub No. 20190298231 A1).
Regarding claim 22, Grant discloses a hydraulic block for dialysis, comprising:
a base body (150 – Fig.13) formed with a fluid accommodating cavity (170a – Fig.14); and at least one standing structure (158, 160 – Fig.13) standing on the base body (Fig.13),
wherein the standing structure comprises at least one vertical fluid cavity (158 – Fig.1, “The perpendicular conduits may also be used as liquid ports for connection to a fluid source” – Para [0105]) fluidly connected with the fluid accommodating cavity (“liquid or actuation lines can be connected to extension conduits” – Para [0105]).
Regarding claim 23, Grant discloses the hydraulic block for dialysis set forth above, wherein the standing structure and the base body are molded integrally (“The conduits originate in the cassette mid-plate (e.g. formed or molded with the mid-plate)” – Para [0105]);
Regarding claim 26, Grant discloses the hydraulic block for dialysis set forth above, wherein the fluid accommodating cavity (170a – Fig.14) comprises a flow path (“actuation channel” – Para [0106]).
Regarding claim 28, Grant discloses the hydraulic block for dialysis set forth above, wherein the base body (150 – Fig.14) is configured as a flat body (Fig.4).
Regarding claim 29, Grant discloses the hydraulic block for dialysis set forth above, wherein the at least one standing structure and the base body are molded as a single plastic piece (“The conduits originate in the cassette mid-plate (e.g. formed or molded with the mid-plate)” – Para [0105], “The cassette plates can be formed (e.g., injection molded) from moldable plastic material” – Para [0099]).
Claims 24-25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Grant.
Regarding claim 24, Grant discloses the hydraulic block for dialysis set forth above, the limitation, “wherein at least one standing structure of the at least one standing structure is molded individually, and the base body and the rest of the at least one standing structure are molded integrally, so that the at least one standing structure can be fitted onto the base body.” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. The product comprises at least one standing structure connected to the base body. Grant discloses a standing structure connected to the base body as seen in Fig.13. Accordingly, the claimed product is the same as, or at least obvious from, the product disclosed by Grant.
Alternatively, it would have been obvious to modify Grant to arrive at the claimed invention since it has been held that the use of one-piece construction would be merely a matter of obvious engineering choice, MPEP 2144.04 V B. Additionally, it has been held that making a component removable for any reason considered desirable is an obvious design choice, MPEP 2144.04 V C.
Regarding claim 25, Grant discloses the hydraulic block for dialysis set forth above, wherein the fluid accommodating cavity initially opens at a side of the base body (162 – Fig.14, “Actuation channel connected to cassette actuation port” – Para [0106]).
Further, the limitation, “after molding of the base body” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. The claimed product is a base body having an opening on a side thereof. Grant discloses a base body having an opening on the side thereof, as shown in Fig.14. Accordingly, the claimed product is the same as, or at least obvious from, the product disclosed by Grant.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Syfonios et al. (US Pub No. 20180272054 A1, herein, Syfonios).
Regarding claim 27, Grant discloses the hydraulic block for dialysis set forth above, wherein the at least one standing structure is configured as at least one of a liquid port (“The perpendicular conduits may also be used as liquid ports for connection to a fluid source” – Para [0105]).
However, Grant does not explicitly disclose wherein the at least one standing structure is configured as at least one of a water inlet chamber.
Syfonios discloses a hydraulic block for dialysis (Fig.1), wherein a structure is configured as at least one of a water inlet chamber (20 – Fig.1).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the at least one standing structure of Grant to be at least one of a water inlet chamber as taught by Syfonios since Syfonios teaches that it is well known to have a water inlet chamber to receive reverse osmosis water in a dialysis system (Syfonios, Para [0035]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Lauman et al. (US Pub No. 20030135250 A1, herein, Lauman).
Regarding claim 30, Grant discloses the hydraulic block for dialysis set forth above, but Grant does not explicitly disclose wherein the at least one vertical fluid cavity comprises at least one vertical fluid chamber and at least one vertical flow channel which are in fluid communication with each other via a fluid communication path.
Lauman teaches a dialysis system (Fig.1) wherein there is at least one vertical fluid cavity (16 – Fig.1) comprising at least one vertical fluid chamber and at least one vertical flow channel which are in fluid communication with each other via a fluid communication path (See annotated Fig.1 below).
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It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the at least one vertical fluid cavity of Grant to comprise at least one vertical fluid chamber, at least one vertical flow channel, and a fluid communication path as taught by Lauman since Lauman teaches that this structure is a well-known formation to use in a fluid cavity.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Giordano et al. (US Pub No. 20200016311 A1).
Regarding claim 31, Grant discloses the hydraulic block for dialysis set forth above, but Grant does not explicitly disclose wherein the base body is molded with at least one installation interface for at least one functional component for dialysis.
Giordano teaches a hemodialysis system (1 – Fig.1) wherein a base body (219 – Fig.3) is with at least one installation interface (Shown at 219 – Fig.3, the base body provides the installation interface) for at least one functional component for dialysis (23 – Fig.3, 25 – Fig.3).
Further, the limitation, “molded” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the base body of Grant to have at least one installation interface for at least one functional component for dialysis as taught by Giordano since Giordano teaches it is well-known to add an installation interface for a functional component for dialysis on the base body.
Claims 32-33 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Giordano as applied to claim 31 above, and further in view of Heyes et al. (US Pub No. 20220001087 A1).
Regarding claim 32, Grant, as modified, discloses the hydraulic block for dialysis set forth above, but Grant does not explicitly disclose wherein the base body is with or fitted with a mixing structure for preparing dialysate.
Heyes teaches a hydraulic block (16 – Fig.3) wherein a base body is with or fitted with a mixing structure (108, 128 – Fig.5) for preparing dialysate (Para [0019]).
Further, the limitation, “molded” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the base body of Grant to be with or fitted with a mixing structure for preparing dialysate as taught by Heyes since Heyes teaches that it is well-known to add a mixing structure onto the base body of a hydraulic block of a dialysis system.
Regarding claim 33, Grant, as modified, discloses the hydraulic block for dialysis set forth above, but Grant does not explicitly disclose wherein the hydraulic block comprises a cover fixedly connected to the base body to close the fluid accommodating cavity.
Heyes teaches a hydraulic block (16 – Fig.3) wherein the hydraulic block comprises a cover (22 – Fig.8) fixedly connected to the base body to close the fluid accommodating cavity (105 – Fig.5, “as to contain the fluids within their respective channels.” – Para [0065]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the hydraulic block of Grant to comprise a cover as taught by Heyes since Heyes teaches that a cover helps contain the fluids within their respective channels (Heyes, Para [0065]).
Regarding claim 37, Grant, as modified, discloses the hydraulic block for dialysis set forth above, wherein the standing structure is with an outward opening directly leading to the fluid communication path (“liquid or actuation lines can be connected to extension conduits” – Para [0105]), and wherein the outward opening is configured to be closeable or to be fluidly connected with an external part (“can connect to external pods situated between two cassettes” – Para [0105]).
Further, the limitation, “molded” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Claims 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Giordano and Heyes as applied to claim 33 above, and further in view of Lauman.
Regarding claim 34, Grant discloses the hydraulic block for dialysis set forth above, but Grant does not explicitly disclose wherein a vertical flow channel is partially defined by a corresponding portion of a vertical wall of a vertical fluid chamber.
Lauman teaches a dialysis system (Fig.1) wherein a vertical flow channel is partially defined by a corresponding portion of a vertical wall of a vertical fluid chamber (See annotated Fig.1 below).
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It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the hydraulic block of Grant to comprise a vertical flow channel that is partially defined by a vertical wall of a vertical fluid chamber as taught by Lauman since Lauman teaches that this structure is a well-known formation to use in a fluid cavity.
Regarding claim 35, Grant, as modified, discloses the hydraulic block for dialysis set forth above, wherein the vertical fluid chamber has a core, but Grant does not explicitly disclose wherein the vertical fluid chamber is molded by a first columnar core comprising a first cylindrical core.
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 vertical fluid chamber’s core shape since it has been held that mere changes in shape are obvious, MPEP 2144.04 IV B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In the instant case, the device of Grant would not operate differently with the claimed shape of the vertical fluid chamber core consider Grant, as modified, discloses a core with a shape. Further, applicant places no criticality on the shape claimed, indicating simply “the vertical fluid chamber is molded by a first columnar core, for example a cylindrical core” (Para [0017]).
Further, the limitation, “molded by a first columnar core comprising a first cylindrical core” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 36, Grant, as modified, discloses the hydraulic block for dialysis set forth above, wherein the vertical flow channel has a core, but Grant does not explicitly disclose wherein the vertical flow channel is molded by at least one second columnar core comprising at least one second cylindrical core.
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 vertical flow channel’s core shape since it has been held that mere changes in shape are obvious, MPEP 2144.04 IV B: In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In the instant case, the device of Grant would not operate differently with the claimed shape of the vertical flow channel’s core consider Grant, as modified, discloses a core with a shape. Further, applicant places no criticality on the shape claimed, indicating simply “the vertical flow channel is molded by at least one second columnar core, for example a cylindrical core” (Para [0017]).
Further, the limitation, “molded by at least one second columnar core comprising at least one second cylindrical core” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Giordano and Heyes as applied to claim 33 above, and further in view of Pudil et al. (US Pub No. 20140217028 A1, herein, Pudil).
Regarding claim 38, Grant, as modified, discloses the hydraulic block for dialysis set forth above, but Grant does not explicitly disclose wherein the mixing structure comprises at least one mixing chamber, a fluid outlet-opening into the mixing chamber, and at least two fluid inlets-each opening into the mixing chamber.
Pudil teaches a Dialysate system (34 – Fig.6), wherein the mixing structure (48 – Fig.6) comprises at least one mixing chamber (“mixing chamber” – Para [0343]), a fluid outlet-opening (2 – Fig.6) into the mixing chamber, and at least two fluid inlets-each (1 – Fig.6, 3 – Fig.6) opening into the mixing chamber.
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the mixing structure of Grant to comprise one mixing chamber, one fluid outlet and two fluid inlets as taught by Pudil since Pudil teaches that it is a well-known structure of a mixing chamber in a dialysis system to have a chamber, an outlet, and multiple inlets.
Claims 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Grant in view of Giordano, Heyes and Pudil as applied to claim 38 above, and further in view of Lauman.
Regarding claim 39, Grant, as modified, discloses the hydraulic block for dialysis set forth above, but Grant does not explicitly disclose wherein a vertical flow channel is located outside of a vertical fluid chamber and adjacent to a vertical wall of the vertical fluid chamber.
Lauman teaches a dialysis system (Fig.1) wherein the vertical flow channel is located outside of the vertical fluid chamber and adjacent to a vertical wall of the vertical fluid chamber (See annotated Fig.1 below).
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It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the hydraulic block of Grant to comprise a vertical flow channel that is located outside of a vertical fluid chamber and adjacent to a vertical wall of the vertical fluid chamber as taught by Lauman since Lauman teaches that this structure is a well-known formation to use in a fluid cavity.
Regarding claim 40, Grant, as modified, discloses the hydraulic block for dialysis set forth above, the limitation, “wherein the vertical flow channel is molded onto the vertical fluid chamber.” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Regarding claim 41, Grant, as modified, discloses the hydraulic block for dialysis set forth above, the limitation, “wherein the vertical fluid chamber is molded by positioning a first columnar core on one side of the mold.” is a product-by-process limitation, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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