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 Status
Claims 1-14 and 16-20 are pending with claims 1-14 being examined with claims 16-20 deemed withdrawn. Claim 15 is canceled.
Response to Amendment
As to the claim amendments and remarks filed on 12/29/2025, the previous 112(b) rejection is withdrawn. Applicant addressed the issues.
The previous drawing objection is withdrawn. Applicant filed replacement drawings that identify the elements and amended the specification to include the elements.
The previous claim objection is withdrawn. Applicant addressed the issues.
As to the claim amendments and remarks, the Examiner has found applicants arguments not persuasive. Therefore, the previous rejection has been modified to address the claim amendments.
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 1-4 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kunnecke (US 20120071788 A1; hereinafter “Kunnecke” previous of record) in view of Rolchigo et al. (US 20100224545 A1).
Regarding claim 1, Künnecke teaches a filtration module (Künnecke; fig.3.10) for filtering a process medium in a bioprocess (Künnecke; [0032] “the probe has a membrane that separates analyte”), the filtration module comprising:
a process flow path through which a process medium is urged during a filtering process (Künnecke; fig. 3. 22) step of the bioprocess,
a filter membrane coupled to the process flow path for performing the filtering process (Künnecke; fig. 3. 5), of the bioprocess and
a sampling membrane (Künnecke; fig. 3. 15) coupled both to the process flow path (Künnecke; fig. 4. 22) and to a sampling flow path (Künnecke; fig. 4. 13) for extracting a sample from the process medium during the filtering process step, the sampling flow path guiding the extracted sample to a sampling outlet of the filtration module (Künnecke; fig. 4. 40).
Künnecke fails to teach the filtration module is a cartridge, a cassette, a capsule or a membrane absorber.
However, Rolchigo teaches the analogous art of a filtration module (Rolchigo; Title) that includes a membrane (Rolchigo; fig. 8. 52) wherein the membrane is in a cartridge (filtration module) (Rolchigo; [0034] “membrane 84 is in a cartridge”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Künnecke’s filtration module to include a cartridge as taught by Rolchigo because Rolchigo teaches a filtration module (Rolchigo; Title) that includes a membrane (Rolchigo; fig. 8. 52) wherein the membrane is in a cartridge (filtration module) (Rolchigo; [0034] “membrane 84 is in a cartridge”).
The modification allows for a housing to protect the membrane.
Regarding claim 2, modified Künnecke teaches the filtration module according to claim 1 (see above), characterized in that the sampling membrane forms at least a portion of a boundary between the process medium and the sampling flow path (Künnecke; fig. 4. 15 and [0122] “window 10 is closed off by membrane 15 from the sample chamber where an analyte is able to diffuse through”).
Regarding claim 3, modified Künnecke teaches the filtration module according to claim 1 (see above), characterized in that the sampling membrane has a pore size which is smaller than the pore size of the filter membrane.
Modified Künnecke teaches a sampling membrane and a filter membrane (Künnecke; fig. 3. 5, 14). Künnecke does not teach the sampling membrane has a pore size which is smaller than the pore size of the filter membrane.
It would have been obvious for the sampling membrane to have a smaller pore size than the filter membrane to filter larger impurities in the sample that might have passed through the filter membrane.
Regarding claim 4, modified Künnecke teaches the filtration module according to claim 1 (see above) to include a membrane, a process flow path and a sampling flow path (see above).
Modified Künnecke fails to teach at least one further sampling membrane is coupled both to the process flow path and to the sampling flow path, the sampling membranes having different characteristics, including different pore sizes.
However, Rolchigo teaches the analogous art of a filtration module (Rolchigo; Title) that includes a membrane (Rolchigo; fig. 8. 52), a process flow path (Rolchigo; fig. 8. 96 illustrated by arrows flowing in longitudinal axis 96) and a sampling flow path (Rolchigo; fig. 8. 98) wherein at least one further sampling membrane is coupled both to the process flow path and to the sampling flow path (Rolchigo; [0022] “filtrate processed in the membrane bioreactor can be further filtered by ultrafiltration”). Rolchigo does not explicitly teach the sampling membranes having different characteristics, including different pore sizes. It is known in the art that ultrafiltration membranes are used in the ultrafiltration process which would require a membrane of a smaller pore size.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Künnecke’s a process flow path and a sampling flow path to include an additional filter as taught by Rolchigo because Rolchigo teaches a filtration module (Rolchigo; Title) that includes a membrane (Rolchigo; fig. 8. 52), a process flow path (Rolchigo; fig. 8. 96 illustrated by arrows flowing in longitudinal axis 96) and a sampling flow path (Rolchigo; fig. 8. 98) wherein at least one further sampling membrane is coupled both to the process flow path and to the sampling flow path (Rolchigo; [0022] “filtrate processed in the membrane bioreactor can be further filtered by ultrafiltration”). Rolchigo does not explicitly teach the sampling membranes having different characteristics, including different pore sizes.
The modification allows to extract different analytes from the process medium.
Regarding claim 6, modified Künnecke teaches the filtration module according to claim 4 (see above) to include individual sampling membranes (see above the modification of Künnecke in view of Rolchigo).
Modified Künnecke fails to teach that the individual sampling membranes are coupled to different process channels of the process flow path.
However, Rolchigo teaches the analogous art of a filtration module (Rolchigo; Title) that includes individual sampling membranes (Rolchigo; fig. 8. 52, 84), and a sampling flow path (Rolchigo; fig. 8. 98) wherein individual sampling membranes are coupled to different process channels of the process flow path (Rolchigo; fig. 5A. 50 illustrates a different process channel of the process flow path where permeate water is collected from the process channel 50 [0041]) (Rolchigo fig. 5A. 50, 52 illustrates an individual sampling membrane coupled to the process channel of the process flow path, Rolchigo; fig 7A. 50, 84 illustrates an additional individual sampling membrane coupled to the process channel of the process flow path).
Examiner notes that Applicant does not illustrate the different process channels of the process flow path therefore, Rolchigo’s process channels meet the limitation until further clarification is provided.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Künnecke’s individual sampling membranes to be coupled to different process channels of the process flow path as taught by Rolchigo because Rolchigo teaches individual sampling membranes are coupled to different process channels of the process flow path (Rolchigo; fig. 5A. 50, 52 and fig. 7A. 50, 84).
The individual sampling membranes coupled to different process channels of the process flow path allows to permeate water during the filtration process.
Regarding claim 7, modified Künnecke teaches the filtration module according to claim 1 (see above) to include a sampling membrane (see above).
Modified Künnecke fails to teach that the sampling membrane is a hollow fiber arranged as a channel in the process flow path.
However, Rolchigo teaches the analogous art of a filtration module (Rolchigo; Title) that includes a sampling membrane (Rolchigo; fig. 5A. 52) wherein the sampling membrane is a hollow fiber arranged as a channel in the process flow path (Rolchigo; [0023] “membrane 52 includes fibers 56 helically wound around the core” and [0024] “the fibers can be hollow” and fig. 8. 52, 96 illustrates the hollow fiber arranged as a channel in the process flow path).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Künnecke’s sampling membrane to be a hollow fiber arranged as a channel in the process flow path as taught by Rolchigo because Rolchigo teaches a sampling membrane that is a hollow fiber arranged as a channel in the process flow path (Rolchigo; fig. 8. 52, 96 and [0023]-[0024]).
Having a sampling membrane being a hollow fiber arranged as a channel in the process flow path allows easy replacement of the membrane placed over the process flow path.
Regarding claim 8, modified Künnecke teaches the filtration module according to claim 1 (see above) to include a sampling membrane and a capture membrane (see above).
Modified Künnecke fails to teach the filtration module is characterized in that the sampling membrane is a capture membrane comprising a binding material on a surface of the capture membrane to capture an analyte from the process medium flowing through the process flow path.
However, Rolchigo teaches the analogous art of a filtration module (Rolchigo; Title) that includes a sampling membrane (Rolchigo; fig. 5A. 52) that is a capture membrane (Rolchigo; [0032] “the helically wound fibers 56 in some embodiments can help capture solids”) comprising a binding material on a surface of the capture membrane to capture an analyte from the process medium flowing through the process flow path. (Rolchigo teaches the fibers 56 can be constructed of a polymeric, hydrophilic material [0027], and that the second plurality of fibers (56) can have different properties in order to achieve different filtering functionalities (Rolchigo; [0006]).
Examiner notes that Applicant does not disclose what is referred to as a binding material and does not provide any working embodiments that would enable one of ordinary skill in the art to identify what is meant as a binding material.
It would have been obvious to include a binding material on a surface of the capture membrane to capture an analyte from the process medium flowing through the process flow path in order to perform a selective separation.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Künnecke’s sampling membrane to be a capture membrane as taught by Rolchigo because Rolchigo teaches a sampling membrane wherein the sampling membrane is a capture membrane (Rolchigo; [0032]).
Having a capture membrane allows to capture impurities.
Regarding claim 9, modified Künnecke teaches the filtration module according to claim 1 (see above), characterized in that the sampling membrane is a hydrophilic membrane or a hydrophobic membrane.
Modified Künnecke teaches sampling body fluid of a human (Künnecke; [0019]), Modified Künnecke further teaches the sample transporting medium is aqueous, wherein the medium is suitable for transporting the analyte (Künnecke; [0066]). Modified Künnecke does not explicitly teach that the sampling membrane is a hydrophilic membrane or a hydrophobic membrane.
However, it would have been obvious to include a hydrophilic membrane to allow filtering the aqueous medium containing the sample transporting the analyte.
Further, if modified Künnecke’s sampling membrane is not taken as being a hydrophilic membrane.
Rolchigo teaches the analogous art of filtration module (Rolchigo; Title) that includes a sampling membrane (Rolchigo; fig. 5A. 52) wherein the sampling membrane is a hydrophilic membrane (Rolchigo; [0027]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Künnecke’s sampling membrane to be a hydrophilic membrane as taught by Rolchigo because Rolchigo teaches a sampling membrane that is constructed of hydrophilic material (Rolchigo; [0027]).
Having a hydrophilic membrane allows filtering the aqueous medium containing the sample transporting the analyte.
Regarding claim 10, modified Künnecke teaches the filtration module according to claim 1 (see above), characterized in that the analyzer is based on at least one of the following techniques: near-infrared spectroscopy (Künnecke; [0040]).
Regarding claim 11, modified Künnecke teaches a filtration assembly for filtering a process medium in a bioprocess the filtration assembly comprising the filtration module according to claim 1 (Künnecke; fig.3.10). Künnecke teaches a filtration module for filtering a process medium in a bioprocess (see claim 1 above).
Examiner notes that Applicant discloses [0027] the filtration assembly is for filtering a process medium in a bioprocess. Examiner will interpret the filtration assembly and the filtration module as the same structure until further clarification is provided,
and an analyzer (Künnecke; [0040]), coupled to the sampling outlet of the filtration module (Künnecke; [0050] “a sampling system comprising a sampling device 10 (filtration module, see claim 1 above), a sensor, wherein the sensor is connected to the outfeed line (sampling outlet).
Regarding claim 12,modified Künnecke teaches the filtration assembly according to claim 11 (see above), characterized in that the analyzer is based on at least one of the following techniques: near-infrared spectroscopy (Künnecke; [0040]).
Regarding claim 13, modified Künnecke teaches the filtration assembly according to claim 11 (see above), characterized by means for urging a transport medium through the sampling flow path (Künnecke; [0058] teaches a pump to generate pressure to transport the sample through the infeed line).
Regarding claim 14, modified Künnecke teaches the filtration assembly according to claim 11 (see above), comprising a process control unit configured to receive data from the analyzer and adjust or control process of the bioprocess.
Modified Künnecke teaches sensors that receive data from what could be an analyzer as Künnecke teaches the sensor makes the results available in the form of an electrical signal. Künnecke further teaches an implanted sensor which can be a component of the bioprocess (Künnecke; [0004]).
Response to Arguments
Applicant’s arguments, filed on 12/29/2025, with respect to the prior art rejections over Künnecke in view of Rolchigo have been fully considered and are not persuasive. The rejections have been modified in accord with the amendment.
With respect to claim 1 Applicant argues Künnecke does not teach a filtration module for filtering a process medium in a bioprocess.
Examiner disagrees. Künnecke teaches a filtration module and what the filtration module is used for is a matter of intended use.
Applicant also argues Künnecke does not teach a filtration module that is a cartridge.
Examiner disagrees. Rolchigo teaches a filtration module that is a cartridge (see claim 1 above).
Applicant further argues Rolchigo does not teach a plurality of different membranes.
Examiner disagrees. Rolchigo teaches a plurality of different membranes.
With respect to claim 5. Applicant argues claim 5 requires individual sampling membranes that are coupled to different sampling flow channels of the sampling flow path.
Examiner agrees. Claim 5 is being allowed.
With respect to claim 8, Applicant argues Künnecke does not teach the sampling membrane comprises a binding material on a surface of the capture membrane to capture an analyte from the process medium flowing through the process flow path.
Examiner disagrees. Rolchigo teaches the fibers 56 can be constructed of a polymeric, hydrophilic material [0027], and that the second plurality of fibers (56) can have different properties in order to achieve different filtering functionalities.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
In addition to the remarks of record, the instant claims define over the prior art because the cited prior art does not teach or fairly suggest the filtration module according to claim 4, characterized in that the individual sampling membranes are coupled to different sampling flow channels of the sampling flow path, and there is no motivation to modify Künnecke to provide these structures.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798