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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 December 2025 has been entered.
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 16 December 2025. Claims 1-31 have been cancelled. Claims 32-40 have been newly added. Claims 32-40 are being examined herein.
Status of Objections and Rejections
The rejections to claims 1, 4, 9, and 13-16 under 35 U.S.C. 103 are withdrawn in view of the cancellation of the claims.
Response to Arguments
Applicant’s arguments, see Remarks pages 06-10, filed 16 December, with respect to the rejection(s) of claim(s) 1, 4, 9, and 13-16 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Burgess, et. al. (US 20100221838 A1) in view of Flieg, et. al. (US 20150320924 A1) and Babcock, et. al. (US 20070205155 A1).
Burgess teaches a dialysis adapter cell [Abstract] for in vitro release testing of colloidal dispersion systems [par. 0007] wherein the system for in vitro release testing of drugs comprises a medium reservoir 102 that consists of a container to hold the dissolution medium that has the ability to be closed or open configuration, a pump 104 to move the fluid from the medium reservoir through a flow through cell with a dialysis adapter and back to the reservoir [Fig. 5; par. 0037].
Flieg teaches a hollow fiber filtration device for medical, chemical and biotechnical applications wherein the filtrate space is filled with "with particles of a chemically or physically active substance" [Abstract]. Flieg teaches a hollow fiber membrane module filtration device comprising a housing 2 holding a plurality of hollow fibers 3 and surrounded by a filtrate space 4. Flieg teaches the fluid to be treated inter the housing through inlet 7b, moves through the hollow fibers 3, interacts with the particulate material (active substance) in the filtrate space 4, and exits the hollow fibers 3 through outlet 8 [Fig. 2, 10; par. 0023]
Claim Objections
Claim 1 is objected to because of the following informalities: The claims recites “or a retentate flow path” in lines 5-6 of the claim. The use of the term “retentate” has sense been amended to recite “dissolution media.” Because the temperature controlling unit is heating the dissolution media within the media reservoir, to maintain the consistency of the claim language and prevent confusion, examiner recommends amending the phrase to recite “or a dissolution media flow path.” Appropriate correction is required.
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 32-40 are 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 32 recites the limitation "the circulating diffusion medium" in line 20 of the claim. There is insufficient antecedent basis for the diffusion medium in the claim. Examiner believes this should read “dissolution media” instead of “diffusion media” and will be examined as such. Appropriate correction is required.
Claim 32 recites the limitation “a retentate medium” in line 21 of the claim. "A retentate medium" is recited previously in line 14 of the same claim. Examiner believes this to be the same retentate medium and will be examined as such. Examiner recommends amending the claim to recite "the retentate medium" or an equivalent thereof.
Claims 33-40 are rejected based on their dependence to claim 32.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 32-40 are rejected under 35 U.S.C. 103 as being unpatentable over Burgess, et. al. (US 20100221838 A1) in view of Flieg, et. al. (US 20150320924 A1) and Babcock, et. al. (US 20070205155 A1).
Regarding claim 32, Burgess teaches a dialysis adapter cell [Abstract] for in vitro release testing of colloidal dispersion systems [par. 0007] (for in-vitro release testing of a drug from a dosage form). Burgess teaches a system for in vitro release testing of drugs comprising a medium reservoir 102 that consists of a container to hold the dissolution medium that has the ability to be closed or open configuration, a pump 104 to move the fluid from the medium reservoir through a flow through cell with a dialysis adapter and back to the reservoir [Fig. 5; par. 0037] (a media reservoir configured to hold dissolution media) (a pump connected to the media reservoir and configured to pump dissolution media from the media reservoir) (wherein the retentate medium is returned… to the media reservoir). Burgess also teaches the dissolution medium can be heated via a water bath when moving from the medium reservoir to the dialysis cell [par. 0039] (at least one temperature-controlling unit in thermal contact with either the media reservoir or a retentate flow path). Burgess teaches a long, cylindrical dialysis adapter cell holding a dialysis membrane is placed in a standard USP dissolution apparatus 4 where the analyte of interest is disposed; the dialysis membrane used can change depending on type of dialysis being performed and type of analyte being tested [par. 0030, 0033, 0042] (wherein the system is compatible with a United States Pharmacopeia (USP) Type-4 dissolution apparatus without immersing the dosage form in bulk dissolution media).
Burgess is silent to a hollow-fiber module comprising: (i) a closed permeate chamber configured to hold the dosage form; and (ii) a retentate chamber comprising a plurality of hollow-fiber microtubular membranes and wherein drug released from the dosage form diffuses through the hollow-fiber membranes into the circulating diffusion medium to form a retentate medium and when the retentate medium is returned to the media reservoir it is returned from the hollow- fiber module and wherein the pump is configured to circulate the dissolution medium only through the retentate chamber of the hollow-fiber module while the permeate chamber remains closed
Flieg teaches a hollow fiber filtration device for medical, chemical and biotechnical applications wherein the filtrate space is filled with "with particles of a chemically or physically active substance" [Abstract]. Flieg teaches a hollow fiber membrane module filtration device comprising a housing 2 holding a plurality of hollow fibers 3 and surrounded by a filtrate space 4. Flieg teaches the fluid to be treated inter the housing through inlet 7b, moves through the hollow fibers 3, interacts with the particulate material (active substance) in the filtrate space 4, and exits the hollow fibers 3 through outlet 8 [Fig. 2, 10; par. 0023] (a hollow-fiber module comprising: (i) a closed permeate chamber configured to hold the dosage form; and (ii) a retentate chamber comprising a plurality of hollow-fiber microtubular membranes). Flieg teaches the inner space of the hollow fibers and the filtrate space are not required to be interconnected through respective inlets 7b, 7a and outlets 8, 9, meaning the filtrate space (permeate chamber) can be effectively closed off from the inner space of the hollow fibers (retentate chamber) keeping the active/treatment media entirely separate from the media to be treated except for what moves across the hollow fiber membranes [par. 0012] (wherein drug released from the dosage form diffuses through the hollow-fiber membranes into the circulating diffusion medium to form a retentate medium). Flieg teaches the use of hollow fiber membranes as a filter for monitoring medically active compounds because hollow fibers allow fluids to interact with a target substance with high productivity and selectivity [par. 0002-0004]
Putting the devices of Burgess and Flieg together, specifically the pump 104 of Burgess [Burgess, Fig. 5; par. 0037], and the hollow fiber module of Flieg [Flieg, Fig. 2; par. 0023], the pump is designed to only pump the dissolution media through the retentate chamber of the hollow fiber module and return it the media reservoir where it is recirculated (wherein the pump is configured to circulate the dissolution medium only through the retentate chamber of the hollow-fiber module while the permeate chamber remains closed) (wherein the retentate medium is returned from the hollow- fiber module to the media reservoir).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the dialysis adapter cell of Burgess to have the membrane be a hollow fiber module as taught by Flieg in order to have a filtration device capable of high productivity and selectivity. Because both systems monitor the flow of a medically active substance around a membrane barrier, modifying the membrane to be hollow fiber module as provided by Flieg, provides likewise sought functionality with reasonable expectation of success. MPEP 2143 (I)(G).
Modified Burgess in view of Flieg is still silent to the plurality of hollow fiber microtubular membranes having a total surface area of between 5 to 92 cm2 and a retentate medium volume processing ability of between 20-1000 mL.
Babcock teaches a membrane-permeation test and microporous membrane for evaluating pharmaceutical compositions [Abstract]. Babcock teaches an embodiment of the microporous membrane system comprising a plurality of hollow-fiber membranes within a housing [Fig. 7; par. 0035]. Babcock teaches the dosage in the feed solution is on the outside surface and moves into the inner area of the membrane to be collected [par. 0026-0027].
Babcock further teaches a plurality of factors define how the filtration device operate. Specifically, Babcock teaches wherein the surface area of the hollow fiber membranes, volume, time, flow rate, solubility factors, concentration and more go in to determine the effectiveness of the hollow fiber module [par. 0048]. Therefore, the goal is to optimize each element of the device in order to closely mimic in vivo absorption rates [par. 0006-0007]. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have the plurality of hollow fibers microtubular membranes to have a total surface area of between 5 to 92 cm2 and a retentate medium volume processing ability of between 20-1000 mL.
Regarding claim 33, Modified Burgess in view of Babcock teaches the dosage in the feed solution is on the outside surface and moves into the inner area of the membrane to be collected [Babcock, par. 0026-0027].
Babcock further teaches a plurality of factors define how the filtration device operate. Specifically, Babcock teaches wherein the surface area of the hollow fiber membranes, volume, time, flow rate, solubility factors, concentration of active substance in the permeate chamber, and more go in to determine the effectiveness of the hollow fiber module [Babcock, par. 0048]. Therefore, the goal is to optimize each element of the device in order to closely mimic in vivo absorption rates [Babcock, par. 0006-0007]. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have the concentration of the active substance applied to the permeate chamber to have an equivalent sampling load of about 1.2 to 1.4 grams.
Regarding claim 34, Modified Burgess in view of Babcock teaches the dosage in the feed solution is on the outside surface and moves into the inner area of the membrane to be collected [Babcock, par. 0026-0027].
Babcock further teaches a plurality of factors define how the filtration device operate. Specifically, Babcock teaches wherein the surface area of the hollow fiber membranes, volume, time, flow rate, solubility factors, concentration and more go in to determine the effectiveness of the hollow fiber module [Babcock, par. 0048]. Therefore, the goal is to optimize each element of the device in order to closely mimic in vivo absorption rates [Babcock, par. 0006-0007]. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have the total surface area of the plurality of hollow-fiber microtubular membranes is about 20 cm2.
Regarding claim 35, Modified Burgess, in view of Flieg teaches the hollow fiber membranes can be made of polysulfones or polyaryl(ether)sulfones, polyacrylonitrile, and polyolefins such as polyethylene [Flieg, par. 0069] (wherein the plurality of hollow-fiber membranes are polysulfone, polyethersulfone, polyacrylonitrile, or polyethylene-based membranes).
Regarding claim 36, Modified Burgess in view of Flieg teaches the material of the hollow fiber membranes influences the size of the molecules that can pass through the membrane [Flieg, par. 0013, 0073, 0075-0076]. Flieg teaches hollow fiber membrane can be made of material that allows up to molecules of 70 kD [Flieg, par. 0013], up to 45 kD, or between 90 to 200 kD to pass through the membrane [Flieg, par. 0073] (wherein the hollow-fiber module is an ultrafiltration module).
Regarding claim 37, Modified Burgess teaches wherein in one example, ophthalmic suspension of dexamethasone was analyzed [Burgess, par. 0043] (wherein the system is configured to evaluate ophthalmic suspensions).
Regarding claim 38, Modified Burgess teaches the pump having flow rates of 4, 8, and 16 mL/min [Burgess, par. 0039] (wherein the retentate medium is recirculated at a flow rate between 4 to 32 ml/min).
Regarding claim 39, Modified Burgess in view of Flieg teaches the hollow fibers are arranged in a linear fashion so that the length of the hollow fibers aligns with the length of the housing in order to provide "optimized permeation of flow" [Flieg, Fig. 2, par. 0012] (wherein the plurality of hollow-fiber membranes are arranged linearly to maintain consistent mass-transfer area).
Regarding claim 40, Modified Burgess in view of Flieg teaches the hollow fiber module can have a wide range of usable volume space ranging from 20 to 500 mL [Flieg, par. 0083] and a wide range of membrane surface area ranging from 0.4 to 1.2 m2 [Flieg, par. 0071]. If a surface area of 0.5 cm2 and a volume space of 350 mL is used, then a membrane area-to-volume (MAV) ratio of just over 14 cm2/mL is realized (wherein the permeate chamber volume and membrane surface areas define a membrane area-to-volume (MAV) ratio of approximately 14-17 cm2/mL).
Further, Flieg teaches wherein the usable volume space of the hollow fiber module can vary depending on the specific use of the module. Specifically, Flieg teaches the type of filtration being performed and the type of material being used will influence the usable volume space [Flieg, par. 0083]. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the permeate chamber volume and thus a membrane area-to-volume (MAV) ratio [to be] approximately 14-17 cm2/mL.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758