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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claim 1- 5, 7, 8, 15-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2013/0231460 to Erbacher et al. (cited by applicant) in view of International Patent Application Publication No. WO0238503 to Iseki et al. (cited by applicant).
Erbacher et al. teaches a method and device for concentrating target compounds, including from urine samples (Title and [0022]).
The device of Erbacher et al. includes a first container 4 containing a super absorbent polymer and a second container 2 into which the first container is provided. The bottom of the first container includes a membrane. [0037], [0056]. (Fig. 4)
In use the super absorbent polymer absorbs water or aqueous solutions so as to form a concentrate of one of more target compounds (Abstract) that are collected in the bottom of the second container. [0056].
Erbacher et al. does not teach that the membrane has a hole diameter of 0.05 to 10 µm.
Erbacher et al. does teach target compounds, such as bacteria. Bacteria can be less than 10µm in size.
It would have been obvious to one of ordinary skill in the art to modify the membrane of Erbacher et al. by conducting routine engineering optimization experimentation and providing a membrane with a hole diameter size suitable for desired target compounds such as bacteria, including a hole diameter size of 0.05 to 10 µm.
Erbacher et al. does not teach using a porous membrane that consists of a material having a surface energy of 40 dynes/cm or more.
Iseki et al. teaches centrifugal cartridge and method of concentrating and capturing microorganisms that use a porous membrane made from any material selected from polyolefin type, cellulose acetate type, polysulfide type, PANA type, polyvinylidene fluoride type. (page 4, paragraph 10 of English translation).
Applicant discloses that cellulose acetate provides a surface energy of 50 dynes/cm at [0152]
It would have been obvious to make the porous membrane of Erbacher et al. from any suitable material, including cellulose acetate as taught by Iseki et al.
I.) Regarding applicant’s claim 1, as noted above Erbacher et al. in view of Iseki et al. teaches all the limitations of claim 1.
Therefore, Erbacher et al. in view of Iseki et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Erbacher et al. in view of Iseki et al. renders claim 1 obvious from which claim 1 depends.
Claim 2 recites that a material of the porous membrane is at least one selected from the group consisting of cellulose acetate, polyether sulfone, glass fiber, nylon, polyvinylidene fluoride, and polyolefin.
As noted above, Iseki et al. teaches centrifugal cartridge and method of concentrating and capturing microorganisms that use a porous membrane made from any material selected from polyolefin type, cellulose acetate type, polysulfide type, PANA type, polyvinylidene fluoride type. (page 4, paragraph 10 of English translation).
Applicant discloses that cellulose acetate provides a surface energy of 50 dynes/cm at [0152]
It would have been obvious to make the porous membrane of Erbacher et al. from any suitable material, including cellulose acetate as taught by Iseki et al.
Therefore, Erbacher et al. in view of Iseki et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Erbacher et al. in view of Iseki et al. renders claim 1 obvious from which claim 3 depends.
Claim 3 recites that the porous membrane is consisting of a material having a surface energy of 40 dynes/cm or more and 75 dynes/cm or less.
As noted above, Iseki et al. teaches centrifugal cartridge and method of concentrating and capturing microorganisms that use a porous membrane made from any material selected from polyolefin type, cellulose acetate type, polysulfide type, PANA type, polyvinylidene fluoride type. (page 4, paragraph 10 of English translation).
Applicant discloses that cellulose acetate provides a surface energy of 50 dynes/cm at [0152]
It would have been obvious to make the porous membrane of Erbacher et al. from any suitable material, including at cellulose acetate as taught by Iseki et al.
Therefore, Erbacher et al. in view of Iseki et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above Erbacher et al. in view of Iseki et al. renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that a swelling ratio of the super absorbent polymer is more than 0.2 g/g and less than 800 g/g.
Erbacher et al. teaches that the super absorbent polymer can be a polyacrylic acid-based polymer [0006].
Applicant discloses that AQUALIC CA® (a polyacrylic acid-based polymer) has a swelling ratio of 30 g/g.
Therefore, Erbacher et al. in view of Iseki et al. renders claim 4 obvious.
V.) Regarding applicant’s claim 5, as noted above Erbacher et al. in view of Iseki et al. renders claim 1 obvious from which claim 5 depends.
Claim 5 recites that the super absorbent polymer is a polyacrylic acid-based, polyacrylamide-based, cellulose-based, or polyethylene oxide-based polymer.
As noted above, Erbacher et al. teaches that the super absorbent polymer can be a polyacrylic acid-based polymer [0006].
Therefore, Erbacher et al. in view of Iseki et al. renders claim 5 obvious.
VI.) Regarding applicant’s claim 7, as noted above Erbacher et al. in view of Iseki et al. renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the sample solution is urine.
Erbacher et al. teaches urine samples. [0020]
Therefore, Erbacher et al. in view of Iseki et al. renders claim 7 obvious.
VII.) Regarding applicant’s claim 8, as noted above Erbacher et al. in view of Iseki et al. renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that a concentration of urea in the sample solution concentrated solution is 5-fold or less with respect to the concentration of the urea in the sample solution.
Erbacher et al. teaches using urine as a sample and using diluted solutions, but does not teach concentration of urea in the sample solution concentrated solution is 5-fold or less.
Since the super absorbent polymer in Erbacher et al. adsorbs water and aqueous solutions, it would have been obvious to one skilled in the art to conduct routine optimization experimentation to determine a suitable amount by which to dilute urine for testing, including determining a dilution amount of 5-fold or less depending in the amount of super absorbent material available.
Therefore, Erbacher et al. in view of Iseki et al. renders claim 8 obvious.
VIII.) Regarding applicant’s claim 15, as noted above Erbacher et al. in view of Iseki et al. renders claim 2 obvious from which claim 15 depends.
Claim 15 recites that the porous membrane is consisting of a material having a surface energy of 24 dynes/cm or more and 75 dynes/cm or less.
Erbacher et al. teaches a porous membrane but does not teach what the membrane is made of.
Iseki et al. teaches centrifugal cartridge and method of capturing, concentrating and capturing microorganisms that uses a porous membrane made from any material selected from polyolefin type, cellulose acetate type, polysulfone type, PANA type, polyvinylidene fluoride type. (page 4, paragraph 10 of English translation).
It would have been obvious to make the porous membrane of Erbacher et al. from any suitable material, including cellulose acetate as taught by Iseki et al.
As noted above, applicant discloses that cellulose acetate has a surface energy of 50 dynes/cm. [0152]
Therefore, Erbacher et al. in view of Iseki et al. renders claim 15 obvious.
IX.) Regarding applicant’s claim 16, as noted above Erbacher et al. in view of Iseki et al. renders claim 2 obvious from which claim 16 depends.
Claim 16 recites that a swelling ratio of the super absorbent polymer is more than 0.2 g/g and less than 800 g/g.
Erbacher et al. teaches that the super absorbent polymer can be a polyacrylic acid-based polymer [0006].
Applicant discloses that AQUALIC CA® (a polyacrylic acid-based polymer) has a swelling ratio of 30 g/g.
Therefore, Erbacher et al. in view of Iseki et al. renders claim 16 obvious.
X.) Regarding applicant’s claim 17, as noted above Erbacher et al. in view of Iseki et al. renders claim 2 obvious from which claim 17 depends.
Claim 17 recites that the super absorbent polymer is a polyacrylic acid-based, polyacrylamide-based, cellulose-based, or polyethylene oxide-based polymer.
As noted above, Erbacher et al. teaches that the super absorbent polymer can be a polyacrylic acid-based polymer [0006].
Therefore, Erbacher et al. in view of Iseki et al. renders claim 17 obvious.
XI.) Regarding applicant’s claim 19, as noted above Erbacher et al. in view of Iseki et al. renders claim 2 obvious from which claim 19 depends.
Claim 19 recite that the sample solution is urine.
Erbacher et al. teaches urine samples. [0020]
Therefore, Erbacher et al. in view of Iseki et al. renders claim 19 obvious.
XII.) Regarding applicant’s claim 20, as noted above Erbacher et al. in view of Iseki et al. renders claim 19 obvious from which claim 20 depends.
Claim 20 recites that a concentration of urea in the sample solution concentrated solution is 5-fold or less with respect to the concentration of the urea in the sample solution.
Erbacher et al. teaches using urine as a sample and using diluted solutions, but does not teach concentration of urea in the sample solution concentrated solution is 5-fold or less.
Since the super absorbent polymer in Erbacher et al. adsorbs water and aqueous solutions, it would have been obvious to one skilled in the art to conduct routine optimization experimentation to determine a suitable amount by which to dilute urine for testing, including determining a dilution amount of 5-fold or less depending in the amount of super absorbent material available.
Therefore, Erbacher et al. in view of Iseki et al. renders claim 20 obvious.
2. Claims 6 and 18 are rejected under 35 USC 103 as being unpatentable over Erbacher et al. in view of Iseki et al. as applied to claims 1 and 2 and further in view of International Patent Application Publication No. WO2020089797 to Freire et al. (cited by applicant)
I.) Regarding applicant’s claim 6, as noted above Erbacher et al. in view of Iseki et al. renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the high-molecular-weight molecule contained in the biological fluid is an antigen.
Erbacher et al. teaches urine samples. [0020]
Erbacher et al. in view of Iseki et al. does not specifically teach targeting antigens.
Freire et al. teaches concentrating antigen from urine samples. (Abstract).
It would have been obvious to one of ordinary skill in the art to modify Erbacher et al. in view of Iseki et al. to concentrate antigen from urine samples as taught by Freire et al. for purposes of detecting prostate cancer.
Therefore, Erbacher et al. in view of Iseki et al, and Freire et al. renders claim 6 obvious.
II.) Regarding applicant’s claim 18, as noted above Erbacher et al. in view of Iseki et al. renders claim 2 obvious from which claim 18 depends.
Claim 18 recites that the high-molecular-weight molecule contained in the biological fluid is an antigen.
Erbacher et al. teaches urine samples. [0020]
Erbacher et al. in view of Iseki et al. does not does not specifically teach targeting antigens.
Freire et al. teaches concentrating antigen from urine samples. (Abstract)
It would have been obvious to one of ordinary skill in the art to modify Erbacher et al. to concentrate antigen from urine samples as taught by Freire et al. for purposes of detecting prostate cancer.
Therefore, Erbacher et al. in view of Freire et al. and Iseki et al. renders claim 6 obvious.
3. Claims 9-11 are rejected under 35 USC 103 as being unpatentable over Erbacher et al. in view of Iseki et al. as applied to claim 1 and further in view of International Patent Application Publication No. WO 2020/108390 to Eric et al. (cited by applicant)
I.) Regarding, applicant’s claim 9, claim 9 recites a sample solution concentration method comprising, in the following order: a sample solution injection step of injecting the sample solution into the first container;
a water absorption step in which a solution contained in the sample solution injected into the first container is absorbed by a super absorbent polymer accommodated in the first container to generate, in the first container, a sample solution concentrated solution, which is a concentration solution of the sample solution;
a discharge step of applying an external force to the sample solution concentrated solution to discharge the sample solution concentrated solution from the discharge unit; and
a recovery step of recovering the sample solution concentrated solution discharged from the discharge unit, in the second container.
As noted above, Erbacher et al. teaches a method and device for concentrating target compounds, including from urine samples (Title and [0022]).
The device of Erbacher et al. includes a first container 4 containing a super absorbent polymer and a second container 2 into which the first container is provided. The bottom of the first container includes a membrane. [0037], [0056].
Erbacher et al. teaches diluting samples and using the super absorbent polymer to absorb water or aqueous solutions so as to form a concentrate of one of more target compounds (Abstract) that are collected in the bottom of the second container. [0056].
Erbacher et al. in view of Iseki et al. does not teach applying an external force to the sample solution concentrated solution to discharge the sample solution concentrated solution from the first container into the second container.
Eric et al. teaches a subjecting hydrogel particles to centrifugation to remove a concentrated filtrate from a first container to a second container (See Fig. 4 and Example 4 on page 7 of English translation).
It would have been obvious to one of ordinary skill in the art to modify Erbacher et al. in view of Iseki et al. to apply a centrifugal force to discharge the concentrated sample from the first container to the second container as taught by Eric et al. for purposes of expediting the recovery of the concentrated sample.
Therefore, Erbacher et al. in view of Iseki et al. and Eric et al. renders claim 9 obvious.
II.) Regarding applicant’s claim 10, as noted above Erbacher et al. in view of Iseki et al. and Eric et al. renders claim 9 obvious from which claim 10 depends.
Claim 10 recites that the external force is a centrifugal force.
As noted above, it would have been obvious to one of ordinary skill in the art to modify Erbacher et al. in view of Iseki et al. to apply a centrifugal force to discharge the concentrated sample from the first container to the second container as taught by Eric et al. for purposes of expediting the recovery of the concentrated sample.
Therefore, Erbacher et al. in view of Iseki et al. and Eric et al. renders claim 10 obvious.
III.) Regarding applicant’s claim 11, as noted above Erbacher et al. in view of Iseki et al. and Eric et al. renders claim 10 obvious from which claim 11 depends.
Eric et al. teaches horizontal rotating head Centrifuge at 3000xg for 3 minutes in Example 4.
It would have been obvious to one of ordinary skill in the art to conduct routine optimization experimentation to determine a suitable rpm by which to centrifuge Erbacher et al. in view of Eric et al. to collect the concentrated sample in a desired period of time.
Therefore, Erbacher et al. in view of Iseki et al. and Eric et al. renders claim 11 obvious.
4. Claims 12 and 13 are rejected under 35 USC 103 as being unpatentable over Erbacher et al. in view of Iseki et al. and Eric et al. as applied to claim 9 above and further in view of U.S. Patent Application Publication No. 2018/0292398 to Wada et al. (cited by applicant)
I.) Regarding applicant’s claim 12, claim 12 recites concentrating a sample solution according to the method of claim 9 and detecting the high-molecular-weight molecule container in the biological fluid in the obtained sample solution concentration.
As noted above, it would have been obvious to one of ordinary skill in the art to modify Erbacher et al. in view of Iseki et al. to apply a centrifugal force to discharge the concentrated sample from the first container to the second container as taught by Eric et al. for purposes of expediting the recovery of the concentrated sample.
Wada et al. teaches an immunochromatographic kit and method for detecting target compounds in biological fluid samples using antigen-antibody reactions [0005].
It would have been obvious to one or ordinary skill in the art to combine Erbacher et al. in view of Iseki et al. and Eric et al. with Wada et al. and detect target compounds in the concentrated samples prepared by Erbacher et al. using the an immunochromatographic kit and method of Wada et al. as a convenient way to perform such detecting.
Therefore, Erbacher et al. in view of Iseki et al., Eric et al. and Wada et al. renders claim 12 obvious.
II.) Regarding applicant’s claim 13, as noted above Erbacher et al. in view of Iseki et al., Eric et al. and Wada et al. renders claim 12 obvious from which claim 13 depends.
Claim 13 recites that the sample solution is an aqueous solution in which an antigen is containable, the detection step is a step of detecting the antigen in the antigen-concentrated solution by immunochromatography using an antigen-antibody reaction.
As noted above, Wada et al. teaches an immunochromatographic kit and method for detecting target compounds in biological fluid samples using antigen-antibody reactions [0005].
Therefore, Erbacher et al. in view of Iseki et al., Eric et al. Wada et al. renders claim 13 obvious.
5. Claims 14 is rejected under 35 USC 103 as being unpatentable over Erbacher et al. in view of Iseki et al. as applied to claim 1 above and further in view of Wada et al.
I.) Regarding applicant’s claim 14, claim 14 recites a kit for detecting a high-molecular-weight molecule contained in a biological fluid in a sample solution which is an aqueous solution containing the high-molecular-weight molecule contained in the biological fluid, the examination kit comprising: the concentration device according to claim 1; and a detection device that includes an examination strip having an examination region for detecting the high-molecular-weight molecule contained in the biological fluid, a first pot and a second pot in which a first amplification solution and a second amplification solution for amplifying an examination signal in the examination region are enclosed respectively, and a housing case encompassing the examination strip, the first pot, and the second pot.
As noted above, Erbacher et al. teaches a method and device for concentrating target compounds, including from urine samples (Title and [0022]).
The device of Erbacher et al. includes a first container 4 containing a super absorbent polymer and a second container 2 into which the first container is provided. The bottom of the first container includes a membrane. [0037], [0056]. (Fig. 4)
In use the super absorbent polymer absorbs water or aqueous solutions so as to form a concentrate of one of more target compounds (Abstract) that are collected in the bottom of the second container. [0056].
Erbacher et al. does not teach that the membrane has a hole diameter of 0.05 to 10 µm.
Erbacher et al. does teach target compounds, such as bacteria. Bacteria can be less than 10µm in size.
It would have been obvious to one of ordinary skill in the art to modify the membrane of Erbacher et al. by conducting routine engineering optimization experimentation and providing a membrane with a hole diameter size suitable for desired target compounds such as bacteria, including a hole diameter size of 0.05 to 10 µm.
Erbacher et al. does not teach using a porous membrane that consists of a material having a surface energy of 40 dynes/cm or more.
Iseki et al. teaches centrifugal cartridge and method of concentrating and capturing microorganisms that use a porous membrane made from any material selected from polyolefin type, cellulose acetate type, polysulfide type, PANA type, polyvinylidene fluoride type. (page 4, paragraph 10 of English translation).
Applicant discloses that cellulose acetate provides a surface energy of 50 dynes/cm at [0152]
It would have been obvious to make the porous membrane of Erbacher et al. from any suitable material, including at cellulose acetate as taught by Iseki et al.
Therefore Erbacher et al. in view of Iseki et al. renders obvious claim 1 obvious.
Wada et al. teaches an immunochromatographic kit and method for detecting target compounds in biological fluid samples that includes first and second amplification liquids that are contained in first and second pots and an inspection strip (“examination strip”) 1. (Fig. 1 and [0011-]).
It would have been obvious to one of ordinary skill in the art to provide the concentration device of Erbacher et al. in view Iseki et al. together with the immunochromatographic kit of Wada et al. as an examination kit for point of care testing purposes.
Therefore, Erbacher et al. in view of Iseki et al. and Wada et al. renders claim 14 obvious.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
Applicant states that Seiki (Iseki) shows cellulose acetate as an exemplary material of a filter, but Seiki fails to teach or suggest that with a material of the filter having a surface energy of 40 dynes/cm or more, the concentration rate is increased.
Iseki et al. together with the other relied upon prior art references render all the limitations of applicant’s claimed invention obvious.
Applicant’s pending claims do not recite that concentration rate is increased, or by what degree the concentration rate is increased.
As noted above, applicant discloses that cellulose acetate provides a surface energy of 50 dynes/cm at [0152] so that the cellulose acetate taught by Iseki et al. meets the surface energy range recited in claim 1.
Applicant’s arguments concerning Iseki et al. teaching polyethylene (polyolefin) are not germane inasmuch as Iseki et al. has been relied upon as teaching cellulose acetate.
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 MICHAEL S. GZYBOWSKI whose telephone number is (571)270-3487. The examiner can normally be reached M-F 8:30-5:00.
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/M.S.G./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798