DETAILED ACTION
This detailed action is in response to the amendments and arguments filed on 12/22/2025, and any subsequent filings.
Notations “C_”, “L_” and “Pr_” are used to mean “column_”, “line_” and “paragraph_”.
Claims 1-20 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Response to Arguments
Claim Rejections - 35 USC § 103
Claims 1-5, 9, 11-13 and 15
The Applicant argues that the cited references do not teach the limitations of the amended Claims 1 and 9 (pg. 8-12). This argument is unpersuasive because this is directed towards the amended claims.
In response to applicant's arguments against the references individually (pg. 9-12), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claims 6-7
The Applicant argues that reference Lee does not cure the deficiencies of Antonchuk, Watzele, Benn and Creasey, as applied to Claim 9, upon which Claims 6-7 depend (pg. 9). This is unpersuasive because no reasons other than those offered with respect to Claim 9, from which Claims 6-7 depend, and thus is not persuasive for the reasons stated above with respect to Claim 9. Furthermore, reference Creasey was not applied to the rejection of Claim 9.
Claims 8 and 16
The Applicant argues that reference Creasey does not cure the deficiencies of Antonchuk, Watzele, Benn and Creasey, as applied to Claim 9, upon which Claims 8 and 16 depend (pg. 10). This is unpersuasive because no reasons other than those offered with respect to Claim 9, from which Claims 8 and 16 depends, and thus is not persuasive for the reasons stated above with respect to Claim 9. Furthermore, reference Creasey was not applied to the rejection of Claim 9.
Claims 10 and 19-20
The Applicant argues that references Nelson and Patterson do not cure the deficiencies of Antonchuk, Watzele and Benn, regarding the amended Claim 9 (pg. 10). This is unpersuasive because no reasons other than those offered with respect to Claim 9, from which Claim 10 depends, and with respect to Claim 16 and thus is not persuasive for the reasons stated above with respect to Claim 9.
Claim 14
The Applicant argues that references Rhode and Creasey do not cure the deficiencies of Antonchuk, Watzele and Benn, regarding the amended Claim 9 upon which Claim 14 depends (pg. 11). This is unpersuasive because no reasons other than those offered with respect to Claim 9, from which Claim 14 depends, and thus is not persuasive for the reasons stated above with respect to Claim 9.
Claim 17
The Applicant argues that references Horn and Tortorella do not cure the deficiencies of Antonchuk, Watzele, Benn and Creasey regarding the amended Claim 9 upon which Claim 17 depends (pg. 11-12). This is unpersuasive because no reasons other than those offered with respect to Claim 9, from which Claim 17 depends, and thus is not persuasive for the reasons stated above with respect to Claim 9. Furthermore, reference Creasey was not applied to the rejection of Claim 9.
Claim 18
The Applicant argues that reference Lee does not cure the deficiencies of Antonchuk, Watzele, Benn and Creasey, as applied to Claim 9, upon which Claim 18 depends (pg. 12). This is unpersuasive because no reasons other than those offered with respect to Claim 9, from which Claim 18 depends, and thus is not persuasive for the reasons stated above with respect to Claim 9. Furthermore, reference Creasey was not applied to the rejection of Claim 9.
Response to Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites “the sample chamber is recessed within the support” and Claim 9, upon which Claim 2 depends, recites “the sample chamber recessed from a support surface of a support such that the support forms a bottom surface of the sample chamber…”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 9, 11-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Antonchuk (US9290731B2) in view of Watzele (US7156996B2) and in further view of Benn (US20020106787A1).
The Applicant’s claims are directed towards an apparatus.
Regarding Claim 1, Antonchuk teaches a device (abstract), comprising:
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media_image1.png
696
520
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Greyscale
a support defining a support surface (Figs. 2A-2B, C13, L26-40, sidewall 212);
a shoulder surface offset from the support surface (Fig. 2B, C13, L26-40, seating surfaces 230 and 232);
a container (Figs. 2A-2B, C12, L61-C13, L7, second reservoir 206) including a semipermeable membrane (Figs. 2A-2B, C12, L61-C13, L7, filter 202) covering a terminal end of the container (Figs. 2A-2B), wherein the semipermeable membrane extends flat across the terminal end of the container (C6, L7-10, Figs. 2A-2B), the container having a container diameter (Figs. 2A-2B), the semipermeable membrane coupled to the terminal end of the container and contacting the shoulder surface (Figs. 2A-2B); and
a sample chamber (Figs. 2A-2B, C12, L61-C13, L7, first reservoir 204) positioned below the container (C11, L1-13 and C12, L14-34, fluid may be provided from either side of the filter into either reservoir) and recessed from the support surface (Figs. 2A-2B, C11, L1-13 and C12, L14-34, fluid may be provided from either side of the filter into either reservoir)
and having a lower chamber surface offset from the shoulder surface by a depth of between 25 μm and 500 μm (the reservoirs may have a diameter of between about 5 cm and about 6.5 cm, and the volume of the reservoirs may be between 0.5 cm3 and 1000 cm3 (C11, L45-46). The formula for the volume of a cylinder is:
V
=
π
r
2
h
The height of the reservoir can be solved by rearranging the formula for the volume of a cylinder thusly:
h
=
V
π
r
2
In the case where the diameter of the reservoir is 6.5 cm and the volume of the reservoir is 0.5 cm3, the height is:
h
=
V
π
r
2
=
0.5
c
m
3
π
(
3.25
c
m
)
2
=
0.0150
c
m
=
150
μ
m
Performing a similar calculation where the diameter is 5 cm and the volume is 0.5 cm3 yields a reservoir height of 250 µm) and equal to the distance (Figs. 2A-2B),
the sample chamber between the semipermeable membrane at the terminal end and the support such that the support forms a bottom surface of the sample chamber (Figs. 3A-3B, C13, L10-25, seating surface is seated on the rim of fluid vessel 334. Figs. 1A-1B, C12, L35-43, end faces 125, 127 of sidewalls may be covered by an end wall), the sample chamber having a sample chamber diameter (Figs. 2A-2B).
However, this embodiment of Antonchuk does not teach that the container diameter is larger than the sample chamber diameter.
Watzele also relates to a device (abstract), wherein the container diameter (dialysate chamber 8, C4, L33-36, Fig. 2) is larger than the sample chamber diameter (sample chamber 7, C4, L33-36, Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the container diameter to be larger than the sample chamber diameter in the device of Antonchuk (note that first 104 and second 106 reservoirs may be of a variety of sizes, Antonchuk, C11, L40-45 and Fig. 26B), as demonstrated by Watzele, so that the dimensions of the sample chamber provide for the use of small sample volumes while providing a large surface area for the sample to be in contact with the membrane to allow for more rapid dialysis of a sample (Benn, [0053], note that the sample chamber 30 has a diameter smaller than that of the membrane 50 (Benn, Fig. 1), which is in contact with dialysate solution (Benn, [0055] and [0094)), and so that the devices can be stacked for storage purposes or used together (Antonchuk, C11, L55-65).
Regarding Claims 9, 2-5, 11-13, and 15, Antonchuk teaches a device (abstract), comprising:
a sample (fluid, C10, L59-67 and C11, L1-13) having a first concentration of a substance (separate and collect two different populations of different sizes, C14, L37-46 and C14, L55-62) in a sample chamber (Figs. 2A-2B, C12, L61-C13, L7, first reservoir 204),
the sample chamber recessed (Figs. 2A-2B, C11, L1-13 and C12, L14-34, fluid may be provided from either side of the filter into either reservoir) from a support surface of a support (Figs. 2A-2B, C13, L26-40, sidewall 212) such that the support forms a bottom surface of the sample chamber (Figs. 3A-3B, C13, L10-25, seating surface is seated on the rim of fluid vessel 334. Figs. 1A-1B, C12, L35-43, end faces 125, 127 of sidewalls may be covered by an end wall) recessed from the support surface by a depth, wherein the depth is between 25 μm and 500 μm (see sample chamber thickness calculations in the analysis of Claim 1) to reduce a time for the sample to reach a target concentration, the sample chamber having a sample chamber diameter (Fig. 2B),
a dialysate (fluid, C10, L59-67 and C11, L1-13) having a second concentration of the substance in a dialysate container (Figs. 2A-2B, C12, L61-C13, L7, second reservoir 206), the dialysate container having a container diameter (Fig. 2B); and
a semipermeable membrane integrally formed with the dialysate container on one end of the dialysate container (Figs. 2A-2B, C12, L61-C13, L7, filter 202), wherein the semipermeable membrane extends flat across the one end of the dialysate container (C6, L7-10, Figs. 2A-2B), wherein the semipermeable membrane is in contact with the sample (C11, L4-13), the sample chamber being formed in a space defined by the semipermeable membrane in contact with the support (Fig. 2B).
However, this embodiment of Antonchuk does not teach that the container diameter is larger than the sample chamber diameter and the semipermeable membrane having a molecular cut-off weight greater than a molecular weight of the substance.
Watzele also relates to a device (abstract), wherein the container diameter (dialysate chamber 8, C4, L33-36, Fig. 2) is larger than the sample chamber diameter (sample chamber 7, C4, L33-36, Fig. 2) and the semipermeable membrane has a molecular cut-off weight greater than a molecular weight of the substance (C1, L15-19 and L50-54, and C4, L59-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the container diameter to be larger than the sample chamber diameter in the device of Antonchuk (note that first 104 and second 106 reservoirs may be of a variety of sizes, C11, L40-45 and Fig. 26B), as demonstrated by Watzele, so that the dimensions of the sample chamber provide for the use of small sample volumes while providing a large surface area for the sample to be in contact with the membrane to allow for more rapid dialysis of a sample (Benn, [0053], note that the sample chamber 30 has a diameter smaller than that of the membrane 50 (Benn, Fig. 1), which is in contact with dialysate solution (Benn, [0055] and [0094)), and so that the devices can be stacked for storage purposes or used together (Antonchuk, C11, L55-65). It would have been obvious to include a semipermeable membrane having a molecular cut-off weight greater than a molecular weight of the substance in the device of Antonchuk, as demonstrated by Watzele (sample chambers are in liquid exchange contact to a neighboring dialysis chamber via an exchange opening covered by a semipermeable membrane, where only molecules with a molecular weight below the molecular cut-off of the semipermeable membrane can diffuse from the sample chamber to the dialysate chamber or from the dialysate chamber to the sample chamber, abstract), in order to allow only desired substances to pass therethrough (Antonchuk, C10, L56-67, C14, L37-54, and C17, L45-59).
Additional Disclosures Included:
Claim 2: the sample chamber is recessed within the support (Antonchuk, Fig. 2B-3A).
Claim 3: the sample chamber is at least partially defined by a volume in a spacer (adhesive secures filter, Antonchuk, C12, L55-59) located between the support and the semipermeable membrane (Antonchuk, Fig. 2B).
Claim 4: the spacer includes double-sided adhesive tape (the side walls could be fashioned out of materials available in the lab, such as tape and parafilm (Antonchuk, C21, L47-67 and C31, L37-47)).
Claim 5: a sample cross-sectional area of the sample chamber is less than a membrane cross-sectional area of the semipermeable membrane (the diameter of the exchange opening 10 increases towards the dialysate chamber 8, Watzele, Fig. 2 and C5, L40-42), such that the sample chamber is completely enclosed by a seal between the dialysate container, the semipermeable membrane, and the support (Antonchuk, Fig. 2B).
Claim 11: the first concentration is less than the second concentration (the volume of fluid that may be provided has a first population of target entities dispersed therein and may further have a second population of target entities dispersed therein. For example, the first population of target entities, may include cellular aggregates and the second population of target entities may include single cells, and it may be desired to separate these entities and collect each (Antonchuk, C14, L55-62). The volume of fluid may be provided to a reservoir, then the fluid, including the aforementioned single cells, will pass through the filter while the cellular aggregates will be retained (Antonchuk, C15, L1-13). The single cells read on “a substance”, so the single cells passing through the semipermeable membrane from one reservoir to the next reservoir reads on “the first concentration is less than the second concentration”).
Claim 12: the support includes a plurality of sample chambers (multiple reservoir wells 708, Antonchuk, Fig. 8, C16, L55-C17, L8. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the support of the device of the combination of Antonchuk, Watzele and Benn to comprise a plurality of sample chambers, as demonstrated by Antonchuk, to wash and process cellular aggregates of each well separately, if desired (Antonchuk, C18, L11-14), and multiple sample chambers are needed for the high throughput required by many screening techniques (Watzele, C3, L5-10 and C3, L33-38)).
Claim 13: at least two sample chambers of the plurality of sample chambers includes a different sample (samples portioned in sample chambers exchange with a common neighboring dialysate chamber via the semipermeable membrane containing a buffer solution (Watzele, C1, L63-C2, L4). Equilibration of the samples originating from different biologic environments, which is a precondition for the comparability of subsequently performed tests, is performed by diffusion exchange (Watzele, C1, L63-C2, L4)).
Claim 15: a sample channel (opening 122, Antonchuk, C12, L35-43, Fig. 1B) connecting the sample chamber to a sample port (second inlet-outlet port 123, Antonchuk, C12, L14-34, Fig. 1B).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Antonchuk (US9290731B2), Watzele (US7156996B2) and Benn (US20020106787A1) as applied to claim 9 above, and further in view of Lee (WO2004029338A1).
The Applicant’s claims are directed towards an apparatus.
Regarding Claims 6-7, the combination of Antonchuk, Watzele and Benn teach the device of Claim 9, including a sample chamber depth of between 25 μm and 500 μm (as calculated in the analysis of Claim 1 above, the reservoirs can have reservoir heights between about 150 and about 250 μm), except that the support is a glass support and wherein that the sample chamber has a volume of between 1 μl and 50 μl.
Lee also relates to a device (abstract), wherein the support is a glass support (pg. 4, L11-27) and wherein the sample chamber has a volume of between 1 μl and 50 μl (pg. 1, L11-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the glass support of Lee and the device of the combination of Antonchuk, Watzele and Benn so that the transparent material can provide an advantage of visualization of the sample chamber during use (Lee, pg. 4, L11-27). It would have been obvious to combine the sample chamber volume of Lee and the device of the combination of Antonchuk, Watzele and Benn based on application of the device (Lee, pg. 2, L11-18 and Watzele, C1, L33-37).
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Antonchuk (US9290731B2), Watzele (US7156996B2) and Benn (US20020106787A1) as applied to claim 9 above, and further in view of Creasey (US20030213740A1).
The Applicant’s claims are directed towards an apparatus and a method.
Regarding Claim 8, the combination of Antonchuk, Watzele and Benn teach the device of Claim 9, including that the semipermeable membrane has a molecular cut-off weight (Watzele, abstract), except that the molecular cut-off weight is of between approximately 1,000 Dalton and 300,000 Dalton.
Creasey also relates to a device (abstract), the semipermeable membrane has a molecular cut-off weight of between approximately 1,000 Dalton and 300,000 Dalton ([0023]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the molecular cut-off weight of Creasey and the device of the combination of Antonchuk, Watzele and Benn to ensure that only target molecules are allowed to pass through the membrane as this varies depending on the particular application (Antonchuk, C10, L56-67), as only molecules with a molecular weight below the molecular weight cut-off of the semipermeable membrane can diffuse from the sample chamber to the dialysate chamber or from the dialysate chamber to the sample chamber (Watzele, abstract).
Regarding Claim 16, the combination of Antonchuk, Watzele and Benn teaches a method (Antonchuk, C5, L6-9), comprising:
placing the sample (fluid, Antonchuk, C10, L59-67 and C11, L1-13) of claim 9 (see analysis of Claim 9) having the first concentration of the substance (separate and collect two different populations of different sizes, Antonchuk, C14, L37-46 and C14, L55-62) in the sample chamber of claim 9 (Antonchuk, Figs. 2A-2B, C12, L61-C13, L7, first reservoir 204);
placing the dialysate container (Antonchuk, Figs. 2A-2B, C12, L61-C13, L7, second reservoir 206) of claim 9 (see analysis of Claim 9) on top of the sample chamber (Antonchuk, Fig. 3B) such that the semipermeable membrane (filter 102, Antonchuk, C10, L35-37, Figs. 1A-1B and 3A-3B) of claim 9 (see analysis of Claim 9) on a bottom of the dialysate container is in contact with the sample (Antonchuk, C11, L1-13 and C12, L14-34, fluid may be provided from either side of the filter into either reservoir),
the dialysate container including the dialysate (fluid, Antonchuk, C10, L59-67 and C11, L1-13) of claim 9 (see analysis of Claim 9) having the second concentration of the substance, the second concentration being different from the first concentration a volume of fluid having a first population of target entities is provided (Antonchuk, C6, L21-24. The first volume of fluid is allowed to pass through the filter membrane while retaining at least some of the second population of target entities, Antonchuk, C6, L32-36), wherein the membrane is permeable to the substance (the first volume of fluid is allowed to pass through the filter membrane while retaining at least some of the second population of target entities, Antonchuk, C6, L32-36).
However, the combination of Antonchuk, Watzele and Benn does not teach waiting for the first concentration to reach a target concentration.
Creasey teaches waiting for the first concentration to reach a target concentration ([0035]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include waiting for the first concentration in the method of the combination of Antonchuk, Watzele and Benn to reach a target concentration, as demonstrated by Creasey, so that, during and upon completion of equilibrium dialysis, quantitative and/or qualitative assays can be performed to further study the samples (Creasey, [0035]).
Claims 10 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Antonchuk (US9290731B2), Watzele (US7156996B2) and Benn (US20020106787A1) as applied to claim 9 above, and over Antonchuk (US9290731B2), Watzele (US7156996B2), Benn (US20020106787A1) and Creasey (US20030213740A1) as applied to claim 16 above, and further in view of Nelson (US5451322A) and Patterson (US6110373A).
The Applicant’s claims are directed towards an apparatus and a method.
Regarding Claims 10 and 19-20, the combination of Antonchuk, Watzele and Benn teaches the device of Claim 9 and the combination of Antonchuk, Watzele, Benn and Creasey teaches the method of Claim 16, except that the substance may be D2O.
Nelson also relates to a device and a method (abstract), wherein the substance includes isotopic water (C7, L38-C8, L2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the device of the combination of Antonchuk, Watzele and Benn and the method of the combination of Antonchuk, Watzele, Benn and Creasey to include a sample comprising isotopic water, as demonstrated by Nelson, such as D2O, so long as the semipermeable membrane used have a pore size and molecular composition sufficient to substantially allow permeation of H2O therethrough while substantially preventing permeation of heavy isotopes of water (Patterson, C3, L46-51).
Additional Disclosures Included:
Claim 20: dilution of the sample prior to reaching the target concentration is less than 40% (Nelson teaches that most samples of isotopic water exhibited a reduced of tritiated water concentration through the membrane from a starting concentration of about 11.0-11.2 pCi/mL to a final concentration ranging from about 2.9 to 10.9 pCi/mL (Nelson, C8, L9-13)).
permeation of heavy isotopes of water (Patterson, C3, L46-51).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Antonchuk (US9290731B2), Watzele (US7156996B2), Benn (US20020106787A1) and Creasey (US20030213740A1) as applied to claim 16 above, and further in view of Horn (US20050019774A1) and Tortorella (US6544417B1).
The Applicant’s claim is directed towards a method.
Regarding Claim 17¸ the combination of Antonchuk, Watzele, Benn and Creasey teaches the method of Claim 16, except that waiting for the first concentration to reach equilibrium includes waiting for less than 100 minutes.
Horn also relates to a method ([0010]), wherein waiting for the first concentration to reach equilibrium includes waiting for less than 100 minutes ([0067] and [0071-0072]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose a waiting time period, such as waiting for less than 100 minutes, as demonstrated by Horn, in the method of the combination of Antonchuk, Watzele, Benn and Creasey that is sufficient to allow molecules to pass through the membrane and into the sample vessels (Tortorella, C7, L56-64).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Antonchuk (US9290731B2), Watzele (US7156996B2), Benn (US20020106787A1) and Creasey (US20030213740A1) as applied to claim 16 above, and further in view of Lee (WO2004029338A1).
The Applicant’s claim is directed towards a method.
Regarding Claim 18¸ the combination of Antonchuk, Watzele, Benn and Creasey teaches the method of Claim 16, except that the sample has a volume of between 1 μl and 50 μl.
Lee also relates to a method (pg. 1, Pr1), wherein the sample chamber has a volume of between 1 μl and 50 μl (pg. 1, L11-15).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the sample chamber volume of Lee and the method of the combination of Antonchuk, Watzele, Benn and Creasey based on application of the device (Lee, pg. 2, L11-18 and Watzele, C1, L33-37).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BOI-LIEN THI NGUYEN whose telephone number is (703)756-4613. The examiner can normally be reached Monday to Friday, 8 am to 6 pm.
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/BOI-LIEN THI NGUYEN/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779
