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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 22, 2025 has been entered.
Response to Amendment
This is an office action in response to applicant’s arguments and remarks filed on December 22, 2025. Claims 2-19, 21-24, 26-27, and 43-49 are pending in the application and are being examined herein.
Status of Objections and Rejections
The objection to the claims is withdrawn in view of Applicant’s amendment.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection under 35 U.S.C. 102(a)(1)/102(a)(2) and 35 U.S.C. 103 are necessitated by the amendments.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 4-5, 11, 16-17, 19, 21, 26-27, and 45-49 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Strickler (US 3,412,008 A) (hereinafter “Strickler-1”).
Regarding claim 2, Strickler-1 teaches an apparatus (an apparatus, Figs. 3-4, col. 4, lns. 31-34; Examiner notes that the elements in Figs. 3-4 that are the same as Figs. 1-2 will be described with the same reference characters as in Figs. 1-2), comprising:
a body (plate 14 and housing 26, Figs. 3-4, col. 3, lns. 3 & 25) defining:
an inlet configured to receive a sample containing a plurality of analytes in a sample buffer (the plate 14 supports a tube 50 for injecting a sample containing a plurality of components into an electrolyte, Figs. 3-4, col. 3, lns. 71-74);
an outlet configured to expel a fractionated portion of the sample (the plate 14 supports a tube 52 for removing a separated component of the sample, Figs. 3-4, col. 4, lns. 6-21);
a catholyte channel containing a first electrolyte buffer and configured to be coupled to a cathode (the housing 26 defines a first elongated chamber 28 containing a single electrolyte buffer composition in a first intermediate zone A and a first electrode space B, Figs. 3-4, col. 3, lns. 23-24, col. 4, lns. 35-49, col. 5, lns. 1-4; a first wire electrode 40 which is a cathode is disposed in the first electrode space B of the first elongated chamber 28, Figs. 3-4, col. 3, lns. 19 & 51-52);
an anolyte channel containing a second electrolyte buffer and configured to be coupled to an anode (the housing 26 defines a second elongated chamber 28 containing a single electrolyte buffer composition in a second intermediate zone A and a second electrode space B, Figs. 3-4, col. 3, lns. 23-24, col. 4, lns. 35-49, col. 5, lns. 1-4; a second wire electrode 40 which is an anode is disposed in the second electrode space B of the second elongated chamber 28, Figs. 3-4, col. 3, lns. 19 & 51-52);
a cover (a plate 12, Fig. 3, col. 3, ln. 3);
a hydrodynamic impediment (an ion-permeable barrier 20 made of regenerated cellulose which does not significantly impede ionic flow while being only very slowly permeable to bulk flow of liquids, Figs. 3-4, col. 3, lns. 7-16); and
a center channel at least partially formed by the hydrodynamic impediment, the body, and the cover (a working space 10 at least partially formed by the ion-permeable barriers 20 and the plates 12 and 14, Figs. 3-4, col. 2, lns. 71-72, col. 3, lns. 1-12); wherein the center channel extends between the inlet and the outlet, wherein the center channel is parallel to the catholyte channel and the anolyte channel (the working space 10 extends between the inlet tube 50 and the outlet tube 52, wherein the working space 10 is parallel to the first and second elongated chambers 28, Figs. 3-4, col. 3, lns. 23-24 & 68-74, col. 4, lns. 4-21); and
wherein the hydrodynamic impediment allows at least some of the plurality of analytes to migrate into the hydrodynamic impediment towards one of the catholyte channel or the anolyte channel (the ion-permeable barrier 20 made of regenerated cellulose does not significantly impede ionic flow while being only very slowly permeable to bulk flow of liquids, Figs. 3-4, col. 3, lns. 7-16; when a potential gradient is applied to the electrolyte in the working space 10 by connecting a source of D.C. power to the electrodes 40, the sample particles are separated under the influence of the electrical field into various particle groups or components forming distinctive zones or bands which typically fan out from the point of sample injection, Figs. 3-4, col. 4, lns. 3-14; thus, the ion-permeable barrier 20 is porous and capable of allowing at least some of the separated sample components to permeate therethrough towards one of the elongated chambers 28).
The limitations "a sample containing a plurality of analytes in a sample buffer," "a fractionated portion of the sample," and "at least some of the plurality of analytes to migrate into the hydrodynamic impediment towards one of the catholyte channel or the anolyte channel" are with respect to an article worked upon (sample and analytes) and not a positively recited element of the apparatus. Inclusion of the material or article worked upon (sample and analytes) by a structure (apparatus) being claimed does not impart patentability to the claims. MPEP § 2115.
The limitations "receive a sample containing a plurality of analytes in a sample buffer," "expel a fractionated portion of the sample," "be coupled to a cathode," "be coupled to an anode," and "allows at least some of the plurality of analytes to migrate into the hydrodynamic impediment towards one of the catholyte channel or the anolyte channel" are interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The apparatus disclosed by Strickler-1 teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as discussed in the rejection supra.
Regarding claim 4, Strickler-1 teaches wherein the hydrodynamic impediment is a first hydrodynamic impediment in direct fluid contact with the center channel and the first electrolyte buffer (the first ion-permeable barrier 20 in direct fluid contact with the working space 10 and the electrolyte buffer in the first elongated chamber 28, Figs. 3-4, col. 3, lns. 6-9 & 21-25, col. 4, lns. 63-65), and wherein the apparatus further comprises:
a second hydrodynamic impediment in direct fluid contact with the center channel and the second electrolyte buffer (the second ion-permeable barrier 20 in direct fluid contact with the working space 10 and the electrolyte buffer in the second elongated chamber 28, Figs. 3-4, col. 3, lns. 6-9 & 21-25, col. 4, lns. 63-65).
Regarding claim 5, Strickler-1 teaches wherein the first electrolyte buffer and the second electrolyte buffer are a common electrolyte buffer (a single electrolyte buffer composition is used throughout the apparatus for the first and second elongated chambers 28, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4).
Regarding claim 11, Strickler-1 teaches the anode (the second wire electrode 40 which is the anode is disposed in the second electrode space B of the second elongated chamber 28, Figs. 3-4, col. 3, lns. 19 & 51-52); and
the cathode (the first wire electrode 40 which is the cathode is disposed in the first electrode space B of the first elongated chamber 28, Figs. 3-4, col. 3, lns. 19 & 51-52).
Regarding claim 16, Strickler-1 teaches wherein the anolyte channel and the catholyte channel are collectively configured to apply an electric field across and perpendicular to the center channel (a potential gradient is applied to the electrolyte in the working space 10 by connecting a source of D.C. power to the electrodes 40 in the first and second elongated chambers 28, and the sample particles are separated under the influence of the electrical field into various particle groups or components forming distinctive zones or bands which typically fan out from the point of sample injection, Figs. 3-4, col. 3, lns. 27-29 & 51-54, col. 4, lns. 3-14).
The limitation "apply an electric field across and perpendicular to the center channel" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The apparatus disclosed by Strickler-1 teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as discussed in the rejection supra.
Regarding claim 17, the limitation "the plurality of analytes includes peptides having different isoelectric points between 1 and 11" is with respect to an article worked upon (analytes) and not a positively recited element of the apparatus. Inclusion of the material or article worked upon (analytes) by a structure (apparatus) being claimed does not impart patentability to the claims. MPEP § 2115.
Regarding claim 19, Strickler-1 teaches wherein the first electrolyte buffer or the second electrolyte buffer has a pH matching a pH of the sample buffer (a single electrolyte buffer composition is used throughout the working space 10 and the first and second elongated chambers 28, Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 5, lns. 1-4; Examiner notes that since the same electrolyte buffer is used throughout the working space 10 and the first and second elongated chambers 28, then the pH is the same).
The limitations "matching a pH of the sample buffer" and "the fractionated portion of the sample expelled through the outlet has an isoelectric point matching the pH" are with respect to an article worked upon (sample and sample buffer) and not a positively recited element of the apparatus. Inclusion of the material or article worked upon (sample and sample buffer) by a structure (apparatus) being claimed does not impart patentability to the claims. MPEP § 2115.
Regarding claim 21, Strickler-1 teaches wherein the hydrodynamic impediment is constructed of at least one of cellulose, polyvinylidene fluoride, polyvinylidene difluoride, or polytetrafluoroethylene (the ion-permeable barrier 20 is made of regenerated cellulose, Figs. 3-4, col. 3, lns. 7-16).
Regarding claim 26, Strickler-1 teaches wherein the hydrodynamic impediment fluidically isolates but electrically couples the center channel to at least one of the anolyte channel or the catholyte channel (the ion-permeable barriers 20 separate the working space 10 from the elongated chambers 28, but does not significantly impede ionic flow, Figs. 3-4, col. 3, lns. 6-16, 21-25, 51-52).
Regarding claim 27, Strickler-1 teaches wherein the hydrodynamic impediment is a porous membrane (the ion-permeable barrier 20 made of regenerated cellulose which does not significantly impede ionic flow while being only very slowly permeable to bulk flow of liquids, Figs. 3-4, col. 3, lns. 7-16).
Regarding claim 45, Strickler-1 teaches wherein the hydrodynamic impediment is in direct fluid contact with at least one of the first electrolyte buffer or the second electrolyte buffer (outer surfaces 24 of the ion-permeable barriers 20 are in direct fluid contact with the electrolyte buffer in the first and second elongated chambers 28, Figs. 3-4, col. 3, lns. 21-33, col. 4, lns. 63-65).
Regarding claim 46, Strickler-1 teaches wherein the hydrodynamic impediment is positioned between the cover and the body (the ion-permeable barriers 20 are positioned between the plate 12 and the housing 26, Figs. 3-4, col. 3, lns. 10-12 & 21-25).
Regarding claim 47, the limitation "the at least some of the plurality of analytes migrating through the hydrodynamic impediment has an isoelectric point different than the pH" is with respect to an article worked upon (analytes) and not a positively recited element of the apparatus. Inclusion of the material or article worked upon (analytes) by a structure (apparatus) being claimed does not impart patentability to the claims. MPEP § 2115.
Regarding claim 48, Strickler-1 teaches wherein the body is plastic (the plate 14 and the housing 26 are made of plastic such as Lucite, Figs. 3-4, col. 3, lns. 3-5 & 25-26).
Regarding claim 49, Strickler-1 teaches wherein the cover is non-porous (the plate 12 is made of glass or plastic and partially defines the electrophoresis working space 10, Figs. 3-4, col. 2, lns. 9-18 & 70-72, col. 3, lns. 1-6).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler-1 as applied to claim 2 above, and further in view of Strickler (US 3,498,905 A) (hereinafter “Strickler-2”).
Regarding claim 3, Strickler-1 teaches the ion-permeable barrier 20, and the working space 10 at least partially formed by the ion-permeable barriers 20, the plates 12 and 14, and rubber gaskets 16 and 18 (Strickler-1, Figs. 3-4, col. 2, lns. 71-72, col. 3, lns. 1-12). Strickler-1 fails to teach wherein the hydrodynamic impediment includes a hollow space formed in the center of the hydrodynamic impediment; and wherein the center channel is at least partially formed by the hollow space.
Strickler-2 teaches a continuous particle electrophoresis apparatus including a pair of flat plates supported in spaced apart, parallel, face-to-face relationship to define an interspace through which an electrolyte freely flows (Strickler-2, col. 1, lns. 14-17). Strickler-2 teaches an embodiment in Figs. 9-10 which is similar to Strickler-1, wherein the apparatus includes an ion-permeable barrier 53 made of regenerated cellulose which does not significantly impede ionic flow while being only very slowly permeable to bulk flow of liquids (Strickler-2, Figs. 9-10, col. 9, lns. 45-51), and wherein an interspace 3b which is an electrophoresis space is at least partially formed by the ion-permeable barriers 53, plates 1a and 2a, and rubber gaskets 50 and 60 (Strickler-2, Figs. 9-10, col. 9, lns. 19-33, col. 10, lns. 25-27). Strickler-2 teaches an alternative embodiment wherein the apparatus includes a microporous membrane 27 surrounding an interspace 3a in the center thereof which is the electrophoresis space between the plates 1 and 2 where electrophoretic separation of the sample takes place (Strickler-2, Figs. 4-6, col. 6, lns. 39-53 & 74-75, col. 7, lns. 1-2).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the ion-permeable barriers 20 and the rubber gaskets 16 and 18 of Strickler-1 with a microporous membrane 27 having an interspace 3a in the center thereof as taught by Strickler-2 in order to yield the predictable result of forming the working electrophoresis space where electrophoretic separation of the sample takes place. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B).
Claims 6-7, 13-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Strickler-1 as applied to claim 2 above, and further in view of Vigh et al. (US 2002/0043465 A1).
Regarding claim 6, Strickler-1 teaches the first and second elongated chambers 28 having a single electrolyte buffer composition flowing therethrough (Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4). Strickler-1 fails to teach wherein at least one of the catholyte channel or the anolyte channel is fluidically connected to a reservoir.
Vigh teaches an electrophoretic apparatus comprising electrolyte chambers 22, 24 connected to flow circuits including electrolyte reservoirs 42, 43 (Vigh, abstract, Fig. 2, para. [0087]). Vigh teaches that the electrolyte reservoirs 42, 43 can be filled with 60 mL or 2 L of an electrolyte solution (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]). Vigh teaches that an anode is placed into the first electrolyte chamber, a cathode is placed into the second electrolyte chamber, a potential is applied, and separation of the sample occurs (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Strickler-1 to include electrolyte reservoirs fluidically connected to the first and second elongated electrolyte buffer chambers as taught by Vigh in order to yield the predictable result of providing electrolyte buffer for flowing through the first and second elongated electrolyte buffer chambers. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Regarding claim 7, Strickler-1 teaches the first and second elongated chambers 28 having a single electrolyte buffer composition flowing therethrough (Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4). Strickler-1 fails to teach a reservoir having a volume between 100 mL and 500 mL that is fluidically connected to at least one of the catholyte channel or the anolyte channel.
Vigh teaches an electrophoretic apparatus comprising electrolyte chambers 22, 24 connected to flow circuits including electrolyte reservoirs 42, 43 (Vigh, abstract, Fig. 2, para. [0087]). Vigh teaches that the electrolyte reservoirs 42, 43 can be filled with 60 mL or 2 L of an electrolyte solution (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]). Vigh teaches that an anode is placed into the first electrolyte chamber, a cathode is placed into the second electrolyte chamber, a potential is applied, and separation of the sample occurs (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Strickler-1 to include electrolyte reservoirs having a volume of 60 mL to 2 L fluidically connected to the first and second elongated electrolyte buffer chambers as taught by Vigh in order to yield the predictable result of providing electrolyte buffer for flowing through the first and second elongated electrolyte buffer chambers so that separation of the sample can occur when a voltage is applied to the anode and the cathode in the first and second elongated electrolyte buffer chambers. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A). Generally, in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05(I). Since the general conditions of the claim are disclosed in the prior art of record, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 13-15, Strickler-1 teaches the first and second elongated chambers 28 having a single electrolyte buffer composition flowing therethrough (Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4). Strickler-1 fails to teach a reservoir containing an electrolyte buffer fluidically coupled to at least one of the catholyte channel or the anolyte channel.
Vigh teaches an electrophoretic apparatus comprising electrolyte chambers 22, 24 connected to flow circuits including electrolyte reservoirs 42, 43 (Vigh, abstract, Fig. 2, para. [0087]). Vigh teaches that the electrolyte reservoirs 42, 43 can be filled with 60 mL or 2 L of an electrolyte solution (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]). Vigh teaches that an anode is placed into the first electrolyte chamber, a cathode is placed into the second electrolyte chamber, a potential is applied, and separation of the sample occurs (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Strickler-1 to include electrolyte buffer reservoirs fluidically connected to the first and second elongated electrolyte buffer chambers as taught by Vigh in order to yield the predictable result of providing electrolyte buffer for flowing through the first and second elongated electrolyte buffer chambers. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Modified Strickler-1 is silent with respect to the materials of the electrolyte buffer, and therefore fails to teach that the reservoir also contains polymers, of instant claim 13, methyl cellulose, of instant claim 14, or between 0.1% and 0.5% methyl cellulose, of instant claim 15.
Vigh teaches an electrophoretic apparatus comprising electrolyte chambers 22, 24 connected to flow circuits including electrolyte reservoirs 42, 43 (Vigh, abstract, Fig. 2, para. [0087]). Vigh teaches that an anode is placed into the first electrolyte chamber, a cathode is placed into the second electrolyte chamber, a potential is applied, and separation of the sample occurs (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]). Vigh teaches using 0.1% methylcellulose solution in focusing medium (Vigh, para. [0078]-[0081], [0130], [0135]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrolyte buffer in the reservoir of Modified Strickler-1 to further include 0.1% methylcellulose solution in order to yield the predictable result of electrophoretic separation. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Regarding claim 18, Strickler-1 teaches the first and second elongated chambers 28 having a single electrolyte buffer composition flowing therethrough (Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4), and that the buffer minimizes pH changes caused by electrolysis (Strickler-1, col. 3, lns. 63-65). Strickler-1 fails to teach a reservoir fluidically coupled to at least one of the catholyte channel or the anolyte channel, the reservoir containing an electrolyte buffer having a pH value between 0.1 and 14.
Vigh teaches an electrophoretic apparatus comprising electrolyte chambers 22, 24 connected to flow circuits including electrolyte reservoirs 42, 43 (Vigh, abstract, Fig. 2, para. [0087]). Vigh teaches that an anode is placed into the first electrolyte chamber, a cathode is placed into the second electrolyte chamber, a potential is applied, and separation of the sample occurs (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]). Vigh teaches that the pH of the anolyte or catholyte may be between 2.9 and 9.9 (Vigh, para. [0079], [0082], [0129], [0134], [0138], [0141]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Strickler-1 to include electrolyte buffer reservoirs having a pH between 2.9 and 9.9 and fluidically connected to the first and second elongated electrolyte buffer chambers as taught by Vigh in order to yield the predictable result of providing electrolyte buffer for flowing through the first and second elongated electrolyte buffer chambers while minimizing pH changes caused by electrolysis. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Claims 8, 10, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Strickler-1 as applied to claims 2 and 5 above, and further in view of Ogle (US 2002/0023842 A1).
Regarding claim 8, Strickler-1 teaches the first and second elongated chambers 28 having a single electrolyte buffer composition flowing therethrough (Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4). Strickler-1 fails to teach a reservoir fluidically connected to at least one of the catholyte channel or the anolyte channel; and a pump configured to recirculate electrolyte buffer from the reservoir through the at least one of the catholyte channel or the anolyte channel.
Ogle teaches an electrophoresis apparatus comprising a flow circuit (Ogle, abstract, para. [0062]). Ogle teaches a shared single buffer reservoir 38 that is fluidically connected to the buffer chambers 12, 14 in the buffer flow circuit (Ogle, Fig. 6, para. [0061]-[0062]), and a shared single buffer pump 40 which is a circulating pump in the buffer flow circuit connecting the buffer reservoir 38 and the buffer chambers 12, 14 (Ogle, Fig. 6, para. [0062]). Strickler-1 also teaches in another embodiment that a pumping means may be used to recirculate the electrolyte buffer in the first and second elongated chambers 28 for conservation of these rinsing media (Strickler-1, Figs. 5-6, col. 5, lns. 42-45).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Strickler-1 to include a single buffer reservoir and a buffer pump fluidically connecting the single buffer reservoir and the first and second elongated electrolyte buffer chambers as taught by Ogle in order to yield the predictable result of providing electrolyte buffer for flowing through the first and second elongated electrolyte buffer chambers and recirculating the electrolyte buffer for conservation of these rinsing media. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
The limitation "recirculate electrolyte buffer from the reservoir through the at least one of the catholyte channel or the anolyte channel" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The buffer pump disclosed by Modified Strickler-1 teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as discussed in the rejection supra.
Regarding claim 10, Strickler-1 teaches the first and second elongated chambers 28 having a single electrolyte buffer composition flowing therethrough (Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4). Strickler-1 fails to teach a reservoir configured to contain the common electrolyte buffer, the reservoir fluidically coupled to the anolyte channel and the catholyte channel; and a pump configured to recirculate the common electrolyte buffer from the reservoir through the anolyte channel and the catholyte channel, separately, in two loops.
Ogle teaches an electrophoresis apparatus comprising a flow circuit (Ogle, abstract, para. [0062]). Ogle teaches a shared single buffer reservoir 38 that is fluidically connected to the buffer chambers 12, 14 in the buffer flow circuit (Ogle, Fig. 6, para. [0061]-[0062]), and a shared single buffer pump 40 which is a circulating pump in the buffer flow circuit connecting the buffer reservoir 38 and the buffer chambers 12, 14 (Ogle, Fig. 6, para. [0062]). Ogle teaches that the buffer flow circuit divides into two paths prior to passing through the two buffer chambers 12, 14, and then the two paths rejoin after passing through the two buffer chambers 12, 14 (Ogle, Fig. 6, para. [0062]). Strickler-1 also teaches in another embodiment that a pumping means may be used to recirculate the electrolyte buffer in the first and second elongated chambers 28 for conservation of these rinsing media (Strickler-1, Figs. 5-6, col. 5, lns. 42-45).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Strickler-1 to include a single buffer reservoir and a buffer pump fluidically connecting the single buffer reservoir and the first and second elongated electrolyte buffer chambers in two paths as taught by Ogle in order to yield the predictable result of providing electrolyte buffer for flowing through the first and second elongated electrolyte buffer chambers and recirculating the electrolyte buffer for conservation of these rinsing media. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
The limitation "recirculate the common electrolyte buffer from the reservoir through the anolyte channel and the catholyte channel, separately, in two loops" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The buffer pump disclosed by Modified Strickler-1 teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as discussed in the rejection supra.
Regarding claim 43, Strickler-1 teaches the ion-permeable barrier 20 made of regenerated cellulose which does not significantly impede ionic flow while being only very slowly permeable to bulk flow of liquids (Strickler-1, Figs. 3-4, col. 3, lns. 7-16). Strickler-1 fails to teach wherein the hydrodynamic impediment is a gel material.
Ogle teaches an electrophoresis apparatus comprising a flow circuit (Ogle, abstract, para. [0062]). Ogle teaches restriction membranes 20a, 20b which separate the inner chambers from the outer chambers 12, 14 housing the electrodes and flow of buffer (Figs. 7-8, para. [0061], [0079]). Ogle teaches that the restriction membranes 20a, 20b are formed from polyacrylamide gel, and have a relatively small pore size so that ions and small molecules may pass through the gel, Figs. 7-8, para. [0069]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the cellulose ion-permeable barrier of Strickler-1 with a polyacrylamide gel membrane as taught by Ogle in order to yield the predictable result of passing ions and small molecules therethrough. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore , the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler-1 as applied to claim 5 above, and further in view of Ogle (US 2002/0023842 A1) and further in view of Laue et al. (US 4,994,161 A).
Regarding claim 9, Strickler-1 teaches the first and second elongated chambers 28 having a single electrolyte buffer composition flowing therethrough (Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4). Strickler-1 fails to teach a reservoir configured to contain the common electrolyte buffer, the reservoir fluidically coupled to the anolyte channel and the catholyte channel; and a pump configured to recirculate the common electrolyte buffer from the reservoir and through the anolyte channel and the catholyte channel.
Ogle teaches an electrophoresis apparatus comprising a flow circuit (Ogle, abstract, para. [0062]). Ogle teaches a shared single buffer reservoir 38 that is fluidically connected to the buffer chambers 12, 14 in the buffer flow circuit (Ogle, Fig. 6, para. [0061]-[0062]), and a shared single buffer pump 40 which is a circulating pump in the buffer flow circuit connecting the buffer reservoir 38 and the buffer chambers 12, 14 (Ogle, Fig. 6, para. [0062]). Ogle teaches that the buffer flow circuit divides into two paths prior to passing through the two buffer chambers 12, 14, and then the two paths rejoin after passing through the two buffer chambers 12, 14 (Ogle, Fig. 6, para. [0062]). Strickler-1 also teaches in another embodiment that a pumping means may be used to recirculate the electrolyte buffer in the first and second elongated chambers 28 for conservation of these rinsing media (Strickler-1, Figs. 5-6, col. 5, lns. 42-45).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Strickler-1 to include a single buffer reservoir and a buffer pump fluidically connecting the single buffer reservoir and the first and second elongated electrolyte buffer chambers as taught by Ogle in order to yield the predictable result of providing electrolyte buffer for flowing through the first and second elongated electrolyte buffer chambers and recirculating the electrolyte buffer for conservation of these rinsing media. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Modified Strickler-1 teaches that the buffer flow circuit divides into two paths prior to passing through the first and second elongated electrolyte buffer chambers, and then the two paths rejoin after passing through the first and second elongated electrolyte buffer chambers (Strickler-1, col. 5, lns. 42-45 & 51-54, Ogle, Fig. 6, para. [0062], see modification supra), and therefore fails to teach the pump being configured to recirculate the common electrolyte buffer from the reservoir and through the anolyte channel and the catholyte channel in a single loop.
Laue teaches an electrophoretic apparatus for migrating a macromolecule (Laue, abstract). Laue teaches a buffer recirculating pump 5 providing external flow of buffer between the two buffer chambers 1A and 1B along tubes 5A and 6A to maintain constancy of buffer in the two buffer chambers as well as constancy and equality of liquid level in the two buffer chambers (Laue, Figs. 1-2, col. 4, lns. 8-12). Laue teaches that the buffer recirculating pump 5 pumps buffer in the tube 5A from the buffer chamber 1A to the tube 6A and thence to the buffer chamber 1B (Laue, Figs. 1-2, col. 4, lns. 15-17).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the buffer pump of Modified Strickler-1 to recirculate the buffer in a single loop through the first and second elongated electrolyte buffer chambers as taught by Laue in order to yield the predictable result of recirculating the same buffer to the two buffer chambers while maintaining constancy of buffer in the two buffer chambers as well as constancy and equality of liquid level in the two buffer chambers. Additionally, generally, differences in a rearrangement of parts will not support the patentability of subject matter encompassed by the prior art absent persuasive evidence that the particular configuration is significant. MPEP § 2144.04(VI)(C). Therefore, it would have been a matter of choice to arrange the single buffer reservoir, the buffer pump, the first elongated electrolyte buffer chamber, and the second elongated electrolyte buffer chamber in a single loop, which a person of ordinary skill in the art would have found obvious.
The limitation "recirculate the common electrolyte buffer from the reservoir and through the anolyte channel and the catholyte channel in a single loop" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The buffer pump disclosed by Modified Strickler-1 teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as discussed in the rejection supra.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler-1 as applied to claim 2 above, and further in view of Vigh et al. (US 2002/0043465 A1) and further in view of Solomon et al. (US 2005/0009994 A1).
Regarding claim 12, Strickler-1 teaches the first and second elongated chambers 28 having a single electrolyte buffer composition flowing therethrough (Strickler-1, Figs. 3-4, col. 3, lns. 27-29, col. 4, lns. 35-49, col. 5, lns. 1-4). Strickler-1 fails to teach a reservoir fluidically coupled to at least one of the catholyte channel or the anolyte channel.
Vigh teaches an electrophoretic apparatus comprising electrolyte chambers 22, 24 connected to flow circuits including electrolyte reservoirs 42, 43 (Vigh, abstract, Fig. 2, para. [0087]). Vigh teaches that the electrolyte reservoirs 42, 43 can be filled with 60 mL or 2 L of an electrolyte solution (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]). Vigh teaches that an anode is placed into the first electrolyte chamber, a cathode is placed into the second electrolyte chamber, a potential is applied, and separation of the sample occurs (Vigh, Fig. 2, para. [0129], [0134], [0138], [0141]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus of Strickler-1 to include electrolyte reservoirs fluidically connected to the first and second elongated electrolyte buffer chambers as taught by Vigh in order to yield the predictable result of providing electrolyte buffer for flowing through the first and second elongated electrolyte buffer chambers. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
Modified Strickler-1 is silent with respect to the material of the single electrolyte buffer composition, and therefore fails to teach that the reservoir contains MES-BisTris.
Solomon teaches electrophoretic techniques using membranes (Solomon, abstract, para. [0001]). Solomon teaches that the buffer may be MES-BisTris buffer (Solomon, para. [0180]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrolyte buffer of Modified Strickler-1 with MES-BisTris buffer as taught by Solomon in order to yield the predictable result of a buffer used for electrophoretic techniques. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 1278. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Claims 22 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Strickler-1 as applied to claim 2 above, and further in view of Dudziak et al. (US 2005/0072675 A1).
Regarding claim 22, Strickler-1 teaches that the ion-permeable barrier 20 does not significantly impede ionic flow while being only very slowly permeable to bulk flow of liquids (Strickler-1, Figs. 3-4, col. 3, lns. 7-16), and that the ion-permeable barrier 20 separates the working space 10 from the elongated chambers 28 housing the electrodes 40 (Strickler-1, Figs. 3-4, col. 3, lns. 6-9, 21-25, 51-52). Strickler-1 fails to teach wherein pores of the hydrodynamic impediment have a median characteristic length between 25 nm and 800 nm.
Dudziak teaches membrane electrophoresis using microfiltration or ultrafiltration membranes (Dudziak, abstract). Dudziak teaches a separation chamber 7 having a diluate space 16, a concentrate space 17, a cathode space 18 with a cathode 20, and an anode space 21 with an anode 19, where the individual spaces are separated from each other by ultrafiltration or microfiltration membranes 14, 15 (Dudziak, abstract, Figs. 1-2, para. [0049]). Dudziak teaches that the membranes 14 have a pore size of 1 to 1000 nm (Dudziak, Figs. 1-2, para. [0021]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of the ion-permeable barrier of Strickler-1 to be 1 to 1000 nm as taught by Dudziak in order to yield the predictable result of not significantly impeding ionic flow while being only very slowly permeable to bulk flow of liquids in order to separate the working space 10 from the elongated chambers 28 housing the electrodes 40. Additionally, generally, in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05(I).
Regarding claim 44, Strickler-1 teaches that the ion-permeable barrier 20 does not significantly impede ionic flow while being only very slowly permeable to bulk flow of liquids (Strickler-1, Figs. 3-4, col. 3, lns. 7-16), and that the ion-permeable barrier 20 separates the working space 10 from the elongated chambers 28 housing the electrodes 40 (Strickler-1, Figs. 3-4, col. 3, lns. 6-9, 21-25, 51-52). Strickler-1 fails to teach wherein the hydrodynamic impediment is a network of microchannels or a network of nanochannels.
Dudziak teaches membrane electrophoresis using microfiltration or ultrafiltration membranes (Dudziak, abstract). Dudziak teaches a separation chamber 7 having a diluate space 16, a concentrate space 17, a cathode space 18 with a cathode 20, and an anode space 21 with an anode 19, where the individual spaces are separated from each other by ultrafiltration or microfiltration membranes 14, 15 (Dudziak, abstract, Figs. 1-2, para. [0049]). Dudziak teaches that the membranes 14 have a pore size of 1 to 1000 nm (Dudziak, Figs. 1-2, para. [0021]; Examiner interprets the nanometer pore size to correspond to a network of nanochannels).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of the ion-permeable barrier of Strickler-1 to be 1 to 1000 nm (forming a network of nanochannels) as taught by Dudziak in order to yield the predictable result of not significantly impeding ionic flow while being only very slowly permeable to bulk flow of liquids in order to separate the working space 10 from the elongated chambers 28 housing the electrodes 40. Additionally, generally, in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05(I).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler-1 as applied to claim 2 above, and further in view of Timperman (US 2004/0202994 A1).
Regarding claim 23, Strickler-1 teaches that the ion-permeable barrier 20 does not significantly impede ionic flow while being only very slowly permeable to bulk flow of liquids (Strickler-1, Figs. 3-4, col. 3, lns. 7-16). Strickler-1 is silent with respect to the value of the width of the ion-permeable barrier, and therefore fails to teach wherein the hydrodynamic impediment has a width between 100 µm and 200 µm.
Timperman teaches a microfluidic device capable of concentrating positively and negatively charged molecules (Timperman, abstract). Timperman teaches that the microfluidic device 5 comprises one or more reaction channels 8 which are from about 50 µm to 200 µm wide (Timperman, Fig. 1B, para. [0085]). Timperman teaches that a portion of the reaction channel 8 comprises a membrane 21 through which a current can move but molecules such as polypeptides cannot move (Timperman, Fig. 1B, para. [0109]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the width of the ion-permeable barrier of Strickler-1 to be 50 µm to 200 µm as taught by Timperman in order to yield the predictable result of not significantly impeding ionic flow while being only very slowly permeable to bulk flow of liquids. Generally, in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05(I). Since the general conditions of the claim are disclosed in the prior art of record, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Strickler-1 as applied to claim 2 above, and further in view of Perry et al. (US 5,087,338 A).
Regarding claim 24, Strickler-1 teaches the working space 10 where electrophoretic separation occurs (Strickler-1, Figs. 3-4, col. 4, lns. 3-14). Strickler-1 is silent with respect to the value of the width and length of the working space 10, and therefore fails to teach wherein the center channel has a width between 1 mm and 10 mm and a length between 10 cm and 20 cm.
Perry teaches an apparatus for continuous separation of electrically charged macromolecular compounds such as proteins (Perry, abstract). Perry teaches a flat electrophoresis apparatus used with electrophoretic flow cells separated by a microfiltration membrane 1, and each cell is 3 mm thick by 3 cm wide by 10 cm long, with fluid inlet and exit ports at the ends of the long dimension of the cells (Perry, Figs. 1 & 4, col. 13, lns. 56-61, col. 15, lns. 54-62).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the width and length of the working space 10 of Strickler-1 to be 3 mm wide by 10 cm long as taught by Perry in order to yield the predictable result of a working space for electrophoretic separation. Additionally, generally the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP § 2144.04(IV)(A).
Response to Arguments
Applicant’s arguments with respect to claims 2-3 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794