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 .
Status of the Claims
The amendment filed 12/5/2025 has been entered. Claims 1, 3, and 4 have been amended, claims 2 and 15-19 have been cancelled, and claims 20-28 are new. Claims 1, 3-14, and 20-28 are currently pending and are examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome various objections and rejections previously set forth in the Non-Final Rejection mailed 10/15/2025.
New claim objections are necessitated by the amendments as outlined below.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by the amendments as outlined below.
Claim Interpretation
Claim 23 recites the limitation “cylindrical space,” which is defined in the instant specification as a space defined by a continuous, inner circumferential sidewall extending upward integrally from a periphery of a closed bottom and terminating at an open top (para. [00100] and Figs. 4b and 6a), rather than a space with a circular or oval cross-section, which is the generally accepted definition in the art. The applicant is free to act as their own lexicographer to specifically define terms of a claim contrary to their ordinary meaning, see MPEP 2173.05(a)(III)).
Claim Objections
Claim 28 is objected to because of the following informalities:
In claim 28 line 2, “comprises 12 to 600” should be amended to --comprises 12 to 600 wells--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 23 recites the limitation “wherein the plurality of protrusions have a shape, and the shape is cylindrical.” However, the instant specification does not detail protrusions with a cylindrical shape, and the protrusions in Figs. 4b and 19 are rectangular. Thus, the limitation is considered new matter.
Claim Rejections - 35 USC § 102
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 24 and 27-28 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Cabilly et al. (US 7122104 B2).
Regarding claim 24, Cabilly teaches a polymerized gel for conducting horizontal electrophoresis separation of proteins (gel matrix 18 in Fig. 2 for separating proteins [col. 4, lines 32-40; col. 5, lines 1-12]) comprising:
a gel matrix (gel matrix 18 in Fig. 2) having a plurality of sample loading wells that are uniformly spaced and aligned in a geometrical arrangement of linear columns and horizontal rows (wells 36 in Figs. 1-2 are arranged into columns and rows [col. 5, lines 1-12; col. 7, lines 7-11]),
wherein each of the plurality of sample loading wells comprises a closed bottom opposing an open top and a continuous, inner circumferential sidewall extending upward integrally from a periphery of the closed bottom and terminating at the open top for receiving a volume of a sample (as shown in Figs. 1-2, wells 36 have a closed bottom and open top connected by a continuous, inner circumferential sidewall to receive a sample volume [col. 7, lines 52-53]).
Regarding claim 27, Cabilly teaches the polymerized gel of claim 24, wherein the gel matrix comprises polyacrylamide (the gel comprises polyacrylamide [claim 33]).
Regarding claim 28, Cabilly teaches the polymerized gel of claim 24, wherein the plurality of sample loading wells comprises 12 to 600 wells (there are 96 wells [see Fig. 1; col. 5, lines 11-12]).
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, 3-8, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Saito et al. (US 5785835 A) in view of Wang et al. (WO 2014088948 A1, referencing previously furnished copy) and Day (US 6071396 A).
Regarding claim 1, Saito teaches a high-throughput multiplexing system for conducting electrophoresis separation of molecules (apparatus for gel electrophoresis of multiple samples [Abstract]), the system comprising:
a gel casting device comprising a top portion and a base (gel casting case 10 includes a top lid 14 and base portion 12 in Fig. 1 [col. 7, lines 15-24]),
wherein the top portion comprises a planar top wall having an upper surface opposing a lower surface from which a first longitudinal sidewall, a second longitudinal sidewall, a first latitudinal sidewall, and a second latitudinal sidewall extend integrally downward about a perimeter of the lower surface forming a continuous wall (see annotated Figs. 1 and 3), and wherein the top portion is detachably connected to the base in an intimate and complementary, co-planar relationship forming an interior, separation medium casting chamber (lid 14 is sealed closed over base 12 in Fig. 3 to form a chamber for the gel medium [col. 7, lines 21-24 and 33-35]),
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Annotated Fig. 1 from Saito
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Annotated Fig. 3 from Saito
wherein the base comprises a bottom wall having a lower surface opposing an upper surface from which a first longitudinal sidewall, a second longitudinal sidewall, a first latitudinal sidewall, and a second latitudinal sidewall extend integrally upward about a perimeter of the upper surface forming a continuous wall (base portion 12 in Figs. 1 and 3 includes a continuous sidewall extending from an upper surface),
wherein the gel casting device further comprises a plurality of protrusions (comb elements 34 with teeth in Fig. 3), and
wherein the plurality of protrusions is uniformly spaced and aligned in a geometrical arrangement of linear columns and horizontal rows (the teeth of the comb elements 34 are arrange in linear columns and horizontal rows, see Figs. 1 and 3).
The limitation “wherein the gel casting device is manipulatable between open and closed positions” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Saito teaches a gel casting device that is configured to perform the functional limitations above (see the open and closed positions in Fig. 2 and Fig. 3, respectively).
Saito is silent to the limitation wherein the plurality of protrusions integrally projects upwardly from the upper surface of the bottom wall.
Wang teaches a gel casting device (gel cassette 10 includes a front plate 14 and back plate 12 in Fig. 1 for making precast gels for gel electrophoresis [0009, 0028]), wherein a plurality of protrusions integrally project from a surface of the gel casting device (teeth 16 in Fig. 1 project from the inner surface of teeth 16 [0029, 0032]). Wang further teaches that integrating a plurality of protrusions onto the surface of the device eliminates the need for a separate removable comb, saving on comb-related materials and labor [Abstract].
Saito and Wang are both considered analogous to the claimed invention because they are in the same field of gel casting devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of protrusions in Saito by integrating the protrusions onto their respective surface, as taught in Wang, such that the protrusions are integrated onto the top portion surface, since this would eliminate the need for a separate removable comb, saving on comb-related materials and labor [Abstract in Wang]. Furthermore, Wang teaches the claimed improvement as a known technique that is applicable to the base device in Saito. One skilled in the art could have applied the integrated protrusions in Wang in the same way to the base device in Saito, yielding predictable results (MPEP 2143(I)(D)).
Day teaches a high-throughput multiplexing system for conducting electrophoresis separation of molecules (a gel-matrix layer for electrophoresis of a large number of samples [Abstract; col. 3, lines 64-67]), the system comprising: a gel casting device (the mold for casting a gel-matrix layer in Fig. 1 [col. 2, lines 26-27]), wherein the gel casting device includes a top portion (cover plate 18 in Fig. 3) and a base (rectangular base plate 11 in Fig. 1), and wherein a plurality of protrusions integrally projects upwardly from the upper surface of the bottom wall (a plurality of teeth 15 project from the flat upper surface 14 of base plate 11 in Fig. 1 [col. 2, lines 39-44 in Day]). With this rearrangement, the plurality of protrusions still interpolates the unpolymerized, flowable separation medium
Modified Saito and Day are both considered analogous to the claimed invention because they are in the same field of gel casting devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of protrusions in modified Saito by rearranging the protrusions onto the base of the device, such that the protrusions integrally project upwardly from the upper surface of the bottom wall, as taught in Day.
Rearrangement of parts where both arrangements are known equivalents is a design choice that gives predicable results. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice) [see MPEP 2144.04 (VI)].
Regarding claim 3, modified Saito teaches the system of claim 1, and further teaches wherein the gel casting device further comprises at least one loading port (lid 14 contains ports 20 [col. 7, lines 45-48 in Saito]).
The limitation “through which an unpolymerized, flowable separation medium is introduced into the separation medium casting chamber” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Saito teaches a loading port that is configured to perform the functional limitations above (ports 20 are included for adding gel medium to the closed device in Fig. 3 [col. 7, lines 45-48 in Saito]).
Regarding claim 4, modified Saito teaches the system of claim 3, and further teaches wherein the unpolymerized, flowable separation medium is introduced through the at least one loading port and into the separation medium casting chamber, the plurality of protrusions interpolate the unpolymerized, flowable separation medium (as stated in the rejection of claim 1, when gel-forming agent is poured into ports 20, the plurality of protrusions interpolate the separation medium [col. 7, lines 15-58 in Saito]).
Regarding claim 5, modified Saito teaches the system of claim 4, but is silent to the limitation wherein the unpolymerized, flowable separation medium comprises polyacrylamide gel.
Wang teaches polyacrylamide gel used as an unpolymerized, flowable separation medium, as polyacrylamide is suitable for protein separation [0003, 0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the separation medium material in modified Saito with polyacrylamide gel, as taught in Wang, because the substitution would enable the separation of proteins [0003, 0030 in Wang]. Furthermore, the claimed device differs from modified Saito by the substitution of some components (the gel-matrix layer material in modified Saito) with other components (the polyacrylamide gel material in Wang) whose functions were known in the prior art. One of ordinary skill in the art could substitute one known element for another to yield predictable results (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).
Regarding claim 6, modified Saito teaches the system of claim 5.
The limitation “wherein the gel casting device is oriented in a horizontal position for a period of time enabling the polyacrylamide gel to polymerize, thereby producing a polymerized gel layer” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Saito teaches a gel casting device that is configured to perform the functional limitations above (the gel solution is poured into the gel cassette via ports 20 in Fig. 1 such that the gel polymerizes in a horizontal configuration in Fig. 3 [col. 7, lines 45-58 in Saito]).
Regarding claim 7, modified Saito teaches the system of claim 6, and further teaches wherein the polymerized gel layer comprises a thickness (the thickness of the gel-matrix layer is preferably 2 to 5 millimeters in Saito [col. 6, lines 14-16]), and wherein the polymerized gel layer comprises a plurality of sample loading wells formed integrally therein via the plurality of protrusions (as shown in Fig. 3 of Saito, after polymerization of the gel, sample wells 18 are formed in gel matrix layer 40. Thus, with the modifications stated in the rejection of claim 4 above, the protrusions extending from the bottom surface form wells in a similar manner shown in Fig. 3 of Day), wherein each of the plurality of sample loading wells comprises a closed bottom, a continuous, inner circumferential sidewall, and an open top opposing the closed bottom, wherein the continuous, inner circumferential sidewall extends upward integrally from a periphery of the closed bottom and terminates at the open top forming a cylindrical space for receiving a volume of a sample (as shown in Fig. 3 in Saito, sample wells 18 are formed with an open top opposed a closed bottom with a continuous, inner circumferential side wall defined by the shape of teeth 34).
Modified Saito is silent to the limitation wherein the gel layer thickness measures in a range of 0.50 millimeters to 2.00 millimeters.
It would have been obvious to have selected and utilized a gel layer thickness within the disclosed range, as taught by Saito, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range (2 to 5 millimeters) to be suitable given that Saito specifically teaches the range as an appropriate thickness for the gel layer [col. 6, lines 14-16 in Saito]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Regarding claim 8, modified Saito teaches the system of claim 7, and further teaches wherein the plurality of sample loading wells comprises a number of sample loading wells in a range comprising 10 to 600 (Fig. 4 shows 96 wells 42 in gel matrix layer 40 [col. 7, lines 45-58 in Saito], which falls within the claimed range).
Regarding claim 20, modified Saito teaches the system of claim 1, and further teaches wherein the top wall integrally extends outwardly past the first latitudinal sidewall forming an eave (see annotated Figs. 1 and 3 from Saito above).
The limitation “wherein the eave provides a handle by which the gel casting device is manipulatable between open and closed positions” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Saito teaches an eave that is configured to perform the functional limitations above (as shown in annotated Fig. 3 from Saito, the eave can be used to hold the edge of the lid to open the gel casting device).
Regarding claim 21, modified Saito teaches the system of claim 1, and further teaches wherein in the closed position, the top portion and the base form a substantially sealed continuous lip edge (lid 14 is sealed closed over base 12 in Fig. 3 to form a chamber for the gel medium [col. 7, lines 21-24 and 33-35 in Saito]).
Regarding claim 22, modified Saito teaches the system of claim 1, and further teaches wherein the plurality of protrusions comprises a number in a range comprising approximately 10 to 600 (Fig. 4 shows 96 wells 42 in gel matrix layer 40 [col. 7, lines 45-58 in Saito], which falls within the claimed range).
Regarding claim 23, modified Saito teaches the system of claim 1, and further teaches wherein the plurality of protrusions have a shape, and the shape is cylindrical (as shown in Fig. 3 in Saito, sample wells 18 are formed with an open top opposed a closed bottom with a continuous, inner circumferential side wall defined by the shape of teeth 34).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Saito, in view of Wang and Day, as applied to claim 8 above, and further in view of Candelari (“Optimization of PEGDA Hydrogel Platform for Gel Electrophoresis Application,” 2017, University of Houston, pgs. 1-39).
Regarding claim 9, modified Saito teaches the system of claim 8, but is silent to the limitation wherein each of the plurality of sample loading wells comprises a sample loading volume measuring in a range comprising 0.50 µl to 5.00 µl.
Candelari teaches a gel electrophoresis platform [pg. 36, para. 1], wherein decreasing the sample loading well volume decreases the strength of the sample lane signal during electrophoresis [pg. 18, para. 1; pg. 37, para. 2], and increasing the sample loading well volume increases the undesirable diffusion of sample out of the loading well [pg. 37, para. 2].
As the signal strength and undesirable sample diffusion are variables that can be modified, among others, by adjusting the sample loading volume, with signal strength decreasing as the volume is decreased and diffusion increasing as the volume is increased, the precise sample loading volume would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed sample loading volume cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the sample loading volume in modified Saito to be approximately 0.50 µL to 5.00 µL in order to obtain the desired balance between the signal strength and undesirable sample diffusion as taught by Candelari. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Saito in view of Wang and Day, as applied to claim 5 above, and further in view of Ben-Asouli et al. (US 20040020776 A1).
Regarding claim 14, modified Saito teaches the system of claim 5, but is silent to the limitation wherein the gel casting device is oriented in a vertical position for a period of time enabling the polyacrylamide gel to polymerize, thereby producing a polymerized gel layer.
Ben-Asouli teaches a gel casting device (cassette 1 in Fig. 1) including a sealable loading port (upper cover 50 includes closable apertures 51 and 53 [0055]). Having sealable loading ports enables multiple configurations for loading gel into the gel casting device without leakage (e.g., pouring the gel into the cassette in a vertical orientation [0066]).
Modified Saito and Ben-Asouli are both considered analogous to the claimed invention because they are in the same field of gel casting devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the loading ports in modified Saito by making the loading ports sealable, as taught in Ben-Asouli, since this would enable multiple configurations for loading gel into the gel casting device without leakage [0055, 0066 in Ben-Asouli]. Furthermore, Ben-Asouli teaches the claimed improvement as a known technique that is applicable to the base device in modified Saito. One skilled in the art could have applied the sealable loading ports in Ben-Asouli in the same way to the base device in modified Saito, yielding predictable results (MPEP 2143(I)(D)).
The limitation “wherein the gel casting device is oriented in a vertical position for a period of time enabling the polyacrylamide gel to polymerize, thereby producing a polymerized gel layer” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, modified Saito teaches a gel casting device that is configured to perform the functional limitations above (as stated above, the loading ports of modified Saito are sealable per the teachings of Ben-Asouli, such that the device can be oriented vertically while the gel is polymerizing).
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Day in view of Ben-Asouli.
Regarding claim 1, Day teaches a high-throughput multiplexing system for conducting electrophoresis separation of molecules (a gel-matrix layer for electrophoresis of a large number of samples [Abstract; col. 3, lines 64-67]), the system comprising:
a gel casting device (the mold for casting a gel-matrix layer in Fig. 1 [col. 2, lines 26-27]) comprising a top portion (cover plate 18 in Fig. 3) and a base (rectangular base plate 11 in Fig. 1 [col. 2, lines 26-27]),
wherein the top portion comprises a planar top wall having an upper surface opposing a lower surface (the lower surface of cover plate 18 is the surface in contact with the gel-matrix layer facing base plate 11 in Fig. 3), and the top portion and the base are in a co-planar relationship (cover plate 18 is layered parallel to the rectangular base plate 11 in Fig. 3 [col. 2, line 66-col. 3, line 7]) forming an interior, separation medium casting chamber (acrylamide material 17 fills the interior space formed between cover plate 18 and rectangular base plate 11 in Fig. 3 [col. 2, line 66-col. 3, line 7]),
wherein the base comprises a bottom wall having a lower surface opposing an upper surface from which a first longitudinal sidewall, a second longitudinal sidewall, a first latitudinal sidewall, and a second latitudinal sidewall extend integrally upward about a perimeter of the upper surface forming a continuous wall (rim 16 in Figs. 1-3 extending integrally upward about the perimeter of the upper surface of base plate 11 [col. 2, lines 62-65]),
wherein a plurality of protrusions integrally projects upwardly from the upper surface of the bottom wall (a plurality of teeth 15 project from the flat upper surface 14 of base plate 11 in Fig. 1 [col. 2, lines 39-44]), and
wherein the plurality of protrusions is uniformly spaced and aligned in a geometrical arrangement of linear columns and horizontal rows (as shown in Fig. 5, teeth 15 are arranged in an evenly-spaced grid).
The limitation “wherein the gel casting device is manipulatable between open and closed positions” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). 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. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Day teaches a gel casting device that is configured to perform the functional limitations above (cover plate 18 can be laid on top of the mold base to close the device and removed to open the device [col. 2, lines 66-67; col. 3, lines 1-6]).
Day is silent to the limitation wherein a first longitudinal sidewall, a second longitudinal sidewall, a first latitudinal sidewall, and a second latitudinal sidewall extend integrally downward about a perimeter of the lower surface forming a continuous wall, wherein the top portion is detachably connected to the base in an intimate and complementary.
Ben-Asouli teaches a gel casting device (cassette 1 in Fig. 1) comprising a top portion (upper cover 50 in Fig. 1 [0055]) and a base (housing 100 in Fig. 1 [0058]), wherein the top portion comprises a planar top wall having an upper surface opposing a lower surface (the surface of upper cover 50 facing housing 100 in Fig. 1 is the lower surface) from which a first longitudinal sidewall, a second longitudinal sidewall, a first latitudinal sidewall, and a second latitudinal sidewall extend integrally downward about a perimeter of the lower surface forming a continuous wall (intermediate wall 19 extends integrally downward from upper cover 50 to align with the perimeter of housing 100 in Fig. 1 [0055]), and wherein the top portion is detachably connected to the base in an intimate and complementary, co-planar relationship forming an interior, separation medium casting chamber (upper cover 50 is releasably mounted onto housing 100 in a complementary manner in Fig. 1 to form a space within the cassette [0015, 0055]). Ben-Asouli teaches that having a continuous wall extending integrally downward from the lower surface of the top portion to form an intimate and complementary relationship with the base aligns the top portion with the base [0055].
Day and Ben-Asouli are both considered analogous to the claimed invention because they are in the same field of gel casting devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the top portion in Day by adding a first longitudinal sidewall, a second longitudinal sidewall, a first latitudinal sidewall, and a second latitudinal sidewall extending integrally downward about a perimeter of the lower surface forming a continuous wall, such that the top portion is detachably connected to the base in an intimate and complementary, co-planar relationship as taught in Ben-Asouli, since this would align the top portion with the base [0055 in Ben-Asouli]. Furthermore, Ben-Asouli teaches the claimed improvement as a known technique that is applicable to the base device in Day. One skilled in the art could have applied the continuous wall on the top portion in Ben-Asouli in the same way to the base device in Day, yielding predictable results (MPEP 2143(I)(D)).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Day in view of Ben-Asouli, as applied to claim 1 above, and further in view of Holger et al. (WO 0077510 A2, referencing previously furnished translation).
Regarding claim 10, modified Day teaches the system of claim 1,
and Day further teaches that electrophoresis of a sample loaded in gel wells 20 in the casted gel is performed by applying a voltage and generating an electric field parallel to sides 22 of Fig. 4 [col. 3, lines 47-53 in Day], wherein the electrophoresis must be performed horizontally to prevent samples loaded into wells 20 in Figs. 4-5 from spilling out of the wells.
Modified Day fails to teach the system further comprising a horizontal electrophoresis tank.
Holger teaches an electrophoresis system, wherein the system comprises a horizontal electrophoresis tank (electrophoresis device 100 in Fig. 2 [pg. 5, para. 3]), wherein a polymerized gel layer (separation gel 131 in Fig. 2 [pg. 6, para. 2]) is seated horizontally superjacent a support base (gel carrier 130 in Fig. 2 [pg. 6, para. 2]). Additionally, the support base may be configured to accommodate a separation gel on a separate gel carrier if necessary [pg. 2, para. 3]. Holger further teaches that this horizontal electrophoresis system extends the separation distance of the samples in the gel without increasing the tank size [pg. 3, para. 4].
Modified Day and Holger are both considered analogous to the claimed invention because they are in the same field of gel electrophoresis. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrophoresis system in modified Day by providing a horizontal electrophoresis tank, as taught by Holger, such that the polymerized gel layer 17 adhered to plate 18 in Fig. 5 of modified Day is placed on top of gel carrier 130 in Fig. 2 of Holger, because it would extend the separation distance of the samples in the gel without increasing the tank size [pg. 3, para. 4 in Holger]. Furthermore, Holger teaches the claimed improvement as a known technique that is applicable to the base device in modified Day. One skilled in the art could have applied the horizontal electrophoresis tank in Holger in the same way to the base device in modified Day, yielding predictable results (MPEP 2143(I)(D)).
Regarding claim 11, modified Day teaches the system of claim 10, and further teaches wherein the horizontal electrophoresis tank comprises a receptacle (buffer chamber 110 formed by rectangular base 111 and side walls 112 in Fig. 2 of Holger [pg. 5, para. 4]), and a support base (gel carrier 130 in Fig. 2 of Holger) joined integrally by a first longitudinal sidewall opposing a second longitudinal sidewall, and a first latitudinal sidewall opposing a second latitudinal sidewall (as shown in Fig. 2 of Holger, gel carrier 130 includes a continuous sidewall along its rectangular perimeter), and wherein a polymerized gel layer is seated horizontally superjacent the support base (as stated in the rejection of claim 10 above, the polymerized gel layer 17 adhered to plate 18 in Fig. 5 of Day is placed on top of gel carrier 130 in Fig. 2 of Holger) and the support base seated atop the receptacle (gel carrier is seated atop rectangular base 111 in Fig. 2 of Holger), the polymerized gel layer comprises a plurality of sample loading wells formed integrally therein (the polymerized gel layer 17 has wells 20 in Figs. 4-5 for sample loading [col. 3, lines 30-33; col. 3, lines 47-52 in Day]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Day in view of Ben-Asouli and Holger, as applied to claim 11 above, and further in view of Flintham (“Top Tips for Optimum SDS-PAGE Results,” 2020, St. John’s Laboratory, pgs. 1-4).
Regarding claim 12, modified Day teaches the system of claim 11, and further teaches wherein each of the plurality of sample loading wells is loaded with a liquid sample via an automated microliter multi-pipette sample loading mechanism (the transfer of samples from the wells of a microtiter plate to the wells of the electrophoresis plate is performed automatically by the use of a multichannel pipette [col. 4, lines 1-6 in Day]), and wherein the receptacle is filled with a buffer solution to a level sufficient to fully immerse the polymerized gel layer (the gel carrier with the loaded separation gel matrix is overlaid with a running buffer [pg. 7, para. 2 in Holger]).
Modified Day is silent to the plurality of sample loading wells being loaded with 1.00 µL of a liquid sample.
Flintham teaches that, during gel electrophoresis, overloading the wells can lead to streaks on the final product and underfilling can lead to inconclusive results, depending on the sensitivity of the desired procedure [pg. 1, para. 1; pg. 2, para. 2].
As the sample streaking and gel result clarity are variables that can be modified, among others, by adjusting the volume of a liquid sample, with sample streaking and result clarity both decreasing as sample volume is decreased, the precise volume of a liquid sample would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed volume of the liquid sample cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the volume of the liquid sample in modified Day to be 1.00 µL in order obtain the desired balance between the sample streaking and result clarity as taught by Flintham. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II).
Alternatively, the limitation of “1.00 µL of a liquid sample” further limits the sample but fails to further limit the apparatus. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." See MPEP 2115. Since the claim further limits the volume of the sample (material worked on) but fails to further limit the electrophoresis system itself (by a structure being claimed), the limitations of the claim have no patentable weight.
Regarding claim 13, modified Day teaches the system of claim 12, and further teaches wherein an electric field is applied to the buffer solution (a regulated power supply is connected to the buffer chamber via electrodes 121-124 in Fig. 2 to generate multiple electric fields [pg. 7, para. 2; pg. 7, para. 4 in Holger]) causing an electric current to pass through the buffer solution, the liquid samples, and through the polymerized gel layer, thereby separating the molecules of the liquid samples (under the effect of the electric fields, current flows through the separating gel to induce separation of the samples in the gel [pg. 7, para. 2 in Holger]).
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Cabilly.
Regarding claim 25, Cabilly teaches the polymerized gel of claim 24, but is silent to the limitation wherein the polyacrylamide gel matrix has a thickness measuring in a range of 0.50 mm to 2.00 mm.
It would have been obvious to have selected and utilized a gel layer thickness within the disclosed range, as taught by Cabilly, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range (walls 12, 14, and 16 in Figs. 1-2 have a thickness ranging from 0.1-10 mm, and the overall height of cassette 10 ranges from 1-10 mm [col. 4, lines 41-56], such that the thickness of gel matrix 18 is 0-9.8 mm) to be suitable given that Cabilly specifically teaches the range as an appropriate thickness for the gel layer [col. 4, lines 41-56]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Regarding claim 26, Cabilly teaches the polymerized gel of claim 24, but is silent to the limitation wherein the sample wells have a volume in a range of 0.50 µL to 10.00 µL.
It would have been obvious to have selected and utilized a sample well volume within the disclosed range, as taught by Cabilly, including those amounts that overlap within the claimed range, since one of ordinary skill in the art would reasonably expect any value within the taught range (wells 36 have a width of 0.5-5 mm, a length of 1-5 mm, and a depth of 3-5 mm, such that the well volume ranges between 1.5-125 µL) to be suitable given that Cabilly specifically teaches the range as an appropriate sample well volume [col. 5, lines 13-25]. It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Response to Arguments
Applicant’s arguments, see Remarks Pg. 9-14, filed 12/5/2025, with respect to the 35 U.S.C. § 102 and 103 rejections have been fully considered. All 35 U.S.C. § 102 and 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment. However, applicant’s arguments are moot in view of the new grounds of rejection.
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.
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/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795