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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/9/2024 has been considered by the examiner.
Election/Restrictions
Applicant's election of Group I and Species D, Claims 1-3, 5, and 7-10, with traverse in the reply filed on 01/20/2026 is acknowledged.
The traversal is on the ground(s) that “Invention I and Invention II overlap in scope, are obvious variants, and as claimed are connected in at least one of design, operation, or effect”; “Inventions I and II are capable of being used together, and are not materially different in design”; “Species A-D clearly overlap in scope, are obvious variants, and as claimed are connected in at least one of design, operation, or effect”; “the Examiner has failed to provide an appropriate explanation concerning the requirement of a different field of search, and the unlikely probability that the prior art applicable to one invention would be applicable to another invention”; and “this application does not contain independent or patentably distinct species or inventions of the claimed invention”. This is not found persuasive because: (1) the inventions I and II are related as product and process of use, and the gel casting device in invention II does not need the particular gel casting device of invention I since the gel casting device of invention II can be a device comprising a single portion providing a gel mold support base such as a gel tray, thus the process for using the product as claimed can be practiced with another materially different product; (2) although Inventions I and II are capable of being used together, the claimed limitations of inventions I and II do not support that the gel casting devices in inventions I and II are not materially different in design; (3) As outlined in the restriction for species A-D, the gel casting devices in the species A-D have different designs and configurations. For example, in species A the bottom portion has upward protrusions while in species D the bottom portion is a flat plate without protrusions. Species C has three portions (top/middle/bottom portions) while Species A-B and D have two portions (top/bottom portions); and (4) for purposes of the initial requirement, a serious burden on the Examiner may be prima facie shown if the Examiner shows by appropriate explanation of separate classification, or separate status in the art, or a different field of search (as defined in MPEP § 808.02). The restriction requirement clearly meets this requirement. While that prima facie showing may be rebutted by appropriate showings or evidence by the Applicant, an unsupported statement by Applicant that no serious burden would exist in the examination of all pending claims does not qualify as an “appropriate showing” or “evidence”. See MPEP § 803. As stated in the prior Office Action, the claims of the present application contain distinct inventions. A search of these inventions may overlap, but the search of one invention does not include all the areas required for the others. A serious burden does exist, as different searches are required for each invention. Therefore, in order to ensure the quality of the search and examination, these inventions should be searched separately to account for their differences.
Upon consideration of the claims, claims 1-17 are drawn to the elected Group I and Species D. Claims 1-17 are therefore examined and claims 18-20 are withdrawn as being drawn to non-elected Group II.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objection
Claims 5, 9, 11-14, and 16-17 are objected to because of the following informalities:
Claim 5: please amend “the casting device” to -- the gel casting device--; “in such vertical orientation” to -- in [[such]] the vertical orientation--.
Claim 9: please amend “measuring in a range comprising” to -- of --.
Claim 11: please amend “gel mold support base support compartment” to -- the gel mold support base support compartment--.
Claim 12: please amend “the compartment” to -- the gel mold support base support compartment--.
Claim 13: please amend “measuring in a range comprising” to -- of --; “1 ml of a liquid sample” to -- 1 ml
Claim 14: please amend “the compartment” to -- the gel mold support base support compartment--.
Claim 16: please amend “measuring in a range comprising” to -- of --.
Claim 17: please amend “measuring in a range comprising” to -- of --.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Regarding claim 1, claim 1 recites “the collaborative structure comprises a sample-loaded polymerized gel layer positioned superjacent a gel mold support base”. It is unclear if “a sample-loaded polymerized gel layer” is the same as or different than “a polymerized gel layer”. Furthermore, it is unclear if “a gel mold support base” of the collaborative structure is the same as or different than “a gel mold support base” of the bottom portion in the gel casting device. Thus, the scope of claim 1 is indefinite. Claims 2-17 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding claim 2, claim 2 recites “the open-end edge”, which lacks antecedent basis. Therefore, the scope of claim 2 is indefinite. Claims 3-10, 13 and 16-17 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 2.
Regarding claim 6, claim 6 recites “a polymerized gel layer”. It is unclear if it is the same as or different than “a polymerized gel layer” recited in claim 1. Thus, the scope of claim 6 is indefinite. Claims 7-9, 13, and 16-17 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 6.
Regarding claim 13, Claim 13 recites “wherein each of the plurality of sample loading wells is loaded sequentially with a liquid sample comprising a volume measuring in a range comprising approximately 0.1 μl to 1 ml of a liquid sample”, while claim 9 recites “wherein each of the plurality of sample loading wells comprises a sample loading volume measuring in a range comprising approximately 1 μl to 1 ml”. It is unclear what is the volume of the sample loaded into each sample loading well since the volume ranges in claims 9 and 13 are not consistent. Note that the volume range in claim 13 is even broader than that in claim 9. Thus, the scope of claim 13 is indefinite.
Regarding claim 15, claim 15 recites “the liquid samples”, which lacks antecedent basis. Thus, the scope of claim 15 is indefinite.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 11-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Day (US6071396A), and in view of Rauth et al. (WO2000077510A2, English translation) and Berninger et al. (US4830725A).
Regarding claim 1, Day teaches a high-throughput multiplexing system for conducting electrophoresis separation of proteins (a gel-matrix layer for electrophoresis of a large number of samples [Abstract; Col. 1 Ln 12-13; Col. 3 Ln 64-67; Figs. 1-3 and 5]; thus the gel-matrix later is configured for performing the intended use of conducting electrophoresis separation of proteins with a high-throughput), the system comprising:
a gel casting device (the mold for casting a gel-matrix layer in Figs. 1-3 [col. 2, lines 26-32]) comprising a top portion (base plate 11 in Fig.1 [Col. 2 Ln 39-41]) and a bottom portion (plate 18 in Figs. 3 and 5 [Col. 3 Ln 3-10]), the bottom portion providing a gel mold support base (the resulting gel-matrix electrophoresis plate 19 consisting of the layer 17 and the support plate 18 to which it is adhered is shown in Figs. 4-5 [Col. 3 Ln 29-32]; Fig.5 shows the support plate 18 supporting the polymerized gel layer 17), the gel mold support base is seated atop the top portion (Fig.3 shows the plate 18 is seated atop the base plate 11 [Col. 3 Ln 2-8]) so as to form an interior gel casting chamber (acrylamide material 17 is casted between the base plate 11 and the cover plate 18 as shown in Fig.3).
Day is silent to: a horizontal electrophoresis tank comprising a polymerized gel layer and gel mold support base support compartment being sizably-shaped, and dimensioned to receive a collaborative structure in a snug, complementary-fit manner, the collaborative structure comprises a sample-loaded polymerized gel layer positioned superjacent a gel mold support base.
Rauth teaches an electrophoresis system, wherein the system comprises
a horizontal electrophoresis tank (buffer chamber 100 in Figs. 1-2 [para. 4 on page 5]) comprising a polymerized gel layer (separation gel 131 in Fig. 2 [para. 2 on page 6]) and gel mold support base support compartment (the middle region of the buffer chamber 100 where the gel carrier 130 is positioned as shown in Fig.2) being sizably-shaped, and dimensioned to receive a collaborative structure (combined gel carrier 130 and the separating gel 131 in Fig.2 is deemed as the collaborative structure), the collaborative structure comprises a sample-loaded polymerized gel layer (separating gel 131 in Fig.2) positioned superjacent a gel mold support base (gel carrier 130 in Fig.2).
Day and Rauth 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 Day by providing a horizontal electrophoresis tank comprising a polymerized gel layer and gel mold support base support compartment being sizably-shaped, and dimensioned to receive a collaborative structure, wherein the collaborative structure comprises a sample-loaded polymerized gel layer positioned superjacent a gel mold support base, as taught by Rauth, and further substitute the collaborative structure comprising the sample-loaded polymerized gel layer positioned superjacent the gel mold support base (the separating gel 131 positioned superjacent the gel carrier 130 in Rauth) with the collaborative structure comprising a sample-loaded polymerized gel layer 17 positioned superjacent the support plate 18 as shown in Fig.5 of Day, because it would significantly improve the utilization of the separating gels and increase the sensitivity of the separation process (para.4-5 on page 4 in Rauth ).
Modified Day is silent to wherein the gel mold support base support compartment is sizably-shaped, and dimensioned to receive the collaborative structure “in a snug, complementary-fit manner”.
Berninger teaches an electrophoresis apparatus comprising an electrophoresis tank 106 supporting a gel casting deck 202 wherein a sample-loaded polymerized gel layer is casted on the gel casting deck 202 (abstract; Figs. 1-4; Col. 6 Ln 7-25). The gel casting deck 202 is designed to fit snugly into the center of the bottom of the electrophoresis tank (Fig.1). Deck end 210 fits snugly against deck stop 120 (Fig.1). The opposite end of the gel casting deck 202 fits snugly against deck stop 108 (Fig.1). The outside walls 214 of the casting deck 202 match a draft on the side walls of the electrophoresis tank 106 (Fig.1). In this manner, the substantial immobility of casting deck 202 within electrophoresis tank 106 is ensure (Col. 6 Ln 7-16). The casting deck 202 corresponds to the gel mold support base; and the compartment comprising the deck stops and side walls of the electrophoresis tank for receiving the casting deck 202 is deemed as the gel mold support base support compartment. The combined polymerized gel layer and the casting deck is deemed as the collaborative structure.
Modified Day and Berninger 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 horizontal electrophoresis tank and the gel mold support base support compartment in modified Day by providing deck stops on the left and right ends of the gel mold support base such that the left and right ends of the gel mold support base fit snugly against the left and right deck stops, respectively, and the front and rear side walls of the gel mold support base are in contact the front and rear side walls of the electrophoresis tank, respectively, as taught by Berninger, since it would ensure substantial immobility of the gel mold support base positioned within electrophoresis tank (Col. 6 Ln 14-16 in Berninger).
Regarding claim 11, modified Day teaches the system of claim 1, wherein the horizontal electrophoresis tank comprises a bottom wall having a perimetric interface from which a right sidewall, a left sidewall, a forward sidewall, and a rear sidewall extend upward integrally enclosing the bottom wall and forming a receptacle for containing a buffer solution (Fig.2 in Rauth shows the horizontal electrophoresis tank 110 comprises a bottom wall [rectangular base 111] having a perimetric interface from which a right sidewall, a left sidewall, a forward sidewall, and a rear sidewall [four side walls 112 in Fig.2] extend upward integrally enclosing the bottom wall and forming a receptacle [The buffer chamber 110 is formed by the rectangular base 111 and the side walls 112 in the form of a flat, upwardly open shell; para. 5 on page 5] for containing a buffer solution [the gel carrier with the loaded separation gel matrix is then overlaid with a so-called running buffer; para. 2 on page 7]), and wherein the polymerized gel layer and gel mold support base support compartment is positioned intermediate along the bottom wall of the tank (see Fig.2 in Rauth; as outlined in the rejection of claim 1 above, the bottom wall of the tank is further modified by Berninger to provide left and right deck stops on the left and right ends of the gel mold support base such that the left and right ends of the gel mold support base fit snugly against the left and right deck stops, respectively).
Regarding claim 12, modified Day teaches the system of claim 11, and as outlined in the rejection of claim 1 above, the compartment is modified by Berninger to provide left and right deck stops on the left and right ends of the gel mold support base such that the left and right ends of the gel mold support base fit snugly against the left and right deck stops, respectively, and the front and rear side walls of the gel mold support base are in contact the front and rear side walls of the electrophoresis tank. Thus, modified Day teaches wherein the compartment comprises a first longitudinal sidewall opposing a second longitudinal sidewall (the added left and right deck stops that fit snugly against the left and right ends of the gel carrier in Fig.2 of Rauth; the left deck stop opposing the right deck stop), and a first latitudinal sidewall opposing a second latitudinal sidewall (the front side wall of the compartment opposing the rear side wall of the compartment), the first longitudinal sidewall and the second longitudinal sidewall each comprises a recessed portion aligned intermediate along the first longitudinal sidewall and the second longitudinal sidewall, respectively (Figs.1 and 3 in Berninger show the left and right deck stops each comprises a recessed portion; thus the added left and right deck stops each comprises a recessed portion for aligned intermediate along the first longitudinal sidewall and the second longitudinal sidewall, respectively), wherein the recessed portions provide spaces enabling the collaborative structure to be grasped by a user in order to be seated in and removed from the compartment (Figs.1 and 3 in Berninger show the recessed portions provide spaces enabling the collaborative structure [gel casting deck 202 and the polymerized gel casted on top of the gel casting deck] to be grasped by a user in order to be seated in and removed from the compartment; the compartment for receiving the gel carrier 130 and the separating gel layer 131 as shown in Figs. 1-2 of Rauth is modified by Berninger to provide left and right deck stops on the left and right ends of the gel mold support base such that the left and right ends of the gel mold support base fit snugly against the left and right deck stops, respectively, and the front and rear side walls of the gel mold support base are in contact the front and rear side walls of the electrophoresis tank. Since the height and length of the collaborative structure [ the polymerized gel layer and the gel mold support base] are, respectively, smaller than the height and length of the horizontal electrophoresis tank, as shown in Fig.2 of Rauth, the recessed portions provide spaces enabling the collaborative structure to be grasped by a user in order to be seated in and removed from the compartment).
Regarding claim 14, modified Day teaches the system of claim 12, wherein the collaborative structure is seated within the compartment of the horizontal electrophoresis tank (Fig.2 in Rauth shows the collaborative structure [gel carrier 130 and the separating gel 113] is seated within the compartment of the horizontal electrophoresis tank; as outlined in the rejection of claim 1 above, the collaborative structure of Rauth is substituted with the collaborative structure comprising the support plate 18 and the polymerized gel layer 17 of Day), the receptacle of the horizontal electrophoresis tank is filled with the buffer solution to a depth so as to completely submerge the polymerized gel layer of the collaborative structure (The gel carrier with the loaded separating gel matrix is then covered with a so-called running buffer [para. 2 on page 7 in Rauth ]).
Regarding claim 15, modified Day teaches the system of claim 14, and Day is silent to wherein the buffer solution having an electric field applied thereto causing an electric current to pass through the buffer solution, the liquid samples, and through the polymerized gel layer so as to facilitate separation of proteins of the liquid samples.
Rauth teaches wherein the buffer solution having an electric field applied thereto causing an electric current to pass through the buffer solution, the liquid samples, and through the polymerized gel layer so as to facilitate separation of proteins of the liquid samples (gel electrophoresis is carried out in accordance with the following steps. First, a gel carrier 130 with a prepared separating gel is loaded with samples in a gel electrophoresis system according to Fig.3 [arrow A] and inserted into the buffer chamber 110 [arrow B]. The gel carrier with the loaded separating gel matrix is then covered with a so-called running buffer [electrolyte]. This is followed by the actual separation process, in which direct voltages for generating electrical fields are applied to the first and second electrode pairs 121, 122 and 123, 124, under the effect of which a current flows through the separating gel 131 [para.2 on page 7]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply an electric field through the buffer solution causing an electric current to pass through the buffer solution, the liquid samples, and through the polymerized gel layer so as to facilitate separation of samples such as proteins of the liquid samples, as taught by Rauth, since it would separate the loaded samples by gel electrophoresis (para.2 on page 7 in Rauth).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Day, Rauth, and Berninger, as applied to claim 1 above, and further in view of Detroy (US4035377A).
Regarding claim 2, modified Day teaches the system of claim 1, and Day teaches wherein the top portion comprises a sample wells molding portion (the rectangular base plate 11 having ends 12, sides 13 and a flat upper surface 14 from which project a plurality of pegs or teeth 15 [Col. 2 Ln 39-41]; the polymerized gel-matrix layer 17 remains adherent to the plate 18 and peels away from the mould surface 14 and teeth 15. The resulting gel-matrix electrophoresis plate 19, consisting of the layer 17 and the support plate 18 to which it is adhered, is shown in Fig. 4 and 5. Formed in the gel layer 17 are wells 20, complementary to the teeth 15 [Col. 3 Ln 27-33]; teeth 15 is deemed as the sample wells molding portion to form wells 20), the sample wells molding portion comprises a floor (base plate 11 in Figs. 1 and 3) having an upper surface (surface 14 of the base plate 11 in Figs. 1-2) opposing a lower surface (bottom surface of the base plate 11), the lower surface having a perimeter from which a first longitudinal sidewall (front sidewall 13 in Fig.1), a second longitudinal sidewall (rear sidewall 13 as shown in Fig.1), and a latitudinal sidewall (right end sidewall 12 in Fig.1) extend integrally upward therefrom forming an integrated wall (see Fig.1).
Day teaches wherein the rectangular base plate 11 having ends 12, sides 13 and a flat upper surface 14 from which project a plurality of pegs or teeth 15 [Col. 2 Ln 39-41].
Day is silent to the integrated wall has an open end opposing the latitudinal sidewall, and wherein the open end includes a base support wall positioned adjacent the open-end edge of the floor and intermediate the first longitudinal sidewall and the second longitudinal sidewall, thereby forming a first portal and a second portal through which an unpolymerized, flowable separation medium is introduced into the gel casting chamber.
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Detroy teaches a gel casting device as shown in Figs.1-2 comprising a top portion (plate 12 [Col. 5 Ln 60-61]) and bottom portion (plate 10 [Col. 5 Ln 60-61]), and an interior gel casting chamber formed by holding the plates 12 and 10 together with clamps 28 and 30 (Col. 5 Ln 60 – Col. 6 Ln 14). Figs. 1-2 show the integrated wall has an open end (top edge of plate 12 has an open end for pouring a liquid 32 into the gel casting chamber between the two plate [Col. 6 Ln 7-8]), and wherein the open end includes a base support wall (projections 54 in Fig.1 [Col. 7 Ln 8-15]) positioned adjacent the open-end edge of the floor (the top edge of the plate 12 in Fig.1) and intermediate the first longitudinal sidewall (left sidewall having a strip member 18 in Fig.1) and the second longitudinal sidewall (the right sidewall having a strip member 18 in Fig.1), thereby forming a first portal (see “first portal” in annotated Fig.1 in Detroy) and a second portal (see “second portal” in annotated Fig.1 in Detroy) through which an unpolymerized, flowable separation medium (liquid 32 that forms the gel in Fig.2 [Col. 6 Ln 7-8]) is introduced into the gel casting chamber (see Fig.2).
-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 gel casting device in modified Day by providing an open end at the left end side wall, which is opposing the latitudinal sidewall (the right end 12 in Fig.1 of Day), wherein the open end includes a base support wall positioned adjacent the open-end edge of the floor (the left edge of the base 11 in Fig.1 of Day) and intermediate the first longitudinal sidewall and the second longitudinal sidewall, thereby forming a first portal and a second portal, and holding the bottom and top portions together by using clamps with the open end and the first and second portals are facing upward such that the unpolymerized, flowable separation medium is introduced from the first and second portals into the gel casting chamber (see Fig.2 in Detroy), as taught by Detroy, since Detroy teaches a suitable alternative gel casting device by vertically holding the gel casting device and pouring the unpolymerized gel medium into the gel casting chamber through the first and second portals positioned at the top open end (see Figs. 1-2).
Regarding claim 3, modified Day teaches the system of claim 2, and Day teaches wherein the top portion comprises a plurality of protrusions (teeth 15 in Figs. 1-3) integrally projecting upwardly from the upper surface of the floor (a flat upper surface 14 from which project a plurality of pegs or teeth 15 [Col. 2 Ln 40-41; Fig.2]), the plurality of protrusions interpolate the unpolymerized, flowable separation medium ( Fig.3 shows the teeth 15 interpolate the unpolymerized, flowable separation medium 17 to form wells 20 which are complementary to the teeth 15 after the polymerized gel-matrix layer 17 is peeled away from the mould surface 14 and the teeth 15 [Col. 3 Ln 24-33]).
Regarding claim 4, modified Day teaches the system of claim 3, and Day teaches wherein the unpolymerized, flowable separation medium comprises a polyacrylamide gel solution (the acrylic material 17 is then polymerized to polyacrylamide [Col. 3 Ln 9-10], thus the unpolymerized, flowable separation medium must comprise a polyacrylamide gel solution since it is polymerized to polyacrylamide).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Day, Rauth, Berninger and Detroy, as applied to claim 4 above, and further in view of Siegel (US20060108729A1).
Regarding claim 5, modified Day teaches the system of claim 4, wherein the gel casting device is positioned in a vertical orientation such that the first portal and the second portal are facing upwards and providing a loading edge (as outlined in the rejection of claim 2 above, the gel casting device is positioned in a vertical orientation such that the first portal and the second portal are facing upwards and providing a loading edge for introducing the unpolymerized, flowable separation medium into the gel casting chamber), and the loading edge having at least one clamp placed and tightened on the loading edge (Fig.2 in Detroy shows the loading edge having two clamps 28 placed and tightened on the loading edge).
Modified Day is silent to wherein the casting device is held in such vertical orientation via a vise.
Siegel teaches holding in such vertical orientation via a vise (a Flexi-vise is disclosed comprising a stationary and movable jaw that can be easily opened and closed. The vise also has the capability to be configured such that the jaws can be aligned down the middle of the base to be used upright with maximum stability, or they can be aligned with the edge of the base so that the vise can lay flat on its side to provide through-access for vertical operations [para. 0019]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to hold the gel casting device in the vertical orientation via a vise, as taught by Siegel, since it would stabilize and hold the clamped device [para. 0003 in Siegel ].
Regarding claim 6, modified Day teaches the system of claim 5, and “wherein the gel casting device is maintained in the vertical orientation for a period of time enabling polymerization of the polyacrylamide gel solution, 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 Day teaches the gel casting device is held in the vertical orientation via a vise, as outlined in the rejection of claim 5 above. Day teaches the acrylamide material 17 is polymerized to form the desired gel-matrix layer [Col. 3, Ln 1 -2]. Detroy teaches a liquid 32 which forms the gel is then poured into the chamber between the plates [Col. 6 Ln 7-14]. Thus, the disclosed gel casting device is capable of maintaining in the vertical orientation for a period of time enabling polymerization of the polyacrylamide gel solution, thereby producing a polymerized gel layer between the two plates.
Regarding claim 7, modified Day teaches the system of claim 6, and Day teaches wherein the polymerized gel layer comprises a plurality of sample loading wells formed integrally therein via the plurality of protrusions (formed in the gel layer 17 are wells 20, complementary to the teeth 15 [Col. 3 Ln 32-33]; sample in the wells [Col. 4 Ln 29]; Wells 20 are deemed as the plurality of sample loading wells).
Regarding claim 8, modified Day teaches the system of claim 7, and Day teaches wherein the plurality of sample loading wells comprises a number equal to the number of the plurality of protrusions (formed in the gel layer 17 are wells 20, complementary to the teeth 15 [Col. 3 Ln 32-33]. Thus, the number of wells 20 is equal to the number of the teeth 15).
Claims 9, 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Day, Rauth, Berninger, Detroy and Siegel, as applied to claim 8 above, and further in view of Candelari (Candelari C., Optimization of PEGDA Hydrogel Platform for Gel Electrophoresis Application, Master thesis, 2017, University of Houston).
Regarding claim 9, modified Day teaches the system of claim 8, and is silent to wherein each of the plurality of sample loading wells comprises a sample loading volume measuring in a range comprising approximately 1 μl to 1 ml.
Candelari teaches a gel electrophoresis platform [para. 1 on page 36], wherein decreasing the sample loading well volume decreases the strength of the sample lane signal during electrophoresis [para. 1 on page 18;para. 2 on page 37], and increasing the sample loading well volume increases the undesirable diffusion of sample out of the loading well [para. 2 on page 37].
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 1 µL to 1.00 mL 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).
Regarding claim 13, modified Day teaches the system of claim 9, and the limitation “wherein each of the plurality of sample loading wells is loaded sequentially with a liquid sample comprising a volume measuring in a range comprising approximately 0.1 μl to 1 ml of a liquid sample” 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 Day teaches each of the plurality of sample loading wells comprises a sample loading volume measuring in a range comprising approximately 1 μl to 1 ml, as outlined in the rejection of claim 9 above. Thus, each of the plurality of sample loading wells is capable of being loaded sequentially with a liquid sample comprising a volume measuring in a range comprising approximately 0.1 μl to 1 ml of a liquid sample. Furthermore, the claimed limitation 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 claimed limitations further limit the liquid sample (material worked upon) but fails to limit the electrophoresis system (by a structure being claimed), the limitations of the claim have no patentable weight.
Regarding claim 17, modified Day teaches the system of claim 9, and the limitations “wherein each of the plurality of sample loading wells is loaded sequentially with a liquid sample, the liquid sample comprising a volume measuring in a range comprising approximately 0.1 μL to 1 mL of molecular weight ladder being loaded in each sample loading well of a first column and a last column of the polymerized gel layer, and a lysate being loaded in each sample loading well positioned between the first column and the last column of the polymerized gel layer” are functional recitations. 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 Day teaches each of the plurality of sample loading wells comprises a sample loading volume measuring in a range comprising approximately 1 μl to 1 ml, as outlined in the rejection of claim 9 above. Day also teaches the plurality of sample loading wells 20 are disposed in rows and columns (see Fig.4). Thus, each of the plurality of sample loading wells is capable of being loaded sequentially with a liquid sample, the liquid sample comprising a volume measuring in a range comprising approximately 0.1 μL to 1 mL of molecular weight ladder being loaded in each sample loading well of a first column and a last column of the polymerized gel layer, and a lysate being loaded in each sample loading well positioned between the first column and the last column of the polymerized gel layer. Furthermore, the claimed limitations further limit the sample but fail 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 claimed limitations further limit the sample (material worked upon) but fails to limit the electrophoresis system (by a structure being claimed), the limitations of the claim have no patentable weight.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Day, Rauth, Berninger and Detroy, as applied to claim 3 above, and further in view of Manusu (US5954934A).
Regarding 10, modified Day teaches the system of claim 3, and is silent to wherein the top portion comprises a continuous, support shelf integrally recessed from the first longitudinal sidewall, the latitudinal sidewall, and the second longitudinal sidewall for seating the gel mold support base in a complementary-fit manner.
Manusu teaches a gel casting device as shown in Figs. 1-3 comprising a top portion (first side wall 11) and a bottom portion (second side wall 13), wherein the first side wall 11 comprise a continuous, support shelf integrally recessed from the left sidewall and the right sidewall for seating the gel mold support base (the second side wall 13) in a complementary-fit manner (see the support shelf integrally recessed from the left sidewall and the right sidewall for fitting the ridges 14 of the second side wall. One part forms a first side wall 11 of the cassette which is bounded on each side by a connecting means comprising a pair of spaced apart ridges 12. The other part forms a second side wall 13 of the cassette which is bounded on each side by a pair of spaced apart ridges 14. The ridges 12 and 14 interdigitate to form a seal along each side of the cassette 10 to prevent leakage there through of the gel forming liquid during setting of the gel [Col. 3 Ln 55-65]).
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 gel casting device in modified Day to provide a continuous, support shelf integrally recessed from the first longitudinal sidewall and the second longitudinal sidewall of the front portion for seating the gel mold support base (the bottom portion) in a complementary-fit manner, as taught by Manusu, since it would form a seal along each side of the cassette to prevent leakage there through the gel forming liquid during setting of the gel [Col. 3 Ln 55-65 in Manusu].
Since Manusu teaches the top portion comprising a continuous, support shelf integrally recessed from the left sidewall and the right sidewall for seating the other plate (bottom portion) to form a seal along each side of the cassette 10 to prevent leakage there through of the gel forming liquid during setting of the gel, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to also provide a continuous, support shelf integrally recessed from the bottom sidewall (the latitudinal sidewall) such that each of the three sidewalls comprises a continuous, support shelf integrally recessed from the corresponding sidewall for seating the gel mold support base in a complementary-fit manner to form a seal along each side of the cassette to prevent leakage there through the gel forming liquid during setting of the gel [Col. 3 Ln 55-65 in Manusu].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Day, Rauth, Berninger, Detroy and Siegel, as applied to claim 7 above, and further in view of Saito et al. (US 5785835 A).
Regarding claim 16, modified Day teaches the system of claim 7, and is silent to wherein the polymerized gel layer comprises a thickness measuring in a range comprising approximately 0.5 mm to 20 mm.
Saito teaches a gel casting device as shown in Fig.1 [col. 7, lines 15-24], and further teaches wherein the polymerized gel layer comprises a thickness measuring in a range comprising approximately 0.5 mm to 20 mm (the thickness of the gel-matrix layer is preferably 2 to 5 millimeters in Saito [col. 6, lines 14-16]).
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 gel casting device in modified Day such that the formed gel-matrix layer has a thickness of 2 to 5 millimeters, as taught by Saito, since Saito teaches it would be preferred to have 2 to 5 mm thick gel-matrix layer to create sharp DNA bands for clear-cut interpretation of results (Col. 6 Ln 1-14).
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Sylvester (US5112470A) teaches a vertical oriented gel electrophoresis apparatus. Hoefer (US3932265A) teaches vertical gel slab. Peterson et al. (US3879280A) teaches vertical gel slab electrophoresis cell. Wang et al. (WO2014088948A1) teaches a gel cassette having a front plate and a back plat.
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/SHIZHI QIAN/Examiner, Art Unit 1795
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