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 .
Response to Amendment
This is an office action in response to applicant’s arguments and remarks filed on August 11, 2025. Claims 1-13 are pending in the application and are being examined herein.
Terminal Disclaimer
The terminal disclaimer filed on August 11, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 9,766,206 B2 and U.S. Patent No. 11,933,759 B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
The information disclosure statement filed August 13, 2025 fails to comply with 37 CFR 1.97(c) because it lacks a timing statement as specified in 37 CFR 1.97(e). It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement filed August 13, 2025 fails to comply with 37 CFR 1.97(c) because it lacks the timing fee set forth in 37 CFR 1.17(p). It has been placed in the application file, but the information referred to therein has not been considered.
Status of Objections and Rejections
The objection to claim 1 is withdrawn in view of Applicant’s amendment.
New objections to the specification are necessitated by the amendments.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification should recite the terms “contact liquid level sensor” (claims 1-2) and “weir” (claim 4) for proper antecedent basis for the claimed subject matter. For example, the specification should disclose how the protrusion is related to the term “contact liquid level sensor” (for example, that they are equivalents). The specification should also disclose that the reference character 358 in Fig. 20 is a weir.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Allington et al. (US 5,169,511 A) in view of Millenson et al. (US 2013/0280696 A1).
Regarding claim 1, Allington teaches an apparatus (a capillary electrophoresis apparatus 10, Allington, Fig. 1, col. 3, lns. 47-48), comprising:
a body defining a reservoir (a fraction collector system 21 defining a sample collection cup 430, Allington, Figs. 1 & 7-8, col. 3, ln. 51, col. 4, lns. 3-5, col. 12, lns. 23-26; Examiner interprets the mounting surface 405, guide rails 406 and 407, support blocks 405 and 409, the support plate 410, the carrier 411, the rotating rod 470, threaded bushing 400, cap sealing pierce 400A, and tube fixing elastic washer 400B of the fraction collector system 21 in Figs. 7-8 to read on the claimed body, Allington, col. 4, lns. 10-13 & 25-26, col. 12, lns. 23-26 & 66-67, col. 13, lns. 13-19);
a capillary fixedly coupled to the body and in fluid communication with the reservoir (a capillary tube 30 is fixedly coupled to the tube fixing elastic washer 400B of the fraction collector system 21 and is in fluid communication with the sample collection cup 430, Allington, Figs. 7-8, col. 12, lns. 32-35, col. 13, lns. 12-18);
a cap coupled to the body (a rotating arm 460 is coupled to the rotating rod 470 of the fraction collector system 21, Allington, Figs. 7-8, col. 13, lns. 18-19); wherein the cap includes an opening in fluid communication with the reservoir and the capillary (the rotating arm 460 includes an opening for the capillary tube 30, the opening in the rotating arm 460 being in fluid communication with the sample collection cup 430 and the capillary tube 30, Allington, Figs. 7-8, col. 12, lns. 23-31, col. 13, lns. 12-18).
Allington teaches that the electrolytes in the wells 430A and 430B of the sample collection cup 430 are preferably lower than the height of a connecting bridge 453 and the top of the supporting wall 452 during this type of fraction collection to keep the separated samples in well 430A and prevent them from being transported to well 430B (Allington, Figs. 7-8, col. 13, lns. 38-55). Allington fails to teach a contact liquid level sensor extending into the reservoir.
Millenson teaches a device for detecting an analyte in a sample of bodily fluid, including at least one hollow needle configured to obtain a sample of bodily fluid (Millenson, abstract). Millenson teaches a fluid volume sensor 674 that measures the volume of the fluid collected in the sample collection chamber 641 (Millenson, Figs. 9-10, para. [0102]). Millenson teaches that the fluid volume sensor 674 may include electrical leads positioned at a predetermined height above the base of the sample collection chamber 641 and configured to become a closed circuit when in mutual contact with a fluid (Millenson, Figs. 9-10, para. [0102]). Millenson teaches that the processor is notified when the volume has reached a predetermined volume, and then the processor proceeds to the next steps and may provide a signal to indicate that a sufficient amount of fluid has been collected (Millenson, Figs. 9-10, para. [0102]).
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 capillary electrophoresis apparatus of Allington to include electrical leads as a fluid volume sensor extending into the sample collection cup as taught by Millenson because it would allow the volume of the fluid collected to be measured by contact with the fluid volume sensor, and provides a signal to indicate that a sufficient amount of fluid has been collected (Millenson, Figs. 9-10, para. [0102]). 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 2, Modified Allington teaches wherein the contact liquid level sensor comprises a protrusion (the fluid volume sensor includes electrical leads extending into the sample collection cup and positioned at a predetermined height above the base of the sample collection cup, Millenson, para. [0102], see modification supra). Modified Allington does not explicitly teach that the protrusion is extending from the cap.
However, 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 fluid volume sensor to extend from the rotating arm 460 of Modified Allington in order to yield the predictable result of the fluid volume sensor being positioned at a predetermined height above the base of the sample collection cup such that it would become a closed circuit when in mutual contact with a fluid and measure the volume of the fluid collected. 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 fluid volume sensor to extend from the rotating arm 460, which a person of ordinary skill in the art would have found obvious.
Regarding claim 3, Modified Allington teaches wherein the protrusion is electrically conductive and configured to produce a signal when a fluid level in the reservoir contacts the protrusion (the fluid volume sensor includes electrical leads that allow the volume of the fluid collected in the sample collection cup to be measured by contact with the fluid volume sensor, and provides a signal to indicate that a sufficient amount of fluid has been collected, Millenson, para. [0102], see modification supra).
The limitation “produce a signal when a fluid level in the reservoir contacts the protrusion” 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 fluid volume sensor including the electrical leads disclosed by Modified Allington teaches all of the structural limitations of the claim and thus is configured for and capable of producing a signal when a fluid level in the reservoir contacts the protrusion as recited in the rejection supra.
Regarding claim 4, Modified Allington teaches wherein the reservoir includes a first portion and a second portion separated from the first portion by a weir (the sample collection cup 430 includes a well 430A and a well 430B separated from the well 430A by a supporting wall 452, Allington, Figs. 7-8, col. 13, lns. 22-23 & 44-55).
Regarding claim 5, Modified Allington teaches an absorbent material positioned within the second portion (a portion of a bridge 453 is positioned within the well 430B, and the bridge 453 provides fluid connection between the wells 430A and 430B by capillary forces drawing electrolyte, Allington, Figs. 7-8, col. 13, lns. 38-41 & 51-55; Examiner interprets the bridge 453 to be an absorbent material since the bridge 453 provides fluid connection by capillary forces, thus absorbing liquid).
Regarding claim 6, Modified Allington teaches wherein the first portion is positioned above a first end of the capillary (the upper portion of the well 430A is positioned above the bottom end of the capillary tube 30, Allington, Figs. 7-8).
Regarding claim 7, Modified Allington teaches wherein the reservoir includes a bottom surface that is orthogonal to the capillary (the sample collection cup 430 includes a bottom surface that is orthogonal to the capillary tube 30, Allington, Figs. 7-8, col. 12, lns. 32-40, col. 13, lns. 22-30).
Regarding claim 8, Modified Allington teaches the capillary tube 30 being fixedly coupled to the tube fixing elastic washer 400B of the fraction collector system 21 and being in fluid communication with the sample collection cup 430 (Allington, Figs. 7-8, col. 12, lns. 32-35, col. 13, lns. 12-18). Modified Allington fails to teach wherein the capillary is one of a plurality of capillaries fixedly coupled to the body and in fluid communication with the reservoir.
However, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the capillary tube 30 of Modified Allington, since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B).
Regarding claim 11, Modified Allington teaches wherein the capillary has a lumen with a diameter within a range of 10 micrometers to 1000 micrometers (the capillary tube 30 has an inside diameter of between 0.03 and 0.2 millimeters which is equivalent to between 30 micrometers and 200 micrometers, Allington, Figs. 7-8, col. 5, lns. 40-42).
Regarding claim 12, Modified Allington teaches wherein the capillary has a rounded cross-sectional shape (the capillary tube 30 has an inside diameter and an outside diameter, Allington, Figs. 7-8, col. 5, lns. 40-42, col. 9, lns. 58-60; Examiner interprets the capillary tube 30 to have a rounded cross-sectional shape since the capillary tube 30 has an inside diameter and an outside diameter).
Regarding claim 13, Modified Allington teaches wherein the capillary extends from the body in a curvilinear path (the capillary tube 30 extends from the fraction collector system 21 in a curvilinear path, Allington, Figs. 1, 3, & 7-8).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Allington in view of Millenson as applied to claims 1 and 8 above, and further in view of Amirkhanian et al. (US 2010/0108513 A1).
Regarding claim 9, Modified Allington teaches the plurality of capillaries (duplicate capillary tubes 30, see modification of claim 8 supra). Modified Allington fails to teach wherein the plurality of capillaries includes twenty five capillaries.
However, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to duplicate the capillary tubes 30 of Modified Allington to have twenty five capillary tubes, since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B).
Modified Allington teaches wherein the plurality of capillaries includes twenty five capillaries for electrophoresis (Allington, Figs. 7-8, col. 12, lns. 27-31, col. 13, lns. 28-29, see modification supra). Modified Allington is silent with respect to resistivity, and therefore fails to teach a total resistivity within a range of 1 to 2 M-ohm.
Amirkhanian teaches an improved capillary tube for use to conduct capillary electrophoresis analysis (Amirkhanian, para. [0003]). Amirkhanian teaches small bore I.D. capillaries (i.e. 10-100 µm ID, 12-30 cm long) combined with low current (i.e., at low resistivity) to provide high speed (shorter separation time) and higher resolution separations of sample fragments (Amirkhanian, Fig. 6, para. [0031]). Amirkhanian teaches wherein the resistivity of the capillaries is a result-effective variable. Specifically, Amirkhanian teaches that the resistivity of the capillaries controls the separation time and resolution of separations of the sample fragments (Amirkhanian, Fig. 6, para. [0031]). Since these particular parameters are recognized as result-effective variables, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See In re Boesch, 617 F. 2d 272, 205 U.S.P.Q. 215 (C.C.P.A. 1980).
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 total resistivity of the twenty five capillaries of Modified Allington to be within a range of 1 to 2 M-ohm through routine experimentation because doing so would yield the predictable desired high speed (shorter separation time) and higher resolution separations of sample fragments.
Regarding claim 10, Modified Allington teaches the capillary tube 30 for electrophoresis (Allington, Figs. 7-8, col. 12, lns. 27-31, col. 13, lns. 28-29). Modified Allington is silent with respect to the length of the capillary tube, and therefore fails to teach wherein the capillary has a length within a range of 2 centimeters to 20 centimeters.
Amirkhanian teaches an improved capillary tube for use to conduct capillary electrophoresis analysis (Amirkhanian, para. [0003]). Amirkhanian teaches small bore I.D. capillaries (i.e. 10-100 µm ID, 12-30 cm long) combined with low current (i.e., at low resistivity) to provide high speed (shorter separation time) and higher resolution separations of sample fragments (Amirkhanian, Fig. 6, para. [0031]).
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 length of the capillary tube of Modified Allington to be 12-30 cm long as taught by Amirkhanian in order to yield the predicable result of separation of sample fragments by capillary electrophoresis. Furthermore, it has been held that 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).
Response to Arguments
Applicant’s arguments with respect to claim 1 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIVIAN A TRAN whose telephone number is (571)272-3232. The examiner can normally be reached Mon - Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794