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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 8/17/2026 is acknowledged. The traversal is on the ground(s) that the special technical feature in common between groups does offer a contribution over the art of Antonio et al. as Antonio does not teach “a measurement zone arranged above a measuring chamber formed between the electrode support and a floor of the base forming a measuring chamber therebetween. This is not found persuasive because Antonio does teach these features. (See Antonio pg. 26 wherein a chamber having measurement electrodes therein is provided and thus a measurement chamber is formed between the electrodes a floor of the base. Also a “measurement zone” may be any point within the device which may be viewed be a user or microscope and thus above a chamber)
The requirement is still deemed proper and is therefore made FINAL.
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 43-45,47,50, and 54 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
Claim 43 recites the limitation "the cell culture liquid medium". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 45, the phrase "for instance" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 47 recites the limitation "the impedance of a cell". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 50, the phrase "for instance" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 54 recites the limitation "the gap". There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 40-43,45,48-50, and 52-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,912,976 in view of Dickerson et al. (US 2014/0367260
Regarding claims 40-43 claims 1-15 of US 11,912,976 discloses all the features thereof except the imaging system and computing unit being configured to have a variable focus and thus is configured take multiple images in a z direction.
Dickerson discloses a DEP cartridge wherein the cartridge is analyzed by utilizing a microscope and CCD camera, i.e. a camera requiring a computing unit, which allows vertical focus adjustment, i.e. images at different z heigh slices, within the cartridge so that an image of a sample in the cartridge may be accurately obtained. (See Dickerson Abstract [0084] and Fig. 11A.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a microscope capable of taking images at various focal heights, i.e. z direction slices, as described by Dickerson et al. in the device of US 11,912,976 because doing so allows imaging of separated cells within the device as would be desirable in the device of US 11,912,976.
Chiou et al. discloses a dep cartridge which includes a microscope and computing unit
Regarding claim 45 the limitations thereof correspond with claim 3 of US 11,912,976.
Regarding claim 48 the limitations thereof correspond with claim 5 of US 11,912,976.
Regarding claim 49 the limitations thereof correspond with claim 6 of US 11,912,976.
Regarding claim 50 the limitations thereof correspond with claims 7 and 9 of US 11,912,976.
Regarding claim 52 the limitations thereof correspond with claim 10 of US 11,912,976.
Regarding claim 53 the limitations thereof correspond with claim 11 of US 11,912,976.
Regarding claim 54 the limitations thereof correspond with claim 15 of US 11,912,976.
Claims 44, 46, 47, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,912,976 in view of Dickerson et al. (US 2014/0367260) as applied to claims above and further in view of Sano et al. (US 2012/0085649).
Regarding claims 44, 46, 47, and 51 the claims of U.S. Patent No. 11,912,976 disclose all the limitations as set forth above but do not disclose:
the signal generator is configured to scan through different electrode signal frequencies, or apply a plurality of discrete different electrode signal frequencies, during a measurement or over a succession of measurements, and the image capture system and computing unit are configured to measure displacements of a cell for different electrode signal frequencies;
the electrodes are insulated with respect to an inside of the measuring chamber by an insulator layer, except for a measurement zone and contacts;
the cartridge comprises at least two impedance measurement electrodes configured for measuring the impedance (Zi) of a cell;
and the electrodes comprise at least two interdigitated electrodes.
Sano discloses a DEP cartridge wherein a signal generator scans through different frequencies (See Sano [0036]-[0044] and Figs. 30B-31D); the electrodes are insulated by an insulator layer (See [0010]-[0011], there are two impedance measurement electrodes (See Sano [0076]) and the device electrodes are interdigitated. (See Sano Figs. 6I and 8D).
It would have been obvious to one of ordinary skill in the art at the time of invention to provide the elements of Sato in the device of U.S. Patent No. 11,912,976 because such elements are known in the art to allow for the effective arrangement of electrodes and detection of signals so that sample materials may be effectively separated and detected in an accurate manner as would be desirable in the device of U.S. Patent No. 11,912,976.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
40. (New) A cell culture monitoring system comprising a monitoring apparatus for coupling to a culture tank containing a cell culture medium therein, and a fluid circulation system for fluidic coupling to the cell culture tank the fluid circulation system comprising supply and return conduits
and a dielectrophoresis cartridge for connection to the cell culture tank via the supply and return conduits, the dielectrophoresis cartridge comprising
a base and an electrode support having electrodes arranged in an electrode plane X-Yin or on the electrode support, the electrodes configured for travelling wave dielectrophoresis and comprising a measurement zone arranged above a measuring chamber formed between the electrode support and a floor of the base forming a measuring chamber therebetween
the monitoring apparatus comprising a signal generator connected to the electrodes, a computing unit, an image capture system connected to the computing unit, and a cartridge holder portion for receiving said dielectrophoresis cartridge such that the image capture system may detect cells in said measuring chamber,
wherein the image capture system is configured to capture the displacement of cells in the cell culture medium within the measuring chamber in an orthogonal direction Z to said electrode plane X-Y to enable measurement of a cell type and/or cell state.
41. (New) The system according to claim 40, wherein the image capture system and computing unit is configured to capture multiple images in slices taken in the orthogonal direction Z that are processed to determine the position and displacement of cells in the orthogonal direction Z.
42. (New) The system according to claim 41, wherein the image capture system comprises a microscope with a depth of field less than a height of the measuring chamber and an electrically adjustable lens for adjustment of the focus to capture slices of image at different heights.
43. (New) The system according to claim 40, wherein cells in the cell culture liquid medium within the measuring chamber are subject to a travelling wave dielectrophoresis force in a plane parallel to the electrode plane X-Y and wherein the image capture system is configured to capture the displacement of cells in the cell culture medium within the measuring chamber in said plane parallel to the electrode plane X-Y to enable measurement of a cell type and/or cell state in conjunction with the measurement based on displacement of the cell in the orthogonal direction Z .
44. (New) The system according to claim 43, wherein the signal generator is configured to scan through different electrode signal frequencies, or apply a plurality of discrete different electrode signal frequencies, during a measurement or over a succession of measurements, and the image capture system and computing unit are configured to measure displacements of a cell for different electrode signal frequencies.
45. (New) The system according to claim 40, wherein the electrode support is made of a transparent polymer or glass, and the electrodes are made of a conductive transparent material, for instance a thin indium tin oxide (ITO) layer.
46. (New) The system according to claim 40, wherein the electrodes are insulated with respect to an inside of the measuring chamber by an insulator layer, except for a measurement zone and contacts.
47. (New) The system according to claim 40, wherein the cartridge comprises at least two impedance measurement electrodes configured for measuring the impedance (Zi) of a cell.
48. (New) The system according to claim 40, wherein the electrodes are formed on an inner surface of the electrode support bounding the measuring chamber and having contact portions extending to an electrode connection window formed in the base for plugging contact to complementary spring contacts of the monitoring apparatus, the electrode connection window being sealingly separated from the measuring chamber.
49. (New) The system according to claim 40, wherein the measuring chamber comprises a raised floor and lateral guides defining a gap between the floor and electrode support.
50. (New) The system according to claim 40, wherein said electrodes comprise one or more spiraling conductive tracks, for instance in two sets in mirror image symmetry, a portion of which forms the measurement zone.
51. (New) The system according to claim 40, wherein the electrodes comprise at least two interdigitated electrodes.
52. (New) The system according to claim 40, wherein the cartridge holder portion of the monitoring apparatus comprises a cartridge holder slot configured for slidable insertion of the dielectrophoresis cartridge therein.
53. (New) The system according to claim 40, wherein the cartridge holder portion comprises locating elements engaging in complementary locating elements in the dielectrophoresis cartridge for positioning and securing the dielectrophoresis cartridge in a measurement position.
54. (New) The system according to claim 40, wherein the gap in the measuring chamber between electrode and floor is in the range of 10 to 500pm.
