Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: In the first paragraph on page 1 of the specification (Cross Reference to Related Applications), the phrase –now U.S. patent no. 11,896,978—should be inserted after the phrase –U.S. Patent Application No. 17/032,524, filed on September 25, 2020” so as to update the status of this application. On each of page 19, lines 7-9, page 20, lines 13-14, page 21, line 29, page 25, lines 28-29, page 28, lines 32-33, page 38, lines 18 and 27, and page 51, lines 19-21, the phrase “serial # USSN 10/744,726, filed December 23, 2003” should be replaced with the phrase –U.S. Patent no. 7,497,997--, and the phrase “serial # USSN 12/959,952, filed December 3, 2010” should be replaced with the phrase “U.S. Patent no. 10,184,884—since both of these patent applications are now U.S. patents.
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 67-71, 77 and 81-84 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.
On line 2 of claim 67, the phrase “comprising a second nucleic acid a second volume of sample and a second volume of lysis” is indefinite since it is not clear whether the “second nucleic acid” is extracted from a lysate produced from combining the second volume of sample and the second volume of lysis buffer. In addition, the word “lysis” in this phrase is indefinite since it is not clear whether this refers to the lysis buffer.
Claim 77 is indefinite since it is not clear when the nucleic acid is first contacted with the membrane to be later eluted from the membrane. Is the nucleic acid contacted with the membrane prior to or after drying the membrane, or prior to or after washing the membrane with the purification reagent?
Claim 81 should depend from claim 80 since claim 81 recites a second set of PCR reagents, and claim 80 positively recites a first set of PCR reagents. On line 3 of claim 81, the phrase “reconstitution chamber in” should be changed to –reconstitution chamber, -- so that line 3 of claim 81 makes proper sense.
Claim 82 should depend from claim 81 since claim 82 recites a third set of PCR reagents, and claim 81 positively recites a second set of PCR reagents.
Claim 83 should depend from claim 82 since claim 83 recites a fourth set of PCR reagents, and claim 82 positively recites a third set of PCR reagents.
Claim 84 should depend from claim 83 since claim 84 recites a fifth set of PCR reagents, and claim 83 positively recites a fourth set of PCR reagents.
Inventorship
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
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 66, 72 and 75-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-55 of U.S. Patent No. 9,731,297 (submitted in the IDS filed on February 8, 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of conducting an analysis of a sample in an assay cartridge, said cartridge comprising a fluidic network and a plurality of chambers, wherein said fluidic network comprises: a primary flow path and one or more fluidic conduits each intersecting said primary flow path and fluidically connecting said primary flow path to a chamber of said plurality of chambers, wherein said fluidic network is configured to meter a volume of fluid in said fluidic network, said method comprising the steps of: metering a volume of sample from said chamber to a second chamber of the plurality of chambers; metering a volume of lysis buffer from a third chamber of said plurality of chambers to said second chamber; lysing said volume of sample to obtain a lysate; extracting nucleic acid from said lysate; moving said nucleic acid to a PCR reaction zone of said primary flow path, the PCR reaction zone having a first temperature controlled zone and a second temperature controlled zone; contacting said nucleic acid with one or more PCR reagents to form a mixture; shuttling said mixture between the first temperature controlled zone and the second temperature controlled zone; moving said mixture from the PCR reaction zone to a detection zone; and measuring a signal from the mixture in the detection zone (see instant claim 66 and claim 47 in U.S. 9,731,297). Both sets of claim also recite repeating the steps of contacting the nucleic acid with the one or more PCR reagents and shuttling the mixture between the first temperature controlled zone and the second temperature controlled zone to form an amplified product mixture, and contacting the amplified product mixture with a detection reagent (see instant claim 72 and claim 47, step (ix) in U.S. 9,731,297). Both sets of claims also recite moving the lysate from a chamber of the plurality of chambers to a purification zone of the primary flow path, and purifying the extracted nucleic acid in the purification zone (see instant claims 75-76, and claim 47, steps (iv) and (vi) in U.S. 9,731,297). Both sets of claims also recite that the purification of the extracted nucleic acid includes drying a membrane, washing the membrane with a purification reagent and eluting nucleic acids from the membrane (see instant claim 77, and claim 49 in U.S. 9,731,297). Both sets of claims also recite the extracting of nucleic acid from the lysate includes capturing lysate on a membrane, removing eluent to a first waste chamber, and washing said membrane with one or more purification reagents (see instant claim 78, and claim 48, steps (xx), (yy) and (zz) of U.S. 9,731,297). Both sets of claims also recite that the contacting of the nucleic acid with the one or more PCR reagents includes reconstituting one or more lyophilized reagents from a plurality of reconstitution chambers, wherein the reconstitution chambers include a first reconstitution chamber containing a first set of PCR reagents comprising reverse transcriptase and dNTP, a second reconstitution chamber containing a second set of PCR reagents comprising dNTPS, primers and polymerase, a third reconstitution chamber containing a third set of PCR reagents comprising primers, a fourth reconstitution chamber containing a fourth set of PCR reagents comprising EDTA and salt, and a fifth reconstitution chamber containing a fifth set of PCR reagents comprising detection reagents (see instant claims 79-84 and claims 50-55 in U.S. 9,731,297). Both sets of claims also recite detecting fluid flow in the primary flow path by an optical fluid sensor (see instant claim 85, and claim 47 (d) in U.S. 9,731,297).
Claims 66 and 72-85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-14 and 17 of U.S. Patent No. 11,896,978. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a method of conducting an analysis of a sample in an assay cartridge, said cartridge comprising a fluidic network and a plurality of chambers, wherein said fluidic network comprises: a primary flow path and one or more fluidic conduits each intersecting said primary flow path and fluidically connecting said primary flow path to a chamber of said plurality of chambers, wherein said fluidic network is configured to meter a volume of fluid in said fluidic network, said method comprising the steps of: metering a volume of sample from said chamber to a second chamber of the plurality of chambers; metering a volume of lysis buffer from a third chamber of said plurality of chambers to said second chamber; lysing said volume of sample to obtain a lysate; extracting nucleic acid from said lysate; moving said nucleic acid to a PCR reaction zone of said primary flow path, the PCR reaction zone having a first temperature controlled zone and a second temperature controlled zone; contacting said nucleic acid with one or more PCR reagents to form a mixture; shuttling said mixture between the first temperature controlled zone and the second temperature controlled zone; moving said mixture from the PCR reaction zone to a detection zone; and measuring a signal from the mixture in the detection zone (see instant claim 66 and claims 1 and 6 in U.S. 11,896,978). Both sets of claim also recite repeating the steps of contacting the nucleic acid with the one or more PCR reagents and shuttling the mixture between the first temperature controlled zone and the second temperature controlled zone to form an amplified product mixture, and contacting the amplified product mixture with a detection reagent (see instant claim 72, and claim 2 and claim 6, step (xi) in U.S. 11,896,978). Both sets of claims also recite that the one or more PCR reagents are dried reagents in the form of a dry pill, wherein the dry pill is completely immersed in the nucleic acid in the PCR reaction zone (see instant claims 73-74, and claims 3-4 in U.S. 11,896,978). Both sets of claims also recite moving the lysate from a chamber of the plurality of chambers to a purification zone of the primary flow path, and purifying the extracted nucleic acid in the purification zone (see instant claims 75-76, and claim 1, steps (v) and (vii) and claim 6, steps (v) and (vii) in U.S. 11,896,978). Both sets of claims also recite that the purification of the extracted nucleic acid includes drying a membrane, washing the membrane with a purification reagent and eluting nucleic acids from the membrane (see instant claim 77, and claim 8 in U.S. 11,896,978). Both sets of claims also recite the extracting of nucleic acid from the lysate includes capturing lysate on a membrane, removing eluent to a first waste chamber, and washing said membrane with one or more purification reagents (see instant claim 78, and claim 7, steps (xx)-(zz) of U.S. 11.896,978). Both sets of claims also recite that the contacting of the nucleic acid with the one or more PCR reagents includes reconstituting one or more lyophilized reagents from a plurality of reconstitution chambers, wherein the reconstitution chambers include a first reconstitution chamber containing a first set of PCR reagents comprising reverse transcriptase and dNTP, a second reconstitution chamber containing a second set of PCR reagents comprising dNTPS, primers and polymerase, a third reconstitution chamber containing a third set of PCR reagents comprising primers, a fourth reconstitution chamber containing a fourth set of PCR reagents comprising EDTA and salt, and a fifth reconstitution chamber containing a fifth set of PCR reagents comprising detection reagents (see instant claims 79-84 and claims 9-14 in U.S. 11,896,978). Both sets of claims also recite detecting fluid flow in the primary flow path by an optical fluid sensor (see instant claim 85, and claim 17 in U.S. 11,896,978).
Allowable Subject Matter
Claims 66-85 would be allowable if a proper terminal disclaimer over both of U.S. Patent no. 9,731,297 and U.S. Patent no. 11,896,978 are filed, and if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims as no prior art was found that teaches or suggests methods of conducting an analysis, such as a PCR analysis, of a sample in an assay cartridge as currently claimed. The closest prior art of Handique et al. (U.S. Patent Pub. No. 2007/0292941, cited on IDS dated February 8, 2024) teaches methods for processing a biological sample using an insertable microfluidic cartridge that comprises a fluidic network within the cartridge that comprises a processing chamber and plurality of particles configured to retain polynucleotides of the sample for purposes of purification, wherein the chamber is connected to a primary flow path that intersects the primary flow path at a junction via a channel that is also connected to a vent (see paragraphs 9, 260, 263-266 and Figures 10 and 11). Handique further teaches that the fluidic network comprises reagent containers and chambers for performing cell lysis, polynucleotide isolation, pre-amplification processing, amplification and detection (paragraphs 263, 266, 321 and 322 and Figures 10 and 15A and B). In addition, Handique teaches that the fluidic network is configured for metering reagents into the primary flow path, including reagents for processing a sample, such as for cell lysis and PCR (paragraphs 38, 45, 409, 419 and 424). However, while Handique teaches that the cartridge may be configured to perform PCR (see paragraphs 45, 46 and 75), the reference is silent with regards to shuttling a PCR reaction mixture between first and second temperature-controlled zones, as the reference does not disclose separate first and second temperature-controlled zones, but rather teaches that the PCR reaction zone comprises heaters configured to cyclically heat the reaction zone in a uniform manner throughout the reaction zone (see paragraph 199).
The next closest prior art of Battrell et al. (WO 2010/144683, cited on IDS dated February 8, 2024) teaches methods and self-contained microfluidic cartridges for molecular biological testing, the cartridge comprising hydraulic networks of channels, chambers, valves, pumps and other microfluidic features, including a sample inlet port and vents, (see Abstract, p. 18, lines 4-12 and Figure 1). Battrell further teaches that the cartridge may be used to perform cycling amplification reactions such as PCR using a format wherein samples are repeatedly flowed between melting and annealing chambers (p. 20, lines 5-31 and Figure 2A and B), or wherein samples are subjected to thermocycling within a single chamber wherein the sample remains stationary, wherein following amplification, the samples are moved to a detection chamber (p. 23, lines 6-21 and Figure 4A). However, modifying the cartridges of Battrell or Handique for purposes of thermocycling a sample to conform to the design of the other cartridge would change of mode of operation of the cartridge, as well as the configuration of the temperature control module. Furthermore, Battrell does not teach a microfluidic cartridge that comprises distinct chambers or zones for sample processing, such as for lysis and purification. While samples may be optionally extracted on a solid phase matrix prior to amplification, sample are generally introduced into the cartridge at an inlet port wherein the sample has been previously extracted and/or purified and is ready for nucleic acid amplification (p. 15, lines 19-27 and p. 20, lines 2-15). In addition, Battrell does not teach a fluidic network that is configured to meter a volume of fluid within the network, such as a volume of sample or lysis buffer.
Another reference of particular interest is Glezer et al. (U.S. Patent Pub. No. 2009/0065357, cited in the IDS dated February 8, 2024). Glezer teaches assay cartridges adapted to receive and analyze a biological sample comprising fluidic components such as reagent, sample and waste chambers, conduits, vents, dry reagent pill zones and a variety of sensors, wherein chambers are connected to a conduit at the bottom of the chamber and a vent conduit connects to a vent port at the top of the chamber (for overview see Abstract and paragraphs 4 and 181 and Figures, 9, 11 and 27). However, like Handique, Glezer is silent with regards to a first and second temperature-controlled zone, wherein a PCR reaction mixture is shuttled between the two zones. While Glezer teaches that the cartridge comprises a heater that heats the entire cartridge to a predetermined temperature, the reference does not teach heating the cartridge or any part of the cartridge in a cycling fashion, as the cartridge is not designed for performing thermocycling-based reactions such as for PCR (see paragraphs 259 and 265 and Figure 34).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Jovanovich et al (US 2013/0224846) who teach of a sample preparation and analysis system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 August 13, 2026
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