DETAILED ACTION
In application filed on 06/22/2023, Claims 72-89 and 91 are pending. The claim set submitted on 02/18/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 72-89 and 91 are considered in the current office 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 06/22/2023 and 06/04/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 05/30/2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Group I, Claims 72-89 and 91 are considered on the merits below.
Claim Objections
Claim 78 is objected to because of the following informalities:
Claim 78 recites the limitation “sealed quality control vessel” in line 1, then recites “quality control vessel” in the rest of the claim.
Consistent language should be used and for the purpose of expedited prosecution, Examiner interprets “sealed quality control vessel” as “quality control vessel”.
Appropriate correction is required.
Claim 78 recites the limitation “output fluid” in lines 2-3, then recites “final output fluid” in the rest of the claim.
Consistent language should be used and for the purpose of expedited prosecution, Examiner interprets “output fluid” as “final output fluid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 72-89 and 91 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 72 recites the limitation "the fluid contents" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of expedited prosecution, the limitation "the fluid contents" is interpreted by the Examiner as "the one or more fluid reagents ".
Moreover, Claims 73-89 and 91 are rejected by virtue of dependence on Claim 72.
Claim 80 recites the limitation "the buffer solution channel" in line 5. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of expedited prosecution, the limitation "the buffer solution channel" is interpreted by the Examiner as "a buffer solution channel".
Moreover, Claims 87-89 are rejected by virtue of dependence on Claim 80.
Claim 81 recites the limitation "the outlet " in line 5. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of expedited prosecution, the limitation "the outlet is interpreted by the Examiner as "the intermediate outlet".
Claim 83 recites the limitation "the primary outlet channel" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
It appears that the "the primary outlet channel" should be recited as “the primary output channel" as recited in line 2 of the Claim.
For the purpose of expedited prosecution, the limitation "the primary outlet channel" is interpreted by the Examiner as "the primary output channel".
Moreover, Claims 84-86 are rejected by virtue of dependence on Claim 83.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 72-77 and 91 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Taylor et al. (US20040166031A1, provided in the IDS of 06/22/2023 as US6783736B1).
Regarding Claim 72, Taylor teaches a sample cartridge (referred to as a cartridge [Abstract]) for a chemical processing instrument (Abstract; Para 0005… A cartridge for analyzing a fluid sample), the sample cartridge (Abstract; Para 0005… A cartridge for analyzing a fluid sample) comprising:
a primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]) configured to accommodate a fluid sample for processing (See Para 0058…holding a fluid sample; See Para 0002…for analyzing a fluid sample) and configured to receive a lid (referred to as cap [Para 0056; Fig. 1, ref. 30]) for closing an open top (referred to as an inlet port [Para 0056]) of the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]);
a reagent vessel (referred to as a reagent chamber [Para 0058; Fig 3. ref. 67]) configured to receive (See Para 0058…‘for holding’) one or more fluid reagents (referred to as lysing reagent [Para 0058]) via an open top (See Para 0169…reagents may be exogenously introduced into the cartridge before use, e.g., through sealable openings in the reagent chamber 67; See Fig. 3 for the top of the reagent chamber,67 being covered by the gasket forming adequate seal [See Para 0059]) of the reagent vessel (See Para 0148… lysing reagent to flow from the chamber 67),
the reagent vessel (referred to as a reagent chamber [Para 0058; Fig 3. ref. 67]) being connected (See Para 0148… lysing reagent (‘contained in the reagent chamber’) to flow from the chamber 67) to the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]) via a primary reagent channel (referred to as channel [Para 0104; Fig 7, ref. 117]) with a primary reagent valve (referred to a valve [Para 0103-0104, Fig. 7, refs. 107 and/or 119]) disposed (See Fig. 7 for the claimed “disposed”) in the primary reagent channel (referred to as channel [Para 0104; Fig 7, ref. 117]) to control fluid flow (See Para 0006…at least one flow controller (e.g., valves) for directing the sample …and for directing the analyte separated from the sample into the analyte flow path.) through the primary reagent channel (referred to as channel [Para 0104; Fig 7, ref. 117]); and
a primary pneumatic port (referred to as pressure port [Para 0056; Figs. 1, 3, ref. 32]) in fluid communication (See Para 0101…The hydrophobic membrane 410 is positioned between the chamber 414(sample) and a pressure port 32, thereby teaching “fluid communication”) with the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]) and configured to be connected to a pneumatic module (referred to as a pressure source (e.g., a vacuum or pneumatic pump) [Para 0101; or pressure sources, e.g., pumps or vacuums [Para 0056]) to selectively adjust a pressure (See Para 0143…Although positive pressure is described herein, negative pressure (vacuum) may also be used to control fluid flow in the cartridge. The maximum amount of positive pressure that can be applied is usually limited by the hydrophobic membranes which may reach liquid break-through pressure above 30 psi. The lower limit of pressure is limited by the need to move sample and other fluids through the cartridge sufficiently quickly to meet assay goals, thereby teaching “selectively adjust a pressure” ) within the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]) when the lid (referred to as cap [Para 0056; Fig. 1, ref. 30]) is closed to draw the fluid contents (See Para 0148… lysing reagent (‘contained in the reagent chamber’) to flow from the chamber 67, thereby teaching “draw the fluid contents) of the reagent vessel (referred to as a reagent chamber [Para 0058; Fig 3. ref. 67]) into the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]).
In addition, Claim 72 recites a lid, primary reagent channel, a pneumatic module and then recites how these structures function. Claim 72 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 73, Taylor teaches a primary pneumatic channel (See Fig. 7, 9…the fluidic pathway between first pressure port, ref. 105 and the sample chamber) extending between the primary pneumatic port (referred to as pressure port [Para 0056; Figs. 1, 3, ref. 32]; See Fig. 7, 9, ref. 105…the first pressure port) and the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]),
wherein an opening (See Annotated Figs.1, 3 for an opening) of the primary pneumatic channel (See Fig. 7, 9…the fluidic pathway between first pressure port, ref. 105 and the sample chamber) into the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]) is located part way up a sidewall (See Annotated Figs.1, 3) of the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]).
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Annotated Figs. 1 and 3, Taylor
Regarding Claim 74, Taylor teaches wherein an opening (See Annotated Figs.1, 3 for an opening) of the primary pneumatic channel (See Fig. 7, 9…the fluidic pathway between first pressure port, ref. 105 and the sample chamber) into the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. Ref. 65]) is located part way up a sidewall (See Annotated Figs.1, 3) of the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. 65]).
Regarding Claim 75, Taylor teaches further comprising a final output channel (referred to as channel [Para 0103; Figs. 7-8]) configured to carry (See Para 0058… a waste chamber 68 for receiving used sample and wash solution) a final output fluid (referred to as used sample and wash solution [Para 0058]) from the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. Ref. 65]) to a removable output vessel (referred to as waste chamber [Para 0058, 0103; Figs.3-4, ref. 68; Taylor does not teach that the waste chamber is not removable]).
Taylor further teaches that the height of the wall 152 is preferably selected such that when a fixed volume of fluid sample from the sample chamber 65 has flowed through the sample flow path to the waste chamber 68 (Para 0110).
Regarding Claim 76, Taylor teaches further comprising an output vessel pneumatic port (referred to as pressure port, 116 [Para 0145]) configured to be in fluid communication with the output vessel (referred to as waste chamber 68 [Para 0145]) via an output vessel pneumatic channel (referred to as channel 106 [Para 0145]) and configured to be connected to a pneumatic module (See Para 056… pressure sources, e.g., pumps or vacuums) to selectively adjust the pressure (See Para 0143…Although positive pressure is described herein, negative pressure (vacuum) may also be used to control fluid flow in the cartridge. The maximum amount of positive pressure that can be applied is usually limited by the hydrophobic membranes which may reach liquid break-through pressure above 30 psi. The lower limit of pressure is limited by the need to move sample and other fluids through the cartridge sufficiently quickly to meet assay goals, thereby teaching “selectively adjust a pressure” ) in the output vessel (referred to as waste chamber 68 [Para 0145]) to draw the final output fluid (referred to as used sample and wash solution [Para 0058]) into the output vessel (referred to as waste chamber 68 [Para 0145]) from the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. Ref. 65]) via the final output channel (referred to as channel [Para 0103; Figs. 7-8]).
Regarding Claim 77, Taylor teaches a temporary lid (referred to as a valve 114 [Para 0103]) configured to close (See Para 0103…a channel 112 leading to the vented waste chamber 68 through a valve 114;See Para 0148…the valves 111, 114 are closed) the output vessel (referred to as waste chamber 68 [Para 0145]) during processing (See Para 0153…In the next step), the temporary lid (referred to as a valve 114 [Para 0103]) being configured to fluidly connect (See Para 0103…a channel 112 leading to the vented waste chamber 68 through a valve 114 the final output channel (referred to as channel [Para 0103; Figs. 7-8]) and output vessel pneumatic channel (referred to as channel 106 [Para 0145]) to the output vessel (referred to as waste chamber 68 [Para 0145]).
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 78-89 are rejected under 35 U.S.C. 103 as being unpatentable over by (US20040166031A1, provided in the IDS of 06/22/2023 as US6783736B1) in view of Battrell et al. (US20160193603A1).
Regarding Claim 78, Taylor does not teach:
a sealed quality control vessel configured to receive an aliquot of the output fluid for quality control analysis;
a quality control channel extending between the quality control vessel and a quality control junction with the final output channel; and
a quality control pneumatic port in fluid communication with the quality control vessel and configured to be connected to a pneumatic module to selectively adjust a pressure within the quality control vessel to draw the aliquot of final output fluid from the final output channel through the quality control channel and into the quality control vessel.
In the analogous art of a microfluidic cartridge and methods for performing a diagnostic, molecular or biochemical assay thereon, where all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample, Battrell teaches:
a sealed quality control vessel (referred to as a three-chambered staging manifold 802′[Para 0118]) configured to receive an aliquot (See Para 0119; Fig. 8A… The splitting of a liquid volume 501… liquid 501 enters three chambered manifold 802′ under pressure) of the output fluid (referred to as eluate [Para 0118; Fig. 8A, ref. 501]) for quality control analysis (See Para 0118…for performing PCR);
a quality control channel (See Annotated Fig. 8A) extending between (See Fig. 8A) the quality control vessel (referred to as a three-chambered staging manifold 802′[Para 0118] and/or detection chambers 806 [Para 0120) and a quality control junction (referred to as via [Para 0118; Fig. 8A, ref. 801]) with the final output channel (referred to as chamber [Para 0133]); and
a quality control pneumatic port (referred to as vent 803 [Para 0120]) in fluid communication with the quality control vessel (referred to as a three-chambered staging manifold 802′[Para 0118] and/or detection chambers 806 [Para 0120) and configured to be connected to a pneumatic module (referred to as diaphragm of chamber 802 [Para 0121]) to selectively adjust a pressure within the quality control vessel (referred to as a three-chambered staging manifold 802′[Para 0118] and/or detection chambers 806 [Para 0120) to draw the aliquot (See Para 0119; Fig. 8A… The splitting of a liquid volume 501… liquid 501 enters three chambered manifold 802′ under pressure) of final output fluid (referred to as eluate [Para 0118; Fig. 8A, ref. 501]) from the final output channel (referred to as chamber [Para 0133]) through the quality control channel (See Annotated Fig. 8A) and into the quality control vessel (referred to as a three-chambered staging manifold 802′[Para 0118] and/or detection chambers 806 [Para 0120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a sealed quality control vessel configured to receive an aliquot of the output fluid for quality control analysis; a quality control channel extending between the quality control vessel and a quality control junction with the final output channel; and a quality control pneumatic port in fluid communication with the quality control vessel and configured to be connected to a pneumatic module to selectively adjust a pressure within the quality control vessel to draw the aliquot of final output fluid from the final output channel through the quality control channel and into the quality control vessel, as taught by Battrell for the benefit of providing built up of laminated and/or molded layers and contain hydraulic and pneumatic networks designed for a PCR assay (Battrell, Para 0107), allowing for the development of a mechanical means and methods for reducing the formation and entrainment of bubbles during initial wetout of assay channels, during rehydration of dry reagents, and for preventing or reducing accumulation and interference of bubbles during operation of the device (Battrell, Para 0013).
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Annotated Fig. 8A, Battrell
Regarding Claim 79, the sample cartridge of claim 78 is obvious over Taylor in view of Battrell.
Taylor does not teaches the quality control vessel is preloaded with a dye to be mixed with the aliquot of final output fluid for quality control analysis.
In the analogous art of a microfluidic cartridge and methods for performing a diagnostic, molecular or biochemical assay thereon, where all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample, Battrell teaches the quality control vessel (referred to as a three-chambered staging manifold 802′[Para 0118] and/or detection chambers 806 [Para 0120) is preloaded with a dye (See Para 0123…In the detection chamber 806, dry reagent spot 820 contains probes such as, for example, “molecular beacons” or intercalation dyes) to be mixed with the aliquot (See Para 0119; Fig. 8A… The splitting of a liquid volume 501… liquid 501 enters three chambered manifold 802′ under pressure) of the output fluid (referred to as eluate [Para 0118; Fig. 8A, ref. 501]) for quality control analysis (See Para 0118…for performing PCR).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the quality control vessel is preloaded with a dye to be mixed with the aliquot of final output fluid for quality control analysis, as taught by Battrell for the benefit of detecting amplicon produced in the amplification (Battrell, Para 0123), allowing for the development of a mechanical means and methods for reducing the formation and entrainment of bubbles during initial wetout of assay channels, during rehydration of dry reagents, and for preventing or reducing accumulation and interference of bubbles during operation of the device (Battrell, Para 0013).
Regarding Claim 80, the sample cartridge of claim 78 is obvious over Taylor in view of Battrell.
Taylor does not teach a buffer solution vessel configured to receive a buffer solution through an open top of the buffer solution vessel for mixing with the final output fluid for quality control analysis; a buffer channel extending between the buffer solution channel and a buffer junction with the final output channel between the quality control junction and the primary reaction vessel; and a buffer channel valve disposed in the buffer channel to control flow of the buffer solution through the buffer channel.
In the analogous art of a microfluidic cartridge and methods for performing a diagnostic, molecular or biochemical assay thereon, where all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample, Battrell teaches:
a buffer solution vessel (referred to as a final liquid-centered diaphragm reservoir [Para 0133]) configured to receive a buffer solution through an open top of the buffer solution vessel for mixing (‘The eluate with eluted nucleic acids 501’) with the final output fluid (‘eluted nucleic acids 501’) for quality control analysis (See Para 0133… The eluate with eluted nucleic acids 501 is then transferred to a staging manifold for entry into a detection subcircuit);
a buffer channel (referred to as channel 1205 [Para 0142]) extending between the buffer solution channel and a buffer junction (See Annotated Fig. 14B) with the final output channel (referred to as chamber [Para 0133; Fig. 14A, ref. 1202]) between the quality control junction (referred to as via [Para 0118; Fig. 8A, ref. 801]) and the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. Ref. 65]); and
a buffer channel valve (referred to a valves 1204 and 1206 [Para 0142]) disposed in the buffer channel (referred to as channel 1205 [Para 0142]) to control flow (See Para 0137-0138… Valves 1204 are initially closed…opening valves 1204) of the buffer solution (referred to as elution buffer Para 0142]) through the buffer channel (referred to as channel 1205 [Para 0142]).
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Annotated. Fig. 14B, Battrell
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate that a buffer solution vessel configured to receive a buffer solution through an open top of the buffer solution vessel for mixing with the final output fluid for quality control analysis; a buffer channel extending between the buffer solution channel and a buffer junction with the final output channel between the quality control junction and the primary reaction vessel; and a buffer channel valve disposed in the buffer channel to control flow of the buffer solution through the buffer channel, as taught by Battrell for the benefit of conducting the nucleic acid assay with PCR amplification on the eluate (Battrell, Para 0133), allowing for the development of a mechanical means and methods for reducing the formation and entrainment of bubbles during initial wetout of assay channels, during rehydration of dry reagents, and for preventing or reducing accumulation and interference of bubbles during operation of the device (Battrell, Para 0013).
Regarding Claim 81, the sample cartridge of claim 78 is obvious over Taylor in view of Battrell.
Taylor does not teach an intermediate outlet from the final output channel between the quality control junction and the output vessel; a sealed chamber into which the intermediate outlet opens;an air-permeable liquid barrier membrane covering the outlet; and an intermediate outlet pneumatic port in fluid communication with the sealed chamber and configured to be connected to a pneumatic module to selectively adjust a pressure within the sealed chamber to draw air through the air-permeable membrane from the final output channel.
In the analogous art of a microfluidic cartridge and methods for performing a diagnostic, molecular or biochemical assay thereon, where all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample, Battrell teaches:
an intermediate outlet (See Annotated Fig. 8A) from the final output channel (referred to as chamber [Para 0133; Fig. 14A, ref. 1202]) between the quality control junction (referred to as via [Para 0118; Fig. 8A, ref. 801]) and the output vessel (referred to as inboard card [Para 0117]);
a sealed chamber (referred to as downstream chambers 804 [Para 0118; Fig. 8A, ref. 804]) into which the intermediate outlet (See Annotated Fig. 8A) opens (See Fig. 8A);
an air-permeable liquid barrier membrane (See Para 0120…a hydrophobic liquid impermeable gas-permeable membrane) covering (See Para 0120…During wetout, all downstream structures are cleared of air ahead of a steadily advancing meniscus via terminal vent 807, which may be operated under sanitary conditions by capping with a hydrophobic liquid impermeable gas-permeable membrane in the manner illustrated for vent 803, ) the outlet (See Annotated Fig. 8A); and
an intermediate outlet pneumatic port in fluid communication with the sealed chamber (referred to as downstream chambers 804 [Para 0118; Fig. 8A, ref. 804]) and configured to be connected to a pneumatic module (See Para 0120…the passively stretching diaphragms 900 (FIGS. 9A-9L)) to selectively adjust a pressure within the sealed chamber (referred to as downstream chambers 804 [Para 0118; Fig. 8A, ref. 804]) to draw air through the air-permeable membrane (See Para 0120…a hydrophobic liquid impermeable gas-permeable membrane) from the final output channel (referred to as chamber [Para 0133; Fig. 14A, ref. 1202]).
In addition, Claim 81 recites a pneumatic module and then recites how this functions. Claim 81 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate that an intermediate outlet from the final output channel between the quality control junction and the output vessel; a sealed chamber into which the intermediate outlet opens; an air-permeable liquid barrier membrane covering the outlet; and an intermediate outlet pneumatic port in fluid communication with the sealed chamber and configured to be connected to a pneumatic module to selectively adjust a pressure within the sealed chamber to draw air through the air-permeable membrane from the final output channel, as taught by Battrell for the benefit of permitting precise filling of parallel downstream networks without entrainment of bubbles (Battrell, Para 0120), allowing for the development of a mechanical means and methods for reducing the formation and entrainment of bubbles during initial wetout of assay channels, during rehydration of dry reagents, and for preventing or reducing accumulation and interference of bubbles during operation of the device (Battrell, Para 0013).
Regarding Claim 82, Taylor teaches a sealed waste vessel (referred to as waste chamber 68 [Para 0145]; See Para 0103…a channel 112 leading to the vented waste chamber 68 through a valve 114; See Para 0148…the valves 111, 114 are closed), thereby teaching “sealed”) configured to receive waste fluid (referred to as used sample and wash solution [Para 0058]) from the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. Ref. 65]) via a waste channel (referred to as channel [Para 0103; Figs. 7-8]); and
a waste pneumatic port (referred to as pressure port, 116 [Para 0145]) in fluid communication with the waste vessel (referred to as waste chamber 68 [Para 0145]) and configured to be connected to a pneumatic module (referred to as a pressure source (e.g., a vacuum or pneumatic pump) [Para 0101; or pressure sources, e.g., pumps or vacuums [Para 0056]) to selectively adjust a pressure (See Para 0143…Although positive pressure is described herein, negative pressure (vacuum) may also be used to control fluid flow in the cartridge. The maximum amount of positive pressure that can be applied is usually limited by the hydrophobic membranes which may reach liquid break-through pressure above 30 psi. The lower limit of pressure is limited by the need to move sample and other fluids through the cartridge sufficiently quickly to meet assay goals, thereby teaching “selectively adjust a pressure”) within the waste vessel (referred to as waste chamber 68 [Para 0145]) to draw fluid (See Para 0109… when a predetermined volume of liquid is present in the waste chamber 68) from the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. Ref. 65]) through the waste channel (referred to as channel [Para 0103; Figs. 7-8]) and into the waste vessel (referred to as waste chamber 68 [Para 0145]).
Regarding Claim 83, Taylor teaches a secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]) configured to receive a primary output fluid (See Para 0103…presence of liquid in the channel…The sample flow path continues from the channel 106 into the lysing chamber 86 ) from the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. Ref. 65]) via a primary output channel (referred to as channel 106 [Para 0103]) fluidly connecting (See Para 0103…the sample chamber 65 through a valve 107 and into a channel 106) the primary reaction vessel (referred to as sample chamber [Para 0058; Fig 3. Ref. 65]) to the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]), and configured to receive one or more fluid reagents (See Para 0058… a lysing reagent) from the reagent vessel (referred to as a reagent chamber [Para 0058; Fig 3. ref. 67]; See Para 0058…a reagent chamber 67 for holding a lysing reagent) via a secondary reagent channel (See Para 0104… channel 117..) fluidly connecting (See Para 0104… the reagent chamber 67 is connected to the lysing chamber 86 through a valve 119, channel 117, and channel 106) the reagent vessel to the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]);
a primary outlet valve (referred to as valve 107 [Para 0103]) disposed in the primary outlet channel [interpreted as primary output channel in view of the 112b rejection] (referred to as channel 106 [Para 0103]) to control flow through the primary outlet channel (referred to as valve 115 [Para 0104]); and
a secondary reagent valve (referred to as valve 119 [Para 0104]) disposed in the secondary reagent channel (See Para 0104… channel 117) to control flow through the secondary reagent channel (See Para 0104… channel 117).
Regarding Claim 84, Taylor teaches the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]) is sealed (See Para 0061…sealing lips 73 surrounding the lysing chamber 86), and
wherein the sample cartridge (referred to as a cartridge [Abstract]) further comprises a secondary pneumatic port (referred to as pressure port, 128 [Para 0144, 0106]) in fluid communication with the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]) and configured to be connected to a pneumatic module (referred to as a pressure source (e.g., a vacuum or pneumatic pump) [Para 0101; or pressure sources, e.g., pumps or vacuums [Para 0056]) to selectively adjust a pressure (See Para 0143…Although positive pressure is described herein, negative pressure (vacuum) may also be used to control fluid flow in the cartridge. The maximum amount of positive pressure that can be applied is usually limited by the hydrophobic membranes which may reach liquid break-through pressure above 30 psi. The lower limit of pressure is limited by the need to move sample and other fluids through the cartridge sufficiently quickly to meet assay goals, thereby teaching “selectively adjust a pressure”) in the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]) to draw fluid (See Para 0109… when a predetermined volume of liquid is present in the waste chamber 68) from the primary outlet channel or secondary reagent channel (referred to as channel 106 [Para 0103]; or See Para 0104… channel 117) into the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]).
Regarding Claim 85, Taylor teaches a secondary pneumatic channel (See Para 0144…the channels 109 and 110, into the U-shaped channel 122) extending between the secondary pneumatic port (referred to as pressure port, 128 [Para 0144, 0106]) and the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]),
wherein an opening (See Fig. 8 where pressure port 128 has an opening) of the secondary pneumatic channel (referred to as pressure port, 128 [Para 0144, 0106]) into the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]) is located near a sidewall of the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]; Under BRI, the lysing chamber has a sidewall), nearer (See Fig. 8, thereby teaching nearer) to a top of the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]; Under BRI, the lysing chamber has a top) than a bottom of the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]; Under BRI, the lysing chamber has a bottom).
Regarding Claim 86, Taylor teaches an inlet or inlets (See Fig. 9 for the inlet of channel 106 leading to the lysing chamber, ref. 86) of the primary output channel (referred to as channel 106 [Para 0103]) and secondary reagent channel (See Para 0104… channel 117) open into the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]) part way up a sidewall of the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]; Under BRI, the lysing chamber has a sidewall), nearer (See Fig. 8, thereby teaching nearer) to a top of the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86] Under BRI, the lysing chamber has a top) than a bottom of the secondary reaction vessel (referred to as lysing chamber [Para 0103; Fig. 7, ref. 86]; Under BRI, the lysing chamber has a bottom).
Regarding Claim 88, the sample cartridge of claim 80 is obvious over Taylor in view of Battrell.
Taylor does not teach wherein, at the buffer junction, the buffer channel forms an obtuse angle with part of the final output channel extending between the quality control junction and buffer junction.
In the analogous art of a microfluidic cartridge and methods for performing a diagnostic, molecular or biochemical assay thereon, where all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample, Battrell teaches wherein, at the buffer junction (See Annotated Fig. 14B), the buffer channel (referred to as channel 1205 [Para 0142]) forms an obtuse angle with part (See Annotated Fig. 14A) of the final output channel (referred to as chamber [Para 0133; Fig. 14A, ref. 1202]) extending between the quality control junction (referred to as via [Para 0118; Fig. 8A, ref. 801]) and buffer junction (See Annotated Fig. 14B).
Examiner interprets “part” as any part or portion of the final output channel.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate wherein, at the buffer junction, the buffer channel forms an obtuse angle with part of the final output channel extending between the quality control junction and buffer junction, as taught by Battrell for the benefit of providing channels and chambers for performing rtPCR (Battrell, Para 0137), allowing for the development of a mechanical means and methods for reducing the formation and entrainment of bubbles during initial wetout of assay channels, during rehydration of dry reagents, and for preventing or reducing accumulation and interference of bubbles during operation of the device (Battrell, Para 0013).
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Annotated Fig. 14A
Regarding Claim 89, the sample cartridge of claim 80 is obvious over Taylor in view of Battrell.
Taylor does not teach that at the buffer junction, a pre-buffer junction part of the final output channel forms an obtuse angle with part of the final output channel extending between the quality control junction and buffer junction, and wherein, at the quality control junction, a post-QC junction part of the final output channel forms an obtuse angle with part of the final output channel extending between the quality control junction and buffer junction.
In the analogous art of a microfluidic cartridge and methods for performing a diagnostic, molecular or biochemical assay thereon, where all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample, Battrell teaches that at the buffer junction (See Annotated Fig. 14B), a pre-buffer junction part (See Figs, Annotated 14A-B) of the final output channel (referred to as chamber [Para 0133; Fig. 14A, ref. 1202]) forms an obtuse angle (See Annotated Fig. 14A) with part of the final output channel (referred to as chamber [Para 0133; Fig. 14A, ref. 1202]) extending between the quality control junction (referred to as via [Para 0118; Fig. 8A, ref. 801]) and buffer junction (See Annotated Fig. 14B), and wherein, at the quality control junction (referred to as via [Para 0118; Fig. 8A, ref. 801]), a post-QC junction part of the final output channel (referred to as chamber [Para 0133; Fig. 14A, ref. 1202]) forms an obtuse angle with part (See Annotated Fig. 14A) of the final output channel (referred to as chamber [Para 0133; Fig. 14A, ref. 1202]) extending between the quality control junction (referred to as via [Para 0118; Fig. 8A, ref. 801]) and buffer junction (See Annotated Fig. 14B).
Examiner interprets “a pre-buffer junction part” as any part or portion of the final output channel or any part or portion of the buffer junction.
In addition, Examiner interprets “part of the final output channel” as any part or portion of the final output channel.
Also, Examiner interprets “a post-QC junction part of the final output channel” as any part or portion of the final output channel.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate that at the buffer junction, a pre-buffer junction part of the final output channel forms an obtuse angle with part of the final output channel extending between the quality control junction and buffer junction, and wherein, at the quality control junction, a post-QC junction part of the final output channel forms an obtuse angle with part of the final output channel extending between the quality control junction and buffer junction, as taught by Battrell for the benefit of providing channels and chambers for performing rtPCR (Battrell, Para 0137), allowing for the development of a mechanical means and methods for reducing the formation and entrainment of bubbles during initial wetout of assay channels, during rehydration of dry reagents, and for preventing or reducing accumulation and interference of bubbles during operation of the device (Battrell, Para 0013
Taylor and Battrell does not explicitly teach the structural arrangement “part of the final output channel extending between the quality control junction and buffer junction”.
However, one having ordinary skill in the art at the time the invention was made would recognize these limitations as nothing more than a rearrangement of parts to effect the determination of the optimal structural configuration and design of the device and could seek the benefits associated with this claimed structural configuration, given that a rearrangement of parts is a supporting rationale of obviousness especially because Taylor discloses all the claimed structures of as cited above only in a different configuration (under broadest reasonable interpretation). Please see MPEP 2144.04(VI) (C) for further details.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the arrangement part of the final output channel extending between the quality control junction and buffer junction for the benefit of providing a device of optimal structural design of choice for the benefit of providing channels and chambers for performing rtPCR (Battrell, Para 0137), allowing for the development of a mechanical means and methods for reducing the formation and entrainment of bubbles during initial wetout of assay channels, during rehydration of dry reagents, and for preventing or reducing accumulation and interference of bubbles during operation of the device (Battrell, Para 0013).
Regarding Claim 91, Taylor teaches a method of use (See Para 0005… a cartridge for analyzing a fluid sample, e.g., to determine the presence or absence of an analyte in the sample) of the sample cartridge of claim 72 (See Claim 72 rejection), the method comprising operating an instrument (See Para 0141… The operation of the…instrument ) to achieve the extraction (See Para 0075… intracellular material (e.g., nucleic acid) released from the ruptured cells or viruses, thereby teaching “extraction”), isolation (See Para 0075… isolating target nucleic acid …), enrichment, concentration or quantification of nucleic acids (See Para 0075… subsequent elution and analysis, thereby teaching “enrichment, concentration or quantification”) from a sample (See Para… target cells or viruses in the fluid sample) in the sample cartridge (referred to as a cartridge [Abstract]). Examiner submits that the limitation “or the preparation of nucleic acid for manipulation, analysis, amplification, sequencing, PCR library preparation or insertion into a vector” is interpreted as an optional due the “or” recitation and therefore not required by the claim.
Conclusion
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797