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 without traverse of Group I, claims 1-15 in the reply filed on 04/30/2026 is acknowledged.
Claims 16-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/30/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) (IDS) were submitted on:
04/18/2023
09/02/2025
04/30/2026
Accordingly, the information disclosure statement(s) are being considered by the examiner.
The information disclosure statement filed 04/30/2026 contains a cited foreign patent document that does not pertain to the instant invention or its prior art on the information disclosure statement:
Citation #2: JP 2020/509479
The IDS has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to because:
Regarding Figure 2, there is a gray rectangular box in the lower right-hand corner that is unlabeled.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities:
Regarding claim 5, lines 1-2, the phrase “wherein first heating zone” should be “wherein the first heating zone”.
Regarding claim 6, lines 1-2, the phrase “wherein first heating zone” should be “wherein the first heating zone”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Relevant claim limitation(s) is/are:
“means for moving liquid sample through the fluidic channel along a sample flow path for a desired distance and direction” in claims 1 and 3
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claims 1 and 3 are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A review of the specification as filed shows that the following appears to be the corresponding structures, materials, or acts described in the specification as filed for the following 35 U.S.C. § 112(f) limitations:
“ … the means for moving fluid around the network of microchannels, with those skilled in the art being aware of the various options available such as various types of positive displacement pump including bellows pumps, syringe pumps etc.” (instant specification, pg. 13, second paragraph)
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Regarding claim 4, the means-plus-function limitation described above is present in the claim. However, in this dependent claim, the limitation is further defined with open-ended “comprising” language, thereby providing structure to the limitation. The 35 U.S.C. § 112(f) interpretation does not apply for the limitation in this dependent claim.
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 3-4, 6, 11, and 15 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 3 recites the limitation “the means for moving liquid” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 contains the similar, but nonidentical phrase “means for moving liquid sample”.
Claim 3 recites the limitation “the liquid” in line 2. There is insufficient antecedent basis for this limitation in the claim. This rejection is based upon the 35 U.S.C. § 112(b) rejection above regarding the phrase “the means for moving liquid”, as it is unclear what liquid (i.e. the liquid sample of parent claim 1; or, alternatively, a different liquid of claim 3) is being considered.
Claim 3 recites the limitation “the microfluidic channel” in line 3. There is insufficient antecedent basis for this limitation in the claim. The term “microfluidic” does not have antecedent basis in parent claim 1 or claim 3.
Claim 4 recites the limitation “the means for moving liquid” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 contains the similar, but nonidentical phrase “means for moving liquid sample”.
Claim 6 recites the limitation “the microfluidic channel” in line 2. There is insufficient antecedent basis for this limitation in the claim. The term “microfluidic” does not have antecedent basis in parent claim 1 or claim 6.
Claim 6 recites the limitation “the flow path” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 contains the similar, but nonidentical phrase “a sample flow path”.
Regarding claim 11, the claim is unclear and indefinite. There are several possible interpretations. The inhibition reduction reagent could be initially located upstream of the first heating zone and the sample is in the flow path but is not located upstream of the first heating zone; or, the sample is initially located in the flow path and is located upstream of the first heating zone and the location of the inhibition reduction reagent is unknown; or, the inhibition reduction reagent and the sample are both to be mixed together and initially are both located upstream of the first heating zone.
Regarding claim 15, the claim is unclear and indefinite. There are at least two interpretations. Either, the claim implies that the fluidic test device was initially not a microfluidic cassette and is now a microfluidic cassette (a form of how to operate the fluidic test device / an intended use of how to configure the fluidic test device; or, alternatively, a method of making); or, the fluidic test device is a microfluidic cassette (structural limitation). It would seem that the latter limitation makes more sense in the context of the device claim (no method of manufacturing and/or intended use), so the phrase “the fluidic test device is in the form of a microfluidic cassette” or the phrase “the fluidic test device is a microfluidic cassette” (with instant specification support at pg. 7, line 4) would be two possible recommended wordings for this limitation.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-7, and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Fukuzawa (US 20180311673) (previously cited).
Regarding claim 1, Fukuzawa discloses a fluidic test device (paragraph [0015] “plate-like reaction processing vessel”) comprising:
a body (Fig. 4, element 10 “reaction processing vessel”; paragraphs [0040]-[0041]);
a fluidic channel through the body (Fig. 4, element 12 “channel”; paragraph [0041]-[0042]);
an inlet in fluid communication with the fluidic channel (Fig. 4, element 17 “first communication port”; paragraph [0038]);
means for moving liquid sample through the fluidic channel along a sample flow path for a desired distance and direction (Fig. 3, element 39 “liquid feeding pump”; paragraphs [0044]-[0047]); and
a first heating zone (Fig. 4, elements 40, 41, or 42 “region”; paragraphs [0041]-[0042]);
wherein the sample flow path is configured such that at a first time point a sample will be within at least a portion of the first heating zone and be heated to a thermal conditioning temperature (Fig. 4, elements 40, 41, or 42 “temperature region”; paragraphs [0041]-[0043]), and at a second time point the sample and one or more polymerase chain reaction reagents will be within the first heating zone and be heated as part of at least one part of a thermocycling profile (Fig. 4, elements 40, 41, or 42 “temperature region; paragraphs [0041]-[0043]).
Regarding the limitation “wherein the sample flow path is configured such that at a first time point a sample will be within at least a portion of the first heating zone and be heated to a thermal conditioning temperature, and at a second time point the sample and one or more polymerase chain reaction reagents will be within the first heating zone and be heated as part of at least one part of a thermocycling profile”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Fukuzawa would be fully capable of operating in this manner given its structures.
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Fukuzawa, Fig. 4
Regarding claim 2, Fukuzawa discloses wherein the fluidic channel is a network of fluidic channels comprising one or more valves configured to open and close to form the flow path (see Figs. 1-9; paragraph [0018]).
Regarding the limitation “configured to open and close to form the flow path” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Fukuzawa would be fully capable of operating in this manner given its structures.
Regarding claim 3, Fukuzawa discloses wherein the means for moving liquid through the fluidic channel allows for predetermined movement of the liquid in a desired direction and for a desired distance along the microfluidic channel (paragraph [0016]; Fig. 3, element 39 “liquid feeding pump”; paragraphs [0044]-[0047]).
Regarding claim 5, Fukuzawa discloses wherein first heating zone (Fig. 4, elements 40, 41, or 42 “region”; paragraph [0042]) is configured to be heated when received within a diagnostic instrument in accordance with programmed protocols (paragraphs [0015] and [0041] “temperature control system” and “CPU”).
Regarding the limitation “is configured to be heated when received within a diagnostic instrument in accordance with programmed protocols” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Fukuzawa would be fully capable of operating in this manner given its structures.
Regarding claim 6, Fukuzawa discloses wherein first heating zone (Fig. 4, elements 40, 41, or 42 “region”; paragraphs [0041]-[0042]) includes a portion of the microfluidic channel and is associated with a portion of the flow path (Fig. 4, element 12 “channel”; paragraph [0041]-[0042]).
Regarding claim 7, Fukuzawa discloses further comprising a second heating zone (Fig. 4, a second of one of the elements 40, 41, or 42 “region”; paragraphs [0041]-[0042]).
Regarding claim 15, Fukuzawa discloses wherein the fluidic test device is configured as a microfluidic cassette (paragraph [0070] and Figs. 1-9 “reaction processing vessel” and “micro blower pump” used for pumping liquid through channels).
Claims 1-3, 5-7, and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Arlett (US 20180021783) (newly cited).
Regarding claim 1, Arlett discloses a fluidic test device (paragraph [0015] “fluidic cartridge”) comprising:
a body (paragraph [0015]);
a fluidic channel through the body (paragraph [0007]);
an inlet in fluid communication with the fluidic channel (paragraph [0099]);
means (paragraph [0121], Fig. 1, element 20 “bellows”) for moving liquid sample (paragraphs [0038] and [0085]) through the fluidic channel along a sample flow path (Fig. 1) for a desired distance and direction (paragraphs [0118] and [0121]); and
a first heating zone (paragraph [0293], Fig. 28, element 362 “first region”);
wherein the sample flow path (Fig. 1) is configured such that at a first time point a sample will be within at least a portion of the first heating zone (paragraph [0293], Fig. 28, element 362 “first region” aligned with element 136 “sample mixing chamber”), and be heated to a thermal conditioning temperature (paragraphs [0292]-[0293]), and at a second time point the sample (paragraphs [0038] and [0085]) and one or more polymerase chain reaction reagents (paragraph [0112]) will be within the first heating zone (paragraph [0293], Fig. 28, element 362 “first region”) and be heated as part of at least one part of a thermocycling profile (paragraphs [0099] and [0111]).
Regarding the limitation “wherein the sample flow path is configured such that at a first time point a sample will be within at least a portion of the first heating zone and be heated to a thermal conditioning temperature, and at a second time point the sample and one or more polymerase chain reaction reagents will be within the first heating zone and be heated as part of at least one part of a thermocycling profile”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Arlett would be fully capable of operating in this manner given its structures.
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Arlett, Fig. 1
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Arlett, Fig. 28
Regarding claim 2, Arlett discloses wherein the fluidic channel is a network of fluidic channels (Fig. 1, paragraph [0107]) comprising one or more valves (paragraph [0097]) configured to open and close to form the flow path (paragraph [0097]).
Regarding the limitation “configured to open and close to form the flow path” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Arlett would be fully capable of operating in this manner given its structures.
Regarding claim 3, Arlett discloses wherein the means (paragraph [0121], Fig. 1, element 20 “bellows”) for moving liquid (paragraphs [0038] and [0085]) through the fluidic channel (Fig. 1) allows for predetermined movement of the liquid in a desired direction and for a desired distance (paragraphs [0118] and [0121]) along the microfluidic channel (paragraph [0110] “microfluidic device”).
Regarding claim 5, Arlett discloses wherein first heating zone (paragraph [0293], Fig. 28, element 362 “first region”) is configured to be heated (paragraph [0293]) when received within a diagnostic instrument (paragraphs [0015] and [0293]) in accordance with programmed protocols (paragraphs [0099] and [0246]-[0248]).
Regarding the limitation “is configured to be heated when received within a diagnostic instrument in accordance with programmed protocols” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Arlett would be fully capable of operating in this manner given its structures.
Regarding claim 6, Arlett discloses wherein first heating zone (paragraph [0293], Fig. 28, element 362 “first region”) includes a portion of the microfluidic channel (Fig. 28, paragraphs [0110] “microfluidic device” and paragraph [0293]) and is associated with a portion of the flow path (Fig. 28, paragraph [0293] Fig. 28, element 136 “sample mixing chamber”).
Regarding claim 7, Arlett discloses further comprising a second heating zone (paragraph [0293], Fig. 28, element 364 “second region”).
Regarding claim 15, Arlett discloses wherein the fluidic test device is configured as a microfluidic cassette (paragraph [0110]).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fukuzawa (US 20180311673) (previously cited) as applied to claim 1.
Regarding claim 4, Fukuzawa discloses wherein the means for moving liquid through the fluidic channel comprises a positive displacement pump (paragraph [0016]; Fig. 3, element 39 “liquid feeding pump”; paragraphs [0044]-[0047] “diaphragm pump”).
Fukuzawa does not disclose a plurality of positive displacement pumps.
Regarding the limitation “a plurality of positive displacement pumps”, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the device of Fukuzawa with the plurality of positive displacement pumps in order to pump different liquids (e.g. reagents and samples) into a channel for reaction processing.
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fukuzawa (US 20180311673) (previously cited) as applied to claim 1 and further in view of Tsaloglou (US 20230332253) (newly cited).
Regarding claim 8, Fukuzawa discloses reagents (paragraph [0039]) in the fluidic channel (paragraph [0038]).
Fukuzawa does not disclose comprising an inhibition reduction reagent.
Tsaloglou discloses comprising an inhibition reduction reagent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Fukuzawa with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding claim 9, Fukuzawa discloses wherein a reagent (paragraph [0039]) is provided in a reagent chamber (paragraphs [0018] and [0038]).
Fukuzawa does not disclose the inhibition reduction reagent.
Tsaloglou discloses the inhibition reduction reagent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Fukuzawa with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding claim 10, Fukuzawa discloses wherein a reagent is provided in liquid form (paragraph [0039] for reagents being part of the sample and paragraph [0111] describing “boiling” inherently implies a liquid sample).
Fukuzawa does not disclose the inhibition reduction reagent.
Tsaloglou discloses the inhibition reduction reagent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Fukuzawa with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding the term “a dried or lyophilized material”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Regarding claim 11, Fukuzawa discloses wherein a reagent is positioned to mix with the sample in the flow path (paragraph [0039]) and the first heating zone (Fig. 4, elements 40, 41, or 42 “region”; paragraphs [0041]-[0042]).
Fukuzawa does not disclose wherein the inhibition reduction reagent is positioned to mix with the sample in the flow path upstream of the first heating zone.
Tsaloglou discloses the inhibition reduction reagent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Fukuzawa with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding the phrase “is positioned to mix with the sample in the flow path upstream of the first heating zone”, this is an obvious rearrangement of the parts of Fukuzawa. Regarding this limitation, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). It would have been obvious to one skilled in the art before the effective filing date to modify modified Fukuzawa with a position of the inhibition reduction reagent to mix with the sample in the flow path upstream of the first heating zone as an effective alternative to the arrangement of parts in Fukuzawa to mix the reagent and sample together before pumping into a microfluidic channel so that there less likelihood of clogging the width of a microfluidic channel which, in turn, is evenly subjected to the first heating zone for enzymatic tests such as those that include polymerase chain reaction (PCR) processes.
Regarding the limitation “is positioned such that it will to mix with the sample in the flow path upstream of the first heating zone” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Fukuzawa would be fully capable of operating in this manner given its structures.
Regarding claim 12, Fukuzawa does not disclose wherein the inhibition reduction reagent comprises a reducing agent.
Tsaloglou discloses wherein the inhibition reduction reagent comprises a reducing agent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Fukuzawa with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fukuzawa (US 20180311673) (previously cited) in view of Tsaloglou (US 20230332253) (newly cited) as applied to claim 8 and as evidenced by Thermo Fisher Scientific (“Introduction to Thiol Modification and Detection Section 2.1”) (newly cited).
Regarding claim 13, Fukuzawa does not disclose wherein the inhibition reduction reagent comprises a thiol reducing agent.
Tsaloglou discloses wherein the inhibition reduction reagent comprises a thiol reducing agent (paragraphs [0235] and [0238], inherent to the reducing agent “tris(2-carboxyethyl)phosphine (TCEP))”, as evidenced by Thermo Fisher Scientific, pg. 99, right column).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Fukuzawa with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding claim 14, Fukuzawa does not disclose wherein the thiol reducing agent comprises tris(2-carboxyethyl)phosphine (TCEP).
Tsaloglou discloses wherein the thiol reducing agent comprises tris(2-carboxyethyl)phosphine (TCEP) (paragraphs [0235] and [0238], inherent to the reducing agent “tris(2-carboxyethyl)phosphine (TCEP))”, as evidenced by Thermo Fisher Scientific, pg. 99, right column).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Fukuzawa with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Arlett (US 20180021783) (newly cited) as applied to claim 1.
Regarding claim 4, Arlett discloses wherein the means for moving liquid through the fluidic channel comprises a positive displacement pump (paragraphs [0118] and [0121], Fig. 1, element 20 “bellows”).
Arlett does not disclose a plurality of positive displacement pumps.
Regarding the limitation “a plurality of positive displacement pumps”, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the device of Arlett with the plurality of positive displacement pumps in order to pump different liquids (e.g. reagents and samples) from different locations into different channels to be combined together for mixing at different times for enzymatic reactions such as polymerase chain reaction processes.
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Arlett (US 20180021783) (newly cited) as applied to claim 1 and further in view of Tsaloglou (US 20230332253) (newly cited).
Regarding claim 8, Arlett discloses reagents (paragraphs [0098]-[0103]) in the fluidic channel (paragraph [0103]).
Arlett does not disclose comprising an inhibition reduction reagent.
Tsaloglou discloses comprising an inhibition reduction reagent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Arlett with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding claim 9, Arlett discloses wherein a reagent (paragraph [0038]) is provided in a reagent chamber (paragraph [0038] “at least one collapsible blister containing a liquid reagent”).
Arlett does not disclose the inhibition reduction reagent.
Tsaloglou discloses the inhibition reduction reagent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Arlett with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding claim 10, Arlett discloses wherein a reagent is provided as a dried material (paragraph [0111]) or in liquid form (paragraph [0038]).
Arlett does not disclose the inhibition reduction reagent.
Tsaloglou discloses the inhibition reduction reagent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Arlett with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding the term “or lyophilized material”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Regarding claim 11, Arlett discloses wherein a reagent is positioned to mix with the sample in the flow path (paragraphs [0222]-[0223]) and the first heating zone (paragraph [0293]).
Arlett does not disclose wherein the inhibition reduction reagent is positioned to mix with the sample in the flow path upstream of the first heating zone.
Tsaloglou discloses the inhibition reduction reagent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Arlett with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding the phrase “is positioned to mix with the sample in the flow path upstream of the first heating zone”, this is an obvious rearrangement of the parts of Arlett. Regarding this limitation, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). It would have been obvious to one skilled in the art before the effective filing date to modify modified Arlett with a position of the inhibition reduction reagent to mix with the sample in the flow path upstream of the first heating zone as an effective alternative to the arrangement of parts in Arlett to mix the reagent and sample together before pumping into a microfluidic channel so that there less likelihood of clogging the width of a microfluidic channel which, in turn, is evenly subjected to the first heating zone for enzymatic tests such as those that include polymerase chain reaction (PCR) processes.
Regarding the limitation “is positioned such that it will to mix with the sample in the flow path upstream of the first heating zone” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Arlett would be fully capable of operating in this manner given its structures.
Regarding claim 12, Arlett does not disclose wherein the inhibition reduction reagent comprises a reducing agent.
Tsaloglou discloses wherein the inhibition reduction reagent comprises a reducing agent (paragraphs [0235] and [0238]).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Arlett with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Arlett (US 20180021783) (newly cited) in view of Tsaloglou (US 20230332253) (newly cited) as applied to claim 8 and as evidenced by Thermo Fisher Scientific (“Introduction to Thiol Modification and Detection Section 2.1”) (newly cited).
Regarding claim 13, Arlett does not disclose wherein the inhibition reduction reagent comprises a thiol reducing agent.
Tsaloglou discloses wherein the inhibition reduction reagent comprises a thiol reducing agent (paragraphs [0235] and [0238], inherent to the reducing agent “tris(2-carboxyethyl)phosphine (TCEP))”, as evidenced by Thermo Fisher Scientific, pg. 99, right column).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Arlett with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Regarding claim 14, Arlett does not disclose wherein the thiol reducing agent comprises tris(2-carboxyethyl)phosphine (TCEP).
Tsaloglou discloses wherein the thiol reducing agent comprises tris(2-carboxyethyl)phosphine (TCEP) (paragraphs [0235] and [0238], inherent to the reducing agent “tris(2-carboxyethyl)phosphine (TCEP))”, as evidenced by Thermo Fisher Scientific, pg. 99, right column).
In the analogous art of coronavirus lysis buffers, it would have been obvious to one skilled in the art before the effective filing date to modify the device of Arlett with the inhibition reduction reagent of Tsaloglou in order to have a viral lysis buffer compatible with amplification and detection of the viral genome (Tsaloglou, paragraph [0235]).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Petersen (US 20010012612) (newly disclosed) – This invention is a device for polymerase chain reaction (PCR).
Conclusion
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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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