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 claims 1-30 in the reply filed on 10/10/2025 is acknowledged. Claim 31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/10/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/14/2023, 10/09/2023, 10/23/2023, 02/08/2024, 03/26/2024 and 09/05/2025 are being considered by the examiner.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12390808. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Application 17941816
U.S. Patent 12390808
Claim 1
Claim 1
A device for detecting nucleic acids in a biological sample, comprising:
A device comprising:
a sample port for receiving therein a biological sample
a sample port for receiving therein a biological sample
a solid-state membrane configured to capture nucleic acids in the biological sample passed across the membrane
a solid-state membrane located downstream of the mixing chamber...pass the sample-lysis mixture across the solid-state membrane to capture nucleic acids in the biological sample therein
a sample conduit in fluid communication between the sample port and the solid-state membrane
a sample conduit in fluid communication between each of the sample port, the lysis chamber and the wash station, and the solid-state membrane
a lysis station in fluid communication with the sample conduit and including a lysis agent therein
a lysis chamber including a lysis agent therein…wherein the … lysis chamber and mixing chamber are configured to mix the biological sample and lysis agent … wherein the sample conduit includes the mixing chamber therein
a wash station in fluid communication with at least one of the sample conduit or the solid- state membrane and including a wash solution therein
a wash station including a wash solution therein … the wash station is configured to introduce the wash solution into the sample conduit …
an elution station in fluid communication with at least one of the sample conduit or the solid-state membrane and including an eluent therein
an elution station including an eluent therein...and the elution station is configured to pass the eluent across the solid-state membrane
a waste chamber located downstream of the solid-state membrane; and
a waste chamber located downstream of the solid-state membrane; and
one or more reaction chambers located downstream of the solid-state membrane
a reaction chamber located downstream of the solid-state membrane;
a mixing chamber for mixing the biological sample and lysis agent into a sample-lysis mixture;
wherein the sample port, lysis station and sample conduit are configured to mix the sample and lysis agent to form a sample-lysis mixture, pass the sample-lysis mixture across the solid-state membrane to capture nucleic acids in the biological sample therein, and receive the remainder of the sample-lysis mixture in the waste chamber, the wash station is configured to introduce the wash solution into at least one of the sample conduit or solid-state membrane following the sample- lysis mixture to purify nucleic acids captured on the solid-state membrane, the wash solution from the solid-state membrane is received in the waste chamber, and the elution station is configured to pass the eluent across the solid-state membrane, elute captured nucleic acids from the solid-state membrane, and pass the captured nucleic acids into one or more reaction chambers configured for amplifying and detecting the captured nucleic acids therein
wherein the sample port, lysis chamber and mixing chamber are configured to mix the biological sample and lysis agent to form a sample-lysis mixture, pass the sample-lysis mixture across the solid-state membrane to capture nucleic acids in the biological sample therein, and receive any remainder of the sample-lysis mixture in the waste chamber, the wash station is configured to introduce the wash solution across the solid-state membrane to purify nucleic acids captured therein, and receive the wash solution from the solid-state membrane in the waste chamber, and the elution station is configured to pass the eluent across the solid-state membrane, elute captured nucleic acids from the solid-state membrane, and pass the captured nucleic acids into the reaction chamber for amplifying the captured nucleic acids,... wherein the sample conduit includes the mixing chamber therein,
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. US 12390808. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Application 17941816
U.S. Patent 12390808 B2
Claim 2/1
Claim 6/3/1
A device as defined in claim 1, further comprising
A device as defined in claim 1
a lysis leg extending in fluid communication between the lysis station and the sample conduit at a sample-lysis junction and configured to direct a flow of the lysis agent from the lysis station into the sample conduit and allow the lysis agent to mix with the sample and form the sample-lysis mixture, and a wash leg extending in fluid communication between the wash station and at least one of the sample conduit or the solid-state membrane at a sample-wash junction and configured to direct a flow of the wash solution from the wash station behind the sample-lysis mixture.
a lysis leg extending in fluid communication between the lysis chamber and the sample conduit and configured to direct a flow of the lysis agent from the lysis chamber into the sample conduit, and (ii) a wash leg extending in fluid communication between the wash station and the sample conduit at a point upstream relative to the lysis leg and configured to direct a flow of the wash solution from the wash station into the sample conduit behind the sample-lysis mixture... the lysis leg is in fluid communication with the sample conduit at a sample-lysis junction located downstream of the biological sample- wash junction and configured to allow the lysis agent to mix with the sample and form the sample- lysis mixture and the wash solution to flow into the sample conduit behind or upstream of the sample-lysis mixture.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 12390808. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Application 17941816
U.S. Patent 12390808 B2
Claim 3/2/1
Claim 6/3/1
A device as defined in claim 2, further comprising
A device as defined in claim 1
a static mixer in fluid communication between the sample-lysis junction and the solid-state membrane and configured to mix the sample and lysis agent prior to passage across the solid-state membrane.
wherein the mixing chamber is defined by a static mixer within the sample conduit in fluid communication between a sample-lysis junction and the solid-state membrane to mix the sample and lysis agent and form the sample-lysis mixture prior to passage across the solid-state membrane.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 12390808. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Application 17941816
U.S. Patent 12390808 B2
Claim 12/1
claim 11/10/1
A device as defined in claim 1, further comprising
A device as defined in claim 10, [which depends on claim 1], further comprising
a reaction chamber valve in fluid communication between the solid-state membrane and the reaction chamber, wherein the reaction chamber valve is (i) closed to prevent fluid flow into the reaction chamber when a fluid pressure between the solid-state membrane and the reaction chamber valve is below a valve- opening pressure and (ii) is open to allow fluid flow into the reaction chamber when the fluid pressure between the solid-state membrane and the reaction chamber valve is above the valve- opening pressure.
a reaction chamber valve in fluid communication between the solid-state membrane and the reaction chamber, wherein the reaction chamber valve configured to be (i) closed to prevent fluid flow into the reaction chamber when a fluid pressure between the solid-state membrane and the reaction chamber valve is below a valve-opening pressure and (ii) open to allow fluid flow into the reaction chamber when the fluid pressure between the solid-state membrane and the reaction chamber valve is above the valve-opening pressure.
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 claim limitations that uses the word “means”. Such claim limitations are:
“ first means for receiving therein a biological sample” in claim 30;
“ second means for capturing nucleic acids in the biological sample” in claim 30;
“third means in fluid communication between the first means and the second means for directing the biological sample to the second means” in claim 30;
“fourth means in fluid communication with the third means for introducing a lysing agent therein with the biological sample and passing a sample-lysis mixture across the second means to capture nucleic acids in the biological sample therein” in claim 30;
“fifth means in fluid communication with at least one of the second means or the third means for introducing a wash solution therein following the sample-lysis mixture and passing the wash solution across the second means to purify nucleic acids captured therein” in claim 30;
“sixth means in fluid communication with at least one of the second means or the third means for introducing an eluent across the second means and eluting captured nucleic acids from the second means” in claim 30;
“seventh means located downstream of the second means for receiving the remainder of the sample-lysis mixture that passes through the second means and the wash solution that passes through the second means” in claim 30; and
“at least one eighth means located downstream of the second means for receiving the captured nucleic acids from the second means and amplifying and detecting the captured nucleic acids therein” in claim 30.
In this instant case, the corresponding structure for:
“ first means for receiving therein a biological sample” is a “sample port” (para. 0012) and equivalents thereof;
“ second means for capturing nucleic acids in the biological sample” is a “solid-state membrane” (para. 0012) and equivalents thereof;
“third means in fluid communication between the first means and the second means for directing the biological sample to the second means” is a “sample conduit” (para. 0012) and equivalents thereof;
“fourth means in fluid communication with the third means for introducing a lysing agent therein with the biological sample and passing a sample-lysis mixture across the second means to capture nucleic acids in the biological sample therein” is a “lysis station” (para. 0012) and equivalents thereof;
“fifth means in fluid communication with at least one of the second means or the third means for introducing a wash solution therein following the sample-lysis mixture and passing the wash solution across the second means to purify nucleic acids captured therein” is a “wash station” (para. 0012) and equivalents thereof;
“sixth means in fluid communication with at least one of the second means or the third means for introducing an eluent across the second means and eluting captured nucleic acids from the second means” is an “elution station” (para. 0012) and equivalents thereof;
“seventh means located downstream of the second means for receiving the remainder of the sample-lysis mixture that passes through the second means and the wash solution that passes through the second means” is a “waste chamber” (para. 0012) and equivalents thereof; and
“at least one eighth means located downstream of the second means for receiving the captured nucleic acids from the second means and amplifying and detecting the captured nucleic acids therein” is at least one “reaction chambers” (para. 0012) and equivalents thereof.
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 5-11 and 24 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 5 recites the limitation "a first eluent" in line 2. It is unclear if this is referring to the same or a different eluent as recited in claim 1. For the purpose of examiner, it is being interpreted as the same eluent as claim 1.
Claims 6-11 are indefinite because of their dependency on claim 5.
Claim 24 recites “wherein the saliva collection swab includes a plunger depressible against the saliva collection swab” in line 2. It is unclear how a swab plunger, which is a part of the swab, can be depressed against the swab itself. For the purpose of examination, it is being interpreted that the swab includes also an absorbent pad, and the plunger depressible against the absorbent pad.
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.
Claims 1-3, 18, 19 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glezer (US 20120178091 A1).
Regarding claim 1, Glezer teaches a device (Fig. 2a) for detecting nucleic acids in a biological sample, comprising:
a sample port (21) for receiving therein a biological sample (para. 0069);
a solid-state membrane (membrane) configured to capture nucleic acids in the biological sample passed across the membrane (para. 0115)(Fig. 3a, which is a flow diagram of cartridge in Fig. 2a, teaches capture nucleic acid on filter);
a sample conduit (primary flow path and mixing chamber 28) in fluid communication between the sample port and the solid-state membrane (Fig. 3a);
a lysis station (lysis reagent chamber, which is interpreted to be one of the reagent chamber 26)(Fig. 2a and paras. 0110, 0113-114, 116 and claim 40) in fluid communication with the sample conduit (para. 0110, primary flow path connects chambers in the cartridge) and including a lysis agent therein (paras. 0011 and 0113 teaches, the cartridge in 2a contains lysis buffer, which is stored in the lysis reagent chamber)
a wash station (the reagent chamber 26 that holds wash solution)(para. 116, wash buffer and elution buffer are the reagents. see also claim 40) in fluid communication with at least one of the sample conduit or the solid- state membrane (para. 0110, primary flow path connects chambers in the cartridge) and including a wash solution therein (para. 0116 wash buffer is a reagents in the purification zone);
an elution station (the reagent chamber 26 that is holding elution buffer) in fluid communication with at least one of the sample conduit or the solid-state membrane and including an eluent therein (para. 0116, elution buffer is a reagents in the purification zone);
a waste chamber (29) located downstream of the solid-state membrane (Fig. 3a); and
one or more reaction chambers (PCR reaction zone 23) located downstream of the solid-state membrane (Fig. 2a and 3a);
wherein the sample port, lysis station and sample conduit (primary flow path and mixing chamber) are configured to mix the sample and lysis agent to form a sample-lysis mixture (para. 0113, mixing of sample and lysis agent occurs at the mixing chamber), pass the sample-lysis mixture across the solid-state membrane to capture nucleic acids in the biological sample therein (para. 0114), and receive the remainder of the sample-lysis mixture in the waste chamber (para. 0114), the wash station is configured to introduce the wash solution into at least one of the sample conduit or solid-state membrane following the sample- lysis mixture to purify nucleic acids captured on the solid-state membrane (para. 0116), the wash solution from the solid-state membrane is received in the waste chamber (para. 0116), and the elution station (the reagent chambers 26 that holds elution solution ) is configured to pass the eluent across the solid-state membrane, elute captured nucleic acids from the solid-state membrane (paras. 00116, 0103), and pass the captured nucleic acids into one or more reaction chambers (PCR reaction zone 23) configured for amplifying and detecting the captured nucleic acids therein (0016).
Regarding claim 2, Glezer teaches all of the elements of the current invention as stated above with respect to claim 1. Glezer further teaches the device further comprising a lysis leg (the fluidic conduit between the lysis reagent chamber and primary flow path, represented by dotted line between chamber 3c and primary flow path 1)(para. 110, Fig. 1a is a schematic representation of the fluidic network of the device shown in 2a) extending in fluid communication between the lysis station and the sample conduit at a sample-lysis junction (mixing chamber 28) and configured to direct a flow of the lysis agent from the lysis station into the sample conduit and allow the lysis agent to mix with the sample and form the sample-lysis mixture, and a wash leg (the fluidic conduit between the reagent chamber 26 with wash solution and primary flow path, represented by dotted line between chamber 3d and primary flow path 1) extending in fluid communication between the wash station and at least one of the sample conduit or the solid-state membrane at a sample-wash junction and configured to direct a flow of the wash solution from the wash station behind the sample-lysis mixture (Fig. 3a and para. 0116, wash solution introduce after, or behind in time, sample-lysis mixture).
Regarding claim 3, Glezer teaches all of the elements of the current invention as stated above with respect to claim 2 further comprising a static mixer (z-transitions at the distal end of the mixing chamber) in fluid communication between the sample-lysis junction (mixing chamber) and the solid-state membrane (z-transitions at the distal end of the mixing chamber) and configured to mix the sample and lysis agent prior to passage across the solid-state membrane (para. 0113, z-transitions promote).
Regarding claim 18, Glezer teaches all of the elements of the current invention as stated above with respect to claim 1. Glezer further wherein the solid-state membrane (9) includes an inlet side (left side of membrane) and an outlet side (right side of membrane), and the device further comprises a membrane inlet (the openings of the membrane pores on at the left side) located on the inlet side of the solid-state membrane and in fluid communication between the solid-state membrane and at least one of the sample conduit or elution station, and a membrane outlet (the openings of the membrane pores at the right side of the membrane) located on the outlet side of the solid-state membrane in fluid communication between the solid-state membrane and at least one of the waste chamber or reaction chamber (Fig. 1a), wherein the membrane inlet defines a plurality of inlet fluid channels configured to facilitate a flow of fluid across the inlet side of the solid-state membrane, and the membrane outlet includes a plurality of fluid outlet channels therein configured to facilitate a flow of fluid across the outlet side of the solid-state membrane (Fig. 1a)(para. 110, Fig. 1a is a schematic representation of the fluidic network of the device shown in 2a).
Regarding claim 19, Glezer teaches all of the elements of the current invention as stated above with respect to claim 1. Glezer further the device further comprising a body including the at least one reaction chamber therein, wherein at least a portion of the body including the reaction chamber is substantially transparent, and includes a substantially transparent top surface extending over the reaction chamber and two substantially transparent side surfaces extending downwardly from the top surface along opposite sides of the reaction chamber relative to each other, wherein the reaction chamber is visually observable in a viewing direction through the substantially transparent top surface, and further comprising a stimulating light source located adjacent to a substantially transparent side surface and configured to transmit stimulating light through the side surface and reaction chamber in a direction substantially lateral to the viewing direction (para. 0151, the cartridge is fabricated from transparent material 106).
Regarding claim 30, Glezer teaches a device for detecting nucleic acids in a biological sample, comprising:
first means (interpreted as sample port under 35 U.S.C. 112(f))(sample input 21) for receiving therein a biological sample (para. 0069);
second means (interpreted as solid state-solid membrane under 35 U.S.C. 112(f))(membrane) for capturing nucleic acids in the biological sample (para. 0115);
third means (interpreted as sample conduit under 35 U.S.C. 112(f))(primary flow path and mixing chamber 28) in fluid communication between the first means and the second means for directing the biological sample to the second means (Fig. 3a);
fourth means (interpreted as lysis station under 35 U.S.C. 112(f))(lysis reagent chamber, which is interpreted to be one of the reagent chamber 26) (Fig. 2a and paras. 0110, 0113-114, 116 and claim 40) in fluid communication with the third means (para. 0110, primary flow path connects chambers in the cartridge) for introducing a lysing agent therein with the biological sample and passing a sample-lysis mixture across the second means to capture nucleic acids in the biological sample therein(para. 0116);
fifth means (interpreted as wash station under 35 U.S.C. 112(f))(the reagent chamber 26 that holds wash solution)(para. 0116, wash buffer and elution buffer are the reagents. see also claim 40) in fluid communication with at least one of the second means or the third means for introducing a wash solution therein following the sample-lysis mixture and passing the wash solution across the second means to purify nucleic acids captured therein (para. 0116);
sixth means (interpreted as elution station under 35 U.S.C. 112(f))(the reagent chamber 26 that is holding elution buffer) in fluid communication with at least one of the second means or the third means for introducing an eluent across the second means and eluting captured nucleic acids from the second means (para. 0116);
seventh means (interpreted as waste chamber under 35 U.S.C. 112(f))(29) located downstream of the second means (Fig. 3a) for receiving the remainder of the sample-lysis mixture that passes through the second means and the wash solution that passes through the second means; and
at least one eighth means (interpreted as reaction chamber under 35 U.S.C. 112(f))(PCR reaction zone 23) located downstream of the second means for receiving the captured nucleic acids from the second means and amplifying and detecting the captured nucleic acids therein (Figs. 2a and 3a).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 12, 17-21 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342.
Regarding claim 1, Ismagilov ‘577 teaches a device (800)(Fig. 8) for detecting nucleic acids in a biological sample, comprising:
a sample port (the opening of sample well) for receiving therein a biological sample (para. 0025);
a solid-state membrane (matrix 805) configured to capture nucleic acids in the biological sample passed across the membrane (paras. 0026 and 0309);
a sample conduit (see annotated Fig. A) in fluid communication between the sample port and the solid-state membrane (Fig. 8C and para. 0270);
a lysis station (the first resistant unit)(para. 0270 and see annotated Fig. A) in fluid communication with the sample conduit and including a lysis agent therein (Fig. 8B and para. 0270);
a wash station (wash resistant unit) (para. 0270 and see annotated Fig. A) in fluid communication with at least one of the sample conduit or the solid- state membrane and including a wash solution therein (Fig. 8D and para. 0270);
an elution station (elution resistant unit) (para. 0270 and see annotated Fig. A) in fluid communication with at least one of the sample conduit or the solid-state membrane and including an eluent therein (Fig. 8F and para. 0270);
a waste chamber (806) located downstream of the solid-state membrane (Fig. 8E and para. 0270); and
wherein the sample port, lysis station and sample conduit are configured to mix the sample and lysis agent to form a sample-lysis mixture (para. 0270, lysis buffer enters the sample well containing sample, and thus mixing occurs), pass the sample-lysis mixture across the solid-state membrane to capture nucleic acids in the biological sample therein (Fig. 8C and para. 0270), and receive the remainder of the sample-lysis mixture in the waste chamber (para. 0270), the wash station is configured to introduce the wash solution into at least one of the sample conduit or solid-state membrane following the sample- lysis mixture to purify nucleic acids captured on the solid-state membrane (Fig. 8D and para. 0270), the wash solution from the solid-state membrane is received in the waste chamber (para. 0270), and the elution station (elution resistant unit) is configured to pass the eluent across the solid-state membrane, elute captured nucleic acids from the solid-state membrane, and pass the captured nucleic acids into one or more reaction chambers configured for amplifying and detecting the captured nucleic acids therein (para. 0270).
Ismagilov ‘577 teaches a sample preparation device for isolating nucleic acid from biological samples.
Ismagilov ‘577 fails to teach the device comprises one or more reaction chambers located downstream of the solid-state membrane (805), wherein the one or more reaction chambers configure for amplifying and detecting the captured nucleic acids.
However, Ismagilov ‘577 teaches the sample preparation device 800 can be integrated with other devices including SlipChip devices such as ones in PG PUB US 20120028342 (hereinafter Ismagilov ‘342) for assaying and processing nucleic acids (abstract and para. 0189). Ismagilov ‘342 teaches a SlipChip (para. 0312) comprises one or more reaction chambers (areas)(para. 0057 “area” can refer to structure such as a well or cavity) configure for amplifying and detecting nucleic acids (Ismagilov ‘342, paras. 0312, SlipChip device for digital PCR).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample preparation device taught by Ismagilov ‘577 with including a SlipChip downstream of matrix 805 for amplification and detection of the captured nucleic acids taught by Ismagilov ‘342 in order to have an integrated device for processing and assaying nucleic acids with a reasonable expectation of success (Ismagilov ‘342, para. 0312 and Ismagilov ‘577 abstract and para. 0189) (MPEP 2143)(I)(G).
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Figure A. Annotated Fig. 8C of Ismagilov ‘577 .
Regarding claim 2, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Ismagilov ‘577 further teaches the device further comprising a lysis leg (see annotated Fig. A above) extending in fluid communication between the lysis station and the sample conduit at a sample-lysis junction (sample well) and configured to direct a flow of the lysis agent from the lysis station into the sample conduit and allow the lysis agent to mix with the sample and form the sample-lysis mixture, and a wash leg (see annotated Fig. A) extending in fluid communication between the wash station and at least one of the sample conduit or the solid-state membrane at a sample-wash junction and configured to direct a flow of the wash solution from the wash station behind the sample-lysis mixture (para. 0270, wash solution introduce after, or behind in time, sample-lysis mixture).
Regarding claim 12, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Ismagilov ‘577 further teaches the device further comprising a reaction chamber valve (valve 831) in fluid communication between the solid-state membrane and the reaction chamber (para. 0484, valve 831 in fluid communication between matrix/filter and elution well. In modified Ismagilov ‘577 the reaction chamber is downstream from the elution well, and thus valve 831 is in fluid communication between matrix/filter and reaction chamber), wherein the reaction chamber valve is (i) closed to prevent fluid flow into the reaction chamber when a fluid pressure between the solid-state membrane and the reaction chamber valve is below a valve- opening pressure and (ii) is open to allow fluid flow into the reaction chamber when the fluid pressure between the solid-state membrane and the reaction chamber valve is above the valve- opening pressure (interpreted as intended use. The valve meets the structural limitation of the intended use. Para. 0487, the valve can be opening and close in the recited conditions).
Regarding claim 17, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Ismagilov ‘577 further teaches the device further comprising a plurality of actuators (barrier units), wherein each actuator is manually movable from a non-actuated position to an actuated position (Fig. 8A-8F), each of the lysis station, wash station and elution station includes a sealed chamber (the corresponding resistant unit) including a frangible or breakable wall and containing therein the lysis agent, wash solution or eluent, respectively, and wherein upon movement of each actuator from the non-actuated to the actuated position, one or more of the frangible or breakable walls is broken to release at least one of the lysis agent, wash solution and/or eluent from its respective sealed chamber (para. 0211, burstable seal, para. 0225, ruptures).
Regarding claim 18, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Ismagilov ‘577 further wherein the solid-state membrane (matrix 805) includes an inlet side (the side that the lysed sample enters) and an outlet side (the side that the lysed sample exits), and the device further comprises a membrane inlet (the openings of the matrix pores at the inlet side) located on the inlet side of the solid-state membrane and in fluid communication between the solid-state membrane and at least one of the sample conduit or elution station, and a membrane outlet (the openings of the matrix pores at the outlet side) located on the outlet side of the solid-state membrane in fluid communication between the solid-state membrane and at least one of the waste chamber or reaction chamber (para. 0270), wherein the membrane inlet defines a plurality of inlet fluid channels (pores of the matrix) configured to facilitate a flow of fluid across the inlet side of the solid-state membrane, and the membrane outlet includes a plurality of fluid outlet channels therein configured to facilitate a flow of fluid across the outlet side of the solid-state membrane (para. 0270, lysed sample flow through the pores of the matrix).
Regarding claim 19, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Ismagilov ‘577 further the device further comprising a body including the at least one reaction chamber therein, wherein at least a portion of the body including the reaction chamber is substantially transparent ( Ismagilov ‘342, paras. 0118 and 0171, SlipChip fabricated from glass or optically transparent materials for optical detection methods), and includes a substantially transparent top surface (para. 0118 and 0171 top substrate is made of glass or optically transparent materials) extending over the reaction chamber and two substantially transparent side surfaces extending downwardly from the top surface along opposite sides of the reaction chamber relative to each other, wherein the reaction chamber is visually observable in a viewing direction through the substantially transparent top surface (para. 0118, the device is made of glass or optically transparent materials).
Modified Ismagilov ‘577 does not explicitly teach the device further comprising a stimulating light source located adjacent to a substantially transparent side surface and configured to transmit stimulating light through the side surface and reaction chamber in a direction substantially lateral to the viewing direction.
However, Ismagilov ‘577 teaches the sample preparation device (800) is meant to be integrated with other device for assaying, processing and/or storing samples (abstract) and the device can comprise or be used in conjunction with a base station (para. 0460). Ismagilov ‘577 further teaches the base station comprises a stimulating light source (0465, detector with light source) configured to transmit stimulating light into the reaction chamber (0465).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified to comprise
the body of the device taught by modified Ismagilov ‘577 include a base station comprises a heater (0464, temperature controller with thermally conductive materials) mounted to the body adjacent to the reaction chamber and configured to heat the reaction chamber (POSITA would mount the heater adjacent to the reaction chamber because PCR reactions requires heating), a stimulating light source (para. 0465, detector with light source) configured to transmit stimulating light into the reaction chamber (para. 0465) in a direction lateral to the viewing direction,
Regarding claim 20, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 19.
With respect to the limitation “wherein the index of refraction of the substantially transparent body and the index of refraction of the fluid in the reaction chamber are configured to facilitate the passage of the stimulating light from the body into the reaction chamber to generate fluorescing light in the reaction chamber such that the fluorescing light is emitted in substantially all directions and is observable in the viewing direction through the top surface of the body,” the fluid in the reaction chamber is not positively recited. The index of refraction of the fluid depends on the reaction reagent. Since the device is made of materials optically transparent materials (‘342, para. 0171), the device meets the structural limitation of this claim.
Regarding claim 21, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 20. With respect to the limitation “wherein there is an observable difference to the human eye between the stimulating light and the fluorescing light to facilitate the ability of an observer to view the fluorescing light and distinguish it from any observed stimulating light,” the reaction reagent is not positively recited. When the appropriate fluorescent reagent is used, there would be an observable difference to the human eye between the stimulating light and the fluorescing light.
Regarding claim 26, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Ismagilov ‘577 further teaches a device further comprising a body (the body of device 800 integrated with a SlipChip) defining therein the sample conduit, a lysis leg extending in fluid communication between the lysis station and the sample conduit and configured to direct a flow of the lysis agent from the lysis station into the sample conduit, a wash leg extending in fluid communication between the wash station and the sample conduit upstream of the lysis leg and configured to direct a flow of the wash solution from the wash station into the sample conduit behind the sample-lysis mixture, an elution leg extending in fluid communication between the elution station and the solid-state membrane (see annotated Fig. A), a viewing window (SlipChip is made of transparent material) overlying the reaction chamber and allowing visual observation of the reaction chamber therethrough in a viewing direction,
Modified Ismagilov ‘577 does not explicitly teaches the device comprises a body defining therein a heater mounted to the body adjacent to the reaction chamber and configured to heat the reaction chamber, a stimulating light source configured to transmit stimulating light into the reaction chamber in a direction lateral to the viewing direction, and a power source connected to the heater and light source and configured to provide power thereto
However, Ismagilov ‘577 teaches the sample preparation device (800) is meant to be integrated with other devices for assaying and processing storing samples (abstract) and the device can comprise or be used in conjunction with a base station (para. 0460). Ismagilov ‘577 further teaches the base station comprises a heater (0464, temperature controller with thermally conductive materials), a stimulating light source (0465, detector with light source) configured to transmit stimulating light into the reaction chamber (0465) in a direction lateral to the viewing direction, and a power source (para. 0466) connected to the heater and light source and configured to provide power thereto.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the body of the device taught by modified Ismagilov ‘577 include a base station comprises a heater (0464, temperature controller with thermally conductive materials) mounted to the body adjacent to the reaction chamber and configured to heat the reaction chamber (POSITA would mount the heater adjacent to the reaction chamber because PCR reactions requires heating), a stimulating light source (para. 0465, detector with light source) configured to transmit stimulating light into the reaction chamber (para. 0465) in a direction lateral to the viewing direction, and a power source (para. 0466) connected to the heater and light source and configured to provide power thereto in order to have an integrated system for nucleic acid preparation and detection system with a reasonable expectation of success (Ismagilov ‘577 , abstract, para. 0464) (MPEP 2143)(I)(G).
Regarding claim 27, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Ismagilov ‘577 further teaches the device further comprising a plurality of reaction chambers (Ismagilov ‘342, paras. 0057 and 0312, SlipChip has a plurality of areas, which are wells).
Modified Ismagilov ‘577 does not explicitly teaches reagents located within or in fluid communication with the reaction chambers and configured to mix with eluted captured nucleic acids flowing from the solid-state membrane and into the reaction chambers and amplify the captured nucleic acids therein.
However, Ismagilov ‘342 teaches reagents located within (Ismagilov ‘342, para. 0189, preloaded reagents in areas/wells) and configured to mix with eluted captured nucleic acids flowing from the solid-state membrane and into the reaction chambers and amplify the captured nucleic acids therein (Ismagilov ‘342, para. 0189 and 0196, combine sample with pre-loaded reagents).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reaction chambers taught by modified Ismagilov ‘577 with preloaded reagent taught by Ismagilov ‘342 in order to eliminate the need of adding reagents by the user with a reasonable expectation of success (‘342, para. 0189 and 0196) (MPEP 2143)(I)(G).
Regarding claim 28, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Ismagilov ‘577 further teaches the device further comprising a first reaction chamber and a second reaction chamber (‘342, paras. 0057 and 0312, SlipChip has a plurality of areas, which are wells).
Modified Ismagilov ‘577 does not teaches the device further comprising a first reaction chamber valve in fluid communication between the solid-state membrane and the first reaction chamber and defining a first valve opening pressure, a second reaction chamber valve in fluid communication between the solid-state membrane and the second reaction chamber and defining a second valve opening pressure greater than the first valve opening pressure, wherein upon substantially filling the first reaction chamber, the fluid pressure at the second reaction chamber valve exceeds the second valve opening pressure to open the second reaction chamber valve and fill the second reaction chamber.
However, Ismagilov ‘577 teaches in the integration of the sample preparation device (800) and other devices of components including one or more valves (para. 0268). Modified Ismagilov ‘577 also teaches the sample preparation device is integrated with a SlipChip for nucleic acids amplification and detection (claim 1). Additionally, It is within ambit for or one of ordinary skill to includes valves between the interface of devices to control fluid flow (para. 0021), in this case the interface is between the elution well of device 8000 which contain isolated nucleic acids and the inlets of the SlipChip areas (comprises the first reaction chamber and the second reaction chamber).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have the device of the modified Ismagilov ‘577 to include a first reaction chamber valve in fluid communication between the solid-state membrane (which is upstream of the elution well, para. 0270) and the first reaction chamber and defining a first valve opening pressure and a second reaction chamber valve in fluid communication between the solid-state membrane and a second reaction chamber valve in fluid communication between the solid-state membrane the second reaction chamber and defining a second valve opening pressure greater than the first valve opening pressure, wherein upon substantially filling the first reaction chamber, the fluid pressure at the second reaction chamber valve exceeds the second valve opening pressure to open the second reaction chamber valve and fill the second reaction chamber.(POSIA would configure the reaction chamber valves 1 and 2 such that under an appropriate fluid pressure the fluid will enter the respective chamber) in order to control fluid flow between the elution well of the sample preparation device 800 to the first and second reactions chambers (locates in the SlipChip) with a reasonable expectation of success (Ismagilov ‘577 , paras. 0021 and 0268) (MPEP 2143)(I)(G).
Regarding claim 29, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 28. Ismagilov ‘577 further teaches the device further comprising a waste chamber vent (the opening of 806 that is exposed to the environment) in fluid communication between the waste chamber (806) and ambient atmosphere; and a waste vent seal (valve 831 in para. 270, also refers to as valve-2 in para.0484) movable between an open position (position 1, Fig. 8) allowing fluid to flow out of the waste chamber vent and thereby allow fluid to flow into the waste chamber, and a closed position (position 2) sealing the vent and thereby preventing fluid from flowing into the waste chamber; wherein in the open position of the waste vent seal, the fluid pressure at the first and second reaction chamber valves is below their valve opening pressures to prevent fluid flow into the first and second reaction chambers and direct fluid flow into the waste chamber (position 1), and in the closed position of the waste vent seal (position 2), the fluid pressure at the first and second reaction chamber valves is greater than the first valve opening pressure to allow filling of the first reaction chamber, and upon substantially filling the first reaction chamber, the fluid pressure at the second reaction chamber valve is greater than the second valve opening pressure to allow filling of the second reaction chamber (para. 484, valve 831 allow fluid flows from matrix 805 to the elution when valve 831, also refers to as valve-2, is in position 2. In modified Ismagilov ‘577 , the reaction chamber valves 1 and 2 are configured such that under an appropriate fluid pressure the fluid will enter the respective chamber, see claim 28 above).
Regarding claim 30, Ismagilov ‘577 teaches a device for detecting nucleic acids in a biological sample, comprising:
first means (interpreted as sample port under 35 U.S.C. 112(f))(opening of the sample well) for receiving therein a biological sample (para. 0022);
second means (interpreted as solid state-solid membrane under 35 U.S.C. 112(f))(matrix 805) for capturing nucleic acids in the biological sample (para. 0207);
third means (interpreted as sample conduit under 35 U.S.C. 112(f))(see Annotated Fig. A above) in fluid communication between the first means and the second means for directing the biological sample to the second means (para. 0207);
fourth means (interpreted as lysis station under 35 U.S.C. 112(f))(the first resistant unit, para. 270 and Fig. 8B, see also annotated Fig. A) in fluid communication with the third means for introducing a lysing agent therein with the biological sample and passing a sample-lysis mixture across the second means to capture nucleic acids in the biological sample therein(para. 0207);
fifth means (interpreted as wash station under 35 U.S.C. 112(f))(washing resistant unit, Fig. 8D and para. 270, see also annotated Fig. A) in fluid communication with at least one of the second means or the third means for introducing a wash solution therein following the sample-lysis mixture and passing the wash solution across the second means to purify nucleic acids captured therein (para. 0207);
sixth means (interpreted as elution station under 35 U.S.C. 112(f))(elution resistant unit, Fig. 8F and para. 270, see also annotated Fig. A) in fluid communication with at least one of the second means or the third means for introducing an eluent across the second means and eluting captured nucleic acids from the second means (para. 0270);
seventh means (interpreted as waste chamber under 35 U.S.C. 112(f))(waste vent 806, Fig. 8C) located downstream of the second means for receiving the remainder of the sample-lysis mixture that passes through the second means and the wash solution that passes through the second means (para. 0270); and
Ismagilov ‘577 fails to teach the device comprises at least one eighth means (interpreted as reaction chambers under 35 U.S.C. 112(f)) located downstream of the second means (matrix 805) for receiving the captured nucleic acids from the second means and amplifying and detecting the captured nucleic acids therein.
However, Ismagilov ‘577 teaches the sample preparation device 800 can be integrated with other devices including SlipChip devices such as ones in PG PUB US 20120028342 (hereinafter Ismagilov ‘342) for assaying and processing nucleic acids (abstract and para. 0189). Ismagilov ‘342 teaches a SlipChip (para. 0312) comprises one or more reaction chambers (areas)(para. 0057 “area” can refer to structure such as a well or cavity) configure for amplifying and detecting nucleic acids (Ismagilov ‘342, paras. 0312, SlipChip device for digital PCR).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample preparation device taught by Ismagilov ‘577 to include a SlipChip downstream of matrix 805 for amplification and detection of the captured nucleic acids taught by Ismagilov ‘342 in order to have an integrated device for processing and assaying nucleic acids with a reasonable expectation of success (Ismagilov ‘342, para. 0312 and Ismagilov ‘577 abstract and para. 0189) (MPEP 2143)(I)(G).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 1, and further in view of Glezer (US 20120178091 A1).
Regarding claim 3, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 2.
Modified Ismagilov ‘577 teaches a microfluidic device (Fig. 2a) for nucleic acid purification, amplification and detection (see claim 1).
Modified Ismagilov ‘577 fails to teach the device further comprising a static mixer in fluid communication between the sample-lysis junction (sample well) and the solid-state membrane and configured to mix the sample and lysis agent prior to passage across the solid-state membrane.
However, Glezer teaches a microfluidic device (Fig. 2a) for nucleic acid purification, amplification and detection. Glezer further teaches the device comprises a sample-lysis junction (28) and the solid-state membrane (purification membrane, Fig. 3a and para. 0023). Glezer further the device includes a static mixer (a series of z-transitions at the distal end of the mixing chamber) in fluid communication between the sample-lysis junction (mixing chamber) and the solid-state membrane (z-transitions at the distal end of the mixing chamber) and configured to mix the sample and lysis agent prior to passage across the solid-state membrane (para. 0113, z-transitions promote mixing). Glezer further teaches that z-transitions promote mixing (para. 0113).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by Ismagilov ‘577 with a series z-transitions (static mixer) in fluid communication between the sample-lysis junction (sample well) and the solid-state membrane taught by Glezer in order to promote mixing with a reasonable expectation of success (Glezer, para. 0113) (MPEP 2143)(I)(G).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 1, and further in view of Theobold et al. (GB 2472454 A).
Regarding claim 4, Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1.
Ismagilov ‘577 further teaches the device further comprising a base station (para. 0460) for receiving the device (para. 0460), wherein in the base station includes a heater (para. 0464).
Modified Ismagilov ‘577 does not explicitly teach how the heater is configured in the base station, and thus fails wherein the base station includes a ramp, a sled mounted on the ramp, and the heater mounted on the sled, wherein upon receiving the device into the base station, the sled is connectable to the device and movable therewith between a non-operational position and an operational position, and during movement between the non-operational position and the operational position, the heater is moved from a non-operational position out of contact with the device to an operational position in contact with the device and adjacent to the reaction chamber for incubating the captured nucleic acids within the reaction chamber.
However, Theobold teaches a PCR apparatus for amplifying nucleic acids (abstract). Theobold further teaches the apparatus comprising a base station (10) for receiving the sample containers, wherein the base station includes a ramp (the inclined rail that is attached to the right side of 31 in Figs. 12 and 14 ), a sled (31) mounted on the ramp, and the heater (Peltier element 29 and heatable member 23) mounted on the sled, wherein upon receiving the device (sample containers 30, a multi-well plate, Fig. 8, 11 and 12) into the base station (10), the sled (31) is connectable to the device (30)(Figs. 12 and 13) and movable therewith between a non-operational position (Fig. 12, p. 6, ln. 12) and an operational position (Fig. 14, p. 6, ln. 26-27), and during movement between the non-operational position and the operational position, the heater is moved from a non-operational position out of contact with the device (Fig. 12, containers 30 is out of contact with the heatable member 23 which is part of the heater )to an operational position in contact with the device (Fig. 14)(p.6, ln 16-27) and adjacent to the reaction chamber for incubating the captured nucleic acids within the reaction chamber (a single well within 30)(abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the configuration with of heater within the base station taught by Ismagilov ‘577 with the base station includes a ramp, a sled mounted on the ramp, and the heater mounted on the sled, wherein upon receiving the device into the base station, the sled is connectable to the device and movable therewith between a non-operational position and an operational position, and during movement between the non-operational position and the operational position, the heater is moved from a non-operational position out of contact with the device to an operational position in contact with the device and adjacent to the reaction chamber for incubating the captured nucleic acids within the reaction chamber taught by Theobold in order to configure the heater to have an operational position and a non-operational position with a reasonable expectation of success (Theobold, Figs. 12 and 14) (MPEP 2143)(I)(G).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 1, and further in view of Akimova et al. (US 20190276870 A1).
Regarding claim 5, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1. Ismagilov ‘577 further teaches wherein the elution station includes a first sealed eluent chamber (eluent resistant unit, Fig. 8F) containing a first eluent (elution buffer)(see 35 U.S.C 112(b) above), a first elution leg (the conduit between the eluent resistant unit and the sample conduit)(see annotate Fig. A) in fluid communication between the first elution station and at least one of the sample conduit or the solid-state membrane (para. 0270) and an elution actuator (push unit and the barrier unit that corresponds to the eluent resistant ) movable between a non-actuated position (Fig. 8A-8E, when the barrier unit above eluent resistant unit is not pushed down by pushing unit 811) and an actuated position (Fig. 8F, when the barrier unit above eluent resistant unit is pushed down by pushing unit 811), wherein in the actuated position the first eluent is released from the first chamber and into the first leg (para. 0270 and Fig. 8F).
Modified Ismagilov ‘577 fails to teach wherein the elution includes a second sealed eluent chamber containing a second eluent, a second elution leg in fluid communication between the second elution station and at least one of the sample conduit or the solid-state membrane, and consequently the elution actuator movable between a non-actuated position and an actuated position, wherein in the actuated position the first and second eluents are released from the first and second eluent chambers and into the first and second elution legs.
However, Ismagilov ‘577 teaches one or more eluting steps (para. 0320). In addition, Akimova teaches extracting DNA from samples. Akimova further teaches performing a second DNA elution provide a better yield of total DNA (para. 0098).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Ismagilov ‘577 to have the capacity to perform a second elution as taught by Akimova in order to provide a better yield of total nucleic acids extracted from the sample with a reasonable expectation of success (Akimova, para. 0098) (MPEP 2143)(I)(G).
In addition, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate an additional eluent resistant unit (second eluent chamber) containing an eluent (second eluent) in the eluent actuator, and duplicate a conduit (a second elution leg) connecting the additional eluent resistant unit to the sample conduit in fluid communication between the second elution station and at least one of the sample conduit or the solid-state membrane (matrix 805), since it have been held that a mere duplication of working parts of a device involves only routine skill in the art. One would have been motived to duplicate the eluent chamber containing an eluent and a conduit connecting the eluent resistant unit to the sample conduit for the purpose having the capacity to perform a second elution (Ismagilov ‘577 , paras. 0239, 0241 and 0320) (MPEP 2144.04(VI)(B)).
The teaching of Modified Ismagilov ‘577 would yield wherein the elution station includes a second sealed eluent chamber containing a second eluent, a second elution leg in fluid communication between the second elution station and at least one of the sample conduit or the solid-state membrane, and the elution actuator (modified Ismagilov ‘577 , the actuator includes push unit and a barrier unit for each eluent resistant unit)movable between a non-actuated position (when the barrier units are not pushed) and an actuated position (when the barrier units are both pushed down), wherein in the actuated position the first and second eluents are released from the first and second eluent chambers and into the first and second elution legs.
Regarding claim 6, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 5.
Modified Ismagilov ‘577 does not explicitly teach wherein the elution actuator substantially simultaneously releases the first and second eluents from the first and second eluent chambers, the second elution leg is longer than the first elution leg to thereby allow the first eluent to pass across the solid-state membrane prior to passage of the second eluent across the solid-state membrane.
However, Akimova teaches the second elution takes place after the first elution (Akimova, para. 0098). Akimova further teaches performing a second DNA elution provide a better yield of total DNA (para. 0098).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by modified Ismagilov ‘577 to have the capacity to perform second elution after the first in order to provide yield of total nucleic acids with a reasonable expectation of success (Akimova, para. 0098) (MPEP 2143)(I)(G).
In addition, Ismagilov ‘577 teaches dispensing fluid by the utilizing pushing unit(s) and barrier/resistant unit(s) to actuate dispensing of fluid/reagent (para.0204). Ismagilov ‘577 further teaches timing control of dispensing fluid by the configurations pushing unit(s) and barrier/resistant unit(s) to introduce delays in a time-dependent manner (para. 0204). Ismagilov ‘577 teaches activation of resistant units/barrier units/dispense fluids or reagents in a particular/desired order, such as sequentially, simultaneously, or in combination (para. 0239). Ismagilov ‘577 further teaches the timing control of dispensing can be achieved by the location and dimension of the channels between the resistant unit to the chamber of destination (para. 0241).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the configuration of the barrier units and the channel dimension taught by modified Ismagilov ‘577 to have barrier units of elution actuator substantially simultaneously releases the first and second eluents from the first and second eluent chambers, the second elution leg is longer than the first elution leg to thereby allow the first eluent to pass across the solid-state membrane prior to passage of the second eluent across the solid-state membrane in order that the second elution takes place after the first elution with a reasonable expectation of success (Ismagilov ‘577, para. 0241) (MPEP 2143)(I)(G).
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 1, and further in view of Selden et al. (US 20170274381 A1).
Regarding claim 23, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Ismagilov ‘577 further teaches the device further comprising a saliva collection swab for collecting saliva (para. 0458, a swab as a sample collector).
Modified Ismagilov ‘577 does not explicitly teach the device the saliva collection swab receivable within the sample port for introducing the saliva directly into the sample port and sample conduct for mixture therein with the lysis agent.
However, Seldon teaches a microfluidic device for isolating, purifying and detecting nucleic acids in biological sample. Seldon teaches using a swab to collect biological. Seldon further teaches the saliva collection swab receivable within the sample port (swab chamber 19 in Fig. 39, para. 0296) for introducing the saliva directly into the sample port and sample conduct for mixture therein with the lysis agent (para. 0296). Seldon further teaches
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample well taught by Ismagilov ‘577 with the swab chamber taught by Seldon in order to introduce saliva directly in to the sample with a reasonable expectation of success (Seldon, para. 0296) (MPEP 2143)(I)(G).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 1, and further in view of Handique (US 20060183216 A1).
Regarding claim 25, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 1.
Ismagilov ‘577 does not teaches the device further comprising a reaction chamber vent in fluid communication between the reaction chamber and ambient atmosphere, wherein the reaction chamber vent defines a venting length extending between the reaction chamber and ambient atmosphere and a venting cross-sectional area, and the venting cross-sectional area is sufficiently small compared to the venting length to create a saturation gradient between the reaction chamber and ambient atmosphere to slow the evaporation of liquid from and prevent the entry of atmospheric air into the reaction chamber.
However, Handique teaches a microfluidic device. Handique teaches the device comprises a chamber 17, and an air vent 15 with a hydrophobic membrane that permits gas but not the liquid to escape and a reservoir, which is a blister pack (para. 0062). Handique further teaches since it is difficult to fabricate a reservoir without automatically ending up with some residual air in the reservoir, a solution to this problem is to configure the microfluidic device so that a vent, such as a hydrophobic vent, permits such residual air to escape.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by modified Ismagilov ‘577 to include an air vent with a hydrophobic membrane to the reaction chamber taught by Handique in order to permit residual air to escape with a reasonable expectation of success (Handique, para. 0058) (MPEP 2143)(I)(G).
The teachings of Ismagilov ‘577 as modified by Handique yield the device further comprising a reaction chamber vent (air vent with hydrophobic membrane) in fluid communication between the reaction chamber and ambient atmosphere, wherein the reaction chamber vent defines a venting length extending between the reaction chamber and ambient atmosphere and a venting cross-sectional area, and the venting cross-sectional area is sufficiently small compared to the venting length (the air vent has a hydrophobic membrane, and thus vent cross-sectional area is the accumulative cross-sectional areas of the pores of the membrane. Consequent, the cross-sectional is sufficiently small more to the venting length) to create a saturation gradient between the reaction chamber and ambient atmosphere to slow the evaporation of liquid from and prevent the entry of atmospheric air into the reaction chamber (Handique, para. 0058).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577 as applied to claim 12, and further in view of Perna et al. (US 20220090587).
Regarding claim 13, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 12.
Modified Ismagilov ‘577 teaches the reaction chamber valve is a three-position push valve and thus fails to teach wherein the reaction chamber valve is a Laplace or burst valve.
However, Perna teaches a microfluidic system (para. 0035). Perna further teaches the use of the he flow management system can be include one or more: pneumatic valves, single use valves (e.g., a burst disc), three position and/or three way valves , and/or any suitable valve (para. 0062).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the three-way valve taught by Ismagilov ‘577 with a burst valve taught by Perna because one of ordinary skill in the art would accordingly have recognized the burst valve would result in the predictable result of providing a valve to allow or prevent fluid flow into the reaction chamber.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 12, and further in view of Glezer (US 20120178091 A1).
Regarding claim 14, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 12.
Ismagilov ‘577 further teaches the device further comprising a waste chamber vent (the opening the waste vent) in fluid communication between the waste chamber and ambient atmosphere (waste vent is open to atmosphere for fluidic movement).
Ismagilov teaches valve 831 (the same valve that control fluid movement to the elution well/ reaction chambers) and thus fails to teach a vent seal movable between an open position and a closed position and thereby allowing and preventing fluid from flowing into the waste chamber; wherein movement of the value causes the fluid pressure between the solid-state membrane and reaction chamber valve to exceed the valve-opening pressure of the reaction chamber valve and thereby allow fluid flow from the solid-state membrane into the reaction chamber (para. 0484).
However, Glezer teaches movement of fluid in the cartridge can be control using a combination of sealing one or more vent ports with seals instead using of valves (paras. 0074, 0077 and 0084).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the valve 831 taught by Ismagilov ‘577 with the valve 831 and a seal taught by Glezer because one of ordinary skill in the art would accordingly have recognized the seal taught Glezer would result in the predictable result of providing control over fluid flow from the membrane to the waster chamber (Glezer, paras. 0074, 0077 and 0084).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al. (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 12, and further in view of Handique et al. (US 20060183216 A1)
Regarding claim 15, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 12. Modified Ismagilov ‘577 further teaches the device further comprising a first reaction chamber, a second reaction chamber (‘342, paras. 0057 and 0312, SlipChip comprises a plurality of areas, which are wells).
Modified Ismagilov ‘577 fails to explicitly teaches a first reaction chamber vent in fluid communication between the first reaction chamber and ambient atmosphere and configured to allow gas but substantially prevent liquid flow therethrough, and a second reaction chamber vent in fluid communication between the second reaction chamber and ambient atmosphere and configured to allow gas but substantially prevent liquid flow therethrough.
However, Handique teaches a microfluidic device. Handique teaches the device comprises a chamber 17, and an air vent 15 with a hydrophobic membrane that permits gas but not the liquid to escape and a reservoir, which is a blister pack (para. 0062). Handique further teaches since it is difficult to fabricate a reservoir without automatically ending up with some residual air in the reservoir, a solution to this problem is to configure the microfluidic device so that a vent, such as a hydrophobic vent, permits such residual air to escape.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by modified Ismagilov ‘577 to include an air vent with a hydrophobic membrane to each the first reaction chamber and the second reaction chamber taught by Handique in order to permit residual air to escape with a reasonable expectation of success (Handique, para. 0058) (MPEP 2143)(I)(G).
Regarding claim 16, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 15, wherein each of the first and second reaction chamber vents includes a hydrophobic vent membrane that allows gas but substantially prevents liquid flow therethrough (Handique, para. 0058).
Claims 22 rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 21, and further in view of Mitsuhashi et al. (US 5545528 A).
Regarding claim 22, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 21.
Ismagilov ‘577 teaches the light source (stimulating light) can produce a specific range of wavelengths (para. 0465).
Modified Ismagilov ‘577 does not explicitly wherein the stimulating light defines a first wavelength within the range of about 425 nm to about 550 nm, and the fluorescing light defines a second wavelength greater than the first wavelength.
However, Mitsuhashi teaches PCR assays using fluorescent detection. Mitsuhashi further teaches there are a variety of commercially available fluorescent dyes show good spectrographic sensitivity for the analysis of nucleic acid sequences, that have excitation wavelengths in the low 400 nm range and emission wavelengths in the high 600 nm range when bound to a nucleic acid sequence (col. 2, lns 3-11).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wavelength of the light source taught by modified Ismagilov ’577 to low 400 nm range (around 425nm) to use the commercially available fluorescent dyes taught by Mitsuhashi in order to the have good spectrographic sensitivity for the analysis of nucleic acid sequences with a reasonable expectation of success (Mitsuhashi, col. 2, lns 3-11) (MPEP 2143)(I)(G).
The teachings of modified Ismagilov ‘577 as modified by Mitsuhashi would yield the stimulating light defines a first wavelength within the range of about 425 nm to about 550 nm (low 400 nm range), and the fluorescing light defines a second wavelength (600 nm range) greater than the first wavelength (Mitsuhashi, col. 2, lns 3-11).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342, further in view of Akimova et al. (US 20190276870 A1) as applied to claim 5 above, and further in view of Creek et al (US 20120225792 A1) further in view of Amstad (US 20140284001 A1claim).
Regarding claim 7, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 5. Ismagilov ‘577 further teaches wherein the wash solution and/or lysis agent leaves an evaporative contaminant on the solid-state membrane after passage therethrough (para. 0348, the wash buffer includes 70% ethanol and para. 0270 teaches the wash buffer pass through the matrix 805).
Ismagilov ‘577 fails to teaches the first elution leg contains a volume of air therein such that upon releasing the first eluent into the first elution leg, the volume of air in the first elution leg is passed across the solid-state membrane and is sufficient to substantially evaporate the evaporative contaminant and thereby prevent contamination of the first eluent and captured nucleic acids received within the reaction chamber.
However, Creek teaches PCR assays. Creek further teaches the necessity of completely air dry and eliminate residual ethanol from tubing because residual ethanol could interfere with subsequent PCR reactions and DNA sequencing (Creek, para. 0033). In addition, Amstad teaches drying in microfluidic device (abstract). Amstad further teaches us a gas such as air may be directed into the fluid-containing channel, which can facilitate drying of the fluid (Amstad, para. 0031).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first elution leg taught by Ismagilov ‘577 to contains a volume of air that is sufficient to facilitate drying of residual ethanol taught by Amstad in order to minimize interferent with subsequent PCR reactions with a reasonable expectation of success (Creek, para. 033) (MPEP 2143)(I)(G).
The teachings of modified Ismagilov ‘577 as modified with Creek and further modified with Amstad with yield the first elution leg contains a volume of air therein such that upon releasing the first eluent into the first elution leg, the volume of air in the first elution leg is passed across the solid-state membrane (interpreted as intended use. The volume of air would first pass through the solid-state membrane) and is sufficient to substantially evaporate the evaporative contaminant and thereby prevent contamination of the first eluent and captured nucleic acids received within the reaction chamber (in the modification, the volume air is sufficient to facility drying of residual ethanol).
Regarding claim 8, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 7. Modified Ismagilov ‘577 further teaches wherein the evaporative contaminant is ethanol (Ismagilov ‘577 , para. 0348, 70% ethanol in the wash buffer), and the volume of air in the first elution leg is sufficient to substantially evaporate the ethanol in and about the solid-state membrane prior to passage of the first eluent across the membrane to substantially prevent ethanol poisoning of the reaction chamber ( the volume air is sufficient to facility drying of residual ethanol).
Claim 24 are rejected under 35 U.S.C. 103 as being unpatentable over Ismagilov et al. (US 20160263577 A1), hereinafter Ismagilov ‘577, in view of Ismagilov et al (US 20120028342), hereinafter Ismagilov ‘342 as applied to claim 1, and further in view of Selden et al. (US 20170274381 A1) as applied to claim 23 and further in view of Parsons et al (US 5056521 A).
Regarding claim 24, modified Ismagilov ‘577 teaches all of the elements of the current invention as stated above with respect to claim 23. Modified Ismagilov ‘577 device as defined in claim 23, wherein the saliva collection swab includes a plunger (the wand of the swab) depressible against the saliva collection swab within the sample port (Seldon, para. 0296)(see 35 U.S.C. 112b. The wand of the swab is depressible against the absorbent pad when there is a surface for the swab to be pressed against) to release saliva from the collection swab into the sample port and sample conduit (Seldon, para. 0296), at least one of the saliva collection swab or the sample port includes a locking tab (Seldon, swab cap, para. 0271), and the other of the saliva collection swab or sample port includes a corresponding locking recess or aperture (the opening of the that receive the cap)(Seldon, para. 0271, swab cap as a locking mechanism to hold the sample swab in place) configured to receive the locking tab and retain the swab within the sample port with the plunger depressed against the swab to facilitate release of saliva therefrom and into the sample port (Seldon, para. 0296). US 5056521 A
Modified Ismagilov ‘577 does not teach the plunger depressed against the swab to facilitate release of saliva therefrom and into the sample port.
However, Parsons (US 5056521 A) teaches collecting and extracting sample oral fluid from a swab (26) comprising a plunger (29). Parson further teaches the plunger depressed against the swab to facilitate release of saliva therefrom (col.2, lns. 5-13, pushing collecting swab 26 and piston 29 is to the end for concentrator 62, thereof to squeeze the fluid sample from collecting swab 26.)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the collection method taught by modified Ismagilov ‘577 to have the plunger depressed against the swab because one of ordinary skill in the art would accordingly have recognized having the plunger depressed against the swab would result in the predictable result of providing a means to facilitate release of saliva (Parsons, col.2, lns. 5-13) therefrom and into the sample port.
Allowable Subject Matter
Claims 9-11 would be allowable 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, Ismagilov ‘577 teaches a device for detecting nucleic acids in a biological sample as discussed above. In addition, Ismagilov ‘577 further teaches wherein the elution actuator (push unit and barrier units) includes a manually-engageable portion (push unit).
However, Ismagilov ‘577 fail to teach the elution actuator includes a plunger mount, a first elution plunger engageable with the first eluent chamber, a second elution plunger engageable with the second eluent chamber, a plunger spring defining a plunger spring force and mounted between the manually-engageable portion and the plunger mount, and a latch, wherein upon manually moving the manually-engageable portion from a non-actuated position to a first actuated position, the latch secures the manually-engageable portion in the first actuated position where the first elution plunger partially dispenses the first eluent chamber and the second elution plunger partially dispenses the second eluent chamber, and the plunger spring drives the plunger mount from the first actuated position to a second actuated position under the plunger spring force to further dispense the first and second eluents from the first and second eluent chambers, respectively.
Kelso teaches an elution actuator for burstable liquid blister for delivering reagent to biological assay in microfluidic cartridge. Kelso teaches the elution actuator includes a manually-engageable portion (stepper motor. Fig. 11 and para. 0116 teaches a single linear stepper motor is used to drive multiple clamps and plungers), a plunger mount (clamp), a first elution plunger (one of the plunger in Fig. 11) engageable with the first eluent chamber, a second elution plunger (another plunger in Fig. 11) engageable with the second eluent chamber, a plunger spring (Fig. 14b, spring between plunger and clamp) defining a plunger spring force and mounted between the manually-engageable portion and the plunger mount. However, Kelso does not teach the eluent actuator comprises a latch, wherein upon manually moving the manually-engageable portion from a non-actuated position to a first actuated position, the latch secures the manually-engageable portion in the first actuated position where the first elution plunger partially dispenses the first eluent chamber and the second elution plunger partially dispenses the second eluent chamber, and the plunger spring drives the plunger mount from the first actuated position to a second actuated position under the plunger spring force to further dispense the first and second eluents from the first and second eluent chambers, respectively.
The prior art whether taken individually or in combination would not disclose all of the cumulative limitations of claim 9. Therefore, claim 9 is deemed allowable. Claims 10-11 are allowable because of its dependency on claim 9.
Conclusion
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/M.L.C./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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