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 Claim 31 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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-lo