DETAILED ACTION
In application filed on 10/24/2023, Claims 1-22 are pending. The claim set submitted on 05/22/2026 is considered because this is the most recent claim set with some preliminary amendments. Claims 16-22 considered in the current office action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/01/2023, 02/08/2024, 03/15/2024, 09/05/2025, 12/11/2025 and 12/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/30/2024 is acknowledged. Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/22/2026.
Group I, Claims 16-22 are considered on the merits below.
Further, regarding the amendment reciting the combination of Claim 16 with Claim 1 and Claim 14, Examiner will consider rejoinder of the nonelected claims (including any properly amended dependent claims) that require all the limitations of the allowable claim in accordance with MPEP § 821.04, if all the claims in the elected invention are found allowable.
Claim Objections
Claims 20-22 are objected to because of the following informalities:
Claim 20 recites “a combination as defined in Claim 19”. It appears that this limitation should be recited as “the formulation as defined in Claim 19”.
Claim 21 recites “a combination as defined in Claim 20”. It appears that this limitation should be recited as “the formulation as defined in Claim 20”.
Claim 22 recites “a combination as defined in Claim 21”. It appears that this limitation should be recited as “the formulation as defined in Claim 21”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16 and 19-20 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Quan et al. (US20160369263A1).
Regarding Claim 16, Quan teaches a formulation (referred to as a chaotropic agent in solid form, a detergent and a buffer, and a solid phase which includes magnetic particles, thus forming a reaction mixture containing the cell-free nucleic acid [Abstract]) for collecting a biological sample of saliva or fluid (referred to as bodily fluid) from a pregnant woman (See Para 0016…, the bodily fluid sample may be obtained from …from pregnant females for purposes of conducting genetic testing to detect for the presence of fetal disease and abnormalities) and capturing nucleic acids (See Abstract…isolating cell-free nucleic acid (including both DNA and RNA)) in the collected biological sample (referred to as bodily fluid) on a solid-state membrane (See Abstract… a solid phase which includes magnetic particles) , including chromosomal cfDNA (See abstract…isolating cell-free nucleic acid (including both DNA and RNA) or an analog thereof ) and a Y chromosome nucleotide sequence (See Para 0069…Y chromosome), if any, in the collected biological sample (referred to as bodily fluid), comprising:
one or more non-toxic chaotropic agents (See Para 0019…The chaotrope or chaotropic agent used in the compositions and methods of the present invention is in the form of a solid…Representative examples of chaotropes that are useful in the present invention include guanidine salts, e.g., guanidine thiocyanate, guanidinium (iso)thiocyanate, and sodium thiocyanate. Other representative chaotropes include iodides (e.g., sodium iodide and potassium iodide) and urea.); ethanol (See Para 0042…above buffer 50:50 v/v with ethanol; See Para 0049…he samples were removed from the magnetic stand and 600 μl of Buffer WA (diluted 1:1 with absolute ethanol before use) was added and used to resuspend the magnetic beads by vortexing for 30 seconds ); The claimed “and/or coloring and/or flavoring agents” is viewed as optional, thus not required by the claim. ,
wherein the formulation is receivable within an oral cavity or other cavity of the pregnant woman to collect the biological sample of saliva or fluid therefrom (This limitation is interpreted as a method of intended use given patentable weight to the extent of effecting the function of the formulation. Please see MPEP 2114(II) for further details,
the one or more non-toxic chaotropic agents at least one (See Para 0019…The chaotrope or chaotropic agent used in the compositions and methods of the present invention is in the form of a solid…Representative examples of chaotropes that are useful in the present invention include guanidine salts, e.g., guanidine thiocyanate, guanidinium (iso)thiocyanate, and sodium thiocyanate. Other representative chaotropes include iodides (e.g., sodium iodide and potassium iodide) and urea.) of lyse the cells of the biological sample (See Para 0003…Some methods entail use of chaotropes which facilitate dissociation of cell-free nucleic acid from proteins. As known in the art, higher concentrations of chaotrope are desirable for release of nucleic acids from proteins and capture on a solid phase such as a silicon phase).
The claimed “or bind or facilitate binding of the chromosomal cfDNA, and a Y chromosome nucleotide sequence, if any, in the cells of the biological sample, to the solid-state membrane” is viewed as an alternative limitation which is optional and thus not required by the Claim.
In addition, Claim 16 recites a formulation and then recites how the formulation functions. Claim 16 is a composition/product claim and MPEP 2112.01 recites that " Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Quan et al. (US20160369263A1).
Regarding Claim 17, Quan teaches formulation as defined in claim 16 (See Claim 16 rejection) comprising about 2.0 to about 5.5 gram non-toxic chaotropic agents (See Para 0010…chaotropic agent is present in an amount of about 2.0 to about 5.5 grams) and ethanol (See Para 0049… (diluted 1:1 with absolute ethanol before use) ).
Quan does not explicitly teach about 0.1% to about 40% w/v non-toxic chaotropic agents and about 5% to about 30% w/v ethanol.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the In the isolation of cell-free nucleic acids (cfNAs) using silica-based methods, chaotropic agents lyse cells, inactivate nucleases, and expose the nucleic acid backbone, while ethanol acts as a precipitant to drive nucleic acids out of solution and bind them to the silica surface. Further, the amount and concentration of ethanol dictate the balance between nucleic acid yield and purity. In the isolation of cell-free nucleic acids (cfNAs), the amount and concentration of ethanol dictate the balance between nucleic acid yield and purity. Precise ethanol ratios are necessary to force cfNAs out of solution and bind them to extraction matrices, while avoiding co-precipitation of salts and inhibitors. Thus, the “0.1% to about 40% w/v non-toxic chaotropic agents and about 5% to about 30% w/v ethanol” are result effective variables.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design a formulation having 0.1% to about 40% w/v non-toxic chaotropic agents and about 5% to about 30% w/v ethanol, for the benefit of facilitating the dissociation of cell-free nucleic acid from proteins (Quan, Para 0003, 0049), which allows for the provision of a solution to a long felt need in the art of diagnostics, and in particular, pre-natal diagnostics. In particular, by proceeding in a direction contrary to the “gold standard” approaches currently employed in the diagnostics industry, the present invention, which employs use of a chaotropic agent in solid form, surprisingly and unexpectedly results in optimal direct capture of cell-free nucleic acid from bodily fluids (Quan, Para 0011).
Regarding Claim 18, Quan teaches wherein the non-toxic chaotropic agents (See Para 0010…chaotropic agent is present in an amount of about 2.0 to about 5.5 grams) are selected from the group including the following individually or in any combination thereof: (i) urea; about 0.1% to about 3% w/v sodium lauryl sulfate; and about 2% to about 40% w/v ammonium trichloroacetate (See Para 0016…Representative examples of chaotropes that are useful in the present invention include guanidine salts, e.g., guanidine thiocyanate, guanidinium (iso)thiocyanate, and sodium thiocyanate. Other representative chaotropes include iodides (e.g., sodium iodide and potassium iodide) and urea.).
Quan does not explicitly teach (i) about 5% to about 30% w/v urea.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the isolation of cell-free nucleic acids (cfNAs) using silica-based methods, chaotropic agents such as urea lyse cells, inactivate nucleases, and expose the nucleic acid backbone, while ethanol acts as a precipitant to drive nucleic acids out of solution and bind them to the silica surface.
Thus, the “(i) about 5% to about 30% w/v urea” is a result effective variable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design a formulation having about 5% to about 30% w/v urea, for the benefit of facilitating the dissociation of cell-free nucleic acid from proteins (Quan, Para 0003, 0049), which allows for the provision of a solution to a long felt need in the art of diagnostics, and in particular, pre-natal diagnostics. In particular, by proceeding in a direction contrary to the “gold standard” approaches currently employed in the diagnostics industry, the present invention, which employs use of a chaotropic agent in solid form, surprisingly and unexpectedly results in optimal direct capture of cell-free nucleic acid from bodily fluids (Quan, Para 0011).
Regarding Claim 19, Quan teaches formulation as defined in claim 16 (See Claim 16 rejection), in combination with a long-chain fatty alcohol wash (See Para 0006… a monohydric alcohol; See Para 0010… a washing buffer optionally containing a drying agent such as a monohydric alcohol) configured to flow over the solid-state membrane (See Para 0006… the thus-washed solid phase is washed at least once with an aqueous solution that contains a drying agent, e.g., a monohydric or dihydric alcohol or a polyol, and then dried) following the formulation (See Claim 16 rejection) to substantially eliminate any residual ethanol (See Para 0049… (diluted 1:1 with absolute ethanol before use) of the formulation (See Claim 16 rejection) on the solid-state membrane (See Abstract… a solid phase which includes magnetic particles).
Regarding Claim 20, Quan teaches the combination as defined in claim 19 (See Claim 19 rejection), further comprising a transfer device (referred to as tube [Para 0046]) containing in a first portion thereof the formulation (referred to as a chaotropic agent in solid form, a detergent and a buffer, and a solid phase which includes magnetic particles, thus forming a reaction mixture containing the cell-free nucleic acid [Abstract]; Also See Para 0046…appropriate amount of plasma or urine was added to the tube containing the composition (#1)) and containing in a second portion thereof the long-chain fatty alcohol wash (See Para 0031…second washing buffer that contains a drying agent (e.g., a monohydric…).), wherein the first portion thereof is receivable within an oral cavity or other cavity of the pregnant woman for collecting saliva or fluid (See Para 0044-0045…Blood samples were collected using K-EDTA (Lavender top) BD Vacutainer™ tubes…Urine samples were collected in sterile urine collection cups), and the transfer device (referred to as tube [Para 0046]) is configured to transfer or dispense the formulation (referred to as a chaotropic agent in solid form, a detergent and a buffer, and a solid phase which includes magnetic particles, thus forming a reaction mixture containing the cell-free nucleic acid [Abstract]; Also See Para 0046…appropriate amount of plasma or urine was added to the tube containing the composition (#1)) and collected biological sample to the solid-state membrane (See Para 0047… Fully resuspended NGS Beads™ (via vortexing for 1 minute) were added via pipetting 30 μl of magnetic beads to the bodily fluid and the composition, thus preparing the reaction mixture) and then transfer or dispense the long-chain fatty alcohol wash to the solid-state membrane (See Par 0031… the solid phase may be washed yet again, at least once, with a second washing buffer that contains a drying agent (e.g., a monohydric or polyhydric alcohol (or polyol), as well as ketones (e.g., acetone) and ethers).).
In addition, Claim 20 recites a transfer device and then recites how the transfer device functions. Claim 20 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Quan et al. (US20160369263A1) as applied to claim 20 above, and further in view of Alcorn et al. (US20220219169A1, submitted in IDS 11/01/2023)
Regarding Claim 21, Quan teaches the combination as defined in claim 20 (See Claim 20 rejection).
Quan does not teach the transfer device is a syringe comprising on a distal end thereof a gauze or other absorbent material that is receivable in the oral cavity or other cavity of the pregnant woman and configured to absorb the saliva or other fluid therein, wherein the syringe defines a first chamber or portion of a chamber in fluid communication with the gauze or other absorbent material and containing therein the formulation, and a second chamber or portion of a chamber located on an opposite side of the first chamber or portion thereof relative to the gauze or other absorbent material and containing therein the long-chain fatty alcohol wash, wherein actuation of the syringe causes the formulation to flow through the gauze or other absorbent material and collect therein the biological sample and to dispense from the syringe a mixture of the formulation and biological sample, and further actuation of the syringe causes the long-chain fatty alcohol wash to be dispensed from the syringe following dispensing of the formulation and biological sample mixture.
In the analogous device of A device for amplifying and detecting nucleic acids in a biological sample has a sample port for receiving a biological sample, a solid-state membrane, a sample conduit, a lysis station, a wash station, an elution station, a waste chamber, and a reaction chamber, Alcorn teaches that the transfer device (referred to as an off-the-shelf absorbent sample collection device 112 (Super-SAL) works with the integrated syringe body style sample port 114 of the device 110 [Para 0082]) is a syringe (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082])) comprising on a distal end (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082]); Under BRI, the syringe body style sample port 114 has a distal end) thereof a gauze or other absorbent material (referred to as a cotton swab or equivalent device [Para 0079]) that is receivable in the oral cavity or other cavity of the pregnant woman and configured to absorb the saliva or other fluid therein (See Para 0079… a sample 80 is collected using a cotton swab or equivalent device inserted into the mouth of the test subject (‘pregnant woman’) and rubbed against surfaces containing saliva thereon; Further this limitation “…that is receivable in the oral cavity or other cavity of the pregnant woman and configured to absorb the saliva or other fluid therein” is interpreted as a method of intended use given patentable weight to the extent of effecting the function of the cotton swab or equivalent device to be used with a test subject [Para 0079]. Please see MPEP 2114(II) for further details.)
wherein the syringe (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082])) defines a first chamber or portion of a chamber (referred to as sample port [Fig. 15A-B, ref. 114; Abstract]) in fluid communication with the gauze or other absorbent material (referred to as a cotton swab or equivalent device [Para 0079]) and containing therein the formulation (referred to as the lysis buffer [Para 0079]), and a second chamber or portion of a chamber (referred to as microfluidic conduit [Para 0083; Fig. 15B, ref. 113]) located on an opposite side (See 15B…opposite]) of the first chamber or portion thereof (referred to as sample port [Fig. 15A-B, ref. 114; Abstract]) relative to the gauze or other absorbent material (See Para 0079…the swab is placed into the sample port 18 of the test cartridge 12…) and containing therein the long-chain fatty alcohol wash (See Para 0006…wash solution; See Para 0007…The wash station is configured to introduce the wash solution into the sample conduit following the sample-lysis mixture, pass 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),
wherein actuation of the syringe (See Para 0083…The sample collection device 112 includes a saliva collection swab 109 for collecting saliva thereon and a syringe-type plunger 111 for compressing the saliva collection swab 109 within the sample port 114 to release the saliva therefrom and into the microfluidic conduit 113) causes the formulation (referred to as the lysis buffer [Para 0079]) to flow through the gauze or other absorbent material (referred to as a cotton swab or equivalent device [Para 0079]) and collect therein the biological sample (See Para 0079… a sample 80) and to dispense from the syringe (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082])) a mixture of the formulation and biological sample (See Para 0083…A lysis station 116 including a lysis buffer blister 118, and a first wash station 120 including a wash buffer blister 122, are then depressed simultaneously. As shown in FIG. 16, this pushes the sample solution and the lysis buffer from the lysis blister 118 into a static mixer 124 for mixing the sample and lysis buffer), and further actuation of the syringe (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082])) causes the long-chain fatty alcohol wash (See Para 0006…wash solution) to be dispensed from the syringe (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082])) following dispensing of the formulation (referred to as the lysis buffer [Para 0079]) and biological sample mixture (See Para 0079…the first actuator or plunger 48 is manually depressed, releasing the wash solution from the blister 46 at the first wash station to wash the solid-state membrane 28 at the first wash position 36…).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the formulation of Quan to include that the transfer device is a syringe comprising on a distal end thereof a gauze or other absorbent material that is receivable in the oral cavity or other cavity of the pregnant woman and configured to absorb the saliva or other fluid therein, wherein the syringe defines a first chamber or portion of a chamber in fluid communication with the gauze or other absorbent material and containing therein the formulation, and a second chamber or portion of a chamber located on an opposite side of the first chamber or portion thereof relative to the gauze or other absorbent material and containing therein the long-chain fatty alcohol wash, wherein actuation of the syringe causes the formulation to flow through the gauze or other absorbent material and collect therein the biological sample and to dispense from the syringe a mixture of the formulation and biological sample, and further actuation of the syringe causes the long-chain fatty alcohol wash to be dispensed from the syringe following dispensing of the formulation and biological sample mixture, as taught by Alcorn for the benefit of isolating, concentrating, amplifying and detecting nucleic acids in biological samples, such as saliva, blood, or urine samples, and more particularly, to such devices or methods including solid-state membranes and microfluidic reaction chambers (Alcorn, Para 0002), allowing for the provision of a device or method to allow for greater volumes of biological samples to be passed across such a membrane, to in turn allow for the capture of greater amounts of targeted nucleic acids to thereby improve the ability to detect such nucleic acids. It would also be desirable to have a system that does not require paraffin or like sealant to prevent hydrolyzation (Alcorn, Para 0004).
In addition, Claim 21 recites a transfer device, a first chamber, the gauze and other absorbent material and a second chamber and then recites how these structures functions. Claim 21 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 22, the combination of claim 21 is obvious over Quan in view of Alcorn.
Quan does not teach wherein the syringe includes a barrel defining the first and second chambers and including a frangible or breakable wall separating the first and second chambers, and the syringe further comprises a plunger received within the barrel, whereupon actuation of the plunger breaks the frangible or breakable wall and dispenses the formulation and then the long-chain fatty alcohol wash from the syringe.
In the analogous device of a device for amplifying and detecting nucleic acids in a biological sample has a sample port for receiving a biological sample, a solid-state membrane, a sample conduit, a lysis station, a wash station, an elution station, a waste chamber, and a reaction chamber, Alcorn teaches that the syringe (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082])) includes a barrel (referred to as sealed chamber [Para 0067]) defining the first (referred to as sample port [Fig. 15A-B, ref. 114; Abstract]) and second chambers (referred to as microfluidic conduit [Para 0083; Fig. 15B, ref. 113]) and including a frangible or breakable wall (See Para 0016… includes a frangible or breakable wall, such as formed by a blister or foil, that is breakable by the actuator in the actuated position to release the lysis agent, wash solution or eluent from the sealed chamber) separating the first (referred to as sample port [Fig. 15A-B, ref. 114; Abstract]) and second chambers (referred to as microfluidic conduit [Para 0083; Fig. 15B, ref. 113]) and the syringe (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082])) further comprises a plunger (referred to as the actuator or blister plunger 48 [Para 0059]) received within the barrel (referred to as sealed chamber [Para 0059, 0067]), whereupon actuation of the plunger breaks the frangible or breakable wall (See Para 0059…Movement of the plunger 48 from the non-actuated position 50 to the actuated position 52 causes the actuator or blister plunger 48 to exert pressure on the sealed chamber or blister 46. Blister rupture pins (not shown) are located below the frangible wall 56 and come in contact with and burst the frangible wall as the blister actuator 48 is compressed to release the wash solution onto the solid-state membrane 28. The upper sealing pad 54A is impermeable to the wash solution and sufficiently compressible to ensure a fluid-tight seal between the interlock 55 and the membrane slider 32) and dispenses the formulation (referred to as the lysis buffer [Para 0079]) and then the long-chain fatty alcohol wash (‘wash solution’) from the syringe (See Para 0082… syringe body style sample port 114 of the device 110 [Para 0082])).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the formulation of Quan to include that the syringe includes a barrel defining the first and second chambers and including a frangible or breakable wall separating the first and second chambers, and the syringe further comprises a plunger received within the barrel, whereupon actuation of the plunger breaks the frangible or breakable wall and dispenses the formulation and then the long-chain fatty alcohol wash from the syringe., as taught by Alcorn for the benefit of isolating, concentrating, amplifying and detecting nucleic acids in biological samples, such as saliva, blood, or urine samples, and more particularly, to such devices or methods including solid-state membranes and microfluidic reaction chambers (Alcorn, Para 0002), allowing for the provision of a device or method to allow for greater volumes of biological samples to be passed across such a membrane, to in turn allow for the capture of greater amounts of targeted nucleic acids to thereby improve the ability to detect such nucleic acids. It would also be desirable to have a system that does not require paraffin or like sealant to prevent hydrolyzation (Alcorn, Para 0004).
In addition, Claim 22 recites a syringe, a barrel, first and second chambers, a frangible or breakable wall and a formulation and then recites how these structures functions. Claim 22 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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