DETAILED ACTION
Notice of AIA Status
The present application, filed on 3/29/2022, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 are pending.
Claims 1-20 are rejected.
Claims 1-20 are objected to
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 claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
(1) the rotating device configured to rotate about an axis at a speed sufficient to dispense the liquid within the well and the corresponding structure in the instant specification as performing the claimed function is an physical object having a face of any shape capable of matching a substrate of any shape and optionally including a motor to actuate rotation as recited in [0046], [0051] and [0053] of the instant specification publication US20230347312. The scope of the claimed rotating device includes manual actuation.
(2) the liquid handler configured to dispense the liquid into the well and the corresponding structure in the instant specification as performing the claimed function is a syringe, or a pipette, or nozzle and optionally including a pump and a motor as recited in [0054], [0055] and [0057] of the instant specification publication US20230347312. The scope of the claimed liquid handler includes manual actuation.
(3) the retaining mechanism is configured to apply a force on the substrate to thereby retain it on the rotating device and the corresponding structure in the instant specification as performing the claimed function is adhesive or a clip, a latch, a screw or a clamp as recited in [0006], and [0006] of the instant specification publication US20230347312.
In addition, as to the retaining mechanism configured to apply a vacuum force to a surface of the substrate thereby securing the substrate to the rotating device, there isn’t sufficient corresponding structure for performing the claimed function in the instant specification.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) they are interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1-20 are objected to because of the following informalities:
Claim 1 recites “a rotating device configured to rotate about an axis;
a substrate disposed on the rotating device, wherein the substrate comprises a well configured to hold a liquid, wherein the substrate is positioned on a surface of the rotating device perpendicular to and concentric with the axis; and
a liquid handler configured to dispense the liquid into the well, wherein the rotating device is configured to rotate at a speed sufficient to disperse the liquid within the well”. For the sake of clarity consider rephrasing to ‘a rotating device configured to rotate about an axis and comprising a rotating device surface perpendicular to and concentric with the axis;
a substrate comprising a well configured to hold liquid, wherein the substrate is positioned on the rotating device surface; and
a liquid handler configured to dispense liquid into the well wherein the rotating device is configured to disperse, within the well, the dispensed liquid by rotating at a speed sufficient.
Claim 2 recites “apply a force on the substrate”. For the sake of clarity, consider rephrasing to “apply a force to the substrate”.
Claim 11 recites “dispensing, from the liquid handler, the liquid on the substrate and/or the at least one sample”. For the sake of clarity consider rephrasing to “dispensing a liquid from the liquid handler onto the at least one sample or onto a region of the substrate without the at least one sample or both”.
Claim 11 recites “rotating the substrate at a speed sufficient to disperse the liquid over the substrate and/or the at least one sample”. For the sake of clarity, consider rephrasing to ‘dispersing the liquid over the at least one sample or over the region of the substrate without the at least one sample or both by rotating the substrate at a sufficient speed’.
Claim 12 recites “wherein the system further comprises a retaining mechanism, wherein the method further comprises using the retaining mechanism to apply a force on the substrate to thereby retain it on the rotating device”. For the sake of clarity, consider rephrasing to ‘wherein the system further comprises a retaining mechanism, wherein the method further comprises retaining the substrate on the rotating device by applying a force on the substrate using the retaining device.
Claim 20 recites “the NTPs”. For uniformity in terminology, consider rephrasing to “the plurality of nucleotide triphosphates (NTPs)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 3-4 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites “the retaining mechanism is configured to apply a vacuum force to a surface of the substrate thereby securing the substrate to the rotating device”. However, the instant specification doesn’t disclose sufficient structure to performed the claimed function. (see MPEP §2181 subsection IV, which states “merely restating a function associated with a means-plus-function limitation is insufficient to provide the corresponding structure for definiteness. See, e.g., Noah, 675 F.3d at 1317, 102 USPQ2d at 1419; Blackboard, 574 F.3d at 1384, 91 USPQ2d at 1491; Aristocrat, 521 F.3d at 1334, 86 USPQ2d at 1239. It follows therefore that such a mere restatement of function in the specification without more description of the means that accomplish the function would also likely fail to provide adequate written description under section 112(a)”).
Claims dependent on an unsupported base claim are unsupported because any claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
Claim Rejections - 35 USC § 112(b)
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.
Claims 2-4 and 11-20 are rejected under 35 U.S.C. 112(b) for being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 recites “it”. It isn’t clear what the noun the pronoun it refers back to. For purposes of prior art, “it” refers to the substrate.
Claim 3 recites “the retaining mechanism”. There is insufficient antecedent basis for limitation in the claim. Consider rephrasing “wherein the retaining mechanism is configured” to “further comprising a retaining mechanism configured…’ or amending the dependency of claim 3 such that claim 3 depends upon claim 2.
Claim 3 recites “the retaining mechanism is configured to apply a vacuum force to a surface of the substrate thereby securing the substrate to the rotating device”. It isn’t clear what structure of the retaining mechanism enables the retaining mechanism to apply a vacuum force to a surface of the substrate thereby securing the substrate to the rotating device. Claim limitation “the retaining mechanism is configured to apply a vacuum force to a surface of the substrate thereby securing the substrate to the rotating device” invokes 35 U.S.C. 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. In this case, the structure described in the specification does not perform the entire function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 5 recites “the retaining mechanism”. There is insufficient antecedent basis for limitation in the claim.
Claim 11 recites “A method of dispensing a sample comprising: providing the system of claim 1; positioning at least one sample on the substrate; dispensing, from the liquid handler, the liquid on the substrate and/or the at least one sample”.
It isn’t clear whether the method is a method of dispensing a sample or a method of dispensing a liquid. Claim 14 recites “the rotating device rotates at a fixed speed”. However claim 11 recites rotating “rotating the substrate at a speed sufficient to disperse the liquid over the substrate and/or the at least one sample” which doesn’t require the rotating to be performed by the rotating device. As a result, it isn’t clear whether claim 14 recites merely a capability of the rotating device or is further limiting the rotating step introduced in claim 11 or something else.
Claim 15 recites “the rotating device rotates at a variable speed.” However claim 11 recites “rotating the substrate at a speed sufficient to disperse the liquid over the substrate and/or the at least one sample” which doesn’t require the rotating to be performed by the rotating device. As a result, it isn’t clear whether claim 15 recites merely a capability of the rotating device or is further limiting the rotating step introduced in claim 11 or something else.
Claim 19 recites “a replicating enzyme, a plurality of nucleotide triphosphates (NTPs), and/or oligonucleotides to the sample”. It isn’t what elements are required and what elements are optional because the use or “and/or” in a list having three items or more introduces uncertainty as to which elements are required and which are optional. Consider rephrasing to ‘a replicating enzyme, a plurality of nucleotide triphosphates (NTPs), and oligonucleotides to the sample, or a combination thereof’.
Claim 20 recites “wherein the replicating enzyme replicates a target nucleic acid with the NTPs”. It isn’t clear where claim 20 recites a mere capability of the replicating enzyme or is a further step of replicating a target acid after dispensing the replicating enzyme and the NTPs to the sample’.
Claims dependent on an indefinite base claim are indefinite because any claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
Claim Rejections - 35 USC § 102(a)(2)
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(a)(2) that form the basis for the rejections under this section made in this Office action:
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-9, 11-15 and 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Beckett (US20250091050).
As to claim 1, Beckett teaches a system comprising:
a rotating device (an automated or manual rotational unit in [0211]) configured to rotate about an axis (see [0211], which recites “the substrate may be rotatable about an axis … an automated or manual rotational unit configured to rotate the substrate … The rotational unit may comprise a motor and/or a rotor 812 to rotate the substrate 808”) (as the rotating device rotates about an axis any substrate disposed on a face of the rotating device perpendicular to the axis rotates as well);
a substrate (substrate 808 in [0211], illustrated in Fig. 9A) disposed on the rotating device (see Fig. 9A), wherein the substrate (substrate 808) comprises a well (pit in [0202], which recites “each individually addressable location may have the general shape or form of a circle, pit”) configured to hold a liquid (see [0300], which recites “the print head 800 may dispense one or more sample droplets 818 onto a substrate with both liquid volume control and spatial control”) (see [0200], which recites “the substrate may comprise a plurality of individually addressable locations. The individually addressable locations may comprise locations that are physically accessible for manipulation. The manipulation may comprise, for example, placement, extraction, reagent dispensing”), wherein the substrate is positioned on a surface of the rotating device perpendicular to and concentric with the axis (see [0309], which recites “sample loading and/or reagent dispensing may comprise one or more feedback systems, such as involving monitoring (e.g., imaging) and control feedback. In an example, a sample or a portion thereof may be loaded on the substrate. For example, a sample comprising particles (e.g., beads) with nucleic acid molecules and/or reagents may be dispensed onto a substrate (e.g., wafer) with various predetermined patterns, as seen in the examples of FIGS. 11A-11D. In some cases, the patterned surface may comprise samples and/or reagents in spatially discrete zones (FIG. 11A), a mixture of spatially discrete zones and circular sectors (FIGS. 11B-C), or one or more concentric rings (FIG. 11D)”); and
a liquid handler (printer head 800 in [0300]) configured to dispense the liquid into the well (see [0300], which recites “The print head 800 may dispense one or more sample droplets 818 onto a substrate with both liquid volume control and spatial control”), wherein the rotating device is configured to rotate at a speed sufficient to disperse the liquid within the well (see [0211], which recites “e substrate may be rotated 814 at a rotational speed of at least 1 revolution per minute (rpm), at least 2 rpm, at least 5 rpm, at least 10 rpm, at least 20 rpm, at least 50 rpm, at least 100 rpm, at least 200 rpm, at least 500 rpm, at least 1,000 rpm, at least 2,000 rpm, at least 5,000 rpm, at least 10,000 rpm, or greater. Alternatively or in addition, the substrate may be rotated at a rotational speed of at most about 10,000 rpm, 5,000 rpm, 2,000 rpm, 1,000 rpm, 500 rpm, 200 rpm, 100 rpm, 50 rpm, 20 rpm, 10 rpm, 5 rpm, 2 rpm, 1 rpm, or less”).
As to claim 2, Beckett teaches the system of claim 1, further comprising a retaining mechanism (chuck 806 in [0211]), wherein the retaining mechanism (chuck 806) is configured to apply a (vacuum) force on the substrate to thereby retain it (the substrate 808) on the rotating device (automated or manual rotational unit) (see [0259], which recites “the chuck may comprise one or more mechanisms for coupling or affixing to the substrate, such as vacuum or suction. In some cases, the chuck may comprise one or more suction cups that contact the substrate”).
As to claim 3, Beckett teaches the system of claim 1, wherein the retaining mechanism (chuck 806 in [0211]) is configured to apply a vacuum force to a surface of the substrate (substrate 808) thereby securing the substrate (substrate 808) to the rotating device (automated or manual rotational unit) (see [0259], which recites “the chuck may comprise one or more mechanisms for coupling or affixing to the substrate, such as vacuum or suction. In some cases, the chuck may comprise one or more suction cups that contact the substrate”).
As to claim 4, Beckett teaches the system of claim 3, wherein the retaining mechanism (chuck 808) comprises an adhesive (see [0257], which recites “chuck may comprise any material…, or any material of the substrate”) (see [0197], which recites “a surface of the substrate may be modified to comprise any of the binders or linkers described herein. In some instances, such binders, linkers, active chemical groups, and the like may be added as an additional layer or coating to the substrate”) (the retaining mechanism comprises an adhesive material because the substrate comprises a binder which is an adhesive and the retaining mechanism comprise any material of the substrate).
As to claim 6, Beckett teaches the system of claim 1, wherein the substrate (substrate 808) comprises glass (see [0197], which recites “the substrate may ..comprise … glass”).
As to claim 7, Beckett teaches the system of claim 1, wherein the substrate (substrate 808) has a thickness of about 1 µm to about 1 mm (see [0198], which recites “the substrate may have a thickness (e.g., a minimum dimension) of at least 100 micrometers (μm), at least 200 μm, at least 500 μm, at least 1 mm”).
As to claim 8, Beckett teaches the system of claim 1, wherein the liquid handler (printer head 800) comprises a nozzle, a syringe, or a pipette (see [0237], which recites “FIGS. 8A 8B and FIG. 9A illustrate use of fluid nozzles (e.g., of a fluid dispenser 810) and print heads (e.g., 800) to dispense fluids to a substrate”) (see also [0234], which recites “the two or more reagents may be mixed in a syringe pump prior to dispensing by the one or more nozzles”) (see [0200], which recites “manipulation may be through … pipet”).
As to claim 9, Beckett teaches the system of claim 1, wherein the liquid comprises a reagent (the liquid is a material worked upon and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935) (see [0300], which recites “the print head 800 may dispense one or more sample droplets 818 onto a substrate with both liquid volume control and spatial control”) (see [0200], which recites “the substrate may comprise a plurality of individually addressable locations. The individually addressable locations may comprise locations that are physically accessible for manipulation. The manipulation may comprise, for example, placement, extraction, reagent dispensing”).
As to claim 11, Beckett teaches a method of dispensing a sample (see [0237], which recites “FIGS. 8A-8B, FIG. 9A, and FIGS. 18A-18E illustrate multiple dispense mechanisms that can be used with the systems described herein, such as to dispense and/or disperse reagents and/or samples to a substrate”) (regarding method claims, a prior art device anticipates a claimed process, if the device carries out the process during normal operation (see MPEP § 2112.02), (the method) comprising:
providing the system of claim 1;
positioning at least one sample on the substrate (see [0237], which recites “FIGS. 8A-8B, FIG. 9A, and FIGS. 18A-18E illustrate multiple dispense mechanisms that can be used with the systems described herein, such as to dispense and/or disperse reagents and/or samples to a substrate”);
dispensing, from the liquid handler (printer head 800), the liquid on the substrate (substrate 808) and/or the at least one sample (see [0217], which recites “Reagent dispensing mechanisms disclosed herein may be applicable to sample dispensing”) (see [0214], which recites “the surface of the substrate 808 may be in fluid communication with at least one fluid nozzle (of a fluid dispenser 810), as seen in FIGS. 8A-8B. … different reagents (e.g., nucleotide solutions of different types, different probes, washing solutions, etc.) may be dispensed via different nozzles, such as to prevent contamination. Each nozzle may be connected to a dedicated fluidic line or fluidic valve, which may further prevent contamination. A type of reagent may be dispensed via one or more nozzles”) (see [0219], which recites “a method for dispensing reagents may comprise agitation, or with a cycle of interrupted movements”); and
rotating the substrate (substrate 808) at a speed sufficient to disperse the liquid over the substrate (substrate 808) and/or the at least one sample (see [0219], which recites “a method for dispensing reagents may comprise agitation, or with a cycle of interrupted movements. For example, during or subsequent to dispensing reagents onto the substrate, the substrate may be subjected to movement, stopped, with such movement and stopping repeating any number of times. The movement may be a rotation”).
As to claim 12, Beckett teaches the method of claim 11, wherein the system further comprises a retaining mechanism (chuck 806 in [0211]),, wherein the method further comprises using the retaining mechanism (chuck 806) to apply a force on the substrate (substrate 808) to thereby retain it (the substrate 808) on the rotating device (automated or manual rotational unit) (see [0259], which recites “the chuck may comprise one or more mechanisms for coupling or affixing to the substrate, such as vacuum or suction. In some cases, the chuck may comprise one or more suction cups that contact the substrate”).
As to claim 13, Beckett teaches the method of claim 11, wherein dispensing the liquid comprises spraying the liquid (see [0214], which recites “One or more nozzles may be configured to deliver fluids to the substrate as a jet, spray (or other dispersed fluid), and/or droplets”. Regarding method claims, a prior art device anticipates a claimed process, if the device carries out the process during normal operation (see MPEP § 2112.02).
As to claim 14, Beckett teaches the method of claim 11, wherein the rotating device (automated or manual rotational unit) rotates at a fixed speed (the rotating device of Beckett is capable of rotating at a fixed speed in operation) (see [0222], which recites “the substrate 1308 rotates at a first rate (i.e., rotation per minute of the substrate (RPM)) for a first period of time”).
As to claim 15, Beckett teaches the method of claim 11, wherein the rotating device (automated or manual rotation unit) rotates at a variable speed the rotating device of Beckett is capable of rotating at a variable speed in operation) (see [0222], which recites “the substrate 1308 rotates at a first rate (i.e., rotation per minute of the substrate (RPM)) for a first period of time and a second rate for a second period of time”).
As to claim 17, Beckett teaches the method of claim 11, further comprising imaging the at least one sample after rotating the substrate (substrate 808) (FIG. 4 illustrates images of a portion of a substrate surface after loading a sample) (the imaging of Beckett is performed after rotating the substrate because the loading the sample can be performed while rotating the substrate) (see [0299], which recites “the substrate 808 may rotate while the print head 800 is translating and dispensing the one or more sample droplets 818 on the substrate. In some instances, the print head may move radially toward or away from a rotational axis of the surface as the print head dispenses one or more droplets”)
As to claim 18, Beckett teaches the method of claim 11, wherein the liquid comprises a labelled oligonucleotide probe (labelled nucleotides) configured to hybridize to a target nucleic acid (a nucleic acid sample in [0057]) in the at least one sample (see [0057], which recites “a system for sequencing a plurality of nucleic acid samples, comprising: a sample loading station configured to dispense a nucleic acid sample of the plurality of nucleic acid samples onto a surface of a substrate”, oligonucleotides are short fragments of nucleic acids) (see also [0084], which recites “a method for mixing reagents, comprising: (a) providing a first reservoir comprising a first sequencing reagent of labeled nucleotides”) (see [0253], which recites “the dispensed solution may comprise any sample or any analyte disclosed herein. The dispensed solution may comprise any reagent disclosed herein. …, the solution can comprise samples, …, probes, nucleotides, oligonucleotides, labels”) (see also [0162], which recites “The terms “nucleic acid,” “nucleic acid molecule,” “nucleic acid sequence,” “nucleic acid fragment,” “oligonucleotide” and “polynucleotide,” as used herein, generally refer to a polynucleotide that may have various lengths of bases”).
As to claim 19, Beckett teaches the method of claim 11, wherein dispensing the liquid comprises dispensing a replicating enzyme, a plurality of nucleotide triphosphates (NTPs), and/or oligonucleotides to the sample (see [0057], which recites “a system for sequencing a plurality of nucleic acid samples, comprising: a sample loading station configured to dispense a nucleic acid sample of the plurality of nucleic acid samples onto a surface of a substrate”, oligonucleotides are short fragments of nucleic acids) (see also [0084], which recites “a method for mixing reagents, comprising: (a) providing a first reservoir comprising a first sequencing reagent of labeled nucleotides”) (see [0253], which recites “the dispensed solution may comprise any sample or any analyte disclosed herein. The dispensed solution may comprise any reagent disclosed herein. …, the solution can comprise samples, …, probes, nucleotides, oligonucleotides, labels”) (see also [0162], which recites “The terms “nucleic acid,” “nucleic acid molecule,” “nucleic acid sequence,” “nucleic acid fragment,” “oligonucleotide” and “polynucleotide,” as used herein, generally refer to a polynucleotide that may have various lengths of bases”).
Claim 20 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Beckett (US20250091050) as evidenced by Fahy (“Self-sustained Sequence Replication (3SR): An Isothermal Transcriptionbased Amplification System Alternative to PCR”).
As to claim 20, Beckett teaches the method of claim 19, wherein the replicating enzyme replicates a target nucleic acid with the NTPs (see [0168], which recites “self-sustained sequence replication (3SR)”) by evidence of “Self-sustained Sequence Replication (3SR): An Isothermal Transcriptionbased Amplification System Alternative to PCR” the self-sustained sequence replication (3SR) reaction requires the external addition of specific replicating enzymes and nucleoside triphosphates (NTPs) to function. The term "self-sustained" refers to the continuous, isothermal nature of the reaction cycle in vitro.
Claim Rejections - 35 USC § 102(a)(1)
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 and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Almogy (US20200291469).
As to claim 1, Almogy teaches a system (system 400 in [0456]) comprising:
a rotating device (rotating stage in [0591]) configured to rotate about an axis (axis of rotation 305 of the substrate in [0642]) (see [0591], which recites “ the rotating stage may be configured to rotate”);
a substrate (substrate 310 in [0456]) disposed on the rotating device (rotating stage), wherein the substrate (substrate 310) comprises a well (plurality of wells in [0216], which recites “surface of the substrate comprises a plurality of wells”) configured to hold a liquid (the well of Almogy is capable of holding a liquid), wherein the substrate (substrate 310) is positioned on a surface of the rotating device ( the rotating stage) perpendicular to and concentric with the axis (see [0590], which recites “the first and second substrates may be affixed to a rotating stage 1220 d (such as approximately at opposing ends of the rotating stage”); and
a liquid handler (dispensing nozzle in [0082]) configured to dispense the liquid into the well (plurality of wells), wherein the rotating device (rotating stage) is configured to rotate at a speed sufficient to disperse the liquid within the well (plurality of wells) (see [0352], which recites “dispensing (to multiple locations and/or of multiple reagents to a single location) may be achieved via relative motion of the substrate and the dispenser (e.g., nozzle). For example, a reagent may be dispensed to the substrate at a first location, and thereafter travel to a second location different from the first location due to forces (e.g., centrifugal forces, centripetal forces”).
As to claim 2, Almogy teaches the system of claim 1, further comprising a retaining mechanism (vacuum chuck in [0396]), wherein the retaining mechanism (vacuum chuck in) is configured to apply a force on the substrate (substrate 310) to thereby retain it (the substrate 310) on the rotating device (rotating stag) (see [0396], which recites “the substrate may be affixed to a chuck (such as a vacuum chuck”).
As to claim 3 Almogy teaches the system of claim 1, wherein the retaining mechanism (vacuum chuck) is configured to apply a vacuum force to a surface of the substrate thereby securing the substrate to the rotating device (see [0396], which recites “the substrate may be affixed to a chuck (such as a vacuum chuck) a spin coating apparatus”).
As to claim 5 Almogy teaches the system of claim 1, wherein the retaining mechanism comprises a clip, a latch, a screw, or a clamp.
As to claim 6 Almogy teaches the system of claim 1, wherein the substrate comprises glass (see [0366]).
As to claim 7 Almogy teaches the system of claim 1, wherein the substrate has a thickness of about 1 µm to about 1 mm (see [0367], which recites “ The substrate may have a thickness (e.g., a minimum dimension) of at least 100 μm, at least 200 μm, at least 500 μm, at least 1 mm, at least 2 mm”)
As to claim 8 Almogy teaches the system of claim 1, wherein the liquid handler comprises a nozzle, a syringe, or a pipette (see [0352], which recites “dispensing (to multiple locations and/or of multiple reagents to a single location) may be achieved via relative motion of the substrate and the dispenser (e.g., nozzle).
As to claim 9 Almogy teaches the system of claim 1, wherein the liquid comprises a reagent (the liquid is a material worked upon and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935).
Claims 1-4 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dutt (US20130136858).
As to claim 1, Dutt (US20130136858) teaches a system comprising:
a rotating device (rotating platform 5 in [0005]) configured to rotate about an axis;
a substrate (substrate 102 in [0005]) disposed on the rotating device (rotating platform 5), wherein the substrate (substrate 7) comprises a well (top surface 118) in [0028]) configured to hold a liquid (see [0028], which recites “the containment pan 110 is positioned to surround the chuck 112 and configured to contain the excess adhesive 106 that is spun off during a spin coating procedure”), wherein the substrate (substrate 102) is positioned on a surface of the rotating device (rotating platform 5) perpendicular to and concentric with the axis (see Figs. 2-3); and
a liquid handler (nozzle 116 in [0028]) configured to dispense the liquid into the well (top surface 118) (see [0028], which recites “nozzle 116 is positioned above the chuck 112 and configured to dispense the adhesive onto a top surface 118 of the substrate 102), wherein the rotating device (rotating platform 5) is configured to rotate at a speed sufficient to disperse the liquid within the well (see [0029], which recites “the chuck 112 then spins to spread out the adhesive to evenly cover the top surface of the substrate 102”).
As to claim 2, Dutt teaches the system of claim 1, further comprising a retaining mechanism (chuck 112 in [0028] which recites “the chuck 112 is configured to receive and hold the substrate 102”), wherein the retaining mechanism (chuck 112) is configured to apply a force on the substrate (substrate 102) to thereby retain it on the rotating device (rotating platform 5).
As to claim 3, Dutt teaches the system of claim 1, wherein the retaining mechanism (chuck 112) is configured to apply a vacuum force to a surface of the substrate thereby securing the substrate to the rotating device (see [0004], which recites “a vacuum chuck”).
As to claim 4, Dutt teaches the system of claim 3, wherein the retaining mechanism (chuck 112) comprises an adhesive (see [0010], which recites “apparatus for applying adhesive).
As to claim 8, Dutt teaches the system of claim 1, wherein the liquid handler (nozzle 116) comprises a nozzle, a syringe, or a pipette (nozzle 116 in [0028]).
As to claim 9, Dutt teaches the system of claim 1, wherein the liquid comprises a reagent (the liquid is a material worked upon and the “material or article worked upon does not limit apparatus claims”, that is, the "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims" see MPEP 2115; see also In re Otto, 312 F.2d 937, 136 USPQ 458, 459 CCPA 1963; and In re Young, 75 F.2d 996, 25 USPQ 69 CCPA 1935). (adhesive liquids include reagents).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Beckett (US20250091050) in view of Andrevski (US20030203491).
As to claim 5, Beckett teaches the system of claim 1.
Beckett doesn’t explicitly teach that the retaining mechanism comprises a clip, a latch, a screw, or a clamp.
In the analogous art of providing biological sample preparation devices, Andrevski (US20030203491) teaches a retaining mechanism (connection element 1050 in [0130]) comprising a clip, a latch, a screw, or a clamp (see [0130], which recites “handle elements 1030 comprise connection element 1050 for removably connecting substrates 1060 onto hanger bracket 1000. Connection element 1050 may be in any form readily known in the art such as, for example, a clamp, a clip, a hook, an adhesive device, a pin, a screw or suction device”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Beckett by replacing the retaining mechanism of Beckett with the retaining mechanism disclosed by Andrevski with a reasonable expectation of success such that retaining mechanism comprises a clip, a latch, a screw, or a clamp for the benefit of removably connecting the substrate to the rotating device and because such modification is a simple substitution of elements and the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, B.).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Beckett (US20250091050) in view of Fan (US20160289669).
As to claim 10, Beckett teaches the system of claim 1, further comprising a lid (lid plate in [0273]) coupled to the substrate (see [0273], which recites “an open substrate system of the present disclosure may comprise a barrier system configured to maintain a fluid barrier between a sample processing environment and an exterior environment. …. A sample environment system may comprise a sample processing environment defined by a chamber and a lid plate”) , wherein the substrate form a flow cell (see [0195], which recites “devices, systems, and methods that use open substrates or open flow cell geometries to process a sample”).
Beckett doesn’t that that the lid and the substrate form an enclosed flow cell having an inlet and an outlet.
In the analogous art of providing biological sample preparation devices, Fan (US20160289669) teaches a lid (cover plate) and a substrate (microwell array substrate) form an enclosed flow cell (see [0303], which recites “the flow cell may comprise a three layer structure that includes the microwell array substrate, a fluid channel layer (fluidics layer), and a cover plate (i.e. a top or interface layer)”) having an inlet and an outlet (see [0048], which recites “having an inlet and an outlet”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Beckett by replacing the flow cell of Beckett with the flow cell disclosed by Fan with a reasonable expectation of success such that the lid and the substrate form an enclosed flow cell having an inlet and an outlet because such modification is a simple substitution of elements and the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, B.).
As to claim 16, Beckett teaches the method of claim 11, further comprising coupling a lid (lid plate in [0273]) to the substrate (see [0273], which recites “an open substrate system of the present disclosure may comprise a barrier system configured to maintain a fluid barrier between a sample processing environment and an exterior environment. …. A sample environment system may comprise a sample processing environment defined by a chamber and a lid plate”) to thereby form an enclosed flow cell having an inlet and an outlet.
Beckett doesn’t that that the lid and the substrate form an enclosed flow cell having an inlet and an outlet.
In the analogous art of providing biological sample preparation devices, Fan (US20160289669) teaches a lid (cover plate) and a substrate (microwell array substrate) form an enclosed flow cell (see [0303], which recites “the flow cell may comprise a three layer structure that includes the microwell array substrate, a fluid channel layer (fluidics layer), and a cover plate (i.e. a top or interface layer)”) having an inlet and an outlet (see [0048], which recites “having an inlet and an outlet”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Beckett by replacing the flow cell of Beckett with the flow cell disclosed by Fan with a reasonable expectation of success such that the lid and the substrate form an enclosed flow cell having an inlet and an outlet because such modification is a simple substitution of elements and the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see MPEP § 2143, B.).
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797