Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 26-45 are pending with claim 26-45 being examined. Claims 1-25 are canceled.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Appropriate correction is required.
Claim Objections
Claim 45 is objected to because of the following informalities:
In line 2, “comprising a mupA gene” should read --comprises a mupA gene--.
Appropriate correction is required.
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 26-45 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
As to line 15 of claim 26, the “first assay workflow” is unclear what Applicant refers to as there are no embodiments or steps that define what the first assay workflow is.
As to line 22 of claim 26, the “second test” lacks antecedent basis.
As to line 24 of claim 26, the “second assay workflow” is unclear what Applicant refers to as there are no embodiments or steps that define what the second assay workflow is.
As to line 26 of claim 26, the “second test” lacks antecedent basis.
Claims 26-45 are rejected based on dependency on a rejected base claim.
As to line 2 of claim 28, the “second test” lacks antecedent basis.
As to line 2 of claim 29, the “second test” lacks antecedent basis.
As to line 2 of claim 30, the “second test” lacks antecedent basis.
As to line 2 of claim 43, the “second test” lacks antecedent basis.
As to line 3 of claim 44, the “second test” lacks antecedent basis.
Appropriate action is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 26-46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The instant rejection reflects the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”).
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea (Prong One); If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With regard to (1), the instant claims recite a “system comprising an automated instrument comprising a processor and an information storage capacity storing instructions for performing automated assays, wherein the instructions when executed by the processor cause the system to scan indicia on the vessels, store the indicia on the vessels, automatically transfer a first portion of each sample to a first vessel, automatically perform a first test, automatically transfer a second portion of each of a subset of samples to a second vessel and automatically perform a second test, and therefore the answer is "yes".
With regard to (2A), Prong One, under the broadest reasonable interpretation (BRI), the instant claims recite claim steps directed to the judicial exception that is an abstract idea of the type that is in the grouping of “mental process” or “mathematical concepts” (See MPEP 2106.04(a)(2) subsections (I) and (III)) because said operations are a mathematical concept rooted in formal logic, computation theory and information representation. Mental operations and mathematical concepts in the instant claims are recited as: “an information storage capacity storing instructions for performing automated assays, wherein the instructions when executed by the processor cause the system to scan indicia on the vessels, store the indicia on the vessels, automatically transfer a first portion of each sample to a first vessel, automatically perform a first test, automatically transfer a second portion of each of a subset of samples to a second vessel and automatically perform a second test”.
In summary, the claim recites “a system comprising an automated instrument comprising a processor and an information storage capacity storing instructions for performing automated assays, wherein the instructions when executed by the processor cause the system to scan indicia on the vessels, store the indicia on the vessels, automatically transfer a first portion of each sample to a first vessel, automatically perform a first test, automatically transfer a second portion of each of a subset of samples to a second vessel and automatically perform a second test that can be performed using a computer which uses mathematical algorithms/formulas as a form of an abstract idea.
Said recited judicial exception steps are directed storing instructions for performing automated assays, wherein the instructions when executed by the processor cause the system to scan indicia on the vessels, store the indicia on the vessels, automatically transfer a first portion of each sample to a first vessel, automatically perform a first test, automatically transfer a second portion of each of a subset of samples to a second vessel and automatically perform a second test, which under the BRI, cover performance of the limitations as mathematical concepts, as said steps under said interpretation would involve the use of a computer which uses mathematical algorithms/formulas as a form of mathematical correlation. Thus, if a claim, under its BRI, covers performance of the limitation by using generic computer elements, then it falls within the “mathematical concept” grouping of abstract ideas (see MPEP 2106.04(a)(2)(III)(C)).
Because the claim is directed to abstract ideas, it must further be analyzed under Prong Two to determine if said judicial exceptions are integrated into a practical application as determined by further assessment of the “additional steps” recited in the claims. With respect to Prong Two, the additional elements and the rationale pertaining to why the additional elements are not integrated, are as follows:
(a) The claims recite mathematical process (judicial exception) which are not integrated into a practical application because the system describes “an information storage capacity storing instructions for performing automated assays”. In summary, the claim(s) recite(s) a system comprising a processor, an information storage capacity storing instructions for performing automated assays, wherein the instructions when executed by the processor cause the system to scan indicia on the vessels, store the indicia on the vessels, automatically transfer a first portion of each sample to a first vessel, automatically perform a first test, automatically transfer a second portion of each of a subset of samples to a second vessel and automatically perform a second test, a mathematical process, but the system does not describe a resultant action/step that is taken by applying the information stored since the information stored is mere instructions to apply an exception on a computer, and therefore the system does not add a meaningful limitation to the abstract idea;
(b) Although the claims recite a system comprising an automated instrument comprising a processor, an information storage capacity storing instructions for performing automated assays, wherein the instructions when executed by the processor cause the system to scan indicia on the vessels, store the indicia on the vessels, automatically transfer a first portion of each sample to a first vessel, automatically perform a first test, automatically transfer a second portion of each of a subset of samples to a second vessel and automatically perform a second test, the claims do not apply the exception, as the claim does not transform the system to a different state or thing beyond its ordinary purpose (See MPEP 2106.05(f) and MPEP 2106.05(c));
(c) An information storage capacity (or memory) stoting instructions for performing automated assays is recited at a high level of generality (as a generic and well-known structure) such that it is no more than mere instructions to apply the exception using a generic computer/diagnostic system (see MPEP 2106.04(a)(2)(III)(C) and MPEP 2106.05(d));
(d) The claims include storing information in the information storage capacity, which is recited at a high level of generality (i.e., generic computer and processor performing generic computer functions) such that the recitations amount to no more than instructions to apply the judicial exceptions on said generic computer (See MPEP 2106.05(f)).
As such, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
Because the claims fail under (2A), the claims are further evaluated under (2B). The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception under (2B) because, as discussed above with regard to integration of the recited abstract idea into a practical application, the additional elements herein amount to no more than a system that includes generic computer elements (processor, memory), which do not provide an inventive concept as a generic diagnostic system with a computer is well-understood, routine and conventional. Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (1) the processor and the information storage capacity are being used in their ordinary capacity and are merely tools to execute the abstract idea (See MPEP 2106.05(d)), (2) the additional claim elements of storing instructions for performing automated assays, whether considered individually or as a whole, do not meaningfully limit the judicial exception (See MPEP 2106.05(e)), (3) the claims recite insignificant extra-solution activity because the activity of using a processor and an information storage capacity is not inventive since all automated instruments have a memory that are used to control the system (See MPEP 2106.05(g)).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the features represent an abstract idea. Dependent claims 27-45 amount to no more executing the instructions stored in the information storage capacity, which is an intangible abstract idea or mathematical concept, and similarly does not integrate the exception into a practical application or include additional elements that amount to significantly more. The instant claims do not include an inventive concept.
Thus, in light of the above considerations the claims remain non-statutory, and are thus not patent eligible under 35 U.S.C. 101.
Step 1: Claims 26-45 are directed towards a system.
Step 2A, Prong One: Claim 26 recites the abstract idea, “storing instructions for performing automated assays…”, scan indicia on vessels…,” “store indicia on the vessels…”, “transfer a first portion of each sample…”, “perform a first test…”, “transfer a second portion…”, “perform the second test…”. Abstract human reasoning or a generic computer is required to store the instructions and perform the operations.
Claim 32 recites the abstract idea, “instructions that when executed by the processor, cause the system to scan indicia…”. Abstract human reasoning or a generic computer is required to store analyte information.
Step 2A, Prong Two: These judicial exceptions are not integrated into a practical application because upon evaluating the system comprising an automated instrument comprising a processor and an information storage capacity storing instructions to perform automated assays, nothing further is performed with the abstract evaluation.
Step 2B: Claim 26 recites the elements “storing instructions for performing automated assays…”, “the instructions, when executed by the processor cause the system to scan…”, “store, transfer vessels and perform tests…”.
Claim 32 recites “instructions that, when executed by the processor, cause the system to scan…”.
These elements are interpreted as extra-solution activity which are incidental to the primary process and are mere storing information for performing automated assays and performing operations, which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity).
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.
Claims 26, 32 and 43-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16, 18, 21 and 23-25 of U.S. Patent No.10,782,309 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding instant claim 26, claim 16 of patent 10,782,309 B2 is drawn to a system comprising: an automated instrument comprising a code reader and a dock configured to receive a test strip carrier including a plurality of samples to be tested for target analytes; a processor; and an information storage capacity storing instructions for performing an automated assay, wherein the instructions, when executed by the processor, cause the system to: automatically transfer, via the automated instrument, a first portion of each sample of the plurality of samples to a respective plurality of first vessels comprising first reagents for a first test for a first target analyte; adjust the automated instrument to automatically perform the first test on the first portion of the plurality of samples according to a first assay workflow, the first test providing a result indicating a presence of the first target analyte in a subset of samples from the plurality of samples; select, via the automated instrument, the subset of samples from the plurality of samples; store, in memory included in the automated instrument, assay-specific data for each of the subset of samples; scan, via a code reader included in the automated instrument, indicia on test strips associated with the subset of samples; assign the stored assay-specific data to a respective position in the test strip carrier of each of the test strips associated with the subset of samples based at least in part on the scanned indicia; automatically transfer, via the automated instrument, a second portion of each of the subset of samples to a respective plurality of second vessels comprising second reagents for a second test for a second target analyte, wherein the first target analyte is different than the second target analyte; and automatically perform, via the automated instrument, the second test on the second portion of each of the subset of samples according to a second assay workflow, the second test providing a result indicating, for an individual sample included in the subset of samples, a presence of the second target analyte in the individual sample.
Regarding instant claim 32, claim 18 of patent 10,782,309 B2 recites: the system of claim 17, wherein the information storage capacity further comprises instructions that, when executed by the processor, cause the system to scan indicia on the second test strip associated with each of the subset of samples.
Regarding instant claim 32, claim 21 of patent 10,782,309 B2 recites: the system of claim 20, wherein the information storage capacity further comprises instructions that, when executed by the processor, cause the system to scan indicia on the single test strip associated with each of the subset of samples.
Regarding instant claim 43, claim 23 of patent 10,782,309 B2 recites: the system of claim 16, wherein the first test or the second test comprises a reaction selected from the group consisting of Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Ligation Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Strand Displacement Amplification (SDA), and a hybridization reaction.
Regarding instant claim 44, claim 24 of patent 10,782,309 B2 recites: the system of claim 16, wherein the first test comprises a test for simultaneous detection of methicillin resistant Staphylococcus aureus and Staphylococcus aureus, and wherein the second test comprises a test for the detection of a determinant for mupirocin resistance.
Regarding instant claim 45, claim 25 of patent 10,782,309 B2 recites: the system of claim 24, wherein the determinant for mupirocin resistance comprising a mupA gene.
Therefore the subject matter of instant claims 26, 32 and 43-45 is not distinct from claims 16, 18, 21 and 23-25 of patent 10,782,309.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 26-27, 31-32, 38 and 40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Miller et al. (US 20110158865 A1; hereinafter “Miller”).
Regarding claim 26, Miller teaches a system (Miller; Title) comprising:
an automated instrument (Miller; Abstract “automated processing apparatus”) comprising a code reader (Miller; [0037] “a reader”), the automated instrument configured to receive a plurality of samples (Miller; fig. 5. 500, 504, 506 and [030])to be tested for target analytes (Miller; [0019]);
a processor (Miller; [0022] [0053], [0070]); and
an information storage capacity storing instructions for performing automated assays (Miller; [0091] “store information to later be used”), wherein the instructions, when executed by the processor, cause the system to:
scan, via a code reader included in the automated instrument, indicia on vessels that contain the plurality of samples (Miller; [0035], [0040]);
store, via the automated instrument, indicia on the vessels that contain the plurality of samples (Miller; [0070], [0096] “reagents may be barcoded to provide a history”);
automatically transfer, via the automated instrument, a first portion of each sample of the plurality of samples to a respective first vessel (Miller; [0070]) ; automatically perform, via the automated instrument, a first test for a first target analyte on a first solution comprising the first portions of the plurality of samples and first reagents according to a first assay workflow (Miller; [0073], [0092] “first assay may be chemiluminescence”), the first test providing a result indicating a presence of the first target analyte in a subset of samples from the plurality of samples (Miller; [0092] “multiple high risk genotypes”);
automatically transfer, via the automated instrument, a second portion of each of the subset of samples to a second vessel (Miller; [0093]) the second portion of each of the subset is implicit since, “sufficient volume may remain in each sample container to allow subsequent testing”), wherein, for the subset of samples, the respective first vessel and the respective second vessel are located on a single test strip (Miller; fig. 6. 600, 604, and [0038] “designated wells 604 may hold reagents and patient samples” [0093] “specimen samples are in a multi-well plate”); and
automatically perform, via the automated instrument, the second test (Miller; [0093] “reflex assay”) for a second target analyte on a second solution comprising the second portion of each of the subset of samples and second reagents according to the second assay workflow (Miller; [0092] “may determine the presence of a genotype”), wherein the first target analyte is different than the second target analyte, the second test providing a result indicating, for an individual sample included in the subset of samples, a presence of the second target analyte in the individual sample (Miller; [0070] “multiple different assays may be processed simultaneously) .
Regarding claim 27, Miller teaches the system of claim 26 (see above), wherein the single test strip comprises four receptacles (Miller; fig. 6, 600, 604 illustrates at least four receptacles), one receptacle configured to receive the first vessel and another receptacle configured to receive the second vessel (Miller; [0038] “designated wells 604 may hold reagents and patient samples”). Examiner notes that test strip 600 can receive more than one vessel.
Regarding claim 31, Miller teaches the system of claim 26 (see above), wherein the single test strip comprises identifying indicia (Miller; [0096] “the sample rack may also include barcode information”).
Regarding claim 32, Miller teaches the system of claim 26 (see above), wherein the information storage capacity further comprises instructions that, when executed by the processor, cause the system to scan indicia on the single test strip (Miller; [0024]).
Regarding claim 38, Miller teaches the system of claim 26 (see above), wherein the single test strip comprises extraction solutions, where bead-based nucleic acid extraction is performed using the extraction solutions (Miller; [0047]).
Regarding claim 40, Miller teaches the system of claim 26 (see above), further comprising a touch screen associated with a display (Miller; [0024).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 28-30, 34-35 and 41-42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller et al. (US 20110158865 A1; hereinafter “Miller”).
Regarding claim 28, Miller teaches the system of claim 26 (see above), wherein the single test strip is configured to be moved from a first test strip holder to a second test strip holder prior to performing the second test.
Miller teaches the single test strip to claim 26 (see above). This claim merely recites an intended use of the claimed invention. The test strip of Miller can be moved from a first test strip holder to a second test strip holder prior to performing the second test. Miller teaches rack 600 may be inserted and removed (Miller; [0039]), thus, Miller meets the limitations of the claim. See MPEP 2114.
Regarding claim 29, Miller teaches the system of claim 26 (see above), further comprising pipette tips (Miller; [0041]), wherein the pipette tips are configured to be replaced prior to conducting the second test.
It would have been obvious to replace the pipette tips prior to conducting the second test in order to prevent cross contamination.
Regarding claim 30, Miller teaches the system of claim 26 (see above), further comprising a fixed volume buffer configured to be added to a residual sample to ensure that there is sufficient volume to perform the second test.
This limitation recited an intended use of the claimed invention since the limitation does not further structurally limit the invention as claimed. Miller further teaches the system contains buffers (Miller [0051]). Thus, it is fully expected that the buffers of Miller can be used with the claimed system. Therefore, Miller meets the limitations of the claim (see MPEP 2114).
Regarding claim 34, Miller teaches the system of claim 26 (see above), wherein the single test strip is configured to receive an extraction tube.
This limitation recited an intended use of the claimed invention since the limitation does not further structurally limit the invention as claimed. Miller further teaches a test strip (Miller; fig. 6. 600, 604) and test tubes (see above); thus, it is fully expected that the test strip that includes test tubes of modified Miller can be used to receive an extraction tube. Therefore, Miller meets the structural limitations of the claim (see MPEP 2114).
Regarding claim 35, Miller teaches the system of claim 26 (see above), wherein the single test strip comprises a plurality of reservoirs configured to hold extraction solutions.
Miller teaches a test strip that includes a plurality of reservoirs (see above), and what the test strip is used for is a matter of intended use.
Examiner will interpret wells 604 as a plurality of reservoirs until further clarification is provided by Applicant as to what elements are being referred to as the “plurality of reservoirs”.
Regarding claim 41, Miller teaches the system of claim 26 (see above), wherein twelve test strips are configured to be placed in a test strip holder (Miller; fig. 5. 500, [0030] [0071], [0104]).
Miller teaches the sample bay (strip holder) may receive samples in a container placed on rack 500 (Miller; [0030], [0071]) where twelve assays (test strips are used to run the assays) can be run simultaneously).
Regarding claim 42, Miller teaches the system of claim 26 (see above), wherein twelve samples are configured to be processed (Miller; [0104]) “where twelve assays (test strips are used to run the assays) can be run simultaneously”), to obtain respective samples of solution comprising isolated nucleic acids (Miller, [0071] “samples have been processed to provide purified nucleic acid”).
Claims 33, 36-37, 39 and 43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller et al. (US 20110158865 A1; hereinafter “Miller”) in view of Williams et al (US 20090130745 A1; hereinafter “Williams”).
Regarding claim 33, Miller teaches the system of claim 26 (see above), to include a test tube (see above).
Miller fails to teach the test tube is used for cell lysis.
However, Williams teaches the analogous art of a test strip (Williams; [0149]) that includes test tubes (Williams; fig. 10A. 520) wherein the test tube is used for cell lysis (Williams; [0167] “cell lysis can occur in tubes 520”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Miller’s test strip to include a cell lysis tube as taught by Williams because Williams teaches a test strip (Williams; [0149]) that includes test tubes (Williams; fig. 10A. 520) wherein the test tube is used for cell lysis (Williams; [0167] “cell lysis can occur in tubes 520”).
The modification allows to have a separate tube designated for cell lysis to prevent contaminating the samples.
Regarding claim 36, Miller teaches the system of claim 26 (see above), to include a single test strip (see above).
Miller fails to teach the single test strip comprises a waste chamber configured to hold waste liquid.
However, Williams teaches the analogous art of a test strip (Williams; [0149]) that includes a waste chamber (Williams; fig. 10A. 560).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Miller’s test strip to include a waste chamber as taught by Williams because Williams teaches a test strip (Williams; [0149]) that includes a waste chamber (Williams; fig. 10A. 560).
The modification allows to collect unwanted fluid to prevent contamination of the sample area.
Regarding claim 37, Miller teaches the system of claim 26 (see above), to include a single test strip (see above).
Miller fails to teach the single test strip comprises sheaths configured to hold pipette tips.
However, Williams teaches the analogous art of a test strip (Williams; [0149]) that includes pipette tip sheaths configured to hold pipette tips (Williams; [0012]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Miller’s test strip to include sheaths configured to hold pipette tips as taught by Williams because Williams teaches a test strip (Williams; [0149]) that includes pipette tip sheaths configured to hold pipette tips (Williams; [0012]).
The modification allows to hold the pipette tips in place.
Regarding claim 39, Miller teaches the system of claim 26 (see above), to include a first test (see above).
Miller fails to teach the first test is performed on a reaction cartridge.
However, Williams teaches the analogous art of a test strip (Williams; [0149]) that includes performing a first test on a cartridge (Williams; [0008] “amplifying nucleic acids in a cartridge” (first test)).
It is well known in the art that nucleic acid amplification is performed in a cartridge.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Miller’s first test to be performed in a cartridge as taught by Williams because Williams teaches a test strip (Williams; [0149]) that includes performing a first test on a cartridge (Williams; [0008] “amplifying nucleic acids in a cartridge” (first test).
The modification allows to detect multiple targets in one run which is useful for identifying different pathogen strains.
Regarding claim 43, Miller teaches the system of claim 26 (see above), to include a first and second test (see above).
Miller fails to teach the first test or the second test comprises a reaction selected from the group consisting of Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Ligation Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Strand Displacement Amplification (SDA), and a hybridization reaction.
However, Williams teaches the analogous art of a test strip (Williams; [0149]) that includes processing of clinical samples (sample testing) wherein the processing includes a reaction selected from the group consisting of Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Ligation Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Strand Displacement Amplification (SDA), and a hybridization reaction (Williams; [0638]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Miller’s tests to include a reaction selected from the group consisting of Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Ligation Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Strand Displacement Amplification (SDA), and a hybridization reaction as taught by Williams because Williams teaches a test strip (Williams; [0149]) that includes processing of clinical samples (sample testing) wherein the processing includes a reaction selected from the group consisting of Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Ligation Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Strand Displacement Amplification (SDA), and a hybridization reaction (Williams; [0638]).
The modification allows to amplify the nucleic acids in the sample.
Claim 44 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller et al. (US 20110158865 A1; hereinafter “Miller”) in view of Williams et al (US 20090130745 A1; hereinafter “Williams”), further in view of O’Hara (US 20110111399 A1; hereinafter ‘O’Hara”).
Regarding claim 44, Miller teaches the system of claim 26 (see above), to include a first and second test (see above).
Miller fails to teach wherein the first test comprises a test for simultaneous detection of methicillin resistant Staphylococcus aureus and Staphylococcus aureus.
However, Williams teaches the analogous art of a test strip (Williams; [0149]) that includes diagnostic testing on multiple biological samples (Williams; Title), the diagnostic testing includes at least one probe that can be configured to allow optical detection, the probe can be selective for a polynucleotide sequence that is characteristic of an organism (Williams; [0362]-[0363]) such as methicillin resistant Staphylococcus aureus and Staphylococcus aureus (Williams; [0364]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Miller’s tests wherein the first test comprises a test for simultaneous detection of methicillin resistant Staphylococcus aureus and Staphylococcus aureus as taught by Williams because Williams teaches a test strip (Williams; [0149]) that includes diagnostic testing on multiple biological samples (Williams; Title), the diagnostic testing includes at least one probe that can be configured to allow optical detection, the probe can be selective for a polynucleotide sequence that is characteristic of an organism (Williams; [0362]-[0363]) such as methicillin resistant Staphylococcus aureus and Staphylococcus aureus (Williams; [0364]).
Miller fails to teach wherein the second test comprises a test for the detection of a determinant for mupirocin resistance.
However, O’Hara teaches the analogous art of diagnostic kits for the detection of Stapylococcus aureus (O’Hara; Title) that includes a first test (O’Hara; [0032] “DNA amplification to identify SA and MRSA”) and second test for the detection of a determinant for mupirocin resistance (O’Hara; [0032] “immunomagnetic detection of mupirocin resistance”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Miller’s tests wherein the second test comprises a test for the detection of a determinant for mupirocin resistance as taught by O’Hara because O’Hara teaches diagnostic kits for the detection of Stapylococcus aureus (O’Hara; Title) that includes a first test (O’Hara; [0032] “DNA amplification to identify SA and MRSA”) and second test for the detection of a determinant for mupirocin resistance (O’Hara; [0032] “immunomagnetic detection of mupirocin resistance”).
The modification allows the simultaneous detection of methicillin resistant Staphylococcus aureus and Staphylococcus aureus and determine the minimum inhibitory concentration of mupirocin.
Claim 45 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller et al. (US 20110158865 A1; hereinafter “Miller”) in view of Williams et al (US 20090130745 A1; hereinafter “Williams”), further in view of O’Hara (US 20110111399 A1; hereinafter ‘O’Hara”) and Fiandaca et al. (US 20080124736 A1; hereinafter “Fiandaca”).
Regarding claim 45, Miller teaches the system of claim 44 (see above), to include detection of a determinant for mupirocin resistance (see above).
Miller fails to teach wherein the determinant for mupirocin resistance comprises a mupA gene.
However, Fiandaca teaches the analogous art of detection of virulence markers of Staphylococci (Fiandaca; Title) wherein the determinant for mupirocin resistance comprises a mupA gene (Fiandaca; [0026] and table 3 “ilS2-2 gene”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Miller’s detection of a determinant for mupirocin resistance comprises a mupA gene as taught by Fiandaca because Fiandaca teaches detection of virulence markers of Staphylococci (Fiandaca; Title) wherein the determinant for mupirocin resistance comprises a mupA gene (Fiandaca; [0026] and table 3 ‘ilS2-2 gene”).
The modification of determining mupA gene in Staphylococcus aureus allows for proper treatment since mupA is the primary determinant in high-level mupirocin resistance in Staphylococcus aureus.
Conclusion
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/A.R./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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