Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on 05/05/2026 is acknowledged. Claim 20 is canceled, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/12/2023, 05/05/2026 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 1-19 and 21 are pending with claims 1-19 and 21 being examined. Claim 20 is canceled.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 1, “preparing a sample of bacteria” should read –preparing an output sample of bacteria-- to be in accord with the description.
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 1-19 and 21are 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 1 of claim 1, the “method of preparing a sample of bacteria” is unclear what Applicant refers to as the bacteria is already in the aliquot. Applicant is encouraged to clarify the method is for preparing a an output sample or bacteria inoculum of a desired concentration.
Claims 2-19 and 21 are rejected based on dependency on a rejected base claim.
Appropriate correction 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.
Claims 1-19 and 21 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 an “a method of preparing a sample of bacteria of a desired or target concentration or within acceptable error margins of the desired or target concentration comprising monitoring a change in oxidation reduction potential (ORP) using a reader electrically coupled to the reference sensor and the active sensor, retrieving a species-agnostic look-up table (LUT) from a database, selecting a species-agnostic ORP change amount as a threshold ORP change amount, determining the concentration of the bacteria in the contained sample has reached a desired or target concentration when the change in ORP of the contained sample monitored by the reader reaches the threshold ORP change amount, wherein the strain specific LUT is generated by monitoring a change in the ORP, periodically conducting optical density measurements, converting the results to reference sample bacterial concentrations, associating the reference sample bacterial concentrations with the change in ORP, calculating a time-to-target, wherein the ORP of the contained sample is determined by the reader based on a potential difference measured between the active electrode material and the reference electrode material”, 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 could be performed in the mind. Mental operations and mathematical concepts in the instant claims are recited as: “monitoring a change in oxidation reduction potential (ORP) using a reader electrically coupled to the reference sensor and the active sensor, retrieving a species-agnostic look-up table (LUT) from a database, selecting a species-agnostic ORP change amount as a threshold ORP change amount, determining the concentration of the bacteria in the contained sample has reached a desired or target concentration when the change in ORP of the contained sample monitored by the reader reaches the threshold ORP change amount, wherein the strain specific LUT is generated by monitoring a change in the ORP, periodically conducting optical density measurements, converting the results to reference sample bacterial concentrations, associating the reference sample bacterial concentrations with the change in ORP, calculating a time-to-target, wherein the ORP of the contained sample is determined by the reader based on a potential difference measured between the active electrode material and the reference electrode material”.
In summary, the claim(s) recite(s) a method of preparing a sample of bacteria of a desired or target concentration or within acceptable error margins of the desired or target concentration comprising monitoring a change in oxidation reduction potential (ORP) using a reader electrically coupled to the reference sensor and the active sensor, retrieving a species-agnostic look-up table (LUT) from a database, selecting a species-agnostic ORP change amount as a threshold ORP change amount, determining the concentration of the bacteria in the contained sample has reached a desired or target concentration when the change in ORP of the contained sample monitored by the reader reaches the threshold ORP change amount, wherein the strain specific LUT is generated by monitoring a change in the ORP, periodically conducting optical density measurements, converting the results to reference sample bacterial concentrations, associating the reference sample bacterial concentrations with the change in ORP, calculating a time-to-target, wherein the ORP of the contained sample is determined by the reader based on a potential difference measured between the active electrode material and the reference electrode material, which are steps that can be performed using a computer which uses mathematical algorithms/formulas, or determining the threshold concentrations in the mind by comparing the LUTs from a database as a form of an abstract idea.
Said recited judicial exception steps are directed to retrieving and comparing information in the look-up tables, determining concentration based on information from the reader, converting the optical density measurements into sample concentrations , and calculating a time-to-target, which under the BRI, cover performance of the limitations in the mind and mathematical concepts, as said steps under said interpretation would involve a making a mental comparison and mental correlation or mathematical correlation. Thus, if a claim, under its BRI, covers performance of the limitation in the mind, but for the recitation of generic computer elements, then it falls within the “mental processes” grouping of abstract ideas (see MPEP 2106.04(a)(2)(III)(C)).
Because the claims are directed to abstract ideas, they 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 method describes “monitoring a change in oxidation reduction potential (ORP) using a reader electrically coupled to the reference sensor and the active sensor, retrieving a species-agnostic look-up table (LUT) from a database, selecting a species-agnostic ORP change amount as a threshold ORP change amount, determining the concentration of the bacteria in the contained sample has reached a desired or target concentration when the change in ORP of the contained sample monitored by the reader reaches the threshold ORP change amount, wherein the strain specific LUT is generated by monitoring a change in the ORP, periodically conducting optical density measurements, converting the results to reference sample bacterial concentrations, associating the reference sample bacterial concentrations with the change in ORP, calculating a time-to-target, wherein the ORP of the contained sample is determined by the reader based on a potential difference measured between the active electrode material and the reference electrode material, which are steps that can be performed using a computer which uses mathematical algorithms/formulas” In summary, the claim(s) recite(s) “monitoring a change in oxidation reduction potential (ORP) using a reader electrically coupled to the reference sensor and the active sensor, retrieving a species-agnostic look-up table (LUT) from a database, selecting a species-agnostic ORP change amount as a threshold ORP change amount, determining the concentration of the bacteria in the contained sample has reached a desired or target concentration when the change in ORP of the contained sample monitored by the reader reaches the threshold ORP change amount, wherein the strain specific LUT is generated by monitoring a change in the ORP, periodically conducting optical density measurements, converting the results to reference sample bacterial concentrations, associating the reference sample bacterial concentrations with the change in ORP, calculating a time-to-target, wherein the ORP of the contained sample is determined by the reader based on a potential difference measured between the active electrode material and the reference electrode material”, a mathematical process, but the method does not describe a resultant action/step that is taken by applying the ORP change amounts from the specific-agnostic look-up-table LUTs, determining the concentration of the bacteria in the contained sample, and therefore the method does not add a meaningful limitation to the abstract idea;
(b) Although the claims recite monitoring a change in oxidation reduction potential using a reader coupled to the active sensor and the reference sensor, the claims do not apply the exception, as the claim does not transform the reader or the active and reference sensors state or thing beyond its ordinary purpose (See MPEP 2106.05(f) and MPEP 2106.05(c));
(c) A reader is recited at a high level of generality (as a generic and well-known structure) such that it is no more than an instrument with 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 monitoring ORP of a reference sample, converting optical density measurement and associating the reference sample change in ORP, 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 reader that includes generic computer elements (memory sensors), 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 memory and the reader 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 determining and linking (compare results against a data table) information, 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 reader coupled to reference and active sensors that read, link/store information is not inventive since all measurement readers that include databases have memory that are used to save and retrieve data (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 2-19 and 21 amount to no more than monitoring a change on (ORP) using a reader, retrieving data from a database, determining information, and linking information, 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 1-19 and 21 are directed towards a method of preparing a sample of bacteria, monitoring a change in (ORP) using a reader , selecting a threshold (ORP) and determining a bacterial concentration based on the (ORP) threshold.
Step 2A, Prong One: Claim 1 recites the abstract idea, “monitoring a change in oxidation reduction potential…”. Abstract human reasoning or a generic computer is required to “monitor a change in oxidation reduction potential.
Claim 2 recites the abstract idea, “retrieving a species-agnostic look-up-table from a database…”. Abstract human reasoning or a generic computer is required to retrieve a species-agnostic look-up-table from a database.
Claim 3 recites the abstract idea “, “selecting one of the species-agnostic ORP change amounts as a threshold ORP…”, “determining that the concentration of the bacteria…”. Abstract human reasoning or a generic computer is required to select one of the species-agnostic ORP change amounts as a threshold ORP and determine the concentration of the bacteria.
Claim 4 recites the abstract idea “the first LUT, the second LUT and the third LUT are generated using ORP measurements…”. Abstract human reasoning or a generic computer is required to generate the first LUT, the second LUT and the third LUT using ORP measurements.
Claim 5 recites the abstract idea “the strain-specific LUTS are generated by monitoring…, conducting optical density measurements…, converting results…, associating the reference sample bacterial concentrations…”. Abstract human reasoning or a generic computer is required to generate strain-specific LUTS by monitoring, conduct optical density measurements…, convert results…, associate the reference sample bacterial concentrations.
Claim 6 recites the abstract idea “calculating a time-to-target concentration…”, “determining that the concentration…”. Abstract human reasoning or a generic computer is required to calculate a time-to-target concentration and determine that the concentration.
Claim 7 recites the abstract idea “calculating a time-to-target concentration…”, “determining that the concentration…”. Abstract human reasoning or a generic computer is required to calculate a time-to-target concentration and determine that the concentration.
Claim 8 recites the abstract idea “ORP of the contained sample is determined by the reader…”. Abstract human reasoning or a generic computer is required to determine the ORP contained in the sample.
Claim 13 recites the abstract idea “the desired target concentration is…”. Abstract human reasoning or a generic computer is required to calculate the desired concentration.
Step 2A, Prong Two: These judicial exceptions are not integrated into a practical application because upon evaluating the method of preparing a sample of bacteria comprising monitoring an (ORP) change using a reader coupled to a reference and active sensor, nothing further is performed with the abstract evaluation.
Step 2B: Claim 1 recites the elements “monitor a change in oxidation reduction potential of the contained sample using a reader…”.
Claim 2 recites the element “retrieving a specific-agnostic look-up table (LUT)…”.
Claim 3 recites “selecting one of the species-agnostic ORP change amounts as a threshold ORP change…”, “determining that the concentration of the bacteria…”.
Claim 4 recites “the species-agnostic LUT is generated…”
Claim 5 recites “monitoring a change …”, “periodically conducting (OD) measurements…”, “converting results…”, “associating the reference…”.
Claim 6 recites “calculating a time to target…”, “determining the concentration…”.
Claim 7 recites “calculating a time to target…”, “determining the concentration…”.
Claim 8 recites “ORP of the contained sample is determined by the reader…”.
Claim 13 recites “the desired target concentration is…”.
These elements are interpreted as extra-solution activity which are incidental to the primary process and are mere data gathering 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 1-2, 4-5, 12, 14 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 10, 12 and 19 of U.S. Patent No.12,422,343 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 1, claim 1 of US patent 12,422,309 B2 is drawn to
A method of preparing an output sample of a bacteria of a defined concentration, comprising:
identifying a species of the bacteria within a source sample;
diluting an aliquot of the source sample comprising the bacteria by a dilution factor to yield a diluted sample, wherein the aliquot is diluted using a dilutive solution; selecting a look-up table based on the species of the bacteria; wherein the look-up table contains concentration data; selecting a first threshold amount and a second threshold amount from the look-up table, wherein the first threshold amount and the second threshold amount are target amounts by which an oxidation-reduction potential (ORP) of the diluted sample is required to change in order for the concentration of the bacteria in the diluted sample to reach the defined concentration, wherein the defined concentration is between 5×105 colony-forming units (CFU)/mL to 3×108 CFU/mL, wherein the first threshold amount and the second threshold amount comprise different values; exposing one or more ORP sensors to the diluted sample, wherein each of the one or more ORP sensors comprises an active electrode and a reference electrode, wherein at least a redox-active layer of the active electrode of each of the one or more ORP sensors is in fluid communication with the diluted sample when exposed to the diluted sample; incubating the diluted sample at an incubation temperature, wherein the diluted sample is incubated when the one or more ORP sensors are exposed to the diluted sample; incubating the diluted sample at an incubation temperature, wherein the diluted sample is incubated when the one or more ORP sensors are exposed to the diluted sample; measuring, using a parameter analyzer coupled to the one or more ORP sensors, a change in an ORP of the diluted and incubated sample, wherein the change in the ORP is measured between the redox-active layer of the active electrode and the reference electrode; obtaining, using the parameter analyzer or a computing device communicatively coupled to the parameter analyzer, a first threshold time corresponding to an amount of time elapsed for the ORP of the diluted and incubated sample to change by the first threshold amount and obtaining a second threshold time corresponding to the amount of time elapsed for the ORP of the diluted and incubated sample to change by the second threshold amount, wherein the first threshold amount and the second threshold amount represent changes in the ORP of the diluted and incubated sample; determining, using the parameter analyzer or a computing device communicatively coupled to the parameter analyzer, a sample preparation time corresponding to the amount of time necessary for the bacteria within the diluted and incubated sample to reach the defined concentration based on the first threshold time, the second threshold time, concentration data from the look-up table, and the defined concentration; and cooling the diluted and incubated sample to a cooling temperature between about 4° C. and about 25° C. when the sample preparation time is reached.
Regarding instant claim 2, claim 2 of US patent 12,422,309 B2 is drawn to the method of claim 1, wherein the look-up table is a species-specific look-up table, wherein the species-specific look-up table is generated from multiple strain-specific look-up tables representing data obtained from multiple reference samples monitored over time, and wherein each of the multiple reference samples comprises a reference bacteria of the same species as the bacteria in the source sample.
Regarding instant claim 4, claim 3 of US patent 12,422,309 B2 is drawn to the method of claim 2, wherein each of the multiple strain-specific look-up tables is generated by: measuring changes in the ORP of a reference sample over a period of time; conducting sample enumeration assays of the reference sample over the same period of time; converting results of the sample enumeration assays to reference sample concentrations using a conversion factor; and associating the reference sample concentrations with the changes in the ORP of the reference sample.
Regarding instant claim 5, claim 3 of US patent 12,422,309 B2 is drawn to the method of claim 2, wherein each of the multiple strain-specific look-up tables is generated by: measuring changes in the ORP of a reference sample over a period of time; conducting sample enumeration assays of the reference sample over the same period of time; converting results of the sample enumeration assays to reference sample concentrations using a conversion factor; and associating the reference sample concentrations with the changes in the ORP of the reference sample.
Regarding instant claim 12, claim 9 of US patent 12,422,309 B2 is drawn to the method of claim 1, wherein the source sample comprises a bodily fluid, a wound swab or sample, a rectal swab or sample, a culture derived therefrom, or a combination thereof.
Regarding instant claim 14, claim 6 of US patent 12,422,309 B2 is drawn to the method of claim 1, wherein the incubation temperature is between about 33° C. and about 37° C.
Regarding instant claim 16, claim 1 of US patent 12,422,309 B2 is drawn to A method of preparing an output sample of a bacteria of a defined concentration, comprising:
identifying a species of the bacteria within a source sample;
diluting an aliquot of the source sample comprising the bacteria by a dilution factor to yield a diluted sample, wherein the aliquot is diluted using a dilutive solution; selecting a look-up table based on the species of the bacteria; wherein the look-up table contains concentration data; selecting a first threshold amount and a second threshold amount from the look-up table, wherein the first threshold amount and the second threshold amount are target amounts by which an oxidation-reduction potential (ORP) of the diluted sample is required to change in order for the concentration of the bacteria in the diluted sample to reach the defined concentration, wherein the defined concentration is between 5×105 colony-forming units (CFU)/mL to 3×108 CFU/mL, wherein the first threshold amount and the second threshold amount comprise different values; exposing one or more ORP sensors to the diluted sample, wherein each of the one or more ORP sensors comprises an active electrode and a reference electrode, wherein at least a redox-active layer of the active electrode of each of the one or more ORP sensors is in fluid communication with the diluted sample when exposed to the diluted sample; incubating the diluted sample at an incubation temperature, wherein the diluted sample is incubated when the one or more ORP sensors are exposed to the diluted sample; incubating the diluted sample at an incubation temperature, wherein the diluted sample is incubated when the one or more ORP sensors are exposed to the diluted sample; measuring, using a parameter analyzer coupled to the one or more ORP sensors, a change in an ORP of the diluted and incubated sample, wherein the change in the ORP is measured between the redox-active layer of the active electrode and the reference electrode; obtaining, using the parameter analyzer or a computing device communicatively coupled to the parameter analyzer, a first threshold time corresponding to an amount of time elapsed for the ORP of the diluted and incubated sample to change by the first threshold amount and obtaining a second threshold time corresponding to the amount of time elapsed for the ORP of the diluted and incubated sample to change by the second threshold amount, wherein the first threshold amount and the second threshold amount represent changes in the ORP of the diluted and incubated sample; determining, using the parameter analyzer or a computing device communicatively coupled to the parameter analyzer, a sample preparation time corresponding to the amount of time necessary for the bacteria within the diluted and incubated sample to reach the defined concentration based on the first threshold time, the second threshold time, concentration data from the look-up table, and the defined concentration; and cooling the diluted and incubated sample to a cooling temperature between about 4° C. and about 25° C. when the sample preparation time is reached.
The combination of instant claims 1 and 16 are different from claim 1 of USP 12,422,343 B2 in that USP 12,422,343 B2 claim 1 is broader and recites identifying a species of the bacteria, diluting an aliquot of the source sample, selecting a look-up table, selecting a first threshold amount, measuring using a parameter analyzer, obtaining a first threshold value, determining a sample preparation time, and instant claims, 1 and 16 are narrower and recite preparing a sample of a bacteria of a desired concentration, introducing an aliquot of the sample into a sample container, incubating and aerating the sample at a flow rate of 7.0pL per second per mL and 10pL per second per mL of the contained sample, monitoring a change in oxidation reduction potential using a reader electrically coupled to the reference sensor and the active sensor, and cooling the sample when a concentration of the bacteria in the contained sample is determined to have reached the target concentration.
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.
Claims 1-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rajan et al (US 20190293529 A1; hereinafter “Rajan”) in view of Buie et al (US 20210131993 A1; hereinafter “Buie” in place of WO 2019246208 A1).
Regarding claim 1, Rajan teaches a method of preparing a sample of bacteria of a desired or target concentration (Rajan; Title) or within acceptable error margins of the desired or target concentration, comprising:
introducing an aliquot of a sample comprising the bacteria into a sample container (Rajan; fig. 1A. 112, 122 step 1A),
wherein the aliquot of the sample within the sample container is a contained sample in fluid communication with a reference sensor and an active sensor (Rajan; [0160] “active and reference electrode can be in communication with the sample”);
incubating the contained sample (Rajan; Abstract),
monitoring a change in an oxidation reduction potential (ORP) of the contained sample using a reader electrically coupled to the reference sensor and the active sensor (Rajan; [0007]), and
cooling the contained sample when a concentration of the bacteria in the contained sample is determined to have reached the desired or target concentration or within acceptable error margins thereof (Rajan; fig.1B, Step 1 and Abstract).
Rajan fails to teach aerating the contained sample, wherein the contained sample is aerated at a flow rate of between 7.0 microliter (pL) per second per milliliter (mL) of the contained sample and 10.0 pL per second per mL of the contained sample.
However, Buie teaches the analogous art of a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract).
Buie does not explicitly teach the contained sample is aerated at a flow rate of between 7.0 microliter (pL) per second per milliliter (mL) of the contained sample and 10.0 pL per second per mL of the contained sample.
Buie teaches gas or ambient air can be pumped into the sample chamber at a constant flow rate between 1mL/min to about 10 mL/min (Buie; [0309]).
It would have been obvious to one of ordinary skill in the art to aerate the sample at a flow rate of between 7.0 microliter (pL) per second per milliliter (mL) of the contained sample and 10.0 pL per second per mL of the contained sample to provide adequate gas supply while reducing the damage to microorganisms due to bubble development.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Rajan’s method of preparing a sample of bacteria of a desired or target concentration to aerate the sample as taught by Buie because Buie teaches a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract).
The modification provides adequate gas supply while reducing the damage to microorganisms due to bubble development.
Regarding claim 2, modified Rajan teaches the method of claim 1 (see above), further comprising retrieving a species-agnostic look-up table (LUT) from a database (Rajan; [0064]), wherein the species-agnostic LUT comprises species- agnostic ORP change amounts associated with species-agnostic bacterial concentrations (Rajan; fig. 1B Step 1D), wherein the species-agnostic LUT is generated from a plurality of constituent LUTs comprising ORP change amounts and bacterial concentrations measured using a plurality of reference bacterial samples incubated (Rajan; fig. 2 Step 2B and 2C).
Rajan fails to teach aerating the contained sample at a flow rate of between 7.0 microliter (pL) per second per mL of each of the reference and bacterial samples and 10.0 pL per second per mL of the reference sample.
However, Buie teaches the analogous art of a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract).
Buie does not explicitly teach the reference bacterial sample is aerated at a flow rate of between 7.0pL per second per mL of the reference bacterial sample and 10.0 pL per second per mL of the reference bacterial sample.
Buie teaches gas or ambient air can be pumped into the sample chamber at a constant flow rate between 1mL/min to about 10 mL/min (Buie; [0309]).
It would have been obvious to one of ordinary skill in the art to aerate the reference bacterial sample at a flow rate of between 7.0pL per second per mL of reference bacterial sample and 10.0 pL per second per mL of the reference bacterial sample to provide adequate gas supply while reducing the damage to microorganisms due to bubble development.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Rajan’s method of preparing a sample of bacteria of a desired or target concentration to aerate the reference bacterial sample to provide enhanced growth of the microorganism within the sample (Buie; [0145]).
Regarding claim 3, modified Rajan teaches the method of claim 2 (see above) to include generating a species-agnostic LUT (see above), further comprising: selecting one of the species-agnostic ORP change amounts as a threshold ORP change amount when the species-agnostic ORP change amount selected is associated with one of the species-agnostic bacterial concentrations equal to the desired or target concentration (Rajan; [0008]; [0067] and fig. 1B Step 1E); and determining that the concentration of the bacteria in the contained sample has reached the desired or target concentration (Rajan; fig. 1B Step 1D, 1E) or within acceptable error margins thereof when the change in the ORP of the contained sample monitored by the reader reaches the threshold ORP change amount (Rajan; fig. 1B Step 1D).
Regarding claim 4, modified Rajan teaches the method of claim 2 (see above), wherein the species-agnostic LUT is generated from at least three constituent LUTs (Rajan; fig. 2. 204) including a first LUT (Rajan; fig. 2. 204), a second LUT (Rajan; fig. 2. 210), and a third LUT (Rajan; fig. 2. 212); wherein each of the first LUT, the second LUT, or the third LUT is either a species-specific LUT or a strain-specific LUT (Rajan; fig. 2. 204, 210, 212); wherein the first LUT, the second LUT, and the third LUT are generated using ORP measurements and bacterial concentration measurements made of a first reference bacterial sample, a second reference bacterial sample, and a third reference bacterial sample, respectively (Rajan; fig. 3C and [0145]; wherein the first reference bacterial sample comprises a bacteria of a first species; wherein the second reference bacterial sample comprises a bacteria of a second species different from the first species; and wherein the third reference bacterial sample comprises a bacteria of a third species different from the second species and the first species (Rajan; fig. 3C illustrates various strain specific LUTs, and [0145]).
Regarding claim 5, modified Rajan teaches the method of claim 4 (see above) wherein each of the strain-specific LUTs is generated by: monitoring a change in the ORP of at least one reference bacterial sample over a period of time; periodically conducting optical density (OD) measurements of the at least one reference bacterial sample over the same period of time (Rajan; [0009]); converting results of the OD measurements to reference sample bacterial concentrations using a conversion factor; and associating the reference sample bacterial concentrations with the change in the ORP of the at least one reference bacterial sample (Rajan; [0009]).
Regarding claim 6, modified Rajan teaches the method of claim 2 (see above) further comprising: calculating a time-to-target concentration (ttarget) representing an amount of time required for the contained sample to reach the desired or target concentration (Rajan; [0112 (“preparation time tt”) (Ntarget) of bacteria (Rajan; Table 1 and [0111] “defined concentration nt”) using the following relationship: ttarget doubling average wherein Ntarget is not included in the species-agnostic LUT (Rajan; equation 1 page 11, and [0111] illustrates equation 1 wheren Ntarget (nt) is not included) and N1 is a species-agnostic bacterial concentration included in the species-agnostic LUT (Rajan; [0098 and fig. 1B. 181), wherein t1 represents a time required for the ORP of the contained sample to change by a species-agnostic ORP change amount (Aoap) associated with N1 from the species-agnostic LUT (Rajan; fig. 3E Title and graph, and [0110]), wherein t1 is determined from real-time ORP monitoring conducted by the reader on the contained sample (Rajan; fig. 3E, and [0110 the computing device can record t1), and wherein tdoublingaverage is an average bacterial doubling time (Rajan; table in page 11, and [0023] illustrates equation 1 wherein Ntarget (nt) is not included); and determining that the concentration of the bacteria in the contained sample has reached the desired or target concentration or within acceptable error margins thereof when a time elapsed equals the time-to-target concentration (Rajan; [0111], [0113).
Regarding claim 7, modified Rajan teaches the method of claim 2 (see above), further comprising: : calculating a time-to-target concentration (ttarget) representing an amount of time required for the contained sample to reach the desired or target concentration (Rajan; [0112] (“preparation time tt”) (Ntarget) of bacteria (Rajan; Table 1 and [0111] “defined concentration nt”) using the following relationship:
ttarget doubling average wherein Ntarget and N1 are both included in the species-agnostic LUT (Rajan; Table 1 page 11, and [0111]), wherein Ntarget is greater than N1 (Ntarget> N1) (Rajan; table 1 page 11 illustrates Ntarget (N2) is greater than N1), wherein t1 represents a time required for the ORP of the contained sample to change by a species-agnostic ORP change amount (Aoap) associated with N1 from the species-agnostic LUT (Rajan; fig. 3E Title and graph, and [0110]), wherein t1 is determined from real-time ORP monitoring conducted by the reader on the contained sample (Rajan; fig. 3E, and [0110] “the computing device can record t1”), and wherein tdoublingaverage is an average bacterial doubling time (Rajan; Table in page 11, and [0023] illustrates Equation 1 wherein Ntarget (nt) is not included); and determining that the concentration of the bacteria in the contained sample has reached the desired or target concentration or within acceptable error margins thereof when a time elapsed equals the time-to-target concentration (Rajan; [0111], [0113).
Regarding claim 8, modified Rajan teaches the method of claim 1 (see above), to include a reference sensor, an active sensor and a reader (see above).
Modified Rajan fails to teach the reference sensor comprises a reference electrode material and a wick in fluid communication with the contained sample such that least some of the contained sample within a chamber cavity of the sample container is drawn by the wick in a direction of the reference electrode material and the contained sample is in fluid contact with the reference electrode material, wherein the active sensor is coupled to at least part of a chamber lateral wall of the sample container, wherein an active electrode material of the active sensor faces the chamber cavity such that the contained sample is in fluid contact with the active electrode material when the contained sample fills the chamber cavity, and wherein the ORP of the contained sample is determined by the reader based on a potential difference measured between the active electrode material and the reference electrode material when the reference sensor and the active sensor are electrically coupled to the reader.
However, Buie teaches the analogous art of a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) that includes a reference sensor (Buie; fig. 9A. 800) wherein the reference sensor comprises a reference electrode material and a wick in fluid communication with the contained sample such that least some of the contained sample within a chamber cavity of the sample container is drawn by the wick in a direction of the reference electrode material and the contained sample is in fluid contact with the reference electrode material (Buie; fig. 9A. 808, 910, and [0007] [0260], [0276]), wherein the active sensor is coupled to at least part of a chamber lateral wall of the sample container (Buie; [0263]), wherein an active electrode material of the active sensor faces the chamber cavity such that the contained sample is in fluid contact with the active electrode material when the contained sample fills the chamber cavity (Buie; fig. 9A. 918), and wherein the ORP of the contained sample is determined by the reader based on a potential difference (Buie; fig. 6) measured between the active electrode material and the reference electrode material (Buie; fig. 10) when the reference sensor and the active sensor are electrically coupled to the reader (Buie; [0009]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Rajan’s reference sensor, active sensor and a reader to include a reference electrode material and a wick in fluid communication with the contained sample such that least some of the contained sample within a chamber cavity of the sample container is drawn by the wick in a direction of the reference electrode material and the contained sample is in fluid contact with the reference electrode material, wherein the active sensor is coupled to at least part of a chamber lateral wall of the sample container, wherein an active electrode material of the active sensor faces the chamber cavity such that the contained sample is in fluid contact with the active electrode material when the contained sample fills the chamber cavity, and wherein the ORP of the contained sample is determined by the reader based on a potential difference measured between the active electrode material and the reference electrode material when the reference sensor and the active sensor are electrically coupled to the reader as taught by Buie because Buie teaches a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) that includes a reference sensor (Buie; fig. 9A. 800) wherein the reference sensor comprises a reference electrode material and a wick in fluid communication with the contained sample such that least some of the contained sample within a chamber cavity of the sample container is drawn by the wick in a direction of the reference electrode material and the contained sample is in fluid contact with the reference electrode material (Buie; fig. 9A. 808, 910, and [0007] [0260], [0276]), wherein the active sensor is coupled to at least part of a chamber lateral wall of the sample container (Buie; [0263]), wherein an active electrode material of the active sensor faces the chamber cavity such that the contained sample is in fluid contact with the active electrode material when the contained sample fills the chamber cavity (Buie; fig. 9A. 918), and wherein the ORP of the contained sample is determined by the reader based on a potential difference (Buie; fig. 6) measured between the active electrode material and the reference electrode material (Buie; fig. 10) when the reference sensor and the active sensor are electrically coupled to the reader (Buie; [0009]).
The modification allows to draw sample from the sample container and determine an ORP with the reader based on a potential differential.
Regarding claim 9, modified Rajan teaches the method of claim 1 (see above), wherein the bacteria is a facultative anaerobe or a strict aerobe (Rajan; [0050] “Acinetobacter” a strict aerobe).
Regarding claim 10, modified Rajan teaches the method of claim 1 (see above), wherein the bacteria is a gram-negative bacteria (Rajan; [0050] “Acinetobacter”).
Regarding claim 11, modified Rajan teaches the method of claim 1 (see above), to include a sample of bacteria of the desired or target concentration (see above).
Modified Rajan fails to teach wherein the sample of bacteria of the desired or target concentration is prepared without any prior knowledge of a species of the bacteria in the contained sample or previously ascertaining a species of the bacteria in the contained sample (Buie; [0116]).
However, Buie teaches the analogous art of a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein sample of bacteria of the desired or target concentration is prepared without any prior knowledge of a species of the bacteria in the contained sample or previously ascertaining a species of the bacteria in the contained sample (Buie; [0116]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Rajan’s sample of bacteria of the desired or target concentration to be prepared without any prior knowledge of a species of the bacteria in the contained sample or previously ascertaining a species of the bacteria in the contained sample as taught by Buie because Buie teaches a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein sample of bacteria of the desired or target concentration is prepared without any prior knowledge of a species of the bacteria in the contained sample or previously ascertaining a species of the bacteria in the contained sample (Buie; [0116]).
The modification allows the bacteria to replicate to later identify the species of the bacteria.
Regarding claim 12, modified Rajan teaches the method of claim 1 (see above), wherein the sample comprises at least one of a bodily fluid and a bacterial culture derived therefrom (Rajan; [0015]).
Regarding claim 13, modified Rajan teaches the method of claim 1 (see above), wherein the desired or target concentration is between 1.4 x 108 CFU/mL and 1.6 x 108 CFU/mL (Rajan; [0113]).
Regarding claim 14, modified Rajan teaches the method of claim 1 (see above), wherein the contained sample is incubated at an incubation temperature of between approximately 33 °C and 37 °C (Rajan; [0019]).
Regarding claim 15, modified Rajan teaches the method of claim 1 (see above), wherein the acceptable error margins are ±0.5 log10.
Rajan teaches a defined concentration (Rajan; Title) and a computing device to set a threshold amount by which a solution characteristic of the diluted sample is required to change (Rajan; [0067]).
It would have been obvious to have acceptable error margins that are in the range of ±0.5 log10 in order to provide a viable sample.
Regarding claim 16, modified Rajan teaches the method of claim 1 (see above), further comprising diluting a source sample comprising the bacteria by a dilution factor between 1:10 and 1:100 to yield a diluted sample; and wherein the aliquot of the sample introduced into the sample container is an aliquot of the diluted sample (Rajan; [0057]).
Regarding claim 17, modified Rajan teaches the method of claim 1 (see above) to include aerating the contained sample (see above).
Modified Rajan fails to teach the contained sample is aerated in accordance with an aeration cycle, wherein the aeration cycle comprises an aeration period followed by a non-aerated period, and wherein the aeration period is longer than the non- aerated period.
However, Buie teaches the analogous art of a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract) and a stagnant (non-aerated) sample (Buie; fig. 12).
Buie does not explicitly teach the contained sample is aerated in accordance with an aeration cycle, wherein the aeration cycle comprises an aeration period followed by a non-aerated period, and wherein the aeration period is longer than the non- aerated period.
Buie teaches the aeration occurs at specific duty cycles (Buie; [0309]).
It would have been obvious to one of ordinary skill in the art to aerate the contained sample in accordance with an aeration cycle, wherein the aeration cycle comprises an aeration period followed by a non-aerated period, and wherein the aeration period is longer than the non- aerated period in order to provide a growth rate of aerated and stagnant samples to achieve a turbidity level of 0.5 McFarland (Buie; [0339]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Rajan’s method of preparing a sample of bacteria of a desired or target concentration to aerate the contained sample in accordance with an aeration cycle, wherein the aeration cycle comprises an aeration period followed by a non-aerated period, and wherein the aeration period is longer than the non- aerated period in order to optimize growth, product formation and cell health.
Regarding claim 18, modified Rajan teaches the method of claim 17 (see above), to include aerating the sample (see above).
Modified Rajan fails to teach the aeration period is between about 7 minutes and 10 minutes and wherein the non-aerated period is between about 3 seconds and 10 seconds.
However, Buie teaches the analogous art of a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract).
Buie teaches aerating the sample between zero minutes and 500 minutes (Buie; fig. 12).
Buie and the claims differ in that although Buie does not teach the exact same times as recited in the instant claims.
To one of ordinary skill in the art at the time the invention was made would have considered the invention to have been obvious because the times taught by Buie overlap the instantly claimed proportions and therefore are considered to establish a prima facie case of obviousness.
It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed times including the instantly claimed times from the times disclosed in the prior art reference in order to provide an optimal aeration time.
Overlapping ranges are prima facie evidence of obviousness
Regarding claim 19, modified Rajan teaches the method of claim 1, to include aerating the contained sample (see above).
Modified Rajan fails to teach aerating the contained sample further comprises pumping ambient air into the sample container through an opening defined along a base of the sample container.
However, Buie teaches the analogous art of a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract) and aerating the contained sample further comprises pumping ambient air into the sample container (Buie; [0309]) through an opening defined along a base of the sample container (Buie; [0014]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Rajan’s aerating the contained sample to pump ambient air into the sample container through an opening defined along a base of the sample container as taught by Buie because Buie teaches a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract) and aerating the contained sample further comprises pumping ambient air into the sample container through an opening defined along a base of the sample container (Buie; [0309]).
The ambient air contains a lower oxygen concentration which provides enough oxygen for growth without the risk of toxic reactive oxygen species buildup.
Regarding claim 21, modified Rajan teaches the method of claim 19 (see above) to include pumping ambient air into the sample container through an opening defined along the base of the sample container (see above).
Modified Rajan fails to teach the ambient air is pumped into the sample container using a motorized piston pump housed within the reader.
However, Buie teaches the analogous art of a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract) with ambient air (Buie; [0309]), wherein the ambient air is pumped into the sample container using a motorized piston pump (Buie; [0309]) housed within the reader.
Buie teaches a pump that pumps ambient air into the sample container, where the sample pump is places is a matter of preference and intended use that does not change how the device operates.
It would have been obvious to house the pump within the reader in order to save space.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Rajan’s pump to be a motorized piston pump as taught by Buie because Buie teaches a system for preparing an output sample of a defined microorganism concentration (Buie; [0330]) wherein the contained sample is aerated (Buie; Abstract) with ambient air (Buie; [0309]), wherein the ambient air is pumped into the sample container using a motorized piston pump (Buie; [0309]).
The motorized piston pump allows for pressurized air delivery.
Conclusion
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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