DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Remarks
In response to communications sent June 6, 2025, claim(s) 1-20 is/are pending in this application; of these claim(s) 1, 14, and 18 is/are in independent form.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 6, 2025 has been entered.
Information Disclosure Statement
The Information Disclosure Statement(s) is/are acknowledged and the references contained therein have been considered by the Examiner. This includes the Information Disclosure Statements(s) filed on: September 4, 2025.
Response to Arguments
Applicant's arguments filed June 6, 2025 have been fully considered but they are not persuasive.
Regarding 35 U.S.C. § 101: Applicant argues that PCR on a quality control sample to validate an instrument is integrates the abstract ideas in the claim into a practical application. The Examiner respectfully disagrees, arguing that objective of validation is an abstract determination itself. While the validation prevents tests from being run on the instrument, there is not step that causes the instrument to be halted. Validation for quality control purposes culminates in a mental determination of quality. Hence, the use of special equipment and instruments to result in the determination of quality are necessary measurements and data collection to support the abstract notion of quality. The determination of quality results in reliability and waste prevention, but it is the abstract quality assessment that directly prevents the waste. Hence, instead of the equipment and measurement process being integrated with the improvement, the abstract idea itself results in the improvement.
Regarding 35 U.S.C. § 103: Applicant’s arguments, see page 10 line 1 to page 11 line 20, filed June 6, 2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. § 103 over US 2016/0356801 A1 (“Glavina”) in view of US 2016/0355871 A1 (“Want”).
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 1-12 and 14-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) the abstract idea of a mental process, including computerized processing of data about samples. The process also includes making determinations for carrying out contingent steps, the determinations being part of the mental process.
This judicial exception is not integrated into a practical application because the additional elements of storing data is extra-solution activity and the element of using the Polymerase Chain Reaction is not pre-solution activity for use by the abstract idea. Validation for quality control purposes culminates in a mental determination of quality. Hence, the use of special equipment and instruments to result in the determination of quality are necessary measurements and data collection to support the abstract notion of quality. The determination of quality results in reliability and waste prevention, but it is the abstract quality assessment that directly prevents the waste. Hence, instead of the equipment and measurement process being integrated with the improvement, the abstract idea itself results in the improvement.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the storage of data is well-understood, routine, and conventional according to MPEP § 2106.05(d) II. See Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. Furthermore, the Polymerase Chain Reaction is well-understood, routine, and conventional by legal precedent. MPEP § 2106.05(d).II recites: “ELEMENTS THAT THE COURTS HAVE RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR FIELDS… ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015)”).
The dependent claims merely limit the abstract idea, although claim 16 introduces the element of releasing records. However, this additional element in claim 16 is extra-solution activity that is well-understood, routine, and conventional according to MPEP § 2106.05(d) II citing to “OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network).”
(Note: claims 13 and 20 are not rejected under 35 U.S.C. § 101 because they involve “a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles”; Applicant’s specification (in the Background section) provides evidence that this element is not routine and conventional for quality control in the context of the claim as a whole.)
1. A method for validating a target analyte detection instrument comprising:
performing a polymerase chain reaction on a first quality control sample using the target analyte detection instrument (MPEP § 2106.05(d).II: “ELEMENTS THAT THE COURTS HAVE RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR FIELDS… ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015)”) to produce a first quality control record (quality control is the intended result, but is not a positively recited step);
storing the first quality control record produced by the target analyte detection instrument in the target analyte detection instrument (storage of data is not significantly more than an abstract idea, and is insignificant extra-solution activity; MPEP § 2106.05(d) II indicates that storage is well-understood, routine and conventional. See “Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93”); and
verifying with the target analyte detection instrument that the first quality control record stored in the target analyte detection instrument is valid after verifying that the first quality control record stored in the target analyte detection instrument is valid (mental process), performing a polymerase chain reaction on a first patient sample to detect a target analyte and generating run data using the target analyte detection instrument (MPEP § 2106.05(d).II: “ELEMENTS THAT THE COURTS HAVE RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR FIELDS… ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015)”) ;
generating with the target analyte detection instrument a first patient sample report from the run data from the first patient sample, wherein the first patient sample report indicates the presence or absence of the target analyte (generating a report is a mental process); and
sending the first patient sample report to a hospital laboratory information system (extra-solution activity; sending information is well-understood, routine, and conventional because MPEP § 2106.05(d) II cites to “OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network)”).
2. The method of claim 1, further comprising sending an alert if the first quality control record is due for an update (this is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process)..
3. The method of claim 1, further comprising removing patient data from the run data by the target analyte detection instrument prior to releasing the run data (removal of information from a report is a mental process).
4. The method of claim 2, wherein the alert is sent 24 or 48 hours before the first quality control is due (the alert is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
5. The method of claim 1, further comprising:
processing a plurality of patient samples by the target analyte detection instrument (by broadest reasonable interpretation, “processing” includes computer processing, which encompasses execution of computations corresponding to abstract mental processes); and
generating an epidemiology report from the patient samples (generating a report is a mental process).
6. The method of claim 1, further comprising:
processing a plurality of patient samples by the target analyte detection instrument (by broadest reasonable interpretation, “processing” includes computer processing, which encompasses execution of computations corresponding to abstract mental processes); and
generating an epidemiology report through the laboratory information system interchange (generating a report is a mental process).
7. The method of claim 1, wherein the first patient sample is in a cartridge, the cartridge comprising a first and a second machine readable identification tag, wherein the target analyte detection instrument discontinues processing the first patient sample if the first machine readable identification tag does not match the second machine readable identification tag (the tag matching is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
8. The method of claim 1, wherein at least one pathogen in the first patient sample is a blood stream pathogen that causes or is suspected of causing sepsis (by broadest reasonable interpretation, “processing” includes computer processing, which encompasses execution of computations corresponding to abstract mental processes; hence the pathogens and samples are merely the semantic meaning of the information about which the processing occurs).
9. The method of claim 1, further comprising sending an alert by the target analyte detection instrument when the sample turnaround time for the first patient sample is violated (the alert is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
10. The method of claim 1 sending an alert by the target analyte detection instrument when a sample stability time for the first patient sample is violated (the alert is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
11. The method of claim 1, sending an alert by the target analyte detection instrument when the target analyte detection instrument has detected 4 or more pathogens in the first patient sample (the alert is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
12. The method of claim 1, receiving by the target analyte detection instrument an order for an assay to detect a target, wherein the first patient sample is processed according to an assay ordered to detect a target (by broadest reasonable interpretation, “processing” includes computer processing, which encompasses execution of computations corresponding to abstract mental processes), and
sending an alert by the target analyte detection instrument when the target detected does not match the assay ordered (the alert is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
14. A method for validating a target analyte detection instrument, comprising:
performing a polymerase chain reaction on a first quality control sample using the target analyte detection instrument (MPEP § 2106.05(d).II: “ELEMENTS THAT THE COURTS HAVE RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR FIELDS… ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015)”);
storing the first quality control record by the target analyte detection instrument in the target analyte detection instrument (storage of data is not significantly more than an abstract idea, and is insignificant extra-solution activity; MPEP § 2106.05(d) II indicates that storage is well-understood, routine and conventional. See “Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93”) to produce a first quality control record (quality control is the intended result, but is not a positively recited step);
verifying whether a valid quality control record is stored in the target analyte detection instrument (mental process); and
preventing the processing of a patient sample by the target analyte detection instrument if there is not a valid quality control record stored in the target analyte detection instrument, wherein processing the patient sample comprises performing a polymerase chain reaction on the patient sample using the target analyte detection instrument (this is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
15. The method of claim 14, wherein the preventing step occurs when the patient sample is loaded into a first test cartridge and the first test cartridge is from a new lot (this is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
16. The method of claim 14, further comprising:
releasing the first quality control record to a hospital laboratory information system by the target analyte detection instrument (extra-solution activity; sending information is well-understood, routine, and conventional because MPEP § 2106.05(d) II cites to “OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network)”).
17. The method of claim 14, further comprising:
tracking preventative maintenance for the target analyte detection instrument by the target analyte detection instrument (tracking is a mental process).
18. A method for validating a target analyte detection instrument in order to process a first patient sample and a second patient sample comprising:
performing a polymerase chain reaction on a first quality control sample using a target analyte detection instrument (MPEP § 2106.05(d).II: “ELEMENTS THAT THE COURTS HAVE RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR FIELDS… ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015)”) to produce a first quality control record (quality control is the intended result, but is not a positively recited step);
storing the first quality control record by the target analyte detection instrument in the target analyte detection instrument (storage of data is not significantly more than an abstract idea, and is insignificant extra-solution activity; MPEP § 2106.05(d) II indicates that storage is well-understood, routine and conventional. See “Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93”);
releasing the first quality control record to a hospital laboratory information system by the target analyte detection instrument (extra-solution activity; sending information is well-understood, routine, and conventional because MPEP § 2106.05(d) II cites to “OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network)”);
receiving a first test order for the first patient sample in a first file format for the first patient sample, and a second test order for the second patient sample in a first file format for the second patient sample, by a bi- directional laboratory information system interchange, wherein the bidirectional laboratory information system interchange is on a target analyte detection instrument, and the bi-directional laboratory information system interchange converts the first file format for the first patient sample to a second file format for the first patient sample, and converts the first file format for the second patient sample to a second file format for the second patient sample (conversion of file information is a mental process);
populating the second file format for the first patient sample with a first accession number and populating the second file format for the second patient sample with a second accession number (managing identifiers is a mental process); and
performing a polymerase chain reaction on the first sample and the second sample using the target analyte detection instrument processing the first patient, when the first accession number and the second accession number are different (the processing is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
19. The method of claim 18, wherein the first patient sample is in a cartridge for the target analyte detection instrument, the cartridge comprising a first and a second machine readable identification tag (the sample is merely the semantic content that the computer processing refers to; the broadest reasonable interpretation of processing involve merely computer processing about data that represents samples, rather than manipulation of the actual samples themselves), wherein the target analyte detection instrument discontinues processing the first patient sample if the first machine readable identification tag does not match the second machine readable identification tag (the process of matching is an abstract idea of a mental process because the conditional limitation requires a determination, which is a human judgement and mental process).
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.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “new” in claim 15 is a relative term which renders the claim indefinite. The term “new” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-12 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 10 and 11 recite "sending an alert"; however, the Examiner believes that Applicant intended "further comprising sending an alert". Claims 12 recites "receiving by the target analyte detection instrument"; however, the Examiner believes that Applicant intended "further comprising receiving by the target analyte detection instrument". Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0356801 A1 (“Glavina”) in view of US 2016/0355871 A1 (“Want”).
The Examiner argues that the claimed invention is “Applying a Known Technique to a Known Device (Method, or Product) Ready for Improvement To Yield Predictable Results” (MPEP § 2143.I.D). The base method is taught by Glavina and the known technique taught by the Want reference.
As to claim 1, Glavina teaches a method for validating a target analyte detection instrument (Glavina Para [0124]: performing a quality control for an instrument) comprising:
performing a [[ (Glavina Para [0124] Step 615, performing a quality control for the instrument using the quality control samples) to produce a first quality control record (Glavina Para [0127], Step 620: obtaining data regarding quality control after the quality control process is performed);
storing the first quality control record produced by the target analyte detection instrument in the target analyte detection instrument (Glavina Para [0133] storing quality control compliance records in a database of the instrument itself; note that storage in the “instruments” is taught as an alternative to storing in the “data manager”); and
verifying with the target analyte detection instrument that the first quality control record stored in the target analyte detection instrument is valid (Glavina Para [0134]: step 640, determining that the quality control was valid) and after verifying that the first quality control record stored in the target analyte detection instrument is valid (Glavina Para [0136]: step 60, after the instruments determine the compliance status), performing a [[(Glavina Para [0136]: performing an analytical test) and generating run data using the target analyte detection instrument (Glavina Para [0137]: step 645, generating data from analyte detection);
generating with the target analyte detection instrument a first patient sample report from the run data from the first patient sample (Glavina Para [0137]: step 645, generating a report from the analytical test), wherein the first patient sample report indicates the presence or absence of the target analyte (Glavina Para [0137]: step 645, the reports contains a result of the analytical test of the target analyte); and
sending the first patient sample report to a hospital laboratory information system (Glavina Para [0138]: step 650, sending the report to the health care team; see Para [0093] : Hospital Information System communications).
However, Glavina does not teach that performing a reaction is a “polymerase chain reaction” as the diagnostic method. Nevertheless, Want teaches the use of the polymerase chain reaction in a similar context to solve a similar problem in a predictable way .
Glavina and Want are in the same field of diagnostics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Glavina to include the teachings of Want because altering the number of cycles improves specificity and helps with optimization of the PCR method (See Want Para [0058]).
As to claim 2, Glavina in view of Want teaches the method of claim 1, further comprising sending an alert if the first quality control record is due for an update (Glavina Para [0081]: sending an actionable alert of various types, including expired devices).
As to claim 3, Glavina in view of Want teaches the method of claim 1, further comprising:
removing patient data from the run data by the target analyte detection instrument prior to releasing the run data (Glavina Para [0065]: using patient identifiers; using numbers instead of patient names is an once envisaged as “patient identifiers”).
As to claim 4, Glavina in view of Want teaches the method of claim 2, wherein the alert is sent 24 or 48 hours before the first quality control is due (Glavina Para [0085]: sending frequent reports a minimum number of times per day to ensure it is received before 24 hours of the time in which it is needed).
As to claim 5, Glavina in view of Want teaches the method of claim 1, further comprising:
processing a plurality of patient samples by the target analyte detection instrument (Glavina Para [0079]: a number of patient samples are processed); and
generating an epidemiology report (Glavina Para [0137]: step 645, generating a report from the analytical test).
As to claim 6, Glavina in view of Want teaches the method of claim 1, further comprising:
processing a plurality of patient samples by the target analyte detection instrument (Glavina Para [0079]: a number of patient samples are processed); and
generating an epidemiology report (Glavina Para [0137]: step 645, generating a report from the analytical test) through the laboratory information system interchange (Glavina Para [0093]: Laboratory Information System communications).
As to claim 7, Glavina in view of Want teaches the method of claim 1 :
wherein the first patient sample is in a cartridge (Glavina Para [0074]: a cartridge for performing a analytical test), the cartridge comprising a first and a second machine readable identification tag (Glavina Para [0041]: various uses of barcodes), wherein the target analyte detection instrument discontinues processing the first patient sample if the first machine readable identification tag does not match the second machine readable identification tag (Glavina Para [0105]: testing whether the lot or sublot numbers do not match).
As to claim 8, Glavina in view of Want teaches the method of claim 1, wherein at least one pathogen in the first patient sample is a blood stream pathogen that causes or is suspected of causing sepsis (Glavina does not teach this, but Glavina in view of Want does; see Want Para [0100]: detection of pathogens involving sepsis).
As to claim 9, Glavina in view of Want teaches the method of claim 1, further comprising sending an alert by the target analyte detection instrument when the sample turnaround time for the first patient sample is violated (Glavina Para [0035]: exceeding an expiration date, which the Examiner interprets exceeds the turnaround time).
As to claim 10, Glavina in view of Want teaches the method of claim 1, sending an alert by the target analyte detection instrument when a sample stability time for the first patient sample is violated (Glavina Para [0043]: exceeding a refrigeration shelf life, which the Examiner interprets exceeds a sample stability time).
As to claim 11, Glavina in view of Want teaches the method of claim 1 sending an alert by the target analyte detection instrument when the target analyte detection instrument has detected 4 or more pathogens in the first patient sample (Glavina does not teach this, but Glavina in view of Want does; see Want Para [0092]: detection of multiple bacteria).
As to claim 12, Glavina in view of Want teaches the method of claim 1, wherein the first patient sample is processed according to the assay (Glavina Para [0137]: step 645, culminating in generating a report from the analytical test), and
sending an alert by the target analyte detection instrument when the target detected does not match the assay ordered (Glavina Para [0103]: comparing to determine if the analyte quantity is not what was ordered or anticipated in the delivery).
As to claim 13, Glavina in view of Want teaches the method of claim 1.
Glavina does not teach performing a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles.
Nevertheless, Want teaches: wherein processing a first patient sample by the target analyte detection instrument, comprises performing a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles (Want Para [0058]: processing a sample with potential bacterial contamination to ultimately generate a report by the system, which comprises PCR involving 30 or 35 cycles that has been optimized the PCR process by adjusting the number of cycles; the Examiner argues that adjustment to the number of cycles to 25 or 30 cycles is “detuned”; Para [0078] provides evidence that the reaction may be “multiplex” using a Stratagene system).
As to claim 14, Glavina teaches a method for validating a target analyte detection instrument (Glavina Para [0124]: performing a quality control for an instrument), comprising:
performing a [[ (Glavina Para [0124] Step 615, performing a quality control for the instrument using the quality control samples) to produce a first quality control record (Glavina Para [0127], Step 620: obtaining data regarding quality control after the quality control process is performed);
storing the first quality control record by the target analyte detection instrument in the target analyte detection instrument (Glavina Para [0133] storing quality control compliance records in a database of the instrument itself; note that storage in the “instruments” is taught as an alternative to storing in the “data manager”);
verifying whether a valid quality control record is stored in the target analyte detection instrument (Glavina Para [0134]: step 640, determining that the quality control was valid); and
preventing the processing of a patient sample by the target analyte detection instrument if there is not a valid quality control record stored in the target analyte detection instrument (Glavina Para [0138]: disabling the analytical test if the instrument is non-compliant) wherein processing the patient sample comprises performing a [[(Glavina Para [0136] and [0138]: disabling an analytical test).
However, Glavina does not teach that performing a reaction is a “polymerase chain reaction” as the diagnostic method. Nevertheless, Want teaches the use of the polymerase chain reaction in a similar context to solve a similar problem in a predictable way .
Glavina and Want are in the same field of diagnostics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Glavina to include the teachings of Want because altering the number of cycles improves specificity and helps with optimization of the PCR method (See Want Para [0058]).
As to claim 15, Glavina in view of Want teaches the method of claim 14, wherein the preventing step occurs when the patient sample is loaded into a first test cartridge (Glavina Para [0074]: a cartridge for performing a analytical test) and the first test cartridge is from a new lot (Glavina Para [0067]: a single cartridge from a single manufacturing lot).
As to claim 16, Glavina in view of Want teaches the method of claim 14, further comprising:
releasing the first quality control record to a hospital laboratory information system by the target analyte detection instrument (Glavina Para [0138]: step 650, sending the report to the health care team; see Para [0093] : Hospital Information System communications).
As to claim 17, Glavina in view of Want teaches the method of claim 14, further comprising:
tracking preventative maintenance for the target analyte detection instrument by the target analyte detection instrument (Glavina Para [0090]: maintenance record upkeep as an administrative check of the reporting results).
As to claim 18, Glavina teaches a method for validating a target analyte detection instrument in order to process a first patient sample and a second patient sample (Glavina Para [0124]: performing a quality control for an instrument) comprising:
performing a [[ (Glavina Para [0124] Step 615, performing a quality control for the instrument using the quality control samples) to produce a first quality control record (Glavina Para [0127], Step 620: obtaining data regarding quality control after the quality control process is performed);
storing the first quality control record by a target analyte detection instrument in the target analyte detection instrument (Glavina Para [0133] storing quality control compliance records in a database of the instrument itself; note that storage in the “instruments” is taught as an alternative to storing in the “data manager”);
releasing the first quality control record to a hospital laboratory information system by the target analyte detection instrument (Glavina Para [0138]: step 650, sending the report to the health care team; see Para [0093]: Hospital Information System communications);
receiving a first test order for the first patient sample in a first file format for the first patient sample (Glavina Para [0090]: different attributes of different tests demand different formats for Individualized Quality Control Plans), and a second test order for the second patient sample in a first file format for the second patient sample (Glavina Para [0090]: different attributes of different tests demand different formats for Individualized Quality Control Plans), by a bi-directional laboratory information system interchange (Glavina Para [0093]: Laboratory Information System communications), wherein the bidirectional laboratory information system interchange is on a target analyte detection instrument (Glavina Para [0133] storing quality control compliance records in a database of the instrument itself; note that storage in the “instruments” is taught as an alternative to storing in the “data manager”), and the bi-directional LIS interchange converts the first file format for the first patient sample to a second file format for the first patient sample (Glavina Para [0090]: different attributes of different tests demand different formats for Individualized Quality Control Plan reports), and converts the first file format for the second patient sample to a second file format for the second patient sample (Glavina Para [0090]: different attributes of different tests demand different formats for Individualized Quality Control Plan reports);
populating the second file format for the first patient sample with a first accession number and populating the second file format for the second patient sample with a second accession number (Glavina Para [0065]: using patient identifiers; using numbers instead of patient names is an once envisaged as “patient identifiers”); and
performing a polymerase chain reaction on the first sample and the second sample using the target analyte detection instrument, when the first accession number and the second accession number are different (this element is a contingent element in a process claim; by broadest reasonable interpretation, the contingency is not met and the step is not necessarily required; see MPEP § 2111.04 II).
However, Glavina does not teach that performing a reaction is a “polymerase chain reaction” as the diagnostic method. Nevertheless, Want teaches the use of the polymerase chain reaction in a similar context to solve a similar problem in a predictable way .
Glavina and Want are in the same field of diagnostics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Glavina to include the teachings of Want because altering the number of cycles improves specificity and helps with optimization of the PCR method (See Want Para [0058]).
As to claim 19, Glavina in view of Want teaches the method of claim 18, wherein the first patient sample is in a cartridge for the target analyte detection instrument (Glavina Para [0074]: a cartridge for performing a analytical test), the cartridge comprising a first and a second machine readable identification tag (Glavina Para [0041]: various uses of barcodes), wherein the target analyte detection instrument discontinues processing the first patient sample if the first machine readable identification tag does not match the second machine readable identification tag (Glavina Para [0105]: testing whether the lot or sublot numbers do not match).
As to claim 20, Glavina in view of Want teaches the method of claim 18, but does not teach: wherein processing the first patient sample comprises performing a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles.
Nevertheless, Want teaches: wherein processing the first patient sample comprises performing a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles (Want Para [0058]: processing a sample with potential bacterial contamination to ultimately generate a report by the system, which comprises PCR involving 30 or 35 cycles that has been optimized the PCR process by adjusting the number of cycles; the Examiner argues that adjustment to the number of cycles to 25 or 30 cycles is “detuned”; Para [0078] provides evidence that the reaction may be “multiplex” using a Stratagene system).
Glavina and Want are in the same field of diagnostics. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Glavina to include the teachings of Want because altering the number of cycles improves specificity and helps with optimization of the PCR method (See Want Para [0058]).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 7, 13-15, and 20 of U.S. Patent No. 11,021,759 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is a genus of the species of the claims of the reference patent; minor variations are at once envisaged (MPEP § 2131.02 II) from the claims of the reference patent.
See the guide below:
Instant Application 17/243,481
US 11,021,759 B2
1. A method for validating a target analyte detection instrument comprising: performing a polymerase chain reaction on a first quality control using the target analyte detection instrument to produce a first quality control record; storing the first quality control record produced by the target analyte detection instrument in the target analyte detection instrument; and verifying with the target analyte detection instrument that the first quality control record stored in the target analyte detection instrument is valid; and after verifying that the first quality control record stored in the target analyte detection instrument is valid, performing a polymerase chain reaction on a first patient sample to detect a target analyte and generating run data using the target analyte detection instrument; generating with the target analyte detection instrument a first patient sample report from the run data from the first patient sample, wherein the first patient sample report indicates the presence or absence of the target analyte; and sending the first patient sample report to a hospital laboratory information system.
1. A method for processing at least a first patient sample comprising: a) receiving a first patient sample; b) receiving a first test order by a bi-directional LIS interchange in a first file format from a hospital laboratory information system (LIS) for the first patient sample, wherein the bidirectional LIS interchange is on a target analyte detection instrument, and the bi-directional LIS interchange converts the first file format to a second file format; and c) processing the first patient sample in the target analyte detection instrument using the second file format, wherein the target analyte detection instrument generates; a first result identifying at least one pathogen in the first patient sample processed by the target analyte detection instrument; and wherein the first result is automatically reported from the bi-directional LIS interchange.
2. The method of claim 1, further comprising sending an alert if the first quality control record is due for an update.
7. The method of claim 1, wherein the target analyte detection instrument sends an alert when preventative maintenance for the target analyte detection instrument is needed.
3. The method of claim 1, further comprising removing patient data from the run data by the target analyte detection instrument prior to releasing the run data.
3. The method of claim 1, wherein the first test order is in an HL7 or ASTM format and the LIS interchange converts the test order from the HL7 or ASTM format to a CSV format. (The Examiner interprets that the conversion step involves removal of data as part of the replacement of data for conversion.)
4. The method of claim 2, wherein the alert is sent 24 or 48 hours before the first quality control is due.
7. The method of claim 1, wherein the target analyte detection instrument sends an alert when preventative maintenance for the target analyte detection instrument is needed.
5. The method of claim 1, further comprising processing a plurality of patient samples by the target analyte detection instrument; and generating an epidemiology report from the patient samples.
6. The method of claim 5, wherein the target analyte detection instrument performs a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles.
6. The method of claim 1, further comprising processing a plurality of patient samples by the target analyte detection instrument; and generating an epidemiology report through the laboratory information system interchange.
2. The method of claim 1, wherein the LIS interchange automatically reports the first result to the hospital LIS.
7. The method of claim 1, wherein the first patient sample is in a cartridge, the cartridge comprising a first and a second machine readable identification tag, wherein the target analyte detection instrument discontinues processing the first patient sample if the first machine readable identification tag does not match the second machine readable identification tag.
See claim 1; a portion of claim 7 is a contingent limitation in a method claim; see MPEP § 2111.04 II.
8. The method of claim 1, wherein at least one pathogen in the first patient sample is a blood stream pathogen that causes or is suspected of causing sepsis.
14. The method of claim 13, wherein the at least one pathogen in the first patient sample is a blood stream pathogen that causes or is suspected of causing sepsis.
13. A method for processing at least a first patient sample comprising: a) receiving a first patient sample; b) receiving a first test order by a bi-directional LIS interchange in a first file format from a hospital LIS for the first patient sample, wherein the bidirectional LIS interchange is on a sample processing instrument, and the bi-directional LIS interchange converts the first file format to a second file format; c) loading the first patient sample into a cartridge, the cartridge comprising a machine readable information tag; d) loading the cartridge into the sample processing instrument comprising a first device that scans machine readable identification tags; e) scanning the machine readable identification tag by the first device; and f) processing the first patient sample in the sample processing instrument using the second file format, wherein the sample processing instrument generates; a first result identifying at least one pathogen in the first patient sample processed by the sample processing instrument; and wherein the first result is automatically reported from the bi-directional LIS interchange.
9. The method of claim 1, further comprising sending an alert by the target analyte detection instrument when the sample turnaround time for the first patient sample is violated.
See claim 1; a portion of claim 9 is a contingent limitation in a method claim; see MPEP § 2111.04 II.
10. The method of claim 1, sending an alert by the target analyte detection instrument when a sample stability time for the first patient sample is violated.
See claim 1; a portion of claim 10 is a contingent limitation in a method claim; see MPEP § 2111.04 II.
11. The method of claim 1, sending an alert by the target analyte detection instrument when the target analyte detection instrument has detected 4 or more pathogens in the first patient sample.
See claim 1; a portion of claim 11 is a contingent limitation in a method claim; see MPEP § 2111.04 II.
12. The method of claim 1, wherein the first patient sample is processed according to the assay and sending an alert by the target analyte detection instrument when the target detected does not match the assay ordered.
See claim 1; a portion of claim 12 is a contingent limitation in a method claim; see MPEP § 2111.04 II.
13. The method of claim 1, further comprising performing a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles.
6. The method of claim 5, wherein the target analyte detection instrument performs a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles.
14. A method for validating a target analyte instrument system, comprising: performing a polymerase chain reaction on a first quality control sample using the target analyte detection instrument to produce a first quality control record; storing the first quality control record by the target analyte detection instrument in the target analyte detection instrument; verifying whether a valid quality control record is stored in the target analyte detection instrument; and preventing the processing of a patient sample by the target analyte detection instrument if there is not a valid quality control record stored in the target analyte detection instrument, wherein processing the patient sample comprises performing a polymerase chain reaction on the patient sample using the target analyte detection instrument.
13. A method for processing at least a first patient sample comprising: a) receiving a first patient sample; b) receiving a first test order by a bi-directional LIS interchange in a first file format from a hospital LIS for the first patient sample, wherein the bidirectional LIS interchange is on a sample processing instrument, and the bi-directional LIS interchange converts the first file format to a second file format; c) loading the first patient sample into a cartridge, the cartridge comprising a machine readable information tag; d) loading the cartridge into the sample processing instrument comprising a first device that scans machine readable identification tags; e) scanning the machine readable identification tag by the first device; and f) processing the first patient sample in the sample processing instrument using the second file format, wherein the sample processing instrument generates; a first result identifying at least one pathogen in the first patient sample processed by the sample processing instrument; and wherein the first result is automatically reported from the bi-directional LIS interchange.
15. The method of claim 14, wherein the preventing step occurs when the patient sample is loaded into a first test cartridge and the first test cartridge is from a new lot.
15. The method of claim 13, wherein the cartridge comprises a second machine readable identification tag and the second machine readable identification tag is scanned by a second device that scans machine readable identification tags prior to loading the cartridge into the sample processing instrument. (The Examiner interprets that the tags are used for managing when to use a new lot.) A portion of claim 15 (of the instant claims) is a contingent limitation in a method claim; see MPEP § 2111.04 II.
16. The method of claim 14, further comprising: releasing the first quality control record to a hospital laboratory information system by the target analyte detection instrument.
15. The method of claim 13, wherein the cartridge comprises a second machine readable identification tag and the second machine readable identification tag is scanned by a second device that scans machine readable identification tags prior to loading the cartridge into the sample processing instrument. (The Examiner interprets management of identification tags to be quality control)
17. The method of claim 14, further comprising: tracking preventative maintenance for the target analyte detection instrument by the target analyte detection instrument.
15. The method of claim 13, wherein the cartridge comprises a second machine readable identification tag and the second machine readable identification tag is scanned by a second device that scans machine readable identification tags prior to loading the cartridge into the sample processing instrument. (The Examiner interprets the management of identification tags to be preventative maintenance for an aspect of the system.)
18. A method for validating a target analyte detection instrument in order to process a first patient sample and a second patient sample comprising: performing a polymerase chain reaction on a first quality control sample using a target analyte detection instrument to produce a first quality control record; storing the first quality control record by the target analyte detection instrument in the target analyte detection instrument; releasing the first quality control record to a hospital laboratory information system by the target analyte detection instrument; receiving a first test order for the first patient sample in a first file format for the first patient sample, and a second test order for the second patient sample in a first file format for the second patient sample, by a bi- directional laboratory information system interchange, wherein the bidirectional laboratory information system interchange is on a target analyte detection instrument, and the bi-directional laboratory information system interchange converts the first file format for the first patient sample to a second file format for the first patient sample, and converts the first file format for the second patient sample to a second file format for the second patient sample; populating the second file format for the first patient sample with a first accession number and populating the second file format for the second patient sample with a second accession number; and performing a polymerase chain reaction on the first sample and the second sample using the target analyte detection instrument when the first accession number and the second accession number are different.
13. A method for processing at least a first patient sample comprising: a) receiving a first patient sample; b) receiving a first test order by a bi-directional LIS interchange in a first file format from a hospital LIS for the first patient sample, wherein the bidirectional LIS interchange is on a sample processing instrument, and the bi-directional LIS interchange converts the first file format to a second file format; c) loading the first patient sample into a cartridge, the cartridge comprising a machine readable information tag; d) loading the cartridge into the sample processing instrument comprising a first device that scans machine readable identification tags; e) scanning the machine readable identification tag by the first device; and f) processing the first patient sample in the sample processing instrument using the second file format, wherein the sample processing instrument generates; a first result identifying at least one pathogen in the first patient sample processed by the sample processing instrument; and wherein the first result is automatically reported from the bi-directional LIS interchange. A portion of claim 18 is a contingent limitation in a method claim; see MPEP § 2111.04 II.
19. The method of claim 18, wherein the first patient sample is in a cartridge for the target analyte detection instrument, the cartridge comprising a first and a second machine readable identification tag, wherein the target analyte detection instrument discontinues processing the first patient sample if the first machine readable identification tag does not match the second machine readable identification tag.
16. The method of claim 15, wherein the sample processing instrument discontinues processing the cartridge if the first machine readable identification tag does not match the second machine readable identification tag.
20. The method of claim 18, wherein processing the first patient sample comprises performing a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles.
20. The method of claim 13, wherein the sample processing instrument performs a single detuned multiplex end-point polymerase chain reaction (PCR) on the first patient sample, the PCR comprising about 30 to about 35 cycles.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 8097416 B2: Pertinent due to sepsis prevention detection of multiple types of bacteria
US 20230392185 A1: Pertinent due to polymicrobial samples, involving inhibition of the microbial samples
US 20210172000 A1: polymicrobial samples, emphasis on determining resistance; electrochemical techniques
US 20200102595 A1: PCR quality control
US 20190051383 A1: Pertinent sepsis alert and decision maker
US 20170211138 A1: Pertinent diagnostic quality control
US 20170204452 A1: Pertinent sepsis detection
US 20170191116 A1: Pertinent polymicrobial samples; same purpose of detection of fungi and bacteria in a PCR sample; by Quest diagnostics
US 20170058430 A1: Bayesian approach to microbiome of a wound
US 20170009297 A1: Biomarkers of sepsis
US 20160239611 A1: sepsis statistical model
US 20110151453 A1: single assay for bacteria and fungus
US 20080145847 A1: sepsis identification
US 20070042355 A1: same purpose, has some laboratory information management; doesn't deal with contamination
US 20050079490 A1: microbial contamination is quantified
US 20040220761 A1: integration of internal and external quality control
US 11274351 B2: generating a report about bacterial contamination
US 10325067 B1: quality control by quest diagnostics
CA 2524086 A1: detection of bacterial contamination in a blood sample... bacterial contamination alert
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/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 September 13, 2025
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