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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on July 16th, 2026 and July 23rd, 2026 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Response to Amendment
The amendment filed July 23rd, 2026 is acknowledged. Regarding the Office Action mailed March 24th, 2026:
The objections to the specification are withdrawn in view of the amendments.
The rejections set forth under 35 U.S.C. 112(b) are withdrawn in view of the amendments and presented arguments.
Maintained, modified, or new rejections are set forth below, as necessitated by the amendments. Responses to arguments, if necessary, follow their respective rejection sections.
Claim Summary
Claims 1-2, 4-5, 7-8, and 10 have been amended. Claims 11-17 have been added. Claims 1-17 are pending. Claims 1-17 are under examination and discussed in this Office action.
Claim Interpretation – Modified – Necessitated by Amendment
Claims 1-17 are drawn to a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system”. Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
Claim Interpretation – 112(f) – Modified – Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claims contain the following limitations:
Claim 1 recites “ (a) data input components configured to…(c) command input components configured to…(d) one or more wash stations configured to…(e) a fluid transfer device configured and controlled to…(f) a thermal processing station configured and controlled to…(g) a detection system configured and controlled to…(h) a reading device configured to…”.
Claim 7 recites “wherein the one or more wash stations are configured to immobilize the first and second analytes on solid supports”.
Claim 8 recites “wherein the one or more wash stations are configured to remove non-immobilized components of the first and second samples while exposing the first and second samples to a magnetic field”.
Claim 9 recites “wherein the one or more wash stations are configured to re-suspend the solid supports in a buffered solution after removing the non-immobilized components of the first and second samples”.
Claim 12 recites “wherein the system is further configured to”.
Claim 15 recites “wherein the detection system is configured to”.
Thus, the cited limitations are drawn to generic means plus function. However, the limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because a review of the specification yields no limiting definition of the generically claimed means.
If applicant intends to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant should indicate where in the specification the specific structure is indicated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Modified – Necessitated by Amendment
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Buse (US 20160060680 A1; cited on the IDS filed February 1st, 2024; previously cited).
Regarding claims 1-10, the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Therefore, the various uses recited in claims 1-10 (e.g., the solid supports of claim 7, among others) fail to define additional structural elements of the claimed system. See MPEP § 2114. As long as the components of the system have structure capable of performing the generic action of the component as claimed, any further description of the component is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
Regarding instant claim 1, Buse teaches an automated system for performing nucleic acid amplification assays on samples provided to the system, wherein the system comprises: (a) data input components configured to enable input specifying one or more user-defined assay parameters (Page 26, paragraph [0308]: “Data input components comprise elements by which data is input for use by the control and computing hardware components.”); (b) data storage media storing a first set of assay parameters, the first set of assay parameters consisting of system-defined parameters, and a second set of assay parameters, the second set of assay parameters including the one or more user-defined parameters (Page 26, paragraph [0308]: “… executing one or more algorithms stored on non-transitory machine-readable media (e.g., software) that provide instruction for manipulating or otherwise acting on the input values…”); (c) command input components configured to enable input specifying (i) that a first nucleic acid amplification assay be performed on a first sample in accordance with the first set of assay parameters, wherein the first nucleic acid amplification assay is an in vitro diagnostic (IVD) assay, and (ii) that a second nucleic acid amplification assay be performed on a second sample in accordance with the second set of assay parameters, wherein the second nucleic acid amplification assay is a lab developed test (LDT) (Page 26, paragraph [0308]: “…manual input elements…”); (d) one or more wash stations configured to produce purified forms of the first and second samples by exposing each of the first and second samples to reagents and conditions sufficient to isolate and purify a first analyte and a second analyte which may be present in the first and second samples, respectively (Page 11, paragraph [0151]); (e) a fluid transfer device configured and controlled to form a first amplification reaction mixture by combining a first amplification reagent specified by the first set of assay parameters with the purified form of the first sample and form a second amplification reaction mixture by combining a second amplification reagent specified by the second set of assay parameters with the purified form of the second sample (Page 11, paragraph [0152]); (f) a thermal processing station configured and controlled to expose the first amplification reaction mixture to first amplification conditions specified by the first set of assay parameters and to expose the second amplification reaction mixture to second amplification conditions specified by the second set of assay parameters (Pages 11-12, paragraph [0158]; Page 16, paragraph [0198]-[0200]); (g) a detection system configured and controlled to, during or after the first and second amplification reaction mixtures are exposed to the first and second amplification conditions, respectively, detect the presence or absence of the first analyte in the first amplification reaction mixture and determine the presence or absence of the second analyte in the second amplification reaction mixture (Page 11, paragraph [0154]; Page 11, paragraph [0157]; Page 16, paragraph [0198]-[0200]); and (h) a reading device configured to read machine-readable indicia identifying which nucleic acid amplification assay to perform on the first and second samples (Pages 22-23, paragraph [0262]; Page 25, paragraph [0299]).
With respect to part (i) of claim 1, Buse teaches a computer controller and a non-transitory computer readable medium encoded with computer-executable instructions that cause the system to perform automated processes (Page 26, paragraphs [0308]: “computing and control modules”; Page 26, paragraph [0309]: “Software comprises instructions stored on non-transitory computer-readable media which, when executed by the control and computing hardware, cause the control and computing hardware to perform one or more automated or semi-automated processes.”). Buse further teaches an automated biological process, such as a PCR reaction (Page 25, paragraph [0292]). Buse further teaches on the system dissolving reaction reagents in solvent (Page 23, paragraph [0263]), forming reaction mixtures for PCR (Page 23, paragraph [0263]), and performing PCR reactions on different samples (Page 25, paragraphs [0299]-[0301]). Therefore, the system of Buse is considered capable of performing steps as claimed in part (i), steps (1)-(8).
With respect to the order of steps, it is noted that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Therefore, the claimed order of steps in part (i) of claim 1 is an obvious variant of the steps of the cited prior art.
Furthermore, it is noted that the courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958); See MPEP 2144.04 III). Thus, automating the claimed steps in part (i) of claim 1 using software is obvious.
Overall, Buse does not specifically teach all of these aspects as directly involved in the same embodiment. However, given that Buse does teach all aspects as cited above, it is obvious that they could be used together in one system. This amounts to combining prior art elements according to known methods to yield predictable results (see MPEP 2141(III)).
Regarding instant claim 2, Buse teaches the system of claim 1. Buse further teaches wherein the system includes one or more receptacle-holding racks supporting receptacles containing the first and second samples (Page 10, paragraph [0148]).
It is noted that given the presented claim language, and the Applicant’s statements regarding the receptacles and samples being an intended use of the system (see Page 11 of the Remarks filed July 23rd, 2026), the receptacles containing the first and second samples are not considered part of the system. Therefore, receptacles containing the first and second samples are considered an “intended use” of the system that does not add further structural limitations to the system. However, Buse includes teachings of receptacles containing samples and thus citations have been included to those teachings.
Regarding instant claim 3, Buse teaches the system of claim 1. Buse further teaches wherein command input components comprise a keyboard (Page 26, paragraph [0308]: “…manual input elements, such as…keyboards…”). Buse also teaches wherein the data input components comprise a graphical user interface (Page 26, paragraph [0308]: “…data inputs may comprise…manual input elements, such as graphic user interfaces…”).
Regarding instant claim 4, Buse teaches the system of claim 1. Buse further teaches wherein the one or more user-defined parameters includes parameters used to process data generated by the detection system (Page 26, paragraph [0308]: “Data input components comprise elements by which data is input for use by the control and computing hardware components.”).
It is noted that given the previously cited teaching of data input components, which are reasonably capable of specifying user-defined assay parameters, any other specifics as described in claim 4 are considered “intended use” of the system and do not add further structural limitations to the system.
Regarding instant claim 5, Buse teaches the system of claim 1. Buse further teaches wherein the first and second nucleic acid amplification assays each comprise a PCR reaction, wherein the user-defined parameters include a thermal profile effected by the thermal processing station, and wherein a first thermal profile of the first nucleic acid amplification assay is the same as or different than a second thermal profile of the second nucleic acid amplification assay (Pages 11-12, paragraph [0158]; Page 16, paragraph [0198]-[0200]).
Regarding instant claim 6, Buse teaches the system of claim 5. Buse further teaches wherein the thermal profiles of the first and second nucleic acid amplification assays differ by at least one of cycle number, time to completion, a denaturation temperature, an annealing temperature, and an extension temperature (Pages 11-12, paragraph [0158]; Page 16, paragraph [0198]-[0200]).
Regarding instant claim 7, Buse teaches the system of claim 1. Buse further teaches wherein the one or more wash stations are configured to immobilize the first and second analytes on solid supports (Page 11, paragraph [0151]).
It is noted that given the previously cited teaching of the structure of one or more wash stations, any other specifics as described in claim 7 are considered “intended use” of the system and do not add further structural limitations to the system. For instance, the magnetic solid supports are not part of the system or required by the claim. These are considered an “intended use” of the system and do not add further structural limitations to the system. However, Buse includes teachings of these limitations and thus citations have been included to those teachings.
Regarding instant claim 8, Buse teaches the system of claim 6. Buse further teaches wherein the solid supports are magnetically-responsive, and wherein the one or more wash stations are configured to remove non-immobilized components of the first and second samples while exposing the first and second samples to a magnetic field (Page 11, paragraph [0151]; Page 19, paragraph [0229]).
It is noted that given the previously cited teaching of the structure of one or more wash stations, any other specifics as described in claim 8 are considered “intended use” of the system and do not add further structural limitations to the system. For instance, the magnetic solid supports are not part of the system or required by the claim. These are considered an “intended use” of the system and do not add further structural limitations to the system. However, Buse includes teachings of these limitations and thus citations have been included to those teachings.
Regarding instant claim 9, Buse teaches the system of claim 8. Buse further teaches wherein the magnetic field is supplied by the same source for the first and second samples (Page 19, paragraph [0230]), and wherein the one or more wash stations are configured to re-suspend the solid supports in a buffered solution after removing the non-immobilized components of the first and second samples (Pages 23-24, paragraph [0274]).
It is noted that given the previously cited teaching of the structure of one or more wash stations, any other specifics as described in claim 9 are considered “intended use” of the system and do not add further structural limitations to the system. For instance, the magnetic solid supports are not part of the system or required by the claim. These are considered an “intended use” of the system and do not add further structural limitations to the system. However, Buse includes teachings of these limitations and thus citations have been included to those teachings.
In addition, it is noted for the second limitation that the courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)). See MPEP 2144.04 III.
Regarding instant claim 10, Buse teaches the system of claim 1. Buse further teaches wherein the second solvent is contained in a vial supported by a first holder of the system (Page 10, paragraph [0148]).
It is noted that given the presented claim language, and the Applicant’s statements regarding the vial being a disposable reagent (see Page 12 of the Remarks filed July 23rd, 2026), the vial and its contents are not considered part of the system. Therefore, the vial and its contents are considered an “intended use” of the system that does not add further structural limitations to the system. However, Buse includes teachings of reagent containers in holders and thus citations have been included to those teachings.
Response to Arguments
Applicant's arguments filed July 23rd, 2026 have been fully considered but they are not persuasive.
The Applicant first provides a summary of the previous rejections (Page 13 of the Remarks filed July 23rd, 2026). The Applicant then provides a detailed explanation of the newly amended aspects of claim 1, arguing that the automated system comprises components for performing the combination of an IVD assay and an LDT assay and benefits thereof represent key features of the claimed automated system that the cited document lacks (Page 14 of the Remarks filed July 23rd, 2026). The Applicant provides more detail related to the system and how it processes IVD and LDT assays in an interleaved and continuous manner (Pages 14-15 of the Remarks filed July 23rd, 2026). The Applicant argues that the benefits discussed present a distinct advantage over the state of the art and are made possible given the steps as claimed in claim 1 (Page 15 of the Remarks filed July 23rd, 2026). The Applicant argues that Buse does not disclose a non-transitory computer readable medium encoded with computer-executable instructions to perform steps 1 and 2 of part (i) as claimed in claim 1 (Pages 15-16 of the Remarks filed July 23rd, 2026). The Applicant then provides several previously cited paragraphs of Buse, noting that none of these citations teach on the non-transitory computer readable medium encoded with computer-executable instructions to perform steps 1 and 2 of part (i) as claimed in claim 1, or alternatively parts (c) and (i) of claim1 as a whole (Pages 16-18 of the Remarks filed July 23rd, 2026). The Applicant concludes that Buse is silent regarding at least the particular system features (c) and (i) related to performing and IVD assay and an LDT assay and computer-executable instructions encoded on a non-transitory computer readable medium for achieving the same (Page 18 of the Remarks filed July 23rd, 2026). The Applicant then cites aspects of the MPEP related to determining obviousness, concluding that given the missing claim elements, one of ordinary skill in the art would have had no motivation to pursue the particular automated system recited in claim 1 nor have any expectation of achieving the unexpected benefits of the claimed system (Pages 18-19 of the Remarks filed July 23rd, 2026). The Applicant the summarizes the arguments, stating that nothing in Buse would teach or suggest the aspects of parts (c) and (i) of claim 1, and that without any suggestion that is both clear and particular as required, there is no motivation or reasonable expectation of achieving the claimed automated system (Page 19 of the Remarks filed July 23rd, 2026).
In response to these arguments, it is first noted that given the above 103 analysis, Buse is considered to teach the aspects of part (i) of claim 1. Buse teaches on both a computer controller and a non-transitory computer readable medium with executable instructions for automated processes, one of which is a biological automated process like PCR. Buse further teaches steps of dissolving reagents, mixing reagents, and running amplification. Any order of steps is prima facie obvious in the absence of new or unexpected results, as cited above, and the steps as claimed result in the expected results of amplification of samples. There is no new or unexpected result achieved. Therefore, this argument is not persuasive.
In response to the Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Buse teaches all aspects of the system as claimed. Therefore, there is sufficient motivation to pursue the claimed automated system with a reasonable expectation of success.
In response to the Applicant's argument that the system features of part (c) of claim 1 are not taught by Buse, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As analyzed above, Buse teaches on command input components capable of enabling input. All other aspects as claimed (e.g., the specific assay parameters) are intended uses of these command input components, and therefore do not add structure to the system as claimed.
Finally, in response to the Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., improved analytical flexibility and overall utility) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
New – Necessitated by Amendment
Claims 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Buse (US 20160060680 A1; cited on the IDS filed February 1st, 2024; previously cited), as applied to claims 1-10 and further applied below.
Regarding claims 11-17, it is reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in claims 11-17 (e.g., the vials of claims 11 and 12, the analytes of claim 15, among others) fail to define additional structural elements of the claimed system. As long as the components of the system have structure capable of performing the generic action of the component as claimed, any further description of the component is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
Regarding instant claim 11, Buse teaches the system of claim 10. Buse further teaches wherein the first holder supports a plurality of vials, wherein at least one of the vials contains a solvent that includes a set of primers not contained in the second solvent (Page 10, paragraph [0148]).
It is noted that given the presented claim language, and the Applicant’s statements regarding a vial being a disposable reagent (see Page 12 of the Remarks filed July 23rd, 2026), the vials and their contents are not considered part of the system. Therefore, the vials and their contents are considered an “intended use” of the system that do not add further structural limitations to the system. However, Buse includes teachings of reagent containers in holders and thus citations have been included to those teachings.
Regarding instant claim 12, Buse teaches the system of claim 11. Buse further teaches wherein the system is further configured to associate the vial containing the second solvent in the first holder with the second nucleic acid amplification assay upon receiving instructions to do so (Pages 22-23, paragraph [0262]; Page 25, paragraph [0299]).
It is noted that given the previously cited teaching of the structure a reading device configured to read machine-readable indicia identifying which nucleic acid amplification assay to perform, any other specifics as described in claim 12 are considered “intended use” of the system and do not add further structural limitations to the system.
Regarding instant claim 13, Buse teaches the system of claim 10. Buse further teaches wherein the first solvent is contained in a second holder of the system having a sealed fluid reservoir and an access chamber that are fluidly connected, and wherein the access chamber is accessible by the fluid transfer device for removing the first solvent from the second holder (Page 10, paragraph [0147]).
Regarding instant claim 14, Buse teaches the system of claim 1. Buse further teaches wherein the first and second amplification reagents are stored and dissolved in mixing wells of the same or different reagent packs of the system, and wherein each reagent pack includes multiple mixing wells (Pages 12-13, paragraph [0167]).
Regarding instant claim 15, Buse teaches the system of claim 5. Buse further teaches wherein the detection system is configured to determine (i) the presence or amount of the first analyte in the first amplification reaction mixture in real-time with the thermal profile of the first nucleic acid amplification assay and (ii) the presence or amount of the second analyte in the second amplification reaction mixture in real-time with the thermal profile of the second nucleic acid amplification assay (Page 7, paragraph [0118]; Page 11, paragraph [0154]; Page 11, paragraph [0157]; Page 16, paragraph [0198]-[0200]).
It is noted that given the presented claim language, the limitations related to the specifics of the first or second analyte and first or second amplification assay are not considered part of the system as they are considered an “intended use” of the system. These analytes and parameters do not add further structural limitations to the system beyond the system’s ability to perform real-time amplification assays. However, Buse includes teachings of real-time amplification and thus citations have been included to those teachings.
Regarding instant claim 16, Buse teaches the system of claim 1. Buse further teaches wherein the first and second amplification reaction mixtures are formed in first and second reaction receptacles, respectively (Page 11, paragraph [0152]; Page 11, paragraph [0154]; Page 11, paragraph [0157]; Pages 11-12, paragraph [0158]; Page 16, paragraph [0198]-[0200]).
It is noted that given the previously cited teaching of the structures of a fluid transfer device, a thermal processing station, and a detection system, as well as the Applicant’s statements regarding receptacles being an intended use of the system (see Page 11 of the Remarks filed July 23rd, 2026), the limitations of claim 16 are considered an “intended use” of the system and do not add further structural limitations to the system. Therefore, the provided citations to the teachings of a fluid transfer device, a thermal processing station, and a detection system are considered to teach claim 16.
Regarding instant claim 17, Buse teaches the system of claim 16. Buse further teaches wherein each of the first and second reaction receptacles is a distinct, individual receptacle that is not physically connected to any other reaction receptacle as part of an integral unit (Page 11, paragraph [0152]; Page 11, paragraph [0154]; Page 11, paragraph [0157]; Pages 11-12, paragraph [0158]; Page 16, paragraph [0198]-[0200]).
It is noted that given the previously cited teaching of the structures of a fluid transfer device, a thermal processing station, and a detection system, as well as the Applicant’s statements regarding receptacles being an intended use of the system (see Page 11 of the Remarks filed July 23rd, 2026), the limitations of claim 17 are considered an “intended use” of the system and do not add further structural limitations to the system. Therefore, the provided citations to the teachings of a fluid transfer device, a thermal processing station, and a detection system are considered to teach claim 17.
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 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 9-10, 13, 24, 26, 29-31, 33-36, 38-39, 43-44, 46-53, 56-68, 70-79 of copending Application No. 16629818, in view of Buse (US 20160060680 A1; cited on the IDS filed February 1st, 2024; previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim amplification oligomers; performing an amplification assay on first samples and second samples using system-defined parameters and user-defined-parameters respectively; purifying first and second samples; dissolving amplification reagents that contain a polymerase and either first sets of amplification oligomers or second sets of amplification oligomers in first and second solvents that do not contain polymerase or amplification oligomers; forming first and second amplification reaction mixtures; exposing mixtures to thermal conditions for amplification; detecting analytes in the reaction mixtures; inputs of a touch screen or keyboard; receptacles and receptacle-holding racks; user-defined parameters for processing detection data; thermal profiles; sealed fluid reservoirs and access chambers fluidly connected; amplification reagents stored and dissolved in mixing wells of reagent packs; machine-readable indicia to identify assay to perform; vials containing solvents; and distinct reaction receptacles for first and second samples.
The applications mainly differ in that the instant application is directed to a system for performing nucleic acid amplification assays, while the ‘818 application is directed to a method of performing nucleic acid amplification assays in an automated analyzer. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of the instant application can be used for the method of ‘818 application. See In re Venner, 262 F.2d 91, 120 USPQ 193 (CCPA (1958), where the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
The ‘818 application claims do not require the data input components, data storage media, command input components, a fluid transfer device, a reading device, a computer controller and a non-transitory computer readable medium encoded with instructions, the non-transitory computer readable medium instructions set forth in steps (1)-(8) of claim 1, aspects of the solid supports being magnetically-responsive, a magnetic field, re-suspending solid supports after removing non-immobilized components, associating solvents with assays, determining presence of analytes with real-time amplification assays as claimed in the instant application, and reaction receptacles that are not physically connected. However, Buse does teach these limitations, as discussed in the above 103 rejections, obviating these variations. One of ordinary skill in the art would be motivated to make these variations because Buse provides an improved method of preparing reaction mixtures within the workflow of an automated instrument (Page 5, paragraph [0062]). Any additional limitations of the claims of Application No. 16629818 are encompassed by the open claim language “comprising” found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-33, 35-37, 40-55, and 57 of copending Application No. 18361763, in view of Buse (US 20160060680 A1; cited on the IDS filed February 1st, 2024; previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim purifying a sample; forming first and second amplification reaction mixtures; exposing mixtures to thermal conditions for amplification; detecting analytes in the reaction mixtures in real-time; dissolving non-liquid amplification reagents with a first solvent for a reaction mixture; performing an amplification assay on a sample; user-defined parameters for processing detection data; immobilizing analytes on magnetically-responsive solid supports; removing non-immobilized components after exposing samples to a magnetic field; re-suspending solid supports after removing non-immobilized components; receptacles and receptacle-holding racks; thermal profiles; vials and holders; sealed fluid reservoirs and access chambers fluidly connected; a fluid transfer device; amplification reagents stored and dissolved in mixing wells of reagent packs; and real-time determining.
The applications mainly differ in that the instant application is directed to a system for performing nucleic acid amplification assays, while the ‘763 application is directed to a method for analyzing samples using an automated analyzer. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of the instant application can be used for the method of ‘763 application. See In re Venner, 262 F.2d 91, 120 USPQ 193 (CCPA (1958), where the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
The ‘763 application claims do not require the data input components, data storage media, command input components, system-defined parameters and user-defined-parameters, input components of a touch screen, keyboard, or graphical user interface, a reading device and machine-readable indicia to identify assay to perform, a computer controller and a non-transitory computer readable medium encoded with instructions, the non-transitory computer readable medium instructions set forth in steps (1)-(8) of claim 1, associating solvents with assays, and first and second reaction receptacles that are not physically connected as claimed in the instant application. However, Buse does teach these limitations, as discussed in the above 103 rejections, obviating these variations. One of ordinary skill in the art would be motivated to make these variations because Buse provides an improved method of preparing reaction mixtures within the workflow of an automated instrument (Page 5, paragraph [0062]). Any additional limitations of the claims of Application No. 18361763 are encompassed by the open claim language “comprising” found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19021925, in view of Buse (US 20160060680 A1; cited on the IDS filed February 1st, 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim purifying first and second samples; forming first and second amplification reaction mixtures; exposing mixtures to thermal conditions for amplification; detecting analytes in the reaction mixtures; immobilizing first or second analytes on magnetically-responsive solid supports; removing non-immobilized components after exposing samples to a magnetic field; re-suspending solid supports after removing non-immobilized components; dissolving amplification reagents that contain a polymerase and a first set of amplification oligomers with a first solvent that does not contain oligomers or polymerase for the first reaction mixture; dissolving amplification reagents that contain a polymerase with a second solvent that contains oligomers, but not polymerase for the second reaction mixture; receptacles and receptacle-holding racks; thermal profiles; sealed fluid reservoirs and access chambers fluidly connected; a fluid transfer device; amplification reagents stored and dissolved in mixing wells of reagent packs; vials and holders; and distinct reaction receptacles for first and second samples.
The applications mainly differ in that the instant application is directed to a system for performing nucleic acid amplification assays, while the ‘925 application is directed to a method of performing nucleic acid amplification assays in an automated analyzer. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of the instant application can be used for the method of ‘818 application. See In re Venner, 262 F.2d 91, 120 USPQ 193 (CCPA (1958), where the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
The ‘925 application claims do not require the data input components, data storage media, command input components, aspects related to specific data and command input components, aspects related to user-defined and system-defined parameters, aspects related to the detecting steps being real-time detection as claimed in the instant application, a reading device and machine-readable indicia to identify assay to perform, a computer controller and a non-transitory computer readable medium encoded with instructions, the non-transitory computer readable medium instructions set forth in steps (1)-(8) of claim 1, associating solvents with assays, determining presence of analytes with real-time amplification assays, and first and second reaction receptacles that are not physically connected as claimed in the instant application. However, Buse does teach these limitations, as discussed in the above 103 rejections, obviating these variations. One of ordinary skill in the art would be motivated to make these variations because Buse provides an improved method of preparing reaction mixtures within the workflow of an automated instrument (Page 5, paragraph [0062]). Any additional limitations of the claims of Application No. 19021925 are encompassed by the open claim language “comprising” found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19022701, in view of Buse (US 20160060680 A1; cited on the IDS filed February 1st, 2024; previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim purifying first and second samples; forming first and second amplification reaction mixtures; exposing mixtures to thermal conditions for amplification; detecting analytes in the reaction mixtures; dissolving amplification reagents that contain a first set of amplification oligomers with a first solvent for the first reaction mixture; dissolving amplification reagents that do not contain amplification oligomers with a second solvent for the second reaction mixture; performing an amplification assay on first samples and second samples using system-defined parameters and user-defined-parameters respectively; inputs of a touch screen or keyboard; user-defined parameters for processing detection data; immobilizing first or second analytes on magnetically-responsive solid supports; removing non-immobilized components after exposing samples to a magnetic field; re-suspending solid supports after removing non-immobilized components; receptacles and receptacle-holding racks; thermal profiles; sealed fluid reservoirs and access chambers fluidly connected; a fluid transfer device; amplification reagents stored and dissolved in mixing wells of reagent packs; machine-readable indicia to identify assay to perform; and distinct reaction receptacles for first and second samples.
The applications mainly differ in that the instant application is directed to a system for performing nucleic acid amplification assays, while the ‘701 application is directed to a method for analyzing samples using an automated analyzer. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of the instant application can be used for the method of ‘701 application. See In re Venner, 262 F.2d 91, 120 USPQ 193 (CCPA (1958), where the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
The ‘701 application claims do not require the data input components, data storage media, command input components, a reading device, a computer controller and a non-transitory computer readable medium encoded with instructions, the non-transitory computer readable medium instructions set forth in steps (1)-(8) of claim 1, associating solvents with assays, determining presence of analytes with real-time amplification assays, and first and second reaction receptacles that are not physically connected as claimed in the instant application. However, Buse does teach these limitations, as discussed in the above 103 rejections, obviating these variations. One of ordinary skill in the art would be motivated to make these variations because Buse provides an improved method of preparing reaction mixtures within the workflow of an automated instrument (Page 5, paragraph [0062]). Any additional limitations of the claims of Application No. 19022701 are encompassed by the open claim language “comprising” found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19027072, in view of Buse (US 20160060680 A1; cited on the IDS filed February 1st, 2024; previously cited). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications claim purifying multiple samples by immobilizing nucleic acids of interest on magnetically-responsive solid supports; forming amplification reaction mixtures; dissolving amplification reagents with a fluid transfer device; exposing mixtures to thermal conditions for amplification; and detecting nucleic acids in the reaction mixtures with real-time amplification.
The applications mainly differ in that the instant application is directed to a system for performing nucleic acid amplification assays, while the ‘072 application is directed to an automated method for analyzing a plurality of samples. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the system of the instant application can be used for the method of ‘818 application. See In re Venner, 262 F.2d 91, 120 USPQ 193 (CCPA (1958), where the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
The ‘072 application claims do not require data input components; data storage media; command input components; dissolving amplification reagents that contain a polymerase and a first set of amplification oligomers with a first solvent that does not contain oligomers or polymerase for the first reaction mixture; dissolving amplification reagents that contain a polymerase with a second solvent that contains oligomers, but not polymerase for the second reaction mixture; performing an amplification assay on first samples and second samples using system-defined parameters and user-defined-parameters respectively; inputs of a graphical user interface, touch screen, or keyboard; user-defined parameters for processing detection data; removing non-immobilized components after exposing samples to a magnetic field; re-suspending solid supports after removing non-immobilized components; receptacles and receptacle-holding racks; thermal profiles; sealed fluid reservoirs and access chambers fluidly connected; amplification reagents stored and dissolved in mixing wells of reagent packs; a reading device and machine-readable indicia to identify assay to perform; a computer controller and a non-transitory computer readable medium encoded with instructions; the non-transitory computer readable medium instructions set forth in steps (1)-(8) of claim 1; associating solvents with assays; first and second reactions in first and second receptacles; or first and second reaction receptacles that are not physically connected as claimed in the instant application. However, Buse does teach these limitations, as discussed in the above 103 rejections, obviating these variations. One of ordinary skill in the art would be motivated to make these variations because Buse provides an improved method of preparing reaction mixtures within the workflow of an automated instrument (Page 5, paragraph [0062]). Any additional limitations of the claims of Application No. 19027072 are encompassed by the open claim language “comprising” found in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed July 23rd, 2026 have been fully considered but they are not persuasive.
For each provisional rejection, the Applicant has requested the Examiner hold the rejection in abeyance until such time as there is an indication of allowability (Pages 19-21 of the Remarks filed July 23rd, 2026). The Applicant states that only at that time will the Applicant be able to determine if non-statutory double patenting is applicable, in view of the provisions of MPEP 808(I)(B)(1)(b)(ii) and given that the claims may be further amended during prosecution of the instant applicant and the corresponding reference applications (Pages 19-21 of the Remarks filed July 23rd, 2026).
In response, these statements are acknowledged. However, the rejections have been modified as necessitated by amendment and maintained as they are still considered to be patentably indistinct in view of Buse.
With regard to the specification rejection over claim 1 of copending U.S. Application No. 19/027,072, the Applicant has requested reconsideration in view of the amended claims presented above (Page 21 of the Remarks filed Justy 23rd, 2026). It appears that this response is directed to the amendments addressed earlier with regard to the rejections under U.S.C. 103. In response, it is noted that this argument relies on alleged deficiencies previously addressed, which are unpersuasive for the reasons discussed above. Therefore, the claims remained rejected as previously presented.
Conclusion
All claims stand rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
