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 February 1st, 2024; February 29th, 2024; June 14th, 2024; August 7th, 2024; August 15th, 2024; October 4th, 2024; December 12th, 2024; January 30th, 2025; April 23rd, 2025; May 16th, 2025; September 16th, 2025; December 17th, 2025; and February 12th, 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.
Claim Summary
Claims 1-10 are pending. Claims 1-10 are under examination and discussed in this Office action.
Specification
The abstract of the disclosure is objected to because the abstract is too long (160 words). The Applicant is reminded that the abstract should be generally limited to a single paragraph within the range of 50 to 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of terms such as Panther, Panther Fusion, and Invader Plus, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claims 1-10 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)
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…”.
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 10 recites “wherein the system is further configured and controlled 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 § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 5, and 7-10 are 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.
Claim 2 recites the limitation “wherein the first and second samples are provided to the system in sample-containing receptacles supported by one or more receptacle-holding racks in the system”. It is unclear from this recitation if the wording of “are provided” following “the first and second samples” indicates that the samples are part of the structure of the system or if their inclusion is an intended use of the system. It is also unclear if the receptables are intended to be part of the structure of the system given that they are only described as “supported by” a structure of the system. For the purpose of compact prosecution, all aspects of the claim are interpreted as “intended uses” of the system, except for the receptable-holding racks which are clearly stated as part of the system and adequately represent a further structural limitation.
Regarding claims 5, 7, and 10, the word "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of compact prosecution, any limitations following the word “preferably” in the noted claims will be interpreted as not being required for the claimed system.
Claim 8 and 9 both recite limitations related to a “magnetic field”. It is unclear from these recitations if the magnetic field is intended to be part of the structure of the system given that there is no clear nexus between it and a previously described structural component of the system. For the purpose of compact prosecution, given the current lack of clear nexus between the magnetic field and a structural component of the system as currently claimed, this will be interpreted as an “intended use” of the system and not a required structural component.
Claim 10 recites the limitation “wherein the system is further configured and controlled to”, followed by a number of other limitations. It is unclear from this recitation what part of the system is intended to be associated with the limitations of claim 10. Given that the claims recite structural limitations of the system, these recited limitations do not appear to add any structural limitations to those already described in claim 1. For the purpose of compact prosecution, structural limitations of the system as described in claim 1 will be interpreted to be carrying out the limitations added by claim 10, namely the fluid transfer device and thermal processing station. As long as a structural component is capable of performing the generic action of the limitation, any other description will be considered an “intended use” of the component.
Claim 10 further recites limitations that refer to vials and holders. It is unclear from these recitations if the vials and holders are intended to be part of the structure of the system given that there is no clear nexus between them and a previously described structural component of the system. For the purpose of compact prosecution, given the current lack of clear nexus between the vials and holders and a structural component of the system as currently claimed, they will be interpreted as “intended uses” of the system and not required structural components.
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.
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).
Regarding all the presented claims, 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, the magnetic field of claims 8 and 9, claim 10 as a whole) 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, and (ii) that a second nucleic acid amplification assay be performed on a second sample in accordance with the second set of assay parameters (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]); and (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]).
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 would be 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 first and second samples are provided to the system in sample-containing receptacles supported by one or more receptacle-holding racks in the system (Page 10, paragraph [0148]).
It is noted given the 112(b) interpretation of claim 2 provided above, all limitations of the claim besides the receptable-holding rack are considered “intended uses” of the system as they do not add further structural limitations. However, Buse includes teachings of these limitations 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, wherein a thermal profile of the first nucleic acid amplification assay is the same as or different than a thermal profile of the second nucleic acid amplification assay (Pages 11-12, paragraph [0158]; Page 16, paragraph [0198]-[0200]), preferably wherein the detection system is configured to determine the presence or absence of the first analyte in the first amplification reaction mixture in real-time during the thermal profile of the first nucleic acid amplification assay, and determine the presence or absence of the second analyte in the second amplification reaction mixture in real-time during the thermal profile of the second nucleic acid amplification assay (Page 11, paragraph [0154]; Page 11, paragraph [0157]; Page 16, paragraph [0198]-[0200]).
It is noted given the 112(b) interpretation of claim 5 provided above, any limitations following the word “preferably” are not required by the claim. However, Buse includes teachings of these limitations and thus citations have been included to those teachings.
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, and preferably wherein the solid supports are magnetically-responsive (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. Furthermore, given the 112(b) interpretation of claim 8 provided above, the magnetic field is not considered part of the system. 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. Furthermore, given the 112(b) interpretation of claim 9 provided above, the magnetic field is not considered part of the system. 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 system is further configured and controlled to: prior to forming the first amplification reaction mixture, dissolve a first non-liquid reagent containing a polymerase and the first set of amplification oligomers, wherein the first non-liquid reagent is dissolved with a first solvent, and wherein the first solvent does not contain an amplification oligomer or a polymerase; and prior to forming the second amplification reaction mixture, dissolve a second non-liquid reagent containing a polymerase, wherein the second non-liquid reagent is dissolved with a second solvent containing the second set of amplification oligomers, and wherein the second non-liquid reagent does not contain any amplification oligomers, preferably wherein the second solvent is contained in a vial supported by a first holder, preferably wherein the first holder supports a plurality of vials, wherein at least one of the vials contain a solvent that includes a set of amplification oligomers not contained in the second solvent, preferably wherein the system is further configured and controlled to associate a vial in the first holder with the second nucleic acid amplification assay upon receiving instructions to do so, preferably wherein the first solvent is contained in a second holder having a sealed fluid reservoir and an access chamber that are fluidly connected, the access chamber being accessible by the fluid transfer device for removing the first solvent from the second holder, and preferably wherein the first and second non-liquid reagents are stored and dissolved in mixing wells of the same or different reagent packs, each reagent pack including multiple mixing wells (Page 24, paragraphs [0284]-[0285]).
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.
It is also noted that given the previously cited teaching of a fluid transfer device and a thermal processing station, which are reasonably capable of transferring liquids to dissolve reagents and holding receptacles for amplification assays, all specifics as described in claim 10 are considered “intended use” of the system and do not add further structural limitations to the system. Furthermore, given the 112(b) interpretations of claim 10 provided above, any limitations following the word preferably are not required by the claim and therefore not required to be taught, and any limitation reciting vials and holders are not considered part of the system, considered an “intended use”, and do not add further structural limitations to the system.
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 1-10 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). 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; and amplification reagents stored and dissolved in mixing wells of reagent packs.
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, aspects of the solid supports being magnetically-responsive, a magnetic field, or re-suspending solid supports after removing non-immobilized components 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. 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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 18361763, 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 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; and amplification reagents stored and dissolved in mixing wells of reagent packs.
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, or input components of a touch screen, keyboard, or graphical user interface 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 1-10 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; and amplification reagents stored and dissolved in mixing wells of reagent packs.
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, or aspects related to the detecting steps being real-time detection 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 1-10 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). 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; and amplification reagents stored and dissolved in mixing wells of reagent packs.
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, or command input components 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 1-10 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). 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; or amplification reagents stored and dissolved in mixing wells of reagent packs 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.
Conclusion
All claims stand rejected.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683