DETAILED ACTION
Notice of AIA Status
The present application, filed on 7/10/2023, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-21 are rejected.
Claims 12-18 are objected to.
Claim Interpretation
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 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
(1) the imaging position configured to receive the sample carrier in claim 1;
(2) the annealing position configured to receive the sample carrier in claim 1;
(3) the at least one storage position being configured to receive a removable storage container for a pipetting liquid of the pipetting liquids in claim 8;
(4) the pipetting unit is configured to pipet the at least one sample receiving compartment when the sample carrier is received in the pipetting position in claim 5;
(5) the pipetting position being configured to receive the sample carrier in claim 9;
(6) the sample transfer unit configured to transfer the sample carrier between at least two of the imaging position the annealing position), and/or a pipetting position in claim 12; and
(7) the loading position being configured to receive the sample carrier in claim 17.
The claim limitations listed above are interpreted under 35 U.S.C. §112(f) because each limitation recites a generic placeholder term (e.g. position) coupled with functional language but fails to recite sufficient structure for performing the recited functions. For example the term imaging position merely denotes a location within the device and does not identify any structure capable of performing the function of receiving sample carrier. Similarly, the annealing position, storage position, loading position and pipetting position describe only locations where functions occur rather than structural components that perform those functions. As a result, the limitations are interpreted under 35 U.S.C. 112(f) as follows:
The corresponding structure for (1) disclosed in the instant specification is the sample stage 142 described in [0040], which recites “The sample stage 142 may be configured to receive the sample carrier 106”. Regarding the location of the sample stage see [0014], which recites “the imaging position and the annealing position may also coincide”.
The corresponding structure for (2) disclosed in the instant specification is the sample stage 142 described in [0040].
The corresponding structure for (3) is slots as illustrated in Fig. 1.
The corresponding structure for (4) is slots as illustrated in Fig. 1.
The corresponding structure for (5) is a pipetting robot described in [0023].
The corresponding structure for (6) is the sample stage 142 described in [0040].
The corresponding structure for (7) is the sample stage 142 described in [0040]. Regarding the location of the sample stage see [0014], which recites “the imaging position and the annealing position may also coincide”, see also [0029], which recites “The annealing position may be configured as a loading position”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 12-18 are objected to because of the following informalities:
Claim 12 recites “at least two of the imaging position the annealing position ) and/or a pipetting position”. For the sake of clarity, consider rephrasing to “at least the imagining position, the annealing position and a pipetting position’.
In addition, claim 14 recites “a housing, the housing enclosing at least the imaging position, the annealing position, and/or a pipetting position”. For the sake of clarity, consider rephrasing to ‘a housing enclosing one of the group consisting of the imaging position, the annealing position, and a pipetting position; or a combination thereof’.
Claims dependent on an objected base claim are objected to because any claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5 and 10-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wohlstadter (US20210033523).
With respect to claim 1, Wohlstadter (US20210033523) teaches an imaging device (reader 1700 in [0505]) for imaging samples received in a sample carrier (multi-well assay plate 1710 in [0509]), the imaging device (reader 1700) comprising:
an imaging position (plate carrier 1740 in [0501]) configured to receive the sample carrier (multi-well assay plate 1710), the sample carrier (multi-well assay plate 1710) comprising at least one sample receiving compartment (multi well) configured to receive a sample (see [0005], which recites “samples and reagents are stored, processed and/or analyzed in multi-well assay plates”);
an optical detection system (photodetector 1706 in [0058]) configured to image the sample when the sample carrier (multi-well assay plate 1710) is received in the imaging position (plate carrier 1740);
an annealing position (plate carrier 1740 in [0501]) configured to receive the sample carrier (multi-well assay plate 1710) (the plate carrier position for annealing and the plate carrier position for imaging coincides in Wohlstadter); and
a temperature control unit (temperature controller in [0497]) configured to control a temperature of the sample receiving compartment when the sample carrier is received in the annealing position (see [0497], which recites “a temperature controller to control the temperature within the well”).
With respect to claim 2, Wohlstadter teaches the imaging device according to claim 1, wherein the sample carrier (muti-well assay plate 1710) comprises at least two sample receiving compartments (muti-well), each sample receiving compartment being (multi well) configured to receive a respective sample (see Fig. 17), and wherein the temperature control unit (temperature controller in [0497]) is configured to control the temperature of each of the at least two sample receiving compartments (multi well) individually (see [0497], which recites “a temperature controller to control the temperature within the well”).
With respect to claim 3, Wohlstadter teaches the imaging device according to claim 1, wherein the temperature control unit (temperature controller) is configured to adjust the temperature of the at least one sample receiving compartment according to a predetermined temperature curve (see [0497], which recites “the computer… comprises memory for … calibration curves from calibration measurements conducted at a variety of temperatures and software for using …calibration curves to normalize test data against variations in temperature. … the apparatus also comprises a temperature controller to control the temperature within the well”).
With respect to claim 5, Wohlstadter teaches the imaging device according to claim 1, further comprising a pipetting system (pipetting station in [0499]) having a pipetting unit (reagent handler 1734 in [0449]) configured to pipet the at least one sample receiving compartment (see [0499], which recites “Reagent handler 1734 is one or more devices that add or remove reagents to multi-well assay plates. In a preferred embodiment, reagent handler 1734 is a pipetting station”).
With respect to claim 10, Wohlstadter teaches the imaging device according to claim 5, wherein the pipetting unit (reagent handler 1734) is a pipetting robot (see [0488], which recites “apparatus further comprises one or more robotic and/or computer systems adapted to perform one or more of the following functions: (i) moving assay modules; (ii) shaking the assay modules (and assay contents therein); (iii) storing plates (e.g., refrigeration unit); (iv) liquid or reagent handling (e.g., mixing reagents); and (v) reagent delivery (e.g., dispensing reagents into wells)”.
With respect to claim 11, Wohlstadter teaches the imaging device according to claim 1, wherein the imaging position (plate carrier 1740) comprises a sample stage (linear translation stage) configured to move the sample carrier (multi-well assay plate 1710) relative to an optical axis of the optical detection system (photodetector 1706) (see Fig. 20) (see also [0493], which recites “Plate transport mechanism 1716 moves multi-well assay plates into, within and out of reader 1700. Plate transport mechanism 1716 comprises a plate carrier 1740 that holds the multi-well assay plates during transport, one or more linear translation stages that move the plate carrier 1740, one or more magnetizable (preferably, reversibly magnetizable) tabs, sensors, and a variety of mechanisms that align and/or hold the multi-well assay plate to the carrier”) (see also [0014], which recites “mechanisms to align and orient the assay plates with the photodetector”).
With respect to claim 12, Wohlstadter teaches the imaging device according to claim 1, further comprising a sample transfer unit (a plate transport mechanism in claim 46, which recites “a plate transport mechanism configured to move the multi-well assay plate within the light tight enclosure”) configured to transfer the sample carrier (multi-well assay plate) between at least two of the imaging position the annealing position), and/or a pipetting position (see also [0499], which recites “Robotics 1738 may comprise one or more electromechanical devices that transport, incubate and/or mix multi-well assay plates and the contents of their wells. Plate stacker 1736 comprises one or more containers for holding one or mom multi-well assay plates and, advantageously, electrical and/or mechanical systems for moving plates. Plate stackers may also comprise mechanisms such as latches, positioning elements, sliders, grabbers, push arms, etc., that can be used to control the movement and position of plates. Plate stackers may have features that aid in the alignment and/or orientation of plates”).
With respect to claim 13, Wohlstadter teaches the imaging device according to claim 12, wherein the sample transfer unit comprises a sample stage (see [0493], which recites “one or more linear translation stages that move the plate carrier 1740”).
With respect to claim 14, Wohlstadter teaches the imaging device according to claim 1, further comprising a housing (light tight enclosure 1904 in [0505]), the housing (light tight enclosure 1904) enclosing at least the imaging position, the annealing position, and/or a pipetting position (see Fig. 19).
With respect to claim 15, Wohlstadter teaches the imaging device according to claim 14, wherein the housing (light tight enclosure 1904) comprises at least one external door (door 1914 in [0505]) providing access to at least one of the imaging position, the annealing position, or the pipetting position from an outside thereof (see Fig. 19).
With respect to claim 16, Wohlstadter teaches the imaging device according to claim 14, wherein the housing (light tight enclosure 1904) is formed such that at least one of the imaging position, the annealing position, or the pipetting position is lighttight (see [0505] and Fig. 19).
With respect to claim 17, Wohlstadter teaches the imaging device according to claim 14, further comprising a loading position different from the imaging position and the annealing position (see Figs. 17-20), the loading position being configured to receive the sample carrier (multi-well assay plate 1710), wherein the housing (light tight enclosure 1904) comprises an external door (door 1914) providing access to the loading position from an outside thereof (see [0493]).
With respect to claim 18, Wohlstadter teaches the imaging device according to claim 17, further comprising at least one lighttight door (aperture 1714 in [0493], which recites “plate transport mechanism 1716 moves plates 1710 from plate stacker 1736 through aperture 1714 into light tight enclosure 1704 and visa versa”) arranged between the loading position and the imaging position and/or the annealing position.
With respect to claim 19, Wohlstadter teaches the imaging device according to claim 1, wherein the optical detection system (photodetector) comprises a microscope objective (lens in [0505]) directed at the imaging position (see Fig. 19).
With respect to claim 20, Wohlstadter teaches the imaging device according to claim 1, further comprising an illumination system (light sources in [0520]) configured to illuminate the sample when the sample carrier is received in the imaging position (see [0520]).
With respect to claim 21, Wohlstadter teaches the imaging device according to claim 20, wherein the optical detection system and the illumination system are configured for fluorescence imaging (see [0520]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wohlstadter (US20210033523) in view of Wiltsie (US20130136670).
With respect to claim 4, Wohlstadter teaches the imaging device according to claim 1.
Wolhstadter doesn’t teach at least one heating element arranged at the annealing position, the at least one heating element being configured to heat the at least one sample receiving compartment when the sample carrier is received in the annealing position.
In the analogous art of providing imaging devices, Wiltsie (US20130136670) teaches at least one heating element arranged at the annealing position, the at least one heating element being configured to heat the at least one sample receiving compartment when the sample carrier is received in the annealing position (see [0523], which recites “the cartridge heater 3005 may comprise a plurality of heating elements 3020. Each heating element 3020 may be sized and position to heat one or more wells in the cartridge 3200. Each heating element 3020 may be under separate control, such that it can produce independent heating output”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the imaging device disclosed by Wohlstadter by incorporating the at least one heating element disclosed by Wiltsie such that the temperature control unit comprises at least one heating element arranged at the annealing position, the at least one heating element being configured to heat the at least one sample receiving compartment when the sample carrier is received in the annealing position with a reasonable expectation of success for the benefit of producing independent heating output under separate control which is desirable in conducting sensitive, high throughput, chemical, biochemical and biological assays.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wohlstadter (US20210033523) in view of Rockel (US20180080876).
With respect to claim 6, Wohlstadter teaches the according to claim 5.
Wohlstadter doesn’t explicitly teach a storage compartment configured to store pipetting liquids.
In the analogous art of providing imaging devices, Rockel (US20180080876) teaches a storage compartment configured to store pipetting liquids (see [0096], which recites “the automated system may further comprise a fluid handling system providing at least one of fluorescence dyes, compounds quenching the fluorescence signals, and washing fluids and buffer to the biological sample. The controller may collect the fluorescence signals from the detector as images of the biological sample stained with a fluorescence dye. The fluid handling system may include a robotically controlled pipette system disposed on a stage, wherein the pipetting system is movable along a z-axis orthogonal to the working plane. The fluid handling system may further include at least one additional fluid vessel containing at least one of reagents, antigen recognizing moieties having detection moieties, antibodies with fluorescent dyes, antibiotics, biological nutrients, toxins, stains, and oxidants”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the imaging device disclosed by Wohlstadter by incorporating the storage compartment disclosed by Rockel such that the pipetting system comprises a storage compartment configured to store pipetting liquids with a reasonable expectation of success for the benefit of effectively conducting sensitive, high throughput, chemical, biochemical and biological assays that require multiple pipetting liquids.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wohlstadter (US20210033523) in view of Wiltsie (US20130136670) as applied to claim 6 further in view of Buse (US20180298427).
With respect to claim 7, Wohlstadter in view of Rockel teaches the imaging device according to claim 6.
Wohlstadter in view of Rockel doesn’t teach a second temperature control unit configured to control a temperature of the storage compartment.
In the analogous art of processing biological samples, Buse (US20180298427) teaches a second temperature control unit configured to control a temperature of the storage compartment (see [0141], which recites “ the first module 100 may further include one or more bulk reagent container compartments configured to store one or more bulk containers that hold bulk reagents or hold waste material. In some embodiments, the bulk reagents include fluids such as water, buffer solution, target capture reagents, nucleic acid amplification reagents. In some embodiments, the bulk reagent container compartments may be configured to maintain the contents of such containers at prescribed storage temperatures”) (see also [0154], which recites “ A controller directs the components of the first module 100 and components of the second module 400 to perform the assay steps”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the imaging device disclosed by Wohlstadter by incorporating the second temperature control unit disclosed by Buse such that the pipetting system comprises a second temperature control unit configured to control a temperature of the storage compartment with a reasonable expectation of success for the benefit of effectively preserving the pipetting liquids by controlling the temperature of the storage compartment containing the pipetting liquids.
With respect to claim 8, Wohlstadter in view of Rockel teaches the imaging device according to claim 6.
Wohlstadter in view of Rockel doesn’t teach that the storage compartment comprises at least one storage position, the at least one storage position being configured to receive a removable storage container for a pipetting liquid of the pipetting liquids wherein the pipetting system comprises a second temperature control unit configured to control a temperature of the storage compartment when the storage container is received in the storage position.
In the analogous art of processing biological samples, Buse (US20180298427) teaches a storage compartment comprises at least one storage position, the at least one storage position being configured to receive a removable storage container for a pipetting liquid of the pipetting liquids (see Fig. 2) and a second temperature control unit configured to control a temperature of the storage compartment (see [0141], which recites “ the first module 100 may further include one or more bulk reagent container compartments configured to store one or more bulk containers that hold bulk reagents or hold waste material. In some embodiments, the bulk reagents include fluids such as water, buffer solution, target capture reagents, nucleic acid amplification reagents. In some embodiments, the bulk reagent container compartments may be configured to maintain the contents of such containers at prescribed storage temperatures”) (see also [0154], which recites “a controller directs the components of the first module 100 and components of the second module 400 to perform the assay steps”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the imaging device disclosed by Wohlstadter by incorporating the second temperature control unit disclosed by Buse such wherein the pipetting system comprises a second temperature control unit configured to control a temperature of the storage container when the storage container is received in the storage position and the storage compartment comprises at least one storage position, the at least one storage position being configured to receive a removable storage container for a pipetting liquid of the pipetting liquids with a reasonable expectation of success for the benefit of effectively preserving the pipetting liquids by controlling the temperature of the storage compartment containing the pipetting liquids.
Claim 9 rejected under 35 U.S.C. 103 as being unpatentable over Wohlstadter (US20210033523) in view of Biro (US 20180361379).
With respect to claim 9, Wohlstadter teaches the imaging device according to claim 5.
Wohlstadter doesn’t a pipetting position different from at least one of the imaging position or the annealing position, the pipetting position being configured to receive the sample carrier, and wherein the pipetting unit is configured to pipet the at least one sample receiving compartment when the sample carrier is received in the pipetting position.
In the analogous art of providing imaging systems, Biro (US 20180361379) teaches a pipetting position different from at least one of the imaging position or the annealing position, the pipetting position being configured to receive the sample carrier, and wherein the pipetting unit is configured to pipet the at least one sample receiving compartment when the sample carrier is received in the pipetting position (see [0039], which recites “the system comprises an assembly subsystem for dispensing the aqueous oil matrices in vessels or containers suitable for PCR processing; a reaction by reaction light-driven, or photonic, heating subsystem comprising multiple light sources configured to emit electromagnetic radiation to individual vessels; a reaction-by-reaction temperature monitoring subsystem configured to monitor the temperature of the aqueous oil matrix and/or the aqueous reaction mix volume in each vessel; a temperature feedback subsystem (e.g., via microcontroller) that controls the energy output of each individual light-driven heating source in response to temperature readings of each individual vessel; a fluorescence detection subsystem configured to detect the fluorescence light emission produced by the PCR products; and a mechanical, electrical, and software control system configured to control the assembly system and move the vessels containing the aqueous oil matrices through the various subsystems and vessel stations of the system via a positioning device”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the imaging device disclosed by Wohlstadter by incorporating a pipetting position different from at least one of the imaging position or the annealing position as disclosed by Biro with a reasonable expectation of success for the benefit of improving system efficiency and reducing contamination and optical interference between liquid handling and imaging operations.
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797