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 .
Response to Arguments
The Amendment filed 06/29/2026 has been entered. Claims 1-7 and 9-10 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 03/27/2026.
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 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.
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:
“optical module” in claim 1.
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.
In this instant case, “optical module” of claim 1 is being interpreted as light source, various filters, such as a fluorescence excitation filter and/or a fluorescence emission filter, lenses and/or beam splitters (specification, [0017]).
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.
Claims 1-3, 6-7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Winter et al. (DE 102006036171 A1, see machine translation) in view of Anyoji et al. (US 20060068488 A1).
Regarding claim 1, Winter teaches a method for polymerase chain reaction with multi-channel fluorescence measurement ([0001]), the method comprising:
coupling excitation light from at least one optical module configured to generate the excitation light (Fig. 1 and [0034] teaches coupling excitation light from excitation light unit A and beam splitter modules 21, 31) into cavities of a column of a two-dimensional arrangement of a plurality of cavities of a sample carrier (Figs. 1-3 teaches excitation light coupled into cavities 41 of a column of a microtiter plate 4) via a respective measuring head (Figs. 1-3, carriage 12);
detecting a fluorescence via fluorescence light emitted from the cavities of the respective columns of the sample carrier using a single detection unit (Figs. 1-3 and [0038],[0040] teaches a scanning processing of measuring of fluorescence light, from a first column of cavities of the microtiter plate using detector 30); and
moving the measuring head laterally across the columns of the two-dimensional arrangement of the cavities of the sample carrier as to excite to the fluorescence in all samples of the sample carrier disposed in the two-dimensional arrangement of the plurality of cavities and to detect the fluorescence light using the detection unit ([0038],[0040] teaches moving the carriage 12 one column to illuminate and further measure fluorescence of each column until all columns of the sample arrangement is measured by the detector 30),
wherein the moving of the measuring head is a step-by-step, lateral movement of the measuring head ([0038],[0040] teaches illumination and measurement is performed on a first column, and then the carriage is moved linearly to the next column for another measurement), which movement is defined as a function of a rotation of a rotatable carrier (Fig. 1 and [0040] teaches following rotation of the disc 20, carriage 12 is moved to the next sample column, therefore movement is defined as a function of rotation of the disc), on which the at least one optical module is disposed (Fig. 1 teaches beam splitter modules 21, 31, which are interpreted as part of the optical module, are disposed on the disc 20, i.e. attached to the bottom of disc 20),
wherein the coupling of the excitation light and the detecting of the fluorescence includes using a single coupling module including a coupling receptacle (Figs. 4-5 teaches a single coupling module including structures, i.e. coupling receptacle, that holds and couples light guides 7 to components of the detection unit D, such as the horizontal surface adjacent to disc drive 22 and under disc 20 and beam splitter module 21; Fig. 1 and paragraphs [0034]-[0035], [0040] teach the light guides or optical fibers 7 allows coupling of excitation light and detecting of fluorescence light) configured to receive at least one light guide configured to guide the excitation light to the measuring head and to guide the fluorescence light from the measuring head to the detection unit (Figs. 4-5 and [0034]-[0035],[0040] teach the structures, i.e. coupling receptacle, that holds and couples light guides 7 to components of the detection unit D is configured to receive light guides 7 to guide excitation light to the carriage 12 and guide fluorescence light from the sample from the carriage 12 to detector 30).
Winter fails to teach: coupling excitation light from at least one optical module configured to generate the excitation light into cavities of a column of a two-dimensional arrangement of a plurality of cavities of at least two sample carriers via a respective measuring head; detecting a fluorescence via fluorescence light emitted from the cavities of the respective columns of the at least two sample carriers using a single detection unit; moving each measuring head laterally across the columns of the two-dimensional arrangement of the cavities of each sample carrier as to excite to the fluorescence in all samples of each sample carrier disposed in the two-dimensional arrangement of the plurality of cavities and to detect the fluorescence light using the detection unit; which movement is defined as a function of a rotational speed of a rotatable carrier; and the coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit.
Winter teaches the rotatable carrier is driven by a stepper motor and rotates at a rotational speed ([0039], “six revolutions per second”). Winter teaches processes of illumination and measurement of cavities are repeated until the disc has completed a full rotation, where fluorescences are measured in eight samples and four color channels after one rotation of the disk (166 ms) ([0040]), and during the following rotation of the disk, the carriage 12 is moved to the next sample column before illumination and measurement ([0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the step of lateral movement of Winter to incorporate Winter’s teachings of the rotatable carrier rotating at a speed, and processes of illumination and measurement based on rotation of the carrier to provide: which movement is defined as a function of a rotational speed of a rotatable carrier. Doing so would have a reasonable expectation of successfully improving control and synchronization of the speed of rotation of the carrier, illumination and measurement, and lateral movement of the measuring head in order to completely measure all of the cavities of each columns.
While Winter teaches that optical fibers are adapted in number to the format of the microtiter plates used ([0023]), modified Winter fails to teach: coupling excitation light from at least one optical module configured to generate the excitation light into cavities of a column of a two-dimensional arrangement of a plurality of cavities of at least two sample carriers via a respective measuring head; detecting a fluorescence via fluorescence light emitted from the cavities of the respective columns of the at least two sample carriers using a single detection unit; moving each measuring head laterally across the columns of the two-dimensional arrangement of the cavities of each sample carrier as to excite to the fluorescence in all samples of each sample carrier disposed in the two-dimensional arrangement of the plurality of cavities and to detect the fluorescence light using the detection unit; and the coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit.
Anyoji teaches a screening apparatus that measures a plurality of wells of a plate and simultaneously measuring different wells (abstract; Figs. 1-2). Anyoji teaches a plurality of plates are mounted on a movable stage (Figs. 1-2 and [0037], movable stage 100 comprising multiple plates 11). Anyoji teaches coupling excitation light (Fig. 2) from at least one optical module (300) into cavities of at least two sample carriers (11) via a single coupling module including a coupling receptacle, i.e. measuring heads (200). Anyoji teaches detecting fluorescence by applying excitation light to each well of each plate (Fig. 2; [0035]-[0038]) using a single detection unit (Fig. 2, interpreted as image acquiring portion 50a; [0046] teaches the fluorescent images are inputted to image acquiring portion 50a). Anyoji teaches moving the stage to detection succeeding wells ([0046]), therefore allowing for measuring of all of the wells of each plate in parallel ([0053]). Anyoji teaches by operating the plurality of detecting portions in parallel, a measuring amount is increased by an amount of a multiplication of a number of the detecting portions ([0018]) and measurement is performed at high speed ([0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Winter to incorporate Anyoji’s teachings of performing simultaneous fluorescent excitation and measurement of wells of multiple plates and successively detecting succeeding wells via translation ([0035]-[0038],[0046],[0053]; Figs. 1-2) to provide: coupling excitation light from at least one optical module configured to generate the excitation light into cavities of a column of a two-dimensional arrangement of a plurality of cavities of at least two sample carriers via a respective measuring head; detecting a fluorescence via fluorescence light emitted from the cavities of the respective columns of the at least two sample carriers using a single detection unit; moving each measuring head laterally across the columns of the two-dimensional arrangement of the cavities of each sample carrier as to excite to the fluorescence in all samples of each sample carrier disposed in the two-dimensional arrangement of the plurality of cavities and to detect the fluorescence light using the detection unit. Doing so would have a reasonable expectation of successfully allowing for analysis of multiple carriers in parallel, therefore improving throughput and speed of fluorescence measurement as taught by Anyoji ([0018],[0050]).
Modified Winter fails to teach: the coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit.
Anyoji teaches a screening apparatus that measures a plurality of wells of a plate and simultaneously measuring different wells (abstract; Figs. 1-2). Anyoji teaches a plurality of plates are mounted on a movable stage (Figs. 1-2 and [0037], movable stage 100 comprising multiple plates 11). Anyoji teaches coupling excitation light (Fig. 2) from at least one optical module (300) into cavities of at least two sample carriers (11) via a single coupling module including a coupling receptacle, i.e. measuring heads (200). Anyoji teaches detecting fluorescence by applying excitation light to each well of each plate (Fig. 2; [0035]-[0038]) using a single detection unit (Fig. 2, interpreted as image acquiring portion 50a; [0046] teaches the fluorescent images are inputted to image acquiring portion 50a). Anyoji teaches moving the stage to detection succeeding wells ([0046]), therefore allowing for measuring of all of the wells of each plate in parallel ([0053]). Anyoji teaches by operating the plurality of detecting portions in parallel, a measuring amount is increased by an amount of a multiplication of a number of the detecting portions ([0018]) and measurement is performed at high speed ([0050]). Anyoji teaches excitation light is guided by an optical fiber from an excitation light source portion to the wells of the plates (Fig. 2 and [0009]). Anyoji teaches output light is guided to each of the detection portions ([0040]). Anyoji teaches excitation light and fluorescence light from each plate is directed through each measuring heads (Fig. 2, element 200) and for detection by the detection unit (50a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupling receptacle of modified Winter to incorporate Anyoji’s teachings of performing simultaneous fluorescent excitation and measurement of wells of multiple plates and successively detecting succeeding wells via translation ([0035]-[0038],[0046],[0053]; Figs. 1-2), and coupling optical fibers to guide excitation and output fluorescence light via each measuring head (Fig. 2;[0009],[0040]), to provide: the coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit. Doing so would have a reasonable expectation of successfully allowing for proper optical coupling of the respective measuring heads with the sample carriers for analysis of multiple carriers in parallel, therefore improving throughput and speed of fluorescence measurement as taught by Anyoji ([0018],[0050]).
Regarding claim 2, Winter further teaches wherein the step-by-step, lateral movement is performed after a complete revolution of the rotatable carrier ([0040] teaches after full rotation of the disc, the carriage 12 is moved to the next sample column).
Regarding claim 3, Winter further teaches wherein the sample carrier (Fig. 1, microtiter plate 4; [0035]) is received in a sample receptacle (receptacle 2) comprising a heating element (heating block 1).
Modified Winter fails to teach wherein each of the at least two sample carriers is received in a sample receptacle comprising a heating element.
Anyoji teaches a screening apparatus that measures a plurality of wells of a plate and simultaneously measuring different wells (abstract; Figs. 1-2). Anyoji teaches a plurality of plates are mounted on a movable stage (Figs. 1-2 and [0037], movable stage 100 comprising multiple plates 11). Anyoji teaches coupling excitation light (Fig. 2) from at least one optical module (300) into cavities of at least two sample carriers (11) via respective measuring heads (200). Anyoji teaches detecting fluorescence by applying excitation light to each well of each plate (Fig. 2; [0035]-[0038]) using a single detection unit (Fig. 2, interpreted as image acquiring portion 50a; [0046] teaches the fluorescent images are inputted to image acquiring portion 50a). Anyoji teaches moving the stage to detection succeeding wells ([0046]), therefore allowing for measuring of all of the wells of each plate in parallel ([0053]). Anyoji teaches by operating the plurality of detecting portions in parallel, a measuring amount is increased by an amount of a multiplication of a number of the detecting portions ([0018]) and measurement is performed at high speed ([0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the at least two sample carriers of modified Winter to incorporate Winter’s teachings of heating blocks ([0035]) and Anyoji’s teachings of performing simultaneous fluorescent excitation and measurement of wells of multiple plates and successively detecting succeeding wells via translation ([0035]-[0038],[0046],[0053]; Figs. 1-2) to provide wherein each of the at least two sample carriers is received in a sample receptacle comprising a heating element. Doing so would have a reasonable expectation of successfully improving control of temperature of each carrier, therefore improving throughput and speed of fluorescence measurement as taught by Anyoji ([0018],[0050]).
Regarding claim 6, Winter wherein the rotatable carrier is disk-shaped (Figs. 1,5 and [0040] teaches disc 20).
Regarding claim 7, modified Winter fails to teach: wherein the at least one optical module includes more than one optical module, and wherein during one complete revolution of the rotatable carrier, excitation light from each optical module arranged on the rotatable carrier passes successively into each measuring head, and the fluorescence light from each measuring head passes successively to each optical module.
Winter teaches during a complete full rotation of the rotatable carrier, excitation light from beam splitter modules 21 is directed into the carriage 12 and fluorescence is measured from the carriage 12 ([0039]-[0040]; Fig. 1). Winter teaches processes of excitation and measurement of fluorescence is repeated for each beam splitter module until the disc completes a full rotation ([0040]).
Anyoji teaches a screening apparatus that measures a plurality of wells of a plate and simultaneously measuring different wells (abstract; Figs. 1-2). Anyoji teaches a plurality of plates are mounted on a movable stage (Figs. 1-2 and [0037], movable stage 100 comprising multiple plates 11). Anyoji teaches coupling excitation light (Fig. 2) from at least one optical module (300) into cavities of at least two sample carriers (11) via respective measuring heads (200). Anyoji teaches detecting fluorescence by applying excitation light to each well of each plate (Fig. 2; [0035]-[0038]) using a single detection unit (Fig. 2, interpreted as image acquiring portion 50a; [0046] teaches the fluorescent images are inputted to image acquiring portion 50a). Anyoji teaches moving the stage to detection succeeding wells ([0046]), therefore allowing for measuring of all of the wells of each plate in parallel ([0053]). Anyoji teaches by operating the plurality of detecting portions in parallel, a measuring amount is increased by an amount of a multiplication of a number of the detecting portions ([0018]) and measurement is performed at high speed ([0050]). Anyoji teaches an embodiment (Fig. 4,[0054]-[0055]) comprising a rotating stage (100a).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Winter to incorporate Winter’s teachings of excitation and measurement of fluorescence is repeated for each beam splitter module until the disc completes a full rotation ([0040]) and Anyoji’s teachings of performing simultaneous fluorescent excitation and measurement of wells of multiple plates and successively detecting succeeding wells via translation ([0035]-[0038],[0046],[0053]; Figs. 1-2) to provide: wherein the at least one optical module includes more than one optical module, and wherein during one complete revolution of the rotatable carrier, excitation light from each optical module arranged on the rotatable carrier passes successively into each measuring head, and the fluorescence light from each measuring head passes successively to each optical module. Doing so would have a reasonable expectation of successfully allowing for proper optical coupling of the respective measuring heads with the optical modules for analysis of multiple carriers in parallel, therefore improving throughput and speed of fluorescence measurement as taught by Anyoji ([0018],[0050]).
Regarding claim 9, Winter further teaches wherein a length of the coupling module tangential to the rotatable carrier is configured as a circular arc defined by circular radii of two adjacent optical modules, wherein the length is less than a circular chord of the circular radii of the two adjacent optical modules (Fig. 5 shows the structure that supports the guides 7 having the claimed length).
If it is determined that modified Winter fails to teach wherein a length of the coupling module tangential to the rotatable carrier is configured as a circular arc defined by circular radii of two adjacent optical modules, wherein the length is less than a circular chord of the circular radii of the two adjacent optical modules, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the coupling module of modified Winter to provide: wherein a length of the coupling module tangential to the rotatable carrier is configured as a circular arc defined by circular radii of two adjacent optical modules, wherein the length is less than a circular chord of the circular radii of the two adjacent optical modules. Doing so would have been an obvious change in size/proportion (see MPEP 2144.04 (IV)), which one of ordinary of skill in the art would arrive at through routine experimentation to properly optimize the size of the coupling module to attach and arrange the desired amount light guides in the overall arrangement.
Regarding claim 10, Winter further teaches wherein the coupling module is movable radially with respect to the rotatable carrier (Figs. 1-5 and [0039] teaches the disk 20 rotates, therefore the structures that holds light guides 7 is movable radially with respect to the rotatable carrier when the disk rotates).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Winter in view of Anyoji as applied to claim 3 above, and further in view of Suda et al. (US 20150259659 A1).
Regarding claim 4, modified Winter fails to teach: the method of claim 3, further comprising: determining whether a predetermined temperature of the respective heating element and/or of the respective sample carrier has been reached; and recording the detected fluorescence light only when the predetermined temperature is reached.
Winter teaches in PCR, fluorescence measurements are performed after each temperature cycle ([0007]).
Suda teaches a method for selectively obtaining a natural variant of an enzyme including detecting a sequence and obtaining a PCR clone, wherein PCR cloning is performed (abstract). Suda teaches a real-time PCR device is used, where after 30 seconds elapsed from when the temperature reached a target temperature, the fluorescence intensity of the respective wells was simultaneously measured ([0199]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Winter to incorporate Winter’s teachings of fluorescence measurements are performed after each temperature cycle ([0007]) and Suda’s teachings of PCR where fluorescence is measured after a target temperature is reached ([0199]) to provide: the method of claim 3, further comprising: determining whether a predetermined temperature of the respective heating element and/or of the respective sample carrier has been reached; and recording the detected fluorescence light only when the predetermined temperature is reached. Doing so would have a reasonable expectation of successfully optimizing and improving control of fluorescence measurements based on a desired temperature reached during PCR processes.
Regarding claim 5, modified Winter fails to teach: wherein the step-by-step, lateral movement of each measuring head and the recording of the detected fluorescence light are performed only after reaching the predeterminable temperature.
Winter teaches in PCR, fluorescence measurements are performed after each temperature cycle ([0007]). Winter teaches linear movement of the measurement head after measurement is complete in order to perform measurement of additional columns of a sample arrangement ([0038]).
Suda teaches a method for selectively obtaining a natural variant of an enzyme including detecting a sequence and obtaining a PCR clone, wherein PCR cloning is performed (abstract). Suda teaches a real-time PCR device is used, where after 30 seconds elapsed from when the temperature reached a target temperature, the fluorescence intensity of the respective wells was simultaneously measured ([0199]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Winter to incorporate Winter’s teachings of fluorescence measurements are performed after each temperature cycle and linear movement of a measurement head after each measurement ([0007]) and Suda’s teachings of PCR where fluorescence is measured after a target temperature is reached ([0199]) to provide: wherein the step-by-step, lateral movement of each measuring head and the recording of the detected fluorescence light are performed only after reaching the predeterminable temperature. Doing so would have a reasonable expectation of successfully optimizing and improving control of fluorescence measurements and continuation of measurements of each columns of the cavities based on a desired temperature reached during PCR processes.
Response to Arguments
Applicant’s arguments, see page 4, filed 06/29/2026, with respect to claim objections and rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive. The claim objections and rejections under 35 U.S.C. 112(b) of 03/27/2026 have been withdrawn.
Applicant's arguments, see page 4, filed 06/29/2026, with respect to the claim interpretation under 35 U.S.C. 112(f), have been fully considered but they are not persuasive. In response to applicant’s argument that the optical module should additionally include “optical modules known from the prior art in many different embodiments…” (specification, paragraph [0017]), the examiner disagrees since “optical modules known from the prior art” does not provide sufficient corresponding structure as performing the claimed function.
Applicant's arguments, see pages 5-8, filed 06/29/2026, with respect to the claim rejections under 35 U.S.C. 103, specifically regarding claim 1, have been fully considered but they are not persuasive.
In response to applicant’s argument that Winter and Anyoji fails to teach “a single coupling module including a coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit” (Remarks, pages 6-7), the examiner disagrees.
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, Winter teaches: wherein the coupling of the excitation light and the detecting of the fluorescence includes using a single coupling module including a coupling receptacle (Figs. 4-5 teaches a single coupling module including structures, i.e. coupling receptacle, that holds and couples light guides 7 to other components of the detection unit D; Fig. 1 and paragraphs [0034]-[0035], [0040] teach the light guides or optical fibers 7 allows coupling of excitation light and detecting of fluorescence light) configured to receive at least one light guide configured to guide the excitation light to the measuring head and to guide the fluorescence light from the measuring head to the detection unit (Figs. 4-5 and [0034]-[0035],[0040] teach the structures, i.e. coupling receptacle, that holds and couples light guides 7 to other components of the detection unit D is configured to receive light guides 7 to guide excitation light to the carriage 12 and guide fluorescence light from the sample from the carriage 12). Note that claim 1 utilizes the transitional phrase of “comprising”, which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (MPEP 2111.03(I)). Therefore, the BRI of “single coupling module including a coupling receptacle” can include additional structural elements that form or make up “a coupling receptacle” that is part of the “single coupling module”. As discussed above, Winter (Figs. 4-7) shows a coupling receptacle, interpreted as the structures that couple light guides 7 to components of the detection unit D, such as the horizontal surface adjacent to disc drive 22 and under disc 20 and beam splitter module 21.
Additionally, note that Anyoji is not used to teach “a single coupling module including a coupling receptacle”. Anyoji is used in combination with Winter to arrive at: “the coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit”.
Winter fails to teach: the coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit.
Anyoji teaches a screening apparatus that measures a plurality of wells of a plate and simultaneously measuring different wells (abstract; Figs. 1-2). Anyoji teaches a plurality of plates are mounted on a movable stage (Figs. 1-2 and [0037], movable stage 100 comprising multiple plates 11). Anyoji teaches coupling excitation light (Fig. 2) from at least one optical module (300) into cavities of at least two sample carriers (11) via a single coupling module including a coupling receptacle, i.e. measuring heads (200). Anyoji teaches detecting fluorescence by applying excitation light to each well of each plate (Fig. 2; [0035]-[0038]) using a single detection unit (Fig. 2, interpreted as image acquiring portion 50a; [0046] teaches the fluorescent images are inputted to image acquiring portion 50a). Anyoji teaches moving the stage to detection succeeding wells ([0046]), therefore allowing for measuring of all of the wells of each plate in parallel ([0053]). Anyoji teaches by operating the plurality of detecting portions in parallel, a measuring amount is increased by an amount of a multiplication of a number of the detecting portions ([0018]) and measurement is performed at high speed ([0050]). Anyoji teaches excitation light is guided by an optical fiber from an excitation light source portion to the wells of the plates (Fig. 2 and [0009]). Anyoji teaches output light is guided to each of the detection portions ([0040]). Anyoji teaches excitation light and fluorescence light from each plate is directed through each measuring heads (Fig. 2, element 200) and for detection by the detection unit (50a). Note that the BRI of “a coupling receptacle” can include additional structural elements that form or make up “a coupling receptacle” that is part of the “single coupling module”. Therefore, Anyoji’s measuring heads 200 are interpreted as forming a coupling receptacle that couples excitation light to the carriers 11 and guides fluorescence light to image acquiring portion 50a.
It would have been obvious to one of ordinary skill in the art to have modified the coupling receptacle of modified Winter to incorporate Anyoji’s teachings of performing simultaneous fluorescent excitation and measurement of wells of multiple plates and successively detecting succeeding wells via translation ([0035]-[0038],[0046],[0053]; Figs. 1-2), and coupling optical fibers to guide excitation and output fluorescence light via each measuring head (Fig. 2;[0009],[0040]), to provide: the coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit. Doing so would have a reasonable expectation of successfully allowing for proper optical coupling of the respective measuring heads with the sample carriers for analysis of multiple carriers in parallel, therefore improving throughput and speed of fluorescence measurement as taught by Anyoji ([0018],[0050]).
Therefore, Winter in view of Anyoji teaches in combination the limitations of: “wherein the coupling of the excitation light and the detecting of the fluorescence includes using a single coupling module including a coupling receptacle configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bedingham et al. (US 20070009382 A1) teaches a multiplex fluorescence detection device (abstract; Fig. 1). Bedingham teaches coupling of excitation light and detecting of fluorescence includes (Fig. 1; paragraphs [0041]-[0046]) using a single coupling module including a coupling receptacle (Fig. 1, optical modules 16 coupled to rotating disc 13) configured to receive at least one light guide configured to guide the excitation light to each measuring head and to guide the fluorescence light from each measuring head to the detection unit (Figs. 1-2; paragraphs [0041]-[0046]).
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).
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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