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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12, in the reply filed on 06/22/2026 is acknowledged.
Claims 13-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups of invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/22/2026.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/EP2021/084960, filed 12/09/2021, which claims benefit under 35 U.S.C. 119(e) to provisional application No. 63/127,428, filed 12/18/2020.
Information Disclosure Statement
The information disclosure statement (IDS) filed 09/28/2023, 10/28/2025, and 05/01/2026 are initialed, considered and are attached hereto.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 appears to be missing the word “to” following “bind” (i.e., can bind to…, the missing words appears to be a typographical error).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “wherein each background region of the detection surface overlaps a respective area of the binding surface”, the claim is indefinite because it is not clear what “respective” is in relation to (i.e., respective area of the binding surface to what structure/structural component). For example, the claim fails to previously disclose or refer to particular areas of the “binding surface”, rather claim 1 merely recites “the detection surface comprises a binding surface”.
Regarding claim 12, the claim recites ‘in response to positive, non-zero optical signals not being obtained from each of the one or more background regions”, the recited language is confusing as it is unclear what is meant by “positive, non-zero…not being obtained”, for example, it is not clear if this means in the event that a background region results in a negative signal value, then the system notifies concentration cannot be determined, or if this language refers to some other range of values. Because the language is not clear, the claim is rejected as being indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The claimed invention is directed to a sensor system comprising a memory storing instructions executable by a processor to perform a series of steps. Non-transitory computer readable storage medium falls within the “manufacture” category of invention.
The U.S. Patent and Trademark Office recently published revised guidance on the application of § 101 (MPEP 2106). Under that guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See 2019 Guidance.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 1 recites “a memory storing instructions executable by a processor to” perform steps of “obtain a background data comprising sensor signals from one or more background regions of the detection surface, obtain sample data comprising sensor signals from the binding surface; and perform a correction of the sample data based on the background data”. Following the steps of obtaining the background and sample data, the claim recites performance of a correction of the sample data based on the background data, which is a mathematical concept/calculation. As a result, the claim recites mathematical calculations which fall within the mathematical concepts groupings of abstract ideas. As explained in MPEP 2106.04, II, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Step 2A, Prong 2
Regarding the structure that is a memory storing instructions, discussed above, the claim recites the additional limitations “obtain background data comprising sensor signals from one or more background regions of the detection surface” and “obtain sample data comprising sensor signals from the binding surface”, the limitation is claimed a high level of generality and could describe obtaining signal using any signal obtaining sensor/detector, the limitation amounts to mere data gathering. The limitation is necessary in order to acquire the data in order to use the judicial exception to perform the calculation that is the correction limitation. As a result, these additional limitations are insignificant extra-solution activity. See MPEP 2106.05(g).
The other additional limitations recited at claim 1 include the structure that is a sample container configured to receive the sample and comprising a detection surface and a plurality of signal generating elements, and the detection surface having a binding surface with capture elements. None of the additional limitations recited in addition to the judicial exception, apply, rely on or use the judicial exception in such a way to amount to integration of the judicial exception into a practical application. The additionally recited limitations are directed to structures necessary/applied during the acquisition of the data.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
The additional elements of the claims do not add significantly more to the judicial exception. In particular a sample container as claimed, provided with memory storing instructions, is routine and conventional in the assay art at the time. See for example, De Theije et al., US PG Pub No. 2010/0277160A1, De Theije et al. teach (abstract) a sensor system (magnetic sensor device) comprising a sample container (e.g., Figure 2A, 12, para [0137]) configured to receive a sample containing an analyte to be tested (paras [0010]-[0012]), the sample container comprising a detection surface and a plurality of signal generating elements in the sample container (See Figure 2A, sensor surface 120, and magnetic/magnetizable labeled binding moieties for labeled target moieties, see labeled target moieties 25, see also paras [0136]-[0138]) wherein the detection surface comprises a binding surface partially functionalized with capture elements that can bind the analyte (see figure 2A, 28). De Theije further teaches a memory storing instructions executable by a processor (see para [0151]), for performing the methods (e.g., paras [0069]-[0074]) performed by the sensor, determining the presence and/or amount of target moieties in a sample, see at para [0152], obtaining one or more detection signals (also paras [0152]-[0156], determining amount based on measured detection signal).
See also Nieuwenhuis et al., (2008), WO2008/142492A1 (IDS entered 09/28/2023), also teaching a biosensor comprising a sample container (sample chamber), the sample container for receiving a sample, comprising a detection surface comprising a binding surface, partially functionalized with capture elements (page 7, lines 28-31), and a memory storing instructions (page 14, lines 17-23).
See also Bernard et al., US PG Pub No. 2009/0176255A1, paras [0011], [0391], teaching a sample container (chamber), capture agent immobilized on a binding surface, the system comprising magnetic particle labeled binding partners, and the system comprising a memory for storing instructions (para [0392]).
Regarding the claimed elements (claim 1, and further dependent claims, further narrowing the judicial exception, e.g., directed to the background/subtraction), none of the claimed elements/limitations either alone or as an ordered combination further apply, rely on or use the judicial exception in a way that integrates into a practical application, and further none of the additional elements amount to more than that which was well known, routine and conventional in the assay art.
For all of these reasons, the claims are rejected under 35 U.S.C. 101.
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.
Claim(s) 1-4, 6, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over De Theije et al US PG Pub No. 2010/0277160A1 in view of Duveneck et al., US PG Pub No. 2005/0163659A1, Hawkins et al., US PG Pub No. 2018/0162927A1 and Belushkin et al., WO2019/186416A1.
De Theije et al. teach (abstract) a sensor system (magnetic sensor device) comprising a sample container (e.g., Figure 2A, 12, para [0137]) configured to receive a sample containing an analyte to be tested (paras [0010]-[0012]), the sample container comprising a detection surface and a plurality of signal generating elements in the sample container (See Figure 2A, sensor surface 120, and magnetic/magnetizable labeled binding moieties for labeled target moieties, see labeled target moieties 25, see also paras [0136]-[0138]) wherein the detection surface comprises a binding surface partially functionalized with capture elements that can bind the analyte (see figure 2A, 28). De Theije further teaches a memory storing instructions executable by a processor (see para [0151]), for performing the methods (e.g., paras [0069]-[0074]) performed by the sensor, determining the presence and/or amount of target moieties in a sample, see at para [0152], obtaining one or more detection signals (also paras [0152]-[0156], determining amount based on measured detection signal).
De Theije et al. fails to the instructions further directing to obtain background data comprising sensor signal from one or more background regions, and to perform a correction of the sample data based on the background signal (claim 1).
However, instrument background correction was generally well known and routinely performed in the assay device/method prior art before the effective filing date of the claimed invention. See for example, Duveneck et al., e.g., at para [0245], detecting a signal at each measurement spot (fluorescence intensity), from which an average background value is subtracted, the background determined from surrounding regions without immobilized recognition elements.
Also, Hawkins et al., para [0144], binding agent (antibody) immobilized on a chip, for data analyses, subtracting interspot (empty chip surface spots, having no protein immobilized or captured) to correct for non-specific binding.
Belushkin et al is another example, see end of page 34 to page 35, in order to control for non-specific binding and background fluctuations, signal from each measured spot was corrected by subtracting the signal from adjacent BSA blocked background area.
It would have been prima facie obvious to one having ordinary skill before the effective filing date of the claimed invention to have modified the sensor system of De Theije et al., such that the stored instructions include instruction to also obtain background signal from a background region free of binding agent, namely at an empty region, the instructions instructing to correct the measured signal with the background signal (correcting based on the measured background), one motivated to modify the instruction of De Theije et al. in this way in order to provide a system that can account for both non-specific binding as well as instrumentation fluctuation (see Duveneck et al., Hawkins et al., and Belushkin et al.).
One having ordinary skill in the art would have a reasonable expectation of success because background correction was a well-known technique implemented in the assay art at the time, as is supported by each of Duveneck et al., Hawkins et al., and Belushkin et al., cited above.
Regarding claim 2, the combination of the cited art addresses instructing to scan background having no binding partner (non-overlapping with binding surface).
Regarding claim 3, De Theije et al. teach the system comprising a magnetic element, the element of De Theije is taught as being capable to be activated to generate a magnetic field to pull the plurality of signal generating elements to the binding surface, and not activated such that the elements are away from the binding surface (see paras [0086], [0089], [0121] activatable magnetic field). The examined invention, the sensor system, is a product invention with an activatable magnetic field (see as cited), the system is recited as being capable of being activated to generate the magnetic field to pull the particles to the surface while data is obtained (for example, while background is obtained, and released while obtaining sample data). The structure of the system of De Theije reads on the structure of the claimed system.
Regarding claim 4, see as cited in detail above, a portion of the signal generating elements of the plurality of signal generating elements includes a capture element that can bind the analyte (antibodies), see citations above, including Figure 2A and further para [0117], and figure 2B.
Regarding claim 6, De Theije et al. teach a sensor system as claimed comprising plurality of discrete areas, each area functionalized with capture elements (e.g., plurality of binding sites 121, paras [0113], [0115], the claims, e.g., claim 1), the combination of the cited art above addressing background region non-overlapping with the capture element functionalized regions.
Regarding claim 10, see as cited in detail above, the combination of the cited art comprising memory with instructions that are executable to perform subtraction between sample and background data to generate corrected sample data.
Regarding claim 11, see De Theije et al. teach the system with instructions executable to determine concentration (see para [0001], [0010], [0031], [0046], [0151]) determining presence and/or amount), the combination of the cited art addressing to determine concentration based on corrected sample data.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over De Theije et al. in view of Duveneck et al., Hawkins et al., and Belushkin et al., as applied to claim 1 above, and further in view of Mitani et al., JP 2005024456A (English translation obtained via PE2E).
De Theije et al. teach a sensor system substantially as claimed, however fails to teach the instructions executable to weight the sensor signals from at least one background region different than at least one other background region.
Mitani teach as a strategy to remove noise from a detected signal for accurate analysis using a biosensor, obtaining signal from reference areas (abstract and para [0010]), that merely subtracting a reference signal can leave behind excessive noise. Mitani teach a strategy comprising obtaining a plurality of reference signals and weighting each of the plurality of reference signals filtered by a reference signal filter according to a correlation between the observation region and the reference region and the weighting unit (para [0017]), the strategy removes noise from a single observation signal based on a plurality of reference signals, so that the reliability of the observation signal can be improved (without leaving additional noise, e.g., drift noise) (see also paras [0042], [0048], [0049], [0050]).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor system instructions of De Theije et al. and the cited prior art, in order to include instructions to obtain more than one reference signal, and to weight the reference signals and use those weighted signals to correct the data signal, as taught by Mitani et al., as a technique in order to improve signal and reliability of the observation (Mitani, that merely subtracting a reference signal can leave behind signal noise). One having ordinary skill in the art would have a reasonable expectation of success because Mitani teach this strategy (plurality of weighted background signals) as improving results as compared to mere background subtraction, as such, the modification would be considered an improvement to mere background subtraction.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over De Theije et al. in view of Duveneck et al., Hawkins et al., and Belushkin et al., as applied to claim 6 above, and further in view of Mitani et al. and Nieuwenhuis et al., WO2011/128808A1.
De Theije et al. and the cited art teach a sensor system substantially as claimed, see further teaching spots can be distributed homogeneously over the sensor surface (para [0015]). See also para [0003] referring to micro-arrays/biochips (arrangement in an array, suggesting an organized arrangement of rows). Duveneck et al., cited previously above teach e.g., at para [0245], background determined from surrounding regions without immobilized recognition elements. Hawkins et al., para [0144], teach subtracting interspot (empty chip surface spots, having no protein immobilized or captured) to correct for non-specific binding. Belushkin et al. cited above refer to regions adjacent (adjacent BSA blocked background area).
However, the cited prior art fails to teach the plurality of discrete areas of the binding surface arranged into a first row of areas and a second row of areas, and wherein the one or more background regions of the detection surface comprise a plurality of background regions arranged into a first row of background regions, and a second row of background regions, and a third row of background regions.
Mitani is as cited in detail previously above, teaching a plurality of background regions, weighted and used for correction of signal data improves signal and removes background, thereby improving reliability (see as cited in detail previously above).
Nieuwenhuis et al. (2011) teach a system similar to that of De Theije et al., see for example, Figure 1 and abstract (detection system for detecting magnetic particles at a surface). See Nieuwenhuis et al. (2011) teach a pattern of investigation sites and reference sites, an investigation site surrounded by a plurality of reference sites, preferentially in an interleaving pattern, investigation sites and reference sites are interleaved. The reference further teaches the system could have other configurations as well (see page 7, lines 3-11, page 19, lines 7-15, figure 6).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have a series of background spots for the same reasons discussed previously above (referring to Mitani, see above reasoning as the same reasoning also applies presently).
Regarding the arrangement of binding surfaces to reference positions, based on the combination of the cited art, it would have been prima facie obvious to have modified the array of biospots (discrete spots to reference spots) such that the spots are arranged in a pattern that is the plurality of discrete areas of the binding surface arranged into a first row of areas and a second row of areas, and background regions arranged into a first row of background regions, and a second row of background regions, and a third row of background regions (interleaved with discrete spots) as in Nieuwenhuis et al. as an obvious matter of a known configuration applied to a biosensor of discrete binding spots, see as discussed above, Nieuwenhuis disclosing a sensor system similar to that of De Theije (magnetic particle sensor system), and further as an obvious matter of design choice (see Nieuwenhuis teach other configurations as also encompassed, other than interleaving, suggesting the pattern of discrete and background spots is not critical), specifically by alternating (providing in an interleaving formation).
Further, because the prior art suggests the configuration is not particularly critical by suggesting either an interleaving arrangement, as well as other configurations, one having ordinary skill in the art would have a reasonable expectation of success. One having ordinary skill in the art would also have a reasonable expectation of success because the sensor system of Nieuwenhuis is similar to that of De Theije et al. (referring to structurally a sample container, a binding surface, the system for magnetic particle detection, comprising a memory for storing instructions).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over De Theije et al. in view of Duveneck et al., Hawkins et al., Belushkin et al., Mitani et al. and Nieuwenhuis et al. (2011), as applied to claim 7 above, and further in view McDade et al., CA2616762A1.
Regarding claim 8, De Theije et al. describe the container as a channel (see paras [0042], [0051], [0059], [0136] binding sites are part of a channel), the reference describes flow over the sensor surface (para [0033]). As such, it is understood (although the reference does not specifically state “inlet”) that system comprise an outlet (a way for sample to enter and flow over the surface). See at para [0059], De Theije refer to the structure as fitting into the instrument, sensor channel may be part of a, e.g., a well plate. See also para [0143], refers to a stage.
However, as indicated above, De Theije and the cited art fails to specify the first row of background regions located proximate to a pinning of the sample container, the third located proximate to an inlet, the second row of the background regions intermediate the first row and third row.
Structures for attaching (pinning) binding surface structures for detection/at a stage are known in the prior art, see for example McDade et al., teaching use of plastic clamps to hold (i.e., pin) a cartridge structure in place (page 18, last line).
It would have been prima facie obvious to one having ordinary skill in the art to have provided the sensor system comprising a structure that pins the binding surface structure in place (e.g., as in McDade et al.), in order to hold the binding surface in place for detection, the modification an obvious matter of applying a known technique to a known structure (e.g., providing clamps to hold the structure in place). One having ordinary skill in the art would have a reasonable expectation of success using a known technique for its intended purpose of holding a binding surface still for detection.
Regarding the arrangement of the rows (a first row, a second row and a third row of background regions as claimed), it would have been obvious to have arrived at the claimed arrangement as an obvious matter of design choice for the reasons discussed above, particularly as there is only a finite amount of space for arrangement on a given surface (only a finite number of ways to arrange the binding surface), the combination of the cited art addressing weighting the different background regions. One having ordinary skill would have a reasonable expectation of success considering the binding surface will cover a finite amount of area, and given that the cited art (discussed previously above), suggests it is within the skill level of the ordinary artisan to select any arrangement.
Claim(s) 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over De Theije et al. in view of Duveneck et al., Hawkins et al., and Belushkin et al., as applied to claim 1 above, and further in view of Nieuwenhuis et al., WO2008/142492A1.
De Theije et al. teach a sensor system substantially as claimed (see as cited in detail above), however, fails to teach background region of detection surface overlapping a respective area of the binding surface.
See for example Nieuwenhuis et al. (2008) teaching alternative types of usable background reference values usable in sensor systems for detecting labeled particles (abstract, page 12, lines 18-26, claim 6) including reference value taken without sample (i.e., at the binding surface, thereby addressing overlapping with the binding surface, but without target analyte) as a background reference.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor system of De Theije et al. such that the instructions direct one background be obtained from regions on the binding surface (i.e., overlapping the binding surface) to obtain signal from the binding surface prior to analyte being captured, the modification an obvious matter of applying a known technique to a known system, specifically since Nieuwenhuis et al. (2008) teach a finite list of known alternatives for obtaining a background value, one of which being binding surface without analyte. Given that the art recognized a finite number of known techniques for obtaining a background value for determining an analyte using a biosensor system, one having ordinary skill could have pursued those known alternatives with a reasonable expectation of success.
Further, because the prior art recognized different ways to obtain background values to be used for detecting an analyte, one being the use of the binding surface without analyte, the ordinarily skilled artisan would have had a reasonable expectation of success (would expect success using a known technique for its intended purpose).
Regarding claim 12, the combination of the cited art teaches a system comprising instructions to determine concentration based on signal corrected relative to a background. The combination of the cited art is silent as to whether the instructions output a notification that the concentration cannot be determined upon obtaining a background that is not non-zero, positive, however, not non-zero, positive suggests no background signal (i.e., unable to obtain a background signal).
However, see further Nieuwenhuis et al. (2008), the reference teaches the system determining if a reference value(s) is outside an “allowed” value to detect an error state (page 6, lines 1-7), such to indicate, e.g., malfunction of the instrumentation. Nieuwenhuis et al. teach displaying an error message when a background is not determined appropriate for achieving detection (page 14, lines 4-13).
It would have been further prima facie obvious to one having ordinary skill to have modified the system in order to further display an error message (instruction to output notification that concentration cannot be determined) due to insufficient background (background that does not meet predetermined criteria, for example not non-zero, positive as this would be equivalent to no background detected), in order to indicate potential malfunction or inability to accurately determine analyte concentration (Nieuwenhuis et al.). One having ordinary skill in the art would have a reasonable expectation of success modifying De Theije’s system for storing instructions to display an error message when unable to accurately output concentration because De Theije’s system is similar in that it is a memory storing instructions for performing an assay (the necessarily components are already part of the system).
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm.
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/ELLEN J MARCSISIN/ Primary Examiner, Art Unit 1677
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