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.
Priority
Acknowledgment is made of the present application as a proper National Stage (371) entry of PCT Application No. PCT/PCT/US21/40767, filed 07/08/2021, which claims benefit under 35 U.S.C. 119(e) to provisional application No. 62/705,639, filed 07/08/2020.
Information Disclosure Statement
The information disclosure statement (IDS) filed 05/01/2026 is considered, initialed and is attached hereto.
Status of the Claims
Claims 1, 4, 9, 11, 20, 22, 24-32 and 63-80 are pending; claims 1, 4, 9, 25, 27-29 and 31 are amended; claims 2-3, 5-8, 10, 12-19, 21, 23, 33-62 are canceled; claims 64-80 are newly recited; and claim 63 remains withdrawn.
Withdrawn Objections/Rejections
The previous rejections of claims 4, 9, 28 and 29 under 35 U.S.C. 112(b) are withdrawn in response to Applicant’s amendments to the claims.
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 1, 4, 9, 11, 20, 22, 24-32, 64-67 and 69-80 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 25, 28 and 29 recite “signal representing a characteristic of the magnetic sensor, the characteristic of the magnetic sensor indicating a magnetic environment”. See at page 14 of the originally filed specification, the specification provides examples of what is considered signal that represents “the magnetic environment”, such signals include current, or proxy for current such as resistance or voltage, however at page 14 the specification also indicates or “some other characteristic that represents the magnetic environment sensed by the magnetic sensor”. The claim language is indefinite because the boundaries of what are encompassed by the recited language are unclear, for example, other than current, resistance or voltage it is not clear what other signals are representative of a characteristic of “magnetic environment” (magnetic environment interpreted as the area at the sensing region, see e.g., claim 1 “magnetic environment of the sensing region”).
Claim 78 recites “between approximately 105 nm3 and approximately 5 x 105 nm3”, the recited language is indefinite because it is unclear if the claimed range is limited to values between 105 nm3 and approximately 5 x 105 nm3 or encompasses values somewhat outside of this range, and if inclusive of values outside of this range, what values. The originally filed specification places not standard of measure or definition on the term “approximately”.
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, 4, 9, 11, 20, 22, 24-32 and 64-80 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, 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 MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 1 recites “determining a first Lorentzian function characterizing the signal obtained from the magnetic sensor during the first detection period”, “determining a second Lorentzian function characterizing the signal obtained from the magnetic sensor during the second detection period” and further recites “wherein detecting the motion of the magnetic particle based on the change in the signal between the first detection period and the second detection period comprises identifying a difference between the first corner frequency of the first Lorentzian function and the second corner frequency of the second Lorentzian function”.
Claim 9 recites “wherein detecting the motion…comprises obtaining a first autocorrelation of a first portion of the signal, the first portion of the signal detected during the first detection period, obtaining a second autocorrelation of a second portion of the signal detected during the second detection period; and identifying at least one difference between the first autocorrelation and the second autocorrelation”.
Specifically, the limitations determining first and second Lorentzian functions” are directed to abstract ideas, namely see the MPEP regarding Groupings of abstract ideas determining Lorentzian functions are mathematical concepts, determining a Lorentzian function encompasses mathematical relationships, formulas/equations, calculations. See further, dependent claim 25, for example, claim 25 recites “determining the first Lorentzian function comprises determining a power spectral density (PSD) of the signal representing the magnet environment of the sensing region during the first detection period, and fitting the first Lorentzian function to the PSD of the signal obtained during the first detection period; and/or determining the second Lorentzian function comprises determining a PSD of the signal representing the magnetic environment of the sensing region during the second detection period, and fitting the second Lorentzian function to the PSD of the signal obtained during the second detection period”. The actions of determining PSD of signal and fitting the function to the PSD are methods of manipulating the data through mathematical calculations/relationships.
See for example, Applicant’s originally filed specification at page 19, applicant refers to power spectral density as a signature of Brownian motion, and the specification indicates/refers to it as a Lorentzian function.
Regarding the above discussed claims, the limitations directed to detecting motion based on change in the signal between the first detection period and the second detection period comprises identifying a difference between the first corner frequency of the first Lorentzian function and the second corner frequency of the second Lorentzian function, these limitations are also directed to abstract ideas, namely mathematical concepts (discussed above), and further mental processes (also considered abstract ideas, see Groupings of Abstract ideas). Specifically, identifying change between the different frequencies amounts to performing a comparing step, which is a mental process, a process performed in the human mind (such as, for example, a practitioner observing the measured signals/calculated corner frequency of the second time period compared to the earlier first reference signal/corner frequency and making an evaluation, judgement, or opinion, in this case the evaluation, judgement or opinion regarding/related to particle motion/magnetic environmental change set forth as a result of the motion).
Similar concepts involving comparing information regarding a sample or test subject to a control or target data (data comparison) have been held to be an "abstract mental process", as in University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014) which involved "comparing BRCA sequences and determining the existence of alterations", the collecting and comparing of known information in Classen, the comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC, as well as Mayo.
Claim 27 recites “determining a noise power spectral density of the magnetic sensor using the signal detected during the third detection period”, determining a PSD using a signal is considered abstract ideas for the reasons discussed above (see as discussed at claims 1 and 9, as the same reasoning also applies presently).
Claims 28 and 29 recite limitations which further narrow/limit the above indicated abstract ideas, see specifically, claim 28 recites “wherein a sum of the first Lorentzian function and the noise of the PSD of the magnetic sensor is approximately equal to a PSD of the signal representing the magnetic environment of the sensing region during the first detection period”, claim 29 recites “wherein a sum of the first Lorentzian function and the noise power spectral density of the magnetic sensor is approximately equal to a first power spectral density of the signal representing the magnetic environment of the sensing region during the first detection period, a sum of the second Lorentzian function and the noise power spectral density of the magnetic sensor is approximately equal to a second power spectral density of the signal representing the magnetic environment of the sending region during the second detection period; and concluding that a biological process has occurred based on the first corner frequency being different from the second corner frequency”.
Claim 31 also further limits the mathematical concepts of claim 1, the claim recites “the first Lorentzian function represents a first noise power spectral density due to motion of the magnetic particle during the first detection period, the second Lorentzian function represents a second noise power spectral density due to the motion of the magnetic particle during the second detection period; and detecting the motion of the magnetic particle based on the change in the signal between the first detection period and the second detection period comprises identifying a difference between the first corner frequency and the second corner frequency”. See for the reasons discussed in detail above, determining the claimed first and second Lorentzian functions represents abstract ideas.
Step 2A, Prong 2
The limitations indicated in detail above, namely the limitations that are the abstract ideas (the judicial exceptions), are not further integrated into a practical application of the judicial exceptions, there are no additional steps/elements claimed which further apply, rely on or use the judicial exceptions in such a way that would amount to a practical application of the judicial exceptions.
Regarding the independent claim 1, in addition to the indicated judicial exceptions, the claim further recites active method steps of “coupling a biopolymer to a binding site sensed by the magnetic sensor, and coupling a magnetic particle to the biopolymer, obtaining signal from the magnetic sensor, the signal representing a magnetic environment of the sensing region”, these steps performed for a first and second detection period. These additional limitations are steps performed in order to obtain the data, i.e., fail to go beyond insignificant pre-solution activity, i.e., steps performed in order to gather the data (the signal) used in the judicial exceptions.
None of the additionally recited dependent claims further recite limitations which apply, rely on or use the judicial exceptions in a manner that imposes a meaningful limit to the judicial exceptions.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additionally recited steps elements (recited in addition to the judicial exception, as discussed above, namely referring to the steps of “coupling a biopolymer to a binding site sensed by the magnetic sensor, and coupling a magnetic particle to the biopolymer, obtaining signal from the magnetic sensor, the signal representing a magnetic environment of the sensing region”) also fail to amount to significantly more than the judicial exceptions because these steps/element fail to go beyond that which well-known, routine and conventional in the assay art at the time.
For example, see De Silva et al., Well-defined and Sequence-Specific Noncovalent Binding Forces of DNA, The Journal of Physical Chemistry B, 117, (2013), p.7554-7558, De Silva teach methods comprising monitoring single-molecule biological processes (binding between two DNA strands, see abstract) using a magnetic sensor (magnetometer, page 7554, col. 2, para 3, Experimental methods), the method of De Silva comprises the steps of coupling a biopolymer (see page 7555, col. 1, paras 1-2, and figure 1(a), a double stranded helix) to a binding site sensed by the magnetic sensor (binding site of De Silva is a gold coated well), coupling a magnetic particle to the biopolymer (through the second strand labeled with the magnetic particle). De Silva teach obtaining a first and second signal during a first and second detection period (see page 7555, end of col. 1, magnetization, M, of the magnetic particle measured by an atomic magnetometer using scanning magnetic imaging, observing M after each force applied). De Silva show at Figure 1(c) plots of the relative magnetization, see from the plot at figure 1(c), De Silva detected motion of the magnetic particle based on change in the signal between the first detection period and the second detection period.
Another example is Wang et al., US PG Pub No. 2011/0223612A1 (IDS entered 01/08/2023, 19 pages), see for example figure 1 and paras [0007], [0061] and [0082], biopolymer coupled to a binding site sensed by a magnetic sensor, magnetic particle coupled to the biopolymer
See also Wang et al., WO2005/047864A2, at the abstract and also Figures 1 and 2A, also para [00031], which is another example of coupling a biopolymer to a sensing region sensed by a magnetic sensor, a magnetic particle coupled to the biopolymer.
Li et al., Spin-valve sensors for ultrasensitive detection of superparamagnetic nanoparticles for biological applications, Sens. Actuators A. Phys., 126(1), (2006), p.98-106 (IDS entered 01/08/2023, 4 pages), teach GMR based magnetic bio-detection, methods comprising biopolymer coupled to a sensing region to be detected by a magnetic sensor, magnetic nanoparticles coupled to the biopolymer (see figure 1, for example).
Based on the above cited evidence, the additional steps (those in addition to the limitations that are the judicial exceptions themselves), individually or as an ordered combination, are considered well-known, routine and conventional in the magnetic biosensing assay art. Further noted, regarding dependent claims (e.g., claims 20 and 22) limitations, see for example Wang et al., (2011, cited above), para [0056], it is well known in the prior art that magnetic sensor devices may have a variety of configurations, including for flow through use (flow cell, flow through configurations). See also para [0090], monitoring the device over time in response to solution, for example containing antigen. Further regarding particle diameter, see also Wang et al., (2011, cited above), para [0075], magnetic nanoparticles as small as 5 nm (given broadest reasonable interpretation, 5 reads on “less than approximately 5 nm”). Also, Wang et al., (2005 cited above) at para [0043] similarly reporting magnetic tag/particle capable of having a variety of diameter, including “5 nm”. Additionally, regarding particle diameter, Applicant’s originally filed specification further supports there is nothing beyond that which was routine/conventional with regard to diameter, see at page 34 (any suitable particle, the specification indicate diameters on the order of a few nanometers or up to different sizes, such as 20 nm.
Also, (under step 2A), the claimed steps/elements recited at the dependent claims are further directed to pre-solution activity, as these are steps/elements necessary to gather the data (or which further narrow the data gathering limitations). It does not appear, based on the above cited evidence, that these steps (which are performed to obtain the data used in the judicial exception) are performed in a manner which is beyond that which is considered to be well-known, routine and conventional.
Additionally, although new claims narrow the magnetic sensor to those comprising MTJ, STO and spin valve (see referring to new claims 75-77), the involvement of the specifically recited sensor is considered to be extra-solution or a field of use, as in the present case the sensor is merely being used in order to obtain the signal (data gathering). See also Wang at paras [0014] and [0030], supporting that detectors that are spin valve or MTJ detectors are routine for magnetic particle detection systems. Further see Applicant’s originally filed specification at page 11, citing Nagasawa et al. (published 2012), in reference to the use of an STO sensor
For all of these reasons, the claims are rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 05/01/2026 have been fully considered but they are not persuasive.
Regarding remarks specific to the IDS, the Examiner confirms, references not lined through on the annotated IDS have been considered.
Regarding the rejection of claims 1, 25, 28 and 29 under 35 U.S.C. 112(b), Applicant argues the limitations are not indefinite, arguing that the skilled artisan understands what is meant by “signal representing the magnetic environment”. However, this argument is not persuasive, as the limitation “signal representing a characteristic of the magnetic sensor, the characteristic of the magnetic sensor indicating magnetic environment” is not limited to only any of current, or proxy for current such as resistance or voltage, rather the specification appears to suggest this includes some other unspecified value of measurement/measurable property (page 14 the specification also indicates or “some other characteristic that represents the magnetic environment sensed by the magnetic sensor”). It is not readily clear what is and is not encompassed by the recited language.
Regarding remarks at pages 11-16, see as indicated in detail above, the other previous rejections under 35 U.S.C. 112(b) are withdrawn as indicated.
Regarding the rejection of claims under 35 U.S.C. 101 (remarks pages 17), Applicant argues that the Office has failed to perform the required analysis for each claim in the rejection and argues the analysis improperly dissects the claims by isolating the mathematical and analytical steps from the physical steps with which they are intertwined (remarks page 17).
Specifically (see page 17), Applicant argues the claim limitations are analyzed in isolation and not assessed as a whole. Specifically, remarks page 19, Applicant argues that as a whole, claim 1 recites a method of monitoring single molecule biological processes using a magnetic sensor, Applicant then referring to each of the claimed active method steps of coupling, obtaining signal, determining a first Lorentzian function”, etc. Applicant asserts the claimed method is not an abstract mathematical exercise or something than can be performed in one’s mind (remarks page 20), but rather a specific technique used to detect nanoscale physical particle motion using data obtained from a magnetic sensor, arguing further that the Lorentzian function corresponds to a physical model of Brownian motion and the corner frequence indicates a physically meaningful characteristic of the particle’s dynamic within the sensing region, and as such is directed to a specific technological measurement technique, not to mathematics in the abstract. See further remarks page 20. Applicant argues the present claims are similar to those as in Thales Visionix Inc. v. United States, that the claims do not recite Lorentzian functions in the abstract, but instead apply a specific signal-processing technique to magnetic sensor data to detection motion of a magnetic particle within a sensing region of the magnetic sensor. Arguing, as in Thales, the mathematical concepts are employed as part of the particular technological solution and do not render the claims abstract (page 21).
However, Applicant’s remarks are not persuasive. For example, Step 2A Prong one consideration, do the claims recite an abstract idea, and in the present case, the claims do recite limitations which amount to mathematical calculations/concepts, as well as mental concepts (comparing), as a result, it is necessary to continue on with the analysis at Prong two, which the consideration at Prong 2 requires evaluation of those limitations recited in addition to the judicial exception(s) themselves. Specifically, the claims are evaluated to determine whether the claim recites additional elements that integrate the exception into a practical application of the exception, and “integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
As indicated in the analysis above, none of those limitations recited in addition to those limitations indicated to be mathematical concepts/mental concepts, further apply, rely on or use the exceptions in such a way to amount to practical application thereof under 35 U.S.C. 101.
Referring to Applicant’s argument that the claimed invention is consistent with the reasoning in Thales, in response it is noted that Thales Visionix, the particular configuration of inertial sensors and the particular method of using the raw data from the sensors was more than simply applying a law of nature. It does not appear to be the case presently, that the claimed invention combines the mathematical concepts with an unconventional utilization of the physical assay components. See 2106.04(a)(2), Thales Visionix, Inc. v. United States, 850 F.3d 1343, 1348-49, 121 USPQ2d 1898, 1902-03 (Fed. Cir. 2017) (determining that the claims to a particular configuration of inertial sensors and a particular method of using the raw data from the sensors in order to more accurately calculate the position and orientation of an object on a moving platform did not merely recite "the abstract idea of using ‘mathematical equations for determining the relative position of a moving object to a moving reference frame’."). For example, a limitation that is merely based on or involves a mathematical concept described in the specification may not be sufficient to fall into this grouping, provided the mathematical concept itself is not recited in the claim.
In the instant claims, the claims do not merely involve a mathematical concept, rather the claims specifically recite “determining” first and second Lorentzian functions characterizing obtained signals during the first and second detection periods, and identifying a difference between a first corner frequency of the first and a second corner frequency of the second. These limitations are performed using mathematical concepts (determining a Lorentzian function, i.e., a specific mathematical function, amounts to performing mathematical concepts/calculations, see as is supported by page 19 of the originally filed specification). Accordingly, the claim recites an abstract idea.
Regarding the remarks at page 21 that the claims are directed to a technological improvement in signal analysis and therefore are patent eligible, in the present case, it is not that the combination of additional claim elements (those in addition to the judicial exception) recite a specific improvement over the prior art, such to integrate the judicial exceptions into a practical application thereof. In order to amount to integration by improvement, the claim itself must reflect the improvement in technology.
Regarding arguments (page 21) that the Office's characterization of the comparison of corner frequencies as a "mental process," (Office Action, p. 10), is incorrect. The claimed methods require (a) obtaining time-dependent sensor signals, (b) determining Lorentzian functions characterizing those signals, and (c) extracting corner frequencies from those functions. These actions involve obtaining a signal from a sensor, which cannot be done in the mind. However, in response see MPEP 2106.04(a)(2)(III)(c), a claim that requires a computer may still recite mental processes.
Applicant further argues (page 22) that the claimed invention satisfies Step 2A, Prong 2, arguing the claimed methods apply the Lorentzian characterization and corner frequency determination to analyze signal provided within a sensing region, that the claims are not reciting mere data manipulation, but rather use signal processing leverage magnetic sensor to allow nanoscale particle motion to be detected. Applicant’s arguments are not persuasive for the reasons as stated in the rejection, in particular these argued limitations are used to obtain the data relied upon as input for the calculations/concepts, and these limitations do not apply, rely on or use the judicial exception (rather, are pre-solution activity, active assay steps used to gather the data).
Regarding remarks at page 23, that new claims are tie the method to a specific sensor technology, see the amended grounds of rejection addressing the newly recited limitations, the involvement of the specifically recited sensor is considered to be extra-solution or a field of use, as in the present case the sensor is merely being used in order to obtain the signal (data gathering).
Regarding remarks at pages 23-25, that there is no art rejection under 35 U.S.C. 102 or 103, so the ordered combination is not routine and conventional, this argument is not persuasive. Rejections under 35 U.S.C. 102 and 103 are distinct from those under 35 U.S.C. 101. In the present case, the limitations directed to determining the first and second Lorentzian functions are the limitations considered to be abstract ideas (judicial exceptions), and the above referenced evidence supports that those steps recited in addition to the judicial exceptions fail to go beyond steps/elements considered to be routine and conventional in the assay art with regard to magnetic particle detection/detecting magnetic particle coupled through biopolymer to a magnetic sensor.
For all of these reasons, Applicant’s arguments are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Corrspondence
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677
Prosecution Insights