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 with traverse of Group I, claims 1, 4, 9, 11, 20, 22 and 24-32, and the species STO (species group b) in the reply filed on 11/17/2025 is acknowledged.
The traversal is on the ground(s) that there is a technical relationship between claims 1 and 33 involving the same or a corresponding special technical feature (asserted by Applicant, remarks 11/17/2025, page 13). Applicant argues the office’s conclusion in the restriction is incorrect because it ignores most of the elements in the claims. However, this argument is not persuasive, in evaluating the claims under Restriction the Examiner determined what was the shared common feature/limitations between the claims.
Applicant argues claim 33 requires “a binding site for holding no more than a single biopolymer” and “the sensing region includes the binding site, but no other binding site”, while claim “uses a corresponding geometry” (remarks page 13), Applicant referring to the claim language “coupling a biopolymer to a binding site sensed by the magnetic sensor, coupling a magnetic particle the biopolymer”. However, the language at claim 1 is not equivalent in scope to the language at claim 33 at the time of restriction. Specifically, “coupling a biopolymer to a binding site sensed by the magnetic sensor, coupling a magnetic particle the biopolymer” is not the same as “binding site for holding no more than a single biopolymer” (referring to this argument by Applicant).
Applicant further argues, remarks page 13, that both claims recite elements to obtain a signal during a first detection period and during a second detection period and use change in that signal to detect motion of the magnetic particle. However, Applicant’s argument is not persuasive, the independent claims are not both directed to method claims, but rather a method and products (systems). For example, the method of Group I does not require the system/product of Group II to perform the method (is not limited toa method performed by the claimed system of the other group).
Referring to the restriction requirement and the claims at the time of restriction, it is maintained that the common feature was of a magnetic sensor having a sensing region, and it is maintained that Wang et al. US PG Pub No. 2011/0223612 as cited in the restriction.
However, even re-evaluated following amendment to the claim, the shared feature between the method and the product groups of invention is a magnetic sensor having a sensor region, a coupled biopolymer at the binding site, a magnetic particle coupled to the biopolymer. The further method steps are limited to a system/structure such as the processor at claim 33. Further prior art made of record in the detailed rejections below also reads on the common feature shared between these different method and product groups, see for Example De Silva et al. (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), and as a result the shared common feature is not a special technical feature in view of this cited prior art. Specifically, 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).
Applicant’s arguments (through remarks page 15) are not persuasive for these reasons. At this time, as there are pending grounds of rejection over the elected Group of invention, the claims are not rejoined.
However, regarding Applicant’s remarks directed to the required election of species (remarks pages 15-17), in light of Applicant’s remarks the requirement for an election of species (claim 38) is withdrawn. Notably, however, claim 38 remains withdrawn as directed to non-elected group of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 33, 35, 38, 41-43, 45, 48-51, 53-55, 57 and 60-63 (newly recited claim 63 is directed to a system, not method as elected) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups of invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/17/2025.
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 statements (IDS) filed 01/08/2023 (2 each 5 pages, 1 4 pages), 08/08/2023, 12/13/2023, 12/09/2024 and 11/17/2025 are considered, initialed and attached hereto.
The information disclosure statement filed 01/08/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
It appears that no copy of each of Foreign Patent Literature document No. 6 (CN2020800345867), and Non-patent literature document Nos. 8 and 9 (E. du Trémolet de Lacheisserie et al. and E. Hall) have been provided.
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 and 24-32 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 the 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 “magnetic environment” (magnetic environment interpreted as the area at the sensing region, see e.g., claim 1 “magnetic environment of the sensing region”).
Claim 4 recites “less than approximately 5 nm”, the recited language is indefinite because it is unclear if “less than approximately 5 nm” encompasses, for example 5 nm, since approximately suggests the value could be any value approximate to 5 nm which would encompass values slightly above and below this number. The originally filed specification places not standard of measure or definition on the term “approximately”. Therefore, it is not readily clear if “less than approximately 5 nm” is strictly those values below 5 nm, or if this range is inclusive of 5nm and/or some value slightly above 5 nm.
Claim 9 recites “obtaining a first autocorrelation of a portion of the signal corresponding to the first detection period” and “obtaining a second autocorrelation of a portion of the signal corresponding to the second detection signal”, the language “a portion” is indefinite because it is not clear what part of the signal the claim is limited to for “obtaining” the autocorrelation (what part of the signal at the first and second time periods). For example, based on the specification, it appears that only signal at a particular portion of the “function” would provide for relevant information pertaining to the intended monitoring (originally filed specification at pages 39-41). It is not clear from the recited claim language if any portion of the signal during each time period is encompassed by the language, or if the claimed method is limited to a specific portion.
Claims 28 and 29 recites “wherein a sum of the first Lorentzian function and the noise PSD of the magnetic sensor is approximately equal to the PSD of the signal representing the magnetic environment of the sensing region during the first detection period”. The recited language is indefinite because PSD represent the converted time domain signal obtained during the assay (time domain signal converted to frequency domain to plot the PSD). From the specification, it is the Lorentzian function(s) that characterize (describe the nature of) the PSD of the confined Brownian motion of the magnetic nanoparticle (e.g., see page 5 of the specification, referring to Figure 12 and page 9) during each measured time period. See page 19, “the PSD of Brownian motion is a Lorentzian function”, further at the end of page 19 “Knowing that the PSD (which may be considered a signature) of confined Browning motion is a Lorentzian function”. As a result, it is not clear what is meant by sum of the Lorentzian function and the noise domain, or further what additional further limitation this language places on the claimed method (i.e., what this recited language further limits the claimed method to that is narrower than that already recited at the prior claims from which it depends). See further this language also recited at claim 29 (referring to a sum of the function and the noise PSD).
Additionally, regarding claim 28 and 29, the claims recite the limitation "the noise PSD”. There is insufficient antecedent basis for this limitation in the claim. The claims make no previous reference to a PSD referred to as “a noise PSD” (not recited until claim 31).
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 and 24-32 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 portion of the signal corresponding to the first detection period, obtaining a second autocorrelation of a portion of the signal corresponding to 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 “PSD” 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 (PSD) 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 PSD of the magnetic sensor is approximately equal to a first PSD 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 PSD of the magnetic sensor is approximately equal to a second PSD 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 PSD due to motion of the magnetic particle during the first detection period, the second Lorentzian function represents a second noise PSD due to the motion of the magnetic particle during the second detection period; and detecting the motion of the magnetic particle base don 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 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 “approximately 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, as discussed in detail previously above (under step 2A), these steps are further directed to pre-solution activity, necessary to gather the data. 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 routine and conventional.
For all of these reasons, the claims are rejected under 35 U.S.C. 101.
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