DETAILED OFFICE 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/28/2025 has been entered.
Priority
The present application was filed on June 17, 2021. The pending and examined claims have an effective filing date of June 17, 2021.
Status of the Claims
Claims 1-8, 12-21, 24-25, 35 and 32-33 are pending. Claims 9-11, 22-23, 26-31, 34, and 36 have been canceled. Claims 32 and 33 have been withdrawn. Claims 1-8, 12-21, 24-25, 35 are examined herein.
Specification
The disclosure is objected to for the following informalities:
Para [0033] appears to contain a punctuation error. Specifically, “determining the presence absence or amount of an analyte” and should read “determining the presence, absence or amount of an analyte”
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 use a generic placeholder for the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such a claim limitation is: "A device for determining an analyte" in claim 14. The Applicant discloses a sufficient structure or material for “a device” in the specifications (para 48: “a system comprising the aforementioned components operatively linked to each other as to allow the determination of the analyte according to the method of the invention”), thus this claim limitation is not being interpreted under 35 U.S.C. 112(f).
Another such claim limitation is: "evaluation unit capable of determining the analyte" in claim 15. The Applicant discloses a sufficient structure or material for “evaluation unit” in the specifications (para 33: “comprise a data processing element, such as a computer, with an implemented algorithm for determining the presence, absence or amount of an analyte”), thus this claim limitation is not being interpreted under 35 U.S.C. 112(f).
Because these claim limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitations do not recite sufficient structure, materials, or acts to perform the claimed function.
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 and 14 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.
Specifically, the terms "closer," "farther," and "sensitivity field" in claim 1 are relative terms which render the claim indefinite. The term “sensitivity field” is a relative term that does not provide a clear and specific basis for understanding which materials, alignments, orientations, geometries, and/or MR ratios are required to achieve optimal detectability. Further, the terms "closer" and "farther" are not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree. Thus, a skilled artisan would not be able to determine the metes and bounds of this claim limitation since the specification does not provide a basis for understanding what are the maximum and minimum distances, relative to the sensor, that are required for detection of the presence or displacement of a magnetic label.
Further, the terms "functional proximity," "closer," and "farther" in claim 14 are relative terms which render the claim indefinite. The terms “functional proximity" "closer," and "farther” are not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree. A skilled artisan would lack a clear and specific understanding of what distances between the magnetic label and the magnetic tunnel junction would make this device and method inoperable.
Claims 2-8, 12-13, 15-21, 24-25, and 35 are included in this rejection because they are dependent on rejected independent claims 1 and 14.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8, 13-21, and 25, are rejected under 35 U.S.C 102(a)(1) as being clearly anticipated by Shultz et al., US Patent Application Publication No. 20170097337 A1.
Throughout the disclosure, Shutlz teaches methods and devices for detection and quantitation of a small analyte suspected to be present in a fluid sample using a competitive assay format in a magnetic biosensor. Shultz teaches that the magnetic biosensor may be a magnetic tunnel junction sesnsor, Hall effect sensor, or magnetoresistive sensor. Furthermore, the fluid sample is added to a biosensor detection chamber together with capture probes, magnetic tags, and, in some embodiments, detection probes. A conformation-changing aptamer, which binds specifically to an analyte and to magnetic tags, or labels, may be used as the detection probe. In embodiments that use only one binding agent to simultaneously serve as the capture and detection probe, it is understood that an aptamer, instead of an antibody, can be used as the binding agent that has a specific affinity for an analyte and can detect if an analyte is present in a sample. Shultz further teaches that the proximity or displacement of magnetic labels to the biosensor surface allows for detection of the aptamer-analyte binding event and thus presence and amount of analyte can be determined.
Regarding claim 1, Shultz teaches method for determining an analyte suspected to be present in a sample comprising: (a) contacting said sample with at least one sensor element comprising: (i) at least one binding agent which is capable of specifically binding to the analyte (para 0004, lines 3-4; para 0005, lines 3-4; para 0024 lines 1-16; para 0034; para 0074, lines 1-3, claim 1) and which comprises at least one magnetic label (para 0004, lines 3-4; para 0024, lines 6-7); and in functional proximity thereto (ii) a magnetic tunnel junction generating a signal which is altered upon binding of the analyte to the binding agent for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the at least one binding agent (para 0004, lines 5-6; para 0024, lines 8-16; para 0070, lines 1-2); (b) measuring an altered signal generated by the magnetic tunnel junction upon analyte binding to the at least one binding agent comprising the at least one magnetic label (para 0004, lines 7-9; para 0029, lines 10-16; para 0070, lines 1-2); and (c) determining the analyte based on the altered signal which is generated by the magnetic tunnel junction[[.]] (para 0004, lines 8-9 para 0070, line 1), wherein said at least one binding agent is an aptamer or fragment thereof (para 0072, lines 1-2), wherein said at least one binding agent is altered in its structure upon binding to the analyte such that the position of the at least one magnetic label becomes located closer (positive mode) or farther away (negative mode) in respect to the sensitivity field of the magnetic tunnel junction (para 0009, lines 6-10; para 0004, lines 13-15 and 18-22; para 0072, lines 1-2; para 0074, lines 4-9; Figs. 6A-6B ).
Regarding claim 2, Shultz teaches the method of claim 1, wherein said measuring the altered signal generated by the magnetic tunnel junction upon analyte binding to the at least one binding agent comprises measuring at least one of the strength of the generated signal and its duration (Figs 1H, 3B).
Regarding claim 3, Shultz teaches the method of claim 2, wherein said measuring comprises measuring a change in the altered signal over time and evaluating said change (Figs. 1H, 3B; para 0016; para 0019; para 0048, lines 7-10).
Regarding claim 4, Shultz teaches the method of claim 1, wherein said altered signal is induced via the at least one magnetic label by application of an external magnetic field as external trigger (para 0008, lines 1-7; para 0048, lines 5-11; claim 9, lines 3-7).
Regarding claim 5, Shultz teaches the method of claim 1, wherein said analyte is selected from the group consisting of a protein, peptide, virus, bacterial cell or small molecule (para 0005, lines 5-7).
Regarding claim 6, Shultz teaches the method of claim 1, wherein said determining an analyte comprises determining the presence or absence of said analyte (para 0029, lines 10-24).
Regarding claim 8, Shultz teaches the method of claim 7, wherein said determining an analyte comprises determining the amount of said analyte (para 0029 lines 10-24; para 0036; claim 9, lines 1-7).
Regarding claim 13, Shultz teaches the method of claim 1, wherein said sample is a biological sample (para 16-17; para 0059, lines 7-10; para 0073, lines 1-4).
Regarding claim 14, Shultz teaches a device for determining an analyte suspected to be present in a sample comprising at least one sensor element comprising: (i) at least one binding agent which is capable of specifically binding to the analyte and which comprises at least one magnetic label; and in functional proximity thereto(ii) a magnetic tunnel junction generating a signal which is altered upon binding of the analyte to the binding agent[[.]],wherein said at least one binding agent is an aptamer or fragment thereof, wherein said at least one binding agent is altered in its structure upon binding to the analyte such that the position of the at least one magnetic label becomes located closer (positive mode) or farther away (negative mode) in respect to the sensitivity field of the magnetic tunnel junction (Figs. 1C-D, 5, 6A-B; paras 0060, 0070, and 0072; ).
Regarding claim 15, Shultz teaches the device of claim 14, wherein said device further comprises:(iii) a detector unit capable of measuring the altered signal generated by the magnetic tunnel junction of the sensor element upon analyte binding to the at least one binding agent; and (iv) an evaluation unit capable of determining the analyte based on the signal which is generated by the magnetic tunnel junction (paras 0070; 0074; 0048, lines 5-11; and Fig. 5).
Regarding claim 16, Shultz teaches the device of claim 14, wherein said measuring the altered signal generated by the magnetic tunnel junctions of the sensor element upon analyte binding to the at least one binding agent comprises measuring at least one of the strength of the generated signal and its duration (paras 0070, 0048, lines 5-11; Figs. 5 and 3C-E).
Regarding claim 17, Shultz teaches the device of claim 14, wherein said analyte is selected from the group consisting of a protein, peptide, virus, bacterial cell or small molecule (para 0073, lines 1-3).
Regarding claim 18, Shultz teaches the device of claim 14, wherein said determining an analyte comprises determining the presence or absence of said analyte (para 0060, lines 10-16).
Regarding claim 20, Shultz teaches the device of claim 19, wherein said determining an analyte comprises determining the amount of said analyte (para 0060, lines 17-19).
Regarding claim 21, Shultz teaches the device of claim 20, wherein said determining the amount of said analyte comprises counting the individual measured altered signals generated by the magnetic tunnel junctions (para 0060, lines 17-19).
Regarding claim 25, Shultz teaches the device of claim 14, wherein said sample is a biological sample (para 0059, lines 8-10 and para 0073, lines 1-3).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 7, 12, 19, 24, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz et al (US Patent Publication No. US 20170097337 A1) in view of Gaster et al (US Patent No. 9,506,919 B2) and evidenced by Chen et al (Yi-Ting Chen, et al., Biosensing Using Magnetic Particle Detection Techniques, 2017, Sensors (Basel), 17(10): 2300).
Regarding claims 7 and 19, Shultz teaches claims 1 and 14, but Shultz does not teach a method or device wherein said sample is contacted with at least 100 sensor elements. However, Gaster, in the same field of endeavor, teaches a method and device wherein a sample is contacted by 100 or more proximity sensors or sensor elements (Gaster et al: col 25, lines 19-24 and lines 34-36).
It would have been prima facie obvious for one having ordinary skill in the art, before the effective filing date, to modify the method and device of determining the presence of an analyte taught by Shultz using the method and device of contacting a sample with 100 or more proximity labels taught by Gaster. A skilled artisan would have been motivated to combine these methods and devices because increasing the amount of sensor elements would increase sensitivity, lower detection limits, improve accuracy, and allow for multiplexing. One having ordinary skill in the art would have a reasonable expectation of success because Gaster teaches contacting a sample with a 100 or more sensor elements to detect an analyte using a magnetic tunnel junction and a skilled artisan would apply these teachings with predicable results.
Regarding claims 12 and 24, Shultz teaches 1 and 14 but Shultz does not teach the method or device wherein said at least one magnetic label is selected from the group consisting of superparamagnetic or ferromagnetic nanoparticles: iron-platinum nanoparticles, iron nanoparticles, nickel nanoparticles, and cobalt nanoparticles. However, Gaster, in the same field of endeavor, teaches a method and device wherein said at least one magnetic label is selected from the group consisting of nanoparticles: iron-platinum nanoparticles, iron nanoparticles, nickel nanoparticles, and cobalt nanoparticles (Gaster: col 9, lines 21-26 and lines 56-57).
It would have been prima facie obvious for one having ordinary skill in the art, before the effective filing date, to apply the method and device wherein at least one magnetic label is either iron-platinum nanoparticles, iron nanoparticles, nickel nanoparticles, and cobalt nanoparticles as taught by Gaster with the method and device for detecting an analyte using detection labels and a magnetic tunnel junction sensor as taught by Shultz. One skilled in the art would have been motivated to apply the method and device of Gaster to the method and device of Shultz because iron-platinum-, iron-, nickel-, and cobalt-based nanoparticles are part of a finite number of metals routinely used in the art due to their known magnetic properties and use with magnetic sensors (see Chen et al., , 2017, Sensors (Basel), 17(10): 2300). One would have a reasonable expectation of success because a skilled artisan would have recognized that applying one of these known elements, from a finite number of identified potential solutions, would yield predicable results.
Regarding claim 35, Shultz teaches claim 14 and further teaches that the detection antibody can be a structure-switching aptamer. Shultz does not teach a kit for determining an analyte suspected to be present in a sample comprising the device of claim 14. However, Gaster, in the same field of endeavor, teaches a kit for determining an analyte suspected to be present in a sample comprising the device of claim 14 (Gaster: col 33, lines 41-55 and Shultz: para 0072, lines 1-2).
It would have been prima facie obvious for one having ordinary skill in the art, before the effective filing date, to combine the device in claim 14 taught by Shultz with the kit taught by Gaster. A skilled artisan would have been motivated to combine the device taught by Shultz with the kit taught by Gaster because it would allow for the method and device of detecting the presence of an analyte in a biological sample to be a standardized, cost-effective, and straightforward test without requiring complex optimizations and ensuring reproducible results. One would have a reasonable expectation of success because Gaster teaches the use of a kit for detecting the presence or absence of analyte in a biological sample and a person having ordinary in the art would have recognized that combining this improvement to the teachings of Shultz would yield predicable results.
Response to Arguments
Applicant’s arguments with respect to the 35 USC 102 rejection of claims 1-8, 12-21, 24, 25 and 35 and with respect to 35 USC rejection of claims 10, 11, 22, 23, and 35 have been considered but are moot because new grounds of rejection are necessary due to the amendment of the claims.
Conclusion
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/M.L.L./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 December 29, 2025