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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/5/2026 has been entered.
Response to Amendment
The Amendment filed on 3/5/2026 has been entered. Claims 25-27, 29-33, 35-41 and 43-45 remain pending in the application.
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.
Claim 44 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 44 recites “a sample mount configured to position a sample within the conductive excitation coil” and “a sample strip.” However, claim 44 is therefore unclear if the sample mount is configured to hold the sample strip as the sample strip would have the sample or if the sample mount is holding a different sample from what the sample strip is holding. For examination purposes, they are interpreted to be the same.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 35-39 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over EP 3470832A1, hereinafter Kokabi in view of United States Application Publication No. 2019/0154671, hereinafter Van Roosmalen.
Regarding claim 35, Kokabi teaches a bioassay system (item 400) comprising: a conductive excitation coil (items HF1 and HF2) configured to generate an alternating magnetic field including at least one of at least one sinusoidal wave, a square wave, a triangular wave, a sawtooth wave, or a combination of sinusoids thereof an apply the alternating magnetic field to a first sample region (intended use MPEP § 2114 (II) and is taught in figure 3b); a sample strip (figures 5 and 6) comprising a first side (figures 5 and 6) and a second side (figures 5 and 6) of the sample strip being opposite to the first side of the sample strip (figures 5 and 6), wherein the conductive excitation coil is disposed on or adjacent to the first side of the sample strip (figure 4), wherein the first sample region (the left side of item 400) comprises: a first surface (item RR) within the first sample region (figure 4A), the first surface coated with at least one probe configured to capture a first analyte type (paragraphs [0003] and [0073]); and a first conductive sensing coil (item D1) configured to determine a magnetic response of a surface functionalized MNP configured to be captured by the first analyte type (intended use MPEP § 2114 (II) and is taught in paragraph [0067]), wherein the first conductive sensing coil is disposed on the second side of the sample strip (figures 5 and 6).
Kokabi fails to teach a second sample region comprises: a second surface within the second sample region, the second surface coated with at least one probe configured to capture a second analyte type, the second analyte type different from the first analyte type; a second conductive sensing coil configured to determine a magnetic response of a surface functionalized MNP configured to be captured by the second analyte type and the second conductive sing coil is disposed on the second side of the sample strip.
Van Roosmalen teaches an immunoassay in which the device has more than one immunoassay unit running more than one immunoassay of different analytes in parallel (Van Roosmalen, paragraph [0071]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the first sample region of Kokabi and added it to the bioassay system and utilized a probe configured to capture a second analyte type which is different from the first analyte type because it would allow for multiple immunoassays of different analytes to be run in parallel (Van Roosmalen, paragraph [0071]).
Regarding claim 36, modified Kokabi teaches wherein the sample strip is a microfluidic sample strip, wherein the first and second sample regions are disposed on the microfluidic sample strip configured to allow a flow of a fluid containing at least one of at least one analyte and at least one surface functionalized MNP over the first and second surfaces (figure 6).
Regarding claim 37, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Kokabi and the apparatus of Kokabi is capable of having the microfluidic sample strip be in fluid communication with a microfluidic device. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Kokabi (see MPEP §2114). Further this limitation is taught in figure 6.
Regarding claim 38, the microfluidic device is not positively claimed and therefore any limitation on the microfluidic device has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Kokabi.
Regarding claim 39, the microfluidic device is not positively claimed and therefore any limitation on the microfluidic device has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Kokabi.
Regarding claim 43, Kokabi teaches wherein the substrate is a polymer (paragraph [0024]) and wherein the conductive excitation coil is integrated into the first side of the sample strip (figure 4).
Claim(s) 40 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kokabi and Van Roosmalen as applied to claim 35 above, and further in view of EP 3581916A1, hereinafter Achtsnicht.
Regarding claims 40 and 41, Kokabi teaches a processor (paragraph [0036]).
However, Kokabi and Van Roosmalen fail to teach the processor is configured to determine at least one harmonic amplitude and at least one ratio of harmonic amplitudes of the determined magnetic responses of the first and second regions and configured to determine the presence of the first analyte type and the second analyte type based on the at least one ratio of harmonic amplitudes, wherein the at least one ratio of harmonic amplitudes is independent of an MINP concentration.
Achtsnicht teaches a magnetic particle determination apparatus which has a processor configured to determine at least one harmonic amplitude and at least one ratio of harmonic amplitudes of the determined magnetic responses of the first and second regions (Achtsnicht, paragraphs [0039] and [0042]) and configured to determine the presence of the first analyte type and the second analyte type based on the at least one ratio of harmonic amplitudes (Achtsnicht, paragraph [0039]) so that various types of magnetic particles can be determined particularly reliably (Achtsnicht, paragraph [0039]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the processor configured to determine at least one harmonic amplitude and at least one ratio of harmonic amplitudes of the determined magnetic responses of the first and second regions and configured to determine the presence of the first analyte type and the second analyte type based on the at least one ratio of harmonic amplitudes because it would allow for various types of magnetic particles can be determined particularly reliably (Achtsnicht, paragraph [0039]).
While Kokabi, Van Roosmalen and Achtsnicht do not address the at least one ratio of harmonic amplitudes is independent of an MNP concentration., it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, capturing an analyte with a probe is discussed. Absent persuasive evidence that the capturing of the analyte with a probe is different, the prior art is considered to have the same properties with respect to the proportionality of the harmonic amplitude ratio to the binding of analytes to MNPs as that is claimed. MPEP § 2112.01 (I-IV).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kokabi in view of Achtsnicht.
Regarding claim 44, Kokabi teaches a bioassay system (item 400) comprising: a conductive excitation coil (items HF1 and HF2) configured to generate an alternating magnetic field including a plurality of frequencies (intended use MPEP § 2114 (II) and is taught in figure 3b); a sample mount configured to position a sample within the conductive excitation coil (figure 4, where the sample strip is placed); a conductive sensing coil (item D1) configured to determine a magnetic response of a sample positioned within the sample mount to the alternating magnetic field (intended use MPEP § 2114 (II) and is taught in paragraph [0067]); a sample strip (figures 5 and 6) comprising a first side and a second side (figures 5 and 6), the second side of the sample strip being opposite to the first side of the sample strip (figures 5 and 6), wherein the conductive excitation coil is disposed on or adjacent to the first side of the sample strip (figure 4); and wherein the conductive sensing coil is disposed on the second side of the sample strip (figure 4).
Kokabi fails to teach a processor configured to determine at least one harmonic amplitude ratio based on the determined magnetic response, wherein the harmonic amplitude ratio comprises at least one of the third to the seventh harmonic amplitudes, the third to the ninth harmonic amplitudes, the third to the eleventh harmonic amplitudes, the fifth to the seventh harmonic amplitudes, the fifth to the ninth harmonic amplitudes, the fifth to the eleventh harmonic amplitudes, the seventh to the ninth harmonic amplitudes, seventh to the eleventh harmonic amplitudes, or the ninth to the eleventh harmonic amplitudes.
Achtsnicht teaches a magnetic particle determination apparatus which has a processor configured to determine at least one harmonic amplitude and at least one ratio of harmonic amplitudes of the determined magnetic responses of the first and second regions (Achtsnicht, paragraphs [0039] and [0042]) and configured to determine the presence of the first analyte type and the second analyte type based on the at least one ratio of harmonic amplitudes (Achtsnicht, paragraph [0039]) so that various types of magnetic particles can be determined particularly reliably (Achtsnicht, paragraph [0039]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the processor configured to determine at least one harmonic amplitude and at least one ratio of harmonic amplitudes of the determined magnetic responses of the first and second regions and configured to determine the presence of the first analyte type and the second analyte type based on the at least one ratio of harmonic amplitudes because it would allow for various types of magnetic particles can be determined particularly reliably (Achtsnicht, paragraph [0039]).
While Kokabi, Van Roosmalen and Achtsnicht do not address the at least one ratio of harmonic amplitudes is independent of an MNP concentration., it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, capturing an analyte with a probe is discussed. Absent persuasive evidence that the capturing of the analyte with a probe is different, the prior art is considered to have the same properties with respect to the proportionality of the harmonic amplitude ratio to the binding of analytes to MNPs as that is claimed. MPEP § 2112.01 (I-IV).
Allowable Subject Matter
Claims 25-27, 29-33 and 45 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record is Achtsnicht which teaches a conductive excitation coil, a sample mount, a conductive sensing coil and a processor. However, the prior art does not disclose, teach or suggest the claimed combination of a sample container configured to be positioned within the sample mount, wherein the sample container contains at least one surface functionalized magnetic nanoparticle (MNP) and at least one surface functionalized microbead; wherein the at least one surface functionalized microbead is configured to increase a hydrodynamic size of the at least one surface functionalized MNP via binding of the least one surface functionalized microbead and the at least one surface functionalized MNP to an analyte, wherein the magnetic response of the sample comprises a magnetic response of the at least one surface functionalized MNP.
Response to Arguments
Applicant's arguments filed 3/5/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding applicant’s argument that Van Roosmalen fails to teach positioning a first conductive sensing coil to determine a magnetic response … and a second conductive sensing coil … second analyte type different from the first analyte type” is not found persuasive. Van Roosmalen is not being utilized for the teaching of the sensing coils nor the method of detecting the analyte. Rather Van Roosmalen is being utilized for the teaching of utilizing one device for the detection of more than one type of analyte on the same substrate in parallel. Based upon this teaching in Van Roosmalen one of ordinary skill in the art would have modified Kakabi so that Kakabi would detect a second different analyte using the same methodology because it would allow for multiple immunoassays of different analytes to be run in parallel (Van Roosmalen, paragraph [0071]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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