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 .
Response to Arguments
Applicant’s arguments, see pages 9-10, filed 2/13/2026, with respect to the rejection(s) of claims 1 and 11 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of U.S. Patent Publication No. 2015/0238636 ("Homyk").
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2012/0251392 ("Sandhu") in view of U.S. Patent Publication No. 2015/0238636 ("Homyk") further in view of U.S. Patent Publication No. 2020/0309695 ("Allender") further in view of U.S. Patent Publication No. 2014/0354275 ("Sheng").
Regarding claim 1, Sandhu discloses a method of detecting paramagnetic material in an aqueous medium, the method comprising:
loading a sample (1, Figs. 1-3) into a holder (2, Figs. 1-3), the sample comprising a material to be detected;
directing light (paragraph [0033]) from a light source (10, Figs. 1-3) to the sample (1, Figs. 1-3) in the holder (2, Figs. 1-3);
applying an oscillating magnetic field (rotating magnetic field, paragraph [0035]) to the sample (1, Figs. 1-3) in the holder (2, Figs. 1-3),
wherein the oscillating magnetic field is a pulsed magnetic field (under the broadest reasonable interpretation a pulse can be interpreted as either having two levels, low and high, or on/off states, therefore the application of a magnetic field is the on state and no magnetic field applied is the off state);
determining a first level of transmittance of the light from the sample (paragraph [0050], light is measured in two situations: when magnetic field is applied in one direction and when it is applied in another one direction) with the oscillating magnetic field in a first state (first direction see Fig. 5b, paragraph [0050]) to orient the optically anisotropic paramagnetic material in the sample along a polarization axis (see Fig. 5b, along θ=0°);
changing a state of the oscillating magnetic field from the first state to a second state (paragraph [0050]: “… the magnetic field to change at least in two directions…”);
determining a second level of transmittance of the light from the sample (paragraph [0050], light is measured in two situations: when magnetic field is applied in one direction and when it is applied in another one direction) with the oscillating magnetic field in the second state (see Fig. 5c, along θ=90°); and
determining a concentration of the material (paragraph [0047]) based on a change in transmittance of the light from the sample based on the first level of transmittance and the second level of transmittance (paragraphs [0047], [0050]).
Sandhu does not disclose a cavity enhancement module, that the material is optically anisotropic paramagnetic material, nor that the oscillating magnetic field is pulsed at a fixed frequency, the frequency being based on a size of the optically anisotropic paramagnetic material and a viscosity of the sample.
However, Homyk discloses the material to be detected can be an optically anisotropic (paragraph [0061]) paramagnetic material (paragraphs [0063], [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to detect optically anisotropic paramagnetic material as disclosed by Homyk in the device of Sandhu in order to enhance detection sensitivity as described in paragraph [0075] by Homyk.
Sandhu in view of Homyk does not disclose a cavity enhancement module, nor that the oscillating magnetic field is pulsed at a fixed frequency, the frequency being based on a size of the optically anisotropic paramagnetic material and a viscosity of the sample.
However, Allender discloses the oscillating magnetic field is at a fixed frequency (constant frequency, paragraph [0066]), the fixed frequency being based on a size of the optically anisotropic paramagnetic material and a viscosity of the sample (paragraphs [0065]-[0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the magnetic field with a fixed frequency based on the size of the material to be detected and a viscosity of the sample as disclosed by Allender in the device of Sandhu in view of Homyk in order to optimize the detection sensitivity and not breakup the material chains formed by the magnetic field.
Sandhu in view of Homyk and Allender does not disclose a cavity enhancement module.
However, Sheng discloses that the holder is in a cavity enhancement module (58, 59, Fig. 2a, paragraph [0023], 58, 59 create an enhanced cavity module because it causes light to pass through the cell multiple times).
It would have been obvious to one of ordinary skill in the art before the effective filing date to create an enhanced cavity as disclosed by Sheng in the device of Sandhu in view of Homyk and Allender in order to improve the signal to noise ratio of the detected signal.
Regarding claim 2, Sandhu in view of Homyk further in view of Allender, and Sheng discloses the method of claim 1, and Sandhu further discloses that the holder (2, Fig. 1, 3) is between a first magnet and a second magnet (see four magnets 20, Fig. 3) configured to apply the oscillating magnetic field (paragraphs [0034]-[0035]).
Regarding claim 3, Sandhu in view of Homyk further in view of Allender, and Sheng discloses the method of claim 1, and Sheng further discloses that the cavity enhancement module comprises a first mirror and a second mirror (58, 59, Fig. 2a) at opposite sides of the holder (cells 46, 48, Fig. 2a).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use two mirrors at opposite sides of the holder as disclosed by Sheng in the device of Sandhu in view of Homyk further in view of Allender and Sheng in order to causes light to pass through the cell multiple times and improve the signal to noise ratio of the detected signal.
Regarding claim 4, Sandhu in view of Homyk further in view of Allender, and Sheng discloses the method of claim 1, and Allender further discloses:
sampling, by a first detector (34, Fig. 1), an intensity of light polarized along a first polarization axis transmitted through the sample (paragraph [0056]); and sampling, by a second detector (36, Fig. 1), an intensity of light polarized along a second polarization axis transmitted through the sample (paragraph [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a second detector as disclosed by Allender in the device of Sandhu in view of Homyk further in view of Allender and Sheng in order to provide a balanced photodetection scheme for common mode rejection and enhanced measurement sensitivity.
Regarding claim 5, Sandhu in view of Homyk further in view of Allender, and Sheng discloses the method of claim 4, and Allender further discloses that determining the change in transmittance further comprises determining a ratio of the intensity sampled by the first detector to the intensity sampled by the second detector (34, 36, Fig. 1, paragraphs [0056], [0070] and see Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to determine a ratio of intensity sampled by two detectors as disclosed by Allender in the device of Sandhu in view of Homyk further in view of Allender, and Sheng in order to cancel out unwanted fluctuations to create a more reliable signal.
Regarding claim 6, Sandhu in view of Homyk further in view of Allender, and Sheng discloses the method of claim 5, and Allender further discloses normalizing the transmittance to 100% utilizing the ratio when the oscillating magnetic field is in the first state (see Fig. 3, a plot of the normalized amplitude of the transmittance, a first state assumed to be with the rotating magnetic field applied, see paragraphs [0070]-[0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to normalize the transmittance as disclosed by Allender in the device of Sandhu in view of Homyk further in view of Allender and Sheng in order to enhance measurement sensitivity and remove irrelevant variation.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sandhu in view of Homyk, Allender, and Sheng further in view of U.S. Patent Publication No. 2009/0053827 ("Taylor").
Regarding claim 7, Sandhu in view of Homyk further in view of Allender, and Sheng discloses the method of claim 5, but does not explicitly disclose that the change in transmittance is based on a change in the ratio between the first state of the oscillating magnetic field and the second state of the oscillating magnetic field.
However, Taylor discloses a change in transmittance is based on a change in the ratio (paragraph [0053]) between the first state of the oscillating magnetic field and the second state of the oscillating magnetic field (paragraph [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to take the ratio between the two sates of the magnetic field as disclosed by Taylor in the device of Sandhu in view of Homyk further in view of Allender and Sheng in order to calculate a concentration of an analyte in the sample.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Sandhu in view of Homyk, Allender and Sheng further in view of U.S. Patent Publication No. 2009/0318784 ("Newman").
Regarding claim 21, Sandhu in view of Homyk, Allender, and Sheng discloses the method of claim 1, and Sandhu further discloses that the fixed frequency is less than or equal to 60 Hz (for example, 0.1 Hz, paragraph [0042]).
Sandhu in view of Homyk, Allender and Sheng does not disclose that the optically anisotropic paramagnetic material to be detected is hemozoin.
However, Newman discloses detecting hemozoins (Abstract, paragraphs [0005], [0023]).
It would have obvious to one of ordinary skill in the art before the effective filing date to detect hemozoins as disclosed by Newman using the device of Sandhu in view of Homyk, Allender and Sheng as hemozoins’ physical properties vary in dependence with an applied magnetic field.
Claims 11-12, 14, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Allender in view of Homyk, Sandhu, and Sheng further in view of U.S. Patent Publication No. 2010/0105026 ("Bruckl").
Regarding claim 11, Allender discloses a system to detect paramagnetic material in an aqueous medium, the system comprising:
a holder (14, Fig. 1), the holder (14, Fig. 1) being configured to receive a sample (12, Fig. 1);
a light source (20, Fig. 1) to emit light (22, Fig. 1) toward the sample (12, Fig. 1) in the holder (14, Fig. 1);
a magnet (16, 18, Fig. 1) to apply an oscillating magnetic field to an optically anisotropic (paragraph [0010], [0058]) material in the sample in the holder (paragraph [0054]), the oscillating magnetic field having a first state to orient the optically anisotropic paramagnetic material along a polarization axis (paragraph [0062], nanorods aligned with axis of polarization);
a first detector (34, Fig. 1) to sample an intensity of light polarized along a first linear polarization axis transmitted through the sample (12, Fig. 1, paragraph [0056]);
a second detector (36, Fig. 1) to sample an intensity of light polarized along a second linear polarization axis transmitted through the sample (12, Fig. 1, paragraph [0056]); and
a processing circuit (not shown, inherent in order to process the measurements) to determine a change in transmittance based on the intensity of light polarized along the first linear polarization axis transmitted through the sample and the intensity of light polarized along the second linear polarization axis transmitted through the sample (paragraph [0056]).
Allender does not disclose a cavity enhancement module, that the material is optically anisotropic paramagnetic material, that the oscillating magnetic field has a first state and a second state, first and second linear polarizers between the sample and the first and second detectors, nor does it explicitly determining a concentration based on a change in transmittance.
However, Homyk discloses the material to be detected can be an optically anisotropic (paragraph [0061]) paramagnetic material (paragraphs [0063], [0075]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to detect optically anisotropic paramagnetic material as disclosed by Homyk in the device of Allender in order to enhance detection sensitivity as described in paragraph [0075] by Homyk.
However, Sandhu discloses a magnetic field having a first state and a second state (paragraphs [0014], [0044], Sandhu describes measuring with and without the application of a magnetic field, under the broadest reasonable interpretation a pulse has two states, in this case the two states are interpreted to be with and without the application magnetic field, respectively).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a pulsed magnetic field as disclosed by Sandhu in the device of Allender in view of Homyk in order to obtain a baseline transmittance level and determine if the magnetic microparticles became bound to each other due to the existence of the target biomaterial even after the application of the magnetic field was stopped.
Allender in view of Homyk and Sandhu does not disclose that the holder is in a cavity enhancement module, nor first and second linear polarizers between the sample and the first and second detectors.
However, Sheng discloses that the holder is in a cavity enhancement module (58, 59, Fig. 2a, paragraph [0023], 58, 59 create an enhanced cavity module because it causes light to pass through the cell multiple times).
It would have been obvious to one of ordinary skill in the art before the effective filing date to create an enhanced cavity as disclosed by Sheng in the device of Allender in view of Homyk and Sandhu in order to improve the signal to noise ratio of the detected signal.
Allender in view of Homyk, Sandhu, and Sheng does not disclose first and second linear polarizers between the sample and the first and second detectors.
However, Bruckl discloses first and second linear polarizers (4, Figs. 3-4, see paragraphs [0048], [0052], several polarizers can be used) between the sample and the first and second detectors (7, 8, Figs. 3-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include first and second linear polarizers as disclosed by Bruckl in the device of Allender in view of Homyk, Sandhu, and Sheng in order to measure the average spatial alignment of the particle set, to determine the relaxation of the particle following a change of the external stimulus.
Regarding claim 12, Allender in view of Homyk, Sandhu, Sheng, and Bruckl disclose the system of claim 11, and Allender further discloses that the magnet comprises a first magnet and a second magnet (16, 18, Fig. 1, paragraph [0036]) configured to apply the oscillating magnetic field (paragraph [0036]).
Regarding claim 14, Allender in view of Homyk, Sandhu, Sheng, and Bruckl disclose the system of claim 11, and Sheng further discloses that the cavity enhancement module comprises a first mirror and a second mirror (58, 59, Fig. 2a) at opposite sides of the holder (cells 46, 48, Fig. 2a).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use two mirrors at opposite sides of the holder as disclosed by Sheng in the device of Allender in view of Homyk, Sandhu and Sheng in order to causes light to pass through the cell multiple times and improve the signal to noise ratio of the detected signal.
Regarding claim 16, Allender in view of Homyk, Sandhu, Sheng, and Bruckl disclose the system of claim 11, and Allender further discloses that the processing circuit is configured to determine a ratio of the intensity sampled by the first detector to the intensity sampled by the second detector (34, 36, Fig. 1, paragraphs [0056], [0070] and see Fig. 3).
Regarding claim 17, Allender in view of Homyk, Sandhu, Sheng, and Bruckl disclose the system of claim 16, and Allender further discloses that the processing circuit is configured to normalize the transmittance to 100% utilizing the ratio when the oscillating magnetic field is in the first state (see Fig. 3, a plot of the normalized amplitude of the transmittance, a first state assumed to be with the rotating magnetic field applied, see paragraphs [0070]-[0071]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Allender in view of Homyk, Sandhu, Sheng, and Bruckl further in view of U.S. Patent Publication No. 2020/0158798 ("Huck").
Regarding claim 13, Allender in view of Homyk, Sandhu, Sheng, and Bruckl disclose the system of claim 12, but does not disclose that the oscillating magnetic field is a pulsed magnetic field at a fixed frequency.
However, Huck discloses an oscillating magnetic field is pulsed at a fixed frequency (see Fig. 5C).
It would have been obvious to one of ordinary skill in the art before the effective filing date to pulse an oscillating magnetic field at a fixed frequency as disclosed by Huck in the device of Allender in view of Homyk, Sandhu, Sheng, and Bruckl in order to minimize noise and improve sensitivity of the measurements.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Allender in view of Homyk, Sandhu, Sheng, and Bruckl further in view of Taylor.
Regarding claim 18, Allender in view of Homyk, Sandhu, Sheng, and Bruckl disclose the system of claim 16, but does not explicitly discloses that the change in transmittance is based on a change in the ratio between the first state of the oscillating magnetic field and the second state of the oscillating magnetic field.
However, Taylor discloses that the change in [light] is based on a change in the ratio between the first state of the oscillating magnetic field and the second state of the oscillating magnetic field (paragraphs [0052]-[0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to take the ratio between the two sates of the magnetic field as disclosed by Taylor in the device of Allender in view of Homyk, Sandhu, Sheng and Bruckl in order to calculate a concentration of an analyte in the sample.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Allender in view of Homyk, Sandhu, Sheng, and Bruckl further in view of U.S. Patent Publication No. 2020/0129982 ("Zhou").
Regarding claim 20, Allender in view of Homyk, Sandhu, Sheng, Bruckl, and Taylor disclose the system of claim 18, but does not disclose: a column containing a metal mesh, the column being configured to receive a sample mixture; and a column magnet to selectively apply a magnetic field to the column, the column magnet being adjacent to the column.
However, Zhou discloses a column containing a metal mesh (37, Fig. 3B), the column being configured to receive a sample mixture (see Fig. 3B); and a column magnet (32, 33, Fig. 3B) to selectively apply a magnetic field to the column (paragraph [0011]), the column magnet being adjacent to the column (see Fig. 3B).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a column with meta mesh and a column magnet adjacent to it as disclosed by Zhou in the device of Allender in view of Homyk, Sandhu, Sheng, Bruckl, and Taylor in order to attract cells to the wire surface due to the local magnetic field produced by the wires and increase separation speed.
Allowable Subject Matter
Claim 9-10 are allowed.
The following is an examiner’s statement of reasons for allowance: while applying a magnetic field to a column containing a metal mesh: loading a sample mixture into the column; and washing the column with a washing buffer; removing the magnetic field applied to the column; eluting a sample out of the column using an elution buffer; loading the sample into a holder in a cavity enhancement module; directing light from a light source to the sample in the holder; applying an oscillating magnetic field to the sample in the holder; determining a first level of transmittance with the oscillating magnetic field in a first state; changing a state of the oscillating magnetic field from the first state to a second state; determining a second level of transmittance with the oscillating magnetic field in the second state; and determining a change in transmittance of the light from the sample based on the first level of transmittance and the second level of transmittance, is not taught or made obvious by the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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/MONICA T TABA/Examiner, Art Unit 2878
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