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 .
DETAILED ACTION
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 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.
Response to Election/Restrictions
Applicants’ election without traverse of Group I (claims 1-2, 5-6, 8-10, 12, 14, 16-17, 19-21, 23, 26-28 and 31-32) is acknowledged. Applicant election of “erythrocyte” for “cell”, “reduced or increased level of iron” for “pathophysiological change” and “sickle cell disease” for “hemoglobinopathy”, in response to election of species requirement, is also acknowledged.
Therefore, claims 35 and 60 are withdrawn from further consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Applicants preserve their right to file a divisional on the non-elected subject matter.
Claim 1-2, 5-6, 8-10, 12, 14, 16-17, 19-21, 23, 26-28 and 31-32 are examined on merits in this office action.
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 1-2, 5-6, 8-10, 12, 14, 16-17, 19-21, 23, 26-28 and 31-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Claim 1 is directed to a process and thus fall under the statutory categories of invention (Step 1, Yes).
ELIGIBILITY STEP 2A; WHETHER A CALIM IS DIRECTED TO A JUDICIAL EXCEPTION. First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A Prong 1
The claim recites a process of identifying a test sample with pathophysiological change associated with a change in magnetic property as compared to a standard cell wherein the standard cell is a normal cell without the pathophysiological change and identifying the test cell has a pathophysiological change wherein the test cell exhibits different magnetic properties as compared to the standard cell. Therefore, the claim is directed to natural correlation between the change in magnetic property to pathophysiological change as compared to standard cell. Claims 5 and 6 also recites natural correlation of the change in magnetic property to particular diseases. The claims thereby recite laws of nature/ natural phenomena. Similar concepts have been held by the courts to constitute laws of nature/ natural phenomena, as in the identification of a correlation between the presence of a marker in a bodily sample (such as blood or plasma) and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017); see also Univ. of Utah Research Found. v. Ambry Genetics Corp., 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)).
Claims 17, 19-21, 23, and 26-28, encompass mathematical calculations and falls within the “mathematical concepts” grouping of abstract idea.
Accordingly, the claims recite judicial exception (Step 2A: Yes).
STEP 2A Prong 2: The analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception.
Claims 1-2, 5-6, 8-10 and 31-32 do not recite an additional step, do not provide an inventive concept and does not integrate the exception into a practical application. Claims 12, 14, 16-17, 19-21, 23 and 26-28 are directed to additional steps of utilizing CVT device for measuring magnetic property of the test cells. But however, the specification does not provide a clear technical explanation of improvement of measuring magnetic property with CVT as compared with other devices. The additional elements of measuring magnetic property of different types of cells, and of different diseases recited in claims 2, 5, 10 and 31-32 are all considered an insignificant extra-solution activity. Thus, the claims 1-2, 5-6, 8-10, 12, 14, 16-17, 19-21, 23, 26-28 and 31-32 do not pertain to an improvement and integrate a judicial exception into a practical application (Step 2B; No).
STEP 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP 2106.05. The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception.
The additional element of CVT device is well-understood, routine, and conventional. This position is supported by Chalmers et al (Anal. Chem. 2017, 89, 3702−3709). Chalmers teaches detection of femtogram resolution of magnetic property of test cell (RBC) using cell tracking velocimetry (CVT) device (Abstract). Chalmers also teach various equations involving measuring magnetically induced velocity (Um) of the cells and gravity induced settling velocity (Us) of the cells and different calculations as recited in claims 19-20 (page 3703-3704).
Therefore, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole, do not amount to significantly more than the exception itself. (Step 2B: NO)
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. For additional guidance, applicants are directed generally to applicant is directed generally to the MPEP § 2106.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 8-10 and 31-32 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Peng et al (US 2016/0313425A1).
In regards to claim 1, Peng discloses a method of monitoring a disease status comprising: obtaining a sample from a subject, measuring a longitudinal relaxation time and a transverse relaxation time in the sample; and assessing a redox state of the sample from the longitudinal relaxation time and the transverse relaxation time of the sample (claim 1 and Para [0005]); assessing the redox state can include plotting a magnetic state diagram of a longitudinal relaxation time and a transverse relaxation time and comparing the ratio with a predetermined ratio of a reference sample, Para. [0006]; the blood sample can be plasma or red blood cells, Para. [00121), the method comprising: a. obtaining a test cell (the blood sample can be plasma or red blood cells, Para. [0012]); b. measuring the magnetic property of the test cell (measuring a longitudinal relaxation time and a transverse relaxation time using a magnetic resonance relaxometry device in a sample, such as a blood sample, Para. [0007]): c. comparing the magnetic property of the test cell to the standard cell, where the standard cell is a normal cell without the pathophysiological change or a standardized version of a normal cell (a method of assessing a redox state of a sample can include calculating a ratio of longitudinal relaxation time to transverse relaxation time of the sample, wherein the longitudinal relaxation time and the transverse relaxation time are measured using a magnetic resonance relaxometry device, and comparing the ratio with a predetermined ratio of a reference sample, Para. [0009]; the blood sample can be plasma or red blood cells, Para. [0012]); and d. identifying that the test cell has the pathophysiological change, wherein the test cell exhibits different magnetic properties as compared to the standard cell (a method of assessing a redox state of a sample can include calculating a ratio of longitudinal relaxation time to transverse relaxation time of the sample, wherein the longitudinal relaxation time and the transverse relaxation time are measured using a magnetic resonance relaxometry device, and comparing the ratio with a predetermined ratio of a reference sample, Para. [0009]; method of monitoring a hemoglobin state using a magnetic state diagram can be represented by a two-dimensional plot of a longitudinal relaxation time and a transverse relaxation time, Para. [0013]; normal physiological condition however, cells would be able to constantly repair and renew themselves provided that proper nutrition and diet is within reach, Para. [0084]).
Regarding claim 2, Peng teaches that the cell is an erythrocyte (red blood cell) (the blood sample can be plasma or red blood cells, Para. [0012]; claims 8, 23).
Regarding claims 5 & 6, Peng teaches that the pathophysiological change is associated with a hemoglobinopathy such as sickle cell anemia and thalassemia (Para. [0050]).
Regarding claim 8, Peng teaches monitoring disease stage which includes sickle cell anemia (para [0050]) and teaches
Regarding claim 9, Peng teaches measuring hemoglobin state using magnetic state diagram (claim 35) and teaches monitoring diseases associated with a hemoglobinopathy such as sickle cell anemia and thalassemia (Para. [0050]). Peng also teaches assessing the redox state of a sample can include calculating a ratio of longitudinal relaxation time to transverse relaxation time of the sample, wherein the longitudinal relaxation time and the transverse relaxation time are measured using a magnetic resonance relaxometry device and comparing the ratio with a predetermined ratio of a reference sample. Thus, reference samples without the disease state (i.e. subject without the hemoglobinopathy) are taught by Peng.
Regarding claim 10, Peng teaches wherein test cell is paramagnetic (para. [0054], [0057] and [0059]).
Regarding claims 31 and 32, Peng teaches monitoring disease status which includes samples such as blood sample or red blood cells and thus multiple cells are analyzed (para [0036]) and Peng also teaches measuring oxidative stress in human erythrocytes and human diseases (para [0051]).
Claim Rejections - 35 USC § 103
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 1-2, 5-6, 8-10, 12, 14, 16-17, 19-21, 23, 26, 28 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Peng et al (US 2016/0313425A1) as described for claims 1-2, 5-6, 8-10 and 31-32 above and further in view of Chalmers et al (Anal. Chem. 2017, 89, 3702−3709).
Peng has been described above anticipating the method of identifying test cells with a pathophysiological change associated with a change in magnetic property as claimed in claims 1-2, 5-6, 8-10 and 31-32.
Peng teaches utilizing relaxometry device comprising an NMR spectroscopy and at least one magnet suppling an external magnetic field for the measurement (claims 4-6).
Peng however, does not teach utilizing a CTV device as claimed in claim 1.
Regarding claims 12 and 28, Chalmers teaches detection of femtogram resolution of magnetic property of test cell (RBC) using cell tracking velocimetry (CVT) device (Abstract and Fig.1).
Therefore, given the fact that CTV device can be utilized for detection/analysis of magnetic property of test cells (e.g. RBC) with high resolution, it would be obvious to one of ordinary skilled in the art to easily envisage using CVT device of Chalmers with the expectation of expanding the arsenal of detection with various other devices with high resolution with a reasonable expectation of success.
Regarding claims 14, 16, 17, and 19, Chalmers teaches measurement of magnetically induced velocity and gravity induced energy gradient (Sm) (page 3704) and also teaches measuring horizontal and vertical velocities (page 3705).
Regarding claim 20, the equations are disclosed by Chalmers (see pages 3703 and 3704).
Regarding claim 21, Chalmers teaches density difference with the suspended fluid (page 3706).
Regarding claims 23 and 26, Chalmers teach magnetic susceptibility of suspending fluid (page 3705, 1st col. and 3706) and the cell would be expected to have inherent material property of magnetic susceptibility as described in claim 26.
Conclusion
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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