DETAILED ACTION
Examiner Notes
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure as evidenced herein may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Applicant is reminded of manner of making amendment in application according to 37 C.F.C. 1.121. The current status of a substantial amount of the claim amendments in the application, including the amendment markings and claim numberings are incorrect.
In the current case, the claim amendments were marked incorrectly. See the at least two Examples (1-2) below of how amendments should be made to the claims:
Example 1.
Previous Claims filed on 06/13/2025 recites:
Claim 30:
“30. The device of claim 29, wherein the depth and the thickness of the portion of tissue is further controlled by selecting further operating parameters of the transmitter including a flip angle and phase.”
Claim 34:
“34. The device of claim 29, wherein the device is configured to be wearable on a body of the patient.”
Newly filed Claims on 03/01/2026:
Recites:
“30. (Currently amended on previous claim 34) The device of claim 29, wherein the device is configured to be worn on a portion of the person’s body, including the wrist.”
Claim 30 is not amended on previous claim 34. The new (claim 30) is not an amendment of that claim. The entire replacement & renumbering of this claim is improper. An amendment to a claim must show changes relative to that immediate prior version of that claim, see Proper Marking Below [emphasis added].
The Proper Marking:
34. (Currently Amended) The device of claim 29, wherein the device is configured to be worn on a portion of the person’s including the wrist
Example 2.
Previous Claims filed on 06/13/2025 recites:
Claim 29:
“A device for monitoring a blood glucose level in a patient, comprising:
a magnet configured to generate a static magnetic field in a portion of tissue under a skin of the patient;
a transmitter configured to deliver radiofrequency (Rf) energy to the portion of tissue to excite proton nuclear spins in the portion of tissue, wherein at least a portion of the transmitter is positioned between the magnet and the skin;
a sensor configured to detect an RF signal from the excited proton nuclear spins in the portion of tissue; and
a processing arrangement configured to receive signal data corresponding to the detected RF signal from the sensor, and to generate a quantitative value corresponding to a level of blood glucose in the patient based on the signal data, wherein the processing arrangement controls operating parameters of the transmitter including an average RF frequency and bandwidth to select in the portion of tissue a locally uniform static magnetic field, wherein the operating parameters of the transmitter are selected to define a depth and thickness of the portion of tissue ensuring that the portion of tissue includes blood vessels and tissue surrounding the blood vessels.”
Claim 31:
“The device of claim 29, wherein the transmitter delivers the RF energy in a frequency bandwidth ranging from 2.1 megahertz (MHz) to 4.2 MHz.”
Newly filed Claims on 03/01/2026:
Recites:
“31. (Currently amended on previous claim 29) The device of claim 29, wherein the device is configured to perform continuous monitoring of blood glucose level through repeatedly measuring it at a time interval of 100 millisecond (ms) or less.”
Claim 31 is not amended on previous claim 29. The new (claim 31) is not an amendment of that claim. The entire replacement & renumbering of this claim is improper. An amendment to a claim must show changes relative to that immediate prior version of that claim, see Proper Marking Below [emphasis added].
The Proper Marking:
31. (Currently Amended) “The device of claim 29, wherein the device is configured to perform continuous monitoring of blood glucose level through repeatedly measuring it at a time interval of 100 millisecond (ms) or less.”
Accordingly, the same applies substantially to each claim. The following should have been filed in accordance with 37 C.F.C. 1.121.
29. (Currently Amended)
A device for continuous monitoring [[a]]of blood glucose level in a person, comprising:
a magnet configured to generate a static magnetic field (Bo) in a target region beneath the person’s the magnet being adapted for wearable use;
a transmitter configured to deliver a radiofrequency (RF) magnetic field (B1) target region (1H) nuclear spins
a sensor configured to detect [[an]] RF signals emitted from the excited proton nuclear spins
a processor, operably coupled to the sensor, and configured to receive s process the data to determine a quantitative value representing the person’s blood glucose level
wherein the magnet, transmitter, and sensor are configured to cooperatively operate in wearable use to enable noninvasive and continuous blood glucose monitoring
30. (Currently Amended) The device of claim 29, wherein the target region includes a zone of locally uniform static magnetic field (B₀). having a selected depth and thickness sufficient to encompass blood vessels and adjacent tissues beneath the skin, the spatial extent of the zone being defined by the RF transmitter's central frequency (fo) and bandwidth (Δf).
31. (Currently Amended) The device of claim 29, wherein the device is configured to perform continuous monitoring of blood glucose level through repeatedly measuring it at a time interval of 100 millisecond (ms) or less.
32. (Currently Amended) The device of claim 29, wherein the magnet comprises a permanent magnet having a form factor suitable for wearing, including a disk-shaped magnet.
33. (Currently Amended) The device of claim [[32]]29, wherein (Bo) in the target region has [[at]] a strength in the range[[ing]] from 0.05 Tesla to 0.1 Tesla.
34. (Currently Amended) The device of claim 29, wherein the device is configured to be worn on a portion of the person’s including the wrist
35. (Currently Amended) The device of claim 29, wherein the transmitter comprises a coil or antenna to emit the RF magnetic field (B1) at a central frequency (fo) between 2.1 MHz to 4.2 MHz corresponding to the static magnetic field strength (Bo).
36. (Currently Amended) The device of claim [[35]]29, wherein the transmitter is positioned at least partially between the magnet and the person’s skin.
37 (Currently Amended) The device of claim [[36]]29, wherein the sensor comprises a coil or antenna that is either integrated with the transmitter or separate from the transmitter.
38. (Currently Amended) The device of claim 29, wherein the processor comprises a hardware module further configured to control operation of the RF transmitter, including adjustment of one or more operating parameters.
39. (Currently Amended)
A method of wearable [[for]] monitoring s in a person
Using a wearable permanent magnet to generate (Bo) to a subcutaneous target region including tissues
using a transmitter to deliver[[ing]] or more pulses (B1) 1H) nuclear spins in the target region
adjusting the RF pulse operating parameters, including central frequency (fo) and bandwidth (Δf), to select the depth and thickness of the target region for a locally uniform static magnetic field (Bo);
using a sensor to detect magnetic resonance (MR) signals from the excited nuclear spins in circulating blood within the target region through a selective procedure;
processing the MR signals to derive a quantitative value representing the blood glucose level of the person.
repeating the steps of the RF exciting and MR signal detecting and processing, at a time interval such as 100 ms, to implement a continuous measurement of blood glucose levels.
40. (Currently Amended) The method of claim 39, wherein thestatic magnetic field (Bo) is generated by a flat permanent magnet, such as a disk magnet, and has a field of strength ranging from 0.05 Tesla to 0.1 Tesla in the target region.
41. (Currently Amended) The method of claim [[40]]39, wherein the RF magnetic field (B1) operates that is in a range from 2.1 to 4.2 MHz.
42. (Currently Amended) The method of claim [[43]]39, wherein the depth and thickness of the target region are further refined by adjusting additional RF parameters including flip angle and phase
43. (Currently Amended) The method of claim [[41]]39, wherein the selective procedure is configured to remove unwanted MR signals of static tissues including fat in the target region, such as acquiring MR signals at two different time points t1 and t2. respectively, then subtracting them from each other, or applying multiple RF pulses for a relatively long period of time (e.g., 5-10 seconds) to suppress (saturate) the unwanted static signals before acquiring MR signals from the target region.
44. (Currently Amended) The method of claim [[43]]39, wherein processing the MR signal data further comprising:
demodulating the signal data from its carrier frequency (fo);
applying a Fast Fourier Transform (FFT) to generate a corresponding MR spectrum; and
calculating AGlu and Aw as areas under the glucose (2.8-4.2 ppm) and water (4.65±0.1 ppm) peaks, respectively.
45. (Currently Amended) The method of claim 39,
wherein the quantitative value of glucose level is calculated as an absolute glucose concentration, CGlu, using the formula CGlu= a* ( AGlu / Aw )+b.
46. (Currently Amended) The method of claim 45, wherein the a and b are calibration parameters obtained through a linear calibration procedure using glucose concentrations measured on human blood samples by certified instruments such as a finger-picking meters or lab analyzers.
47. (Canceled)
48. (Canceled)
Prosecution will continue using the above identified proper markings.
DETAILED ACTION
This Office action is responsive to communications filed on 03/01/2026. Using the above appropriate markings of the claims: Claims 29-46 have been amended. Claims 47-48 are canceled. Presently, Claims 29-46 remain pending and are hereinafter examined on the merits.
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 03/01/2026 has been entered.
Response to Arguments
Previous interpretations under 35 USC § 112(f) are withdrawn in view of the amendments filed on 03/01/2026.
Previous rejections under 35 USC § 112(b) are withdrawn in view of the amendments filed on 03/01/2026.
Previous rejections under 35 USC § 112(a) are withdrawn in view of the amendments filed on 03/01/2026.
Previous claim objections are withdrawn in view of the amendments filed on 03/01/2026.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, Claim 45 feature of “CGlu= a* ( AGlu / Aw )+b.” in the drawings filed on 06/13/2025 of FIG. 13, the annotations are not acceptable (i.e., “Removed” & “Added”). Replacement sheets are need to show the actual changes. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities and should recite:
The specification refers to “underlying tissue 2” & “tissue 2”-¶0034, “underlying tissue 2” & “tissue 2”-¶0037, & “tissue 2”-¶0053, but also refers to the RF transceiver as numeral 2, see ¶0036, ¶0038, ¶0040-0041, ¶0043. There is improper numbering in the drawings and specification. Appropriate correction is required.
When describing the transmit and receive subsystem, the numerical number 22 is assigned to both the “tuning capacitor (Ct)” and the transmit/receive switch”, see ¶0040. The tuning capacitor is numerical number 27, not 22. There is improper numbering in the specification. Appropriate correction is required.
In the same paragraph ¶0040, the numerical number 24 & 25 are assigned to the “matching circuit”. The matching circuit is numerical number 24, not 25. There is improper numbering in the specification. Appropriate correction is required.
Additionally, the disclosure is objected to because of the following informalities and should recite:
¶0004, “One of the embodiments”.
¶0032, “not limited to a two-dimensional area along a single [[plain]]plane.”
¶0032, “This non-invasive monitoring of blood glucose may reduce the level of discomfort, such as pain, experienced by patients as compared to invasive blood sampling”
¶0032, “(e.g., measurements that are correlated to other physiological variables that are affected by, but not directly correlated to, changing levels of blood glucose).”
¶0041, “The device 100 further comprises a processing arrangement that is configured to execute instructions stored on a computer accessible medium (e.g., memory storage device).”
¶0048, “For example, the coil/antenna may comprise N-turns of copper wires configured to
¶0058, “the calibration parameters are determined in a[[n]] one-time process”
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The Applicant is reminded. Amendments that introduce new matter into the disclosure will be objected to under 35 U.S.C. 132(a) if it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The corrections of numerical numbering and clear grammatical errors will not be considered as introducing new matter.
Claim Objections
The following claims are objected to because of the following informalities and should recite:
As noted above Prosecution will continue using the above identified proper markings.
(Claim 29)
A device for continuous monitoring of blood glucose level in a subject, comprising:
a magnet configured to generate a static magnetic field subject’s skin the magnet being adapted for wearable use;
a transmitter configured to deliver a radiofrequency (RF) magnetic field
a sensor configured to detect RF signals emitted from the excited proton nuclear spins; and
a processor, operably coupled to the sensor, and configured to receive data corresponding to the detected RF signals and process the data to determine a quantitative value,
wherein the magnet, transmitter, and sensor are configured to cooperatively operate in wearable use to enable noninvasive and continuous blood glucose monitoring.
(Claim 30) The device of claim 29, wherein the target region includes a zone of locally uniform static magnetic field subject’s skin, the spatial extent of the zone being defined by the RF transmitter's central frequency
(Claim 31) The device of claim 29, wherein the device is configured to perform the continuous monitoring of the blood glucose level through repeatedly measuring it at a time interval of 100 milliseconds (ms) or less.
(Claim 33) The device of claim 29, wherein the static magnetic field a range from 0.05 Tesla to 0.1 Tesla.
(Claim 34) The device of claim 29, wherein the device is configured to be worn on a portion of the subject’s body including the wrist.
(Claim 35) The device of claim 29, wherein the transmitter comprises a coil or antenna to emit the RF magnetic field megahertz (MHz) to 4.2 MHz corresponding to the static magnetic field strength
(Claim 36) The device of claim 29, wherein the transmitter is positioned at least partially between the magnet and the subject’s skin.
(Claim 37) The device of claim 29, wherein the sensor comprises a coil or antenna either the transmitter or separate from the transmitter.
(Claim 39)
A method of wearable monitoring blood glucose levels in a subject, comprising:
using a wearable permanent magnet to generate a static magnetic field
using a transmitter to deliver one or more radiofrequency (RF) pulses
adjusting the RF pulse operating parameters, including central frequency
using a sensor to detect magnetic resonance (MR) signals from the excited nuclear spins in circulating blood within the target region through a selective procedure;
processing the MR signals to derive a quantitative value representing the blood glucose level of the subject[[.]]; and
repeating the steps of the RF exciting and MR signal detecting and processing, at a time interval such as 100 milliseconds (ms), to implement a continuous measurement of blood glucose levels.[[.]]
(Claim 40) The method of claim 39, wherein the static magnetic field
(Claim 41) The method of claim 39, wherein the RF magnetic field megahertz (MHz) to 4.2 MHz.
(Claim 43) The method of claim 39, wherein the selective procedure is configured to remove unwanted MR signals of static tissues including fat in the target region, such as acquiring MR signals at two different time points t1 and t2. respectively, then subtracting them from each other, or applying multiple RF pulses for a relatively long period of time (e.g., 5-10 seconds) to suppress (saturate) the unwanted static signals before acquiring MR signals from the target region.
(Claim 44) The method of claim 39, wherein processing the MR signal data further comprising:
demodulating the signal data from its carrier frequency
applying a Fast Fourier Transform (FFT) to generate a corresponding MR spectrum; and
calculating AGlu and Aw as areas under the glucose (2.8-4.2 ppm) and water (4.65±0.1 ppm) peaks, respectively.
(Claim 46) The method of claim 45, wherein the a and b are calibration parameters obtained through a linear calibration procedure using glucose concentrations measured on human blood samples by certified instruments such as [[a]] finger-picking meters or lab analyzers.
A parenthetical notation that is never used again serves no functional purpose. Removal is requested. Appropriate correction is needed of all the above requested changes. Applicant is reminded that proper markings are required, see 37 CFR 1.121.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f), 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f), is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
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) except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitations use a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
The nonce term “hardware module” for controlling operations of the RF transmitter including adjustment of one or more operating parameters is used in claim(s) 38, for invokes 35 USC 112(f)
The term, “module” is a non-structural generic placeholder that does not include any specific structure for performing the accompany functions. See MPEP 2181.I.A: The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, paragraph 6: "mechanism for," "module for," "device for," "unit for," "component for," "element for," "member for," "apparatus for," "machine for," or "system for." Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Massachusetts Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2d at 1886–87; Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir. 1998).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
Please note that for the purposes of this examination the phrase “hardware module” is being interpreted to include the generic processor as described in Paragraphs [¶0068] in the specification as performing the claimed function, and equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 43-44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 43: recites:
“or applying multiple RF pulses for a relatively long period of time (e.g., 5-10 seconds) to suppress (saturate) the unwanted static signals before acquiring MR signals from the target region.”-lines 4-6.
The claim is rejected under 35 U.S.C. 112(a) for lack of written description. The specification does not provide proper written description for this alternative method. The specification relies on a subtraction method of data from different time points to remove the static and fat tissue signals, ¶0058. The specification does not support suppressing or saturating signals, nor does it describe multiplying RF pulses over a 5-10 second period to achieve this effect prior to acquiring the target MR signals.
Claim 44: recites:
“wherein processing the MR signal data further comprising:
demodulating the signal data from its carrier frequency (fo);
applying a Fast Fourier Transform (FFT) to generate a corresponding MR spectrum; and
calculating AGlu and Aw as areas under the glucose (2.8-4.2 ppm) and water (4.65±0.1 ppm) peaks, respectively.”
The claim is rejected under 35 U.S.C. 112(a) for lack of written description. The specification does not provide proper written description for these specific numerical ppm ranges. In fact, ¶0057 only supports, “It is believed that the signal data can be analyzed to obtain quantitative measurements for blood glucose because glucose exhibits a unique chemical shift in magnetic resonance spectroscopy (e.g., a range of 3.2-3.9 ppm, or a range of 3.2-3.8 ppm) in magnetic resonance spectroscopy, distinct from circulating water (e.g., at 4.7 ppm or 4.8 ppm) in the vascular systems.”.
In summary, consequently, one of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended to achieve said aforementioned claimed features. In addition, an assertion that could be derived using simulations or test (i.e., prophetic examples) does not demonstrate that the inventor’s actual did so or had possession of the specific functional relationships and constraints to obviate the lack of written description requirement. Since the instant specification fails to provide written description for the phrase above in claims 43-44, the aforementioned claims 43-44 fail to meet the written description requirement under 35 U.S.C. 112(a).
The dependent claims of the above rejected claims are rejected due to their dependency.
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 30, 31, 39-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
As noted above Prosecution will continue using the above identified proper markings.
Claim 30:
lines 1-4, “wherein the target region includes a zone of locally uniform static magnetic field (B₀). having a selected depth and thickness sufficient to encompass blood vessels and adjacent tissues beneath the skin, the spatial extent of the zone being defined by the RF transmitter's central frequency (fo) and bandwidth (Δf).”, is indefinite. There is insufficient antecedent basis for the limitations “the spatial extent” & “the RF transmitter's central frequency (fo) and bandwidth (Δf)” in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes a spatial extent of the zone being defined by a central frequency and bandwidth of the RF transmitter. Accordingly, proper antecedent basis is required.
line 1-2, “of locally uniform static magnetic field (B₀)”. It is unclear if the phrase is the same or different than the static magnetic field generated in the target region as defined in claim 1 lines 2-4. For examination purposes, the Examiner assumes the are the same (i.e., the static magnetic field). Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 31:
line 2, “measuring it”. It is unclear what “it” refers to. For examination purposes, the Examiner assumes the glucose level. Appropriate correction is required.
Claim 39:
line 6, “the RF pulse operating parameters”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes adjusting one or more operating parameters of the one or more RF pulses. Consistent claim language is required when referring to the same term. Accordingly, proper antecedent basis is required.
line 7-8, “for a locally uniform static magnetic field (B₀)”. It is unclear if the phrase is the same or different than the static magnetic field generated in the target region as defined in claim 39 lines 2-34. For examination purposes, the Examiner assumes the are the same (i.e., the static magnetic field). Consistent claim language is required when referring to the same term. Appropriate correction is required.
line 7, “the depth and thickness”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes a depth and a thickness. Accordingly, proper antecedent basis is required.
line 11-12, “the blood glucose level of the person”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes a blood glucose level of the subject. Accordingly, proper antecedent basis is required.
line 13, “the RF exciting and MR signal detecting”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). Consistent claim language is required when referring to the same terms. Accordingly, proper antecedent basis is required.
Claim 41:
line 1, ‘The RF magnetic Field”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes a RF magnetic field. Accordingly, proper antecedent basis is required.
Claim 42:
line 2, “additional RF parameters”. Its is unclear if the phrase refers to or is separate from the one or more operation parameters. For examination purposes, the Examiner assumes the one or more operational parameters. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 43:
lines 1-6, “wherein the selective procedure is configured to remove unwanted MR signals of static tissues including fat in the target region, such as acquiring MR signals at two different time points t1 and t2. respectively, then subtracting them from each other, or applying multiple RF pulses for a relatively long period of time (e.g., 5-10 seconds) to suppress (saturate) the unwanted static signals before acquiring MR signals from the target region.”, is indefinite for the following reasons.
It unclear if at line 3 “acquiring MR signals” & at line 5-6, “acquiring MR signals”, is refers to or is separate from the detected MR signals. For examination purposes, the Examiner assumes the detected MR signals. Consistent claim language is required when referring to the same term. Appropriate correction is required.
“then subtracting them from each other”. The sentence is not proper. Its unclear what “them” and “each other” refer to. For examination purposes, the Examiner assumes a first set and second set of detected MR signals are subtracted at two different time points from each other. Appropriate correction is required.
“multiple RF pulses”-line 4. It is unclear if the multiple RF pulses refers to or is separate from the one or more RF pulses. For examination purposes, the Examiner assumes the one or more RF pulses. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim positively recites “(e.g., 5-10 seconds)” & “(saturate)”.. The scope of the claim is indeterminate with respect to if these limitations within parenthesis is required. Thus, the claim is indefinite as the metes and bounds of the claimed invention are unclear. For examination purposes, the Examiner assumes they are not. Appropriate correction is required.
Claim 44:
line 2, “the MR signal data” & line 3, “the signal data”. There is insufficient antecedent basis for these limitations in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes the MR signals. Consistent claim language is required when referring to the same term. Accordingly, proper antecedent basis is required.
line 3, it is unclear what “its” refers to. As such it’s unclear what the relationship is with the carrier frequency is in the context of the claim. For examination purposes, the Examiner assumes the demodulating the MR signals from a resonance frequency of the device. Appropriate correction is required.
The claim positively recites “(2.8-4.2 ppm)” & “(4.65±0.1 ppm)”. The scope of the claim is indeterminate with respect to if the limitation within parenthesis is required. Thus, the claim is indefinite as the metes and bounds of the claimed invention are unclear. For examination purposes, the Examiner assumes they are not required. Appropriate correction is required.
Claim 45:
line 1, “the quantitative value of glucose level”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes the quantitative value representing the blood glucose level of the subject. Consistent claim language is required when referring to the same term. Accordingly, proper antecedent basis is required.
line 2-3, it is unclear what “a” and “b” refer to in the claim. The claim 45 does not establish what the variables refer to. However, claim 46 (depends from 45) establishes that “a” and “b” are calibration parameters. The dependent claim 46 that defines these variables does not cure the indefiniteness. The variable definitions need to be incorporated into claim 45 for that claim to particularly point out and distinctly claim the subject matter regarded as the invention. Appropriate correction is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
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 29-46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 29-38 are directed to an “device” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Claim 39-46 are directed to a “method” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One:
Claims 29 recites (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), & the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“process the data to determine a quantitative value,”
Claims 39 recites (“sets forth” or “describes”) the abstract idea of “a mental process” (MPEP 2106.04(a)(2).III.), & the abstract idea of “mathematical concepts” (MPEP 2106.04(a)(2).I.), substantially as follows:
“processing the MR signals to derive a quantitative value representing the blood glucose level of the person”
For each claim 29 and 39, the identified abstract idea above, respectively, recite mathematical concepts and mental processes. For claim 29, processing the data to determine a quantitative value, as recited at a high level of generality recites mathematical concepts because it requires numerical analysis, or calculation of the analyzed data results to produce a quantitative result. The limitation also recites a mental process because it broadly describes evaluating the received data and determining a corresponding value, which encompasses evaluating the received data and determining the resulting value through observation, judgment, and calculation that could be performed mentally or with pen and paper.
Similarly, for claim 39, processing the MR signals to derive a quantitative value representing the blood glucose level recites mathematical concepts because it requires mathematically analyzing the measured signal data to calculate a numerical value representative of glucose. The limitation also recites a mental process because it broadly describes evaluating the MR signal data results and determine the glucose level represented by that information. . There is nothing recited in the claim to suggest an undue level of complexity in how the derivation/determination of the quantitative value.
Prong Two: Claims 29 and 39 do not include additional elements that integrate the mental process into a practical application.
This judicial exception is not integrated into a practical application. In particular, the claims recites
(1) additional steps of “a magnet configured to generate a static magnetic field (Bo) in a target region beneath the person’s skin the magnet being adapted for wearable use; a transmitter configured to deliver a radiofrequency (RF) magnetic field (B1) to the target region to excite proton (1H) nuclear spins; a sensor configured to detect RF signals emitted from the excited proton nuclear spins; and a processor, operably coupled to the sensor, and configured to receive data corresponding to the detected RF signals”- (claim 29), “using a wearable permanent magnet to generate a static magnetic field (Bo) to a subcutaneous target region including blood vessels and surrounding tissues; using a transmitter to deliver one or more RF pulses (B1) to excite proton (1H) nuclear spins in the target region; adjusting the RF pulse operating parameters, including central frequency (fo) and bandwidth (Δf), to select the depth and thickness of the target region for a locally uniform static magnetic field (Bo); using a sensor to detect magnetic resonance (MR) signals from the excited nuclear spins in circulating blood within the target region through a selective procedure;" (claim 39); and;
(2) further an additional step of “wherein the magnet, transmitter, and sensor are configured to cooperatively operate in wearable use to enable noninvasive and continuous blood glucose monitoring.” (claim 29), “repeating the steps of the RF exciting and MR signal detecting and processing, at a time interval such as 100 ms, to implement a continuous measurement of blood glucose levels.” (claim 39).
The steps in (1) represent merely data gathering or pre-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality with conventionally used tools (see below Step IIB for further details). Data gathering and mere instructions to implement an abstract idea on a computer do not integrate a judicial exception into a practical application (MPEP 2106.05 (f and g)).
The step in (2) represents merely amount to post-solution activity and is recited at a high level of generality. Specifically, its merely the intended operating environment and desired result of the claimed data processing. Thus, the limitations at (2) merely applies the abstract determination in a wearable blood-glucose monitoring context at a high level of generality.
Regarding the limitations of claim 1, directed to the “a processor,” operably coupled to the sensor, and configured to receive data corresponding to the detected RF signals and process the data to determine a quantitative value, is treated as a generic computer implementation, which falls under mere instructions to apply the abstract idea on a computer and therefore does not place the abstract idea into a practical application that solves a technological solution in a meaningful way or improve the functionality of the technology or generic computer “itself”. Simply, it’s a generic computer implementation of a mental process rather than a meaningful limitation. Regarding the processor language written at such a high level of generality of structural limitations, the processor language amounts to a generic computer component with mere instructions to implement the abstract idea on a computer.
As a whole, the additional elements merely serve to gather and feed information to the abstract idea and to arrive at a desired result based on the abstract idea, while generically implementing it on conventionally used tools. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the estimated bio-information is not outputted in any way such that a practical benefit is realized. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or technological solution to a technological problem. Ultimately, the Applicant’s describe improvement in the process of using magnetic resonance spectroscopy techniques, but this is not an improvement in the function of a computer or other technology (See MPEP 2106.05(a)(ii); “the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology”; See MPEP 2106.04(d)(1); 2106.05(a); and 2106.05(f)). The claims are directed to the abstract idea. Also, there does not appear to be any particular structure or machine, treatment or prophylaxis, transformation, or any other meaningful application that would render the claim eligible at step 2A, prong 2.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 29 & 39 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claims recite additional steps of a magnetic configured to generated a static magnetic field in a target region beneath the persion’s skin the magnetic being adapted for wearable use, a transmitter configured to deliver a radiofrequency (RF) magnetic field (B1) to the target region to excite proton (1H) nuclear spins; a sensor configured to detect RF signals emitted from the excited proton nuclear spins through a selective procedure; and adjusting the RF pulse operating parameters, including central frequency (fo) and bandwidth (Δf), to select the depth and thickness of the target region for a locally uniform static magnetic field (Bo); using a sensor to detect magnetic resonance (MR) signals from the excited nuclear spins in circulating blood within the target region through a selective procedure; and a processor, operably coupled to the sensor, and configured to receive data corresponding to the detected RF signals. These steps represents mere data gathering, data outputting or pre/post/extra-solution activities that are necessary for use of the recited judicial exception and are recited at a high level of generality. Furthermore, as discussed above, limitations with respect to the processor languages/terms, respectively, amount to mere instructions to implement the abstract idea on a computer. As discussed with respect to Step 2A Prong Two, the additional elements in the claims amount to no more than insignificant extra solution activity and mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B and does not provide an inventive concept. The data gathering steps that were considered insignificant extra-solution activity in Step 2A Prong Two, have been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field.
For similar reasons set forth in Step 2A, Prong Two above, the additional elements of “adjusting the RF pulse operating parameters, including central frequency (fo) and bandwidth (Δf), to select the depth and thickness of the target region for a locally uniform static magnetic field (Bo)” do not provide an inventive concept under Step 2B.
As an evidence, Kuhara et al (US 5043665 A) discloses:
[Col. 1 l. 10-22], ‘As is well known, magnetic resonance imaging (MRI) is a method of imaging chemical and physical information of molecules utilizing a magnetic resonance phenomenon in which, when placed in a uniform static magnetic field of an intensity of Ho, nuclear spins having an intrinsic magnetic moment absorb the energy of a radio-frequency magnetic field rotating at a specific angular velocity .omega.=.gamma. Ho (.gamma.=gyromagnetic ratio) in a plane orthogonal to the direction of the static magnetic field.’
As an evidence, Bachus et al (US 4776341 A) discloses:
[Col. 1 l.15-22], ‘Nuclear magnetic resonance tomography devices are known in the art wherein a patient is disposed within a fundamental magnetic field and a plurality of gradient magnetic fields and radio-frequency excitation pulses are applied to the examination subject to displace the axes of nuclear spin in the examination subject from an equilibrium position so that nuclear magnetic resonance signals generated by the spin precession during relaxation can be obtained.’
As an evidence, Knuttel et al (US 5646532 A) discloses:
[Col. 9 l.35-42], ‘The NMR tomography magnet system 1 in accordance with the invention is configured with all the conventional components which are also used in nuclear spin resonance apparatus applications known in the art, for example, RF transmitter and receiver coil systems, a computer for controlling the measuring and for taking and processing the data, a room temperature shim system, and, if appropriate, a superconducting shim system for the magnet coil, etc.”
As an evidence, Hushek (US 5749834 A) discloses:
[Col. 4 l.43-555], ‘As is known in the art, the frequency and bandwidth of the rf pulse 208 is selected to properly locate the slice 200 along the y axis and to excite the desired slice thickness. It is a teaching of the present invention that the flip-angle of the rf pulse 208 is chosen to maintain the intersection 204 iso-intense, and in this embodiment of the invention the flip-angle is set to 60.degree.. The spins are then re-phased in conventional manner by a re-phasing gradient pulse 210 and the transverse magnetization in slice 200 is phase encoded by a gradient pulse 212 produced by the G.sub.z gradient. As is well known in the art, the phase encoding pulse 212 is stepped through a series of values during the scan to sample k-space along the z axis.’
For these reasons, there is no inventive concept. The claim is not patent eligible. Even when viewed as a whole, nothing in the claim adds significantly more to the abstract idea.
Dependent Claims
The following dependent claims merely further define the abstract idea and are, therefore, directed to reciting an abstract idea for similar reasons and therefore are not eligible:
defining, (Claim 45) wherein the quantitative value of glucose level is calculated as an absolute glucose concentration, CGlu, using the formula CGlu= a* ( AGlu / Aw )+b.
The following dependent claims merely further describe the extra-solution activities and therefore, do not amount to significantly more than the judicial exception or integrate the abstract idea into a practical application for similar reasons and therefore are not eligible:
describing (Claim 30) wherein the target region includes a zone of locally uniform static magnetic field (B₀). having a selected depth and thickness sufficient to encompass blood vessels and adjacent tissues beneath the skin, the spatial extent of the zone being defined by the RF transmitter's central frequency (fo) and bandwidth (Δf).
describing (Claim 31) wherein the device is configured to perform continuous monitoring of blood glucose level through repeatedly measuring it at a time interval of 100 millisecond (ms) or less.
describing (Claim 32) wherein the magnet comprises a permanent magnet having a form factor suitable for wearing, including a disk-shaped magnet.
describing (Claim 33) wherein the static magnetic field (Bo) in the target region has a strength in the range from 0.05 Tesla to 0.1 Tesla.
describing wherein the device is configured to be worn on a portion of the person’s body including the wrist.
describing (Claim 34) wherein the device is configured to be worn on a portion of the person’s body including the wrist.
describing (Claim 35) wherein the transmitter comprises a coil or antenna to emit the RF magnetic field (B1) at a central frequency (fo) between 2.1 MHz to 4.2 MHz corresponding to the static magnetic field strength (Bo).
describing (Claim 36) wherein the transmitter is positioned at least partially between the magnet and the person’s skin. 36) wherein the transmitter is positioned at least partially between the magnet and the person’s skin.
describing (Claim 37) wherein the sensor comprises a coil or antenna that is either integrated with the transmitter or separate from the transmitter.
describing (Claim 38) wherein the processor comprises a hardware module further configured to control operation of the RF transmitter, including adjustment of one or more operating parameters.
describing (Claim 40) wherein the static magnetic field (Bo) is generated by a flat permanent magnet, such as a disk magnet, and has a field of strength ranging from 0.05 Tesla to 0.1 Tesla in the target region.
describing (Claim 41) wherein the RF magnetic field (B1) operates at a frequency that is in in a range from 2.1 MHz to 4.2 MHz.
describing (Claim 43) wherein the selective procedure is configured to remove unwanted MR signals of static tissues including fat in the target region, such as acquiring MR signals at two different time points t1 and t2. respectively, then subtracting them from each other, or applying multiple RF pulses for a relatively long period of time (e.g., 5-10 seconds) to suppress (saturate) the unwanted static signals before acquiring MR signals from the target region.
describing (Claim 44) wherein processing the MR signal data further comprising: demodulating the signal data from its carrier frequency (fo); applying a Fast Fourier Transform (FFT) to generate a corresponding MR spectrum; while calculating AGlu and Aw as areas under the glucose (2.8-4.2 ppm) and water (4.65±0.1 ppm) peaks, respectively is directed to the abstract ideas of mental and mathematical concepts.
describing wherein the a and b are calibration parameters obtained through a linear calibration procedure using glucose concentrations measured on human blood samples by certified instruments such as a finger-picking meters or lab analyzers.
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
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.
(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 29, & 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rapoport et al (US 4875486 A).
Claim 29: Rapoport discloses, A device for continuous monitoring of blood glucose level in a person, comprising: ([Col. 1 l.42-53], “It is therefore an object of this invention to provide a glucose testing device which can be used to monitor a patient's glucose level continuously, if desired, so as to provide a more uniform administration of insulin and a more uniform glucose concentration in the blood over time.”; [Col. 2 l.45-49], ‘It is yet a further object to provide an NMR instrument for use by a diabetic in noninvasively analyzing his blood serum for glucose concentration.’; [Col. 2 l.61-64], ‘Specifically, a diabetic can use the instrument to noninvasively and substantially instantaneously analyze his blood for glucose, thereby eliminating the need to invasively obtain a blood sample which is then tested.’)
a magnet configured to generate a static magnetic field (Bo) in a target region beneath the person’s skin the magnet being adapted for wearable use; ([Col. 1-Col. 2 l.64-68-l.1-10] & [Col. 3 l.14-30], The instrument/device relies on the first or biasing magnet for providing the first magnetic field to align protons. [Col. 5 l.4-24] & [Col. 9 l.35-39], the target region for the field is beneath the skin, such as a bed of active blood vessels positioned just below the nail or a surface blood vessel. Under the broadest reasonable interpretation, the magnetic is adapted for wearable use (i.e., capable of being worn). Rapoport teaches in this device “the biasing magnet is physically much smaller than the magnets used in standard NMR machines”, [Col. 3 l.14-30], weighing as little as one pound in weight.)
a transmitter configured to deliver a radiofrequency (RF) magnetic field (B1) to the target region to excite proton (1H) nuclear spins; ([Col. 5 l.25-34] & Claim 29, The device of Rapoport uses an RF generator that produces gated radio frequency pulses. [Col. 1-Col. 2 l.64-68-l.1-10] & [Col. 5 l.25-34], this RF generator excites a surface coil or coil assembly to apply a second field or burst of energy to increase the energy of a selected nucleus. Claim 29, The selected nuclei is “1H”, in that the coil is cyclically energized by the RF pulses for cyclically flipping these 1H protons from the first position to an aligned position.)
a sensor configured to detect RF signals emitted from the excited proton nuclear spins; and (Rapoport discloses a separate receiving coil which is a sensor. When the RF generator is deactivated, the 1H protons dipoles relax and return to their first alignment. The coils detects the energy released during relaxation and realignment, and senses the magnetic changes as analog data signals during realignment of said 1H protons, [Col. 5 l.35-39] & Claim 29.)
a processor, operably coupled to the sensor, and configured to receive data corresponding to the detected RF signals and process the data to determine a quantitative value, ([Col. 3 l.1-14], [Col. 5 l.35-39], [Col. 7 l.13-30], [Col 7-8] see the normalization of patient glucose levels from the determination of the quantitative value], The sensor coils are operably coupled to the processing circuitry. The detected signals are received by the receiver/gate 48, converted from analog signals to digital signals by the A/D converter 50 and fed to the microprocessor 44. The analytical means or microprocessor is configured for receiving and analyzing the signals emitted to obtain the concentration of constituents. The microprocessor processes this data by comparing the patient’s glucose peak height to a standard sample, determining a precise quantitative value of blood glucose concentration expressed in mg/dl.)
wherein the magnet, transmitter, and sensor are configured to cooperatively operate in wearable use to enable noninvasive and continuous blood glucose monitoring. ([Col. 1 l.42-53], [Col. 2 l.61-64], [Col. 5 l.25-34], [Col. 5 to Col. 6 l.64-68 to l.1-133], [Col. 6 to Col 7 l.52-68 to l.1-30], The components of Rapoport directly integrate into a unified testing circuit 40 cooperatively operate to execute the testing cycle. The integrated system accomplishes noninvasive analyzation of blood fluids, and it operates without required periodic blood withdrawal. The components cooperatively enable the noninvasive and continuous blood glucose monitoring.)
Claim 36: Rapoport discloses all the elements above in claim 29, Rapoport discloses, wherein the transmitter is positioned at least partially between the magnet and the person’s skin. ([Col. 4], Claim 29)
Claim 37: Rapoport discloses all the elements above in claim 29, Rapoport discloses, wherein the sensor comprises a coil or antenna that is either integrated with the transmitter or separate from the transmitter. ([Col. 5 l.35-50], [Col 4 l.47-64], Claim 15. FIG. 12)
Claim 38: Rapoport discloses all the elements above in claim 29, Rapoport discloses, wherein the processor comprises a hardware module further configured to control operation of the RF transmitter, ([Col. 3 l. 15-30], [Col. 5 l.25-50], Claim 17, Claim 30) including adjustment of one or more operating parameters ([Col. 5 l.25-50], [Col. 5 to Col. 6 l.65 to l.32]).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 31 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A), as applied to claim 29, in further view of Walker et al (US 20050256384 A1).
Claim 31: Rapoport as modified discloses all the elements above in claim 29, Rapoport fails to disclose: wherein the device is configured to perform continuous monitoring of blood glucose level through repeatedly measuring it at a time interval of 100 millisecond (ms) or less.
However, Walker in the context of noninvasive glucose monitoring discloses, wherein the device is configured to perform continuous monitoring of blood glucose level through repeatedly measuring it at a time interval of 100 millisecond (ms) or less. (¶0038, “the apparatus can be configured or controlled to measure blood glucose continuously every 100 msec, a rate that enables early trend analysis and real-time analysis of changes in glucose.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of Rapoport such that it is configured to perform continuous monitoring of blood glucose level through repeatedly measuring it at a time interval of 100 millisecond (ms) or less as taught by Walker. The motivation to do this yield predictable results such as enabling early trend analysis and real-time analysis of changes in glucose, as suggested by Walker, ¶0038.
Claims 30, 32-33, & 35 are rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A), as applied to claim 29, in further view of Slade et al (US 20040066194 A1).
Claim 30: Rapoport as modified discloses all the elements above in claim 29, Rapoport fails to disclose: wherein the target region includes a zone of locally uniform static magnetic field (B₀). having a selected depth and thickness sufficient to encompass blood vessels and adjacent tissues beneath the skin, the spatial extent of the zone being defined by the RF transmitter's central frequency (fo) and bandwidth (Δf).
However, Slade in the context of magnetic field generating assembly and method disclose, wherein the target region includes a zone of locally uniform static magnetic field (B₀). (¶Abstract, ¶0025-0026, ¶0034-0035, ¶0122) having a selected depth and thickness sufficient to encompass blood vessels and adjacent tissues beneath the skin, (¶0015-0016, ¶0017, ¶0092-0095, ¶0122, ¶0124-0125) the spatial extent of the zone being defined by the RF transmitter's central frequency (fo) and bandwidth (Δf) (¶0009, ¶0013, ¶0077-0078, ¶0091-0095, ¶0107).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the target region of Rapoport to incorporate the teachings of Slade. The motivation to do this yield predictable results such as generating the strong pre-polarization field, which boosts NMR signal and improves performance, in this way is more cost effective than adding extra hardware, as suggested by Slade, ¶0036.
Claim 32: Rapoport as modified discloses all the elements above in claim 29, Rapoport discloses, disclose: wherein the magnet comprises a permanent magnet having a form factor suitable for wearing, including a C-shaped permanent magnet ([Col 4. l.8-32], [Col 9. l.40-68])
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the embodiment of Rapoport with the fifth embodiment suitable for wearing that includes a C-shaped permanent magnet. The motivation to do this yield predictable results such as to isolate a targeted surface blood vessel for testing in order to minimize interfering signal noise from surrounding body tissue, as suggested by Rapoport, [Col 5 & Col 9].
Rapport fails to disclose: including a disk-shaped magnet.
However, Slade in the context of magnetic field generating assembly and method disclose, wherein the magnet comprises a permanent magnet [...] including a disk-shaped magnet. (¶0006, ¶0038-0039, ¶0089, ¶0098, ¶0113, ¶0117 – the shim magnets may be disk or bars as required)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the magnet of modified Rapoport to include a disk-shaped magnet as taught by Slade. The motivation to do this yield predictable results such as generating the strong pre-polarization field, which boosts NMR signal and improves performance, in this way is more cost effective than adding extra hardware, as suggested by Slade, ¶0036.
Claim 33: Rapoport as modified discloses all the elements above in claim 29, Rapoport fails to disclose: wherein the static magnetic field (Bo) in the target region has a strength in the range from 0.05 Tesla to 0.1 Tesla.
However, Slade in the context of magnetic field generating assembly and method disclose, wherein the static magnetic field (Bo) in the target region has a strength in the range from 0.05 Tesla to 0.1 Tesla. (¶0123, ¶0125, ¶0148 0.1 Tesla falls on the upper boundary of the specified range.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the static magnetic field of Rapoport to include the teachings taught by Slade. The motivation to do this yield predictable results such as generating the strong pre-polarization field, which boosts NMR signal and improves performance, in this way is more cost effective than adding extra hardware, as suggested by Slade, ¶0036.
Claim 35: Rapoport as modified discloses all the elements above in claim 29, Rapport discloses, wherein the transmitter comprises a coil or antenna to emit the RF magnetic field (B1) ([Col. 4 l.47-56], [Col. 5 l.25-35], Claim 29) corresponding to the static magnetic field strength (Bo). (Claim 3 & Claim 23)
Rapoport fails to disclose: to emit the RF magnetic field (B1) at a central frequency (fo) between 2.1 MHz to 4.2 MHz corresponding to the static magnetic field strength (Bo).
However, Slade in the context of magnetic field generating assembly and method disclose, to emit the RF magnetic field (B1) at a central frequency (fo) between 2.1 MHz to 4.2 MHz corresponding to the static magnetic field strength (Bo). (¶0091, ¶0141-0143, ¶0135-4 Mhz falls within the specified range.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the transmitter of Rapoport such that it configured to emit the RF magnetic field (B1) at a central frequency (fo) between 2.1 MHz to 4.2 MHz corresponding to the static magnetic field strength (Bo) as taught by Slade. The motivation to do this yield predictable results such as generating the strong pre-polarization field, which boosts NMR signal and improves performance, in this way is more cost effective than adding extra hardware, as suggested by Slade, ¶0036.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A), as applied to claim 29, in further view of Gray et al (US 20160270725 A1).
Claim 34: Rapoport as modified discloses all the elements above in claim 29, Rapoport fails to disclose: wherein the device is configured to be worn on a portion of the person’s body including the wrist.
However, Gray in the context radio frequency which provides static magnetic field to an anatomical region over a period of time discloses, wherein the device is configured to be worn on a portion of the person’s body including the wrist. (Claim 11, FIG. 4)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device the is capable be worn of Rapoport such that it is configured to be worn on a portion of the person’s body including the wrist as taught by Gray. The motivation to do this yield predictable results such as improving a training device that can be used during a variety of exercises and provide flexibility with respect to an anatomical location at which the device may be worn, as suggested by Gray ¶0005.
Claims 39 & 41 are rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A) in view of Slade et al (US 20040066194 A1) in view of Walker et al (US 20050256384 A1).
Claim 39: Rapoport discloses, A method of wearable monitoring blood glucose levels in a person, comprising: ([Col. 1 l.42-53], “It is therefore an object of this invention to provide a glucose testing device which can be used to monitor a patient's glucose level continuously, if desired, so as to provide a more uniform administration of insulin and a more uniform glucose concentration in the blood over time.”; [Col. 2 l.45-49], ‘It is yet a further object to provide an NMR instrument for use by a diabetic in noninvasively analyzing his blood serum for glucose concentration.’; [Col. 2 l.61-64], ‘Specifically, a diabetic can use the instrument to noninvasively and substantially instantaneously analyze his blood for glucose, thereby eliminating the need to invasively obtain a blood sample which is then tested.’) Under the broadest reasonable interpretation, the magnetic is adapted for wearable use (i.e., capable of being worn). Rapoport teaches in this device “the biasing magnet is physically much smaller than the magnets used in standard NMR machines”, [Col. 3 l.14-30], weighing as little as one pound in weight.)
using a wearable permanent magnet to generate a static magnetic field (Bo) to a subcutaneous target region including blood vessels and surrounding tissues; ([Col. 1-Col. 2 l.64-68-l.1-10] & [Col. 3 l.14-30], The instrument/device relies on the first or biasing magnet for providing the first magnetic field to align protons. [Col. 5 l.4-24] & [Col. 9 l.35-39], the target region for the field is beneath the skin, such as a bed of active blood vessels positioned just below the nail or a surface blood vessel. Under the broadest reasonable interpretation, the magnetic is adapted for wearable use (i.e., capable of being worn). Rapoport teaches in this device “the biasing magnet is physically much smaller than the magnets used in standard NMR machines”, [Col. 3 l.14-30], weighing as little as one pound in weight.)
using a transmitter to deliver one or more RF pulses (B1) to excite proton (1H) nuclear spins in the target region; ([Col. 5 l.25-34] & Claim 29, The device of Rapoport uses an RF generator that produces gated radio frequency pulses. [Col. 1-Col. 2 l.64-68-l.1-10] & [Col. 5 l.25-34], this RF generator excites a surface coil or coil assembly to apply a second field or burst of energy to increase the energy of a selected nucleus. Claim 29, The selected nuclei is “1H”, in that the coil is cyclically energized by the RF pulses for cyclically flipping these 1H protons from the first position to an aligned position.)
using a sensor to detect magnetic resonance (MR) signals from the excited nuclear spins in circulating blood within the target region through a selective procedure; (Rapoport discloses a separate receiving coil which is a sensor. When the RF generator is deactivated, the 1H protons dipoles relax and return to their first alignment. The coils detects the energy released during relaxation and realignment, and senses the magnetic changes as analog data signals during realignment of said 1H protons, [Col. 5 l.35-39] & Claim 29.)
processing the MR signals to derive a quantitative value representing the blood glucose level of the person; and ([Col. 3 l.1-14], [Col. 5 l.35-39], [Col. 7 l.13-30], [Col 7-8] see the normalization of patient glucose levels from the determination of the quantitative value], The sensor coils are operably coupled to the processing circuitry. The detected signals are received by the receiver/gate 48, converted from analog signals to digital signals by the A/D converter 50 and fed to the microprocessor 44. The analytical means or microprocessor is configured for receiving and analyzing the signals emitted to obtain the concentration of constituents. The microprocessor processes this data by comparing the patient’s glucose peak height to a standard sample, determining a precise quantitative value of blood glucose concentration expressed in mg/dl.)
repeating the steps of the RF exciting and MR signal detecting and processing, at a time interval, to implement a continuous measurement of blood glucose levels. ([Col. 1 l.42-53], The invention of Rapport is explicitly directed to monitor the patient’s glucose level continuously, see “It is therefore an object of this invention to provide a glucose testing device which can be used to monitor a patient's glucose level continuously”. To achieve this continuous monitoring, the patient can use the device “periodically, frequently if necessary, and painlessly”-[Col 2 l. 58-68], over time intervals, [Col 2 l. 58-68]. That taking of sampling pulses and detecting the decay and storing the data is even, “repeated (i.e., looped) perhaps one hundred times”-[Col. 6 l.40-42]. By repeatedly looping the excitation and detection steps and performing this testing periodically over time intervals, the device implements continuous monitoring of blood glucose levels.)
Rappoport fails to disclose: adjusting the RF pulse operating parameters, including central frequency (fo) and bandwidth (Δf), to select the depth and thickness of the target region for a locally uniform static magnetic field (Bo) for a locally uniform static magnetic field (Bo);
However, Slade in the context of magnetic field generating assembly and method discloses, adjusting the RF pulse operating parameters, including central frequency (fo) and bandwidth (Δf), to select the depth and thickness of the target region (¶0090-0091 the targeting of the spatial location the RF pulse is applied is at a central frequency that matches the Larmor frequency (LF) of the magnetic field at that specific depth. See ¶0090, the radius (i.e., depth of 85 mm) with the field is 30 Gauss, so the RF pulse must be applied with a frequency 4.258*30 =127.7 kHz to tip and re-focus magnetization in the SV, ¶0091. The adjustment of the RF pulse duration to the bandwidth in turn calculates the thickness of the target area, by selecting a re-focusing duration of 30 μS yields an effective bandwidth of 33 kHz, ¶0097. “The thickness of the SV can be calculated from the RF bandwidth and static field gradient:”, ¶0091, which demonstrates that a 33 kHz bandwidth combined with a 9 Gauss/cm gradient results in a selected radial thickness of 8.7 mm, ¶0092.) for a locally uniform static magnetic field (Bo) (Slade teaches that the RF pulse sequence that includes these frequency and bandwidth parameters to selected the volume, is applied during the measurement phase that utilizes weaker but uniform static magnetic field, ¶0024-0025, ¶0096. Hence, by maximizing the target region size relies on this locally uniform static magnetic field.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the RF pulse of Rapporport to incorporate the teachings of Slade. The motivation to do this yield predictable results such as maximizing the size of the sensitive volume thereby maximizing the NMR signal to make continuous accurate measurements, as suggested by Slade, ¶0009.
Rapoport fails to disclose repeating at a time interval such as 100 ms.
However, Walker in the context of noninvasive glucose monitoring discloses, repeating at a time interval such as 100 ms. (¶0038, “the apparatus can be configured or controlled to measure blood glucose continuously every 100 msec, a rate that enables early trend analysis and real-time analysis of changes in glucose.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the device of modified Rapoport such that it is configured to perform continuous monitoring of blood glucose level through repeatedly measuring it at a time interval of 100 millisecond (ms) or less as taught by Walker. The motivation to do this yield predictable results such as enabling early trend analysis and real-time analysis of changes in glucose, as suggested by Walker, ¶0038.
Claim 41: Rapoport as modified discloses all the elements above in claim 39, Rapoport fails to disclose: wherein the RF magnetic field (B1) operates at a frequency that is in in a range from 2.1 MHz to 4.2 MHz.
However, Slade in the context of magnetic field generating assembly and method disclose wherein the RF magnetic field (B1) operates at a frequency that is in in a range from 2.1 MHz to 4.2 MHz. (¶0091, ¶0141-0143, ¶0135-4 Mhz falls within the specified range.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the transmitter of Rapoport such that it configured to operate at a frequency that is in in a range from 2.1 MHz to 4.2 MHz as taught by Slade. The motivation to do this yield predictable results such as generating the strong pre-polarization field, which boosts NMR signal and improves performance, in this way is more cost effective than adding extra hardware, as suggested by Slade, ¶0036.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A) in view of Slade et al (US 20040066194 A1) in view of Walker et al (US 20050256384 A1), as applied to claim 39, in further view of Goldberg et al (US 20150238357 A1).
Claim 40: Rapoport as modified discloses all the elements above in claim 39, wherein the static magnetic field (Bo) is generated by a permanent magnet, ([Col 4. l.8-32], [Col 9. l.40-68])
Rapoport fails to disclose: by a flat permanent magnet, such as a disk magnet, and has a field of strength ranging from 0.05 Tesla to 0.1 Tesla in the target region.
However, Goldberg in the context of magnetic therapeutics discloses and diagnosis discloses, a flat permanent magnet, such as a disk magnet, and has a field of strength ranging from 0.05 Tesla to 0.1 Tesla in the target region. (¶0036, ¶0045, Fig. 2B-ring shaped, the ring shaped permanent magnet would be flat at least one a surface. ¶0044, “magnetic field strength, [...].(e.g., ranging from [...] 0.05 Tesla to 0.1 Tesla”)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the magnet of modified Rapoport to include the flat disk magnet that has a field strength ranging from 0.05 Tesla to 0.1 Tesla as taught by Goldberg. The motivation to do this yield predictable results such as generating al field strength for depth of the target tissue that is susceptible for improved diagnostics, as suggested by Goldberg ¶0044.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A) in view of Slade et al (US 20040066194 A1) in view of Walker et al (US 20050256384 A1), as applied to claim 39, in further view of Garwood et al (RF pulse methods for use with surface coils: Frequency-modulated pulses and parallel transmission. J Magn Reson. 2018 Jun)
Claim 42: Rapoport as modified discloses all the elements above in claim 29, Rapoport fails to disclose: wherein the depth and thickness of the target region are further refined by adjusting additional RF parameters including flip angle and phase.
However, Garwood in the context of PF pulse methods (‘ our research focus turned to creating methods to produce uniform flip angles with RF coils that have highly inhomogeneous B1, ‘ [Introduction pg. 3]) discloses, refining the depth and thickness of the target region ([Introduction / pg 2], [Basics of FM pulses / pg. 4], [Design and optimization methods for FM pulses / pg. 5]) by adjusting additional RF parameters including flip angle and phase (The adjusting of the RF parameters include the flip angle, see ([Basics of FM pulses / pg. 4], [Design and optimization methods for FM pulses / pg 5])) and include the phase, see ([[Basics of FM pulses / pg. 4]], [Surface Coils in Correcting B1 Inhomogeneities / pg. 8])).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to further modify the depth and thickness of the target region of modified Rapoport to incorporate the teachings of Garwood refining of the depth and thickness of the target region by adjusting additional RF parameters including flip angle and phase. The motivation to do this yield predictable results such as overcoming physical limitations and artifacts introduced by ultra-high magnetic fields and surface coils, as suggested by Garwood.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A) in view of Slade et al (US 20040066194 A1) in view of Walker et al (US 20050256384 A1), as applied to claim 39, in further view of Siegle Jr et al (US 5,521,502).
Claim 43: Rapoport as modified discloses all the elements above in claim 39, Rapoport fails to disclose: wherein the selective procedure is configured to remove unwanted MR signals of static tissues including fat in the target region, such as acquiring MR signals at two different time points t1 and t2. respectively, then subtracting them from each other.
However, Siegel in the context of MRI imaging processing and analysis discloses, wherein the selective procedure is configured to remove unwanted MR signals of static tissues ([Col 3], [Col. 5-6 l.55-68 to l.1-4], [Col. 4 l.56-60], the flow differentiation scheme (i.e., selective procedure) is designed to suppress the signal of static material. The static tissue signal is removed via the appling of the logical differentiation resulting in an image where static objects contribute nothing to the image. [Col 5 lines 28-32], ‘Generally, the signal level in a region of disturbed flow is less than the signal level of static material for substances such as water, muscle, fat, or tissue, and therefore, this signal is perceived to be lost.’; [Col. 3 lines 19-21], ‘Another object of the present invention is to provide a process and system having the improved ability in MRI to suppress the signal of the static material.’; [Col 8 lines 12-16], ‘the flow differentiation process provides excellent suppression of the signal from static tissue, and thereby creating angiograms where flow is clearly differentiated from static tissue.’) including fat in the target region, ([Col. 5 l.29-32], ‘the signal level in a region of disturbed flow is less than the signal level of static material for substances such as water, muscle, fat, or tissue, and therefore, this signal is perceived to be lost.’) such as acquiring MR signals at two different time points t1 and t2. respectively, then subtracting them from each other (¶Abstract, [Col. 5], The images are generated at one time after the other, hence the images occur at two different time points. Generating sequential images with different times aligns with the acquiring MR signals at two different time points (i.e., t1 and t2), respectively. The images are then compared to create the difference image, ¶Abstract. The change in intensity level between the two images is determined, [Col. 6 l.52-56]. In determining the change in intensity level, the system would subtract the MR signal data of one from the other, to result in the difference of more than a given intensity amount.).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the selective procedure of modified Rapoport to incorporate the teachings of Siegel. The motivation to do this yields predictable results such as eliminating artifacts or signal loss caused by turbulence, [Col 1 lines 6-9] of Siegel Jr.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A) in view of Slade et al (US 20040066194 A1) in view of Walker et al (US 20050256384 A1), as applied to claim 39, in further view of Deckard (US 5309102 A) in view of Iannello (US 2016/0011290 A1).
Claim 44: Rapoport as modified discloses all the elements above in claim 39, Rapoport fails to disclose: wherein processing the MR signal data further comprising:
demodulating the signal data from its carrier frequency (fo);
applying a Fast Fourier Transform (FFT) to generate a corresponding MR spectrum; and
However, Deckard in the context of calibrating a NMR scanner discloses:
wherein processing the MR signal data further comprising: ([Col. 4-5 l.50-68 to l.1-5], FIG. 4)
demodulating the signal data from its carrier frequency (fo); ([Col. 4-5 l.50-68 to l.1-5], [Col. 6 l.7-26], [Col. 8 l.1-32])
applying a Fast Fourier Transform (FFT) to generate a corresponding MR spectrum; ([Col. 6 l.7-26] & [Col. 9 l.30-48])
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processing of modified Rapoport to incorporate the teachings of Deckard. The motivation to do this yield predictable results such as to improve the accuracy of the RF frequency calibration of the system, as suggested by Deckard, [Col. 2 l.35-39].
Rapoport fails to disclose:
calculating AGlu and Aw as areas under the glucose and water peaks, respectively.
However, Iannello in the context of non-invasive blood measurments in NMR discloses, calculating AGlu and Aw as areas under the glucose and water peaks, respectively. (¶0033, ‘The glucose level in the blood then can be determined by calculating the area under the glucose peak relative to the area under the water peak. This ratio then can be compared against a standard to obtain the actual glucose level.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify processing of modified Rapoport such that it is further configured to calculating AGlu and Aw as areas under the glucose and water peaks, respectively as taught by Iannello for the advantage of providing an improved apparatus being able to obtain the actual glucose level, Iannello ¶0033.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A) in view of Slade et al (US 20040066194 A1) in view of Walker et al (US 20050256384 A1), as applied to claim 39, in further view of De Feyter et al (Deuterium metabolic imaging (DMI) for MRI-based 3D mapping of metabolism in vivo.Sci. Adv.4,eaat7314(2018)).
Claim 45: Rapoport as modified discloses all the elements above in claim 39, Rapoport teaches wherein the quantitative value of glucose level is calculated as an absolute glucose concentration ([Col. 3 l.1-14], [Col. 5 l.35-39], [Col. 7 l.13-30], [Col 7-8] see the normalization of patient glucose levels from the determination of the quantitative value], The sensor coils are operably coupled to the processing circuitry. The detected signals are received by the receiver/gate 48, converted from analog signals to digital signals by the A/D converter 50 and fed to the microprocessor 44. The analytical means or microprocessor is configured for receiving and analyzing the signals emitted to obtain the concentration of constituents. The microprocessor processes this data by comparing the patient’s glucose peak height to a standard sample, determining a precise quantitative value of blood glucose concentration expressed in mg/dl.)
Rapoport fails to disclose: calculated as an absolute glucose concentration, CGlu, using the formula CGlu= a* ( AGlu / Aw )+b. (note; the formula that is merely the standard Y=M*X+B linear algebraic format/equation applied to the ratio of glucose and water.)
However, De Feyter in the context of metabolic glucose monitoring discloses a method where glucose concentration is calculated by taking the ratio of glucose peak amplitude to the water peak amplitude and multiplying it by a calibrated internal reference value, see [MR signal processing / pg. 9] & [Quantification / pg. 9], the areas under the glucose and water peaks are determined, where the calibration parameters a and b. To find the glucose concentration the glucose signal amplitude is divided by the water signal amplitude and then multiplied by the internal reference value. The 10.12mM is a calibration parameter, where “b” is simply equal to zero.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the calculation of absolute glucose concentration of modified Rapoport to incorporate the formula of De Feyter known teachings. The motivation to do this yield predictable results such as improve metabolic maps in magnetic resonance spectroscopic imaging, as suggested by De Feyter, ¶Abstract.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport et al (US 4875486 A) in view of Slade et al (US 20040066194 A1) in view of Walker et al (US 20050256384 A1) in view of De Feyter et al (Deuterium metabolic imaging (DMI) for MRI-based 3D mapping of metabolism in vivo.Sci. Adv.4,eaat7314(2018)), as applied to claim 45, in further view of in view of Cui et al (Water can be a probe for sensing glucose in aqueous solutions by temperature dependent near infrared spectra. Anal Chim Acta. 2017 Mar 8;957:47-54. doi: 10.1016/j.aca.2017.01.004. Epub 2017 Jan 5).
Claim 46: Rapoport as modified discloses all the elements above in claim 45, Rapoport fails to disclose: wherein the a and b are calibration parameters
However, De Feyter is relied upon above discloses, wherein the a and b are calibration parameters obtained (see [MR signal processing / pg. 9] & [Quantification / pg. 9], the areas under the glucose and water peaks are determined, where the calibration parameters a and b. To find the glucose concentration the glucose signal amplitude is divided by the water signal amplitude and then multiplied by the internal reference value. The 10.12mM is a calibration parameter, where “b” is simply equal to zero.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the calculation of absolute glucose concentration of modified Rapoport to incorporate the formula including the calibration parameters obtained of De Feyter known teachings. The motivation to do this yield predictable results such as improve metabolic maps in magnetic resonance spectroscopic imaging, as suggested by De Feyter, ¶Abstract.
Rapoport fail to disclose that the calibration parameters are obtained through a linear calibration procedure using glucose concentrations measured on human blood samples by certified instruments such as a finger-picking meters or lab analyzers.
However, Cui in the context of sensing glucose in NIR spectra discloses: calibration parameters are obtained through a linear calibration procedure using glucose concentrations measured on human blood samples by certified instruments such as a finger-picking meters or lab analyzers. (¶Abstract, [Results and discussion / 3.4 / pg. 53 right col.], the calibration parameters are obtained through a linear calibration procedure. [¶Abstract], & [2. Materials / pg. 48], baseline measurements of glucose in the serum were obtained by biochemical analysis from the hospital. Under the broadest reasonable interpretation, obtaining this via biochemical analysis from the hospital satisfies the limitation of measuring the concentration using a certified instrument such as a lab analyzer.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the calibration parameters of modified Cui in be obtained through a linear calibration procedure using glucose concentrations measured on human blood samples by certified instruments such as lab analyzers as taught by Cui. The motivation to do this yield predictable results such that the accuracy of noninvasive blood glucose measurement can be greatly improved, as suggested by Cui, [Introduction].
Conclusion
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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