DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to because of the following issues:
Fig. 6A: axes are unlabeled for each of the four graphs shown. Applicant’s Paragraph 0115 states “plots of Hdp variation values from four different patients diagnosed with hepatocellular carcinoma shown.” However, it is unclear which hemodynamic parameters (Hdp) are monitored to extract a variation value thereof. While Paragraphs 0113-0114 provides Tables 1 and 2 of possible Hdp variation values that may be exhibited by a single patient, it is unclear whether these Hdp parameters are what are utilized to generate the plotted variation values for patients referred to in Fig. 6A, or whether a subset or larger set of parameters are shown. Examiner requests clarification as to what particular parameters whose variation values are displayed in Fig. 6A.
Fig. 6B: axes are unlabeled for each of the four graphs shown. The legends for each graph are not provided with clear description in Applicant’s Specification. For instance, it is unclear what is meant by “Ft. line for Total.” Applicant’s Paragraph 0116 states “there are a series of plots of physiological responses in responses to reactive and non-reactive pulses for four patients with diagnosis of hepatocellular carcinoma shown.” It is unclear what the phrase “physiological responses” and whether such a phrase intends to refer to hemodynamic parameters.
Fig. 6C: axes are unlabeled for each of the four graphs shown. Applicant’s Paragraph 0118 states “there are shown plots demonstrating that different health condition-specific SFq can be defined by linear relationships.” This does not provide clarifying information as to what is depicted in Fig. 6C.
Fig. 6D: it is understood that the x-axes (showing a range from below 0.0 to above 8.0) of the three columnar graphs represent a unitless distribution. Examiner is interpreting the Y-axis labeled “patient” as numbers corresponding to identifying particular patients. It is unclear what is identified by filled and non-filled circles. Paragraph 0027 recites: “FIG. 6D shows the distribution of disease-specific SFq (gray or light) and healthy-specific SFq (dark) during the exposure to three different groups of cancer-specific frequencies in 21 patients.” This does not provide enlightening information on the difference between filled and non-filled circles shown. Additionally, it is unclear how a distribution of SFq (i.e. electromagnetic signals having amplitude modulated frequencies) is calculated in order to be graphed as shown.
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:
Paragraph 0134 states “a total of three million hemodynamic parameters were analyzed in this study.” Examiner wishes to clarify if Applicant intends to mean “three million hemodynamic parameter values were analyzed in this study,” since it is unclear how three million hemodynamic parameters could be gleaned from the measurements provided in Paragraph 0133 without further statement of statistical processing techniques used to form more statistical features.
Paragraph 151 states “ SFq can be organized in seven infinite families of congruent elements (mod 7).” It is unclear how a bounded range of frequencies can be organized infinitely.
Paragraph 0152 uses the term “AP’s ratio” without providing definition for such a term.
Paragraphs 0151-0154 describes a process which appears incoherent or unclear. Should the term “SFq” as claimed be interpreted as narrowly as including the methodology in these cited portions, Examiner requests clarification as to how such mathematical operations identify and generate “infinite series of SFq correlated with a heath condition of a warm-blooded mammalian subject”.
Appropriate correction or response to the above inquiries is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
WRITTEN DESCRIPTION:
(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.
Claims 19 and dependent claims thereof 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.
Re. Claim 19: Claim 19 recites a “system for diagnosing a cancer in a patient… a processing system configured to… identify a hemodynamic response pattern for each of the plurality of hemodynamic parameters” [emphasis added]. This indicates that the claim obtains two hemodynamic response patterns – one for each of at least two hemodynamic parameters (i.e., the minimum value required by “plurality”). Claim 19 further recites “diagnose the form of cancer in the patient by identifying the cancer that corresponds to the identified hemodynamic response pattern.” Thus, the full scope of the invention encompasses a system which is capable of diagnosing any form of cancer based on a single hemodynamic response pattern. Applicant’s disclosure is insufficient to support the full scope of the claimed invention.
Paragraph 0040 states “Hdp values may include the values of, for example, one or more of the following hemodynamic parameters;” however, no evidence is provided thereafter which indicates a diagnosis of any cancer by identifying a cancer corresponding to a single hemodynamic response pattern.
Fig. 6A shows Hdp variation values for four patients diagnosed with hepatocellular carcinoma (at least one form of cancer). However, it is unclear whether the graphed “Hdp variation values” (understood as equivalent to the claimed “hemodynamic response patterns”) correspond to a single or multiple differing hemodynamic parameters values. Fig. 6B is described as showing “plots of physiological responses in responses to reactive and non-reactive pulses for four patients with diagnosis of hepatocellular carcinoma.” It is unclear what “physiological response” refers to. It is unclear what is depicted in Figs. 6C in light of the issues identified in the Drawing Objection section. Figs 6B-6D are not provided with discussion of Hdp variation values in the Specification.
The sections of the Specification titled “Example 6” (Paragraphs 0120-0124) and “Example 7” (Paragraphs 0125-129) appear to be excerpts from scientific literature naming at least one inventor of the present application, and are directed to using electromagnetic signals to treat breast, ovary, pancreas, and liver cancer. No discussion of diagnosis or association of diagnosis to hemodynamic response patterns is provided.
Paragraphs 0131-0154 describe an embodiment of the invention which explicitly discusses diagnosis of at least hepatocellular carcinoma (i.e., a liver cancer) and breast cancer. Paragraph 0134 describes obtaining eleven hemodynamic parameters, and further states “a total of three million hemodynamic parameters were analyzed in this study.” None of Paragraphs 0131-0154 provide substantive evidence for a system capable of diagnosing a cancer corresponding to a single Hdp variation value as claimed. Paragraph 0149 makes reference to U.S. patent applications and patents which have identified frequencies which are efficacious in characterization, diagnosis, treatment, and frequency discovery of a type of cancer or tumor of a subject; however, these documents are not incorporated by reference, nor is their discussion in Paragraph 0149 supportive of the capability of the invention to diagnose any cancer based on a single hemodynamic response pattern.
Thus, what appears to be claimed is a system which applies one or more specific electromagnetic frequencies (SFq) known to cause a physiological response corresponding to a form cancer, whereby such response is detected via changes in hemodynamic parameters (Hdp) between an SFq application period and non-application period. However, the application identifies only a limited number of frequencies corresponding to a limited number of health states.
In light of the above, Applicant’s disclosure appears to provide support for diagnosis of specific mass-based cancers (i.e., breast, ovarian, pancreatic, and hepatocellular carcinoma). For instance, diagnosis of cancers such as leukemia (which does not typically form tumors) does not appear to be supported by Applicant’s method of identifying a corresponding hemodynamic response pattern.
Furthermore, Applicant’s claimed method is a computer-implemented functional claim; however, the specification does not describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. Paragraph 0138 states that patient data may constitute a base for machine learning; however, the particulars of the machine learning algorithm used and how patient data is processed via a machine learning algorithm is not provided with detail. It is unclear if Paragraph 0042, providing detail of known statistical and machine learning techniques, are the steps which are applied in Paragraph 0138; as best understood, Paragraph 0042 (and 0044-0050) appear(s) directed to identification of health-condition specific frequencies and not processing of Hdp variation values. Similarly, Paragraph 0139 describes identification of HRV (a hemodynamic parameter) patterns “with application of mathematical algorithms and artificial intelligence processing,” without specific direction as to which or how a machine learning algorithm is applied. Similarly, Paragraphs 0144 and 0146 similarly refer to an “artificial intelligent processing algorithm” with no detail of the algorithm provided. As MPEP 2161.01:
“It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding "whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved"). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made.”
ENABLEMENT:
Claims 19 and dependent claims thereof 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Re. Claim 19: Applicant’s disclosure is further not enabling of the full scope of the invention (i.e., a system which is capable of diagnosing any form of cancer based on a single hemodynamic response pattern). The nature of the invention is directed to, essentially, mathematical correlation of data obtained with a particular electromagnetic probe device. The state of the prior art discloses the concept of correlating sensor data to certain disease states, but does not disclose inventions capable of diagnosing any cancer from a single hemodynamic response pattern. The level of one of ordinary skill in the arts is high - one of ordinary skill in the art would be apprised of statistical techniques described in the Specification; however, the central thrust of the invention is dependent upon accruing sufficient data from a tested population to correlate hemodynamic response patterns (resultant from application of electromagnetic energy via a particular electromagnetic probe device) to specific electromagnetic frequencies in order to identify which frequencies correspond to disease states, which is determined as a “diagnosis.” The determination of the diversity of disease states is dependent on the diversity of disease states in a population tested via this particular device and method. The amount of direction provided by the inventor is insufficient to carry out the full scope of the invention. For instance, Paragraph 0110 states “[t]he patient's diagnosis and the nature of AM RF EMIF exposure (HCC-specific, breast cancer specific, and randomly chosen frequencies) were disclosed before computational analysis in order to constitute a knowledge base.” That is, the specific frequencies (SFq) associated with a particular disease state which are applied to a patient are obtained from a knowledge base created via experimentation. Paragraph 0138 describes forming a knowledge base consisting of patients with hepatocellular carcinoma, breast cancer, and healthy controls. Paragraphs 0143 and 0145 further describe using a previously selected knowledge base group. Thus, it appears that, in order to provide an invention which is capable of diagnosing any cancer from a single hemodynamic response pattern, a knowledge base must be created which contains correlations of hemodynamic response patterns derived from application of a specific electromagnetic probe. Examiner is unaware of a working example of universal cancer diagnosis via such electromagnetic signal response analysis. Examiner considers such a task to constitute undue quantity of experimentation.
INDEFINITENESS:
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 19, 21, 26, and dependent claims thereof are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re. Claim 19: Claims 19 possesses multiple issues of indefiniteness:
Claim 19 describes first values are obtained during a non-exposure period, and second values are obtained during or after an exposure period; however, such a definition for “second values” overlaps with what can be considered a first value in a non-exposure period. For instance, a period “after an exposure period” also encompasses periods that can be considered a “non-exposure period.” Thus, the delineation between what can be considered defined as a second value is unclear.
Claim 19 recites “identify a hemodynamic response pattern for each of the plurality of hemodynamic parameters…” Because the claim requires a plurality of hemodynamic parameters, the above limitation indicates that the claim requires, at minimum, two hemodynamic response patterns. Claim 19 later recites “diagnose the [singular] form of cancer in the patient by identifying the cancer [singular] that corresponds to the identified hemodynamic response pattern” (annotated). In this limitation, it appears that claim 19 requires diagnosing a singular form of cancer per hemodynamic response pattern. Claim 19, as best understood, requires associating two hemodynamic response patterns that each correspond to a form of cancer, thus yielding two diagnoses. It is unclear if the claim forms a singular diagnosis or multiple.
Re. Claim 21: The phrase “highly specific” in claim 21 is a relative term which renders the claim indefinite. The terms “highly” and “specific” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree(s), and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the specificity to which RF signals must be generated is unclear.
Re. Claim 26: Claim 26 describes first values are obtained during a non-exposure period, and second values are obtained during or after an exposure period; thus, claim 26 possesses an identical issue to claim 19. See rejection of claim 19 regarding lack of clarity surrounding “second values.”
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over:
Chang et al. (US 5441528 A) (cited in abandoned parent application 15/844,214) (hereinafter – Chang) in view of
Chen et al. (US 20170071478 A1) (hereinafter – Chen).
Re. Claim 19: Chang teaches a system for diagnosing a cancer in a patient (intended use),
comprising:
a hemodynamic parameter (Hdp) monitoring system configured to
detect, measure, and record a plurality of first values for each of a plurality of hemodynamic parameters exhibited by a patient during a non-exposure period (Col. 17, lines 35-43: pretreatment parameters measured by PSG, which is known in the art to obtain hemodynamic parameter values including, but not limited to, values representing heart rate, RR interval/peak-to-peak, respiratory rate etc.) and
a plurality of second values for each of the plurality of hemodynamic parameters exhibited by the patient during or after an exposure period (Col. 7, lines 44-59: posttreatment parameters were measured by PSG),
wherein the exposure period comprises a time period in which the patient is exposed to one or more electromagnetic signals having amplitude modulated frequencies (SFq), wherein the SFq are selected from a range of 0.01 Hz to 150 kHz (Col. 7, lines 15-38: the amplitude modulation signal in the form of low energy RF electromagnetic radiation applied to the patient comprises spectral frequency components between 0.1 Hz and 10 KHz, and preferably between 1 Hz and 1000 Hz);
an electrically powered frequency generator adapted to generate the one or more electromagnetic signals during the exposure period (Claim 1: “… a controllable electromagnetic energy generator means for generating a high frequency low energy carrier signal, and for modulating an amplitude of the carrier signal with a plurality of programmable modulation signals to generate a modulated carrier signal; a data processor means, connected to said generator means for controlling said generator means to produce said modulated carrier signal; an interface means for an application storage device, connected to said data processor means and adapted for connection to an application storage device, for receiving control information, including modulation signal control information, from the application storage device, and for transferring said control information to said data processor means; and a probe, connected to the generator means to receive said modulated carrier signal, for applying said modulated carrier signal to a patient;” Abstract: “A low energy emission therapy system is provided which includes an emitter of low energy electromagnetic emissions and a probe for applying the emissions to a patient under treatment”);
a probe coupled to the frequency generator, the probe configured to intrabuccally administer the one or more electromagnetic signals to the patient (Col. 4, lines 23-25, 34-44: probe 13 is illustrated as a mouthpiece is adapted to apply the electromagnetic energy to the oral mucosa); and
a processing system coupled to the Hdp monitoring system and the frequency generator
(Col. 4, lines 53-58: “As presented in more detail below, application storage device 52 can be provided with a microprocessor which, when applied to interface 16, operates to control the function of system 11 to apply the desired low energy emission therapy. Alternatively, application storage device 52 can be provided with a microprocessor which is used in combination with microprocessor 21 within system 11. In such case, the microprocessor within device 52 could assist in the interfacing of storage device 52 with system 11, or could provide security checking functions”),
the processing system configured to:
load the SFq from a library into the frequency generator to cause the probe to administer the one or more electromagnetic signals to the patient during the exposure period (Col. 5: lines 25-32; Col. 6, lines 59-61; FIGS. 11a-d; in the cited portions, the operating program is loaded from the modulation waveform storage device 4/library[indicated as a look up table in FIG. 2] into microprocessor 21 which functions to control controllable electromagnetic energy generator circuit 29 to produce a desired form of modulated low energy electromagnetic emission for application to a patient through probe 13),
identify a hemodynamic response pattern for each of the plurality of hemodynamic parameters in response to exposure to the one or more electromagnetic signals based on the plurality of first values to the plurality of second values (Col. 17, lines 45-59: “In the placebo group, the PSG TST decreases slightly at the conclusion of the study, compared with baseline values (from 337.0.+-.57.2 to 326.0.+-.130.5 TST change of -11.0.+-.122.8, p=0.74). Similarly, the pre- and post-patient reported measures of TST were nearly identical in the placebo group (from 269.0.+-.73.6 to 274.3.+-.103.2, TST change of 5.+-.122, p=0.87). In contrast, the PSG measured TST increased in the active group by nearly 90 minutes (from 265.9.+-.67.5 to 355.8.+-.103.5, TST increase of 89.9.+-.93.9, p=0.002). This finding is consistent with the patient reported improvement reported by the active treatment group (from 221.7.+-.112.3 to 304.0.+-.144.7, TST increase of 82.3.+-.169.0 minutes, p=0.08)”).
Chang performs PSG measurements (i.e., comprising monitoring hemodynamic parameters) and performs statistical analysis to compare a change between the treatment groups pre- and post-treatment. Chang does not, as best understood, identify a cancer corresponding (i.e., associated with) to the identified hemodynamic response pattern.
Chen teaches analogous art in the technology of analyzing physiological signals (Abstract). Chen further teaches the invention configured to diagnose the form of cancer in the patient by identifying the cancer that corresponds to the identified hemodynamic response pattern (Fig. 6: biometric signal extraction, classification via disease models, comparison to historical classifications, and prediction of disease; Paragraph 0048: “This classification determines the likelihood of certain diseases or fitness conditions or the presence thereof. For example, the analysis of the current biometric signal may be used to predict and/or diagnosis the user with obesity, high stress, advanced heart age, low heart rate variability, or other medical conditions such as previous heart attack, congestive heart failure, chronic obstructive pulmonary disease (COPD), anemia, lung cancer, asthma, or pneumonia;” Examiner notes that Chen does not preclude other types of cancer in reciting exemplary diseases which may be treated).
It would have been obvious to one having skill in the art before the effective filing date to have modified Chang to include the predictive process of Chen, the motivation being that doing so enables the pre- and post-treatment hemodynamic parameters of Chang to be utilized in a diagnostic capacity for disorders other than insomnia.
Re. Claim 20: Chang as modified by Chen teaches the invention according to claim 19. Chang further teaches the invention wherein the plurality of hemodynamic parameters comprise one or more of RR interval, heart rate, systolic blood pressure, diastolic blood pressure, median blood pressure, pulse pressure, stroke volume, cardiac output, and total peripheral resistance (see the above referenced portions of Chang providing measurements made using PSG being recognized in the art and long established in the art to be comprised of a variety of hemodynamic parameters, and further see Chen, who discloses a plurality of hemodynamic parameters: Paragraphs 0038-0039: periodicity and wave magnitude features of cardiac signal; Paragraph 0029: heart rate).
Re. Claim 21: Chang as modified by Chen teaches the invention according to claim 19. Chang further teaches the invention wherein the processing system is further configured to actuate the frequency generator to generate one or more highly specific frequency radio frequency (RF) carrier signals based on at least the plurality of first values for each of the plurality of hemodynamic parameters (Col. 5, lines 58-62: “The desired modulation signal is retrieved from modulation signal storage device 43 and applied to modulation signal bus 44 in digital form;” Col. 6, lines 19-34: the desired modulation signal/SFq is retrieved from modulation signal storage device 43 and applied to modulation signal bus 44 in digital form) based on detected patient data and actuate the programmable generator to generate RF carrier signals based on the one or more frequencies selected from the SFq; Claim 12, Col. 3, lines 33-46 and Col. 7, lines 40-63: a power reflectance detector 54 provides monitoring of the patient during the application of electromagnetic energy by detecting an amount of power applied to a patient and compares that amount to an amount of power emitted by the system, the power reflectance detector also detects a number of treatments applied to particular patient, the time elapsed for each treatment, and actual time of day of each treatment is recorded and stored in the application storage device for later retrieval and analysis; this information is used to assess the treatment effect for the patient and can be used to detect and control the level of the applied power and can be recorded on the application storage device 52 for information related to the actual treatments being applied; the findings provided by the PSG indicate the effective low-energy admission therapy LEET therapy from the one or more modulation frequencies sequence to form the modulation signal; Paragraphs 0054, 0072-0073: a memory 29 storing a look-up table containing calibration data representing different values of the signals for different values of the physiological parameter in question, calibration data obtained by the ECG subsystem allows the signal processing function to use the ECG R-Peak to synchronize the Bio-impedance measurements to improve the bio-impedance signal processing by focusing the processing to a specific interval in the cardiac period).
Re. Claim 22: Chang as modified by Chen teaches the invention according to claim 19. Chang further teaches the invention wherein the frequency generator comprises a programmable generator (Claim 1).
Re. Claim 23: Chang as modified by Chen teaches the invention according to claim 22. Chang further teaches the invention wherein the programmable generator comprises one or more controllable generator circuits, wherein each controllable generator circuit is configured to generate one or more highly specific frequency RF carrier signals (Col. 8, line 66 – Col. 9, line 17: the carrier frequency produced by carrier oscillator 32 is variable and controllable by microprocessor 21 by use of control information stored on application storage device 52).
Re. Claim 24: Chang as modified by Chen teaches the invention according to claim 23. Chang further teaches the invention wherein each controllable generator circuit comprises an amplitude modulation (AM) frequency control signal generator configured to control amplitude modulated variations of the one or more highly specific frequency RF carrier signals (Col. 5, lines 39-44: “Controllable generator circuit 29 also includes an AM modulator and power generator 34 which operates to amplitude modulate a carrier signal produced by carrier oscillator 32 on carrier signal line 36, with a modulation signal produced by modulation signal generator circuit 31 on modulation signal line 37”).
Re. Claim 25: Chang as modified by Chen teaches the invention according to claim 19. Chang further teaches the invention further comprising:
a storage medium adapted to store one or more electromagnetic field amplitude modulated frequencies (SFq) (Col. 6, lines 3-7 & 11-14: each modulation signal waveform is stored using 256 bytes of memory storage in the modulation signal storage device 43),
wherein the processing system is further configured to retrieve one or more SFq from the storage medium based on the plurality of first values for each of the plurality of hemodynamic parameters and actuate the programmable generator to generate highly specific frequency RF carrier signals based on the one or more SFq (Col. 5, lines 58-62: “The desired modulation signal is retrieved from modulation signal storage device 43 and applied to modulation signal bus 44 in digital form;” Col. 6, lines 19-34: the desired modulation signal/SFq is retrieved from modulation signal storage device 43 and applied to modulation signal bus 44 in digital form) based on detected patient data and actuate the programmable generator to generate RF carrier signals based on the one or more frequencies selected from the SFq; Claim 12, Col. 3, lines 33-46 and Col. 7, lines 40-63: a power reflectance detector 54 provides monitoring of the patient during the application of electromagnetic energy by detecting an amount of power applied to a patient and compares that amount to an amount of power emitted by the system, the power reflectance detector also detects a number of treatments applied to particular patient, the time elapsed for each treatment, and actual time of day of each treatment is recorded and stored in the application storage device for later retrieval and analysis; this information is used to assess the treatment effect for the patient and can be used to detect and control the level of the applied power and can be recorded on the application storage device 52 for information related to the actual treatments being applied; the findings provided by the PSG indicate the effective low-energy admission therapy LEET therapy from the one or more modulation frequencies sequence to form the modulation signal; Paragraphs 0054, 0072-0073: a memory 29 storing a look-up table containing calibration data representing different values of the signals for different values of the physiological parameter in question, calibration data obtained by the ECG subsystem allows the signal processing function to use the ECG R-Peak to synchronize the Bio-impedance measurements to improve the bio-impedance signal processing by focusing the processing to a specific interval in the cardiac period).
Claims 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over:
Chang et al. (US 5441528 A) (cited in abandoned parent application 15/844,214) (hereinafter – Chang) in view of
Bryenton et al. (US 20100004517 A1) (hereinafter – Bryenton).
Re. Claim 26: Chang teaches a system for establishing hemodynamic parameter marker values for comparison with patient hemodynamic parameter values stored during treatment of a patient, comprising:
a hemodynamic parameter (Hdp) monitoring system configured to detect, measure and store
a plurality of first values for a plurality of hemodynamic parameters exhibited by one or more subjects during a basal or non-exposure period (Col. 17, lines 35-43: pretreatment parameters measured by PSG, which is known in the art to obtain hemodynamic parameter values including, but not limited to, values representing heart rate, RR interval/peak-to-peak, respiratory rate etc.) and
a plurality of second values for the plurality of hemodynamic parameters exhibited by the one or more subjects during or after an exposure period in which the one or more subjects are exposed to low-energy electromagnetic carrier output signals having amplitude modulated frequencies (SFq) (Col. 7, lines 44-59: posttreatment parameters were measured by PSG),
wherein the SFq are selected from a range of 0.01 Hz to 150 kHz (Col. 7, lines 15-38: the amplitude modulation signal in the form of low energy RF electromagnetic radiation applied to the patient comprises spectral frequency components between 0.1 Hz and 10 KHz, and preferably between 1 Hz and 1000 Hz);
an electrically powered frequency generator adapted to be actuated to generate the low-energy electromagnetic carrier output signals for exposing or applying the low-energy electromagnetic carrier output signals to the one or more subjects during the exposure period (Claim 1: “… a controllable electromagnetic energy generator means for generating a high frequency low energy carrier signal, and for modulating an amplitude of the carrier signal with a plurality of programmable modulation signals to generate a modulated carrier signal; a data processor means, connected to said generator means for controlling said generator means to produce said modulated carrier signal; an interface means for an application storage device, connected to said data processor means and adapted for connection to an application storage device, for receiving control information, including modulation signal control information, from the application storage device, and for transferring said control information to said data processor means; and a probe, connected to the generator means to receive said modulated carrier signal, for applying said modulated carrier signal to a patient;” Abstract: “A low energy emission therapy system is provided which includes an emitter of low energy electromagnetic emissions and a probe for applying the emissions to a patient under treatment”);
a probe coupled to the frequency generator, the probe configured to intrabuccally administer the one or more electromagnetic signals to the one or more subjects (Col. 4, lines 23-25, 34-44: probe 13 is illustrated as a mouthpiece is adapted to apply the electromagnetic energy to the oral mucosa),
wherein the one or more subjects have a form of cancer (Col. 4: lines 38-44: “Although probe 13 is illustrated as a mouthpiece, any probe that is adapted to be applied to any mucosa may be used. For example, oral, nasal, optical, urethral, anal, and/or vaginal probes may be used without departing from the scope of the invention. Probes situated closer to the brain, for example endonasal or oral probes, are presently preferred;” Col. 8, lines 6-16: “The level of power applied is preferably controlled to cause the specific absorption rate (SAR) of energy absorbed by the patient to be from 1 microWatt per kilogram of tissue to 50 Watts per kilogram of tissue. Preferably, the power level is controlled to cause an SAR of from 100 microWatts per kilogram of tissue to 10 Watts per kilogram of tissue. Most preferably, the power level is controlled to cause an SAR of from 1 milliWatt per kilogram of tissue to 100 milliWatts per kilogram of tissue. These SARs may be in any tissue of the patient, but are preferably in the tissue of the central nervous system;” Examiner notes that SARs may be in any tissue of the patient, and the memory is programmed with control information used to control the operation of system to apply the desired type of low energy emission therapy to the patient under treatment; the above disclosure of Chang indicates application to patients including those having “a form of cancer” since the device from which the electromagnetic output signals are applied is not limited to a particular type of tissue or health condition); and
a processing system coupled to the Hdp monitoring system and the frequency generator (Col. 4, lines 53-58: “As presented in more detail below, application storage device 52 can be provided with a microprocessor which, when applied to interface 16, operates to control the function of system 11 to apply the desired low energy emission therapy. Alternatively, application storage device 52 can be provided with a microprocessor which is used in combination with microprocessor 21 within system 11. In such case, the microprocessor within device 52 could assist in the interfacing of storage device 52 with system 11, or could provide security checking functions”),
the processing system configured to:
load the SFq from a library into the frequency generator to cause the probe to administer the one or more electromagnetic signals to the patient during the exposure period (Col. 5: lines 25-32; Col. 6, lines 59-61; FIGS. 11a-d; in the cited portions, the operating program is loaded from the modulation waveform storage device 4/library[indicated as a look up table in FIG. 2] into microprocessor 21 which functions to control controllable electromagnetic energy generator circuit 29 to produce a desired form of modulated low energy electromagnetic emission for application to a patient through probe 13),
identify representative Hdp variation values for the plurality of hemodynamic parameters in response to exposure to the one or more electromagnetic signals based on the plurality of first values to the plurality of second values (Col. 17, lines 45-59: “In the placebo group, the PSG TST decreases slightly at the conclusion of the study, compared with baseline values (from 337.0.+-.57.2 to 326.0.+-.130.5 TST change of -11.0.+-.122.8, p=0.74). Similarly, the pre- and post-patient reported measures of TST were nearly identical in the placebo group (from 269.0.+-.73.6 to 274.3.+-.103.2, TST change of 5.+-.122, p=0.87). In contrast, the PSG measured TST increased in the active group by nearly 90 minutes (from 265.9.+-.67.5 to 355.8.+-.103.5, TST increase of 89.9.+-.93.9, p=0.002). This finding is consistent with the patient reported improvement reported by the active treatment group (from 221.7.+-.112.3 to 304.0.+-.144.7, TST increase of 82.3.+-.169.0 minutes, p=0.08)”).
Chang performs PSG measurements (i.e., comprising monitoring hemodynamic parameters) and performs statistical analysis to compare a change between the treatment groups pre- and post-treatment. Chang does not expressly disclose the stored data being the representative Hdp variation values in association with the cancerous health condition.
Bryenton teaches analogous art in the technology of analyzing physiological attributes (Abstract). Bryenton further teaches the invention configured to store the representative Hdp variation values in association with the form of cancer (Paragraph 0016: “….taking measurements and creating a table and then consulting the table to obtain a parameter from a particular combination of results, or alternatively predicting the effects of changes in the physiological parameter on the properties using a mathematical model of animal physiology;” Paragraph 0018: “… determining the effect of changes in said physiological parameter on each of said at least two disparate physical properties; and processing said signals to derive said physiological parameter from the aggregate effect of said physiological parameter on said at least two disparate physical properties;” Paragraph 0054: “The processor sub-system 24 may include a memory 29 storing a look-up table containing calibration data representing different values of the signals for different values of the physiological parameter in question;” Paragraph 0059: variety of sensor modules employed; Paragraph 0072: sensor data includes response to 100kHz injection of sinusoidal signal; Paragraphs 0116-0117: hemodynamic parameters considered; Accordingly, the above disclosure of Bryenton has been interpreted to be inclusive of the representative Hdp variation values in association with the cancerous health condition).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Chang with storing the representative Hdp variation values (implicit in PSG measurements) in association with predicted effects of physiological changes (e.g., a cancerous health condition) as taught by Bryenton in order to provide a look-up table containing calibration data representing different values of the signals for different values of the physiological parameter since doing so allows for additional measurement and analysis of additional aspects of a patient's physiology, such as cardiac output, blood pressure, and determination of the effect of changes in a specific parameter or multiple physiological parameters (Paragraphs 0015, 0026, 0054).
Re. Claim 27: Chang as modified by Bryenton teaches the invention according to claim 26. Chang further teaches the invention wherein the plurality of hemodynamic parameters include one or more of RR interval, heart rate, systolic blood pressure, diastolic blood pressure, median blood pressure, pulse pressure, stroke volume, cardiac output, and total peripheral resistance (see the above referenced portions of Chang providing measurements made using PSG being recognized in the art and long established in the art to be comprised of a variety of hemodynamic parameters, and further see Bryenton, who discloses a plurality of hemodynamic parameters which include Paragraph 0068: statistics on the timing and interval of the R-peaks are analyzed, Paragraph 0069: heart rate is calculated from the time between R-peaks and was averaged over a 5 second moving window, Abstract and Paragraphs 0023, 0025: blood pressure, cardiac output, blood pressure).
Re. Claim 28: Chang as modified by Bryenton teaches the invention according to claim 26. Chang further teaches the invention wherein the frequency generator comprises a programmable generator (Claim 1).
Re. Claim 28: Chang as modified by Bryenton teaches the invention according to claim 26. Chang further teaches the invention wherein the programmable generator comprises one or more controllable generator circuits (Col. 8, line 66 – Col. 9, line 17: the carrier frequency produced by carrier oscillator 32 is variable and controllable by microprocessor 21 by use of control information stored on application storage device 52),
wherein each controllable generator circuit is configured to generate one or more highly specific frequency RF carrier signals (see previous citation: carrier oscillator 32 is constructed around carrier oscillator crystal 59. In one embodiment, carrier oscillator 32 produces a Radio Frequency (RF) carrier frequency of 27 MHz. Other embodiments of the invention contemplate RF carrier frequencies of 48 MHz, 450 MHz or 900 MH),
optionally wherein each controllable generator circuit comprises an amplitude modulation (AM) frequency control signal generator configured to control amplitude modulated variations of the one or more highly specific frequency RF carrier signals.
Re. Claim 30: Chang as modified by Bryenton teaches the invention according to claim 28. Chang further teaches the invention further comprising:
a storage medium adapted to store one or more electromagnetic field amplitude modulated frequencies (SFq) (Col. 6, lines 3-7 & 11-14: each modulation signal waveform is stored using 256 bytes of memory storage in the modulation signal storage device 43),
wherein the processing system is further configured to retrieve one or more SFq from the storage medium based on the plurality of first values for each of the plurality of hemodynamic parameters and actuate the programmable generator to generate highly specific frequency RF carrier signals based on the one or more SFq (Col. 5, lines 58-62: “The desired modulation signal is retrieved from modulation signal storage device 43 and applied to modulation signal bus 44 in digital form;” Col. 6, lines 19-34: the desired modulation signal/SFq is retrieved from modulation signal storage device 43 and applied to modulation signal bus 44 in digital form) based on detected patient data and actuate the programmable generator to generate RF carrier signals based on the one or more frequencies selected from the SFq; Claim 12, Col. 3, lines 33-46 and Col. 7, lines 40-63: a power reflectance detector 54 provides monitoring of the patient during the application of electromagnetic energy by detecting an amount of power applied to a patient and compares that amount to an amount of power emitted by the system, the power reflectance detector also detects a number of treatments applied to particular patient, the time elapsed for each treatment, and actual time of day of each treatment is recorded and stored in the application storage device for later retrieval and analysis; this information is used to assess the treatment effect for the patient and can be used to detect and control the level of the applied power and can be recorded on the application storage device 52 for information related to the actual treatments being applied; the findings provided by the PSG indicate the effective low-energy admission therapy LEET therapy from the one or more modulation frequencies sequence to form the modulation signal; Paragraphs 0054, 0072-0073: a memory 29 storing a look-up table containing calibration data representing different values of the signals for different values of the physiological parameter in question, calibration data obtained by the ECG subsystem allows the signal processing function to use the ECG R-Peak to synchronize the Bio-impedance measurements to improve the bio-impedance signal processing by focusing the processing to a specific interval in the cardiac period).
Conclusion
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/JUSTIN XU/ Primary Examiner, Art Unit 3791