DETAILED ACTION
This action is pursuant to the claims filed on 11/20/2025. Claims 1, 4-31, and 33-44 are pending. A first action on the merits of claims 1, 4-31, and 33-44 is as follows.
Response to Amendment
Applicant’s amendment to the claims are acknowledged and entered accordingly.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 4-31, 33-38 and 40-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costa (U.S. PGPub No. 2022/0000373).
Regarding claim 1, Costa teaches A method of treating a subject suffering from cancer, the method comprising: exposing the subject to radio frequency radiation, wherein the radio frequency radiation comprises one or more amplitude-modulated output signals ([0014]), wherein the one or more amplitude-modulated output signal(s): have a carrier frequency from about 1KHz to 5000 MHz ([0262] RF carrier signal can be between 1 MHz and 900 MHz); and have amplitude modulation frequencies from about 0.1 Hz to about 150,000 Hz ([0014] modulation frequency between 0.01 Hz and 150 KHz), and wherein the amplitude modulation frequencies are selected to be cancer-specific frequencies ([0271-0273]); wherein the cancer is selected from the group consisting of: breast cancer, neuroendocrine cancer, non-Hodgkin lymphoma, adenocarcinoma of a pancreas, head and neck cancer, gastric cancer, glioblastoma, squamous cell carcinoma of the anal canal, hepatocellular carcinoma, cholangiocarcinoma, mesothelioma, thyroid cancer, prostate cancer, rhabdomyosarcoma, and colorectal cancer ([0133] [0503]); and wherein: (i) when the cancer is hepatocellular carcinoma, the subject is treated with one or more hepatocellular carcinoma specific amplitude modulation frequencies comprising: Table 12 ([0273] disclosing HCC and being treated “every 3 Hz or 10 Hz in a range from about 0.01 Hz to about 20 KHz” includes at least one of the frequencies in table 12). Examiner notes, the remaining limitations (a) through (h) and (j) through (o) are contingent limitations that are not required to practice the claimed method (MPEP 2111.04 II).
Costa discloses the invention substantially as claimed above except for the exact carrier frequency range and the amplitude modulation frequencies range.
However it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Costa to use a carrier frequency from about 1 KHz to 5000 MHz and a amplitude modulation frequency from about 0.1 Hz to about 150,000 Hz as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 4, Costa further teaches wherein the carrier frequency is from about 0.1 - 1000 MHz ([0262] RF carrier signal can be between 1 MHz and 900 MHz).
Regarding claim 5, Costa further teaches wherein the amplitude modulation frequency is from 100 Hz to 99,000 Hz ([0273] disclosing HCC and being treated “every 3 Hz or 10 Hz in a range from about 0.01 Hz to about 20 KHz” includes at least one of the frequencies in table 12). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Costa to use a modulation frequency from about 100 Hz to about 99,000 Hz as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 6, Costa further teaches wherein the frequency of each of the one or more modulated output signals is controlled to within an accuracy of 1 part per 10,000 relative to a reference amplitude modulation frequency ([0178] accuracy of at least 1000 parts per million which is within an accuracy of 1 part per 10,000).
Regarding claim 7, Costa further teaches wherein each of the one or more amplitude modulated output signals is maintained at a stability during emission of at least 10-5 ([0205]).
Regarding claim 8, Costa further teaches wherein specific absorption rate (SAR) of the radio frequency radiation absorbed by the patient is from about 1 microWatt per kilogram of tissue to about 50 Watts per kilogram of tissue ([0266]).
Regarding claims 9-10, Costa further teaches wherein the radio frequency radiation is applied to the subject undergoing treatment via an electrically conductive probe (Fig 7 and [0241] electrically conductive probe 13); wherein the electrically conductive probe is configured for contact with a mucosa of the subject or with the skin of the subject ([0241] probe 12 is capable of contacting mucosa or skin).
Regarding claim 11, Costa further teaches wherein the one or more amplitude modulated output signals are generated either sequentially or simultaneously ([0274]).
Regarding claim 12, Costa further teaches wherein the amplitude modulation frequency has been determined or predetermined by a bio-feedback process involving measurements of one or more physiological responses by subjects pre- diagnosed with the cancer type upon exposure of the pre-diagnosed subjects to the amplitude modulation frequency ([0309, 0342, 0511]).
Regarding claim 13, Costa further teaches wherein the low energy high frequency radiation comprises 40 or more modulated output signals ([0274] [0280] comprises 40 or more modulated output signals).
Regarding claim 14, Costa further teaches wherein the cancer is breast cancer ([0133] method is directed to treating breast cancer with RF frequencies) and wherein the subject is treated with 10 or frequencies comprising: ([0271-0274] disclosing with at least 10 frequencies overlapping the claimed frequencies, specifically “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” and “that occur every 10 Hz in a range from about 0.01 Hz to about 20 KHz”).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “breast cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 breast cancer specific amplitude modulation frequencies to arrive at claim 14. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating breast cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 14.
Regarding claim 15, Costa further teaches wherein the cancer is neuroendocrine cancer ([0503] small cell lung carcinoma is a type of neuroendocrine cancer) and wherein the subject is treated with 10 or more frequencies comprising: ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “neuroendocrine cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 neuroendocrine cancer specific amplitude modulation frequencies to arrive at claim 15. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating neuroendocrine cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 15.
Regarding claim 16, Costa further teaches wherein the cancer is non-Hodgkin lymphoma ([0133] B-cell lymphoma is a non-Hodgkin lymphoma) and wherein the subject is treated with 10 or more frequencies comprising ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “non-Hodgkin lymphoma cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 non-Hodgkin lymphoma cancer specific amplitude modulation frequencies to arrive at claim 16. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating non-Hodgkin lymphoma cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 16.
Regarding claim 17, Costa further teaches wherein the cancer is adenocarcinoma ([0503]) of the pancreas and wherein the subject is treated with 10 or more frequencies comprising ([0271-0274] being treated with at least 10 frequencies overlapping the claimed frequencies, specifically “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” and “that occur every 10 Hz in a range from about 0.01 Hz to about 20 KHz”). Costa further teaches pancreatic cancer ([0133]).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “adenocarcinoma of the pancreas cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 adenocarcinoma of the pancreas cancer specific amplitude modulation frequencies to arrive at claim 17. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating adenocarcinoma of the pancreas cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 17.
Regarding claim 18, Costa further teaches wherein the cancer is head and neck cancer ([0133]) and wherein the subject is treated with 10 or more frequencies comprising ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in frequencies 6897, 7080, 9573, 11559, 14052, 17379, and 19269 Hz being used in the claimed table; as well as frequencies 2892 Hz, 5151 Hz, 7275 Hz, 8754 Hz, 9657 Hz, 10440 Hz, 10485 Hz, 10644 Hz, and 10674 Hz each of which is either 0.3 Hz or 1 Hz from falling within a corresponding value on the claimed table) Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate the use of at least 10 head and neck cancer specific frequencies recited in claim 18, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would have done so to provide a modulated treatment frequency that effectively targets head and neck cancer as it is known that each type of cancer possesses a specific frequency signature to inhibit cancer cell proliferation ([0268]), such that optimizing the head and neck cancer-specific amplitude modulation frequencies is a result-effective variable.
Regarding claim 19, Costa further teaches wherein the cancer is gastric cancer ([0133]) and wherein the subject is treated with 10 or more frequencies comprising ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “gastric cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 gastric cancer specific amplitude modulation frequencies to arrive at claim 19. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating gastric cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 19.
Regarding claim 20, Costa further teaches wherein the cancer is glioblastoma ([0133]) and wherein the subject is treated with 10 or more frequencies comprising ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “glioblastoma cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 glioblastoma cancer specific amplitude modulation frequencies to arrive at claim 20. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating glioblastoma cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 20.
Regarding claim 21, Costa further teaches wherein the cancer is squamous cell carcinoma ([0503]) of the anal canal ([0133]) and wherein the subject is treated with 10 or more frequencies comprising ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated squamos cell carcinoma of the anal canal to arrive at the method of claim 21. Doing so would have been obvious to one of ordinary skill in the art as Costa explicitly contemplates treating squamous cell carcinoma ([0503]) and rectal cancer ([0133]) such that treating squamous cell carcinoma of the anal canal would be an obvious matter of utilizing well-known cancer treatment methods to yield the predictable result of treating squamous cell carcinoma in the anal canal.
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “squamous cell carcinoma of the anal canal specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 squamous cell carcinoma of the anal canal cancer specific amplitude modulation frequencies to arrive at claim 21. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating squamous cell carcinoma of the anal canal cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 21.
Regarding claim 22, Costa further teaches wherein the cancer is hepatocellular carcinoma ([0224]) and wherein the subject is treated with 10 or more frequencies comprising ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “hepatocellular carcinoma specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 hepatocellular carcinoma cancer specific amplitude modulation frequencies to arrive at claim 22. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating hepatocellular carcinoma of the with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 22.
Regarding claim 23, Costa further teaches wherein the cancer is cholangiocarcinoma ([0503] bile duct carcinoma is cholangiocarcinoma) and wherein the subject is treated with 10 or more frequencies comprising ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed):
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “cholangiocarcinoma specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 cholangiocarcinoma cancer specific amplitude modulation frequencies to arrive at claim 23. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating cholangiocarcinoma with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 23.
Regarding claim 24, Costa further teaches wherein the cancer is mesothelioma ([0503]) and wherein the subject is treated with 10 or more frequencies comprising: ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed262)
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “mesothelioma specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 mesothelioma cancer specific amplitude modulation frequencies to arrive at claim 24. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating mesothelioma with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 24.
Regarding claim 25, Costa further teaches wherein the cancer is thyroid cancer ([0554]) and wherein the subject is treated with 10 or more frequencies comprising: ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “thyroid cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 thyroid cancer specific amplitude modulation frequencies to arrive at claim 25. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating thyroid cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 25.
Regarding claim 26, Costa further teaches wherein the cancer is prostate cancer ([0133]) and wherein the subject is treated with 10 or more frequencies comprising: ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “prostate cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 prostate cancer specific amplitude modulation frequencies to arrive at claim 26. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating prostate cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 26.
Regarding claim 27, Costa further teaches wherein the cancer is rhabdomyosarcoma ([0503]) and wherein the subject is treated with 10 or more frequencies comprising: ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “rhabdomyosarcoma specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 rhabdomyosarcoma specific amplitude modulation frequencies to arrive at claim 27. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating rhabdomyosarcoma with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 27.
Regarding claim 28, Costa further teaches wherein the cancer is colorectal cancer ([0133]) and wherein the subject is treated with 10 or more frequencies comprising: ([0271-0274] “every 3 Hz in a range from about 0.01 Hz to about 20 KHz” results in a treatment frequency of at least 10 frequencies claimed).
Costa fails to explicitly teach wherein said amplitude modulation frequencies are “colorectal cancer specific”.
However, Costa further teaches wherein patients are exposed to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Costa to incorporate treatment with the at least 10 colorectal cancer specific amplitude modulation frequencies to arrive at claim 28. Doing so would have been obvious to try by one of ordinary skill in the art as it is known in the art that specific cancers have specific modulation frequencies that cause said cancer cells to undergo cell death and/or modify their proliferative capacity ([0271-0273] [0342]) and that there are a finite number of identified, predictable frequencies, such that one of ordinary skill would have a reasonable expectation of success by treating colorectal cancer with the frequency ranges disclosed by Costa that overlap at least 10 of the claimed frequencies of claim 28.
Regarding claim 29, Costa teaches An apparatus for treating a subject suffering from cancer, the apparatus comprising: a conductive applicator configured to apply to the subject radio frequency radiation (Fig 7 and [0241] electrically conductive probe 13), wherein the low energy high frequency radiation comprises amplitude- modulated output signals ([0014]); and a frequency synthesizer coupled to the conductive applicator and configured to generate the amplitude-modulated output signals ([0135] Figs 3-7) by generating: a carrier frequency signal having a carrier frequency from about 1KHz to 5000 MHz ([0262] RF carrier signal can be between 1 MHz and 900 MHz); and amplitude modulation frequency signals having amplitude modulation frequencies from about 0.1 Hz to about 150,000 Hz ([0014] modulation frequency between 0.01 Hz and 150 KHz), wherein the amplitude modulation frequencies are selected to be cancer-specific frequencies ([0271-0273]); wherein the frequency synthesizer comprises: a digital carrier frequency synthesizer for generating the carrier frequency digital signal (Fig 3 carrier frequency oscillator 302); a digital modulation frequency synthesizer for generating the amplitude modulation frequency digital signal (digital synthesizer 306); an arithmetic logic unit (ALU) to numerically compute digital amplitude modulated signals from the carrier frequency digital signal and amplitude modulation frequency digital signal in real-time (Figs 3-4, device computes digital modulated signals from the carrier frequency signal and modulation frequency digital signal to provide each modulated digital signals at 304); and a digital to analog converter (DAC) to convert the digital amplitude modulated signals to the amplitude modulated output signals ([0164]); a controller communicatively coupled to the frequency synthesizer ([0254] Figs 3-7); and memory used by the controller and specifying the frequencies of the cancer-specific amplitude modulation frequencies ([0254] disclosing microprocessor 21 with storage that stores specific modulation waveforms to retrieve selected modulation signal); wherein the amplitude modulation frequency signals specified in the memory to be produced by the frequency synthesizer ([0254]) comprise 10 or more cancer-specific amplitude modulation frequencies selected from Table A: Table A ([0274] [0280] “a modulated signal can be produced at a series of electromagnetic frequencies that occur every 3 Hz in a range from about 0.01 Hz to about 20 KHz” which overlaps with at least 10 frequencies of Table A).
Costa discloses the invention substantially as claimed above except for the exact carrier frequency range and the amplitude modulation frequencies range.
However it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Costa to use a carrier frequency from about 1 KHz to 5000 MHz and a amplitude modulation frequency from about 0.1 Hz to about 150,000 Hz as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 30, Costa further teaches the cancer is selected from the group consisting of breast cancer, neuroendocrine tumors, non-Hodgkin lymphoma, adenocarcinoma, head and neck cancer, gastric cancer, glioblastoma, squamous cell carcinoma, hepatocellular carcinoma, cholangiocarcinoma, mesothelioma, thyroid cancer, prostate cancer, rhabdomyosarcoma, lung cancer, kidney cancer, ovarian cancer, bladder cancer, leiomyosarcoma, myeloma, lymphoma, leukemia, chronic lymphoid cancer, brain cancer, and colorectal cancer ([0271-0274] disclose breast cancer and HCC).
Regarding claim 31, Costa further teaches wherein the carrier frequency is from about 0.1 - 1000 MHz ([0262] RF carrier signal can be between 1 MHz and 900 MHz).
Regarding claim 33, Costa teaches An apparatus for treating a subject suffering from cancer, the apparatus comprising: a conductive applicator configured to apply to the subject radio frequency radiation (Fig 7 and [0241] electrically conductive probe 13), wherein the radio frequency radiation comprises one or more amplitude- modulated output signals ([0014]); and a frequency synthesizer coupled to the conductive applicator and configured to generate the one or more amplitude-modulated output signals ([0135] Figs 3-7) by generating: a carrier frequency signal having a carrier frequency from about 1KHz to 5000 MHz ([0262] RF carrier signal can be between 1 MHz and 900 MHz); and amplitude modulation frequency signals having amplitude modulation frequencies from about 0.1 Hz to about 150,000 Hz ([0014] modulation frequency between 0.01 Hz and 150 KHz), wherein the amplitude modulation frequencies are selected to be cancer-specific frequencies ([0271-0273]); wherein the frequency synthesizer is a digital frequency synthesizer comprising (Fig 3 carrier frequency oscillator 302): a digital carrier frequency synthesizer configured to output the carrier frequency digital signal (Fig 3 [0158] oscillator 302 outputs carrier frequency signal); a digital amplitude modulation frequency synthesizer configured to output the one or more amplitude modulation frequency digital signals (digital synthesizer 306); an arithmetic logic unit (ALU) configured to numerically compute one or more digital amplitude modulated signals from the carrier frequency digital signal and the amplitude modulation frequency digital signal in real-time (Figs 3-4, device computes digital modulated signals from the carrier frequency signal and modulation frequency digital signal to provide each modulated digital signal at 304 with “ALC”); and a digital to analog converter (DAC) configured to convert the one or more digital amplitude modulated signals to the one or more amplitude-modulated output signals ([0164]).
Costa discloses the invention substantially as claimed above except for the exact carrier frequency range and the amplitude modulation frequencies range.
However it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Costa to use a carrier frequency from about 1 KHz to 5000 MHz and a amplitude modulation frequency from about 0.1 Hz to about 150,000 Hz as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Costa fails to explicitly teach wherein the carrier frequency synthesizer is digital.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the carrier signal synthesizer of Costa to incorporate a digital carrier signal synthesizer to arrive at claim 33. Doing so would be obvious to one of ordinary skill in the art as digital frequency synthesizers are well-known in the art to yield predictable results of generating frequency signals therein for use radio frequency radiation application.
Regarding claim 34, Costa further teaches the cancer is selected from the group consisting of breast cancer, neuroendocrine tumors, non-Hodgkin lymphoma, adenocarcinoma, head and neck cancer, gastric cancer, glioblastoma, squamous cell carcinoma, hepatocellular carcinoma, cholangiocarcinoma, mesothelioma, thyroid cancer, prostate cancer, rhabdomyosarcoma, lung cancer, kidney cancer, ovarian cancer, bladder cancer, leiomyosarcoma, myeloma, lymphoma, leukemia, chronic lymphoid cancer, brain cancer, and colorectal cancer ([0271-0274] disclose breast cancer and HCC).
Regarding claim 35, Costa further teaches wherein the carrier frequency is from about 0.1 - 1000 MHz ([0262] RF carrier signal can be between 1 MHz and 900 MHz).
Regarding claim 36, Costa further teaches wherein the modulation frequency is from 100 Hz to 99,000 Hz ([0014] [0262] modulation frequency between 0.01 Hz and 150 KHz). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Costa to use a modulation frequency from about 100 Hz to about 99,000 Hz as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 37, Costa further teaches wherein the digital frequency synthesizer further comprises a controller configured to control a frequency (Fig 3-4, digital synthesizer controls frequency and is connected to microprocessor interface) and a power associated with the one or more amplitude-modulated output signals (Fig 3 power monitor 314 [0160]).
Regarding claim 38, Costa further teaches a directional coupler for providing, to the controller, power and absorption information relating to each of the one or more amplitude-modulated output signals (Fig 3 directional coupler 312; [0160, 0171] direction coupler works with power monitor to provide info relating to power and absorption of the amplitude modulated signals to the microprocessor).
Regarding claim 40, Costa teaches the use of a direct digital synthesizer (DDS) (DDS 306 [0159]).
Costa fails to explicitly teach wherein the digital carrier frequency synthesizer is a direct digital synthesizer (DDS).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the carrier signal synthesizer of Costa to incorporate a direct digital synthesizer for the digital carrier frequency synthesizer to arrive at claim 40. Doing so would be obvious to one of ordinary skill in the art as direct digital frequency synthesizers are well-known in the art to yield predictable results of generating frequency signals therein for use in a low energy high frequency radiation application.
Regarding claim 41, Costa further teaches wherein the digital modulation frequency synthesizer is a direct digital synthesizer (DDS) (DDS 306 [0159]).
Regarding claim 42, Costa further teaches wherein the frequency synthesizer is configured to generate the one or more amplitude-modulated output signals, either sequentially or simultaneously ([0274]).
Regarding claim 43, Costa further teaches wherein the conductive applicator is configured for insertion into an oral cavity of the subject undergoing treatment ([0515] [0520] etc.).
Regarding claim 44, Costa further teaches wherein the amplitude modulation frequencies are determined or predetermined by a bio- feedback process involving observations or measurements of physiological reactions by the subject during a time that cellular functions of the subject are excited by exposing the subject to emission of a modulated output signal ([0511]).
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Costa (U.S. PGPub No. 2022/0000373) in view of Cerussi (U.S. PGPub No. 2015/0351635).
Regarding claim 39, Costa further teaches wherein the digital frequency synthesizer further comprises a phase-locked loop (PLL) frequency multiplier ([0064] disclosing a phased locked loop system).
Costa fails to explicitly teach wherein the PLL is configured to set a system clock for one or more of the following: the digital carrier frequency synthesizer or the digital modulation frequency synthesizer.
In related prior art, Cerussi teaches a similar system comprising a PLL oscillator for providing a stable and precise frequencies ([0046] [0059]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Costa in view of Cerussi to incorporate the PLL configured to set a system clock for one or more of the following: the digital carrier frequency synthesizer or the digital modulation frequency synthesize to arrive at claim 39. Doing so would advantageously provide for stable and precise frequencies of the carrier or digital modulation frequencies ([0046] [0059]).
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive.
Regarding arguments directed to claim 1 on page 61 of the remarks, applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. In the instant case, the examiner respectfully disagrees and finds that one of ordinary skill in the art would be motivated to try a large variety of frequencies based on the teachings of Costa to arrive at the various claimed cancer specific treatment frequencies. Said teachings of Costa including a disclosure that exposing patients to a large number of amplitude-modulated frequencies ([0274] [0280] [0335]) is beneficial for multiple purposes ([0273]) and that it is known in the art that cancers exposed to tumor-specific modulation frequencies causing said cancer cells to undergo cell death, modify their proliferative capacity, or a combination thereof ([0271-0273] [0342]).
Regarding claims 29 and 33, applicant argues that the modification to incorporate the carrier frequency synthesizer as a digital carrier frequency synthesizer provides no discernable motivation. These arguments are unpersuasive. One of ordinary skill in the art is aware of both digital and analog carrier frequency synthesizers such that the use of either is clearly known and understood in the art to yield predictable results. For purposes of expedited prosecution, the Gilbert (U.S. PGPub No. 2011/0028963) reference clearly establishes the interchangeable use of analog or digital oscillators for waveform synthesis ([0048]). Regarding arguments directed to the alleged lack of ALU. The Costa reference discloses an “ALC” in Figure 3 that functions with the modulator 304 to output the modulated analog output signal as claimed. As such, these arguments are unpersuasive.
All arguments to dependent claims are equally unpersuasive for the reasons stated above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794