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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 29, 2023 and August 18, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on June 16, 2023 are accepted.
Election/Restrictions
This application contains claims directed to the following patentable distinct species related to methods of treating different types of disease groups:
Species A: a method of treating a neuroinflammatory disorder (claim 47)
Species B: a method of treating a SARS-CoV-2 infection (claim 48)
Species C: a method of treating a cardiovascular inflammatory disorder (claim 49)
Species D: a method of treating a respiratory inflammatory disorder (claim 50)
Species E: a method of treating one or more of disorders as recited (claim 53)
Claim 33 is generic to the above disclosed patentably distinct species and it is the linking claim. The species disclosed in the consequent dependent claims are independent or distinct because as disclosed the different species have mutually exclusive characteristics for each identified species. That is, each species related to the medical procedure, each species related to the medical instrument, and each species related to the medical imaging equipment is directed to a different method or system embodiment. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species from species A-E, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species do not share the same or corresponding technical feature. Please see the various features listed in the characterizations of the species above, as well as the representative features in the drawings as to the lack of a corresponding technical feature.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
A telephone call was made to Richard Shoop (Reg. No. 45,763) on February 20, 2026 to request an oral election to the above restriction requirement. Applicant made an election to elect Species A (claim 47).
Accordingly, claims 48-50 and 53 are withdrawn.
Claim Objections
Claims 36-37, 40 and 43-46 are objected to because of the following informalities:
Claims 36, 37 and 40 and 43-46: “applying pulsed electromagnetic energy” should be corrected to –applying the pulsed electromagnetic energy--.
Claim 40 recites “busts” in line 2 that should be corrected to –bursts--; and “pulsed electromagnetic energy” should be corrected to –the pulsed electromagnetic energy--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 34, 35, 43, 44 and 54 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.
Claims 34 and 35 recite “the cytokine/chemokine”, yet the species of TNF, MIP, IL, IP and MCP only belong to the cytokine family. Regardless, the term “the cytokine/chemokine” should be corrected to –the cytokine or chemokine--.
Claims 43 and 44 recite “a plurality of coils”. It is unclear whether the plurality of coils is related to “a coil” recited in line 2 of claim 33.
Claim 43 recites “the coil adjacent to the target tissue” that lacks proper antecedent basis. Claim 43 depends on claim 33 and claim 33 does not recite a coil that is adjacent to the target tissue.
Claim 54 recites “a patient’s body”. It is unclear whether it refers to the same patient as recited in line 1 of claim 33 (“a patient”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 33-38, 40, 43, 45 and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Gurfein et al., US 2018/0043174 A1, hereinafter Gurfein, in view of Luttrull et al., US 2017/0232269 A1, hereinafter Luttrull.
Claim 33. Gurfein teaches a method of reducing inflammation in a patient ([0005]: Time-varying electromagnetic fields, comprising PEMF, or PRF…have been found to be clinically beneficial when used as a therapy for…reducing inflammation…), the method comprising:
applying pulsed electromagnetic energy to the patient from a coil ([0130]: FIG.8 and 9 illustrate examples of apparatuses that may be used to deliver the therapies…In FIG.8, the foam mat 802 includes two (though one or more than 2 may be incorporated ) embedded PEMG applicator coils 803, 803’. Within the coil region is a therapeutic space 801 onto which the patient’s head and/or neck and/or spine may be placed), wherein
an amplitude of between 0.2G and 1G ([0140]: the amplitude between 0.001 milliGauss to 200 milliGauss), resulting in
a decrease in the patient of 20% or more of a cytokine or chemokine ([0138]: a PEMF signal having parameters centered around a carrier frequency of 10 MHz, with burst duration of about 10 msec, and a burse frequency of about 1 Hz rep rate may have substantially and surprisingly increased efficacy. This has been seen in a cell culture, showing an increase in outcome by about 20% compared to values outside of this range; [0048]: FIGS. 10A-10H illustrate the effect of PEMF treatment on various cytokines in microglia, generally illustrating a reduction in inflammatory cytokines following PEMF treatment; and [0136]: FIGS.10A-10H show a reduction in IL-1β (FIG.10A),…MIP-1a (FIG.10D),…MCP-1 (FIG.10F), and TNFa (FIG.10G)) – in FIG.10A, 10D, 10F and 10G, the reduction is estimated based on the scale of the plot to be more than 20%.
In regard to the claimed feature of the pulsed electromagnetic energy having a duty cycle of 4% of greater, any electromagnetic pulses comprise a non-zero duty cycle. Though Gurfein does not teach the duty cycle of the pulsed electromagnetic energy is 4% or greater, in an analogous PEMF based inflammation reduction field of endeavor, Luttrull teaches such a feature.
Luttrull teaches in [0114] the controlled application of pulsed ultrasound or electromagnetic radiation to treat abnormal conditions including inflammations…by means of fiber optics of endoscopes or surface probes as well as focused electromagnetic/sound waves.
Luttrull further teaches
applying pulsed electromagnetic energy that has a duty cycle of 4% or greater ([0013]: the pulsed energy source may comprise a radiofrequency…and has a duty cycle of between 2.5% to 5%...with a device having a coil radii between 2 and 6 mm; [0014]: when the pulsed energy source comprises a microwave frequency,…a duty cycle between 2% and 5%; [0015]: when the pulsed energy source is a pulsed light beam, the light beam may have…a duty cycle of less than 10%; [0125]: the selection of the duty cycle and the total pulse train duration provide time intervals in which the heat can dissipate. A duty cycle of less than 10%, and preferably between 2.5% and 5%,…has been found to be effective; [0128]: the parameters differ from the individual energy sources,…because the absorption properties of tissues differ for these different types of energy sources).
Gurfein’s teaching of the amplitude of between 0.001 milliG to 200 milliG overlaps with the claimed range of 0.2G to 1G.
Luttrull’s teaching of the duty cycle between 2-5%, between 2.5-5% and less than 10% overlaps with the claimed range of 4% or greater.
A prima facie case of obviousness exists when the claimed ranges overlap or lie inside ranges disclosed by the prior art. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). See MPEP 2144.05.I.
Further, in regard to the magnitude of the amplitude (0.2G to 1G), the duty cycle (4% or greater) and the resulted quantity of decrease of the cytokine/chemokine (20% or more), Gurfein teaches in [0140]: described herein are dose regimes in which subsequent doses vary one or more parameters (e.g., burst duration, burst frequency, amplitude/field strength, etc) between individual dose. Parameters may be varied within a dose and/or between doses…either randomly, or with a preset patter, or some combination thereof. Varying the signals in this manner may minimize attenuation of therapeutic response over time in patients that require chronic treatment. Similarly, Luttrull teaches in [0121]: the energy source to be applied to the target tissue will have energy and operating parameters which must be determined and selected so as to achieve the therapeutic effect while not permanently damaging the tissue. Using a light beam energy source, such as a laser light beam, as an example, the laser wavelength, duty cycle and total pulse train duration parameters must be taken into account. Hence, these features of the pulsed electromagnetic energy are considered merely a design choice, and the resulted therapeutic effect is a consequence of the parameter settings. It is a well-known knowledge in the field of art to adjust the amplitude and the duty cycle of the pulses to achieve a desired therapeutic effect suitable for particular applications. Note that the therapeutic effect, or more specifically, the percentage of the decrease of cytokine or chemokine depends not only on the setting parameters of the pulses, but also on the type of electromagnetic energy source, the dimension and configuration of the coil, the individual patient’s medical condition, the type of disorders, and the area where the pulses are applied onto. The therapeutic effect is a combined effect of all these factors. Therefore, it would have been obvious for one of ordinary skills in the art before the effective filing date of the claimed invention to have alternatives of the magnitude of the amplitude, the duty cycle and the resulted quantity of decrease of the cytokine/chemokine. The provision of such alternative configurations, where needed, involves only routine skill in the art to achieve with reasonable expectation of success.
Note that the above obviousness consideration also applies to the dependent claims 36, 37, 38 and 40 for the pulse application time, the duty cycle, the percentage in decrease, and the burst width recited in these claims.
Claims 34-35. As applied to claim 33, Gurfein teaches that
the cytokine/chemokine is one or more of (claim 34) and three or more of (claim 35): Tumor Necrosis Factor alpha (TNF-a), Macrophage Inflammatory Protein (MIP1a), Interleukin 1 beta (IL-1b), Interferon gamma-induced protein 10 (IP-10), and Monocyte Chemoattractant Protein-1 (MCP-1) ([0048]: FIGS. 10A-10H illustrate the effect of PEMF treatment on various cytokines in microglia, generally illustrating a reduction in inflammatory cytokines following PEMF treatment; [0136]: FIGS.10A-10H show a reduction in IL-1β, IL-6, IL-12, MIP-1a, GM-CSF, MCP-1, TNFa, and IL-4).
Claim 36. Gurfein further teaches
applying pulsed electromagnetic energy comprises applying for at least 10 minutes ([0140]: the duration of treatment (e.g., between 0.2-30 mins)).
Claim 37. Luttrull further teaches that
the applied pulsed electromagnetic energy has a duty cycle of between 4% and 20% ([0013]: the pulsed energy source may comprise a radiofrequency…and has a duty cycle of between 2.5% to 5%...with a device having a coil radii between 2 and 6 mm; [0014]: when the pulsed energy source comprises a microwave frequency,…a duty cycle between 2% and 5%; [0015]: when the pulsed energy source is a pulsed light beam, the light beam may have…a duty cycle of less than 10%; [0125]: the selection of the duty cycle and the total pulse train duration provide time intervals in which the heat can dissipate. A duty cycle of less than 10%, and preferably between 2.5% and 5%,…has been found to be effective; [0128]: the parameters differ from the individual energy sources,…because the absorption properties of tissues differ for these different types of energy sources).
Luttrull’s teaching of the duty cycle between 2-5%, between 2.5-5% and less than 10% overlaps with the claimed range between 4% and 20%.
A prima facie case of obviousness exists when the claimed ranges overlap or lie inside ranges disclosed by the prior art. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). See MPEP 2144.05.I.
Claim 38. Gurfein further teaches
decreasing levels of one or more of: Tumor Necrosis Factor alpha (TNF-a), Macrophage Inflammatory Protein (MIP1a), Interleukin 1 beta (IL-1b), Interferon gamma-induced protein 10 (IP-10), and Monocyte Chemoattractant Protein-1 (MCP-1), by 40% or more in the target tissue ([0138]: a PEMF signal having parameters centered around a carrier frequency of 10 MHz, with burst duration of about 10 msec, and a burse frequency of about 1 Hz rep rate may have substantially and surprisingly increased efficacy. This has been seen in a cell culture, showing an increase in outcome by about 20% compared to values outside of this range; [0048]: FIGS. 10A-10H illustrate the effect of PEMF treatment on various cytokines in microglia, generally illustrating a reduction in inflammatory cytokines following PEMF treatment; and [0136]: FIGS.10A-10H show a reduction in IL-1β (FIG.10A),…MIP-1a (FIG.10D),…MCP-1 (FIG.10F), and TNFa (FIG.10G)) – in FIG.10D, the reduction is estimated based on the scale of the plot to be more than approximately 40%.
Claim 40. Gurfein further teaches
applying busts of pulsed electromagnetic energy having a burst width of between about 10 msec and 150 msec ([0033]: a 10 msec burst width; and [0140]: the burst width (e.g., between 2 msec-20msec)).
Claim 43. Gurfein further teaches
applying pulsed electromagnetic energy from the coil adjacent to the target tissue comprises applying from a plurality of coils adjacent a patient's head ([0130]: FIG.8 and 9 illustrate examples of apparatuses that may be used to deliver the therapies…In FIG.8, the foam mat 802 includes two (though one or more than 2 may be incorporated ) embedded PEMG applicator coils 803, 803’. Within the coil region is a therapeutic space 801 onto which the patient’s head and/or neck and/or spine may be placed).
Claim 45. Gurfein further teaches
applying pulsed electromagnetic energy from a plurality of coils that are fired independently, simultaneously, or in sequence ([0131]: the head and spinal cord can be treated simultaneously).
Claim 57. Gurfein a method of reducing inflammation in a target tissue ([0005]: Time-varying electromagnetic fields, comprising PEMF, or PRF…have been found to be clinically beneficial when used as a therapy for…reducing inflammation…), the method comprising:
applying pulsed electromagnetic energy from a coil adjacent to the target tissue for more than 10 minutes ([0130]: FIG.8 and 9 illustrate examples of apparatuses that may be used to deliver the therapies…In FIG.8, the foam mat 802 includes two (though one or more than 2 may be incorporated ) embedded PEMG applicator coils 803, 803’. Within the coil region is a therapeutic space 801 onto which the patient’s head and/or neck and/or spine may be placed; and [0140]: the duration of treatment (e.g., between 0.2-30 mins)),
an amplitude of between 0.2G and 0.9G ([0140]: the amplitude between 0.001 milliGauss to 200 milliGauss), resulting in
a decrease in the target tissue of 30% or more of one or more of: Tumor Necrosis Factor alpha (TNF-a), Macrophage Inflammatory Protein (MIP1a), Interleukin 1 beta (IL-1β), Interferon gamma-induced protein 10 (IP-10), and Monocyte Chemoattractant Protein-1 (MCP-1) ([0138]: a PEMF signal having parameters centered around a carrier frequency of 10 MHz, with burst duration of about 10 msec, and a burse frequency of about 1 Hz rep rate may have substantially and surprisingly increased efficacy. This has been seen in a cell culture, showing an increase in outcome by about 20% compared to values outside of this range; [0048]: FIGS. 10A-10H illustrate the effect of PEMF treatment on various cytokines in microglia, generally illustrating a reduction in inflammatory cytokines following PEMF treatment; and [0136]: FIGS.10A-10H show a reduction in IL-1β (FIG.10A),…MIP-1a (FIG.10D),…MCP-1 (FIG.10F), and TNFa (FIG.10G)) – in FIG.10A, 10D, 10F and 10G, the reduction is estimated based on the scale of the plot to be more than approximately 30%.
In regard to the claimed feature of the pulsed electromagnetic energy having a duty cycle of 4% of greater, any electromagnetic pulses comprise a non-zero duty cycle. Though Gurfein does not teach the duty cycle of the pulsed electromagnetic energy is 4% or greater, in an analogous PEMF based inflammation reduction field of endeavor, Luttrull teaches such a feature.
Luttrull teaches in [0114] the controlled application of pulsed ultrasound or electromagnetic radiation to treat abnormal conditions including inflammations…by means of fiber optics of endoscopes or surface probes as well as focused electromagnetic/sound waves.
Luttrull further teaches
applying pulsed electromagnetic energy that has a duty cycle of 4% or greater ([0013]: the pulsed energy source may comprise a radiofrequency…and has a duty cycle of between 2.5% to 5%...with a device having a coil radii between 2 and 6 mm; [0014]: when the pulsed energy source comprises a microwave frequency,…a duty cycle between 2% and 5%; [0015]: when the pulsed energy source is a pulsed light beam, the light beam may have…a duty cycle of less than 10%; [0125]: the selection of the duty cycle and the total pulse train duration provide time intervals in which the heat can dissipate. A duty cycle of less than 10%, and preferably between 2.5% and 5%,…has been found to be effective; [0128]: the parameters differ from the individual energy sources,…because the absorption properties of tissues differ for these different types of energy sources).
Gurfein’s teaching of the amplitude of between 0.001 milliG to 200 milliG overlaps with the claimed range of 0.2G to 0.9G.
Luttrull’s teaching of the duty cycle between 2-5%, between 2.5-5% and less than 10% overlaps with the claimed range of 4% or greater.
A prima facie case of obviousness exists when the claimed ranges overlap or lie inside ranges disclosed by the prior art. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). See MPEP 2144.05.I.
Further, in regard to the magnitude of the amplitude (0.2G to 0.9G), the pulse application time (more than 10 minutes), the duty cycle (4% or greater) and the resulted quantity of decrease of the claimed species in the cytokine family (30% or more), Gurfein teaches in [0140]: described herein are dose regimes in which subsequent doses vary one or more parameters (e.g., burst duration, burst frequency, amplitude/field strength, etc) between individual dose. Parameters may be varied within a dose and/or between doses…either randomly, or with a preset patter, or some combination thereof. Varying the signals in this manner may minimize attenuation of therapeutic response over time in patients that require chronic treatment. Hence, these features of the pulsed electromagnetic energy are considered merely a design choice, and the resulted therapeutic effect is a consequence of the parameter settings. It is a well-known knowledge in the field of art to adjust the amplitude, the pulse application time and the duty cycle of the pulses to achieve a desired therapeutic effect suitable for particular applications. Note that the therapeutic effect, or more specifically, the percentage of the decrease of cytokine or chemokine depends not only on the setting parameters of the pulses, but also on the type of electromagnetic energy source, the dimension and configuration of the coil, the individual patient’s medical condition, the type of disorders, and the area where the pulses are applied onto. The therapeutic effect is a combined effect of all these factors. Therefore, it would have been obvious for one of ordinary skills in the art before the effective filing date of the claimed invention to have alternatives of the magnitude of the amplitude, the pulse application time, the duty cycle and the resulted quantity of decrease of the cytokine family species. The provision of such alternative configurations, where needed, involves only routine skill in the art to achieve with reasonable expectation of success.
Claim 58. Gurfein teaches a method of reducing inflammation in a patient ([0005]: Time-varying electromagnetic fields, comprising PEMF, or PRF…have been found to be clinically beneficial when used as a therapy for…reducing inflammation…), the method comprising:
applying pulsed electromagnetic energy to the patient from a coil for 10 minutes or longer ([0130]: FIG.8 and 9 illustrate examples of apparatuses that may be used to deliver the therapies…In FIG.8, the foam mat 802 includes two (though one or more than 2 may be incorporated ) embedded PEMG applicator coils 803, 803’. Within the coil region is a therapeutic space 801 onto which the patient’s head and/or neck and/or spine may be placed; and [0140]: the duration of treatment (e.g., between 0.2-30 mins)), wherein
an amplitude of between 0.2G and 1G ([0140]: the amplitude between 0.001 milliGauss to 200 milliGauss), resulting in
a decrease in the patient of 30% or more of one or more of: Tumor Necrosis Factor alpha (TNF-a), Macrophage Inflammatory Protein (MIP1a), Interleukin 1 beta (IL-1b), Interferon gamma-induced protein 10 (IP-10), and Monocyte Chemoattractant Protein-1 (MCP-1) ([0138]: a PEMF signal having parameters centered around a carrier frequency of 10 MHz, with burst duration of about 10 msec, and a burse frequency of about 1 Hz rep rate may have substantially and surprisingly increased efficacy. This has been seen in a cell culture, showing an increase in outcome by about 20% compared to values outside of this range; [0048]: FIGS. 10A-10H illustrate the effect of PEMF treatment on various cytokines in microglia, generally illustrating a reduction in inflammatory cytokines following PEMF treatment; and [0136]: FIGS.10A-10H show a reduction in IL-1β (FIG.10A),…MIP-1a (FIG.10D),…MCP-1 (FIG.10F), and TNFa (FIG.10G)) – in FIG.10A, 10D, 10F and 10G, the reduction is estimated based on the scale of the plot to be more than approximately 30%.
In regard to the claimed feature of the pulsed electromagnetic energy having a duty cycle of 4% of greater, any electromagnetic pulses comprise a non-zero duty cycle. Though Gurfein does not teach the duty cycle of the pulsed electromagnetic energy is 4% or greater, in an analogous PEMF based inflammation reduction field of endeavor, Luttrull teaches such a feature.
Luttrull teaches in [0114] the controlled application of pulsed ultrasound or electromagnetic radiation to treat abnormal conditions including inflammations…by means of fiber optics of endoscopes or surface probes as well as focused electromagnetic/sound waves.
Luttrull further teaches
applying pulsed electromagnetic energy that has a duty cycle of 4% or greater ([0013]: the pulsed energy source may comprise a radiofrequency…and has a duty cycle of between 2.5% to 5%...with a device having a coil radii between 2 and 6 mm; [0014]: when the pulsed energy source comprises a microwave frequency,…a duty cycle between 2% and 5%; [0015]: when the pulsed energy source is a pulsed light beam, the light beam may have…a duty cycle of less than 10%; [0125]: the selection of the duty cycle and the total pulse train duration provide time intervals in which the heat can dissipate. A duty cycle of less than 10%, and preferably between 2.5% and 5%,…has been found to be effective; [0128]: the parameters differ from the individual energy sources,…because the absorption properties of tissues differ for these different types of energy sources).
Gurfein’s teaching of the amplitude of between 0.001 milliG to 200 milliG overlaps with the claimed range of 0.2G to 1G.
Luttrull’s teaching of the duty cycle between 2-5%, between 2.5-5% and less than 10% overlaps with the claimed range of 4% or greater.
A prima facie case of obviousness exists when the claimed ranges overlap or lie inside ranges disclosed by the prior art. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). See MPEP 2144.05.I.
Further, in regard to the magnitude of the amplitude (0.2G to 1G), the pulse application time (more than 10 minutes), the duty cycle (4% or greater) and the resulted quantity of decrease of the claimed species in the cytokine family (30% or more), Gurfein teaches in [0140]: described herein are dose regimes in which subsequent doses vary one or more parameters (e.g., burst duration, burst frequency, amplitude/field strength, etc) between individual dose. Parameters may be varied within a dose and/or between doses…either randomly, or with a preset patter, or some combination thereof. Varying the signals in this manner may minimize attenuation of therapeutic response over time in patients that require chronic treatment. Similarly, Luttrull teaches in [0121]: the energy source to be applied to the target tissue will have energy and operating parameters which must be determined and selected so as to achieve the therapeutic effect while not permanently damaging the tissue. Using a light beam energy source, such as a laser light beam, as an example, the laser wavelength, duty cycle and total pulse train duration parameters must be taken into account. Hence, these features of the pulsed electromagnetic energy are considered merely a design choice, and the resulted therapeutic effect is a consequence of the parameter settings. It is a well-known knowledge in the field of art to adjust the amplitude and the duty cycle of the pulses to achieve a desired therapeutic effect suitable for particular applications. Note that the therapeutic effect, or more specifically, the percentage of the decrease of cytokine or chemokine depends not only on the setting parameters of the pulses, but also on the type of electromagnetic energy source, the dimension and configuration of the coil, the individual patient’s medical condition, the type of disorders, and the area where the pulses are applied onto. The therapeutic effect is a combined effect of all these factors. Therefore, it would have been obvious for one of ordinary skills in the art before the effective filing date of the claimed invention to have alternatives of the magnitude of the amplitude, the duty cycle and the resulted quantity of decrease of the cytokine/chemokine. The provision of such alternative configurations, where needed, involves only routine skill in the art to achieve with reasonable expectation of success.
Claims 44 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Gurfein et al., US 2018/0043174 A1, hereinafter Gurfein, in view of Luttrull et al., US 2017/0232269 A1, hereinafter Luttrull, further in view of Dimino et al., US 2020/0094068 A1, hereinafter Dimino.
Claim 44. Gurfein and Luttrull combined teaches all the limitations of claim 33.
Neither Gurfein nor Luttrull teaches applying pulsed electromagnetic energy from a plurality of coils coupled to a headgear configured to be worn by a patient.
However, in an analogous PEMF device configuration field of endeavor, Dimino teaches
applying pulsed electromagnetic energy from a plurality of coils coupled to a headgear configured to be worn by a patient ([0368]: FIG.12, an electromagnetic treatment inductive apparatus integrated into a head and face support garment 12500 is illustrated. Several light weight flexible coils 12501 are integrated into the support garment).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Gurfein and Luttrull combined employ such a feature of applying pulsed electromagnetic energy from a plurality of coils coupled to a headgear configured to be worn by a patient as taught in Dimino for the advantage of “providing an apparatus and method that more effectively modulates biochemical processes that…incorporates miniaturized circuitry and light weight applicators that can be constructed to be implantable”, as suggested in Dimino, [0020].
Claim 54. Gurfein and Luttrull combined teaches all the limitations of claim 33.
Neither Gurfein nor Luttrull teaches that the coil is implanted into a patient body.
However, in an analogous PEMF device configuration field of endeavor, Dimino teaches that
the coil is implanted into a patient's body ([0046]: an apparatus and methods for delivering electromagnetic signals to human, animal and plant target pathway structures…for therapeutic and prophylactic purposes. A preferred embodiment according to the present disclosure utilizes a Power Signal to Noise Ratio approach to configure bioeffective waveforms and incorporates miniaturized circuity and light weight flexible coils. This advantageously allows a device…to be completely portable and if desired to be constructed as disposable and if further desired to be constructed as implantable).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the coil of Gurfein and Luttrull combined employ such a feature of it being implanted into a patient's body as taught in Dimino for the advantage of “providing an apparatus and method that more effectively modulates biochemical processes that…incorporates miniaturized circuitry and light weight applicators that can be constructed to be implantable”, as suggested in Dimino, [0020].
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Gurfein et al., US 2018/0043174 A1, hereinafter Gurfein, in view of Luttrull et al., US 2017/0232269 A1, hereinafter Luttrull, further in view of Poltorak et al., US 2020/0368491 A1, hereinafter Poltorak.
Claim 46. Gurfein and Luttrull combined teaches all the limitations of claim 33.
Neither Gurfein nor Luttrull teaches modifying a location or energy applied by the coil based on electroencephalography data acquired before or after application of pulsed electromagnetic energy.
However, in an analogous PEMF setting field of endeavor, Poltorak teaches
modifying a location or energy applied by the coil based on electroencephalography data acquired before or after application of pulsed electromagnetic energy ([0248]: a set of brain electrical activity patterns…is determined…and correlated with surface EEG findings…Audiovisual stimulation may be exclusively used. A set of EEG electrodes is provided to measure brain activity, and an adaptive or genetic algorithm scheme is provided to optimize the audiovisual presentation…In some cases, audiovisual stimulation is insufficient…PEMF is employed to assist in achieving the desired state and maintain it for the desired period).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Gurfein and Luttrull combined employ such a feature of modifying a location or energy applied by the coil based on electroencephalography data acquired before or after application of pulsed electromagnetic energy as taught in Poltorak for the advantage of “assisting in achieving the desired state and maintaining it for the desired period”, as suggested in Poltorak, [0248].
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Gurfein et al., US 2018/0043174 A1, hereinafter Gurfein, in view of Luttrull et al., US 2017/0232269 A1, hereinafter Luttrull, in view of Coticchia et al., “New paradigms in the pathogenesis of otitis media in children”. Frontiers in Pediatrics. Review Article 23 December 2013 Vol.1, Article 52, pp.1-7, hereinafter Coticchia.
Claim 47. Gurfein and Luttrull combined teaches all the limitations of claim 33.
Gurfein teaches that the method of reducing inflammation is a method of treating a neuroinflammatory disorder (Abstract: Method and apparatuses for the treatment of neurological disorders).
Neither Gurfein nor Luttrull teaches the claimed disorders.
However, in an analogous medical utility of pulsed electromagnetic wave field of endeavor, Coticchia teaches
treating a neuroinflammatory disorder including Otitis media (Title: New paradigms in the pathogenesis of otitis media in children; and p.4, Col. Left, ¶-4: pulsed laser therapy has been demonstrated to dislodge middle ear biofilms by generating shockwaves. Electromagnetic, ultrasonic, and photo-therapy may enhance antimicrobial delivery or activity in certain applications).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Gurfein and Luttrull combined employ such a feature of treating Otitis media as taught in Coticchia for the advantage of “enhancing antimicrobial delivery”, as suggested in Coticchia, p.4, Col. Left, ¶-4.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Gurfein et al., US 2018/0043174 A1, hereinafter Gurfein, in view of Luttrull et al., US 2017/0232269 A1, hereinafter Luttrull, further in view of Leonhardt et al., US 12,109,410 B, hereinafter Leonhardt.
Claim 55. Gurfein and Luttrull combined teaches all the limitations of claim 33, including determining the level, and the level of decrease of one or more of: Tumor Necrosis Factor alpha (TNF-a), Macrophage Inflammatory Protein (MIP 1 a), Interleukin 1 beta (IL-13),Interferon gamma-induced protein 10 (IP-10), and Monocyte Chemoattractant Protein-1 (MCP-1) (Gurfein: FIG.10).
Neither Gurfein nor Luttrull teaches adjusting the pulsed electromagnetic energy based on the level.
However, in an analogous PEMF setting field of endeavor, Leonhardt teaches
adjusting the pulsed electromagnetic energy based on the level (Col.30, ll.17-21: Cytokine and chemotherapeutic and regenerative treatment for certain cancers may be combined with low intensity, intermediate frequency alternating electric fields that are tuned to release specific beneficial proteins at specific time intervals) – tuning the EM field to release specific beneficial proteins is considered adjusting the EM energy based on the level of the cytokine species as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the method of Gurfein and Luttrull combined employ such a feature of adjusting the pulsed electromagnetic energy based on the level as taught in Leonhardt for the advantage of “releasing specific beneficial proteins at specific time intervals”, as suggested in Leonhardt, Col.30, ll.20-21.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mishelevich et al., US 2017/0246481 A1. This reference discloses various parameter settings including the duty cycle used for PEMF.
Ross et al., “The use of pulsed electromagnetic field to modulate inflammation and improve tissue regeneration: a review”. Bioelectricity Vol.1, No. 4, 2019. This reference teaches various application and configuration of PEMF.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798