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 .
Specification
The disclosure is objected to because of the following informalities: Pg. 4, Ln. 15-20 appear to contain a typographical error regarding the unit of frequency contained therein. Lns. 16, 17 and 18 recite “300 MFIz to 300 GFIz,” which units (i.e., “MFIz” and “GFIz”) appears to be a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, and Claims 2-5 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Independent Claim 1, Claim 1 recites “sufficient to reduce the level of malarial parasites in the patient….” However, the Present Specification provides no guidance as to what “sufficient to reduce the level of malarial parasites in the patient” constitutes, and does not provide any particular characteristics of the recited “microwave energy” that would render them so-sufficient. One of ordinary skill in the art would be unable to discern from the Present Specification whether any particular microwave radiation that he might apply to a patient would be “sufficient to reduce the level of malarial parasites in the patient.” The Present Specification thus fails to convey to one skilled in the art that the inventor had possession of the claimed invention at the time the application was filed.
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 1, 2, 4 and 5, and Claim 3 by dependency, 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.
Regarding Independent Claim 1, Claim 1 recites “applying microwave energy to a patient, sufficient to reduce the level of malarial parasites in the patient under non-thermal conditions.” The term “under non-thermal conditions” is, grammatically, a dangling modifier. As such, it is grammatically unclear which Claim 1 limitation is modified by the term “under non-thermal conditions.” For example, the term “applying microwave energy” could be modified by the term “under non-thermal conditions” (e.g., microwave energy is applied under non-thermal conditions), the term “reduce the level of malarial parasites” could be modified by the term “under non-thermal conditions” (e.g., the reduction is done under non-thermal conditions), the term “sufficient to reduce” could be modified by the term “under non-thermal conditions” (e.g., the reduction is sufficient under non-thermal conditions), the term “under non-thermal conditions” could be an effect of “applying microwave energy” (e.g., temperature of patient tissue does not rise significantly as a result of the applied microwave energy), or something else.
The Examiner notes that the definition of “non-thermal conditions” set forth on Pg. 3, Ln. 10-11 of the Present Specification does not resolve this grammatical issue.
For purposes of this Office Action, Claim 1 is being interpreted to mean that microwave energy is applied under non-thermal conditions.
Regarding Claim 2, Claim 2 recites “the temperature of the tissue of a patient.”
The is insufficient antecedent basis for the terms “the temperature” and “the tissue.”
It is unclear whether the “a patient” of Claim 2 is the same or different from the “a patient” of Claim 1.
Regarding Claim 4, Claim 4 recites “the interval between pulses.” There is insufficient antecedent basis for this term.
Regarding Claim 5, Claim 5 recites “the treatment period.” There is insufficient antecedent basis for this term.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Promising new microwave treatment for malaria,” youtube, 30 August 2011, page 4, retrieved from the Internet: https://www.youtube.com/watch?v=ZtH-qs5Ysh4, retrieved on 2026-09-071 (“Youtube”) as evidenced by Michaelson, "Microwave Biological Effects: An Overview," Proceedings of the IEEE, Vol. 68, No. 1, January 1980 (Michaelson”).
Regarding Independent Claim 1, Youtube discloses:
A method for the treatment of malaria which comprises applying microwave energy to a patient, sufficient to reduce the level of malarial parasites in the patient under non-thermal conditions (Youtube at Time Stamp 0:02, reproduced below).
As explained above, Claim 1 is being interpreted to mean that microwave energy is applied under non-thermal conditions.
Consistent with the definition provided at Pg. 3, Ln. 10-11 of the Present Specification, the term “under non-thermal conditions” is being interpreted to mean that “the tissues of the patient subjected to microwave energy do not significantly rise in temperature.” Youtube’s disclosure “…kills the malaria parasites while leaving healthy red cells unharmed” (Youtube at Time Stamp 0:02), and “involved placing a patient’s limbs inside a specially modified microwave where they receive a low dose of non-ionizing radiation” (Youtube at Time Stamp 0:22 through Time Stamp 0:31; see Youtube at Time Stamp 0:25 and Youtube at Time Stamp 0:31, reproduced below). Youtube’s microwave treatment is thus “sufficient to reduce the level of malarial parasites in the patient under non-thermal conditions” as claimed, as the patient’s limbs would not otherwise be able to be subjected to microwave radiation without pain. See Michaelson at Pg. 46, Right Column, Fifth Paragraph.
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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.
Claim 1 is alternatively rejected and Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over “Promising new microwave treatment for malaria,” youtube, 30 August 2011, page 4, retrieved from the Internet: https://www.youtube.com/watch?v=ZtH-qs5Ysh4, retrieved on 2026-09-07 (“Youtube”) in view of Michaelson, "Microwave Biological Effects: An Overview," Proceedings of the IEEE, Vol. 68, No. 1, January 1980 (Michaelson”) as evidenced by National Library of Medicine, medlineplus.gov, "Body temperature norms," Review Date 1/1/2025, accessed 9/7/26 via https://medlineplus.gov/ency/article/001982.htm (“MedlinePlus.gov”) and as further evidenced by Mumford, "Some Technical Aspects of Microwave Radiation Hazards," PROCEEDINGS OF THE IRE, Volume 49, Issue 2, pg. 427-447, February 1961 (“Mumford”).
Regarding Independent Claim 1, Youtube discloses:
A method for the treatment of malaria which comprises applying microwave energy to a patient, sufficient to reduce the level of malarial parasites in the patient …(Youtube at Time Stamp 0:02, see Rejection of Claim 1 under 35 USC 102, above).
Youtube does not disclose:
under non-thermal conditions
Michaelson describes the biological effects of microwaves (Title). Michaelson is analogous art.
Michaelson teaches:
under non-thermal conditions (Pg. 46, Right Column, Fifth Paragraph, “Perception of MW energy is a function of cutaneous thermal sensation or pain. The physiology of thermal sensation and pain has been the subject of several studies which suggest that a threshold sensation is obtained when the temperature of the warmth receptors in the skin is increased by a certain amount…”).
As explained above, Claim 1 is being interpreted to mean that microwave energy is applied under non-thermal conditions.
Consistent with the definition provided at Pg. 3, Ln. 10-11 of the Present Specification, the term “under non-thermal conditions” is being interpreted to mean that “the tissues of the patient subjected to microwave energy do not significantly rise in temperature.”
Michaelson teaches that such a “significant[] rise in temperature” would result in pain.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Youtube with the teachings of Michaelson (i.e., to perform the application of microwave energy under non-thermal conditions) in order to prevent the patient from experiencing pain as a result of the treatment (Michaelson at Pg. 46, Right Column, Fifth Paragraph).
Regarding Claim 2, the combination of Youtube and Michaelson renders obvious the entirety of Claim 1 as explained above.
Michaelson additionally discloses:
wherein the temperature of the tissue of a patient does not exceed 42 degrees Celsius. (Pg. 42, Right Column, Fourth Paragraph, “There are numerous reports of abnormalities from the induction of systemic hyperthermia of 2.5 to 5°C above the normal temperature for the species…”).
The “normal temperature” of the human body is 37°C. See MedlinePlus.gov at Pg. 1, First Paragraph.
Michaelson’s “5°C above the normal temperature for the species” corresponds to 42 degrees Celsius.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Youtube and Michaelson with the teachings of Michaelson (i.e., to prevent the tissue of the patient from exceeding 42 degrees Celsius) in order to prevent “numerous abnormalities” caused by “the induction of systemic hyperthermia of … 5°C above the normal temperature for the species” (Michaelson at Pg. 42, Right Column, Fourth Paragraph).
Regarding Claim 4, the combination of Youtube and Michaelson renders obvious the entirety of Claim 1 as explained above.
The combination of Youtube and Michaelson does not disclose:
wherein the interval between pulses is from 18 to 30 seconds.
However, one of ordinary skill in the art would understand that “the chief effect of microwave energy on living tissue is to produce heating,” and that “[c]onsequently, exposure to microwave radiation should probably represent no hazard unless overheating is a possibility” (Mumford at Pg. 429, Left Column, Bottom Paragraph). One of ordinary skill in the art would further understand that such problematic heating is dependent on strength of the microwave field and time of exposure (see, e.g., Mumford at Pg. 429, Right Column, Second Paragraph).
It would have been obvious for a person of ordinary skill in the art to adjust the interval between pulses of microwave radiation such that the interval between pulses is from 18 to 30 seconds because such an adjustment would alter time of exposure (thus, by the understanding of an ordinarily skilled artisan, reducing the probability of hazard to the patient).
Such an adjustment entails mere optimization of a result effective variable through routine experimentation. The Present Specification discusses the claimed pulse interval at Pg. 4, Ln. 1-7. The claimed interval is not described to be critical. It would have been obvious for a person of ordinary skill in the art to arrive at the claimed interval between pulses through routine experimentation wherein heat caused by various pulse intervals is assessed and an optimum pulse interval selected.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over “Promising new microwave treatment for malaria,” youtube, 30 August 2011, page 4, retrieved from the Internet: https://www.youtube.com/watch?v=ZtH-qs5Ysh4, retrieved on 2026-09-07 (“Youtube”) in view of Michaelson, "Microwave Biological Effects: An Overview," Proceedings of the IEEE, Vol. 68, No. 1, January 1980 (Michaelson”) as applied to Claim 1 above, and further in view of US 2012/0089209 A1 to Schoenbach et al. (“Schoenbach”).
Regarding Claim 3, the combination of Youtube and Michaelson renders obvious the entirety of Claim 1 as explained above.
The combination of Youtube and Michaelson does not disclose:
wherein microwave energy is switched on in pulses lasting less than 6 seconds.
Schoenbach describes a “Method and System for Treating a Biological Target Region Using Pulsed Electromagnetic Radiation” (Title), which electromagnetic radiation includes microwave radiation (Para. [0022]). Schoenbach aims to “reduce such heating effects [caused by microwave radiation treatment] in the normal tissues, yet still maintain therapeutic effectiveness at the target for patient treatments” (Schoenbach at Para. [0021]). Schoenbach is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Schoenbach teaches:
wherein microwave energy is switched on in pulses lasting less than 6 seconds (Claim 3, “…wherein the predetermined time period is within a range of approximately one microsecond to approximately ten seconds.”).
Schoenbach’s range of “one microsecond to approximately ten seconds” overlaps the claimed range of “less than 6 seconds.” In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Although Schoenbach’s range of “one microsecond to approximately ten seconds” does not disclose the precise range of “less than 6 seconds,” it would have been obvious for a person of ordinary skill in the art to select any length of time from Schoenbach’s range including “less than 6 seconds” because so-doing would be likely to result in success for Schoenbach’s purpose of controlling for temperature increase of treated tissue (see Schoenbach at Para. [0030]; compare with Present Specification at Pg. 3, Ln. 15-19). See MPEP 2144.05(I).
The claimed range is described at Pg. 3, Ln. 15-19 of the Present Specification. The claimed range of “less than 6 seconds” is not described as critical. One of ordinary skill in the art would understand based at least on Schoenbach’s teachings that pulse length is a result effective in the context of its effect on tissue temperature. Arriving at the claimed range of “less than 6 seconds” from Schoenbach’s range of “one microsecond to approximately ten seconds” amounts to routine optimization within prior art conditions or through routine experimentation, and does not support patentability. See MPEP 2144.05(II)(A).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Youtube and Michaelson with the teachings of Schoenbach (i.e., to use microwave energy that is switched on in pulses lasting less than 6 seconds) in order to control for temperature increase of treated tissue (Schoenbach at Para. [0030]; Para. [0021]).
Regarding Claim 5, the combination of Youtube and Michaelson renders obvious the entirety of Claim 1 as explained above.
The combination of Youtube and Michaelson does not disclose:
wherein the treatment period is from 25 minutes to 45 minutes
Schoenbach describes a “Method and System for Treating a Biological Target Region Using Pulsed Electromagnetic Radiation” (Title), which electromagnetic radiation includes microwave radiation (Para. [0022]). Schoenbach aims to “reduce such heating effects [caused by microwave radiation treatment] in the normal tissues, yet still maintain therapeutic effectiveness at the target for patient treatments” (Schoenbach at Para. [0021]). Schoenbach is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Schoenbach teaches:
wherein the treatment period is from 25 minutes to 45 minutes (Para. [0021], “…, the process of heating tissue to temperatures that will induce cell death has been used as a form of cancer treatment. However, as also has been noted, such treatments generally require extended exposure of the tissue to electromagnetic radiation, which can take minutes or even hours.”).
Schoenbach’s range of “minutes or even hours” overlaps the claimed range of “25 minutes to 45 minutes.” In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Although Schoenbach’s range of “minutes or even hours” does not disclose the precise range of “25 minutes to 45 minutes,” it would have been obvious for a person of ordinary skill in the art to select any length of time from Schoenbach’s range including “25 minutes to 45 minutes” because so-doing would be likely to result in success for Schoenbach’s purpose causing cell death via microwave radiation in a manner sufficient to effect treatment for particular disease (see Schoenbach at Para. [0021]). See MPEP 2144.05(I).
The claimed range is described at Pg. 4, Ln. 8-14 of the Present Specification. The claimed range of “25 minutes to 45 minutes” is not described as critical. One of ordinary skill in the art would understand based at least on Schoenbach’s teachings that treatment length is a result effective variable in the context of its effect on treatment efficacy. Arriving at the claimed range of “25 minutes to 45 minutes” from Schoenbach’s range of “minutes or even hours” amounts to routine optimization within prior art conditions or through routine experimentation, and does not support patentability. See MPEP 2144.05(II)(A).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Youtube and Michaelson with the teachings of Schoenbach (i.e., to use a treatment period between 25 minutes and 45 minutes) in order to ensure sufficient time to ensure cell death is induced (Schoenbach at Para. [0021]).
Art Deemed Relevant Although Not Relied Upon
The Examiner makes note of the following prior art, which is deemed relevant although not relied upon in any foregoing rejection.
Cleary, "Microwave Radiation Effects on Humans," BioScience Vol. 33 No.4 , Pg. 271-273, April 1983 describes various means of mitigating heat caused by microwave energy via parameter adjustment at Pg. 271, which is pertinent to Claims 2-5.
US 2018/0200532 A1 describes “A process for heat treating biological tissue includes repeatedly applying a pulsed energy to a target tissue over a period of time so as to controllably raise a temperature of the target tissue to create a therapeutic effect to the target tissue without destroying or permanently damaging the target tissue” (Abstract), and discusses alterations to duty cycle as a means of mitigating temperature increase at Para. [0086] and pulse length as a means of mitigating temperature increase at Paras. [0013] through [0017].
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in United Kingdom on 2019-02-27. It is noted, however, that applicant has not filed a certified copy of the GB 1902634.3 application as required by 37 CFR 1.55.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 “Promising new microwave treatment for malaria,” youtube, 30 August 2011, page 4, retrieved from the Internet: https://www.youtube.com/watch?v=ZtH-qs5Ysh4 was disclosed by Applicant in the IDS dated 4/7/2025.
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