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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/4/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 5/4/2026 with respect to the rejection of Independent Claim 1 under 35 USC 102(a)(1) as anticipated by US 2017/0340384 A1 to Deem et al. (“Deem”) have been fully considered but are not persuasive.
Claim 1 has been amended to recite “control means adapted to adjust the parameters of power, pulse times, interval times and treatment times to cause the generator to provide pulses of microwave energy under non-thermal conditions to the patient through the applicator sufficient to reduce a level of malarial parasites in the patient.” Applicant argues that the underlined additions are sufficient to differentiate Claim 1 from Deem. The Examiner respectfully disagrees. Deem teaches these additions at Para. [0342].
Applicant further argues that Deem does not disclose the Claim 1 limitation “sufficient to reduce a level of malarial parasites in the patient.” The Examiner respectfully disagrees. Such a reduction is an effect of using the claimed system. Deem discloses the entire structure of Claim 1. As such, Deem’s device is structurally capable of being used to achieved the recited effect of “reduction….”
Applicant’s arguments regarding dependent Claims 3 and 5-6 are based on Applicant’s arguments regarding Claim 1. Applicant’s arguments have been fully considered and are not persuasive for the same reasons as explained above with respect to Claim 1.
Applicant’s arguments regarding the rejection of Claim 1 under 35 USC 112(b) have been fully considered and are persuasive. The Examiner agrees that Applicant’s amendments have resolved the cited indefiniteness issues. The rejection is withdrawn.
Applicant’s arguments regarding the rejection of Claim 1 under 35 USC 112(a) have been fully considered but are not persuasive. Applicant argues that Pg. 6, Ln. 11-13 of the Present Specification is sufficient 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 Examiner respectfully disagrees.
Pg. 6, Ln. 11-13 of the Present Specification “The above-mentioned parameters of power, pulse times, interval times and treatment times may be varied to maintain non-thermal conditions and achieve the most effective reduction in the level of malarial parasites in the patient.” The recitation “sufficient to reduce the level of malarial parasites in the patient” is an effect achieved by use of the claimed device (i.e., reduction of the level of malarial parasites is an effect): this is clear from the language of Pg. 6, Ln. 11-13 (i.e., “…may be varied to … achieve the most effective reduction…”). The Present Specification provides no guidance as to what particularly is required “…to … achieve…” such reduction: of the infinitely many possible variations, the Present Specification highlights none as adequate “…to … achieve…” such sufficient reduction as required by the claim. Further, the Present Specification provides no guidance as to what “sufficient reduction” itself constitutes. One of ordinary skill in the art would be unable to discern from the present disclosure what is being done. Accordingly, Applicant’s arguments are not persuasive.
Applicant’s arguments regarding the objection to Claim 1 for minor informalities have been fully considered and are persuasive. The objection has been withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In particular, the following limitations are being interpreted under 35 U.S.C. 112(f):
Claim 1, Ln. 3, “control means,” which is being interpreted as “a manual or programmable switch, such as in the form of a computer and functional equivalents thereof” (Present Specification at Pg. 5, Ln. 22-25) and functional equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, and Claims 3-6 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 such “pulses of microwave energy” that would render them so-sufficient. 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.
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.
Claims 1, 3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by previously cited US 2017/0340384 A1 to Deem et al. (“Deem”).
Regarding Independent Claim 1, Deem teaches:
A device for the treatment of malaria in a patient, (Abstract, “A system for the application of microwave energy to a tissue can include…”);
The preamble recitation “for the treatment of malaria in a patient” is being interpreted as a statement reciting purpose or intended use. See MPEP 2111.02(II).
comprising a microwave generator, (Abstract, “A system for the application of microwave energy to a tissue can include … a signal generator adapted to generate a microwave signal having predetermined characteristics…”);
an applicator connected to the microwave generator (Abstract, “A system for the application of microwave energy to a tissue can include … an applicator connected to the generator and adapted to apply microwave energy to tissue…”);
and a control means adapted to adjust the parameters of power, pulse times, interval times and treatment times to cause the generator to provide pulses of microwave energy under non-thermal conditions to the patient through the applicator sufficient to reduce a level of malarial parasites in the patient (Abstract, “A system for the application of microwave energy to a tissue can include … and a controller adapted to control the signal generator…;” Para. [0342], “…the method of delivering energy includes the step of adjusting energy delivery duration; pre-cooling duration; post-cooling duration; output power; frequency; vacuum pressure as a result of feedback of tissue parameters such as, for example, skin temperature;” Para. [0205]).
Para. [0205] describes a “continuous wave” as contemplated by Deem’s disclosure. Deem’s “continuous wave” constitutes such “pulses of microwave energy” as claimed. Deem’s “control means” is thus “adapted” in the manner claimed.
Deem’s “frequency” is such a “pulse time” as claimed.
Deem’s “energy delivery duration” is such a “treatment time” as claimed.
Deem’s “power” is such “power” as claimed.
Deem’s “pre-cooling duration” and Deem’s “post-cooling duration” is such “interval times” as claimed.
Deem’s device controls the recited parameters “as a result of feedback of tissue parameters such as, for example, skin temperature,” and as such is structurally capable of “caus[ing] the generator to provide pulses of microwave energy under non-thermal conditions to the patient through the applicator sufficient to reduce a level of malarial parasites in the patient.”; see MPEP 2114.
Regarding Claim 3, Deem discloses the entirety of Claim 1 as explained above.
Deem additionally discloses:
wherein the device is adapted to switch microwave energy in pulses (Para. [0329], “In one embodiment of the invention, energy is delivered to the skin for a period of time which optimizes the desired tissue effect. In one embodiment of the invention, energy is delivered to the skin for a period of between 3 and 4 seconds. In one embodiment of the invention, energy is delivered to the skin for a period of between 1 and 6 seconds.”).
Deem’s “period of between 3 and 4 seconds” is such “switch[ing] microwave energy in pulses” as claimed.
Regarding Claim 5, Deem discloses the entirety of Claim 1 as explained above.
Deem additionally discloses:
wherein the device is adapted to provide a treatment period from 25 minutes to 45 minutes (Para. [0329], “In one embodiment of the invention, energy is delivered to the skin for a period of time which optimizes the desired tissue effect.”).
Deem’s device is capable of any treatment period “which optimizes the desired tissue effect,” and is thus capable of and adapted for such a treatment period as that claimed.
Regarding Claim 6, Deem discloses the entirety of Claim 1 as explained above.
Deem additionally discloses:
wherein the applicator is a waveguide (Para. [0178], “FIG. 129 shows a schematic of an underside of a waveguide applicator system including waveguide antenna and tissue capture according to one embodiment.”).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2017/0340384 A1 to Deem et al. (“Deem”). The rejection is maintained.
Regarding Claim 4, Deem discloses the entirety of Claim 1 as explained above.
Deem additionally discloses:
wherein interval between pulses is from 18 to 30 seconds (Para. [0330], “In one embodiment of the invention, the skin surface is cooled for a period of between 10 and 20 seconds after the time energy is delivered to the skin. In one embodiment of the invention, the skin surface is cooled for a period of approximately 20 seconds after the time energy is delivered to the skin.”).
Deem’s disclosed range overlaps the claimed range. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I).
Deem fails to explicitly teach an interval of the exact range of 18 to 30 seconds. However, based on Deem’s disclosed overlapping interval range of “10 and 20 seconds,” it would have been obvious for a person of ordinary skill in the art to choose any one of the interval lengths disclosed by Deem, including 18 to 30 seconds, as this is merely choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success or alternatively optimizing a result effective variable
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
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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