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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/19/2025 has been entered.
Priority
This application claims benefit of priority to Provisional Applications 62/471,861 filed on 03/15/2017 and 63/015,388 filed on 04/24/2020. This application is also a Continuation in Part of Application No. 15/922,867 filed on 03/15/2018. Additionally, Application No. 17/498,899 is a continuation of the instant application.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the Drawings are in color. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Amendment and Claim Status
In the reply filed on 05/19/2025, Applicant amended claims 1-3 and 8 and canceled claims 4-6.
Claims 1-3 and 7-9 are currently pending and under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “retrieving a target pathogen data.” This statement is grammatically awkward. Appropriate correction is required.
Claims 7 and 9 are objected to because of the following informalities: Claims 7 and 9 indicate they are amended. However, claims 7 and 9 do not contain any markings indicating any changes. Additionally, instant claims 7 and 9 appear to be identical to claims 7 and 9 filed on 05/06/2024. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Claim 8 is missing a comma after “the method of claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 7-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite “retrieving” specific data and specific values and “calculating” multiple variables such as amplitude and operational frequency.
The limitations regarding retrieving specific data and specific values and utilizing that data to calculate different variables, as-drafted, is a process that, under its broadest reasonable interpretation, covers a mental process. That is, nothing in the claims preclude the steps from practically being performed in the mind. For example, “retrieving” and “calculating” in the context of the claims encompass the user manually determining or calculating specific data regarding a medium and a target pathogen. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Thus, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims only recite steps regarding data gathering to perform the calculating steps. The data gathering in all steps of the method are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the exception. Accordingly, these additional steps do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea and are considered insignificant extra-solution activities. Thus, the claims are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of data gathering steps amount to no more than mere instructions to apply the exception. Mere instructions to apply an exception using data gathering steps cannot provide an inventive concept. Additionally, the step of “exposing the target pathogen to an acoustic wave” is well-understood, routine and conventional as are the measurement steps recited in instant claims 2-3 which are also well-understood, routine and conventional as discussed in the prior art. Therefore, the claims are not patent eligible.
For the foregoing reasons, the inventions as claimed is not deemed to encompass patent eligible subject matter under 35 U.S.C. 101.
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.
Claims 1-3 and 7-9 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. This is a new matter rejection.
Claim 1, as-amended, recites:
A method of pathogen suppression-comprising:
retrieving a target pathogen data, wherein the target pathogen data includes a target resonance frequency;
retrieving a medium acoustic damping value, wherein the target pathogen is embedded in the medium;
retrieving the target pathogen acoustic damping value;
retrieving a maximum frequency value of the system;
retrieving a maximum amplitude value of the system;
calculating an operational amplitude, wherein the operational amplitude is calculated using the medium acoustic damping value and the target pathogen acoustic damping value, wherein operational amplitude will be less than a cavitation amplitude for the medium;
retrieving a target deformation of the target pathogen;
calculating the operational frequency and the exposure time to achieve the target deformation using the operational amplitude, the medium acoustic damping value and the target pathogen acoustic damping value, wherein the operational frequency is an integer (n) fraction (1/n) of the target resonance frequency; and
exposing the target pathogen to an acoustic wave generated by an acoustic wave generator, wherein the acoustic wave amplitude is the operational amplitude and the acoustic wave has a frequency at the operational frequency for a time that is at least as long as the exposure time.
This entire claim is new matter. The instant Specification does not provide support for this claim. It is noted Applicant does not indicate where in the Specification support for the amended claims can be found. After searching the instant Specification, the Examiner could not find support for the amended claims. For example, “target pathogen data,” “acoustic damping value,” “embedded in the medium,” “maximum frequency,” “maximum amplitude” and “operational frequency” are not present anywhere in the instant Specification. Thus, the limitations of amended claim 1 are new matter.
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 1-3 and 7-9 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.
Claim 1 recites “retrieving a medium acoustic damping value, wherein the target pathogen is embedded in the medium” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite “a medium” anywhere prior to the aforementioned limitation. Additionally, there is insufficient antecedent basis for “target pathogen” because only target pathogen data is previously recited in the claim. “Target pathogen data” does not provide antecedence for “target pathogen.”
Claim 1 recites the “retrieving a medium acoustic damping value, wherein the target pathogen is embedded in the medium” in lines 4-5. It is unclear how the medium acoustic dampening value is retrieved or how the target pathogen is embedded in the medium when the claim does not recite “retrieving a medium.” The claim simply recites “retrieving a medium acoustic dampening value” with no mention of retrieving the medium itself so the acoustic dampening value can be retrieved and so the target can be embedded in the medium. Thus, it is unclear exactly what the limitation “retrieving a medium acoustic damping value, wherein the target pathogen is embedded in the medium” is trying to claim.
Claim 1 recites the limitation "retrieving a maximum frequency value of the system" and “retrieving a maximum amplitude value of the system” in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite “a system” anywhere prior to the aforementioned limitations. Thus, limitations to “the system” lack antecedent basis.
Claim 1 recites the limitation "retrieving a maximum frequency value of the system" and “retrieving a maximum amplitude value of the system” in lines 7-8. It is unclear what system is being referred to as a system is not previously recited before the aforementioned limitations. It is unclear what the maximum frequency value or maximum amplitude value is of as it is unclear what ‘system’ is being referred to. Therefore, claim 1, and all claims dependent upon claim 1, are rendered indefinite.
Claim 1 recites “retrieving a target deformation of the target pathogen” in line 13. It is unclear exactly what is being retrieved. A target deformation is a change in the target. Thus, it is unclear what is being retrieved as it appears this limitation is directed to retrieving a change. It is unclear how to retrieve an action.
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 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 1, 3 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Heckerman et al. (US 20100113983 A1, 05/06/2010) (Of Record).
Regarding claim 1, Heckerman et al. disclose methods for treating illnesses and conditions using ultrasound tuned to a resonant frequency of a target material with the assistance of computer processing wherein the target material is destroyed without harming the healthy material surrounding the target material (See entire document, Abstract). All objects, and portions of individual objects, have a specific resonance frequency that can be exploited in order to change, disrupt or destroy the specific object, or target, without harming healthy material that surrounds that target (Paragraph [0006]). Additionally, a resonance frequency database, reading on retrieving target pathogen data, can be created to ensure the local healthy material surrounding a target has a natural resonance frequency dissimilar enough from the tuned resonance frequency that affects some portion of the target (Paragraph [0006]). More specifically, Heckerman et al. disclose:
The effects of the resonant frequencies can be determined in vitro. Using standard culture methods, known to those skilled in the art, the target material culture may be placed in a reusable/autoclavable test cylinder. The bottom surface of the test cylinder is the transducer, constructed for the appropriate frequencies, such as a thin film zinc oxide on a sapphire substrate. The host medium thus placed in the test cylinder spreads over the bottom of the cylinder in a monolayer and in direct contact with the transducer. Ultrasound energy of the desired resonant frequency is then delivered through the culture fluid and host medium to the target materials, reading on the target being embedded in the medium, and the effects on growth and function are assessed using standard methods. By varying the ultrasound wave characteristics, such as amplitude, mode (continuous vs. pulsed), shape (sinusoidal vs. square), intensity, etc., the ideal frequency and waveform required to obtain specific effects can be determined (Paragraph [0058]).
Further, the induction of resonance in a target material can lead to sudden and irreversible structural failure due to rupture of one or more components of the target material (Paragraph [0060]). Ultrasound energy, including the resonant frequencies may be applied at a power level sufficient to destroy the target material (Paragraph [0070]), reading on target deformation. The power intensity is dependent upon the nearby or surrounding tissue, target material and location/depth of the target material, wherein the power intensity can range anywhere from 0.01 to 1x1011 W/m2 (Paragraph [0071]). Depending on the size, shape and composition of the target material, there can be more than one naturally occurring resonant frequency, as well as numerous subharmonic and superharmonic resonant acoustic frequencies (Paragraph [0070]). Additionally, the duration of the treatment or application of ultrasound tuned to a narrow band of frequencies is sufficient to achieve destruction of at least some of the target material, wherein up to about 99% of the target material may be destroyed (Paragraph [0069]).
It is noted ‘acoustic damping value’ is not defined nor mentioned in the instant Specification. Thus, ‘acoustic damping value’ is being interpreted as a measurement of how well a material reduces energy. As discussed above, Heckerman et al. disclose the depth of the target within the medium, the target itself and the surrounding environment are all variables considered when determining the needed power intensity of the resonant frequencies. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that these variables being taken into consideration by Heckerman et al. are determining the dampening information of the target and the medium the target is embedded in.
Therefore, Heckerman et al. discloses the limitations of instant claim 1 insofar as retrieving target pathogen data including target resonance frequency, retrieving a medium acoustic damping value and a target pathogen acoustic damping value, the target is embedded in the medium, an operational amplitude, an operational frequency and an exposure time to achieve target deformation and exposing the target to an acoustic wave long enough to cause target deformation.
Regarding claim 3, Heckerman et al. disclose delivering tuned ultrasound energy at resonant frequencies to target materials wherein the target material can be in a fluid (Paragraph [0052]). Further, by varying the ultrasound wave characteristics, such as amplitude, mode (continuous vs. pulsed), shape (sinusoidal vs. square), intensity and etc., the ideal frequency and waveform required to obtain specific effects can be determined (Paragraph [0058]).
Regarding claim 7, Heckerman et al. disclose a specific example testing the destruction of resonant ultrasound frequencies on human immunodeficiency virus (HIV) (Paragraph [0058]), reading on a virus. Heckerman et al. further disclose examples of target materials include bacteria, viruses and cancer cells/tissues (Paragraph [0027]).
Regarding claim 8, Heckerman et al. disclose the frequency at which resonance occurs depends on the size, shape and composition of the target material whereby the resonant frequency of a sphere is the frequency at which the acoustic wavelength is equal to the sphere diameter while more complex structures have more complex resonant frequency patterns. (Paragraph [0049]). Even so, the wavelength at which resonance occurs is roughly equivalent to the size of the target material (Paragraph [0049]). Further, the frequency which matches a particular acoustic wavelength depends on the composition of the target material according to the following equation: velocity = frequency x wavelength (Paragraph [0050]). Velocity refers to the speed of the acoustic wave propagation in the medium leading to the target material and is roughly equivalent to the speed of sound in water since most living bodies or bodily samples mainly contain water (Paragraph [0050]). Heckerman et al. include Table 1 which contains approximate resonant frequencies ranging from 150 MHz to 150 gHz (Paragraph [0052]). Additionally, Heckerman et al. state the settings component and datastore facilitate determining the operational parameters of the ultrasound generator so that ultrasound energy at a select resonant frequency is tuned to the resonant frequency of a target material. Thus, it would have been obvious to one of ordinary skill in the art that the operation frequency would be determined by the resonant frequency based upon the disclosure of Heckerman et al.
Regarding claim 9, Heckerman et al. do not explicitly state ‘n’ is a positive integer greater than 10.
However, as discussed above, Heckerman et al. disclose resonant frequencies ranging from 150 MHz to 150. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that ‘n’ would be an integer greater than 10 as the values disclosed by Heckerman et al. were greater than 10.
Claims 1-3 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Heckerman et al. (US 20100113983 A1, 05/06/2010) (Of Record) in view of Turner et al. (Applied Physical Letters, 01/26/2009) (Of Record).
The teachings of Heckerman et al. are discussed above.
Regarding claim 2, Heckerman et al. do not disclose the resonance frequency is determined using an atomic force microscope (AFM).
However, Turner et al. disclose intermittent contact mode atomic force microscopy (AFM) under liquid has proved to be a useful tool for studying bacteria (Page 1, Paragraph 1). Further, Turner et al. disclose an AFM cantilever in liquid can be modeled as a harmonic oscillator for bacteria.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized an AFM in the method of Heckerman et al. to determine the resonance frequency as Turner et al. disclose an AFM cantilever is useful as a harmonic oscillator for bacteria and one of the target materials of Heckerman et al. is bacteria.
Conclusion
Claims 1-3 and 7-9 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY T WHITE whose telephone number is (571)272-0683. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653