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 .
Status of Claims
2. Claims 1-22 are pending and currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The listing of references in the specification (i.e., para. [0007]) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claim Objections
Claims 3, 7, are objected to because of the following informalities:
Claim 3, line 1 recites “metabolic diseases” and the Examiner suggests –the metabolic diseases—to clarify the antecedent basis.
Claim 7, the last line recites “treating infectious diseases” and the Examiner suggests –treating the infectious diseases” to clarify the antecedent basis from claim 6, line 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 1-4, 6-10, 12-14, 16-18, and 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while purportedly being enabling for treating COVID-19, does not reasonably provide enablement for the full scope of:
“preventing, alleviating, and treating diseases in a subject” (Claim 1); “hypertension, metabolic disease, cancer, gynecological diseases, and constipation” (Claim 2); “diabetes” (Claim 3); “prevent, alleviate, or treat infectious diseases” (Claim 6). It is noted that the remaining claims depend from one or more of claims 1-3, and claim 6.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims without undue experimentation. The Examiner notes the Wands factors with specific emphasis on the amount of direction provided by the inventor, and the quantity of experimentation needed. In re Wands, 858 F.2d 731 (Fed. Cir. 1988); MPEP 2164.01(a). It is noted that the determination of undue experimentation has been reached by weighing all the factors and that no single factor is dispositive (MPEP 2164.01(a)).
Regarding the breadth of the claims, “the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims” (MPEP 2164.08). The claims at issue are very broad, as claim 1 merely recites “a life wave” (an undefined type of energy) “preventing, alleviating, and treating diseases in a subject” (this covers the prevention, alleviation, and treatment of any and every type of disease). Similarly, claim 6 recites “using life waves to prevent, alleviate, or treat infectious diseases” (this covers the prevention, alleviation, and treatment of any and every type of infectious disease).
Regarding the nature of the invention, the subject matter of the claimed invention is a device designed to stimulate the pelvic region with acupressure and sound waves. “The nature of the invention becomes the backdrop to determine the state of the art and the level of skill possessed by one skilled in the art” (MPEP 2164.05(a)).
Regarding the state of the prior art, this is “what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” (MPEP 2164.05(a)). The state of the prior art is evaluated based on its filing date. In the instant case, the provisional application has an effective filing date of March 2, 2023. Prior to that date, Zhang (2020/0390650) discloses substantially the same structures as the instant invention, to be used to treat COVID-19. Other diseases are broadly referred to, but there is no specific instruction as to how to use the acupressure and sound therapy to treat any specific disease other than COVID-19.
Regarding the level of one of ordinary skill, the instant invention is directed to the mechanical art, as the acupressure device provides non-invasive stimulation to the body through pressure and sound waves.
Regarding the level of predictability in the art, “if one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art.” (MPEP 2164.03). Here, the level of predictability is low because it is unclear how the body will react to acupressure combined with “life waves.” It is entirely unclear how or why these “life waves” would be expected to “prevent, alleviate, or treat” any and all types of diseases or infectious diseases. Furthermore, any measurable response would be expected to vary significantly among patients. Thus, there would be a need for a significant amount of testing to determine how to prevent, alleviate, or treat each disease.
Regarding the amount of direction provided by the inventor, the amount needed to enable the invention is “inversely related to the amount of knowledge in the state of the art as well as the predictability in the art” (MPEP 2164.03). Here, the amount of direction provided is very low, as the only particular example in the specification appears to be directed towards COVID-19. The predictability is also low because it depends heavily how the human body, having any and/or every disease in existence, would respond to pressure and the sound of one or more “life waves”.
Regarding the existence of working examples, the aforementioned Zhang reference is a working example of an acupressure device that applies “life waves.” However, there is no evidence of its use to prevent, alleviate, or treat the full scope of diseases that are claimed.
Regarding the quantity of experimentation needed to make or use the invention, the quantity is unreasonable because it is related to the amount of direction or guidance provided (MPEP 2164.06). The originally filed disclosure provides very little guidance for how to “prevent, alleviate, or treat” the full scope of the claimed diseases. One of ordinary skill in the art would need to experiment on human subjects having every known type of disease for a lengthy time to determine what dosage and/or particular “life waves” would prevent, alleviate, or treat each disease. Due to the breadth of the claims and the failure of Applicant to adequately describe the invention, one of ordinary skill in the art would have to experiment unduly to make/use the full scope of the claimed invention, and thus, the invention is not enabled.
The remaining claims are rejected based on their dependence on a rejected base claim.
Claim Rejections - 35 USC § 112(b)
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 1-22 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 lacks any transitional phrase (i.e., “comprising”, “consisting”, etc.), and thus the scope of the claim is unclear.
Claim 1, line 1 recites “A life wave” and it is unclear what is meant by this term. The phrase “life wave” is not defined in the specification. As best understood, “life wave” appears to be referring to one of three particular copyrighted sounds (“the life wave is life wave A, B. C or in combination thereof. [Life wave A, copyright case number 1-13563734271; Life wave B, copyright case number 1-13564472558; Life wave C, copyright case number 1-13564553374]” see para. [0022] of the instant specification). Are these specific copyrighted sounds the only sounds that would read on a “life wave”? What other sounds or “waves” would read on a “life wave?” There is no explanation and thus the metes and bounds of the claim are unclear.
Claim 1, lines 1-2 recite “a subject comprising effective amount of said life wave” and it is unclear if this is reciting that the subject themselves comprises the life wave, as part of their body.
Claim 1, line 2 recites “effective amount of said life wave” and it is unclear what amounts of the “life wave” would be considered an “effective amount” for treating “hypertension, metabolic disease, cancer, gynecological diseases, and constipation” as recited in claim 2. Para. [0031] of the specification states “An effective dose for alleviating or treating a disease including the COVID-19 infection is defined as a dose of energy that can effectively cure the disease or cause the related symptoms to disappear … In one embodiment … an effective dose of energy may range from 30 minutes to 6 hours of continuous or cumulative use of the device… equivalent to 5 to 60 watt hours of energy emitted” but this “dose” is not explained for any of “hypertension, metabolic disease, cancer, gynecological diseases, and constipation” as recited in claim 2.
Claim 5 lacks any transitional phrase (i.e., “comprising”, “consisting”, etc.), and thus the scope of the claim is unclear.
Claim 5, line 1 recites “A device capable of delivering life waves” and it is unclear what devices would be considered to have this capability. Would this be every device that has a speaker? Are there any particular requirements to be “capable” of delivering life waves?
Claim 5, line 1 recites “life waves” and it is unclear what is meant by this term. The phrase “life wave” is not defined in the specification, as discussed above in the claim 1 rejection under 35 USC 112(b). There is no explanation and thus the metes and bounds of the claim are unclear.
Claim 6 lacks any transitional phrase (i.e., “comprising”, “consisting”, etc.), and thus the scope of the claim is unclear.
Claim 6, line 1 recites “life waves and it is unclear what is meant by this term. The phrase “life wave” is not defined in the specification, as discussed above in the claim 1 rejection under 35 USC 112(b). There is no explanation and thus the metes and bounds of the claim are unclear.
Claim 7, line 6 recites “energy waves” and it is unclear if this is referring to the previously recited “life waves” (claim 6, line 1). If this is a distinct “wave”, it is unclear what the relationship is between the “life waves” and the “energy waves.”
Claim 7, line 12 recites “exogenous energy” and it is unclear if this is referring to the previously recited “life waves” (claim 6, line 1) or “energy waves” (claim 7, line 6). If this is a distinct “wave”, it is unclear what the relationship is between the “life waves,” “energy waves,” and “exogenous energy.”
Claim 7, the last three lines recite “therapeutically effective doses of an exogenous energy … thus preventing, alleviating or treating infections diseases” and it is unclear what amounts of the “exogenous energy” would be considered a “therapeutically effective dose” for preventing, alleviating or treating infectious diseases as recited in claim 6.
Claim 7, the last two lines recite “noninvasively delivered to one or more body parts of a subject in need thereof” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim 8, line 1 recites “the front of said energy source” which lacks antecedent basis. Claim 8 depends from claim 6, which only recites “A device using life waves to prevent, alleviate, or treat infectious diseases.”
Claim 8, line 1 recites “said energy waves” which lacks antecedent basis.
Claim 8, line 2 recites “the center of said bottom” which lacks antecedent basis.
Claim 8, line 2 recites “said protruding point” which lacks antecedent basis.
Claim 9, line 1 recites “the exogenous energy” which lacks antecedent basis. Claim 9 depends from claim 6, which only recites “A device using life waves to prevent, alleviate, or treat infectious diseases.”
Claim 9, lines 1-2 recite “the exogenous energy is delivered to fascia or fasciae in the one or more body parts” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim 9, line 2 recites “the one or more body parts” which lacks antecedent basis.
Claim 9, line 2 recites “the subject” which lacks antecedent basis.
Claim 10, line 2 recites “said energy pin” which lacks antecedent basis. Claim 10 depends from claim 6, which only recites “A device using life waves to prevent, alleviate, or treat infectious diseases.”
Claim 10, line 3 recites “said energy source” which lacks antecedent basis.
Claim 10, lines 3-4 recite “the protruding point” which lacks antecedent basis.
Claim 10, line 5 recites “said curved top” which lacks antecedent basis.
Claim 10, line 6 recites “said energy waves” which lacks antecedent basis.
Claim 10, line 6 recites “energy waves” and it is unclear if this is referring to the previously recited “life waves” (claim 6, line 1). If this is a distinct “wave”, it is unclear what the relationship is between the “life waves” and the “energy waves.”
Claim 10, line 7 recites “said one or more energy rings” which lacks antecedent basis.
Claim 10, the penultimate line recites “said housing” which lacks antecedent basis.
Claim 10, the penultimate line recites “the flat bottom” which lacks antecedent basis.
Claim 10, the last line recites “one energy ring” and the Examiner suggests –one respective energy ring of said one or more energy rings—to clarify.
Claim 11, lines 1-2 recite “said housing” which lacks antecedent basis. Claim 11 depends from claim 5, which only recites “A device capable of delivering life waves.”
Claim 11, line 2 recites “said curved top” which lacks antecedent basis.
Claim 11, lines 2-3 recite “the edge of the flat bottom” which lacks antecedent basis.
Claim 11, line 3 recites “the center” which lacks antecedent basis.
Claim 11, line 3 recites “said protruding point” which lacks antecedent basis.
Claim 11, line 4 recites “the human body” which lacks antecedent basis.
Claim 11, line 5 recites “energy waves” and it is unclear if this is referring to the previously recited “life waves” (claim 5, line 1). If this is a distinct “wave”, it is unclear what the relationship is between the “energy waves” and the “life waves.”
Claim 11, line 5 recites “the body” which lacks antecedent basis.
Claim 11, line 5 recites “said energy source” which lacks antecedent basis.
Claim 11, line 7 recites “said energy pin” which lacks antecedent basis.
Claim 11, line 9 recites “said one or more energy rings” which lacks antecedent basis.
Claim 11, the penultimate line recites “the longitudinal axis” which lacks antecedent basis.
Claim 11, the penultimate line recites “said energy ring” which is confusing because the claim previously recites “one or more energy rings” and thus it is unclear which energy ring in particular is being referred to out of the plurality of energy rings.
Claim 11, the last line recites “treating another condition” which is confusing because the claims have not recited a first condition.
Claim 11, the last line recites “said subject” which lacks antecedent basis.
Claim 12, line 1 recites “The device of claim 3” which is confusing because claim 3 is not a device.
Claim 12, line 1 recites “said micrite” which lacks antecedent basis.
Claim 13, line 1 recites “The device of claim 1” which is confusing because claim 1 is not a device.
Claim 13, line 1 recites “the length of said housing” which lacks antecedent basis.
Claim 13, lines 1-2 recite “the width of said housing” which lacks antecedent basis.
Claim 13, line 2 recites “the height of said housing” which lacks antecedent basis.
Claim 13, line 3 recites “said protruding point” which lacks antecedent basis.
Claim 13, line 5 recites “said one or more energy rings” which lacks antecedent basis.
Claim 13, line last two lines recite “said energy pin” which lacks antecedent basis.
Claim 14, line 1 recites “The device of claim 1” which is confusing because claim 1 is not a device.
Claim 14, line 1 recites “said one or more therapeutically effective doses” which lacks antecedent basis.
Claim 15, the third to last line recites “exogenous energy” and it is unclear if this is referring to the previously recited “energy waves” (line 8). If this is a distinct “energy”, it is unclear what the relationship is between the “energy waves” and the “exogenous energy.”
Claim 16, line 1 recites “the front of said energy source” which lacks antecedent basis.
Claim 16, line 1 recites “said energy waves” which lacks antecedent basis.
Claim 16, line 1 recites “said energy waves” and it is unclear if this is referring to the previously recited “exogenous energy” (claim 9, line 1) or the “life waves” (claim 6, line 1). If this is a distinct “energy wave”, it is unclear what the relationship is between the “energy waves,” the “life waves,” and the “exogenous energy.”
Claim 16, line 2 recites “the center of said bottom” which lacks antecedent basis.
Claim 16, line 2 recites “said protruding point” which lacks antecedent basis.
Claim 17, line 3 recites “said energy point” which lacks antecedent basis.
Claim 17, line 4 recites “said energy source” which lacks antecedent basis.
Claim 17, line 5 recites “the protruding point” which lacks antecedent basis.
Claim 17, line 6 recites “said curved top” which lacks antecedent basis.
Claim 17, line 7 recites “said energy waves” which lacks antecedent basis.
Claim 17, line 7 recites “energy waves” and it is unclear if this is referring to the previously recited “exogenous energy” (claim 9, line 1) or the “life waves” (claim 6, line 1). If this is a distinct “energy wave”, it is unclear what the relationship is between the “energy waves,” the “life waves,” and the “exogenous energy.”
Claim 17, line 8 recites “said one or more energy rings” which lacks antecedent basis.
Claim 17, line 12 recites “said housing” which lacks antecedent basis.
Claim 17, line 12 recites “the flat bottom” which lacks antecedent basis.
Claim 17, the last line recites “one energy ring” and the Examiner suggests --one respective energy ring of said one or more energy rings—to clarify.
Claim 18, lines 1-2 recite “said housing” which lacks antecedent basis.
Claim 18, line 2 recites “said curved top” which lacks antecedent basis.
Claim 18, lines 2-3 recite “the edge of the flat bottom” which lacks antecedent basis.
Claim 18, line 3 recites “the center” which lacks antecedent basis.
Claim 18, line 3 recites “said protruding point” which lacks antecedent basis.
Claim 18, line 4 recites “the human body” which lacks antecedent basis.
Claim 18, line 5 recites “energy waves” and it is unclear if this is referring to the previously recited “exogenous energy” (claim 9, line 1) or the “life waves” (claim 6, line 1). If this is a distinct “energy wave”, it is unclear what the relationship is between the “energy waves,” the “life waves,” and the “exogenous energy.”
Claim 18, line 5 recites “said energy source” which lacks antecedent basis.
Claim 18, line 7 recites “said energy pin” which lacks antecedent basis.
Claim 18, line 9 recites “said energy ring” which lacks antecedent basis.
Claim 18, line 10 recites “the longitudinal axis of said energy ring” which lacks antecedent basis.
Claim 19, line 1 recites “said micrite” which lacks antecedent basis.
Claim 20, lines 15-16 recite “an exogenous energy” and it is unclear if this is referring to the previously recited “energy waves” (claim 20, line 9). If this is a distinct “energy”, it is unclear what the relationship is between the “energy waves,” and the “exogenous energy.”
Claim 21, line 1 recites “The method of claim 14” which is confusing because claim 14 is not a method claim.
Claim 21, line 1 recites “exogenous energy” and it is unclear if this is referring to the previously recited “life wave” (claim 1). If this is a distinct “energy”, it is unclear what the relationship is between the “life wave,” and the “exogenous energy.”
Claim 21, line 1 recites “the exogenous energy” which lacks antecedent basis.
Claim 21, line 2 recites “said one or more body parts” which lacks antecedent basis.
Claim 22, line 1 recites “The method of claim 14” which is confusing because claim 14 is not a method claim.
Claim 22, line 1 recites “the exogenous energy” which lacks antecedent basis.
Claim 22, line 1 recites “exogenous energy” and it is unclear if this is referring to the previously recited “life wave” (claim 1). If this is a distinct “energy”, it is unclear what the relationship is between the “life wave,” and the “exogenous energy.”
Any remaining claims are rejected based on their dependence on a rejected base claim.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-4, 12-14, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 1 recites “A life wave capable of preventing, alleviating, and treating diseases…”. A “life wave” as best understood is referring to a particular sound. A sound does not fall within a recognized statutory category (process, machine, manufacture, or composition of matter). Thus, claim 1 and all claims depending thereon are rejected because they are directed to non-statutory subject matter.
Due to the vast number of issues under 35 U.S.C. 112 and 101 for claims 1-4, 12-14, and 21-22, no prior art has been applied. However, the Examiner reserves the right to apply prior art in the future if and when the issues are resolved.
Claims 7 and 9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 7, the last two lines recite “noninvasively delivered to one or more body parts of a subjecting need thereof” which is encompassing a human.
Claim 9, lines 1-2 recite “the exogenous energy is delivered to fascia or fasciae in the one or more body parts” which is encompassing a human.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 5-11, and 15-20, as best understood, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (2020/0390650).
Regarding claim 5, Zhang discloses a device (Fig. 2) capable of delivering life waves (via speaker 105, Fig. 2; which may include a storage medium for storing audio files, see para. [0045]-[0046]. The speaker can be used to treat a disease such as COVID-19 as described in para. [0029], and thus is considered capable of delivering “life waves” as best understood).
It is additionally noted that any device capable of playing a pre-recorded sound wave would anticipate claim 5. Any computer, multimedia player, headphones, speaker, etc.
Regarding claim 6, Zhang discloses a device (Fig. 2) using life waves (sound waves are emitted by speaker 105, Fig. 2. Used to treat diseases and thus considered “life waves” as best understood) to prevent, alleviate, or treat infectious diseases (to treat a disease such as COVID-19 as described in para. [0029]).
Regarding claim 7, Zhang discloses comprising: a housing (housing 101, Fig. 2) comprising a flat bottom (see Fig. 2) and a curved top (see Fig. 2), wherein the curved top comprises a protruding point (protruding point 102, Fig. 2) in the center; wherein the following are contained in said housing: an elongated energy pin (energy pin 103, Fig. 2); one or more energy rings (energy rings 104, Fig. 2); and an energy source (energy source 105, “e.g., a speaker” see Fig. 2 and para. [0013]) for generating energy waves (sound waves), said energy source (105) comprising a front and a back (see Fig. 2 and para. [0027]); wherein said energy source (105) is placed in the center of said flat bottom (See Fig. 2), wherein one energy ring (104) encircles said energy pin (103, see Fig. 2; see para. [0024]), which is placed between said energy source (105) and said protruding point (102, see Fig. 2), with the longitudinal axes of the one energy ring (104) and the energy pin (103) aligned (see Fig. 2), wherein one or more therapeutically effective doses of an exogenous energy generated by said device are noninvasively delivered to one or more body parts of a subject in need thereof, thus preventing, alleviating or treating infectious diseases (see all of para. [0029], describing therapeutically effective doses for delivering sound energy to treat an infectious disease such as COVID-19).
Regarding claim 8, Zhang discloses wherein the front of said energy source (105) emits said energy waves (sounds) and faces the center of said bottom (“speaker wherein its front emits sound waves and faces the bottom of the housing (101)” see para. [0013]), or faces said protruding point.
Regarding claim 9, Zhang discloses wherein the exogenous energy (sound) is delivered to fascia or fasciae in the one or more body parts, improving immunity of the subject (this is a recitation of a method step in an apparatus claim. The device of Zhang is capable of being used to perform this function because it discloses the same structure, and is intended to treat various parts of the human body; see “ Components in the device (100) of the present invention further moderate the physical energy to cause harmonic resonance in human cells and tissues in the cranial cavity, chest cavity, abdominal cavity or certain other tissues. The resonance caused by such energy waves will directly affect a human's brainwaves, heart rate, breathing rhythm, and other measurable physiological parameters.” In para. [0207]. See also the second sentence of [0044]).
Regarding claim 10, Zhang discloses wherein said device is characterized by one or more of the following: a) said energy pin comprises a flat end and a spherical end, wherein the flat end points towards said energy source, and said spherical end is in touch with the protruding point (“the flat end of one energy pin (103) is attached to the stand (106) with the spherical end of the energy pin (103) pointing towards the protruding point (102)” see Fig. 2 and the last sentence of [0027]). Thus, Zhang satisfies the limitations of claim 10 by disclosing at least “one or more” of the recited list.
Regarding claim 11, Zhang discloses wherein said device further comprises a storage medium in said housing for storing audio files (“said housing (101) containing inside: (b) a storage medium for storing audio files” para. [0060]); said curved top gradually inclines upwards from the edge of the flat bottom towards the center to form said protruding point (102, see Fig. 2, this is a gradual incline), so that said protruding point (102) can be in touch with a part of the human body where acupoints are located, allowing transmission of energy waves into the body (“protruding point (102) is configured to be able to touch the body parts where acupoints are located so as to transmit energy waves into the body” see the second sentence of [0044]; see also para. [0073]); said energy source (105) is a speaker (“e.g., a speaker” see Fig. 2 and para. [0013]; see also para. [0073]); said energy waves are sound waves emitting from the front of said speaker facing either the bottom of said housing or said protruding point (see para. [0073]); said energy pin (103) has two ends, with one end flat and attached to said speaker, and the other end spherical in shape and in touch with said protruding point (see para. [0073]); and said one or more energy rings reflect said sound waves, causing said sound waves to transmit primarily along the longitudinal axis of said energy ring (see para. [0073]); wherein said device is used for alleviating or treating another condition in said subject (see the last three lines of [0073]).
Regarding claim 15, Zhang discloses a system (i.e., Fig. 2) for preventing, alleviating or treating COVID-19 (SARS-CoV-2) coronavirus infection (para. [0141]), said system comprising:
1) a device (100, Fig. 2) comprising a housing (housing 101, Fig. 2) which comprises a flat bottom and a curved top (see Fig. 2 and the first sentence of [0142]), wherein the curved top comprises a protruding point (protruding point 102, Fig. 2; see para. [0142]) in the center (see Fig. 2); wherein the following are contained in said housing (101):
an elongated energy pin (energy pin 103, Fig. 2; para. [0143]); one or more energy rings (energy rings 104, Fig. 2; para. [0144]); and an energy source (energy source 105, Fig. 2) for generating energy waves (para. [0145]), said energy source comprising a front and a back (para. [0145]); wherein said energy source (105) is placed in the center of said flat bottom (see Fig. 2 and para. [0146]), wherein one energy ring encircles said energy pin (see para. [0146]), which is placed between said energy source (105) and said protruding point (102, Fig. 2; see para. [0146]), with the longitudinal axes of the one energy ring (104) and the energy pin (103) aligned (see the last two lines of 0146]);
2) a computer processor ([0147]);
3) one or more data stores storing ([0148]):
a) audio files, each file characterized by features comprising frequency, amplitude, wavelength, waveform, velocity of wave, and intensity (see para. [0149]); and
b) a relational dataset that correlates one or more of said features to a plurality of conditions (para. [0150]); and
4) a computer readable storage medium storing program instructions configured for execution by the computer processor to cause the system to (see para. [0151]):
a) upon an input of a condition, identify a corresponding audio file among said audio files (see [0152]);
b) retrieve said corresponding audio file from said one or more data stores to said energy source (105) of said device (see para. [0153]); and
c) noninvasively deliver one or more therapeutically effective doses of an exogenous energy generated by said device to one or more body parts of a subject in need thereof, thereby preventing, alleviating or treating COVID- 19 (SARS-CoV-2) coronavirus infection (see para. [0154] and see Fig. 2, this is a non-invasive device that emits sound).
Regarding claim 16, Zhang discloses wherein the front of said energy source (105) emits said energy waves and faces the center of said bottom, or faces said protruding point (see para. [0071]).
Regarding claim 17, Zhang discloses wherein said device is characterized by one or more of the following: a) said energy pin comprises a flat end and a spherical end, wherein the flat end points towards the back or the front of said energy source, and said spherical end is in touch with the protruding point (“the flat end of one energy pin (103) is attached to the stand (106) with the spherical end of the energy pin (103) pointing towards the protruding point (102)” see Fig. 2 and the last sentence of [0027]). Thus, Zhang satisfies the limitations of claim 10 by disclosing at least “one or more” of the recited list.
Regarding claim 18, Zhang discloses wherein said device further comprises a storage medium in said housing for storing audio files (“said housing (101) containing inside: (b) a storage medium for storing audio files” para. [0060]); said curved top gradually inclines upwards from the edge of the flat bottom towards the center to form said protruding point (102, see Fig. 2, this is a gradual incline), so that said protruding point (102) can be in touch with a part of the human body where acupoints are located, allowing transmission of energy waves into the body (“protruding point (102) is configured to be able to touch the body parts where acupoints are located so as to transmit energy waves into the body” see the second sentence of [0044]; see also para. [0073]); said energy source (105) is a speaker (“e.g., a speaker” see Fig. 2 and para. [0013]; see also para. [0073]); said energy waves are sound waves emitting from the front of said speaker facing either the bottom of said housing or said protruding point (see para. [0073]); said energy pin (102) has two ends, with one end flat and attached to said speaker, and the other end spherical in shape and in touch with said protruding point (see para. [0073]); and said energy ring reflects said sound waves, causing said sound waves to transmit primarily along the longitudinal axis of said energy ring (see para. [0073]); wherein said device is used for alleviating or treating another condition in said subject (see the last three lines of [0073]).
Regarding claim 19, Zhang discloses wherein said micrite has a crystal size of no more than 30 micrometers (see para. [0048], energy rings 104 comprise micrite and are manufactured into a ring shape approximately 4.8 to 7.2 millimeters in height. See also para. [0138]).
Regarding claim 20, Zhang discloses a method for preventing, alleviating or treating COVID-19 (SARS-CoV-2) coronavirus infection in a subject in need thereof (using the device of Fig. 2, according to para. [0155]-[0161]), said method comprising the steps of:
1) placing a device (Fig. 2) for acumoxa therapy in close proximity to one or more body parts of said subject (para. [0156]), wherein said device comprises a housing (housing 101, Fig. 2; para. [0156]) comprising a flat bottom and a curved top (see Fig. 2, see para. [0156]), wherein the curved top (see Fig. 2 and [0156]) comprises a protruding point (protruding point 102, Fig. 2) in the center; wherein the following are contained in said housing (101):an elongated energy pin (energy pin 103, Fig. 2; para. [0157]); one or more energy rings (energy rings 104, Fig. 2; para. [0158]); and an energy source (energy source 105, Fig. 2; para. [0159]) for generating energy waves, said energy source comprising a front and a back (para. [0159]); wherein said energy source (105) is placed in the center of said flat bottom (see para. [0160]), wherein one energy ring (104) encircles said energy pin (103, Fig. 2; para. [0160]), which is placed between said energy source (105) and said protruding point (102, Fig. 2; para. [0160]), with the longitudinal axes of the one energy ring (104) and the energy pin (103) aligned (see Fig. 2 and para. [0160]), and 2) noninvasively delivering one or more therapeutically effective doses of an exogenous energy generated by said device to said one or more body parts of a subject in need thereof, thereby preventing, alleviating or treating COVID-19 (SARS-CoV-2) coronavirus infection (see para. [0161], and see Fig. 2, this is a non-invasive device that emits sound).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,925,806.
Even assuming the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are merely broader versions of the patented claim(s).
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,786,440.
Even assuming the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are merely broader versions of the patented claim(s).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kang (2025/0064662) discloses a related pelvic floor treatment device. Warlick et al. (2018/0296432) discloses a related device for applying acoustic therapy to the body. Oser (2005/0207609) discloses a related device for applying acoustic therapy to the body. Hsu (2016/0101010) discloses a related device for applying physiotherapeutic energy waves. Snow (10,182,964) discloses a related device for applying audio and tactile stimulation therapy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER E MILLER whose telephone number is (571)270-1473. The examiner can normally be reached Mon-Fri 9:00-5:30 (Eastern).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
