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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Drawings
The drawings filed on November 20, 2024 are accepted.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1, line 1: “physiological tissue state” should be corrected to –a physiological tissue state--.
Claim 4, line 3: “the analysis mode” should be corrected to –the desired state analysis mode--.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1: the claim limitation of “a wave emitting unit…used to generate a detection wave” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “to generate” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 1: the claim limitation of “a wave receiving unit…used to receive a feedback wave” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “to receive” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 1: the claim limitation of “a control unit…used to control the wave emitting unit”; claims 2 and 6: the claim limitation of “the control unit selects an audio signal”; claim 5: the claim limitation of “the control unit controls the wave emitting unit”; claims 2, 3, 5 and 6: the claim limitation of “the control unit provides the feedback wave”; and claim 3: the claim limitation of “the control unit selects multiple audio signals” have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “to control/select/provide/select/allow” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claim 1: the claim limitation of “an analysis unit…used to store multiple audio signals and comparison parameters”; claims 2, 3 and 6: the claim limitation of “the analysis unit analyzes the waveform amplitude”; claims 2, 3 and 5: the claim limitation of “the analysis unit sets the waveform determined to be in the pathological state”; claims 3 and 5: the claim limitation of “the analysis unit processes the time-domain information”; claims 3: the claim limitation of “the analysis unit analyzes the frequency peaks”; and claim 11: the claim limitation of “the analysis unit stores a basic information of the evaluated subject” have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “to store/analyze” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Claims 4 and 7: the claim limitation of “a setting module that allows the user to set the desired analysis mode” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “module” coupled with functional language “allow” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “module”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that there is no corresponding structural information disclosed in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation for the above identified claim limitations.
For examination purpose, the wave emitting unit and the wave receiving unit are interpreted as a machine that is capable of emitting and receiving waves. The control unit and the analysis unit are interpreted as a processor, along with the instructions/algorithm for performing the corresponding functions as described in the specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 1-11 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, yet neither the claim nor the specification provides the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
As discussed above, the claim limitations below are interpreted under 35 U.S.C. 112 (f).
claim 1: the claim limitation “a wave emitting unit…used to generate a detection wave”.
claim 1: the claim limitation “a wave receiving unit…used to receive a feedback wave”.
claim 1: the claim limitation of “an analysis unit…used to store multiple audio signals and comparison parameters”;
Claims 1 and 5: the claim limitation of “a control unit…used to control the wave emitting unit”;
claims 2 and 6: the claim limitation of “the control unit selects an audio signal”;
claims 2, 3, 5 and 6: the claim limitation of “the control unit provides the feedback wave”; and
claims 2, 3 and 6: the claim limitation of “the analysis unit analyzes the waveform amplitude”;
claims 2, 3 and 5: the claim limitation of “the analysis unit sets the waveform determined to be in the pathological state”;
claims 3 and 5: the claim limitation of “the analysis unit processes the time-domain information”
claim 3: the claim limitation of “the control unit selects multiple audio signals”
claims 3: the claim limitation of “the analysis unit analyzes the frequency peaks”
claims 4 and 7: the claim limitation of “a setting module that allows the user to set the desired analysis mode”;
claim 11: the claim limitation of “the analysis unit stores a basic information of the evaluated subject”
The specification discloses the functions performed by these limitations. However, one of ordinary skill in the art would not understand the specification, the drawing and the original claims to disclose any particular structure that achieves the disclosed functionality.
Applicant is remined that –
When a claim limitation is determined to invoke 35 U.S.C. 112(f), the invocation “is overcome when the limitation further includes the structure necessary to perform the recited function. TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259-60, 85 USPQ2d 1787, 1789 (Fed. Cir. 2008) ("Sufficient structure exists when the claim language specifies the exact structure that performs the function in question without need to resort to other portions of the specification or extrinsic evidence for an adequate understanding of the structure."); see also Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1376, 65 USPQ2d 1865, 1874 (Fed. Cir. 2003)”. See MPEP 2181.I; and
Enablement of a device requires only the disclosure of sufficient information so that a person of ordinary skill in the art could make and use the device. A section 112[(f) or pre-AIA ] paragraph 6 disclosure, however, serves the very different purpose of limiting the scope of the claim to the particular structure disclosed, together with equivalents. … For example, in Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1380[, 53 USPQ2d 1225, 1230] (Fed. Cir. 1999), the court embraced the proposition that ‘consideration of the understanding of one skilled in the art in no way relieves the patentee of adequately disclosing sufficient structure in the specification.’ It is not enough for the patentee simply to state or later argue that persons of ordinary skill in the art would know what structures to use to accomplish the claimed function. The court in Biomedino, LLC v. Waters Technologies Corp., 490 F.3d 946, 953[, 83 USPQ2d 1118, 1123] (Fed. Cir. 2007), put the point this way: "The inquiry is whether one of skill in the art would understand the specification itself to disclose a structure, not simply whether that person would be capable of implementing that structure. See MPEP 2181.II.A.
In this case, in regard to the wave emitting unit and the wave receiving unit, depending on what type of waves being emitted and received, the operational principle hence the design and the configuration of the wave emitting unit and the wave receiving unit would be distinct. For example, the requirement for a wave unit emitting unit configured for emitting ultrasound waves is completely different from that for a wave unit emitting unit configured for emitting optical waves, and that for a wave unit emitting unit configured for emitting audio waves.
These limitations along with the control unit and the analysis unit all fail to comply with the written description requirement as the limitations are unbound functional imitations which cover all ways of performing the respective functions and inventor has not provided sufficient disclosure to show possession of such an invention. The limitations therefore fails to comply with the written description requirement. See MPEP 2181.II.A.
Further because claims including a 112(f)-invoking term are interpreted as requiring the disclosed corresponding structure for that term, absent the disclosure of any such corresponding structure, the written description is insufficient to show that Applicant was in possession of the invention as claimed at the time of the invention, and such a claim must be rejected under 35 USC 112(a). (MPEP 2181.IV).
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the detection wave to be waves in the 2000-3000 Hz range, does not reasonably provide enablement for the detection wave to be any type of wave, for example, EM waves in the frequency of THz range, ultrasound waves in the frequency of kHz to GHz range, or infrasound waves in the frequency of 20 Hz and below. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claims 1-11 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.
The following limitations are computer/processor-implemented functional claim limitations as they are directed to a processor implemented steps. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing.
Claim 1, lines 18-22: “an analysis unit…enabling the control unit to control the wave emitting unit to dynamically adjust the detection wave output by the wave emitting unit based on the multiple audio signals” – the specification does not disclose the computer and the algorithm (e.g., necessary steps and/or flowcharts) in sufficient details in regard to how the detection wave output is dynamically adjusted based on the multiple audio signals, i.e., do the multiple audio signals merely serve as an instruction (i.e., to trigger or to initiate) to control the emission of the detection wave, as a reference to adjust the detection wave, or these signals actively participate in the generation of the detection wave such that they are part of the detection wave. In either case what kind of relationship there is between the audio signals and the detection wave such that the detection wave output may be dynamically adjusted based on the audio signals
Claim 1, lines 22-25: “the analysis unit analyzes the feedback wave recorded by the control unit and the comparison parameters to obtain a characteristic parameter, thereby establishing a characteristic model for the physiological tissue” - the specification does not disclose the computer and the algorithm (e.g., necessary steps and/or flowcharts) in sufficient details in regard to how the characteristic model is established. Does it use the single characteristic parameter to establish the characteristic model and what parameter and what kind of model is it?
It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
The dependent claims of the above rejected claims are rejected due to their dependency.
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.
The following claim limitations invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph:
Claim 1: “a wave emitting unit”;
Claim 1: “a wave receiving unit”;
Claims 1, 2, 3, 5 and 6: “a/the control unit”;
Claims 1, 2, 3, 5, 6 and 11: “a/the analysis unit”; and
Claims 4 and 7: “a setting module”.
A claim with a 112(f)-invoking term must be construed as requiring the corresponding structure for that term, or its equivalents. Consequently, absent the disclosure of such corresponding structure, the metes and bounds of the claim cannot be determined, and the claim must be rejected under 112(b) as being indefinite. (MPEP 2181.III)
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-11 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, line 1 recites “a detection wave” that renders the scope of the claim indefinite. It is unclear what kind of wave the detection wave is, for example, whether it is an electromagnetic wave or a light wave, an audio wave, an ultrasound wave or a sound wave. As different type of wave carries distinct operational principle. Without defining what kind of wave it is, the scope is considered indefinite.
Claim 1, lines 18-22: “an analysis unit…enabling the control unit to control the wave emitting unit to dynamically adjust the detection wave output by the wave emitting unit based on the multiple audio signals” that renders the scope of the claim indefinite - (1) it is unclear what kind of basis the multiple audio signals provides – for example whether the audio signals function as a reference basis for the adjustment, function as a trigger signal for the adjustment, or whether the audio signals actively participate the adjustment such that these signals are part of the detection wave; and (2) it is unclear whether it is the output parameter that is adjusted or the property of the wave that is adjusted. Note that the term “the detection wave output” lacks proper antecedent basis.
Claim 1, lines 24-25: “…thereby establishing a characteristic model for the physiological tissue” that renders the scope of the claim indefinite. It is unclear whether the characteristic model is established solely based on the single characteristic parameter, or it is based on the analysis of the feedback.
Claim 2 recites in line 2 “the control unit selects an audio signal…” that is a method step. Claim 2 depends on claim 1 and claim 1 is a system claim. Reciting a method step in a system claim renders the scope of the claim indefinite. For examination purpose, it is interpreted such that the control unit is configured to select an audio signal.
Claim 2 recites in lines 9-10 “the analysis unit then sets the waveform determined to be in the pathological state as a characteristic parameter and stores the characteristic parameter in the characteristic model” that renders the scope of the claim indefinite. (1) In lines 6-7, the waveform is recited to be analyzed to determine whether the tissue is in a pathological state. It is hence unclear what it means by “the waveform determined to be in the pathological state”. In other words, the pathological state is a characteristic of the tissue. The waveform, which refers to the feedback form that is the reflection of the detection form emitted by the wave emitting unit. Hence the waveform would not be part of the physiological state. (2) in lines 24-25 of claim 1, the characteristic parameter is recited in be used to establish the characteristic model. Hence it is unclear what it means by “store the characteristic parameter in the characteristic model”.
Claim 3 recites in line 4 “the control unit selects multiple audio signals from the multiple audio signals” that renders the scope fo the claim indefinite. It is unclear whether the first “multiple audio signals” refers to the second “multiple audio signals” in the above limitation as both terms are identical.
Claim 4 recites “a setting module that allows the user to set the desired state analysis mode” that is a method step. Claim 4 depends on claim 1 and claim 1 is a system claim. Reciting a method step in a system claim renders the scope of the claim indefinite. For examination purpose, it is interpreted such that the setting module is configured to allow the user to set the desired state analysis mode.
Claim 5 recites “the control unit selects multiple audio signals from the multiple audio signals…provides the feedback wave…and analyzes the frequency peaks…and the analysis unit then sets the waveform…” that are method steps. Claim 5 depends on claim 1 and claim 1 is a system claim. Reciting a method step in a system claim renders the scope of the claim indefinite. For examination purpose, it is interpreted such that the control unit and the analysis units are configured to perform the recited functions.
Claim 5 recites “the control unit selects multiple audio signals from the multiple audio signals” that renders the scope fo the claim indefinite. It is unclear whether the first “multiple audio signals” refers to the second “multiple audio signals” in the above limitation as both terms are identical.
Claim 6 recites “the control unit selects an audio signal from the multiple audio signals…provides the feedback wave…and analyzes the waveform amplitude …and the analysis unit then sets the waveform…” that are method steps. Claim 6 depends on claim 1 and claim 1 is a system claim. Reciting a method step in a system claim renders the scope of the claim indefinite. For examination purpose, it is interpreted such that the control unit and the analysis units are configured to perform the recited functions.
Claim 7 recites “a setting module that allows the user to set the desired state analysis mode” that is a method step. Claim 7 depends on claim 1 and claim 1 is a system claim. Reciting a method step in a system claim renders the scope of the claim indefinite. For examination purpose, it is interpreted such that the setting module is configured to allow the user to set the desired state analysis mode.
Claim 11 recites “the analysis unit further stores a basic information…and establishes the characteristic parameters” that are method steps. Claim 11 depends on claim 1 and claim 1 is a system claim. Reciting a method step in a system claim renders the scope of the claim indefinite. For examination purpose, it is interpreted such that the setting module is configured to allow the user to set the desired state analysis mode.
Claim 11 recites in line 5: “the analysis unit establishes the characteristic parameters” that renders the scope of the claim indefinite. It is unclear if this establishment of the plural characteristic parameters refers to the same as “the analysis unit analyzes the feedback wave…and the comparison parameters to obtain a characteristic parameter” recited in lines 22-24 of claim 1. In claim 1 a singular characteristic parameter is recited, yet in claim 11, a plural characteristic parameters are recited. Hence it is unclear whether claim 1 obtains one parameter, and claim 11 has a different analysis that obtain further multiple parameters.
Claim 11 recites in lines 6-8 “the physiological tissue of the assessed obtained from the analysis and the basic information for the assessed to be data parameters required for artificial intelligence algorithms” that renders the scope of the claim indefinite: (1) “the assessed” is grammatically incorrect. It is unclear what object it refers to, i.e., what is obtained from the analysis. (2) it is unclear what “analysis” refers to. (3) it is unclear what the “artificial intelligence algorithm” refers to, and what is the link of this algorithm with the rest of the claims including claim 1 that claim 11 depends on. (4) it is unclear what is required for the AI algorithm, whether it is just the basic information, or it is the characteristic parameters and the basic information.
The following terms lack antecedent basis:
Claim 1, line 20: “the detection wave output”
Claim 2, line 6: “the waveform amplitude”
Claim 2, line 9: “the waveform”
Claim 3, line 8: “the time-domain information”
Claim 3, line 9: “the frequency-domain information”
Claim 3, line 10: “the frequency peaks”
Claim 4, line 3: “the user” and “the desired state analysis mode”
Claim 5, line 6: “the time-domain information”
Claim 5, line 7: “the frequency domain information”
Claim 5, line 8: “the frequency peaks”
Claim 5, line 11: “the pathological state”
Claim 6, line 5: “the waveform amplitude”
Claim 7, line 3: “the user” and “the desired analysis mode”
Claim 11, line 4: “the evaluated subject”
Claim 11, line 5: “the characteristic parameters of the physiological tissue”
Claim 11, lines 6 and 7: “the assessed…”.
The dependent claims of the above rejected claims are rejected due to their dependency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2019/0192047 A1.
Elhilali et al., US 2023/0240641 A1. This prior art discloses obtaining quality metric for lung sounds. It uses a digital stethoscope for collecting lung sounds from one or more body positions that is converted to digital signals for modeling and analysis.
Lannini et al., US 2024/0188835 A1. This prior art discloses a method or system for noninvasive evaluating and monitoring of abnormal cardiopulmonary vibrations including obtaining one or more signals using one or more noninvasive heart and/or lung vibration signal sensors that provide a measure of physiological effects.
Lee et al., US 2025/0000477 A1. This prior art discloses an inspiration system that is configured to determine the physiological state based on vibrations or sounds of the organism. The device is in a format of a wearable flexible patch.
Etwaru et al., US 2019/0104993 A1. This prior art discloses a dual-patch configuration sensing system for sensing audio signals emitted from the patient’s lungs and/or airways to correlate the movement with the respiratory effort or the breathing rate of a user to reveal information about the breathing and/or sleep issues of the user.
Reuveny et al., US 2023/0017830 A1. This prior art discloses a patch of sensors affixed on the surface of a subject to acquire acoustic signals at different locations. The acquired sound data is analyzed using a ML model trained using a database of sounds in respect of normal and abnormal pathologies to assess the abnormality of the lung region.
Stamatopoulos et al., US 2023/0380719 A1. This prior art discloses a computer-implemented method for determining lung pathology from audio respiratory and breath flow signals comprising receiving a plurality of breath flow signals and a plurality of audio signals comprising a training set for a convolutional neural network. The plurality of breath flow signals and the plurality of audio signals are extracted from sessions with patient with known pathologies of known degrees of severity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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