DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The abstract of the disclosure is objected to because of its undue length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1-8 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 claims contain 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. Specifically, the claimed “non-contact” assessment and training system.
Claims 1–8 recite "non-contact pelvic floor assessment," “non-contact pelvic floor training,” "non-contact biofeedback," "non-contact feedback waveform," and "non-contact feedback database." Claim 2, step S2-4 specifically recites obtaining the maximum contraction force based on the "maximum distance $D_{max} = \max(D)$ that the pelvic floor muscle of the subject can contract." Pelvic floor muscles (such as the levator ani) are deep internal skeletal muscles located within the pelvic cavity. Traditionally, pelvic floor biofeedback requires physical contact (e.g., invasive vaginal/rectal pressure probes or surface EMG contact electrodes). The instant specification fails to describe any physical sensor hardware, optical system, electromagnetic transceiver, or diagnostic apparatus capable of remotely measuring internal pelvic floor muscle contractions, force, or physical movement "distance" ($D_{max}$) in a truly "non-contact" manner. The specification treats "non-contact biofeedback" as a functional black box, failing to disclose the structural and physical boundaries of the remote sensor mechanism necessary to prove possession of the invention.
Additionally, the claims recite an extensive array of system constants and thresholds (e.g., $x, a, b, c, d, e, f, g, h, k, m, n, p, q, r, y, z$, and $s_1$ through $s_5$) and a "weighted formula combining active muscle indexes and the degree of neurological injury" to calculate an integrated score $M$ (Claim 4, S4-4). However, the specification fails to provide written description support for the concrete values, ranges, or mathematical relationships governing these constants. It merely identifies them as placeholders "set by the system" or selected from "big data." Without detailing the underlying statistical distributions, weighting coefficients, or criteria used to define and set these thresholds, the disclosure fails to demonstrate possession of a functional, closed-loop training adjustment system.
Claims 1-8 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Non-contact physiological sensing of deep, internal muscular contractions (especially while a user is seated on a magnetic stimulation device) is not established in the prior art. Traditional pelvic floor assessment relies heavily on contact probes to isolate contractions from surrounding muscle groups (such as gluteal or abdominal muscles). The specification provides no electrical, mechanical, or physical schematics of the "non-contact biofeedback module" or how it isolates pelvic floor contractions from other bodily movements. It is noted that a person having ordinary skill in the art would have to engage in extensive research and development to invent, calibrate, and validate a non-contact sensor that can measure internal muscle contraction "distance" ($D_{max}$) without physical touch, skin-surface contact, or invasive probes.
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 1-5 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.
In re Claims 1-5
The term “force exerting way” in claim 1-3 is a relative term which renders the claim indefinite. The term “force exerting way” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This is a non-standard and vague term. It is unclear what structural or biological characteristics of pelvic contraction constitute a "way" of exerting force, or how "correctness" is objectively determined.
In re Claim 3
The term “as high as possible” in claim 3 is a relative term which renders the claim indefinite. The term “as high as possible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This term of degree relies entirely on the subjective physical effort and intent of the patient. Because physical capabilities vary from patient to patient and from day to day, this does not provide an objective standard for determining infringement, rendering the boundary of the claim indefinite.
Claim 2 recites the limitation "in the lower portion of the template" in step S2-7. There is insufficient antecedent basis for this limitation in the claim.
In re Claim 5
Claim 5 depends on claim 1 (which is a method claim) but fails to provide any method steps but is rather merely definitions. This is interpreted as a mixed claim type and is held to be indefinite since it is unclear whether infringement occurs when the system of claim 5 is made or the method of claim 1 is performed.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim 5 is merely defining terms and fails to add any method steps to independent claim 1. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims are directed to a "non-contact pelvic floor assessment method" (Claims 1–5) and a "non-contact pelvic floor training method" (Claims 6–8). These claims are directed to a process, which is a patent-eligible category of invention under 35 U.S.C. § 101.
Claims 1-3 recite steps of "determining whether the user's sitting posture and force exerting way... are correct" and "assessing various functions." These steps are cognitive evaluations of physiological correctness. Claims 2-4 and 7-8 also recite specific Mathematical Concepts.
Claims 6, 7, and 8: Recite "formulating a rehabilitation training program" and "making a real-time adjustment" based on rule-based comparisons (e.g., if a score increases, decrease intensity; if a score decreases, increase intensity). Formulating programs and adjusting exercises according to logical rules represent mental processes and methods of managing personal rehabilitation behavior.
The judicial exceptions identified above are not integrated into a practical application because the claims do not apply, limit, or use the exceptions in a manner that provides a meaningful, physical limitation. Specifically, the claims do not improve the physical structure or operation of the "magnetic stimulation therapy device" or the "biofeedback module." The stimulation device and biofeedback sensor are described in a purely generic and functional manner. Additionally, the claims merely use the mathematical equations and logical comparisons to guide a therapist's or system's conventional selection of training templates and magnetic intensities. Under MPEP § 2106.04(d)(1), simply applying an abstract idea on a generic computer, or limiting the field of use of an abstract idea to a specific environment (e.g., pelvic floor rehabilitation), does not integrate the exception into a practical application. Because the physical components of the claims are generic, the claims effectively preempt the use of these mathematical algorithms and logical assessment rules in the generic field of pelvic floor rehabilitation. Therefore, the claims are held as being directed to the abstract ideas themselves.
The physical elements recited in the claims are a "magnetic stimulation therapy device," a "biofeedback module," a "display" showing "prompts," and a "database." These are conventional, generic computer and medical components performing their standard, well-known functions of data storage, user interface display, magnetic stimulation, and biological signal collection. It is noted that steps such as "collecting... feedback waveform," "comparing... with the standard cut-off," "setting a threshold," and "calculating an integrate score" represent generic data-processing, storage, and calculation functions. When viewed as an ordered combination, the claims merely recite collecting patient data, running the data through mathematical algorithms, and outputting control signals to adjust a conventional magnetic stimulator. This represents the basic, routine function of a feedback control loop on a generic computer. Accordingly, the additional elements, both individually and as an ordered combination, do not amount to significantly more than the abstract ideas and the claims are held as being patent-ineligible under 35 U.S.C. § 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5,154,177 (Eisman).
US 6,063,045 (Wax).
US 2001/0047132 (Johnson).
US 2007/0112284 (Hoffman).
US 2020/0384311 (Zemp).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY-DARYL FLETCHER whose telephone number is (571)270-5054. The examiner can normally be reached Monday -Thursday (7-5).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marivelisse Santiago-Cordero can be reached at 571-272-7839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JERRY-DARYL FLETCHER/Supervisory Patent Examiner, Art Unit 3763
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