DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed 09/15/2025 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims, specification, and drawings have overcome the objections, and 112(b) rejections previously set forth in the Non-Final Office Action mailed 06/13/2025.
Information Disclosure Statement
The information disclosure statement (IDS) dated 09/15/2025 has been received and considered.
Response to Arguments
Applicant's arguments filed 09/15/2025 (“Remarks”) have been fully considered.
The amendments to the specification, drawings, and claims have overcome the previously set forth objections, which have been withdrawn.
“Remarks” page 10 only partially addresses the 112(a) rejection of the frequency range claimed by claims 1, 4, and 6. Please see below for the maintained rejection, which pertains to the specific range claimed, versus what is actually disclosed.
The amendments to the claims have rendered the previously set forth 112(b) rejections moot, and have been withdrawn.
Applicant argues on page 13 of “Remarks” that the limitation now incorporated into independent claim 1 of “a data capture module configured to measure an attenuation signal” is allowable, is persuasive. The examiner agrees that Omata does not disclose an attenuation signal, where attenuation is defined as a reduced amplitude of a signal. Omata teaches a phase shift or a frequency change in the signal in [0048-0050]. Please see below for the reasons for indicating allowable subject matter.
Claim Interpretation- 35 USC § 112 – Sixth Paragraph/35 USC § 112(f)
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.
At present, no claims are interpreted under 35 USC 112(f).
Claim Objections
Claim 1 is objected to because of the following informalities: Claim1 appears to have a stray comma in the limitation that should be removed: “An apparatus for[[,]] testing a property…”
Claim 20 is objected to for missing a comma: “The apparatus of claim 1, further comprising…”
Appropriate correction is required.
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 1-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitation “an application signal having a frequency in a range from approximately 0.1 to greater than 4 kHz” (ln. 5) does not appear to be a limitation that the applicant had possession of at the time the application was filed. Applicant’s own specification states “Commercial vibrational testing accelerometers of this type typically have a frequency range from approx. 0.1 to above 4kHz, i.e. far outside the range of 15-120Hz preferred in the present invention” (Page 9, second paragraph, emphasis added by examiner). It appears the applicant claimed this higher frequency range of a “commercial vibrational testing accelerometer” in error. The remaining disclosure does not appear to utilize the broader range claimed in claim 1. In particular, pages 15-16 disclose the application signal operating using values within the preferred narrower range of 15-120Hz. Additionally, the range disclosed on page 9 appears to refer to the frequency range 0.1 Hz to greater than 4 kHz as the range detected by a commercial accelerometer, not the range produced by the oscillator as claimed.
For examination purposes, this limitation will be interpreted as a range between 0.1 Hz to 4kHz such that the lower end of the range at least includes a frequency close to that contemplated by the application.
Similarly, claim 4 recites the oscillator configured to produce an application signal in a frequency range a range of less than 0.1 to 15Hz, and claim 6 recites between 120Hz to 4kHz or greater than 4kHz. However, the specification does not appear to indicate that the oscillator is configured to emit a frequency in either range, as cited above.
It is suggested to claim the oscillator being configured to emit the frequency range disclosed in the specification as being within 15-120Hz.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Interpretation
Claim 1 term “an attenuation signal” is interpreted to mean a signal which is attenuated, or has a reduced amplitude. This is supported by original specification page 17, first full para.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action.
The closest prior art of record includes Hoffman et al (2007/0112284) in view of Omata (2005/0256387) and Shim (2010/0174218).
Regarding claim 1, Hoffman discloses an apparatus for, testing a property of one or more muscles, exercising one or more muscles, or testing a property of and exercising one or more muscles (Fig. 30 depicts an apparatus for exercising the pelvic floor muscles. See annotated Fig. 30 below for convenience. The abstract discloses the device used to train pelvic muscles), the apparatus comprising: a probe having an interior, the probe being configured for contacting a muscle to be tested or exercised (Fig. 30, probe 404 has an interior for holding battery module 78 and vibrator assembly 402); an oscillator housed in the interior of the probe and configured to produce an application signal having a frequency in a range from approximately 0.1 Hz to greater than 4 kHz (Fig. 30, vibrator assembly 402 is an “oscillator” housed within the probe 400. [0104] discloses that the frequency of the vibrator can be from about 1-100 Hz); a controller in operative communication with at least one of the oscillator or accelerometer and configured to detect, control, or process the application signal, return signal, or both (Figs. 30 and 32, signal processor module 80 and frequency control module 410 are in operative communication with vibrator assembly 402 and control the application signal send to the vibrator assembly 402; see [0102]); wherein the oscillator is configured to produce the application signal that is transmitted into the muscle to be tested or exercised (Fig. 15 depicts a probe transmitting into pelvic muscle).
Hoffman does not disclose a data capturing module configured to measure an attenuation signal; an accelerometer housed in the interior of the probe and configured to detect and read a frequency of a return signal, wherein the accelerometer is configured to detect the return signal from the tested or exercised muscle, and the controller is configured to compare the frequency of application signal to the frequency of return signal to determine a frequency of the attenuation signal to be measured by the data capture module; wherein the attenuation signal of the application signal correlates to a muscle property or a change in a muscle property due to exercising.
However, Omata teaches an apparatus for testing and exercising pelvic floor musculature (Fig. 1, apparatus 1; [0007] discloses placing the device in an inner portion of a canal part of the body), the apparatus comprising an elongate housing (Fig. 1, base 5 and sleeve 9), wherein the elongate housing accommodates an oscillator (Fig. 7, vibration element 43) and a vibration detector in addition to the oscillator (Fig. 7, vibration detector 45) connected to a signal processor configured for communicating a return signal, wherein the signal processor compares the frequency of application signal to the frequency of return signal to determine a frequency of a signal ([0048]-[0050] discloses a frequency deviation circuit that detects a change in the frequency of the application signal compared to the return signal which corresponds to a value of tissue harness that is determined by the hardness converter 59). Omata also discloses a data capturing module that processes signals (Fig. 7, hardness detection means 51 is; see [0048]-[0049]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the inside of the housing of Hoffman to include a vibration detection element and a signal process that determines the hardness or elasticity of the tissue/muscle being treated via changes in frequency between the application signal and the return signal as taught by Omata to provide the user with additional information about the health and strength of the pelvic floor musculature, as well as a data capture module to determine the frequency of the signals in order to determine hysteresis of the tissue (Omata [0049]).
The modified apparatus of Hoffman does not have the vibration detection element as an accelerometer (although vibration detection elements are frequently types of accelerometers).
However, Shim teaches a pelvic exercise and measurement device and method wherein the device comprises sensors that include an accelerometer that would measure vibrations of the device ([0227] discloses use of an accelerometer).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to design the vibration detection element of the modified device of Hoffman to be an accelerometer as taught by Shim to provide an accurate means of detecting vibrations as a result of biological tissue characteristics.
The modified apparatus remains silent on the data capturing module configured to measure an attenuation signal (as interpreted above, an attenuation signal is a signal with a reduced amplitude).
There does not appear to be prior art of record which measures a muscle property based on an attenuation signal. Thus, claim 1 would be allowed over the prior art should it be rewritten to overcome the 112(a) rejection above directed toward the claimed range of frequencies produced by the oscillator.
Folkerts et al. (US 2009/0082830 A1) discloses measuring attenuation in the BCR signal (bulbocavernous reflex; see [0052-0056]). However, Folkerts applies EMG testing using an electrode to apply a voltage, rather than an oscillator applying a mechanical vibration, to test a reflex, rather than to assess a muscle hardness. It would not have been obvious to one of ordinary skill in the art to apply Folkerts since the modality of the signal applied differs significantly from the claimed invention.
Hynynen et al. (US 2009/0264798 A1) discloses measuring localized harmonic motion delivered by ultrasound ([0023]) in which a measured amplitude and/or frequency in the target tissue is sued to determine the state of the tissue ([0029]). However, the state determined is thermal coagulation in a sonicated tissue. It would not have been obvious to one of ordinary skill in the art to apply Hynynen to the above combination since the field of endeavor is not relevant to the invention.
Claims 2-20 would be allowed as depending from claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kushnir (2012/0053017), McCoy (2013/0130871), Schuurmans et al (2007/0142191), Pauser et al (5,483,832), and Guagliano et al (6,406,411) disclose pelvic floor exercisers and measurement devices.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA K. TOICH whose telephone number is (703)756-1450. The examiner can normally be reached M-Th 7:30 am - 4:30 pm, every other F 7:30-3:30 ET.
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/SARA K TOICH/ Examiner, Art Unit 3785
/VICTORIA MURPHY/ Primary Patent Examiner, Art Unit 3785
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