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 .
Drawings
Fig. 1 is objected to because “PRIOR ART” is written, however in the specification, it is regarded as part of the invention. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Paragraphs are numbered incorrectly. The number should consist of at least four numerals enclosed in square brackets, including leading zeros (e.g., [0001]), in compliance with 37 CFR 1.52.
Appropriate correction is required.
Claim Objections
Claims 13 and 16 is objected to because of the following informalities:
Regarding claim 13, “valuesfrom” should be changed into two separate words: “values” and “from” in “the control unit receives pressure valuesfrom the seat pressure sensors”
Regarding claim 16, “valuesfrom” should be changed into two separate words: “values” and “from” in “the control unit receives pressure valuesfrom the seat pressure sensors”, and “muscle” in “transversus abdominis muscle” should be plural.
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:
“magnetic field generation units…”, “a first/second/third magnetic field generation unit…” [Wingdings font/0xE0] defined as a first/second/third magnetic field probe or equivalents thereof
“a first/second/third probe moving unit…” [Wingdings font/0xE0] defined as “an X-axis linear moving portion” and “a Y-axis linear moving portion” for each unit (see par. 22)
“a spacing adjustment moving unit..” [Wingdings font/0xE0] moving screw units and a rotary motor (claim 10)
“moving screw unit…” [Wingdings font/0xE0] par. 62, figure 4, item 508 including 508a, 508b
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.
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.
Claim Rejections - 35 USC § 112
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 5, 10 and 16 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 5 recites the limitations “the first magnetic field generation unit”, “the second magnetic field generation unit”, and “the control unit”. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitations “screw units”, however it is unclear whether the invention is moving a screw, or it is part of the invention. It also recites the limitation “the moving screw unit”. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitations “the backrest portion”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishikawa et al. (US 6223750 B1).
Regarding claim 1, Ishikawa et al. teaches an apparatus for treating urinary incontinence using a magnetic field (urinary incontinence treatment instrument shown in Fig. 1 and 2, also in annotated Fig. 1 below), the apparatus comprising:
Magnetic field generation units configured to apply magnetic fields to different muscles of a patient, the muscles being muscles that affect a treatment of the urinary incontinence of the patient (“stimulating coil for generating a magnetic flux, thereby producing an eddy current on a living body for urinary incontinence”, Col. 2, lines 64-66; stimulating coil 3, Fig. 1 and 2, also in annotated Fig. 1 below);
A control unit configured to control an operation of the magnetic field generation units (“control unit to set magnetic stimulating conditions”, Col. 4, lines 41-42; control unit 18, Fig. 1, also in annotated Fig. 1 below); and
A power supply unit configured to supply power to the magnetic field generation units and the control unit (“power supply section is connected to a commercial power supply and supplies necessary electric power to the stimulating coil and the cooling unit under the control of the control unit”, Col. 3, lines 35-38; power supply section 17, Fig. 1, also in annotated Fig. 1 below).
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Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 3, 5, 6 and 7 are rejected under 35 U.S.C. 103 as being obvious over Ishikawa et al. in view of Gallagher et al. (US 10363846 B2).
Regarding claims 2 and 3, Ishikawa et al. teaches all the limitations of claim 1, but does not teach a first, second, and third magnetic field generation unit.
However, Gallagher et al. teaches a first magnetic field generation unit configured to apply a magnetic field to pelvic floor muscles of the patient (electromagnetic coils 20; shown in annotated Fig. 4 below); and
A second magnetic field generation unit configured to apply a magnetic field to adductor muscles of the patient (electromagnetic coils 20; shown in annotated Fig. 4 below).
Furthermore, Gallagher teaches a third magnetic field generation unit configured to apply a magnetic field to a transversus abdominis muscle of the patient (electromagnetic coils 20; shown in annotated Fig. 4 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus for treating urinary incontinence of Ishikawa et al. with the first, second and third magnetic field generation units of Gallagher et al. in order to apply magnetic fields to the pelvic floor of the patient, as well as the adductor muscles and transversus abdominis muscles of the patient, as weak adductor muscles and transversus abdominis muscles can result in urinary incontinence.
Regarding claim 5, Ishikawa et al. in view of Gallagher et al. teaches all the limitations of claim 3.
Furthermore, Gallagher et al. teaches the control unit controlling operations of the first magnetic field generation unit, the second magnetic field generation unit, and the third magnetic field generation unit to generate magnetic fields having at least two different stimulation patterns (“controller is configured…to have the current generator generate the electrical currents for electromagnetic coils…control signals may include information indicative of characteristics (e.g., amplitude, frequency, intensity, strength, duration, continuous vs. pulse, shape, sinusoidal, triangle, vs. square waveform, duration, repetition, etc.)”, Col. 5, lines 10-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Ishikawa et al. with the control unit of Gallagher et al. and configure the magnetic field generation units to generate magnetic fields having at least two different stimulation patterns in order to
Regarding claims 6 and 7, Ishikawa et al. in view of Gallagher et al. teaches all the limitations of claim 2.
Furthermore, Gallagher et al. teaches a seat portion on which the first magnetic field generation unit and the second magnetic field generation unit are located and on which a patient sits (seat bottom 54, also shown in annotated Fig. 4 above); and
A backrest portion that is built on a rear side of the eat portion to support the patient’s back and on which the third magnetic field generation unit is located (seat back 56, also shown in annotated Fig. 4 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Ishikawa et al. which already has a seat portion and a backrest portion, but integrate the first, second and third magnetic field generation units of Gallagher et al. into it, in order to ensure the patient sits comfortably while receiving the treatment.
Claim 4 is rejected under 35 U.S.C. 103 as being obvious over Ishikawa et al. in view of Gallagher et al. and further in view of Mo (US 20060187607 A1).
Regarding claim 4, Ishikawa et al. in view of Gallagher et al. teaches the control unit comprising a user mode unit with which a patient or an operator is able to select a stimulation area and stimulation sequence (“operator operates the control unit to set magnetic stimulating conditions…repetitive frequency of a generated magnetic field…stimulating strength…stimulating time…etc.”, Col. 4, lines 41-46), but does not teach a treatment mode unit for treating urinary incontinence according to a predetermined stimulation area and stimulation sequence, comprising a circulation operation mode, a complex stimulation cycle mode, and a sequential stimulation treatment mode.
However, Mo further teaches the treatment mode unit for treating urinary incontinence according to a predetermined stimulation area and stimulation sequence (“modulation modes which can be implemented in the apparatus for creating pulse magnetic stimulation”, paragraph [0153]),
Wherein the treatment mode comprises a predetermined stimulation area, and treatment modes for stimulating the predetermined stimulation area according to a predetermined sequence,
Wherein the treatment modes comprise:
A circulation operation mode in which the first magnetic field generation unit, the second magnetic field generation unit, and the third magnetic field generation unit are operated cyclically in random order but operated individually (“ramp modulation…in which the first start portion and the last end portion in a burst configuration are increased or decreased step by step”, paragraph [0154]);
A complex stimulation cycle mode in which at least two of the first magnetic field generation unit, the second magnetic field generation unit, and the third magnetic field generation unit are operated at the same time to apply complex stimulation, but different complex stimulations are applied cyclically (“amplitude modulation…in which the peak intensity is varied gradually or variously for the burst on time…serves for directly adjusting the intensity of stimulation”, paragraph [0158]); and
A sequential stimulation treatment mode in which the first magnetic field generation unit, the second magnetic field generation unit, and the third magnetic field generation unit are operated sequentially in random order (“frequency modulation…frequency is varied gradually or variously for the burst on time…pulses having various resonance periods can exist for the bust on time”, paragraph [0159]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified apparatus for treating urinary incontinence of Ishikawa et al. in view of Gallagher et al. with the treatment modes of Mo, in order to allow the user or operator to select different set modes that apply different stimulation sequences at the predetermined stimulation areas to deliver the most effective treatment to a user or patient.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being obvious over Ishikawa et al., hereinafter Ishikawa A in view of Gallagher et al. and further in view of Ishikawa et al. (US 5984854 A), hereinafter Ishikawa B.
Regarding claim 8, Ishikawa A in view of Gallagher et al. teaches all the limitations of claim 7, but does not teach a first and second arm member connected to the backrest portion, alongside a first and second transverse abdominis cover plate member connected to the arm members.
However, Ishikawa B teaches a first arm member and a second arm member rotatably connected to each side of the backrest portion (“coil supporting arms 45 and 45a are opened, the patient is allowed to enter into the space between the arms”, Col. 7, lines 35-36; supportive shaft 42, shown in annotated Fig. 7A and 7B below);
A first transverse abdominis cover plate member connected to an end of the first arm member, and a second transverse abdominis cover plate member connected to an end of the second arm member, each equipped with the third magnetic field generation unit, and positioned to cover the transversus abdominis muscle connected to a side of an abdomen (“the semicircular coil supporting arms 45, 45a contain respectively the magnetic stimulation coils 46 disposed in a circular form”; Col. 7, lines 26-28, “magnetic stimulation coils 46 are set around the patient’s abdomen”, Col. 7, lines 37-38; coil supporting arms 45, 45a, magnetic stimulation coils 46, shown in annotated Fig. 7A and 7B below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the modified apparatus for treating urinary incontinence of Ishikawa A in view of Gallagher et al. with arm members and their respective cover plate members with a magnetic field generation unit of Ishikawa B, by attaching the arm members to the backrest portion, in order to apply a magnetic field stimulation to the entire transversus abdominis muscle, targeting the abdominal region of the patient while the patient is sitting down, which is crucial to treating urinary incontinence in a patient.
Regarding claim 9, Ishikawa A in view of Gallagher et al. and further in view of Ishikawa B teaches all the limitations of claim 8.
Furthermore, Ishikawa B teaches a spacing adjustment moving unit configured to adjust a distance between the first transverse abdominis cover plate member and the second transverse abdominis cover plate member by moving the first transverse abdominis cover plate member and the second transverse abdominis cover plate member in a width direction of the backrest portion (“the coil supporting arms 45 and 45a are opened…patient is allowed to enter into the space…and the arms are closed”, Col. 7, lines 34-37; supporting arms 45, 45a, shown in annotated Fig. 7A and 7B above). The cover plate members must be able to be adjusted within the width direction of the backrest portion in order to allow the patient to enter the apparatus and then be enclosed by the cover plate members.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified apparatus of Ishikawa A in view of Gallagher et al. and further in view of Ishikawa B and incorporate a spacing adjustment moving unit in order to easily open the cover plate members and allow a patient or user to enter and sit, and then further close the plates, accommodating to fit around the patient to apply magnetic field stimulus.
Claims 11, 13, 14 and 16 are rejected under 35 U.S.C. 103 as being obvious over Ishikawa A in view of Gallagher et al. and further in view of Kang (US 7338417 B2).
Regarding claims 11 and 14, Ishikawa A in view of Gallagher et al. teaches all the limitations of claim 6, but does not teach probe moving units located on the seat portion that are configured to move a magnetic field probe in the magnetic field generation units.
However, Kang teaches a probe moving unit (“lifting means which is connected to the pressure head and moves it upwardly and downwardly”, Col. 3, lines 59-60; lifting means 30, shown in annotated Fig. 2 below) located on the seat portion configured to move a magnetic field probe (“a magnet (not shown in the drawings) is provided in the pressure head”, Col. 5, lines 41-42; pressure head 20, shown in annotated Fig. 2 below) of the magnetic field generation unit. The magnetic field probe is what generates a magnetic field within the magnetic field generation unit (stimulating coil 3 of Ishikawa A), and the probe moving unit moves the magnetic field probe to adhere to a patient or user’s body shape and posture (“pressure head is moved upwardly by the lifting means and the perineum region of the sitter is pressed by it”, Col. 7, lines 62-65 of Kang).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the apparatus of Ishikawa A in view of Gallagher et al. with the probe moving unit of Kang in order to move the magnetic field probes of Ishikawa A in view of Gallagher et al. to move around the patient’s body to deliver treatment. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate multiple probe moving units for respective magnetic field probes, as the apparatus for treating urinary incontinence of Ishikawa A in view of Gallagher et al. teaches a first and second magnetic field generation unit on the seat portion, and a third magnetic field generation unit on the backrest portion in order to target different areas on a patient. It has been held that mere duplication of essential working parts of a device involves only routine skill in the art and one of ordinary skill in the art would have had reasonable expectation of success. See MPEP 2144.04 St. Regis Paper Co. v. Bernis Co., 193 USPQ 8.
Regarding claims 13 and 16, Ishikawa A in view of Gallagher et al. and further in view of Kang teaches seat pressure sensors provided to be spaced apart on the seat portion and detect pressure generated when the patient sits down (shown in annotated Fig. 4 of Gallagher et al. below), and
Backrest pressure sensors provided to be spaced apart on the backrest portion and detect pressure generated when the patient leans against the backrest portion (shown in annotated Fig. 4 of Gallagher et al. below).
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Furthermore, Kang teaches the control unit receiving pressure values from the seat pressure sensors and the backrest pressure sensors, and checks the body shape and posture of the seated patient, and, according to the body shape and posture of the patient, positions the first magnetic field probe, the second magnetic field probe, and the third magnetic field probe to face the pelvic floor muscles, the adductor muscles, and the transversus abdominis muscles, respectively, for treatment of urinary incontinence by means of the first probe moving unit, the second probe moving unit, and the third probe moving unit (“a first detection means which is provided at the pressure assembly and detects the force or the pressure applied to the pressure assembly as the sitter shrinks the perineum muscle…lifting means which moves the pressure head upwardly and downwardly”, Col. 5, lines 2-12; detection means 53, pressure head 20, lifting means 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Ishikawa A in view of Gallagher et al. and further in view of Kang and utilize pressure sensors to detect the body shape and posture of a patient in order to adhere to the patient’s body and deliver treatment.
Allowable Subject Matter
Claims 12, 15, 17 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791