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 .
This action is in response to the filing on 4/21/2023. Since the initial filing, claims 4-15 and 20-21 have been amended and no claims have been added or cancelled. Thus, claims 1-22 are pending in the application.
Claim Objections
Claims 2-15 and 17-21 are objected to because of the following informalities:
Claim 2-15 and 17-21: “Claim” should be “claim”
Claim 4: should depend on claim 3 so the “tertiary” follows “secondary”
Claim 12: “memory form” should be “memory foam”
Appropriate correction is required.
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 10, 13 and 14 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 10 recites the limitation "the second recess section" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing dependency to claim 3 to overcome this rejection.
Claim 13 recites the limitation "the first actuation signals" and “the second actuation signals” in line 2 and 2-3. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “first actuation signals” and “second actuation signals” to overcome these rejections.
Claim 14 recites the limitation " the first actuation signals" and “the second actuation signals” in line 2. There is insufficient antecedent basis for this limitation in the claim. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “first actuation signals” and “second actuation signals” to overcome these rejections.
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.
Claim(s) 1-5, 10-11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (US 2017/0360653) in view of Haarlander (US 2014/0303693) and evidenced by Zhu (US 10441498).
In regards to claim 1, Marshall discloses an erectile dysfunction treatment apparatus (stimulation device 1) comprising: a pad adapted to contact a hind region of a patient, the pad comprising a perineal section (nubs 21) and a penile section (strap 19), a pouch connected to the penile section of the pad (device 4), the pouch configured to wrap around a penile shaft of the patient (Fig 8), the pouch including at least one primary vibrating pad, a control unit electrically coupled to the at least one vibrating pad (paragraph 29 last 7 lines), wherein the control unit is configured to provide first actuation signals, and configured to provide second actuation signals to the at least one primary vibrating pad (paragraph 29 last 7 lines).
Marshall does not disclose an acoustic wave actuator, the pouch including at least one primary LED, wherein the control unit is electrically coupled to the acoustic wave actuator, the at least one vibrating pad, and the at least one LED.
However, Haarlander teaches the perineal section including an acoustic wave actuator (sonic or ultrasonic vibrational therapy, paragraph 72); pouch including at least one primary LED (light sources 6 may be LEDs); and a control unit electrically coupled to the acoustic wave actuator, the at least one vibrating pad, and the at least one LED for performing vasodilation treatment (control unit 50, paragraph 74; light for vasodilation paragraph 5 and 6).
While Haarlander does not disclose wherein the acoustic wave generator is for neovascularization treatment, it is known that acoustic shock wave therapy is effective for revascularization (Zhu: column 1 line 29-33)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall to have an acoustic wave actuator for neovascularization treatment, the pouch including at least one primary LED, wherein the control unit is electrically coupled to the acoustic wave actuator, the at least one vibrating pad, and the at least one LED for vasodilation treatment as taught by Haarlander as evidenced by Zhu as this would provide a variety of therapeutic treatments which could be applied as needed for best effect.
In regards to claim 2, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1.
Marshall does not disclose wherein the penile section of the pad comprises a first recess section and a second recess section together forming a penile shape and configured to respectively cradle a scrotum of the patient and at least a portion of the penile shaft of the patient.
However, Haarlander teaches wherein the penile section of the pad comprises a first recess section and a second recess section together forming a penile shape (tube 10) and configured to respectively cradle a scrotum of the patient and at least a portion of the penile shaft of the patient (cup 20, paragraph 74, Fig 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall wherein the penile section of the pad comprises a first recess section and a second recess section together forming a penile shape and configured to respectively cradle a scrotum of the patient and at least a portion of the penile shaft of the patient as taught by Haarlander as this would allow the device to comfortably fit the user to provide therapy.
In regards to claim 3, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 2 and Haarlander further teaches wherein the second recess section configured to cradle at least a portion of the penile shaft of the patient includes at least one of a secondary vibrating pad and a secondary LED (paragraph 72).
In regards to claim 4, Marshall in view of Haarander as evidenced by Zhu teaches the device of claim 1 and Haarlander teaches wherein the perineal section includes at least one of a tertiary vibrating pad and a tertiary LED (paragraph 72).
In regards to claim 5, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1 and Haarlander further teaches wherein the pouch is made from a flexible material configured to stretch around the penile shaft (paragraph 77).
In regards to claim 10, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1 and the combination further teaches wherein the pouch includes a first side and a second, opposite side, the first side being connected to the pad at the second recess section, and the second side having a greater length compared to the first side (Marshall: Fig 4 and 6; Haarlander: Fig 4).
In regards to claim 11, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1 and Marshall further teaches wherein the pad has at least one of a seat-shape (Fig 6).
In regards to claim 13, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1 and the combination further teaches wherein the control unit transmits the first actuation signals at a first time during a session and the second actuation signals at a second, subsequent time during the session (Marshall: asynchronous application of therapy, paragraph 29 last 7 lines; Haarlander: paragraph 28 and 91).
In regards to claim 14, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1 and Haarlander further teaches wherein the control unit transmits the first actuation signals and the second actuation signals at a same time during a session (synchronous application of therapy, paragraph 29 last 7 lines; Haarlander: paragraph 28 and 91).
Claim(s) 16 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (US 2017/0360653) in view of Haarlander (US 2014/0303693).
In regards to claim 16, Marshall discloses an erectile dysfunction treatment apparatus (stimulation device 1) comprising: a pad adapted to contact a hind region of a patient, the pad including perineal (nubs 21) and penile sections (strap 19); a pouch connected to the penile section of the pad configured to wrap around the penile shaft (device 4).
Marshall does not disclose the perineal section including an acoustic wave actuator, first and second recess sections located at the penile section, a pouch connected to the penile section of the pad at the second recess section the pouch configured to wrap around the penile shaft, the pouch including at least one primary vibrating pad, and at least one primary LED.
However, Haarlander teaches the perineal section including an acoustic wave actuator (sonic or ultrasonic vibrational therapy, paragraph 72); first and second recess sections located at the penile section, the first and second recess sections configured to respectively cradle a scrotum of the patient and at least a portion of a penile shaft of the patient; a pouch connected to the penile section of the pad at the second recess section (tube 10 and cup 20, paragraph 74, Fig 2), the pouch configured to wrap around the penile shaft (paragraph 74), the pouch including at least one primary vibrating pad, and at least one primary LED (sonic or ultrasonic vibrational therapy, paragraph 72, light sources 6, paragraph 74).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall such that the perineal section including an acoustic wave actuator, first and second recess sections located at the penile section, a pouch connected to the penile section of the pad at the second recess section the pouch configured to wrap around the penile shaft, the pouch including at least one primary vibrating pad, and at least one primary LED as taught by Haarlander as this would provide a variety of therapeutic treatments which could be applied as needed for best effect.
In regards to claim 20, Marshall in view of Haarlander teaches the device of claim 16 and Haarlander further teaches wherein the second recess section is configured to cradle the portion of patient's penile shaft and includes at least one of a secondary vibrating pad and a secondary LED, wherein the perineal section includes at least one of a tertiary vibrating pad and a tertiary LED (paragraph 72, Fig 2).
In regards to claim 21, Marshall in view of Haarlander teaches the device of claim 16 and the combination further teaches a method of treating erectile dysfunction, wherein a patient is treated with the apparatus of claim 16 (see Rejection of claim 16 above, Haarlander: device used to treat erectile dysfunction, paragraph 71).
Claim(s) 17-19 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (US 2017/0360653) in view of Haarlander (US 2014/0303693) and evidenced by Zhu (US 10441498).
In regards to claim 17, Marshall in view of Haarlander teaches the device of claim 16.
Marshall does not disclose further comprising a control unit communicatively coupled to the acoustic wave actuator, the at least one primary vibrating pad, and the at least one primary LED, the control unit configured to provide first actuation signals, and configured to provide second actuation signals to the at least one primary vibrating pad and the at least one primary LED for performing a vasodilation treatment.
However, Haarlander teaches further comprising a control unit (control unit 50) communicatively coupled to the acoustic wave actuator, the at least one primary vibrating pad, and the at least one primary LED (paragraph 64), the control unit configured to provide first actuation signals to the acoustic wave actuator, and configured to provide second actuation signals to the at least one primary vibrating pad and the at least one primary LED for performing a vasodilation treatment (Haarlander: paragraph 28 and 91, light therapy causes vasodilation, paragraph 5 and 6).
While Haarlander does not disclose wherein the acoustic wave generator is for neovascularization treatment, it is known that acoustic shock wave therapy is effective for revascularization (Zhu: column 1 line 29-33)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall further comprising a control unit communicatively coupled to the acoustic wave actuator, the at least one primary vibrating pad, and the at least one primary LED, the control unit configured to provide first actuation signals to the acoustic wave actuator for performing a neovascularization treatment, and configured to provide second actuation signals to the at least one primary vibrating pad and the at least one primary LED for performing a vasodilation treatment as taught by Haarlander as evidenced by Zhu as this would allow the device to more precisely control applied therapy.
In regards to claim 18, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 17 and Haarlander further teaches wherein the control unit is at least one of included within the pad or is located separately from the pad (control unit 50 may be wired or wireless, paragraph 74 and 79).
In regards to claim 19, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 17 and Haarlander further teaches wherein the control unit is included within a remote control or an application on a user device (paragraph 79).
In regards to claim 22, Marshall discloses a method of treating a user with a treatment apparatus (stimulation device 1) comprising: a pad adapted to contact a hind region of a patient, the pad comprising a perineal section (nubs 21) and a penile section (strap 19); a pouch connected to the penile section of the pad, the pouch configured to wrap around a penile shaft of the patient (device 4, Fig 8), wherein the control unit is configured to provide first actuation signals, and configured to provide second actuation signals (paragraph 29 last 7 lines).
While Marshall does not explicitly disclose wherein the method is for treating erectile dysfunction, it does discuss a similar prior art device which is used for treating erectile dysfunction (paragraph 8). Marshall further does not disclose the perineal section including an acoustic wave actuator, the pouch including at least one primary vibrating pad and at least one primary LED, and a control unit electrically coupled to the acoustic wave actuator for performing a neovascularization treatment, the at least one vibrating pad, and the at least one LED for vasodilation treatment.
However, Haarlander teaches a method for treating erectile dysfunction (paragraph 71) with a device wherein the perineal section including an acoustic wave actuator (sonic or ultrasonic vibrational therapy, paragraph 72); the pouch including at least one primary vibrating pad (sonic or ultrasonic vibrational therapy, paragraph 72) and at least one primary LED (light sources may be LEDs, paragraph 74); and a control unit electrically coupled to the acoustic wave actuator, the at least one vibrating pad, and the at least one LED for vasodilation treatment (control unit 50, paragraph 74 and 78; light for vasodilation paragraph 5 and 6).
While Haarlander does not disclose wherein the acoustic wave generator is for neovascularization treatment, it is known that acoustic shock wave therapy is effective for revascularization (Zhu: column 1 line 29-33)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall such that the perineal section including an acoustic wave actuator, the pouch including at least one primary vibrating pad and at least one primary LED, and a control unit electrically coupled to the acoustic wave actuator for performing a neovascularization treatment, the at least one vibrating pad, and the at least one LED for vasodilation treatment as taught by Haarlander as evidenced by Zhu as this would allow for the method to perform therapy as needed to suit the user.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (US 2017/0360653) in view of Haarlander (US 2014/0303693) as evidenced by Zhu (US 10441498) and in further view of Courtion (US 2017/0095398).
In regards to claim 6, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1 and Haarlander further teaches wherein the at least one primary LED includes 40 LEDs (Fig 2).
While Haarlander does not explicitly teach wherein each of the LEDs configured to emit light at a wavelength between 685 nm and 780 nm, it does teach that the device may run any desired safe wavelength of light (paragraph 88) and that red or infrared light in particular enhance vasodilation (paragraph 6). Further, Courtion teaches wherein a personal massage device which emits red light at a wavelength between 685 nm and 780 nm (paragraph 90).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall wherein each of the LEDs configured to emit light at a wavelength between 685 nm and 780 nm as taught by Courtion as this range is known to have beneficial effect (Haarlander: paragraph 6; Courtion: paragraph 40).
Claim(s) 7-9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (US 2017/0360653) in view of Haarlander (US 2014/0303693) as evidenced by Zhu (US 10441498) and in further view of Zipper (US 2018/0042809).
In regards to claim 7, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1.
Marshall does not disclose further comprising a memory device storing a treatment profile specifying at least one of: (i) a first time duration, a frequency, an amplitude, and a waveform shape for the acoustic wave actuator; (ii) a second time duration and a light intensity for the at least one primary LED, and (iii) a third time duration, a frequency, an amplitude, and a waveform shape for the at least one primary vibrating pad.
However, Zipper teaches a personal massage device further comprising a memory device storing a treatment profile specifying at least one of: (i) a first time duration, a frequency, an amplitude, and a waveform shape for the acoustic wave actuator; (ii) a second time duration and a light intensity for the at least one primary LED, and (iii) a third time duration, a frequency, an amplitude, and a waveform shape for the at least one primary vibrating pad (paragraph 128 and 152 and 154-155 and 158-159).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall further comprising a memory device storing a treatment profile specifying at least one of: (i) a first time duration, a frequency, an amplitude, and a waveform shape for the acoustic wave actuator; (ii) a second time duration and a light intensity for the at least one primary LED, and (iii) a third time duration, a frequency, an amplitude, and a waveform shape for the at least one primary vibrating pad as taught by Zipper as this would allow the device to apply the desired therapeutic treatments to the user.
In regards to claim 8, Marshal in view of Haarlander and Zipper teaches the device of claim 7 and Zipper further teaches wherein the light intensity is specified by a pulse width modulation percentage (paragraph 66).
In regards to claim 9, Marshall in view of Haarlander as evidenced by Zhu and in further view of Zipper teaches the device of claim 7 and Haarlander further teaches wherein the treatment profile is received by the control unit wirelessly from a user device or is input by a user via a user interface (paragraph 79).
In regards to claim 15, Marshall in view of Haarlander as evidenced by Zhu teaches the device of claim 1.
Marshall does not disclose wherein the control unit is configured to provide the neovascularization treatment and the vasodilation treatment for a duration of between 5 minutes and 20 minutes.
However, Zipper teaches a personal massage device wherein the control unit is configured to provide the neovascularization treatment and the vasodilation treatment for a duration of between 5 minutes and 20 minutes (paragraph 155).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall wherein the control unit is configured to provide the neovascularization treatment and the vasodilation treatment for a duration of between 5 minutes and 20 minutes as taught by Zipper as this is a time frame which would provide effective therapy.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marshall (US 2017/0360653) in view of Haarlander (US 2014/0303693) and in further view of Callow (US 10449111).
In regards to claim 12, Marshall in view of Haarlander teaches the device of claim 1.
Marshall does not disclose wherein the pad includes memory form and a cover.
However, Haarlander teaches wherein the pad includes foam and a cover (device may be constructed of a variety of materials and lined with foam, paragraph 77).
Further, Callow teaches that memory foam is a known material to be used within such devices (column 4 line 48-51).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marshall wherein the pad includes memory form and a cover as taught by Haarlander and Callow as this would provide a comfortable, biocompatible and hypoallergenic material for the device (Callow: column 4 line 43-45).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785