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 .
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13, line 2 recites “further comprise a coupling portion” but should read --further comprises a coupling portion--.
Claim 13, line 3 recites “its distal end” but should read --the distal end--.
Claim 13, line 4 recites “a vacuum” but should read --the vacuum--.
Claim 13, lines 4-5 recite “a coupling portion” but should read --the coupling portion--.
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 1-20 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.
The term “substantially” in Claims 1, 5, and 12 is a relative term which renders the claim indefinite. The term “substantially” 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. It is unclear from the claims what degree a component would need to meet in order to be consider “substantially” rendering the claims unclear.
Claims 2-11 and 13-20 inherit the same deficiencies.
The term “substantial” in Claim 14 is a relative term which renders the claim indefinite. The term “substantial” 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. It is unclear from the claim what degree a coupling would need to form a hermetic seal in order to be considered a “substantial” seal rendering the claim indefinite.
Claim 8 recites the limitation “the stimulation region” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitations “the pad” in line 5 and “the opening” in line 11. There is insufficient antecedent basis for these limitations in the claim.
Claims 13-20 inherit the same deficiency.
Claim 14 recites the limitation “the coupling” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the Claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the Claimed invention.
Claim(s) 1-6, 9-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldfarb (US 20170202731 A1).
Regarding Claim 1, Goldfarb discloses a method for enhancing blood flow to an anatomical region of a patient, the method comprising the steps of: positioning an applicator (Paragraph [0040] and Figures 1A-D; combination of suction chamber “220” and flange “225”) in relation to the anatomical region (Paragraph [0064] and Figures 4A-C; the device is placed over the clitoris), the applicator comprising: a stimulation portion (Paragraph [0040] and Figures 1A-D; suction chamber “220”), the stimulation portion defining a protrusion extending from the applicator (Figures 1A-D; the figures show that the walls of suction chamber “220” protrude), the protrusion defining an outer surface (Figures 1A-D; the outside surface of suction chamber “220”) and an inner surface (Figures 1A-D; the inside surface of suction chamber “220”); and a membrane portion (Paragraph [0040] and Figures 1A-D; flange “225”), the membrane portion comprising a substantially impermeable material (Paragraph [0040] and Figures 1A-D; flange “225” is adapted to be substantially airtight and is made of silicone); positioning a blood flow enhancement device (Paragraph [0040]-[0045] and Figures 1A-D; combination of device body “210”, stimulators “280”, temperature sensors “5242”, and circuitry) in association with the applicator (Figures 1A-D; the figures show the parts positioned so as to be associated); and actuating the blood flow enhancement device to apply a vacuum to the anatomical region (Paragraph [0045] when suction is applied, tissue is brought into contact with the stimulator), the blood flow enhancement device having a distal end (Figures 1A-D; the distal end is shown as the part that contains stimulators “280” and temperature sensors “5242”) and a proximal end (Figures 1A-D; the proximal end is shown as the top portion of device body “210” opposite the suction chamber), the blood flow enhancement device comprising a tube defining a fluid passageway therein (Paragraph [0057] and Figure 3A’; the tubing in the figure shown between suction inlet “309'” and suction pump “305'”), the fluid passageway fluidly connecting the vacuum (Paragraph [0057] and Figure 3A'; suction pump “305'”) and an opening defined by the distal end (Paragraph [0057] and Figure 3A'; suction inlet “309'”).
Regarding Claim 2, Goldfarb discloses the method of Claim 1, wherein said positioning of the applicator emplaces the stimulation portion at a predetermined area of the anatomical region such that the protrusion is operative to stimulate the predetermined area (Paragraph [0043]; the active stimulators are for stimulating the user's clitoris).
Regarding Claim 3, Goldfarb discloses the method of Claim 1, wherein the step of positioning the blood flow enhancement device in association with the applicator comprises locating a portion of the blood flow enhancement device in the inner surface of the protrusion (Paragraph [0040]-[0045] and Figures 1A-D; stimulators “280” are on an inner surface of the suction chamber to cause the suction and create an airtight seal).
Regarding Claim 4, Goldfarb discloses the method of Claim 1, wherein the stimulation portion comprises a receiving structure (Paragraph [0040] and Figures 1A-D; the top of suction chamber “220” where it meets device body “210”); and wherein the step of positioning the blood flow enhancement device in association with the applicator comprises coupling a portion of the distal end of the blood flow enhancement device with the receiving structure (Paragraph [0040] and Figures 1A-D; the figures show suction chamber “220” couple to device body “210”).
Regarding Claim 5, Goldfarb discloses the method of Claim 4, wherein said coupling of the portion of the distal end with the receiving structure forms a substantially hermetic seal (Paragraph [0040] and Figures 1A-D; the components are shown coupled together and suction chamber “220” is sealed airtight).
Regarding Claim 6, Goldfarb discloses the method of Claim 1, wherein the blood flow enhancement device further comprises a vibrator (Paragraphs [0043]-[0046]; the three active stimulator system includes vibratory motors); and wherein the method further comprises a step of: actuating the vibrator to apply vibration to the anatomical region (Paragraphs [0043]-[0046]; vibrating stimulators are for stimulating a user's clitoris).
Regarding Claim 9, Goldfarb discloses the method of Claim 1, wherein the method further comprises a step of: adjusting a size of the protrusion (Paragraph [0040] flange “225” and suction chamber “220” are composed of a suitable elastic to facilitate engagement with the user, which is interpreted to mean that the size is adjusted via elasticity to fit).
Regarding Claim 10, Goldfarb discloses the method of Claim 1, wherein the applicator is sized and configured to interface with one or more anatomical regions of a patient (Paragraph [0042] the device is sized to fit between the outer and inner labia over the clitoris).
Regarding Claim 11, Goldfarb discloses the method of Claim 10, wherein the one or more anatomical regions are selected from the group consisting of: a male glans, a female glans, a labia majora, a labia minora, a clitoris, an anterior wall of a vagina (Paragraph [0042] the device is sized to fit between the outer and inner labia over the clitoris).
Regarding Claim 12, Goldfarb discloses a system for enhancing blood flow to an anatomical region of a patient, the system comprising: at least one applicator (Paragraph [0040] and Figures 1A-D; combination of suction chamber “220” and flange “225”), the least one applicator comprising: a stimulation portion (Paragraph [0040] and Figures 1A-D; suction chamber “220”), the stimulation portion being operative to define a protrusion extending from the applicator (Figures 1A-D; the figures show that the walls of suction chamber “220” protrude), the protrusion defining an outer surface (Figures 1A-D; the outside surface of suction chamber “220”) and an inner surface (Figures 1A-D; the inside surface of suction chamber “220”); and a membrane portion (Paragraph [0040] and Figures 1A-D; flange “225”), the membrane portion comprising a substantially impermeable material (Paragraph [0040] and Figures 1A-D; flange “225” is adapted to be substantially airtight and is made of silicone); and a blood flow enhancement device (Paragraph [0040]-[0045] and Figures 1A-D; combination of device body “210”, stimulators “280”, temperature sensors “5242”, and circuitry) having a distal end (Figures 1A-D; the distal end is shown as the part that contains stimulators “280” and temperature sensors “5242”) and a proximal end (Figures 1A-D; the proximal end is shown as the top portion of device body “210” opposite the suction chamber), the blood flow enhancement device comprising a tube defining a fluid passageway therein (Paragraph [0057] and Figure 3A'; the tubing in the figure shown between suction inlet “309'” and suction pump “305'”), the fluid passageway being operative to impart a vacuum (Paragraph [0057] and Figure 3A'; suction pump “305'”) to the opening defined by the distal end (Paragraph [0057] and Figure 3A'; suction inlet “309'”), the blood flow enhancement device being operative to be positioned in association with the applicator so as to impart a vacuum to the anatomical region (Paragraph [0057] Figures 1A-D and 3A'; the figures show the components associated and the pump applies suction to the clitoris).
Regarding Claim 13, Goldfarb discloses the system of Claim 12, wherein the stimulation portion further comprises a receiving structure (Paragraph [0040] and Figures 1A-D; the top of suction chamber “220” where it meets device body “210”) and the blood flow enhancement device further comprises a coupling portion at its distal end (Paragraph [0040] and Figures 1A-D; the portion of the device body “210”, stimulators “280”, temperature sensors “5242”, and circuitry that connects within suction chamber “220”), and wherein the blood flow enhancement device is operative to be positioned in association with the applicator so as to impart a vacuum to the anatomical region (Paragraph [0057] Figures 1A-D and 3A'; the figures show the components associated and the pump applies suction to the clitoris) via a coupling portion being operative to be coupled with the receiving structure (Paragraph [0040] and Figures 1A-D; the device body “210”, stimulators “280”, temperature sensors “5242”, and circuitry are connected within suction chamber “220”).
Regarding Claim 14, Goldfarb discloses the system of Claim 13, wherein the coupling of the coupling portion of the distal end with the receiving structure is operative to form a substantial hermetic seal (Paragraph [0040] and Figures 1A-D; the components are shown coupled together and suction chamber “220” is sealed airtight).
Regarding Claim 15, Goldfarb discloses the system of Claim 12, wherein the blood flow enhancement device further comprises a vibrator (Paragraph [0043]-[0046]; the three active stimulator system includes vibratory motors).
Regarding Claim 17, Goldfarb discloses the system of Claim 12, wherein the blood flow enhancement device is operative to adjust a level of suction of the imparted vacuum (Paragraph [0038] the user may rapidly and easily adjust the suction levels).
Regarding Claim 18, Goldfarb discloses the system of Claim 12, wherein a size of the protrusion is operative to be adjusted (Paragraph [0040] flange “225” and suction chamber “220” are composed of a suitable elastic to facilitate engagement with the user, which is interpreted to mean that the size is adjusted via elasticity to fit).
Regarding Claim 19, Goldfarb discloses the system of Claim 12, wherein each of the one or more applicators is sized and configured to interface with one or more anatomical regions of a patient (Paragraph [0042] the device is sized to fit between the outer and inner labia over the clitoris).
Regarding Claim 20, Goldfarb discloses the system of Claim 19, wherein the one or more anatomical regions are selected from the group consisting of: a male glans, a female glans, a labia majora, a labia minora, a clitoris, an anterior wall of a vagina (Paragraph [0042] the device is sized to fit between the outer and inner labia over the clitoris).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7, 8, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb (US 20170202731 A1) as applied to claims 1 and 12 above, and further in view of Shaheen (“Effect of High-Intensity Focused Ultrasound on Vaginal Relaxation Syndrome.” 2023).
Regarding Claim 7, Goldfarb discloses the method of claim 1, wherein the blood flow enhancement device further comprises a sound transducer (Paragraphs [0044]-[0045] the three active stimulators include a sonic stimulator); and wherein the method further comprises a step of: actuating the sound transducer (Paragraphs [0044][0045] low frequency sounds or pressures may be delivered for stimulation). Goldfarb fails to explicitly disclose an ultrasonic transducer applying heat to the anatomical region. Shaheen is in the art of female sexual health and teaches actuating an ultrasonic transducer to apply heat to an anatomical region (Introduction section, para 5; high intensity focused ultrasound for vaginal rejuvenation uses focused thermal effects at specific depths determined by a 20 mm ultrasound transducer emitting convergent ultrasonic waves). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Goldfarb, to include an ultrasonic transducer applying heat to the anatomical region as taught by Shaheen for the purpose of improving sexual health.
Regarding Claim 8, modified Goldfarb discloses the method of claim 7, wherein sound waves emitted by the sound transducer are transmitted across the stimulation region (Paragraphs [0044]-[0045] the three active stimulators include a sonic stimulator and low frequency sounds or pressures may be delivered for stimulation). Goldfarb fails to explicitly disclose ultrasonic waves emitted by the ultrasonic transducer. Shaheen is in the art of female sexual health and teaches actuating an ultrasonic transducer to apply heat to an anatomical region (Introduction section, para 5; high intensity focused ultrasound for vaginal rejuvenation uses focused thermal effects at specific depths determined by a 20 mm ultrasound transducer emitting convergent ultrasonic waves). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Goldfarb, to include ultrasonic waves emitted by the ultrasonic transducer as taught by Shaheen for the purpose of improving sexual health.
Regarding Claim 16, Goldfarb discloses the system of claim 12, wherein the blood flow enhancement device further comprises a sound transducer (Paragraphs [0044]-[0045] the three active stimulators include a sonic stimulator); and wherein the stimulation portion is operative to permit sound waves to be transmitted therethrough (Paragraphs [0044]-[0045] the three active stimulators include a sonic stimulator and low frequency sounds or pressures may be delivered for stimulation). Goldfarb fails to explicitly disclose an ultrasonic transducer or ultrasonic waves. Shaheen is in the art of female sexual health and teaches an ultrasonic transducer (Introduction section, para 5; high intensity focused ultrasound); and wherein the stimulation portion is operative to permit ultrasonic waves to be transmitted therethrough (Introduction section, para 5; high intensity focused ultrasound for vaginal rejuvenation uses focused thermal effects at specific depths determined by a 20 mm ultrasound transducer emitting convergent ultrasonic waves). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Goldfarb, to include an ultrasonic transducer and ultrasonic waves as taught by Shaheen for the purpose of improving sexual health.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lenke (US 12090110 B2), Sedic (US 11998502 B2), Witt (US 20170281457 A1), Makower (US 8579837 B1), and Mertens (US 20080071138 A1) disclose devices for applying a vacuum stimulation to an anatomical region. Gordon (US 20200268597 A1) discloses a device for applying vacuum, vibration and acoustic stimulation to an anatomical region. Gaines (US 11819689 B1) discloses a medical procedure for applying acoustic waves for treating human male and female patients suffering from erectile or sexual dysfunction.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791
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