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 .
DETAILED ACTION
1. This office action is in response to the Request for Continued Examination (RCE) and amendment filed 7/18/2025. As directed to the amendment, claims 1, 4, 7, 10, 12, 17, and 19 have been amended, claims 2-3, 8, 13, 15, and 21-23 have been canceled, and claims 25-33 have been added. Thus, claims 1, 4-7, 9-12, 14, 16-20, and 24-32 are pending in the application.
Drawings
2. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s).
“a proximity sensor coupled to the shell portion” (claim 11, ln. 1-2; claim 20, ln. 1-2);
“an external motor and a counterweight attached to an external appendage of the device” (claim 26, ln. 1-2).
No new matter should be entered.
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
3. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The term “vibration mechanism” (claim 4, ln. 2).
Claim Interpretation- 35 USC § 112 – Sixth Paragraph/35 USC § 112(f)
4. 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 limitations are interpreted as invoking 35 USC 112(f).
Claim Objections
5. Claims 10-11, 20, 24, 26-29, and 31 are objected to for the following reasons:
Regarding claim 10, the limitation “through which light can pass for treatment of tissue” (ln. 3) should read --through which light is able to pass for treatment of tissue-- to avoid any possibility that the word “can” implies that the limitation is optional.
Regarding claim 11, the limitation “the proximity sensor detects contact” (ln. 2) should read --the proximity sensor is configured to detect contact-- to avoid any interpretation that the claim is directed to a method instead of a device.
Regarding claim 20, the limitation “the proximity sensor…detects contact” (ln. 2-3) should read --the proximity sensor…is configured to detect contact-- to avoid any interpretation that the claim is directed to a method instead of a device.
Regarding claim 24, the term “the light emitter component” (ln. 1) should read --the light emitting subsystem-- for the sake of consistency with how the term is originally introduced in claim 1
Regarding claim 26, the term “the shell of the device” (ln. 3) should read --the shell portion of the device-- for the sake of consistency with how the term is originally introduced in claim 1
Regarding claim 27, the phrase “wherein the device adjusts light emitted” (ln. 5) should read --wherein the device is configured to adjust light emitted-- to avoid any interpretation that the claim is directed to a method instead of a device.
Regarding claim 28, the phrase “wherein the device adjusts light emitted” (ln. 5) should read --wherein the device is configured to adjust light emitted-- to avoid any interpretation that the claim is directed to a method instead of a device.
Regarding claim 29, “wherein the device further comprises a vibration within the device” (ln. 2-3) appears as though it should read -- wherein the device further comprises a vibrator within the device body--.
Regarding claim 31, “wherein the device further comprises a vibration within the device” (ln. 2-3) appears as though it should read -- wherein the device further comprises a vibrator within the device body--.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 18 and 25 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.
Regarding claim 18, the term “the safety temperature component” (ln. 5) lacks an antecedent basis. For the purposes of examination, the claim will be interpreted as introducing the option of a safety temperature component as providing “thermal adjustment to the human tissue.”
Regarding claim 25, the limitation “to maximize surface reflection or vibration” (ln. 2) is unclear as to the degree required to “maximize” reflection or vibration. For the purposes of examination, the limitation will be interpreted as requiring a resonant drive motor that introduces vibrations to the outer walls of the device.
Claim Rejections - 35 USC § 103
8. 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 of this title, 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.
9. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
10. Claims 1 and 4-7, 10, 12, 14, 16-17, 24-26, and 32 are rejected under 35 U.S.C. 103 as being obvious over Zipper (2013/0261385) in view of Black (2006/0183071).
Regarding claim 1, Zipper discloses a device for tissue rejuvenation therapy (Fig. 1 depicts a tissue rejuvenation device), the device comprising: a device body (Fig. 5, the entire device forms a “device body.” See annotated Fig. 5 below for convenience) comprising: a shell portion forming an external surface of the device body (Fig. 5, front cover plate 410, rear cover plate 411, main support structure 412, rear cover 413, and flexible cover 402 together form a “shell portion.” Flexible cover 402 forms an “external surface” together with front cover plate 410 and rear cover 413); a treatment area designed to allow the passage of light therethrough (See annotated Fig. 5, which depicts a light emitting subsystem that emits light that passes through the corresponding area of flexible cover 402. [0045] discloses that flexible cover 402 is made of a material that allows light to pass through); a proximal handle portion composed at least in part of an opaque polymer material (Fig. 5, front cover plate 410 and rear cover 413 join to form a “proximal handle portion.” [0050] discloses use of silicone compounds or any flexible polymer material); and a light emitting subsystem within the device body (Fig. 6, vaginal light source group 202 is located within the device body), the light emitting subsystem comprising: a set of light emitters distributed along a longitudinal axis within the treatment area of the shell portion of the device body (Fig. 7a depicts light sources 202a, 202b, and 202c as part of the light source group 202. Fig. 6 shows the light source group 202 distributed along a longitudinal axis), and a set of components that focus light emitted from the set of light emitters onto a human tissue, during operation, to provide adjustment of light transmission to the human tissue ([0031] discloses the use of a lens or lenses placed over the light source(s) to alter the emitted light).
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Zipper does not disclose the treatment area as explicitly transparent and formed radially around the shell portion (although [0042] of Zipper discloses that cover 402 is made of silicone, which is arguably “transparent” to the treatment light), or that the set of light emitters is distributed radially around a longitudinal axis.
However, Black teaches a light treatment device for application of hygienic effects comprising a shell portion (see annotated Fig. 2 below), a transparent treatment area formed radially around the shell portion (Fig. 2, hollow cover 230 is formed radially around the shell portion. [0016] discloses that the cover is explicitly transparent to the light treatments), and a set of light emitters distributed radially around a longitudinal axis within the treatment area of the shell portion of the device (Fig. 2, lights 250 are radially distributed around longitudinal support element 260).
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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 the light emitting subsystem of Zipper to have a set of light emitters distributed radially around a longitudinal axis within the treatment area of the device body as taught by Black. Such a radial arrangement of the light emitters would allow light treatment to emit in a 360-degree range to treat more tissue at once. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that Zipper’s cover 402 is transparent in a radial manner around the shell portion at the location of the treatment area as taught by Black. Black explicitly teaches that its cover 230 is made of a “transparent” material and gives an example of silicone, which is the same material as Zipper’s cover 402. In any case, Black teaches that making the cover out of a material that is transparent to the treatment light would provide for an effective treatment of the target tissue.
Regarding claim 4, the modified device of Zipper has a vibration mechanism within the device body (Zipper, Fig. 6 depicts a vibration mechanism 204), wherein the vibration mechanism comprises a resonant drive motor (Zipper, Fig. 6, vibrator 204 is depicted as a resonant drive motor with an eccentric weight attached to the motor shaft) flexibly coupled to a distal portion of the shell portion of the device body configured to apply vibration to the human tissue (Zipper, Fig. 6, vibrator supports 441 and vibrator retaining structure 440 would “flexibly” couple the vibrator 204 to the distal portion of the shell portion and provide vibrations to the distal portion of the shell portion).
Regarding claim 5, the modified device of Zipper has the set of light emitters further configured to provide a treatment mode in which the set of light emitters emit light in a first wavelength range (Zipper, [0058] discloses a “red” and “infrared” LEDs emitting wavelengths between 610 nm to 640 nm and between 820 to 880 nm, respectively. This wavelength falls within the applicant’s disclosed “treatment mode” wavelength parameters. See specification paragraph [0060], which calls for light in the range of 600-1000 nm), and a sterilization mode in which the set of light emitters emit light in a second wavelength range (Zipper, [0058] additionally discloses a “blue” LED emitting at a wavelength of 400 nm. While Zipper does not explicitly state this as performing “sterilization,” a wavelength of 400 nm falls within the applicant’s disclosed “sterilization mod” parameters. See specification paragraph [0059], which calls for light in the range of 250-400 nm for sterilization), wherein the device is operable to transition between the treatment mode and the sterilization mode (Zipper, Fig. 9 depicts “PulseWave Pattern 3” transitioning from a mode in which the “red” and “infrared” source is on to a mode in which the “blue” light source is on). The modified device of Zipper would incorporate these light modes into the radial light configuration taught by Black.
Regarding claim 6, the modified device of Zipper has the set of light emitters comprising a set of lines of light emitting diodes distributed along the longitudinal axis (Black, Fig. 2, depicts the lights 250A, 250B, and 250C as forming lines).
Regarding claim 7, the modified device of Zipper has the shell portion as flexible and composed of, at least in part, a silicone material (Zipper, [0045], discloses the cover 402 as flexible and made of silicone).
Regarding claim 10, the modified device of Zipper has the treatment area forming a band positioned radially around the shell portion of the device body through which light is able to pass for treatment of tissue (Zipper, Fig. 6, the portion of flexible cover 402 that is located at the vaginal 200 is a type of “band” that allows light emitted from the light emitting elements to pass through. In the modified device, this portion of the cover 402 is explicitly “transparent”).
Regarding claim 12, Zipper discloses a device for tissue rejuvenation therapy (Fig. 1 depicts a tissue rejuvenation device), the device comprising: a device body (Fig. 5, the entire device forms a “device body.” See annotated Fig. 5 below for convenience) comprising: a shell portion composed of at least partially of an opaque material (Fig. 5, front cover plate 410, rear cover plate 411, main support structure 412, rear cover 413, and flexible cover 402 together form a “shell portion,” with the rear cover 413 and the front cover plate being opaque); and defining a treatment area designed to allow the passage of light therethrough (See annotated Fig. 5, which depicts a light emitting subsystem that emits light that passes through the corresponding area of flexible cover 402. [0045] discloses that flexible cover 402 is made of a material that allows light to pass through); a light emitting subsystem integrate with the device body (Fig. 6, vaginal light source group 202 is located within and “integrated with” the device body), the light emitting subsystem comprising: a set of light emitters distributed along a longitudinal axis within the shell portion of the device body and positioned at the treatment area, the set of light emitters comprising at least one light emitter configured for providing treatment to a human tissue (Fig. 7a depicts light sources 202a, 202b, and 202c as part of the light source group 202. These light sources 202 emit light for treating human tissue. Fig. 6 shows the light source group 202 distributed along a longitudinal axis),
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Zipper does not disclose the treatment area as explicitly transparent and formed radially around the shell portion (although [0042] of Zipper discloses that cover 402 is made of silicone, which is arguably “transparent” to the treatment light), or that the set of light emitters is distributed radially around a longitudinal axis.
However, Black teaches a light treatment device for application of hygienic effects comprising a shell portion (see annotated Fig. 2 below), a transparent treatment area formed radially around the shell portion (Fig. 2, hollow cover 230 is formed radially around the shell portion. [0016] discloses that the cover is explicitly transparent to the light treatments), and a set of light emitters distributed radially around a longitudinal axis within the treatment area of the shell portion of the device (Fig. 2, lights 250 are radially distributed around longitudinal support element 260).
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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 the light emitting subsystem of Zipper to have a set of light emitters distributed radially around a longitudinal axis within the treatment area of the device body as taught by Black. Such a radial arrangement of the light emitters would allow light treatment to emit in a 360-degree range to treat more tissue at once. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that Zipper’s cover 402 is transparent in a radial manner around the shell portion at the location of the treatment area as taught by Black. Black explicitly teaches that its cover 230 is made of a “transparent” material and give an example of silicone, which is the same material as Zipper’s cover 402. In any case, Black teaches that making the cover out of a material that is transparent to the treatment light would provide for an effective treatment of the target tissue.
Regarding claim 14, the modified device of Zipper has the shell portion configured for a lubricant matching a refractive index of the treatment area (Zipper, Fig. 5, silicone flexible cover 402 is “configured” for a lubricant. It is noted that the claims do not actually claim the lubricant).
Regarding claim 16, the modified device of Zipper has the set of light emitters comprising a set of lines of light emitting diodes distributed along the longitudinal axis (Black, Fig. 2, depicts the lights 250A, 250B, and 250C as forming lines).
Regarding claim 17, the modified device of Zipper has the shell portion composed at least in part of a material that provides a slight deformability (Zipper, [0045] discloses the cover 402 as flexible or deformable).
Regarding claim 24, the modified device of Zipper has the light emitter component is configured to apply a power density of about 150 mW/Cm2 (Zipper, [0036], discloses intensities of 0.001W/cm2 to 100 W/cm2).
Regarding claim 25, the modified device of Zipper has a resonant drive rotor coupled to the outer walls of the device and configured to maximize surface reflection or vibration (Zipper, Fig. 6, both vibrators 204 and 304 are “coupled to” the outer walls of the device. Vibrations generated by vibrators 204 and 304 are transmitted to the outer walls of the device, indicated that the vibrators are “coupled to” the outer walls of the device).
Regarding claim 26, the modified device of Zipper has an external motor and a counterweight attached to an external appendage of the device or flexibly coupled to a portion of an inner wall of the shell of the device (Zipper, Fig. 6, vibrator 304 has an eccentric counterweight and is located on an inner wall of the clitoral finger 300).
Regarding claim 32, the modified device of Zipper has the light emitting subsystem further comprising a set of components that focus light emitted from the set of light emitters onto a human tissue, during operation, to provide adjustment of light transmission to the human tissue ([0031] discloses the use of a lens or lenses placed over the light source(s) to alter the emitted light).
11. Claims 9, 11, 18, 20, and 27-28 are rejected under 35 U.S.C. 103 as being obvious over Zipper in view of Black, as applied to claims 1 and 12 above, and further in view of Altschuler et al (20080058783).
Regarding claim 9, the modified device of Zipper does not disclose a cooling subsystem comprising at least one of a reservoir of cryogenic fluid and a Peltier cooler thermally coupled to the shell portion.
However, Altshuler teaches a handheld photo cosmetic device used to treat tissue ([0074] discloses treating vaginal tissue), wherein the device comprises a temperature safety mechanism having a thermocouple ([0092] discloses a temperature safety mechanism comprising a thermocouple embedded in the device for communicating with the controller to deactivate the light source if the device is overheating) and a cooling mechanism integrated with the device ([0101]-[0103] disclose numerous a cooling mechanisms for maintaining the device within an acceptable temperature range, including a thermoelectric or “Peltier” cooler). Altshuler additionally teaches that the device adjusts light emitted by the set of light emitters in response to a thermal condition (Altshuler, [0092], discloses a feedback mechanism comprising a temperature sensor 28a that monitors the operating temperature of the device and adjusts the light emitted by the device to ensure that the temperature remains within a safe range for the user (e.g. the EMR source is deactivated if the temperature exceeds a predefined value)).
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 the device of Zipper to have a safety temperature mechanism comprising a thermocouple, a cooling mechanism (i.e. thermoelectric or Peltier cooler), and a light emitter adjustment mechanism as taught by Altshuler in order to prevent the device from overheating and possibly burning the user.
Regarding claim 11, the modified device of Zipper does not have a proximity sensor coupled to the shell portion, wherein the proximity sensor detects contact between the human tissue and the device during operation.
However, Altshuler additionally teaches a contact sensor for sensing contact between the device and the skin of a user. This provides a safety mechanism that prevents the delivery of light to the skin if there is not sufficient contact between the device and the skin ([0023]).
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 the device of Zipper to have a proximity sensor for detecting contact between the device and the user as taught by Altshuler. This modification provides a safety mechanism that prevents the delivery of light to the skin if there is not sufficient contact between the device and the skin.
Regarding claim 18, the modified device of Zipper does not disclose a cooling subsystem comprising at least one of a reservoir of cryogenic fluid and a Peltier cooler thermally coupled to the shell portion., wherein the set of light emitters are configured to transmit light onto the human tissue during operation, to provide thermal adjustment to the human tissue to a first penetration depth in association with tissue restoration; and wherein at least one of the cooling subsystem and a safety temperature component provides thermal adjustment to the human tissue, during operation, to a second penetration depth in association with perceived discomfort reduction.
However, Altshuler teaches a handheld photo cosmetic device used to treat tissue ([0074] discloses treating vaginal tissue), wherein the device comprises a temperature safety mechanism having a thermocouple ([0092] discloses a temperature safety mechanism comprising a thermocouple embedded in the device for communicating with the controller to deactivate the light source if the device is overheating) and a cooling mechanism integrated with the device ([0101]-[0103] disclose numerous a cooling mechanisms for maintaining the device within an acceptable temperature range, including a thermoelectric or “Peltier” cooler). Altshuler additionally teaches that the device adjusts light emitted by the set of light emitters in response to a thermal condition (Altshuler, [0092], discloses a feedback mechanism comprising a temperature sensor 28a that monitors the operating temperature of the device and adjusts the light emitted by the device to ensure that the temperature remains within a safe range for the user (e.g. the EMR source is deactivated if the temperature exceeds a predefined value)).
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 the device of Zipper to have a safety temperature mechanism comprising a thermocouple, a cooling mechanism (i.e. thermoelectric or Peltier cooler), and a light emitter adjustment mechanism as taught by Altshuler in order to prevent the device from overheating and possibly burning the user.
This modified device of Zipper would have the set of light emitters are configured to transmit light onto the human tissue, during operation, to provide thermal adjustment to the human tissue to a first penetration depth in association with tissue restoration (Zipper, [0034] discloses the use of light therapy to trigger neurological responses within the body. In order to trigger these responses, the light from the light emitters must penetrate tissue to a certain depth. Furthermore, this light penetration would provide some degree of heating of the tissue); wherein at least one of the cooling subsystem and the safety temperature component provides thermal adjustment to the human tissue, during operation, to a second penetration depth in association with perceived discomfort reduction (Altshuler, [0101]-[0103] the cooling fluid and/or the thermoelectric cooler would provide thermal adjustments during operation. Additionally, Altshuler’s teaching of controlling temperature via control of the light therapy would provide thermal adjustments during operation. These thermal adjustments would penetrate the skin to a “second penetration depth”).
Regarding claim 20, the modified device of Zipper does not have a proximity sensor coupled to the shell portion, wherein the proximity sensor comprises at least one of an optical sensor and a capacitive sensor and detects contact between the human tissue and the device during operation.
However, Altshuler additionally teaches a contact sensor for sensing contact between the device and the skin of a user. This provides a safety mechanism that prevents the delivery of light to the skin if there is not sufficient contact between the device and the skin ([0023]). Altshuler additionally states that the contact sensor can be a conductance (i.e. capacitive) sensor ([0023]).
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 the device of Zipper to have a proximity sensor in the form of a capacitive sensor for detecting contact between the device and the user as taught by Altshuler. This modification provides a safety mechanism that prevents the delivery of light to the skin if there is not sufficient contact between the device and the skin.
Regarding claims 27 and 28, the modified device of Zipper does not have a safety temperature component comprising a thermocouple assembly in thermal communication with the human tissue, through the shell portion, wherein the safety temperature component is configured to detect that a thermal condition of the human tissue of a user satisfies a threshold condition, wherein the device adjusts light emitted by the set of light emitters in response to the thermal condition.
However, Altshuler teaches a handheld photo cosmetic device used to treat tissue ([0074] discloses treating vaginal tissue), wherein the device comprises a temperature safety mechanism having a thermocouple ([0092] discloses a temperature safety mechanism comprising a thermocouple embedded in the device for communicating with the controller to deactivate the light source if the device is overheating) and a cooling mechanism integrated with the device ([0101]-[0103] disclose numerous a cooling mechanisms for maintaining the device within an acceptable temperature range, including a thermoelectric or “Peltier” cooler). Altshuler additionally teaches that the device adjusts light emitted by the set of light emitters in response to a thermal condition (Altshuler, [0092], discloses a feedback mechanism comprising a temperature sensor 28a that monitors the operating temperature of the device and adjusts the light emitted by the device to ensure that the temperature remains within a safe range for the user (e.g. the EMR source is deactivated if the temperature exceeds a predefined value)).
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 the device of Zipper to have a safety temperature mechanism comprising a thermocouple, a cooling mechanism (i.e. thermoelectric or Peltier cooler), and a light emitter adjustment mechanism as taught by Altshuler in order to prevent the device from overheating and possibly burning the user.
12. Claims 29-31 are rejected under 35 U.S.C. 103 as being obvious over Zipper in view of Black, as applied to claims 6 and 16 above, and further in view of Barnard et al (2012/0136287).
Regarding claims 29 and 31, the modified device of Zipper has the light emitting diodes configured to emit light in one or both of a red or near-infrared portion of the spectrum ([0033] discloses both infrared and near infrared), and wherein the device further comprises a vibrator (Zipper, vibrators 204 and 304)
The modified device of Zipper does not disclose a vibration setting that operates in the 8-10 Hz range.
However, Barnard teaches a vaginal tissue regeneration device having a vibration features wherein vibrations are applied to tissue at a frequency between 500-7,000 rpm ([0013]), which equates to 8.33 - 116,67 Hz.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the vibration of the modified device of Zipper to generate vibrations at 8.33 Hz as taught by Barnard because such a frequency is shown to be effective and rejuvenating vaginal tissue.
Regarding claim 30, the modified device of Zipper has the device with at least one setting to operate for a time period equal to any amount of time in the range of 1 to 10 minutes (Zipper, [0067], discloses a treatment time period of 7 minutes).
Allowable Subject Matter
13. Claim 19 is 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. The prior art of record does not disclose the treatment area as a transparent treatment band, “the transparent treatment band flanked on either side by the opaque material of the shell portion” (ln. 3-4).
Response to Arguments
14. Applicant’s arguments filed 7/18/2025 on Pages 8-9 with respect to Zipper not disclosing a transparent treatment area because the flexible cover 402 is not transparent have been considered, but are not fully persuasive. The examiner acknowledges that the matter of a silicone being “transparent” is a close call. While Zipper does not explicitly call the cover 402 “transparent,” the cover clearly allows for light to pass through. In any case, the argument is moot because the new reference of Black has been applied in the above rejection. Black clearly discloses its cover as “transparent” (see [0016], which also provides “silicone” as an example of a transparent cover).
15. Applicant’s arguments on Page 10 regarding Zipper failing to disclose a transparent treatment area “formed radially around the shell portion” have been considered, but are moot in view of the newly applied reference of Black.
16. Applicant’s arguments on Pages 10-11 regarding Zipper failing to disclose light emitters “distributed radially around a longitudinal axis” have been considered, but are moot in view of the newly applied reference of Black.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY A STANIS whose telephone number is (571)272-5139. The examiner can normally be reached on Mon - Fri 8:30-5:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached on 571-272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY A STANIS/Primary Examiner, Art Unit 3785