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 .
Response to Amendment
This Office Action is in response to an amendment filed on 3/2/2026. As directed by the amendment, claims 2-3, 8, 11, 13 ,15, 20-23, and 26 were canceled, claims 1, 4, 10, 12, 18, 24, 25, 27, 28, 29, and 31 were amended, and no new claims were added. Thus, claims 1, 4-7, 9-10, 12, 14, 16-19, 24-25 and 27-32 are pending for this application.
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 (2006/0183072).
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 that are fixed in position (fixed to support element 260 and thus fixed in position relative to support element 260) and 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 device within the device body (Zipper, Fig. 6 depicts a vibration device 204), wherein the vibration device 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 fixed in position and 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 that are fixed in position (fixed to support element 260 and thus fixed in position relative to support element 260) and 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 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).
Claims 9, 18, 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 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 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.
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
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
Applicant’s arguments filed 3/2/2026 have been fully considered.
Applicants amendments to the claims overcome drawing and claim objections and rejections under 35 USC 112(b) have been fully considered and are deemed sufficient to overcome. The objections and rejections have been withdrawn accordingly.
Regarding rejection of claim 1, applicant argued (page 13 paragraph 1 Remarks) that Black’s light emitters are not fixed in position, rather the light emitters rotate around an axis, and thus do not teach the amended claim 1.
Examiner respectfully disagrees.
While the light emitters of Black may rotate about an axis, applicant has not provided a point of reference in the claim for what makes the lights “fixed in position” (relative to what?). Examiner contends that Black discloses the limitation “light emitters fixed in position” because the light emitters are fixed in position relative to the support element to which they are attached and rotate together with (attached to an rotate due to rotation of the support element, and thus are in fixed position relative to the support element). Thus, Zipper in view of Black disclose the claimed invention.
Applicant further argued (page 14 paragraphs 1-2 Remarks) that there is no motivation to combine Zipper with the teachings of Black. Specifically, there is no guidance in Zipper to treat more tissue at once as alleged by Examiner, as Zipper already achieves intended tissue treatment with its light arrangement. Zipper is designed specifically to treat specific areas with the light sources specifically positioned in two different areas to irradiate targeted areas at or near the G spot and at or near the clitoris, not to provide 360 degree coverage.
Examiner respectfully disagrees.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill would recognize that providing for 360 degree coverage would improve the operation of the device of Zipper due to being able to accommodate a variety of users, as user anatomical size differs therefore increasing the area of coverage would allow for more users to receive optimal treatment.
Applicant further argued (page 14 paragraph 3 Remarks) that Zipper would not be motivated to include the rotating light sources of Black because this rotation would be incompatible and potentially unsafe to a user because it must be inserted into the vagina. Furthermore, the device of Black is not a vaginal massage device, and thus non-analagous.
Examiner respectfully disagrees.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Regarding the invention of Black being unsafe, applicant is reminded that the device of Black interfaces with a user via a cover (cover 230) and thus injury to a user due to the rotation of the shaft 260 is not persuasive.
In response to applicant's argument that Black is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Black is in the same field of endeavour of applicant’s invention (tissue rejuvenation) and thus is analogous. Applicant appears to be arguing that because Black and Zipper are used for different anatomical regions that they are not analaous, however applicant is reminded that the test of analogous art is whether the reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned. The test is not between the references used in the rejection. Therefore, applicant’s argument of non-analogousness is not persuasive.
Applicant’s arguments regarding allowability of the dependent claims have been considered but are moot because all independent claims are rejected at this time. Claim 19 stands objected to, and would be allowable if it contained all limitations of the claims from which it depends.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights