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 Action is in response to the Amendment filed July 29, 2026.
In view of the Amendment, the rejection of claim 15 under 35 USC 112 and the rejection of claim 15 under 35 USC 101, as set forth in the Office Action dated 04/29/2026, are withdrawn.
Claims 1 and 9 are amended.
Claims 8 and 15 are canceled.
Claims 1-7 and 9-14 are pending.
Priority
Claims 1-14 are deemed to have an effective filing date of December 09, 2021.
Response to Arguments
Applicant's arguments filed 07/29/2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that the prior references, including Xu (US 2021/0205632), fail to disclose the newly added limitation: a substrate for supporting at least one tissue penetrating member and the UV-B light source, wherein the substrate is at least optically transparent, the Examiner disagrees. Fig. 16 of Xu illustrates a device with UVA1 LEDs coupled to PLGA microneedles where the microneedles and its substrate are made of a clear/transparent material so that the array of LEDs can be seen in the photographs of the device (see paragraphs [0091]; [0006]: flexible substrate top surface may support flexible optical light sources, flexible substrate bottom surface supports tissue penetrating members, the optical light sources are in optical communication with the tissue penetrating members so that the light sources provide light to the penetrating members, which in turn provide light to the surrounding tissue – that is, the top and bottom surfaces supporting the LEDs and penetrating members respectively necessarily be partly optically transparent; [0130]: substrate 80 supports microarray 30 of penetrating members 40; [0131]: optical source 90 may comprises UVA and/or UVB LEDs where members 40 and bottom substrate/substrate 80 may be removably connected to light source 90 and corresponding top substrate/electronic circuit 430).
In response to applicant's arguments that Xu teaches away from the instant invention, the applicant is respectfully advised that a reference is no less anticipatory if, after disclosing the invention, the reference then disparages it. The question whether a reference “teaches away” from the invention is inapplicable to an anticipation analysis. Celeritas Technologies Ltd. v. Rockwell International Corp., 47 USPQ2d 1516 (Fed. Cir. 1998).
The Examiner further notes that Xu does not disparage that the bottom substrate is transparent (as clearly shown in Fig. 16). The use of optical dispersion elements can be used with a substrate that is partly optically transparent as discussed in paragraph [0133]: The embodiment of Xu in Fig. 1A-1D may include a substrate component 420 to improve light delivery. The device of Xu does not require an optical dispersion element for its device to deliver light through the top and bottom surfaces of the substrate as shown in Fig. 23. Moreover, the bottom substrate supporting the needles of Fig. 23 is labeled: therapeutic and/or optical enhancing substrate. That is, the bottom substrate may be made from a material that is optically enhancing of the at least partly optically transparent (e.g., paragraph [0009]; [0098]: therapeutic and/or optical enhancing substrate include optical components to improve directed optical path for light between light sources and underlying tissue penetrating members).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2021/0205632 to Xu et al. (EFD: 05/17/2019 and hereinafter referred to as “Xu”).
Regarding claim 1, Xu discloses a device that is capable of stimulating vitamin D production in a tissue (e.g., abstract: light delivery devices for increasing light penetration depth), the device comprising: a UV light source configured to emit light with a wavelength between 280 nm and 320 nm (e.g., paragraphs [0130]-[0131]: conformable light delivery device 10 comprises a UV light source including UVB LEDs; and [0173]: UVB (290-320 nm) and more specifically narrow-band ultraviolet light (322nm) are known wavelengths for treating a patient; Fig. 1A); and at least one tissue penetrating member optically coupled to the UV light source to deliver light emitted from the UV light source into the tissue (e.g., paragraphs [0017] and [0130]: conformable light delivery device 10 comprises tissue penetrating members 40 that facilitate increased penetration depth of light into tissue), wherein the at least one tissue penetrating member has a length greater than or equal to 10 μm and less than 10 mm (e.g., paragraph [054]: tissue penetrating members have a length that is greater than or equal to 10 µm and less than or equal to 100 µm) and a substrate for supporting at least one tissue penetrating member and the UV-B light source, wherein the substrate is at least optically transparent (see paragraph [0006]: flexible substrate top surface may support flexible optical light sources, flexible substrate bottom surface supports tissue penetrating members, the optical light sources are in optical communication with the tissue penetrating members so that the light sources provide light to the penetrating members, which in turn provide light to the surrounding tissue – that is, the top and bottom surfaces/substrates supporting the LEDs and penetrating members respectively necessarily be partly optically transparent in order to provide light from the LEDs through the top and bottom substrates to the tissue penetrating members and to the surrounding tissue).
With respect to claim 2, Xu discloses the device according to claim 1, wherein the UV light source is an LED (e.g., paragraph [0131]: optical light source 90 may comprise a plurality of LEDs, 100 including UVB LEDs).
As to claim 3, Xu discloses the device according to claim 1, wherein the UV light source is configured to emit light with a wavelength between 290 nm and 308 nm (e.g., paragraph [0201]: LEDs for UVB manufacturers include MarkTech Optoelectronics (Albany N.Y.) which offers LEDS at the 310 nm +/-5 nm or between 290 nm and 308 nm).
With respect to claim 4, Xu discloses the device according to claim 1, wherein the UV light source is configured to emit light with a wavelength of 293 nm, 295 nm, 298 nm or 305 nm (e.g., paragraph [0201]: LEDs for UVB manufacturers include MarkTech Optoelectronics (Albany N.Y.) which offers LEDS at the 310 nm +/-5 nm where the light source emits light with a wavelength of 305 nm (-5 of 310)).
As to claim 5, Xu discloses the device according to claim 1, wherein the at least one tissue penetrating member is a microneedle (e.g., paragraph [0171]: the second layer of the device, attached to the skin, includes a microneedle patch with tiny needles (length 100µm)).
With respect to claim 6, Xu discloses the device according to claim 1, wherein the device comprises a plurality of tissue penetrating members, wherein each tissue penetrating member is optically coupled to the UV light source to deliver light emitted from the UV light source into the tissue (e.g., paragraph [0171]: microneedle patch with tine needles guides narrow-band UVB deeper into the tissue).
As to claim 7, Xu discloses the device according to claim 6, wherein the plurality of tissue penetrating members are arranged in an array (e.g. abstract and paragraphs [0006], [0026], [0017], [0025] and [0131]: device comprises a microarray of tissue penetrating members).
As to claim 9, Xu discloses the device according to claim 1, wherein the substrate comprises a patch with an adhesive layer thereon for reversibly attaching the device to the tissue (e.g., paragraph [0183]: a flexible microneedle light therapy system directly adhered to the skin implies attaching with adhesive).
With respect to claim 10, Xu discloses the device according to claim 1, wherein the at least one tissue penetrating member is reversibly couplable to the UV light source (e.g., paragraphs [0007]: tissue penetrating member component is attached to the light source component with a removable connection; and [0131]: the portion of the device that comes into contact with the biological material may be removably connected where the connection may be a removable adhesive;).
As to claim 11, Xu discloses the device according to claim 10, wherein the UV light source is reusable and the at least one tissue penetrating member is disposable (e.g., paragraph [0007]: light source component may be reusable and the tissue penetrating member component is single use or disposable).
With respect to claim 12, Xu discloses the device according to claim 1, wherein the UV light source and the at least one tissue penetrating member are integrally formed (e.g., paragraphs [0023]: the optical source and the microarray of penetrating members are integrated or removably connected to each other; [0076]: integrated wearable light therapy device combining a LED patch with an array of tissue penetrating members; and [0131]: microarray of members 40 may be integrated with the optical light source).
As to claim 13, Xu discloses the device according to claim 1, further comprising a battery to power the UV light source (e.g., paragraph [0176]: LEDs for UVB delivery are operated using direct current that enables battery power for their operation).
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Xu and US Patent Application Publication No. 2021/0060323 to Rape et al. (hereinafter referred to as “Rape”).
Xu discloses the device according to claim 1, but does not expressly disclose a timer configured to provide user feedback when an activation period of the UV light source meets a predefined time limit. However, Rape, in a related art: wearable apparatus containing a microneedle array for intradermal drug delivery, teaches a device having an array of microneedles and a light -to-heat element where a timer provides for the administration of a dosage (e.g., paragraph [0017] of Rape). Accordingly, one of ordinary skill in the art would have recognized the benefits of a timer for an intradermal medical device in view of the teachings of Rape. Consequently, one of ordinary skill in the art would have modified the device of Xu to further include a timer that is configured to or capable of providing user feedback to activate/deactivate the UV-B light source of Xu in view of the teachings of Rape that such was a well-known expedient in the intradermal medical device art, and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2011/0224515 to Mir et al. is directed to replaceable microneedle for biomedical monitoring where a substrate 24, at least in the area of the microneedle base 30 is transparent or translucent (e.g., paragraph [0100] and Fig. 15).
US Patent Application Publication No. 2019/0099613 to Estes et al. is directed to
wearable ultraviolet light phototherapy device where the substrate can have a reflective layer, diffusive layer and a core layer that can be coupled to the ultraviolet light emitting sources and is made from an ultraviolet transparent layer (e.g., paragraphs [0012]); and the material/structure/layer is considered “ ‘transparent’ to ultraviolet radiation … when the material/structure/layer allows at least 10 percent of radiation … to pass there through (e.g., paragraph [0042]).
US Patent Application Publication No. 2021/0060323 to Rape et al. directed to a wearable apparatus having a microneedle array for drug delivery also teaches that the device is designed to enable radiation transparency by making the adhesive 104 connecting the microneedle array to the substrate (flexible printed circuit board) and the substrate 109 for the microneedle array 101 must be transparent with respect to the wavelength of light used to activate the microneedle array (e.g., paragraph [0019] and Figs 1-2).
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 CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
