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 .
Priority
Claims 1-15 are deemed to have an effective filing date of December 09, 2021.
Claim Rejections - 35 USC § 112
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 merely recites a use of the device of claim 1 without reciting any active, positive steps that delimit how this use is actually practiced. Thus, the scope of claim 15 is vague and indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because “use” claims do not purport to claim a process, machine, manufacture, or composition of matter. See MPEP 2173.05(q).
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).
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).
With respect to claim 8, Xu discloses the device according to claim 1, wherein the device comprises a substrate for supporting the at least one tissue penetrating member and the UV light source (e.g., paragraphs [0006], [0013] and [0130]-[0131]: flexible light sources are supported by a top surface of a flexible substrate and tissue penetrating members are supported by the bottom surface of the substrate).
As to claim 9, Xu discloses the device according to claim 8, 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 a 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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of US Patent Application Publication No. 2019/0099613 to Estes et al. (hereinafter referred to as “Estes”).
Xu discloses the device of claim 1but does not expressly disclose stimulating vitamin D production in a human body. However, Estes, in a related art: wearable ultraviolet light phototherapy device, teaches that wearable ultralight phototherapy devices can be attached to a body part of patient in order to irradiate a patient’s skin with UV-B light in the 295 nm to 315 nm range to increase vitamin D in the patient (e.g., paragraphs [0002], [0006], and [0008]-[0011] of Estes). Accordingly, one of ordinary skill in the art would have recognized the benefits of using a wearable UV-B light device to treat vitamin D deficiency by stimulating vitamin D production by increasing vitamin D content in the patient in view the teachings of Estes. Consequently, one of ordinary skill in the art would have modified the device of Xu to treat vitamin D deficiency by increasing vitamin D content in the patient by wearing the device of Xu in view of the teachings of Estes, 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. 2020/0376292 to Moffat et al. is directed to dynamic dosing systems for phototherapy where exposure to UVB radiation (i.e., wavelengths of 280-320 nm) produces vitamin D within the body exposed (e.g., paragraph [0033]) and that its UV radiation delivers radiation within a predetermined wavelength spectrum between 292 nm and 307 nm to initiate vitamin D production (e.g., paragraph [0181]).
US Patent Application Publication No. 2018/0353770 to Moffat et al. is directed to
System and methods for targeted UVB phototherapy for autoimmune disorders and other indications where phototherapy device providing specific wavelength-focused UVB promote vitamin D production in the skin (e.g., paragraphs [0034]-[0035]); and phototherapy dosage is described as the product of the intensity of a light source and time of exposure to that light source (e.g., paragraph [0068]).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
Prosecution Insights