DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 02/19/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 5, and 7-11 are rejected under 35 U.S.C. 103 as being as being obvious over Toprak (DE 102017121900 A1) in view of Shiels et al. (US 2016/0243171 A1) and Klitzman et al. (US 6,013,122).
Regarding claim 1, Toprak discloses tattoo compositions for aesthetic purposes (abstract; English translation, pg. 1, bottom paragraph) which in Example 1 includes a black tattoo ink and a local anesthetic in aqueous solution (English translation, pg. 11) where the formulation is configured for insertion into a dermal layer of skin by percutaneous punctures (English translation, pg. 2, paragraph 5). A solution is defined as a dispersion in which the constituents are distributed in the liquid phase (English translation, pg. 6, paragraph 7).
Toprak does not disclose the composition includes extracellular vesicles, as recited in claim 1.
Shiels teaches the intradermal administration of microvesicles (i.e., exosomes [0060]) [0017] [abstract]. Shiels teaches that microvesicles (i.e., exosomes [0060]) provide therapeutic effects such as enhancing cosmetic appearance [0148], preventing or reducing scarring [0156], treating inflammation [0138], and treating conditions associated with a cosmetic procedure [0138].
Klitzman teaches a tattooing composition delivered into the dermis with an ink/pigment and liposomes (abstract; Col 4, lines 1-4; Col 8, line 66- Col 9, line 53).
Since Toprak generally teaches a composition for insertion into the dermal layer of skin, it would have been prima facie obvious to one of ordinary skill in the art to include exosomes, within the teachings of Toprak, because Shiels teaches that microvesicles (i.e., exosomes [0060]) can be administered intradermally [0017] and provide therapeutic effects such as enhancing cosmetic appearance [0148], preventing or reducing scarring [0156], treating inflammation [0138], and treating conditions associated with a cosmetic procedure [0138]. There would be a reasonable expectation of success in incorporating exosomes within a tattooing composition to be delivered to the dermal layer of skin because Klitzman teaches a tattooing composition delivered into the dermis with an ink/pigment and liposomes (abstract; Col 4, lines 1-4; Col 8, line 66- Col 9, line 53) and exosomes and liposomes share close chemical similarities as lipid particles.
Further regarding claim 1, the limitation of “formulated for insertion into a dermal layer” is interpreted as product-by-process limitations. Even though the product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, then the claim is unpatentable even though the prior product was made by a different process. In the instant case, the combined teachings of the prior art, disclosed to be inserted into the dermal layer of skin by percutaneous punctures, reads on the claimed aesthetic-enhancing formulation containing a pigment, an active ingredient and a vehicle. As such, the patentability of the instant formulation does not depend on its method of production, and the Applicant' s limitation regarding the process of formulating for insertion into a dermal layer of skin is not patentable, in view of Toprak, Shiels and Klitzman.
Claim 5 is rendered prima facie obvious because Toprak discloses the composition includes a local anesthetic (Example 1, English translation, pg. 11).
Claim 7 is rendered prima facie obvious because Toprak discloses the vehicle is water (Example 1, English translation, pg. 11).
Claims 8-11 are rendered prima facie obvious because Toprak discloses the tattoo ink of Example 1 (English translation, pg. 11) includes “the auxiliaries mentioned above”, where mentioned auxiliaries are stabilizers, antioxidants, emulsifiers, and preservatives (English translation, pg. 6, paragraph 8).
Further regarding claim 8, while the stabilizer preventing degradation of any component or combination of the components is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches a tattoo composition with the same components (e.g., stabilizer, antioxidant, and emulsifier), the properties the applicant discloses and/or claims are necessarily present.
Further regarding claim 9, while the antioxidant preventing oxidative degradation is not explicitly disclosed, a chemical composition and its properties are inseparable, as previously discussed. Therefore, because the prior art teaches a tattoo composition with the same components (e.g., an antioxidant), the properties the applicant discloses and/or claims are necessarily present.
Further regarding claim 10, while the emulsifier preventing separation of the components into layers is not explicitly disclosed, a chemical composition and its properties are inseparable, as previously discussed. Therefore, because the prior art teaches a tattoo composition with the same components (e.g., an emulsifier), the properties the applicant discloses and/or claims are necessarily present.
Further regarding claim 11, while the preservative preventing microbiological growth is not explicitly disclosed, a chemical composition and its properties are inseparable, as previously discussed. Therefore, because the prior art teaches a tattoo composition with the same components (e.g., a preservative), the properties the applicant discloses and/or claims are necessarily present.
Claim 2 is rejected under 35 U.S.C. 103 as being as being obvious over Toprak (DE 102017121900 A1) in view of Shiels et al. (US 2016/0243171 A1) and Klitzman et al. (US 6,013,122) and further in view of Adeel et al. (Environ Sci Pollut Res, 2018, 25:11100–11110)
The 35 U.S.C. 103 rejection over Toprak in view of Shiels and Klitzman was previously discussed.
Additionally, Toprak discloses that natural dyes are suitable colorants (English translation, pg. 5, paragraph 8).
Toprak does not disclose that the natural dye is plant-based, as recited in claim 2.
Adeel discloses that harmala (Peganum harmala) seed is a natural dye that is used for tattoos (pg. 11101, right column, first paragraph; abstract).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Toprak generally taught natural dyes for tattoo compositions, it is prima facie obvious to select a plant-derived natural dye, such as harmala seed, for incorporation into a tattoo composition based on its recognized suitability for the intended use as a natural dye, as taught by Adeel.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being as being obvious over Toprak (DE 102017121900 A1) in view of Shiels et al. (US 2016/0243171 A1) and Klitzman et al. (US 6,013,122) and further in view of Vassileva et al (Clinics in Dermatology, 2007, 25: 367–374).
The 35 U.S.C. 103 rejection over Toprak in view of Shiels and Klitzman was previously discussed.
Additionally, Toprak discloses that any colorant that is suitable for tattooing can be used (English translation, pg. 5, paragraph 7) and that almost all shades can be produced from white to black (English translation, pg. 6, first paragraph).
Toprak does not disclose that the pigment is chosen to match a natural color of human hair, as recited in claim 3.
Vassileva discloses tattooing for aesthetic purposes (abstract) and teaches that eyebrow coloring gives the appearance of hair in the brow line and more fullness for sparse eyebrows, or creating an artificial brow when the hair is absent (pg. 370, first full paragraph).
Since Toprak generally teaches tattooing for aesthetic purposes, it would have been prima facie obvious to one of ordinary skill in the art to choose a pigment that matches a natural color of human hair, within the teachings of Toprak, because Toprak teaches that any color may be used, and Vassileva teaches that color matching a tattooing composition to eyebrows gives the appearance of hair in the brow line and more fullness for sparse eyebrows and also creates an artificial brow when the hair is absent (pg. 370, first full paragraph).
Toprak does not disclose that the pigment is chosen to match a natural color of human skin, as recited in claim 4.
However, Vassileva teaches that complete color matching of the surrounding skin can be obtained (pg. 370, left column, fourth full paragraph). Vessileva teaches that color matching to the skin has been applied with excellent results in a wide range of instances, including hyperpigmentation and depigmentation caused by congenital defects, skin diseases, traumata, and after surgery (pg. 371, left column, first paragraph).
Since Toprak generally teaches tattooing for aesthetic purposes, it would have been prima facie obvious to one of ordinary skill in the art to choose a pigment that matches a natural color of human skin, within the teachings of Toprak, because Toprak teaches that any color may be used, and Vassileva teaches that color matching a tattooing composition to skin has been applied with excellent results in a wide range of instances, including hyperpigmentation and depigmentation caused by congenital defects, skin diseases, traumata, and surgery (pg. 371, left column, first paragraph).
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612