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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 08/08/2025 has been entered.
Claims 5, 7, 13, 18, 19, 22, 28, 49, 61, 94, 102, 132 and 147-153 are pending in the Claim Set filed 8-8/2025.
Adhesive Applicator Article:
Claim 94 is an independent claim. Claims 5, 7, 13, 18, 19, 22, 28, 44, 49, 61 and 148-151 depend from claim 94.
Claim 102 is an independent claim.
Claim 132 is an independent claim. Claim 147 depends from claim 132.
Claims
Claims 61, 94, 102, 132 have been amended.
Claims 150 and 151 (Adhesive Applicator Article) and claims 152 and 153 (Methods of producing Adhesive Applicator Article) are newly added.
Claims 1-4, 6, 8-12, 14-17, 20-21, 23-27, 29-43, 45-48, 50-60, 62-93, 95-101, 103-131, 133-146 are cancelled.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 152 and 153 (Methods of producing Adhesive Applicator Article) are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP §821.03.
Applicants’ elected species made in the reply filed 3/01/2021 are as follows: semi-permanent colorant: genipin; volatile solvents: water and ethanol; semi-volatile semi-permanent color solubilizer: diethylene glycol monoethyl ether; surface active agent: 1, 2-hexanediol; matrix component: trehalose; skin penetration enhancer: polyethylene glycol, and, temporary colorant: acid blue.
Herein, claims 5, 7, 13, 18, 19, 22, 28, 44, 49, 61, 94, 102, 132 and 147-151 are for examination to the extent that they read on the elected species.
Withdrawn Objections/Rejections
The objection to claims 94 and 132 is withdrawn in view of the claim amendments.
The rejection of claims 2, 4, 5, 7, 13, 18, 19, 22, 27, 28, 44, 49, 61, 94, 148 and 149 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 pre-AIA the applicant regards as the invention is withdrawn in view of the claim amendments.
The rejection of claims 2, 4, 5, 7, 13, 18, 19, 22, 27, 28, 44, 49, 61, 94, 148 and 149 under 35 U.S.C. 103(a) as being unpatentable over Handley et al (US20160367460, cited in IDS filed 3/03/2020) [Handley] in view of Cross et al (USP 9670372), Sano et al (USP 5324349, of record) [Sano], Stroud et al (WO2010054219, of record) [Stroud], Edaka et al (US 20170135921, of record) [Edaka], Jager-Lezer (WO02/36364; herein referenced to English Translation (attached)) and Blette et al (USP 8545613, cited in IDS filed 11/30/2021) is withdrawn in view of the claim amendments.
Rejections Reformulated in view of the claim amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL- The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 7, 13, 18, 19, 22, 28, 44, 49, 61, 94, 132 and 147-151 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection. There is lack of written description for claims 94 and 132.
Claim 94 recites in part: wherein the composition is printed by an inkjet printer directly upon the first surface of the adhesive to dispose the composition on the first surface of the adhesive prior to adherence of the first surface to the skin of the user.
Claim 132 recites in part: wherein the composition is printed by an inkjet printer directly upon the first portion of the external layer to dispose the composition on the first portion of the external layer prior to adherence of the first portion of the external layer to the skin of the user.
Particularly, regarding claim 94, there is no support in the Specification for the limitation: composition is printed by an inkjet printer directly upon the first surface of the adhesive to dispose the composition on the first surface of the adhesive prior to adherence of the first surface to the skin of the user.
Particularly, regarding claim 132, there is no support in the Specification for the limitation: composition is printed by an inkjet printer directly upon the first portion of the external layer to dispose the composition on the first portion of the external layer prior to adherence of the first portion of the external layer to the skin of the user.
A complete search of the Specification did not provide support for the limitations of claims 94 and 132 (as described above).
Moreover, the phrase ‘prior to adherence’ is not disclosed in Instant Specification.
M.P.E.P. §2163 states that amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement.
Thus, the disclosure does not provide support for the claim amendments by changing the scope of the disclosure; thereby, constituting new matter.
The remaining claims are rejected as depending from a rejected claim.
Response to Arguments
Applicants argue in the reply filed 8/8/2025 that there is support at various portions of the as-filed application for the phrase "prior to adherence of the first surface to the skin of a user'' in claim 94, and for the phrase "prior to adherence of the first portion of the external layer to the skin of the user'' in claim 132. For example, at page 107 of the as-filed application, under the heading "Characterization Method #5: Stability of printed ink compositions," the specification states, in relevant part, "Adhesive substrates with printed ink were placed at 25 °C and 60% room humidity ... The semi-permanent tattoos were applied and given 36 hours to develop. The skin transfer results were visually graded based on the 0-8 ink intensity scale .... " (emphasis added). Further, Example 5 at pages 113-14 of the as-filed application describes example ink compositions, and Example 6 at pages 114-17 describes the deposition of the ink compositions onto an adhesive that was subsequently applied to skin.
Specification at page 107 states:
Characterization Method #5: Stability of printed ink compositions Adhesive substrates with printed ink were placed at 25 °C and 60% room humidity (normal condition) and at 40 °C and 75% room humidity (accelerated condition) for 2 weeks. At the 2-week time point, the samples were removed from the stability chambers and submitted for dissolution 25 testing and content analysis.
The semi-permanent tattoos were applied and given 36 hours to develop. The skin transfer results were visually graded based on the 0-8 ink intensity scale and ink density scale shown in FIG. 8A and the 1-8 image quality scale shown in FIG. SB.
Firstly, claims 94 and 132 comprise an adhesive applicator comprising a mixture of ingredients, whereas the Stability studies in Method #5 are directed to Adhesive substrates with printed ink. Secondly, above all, claims 94 and 132 require that the composition is printed by ‘inkjet’ printer.
Example 5 at pages 113-14 describes a single ink composition. However, this ink composition example fails to provide support full the entire scope of the claimed invention. Instant claims are far broader than the single ink composition disclosed in Table 15 on page 114.
Finally, Specification fails to disclose the phrase ‘prior to adherence’.
At least for these reasons the rejection is maintained.
Applicant is reminded that although the PTO has the initial burden of presenting evidence or reasons why a person skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the disclosure for new or amended claims. See MPEP 714.02 and 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”).
The remaining claims are rejected as depending from a rejected claim.
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 5, 7, 13, 18, 19, 22, 28, 44, 49, 61, 94, 102, 132 and 147-151 are rejected under 35 U.S.C. 103(a) as being unpatentable over Handley et al (US20160367460, cited in IDS filed 3/03/2020) [Handley] in view of Cross et al (USP 9670372, of record), Sano et al (USP 5324349, of record) [Sano], Stroud et al (WO2010054219, of record) [Stroud], Edaka et al (US 20170135921, of record) [Edaka], Jager-Lezer (WO02/36364; herein referenced to English Translation, of record) and Blette et al (USP 8545613, cited in IDS filed 11/30/2021).
Regarding claims 5, 7, 13, 18, 19, 22, 28, 44, 49, 61, 94, and 148-151 (claims 94, 102 and 132 are independent claims),
Handley teaches an adhesive applicator article to be used for semi-permanent tattooing comprising a composition including purified genipin (elected semi-permanent colorant), water and ethyl alcohol (elected volatile solvent), wherein ethyl alcohol is added to water solvent to enhance drying capabilities and to increase the solubility of genipin ([0032-0038]; ([0052-0065], Formula 3; [0070]; claims 1-19). Handley teaches that the composition comprises genipin in an amount in the range of 75 mM (about 0.8 w/w) to 200 mM (about 20 w/w) ([0038]; [0054]), i.e., genipin is present in an amount of about 0.8% to about 20% w/w of the composition., of which overlaps with the claimed amount recited in claims 5, 7. Hanley teaches the solvent contains 75-99 percent by volume water and 1-20% organic co-solvent (e.g., ethanol), of which overlaps with volatile solvents are present in amount of about 60% to about 90% w/w of the composition as claimed in claim 13 [0019]. In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Handley teaches an adhesive applicator article for applying a temporary tattooing ink comprising multi-layered adhesive layers and an adhesive backing, wherein genipn (temporary tattooing ink) is absorbed into the ink containing layer; wherein the adhesive layers comprise double-sided adhesive layers (Abstract: See entire document). (Instant claims 94,6,7,13,18, 61).
Handley differs from the claims in that the document does not teach the adhesive includes a first surface configured to adhere to skin of a user, wherein the composition is printed by an inkjet printer directly upon the first surface of the adhesive to dispose the composition on the first surface of the adhesive prior to adherence of the first surface to the skin of a user, and wherein the composition is transferred from the adhesive to the skin of the user in a single step. Further, Handley does not teach a removable silicon-coated liner.
However, Jager-Lezer cures the deficiencies.
Jager-Lezer teaches a system for transferring a colored pattern to the skin making it possible to create semi-permanent decorative patterns on the skin (p.1). Jager-Lezer teaches the transfer system comprises a composite structure consisting of at least two elements: a first element is the support layer consisting of a material impermeable to the skin coloring agent so as to prevent evaporation of the latter and facilitate contact with, and transfer onto, the skin and avoid stains on clothing (i.e., a backing on the adhesive layer to eliminate stickiness of the adhesive layer when applying the adhesive layer to the skin); a second element is an adhesive matrix fixed on the support layer and comprising at least one adhesive polymer and the skin coloring agent (i.e., coloring agent is dispersed in the polymeric adhesive material), this matrix (i.e., adhesive layer that contains the coloring agent) being able to come directly into contact with the skin. Moreover, Jager-Lezer teaches that the system may comprise additional adhesive layers such as for example, an adhesive layer used to ensure adhesion a stencil layer (p.3). Jager-Lezer teaches that the support layer is adhesive. The support layer can, for example, be made of adhesive non-woven fabric (p.4), wherein the adhesive matrix (i.e., adhesive layer) is fixed on the support layer (backing on the adhesive layer, i.e., an adhesive backing) and comprises at least one adhesive polymer and the coloring agent (p.4), wherein the coloring agent is dispersed and/or solubilized within the polymeric composition (p.5). The coloring agents that can be used are chosen from dyes of plant or synthetic origin, for example, Genipa Americana (i.e., a source of genipin: See Handley at paragraph [0033]: Fruit juices extracted from genipin-containing fruits, such as Genipa Americana, have been used in tattoo and body ink compositions in the prior art). Jager-Lezer teaches that the skin coloring agent is present in the adhesive matrix in proportions sufficient to impart coloring to the skin after application. It is thus generally present in proportions ranging from 0.5 to 50% by weight of active material relative to the total weight of the adhesive matrix, and preferably ranging from 10 to 35% by weight of active material relative to the total weight of the adhesive matrix (p.7). Jager-Lezer teaches that the transfer system may optionally further comprise at least one other layer, e.g., adhesive, and may optionally comprise active ingredients (p.8). The transfer system can have any desired shape and dimension, corresponding to the intended use; it can be adapted to the skin surface intended to receive the makeup, for example, it has a decorative pattern that one wishes to transfer to the skin and then keep on the skin for a period that can vary from several hours to several weeks, wherein the transfer system may represent a decorative motif (p.8). Jager-Lezer teaches transfer systems with several colours by using different colouring agents, distributed in different places in the matrix, for example, in different layers, wherein this may be used to provide a decorative pattern in several colors on the skin (p.9). Jager-Lezer teaches that the application time may vary depending on the coloring agent used, depending on the concentration of said coloring agent within the adhesive matrix and depending on the intensity of the color desired in the end on the skin. In fact, the total or partial transfer of the coloring agent from the adhesive matrix into the stratum corneum of the skin will depend on the time the system is applied to the skin (p.9). Jager-Lezer teaches that the transfer system consists of a support layer and an adhesive matrix comprising a coloring agent; wherein colored pattern transfer system is applied directly to the skin, e.g., a person’s forearm, to provide a colored marking on the skin (see example 1 at page 10).
Further, Jager-Lezer teaches in an advantageous embodiment of the invention, the system further comprises a protective peelable layer covering the adhesive matrix. Jager-Lezer teaches that the system is protected by a protective peelable layer, this is removed at the time of use. It can be made of any material impermeable to the skin coloring agent as well as to any other component present in the adhesive matrix. Among the materials that can be used, mention may preferably be made of a sheet of silicone paper (i.e., reads on removable silicon-coated liner. In the case where the system according to the invention comprises a peelable protective layer, the adhesive matrix comprising the coloring agent being protected within the system both by the support layer and by the peelable protective layer, the system can be easily transported, in a bag for example, and can be used when traveling for example. It is therefore extremely practical, quick and easy to use) (p.8, lns.322-335; Figure 1). Jager-Lezer that the transfer system according to the invention can be used, after removal of the protective peelable layer on the surface of the skin which it is desired to decorate, by directly applying the system to said surface (p.9, lns.369-370). Jager-Lezer teaches the system comprises non-adhesive layers such as for example, a protective peelable layer, so as to protect it from any external contamination during the storage time prior to use of the system (p.3, lns.112-115).
Thus, it would have been obvious to modify Handley in view of Jager-Lezer to provide an adhesive comprising a first surface configured to adhere to skin of a user, wherein the composition is printed directly upon the first surface of the adhesive to dispose the composition on the first surface of the adhesive prior to adherence of the first surface to the skin of a user, and wherein the composition is transferred from the adhesive to the skin of the user in a single step. Furthermore, it would have been obvious to provide a removable silicon-coated liner in view of Jager-Lezer. One skilled in the art would have been motivated to do so in order to provide a semi-tattoo as taught by Handle wherein the tattoo is transferred to the user in single, thus, avoiding the potential complication associated with transferring an ink using multistep procedure. Moreover, Jager-Lezer teaches many advantages such as the use of the transfer system is extremely easy: it is sufficient to apply the system to the area of the body where one wishes to create a pattern for the desired time for the desired intensity and then to remove the system. This produces a decorative pattern that will last on the skin, under normal conditions of use, generally for at least six hours, for example from more than six hours to a few weeks. The decorative pattern will fade over time through repeated washing and/or flaking. We can therefore speak of semi-permanent coloring. The duration of the application and therefore the intensity of the resulting coloring can be controlled as desired. In addition, since the dyes are not subject to oxidation in the air or degradation by UV radiation, they are stable and more effective. Moreover, one skilled in the art would have recognized of the advantages of a protective peelable layer, i.e., a removable silicon-coated liner, covering the adhesive matrix, wherein this can be removed at the time of use. Thus, the system can be easily transported, in a bag for example, and can be used when traveling for example. Further, Jager-Lezer that the transfer system can be used, after removal of the protective peelable layer on the surface of the skin which it is desired to decorate, by directly applying the system to said surface (p.9, lns.369-370).
.Jager-Lezer does not teach the composition is transferrable from the first surface of the adhesive to the skin of the user in a single step following removal of the removable silicone-coated liner from the first surface of the adhesive. However, this is a product by process limitation. 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, the claim is unpatentable even though the prior art product was made by a different process. "In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, patentability determination of a product-by-process claim is based on the structure imparted to the product by the process steps. When there is no physical evidence to support or a reason to believe that a patentably distinct structure is imparted by the process steps, the burden of proving otherwise falls to the Applicants’. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP § 2113.
Jager-Lezer does not teach that the composition, e.g., coloring agent, is printed by an inkjet printer directly upon the first surface of the adhesive to dispose the composition on the first surface of the adhesive prior to adherence of the first surface to the skin of a user
However, Blette cure the deficiencies.
Blette teaches a device comprising a substrate having an image printed thereon with a composition of matter, wherein the method includes using an inkjet printer to print a graphic on a first major surface of a substrate; contacting the first major surface of the substrate to the user's skin surface; and removing the substrate from the user's skin surface, thereby leaving a mirror image of the printed graphic on the user's skin surface (Abstract). Blette teaches an several advantages of a method of using an inkjet printer to print a graphic on a first major surface of a substrate comprise it provides for printing of the printed image on any suitable flexible substrate, so that this eliminates the need for expensive specialty papers such as thermal paper or hectograph paper, furthermore, printing onto a transfer substrate provides for more of the dye to be transferred to the skin resulting in a clearer reference image. Moreover, the method of using an inkjet printer to print a graphic comprises obtaining a graphic to be tattooed in a computer-printable form by means including downloading the graphic from the Internet, scanning a hard copy graphic, opening an email attachment containing the graphic, and creating or manipulating a computer-drawn Graphic ((col.6, lns.4-65).
Thus, one skilled in the art would have been motivated to use an inkjet printer in view of Blette. It would have been obvious to one skilled in the art to print a decorative pattern on the adhesive by an inkjet printer as taught by Blette. One skilled in the art would have been motivated to do so in view of the many advantages of providing a decorative pattern on the skin of a user as taught by Blette that includes inkjet printing can be provided to print an image on any suitable flexible substrate and inkjet printing onto a transfer substrate, e.g., adhesive, particularly provides for more of the inkjet ink composition to be transferred to the skin resulting in a clearer reference image.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide an adhesive applicator article comprising an adhesive having a surface configured to adhere to skin of a user, wherein an ink composition is printed by an inkjet printer directly upon the adhesive surface to dispose the ink on the surface of the adhesive to provide a decorative pattern, e.g., tattoo, prior to adherence of the adhesive comprising the decorative pattern that has been printed on the adhesive by inkjet printer, to the surface to the skin of a user, so that the composition comprising a decorative pattern printed on the adhesive is transferred from the adhesive to the skin of a user in a single step in view of the teachings of Jager-Lezer and Blette, as a whole, having a reasonable expectation of success.
Further, Handley differs from the claims in that the document does not teach viscosity or surface tension of the semi-permanent tattooing ink composition or that the composition further comprises a semi-volatile semi-permanent color solubilizer: diethylene glycol monoethyl ether; surface active agent: 1, 2-hexanediol; matrix component: trehalose; skin penetration enhancer: polyethylene glycol, and a temporary colorant: acid blue.
However, Cross, Sano, Stroud and Edaka, as a whole, cure the deficiencies.
Cross teaches inkjet ink compositions comprising colorants, wherein the inkjet ink compositions have a viscosity of less than about 10 mPa·s (i.e., centipoise) preferably less than about 5 mPa·s, more preferably less than about 3 mPa·s, and most preferably less than about 2 mPa·s, for example, a viscosity from about 1 to 4 or from about 1 to about 3 mPa·s at 25° C. Cross teaches that if the viscosity of inkjet ink compositions is too high (i.e., above 10 mPa·s at 25° C.) it is difficult to achieve good jetting behaviour from a thermal inkjet ink. Cross teaches more preferably the viscosity is below 5 mPa·s (centipoise) at 25° C (col.5, lns.40-51; col.10, lns.31-38). Furthermore, Cross that the inkjet composition has a surface a tension from about 20 to about 50 mN/m (i.e., dynes/cm) preferably from about 21 to about 35 mN/m (dynes/cm) at 25° C (Title; Abstract; col.2, lns.51-67; col.5, lns.39-51; col.10, lns.31-44; See entire document). (Instant claims 2, 4). Thus, one skilled in the art would have been motivated to provide an adhesive applicator article comprising an inkjet composition as taught by Handley having a viscosity of from about 5 mPa·s (centipoise) and a surface tension from about 21 to about 35 mN/m (dynes/cm) in order to provide good jetting behavior in accordance with the teachings of Cross, of which overlaps with the claimed amounts in instant claims 2,4. In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Sano teaches an ink for inkjet printing comprising a pigment type ink composition for ink jet printing, which is capable of evenly producing an image, excellent in preservability and does not cause obstruction in a nozzle, wherein the ink composition for ink jet printing is capable of producing an image which has a high optical density and is excellent in rapid drying properties and moisture abrasion resistance, wherein the ink composition comprises an organic pigment and a component selected from saccharides, wherein the saccharide is trehalose in about 0.5% to 30% by weight (reads on claims 148, of which overlaps with the claimed amounts (Abstract; col.2, lns.1-30; col.3, lns.50-68: component b; col.5, lns.17-25; claims 1,2,11). In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, Sano teaches an ink for inkjet printing further comprises ethanol and a wetting agent that is polyethylene glycol. Further, Sano teaches trehalose is a saccharide that enhances the stability of the ink composition and polyethylene glycol is taught as a wetting agent of which would increase penetrating properties of the inkjet printing composition. Furthermore, trehalose can similarly be classified as matrix component and polyethylene glycol can be classified as a skin penetration enhancer because if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. (Instant claims 94,44,61,148)
Stroud teaches ink compositions for marking surgical patients and for other uses needing a scrub-resistant ink comprising water and water miscible alcohol, e.g., ethanol, (i.e., the residue or balance of the composition), wherein glycol ethers enhance penetration through skin, wherein flammability issues are abated when glycol ethers are substituted for primary alcohols in dye formulations, wherein ethoxydiglycol (diethylene glycol monoethyl ether) is a preferable glycol ether because of its low toxicity (p.4-5, [0022]; Stroud: claim 7), wherein the balance of the ink composition is no more than about 20 percent of glycol-ether, of which overlaps with the claimed amounts, wherein the balance of the solution containing glycol ethers is no more than 5%, or 3%, or 2%, or 1 %, or 0.5% of the ink composition [0023]. (Instant claims 94,22,27). In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Stroud teaches ethoxydiglycol (diethylene glycol monoethyl ether) enhances ink penetration through the skin, however, ethoxydiglycol can similarly be classified as semi-volatile semi-permanent color solubilizer because if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Edaka teaches colorants and ink formulation materials for use in cosmetic applications comprising 1, 2-hexanediol in an of about 2.5% wt, wherein 1, 2-hexanediol is provided therein as a penetrant, polyethylene glycol is used for humectant and colorant blue dye is disclosed as a suitable colorant, wherein an advantage of the formulations comprise ink sets used to provide a full spectrum of colors for use in cosmetic applications ([0002]; [0009]; Table 1; see entire document). Edaka teaches colorants and ink formulation materials for use in cosmetic applications comprising 1, 2-hexanediol, wherein 1, 2-hexanediol is provided therein as a penetrant, polyethylene glycol is used for humectant and colorant blue dye is disclosed as a suitable colorant, wherein an advantage of the formulations comprise ink sets used to provide a full spectrum of colors for use in cosmetic applications ([0002]; [0009]; Table 1; see entire document). (Instant claims 49, 61). Furthermore, 1, 2-hexanediol can similarly be classified as surface active agent and polyethylene glycol can be classified as a skin penetration enhancer because if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
One skilled in the art would have been motivated to include ethoxydiglycol (diethylene glycol monoethyl ether) in the composition because it enhances penetration of the ink composition through skin as taught by Stroud. Furthermore, one skilled in the art would have been motivated to include 1, 2-hexanediol because it acts as surface active agent and a penetrant for colorants and polyethylene glycol because it can advantageously act as skin penetration enhancer, a wetting agent and a humectant, in accordance with the teachings of Sano and Edaka. Accordingly, a compound cannot be separated from its properties, regardless of what type of excipient it is classified as. See MPEP 2112. 01. Furthermore, one skilled in the art would have been motivated to include a blue dye as taught by Edaka for use in ink sets in order to provide a full spectrum of colors for use in tattooing applications having a reasonable expectation of success.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide a composition to provide a temporary tattooing ink comprising genipin and a volatile solvent combination comprising water and ethyl alcohol in view of Handley. One skilled in the art would have recognized the benefit and many advantages of modifying the composition as taught by Handley to further comprise trehalose (elected matrix), a semi-volatile semi-permanent colorant solubilizers that is diethylene glycol monoethyl ether (elected solubilizers), surface active agent that is 1, 2-hexanediol (elected surface-active agent), and a skin penetration enhancer that is polyethylene glycol (elected skin penetration enhancer) and a temporary colorant that is acid blue (elected temporary colorant) in accordance with the teachings of Cross, Sano, Stroud and Edaka, as a whole, that provides a composition for particular use as a tattooing ink composition that is designed to provide an adhesive applicator article that can transfer a decorative pattern directly to the skin in a single step of the user having a reasonable expectation of success.
Regarding claim 102,
The temporary tattooing ink composition as taught by Handley, Jager-Lezer, Blette, Cross, Sano, Stroud and Edaka, as a whole.
In particular, as described above, Jager-Lezer teaches in an advantageous embodiment of the invention, the system further comprises a protective peelable layer covering the adhesive matrix. Jager-Lezer teaches that the system is protected by a protective peelable layer, this is removed at the time of use. It can be made of any material impermeable to the skin coloring agent as well as to any other component present in the adhesive matrix. Among the materials that can be used, mention may preferably be made of a sheet of silicone paper (i.e., reads on removable silicon-coated liner. In the case where the system according to the invention comprises a peelable protective layer, the adhesive matrix comprising the coloring agent being protected within the system both by the support layer and by the peelable protective layer, the system can be easily transported, in a bag for example, and can be used when traveling for example. It is therefore extremely practical, quick and easy to use) (p.8, lns.322-335; Figure 1). Jager-Lezer that the transfer system according to the invention can be used, after removal of the protective peelable layer on the surface of the skin which it is desired to decorate, by directly applying the system to said surface (p.9, lns.369-370). Jager-Lezer teaches the system comprises non-adhesive layers such as for example, a protective peelable layer, so as to protect it from any external contamination during the storage time prior to use of the system (p.3, lns.112-115). Thus, Handley, Jager-Lezer, Blette, Cross, Sano, Stroud and Edaka, as a whole, make prima facie obvious the subject matter as claimed in claim 102.
Regarding claims 132 and 147,
The temporary tattooing ink composition as taught by Handley, Cross, Sano, Stroud and Edaka, as a whole, is described above.
Jager-Lezer teaches a system for transferring a colored pattern to the skin making it possible to create semi-permanent decorative patterns on the skin (p.1). Jager-Lezer teaches the transfer system comprises a composite structure consisting of at least two elements: a first element is the support layer consisting of a material impermeable to the skin coloring agent so as to prevent evaporation of the latter and facilitate contact with, and transfer onto, the skin and avoid stains on clothing (i.e., a backing on the adhesive layer to eliminate stickiness of the adhesive layer when applying the adhesive layer to the skin); a second element is an adhesive matrix fixed on the support layer and comprising at least one adhesive polymer and the skin coloring agent (i.e., coloring agent is dispersed in the polymeric adhesive material), this matrix (i.e., adhesive layer that contains the coloring agent) being able to come directly into contact with the skin. Particularly, Jager-Lezer teaches that the system comprises additional layers that would encompass additional adhesive layers comprising a coloring agent composition, e.g., inkjet composition, and additional adhesive backings. Jager-Lezer teaches the transfer system comprises several colours by using different coloring agents, distributed in different layers in order to provide a decorative pattern in several colors on the skin. Thus, it would be obvious to one of ordinary skill in the art to provide additional adhesive backings, e.g., a first adhesive layer; a first backing; a second adhesive layer; and a second backing; in order to provide multiple adhesive layers comprising different colored inks, wherein an adhesive backing is adhered to the adhesive in order to separate the adhesive layers in order to provide a multi-colored decorative pattern to provide a clear and distinct image on the skin of the user. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide adhesive layer that is configured to adhere to skin of a user, and wherein the first adhesive layer is configured to receive the composition and to allow release of at least a portion of the composition onto and/or into the skin of a use having a reasonable expectation of success. Moreover, it would have been obvious to one skilled in the art to print a decorative pattern on the adhesive by an inkjet printer as taught by Blette. One skilled in the art would have been motivated to do so in view of the many advantages of providing a decorative pattern on the skin of a user as taught by Blette that includes inkjet printing can be provided to print an image on any suitable flexible substrate and inkjet printing onto a transfer substrate, e.g., adhesive, particularly provides for more of the inkjet ink composition to be transferred to the skin resulting in a clearer reference image. Thus, it would have been prima facie obvious to provide an adhesive applicator article comprising a temporary ink composition wherein the first portion of the external layer, i.e., adhesive layer comprising the temporary tattooing composition as taught by Handley, Cross, Sano, Stroud and Edaka, as a whole, that is configured to adhere to skin of a user, wherein the temporary ink composition is printed by an inkjet printer directly upon the first portion of the external layer to dispose the composition on the first portion of the external layer prior to adherence of the first portion of the external layer to the skin of the user, and wherein the adhesive layer is the external layer so that the temporary tattooing composition is transferred from the external layer to the skin of the user in a single step in view of the teachings of Jager-Lezer and Blette, as a whole, having a reasonable expectation of success.
Moreover, as described above, Jager-Lezer teaches in an advantageous embodiment of the invention, the system further comprises a protective peelable layer covering the adhesive matrix. Jager-Lezer teaches that the system is protected by a protective peelable layer, this is removed at the time of use. It can be made of any material impermeable to the skin coloring agent as well as to any other component present in the adhesive matrix. Among the materials that can be used, mention may preferably be made of a sheet of silicone paper (i.e., reads on removable silicon-coated liner. In the case where the system according to the invention comprises a peelable protective layer, the adhesive matrix comprising the coloring agent being protected within the system both by the support layer and by the peelable protective layer, the system can be easily transported, in a bag for example, and can be used when traveling for example. It is therefore extremely practical, quick and easy to use) (p.8, lns.322-335; Figure 1). Jager-Lezer that the transfer system according to the invention can be used, after removal of the protective peelable layer on the surface of the skin which it is desired to decorate, by directly applying the system to said surface (p.9, lns.369-370). Jager-Lezer teaches the system comprises non-adhesive layers such as for example, a protective peelable layer, so as to protect it from any external contamination during the storage time prior to use of the system (p.3, lns.112-115). Thus, Handley, Jager-Lezer, Blette, Cross, Sano, Stroud and Edaka, as a whole, make prima facie obvious the subject matter as claimed in claim 102.
All the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention.
It would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Handley, Cross, Sano, Stroud, Edaka, Jager-Lezer and Blette, as a whole,
Response to Arguments
Applicants argue that the cited references fail to disclose an adhesive applicator article that includes a removable silicone liner disposed over an adhesive layer and (an ink) composition.
Applicant’s arguments have been fully considered but they are not persuasive, because Jager-Lezer cures the deficiency. Jager-Lezer teaches in an advantageous embodiment of the invention, the system further comprises a protective peelable layer covering the adhesive matrix. Jager-Lezer teaches that the system is protected by a protective peelable layer, this is removed at the time of use. It can be made of any material impermeable to the skin coloring agent as well as to any other component present in the adhesive matrix. Among the materials that can be used, mention may preferably be made of a sheet of silicone paper (i.e., reads on removable silicon-coated liner. In the case where the system according to the invention comprises a peelable protective layer, the adhesive matrix comprising the coloring agent being protected within the system both by the support layer and by the peelable protective layer, the system can be easily transported, in a bag for example, and can be used when traveling for example. It is therefore extremely practical, quick and easy to use) (p.8, lns.322-335; Figure 1). Jager-Lezer that the transfer system according to the invention can be used, after removal of the protective peelable layer on the surface of the skin which it is desired to decorate, by directly applying the system to said surface (p.9, lns.369-370). Jager-Lezer teaches the system comprises non-adhesive layers such as for example, a protective peelable layer, so as to protect it from any external contamination during the storage time prior to use of the system (p.3, lns.112-115). Thus, Jager-Lezer provides sufficient motivation to modify Handle to further comprise a removable silicon-coated resin, having a reasonable expectation of success.
Applicants argue that Sano relates to ink compositions for inkjet printing comprising a pigment, a resin emulsion and a component selected from saccharides or their derivatives, and polyols having 5 or more hydroxyl groups. However, in Sano, trehalose is part of a long list of saccharides. There is no disclosure in Sano to use trehalose. Further, Sano suggests that a polyol may be used instead of a saccharide.
Applicant’s arguments have been fully considered but they are not persuasive, because though picked from a "laundry list", it has been held that though a specific embodiment is not taught as preferred makes it no less obvious, also, the mere fact that a reference suggests a multitude of possible combinations does not in and of itself make any one of those combinations less obvious, see Merck v. Biocraft, 10 USPQ2d 1843 (Fed Cir 1985). Furthermore, it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. BiocrafiLabs, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500, (Fed. Cir. 1985). The mere fact that a reference suggests a multitude of possible combinations does not in and of itself make any one of those combinations less obvious, see Merck v. Biocraft, 10 USPQ2d 1843 (Fed Cir 1985).
Applicants argue that the combination of the volatile solvent and the semi-volatile semi-permanent colorant solubilizer with the semi-permanent colorant facilitates the solubilization of the semipermanent colorant, thereby improving the delivery of the semi-permanent colorant into upper skin layers. Hence, the combination of the four claimed compounds in the composition provides a suitable delivery vehicle and achieves a suitable semipermanent skin tattoo, in particular a stable composition, that develops properly on skin due to adequate delivery on the skin and a sufficient longevity. This can encourage user adoption and improved semi-permanent tattoo transfer and development by improving ease of generating a successful semi-permanent tattoo result." In other words, the four claimed compounds provide a strong synergistic effect.
It appears that Applicants are arguing unexpected Results:
The scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim(s).
That is, the composition(s) that generated said alleged unexpected results are not commensurate in scope with composition which is presently claimed as argued above, is/are not commensurate in scope with claimed edible composition.).
The scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim(s).
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Instant independent claims are broadly claimed, thus, fail to commensurate with applicants alleged unexpected result.
Furthermore, MPEP 716.02(d) II. DEMONSTRATING CRITICALITY OF A CLAIMED RANGE
To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Applicants have not presented results demonstrating that the unexpected results lie inside the entire scope of the claimed invention compared to results that fall outside the claimed range. Applicants bear the burden to establish that the results are unexpected and significant. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b).
Therefore, Applicants’ arguments directed to Unexpected Results are not persuasive.
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619