FINAL 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/11/2025 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 12/11/2025 in which claims 1-52, 54, and 61-64 were canceled; claims 67-68 were withdrawn; and claims 1 and 66 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 53, 55-60, and 65-66 are under examination.
Withdrawn Rejection
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Maintained-Modified Rejections
Modification Necessitated by Applicant’s Claim Amendments
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.
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.
Claim(s) 53, 55-57, 59-60, and 65-66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klitzman et al (US 6,013,122) in view of Markland et al (US 2016/0136096 A1).
Regarding claim 53, Klitzman teaches a semi-permanent tattoo composition comprising microparticles containing polymer matrix comprising a biodegradable and bioabsorbable polymer selected from poly D-lactic acid, Poly L-actic acid, polycaprolactone, and mixtures thereof (Abstract; columns 1-7, 12 and 15-18; claims 1-11). Klitzman teaches the semi-permanent tattoo composition further contains a carrier solution (column 10, lines 43-57). Klitzman teaches the microparticles contain a coloring agent selected from organic dyes including annatto extract, beta-carotene, canthazanthin, paprika, colorants from natural sources such as saffron, turmeric, and vegetable juices, and color additives for use in the U.S. for foods, drugs, cosmetics, and medical devices which are enumerated in 21 C.F.R. Sections 73, 74 and 82 (column 12, lines 26-41). Klitzman teaches the semi-permanent tattoo composition provides release of the coloring agent (pigment/tattoo ink) continuously over a predetermined period, in which the tattoo inks remain in the dermis for a predetermined period of time (e.g., 3, 6, 9, months or 1 year, etc.) (column 5, lines 29-47).
However, Klitzman does not teach the particles are present in the carrier solution at a concentration of about 5% w/v to about 60% w/v of the carrier solution, wherein about is ±20% of claim 53.
Regarding the particles are present in the carrier solution at a concentration of about 5% w/v to about 60% w/v of the carrier solution of claim 53, Markland teaches composition containing biocompatible/biodegradable microparticles, wherein the composition is in the form of a suspension, and wherein the microparticles contain a polymer matrix prepared from biodegradable polymers such as poly(lactide), poly(lactide-co-glycolide) and polycaprolactone (Abstract; [0016]-[0051], [0060]-[0075], [0077]-[0095], and [0107]-[0119]). Markland teaches the microparticles encapsulate dyes ([0107]). Markland teaches the microparticles is present in the suspension in amount from 10 wt.% to 30 wt% ([0067], [0099], [0174]). Markland teaches microparticle composition provide controlled release or prolonged delivery of the active agent encapsulated therein for extended period of time following the administration ([0117]-[0119]; claim 31).
It would have been obvious to one of ordinary skill in the art to routinely optimize the concentration of particles in the carrier solution of Klitzman to an amount of about 5% w/w to about 60% w/v of the carrier solution, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Markland provided the guidance to do so by teachings that biodegradable particles which is used to encapsulate active materials such as dyes can be present in a carrier solution (suspension) in an amount from 10 wt.% to 30 wt%, which is a range that overlaps the claimed range of “5% w/w to about 60% w/v, wherein about is ±20%.” Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Furthermore, the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Absent some demonstration of unexpected results showing criticality from the claimed parameter, the optimization of the concentration of particles in the carrier solution would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
With respect to the claimed “the semi-permanent tattoo composition provides a semi-permanent tattoo that retains its vibrancy for about 2 months to about 2 months after the semi-permanent tattoo composition is administered via injection to a subject’s skin, wherein about is ±20%,” it is noted that Klitzman teaches the semi-permanent tattoo composition comprising carrier solution and microparticles containing coloring agents and polymer matrix comprising a biodegradable and bioabsorbable polymer selected from poly D-lactic acid, Poly L-actic acid, polycaprolactone, and mixtures thereof, provides release of the coloring agent (pigment/tattoo ink) continuously over a predetermined period, in which the tattoo inks remain in the dermis for a predetermined period of time (e.g., 3, 6, 9, months or 1 year, etc.) (Klitzman: column 5, lines 29-47). Thus, the claimed characteristic of ““the semi-permanent tattoo composition provides a semi-permanent tattoo that retains its vibrancy for about 2 months to about 2 months after the semi-permanent tattoo composition is administered via injection to a subject’s skin, wherein about is ±20%,” would have been an implicit characteristic from the structurally same semi-permanent tattoo composition of Klitzman in view of Markland. It is noted that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Furthermore, [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Regarding claims 55 and 56, as discussed above, Markland teaches the microparticles is present in the suspension in amount from 10 wt.% to 30 wt% ([0067], [0099], [0174]), which overlaps the ranges of concentrations as recited in claims 55 and 56. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Furthermore, the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Absent some demonstration of unexpected results showing criticality from the claimed parameter, the optimization of the concentration of particles in the carrier solution would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
Regarding claim 57, Klitzman teaches the microparticles are about 5 to 300 microns in diameter (column 7, lines 40-50), which overlaps the claimed range of the particles have an average diameter of less than 100 µm. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameter, the optimization of the average diameter of particles would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
Regarding claims 59 and 60, Markland teaches and provide guidance for the composition containing the microparticles to further contain buffers and surfactants ([0110]-[0113]).
Regarding claim 65, Markland teaches and provides guidance for selecting and using poly(lactide-co-glycolide) (PLGA) from a list of biodegradable polymer known to be suitable for use as polymer matrix material of the microparticle (Abstract; [0017], [0040], and [0073]-[0086]). Thus, it is noted that [t]he selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).
Regarding claim 66, Klitzman teaches the tattoo pigment/colorant and vehicle (polymer) are present together such they induce aggregation of the microparticles to provide the necessary characteristics to resist spontaneous elimination from the dermis (column 11, lines 1-23).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
Applicant argues that “Klitzman even in view of Markland does not teach the combination of semi-permanent tattoo composition components or the amounts necessary to arrive at the claimed semi- permanent tattoo compositions, much less how to achieve a semi-permanent tattoo that retains its vibrancy for about 2 months to about 12 months after administering the composition via injection to the subject's skin.” (Remarks, page 7, last paragraph).
In response, the Examiner disagrees. As discussed above in the pending 103 rejection, Klitzman in view of Markland remain to teach and render obvious Applicant’s amended claim 53. See 103 rejection, pages 3-7 of this office action.
Applicant argues that “Klitzman among its broad disclosure relating to coloring agents does not suggest using lipophilic coloring agents, let alone those specific lipophilic coloring agents recited in presently pending claim 53.” (Remarks, top of page 2).
In response, the Examiner disagrees. As discussed above in the pending 103 rejection, Klitzman teaches suitable coloring agents include annatto extract, beta-carotene, canthazanthin, and paprika, which reads on the claimed coloring agent.
Applicant argues that Markland “cannot provide motivation to select specific lipophilic coloring agents recited in claim 53 because Markland does not teach a single specific coloring agent, much less a lipophilic coloring agent.” Applicant further alleges that “Markland also fails to disclose a tattoo composition, much less a semi-permanent tattoo composition, less still a semi-permanent tattoo composition that provides a semi-permanent tattoo that retains its vibrancy for about 2 months to about 12 months after the semi-permanent tattoo composition is administered via injection to a subject's skin.” (Remarks, page 8, 2nd and 3rd paragraphs).
In response, the Examiner disagrees. As discussed above, Klitzman teaches suitable coloring agents include annatto extract, beta-carotene, canthazanthin, and paprika, which reads on the claimed coloring agent.
With respect the claimed characteristic of “the semi-permanent tattoo composition provides a semi-permanent tattoo that retains its vibrancy for about 2 months to about 2 months after the semi-permanent tattoo composition is administered via injection to a subject’s skin, wherein about is ±20%,” it is noted that Klitzman teaches the semi-permanent tattoo composition comprising carrier solution and microparticles containing coloring agents and polymer matrix comprising a biodegradable and bioabsorbable polymer selected from poly D-lactic acid, Poly L-actic acid, polycaprolactone, and mixtures thereof, provides release of the coloring agent (pigment/tattoo ink) continuously over a predetermined period, in which the tattoo inks remain in the dermis for a predetermined period of time (e.g., 3, 6, 9, months or 1 year, etc.) (Klitzman: column 5, lines 29-47). Thus, the claimed characteristic of ““the semi-permanent tattoo composition provides a semi-permanent tattoo that retains its vibrancy for about 2 months to about 2 months after the semi-permanent tattoo composition is administered via injection to a subject’s skin, wherein about is ±20%,” would have been an implicit characteristic from the structurally same semi-permanent tattoo composition of Klitzman in view of Markland. It is noted that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Furthermore, [w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
As a result, for at least the reasons discussed above, claims 53, 55-57, 59-60, and 65-66 remain rejected as being obvious and unpatentable over the combined teachings of Klitzman and Markland, in the pending 103 rejection as set forth in this office action.
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klitzman et al (US 6,013,122) and Markland et al (US 2016/0136096 A1), as applied to claim 53 above, and further in view of Ferrari et al (US 2002/0164297 A1).
The compositions of claim 53 is discussed above, said discussion being incorporated herein in its entirety.
However, Klitzman and Markland do not teach the composition further comprising humectant of claim 58.
Regarding claim 58, Ferrari teaches a composition comprising colored polymer particles and colloidal dispersion of colored particles, wherein the composition is in form of an oil-in-water emulsion, and the composition further contains glycerol (a humectant) (Abstract; [0017]-[0030] and [0109]-[0123]).
It would have been obvious to one of ordinary skill in the art to include glycerol in the composition of Klitzman, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Ferrari provided the guidance to do so by teaching that a composition containing colored particles can further contain glycerol so as to aid in stabilizing the dispersed particles (Ferrari: [0111]). Thus, an ordinary artisan seeking to stabilize the particles of Klitzman in the composition would have looked to including glycerol in the composition, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
Applicant argues that “Ferrari does not suggest, much less disclose, semi-permanent tattoo compositions that provide a semi-permanent tattoo that retains its vibrancy for about 2 months to about 12 months after the semi-permanent tattoo composition is administered via injection to a subject's skin.” (Remarks, page 9).
In response, the Examiner disagrees. Ferrari was use for teaching the humectant of dependent claim 58. The claimed characteristic “semi-permanent tattoo compositions that provide a semi-permanent tattoo that retains its vibrancy for about 2 months to about 12 months after the semi-permanent tattoo composition is administered via injection to a subject's skin” as recited in independent claim 53 was rendered obvious by the teachings from Klitzman. See 103 rejection, pages 3-4 of this office action.
As a result, for at least the reason discussed above, claim 58 remained rejected as being obvious and unpatentable over the combined teachings of Klitzman, Markland, and Ferrari, in the pending 103 rejection as set forth in this office action.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613