DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claim(s) 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 December 2025.
Applicant's election with traverse of Group I (claims 1-22) in the reply filed on 23 February 2026 is acknowledged. The traversal is on the ground(s) that Jaklenec et al. (US 2019/0015650A1) does not disclose a microneedle patch wherein each microneedle corresponds to a dot or a pixel or having two or more microneedle patches configured to form a tattoo image in skin. This is not found persuasive because Groups I, II and III do not share the features of each microneedle corresponds to a dot or a pixel or two or more microneedle patches. The technical feature shared by each group is directed to the use of a tattoo substance which does not make a contribution over the prior art in view of Jaklenec et al.
The requirement is still deemed proper and is therefore made FINAL.
CLAIM INTERPRETATION
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 4, 8 and 9 are 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.
Regarding claim 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of art rejections, “such as” has been omitted.
Regarding claim 8, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of art rejections, “for example” has been omitted.
Regarding claim 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of art rejections, “such as” has been omitted.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-8 and 11-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jin (KR 20200140018A).
Regarding claim 1, Jin discloses a microneedle patch capable of creating a tattoo image on skin. The microneedle patch includes a backing layer (100; Fig. 1; [0006, 0011]) and an array of microneedles (600) extending from the backing layer. Each microneedle includes a distal tip portion (300; Fig. 1; [0011]) including a tattoo substance (dye; [0008]). The microneedles are capable of being inserted into a subject’s skin and releasing tattoo substance in the skin thereby creating the tattoo image in the skin [0008]. Each microneedle in the array of microneedles corresponds to a dot or a pixel of the tattoo image or portion thereof [0012, 0013].
Regarding claims 3 and 4, Jin discloses that the subject is capable of being a human or an animal [0016].
Regarding claim 5, Jin discloses that at least a portion of the microneedles are capable of dissolving in vivo to release the tattoo substance [0011].
Regarding claim 7, Jin discloses that a proximal portion of the microneedles between the backing layer (100) and each distal tip portion is substantially free of the tattoo substance (Fig. 1; [0011]).
Regarding claims 6 and 8, Jin discloses that the proximal portion may be formed of the same material as the distal tip [0011] or formed of different components. For example, the proximal portion (200) and distal tip (300) may both be formed of a water-soluble material, e.g. polyvinypyrrolidone, such that the microneedles are capable of separating from the backing layer [0009].
Regarding claims 11 and 12, Jin discloses that the tattoo image is capable of being temporary or permanent [0008].
Regarding claims 13 and 14, Jin discloses that the tattoo image is capable of including letters and a medical/veterinary medical information [0016].
Regarding claim 15, Jin discloses that the tattoo substance may be single-color ink or fluorescent ink [0006, 0011].
Regarding claim 16, Jin discloses that the microneedles are drug-free, wherein the microneedles include dyes, pigments and fluorescent substances to create tattoos [0008].
Regarding claim 17, Jin discloses that the microneedles may include drugs [0007].
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(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Peppou et al. (US 2017/0055499A1, “Peppou”).
Regarding claim 9, Jin does not disclose a microneedle density in the array of from 50 microneedles/cm2 to 20,0000 microneedles/cm2. Peppou teaches a density within the claimed range of 10-600 needles per square centimeter [0224]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the density of the array of microneedles of Jin by making the density from 50 microneedles/cm2 to 20,0000 microneedles/cm2, as taught by Peppou, since it has been held that “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, applicant appears to have placed no criticality on the claimed range (see instant specification [0042] indicating the angle “may” be within the claimed range).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Daddona et al. (US 2015/0038897A1, “Daddona”).
Regarding claim 10, Jin does not disclose an area in which the array of microneedles is capable of being inserted of from about 0.5cm2 to 10cm2. Daddona teaches a microneedle array portion having an area of about 2cm2 to 10cm2[0081] which is within the claimed range. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the area of the array of microneedles of Jin to be within the claimed range, as taught by Daddona, since it has been held that “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 , applicant appears to have placed no criticality on the claimed range (see instant specification [0043]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin in view of Bonnett (US 2020/0330740A1”).
Regarding claim 18, Jin discloses a microneedle patch capable of creating a tattoo image on skin. The microneedle patch includes a backing layer (100; Fig. 1; [0006, 0011]) and an array of microneedles (600) extending from the backing layer. Each microneedle includes a distal tip portion (300; Fig. 1; [0011]) including a tattoo substance (dye; [0008]). The microneedles are capable of being inserted into a subject’s skin and releasing tattoo substance in the skin thereby creating the tattoo image in the skin [0008]. However, Jin does not expressly disclose two or more microneedle patches.
In the same field of endeavor, microneedles patches, Bonnett teaches a system including two or more microneedle patches/blocks [0015]. Two or more independently movable blocks are used to create a pad which forms a tattoo image, wherein each needle constitutes a pixel [0003]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided Jin with two or more microneedle patches, as taught by Bonnett, to form a desired image [0003, 0015, 0034, Fig. 6].
Regarding claim 19, the combination of Jin and Bonnett discloses that the two microneedle patches are capable of cooperating to produce a composite tattoo resulting from the tattoo images from each microneedle patch being selectively positioned relative to one another such as adjacent to one another and/or overlapping one another (Fig. 6; [0015, 0034]).
Regarding claims 20 and 21, the combination of Jin and Bonnett discloses a pneumatic injection applicator that includes an alignment template in the form of a pneumatic device similar to a blood pressure cuff and capable of facilitating selective positioning of the two or more microneedle patches on the skin [0032].
Regarding claim 22, the combination of Jin and Bonnett discloses that the tattoo image is visible to the human eye when pigment or dye is used [0008; Jin].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. McAllister et al. (US 2018/0133447A1) discloses microneedle patches.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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