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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/10/2026 has been entered.
The Amendment filed 03/10/2026, amended claims 1, 7, and 14 are amended.
Claims 1-3 and 5-20 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant elected Group I, the composition, and the species titanium dioxide as the pigment, ethoxydiglycol diethyleneglycol monoethyl ether as the anesthetic action accelerator, and serum as the composition form, in the reply filed on 11/05/2024.
In the course of the search, the species were broadened to include fatty acid ester as the anesthetic action accelerator, and liquid as the composition form.
It is noted that the 03/10/2026, Amendment to the claims limits the pigment to micronized titanium dioxide. It is further noted that neither the anesthetic action accelerator nor the form of the composition are limitations of the independent claim.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-3 and 5-19 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
Applicant’s amendments to claim 7 are sufficient to overcome this rejection.
35 U.S.C. § 112(a)
Applicant’s amendment to 1 that deletes “insoluble pigment is provided in the composition at a concentration sufficient to be visible on the surface of the organic tissue,” and amendment to claim 14 that deleted “a second quantity of glycerine,” is sufficient to overcome these rejections.
35 U.S.C. § 103 over Ryoo in view of Ernst, Rowe, and Chen
Applicant’s amendments to the claims are sufficient to overcome this rejection.
Ryoo teaches lidocaine as comprising about 1% to about 6% of the composition, which is distinct from the instant claims which require 10-30% lidocaine.
Ryoo does not teach a composition comprising a second anesthetic selected from procaine and tetracaine.
While Ernst teaches a composition comprising a combination of 1-10% lidocaine and 0.25-4% tetracaine, it does no teach 5-25% tetracaine.
Ryoo does titanium dioxide as comprising 0.2% of its composition, but does not teach it as comprising a concentration of 0.5-20% by weight. Ryoo further does not teach the titanium dioxide as micronized.
Ryoo additionally does not teach the water and glycerine as having a density of between 0.95 and 1.20 g/ml.
As such, these rejections are overcome.
35 U.S.C. § 103 over Toprak in view of Ernst, and BfR
Applicant’s amendments to the claims are sufficient to overcome this rejection.
While Toprak teaches that its compositions can comprise 4-20% of one or more anesthetic, and teaches lidocaine, prilocaine, etidocaine, bupivacaine, ropivacaine, levobupivacaine, procaine and tetracaine as local anesthetics (pg. 1, claim 1), Toprak only exemplifies a composition comprising 4% of a single anesthetic, i.e., lidocaine.
While Ernst teaches a composition comprising a combination of 1-10% lidocaine and 0.25-4% tetracaine, it does no teach 5-25% tetracaine.
As such, there is no motivation to modify the anesthetics of Toprak to select both lidocaine and procaine or tetracaine, and further to select the lidocaine at 10-30% by weight and the procaine or tetracaine at 5-25% by weight.
While Toprak teaches that its compositions can comprise 1-35% by weight colorants, and further teaches that the colorants may be inorganic pigments, such as titanium dioxide, Toprak provides no motivation to select titanium dioxide as the colorant from the laundry list of colorants, let alone to provide it specifically in a concentration of 0.5%-20% by weight. And Toprak does not teach the titanium dioxide as micronized.
Toprak additionally does not teach the water and glycerine as having a density of between 0.95 and 1.20 g/ml, or a pH of between 4.5 and 6.5.
As such, these rejections are overcome.
Claim Objections
Claim 11 is objected to because of the following informalities:
-Since claim 1 recites “wherein the at least one insoluble pigment is micronized titanium dioxide,” claim 11, should be amended to recite “wherein said micronized titanium dioxide is visible under visible or ultraviolet light.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-New Matter
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-3 and 5-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
-In claim 1, the phrase “wherein the insoluble pigment, after the organic tissue is anesthetized, is removed from the outer surface of the organic tissue,” is new matter.
[004] of the Specification states, “Prior anesthesia in general is required before most minimally invasive procedures. The procedures for marking biological/organic tissue, such as skin, mucosae, among others, are currently carried out after the application of topical anesthetics throughout the area, which are subsequently removed, whereupon the biological tissue is marked and the being initiated.” This statement is referencing the state of the art and not the instant invention. Moreover, this statement appears to state that the anesthetics are subsequently removed, and it is not clear what “the being initiated” means.
[023] of the Specification states, “In a given embodiment, the dye composition for marking organic tissue may be such that said at least one pigment remains on the outer surface, marking it, while the topical anesthetic attains its target of action.” However this does not provide support for “wherein the insoluble pigment, after the organic tissue is anesthetized, is removed from the outer surface of the organic tissue.”
[067] of the Specification states, “In preferred embodiments, said at least one pigment does not penetrate into the organic tissue and remains temporarily on the outer surface of the organic tissue while the anesthetic compound is absorbed by the tissue which is then anesthetized.” However, this does not provide support for ““wherein the insoluble pigment, after the organic tissue is anesthetized, is removed from the outer surface of the organic tissue.”
Moreover, Applicant has not pointed to support for this limitation.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7-10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Independent claim 1 recites “at least one insoluble pigment. . .wherein the at least one insoluble pigment is micronized titanium dioxide provided in the composition at a concentration between 0.5% and 20% by weight.”
Claim 7, which depends from claim 1, recites a laundry list of “said at least on pigment,” which broadens the scope of claim 1, which recites micronized titanium dioxide is the at least one insoluble pigment.
Claim 8, which depends from claim 7 which depends from claim 1, recites “wherein said at least one pigment is titanium dioxide,” which broadens the scope of claim 1 since claim 1 recites “wherein the at least one insoluble pigment is micronized titanium dioxide.”
Claim 9, which depends from claim 1, recites “wherein said at least one pigment is a micronized pigment.” However, claim 1 recites “wherein the at least one insoluble pigment is micronized titanium dioxide.”
Claim 10, which depends from claim 1, recites “wherein said at least one pigment is in a concentration between 0.5% and 20% by weight.” However claim 1 already recites wherein the at least one insoluble pigment is micronized titanium dioxide provide in the composition at a concentration between 0.5% and 20% by weight.”
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
This rejection can be overcome by cancelling claims 7-10.
Free of the Prior Art
The instant claims are free of the prior art.
The closest prior art is US 2016/0015731 to Ryoo (published 2016, PTO-892 of 02/06/2025) and Translation of WO 2019/057822 to Toprak (effectively filed 09/20/2018, PTO-892 of 02/06/2025).
While Ryoo teaches:
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(pg. 6, Table 1), it does not teach a) 10-30% by weight lidocaine, b) 5-25% by weight of procaine or tetracaine, c) micronized titanium dioxide, d) a concentration of between 0.5% and 20% by weight micronized titanium dioxide, e) a carrier comprising water and glycerine having a density of between 0.95 and 1.20 g/ml, which are distinct features of the instantly claimed invention.
While Toprak teaches:
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(pg. 6), and teaches:
-a composition comprising water, ethanol, caustic soda to adjust the pH, poloxamer, black tattoo ink, and 4 wt.% lidocaine (pg. 8, examples 1 and 2),
-the local anesthetics as lidocaine, prilocaine, etidocaine, bupivacaine, ropivacaine, levobupivacaine, procaine and tetracaine as local anesthetics (pg. 1, claim 1), and
-the solvent as a combination of water and ethanol or glycerol,
-colorants as the tattooing ink, wherein the colorant may be:
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(pg. 5), it does not specifically teach a) a combination of two anesthetics, wherein one is selected 10-30% lidocaine and the other is 5-25% tetracaine or procaine, b) titanium dioxide let alone micronized titanium dioxide or a concentration of between 0.5% and 20% by weight micronized titanium dioxide, or c) a carrier comprising water and glycerine having a density of between 0.95 and 1.20 g/ml, which are distinct features of the instantly claimed invention.
As such, the instant claims are free of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622
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