Prosecution Insights
Last updated: October 25, 2026
Application No. 18/849,858

SKIN EXTERNAL AGENT COMPOSITION IN WHICH FINE NEEDLE-LIKE OR COLUMNAR CRYSTALS OF TAURINE ARE BLENDED

Non-Final OA §102§103§112§DP
Filed
Sep 23, 2024
Priority
Apr 15, 2022 — JP 2022-067637 +1 more
Examiner
WERTZ, ASHLEE ELIZABETH
Art Unit
1612
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Cosmed Pharmaceutical Co. Ltd.
OA Round
1 (Non-Final)
53%
Grant Probability
Moderate
1-2
OA Rounds
1y 3m
Est. Remaining
88%
With Interview

Examiner Intelligence

Grants 53% of resolved cases
53%
Career Allowance Rate
29 granted / 55 resolved
-7.3% vs TC avg
Strong +36% interview lift
Without
With
+35.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
58 currently pending
Career history
112
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
50.0%
+10.0% vs TC avg
§102
7.1%
-32.9% vs TC avg
§112
17.4%
-22.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 55 resolved cases

Office Action

§102 §103 §112 §DP
DETAILED 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 . 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. Election/Restrictions Applicant's election without traverse of Group II, claims 5-16, in the reply filed on 08/18/2026 is acknowledged. Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim Rejections - 35 USC § 112, Second Paragraph 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. Claims 8-9 and 13-14 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 claims 8 and 13, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 8 and 13 recite the broad recitation “the liquid substance having low solubility of taurine is a water-soluble organic solvent having a taurine solubility of 1.0 g or less per 100 g of the liquid substance”, and the claims also recite (25°C) in parenthesis which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The remaining claims are rejected for depending on the indefinite base claim(s). Claim Rejections - 35 USC § 102 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. Claims 5-6 and 8-9 are rejected under 35 U.S.C. 102 as being as being anticipated by Zhao et al. (CN 109574886 A). Claim 5 is anticipated because Zhao discloses adding taurine into water, heating to 55 degrees C to dissolve, and adding ethanol (the aqueous solution in which taurine is dissolved is brought into contact with ethanol) to obtain “blocky-shaped particles” of taurine (English translation pg. 3, Embodiment 2). The “blocky-shaped particles” as disclosed would include “columnar” crystals as claimed because Zhao shows the crystalline product according to the invention in figure 1, where many of the crystals have a columnar structure (Fig 1, pg. 7 in non-translated document). Claim 6 is anticipated because Zhao discloses the taurine concentration in the aqueous solution is 18 wt.% (English translation pg. 3, Embodiment 2). If the prior art discloses a point within the claimed range, the prior art anticipates the claim. See MPEP 2131.03. I. Claims 8 and 9 are anticipated because Zhao discloses the organic solvent is ethanol (English translation pg. 3, Embodiment 2). While Zhao does not explicitly disclose that the ethanol has a taurine solubility of 1.0 g or less per 100 g of the liquid substance, as recited in claim 8, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches ethanol, the properties the applicant discloses and/or claims (solvent having a taurine solubility of 1.0 g or less per 100 g of the liquid substance) are reasonably expected to be necessarily present. Claims 5 and 8-9 are rejected under 35 U.S.C. 102 as being as being anticipated by Li et al. (CN 101671283 A). Claim 5 is anticipated because Li discloses dissolving taurine in water and after completely dissolving adding ethanol to obtain “columnar crystal taurine” (English translation, pg. 2, bottom – pg. 3, top). Claims 8 and 9 are anticipated because Li discloses the organic solvent is ethanol (English translation, pg. 2, bottom – pg. 3, top). While Li does not explicitly disclose that the ethanol has a taurine solubility of 1.0 g or less per 100 g of the liquid substance, as recited in claim 8, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches ethanol, the properties the applicant discloses and/or claims (solvent having a taurine solubility of 1.0 g or less per 100 g of the liquid substance) are reasonably expected to be necessarily present. Claim 7 is rejected under 35 U.S.C. 102 as being as being anticipated by Li et al. (CN 101671283 A) and as evidenced by Ethanol (Material Safety Data Sheet). Claim 7 is anticipated because Li discloses that the taurine is dissolved in 500 mL of water and 40 mL of ethanol is added to produce the taurine crystal (English translation, pg. 2, bottom – pg. 3, top). While Li does not explicitly disclose the mass % of the ethanol with respect to the total amount of the aqueous solution, water is known to have a density around 1 g/mL and as evidenced by “ethanol”, ethanol has a density of 0.8-0.77 g/mL depending on the temperature (pg. 4 bottom – pg. 5, top). The amount of water is around 500 g and the amount of ethanol is around 31.4 g ( 40   m L   x   0.785   g 1   m L = 31.4   g ) . Therefore, the amount of ethanol is 50 mass % or less with respect to the total amount of aqueous solution (around 6.28 mass %; 31.4/500 = 6.28%). 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. 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. Claim 7 is rejected under 35 U.S.C. 103 as being as being obvious over Zhao et al. (CN 109574886 A). Claims 5-6 and 8-9 are anticipated by Zhao as discussed above. Regarding claim 7, Zhao does not disclose that the amount of liquid substance having low solubility of taurine is 50 mass % or less with respect to a total amount of the aqueous solution in which taurine is dissolve because Zhao discloses that Embodiment 2 (English translation pg. 3) includes 8 times the volume of ethanol to water. However, the amount of solvent in relation to the amount of water, as claimed, would be achieved by one of ordinarily skill in the art through routine experimentation. Zhao teaches that supersaturation of the system can be controlled by controlling the amount of solvent added, in this way, the morphology of the final crystal product can be controlled (English translation, pg. 2, bottom – pg. 3, top; [0026] non-translated version). 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. See MPEP 2144.05(II)(A). In this case, the general condition of producing taurine crystals through solvent crystallization with taurine dissolved in water and the addition of ethanol has been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of the solvent in relation to the water via routine experimentation to control the morphology of the final crystal product as taught by Zhao (English translation, pg. 2, bottom – pg. 3, top; [0026] non-translated version). Claims 10-16 are rejected under 35 U.S.C. 103 as being as being obvious over Zhao et al. (CN 109574886 A) in view of CN 113171331 A. Regarding claim 10, Zhao discloses adding taurine into water, heating to 55 degrees C to dissolve and adding ethanol (the aqueous solution in which taurine is dissolved is brought into contact with ethanol) to obtain “blocky-shaped particles” of taurine (English translation pg. 3, Embodiment 2). The “blocky-shaped particles” as disclosed would include “columnar” crystals as claimed because Zhao shows the crystalline product according to the invention in figure 1, where many of the crystals have a columnar structure (Fig 1, pg. 7 in non-translated document). Zhao does not disclose that the crystals of taurine are blended into a skin external agent composition. CN 113171331 A discloses a crystalline taurine bath lotion for the skin (abstract; English translation pg. 6, third paragraph from bottom). The taurine is blended (stirred) into the composition (Example 3, English translation, pg. 5, bottom, “adding B phase component, stirring”; “adding E phase component, stirring” – both of these phases have taurine). CN 113171331 A teaches that the crystalline taurine in the bath lotion gives a fresh and comfortable feel to people (English translation pg. 6, third paragraph from bottom) and that taurine has the effect of moisturizing and soothing the skin (English translation, pg. 3, bottom paragraph). Since Zhao generally teaches crystalline taurine, it would have been prima facie obvious to one of ordinary skill in the art to blend the taurine into a skin external agent composition, because CN 113171331 A discloses a crystalline taurine composition for the skin where taurine is blended into the composition. An ordinarily skilled artisan would have been motivated to blend the crystalline taurine into a bath lotion because CN 113171331 A teaches that the crystalline taurine in the bath lotion gives a fresh and comfortable feel to people (English translation pg. 6, third paragraph from bottom) and that taurine has the effect of moisturizing and soothing the skin (English translation, pg. 3, bottom paragraph). Claim 11 is rendered prima facie obvious because Zhao discloses the taurine concentration in the aqueous solution is 18 wt.% (English translation pg. 3, Embodiment 2). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A. Regarding claim 12, Zhao does not disclose that the amount of liquid substance having low solubility of taurine is 50 mass % or less with respect to a total amount of the aqueous solution in which taurine is dissolved because Zhao teaches that Embodiment 2 (English translation pg. 3) includes 8 times the volume of ethanol compared to water. However, the amount of solvent in relation to the amount of water, as claimed, would be achieved by one of ordinarily skill in the art through routine experimentation. Zhao teaches that supersaturation of the system can be controlled by controlling the amount of solvent added, in this way, the morphology of the final crystal product can be controlled (English translation, pg. 2, bottom – pg. 3, top; [0026] non-translated version). 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. See MPEP 2144.05(II)(A). In this case, the general condition of producing taurine crystals through solvent crystallization with taurine dissolved in water and the addition of ethanol has been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of the solvent in relation to the water via routine experimentation to achieve the morphology of the final crystal product as taught by Zhao (English translation, pg. 2, bottom – pg. 3, top; [0026] non-translated version). Claims 13-14 are rendered prima facie obvious because Zhao discloses the organic solvent is ethanol (English translation pg. 3. Embodiment 2). While Zhao does not explicitly disclose that the ethanol has a taurine solubility of 1.0 g or less per 100 g of the liquid substance, as recited in claim 13, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches ethanol, the properties the applicant discloses and/or claims (solvent having a taurine solubility of 1.0 g or less per 100 g of the liquid substance) are reasonably expected to be necessarily present. Regarding claim 15, it would have been prima facie obvious to include crystalline taurine in a composition for the skin, as taught by CN 113171331 A, as previously discussed. Furthermore, CN 113171331 A discloses that the composition is a bath lotion/aqueous shower gel (abstract; English translation pg. 6, third paragraph from bottom; Example 3, English translation, pg. 5, bottom), that the taurine is blended in an aqueous phase (phase A includes majority water, taurine (in phase B) is stirred into phase A, phase C includes more water, taurine (in phase E) is further blended into the aqueous composition - Example 3, English translation, pg. 5, bottom), and that the crystals are retained in the composition (English translation pg. 6, third paragraph from bottom, Fig. 1-2). As the taurine crystals are retained in the composition, the taurine concentration is necessarily at saturation or higher. Claim 16 is rendered prima facie obvious because Zhao discloses that the taurine crystals are filtered (“positive press filtration”) and dried (“dry after, obtain the taurine crystal product”) (English translation pg. 3, Embodiment 2). It would have been prima facie obvious to blend crystalline taurine in a composition for the skin, as taught by CN 113171331 A, within the teachings of Zhao, as previously discussed. CN 113171331 A discloses that the composition is a bath lotion/aqueous shower gel (abstract; English translation pg. 6, third paragraph from bottom; Example 3, English translation, pg. 5, bottom). As an “ointment” as claimed is not explicitly defined in the claim and/or specification and is generally understood to mean a composition for application to skin, the bath lotion/aqueous shower gel for application to skin taught by CN 113171331 A reads on “ointment” as claimed. Claim 6 is rejected under 35 U.S.C. 103 as being as being obvious over Li et al. (CN 101671283 A) in view of Zhao et al. (CN 109574886 A). Claims 5 and 7-9 are anticipated by Li as previously discussed. Regarding claim 6, Li does not disclose that the taurine concentration in the aqueous solution is 3 to 28 mass %. Zhao discloses a method of producing taurine crystals in which taurine is added to water and taurine crystals are formed through solvent crystallization with ethanol [abstract] (English translation pg. 3, Embodiment 2). Zhao teaches that the taurine is added to water at a concentration of 15-25 wt.% (English translation, pg. 2, middle; pg. 3, Embodiment 2) and that the method of preparation which uses taurine at this concentration produces a taurine product with better flow properties and no agglomeration (English translation, pg. 3, second paragraph, [0027] non-translated version; English translation pg. 3, Embodiment 2). Since Li generally teaches a method for producing taurine crystals in which taurine is added to water and taurine crystals are formed through solvent crystallization with ethanol, it would have been prima facie obvious to one of ordinary skill in the art to include taurine in an amount of 15-25 wt.%, within the teachings of Li, because Zhao teaches a preparation method for taurine crystals in which taurine is added to water and taurine crystals are formed through solvent crystallization with taurine in this amount. An ordinarily skilled artisan would have been motivated to use this amount of taurine because Zhao teaches the method of preparation which uses taurine at this concentration produces a taurine product with better flow properties and no agglomeration (English translation, pg. 3, second paragraph, [0027] non-translated version; English translation pg. 3, Embodiment 2). In regards to the amount of taurine, a prima facie case of obviousness exists because of overlap, as previously discussed. Claims 10 and 13-16 are rejected under 35 U.S.C. 103 as being as being obvious over Li et al. (CN 101671283 A) in view of CN 113171331 A. Regarding claim 10, Li discloses dissolving taurine in water and after completely dissolving adding ethanol to obtain “columnar crystal taurine” (English translation, pg. 2, bottom – pg. 3, top). Li does not disclose that the crystals of taurine are blended into a skin external agent composition. CN 113171331 A discloses a crystalline taurine bath lotion for the skin (abstract; English translation pg. 6, third paragraph from bottom). The taurine is blended (stirred) into the composition (Example 3, English translation, pg. 5, bottom, “adding B phase component, stirring”; “adding E phase component, stirring” – both of these phases have taurine). CN 113171331 A teaches that the crystalline taurine in the bath lotion gives a fresh and comfortable feel to people (English translation pg. 6, third paragraph from bottom) and that taurine has the effect of moisturizing and soothing the skin (English translation, pg. 3, bottom paragraph). Since Li generally teaches crystalline taurine, it would have been prima facie obvious to one of ordinary skill in the art to blend the taurine into a skin external agent composition because CN 113171331 A discloses a crystalline taurine composition for the skin where taurine is blended into the composition. An ordinarily skilled artisan would have been motivated to blend the crystalline taurine into a bath lotion because CN 113171331 A teaches that the crystalline taurine in the bath lotion gives a fresh and comfortable feel to people (English translation pg. 6, third paragraph from bottom) and that taurine has the effect of moisturizing and soothing the skin (English translation, pg. 3, bottom paragraph). Claims 13 and 14 are rendered prima facie obvious because Li discloses the organic solvent is ethanol (English translation, pg. 2, bottom – pg. 3, top). While Li does not explicitly disclose that the ethanol has a taurine solubility of 1.0 g or less per 100 g of the liquid substance, as recited in claim 13, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches ethanol, the properties the applicant discloses and/or claims (solvent having a taurine solubility of 1.0 g or less per 100 g of the liquid substance) are reasonably expected to be necessarily present. Regarding claim 15, it would have been prima facie obvious to include crystalline taurine in a composition for the skin, within the teachings of Li, as taught by CN 113171331 A, as previously discussed. Furthermore, CN 113171331 A discloses that the composition is a bath lotion/aqueous shower gel (abstract; English translation pg. 6, third paragraph from bottom; Example 3, English translation, pg. 5, bottom), that the taurine is blended in an aqueous phase (phase A includes majority water, taurine (in phase B) is stirred into phase A, phase C includes more water, taurine (in phase E) is further blended into the aqueous composition - Example 3, English translation, pg. 5, bottom), and that the crystals are retained in the composition (English translation pg. 6, third paragraph from bottom, Fig. 1-2). As the taurine crystals are retained in the composition, the taurine concentration is necessarily at saturation or higher. Claim 16 is rendered prima facie obvious because Li discloses filtering and drying the crystalline taurine (English translation, pg. 2, bottom – pg. 3, top). It would have been prima facie obvious to blend crystalline taurine in a composition for the skin, within the teachings of Li, as taught by CN 113171331 A, as previously discussed. CN 113171331 A discloses that the composition is a bath lotion/aqueous shower gel (abstract; English translation pg. 6, third paragraph from bottom; Example 3, English translation, pg. 5, bottom). As an “ointment” as claimed is not explicitly defined in the claim and/or specification and is generally understood to mean a composition for application to skin, the bath lotion/aqueous shower gel for application to skin taught by CN 113171331 A reads on “ointment” as claimed. Claim 11 is rejected under 35 U.S.C. 103 as being as being obvious over Li et al. (CN 101671283 A) in view of CN 113171331 A and further in view of Zhao et al. (CN 109574886 A). The 35 U.S.C. 103 rejection over Li in view of CN 113171331 A was previously discussed. Regarding claim 11, Li does not disclose that the taurine concentration in the aqueous solution is 3 to 28 mass %. Zhao discloses a method of producing taurine crystals in which taurine is added to water and taurine crystals are formed through solvent crystallization with ethanol [abstract] (English translation pg. 3, Embodiment 2). Zhao teaches that the taurine is added to water at a concentration of 15-25 wt.% (English translation, pg. 2, middle; pg. 3, Embodiment 2) and that the method of preparation which uses taurine at this concentration produces a taurine product with better flow properties and no agglomeration (English translation, pg. 3, second paragraph, [0027] non-translated version; English translation pg. 3, Embodiment 2). Since Li generally teaches a method for producing taurine crystals in which taurine is added to water and taurine crystals are formed through solvent crystallization with ethanol, it would have been prima facie obvious to one of ordinary skill in the art to include taurine in an amount of 15-25 wt.%, within the combined teachings of the prior art, because Zhao teaches a preparation method for taurine crystals in which taurine is added to water and taurine crystals are formed through solvent crystallization with taurine in this amount. An ordinarily skilled artisan would have been motivated to use this amount of taurine because Zhao teaches the method of preparation which uses taurine at this concentration produces a taurine product with better flow properties and no agglomeration (English translation, pg. 3, second paragraph, [0027] non-translated version; English translation pg. 3, Embodiment 2). In regards to the amount of taurine, a prima facie case of obviousness exists because of overlap, as previously discussed. Claim 12 is rejected under 35 U.S.C. 103 as being as being obvious over Li et al. (CN 101671283 A) in view of CN 113171331 A and as evidenced by Ethanol (Material Safety Data Sheet). The 35 U.S.C. 103 rejection over Li in view of CN 113171331 A was previously discussed. Claim 12 is rendered prima facie obvious because Li discloses that the taurine is dissolved in 500 mL of water and 40 mL of ethanol is added to produce the taurine crystal (English translation, pg. 2, bottom – pg. 3, top). While Li does not explicitly disclose the mass % of the ethanol with respect to the total amount of the aqueous solution, water is known to have a density around 1 g/mL and as evidenced by “ethanol”, ethanol has a density of 0.8-0.77 g/mL depending on the temperature (pg. 4 bottom – pg. 5, top). The amount of water is around 500 g and the amount of ethanol is around 31.4 g ( 40   m L   x   0.785   g 1   m L = 31.4   g ) . Therefore, the amount of ethanol is 50 mass% or less with respect to the total amount of aqueous solution (around 6.28 mass %; 31.4/500 = 6.28%). Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 5-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-19 of U.S. Patent Application No. 18/565,074 in view of CN 113171331 A and Zhao et al. (CN 109574886 A). Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the features instantly recited for the composition expect for the form of the external agent (e.g., lotion/ointment), the taurine concentration in an aqueous phase in a blending step being maintained at a saturation concentration or higher, whereby the crystals of taurine are retained, and filtering and drying the crystals of taurine. CN 113171331 A discloses a crystalline taurine bath lotion for the skin (abstract; English translation pg. 6, third paragraph from bottom). CN 113171331 A discloses that the composition is a bath lotion/aqueous shower gel (abstract; English translation pg. 6, third paragraph from bottom; Example 3, English translation, pg. 5, bottom), that the taurine is blended in an aqueous phase (phase A includes majority water, taurine (in phase B) is stirred into phase A, phase C includes more water, taurine (in phase E) is further blended into the aqueous composition - Example 3, English translation, pg. 5, bottom), and that the crystals are retained in the composition (English translation pg. 6, third paragraph from bottom, Fig. 1-2). CN 113171331 A teaches that the crystalline taurine in the bath lotion gives a fresh and comfortable feel to people (English translation pg. 6, third paragraph from bottom) and that taurine has the effect of moisturizing and soothing the skin (English translation, pg. 3, bottom paragraph). Zhao discloses a method of producing taurine crystals in which taurine is added to water and taurine crystals are formed through solvent crystallization with ethanol [abstract] (English translation pg. 3, Embodiment 2). Zhao discloses that the taurine crystals are filtered (“positive press filtration”) and dried to obtain the crystal product (“dry after, obtain the taurine crystal product”) (English translation pg. 3, Embodiment 2). The ordinarily skilled artisan would have been motivated to blend the taurine crystals into a bath lotion/aqueous shower gel and to retain the crystals of taurine, within the copending claims, because CN 113171331 A teaches that the crystalline taurine in the bath lotion/aqueous shower gel gives a fresh and comfortable feel to people (English translation pg. 6, third paragraph from bottom) and that taurine has the effect of moisturizing and soothing the skin (English translation, pg. 3, bottom paragraph). The ordinarily skilled artisan would have been motivated to form the composition as taught by CN 113171331 A (Example 3, English translation, pg. 5, bottom). The ordinarily skilled artisan would have been motivated to filter and dry the taurine to obtain the taurine crystals as taught by Zhao (English translation pg. 5, Example 2). This is a provisional nonstatutory double patenting rejection. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ASHLEE E WERTZ/Examiner, Art Unit 1612
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Prosecution Timeline

Sep 23, 2024
Application Filed
Sep 28, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12758479
ADHESIVE PHOTOPROTECTIVE COMPOUNDS AND USES THEREOF
4y 4m to grant Granted Oct 13, 2026
Patent 12708618
PHARMACEUTICAL COMPOSITE FORMULATION COMPRISING PROTON PUMP INHIBITOR AND ANTACID, AND METHOD FOR PREPARING SAME
3y 7m to grant Granted Aug 18, 2026
Patent 12702632
PROTEASE FORMULATION FOR TREATMENT OF MICROBIAL INFECTIONS
3y 9m to grant Granted Aug 11, 2026
Patent 12673015
LOW SULFATE SURFACTANT COMPOSITION
3y 11m to grant Granted Jul 07, 2026
Patent 12660823
FUNGICIDAL COMBINATIONS
3y 6m to grant Granted Jun 23, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

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Prosecution Projections

1-2
Expected OA Rounds
53%
Grant Probability
88%
With Interview (+35.6%)
3y 5m (~1y 3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 55 resolved cases by this examiner. Grant probability derived from career allowance rate.

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