DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 08/06/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 (New, Necessitated by Amendment)
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.
Claims 1, 3-6, and 10 are rejected under 35 U.S.C. 103 as being as being obvious over Smart et al. (US 2019/0169548 A1) in view of Lin et al. (Ind. Eng. Chem. Res. 2013, 52:3449−13458) and further in view of CN 113171331 A.
Regarding claim 1, Smart discloses a composition with dispersed taurine crystals (“precipitates”) [0067]-[0069]. Smart discloses that the taurine in water shows precipitates [0067]-[0069] (i.e., is therefore, at least at/greater than its saturation solubility with respect to the moisture content). Smart discloses the compositions with taurine are for application to skin [0001]-[0002].
Smart does not disclose that the taurine crystals are “needlelike”, that the length of the crystals is 5 µm or more and 3000 µm or less or that the examples at paragraphs [0067]-[0069] have an amount of taurine of 1.0 to 5.0 times the saturation solubility with respect to the moisture content in the composition.
Lin discloses taurine crystals where the length ranges from about 1-900 µm (pg. 13452, Fig 4). Lin teaches that the size of taurine crystals affects its properties, such as fluidity, caking, and stickiness (pg. 13449, left column, second paragraph).
The size of taurine crystals is recognized to have different effects (fluidity, caking, and stickiness) with changing sizes used. Thus, the general condition (size of taurine crystals) is known and the size is recognized to be result effective. As such, result effective variables can be optimized by routine experimentation, and it would have been prima facie obvious to optimize the size of the taurine crystals, as taught by Lin. See MPEP 2144.05.
Furthermore, as evidenced by Lin, taurine crystalizes as tetragonal needles (pg. 13449, left column, top), therefore, the taurine crystals of Smart taught at [0067]-[0069] would be reasonably expected to be “needlelike”.
The combined teachings of Smart and Lin do not disclose the claimed saturation solubility with respect to the moisture content in the composition.
CN 113171331 A discloses a crystal amino acid bath lotion with taurine (English translation, pg. 2). The taurine in the composition is in crystalline form (pg. 3 bottom – pg. 4, top; Fig 1 and 2). CN 113171331 A teaches that the amount of water affects the crystallization of taurine which has an effect on the moisturization of the composition (English translation, pg. 3, bottom – pg. 4, top).
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 a saturated taurine solution has been taught by the prior art (Smart); and the ratio of taurine to water is recognized to have an effect on the composition (i.e., moisturization, CN 113171331 A) as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of taurine with respect to the moisture content in the composition via routine experimentation.
Examiner’s Note: The limitation of claim 1, “for application to skin”, is interpreted as an intended use of the composition, nevertheless, the compositions of Smart are capable of meeting the intended use because Smart discloses the compositions with taurine are for application to skin [0001]-[0002].
Regarding claim 3, as evidenced by CN 113171331 A, taurine is soluble in water (English translation, pg. 3, bottom), therefore, claim 3 is rendered prima facie obvious because Smart teaches taurine [0067]-[0069] and taurine is inherently water soluble.
Claims 4-5 are rendered prima facie obvious because Smart discloses a composition with dispersed taurine crystals [0067]-[0069].
Claim 6 is rendered prima facie obvious because Smart discloses the taurine compositions include an aqueous medium, but some precipitates (i.e., crystals) are observed [0067]-[0069]. As taurine is inherently soluble in water, some of the taurine is reasonably expected to be necessarily present in the dissolved state.
Claim 10 is rendered prima facie obvious because Smart discloses the taurine composition includes an aqueous medium [0067]-[0069].
Response to Arguments
Applicant’s arguments filed 08/06/2026 have been fully considered but are not persuasive.
Applicant argues at pg. 8 that Smart teaches away from the presently claimed feature wherein the substance is a needlelike crystal, and a length of the crystal is 5 µm or more and 3000 µm or less because Smart teaches that taurine crystallization is undesirable.
The Examiner disagrees. Patents are relevant as prior art for all that they contain and nonpreferred or alternative embodiments constitute prior art. See MPEP 2123. Therefore, although not a preferred embodiment, Smart does teach compositions with dispersed taurine crystals (“precipitates”) [0067]-[0069]. Lin discloses taurine crystals where the length ranges from about 1-900 µm (pg. 13452, Fig 4). Lin teaches that the size of taurine crystals affects its properties, such as fluidity, caking, and stickiness (pg. 13449, left column, second paragraph). and it would have been prima facie obvious to optimize the size of the taurine crystals, as taught by Lin, within the teachings of Smart, as discussed above.
Claims 1, 3-6, and 10 are rejected under 35 U.S.C. 103 as being as being obvious over CN 113171331 A in view of Lin et al. (Ind. Eng. Chem. Res. 2013, 52:3449−13458).
Regarding claim 1, CN 113171331 A discloses a crystal amino acid bath lotion with dispersed taurine (English translation, Example 1, pg. 4 bottom) The taurine in the composition is in needlelike, crystalline form (pg. 3 bottom – pg. 4, top; Fig 1 and 2). CN 113171331 A also teaches varying amounts of the taurine (pg. 2) and solvents (i.e., water, pg. 2) can be used and that that the amount of water affects the crystallization of taurine which has an effect on the moisturization of the composition (English translation, pg. 3, bottom – pg. 4, top). CN 113171331 A discloses the composition is used as a lotion to be applied to the skin (Example 1, pg. 4 bottom, pg. 2).
CN 113171331 A does not disclose that the length of the crystals is 5 µm or more and 3000 µm or less or that the amount of the substance in the composition is 1.0 to 5.0 times the saturation solubility with respect to the moisture content in the composition.
Regarding the amount of the substance, 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 a crystalline taurine composition is known in the art and the ratio of taurine to water is recognized to have an effect on the composition (i.e., moisturization, pg. 3, bottom – pg. 4, top) as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of taurine with respect to the moisture content in the composition via routine experimentation within the teachings of CN 113171331 A.
Regarding the length of the crystals, Lin discloses taurine crystals where the length ranges from about 1-900 µm (pg. 13452, Fig 4). Lin teaches that the size of taurine crystals affects its properties, such as fluidity, caking, and stickiness (pg. 13449, left column, second paragraph).
The size of taurine crystals is recognized to have different effects (fluidity, caking, and stickiness) with changing sizes used. Thus, the general condition (size of taurine crystals) is known and the size is recognized to be result effective. As such, result effective variables can be optimized by routine experimentation, and it would have been prima facie obvious to optimize the size of the taurine crystals, as taught by Lin. See MPEP 2144.05.
Examiner’s Note: The limitation of claim 1, “for application to skin”, is interpreted as an intended use of the composition, nevertheless, the compositions of CN 113171331 A are capable of meeting the intended use because CN 113171331 A discloses the compositions are used as a lotion to be applied to the skin (Example 1, pg. 4 bottom, pg. 2).
Claim 3 is rendered prima facie obvious because taurine is soluble in water (pg. 3, bottom).
Claims 4-5 are rendered prima facie obvious because CN 113171331 A discloses a crystal amino acid bath lotion with dispersed taurine (English translation, Example 1, pg. 4 bottom)
Claim 6 is rendered prima facie obvious because CN 113171331 A discloses the crystal amino acid bath lotion has crystallized taurine and water (Example 1, pg. 4 bottom). Because taurine is soluble in water (pg. 3, bottom) some of the taurine is reasonably expected to be necessarily present in the dissolved state.
Claim 10 is rendered prima facie obvious because CN 113171331 A discloses the composition includes an aqueous medium (Example 1, pg. 4 bottom).
Response to Arguments
Applicant’s arguments filed 08/06/2026 have been fully considered but are not persuasive.
Applicant argues at pg. 9 that CN’331 fails to teach or suggest the features of wherein the substance is a “needlelike” crystal.
The Examiner disagrees. The features the crystal must have to be “needlelike” are not defined in the specification and CN 113171331 A discloses in Figures 1 and 2 images of the crystals which appear to be “needlelike” (i.e., crystalline, length longer than width). Therefore, CN 113171331 A discloses the instantly claimed feature of “needlelike crystals”.
Applicant argues at pg. 9-10 that CN’331 fails to teach or suggest the feature where a length of the crystal is 5 µm or more and 3000 µm or less.
The Examiner disagrees. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In the instant case, Lin discloses taurine crystals where the length ranges from about 1-900 µm (pg. 13452, Fig 4). Lin teaches that the size of taurine crystals affects its properties, such as fluidity, caking, and stickiness (pg. 13449, left column, second paragraph). It would have been prima facie obvious to optimize the size of the taurine crystals, as taught by Lin, within the teachings of CN 113171331 A, as previously discussed.
Analysis of Alleged Unexpected Results
Applicant further argues that the features of the present invention provide for unexpected and superior results (such as sense of “prickly feel” and “irritation” and “permeation into the skin”) which is not disclosed in the cited references. The Examiner is directed to paragraphs [0126]-[0137].
The Examiner has fully reviewed paragraphs [0126]-[0137] (in reference to PG pub). The provided data shows that the following examples were rated for sense of use and sense of irritation (“ND” refers to no data given in the example).
Inventive
Ex. 1
Ex. 2
Ex. 3
Ex. 4
Ex. 5
Ex. 6
Ex. 7
Ex. 8
Substance
taurine
taurine
taurine
pyridoxine hydrochloride
glycylglycine
glutathione
tryptophan
taurine
Saturation
2.38
3.01
4.5
1.5
2.5
2.0
ND
1.80
Length (µm)
500-1000
50-1000
50-1500
ND
≤ 1000
ND
ND
ND
Sense of use
21
23
24
22
22
21
20
24
Sense of irritation
1
1
5
1
2
0
1
2
First, it does not appear that applicant has adequately explained the data presented as being evidence of non-obvious. See MPEP § 716.02(b)(II).
It is explained in paragraph [0126] that the rating for sense of use ranges for 0-5 with 0 being “no prickly feel was felt” and 5 being “a prickly feel was felt very strongly”. However, the ratings vary from 20-24 which is well outside this range. For the sake of compact prosecution, the Examiner is assuming (based on the scale given at [0126]) that a higher value for “sense of use” means more prickly feeling felt, however further clarification is required to adequately assess the data. Additionally, the applicant asserts (pg. 10 of remarks) that the claimed saturation and length is critical for achieving the unexpected results, however, data is not given for the crystal length for Examples 4 and 6-8.
Examples 1-3 and 5 (for which all data has been provided) show the sense of use and irritation for crystals of taurine (examples 1-3) and glycylglycine (example 5). “No sense of irritation” was only demonstrated with taurine crystals of length 50-1000 µm and a saturation of 2.38 or 3.01. The disadvantage of the higher saturation solubility of 4.5 (which is within the claimed range) is shown in Example 3, as this composition has a strong sense of irritation which remained after application.
The compositions of taurine crystals of length 50-1000 µm and a saturation of 2.38 to 3.01 having less irritation than compositions with higher saturation solubility (i.e., 4.5) is unexpected over the prior art.
However, the claims are not “commensurate in scope” with the showing. See MPEP § 716.02(d). The Applicant has demonstrated less irritation, but this has only been shown with taurine crystals with a crystal length of 50-1000 µm and a saturation of 2.38-3.01 It is unclear that a comparative composition containing these specific components would be reasonably representative of compositions containing other “substances” (e.g., other than taurine), with other lengths, and with different saturation solubilities, falling within the broader scope currently claimed.
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 1, 3-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-19 of U.S. Patent Application No. 18/565,074 in view of CN 113171331 A.
Claims 1, 3-6 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent Application No. 18/849,858 in view of CN 113171331 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 except for the blending amount of the valuable substance in the composition being in an amount of 1.0 to 5.0 times the saturation solubility with respect to the moisture content in the composition.
CN 113171331 A discloses a crystal amino acid bath lotion with dispersed taurine (English translation, Example 1, pg. 4 bottom). The taurine in the composition is in crystalline form (pg. 3 bottom – pg. 4, top; Fig 1 and 2). CN 113171331 A teaches varying amounts of the taurine (pg. 2) and solvents (i.e., water, pg. 2) can be used and that that the amount of water affects the crystallization of taurine which has an effect on the moisturization of the composition (pg. 3, bottom – pg. 4, top).
It would have been prima facie obvious to one of ordinary skill in the art to include the blending amount of the taurine in the composition in an amount of 1.0 to 5.0 times the saturation solubility with respect to the moisture content in the composition, within the copending claims. 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 the instant case, it would have been prima facie obvious to optimize the amount of taurine with respect to the moisture content in the composition via routine experimentation following the teachings of CN 113171331 A.
These are provisional nonstatutory double patenting rejections.
Response to Arguments
Applicant’s arguments filed 08/06/2026 have been fully considered but are not persuasive.
Applicant argues that the claims of U.S. patent application Nos. 18/565,074 and 18/849,858 only recite a thickness of 150 micrometers or less and a length of 3000 micrometers and do not teach the amount of 1.0 to 5.0 times the saturation solubility with respect to the moisture content in the composition. Thus, the skin care composition of the present invention differs from that recited in the claims of U.S. Patent Application Nos. 18/565,074 and 18/849,858.
The Examiner disagrees. U.S. patent application Nos. 18/565,074 and 18/849,858 teach lengths of the crystals which overlap with the claimed range and it would have been prima facie obvious to optimize the amount of taurine with respect to the moisture content in the composition via routine experimentation following the teachings of CN 113171331 A.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Correspondence
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.
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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.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
