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 I, claims 1-11, and an amino acid as the “valuable substance” in the reply filed on 04/19/2026 is acknowledged. Claims 1-6 and 9-10 read on the elected invention and species.
Claims 7-8 and 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-6 and 9-10 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.
Claim 1 recites the limitation “valuable substance”. This phrase renders the claim indefinite because the scope of the claim limited by the term “valuable” is not clear. The term “valuable” is indefinite and it would not be clear to one of ordinary skill in the art how much value/worth a substance should have to be considered “valuable”.
Claim 9 recites the limitation “the blending amount" in line 2. There is insufficient antecedent basis for the limitation “the blending” in the claim. To overcome this rejection, this limitation can be changed to, for example, “the amount”.
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 1, 4-5, and 10 are rejected under 35 U.S.C. 102 as being as being anticipated by Smart et al. (US 2019/0169548 A1).
Claims 1 and 4-5 are anticipated because Smart discloses a composition with dispersed taurine crystals [0067]-[0069].
Examiner’s Note: The limitation of claim 1, “for application to skin”, is interpreted as an intended use of the composition, nevertheless, the composition of Smart is capable of meeting the intended use because Smart teaches the compositions with taurine are for application to skin [0001]-[0002].
Claim 10 is anticipated because Smart teaches the taurine composition includes an aqueous medium [0067]-[0069].
Claims 3 and 6 are rejected under 35 U.S.C. 102 as being as being anticipated by Smart et al. (US 2019/0169548 A1) and as evidenced by CN 113171331 A.
The 35 U.S.C. 102 rejection over Smart was previously discussed.
As evidenced by CN 113171331 A, taurine is soluble in water (English translation, pg. 3, bottom).
Claim 3 is anticipated because Smart teaches taurine [0067]-[0069] and taurine is inherently water soluble.
Claim 6 is anticipated because Smart teaches 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.
Claims 1, 3-6, and 10 are rejected under 35 U.S.C. 102 as being as being anticipated by CN 113171331 A.
Claims 1 and 4-5 are anticipated because 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).
Examiner’s Note: The limitation of claim 1, “for application to skin”, is interpreted as an intended use of the composition, nevertheless, the composition of CN 113171331 A is capable of meeting the intended use because CN 113171331 A teaches the composition is used as a lotion to be applied to the skin (Example 1, pg. 4 bottom, pg. 2).
Claim 3 is anticipated because taurine is soluble in water (pg. 3, bottom).
Claim 6 is anticipated 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 anticipated because CN 113171331 A discloses the composition includes an aqueous medium (Example 1, pg. 4 bottom).
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 2 is 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).
Regarding claim 2, Smart teaches a composition with dispersed taurine crystals [0067]-[0069].
Examiner’s Note: The limitation of claim 2, “for application to skin”, is interpreted as an intended use of the composition, nevertheless, the composition of Smart is capable of meeting the intended use because Smart teaches the compositions with taurine are for application to skin [0001]-[0002].
Smart does not teach that the taurine crystals are needlelike or that the length of the crystals is 5 µm or more and 3000 µm or less.
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 effects 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 sized 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”.
Claim 9 is rejected under 35 U.S.C. 103 as being as being obvious over Smart et al. (US 2019/0169548 A1) in view of CN 113171331 A.
The 35 U.S.C. 102 rejection over Smart was previously discussed.
Regarding claim 9, Smart does not explicitly disclose at paragraphs [0067]-[0069] that the blending amount of the valuable substance in the composition is 1.0 to 5.0 times the saturation solubility with respect to the moisture content in the composition.
However, Smart does disclose that the taurine in water shows precipitates [0067]-[0069] and is therefore, at least at/greater than its saturation solubility with respect to the moisture content. Smart also discloses that the ratio of taurine to water maybe be from about 1:1 to about 3:1 or greater [0035].
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.
Claim 2 is 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 2, 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 the form of a needlelike crystal (pg. 3 bottom – pg. 4, top; Fig 1 and 2).
Examiner’s Note: The limitation of claim 2, “for application to skin”, is interpreted as an intended use of the composition, nevertheless, the composition of CN 113171331 A is capable of meeting the intended use because CN 113171331 A teaches 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.
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 effects 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 sized 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.
Claim 9 is rejected under 35 U.S.C. 103 as being as being obvious over CN 113171331 A.
The 35 U.S.C. 102 rejection over CN 113171331 A was previously discussed.
Regarding claim 9, CN 113171331 A does not explicitly disclose that the blending amount of the valuable substance in the composition is 1.0 to 5.0 times the saturation solubility with respect to the moisture content in the composition.
However, CN 113171331 A does disclose that the taurine in the composition is in 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).
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.
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 1-6 and 9-10 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 1-6 and 9-10 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 optimum 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.
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.
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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