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 .
Applicant’s response filed on July 1, 2026 and July 20, 2026 has been received and fully considered. New claims 28 and 29 have been introduced; claim 29 has been withdrawn from consideration for depending on the withdrawn process claim, claim 25.
The previous claim rejection made under 35 U.S.C. 112 (b) on claims 1 and 2, which was indicated in the Office action dated April 1, 2026, have been withdrawn in view of further consideration.
The previous claim rejection made under 35 U.S.C. 112 (b) on claims 7, 10, 16-21 have been maintained for reasons of record.
The previous claim rejection made under 35 USC 102 (a)(1) and (a)(2) over Bernard et al. (US 20150335560 A1) has been withdrawn, but modified to address the amended claims.
All previous claim rejections made under 35 USC 103 have been maintained for reasons of record.
Terminal Disclaimer
The terminal disclaimer filed on July 13, 2026, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12357546 has been reviewed and is NOT accepted.
Accordingly, the previous obviousness-type double patenting rejection made over the claims of the above patent has been maintained for reasons of record.
This application was filed on or after September 16, 2012. The party identified in the terminal disclaimer (“TCI Buyer LLC”), is not the applicant of record (“Leading Edge Innovations, LLC”).
A request to change the applicant under 37 CFR 1.46(c) must be filed and must include an application data sheet specifying the applicant in the applicant information section and comply with 37 CFR 3.71 and 3.73. To be reconsidered, the terminal disclaimer must be filed with the request under 37 CFR 1.46(c).
For cases filed on or after September 16, 2012, 37 CFR 1.321 specifies that the applicant can disclaim, and the terminal disclaimer must specify the extent of the applicant’s ownership. A request under 37 CFR 1.46 (c ) to change the applicant needs to filed, which is (1) a request, signed by a 1.33 (b) party, (2) a corrected ADS (37 CFR 1.76 (c)) that identifies the “new “ applicant in the applicant information, and is underlined since it is new, and (3) a 3.73 (c) statement showing chain of title to the new applicant. Along with the § 1.45 (c) request we need a POA that gives power to the attorney who is signing the TD, along with another copy of the TD, unless they file a TD that is signed by the applicant.
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.
Claims 7, 10 and 16-21 remain 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.
Applicant uses the term “any derivatives . . . thereof” without defining or explaining compounds or materials might be included in the scope of the present claims. Claim 5 discloses a Markush group of specific glyceryl acyloates or polyglyceryl acyloates nonionic surfactants or emulsifiers, such as polyglyceryl oleate, polyglyceryl-3 oleate, etc., and then includes “any derivatives and combinations thereof” without providing any examples or definition in the specification. Furthermore, as the term “any derivatives” can include any compounds that are not yet developed or discovered, the metes and bound of the scope of the invention is uncertain. Similarly, it is not clear what applicant means by “any derivatives” of the sucrose surfactants or emulsifiers in claim 5.
Claim 7 recites “saturated and unsaturated, linear and branched natural or vegetable oils selected from the group consisting of soybean oil, almond, castor oil, …and any derivatives or combination thereof”. Similarly in claim 7, it is unclear what might be included in the scope of the term “any derivatives”.
Similarly, claims 10 and 16-21 are rejected for being vague and indefinite as the claims recite functional agent (e.g., “anti-acne agents”), the state of a material (e.g., “liquid”) or genus (e.g, “peptide”) without disclosing the specific chemical compounds and yet still include “any derivatives” thereof.
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.
Claim 28 is 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.
Claim 28 depends on claim 1 and requires that the average particle size of the one or more hydrophobic agent(s) in the first emulsion is less than about 150 microns. Claim 1, however, limits the average particle size to be no more than about 1000 nm (about 1 micron), and the independent claim improperly broadens the scope of the base claim.
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.
Claim Rejections - 35 USC § 102
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-7, 9, 11-17, 19-24, 27 and 28 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Bernard et al. (US 20150335560 A1, published on November 26, 2015) (“Bernard” hereunder)
Amended claim 1 is directed to a composition comprising:
a concentrated emulsion comprising (i) submicron particles of one or more hydrophobic agent(s), (ii) an emulsifier system comprising one or more nonionic surfactant(s) or emulsifier(s), and (iii) an aqueous-solute fluid;
wherein the submicron particles of one or more hydrophobic agent(s) are present in an amount from about 0.01% wt. to about 70% wt., the aqueous-solute fluid is present in an amount from about 1.0% wt. to about 98.5% wt., and the one or more nonionic surfactant(s) or emulsifier(s) are present in an amount from about 0.01% wt. to about 10% wt., all based on the total weight of the composition;
wherein the submicron particles of one or more hydrophobic agent(s) (i) have an average particle size from about 100 nm to less than about 1000 nm, (ii) have a solubility of less than about 0.1% by weight in water under standard conditions, and (iii) are 85% or more of a size within ±2.0 standard deviations, of the average particle size;
wherein the one or more nonionic surfactant(s) or emulsifier(s) comprise ester(s) of one or more fatty acid moieties with one or more hydroxyl groups of glycerol or polyglycerol having a HLB from about 3 to about 20, based on the degree of glyceryl units or ethoxyl units, or combinations thereof; and optionally ester(s) of one or more fatty acid moieties with one or more hydroxyl groups of sucrose having a HLB from about 2 to about 18, based on the degree of glyceryl units or ethoxyl units, or combinations thereof; and
wherein the one or more nonionic surfactant(s) or emulsifier(s) are sufficient to stabilize the submicron particles of one or more hydrophobic agent(s) in said concentrated emulsion, at a level from about 0.05% w/w to about 70% w/w of said one or more hydrophobic agent(s), in said concentrated emulsion,
wherein the concentrated emulsion is prepared by a process comprising:
preparing a premix comprising (i) one or more hydrophobic agent(s), (ii) an emulsifier system comprising one or more nonionic surfactant(s) or emulsifier(s), (iii) an aqueous-solute fluid, and optionally (iv) one or more additive(s);
subjecting the premix to low energy mixing to form a first emulsion; and
subjecting the first emulsion to ultra-high energy mixing to form a second emulsion;
wherein the second emulsion comprises said concentrated emulsion.
Bernard discloses a cosmetic nano- or micro-emulsion comprising (i) an oil in the form of a droplet with a number average particle size of 300 nm or less; (ii) at least one nonionic surfactant with an HLB value of from 8-14, most preferably from 10-13; and (iii) water. See [0036].
Bernard further teaches that (i) the amount of the oil ranges from 0.1 – 50 % by weight; (ii) the amount of the nonionic surfactants can be 0.1-25 % by weight; and (iii) the amount of the water ranges from 40-90 % by weight relative to the weight of the composition. See [0101, 0114 and 0146].
Although the reference does not specifically disclose the standard deviation of the oil droplet sizes, the reference teaches that the emulsion in the form of a nano-emulsion, which indicates that the particle sizes of the droplets are well below 1000 nm. See [0320].
Bernard teaches at least one polyglyceryl fatty acid ester having HLB value of from 8-14 are used as the nonionic surfactants in the nano-emulsions. Example 1 discloses such a nano-emulsion comprising isopropyl palmitate 15 wt % (a hydrophobic agent), polyglyceryl-5 laurate 7.5 wt %, vitamin B3 and water 71.5 wt%; the particle size is 101.9 nm, and the amount of the nonionic surfactant is at the level of 50 % w/w of isopropyl palmitate, the hydrophobic agent in the example. See Table 1; the present claims 1, 3, 6, 7, 14, 22 and 28.
Amended claim 1 is a product-by-process claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); MPEP 2113. In this case, the Bernard emulsion comprising vitamin B3 satisfies all limitations of the product of the present claim 1, which includes an additive, and anticipates the claim even though the reference does not specifically disclose whether the emulsion is treated with a low energy mixing.
Amended claim 1 requires the emulsion which is present in the final composition is “a concentrated” emulsion. Since the reference does not require the final composition be in the form of a concentrate, the claimed composition can be in a diluted form.
Regarding claims 4, 9,12, 21 and 27, Bernard further teaches adding at least one thickening agent. see [0259-0303]. Claims 9, 12, 21 and 27 are product-by-process claims; the presently claimed method steps of how a rheology modifier is added will not be given patentable weight.
Regarding claim 5, the glyceryl acyloates or polyglyceryl acyloates of the present claim are disclosed in paragraph [0105-0112], and include polyglyceryl oleate, polyglyceryl-3 oleate … polyglyceryl-6 laurate, polyglyceryl-10 diisostearate, etc.
Regarding claim 6, the disclosed glyceryl acyloates and polyglyceryl acyloates have an HLB value of from 8-14.
Regarding claims 11 and 13, Bernard teaches that the oil (i) can be silicone oils. See [0017, 0072-0093],
Regarding claims 15-17, and 19, Bernard teaches using polyols including glycerin and sorbitol, which water soluble liquid and solid, respectively. See [0252-0258].
Regarding claim 20, Bernard teaches skin whitening agents, antiaging agents, UV filters, keratolytic and anti-bacterial agents are preferably added to the emulsions according to the invention. Examples contain vitamin B3 and Mexoryl SBO, which is a sunscreen agent.
Regarding claims 23 and 24, Example 7 discloses a nanoemulsion according to the teachings of the reference comprising Mexoryl SBO, a sunscreen agent; since no rheology modifier is present in the oi-in-water composition, it is viewed that the emulsion satisfies the limitation of a light liquid or fluid in the present claim 23 and a sunscreen sprayable composition or a toner in the present claim 24.
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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bernard as applied to claims 1, 3-7, 9, 11-17, 19-24, 27 and 28 as above, and further in view of Crumrine (US 20210401746 A1, effective filing date June 26, 2020).
Regarding claim 8, Bernard states, “if the dispersed phase is an oil phase and includes one or more lipophilic or even amphiphilic active ingredients, the dispersed oil phase can function as a carrier of the active ingredient and accelerate the penetration of the active ingredients into the skin, or can distribute the active ingredients on the skin.” See [0050].
Although the Bernard invention is drawn to a cosmetic composition comprising cosmetic ingredients, Crumrine teaches and suggests therapeutic agents can also be used in a similarly formulated microemulsions, which are thermodynamically more stable than conventional emulsions. See [0009]. The reference teaches that a microemulsion protein, nutraceuticals and therapeutic agents such as cannabinioid can be added to a microemulsion and formulated as a topical and pharmaceutical products. See [0011].
In view of such teaching, one of ordinary skill in the art before the effective filing date of the present application would have been obviously motivated to look for prior art such as Crumrine for adding one or more lipophilic or amphiphilic active agents in the oil phase of the Bernard emulsion and use the composition as the carrier of topical active agent. As 1) both Bernard and Crumrine teach submicron emulsions that are suitable for topical delivery vehicles of active agents, and 2) Bernard specifically teaches and suggests adding one or more lipophilic or amphiphilic active agents in the oil phase, the skilled artisan would have had a reasonable expectation of successfully producing a stable submicron emulsion which safely delivers therapeutic agents to the skin.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bernard as applied to claims 1, 3-7, 9, 11-17, 19-24, 27 and 28 as above, and further in view of Schreier et al. (US 6451293 B1, published on March 14, 2002).
Although Bernard generally teaches that various common adjuvants and cosmetic ingredients are added to the emulsion, the reference fails to specifically disclose the at least one water soluble liquids of the present claim 18.
Schreier teaches that a combination of erythrulose and at least one additional reducing sugar is used in self-tanning cosmetics and provides even and longer-lasting coloration of the skin while preventing skin dehydration and uneven peeling. See abstract. Example 1 teaches a self-tanning lotion in the form of an oil and water emulsion which comprises an aqueous solution comprising erythrulose.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Bernard and incorporate to emulsion self-tanning active agents such as erythrulose and other reducing sugar (e.g., glyceraldehyde and erythrose, etc) as motivated by Schreier. The skilled artisan would have been motivated to do so, as 1) both references are directed to cosmetic emulsions for delivering cosmetic agents to the skin and 2) Schreier teaches erythrulose and reducing sugars provide even and long-lasting self-tanning effects without drying the skin or uneven peeling. As the latter teaches that the reducing sugars are added in the aqueous phase of the oil-in-water emulsion or the after emulsification, the skilled artisan would have had a reasonable expectation of successfully producing a stable oil-in-water emulsion useful as a self-tanning composition with predictable cosmetic effects.
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, 3-24, 27 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 12357546 B2, (issued from Application No. 18/544975, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of the claims are directed to emulsions having overlapping limitations. The process of making as described in present claim 1 is disclosed in reference claim 1.
Regarding the present claim 3, the particle size limitations are described in reference claim 2.
Regarding the present claim 5, the nonionic surfactants or emulsifiers are described in reference claim 3.
Regarding the present claim 6, the HLB ranges of the surfactants or emulsifiers are disclosed in reference claim 9.
Regarding the present claims 7 and 8, the one or more hydrophobic agents are disclosed in reference claims 4 and 10.
Regarding the present claims 9 and 12, the process of adding at least one functional agent to the emulsion is described in reference claims 11 and 14.
Regarding the present claim 10, the one or more therapeutic agents are disclosed in reference claim 12.
Regarding the present claims 11 and 13, the at least one aesthetic modifying agent(s) are described in reference claims 13 and 15.
Regarding the present claims 14-19, the one or more polar solutes of the claims are disclosed in reference claims 16-20.
Regarding the present claims 20-21, the one or more additives and the one or more functional agents are disclosed in reference claim 21.
Regarding the present claims 22-24, the disclosed composition is in the form of a sprayable composition, and reference claim 28 discloses using therapeutic agents, which suggests applications in pharmaceutical, biomedical, over-the counter drug, cosmetic, personal care, etc.
Regarding claims 4 and 27, the one or more humectants and/or one or more neutralizing agents are disclosed in reference claim 8 and 22.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed on July 20, 2026, have been considered but are moot in view of the new grounds of rejections above.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 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, BETHANY BARHAM can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
