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 .
Claim Status
Applicants’ amendments and arguments filed 12/23/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 1 is amended.
Claim 20 is canceled.
Claims 1-19 and 21 are examined on the merits.
New Rejections Necessitated on Claim Amendments
Claim Rejections - 35 USC § 103
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.
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 1-2, 4, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over by Gross et al. (US20130331466A1, published 12/12/2013, published patent found in IDS, hereafter Gross).
Gross claims a modified sophorolipids as mixtures with natural sophorolipids for use in dispersion solubilization or emulsification of various oil types, and nutraceuticals (title and abstract; according to the claim limitations of the instant claims 1-2). Gross claims the method for producing a modified sophorolipid for use in dispersion, solubilization, or emulsification processes (claim 1; according to the claim limitations of the instant claim 8). Gross teaches the modified sophorolipids and natural sophorolipids have the following formula:
PNG
media_image1.png
487
220
media_image1.png
Greyscale
wherein:
X1 and X2 are—oxymethyl (—CH2O—); R1 and/or R2 are selected from the group of functional groups consisting of: hydrogen, acetyl, acryl, urethane, hydroxyalkyl, ether, and carboxyalkyl or alkyl containing heteroatoms (1°, 2°, and 3° amino, tetraalkylammonium, sulfate, phosphate); R3 is a hydrogen or alkyl group; R4 is an alkyl chain that has between 9 and 19 carbons and that has an unsaturation (C═C bond) at least one site; X3 contains heteroatoms; and the combination of X3R3 is selected from the group of functional groups consisting of hydroxy, alkanethiolate, amide, alkanamide, alkanamide containing heteroatoms, alkylsulfate, alkylphosphate, carbohydrate, and mono- or oligopeptide with 2-50 amino acids ([0018]; according to the claim limitations of the instant claim 1). Furthermore, Gross teaches the following peptide derivative of a modified sophorolipid:
PNG
media_image2.png
378
647
media_image2.png
Greyscale
(page 10, FIG. 9; according to the claim limitations of the instant claim 1).
Claim 3 of Gross further claims the composition is used as at least one of: oil solubilizer, an emulsifier, a dispersant, and a surface active agent in a product selected from the group consisting of environmental, industrial, medical, personal care, cosmetics, and cleaning products (according to the claim limitations of the instant claims 1 and 8). Gross further claims the personal care and cosmetic products to be: solubilizers, emulsifiers, dispersants and surface active agents for personal care products, lip balm, cleansing pads, deodorant, perfumes, fragrances, eye liner, facial tissue, lipstick, lotion, makeup, mouthwash, nail files, pomade, perfumes, razors, shampoo, conditioner, talcum powder, shaving cream, skin cream, toothpaste, hand wash liquids, skin care cleaning liquids, and disinfectants (claim 3; according to the claim limitations of the instant claims 1 and 8). Gross claims the compound is further combined with at least one of: a buffering agent selected from the group consisting of natural buffers, organic and amino acids or their salts, citrate, gluconate, tartrate, malate, acetate, lactate, oxalate, aspartate, malonate, glucoheptonate, pyruvate, galactarate, glucarate, tartronate, glutamate, glycine, lysine, glutamine, methionine, cysteine, arginine and a mixture thereof, phosphoric and phosphorous acids or their salts, and synthetic buffers; a solubility control agent or excipient, to control the release of the active substances, selected from the group consisting of wax, chitin, chitosan, C12-C20 fatty acids, C12-C20 alcohols, amphiphilic esters of fatty acids with glycerol, glycol esters of fatty acids, C12-C20 amines, and amides of C12-C20 fatty acids; a pH adjusting agent selected from the group consisting of potassium hydroxide, ammonium hydroxide, potassium carbonate or bicarbonate, hydrochloric acid, nitric acid, sulfuric acid, and mixtures thereof; and a salt form of polyprotic acids (claim 18; according to the claim limitations of the instant claims 1 and 7). Gross further claims the composition is in a solution, a suspension, a powder, incorporated into wipes, papers, or polymers (claim 21; according to the claim limitations of the instant claim 8). Gross teaches that when mixing two or more sophorolipids, to include a modified sophorolipid with a natural sophorolipid, it increased the solubility of the compounds in water relative to each compound individually ([0011]; according to the claim limitations of the instant claim 2). Lastly, Gross further teaches the compositions biosurfactant to be selected from a group including mannosylerythritol lipid (claim 20; according to the claim limitations of the instant claim 4).
Per MPEP § 2144.08(II)(A)(4)(c), the closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. In addition or in the alternative, per MPEP § 2144.09(I)-(II), “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities” because “[c]ompounds which are…isomers…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties” (see, e.g., MPEP § 2144.09(I)-(II)), and the Court has stated that “[i]f a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” KSR, 127 S.Ct. at 1740. Here, the prior art teaches highly similar structural compounds differing only by a small number of carbons on a chain of the instantly claimed invention, wherein such compounds have the same, exact utility as the instantly claimed compounds (i.e. hair cosmetic); accordingly, an artisan would readily appreciate that such compounds could be utilized in the conditioning of hair, exactly as taught and suggested in view of the prior art.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5].
“[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). Therefore, it would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim the compound and uses of the instant invention as outlined by Gross.
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US20130331466A1, published 12/12/2013, published patent found in IDS, hereafter Gross) in view of Gross et al. (US20130142855A1, published 03/06/2013, hereafter Gross2).
As outlined above, Gross teaches a conditioning composition comprising the modified cationic sophorolipid molecule of instant claim 1 with the addition of a natural sophorolipid. However, Gross fails to teach the content of the modified sophorolipid in relation to natural lipid as in instant claim 3.
Gross2 teaches modified sophorolipids combination as antimicrobial agents (title). Gross2 teaches the admixture can comprise a mixture of 1 modified sophorolipid (MSL) component and 1 or more natural sophorolipids components ([0067]). Gross2 teaches the admixture acts synergistically in a ration where the compound with the lowest concentration is 1:200 (w/w) of the summation of the other components and the component of the admixture this is in the highest concentration is up to 20 times greater than the summation of the other components ([0069]).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a conditioner composition comprising a modified sophorolipid and a natural sophorolipid as outlined by Gross with the ready for improvement with the known technique of adjusting the ratio of modified sophorolipid to the natural sophorolipid in a composition together as outlined by Gross2. Adjusting the forementioned components of a conditioner composition comprising a modified sophorolipid and a natural sophorolipid as claimed by instant claim 3 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US20130331466A1, published 12/12/2013, published patent found in IDS, hereafter Gross) in view of Alibek et al. (CA3136067A1, published 09/16/2021, hereafter Alibek).
As outlined above, Gross teaches a conditioning composition comprising the modified cationic sophorolipid molecule of instant claim 1 with the addition of mannosylerythritol lipid. However, Gross fails to teach the content of the modified sophorolipid in relation to mannosylerythritol lipid as in instant claims 5-6.
Alibek teaches a composition for replacing chemical surfactants, specifically those used in personal care products such as cosmetics (title and page 1, lines 9-14). Alibek teaches embodiments of the composition comprising a sophorolipid and mannosylerythritol lipid (claim 9 and page 3, lines 30-31 and page 15, lines 4-5). Alibek teaches the concentration of the sophorolipid to be from 0% to 100%, 5% to 95%, 10% to 90%, 15% to 85%, 20% to 80%, 25% to 75%, 30% to 70%, 35% to 65%, 40% to 60%, 45% to 55%, or 50%, by weight (page 15, lines 6-8). Furthermore, Alibek teaches the concentration of the mannosylerythritol lipid to be 0% to 100%, 5% to 95%, 10% to 20 90%, 15% to 85%, 20% to 80%, 25% to 75%, 30% to 70%, 35% to 65%, 40% to 60%, 45% to 55%, or 50%, by weight (page 15, lines 19-21).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a conditioner composition comprising a modified sophorolipid and mannosylerythritol lipid as outlined by Gross with the ready for improvement with the known technique of adjusting the concentrations of sophorolipid and mannosylerythritol lipid in a cosmetic composition as outlined by Alibek. Adjusting the forementioned components of a conditioner composition comprising a modified sophorolipid and mannosylerythritol lipid as claimed by instant claims 5-6 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
Claims 9-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al. (US20130331466A1, published 12/12/2013, published patent found in IDS, hereafter Gross), in view of Daminikumari (“What are conditioners? Describe any five types of conditioners.”, Sarthaks eConnect, published 09/28/2021, https://www.sarthaks.com/1351210/what-are-conditioners-describe-any-five-types-of-conditioners, hereafter Daminikumari) and as evidenced by Dictionary (Rinsing off - definition of rinsing off by the Free Dictionary. The Free Dictionary. (2021, August 22)., via wayback machine, https://www.thefreedictionary.com/rinsing+off, hereafter Dictionary).
As evidenced by Dictionary, rinsing means to wash lightly with water (page 1, definition 1).
As outlined above, Gross teaches a conditioning composition, as a conditioner, comprising the modified cationic sophorolipid molecule with the additives of the instant claims 9-15. However, Gross fails to explicitly teach the method in which the conditioning composition is used as in instant claims 9-19 and 21.
Daminikumari teaches conditioners are compositions that comprise amino acids, cationic surfactants, and other cleaners (page 2, paragraph 1). Furthermore, Daminikumari teaches the types of conditioners: basic conditioners, conditioning sprays, intensive conditioners, leave in conditioner, hot oils, deep conditioners, restructurants, color/perm conditioner, and split end treatment/serum (page 2-3; according to the claim limitations of the instant claims 17 and 21). Daminikumari teaches that basic conditioners are coated on the hair with a fine film temporary and then rinsed off after a few minutes (page 3, paragraph 2; according to the claim limitations of the instant claims 9, 16, and 19). Daminikumari teaches leave in conditioner is applied after shampoo, but not rinsed off, thus forming a barrier reducing damage from heat styling (page 3, paragraph 5; according to the claim limitations of the instant claims 17-18, and 21).
One skilled in the art before the effective filing date of the claimed invention would claim cosmetic conditioner composition comprising a modified sophorolipid with an attached amino acid as outlined by Gross with the ready for improvement with the known technique of using the conditioner by applying it to hair and either rinsing with water or leaving it in as outlined by Daminikumari. Using a conditioner composition comprising a modified sophorolipid in a method of conditioning hair as claimed by instant claims 9-19 and 21 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, and 9-11 of copending Application No. 18252394 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
18252394 claims a compound with formula (I):
PNG
media_image3.png
170
428
media_image3.png
Greyscale
wherein:
R1 is an amino acid linked to the adjacent carbonyl moiety via an amide linkage; R2 is each independently H or -CОСH3; R3 is a saturated or unsaturated aliphatic hydrocarbon chain having 5-15 carbons; and R4 is H or -CH3 (claim 1; according to the claim limitations of the instant claim 1).
Claim 5 of 18252394 claims a compound of formula (II) or a salt thereof:
PNG
media_image4.png
213
436
media_image4.png
Greyscale
wherein:
R1 is an amino acid linked to the adjacent carbonyl moiety via an amide linkage; R2 is each independently H or -CОСH3; R4 is H or -CH3 (according to the claim limitations of the instant claim 1).
Claims 3 and 7 of 18252394 claims the amino acid is lysine, methionine, or glutamine (according to the claim limitations of the instant claim 1). Claims 9-11 of 18252394 claims the compounds are in a composition with cosmetically acceptable carrier (according to the claim limitations of the instant claim 1).
These compounds claimed in 18252394 would anticipate compounds of the composition of claim 1. Both applications are also drawn to pharmaceutical compositions comprising the same and methods of treating a disease. As such, a skilled artisan would see the applications are substantially overlapping. Likewise, it would be prima facia obvious to modify the amino acids of 18252394 with other amino acids as done herein. Substituting one amino acid for another would be prima facia obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7-10, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18248441 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
18248441 claims a compound having the following structure:
PNG
media_image5.png
673
402
media_image5.png
Greyscale
wherein R' and R2 are each independently selected from hydrogen, alkyl, substituted alkyl, acyl, substituted acyl, alkenyl, and substituted alkenyl; R3 is hydrogen or alkyl; R4 is alkane, alkylene, substituted alkylene, alkenylene or substituted alkenylene; and R is hydrogen or a cation selected from Na+, K+, Lit, Cs+, Rb+, Ca2+, Mg2+ and NH4+ (claims 1 and 5; according to the claim limitations of the instant claim 1). Claim 2 of 18248441 further claims the wherein R' and R2 are hydrogen; and R3 is methyl and claim 3 of claims wherein R4 is C5-C5 alkylene, or C5-C5 alkenylene (according to the claim limitations of the instant claim 1). Claim 9 of 18248441 claims the compound is in a composition and claim 10 claims the composition further comprising a pharmaceutically or cosmetically acceptable carrier (according to the claim limitations of the instant claims 1 and 7). Claim 12 claims the composition is formulated as a suspension, emulsion, nano-emulsion, hydrogel, multiphase solution, liposomal dispersion, lotion, cream, gel, foam, ointment, paste, spray, conditioner, shampoo, cleanser, micellar water, tonic, toothpaste, mouthwash or makeup (according to the claim limitations of the instant claim ). Claim 13 of 18248441 claims a method for improving the foaming performance of a sophorolipid, the method comprising providing the sophorolipid, and functionalizing the sophorolipid by covalently linking to taurine through an amide bond or amine bond (according to the claim limitations of the instant claim 9). Claim 17 claims the method for producing a composition, the method comprising providing a sophorolipid, functionalizing the sophorolipid by covalently linking to taurine through an amide bond or amine bond, and mixing the functionalized sophorolipid with a solvent (according to the claim limitations of the instant claim 9). Claim 20 of 18248441 claims method for improving a skin condition of a subject, wherein the method comprising applying the composition to the hair of the subject (according to the claim limitations of the instant claim 19).
Both applications are drawn to a conditioner and method of treating hair. As such, a skilled artisan would see the applications are substantially overlapping. Furthermore, it would be prima facia obvious to modify the amino acid (taurine) of 18248441 with other amino acids as in the instant application. Substituting one amino acid for another would be prima facia obvious. As such, a skilled artisan would see the applications are substantially overlapping. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant’s arguments filed on 12/23/2025 have been considered by the examiner.
In response to the 35 U.S.C. 103 rejections, Applicant’s amendments have necessitated new grounds of rejections.
In response to the Double Patenting rejections, Applicant requests the rejections are held in abeyance.
A request to hold abeyance is an improper response to a double patenting rejection. Therefore, Applicant’s argument is not found persuasive and the rejections are updated for amendments.
Conclusion
No claims 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 ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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.
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.
/Isis A Ghali/Primary Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611