DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 04 August 2026, in response to the Office Correspondence dated 04 May 2026, are acknowledged.
The listing of Claims filed 04 August 2026, have been examined. Claims 1-3, 6-18, and 20-23 are pending. Claims 1, 16, and 18 are amended. Claims 4, 5, and 19 remain cancelled, and claim 17 is newly cancelled. No new claims have been added.
Response to Amendment
The amendments to claims 1, 16, and 18 and the cancellation of claim 17 are acknowledged and have been entered for purposes of examination. Entry of an amendment is not an indication that the amended claims are allowable. The patentability of the amended claims has been reconsidered in light of the amendment and applicant’s arguments.
The applicant argues that the objection to claim 18 should be withdrawn because claim 18 has been amended to replace the inconsistent reference to the “wetted bodily surface” with “wetted target body surface.” The argument is persuasive. The amendment provides antecedent consistency with the previously recited “target body surface.” Accordingly, the objection to claim 18 is withdrawn.
Claim 17 has been canceled. Accordingly, the rejection of claim 17 under 35 U.S.C. § 112(b) is moot and withdrawn. The applicant amended claim 16 to replace the previously recited “synergistic conditioning benefit according to the Wet Hair ILS method” with, “the composition exhibits a greater than two times increase in Ease of Combing rating according to the Wet Hair ILS method.” The prior basis for rejecting the expression “synergistic conditioning benefit” is therefore withdrawn. However, amended claim 16 presents a different indefiniteness issue. A new rejection of claim 16 under 35 U.S.C. § 112(b) as indefinite is detailed below, wherein the protocol itself does not calculate an “increase” or specify a reference composition against which an increase is determined.
Regarding the prior rejection of claims 1-3, 6-11, 15, 17, and 21-23 under 35 U.S.C. § 103, the applicant argues that the cited combination fails to teach or suggest all limitations of amended claim 1, particularly, a first sophorolipid having an HLB of about 2 to about 7; a second sophorolipid having an HLB of about 15 to about 20; and the newly added ratio of total first and second sophorolipids : total anionic surfactant : total amphoteric surfactant of about 0.1:0.6:1. Upon reconsideration, the applicant’s arguments identify deficiencies in the rejection as previously formulated. In particular, the cited record does not adequately establish the numerical HLB limitations or the newly added 0.1:0.6:1 ternary surfactant ratio of claim 1. Accordingly, the previously formulated rejection of claims 1-3, 6-11, 15, 17, and 21-23 under 35 U.S.C. § 103 over Parry in view of Schelges, Hayes, and Song is withdrawn.
Regarding the rejection of claims 1, 12-14, 16, and 18 under 35 U.S.C. § 103, because claims 12-14, 16, and 18 depend from claim 1, the rejection based on Parry, Schelges, Hayes, Song, and Hutton necessarily depends upon an adequate showing that the subject matter of amended claim 1 would have been obvious, which has not been established by the rejection as previously formulated. Accordingly, the prior rejection of claims 12-14 and 18 over Parry, Schelges, Hayes, Song, and Hutton is withdrawn.
The prior rejection of claim 20 under 35 U.S.C. § 103 over Parry, Schelges, Hayes, Song, Cruz, and Cochran is withdrawn as previously formulated because the presently cited evidence does not establish all limitations of claim 20. Because claims 21-23 depend from claim 20, the corresponding prior rejection of claims 21-23 is likewise withdrawn. However, it is noted that the applicant’s argument under In re Ratti concerning claim 20 is not persuasive as a categorical prohibition against combining Schelges with lactylate-free cleansing references, because obviousness is determined from the combined teachings rather than bodily incorporation of one complete reference into another (see Response to Arguments section below).
Pending claims 1-3, 6-18, and 20-23 are newly rejected under 35 U.S.C. § 103, as necessitated by amendment, as detailed below. Although Schelges and Hayes are no longer cited for the rejection of the pending claims, as amended under 35 U.S.C. § 103, the following factual corrections are made for clarity of the prosecution record, to ensure that any subsequent rejection rests on factual findings accurately supported by the references: Schelges does not disclose the asserted HLB 2-7 and HLB 15-20 values. The prior attribution of those numerical HLB ranges to Schelges ¶[0026] is withdrawn; Schelges claim 13 does not teach a composition “free of thickeners.” Claim 13 only recites that the cleansing agent is formulated as a shampoo or shower gel. Schelges permits embodiments containing thickeners and separately describes embodiments in which a thickener is not affirmatively required; Hayes was published 12 March 1991, not 12 March 2008. The previously stated 2008 date corresponds to other bibliographic information, not the publication date; and Hayes’s 0.04-0.2 wt.% disclosure concerns Acinetobacter emulsan, rather than a sophorolipid concentration range.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 04 May 2026, as the applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
Claim Rejections - 35 USC § 112(b)
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 Applicant regards as his invention.
Claim 16 is 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, regards as the invention.
Claim 16 is rejected as indefinite for reciting that, “the composition exhibits a greater than two times increase in Ease of Combing rating according to the Wet Hair ILS method.” The metes and bounds of this limitation are unclear because the claim does not identify the reference or baseline rating relative to which the recited “increase” is determined.
The specification describes the Wet Hair In-Lab Screening (“ILS”) protocol at ¶[0094]-[0107]. The protocol instructs that a treated hair tress is evaluated after rinsing by combing the tress using the lowest pressure and minimal force and assigning an absolute rating on a scale of 0 (“Hard”) to 10 (“Easy”). The Wet Hair ILS protocol itself does not define an “increase” in the rating, identify a comparator or baseline composition against which such an increase is calculated, or provide an equation for calculating a fold increase.
The Examples separately report an “Ease of Combing rating.” For example, Table 2 reports an Ease of Combing rating of 1 for comparative composition C1 and ratings of 6, 6, 8, 8, 7, 3, and 3 for INV 1-INV 7, respectively. Table 3 similarly reports an Ease of Combing rating of 1 for C1 and ratings of 5, 4, 9, 10, 2, and 1 for INV 9-INV 14, respectively. The specification ¶[0116] and ¶[0118]-[0119] characterize certain inventive compositions as providing improved conditioning relative to the control. However, claim 16 does not recite C1 as the comparator, does not define a control composition, and does not otherwise state that the recited “increase” is relative to the C1 composition disclosed in the Examples.
Consequently, a person of ordinary skill cannot determine from claim 16 whether the comparison is to C1, the same formulation without one or both sophorolipids, untreated hair, the hair tress before treatment, another commercially available shampoo, or some other baseline. The phrase “greater than two times increase” could also have materially different mathematical interpretations. For example, the limitation could mean that the measured Ease of Combing rating is greater than two times the reference rating (i.e., test rating > 2 × reference rating), or it could mean that the increase itself is greater than two times the reference rating (i.e., (test rating − reference rating) > 2 × reference rating), which is equivalent to a test rating greater than three times the reference rating. These interpretations establish different boundaries for the claim.
Further, although Tables 1B, 2, and 3 use the expression “Ease of Combing,” the Wet Hair ILS protocol itself identifies the apparent corresponding post-rinse endpoint as “Evaluate Post Rinse Comb.” The disclosure appears to associate these concepts, but does not expressly define “Ease of Combing rating” as the “Post Rinse Comb” rating for purposes of the newly amended quantitative limitation.
Thus, claim 16 does not define the claimed subject matter with a reasonable degree of clarity and particularity (see In re Packard, 751 F.3d 1307, 1313-14 (Fed. Cir. 2014); MPEP § 2173.02 and § 2173.05). A term of degree is not indefinite merely because it is relative, however, the specification must provide an objective standard for measuring the degree, or the meaning must otherwise be ascertainable to a person of ordinary skill (Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370-71 (Fed. Cir. 2014); MPEP § 2173.05(b)). Likewise, functional language is permissible, but it must provide sufficiently definite boundaries (see In re Swinehart, 439 F.2d 210, 212-13 (CCPA 1971); Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255-56 (Fed. Cir. 2008); MPEP § 2173.05(g)).
Here, because neither the identity of the reference value nor the mathematical meaning of “greater than two times increase” is specified, the limitation does not provide an objective boundary by which a person of ordinary skill can determine whether a particular composition falls within or outside the scope of claim 16. Claim 16 is therefore indefinite under 35 U.S.C. 112(b).
The applicant may overcome the rejection, for example, by amending the claim to identify the comparative composition or other reference against which the Ease of Combing rating is compared; the particular Wet Hair ILS endpoint intended by “Ease of Combing rating”; and the mathematical relationship intended. For example, if the applicant intends the limitation to mean that the test composition produces an Ease of Combing/Post Rinse Comb score greater than twice the score obtained using a specifically defined control composition tested under the same Wet Hair ILS protocol, the claim should expressly state this. If the applicant instead intends an increase of greater than 200%, the claim should expressly define that relationship.
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-AlA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) 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.
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.
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 underlying obviousness under 35 U.S.C. § 103 are those set forth in Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966), and 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 non-obviousness.
The analysis must consider the claim as a whole and provide an articulated reason with a rational underpinning for the proposed modification or combination (see KSR International Co. v. Teleflex Inc., 550 U.S. 398, 418-22 (2007); In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
A person of ordinary skill in the art at the relevant time would have been a formulation scientist, cosmetic chemist, or comparably trained scientist having practical experience formulating personal-care cleansing compositions and familiarity with surfactant systems, biosurfactants, conditioning polymers, gel networks, rheology, pH adjustment, and conventional methods for evaluating shampoo lather and conditioning performance. Such an artisan would have been capable of selecting among known surfactant species and adjusting concentrations and relative proportions within known formulation ranges through routine experimentation directed toward recognized formulation properties.
Claims 1, 6-11, and 15 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), Ito et al. (US20160324747A1; published 10 November 2016, hereinafter “Ito”), and Xue et al. (US20200199492A1; published 25 June 2020, hereinafter “Xue”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date.
Cochran teaches sulfate-free personal-cleansing compositions, including shampoos, comprising an anionic non-sulfate surfactant, an amphoteric surfactant, a cationic polymer, and aqueous carrier. Cochran claim 1 recites about 3 wt% to about 35 wt% anionic surfactant, about 3 wt% to about 15 wt% amphoteric surfactant, about 0.01 wt% to about 2 wt% cationic polymer, and an aqueous carrier, with the composition substantially free of sulfate-based surfactants (claim 1).
Cochran teaches that the surfactant system may have an anionic-surfactant:amphoteric-surfactant weight ratio of about 1:5 to about 10:1, including about 1:2 to about 7:1 (¶[0045]). Cochran’s Inventive Examples 14-18 provide particularly pertinent quantitative guidance, wherein each contains 9.75 wt% lauramidopropyl betaine (“LAPB”) and 6 wt% sodium cocoyl isethionate (“SCI”), corresponding to an anionic:amphoteric ratio of approximately 0.615:1 (Table 4).
Cochran further identifies the desirability of formulating its sulfate-free shampoos “without the use of a rheology modifier or a thickener” (¶[0002]). Thus, Cochran teaches or directly suggests the claimed sulfate-free and substantially-thickener-free personal-care chassis containing anionic surfactant, amphoteric surfactant, and carrier. Cochran does not expressly disclose a first sophorolipid having HLB about 2-7 and a second sophorolipid having HLB about 15-20.
However, Speight supplies those teachings in the personal-care art. Speight explains that linear sophorolipids are relatively water-soluble and hydrophilic, lactonic sophorolipids are less water-soluble and relatively lipophilic, and the forms may be blended to obtain desired performance parameters (p. 24, ¶2; p. 26, ¶3-4).
More specifically, Speight identifies FERMA™ SL Pure as a predominantly lactonic, strongly lipophilic sophorolipid having optimal activity in applications requiring an HLB of 2-7 (p. 26, right col., ¶2). Speight separately identifies FERMA™ SH Pure as a predominantly linear sophorolipid useful in applications requiring an HLB higher than 15, and expressly identifies shampoos, body washes, and face washes as ideal applications (p. 26, right col., ¶3).
Speight additionally teaches that FERMA products at opposite ends of the HLB scale were “designed and tested to be perfectly compatible with one another,” thereby permitting formulators to create their own blends (p. 27, ¶1). Speight further identifies sophorolipids as a means of reducing or removing sulfate surfactants from personal-care products (p. 27, ¶2).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to incorporate both Speight’s low-HLB and high-HLB sophorolipid surfactants into Cochran’s sulfate-free shampoo because Speight teaches the materials for personal-care formulation, expressly identifies shampoo as an application of the high-HLB material, teaches mutual compatibility, and recommends blending the endpoint materials to customize performance. This is the application of known surfactant ingredients according to their known functions to a known sulfate-free cleansing system (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 4-17 418 (2007); MPEP § 2143).
The combined Cochran and Speight disclosures do not expressly select a total first-plus-second sophorolipid concentration of about 0.1-0.6 wt%. However, Ito teaches sophorolipid-containing hair washes and establishes that sophorolipid concentration was a conventional formulation parameter in that use. Ito’s hair-wash disclosure encompasses about 0.01-30 mass% sophorolipid-containing composition, and Test Example 7 evaluates operative sophorolipid-containing liquid hair washes at multiple pH values (Test Example 7, Table 10). Thus, Ito’s disclosed hair-wash concentration encompassing the presently claimed 0.1-0.6 wt% interval.
In addition, Xue provides even more specific evidence that sophorolipid could function at concentrations falling directly within instant claim 1. For example, Xue Example 10 employs 0.12 wt% sophorolipid, within the claimed 0.1-0.6 wt% interval (Example 10, Table 11). Although Xue primarily concerns hard-surface cleaning, Xue is relied upon for the narrower formulation principle concerning relative concentrations of glycolipid biosurfactant and conventional aqueous surfactants. That teaching is reasonably pertinent to the formulation problem presented here because it addresses the same physicochemical problem of selecting biosurfactant/conventional-surfactant proportions to obtain an aqueous surfactant composition having acceptable stability and performance (see In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004); MPEP § 2141.01(a)).
The instant claimed amended three-component ratio is total sophorolipid:total anionic surfactant:total amphoteric surfactant of about 0.1:0.6:1.0.
Cochran recognizes the anionic:amphoteric ratio as a formulation parameter and discloses a broad 1:5-10:1 interval (¶[0045]) encompassing 0.6:1. Cochran Examples 14-18 provide an approximately 0.615:1 ratio (Table 4). The claimed three-way ratio also corresponds to a sophorolipid:total-conventional-surfactant ratio of 0.1 ÷ (0.6 + 1) = 0.0625. Xue teaches that the weight ratio of total biosurfactants A1 to total conventional surfactants A3 may be 0.01-1, preferably 0.05-0.8, and more preferably 0.05-0.6 (¶[0042]). The instant claimed value of 0.0625 therefore lies within both Xue’s preferred and more-preferred intervals.
Xue additionally establishes that this ratio was a recognized result-effective variable rather than an arbitrarily selected numerical parameter. Xue explains that the A1:A3 ratio and overall contents can be varied and expressly states that, depending on requirements such as aqueous stability and cleaning performance, the skilled person can “fine-tune” the compositions (Examples 9a-9c discussion, ¶[0123]).
Thus, the two constituent relationships making up the instant claimed ternary ratio were independently recognized in the prior art as adjustable formulation parameters, wherein Cochran teaches the anionic:amphoteric ratio, and Xue teaches the biosurfactant:conventional-surfactant ratio and identifies performance consequences of changing it. Further, the instant claimed ratio also produces concentrations within Cochran’s disclosed formulation paramaters. Selecting, for example, 0.5 wt% total sophorolipid within instant claim 1 and applying the claimed normalized ratio gives a total sophorolipid of 0.5 wt%, an anionic surfactant of 3.0 wt%, and an amphoteric surfactant of 5.0 wt%. The latter two amounts fall within Cochran’s disclosed concentration intervals. This calculation is not relied upon as an explicitly disclosed prior-art example, rather, it is used to demonstrate that the instant claimed concentration and ratio occupy formulation range jointly encompassed by the applied prior art teachings of Cochran and Xue.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to adjust the relative amounts of Speight’s sophorolipids and Cochran’s conventional surfactants within the overlapping formulation ranges in order to obtain suitable aqueous stability, cleansing, lathering, and conditioning performance. The prior art itself identifies the relevant concentrations and ratios as variables affecting formulation performance (see In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003); In re Aller, 220 F.2d 454, 456 (CCPA 1955); In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012); MPEP § 2144.05). This rejection does not rest merely on a generalized assertion that all concentration variables are routinely optimized. Xue and Cochran identify the relevant ratios as adjustable variables and Xue teaches pertinent results affected by their adjustment.
A reasonable expectation of success existed because Cochran demonstrates functioning sulfate-free anionic/amphoteric shampoos, Speight expressly teaches mutual compatibility of the two endpoint sophorolipid products and shampoo use, Ito demonstrates functioning sophorolipid-containing hair washes, and Xue demonstrates workable aqueous compositions using low sophorolipid concentrations and overlapping biosurfactant:conventional-surfactant ratios. Accordingly, claim 1 would have been obvious over Cochran in view of Speight, Ito, and Xue.
Regarding instant claim 6, Cochran identifies isethionates as suitable non-sulfate anionic surfactants and employs 6 wt% sodium cocoyl isethionate in Inventive Examples 14-18 (Table 4). Therefore, it would have been obvious to select Cochran’s exemplified SCI as the anionic surfactant in the modified composition because SCI is taught for precisely the same sulfate-free cleansing purpose.
Regarding instant claim 7, Cochran’s Inventive Examples 14-16 and 18 contain SCI while sodium lauroyl sarcosinate is absent, wherein Example 17 separately adds sodium lauroyl sarcosinate (Table 4). Cochran therefore establishes that sarcosinate is not necessary to its SCI/LAPB embodiments. Selecting one of Cochran’s expressly disclosed SCI formulations without the separately optional sarcosinate provides the required limitation of instant claim 7, and incorporation of Speight’s sophorolipids would not have required introduction of a sarcosinate. Thus, instant claim 7 is also obvious.
Regarding instant claim 8, Cochran teaches and exemplifies lauramidopropyl betaine and cocamidopropyl betaine in its sulfate-free surfactant systems. In particular, Examples 14-18 employ LAPB (Table 4). Accordingly, the additional limitation of instant claim 8 is taught by the primary reference, and is therefore obvious.
Regarding instant claim 9, Ito’s Test Example 7 evaluates sophorolipid-containing liquid hair washes having pH values within the claimed approximately 5.5-7.2 interval, including pH 5.5 and pH 7.0 formulations (Test Example 7, Table 10). Thus, it would have been obvious to employ one of Ito’s expressly demonstrated hair-wash pH values in the sophorolipid-containing shampoo resulting from the combination because Ito establishes those pH values as operable for the same hair-cleansing use.
Regarding instant claim 10, Ito demonstrates a sophorolipid-containing hair wash at pH 5.5 (Test Example 7, Table 10), directly within the instant claimed about 5.5-5.8 interval. An expressly disclosed prior-art value within a claimed interval supports a prima facie case of obviousness (see In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003); MPEP § 2144.05). Regarding instant claim 11, Ito demonstrates a sophorolipid-containing hair wash at pH 7.0 (Test Example 7, Table 10), directly within the instant claimed about 6.8-7.2 interval, so is therefore also obvious.
Regarding instant claim 15, Cochran teaches cationic conditioning polymers and specifically exemplifies polyquaternium-10 in the pertinent SCI/LAPB compositions (Table 4). Thus, it would have been obvious to retain Cochran’s cationic conditioning polymer when incorporating the sophorolipids because nothing in the secondary references requires its removal and the polymer would continue to perform its established conditioning/deposition function.
Claims 1 and 2 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), Ito et al. (US20160324747A1; published 10 November 2016, hereinafter “Ito”), and Xue et al. (US20200199492A1; published 25 June 2020, hereinafter “Xue”), as applied above to instant claim 1, and in further view of Allef et al. (US20140349902A1; published 27 November 2014, hereinafter “Allef”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date. Cochran, in view of Speight, Ito and Xue, teach the limitations of instant claim 1, as described above, from which instant claim 2 depends, however do not explicitly teach the specific limitations of instant claim 2, requiring a rhamnolipid surfactant.
Allef teaches hair and skin cleansing compositions containing glycolipid biosurfactants. Allef Table 21, entitled “Hair and body cleanser”, contains both 1.5% sophorolipid and 1.5% rhamnolipid, together with coco-betaine, polyquaternium-10, water, and other conventional cleanser ingredients. Allef independently establishes the suitability of rhamnolipid in sulfate-free shampoo in Table 43, entitled “Shampoo, PEG- & sulphate-free”, containing 2.0% rhamnolipid, sodium cocoamphoacetate, disodium cocoyl glutamate, polyquaternium-10, water, and conventional shampoo components at pH 5.5.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to add Allef’s rhamnolipid to the sophorolipid-containing sulfate-free shampoo rendered obvious by the instant claim 1 combination because Allef provides direct experimental evidence that sophorolipid and rhamnolipid may be co-formulated in a hair and body cleanser and independently demonstrates rhamnolipid use in a sulfate-free shampoo. The modification amounts to using a known glycolipid surfactant according to its known cleansing/foaming function in a closely related personal-care system, and Allef’s working examples provide a reasonable expectation of success (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-418 (2007); MPEP § 2143, § 2143.02).
Claims 1-3 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), Ito et al. (US20160324747A1; published 10 November 2016, hereinafter “Ito”), Xue et al. (US20200199492A1; published 25 June 2020, hereinafter “Xue”), and Allef et al. (US20140349902A1; published 27 November 2014, hereinafter “Allef”), as applied above to instant claim 2, and in further view of Burch et al. (Novel high-throughput detection method to assess bacterial surfactant production. Appl Environ Microbiol. 2010 Aug;76(16):5363-72. Epub 2010 Jun 18; hereinafter “Burch”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date. Cochran, in view of Speight, Ito, Xue, and Allef teach the limitations of instant claims 1 and 2, as described above, from which instant claim 3 depends, however do not explicitly teach the specific limitations of instant claim 3, wherein Allef does not identify the HLB of its specific rhamnolipid.
Burch, however, reports an HLB of 9.5 for crude rhamnolipid (p. 5366, Table 2). Burch further explains in the discussion that rhamnolipid has a predicted HLB of 9.5 (p.5370, right col., 1st full ¶). An HLB of 9.5 falls within instant claim 3’s about 4-13 interval limitation. Allef supplies the reason to employ rhamnolipid in a sophorolipid-containing personal cleanser and Burch establishes that rhamnolipid surfactant having an HLB within the instant claimed range was known.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to employ a known rhamnolipid species having the HLB characteristic reported by Burch in the Allef-modified personal-care formulation. The rejection does not rely upon inherency of Allef’s unidentified commercial rhamnolipid. Rather, the rejection rests upon selection of a known HLB-qualified rhamnolipid species for the known rhamnolipid function taught by Allef.
Claims 1, 12, and 14 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), Ito et al. (US20160324747A1; published 10 November 2016, hereinafter “Ito”), and Xue et al. (US20200199492A1; published 25 June 2020, hereinafter “Xue”), as applied above to instant claim 1, and in further view of Hutton et al. (US20180098923A1; published 12 April 2018, hereinafter “Hutton”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date. Cochran, in view of Speight, Ito and Xue, teach the limitations of instant claim 1, as described above, from which instant claims 12 and 14 depend, however do not explicitly teach the specific limitations of instant claims 12 and 14, requiring a dispersed gel network.
Hutton is directed to personal-care compositions substantially free of sulfated surfactants and containing a dispersed gel network (Abstract). Hutton teaches that a gel network phase or dispersed gel network phase is a lamellar or vesicular solid crystalline phase comprising at least one fatty alcohol, at least one gel-network surfactant, and liquid carrier, wherein the dispersed gel network provides cleaning benefits in combination with detersive surfactants (¶[0046]- [0050]) in sulfate-free personal-care compositions (Abstract).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to incorporate Hutton’s dispersed gel network into the sulfate-free shampoo rendered obvious by Cochran, Speight, Ito, and Xue because Hutton teaches the gel-network technology in the same class of sulfate-free personal-care cleansing compositions for compatible cleaning and conditioning purposes. The modification is application of a known personal-care gel-network technology to another known sulfate-free cleansing composition for its established function and would have produced predictable results (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-418 (2007); MPEP § 2143). One would have had a reasonable expectation of success in doing so from Hutton’s formulation teachings and working sulfate-free personal-care embodiments.
In addition, Hutton teaches the quantitative limitations of instant claim 14. Hutton claim 1 requires a dispersed gel network comprising about 0.05 wt% or more fatty alcohol and about 0.01 wt% or more gel-network surfactant, with the gel-network surfactant selected from anionic, cationic, amphoteric, zwitterionic, nonionic surfactants, and combinations thereof, together with a liquid carrier. Accordingly, instant claim 14’s additional limitations are expressly disclosed by Hutton and are therefore obvious.
Claims 1, 12, and 13 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), Ito et al. (US20160324747A1; published 10 November 2016, hereinafter “Ito”), Xue et al. (US20200199492A1; published 25 June 2020, hereinafter “Xue”), and Hutton et al. (US20180098923A1; published 12 April 2018, hereinafter “Hutton”), as applied above to instant claim 12, and in further view of Song et al. (US20190105247A1; published 11 April 2019, hereinafter “Song”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date. Cochran, in view of Speight, Ito, Xue, and Hutton teach the limitations of instant claims 1 and 12, as described above, from which instant claim 13 depends, however do not explicitly teach the specific limitations of instant claim 13, additionally requiring that the dispersed gel network comprise a fatty alcohol, gel-network surfactant, and liquid carrier, “wherein the fatty alcohol is in the form of liquid crystal drops.”
For purposes of this rejection, the limitation is interpreted consistently with the terminology and gel-network formation mechanism expressly used in the applicant’s specification. The applicant defines its gel-network phase as a lamellar or vesicular solid-crystalline phase comprising fatty alcohol, gel-network surfactant, and liquid carrier, but then expressly teaches formation of that gel network by heating above the fatty-alcohol melting point such that mixing converts isotropic fatty-alcohol drops into liquid crystalline phase drops, followed by conversion to the solid crystalline gel network upon cooling. Thus, the instant specification itself associates the phrase “liquid crystalline phase drops” with the known morphology generated in forming the dispersed gel network recited in instant claim 12.
Hutton contains materially the same disclosure. Hutton teaches combining fatty alcohol and gel-network surfactant in a suitable ratio and heating the dispersion above the fatty-alcohol melting point. During mixing, the fatty alcohol melts, gel-network surfactant partitions into the fatty alcohol, water is incorporated, and the isotropic fatty-alcohol drops are changed into liquid crystalline phase drops. Hutton further teaches subsequently cooling the mixture below its melt-transition temperature, at which point the liquid-crystalline phase converts into the solid crystalline gel network (¶[0046]-[0056]).
Song independently corroborates that this was a conventional gel-network formation mechanism in sulfate-free personal-cleansing formulations (¶[0004]-[0005], and ¶[0151]-[0160]). Song concerns sulfate-free personal cleansing compositions and teaches conventional conditioning evaluation of those compositions, including wet combing characterization (¶[0193]), and the same personal-care formulation environment relied upon by Cochran. Song’s sulfate-free compositions expressly include CAPB/LAPB and known conditioning components (see Examples, ¶[0194]-[0216]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to prepare Hutton’s dispersed gel network for the modified Cochran shampoo according to the conventional fatty-alcohol gel-network procedure taught in the personal-care art, including formation of the liquid-crystalline fatty-alcohol droplet morphology during manufacture. Hutton teaches the process for the same class of sulfate-free personal-care product, and Song corroborates use of related sulfate-free personal-cleansing and conditioning technology. Applying Hutton’s known gel-network preparation method to the otherwise-obvious sulfate-free composition would have constituted use of a known technique to improve a similar product in the same way, with predictable formation of the known intermediate liquid-crystalline droplet morphology (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-418 (2007); MPEP § 2143). There would have been a reasonable expectation of success in doing so because Hutton expressly teaches the relevant gel-network ingredients, heating step, liquid-crystalline droplet formation, cooling step, and incorporation of the resulting gel network into sulfate-free personal-care compositions.
Claims 1 and 16 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), Ito et al. (US20160324747A1; published 10 November 2016, hereinafter “Ito”), and Xue et al. (US20200199492A1; published 25 June 2020, hereinafter “Xue”), as applied above to instant claim 1, and in further view of Amin et al. (WO2021236927A1; published 25 November 2021, hereinafter “Amin”), Kitko et al. (US20090221463A1; published 03 September 2009, hereinafter “Kitko”), and Song et al. (US20190105247A1; published 11 April 2019, hereinafter “Song”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date. Cochran, in view of Speight, Ito and Xue, teach the limitations of instant claim 1, as described above, from which instant claim 16 depends, however do not explicitly teach the specific limitations of instant claim 16. The Cochran, Speight, Ito, and Xue combination renders the structural and compositional limitations of instant claim 1 obvious for the reasons stated above but does not expressly report a “greater than two times increase in Ease of Combing rating according to the Wet Hair ILS method.”
Amin teaches a large sophorolipid-associated wet-combing benefit, providing direct experimental evidence that sophorolipid materially improves wet-hair combability. Amin Example D prepares compositions containing approximately 10 wt% acidic sophorolipid in water at about pH 6.5 and evaluates wet-combing performance (Example D; Table 6). Amin reports that the acidic sophorolipid composition without hyaluronic acid produced approximately 54.4% reduction in wet-combing force and reports highly improved conditioning performance attributable to the sophorolipid-containing compositions (Table 6 and ¶[0054]-[0055]).
Amin further compares wet-combing performance with a commercially available sulfate-free shampoo and teaches that the large decrease in wet-combing force corresponds to increased lubrication, reduced tangling, and improved sensory performance (Table 6 and ¶[0054]-[0055]). Amin therefore supplies an express reason for one of ordinary skill to expect that incorporation of sophorolipid into a hair-cleansing composition would improve wet combability and to optimize the sophorolipid-containing surfactant system toward that recognized conditioning result.
Kitko establishes a materially similar conventional subjective wet-combing evaluation. Kitko establishes that subjective evaluation of wet combing on a ten-point scale using treatment conditions very similar to the applicant’s Wet Hair ILS protocol. Kitko’s Wet and Dry Conditioning Test Method is designed to permit subjective evaluation of conditioning shampoos for wet-combing efficacy. Kitko combines five 4-g hair switches (i.e., 20 g of hair), wets them with 40°C water, and applies 0.1 g shampoo per gram of dry hair (i.e., 2 g product to 20 g hair). Kitko then lathers the hair for 30 seconds and rinses for 30 seconds using water flowing at 5.68 L/min at 40°C. After treatment, trained graders comb the wet switches with a consumer-type narrow-tooth nylon comb and assign a subjective rating on a zero-to-ten ease/difficulty scale (¶[0164]-[0167]).
The applicant’s Wet Hair ILS procedure similarly employs a 20-g hair switch, approximately 38°C water at 5.7 L/min, 0.1 g product/g hair, 30 seconds total lathering, a 30-second rinse, and subjective post-rinse combability assessment using a 0-10 hard-to-easy scale (Applicant’s specification, Wet Hair ILS Protocol). The direction of Kitko’s numerical convention is reversed relative to the applicant’s, wherein Kitko assigns lower values to easier combing, and whereas the applicant assigns higher values to easier combing, however, this represents merely a reversed reporting convention for the same underlying subjective endpoint of how easily treated wet hair can be combed. Kitko therefore establishes that the basic treatment and subjective evaluation embodied in the applicant’s Wet Hair ILS method were conventional in the shampoo art.
Song confirms that wet-combing force was a conventional conditioning endpoint in sulfate-free shampoos. Song independently teaches a Wet Combing Force Method specifically for sulfate-free personal-cleansing compositions. Song uses 4-g, 8-inch hair switches, applies 0.1 g cleansing composition/g hair, conducts repeated lather/rinse cycles, and while the hair remains wet pulls the switch through fine-tooth combs while measuring combing force using an Instron- or MTS-type friction analyzer (Wet Combing Characterization, Wet Combing Force Method, ¶[0193]). Song therefore confirms that the instrumental endpoint used by Amin and the subjective endpoint used by Kitko address the same recognized shampoo-conditioning property of resistance/ease of combing wet hair. Song also concerns the same sulfate-free personal-cleansing formulation field and expressly teaches CAPB/LAPB as amphoteric surfactants and anionic:amphoteric ratios overlapping the Cochran system (see Examples ¶[0194]-[0216]).
In view of these teachings, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, preparing the sophorolipid-containing sulfate-free shampoo rendered obvious by Cochran, Speight, Ito, and Xue to optimize the surfactant formulation for wet-hair conditioning because Speight recommends sophorolipid use and blending in personal-care and shampoo formulations, Amin experimentally establishes that sophorolipid can produce large improvements in wet-combing performance, Kitko establishes a conventional subjective ten-point method for evaluating wet-combing efficacy under essentially the same treatment conditions later selected by the applicant, and Song establishes instrumental wet-combing force as a conventional conditioning metric in sulfate-free shampoo formulations. One of ordinary skill in the art, therefore, would have had both a reason to pursue improved wet combability and known, routine methods for quantifying that result.
Use of Kitko’s subjective grader assessment instead of, or in addition to, Song’s and Amin’s instrumental force measurement would have been use of a known analytical technique for evaluating the same known hair-conditioning property, with predictable results (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-418 (2007)). The relevant composition variables also were known to be adjustable. Speight expressly encourages blending the different sophorolipid forms to tailor formulation performance, while Cochran and Xue teach adjustment of conventional-surfactant and biosurfactant proportions. Thus, optimization of the otherwise-obvious surfactant formulation toward improved wet combability would have represented routine optimization of recognized formulation variables toward a recognized result (see In re Aller, 220 F.2d 454, 456 (CCPA 1955); In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012); MPEP § 2144.05).
A reasonable expectation of obtaining a substantial effect arises particularly from Amin’s actual experimental demonstration of large sophorolipid-associated reductions in wet-combing force. The skilled artisan therefore would not have been proceeding merely with a general hope that sophorolipid might have some unidentified sensory effect.
The applied references do not literally report the applicant’s precise “greater than two times increase in Ease of Combing rating” using the applicant’s named Wet Hair ILS protocol. Rather, the claimed numerical property is addressed in view of the independent obviousness of the underlying instant claim 1 composition, Amin’s direct pre-filing experimental evidence of a large sophorolipid-associated wet-combing improvement, Kitko’s materially similar subjective ten-point wet-combing evaluation, Song’s recognition of wet-combing force as a conditioning endpoint in the same sulfate-free shampoo field, and the recognition in Speight that sophorolipid type/blend is adjustable to tailor formulation performance.
Where the Office establishes a sound basis for believing that an otherwise-old or obvious composition is identical or substantially identical to the claimed composition, a property inherent in that composition does not render the composition patentable merely because the property had not previously been measured or expressed in the same terminology (see In re Best, 562 F.2d 1252, 1255 (CCPA 1977); In re Spada, 911 F.2d 705, 708-09 (Fed. Cir. 1990); MPEP § 2112). The rejection does not depend solely on inherency, however. Amin independently teaches the direction and large magnitude of the sophorolipid-associated wet-combing effect, Kitko independently teaches a materially equivalent subjective combability-testing framework, and the applied formulation art supplies reasons to optimize the surfactant blend toward conditioning performance.
Accordingly, one of ordinary skill would have been motivated to prepare the otherwise-obvious sophorolipid-containing sulfate-free shampoo, optimize the known surfactant variables for improved wet combability, and evaluate that property using the conventional subjective wet-combing methodology taught by Kitko, with a reasonable expectation of obtaining a substantial improvement.
To the extent that the applicant establishes through competent evidence that compositions resulting from the prior-art combination do not necessarily or predictably produce the recited greater-than-twofold ILS improvement, or demonstrates that the claimed numerical threshold reflects a critical and unexpected difference in kind rather than the expected improvement identified by Amin, the evidence should be reconsidered as set forth in accordance with PAR Pharmaceutical, 773 F.3d at 1194-96; MPEP § 2112.
Claims 1 and 18 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), Ito et al. (US20160324747A1; published 10 November 2016, hereinafter “Ito”), and Xue et al. (US20200199492A1; published 25 June 2020, hereinafter “Xue”), as applied above to instant claim 1, and in further view of Hutton et al., US20180098923A1; published 12 April 2018, hereinafter “Hutton”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date. Cochran, in view of Speight, Ito and Xue, teach the limitations of instant claim 1, as described above, from which instant claim 18 depends, however do not explicitly teach the specific limitations of instant claim 18.
Hutton teaches treating hair or skin by applying its sulfate-free personal-care composition to hair or skin that has been wetted with water and then rinsing the composition away with water. Hutton teaches that effective amounts generally range from about 1-50 g and that application to hair includes working the composition through the hair such that most or all of the hair is contacted (Method of Use, ¶[0177]-[0178]).
Hutton’s cleansing compositions include lathering surfactant compositions that form a lather with water (¶[0005]; ¶[0211]; surfactant selection may be selected to provide the desired lather performance, ¶[0045]; co-surfactants may be added to improve later production, ¶[0075]), and working a shampoo-type surfactant composition through wetted hair to produce lather was a conventional mode of use at the time of the instant invention.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to use the otherwise obvious instant claim 1 composition according to Hutton’s conventional shampoo/body-cleansing procedure because Cochran and Speight expressly contemplate shampoo and personal cleansing and Hutton teaches the ordinary manner of using the same class of sulfate-free personal-care composition. The method therefore amounts to use of an obvious cleansing composition for its intended purpose according to conventional cleansing steps (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416-418 (2007); MPEP § 2143, § 2143.02), with a reasonable expectation of successful cleansing.
Claims 20-22 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), and Farmer et al. (WO2021236904A1; published 25 November 2021, hereinafter “Farmer”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date.
Cochran teaches the relevant sulfate-free, substantially-thickener-free-capable personal-cleansing chassis comprising anionic surfactant, amphoteric surfactant, and aqueous carrier as discussed above. Cochran specifically teaches and exemplifies sodium cocoyl isethionate as the non-sulfate anionic surfactant and LAPB/CAPB as amphoteric surfactants (Table 4). Sodium cocoyl isethionate is neither a sulfate nor a lactylate surfactant. Selecting Cochran’s SCI embodiment therefore supplies the claimed non-sulfate, non-lactylate anionic surfactant. The applied Cochran embodiment does not require a lactylate, and neither Speight nor Farmer requires introduction of a lactylate. Accordingly, selection of Cochran’s SCI/betaine embodiment and modification only by the applied sophorolipid teachings yields a composition free of sulfate and lactylate surfactants.
Cochran does not expressly teach the claimed two sophorolipid HLB classes or their claimed relative ratio. However, Speight teaches FERMA SL Pure at HLB 2-7 and FERMA SH Pure at HLB greater than 15, identifies shampoo as an application of the high-HLB product, and teaches that the endpoint products were designed and tested for mutual compatibility so that formulators may prepare blends (p. 26, right column, ¶2-3).
Farmer independently teaches high-HLB hydrophilic sophorolipid compositions having HLB greater than 16, as high as 18-20 or greater (p. 3, ll. 29-32; p. 6, ll. 21-23). Farmer also teaches compositions containing hydrophilic and hydrophobic sophorolipid molecules in approximately 60:40 to 70:30 hydrophilic:hydrophobic ratios (claim 14) and states that the ratio may be adjusted to about 60:40, 65:35, 70:30, or 75:25 (p. 5, ll. 25-28). Instant claim 20’s limitation is expressed in the opposite orientation, low-HLB/hydrophobic:first to high-HLB/hydrophilic:second, whereas Farmer’s ratios correspond to 40:60 = 2:3; 35:65; 30:70; and 25:75 = 1:3, wherein each lies within instant claim 20’s 1:3-3:1 interval. Farmer additionally teaches that its water-washed hydrophobic sophorolipid fraction has an HLB of about 1-8 and predominantly comprises hydrophobic sophorolipid molecules (p. 21, Hydrophobic SLP preparation, see ll. 30-31). The exact claim-20 low-HLB interval of 2–7 is supplied more precisely by Speight.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to incorporate Speight’s mutually compatible low- and high-HLB sophorolipids into Cochran’s sulfate-free shampoo because Speight expressly teaches the products for personal-care formulation and shampoo and expressly recommends blending them. Farmer provides quantitative guidance concerning the relative proportions of hydrophilic and hydrophobic sophorolipid forms.
Although Farmer’s principal examples concern service-fluid applications, Farmer is relied upon for the narrower physicochemical teaching concerning HLB and relative amounts of the same hydrophilic/hydrophobic sophorolipid molecular forms. Speight independently provides the personal-care motivation. Farmer is therefore reasonably pertinent to the formulation problem of selecting the relative proportions of different-HLB sophorolipids (see In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004); MPEP § 2141.01(a)).
There would have been a reasonable expectation of success in doing so because Speight expressly teaches compatibility of the endpoint materials and Farmer demonstrates actual mixed hydrophilic/hydrophobic sophorolipid compositions. Farmer’s ratios expressly overlap with instant claim 20’s 1:3-3:1 interval. The claimed ratio therefore is prima facie obvious absent persuasive evidence of criticality or unexpected results (see In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003); MPEP § 2144.05).
Regarding instant claim 21, Cochran expressly teaches and repeatedly exemplifies sodium cocoyl isethionate as the non-sulfate anionic surfactant (Table 4). Thus, instant claim 21 recites a species expressly taught by the primary reference and is therefore obvious. Regarding instant claim 22, Cochran expressly teaches cationic polymers and specifically exemplifies polyquaternium-10 in its sulfate-free SCI/LAPB compositions (Table 4). Therefore, it would have been obvious to retain Cochran’s polyquaternium-10 upon incorporation of the sophorolipid blend because the polymer would continue to perform its known conditioning/deposition function.
Claims 20 and 23 are rejected under AIA 35 U.S.C. § 103 as being unpatentable over Cochran et al. (US20190105246A1; published 11 April 2019, hereinafter “Cochran”), in view of Speight and Cherfan (Sophorolipid Biosurfactants: A New, Multifunctional Solution for Formulators Addressing Safety and Sustainability Concerns, Euro Cosmetics, published October 2020, pp. 23-27; hereinafter “Speight”), and Farmer et al. (WO2021236904A1; published 25 November 2021, hereinafter “Farmer”), as applied to instant claim 20 above, in further view of Peggau et al. (US20170306264A1; published 26 October 2017, hereinafter “Peggau”).
The instant effective filing date of the invention is 11 April 2022. The references cited above qualify as prior art because they were published prior to the instant effective filing date. Cochran, in view of Speight, and Farmer, teach the limitations of instant claim 20, as described above, from which instant claim 23 depends, however do not explicitly teach the specific limitations of instant claim 23.
Farmer expressly teaches mixed high-HLB/hydrophilic and low-HLB/hydrophobic sophorolipid systems, but Farmer’s specifically identified 60:40-75:25 hydrophilic:hydrophobic ratios does not expressly reach the 1:1 ratio recited in instant claim 23. However, Peggau teaches formulations containing sophorolipid in acid and lactone forms and states that preferred sophorolipid compositions have a lactone-form:acid-form weight ratio of 20:80 to 80:20 (¶[0027]). The disclosed interval encompasses a 50:50 (i.e., 1:1) ratio.
Peggau additionally teaches betaines, including alkylamidobetaines such as cocamidopropyl betaine, as preferred conventional surfactants for use with the sophorolipid (¶[0028]). Speight supplies the relevant HLB characterization, wherein the predominantly lactonic sophorolipid is low-HLB/lipophilic, whereas the predominantly linear sophorolipid is high-HLB/hydrophilic (p. 26, right column, ¶2-3). Farmer independently confirms that higher hydrophilicity corresponds to higher HLB and lower hydrophilicity corresponds to lower HLB (p. 1, ll. 21-23). Thus, the combined prior art teaches a low-HLB/lactonic/hydrophobic sophorolipid, a high-HLB/linear or acidic/hydrophilic sophorolipid, mixtures of those sophorolipid forms, and a lactone:acid ratio range encompassing 1:1.
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the instant effective filing date, to select an equal proportion when preparing the low-/high-HLB sophorolipid blend of instant claim 20 because 1:1 lies directly within Peggau’s expressly disclosed 20:80-80:20 interval. Where a claimed value falls within a prior-art range, a prima facie case of obviousness ordinarily exists (see In re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003); MPEP § 2144.05). There would have been a reasonable expectation of success in doing so because Speight expressly states that the endpoint sophorolipid products are compatible, Farmer demonstrates actual mixtures of hydrophilic and hydrophobic forms, and Peggau independently teaches broad mixtures of lactone and acid sophorolipids encompassing 1:1. Peggau is not relied upon to establish the precise HLB values of the two sophorolipids. Speight supplies the exact HLB endpoint teaching, Farmer corroborates the hydrophilic/hydrophobic relationship, and Peggau supplies the quantitative 1:1 blend teaching.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 04 August 2026, have been fully considered.
The applicant argues that the cited combination of Parry in View of Schelges, Hayes, and Song fails to teach or suggest all limitations of amended claim 1, particularly, a first sophorolipid having an HLB of about 2 to about 7; a second sophorolipid having an HLB of about 15 to about 20; and the newly added ratio of total first and second sophorolipids : total anionic surfactant : total amphoteric surfactant of about 0.1:0.6:1. Upon reconsideration, the applicant’s arguments identify deficiencies in the rejection as presently formulated.
The applicant correctly observes that Schelges does not expressly disclose HLB values for its sophorolipids. Schelges teaches that sophorolipids ordinarily occur as mixtures of lactone and free-acid forms and preferably contain approximately 20-60 wt.% acid form with the remainder lactone form. Schelges, however, does not assign an HLB of about 2-7 to the lactone fraction or about 15-20 to the acid fraction. A search of the reference likewise reveals no use of “HLB.” Accordingly, the prior Office Action’s statement that Schelges (¶[0026]) itself teaches the claimed HLB ranges is withdrawn as factually unsupported by that reference. The same correction applies to the previous assertion that Schelges teaches rhamnolipid R90 as having an HLB of about 10-12. The cited Schelges disclosure identifies R90 as a preferred rhamnolipid but does not provide that HLB value.
The applicant is correct that an obviousness rejection must account for every limitation of the claim. Although no single reference must teach every limitation where a combination is properly supported, the combined teachings must nevertheless establish the claimed subject matter as a whole. The amendment to claim 1 materially changes the obviousness inquiry. The previous rejection established general ranges for individual surfactant constituents but did not establish that the particular three-component relationship now claimed would have been selected by a person of ordinary skill.
Parry teaches a surfactant combination in which a glycolipid biosurfactant constitutes approximately 50-75% of the combination of biosurfactant and synthetic anionic surfactant. Thus, Parry’s expressly disclosed relationship between those two components is materially different from the approximately 1:6 sophorolipid-to-anionic relationship resulting from the presently claimed 0.1:0.6:1 ratio.
Song teaches broad concentrations of about 3-35 wt.% anionic surfactant and about 3-15 wt.% amphoteric surfactant and gives, for example, formulations containing 6% sodium cocoyl isethionate and 9.75% lauramidopropyl betaine. Those teachings demonstrate that the anionic and amphoteric components are compatible, but they do not by themselves disclose the complete claimed ternary relationship including 0.1-0.6 wt.% total sophorolipid. Further, the prior reliance upon Hayes requires correction. Hayes’s expressly disclosed concentration of about 0.04-0.2 wt.% concerns emulsans produced by Acinetobacter, not sophorolipids. Thus, that range cannot, without additional reasoning and evidence, be treated as an overlapping prior-art range for the presently claimed sophorolipid concentration.
The mere fact that individual ingredient concentrations were generally known to be adjustable is insufficient, standing alone, to establish that the claimed ternary ratio would have resulted from routine optimization. Accordingly, the previous rejection of claim 1, and of claims depending therefrom, cannot properly be maintained unchanged based merely on In re Aller or In re Peterson. Therefore, the rejection of claims 1-3, 6-11, and 15 over Parry in view of Schelges, Hayes, and Song is withdrawn as previously formulated. The rejections of dependent claims are accordingly withdrawn as well. New rejections have been formulated as outlined above, in view of the new amendments to the claims.
Although the foregoing rejections were withdrawn as previously formulated, the applicant’s evidence and arguments concerning unexpected results have been considered because objective evidence must be considered as part of the obviousness determination whenever presented. The evidence is relevant, but applicant’s characterization overstates what the data establish. The applicant argues that the claimed 0.1:0.6:1 compositions provide unexpectedly superior conditioning. The evidence is probative, but does not overcome the prima facie case for claim 1 for several reasons.
First, the Specification itself establishes that the 0.1:0.6:1 relationship is not unique to the strongest-performing compositions. Table 1A assigns that same glycolipid:anionic:amphoteric ratio to INV 2-INV 7, while their Ease of Combing ratings range from approximately 3 to 8. Table 1B likewise identifies INV 9-INV 12 as having the same 0.1:0.6:1 ratio, with Ease of Combing values ranging from 4 to 10. Thus, the claimed ternary ratio alone does not correspond to a single sharply defined performance result.
Second, the applicant’s remarks characterize INV 10 and INV 11 as examples “outside” the claimed ratio, but Table 1B expressly identifies both INV 10 and INV 11 as 0.1:0.6:1 compositions. Accordingly, those examples cannot establish a performance discontinuity between compositions inside and outside the claimed ratio.
Third, the Specification identifies the 1:1 high-HLB:low-HLB composition INV 3 as appearing to exhibit synergistic conditioning relative to control C1. That evidence is relevant, but claim 1 is substantially broader. It does not require a 1:1 high/low-HLB sophorolipid ratio. The cited data therefore do not establish that the asserted synergy extends throughout claim 1’s entire scope.
Fourth, the principal control C1 contains no sophorolipid. Comparison against a zero-sophorolipid control tends to show that addition of sophorolipid improves conditioning, but does not isolate the criticality of the specific 0.1:0.6:1 ratio against otherwise substantially identical formulations immediately outside that ratio. Evidence asserted to establish criticality of a numerical range or ratio is most probative where comparisons reasonably isolate the claimed parameter.
Fifth, Table 3 introduces an additional variable: C1 is reported at pH 5.8 while INV 9-INV 14 are at pH 7.0. The Specification expressly acknowledges that Table 3 suggests pH may play an important role in cleaning, lathering and/or conditioning properties. Thus, the Table 3 differences cannot necessarily be attributed solely to the claimed surfactant ratio or sophorolipid mixture.
The evidence nevertheless must be weighed, not disregarded. In particular, INV 3 provides meaningful evidence that a 1:1 high-/low-HLB sophorolipid mixture can provide particularly favorable conditioning. That evidence is more pertinent to claim 23 than to broad claim 1. But claim 23’s 1:1 ratio lies within the cited prior art’s disclosed 20:80-80:20 sophorolipid-form range, while the prior art also expressly identifies sophorolipid fraction ratio as a result-effective HLB variable. On balance, the evidence as presently presented does not establish a sufficiently controlled, commensurate showing of unexpected results to outweigh the strong prior-art evidence that selection of the relevant sophorolipid forms and their ratios was known and subject to optimization.
MPEP § 716.02(d) states that, when criticality of a claimed range is asserted, a sufficient number of tests inside and outside the claimed range ordinarily should establish that criticality (see In re Hill, 284 F.2d 955 (CCPA 1960). Unexpected results evidence also should be reasonably commensurate with the scope of the claims (see In re Kao, 639 F.3d 1057, 1068-1070 (Fed. Cir. 2011)). There must be an adequate factual basis for extending the demonstrated result to the breadth of the claimed invention. Here, that condition is not met. Table 3 difference cannot automatically be attributed exclusively to the newly claimed ternary surfactant ratio and the evidence provided is not sufficient to establish that the entire breadth of claim 1, particularly the full about 0.1-0.6 wt.% concentration interval and the exact 0.1:0.6:1 ternary relationship is critical or produces the asserted unexpected result throughout its scope.
Regarding claims 12-14, 16 and 18, the applicant states that Hutton “fails to correct the deficiencies of Parry and Schelges.” To the extent the applicant contends that Hutton itself fails to disclose the dependent-claim subject matter for which it was cited, that assertion is not persuasive. Hutton was relied upon for additional teachings concerning a dispersed gel network, including fatty alcohol, a gel-network surfactant, liquid carrier, and sulfate-free personal-care formulations, and for conventional methods of treating wetted hair or skin by applying an effective amount of composition and rinsing. The applicant has not substantively identified an error in those specific findings. It is well established that obviousness does not require bodily incorporation of every feature of one reference into another; the inquiry concerns what the combined teachings would have suggested to a person of ordinary skill (see In re Keller, 642 F.2d 413, 425 (CCPA 1981)).
Nevertheless, because claims 12-14, 16, and 18 depend from claim 1, the rejection based on Parry, Schelges, Hayes, Song, and Hutton necessarily depends upon an adequate showing that the subject matter of amended claim 1 would have been obvious. For the reasons discussed above concerning the HLB and newly added ternary-ratio limitations, that predicate has not been established by the previous rejection and it has been withdrawn. A new rejection has been outlined as detailed above.
The previous §103 analysis of claim 16 has not been maintained after the amendment. Hutton’s disclosure of improved “manageability,” “body,” or other generalized conditioning properties does not establish that a composition necessarily exhibits the newly claimed greater-than-two-times increase in Ease of Combing rating according to the particular Wet Hair ILS method. A new rejection has been outlined for claims 16, as detailed above.
The applicant argues that removing lactylate from Schelges would improperly change Schelges’s principle of operation under In re Ratti, 270 F.2d 810, 813 (CCPA 1959). The applicant is correct that Schelges places substantial emphasis on the combination of biosurfactants with acyl lactylates. Schelges’s principal disclosure identifies biosurfactant/acyl-lactylate combinations as the surfactant system responsible for the reported cleansing and foaming properties. Thus, an analysis framed merely as physically deleting the acyl lactylate from Schelges’s own complete inventive formulation would be vulnerable to the applicant’s Ratti argument. However, the applicant’s broader proposition, that Schelges therefore cannot be considered in any obviousness combination directed to a lactylate-free composition, is not persuasive.
The obviousness inquiry does not require that the references be physically combined or that the secondary reference be incorporated bodily into the primary reference (see In re Keller, 642 F.2d at 425). In re Mouttet, 686 F.3d 1322, 1332-34 (Fed. Cir. 2012), rejects an argument premised on the need to physically substitute one reference’s structure into another and distinguishes such an argument from a genuine change in principle of operation.
Accordingly, Schelges may properly be considered for the severable teaching that acid-form and lactone-form sophorolipids are preferably used as a mixture, without requiring that the skilled artisan also adopt every other feature of Schelges’s preferred cleansing composition. Schelges expressly teaches approximately 20-60 wt.% acid-form sophorolipid with the remainder lactone form. Moreover, the other references provide affirmative evidence that functional sulfate-free cleansing systems do not require lactylates. Therefore, the applicant’s Ratti argument does not, standing alone, demonstrate that the negative limitation “free of lactylate surfactants” is nonobvious. A properly articulated combination could begin with a lactylate-free cleansing platform taught by the prior art and use Schelges only for its teaching concerning selection of acid- and lactone-form sophorolipids. Such an analysis does not require modifying Schelges by destroying the feature Schelges regards as important. Accordingly, the applicant’s Ratti argument is not persuasive as a categorical bar to the combination, the rejection of claim 20 over Parry, Schelges, Hayes, Song, Cruz, and Cochran.
Nevertheless, the rejection of claim 20 as previously formulated contains the same HLB evidentiary problem discussed above. Schelges does not itself establish that its acid- and lactone-form sophorolipids satisfy the claimed HLB intervals of about 15-20 and about 2-7, respectively, and thus has been withdrawn as previously formulated because the presently cited evidence does not establish all limitations of claim 20. Because claims 21-23 depend from claim 20, the corresponding rejection of claims 21-23 is likewise withdrawn as previously formulated and new rejections have been outlined, as detailed 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 (87 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.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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