DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Applicant’s amendment of 03/05/2026 is acknowledged. Claim 1 is amended; claim 5 was previously cancelled; and claims 11-14 are new. Claims 1-4 and 6-14 are currently pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/US2021/022649 filed on 03/17/2021 and
claims domestic benefit to U.S. Application No. 62/993,779 filed on 03/24/2020 as
reflected in the filing receipt dated on 12/16/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 05/07/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome/rendered moot the previous 102 and 103 rejections. Thus, the rejections are hereby withdrawn.
Applicant’s amendment and introduction of new claims have prompted the new/revised grounds of objection and rejection presented herein. Applicant’s arguments insofar as they pertain to any revised grounds of rejection are addressed herein.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 recites the limitation “wherein after applying to mammalian hair and rinsing at least 10 mol% of the dermatologically acceptable silicone is deposited”. To clarify that the at least 10 mol% silicone is not rinsed off but instead deposited, a comma should be inserted between the terms “rinsing” and “at least”.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites the limitation “dermatologically acceptable”, which the Examiner is interpreting to mean “ingredients that are typically used for topical application to the skin”, in light of the definition provided in Applicant’s instant specification [0012].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lizarraga et al. (US20140154200A1; published: 06/05/2014; PTO-892 of 02/02/2026) in view of Sigma-Aldrich 2014 (Life Science, cat. no. 5, pg. 1-2, 64, and 1088; published: 09/2014; PTO-892 of instant action) and as evidenced by Sigma-Aldrich 2001 (Product Information, pg. 1-3; published: 03/21/2001; PTO-892 of instant action).
Lizarraga, throughout the reference, teaches non-cellulosic polysaccharide derivatives containing one or several cationic groups [0014]. Lizarraga specifically teaches a shampoo composition comprising: sodium laureth sulfate; cocamidopropyl betaine; cationic polymer; dimethicone emulsion; sodium chloride; citric acid; preservative; and water to 100 [0240].
Regarding claims 1-3 and 13: The shampoo composition reads on the instantly claimed hair care formulation as evidenced by instant claims 2 and 3. Because water is the medium used to deliver the active ingredients, it reads on the instantly claimed dermatologically acceptable vehicle. Because dimethicone emulsion comprises silicone, it reads on the instantly claimed dermatologically acceptable silicone.
Regarding the cationic polymer, Lizarraga further teaches that the non-cellulosic polysaccharide derivative is selected from a limited list of polysaccharides, including dextran [0015], wherein the average molecular weight of the non-cellulosic polysaccharide derivative is higher than about 150,000 g/mol and lower than about 1,800,000 g/mol (same as Daltons), and wherein “average molecular weight” means the weight average molecular mass of said polysaccharide [0018-0021]. The derivatizing agent is typically a quaternary ammonium moiety, wherein Lizarraga exemplifies 2,3-epoxypropyltrimethylammonium chloride as a preferred agent [0035-0038], and the degree of substitution is from about 0.20 to about 0.30 [0056].
Therefore, when considering Lizarraga’s preferred features of the cationic polymer, one of ordinary skill in the art before the effective filing date of the claimed invention could at once envisage an embodiment wherein the cationic polymer in Lizarraga’s shampoo composition is a dextran polymer substituted with 2,3-epoxypropyltrimethylammonium chloride, wherein the degree of substitution is about 0.20.
However, Lizarraga is silent as to the molecular weight of the dextran polymer prior to quaternary ammonium substitution, as well as the content of linkages between glucose units in the cationic dextran as required by claim 1.
Sigma-Aldrich 2014 teaches a limited listed of commercially available dextran polymers, wherein dextran D4876 has an average molecular weight of 150,000 [pg. 64, right col.], which lies within and thus reads on the instantly claimed range. Dextran D4876 is composed of 95% α-D-(1-6)-linkages and 5% α(1-3)-linkages as evidenced by Applicant’s instant specification [pg. 15, table 1] and by Sigma-Aldrich 2001, which teaches that the α(1-3) linkages account for the branching of dextran [pg. 1, “Product Description”], and thus reads on the instantly claimed branched chain dextran polymer.
Regarding the dextran polymer of claim 1: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shampoo composition of Lizarraga by substituting the dextran backbone of the cationic dextran with the dextran D4876 taught by Sigma Aldrich 2014 according to known methods to yield the predictable result of a cationic branched dextran polymer functionalized with 2,3-epoxypropyltrimethylammonium chloride having 100% α-linkages. Because the prior art cationic polymer has no β-1,4-linkages, it reads on the ranges recited in claims 1 and 13. It would have been obvious and there is a reasonable expectation of success because it would have been customary for an ordinarily skilled art to choose any dextran commercially available at the time of the invention as the non-cellulosic polysaccharide so long as it produces a cationic polymer with the desired molecular weight (see Examiner’s calculation below). Additionally, using a commercially available dextran offers other advantages such as improved reproducibility, time savings, and potentially lower costs.
Supporting a reasonable expectation of success, the prior art combination would produce a cationic dextran within the molecular weight range permitted by Lizarraga. For instance, the molecular mass of a D-glucose monomer is 180 Da (calculated by Examiner), and the molecular mass of a 2,3-epoxypropyltrimethylammonium ion is 116 Da (calculated by Examiner), which is substituted on 20% of the glucose residues in the cationic polymer. Since the dextran backbone has a molecular weight of 150,000 Da, the cationic dextran product would have a molecular weight of ~169,372 Da (calculated by Examiner: 150,000 Da / 180 Da = ~833 glucose residues in the dextran backbone; 833 glucose residues * 0.20 degree of substitution = ~167 substituted residues; 167 residues * 116 Da per ammonium ion = ~19,372 Da increase in molecular weight; 150,000 Da + 19,372 Da = ~169,372 Da final molecular weight).
It is noted that the recitations “hair care” and “enhances the deposition of silicone from the hair care formulation onto mammalian hair” in claim 1 are intended uses of the claimed formulation and deposition aid polymer, respectively. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the shampoo composition taught by the combination of Lizarraga and Sigma-Aldrich 2014 is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02. Further, Lizarraga explicitly teaches that use of the non-cellulosic polysaccharide in hair shampoo compositions is effective in delivering improved silicone deposition to the hair [0103].
Regarding claims 4 and 11-12: While the prior art combination is silent as to the Kjeldahl nitrogen content of the cationic dextran polymer, the structure of the prior art polymer is nearly identical to that produced in Applicant’s Example S1, wherein dextran D4876 (Sigma-Aldrich) is functionalized with 2,3-epoxypropyltrimethylammonium chloride to produce a cationic dextran having a Kjeldahl nitrogen content of 1.41, which corresponds to a degree of substitution of 0.19 [instant spec., 0036-0037, table 1]. Therefore, an ordinarily skilled artisan would reasonably expect that the prior art cationic dextran polymer, which has a degree of substitution of about 0.20 which reasonably encompasses 0.19, would possess substantially the same properties as Applicant’s exemplary cationic dextran polymer and, therefore, would necessarily have a Kjeldahl nitrogen content that lies within in the range recited in claim 4 and that lies within or closely approaches the ranges recited in claims 11-12. Note: MPEP 2144.05(I). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Regarding claim 6: The sodium laureth sulfate (same as sodium lauryl ether sulfate) and/or the cocamidopropyl betaine in the prior art shampoo composition read on the instantly claimed hair cleansing surfactant as evidenced by instant claim 8.
Regarding claim 10: Lizarraga further teaches a method for evaluating the silicone deposition efficiency, wherein Caucasian hair tresses were treated with the shampoo followed by rinsing [0188-0193]. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the method of Lizarraga in order to evaluate the silicone deposition efficiency of the shampoo composition taught by the combination of Lizarraga and Sigma-Aldrich 2014. As discussed above, the prior art shampoo composition meets all limitations of instant claim 1. Therefore, the prior art method reads on the instantly claimed steps of selecting a hair care formulation according to claim 1 and applying the hair care formulation to mammalian hair.
It is noted that the recitation “of depositing silicone on to mammalian hair” in claim 10 is an intended outcome of practicing Applicant’s method as claimed. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the composition taught by the combination of Lizarraga and Sigma-Aldrich 2014 is capable of performing the intended use when practicing the method steps as claimed, then it meets the claim. Note: MPEP 2111.02. Further, Lizarraga explicitly teaches that use of the non-cellulosic polysaccharide in hair shampoo compositions is effective in delivering improved silicone deposition to the hair [0103].
Regarding claim 14: As discussed above, the combination of Lizarraga and Sigma-Aldrich teaches a shampoo composition comprising all components as instantly claimed, and the cationic dextran taught by the prior art combination is nearly identical to that of Applicant’s Example S1. As such, the instantly claimed amount of silicone deposition is a mechanistic outcome that would flow naturally from applying the prior art composition to mammalian hair and rinsing. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicant discloses and/or claims are necessarily present. Note MPEP 2112.01.
Claims 1-4 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lizarraga et al. (US20140154200A1; published: 06/05/2014; PTO-892 of 02/02/2026) in view of Sigma-Aldrich 2014 (Life Science, cat. no. 5, pg. 1-2, 64, and 1088; published: 09/2014; PTO-892 of instant action), as applied to claims 1-4, 6, and 10-14 above, and further in view of Pimenta et al. 2017 (US9820924B2; published: 11/21/2017; PTO-892 of 04/07/2025) and Ingredients to Die For (archived: 06/16/2015; PTO-892 of 04/07/2025) and as evidenced by Sigma-Aldrich 2001 (Product Information, pg. 1-3; published: 03/21/2001; PTO-892 of instant action).
The combination of Lizarraga and Sigma-Aldrich 2014 as evidenced by Sigma-Aldrich 2001 teaches the invention(s) of claims 1-4, 6, and 10-14 as discussed in detail above and further incorporated herein.
Regarding claim 8: The shampoo composition of the prior art combination comprises sodium laureth sulfate (same as sodium lauryl ether sulfate) and cocamidopropyl betaine, which read on two of the three of the hair care cleansing surfactants recited in the instantly claimed mixture.
Regarding claim 9: The shampoo composition of the prior art combination comprises a preservative and, therefore, meets the claim.
However, the prior art combination does not expressly teach that the shampoo composition further comprises a chelating agent and a thickener as recited in claim 7, from which claims 8 and 9 depend, or that the composition further comprises cocamide monoethanolamie, tetrasodium ethylenediaminetetraacetic acid, or PEG-150 pentaerythrityl tetrastearate as recited in claim 8, from which claim 9 depends.
Pimenta, drawn to liquid personal cleansers, teaches that particular combinations of surfactants and rheology modifiers are found to maintain target viscosity while lowering relaxation time of surfactants, which allows cleaner product dispensing while using significantly lower surfactant levels [col. 1].
Ingredients to Die For teaches PEG-150 pentaerythrityl tetrastearate, as a high performance thickener for aqueous surfactant systems [pg. 1].
Regarding the thickener recited in claims 7 and 8 and the hair cleansing surfactant mixture recited in claim 8: In exemplary embodiments, the surfactant system of Pimenta comprises sodium lauryl ether sulfate (SLES), cocamidopropyl betaine (CAP Betaine), and cocamide monoethanolamine (CMEA) [col. 7, prototypes 1a, 1b, and 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shampoo composition taught by the combination of Lizarraga and Sigma-Aldrich 2014 by further including cocamide monoethanolamine and a rheology modifier (i.e., a thickener) because Pimenta teaches that these—in combination with the sodium laureth sulfate and cocamidopropyl betaine of Lizarraga—advantageously reduce the concentration of surfactant within a liquid personal cleanser and, thus, the cost of manufacturing [col. 1].
Regarding the chelating agent recited in claims 7 and 8: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shampoo composition taught by the combination of Lizarraga, Sigma-Aldrich 2014, and Pimenta by adding the chelating agent tetrasodium EDTA, because Pimenta teaches that the compound is useful for forming complexes with metal cations that do not cross a lipid bilayer, for example at the surface of the skin [col. 5-6].
Regarding the thickener recited in claim 8: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shampoo composition taught by the combination of Lizarraga, Sigma-Aldrich 2014, and Pimenta by selecting PEG-150 pentaerythrityl tetrastearate as the thickener because Ingredients to Die For teaches that the compound exhibits high performance in aqueous surfactant systems and mitigates irritation, which allows formulators to create mild, rheologically balanced shampoos [pg. 1].
An ordinarily skill artisan would reasonably expect success in modifying the shampoo composition taught by the combination of Lizarraga and Sigma-Aldrich 2014 with the prior art teachings as proposed because all ingredients are known in the art to be useful in personal cleansing compositions, and Lizarraga expressly teaches that its compositions may contain further hair composition ingredients including surfactants, viscosity modifiers, etc. [0135].
Response to Arguments
Applicant’s arguments submitted on 03/05/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that nothing in Lizarraga would suggest to the skilled worker to use a deposition aid polymer having the claimed content of β-1,4-linkages. This argument was not found to be persuasive. Lizarraga expressly teaches that dextran may be used as the cationic polymer, and Sigma-Aldrich 2014 teaches dextran D4876, which has the same properties as instantly claimed as evidenced by Applicant’s own specification [pg. 15, table 1]. For the reasons discussed in the prior art rejections above, it would have been prima facie obvious to one of ordinary skill in the art to use any commercially available dextran so long as it produces a cationic polymer having a molecular weight in the range disclosed by Lizarraga.
Applicant further argues that as it relates to the instantly claimed TKN, Lizarraga requires a degree of substitution of at least 0.20 and that nothing in Lizarraga would lead a skilled worker to use this lower degree of substitution. This argument was not found to be persuasive. First, Applicant provides no data to support the assertion that a TKN of 1.41 or less always corresponds to a degree of substitution of 0.19 or less, as the calculated degree of substitution estimated from TKN can vary based on the quaternary ammonium reagent used. Additionally, Lizarraga expressly teaches that the cationic polymer has a degree of substitution of “about” 0.20, which reasonably encompasses 0.19, not “at least” 0.20 as asserted by Applicant. Thus, as discussed in detail above, an ordinarily skilled artisan has reason to believe that the cationic dextran taught by the combination of Lizarraga and Sigma-Aldrich 2014, which is nearly identical to that produced in Applicant’s Example S1 having a degree of substitution of 0.19, would possess substantially the same TKN as instantly claimed. Applicant further points to Examples CF3 and CF4 as having poorer silicone deposition, which Applicant attributes to having a higher TKN. However, these examples are not relevant, as the prior art combination teaches a nearly identical structure to that instantly claimed, and Applicant’s examples use cationic guar rather than cationic dextran, which could also contribute to observed differences in silicone deposition.
Applicant further argues that Lizarraga provides no data in regard to the instantly claimed silicone deposition and asserts that Applicant’s Examples F2, F3, F6, and F7 demonstrate that not all quaternary ammonium functionalized dextrans meet the silicone deposition limitation of instant claim 14. This argument was not found to be persuasive. As evidenced by Applicant’s own disclosure in Examples F1 and F5 [pg. 19, table 5], the instantly claimed amount of silicone deposition is a mechanistic outcome that would flow naturally from applying the prior art composition, which comprises all claimed components including a cationic dextran nearly identical to that of Applicant’s Example S1, to mammalian hair and rinsing. While all quaternary ammonium functionalized dextrans may not meet the instantly claimed silicone deposition limitation, Applicant’s own data demonstrate that the cationic dextran taught by the combination of Lizarraga and Sigma-Aldrich 2014 would reasonably meet the limitation.
In view of the foregoing, the prior art rejections of record are maintained.
Conclusion
No claim is 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 SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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