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 05 June 2026, in response to the Office Correspondence dated 17 December 2025, are acknowledged.
The listing of Claims filed 05 June 2026, have been examined. Claims 1-23 are pending. Claims 1, 2, 4, 5, 7, 10, 18, and 19 are amended, new claims 21-23 have been added, and no claims have been canceled.
Response to Amendment
The amendments have been entered. The applicant's amendments correcting the typographical errors identified in claims 2, 4, 5, and 10 have overcome the outstanding objections. Claim 2 now recites "coacervation enhancer" without the prior typographical error "coascervation." Claim 4 and 5 now recite "deposition polymer" without the prior typographical error "disposition polymer." Claim 10 has been amended to correct the prior typographical errors. Accordingly, the objections to claims 2, 4, 5, and 10 are withdrawn.
The applicant argues that Cunningham fails to anticipate amended claim 1 because Cunningham allegedly does not disclose a rinse-off cleansing composition, a cationic polymer/anionic surfactant coacervate formed upon dilution, hydroxypropyl bis-hydroxyethyldimonium chloride (HBHEC) functioning as a coacervation enhancer, and enhancement of deposition relative to an otherwise identical composition lacking HBHEC. The arguments have been fully considered and are persuasive with respect to the anticipation rejection.
Amended claim 1 now recites, "...wherein the hydroxypropyl bis-hydroxyethyldimonium chloride coacervation enhancer is present in an amount effective to enhance deposition of the coacervate onto hair or skin relative to an otherwise identical rinse-off cleansing composition lacking the hydroxypropyl bis-hydroxyethyldimonium chloride coacervation enhancer." The prior rejection relied upon Cunningham's disclosure of HBHEC as an emulsifying agent together with disclosures of cationic polymers and surfactants elsewhere in the reference. While Cunningham teaches each component individually, Cunningham does not expressly disclose a dilution-triggered coacervate formed between a cationic deposition polymer and an anionic surfactant, nor HBHEC enhancing deposition of such coacervates relative to a control formulation lacking HBHEC. The examiner agrees that the amended comparative functional limitation is not expressly disclosed in Cunningham.
The previous rejection additionally relied upon inherency. However, inherency requires that the missing characteristic necessarily be present in the prior-art composition and not merely probably or possibly present (see MPEP §2112). The present record does not establish that Cunningham necessarily exhibits the claimed enhancement in deposition relative to an otherwise identical composition lacking HBHEC.
Accordingly, the rejection of claims 1-9 under 35 U.S.C. §102(a)(1) is withdrawn and the previous rejection of claims 10-20 under 35 U.S.C. §103. However, new grounds of rejection are made for claims 1-23, under 35 U.S.C. §103 over Cunningham in view of Peffly, as detailed below. In addition, claims 1-23 are rejected under 35 U.S.C. §112(b) as indefinite, as necessitated by amendment to the claims, as detailed below.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 17 December 2025, 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.
Claims 1-23 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 2 is indefinite because it recites "The coacervate composition of claim 1," whereas claim 1 is directed to a "rinse-off cleansing composition" and does not recite a "coacervate composition". There is no antecedent basis for the term "coacervate composition" in claim 1. To avoid confusion and provide clarity, claim 2 should be amended to recite "The rinse-off cleansing composition of claim 1, wherein...".
Claim 9 recites "a coacervate composition of claim 1," but claim 1 is directed to a "rinse-off cleansing composition" and does not recite a "coacervate composition." To provide clarity and proper antecedent basis, claim 9 should be amended to recite "A cleansing formulation comprising the rinse-off cleansing composition of claim 1 and at least one of...". In addition, potential ambiguity in claim 10 of "adding a coacervate composition to the agent" exists, however no antecedent basis problem exists because "a coacervate composition" is newly introduced. Yet, it is unclear whether the coacervate already exists before addition, or the composition forms a coacervate only after dilution.
Likewise, claim 8 is indefinite for reciting "the surfactant," but the term "a surfactant" is not previously recited in claim 1, claim 1 recites only "an anionic surfactant." To avoid ambiguity, claim 8 should be amended to recite "the anionic surfactant". Claim 11 refers to "hair and skin conditioning agents" (plural) of claim 10, yet claim 10 introduced "a hair and skin conditioning agent" (singular). To establish proper antecedent bais in claim 11, claim 10 should be amended to "hair and skin conditioning agents" (plural).
Claim 17 recites, “wherein the composition comprises...". Potential ambiguity exists because claim 10 introduces hair and skin conditioning agent, coacervate composition, and enhanced conditioning agent. It is unclear which composition is being referenced.
Claim 22 recites that the enhancer is present "in an amount of about 2 wt% active." The term "active" is not defined in the claims or the specification. It is unclear whether "active" refers to the weight percentage of the active ingredient (hydroxypropyl bis-hydroxyethyldimonium chloride) excluding any solvent or carrier, the weight percentage of the commercial product (e.g., 2 wt% of the 70% active solution), or some other measure of active ingredient concentration. The specification notes that "Cola®Moist 200 is sold as a 70% actives solution in water," which may clarify the meaning of "active" in the context of the commercial product. However, this definition is not incorporated into the claim, and it is unclear whether the claim is limited to the commercial product or includes other forms of the enhancer.
The applicant may consider defining "active" in the claim (e.g., "about 2 wt% of the hydroxypropyl bis-hydroxyethyldimonium chloride present as a 70% actives solution, based on the total weight of the composition”), or removing the term "active" and recite the amount of the compound directly (e.g., "about 1.4 wt% hydroxypropyl bis-hydroxyethyldimonium chloride based on the total weight of the composition”).
Claims 1, 10, and 18 are rejected as indefinite for failing to particularly point out and distinctly claim the subject matter regarded as the invention. The phrase "an amount effective to enhance deposition of the coacervate onto hair or skin relative to an otherwise identical rinse-off cleansing composition lacking the hydroxypropyl bis-hydroxyethyldimonium chloride coacervation enhancer" is a functional limitation that does not provide an objective, measurable standard for determining compliance with the claim. Whether a composition falls within the scope of the claims therefore cannot be determined with reasonable certainty (see MPEP 2173.05(b)).
Specifically, the claim does not specify how "deposition" is to be measured (e.g., gravimetric analysis, spectroscopic analysis, dye binding assays, radio-labeling, combing force measurements, or other methods), what constitutes a statistically significant "enhancement" (e.g., minimum percentage increase, p-value threshold, or number of replicates), the conditions under which the enhancement is to be measured (e.g., temperature, water hardness, dilution ratio, application time, rinse protocol), the substrate characteristics (e.g., hair type, damage level, skin type, hydration state), or the identity and concentration of the "otherwise identical" composition's components. Thus, the present functional limitation fails this test because it lacks any objective criteria for determining whether the "enhancement" requirement is satisfied. Without an objective test, the claim scope is unclear and could encompass compositions that do not actually perform the recited function, as there is no way to verify compliance.
Moreover, the phrase "relative to an otherwise identical composition lacking the enhancer" creates additional uncertainty because the "otherwise identical" composition is not part of the claimed composition, it is a hypothetical comparator. This leads to ambiguity regarding what constitutes "otherwise identical" when the claimed composition requires the enhancer. The claim does not specify what concentration of the enhancer is "effective," rendering the claim scope unclear. The claims fail to specify formulation variables to be held constant, deposition test methodology, and deposition endpoint measured. Consequently, claim scope depends upon an undefined comparison (see MPEP 2173.05(g)).
Additionally, claim 10 recites a "method of enhancing or boosting the deposition of hair and skin conditioning agents" and includes the step of "providing a hair and skin conditioning agent." The term "hair and skin conditioning agents" is broad and could encompass the claimed composition itself, creating potential circularity in the method. The claim further recites "adding a coacervate composition to the agent," but does not specify whether the coacervate composition is pre-formed or forms in situ. The meaning of "providing" and "adding" are not clearly defined in the context of the claimed method.
To overcome these rejections, the applicant is advised to consider amending the claims to specify an objective test or measurement protocol for determining "enhancement of deposition," including the substrate, measurement technique, and statistical significance requirements; the conditions under which the enhancement is measured (e.g., dilution ratio, water temperature, application time); a defined comparator composition with specified concentrations of all components; and a minimum percentage or amount of enhancement to establish an objective standard.
Dependent claims 2-9, 11-17, and 19-23 are included in this rejection of claims 1, 10, and 18 because they do not cure the defect noted above.
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.
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 10-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Cunningham et al. (US20100158964A1; published 24 June 2010, hereinafter referred to as “Cunningham”) in view of Peffly et al. (WO2004064802A2; published 05 August 2004, hereinafter referred to as “Peffly”).
Cunningham teaches liquid personal care compositions and personal care products comprising a protonated skin aesthetic agent, an acidifying agent, and an emulsifying agent, wherein the emulsifying agent can be selected from a list including hydroxypropyl bis-hydroxyethyldimonium chloride (HBHEC) (claim 12; ¶[0028]). Cunningham further teaches that the composition includes cationic deposition polymers, such as polyquaternium-7, polyquaternium-10, and guar hydroxypropyltrimonium chloride (¶[0083]), and one or more surfactants (¶[0084]), including anionic surfactants such as alkyl sulfates and alkyl ether sulfates (¶[0087]), which encompasses sodium lauryl sulfate and sodium laureth-n sulfate.
Cunningham's composition is intrinsically a coacervate or coacervate-like system, as it is formed by acidifying agent protonation of a deprotonated skin agent within an aqueous liquid to produce an emulsified oil phase (¶[0019], ¶[0032]). Cunningham further teaches optional thickeners, colorants, preservatives, pH adjusters, chelating agents, and cleansers (¶[0056], ¶[0076], and ¶[0091]).
The claimed invention differs from Cunningham in that Cunningham is directed primarily to wet wipe compositions, whereas the claims are directed to rinse-off cleansing compositions (i.e., shampoos) wherein the cationic deposition polymer and anionic surfactant form a coacervate upon dilution, and HBHEC is present in an amount effective to enhance coacervate deposition.
Peffly directly teaches rinse-off shampoo compositions with a cationic deposition polymer and an anionic surfactant coacervate system to maximize deposition of conditioning agents onto hair and skin during the cleansing process (page 1, paragraphs 1-4; claim 28). Peffly teaches that coacervates are formed by the interaction of a cationic deposition polymer, such as polyquaternium-10, with an anionic surfactant system, such as alkyl sulfates or alkyl ether sulfates (e.g., sodium lauryl sulfate, sodium laureth sulfate; claims 1, 5, 6, and 8 and Table 1).
Peffly teaches coacervate formation from interaction of cationic polymers and anionic surfactants upon dilution (page 1, paragraph 4 and Table 1), which is further supported by evidentiary reference Stella et al. (US20100322878A1, published 17 June 2010) explicitly teaching that it was known in the art at the time of the invention wherein coacervate formation occurs upon dilution (¶[0003]).
Peffly further teaches administering coacervate compositions for treating hair or skin and includes examples of topical rinse-off shampoo cleansing system compositions containing a high molecular weight conditioning agent (claim 28; page 22, last paragraph; Table 1). Thus, both Cunningham and Peffly use aqueous carriers in their compositions (Cunningham ¶[0070]; Peffly Table 1).
The claimed invention differs from Peffly in that Peffly does not disclose HBHEC as a coacervation enhancer. However, it is well-established that cationic polymers interact with anionic surfactants to form coacervates that enhance deposition of conditioning agents (see evidentiary reference Stella et al., US20100322878A1, published 17 June 2010, ¶[0003]; and evidentiary reference CarnaIi et al., US20070259803A1, published 11 August 2007, ¶[0002]). Further, Cunningham teaches that HBHEC is an effective emulsifying agent in personal care compositions (¶[0028]).
The publicly available Alfa Chemistry product page for HBHEC expressly states that HBHEC is a conditioning agent that "enhance[s] the deposition of other active ingredients onto the hair" and is "commonly used in shampoos, conditioners, hair serums, and other hair styling products" (evidentiary reference: Alfa Chemistry product page for hydroxypropyl bis-hydroxyethyldimonium chloride; https://cosmetics.alfa-chemistry.com/product/hydroxypropyl-bis-hydroxyethyldimonium-cas-110528-94-4-394921.html). A person of ordinary skill seeking to enhance deposition in a rinse-off shampoo coacervate system would have been motivated to incorporate HBHEC based on this known function.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine Cunningham's teachings of HBHEC-containing personal care compositions with Peffly's teachings of rinse-off shampoo coacervate systems because both Cunningham and Peffly are directed to personal care compositions for topical application to hair and skin to provide conditioning and aesthetic benefits. Cunningham expressly addresses skin and hair aesthetic benefits (e.g., softness, quietness, drapability), and Peffly addresses conditioning from rinse-off cleansing systems.
A person of ordinary skill in the art would be motivated to combine teachings from references in the same technical field addressing related problems.
In addition, Cunningham teaches that HBHEC is useful in personal care compositions. Peffly teaches rinse-off shampoo coacervate systems. The combination of a known personal care ingredient with a known coacervate system would have been a straightforward and predictable modification for a person of ordinary skill. The combination of known ingredients in known product forms is routine optimization within the personal care industry.
A person of ordinary skill would have been motivated to incorporate Cunningham's HBHEC into Peffly's shampoo coacervate system with a reasonable expectation of success, as both references operate in the same technical field and address the same problem of enhancing deposition of benefit agents onto hair and skin. Thus, both Cunningham and Peffly are analogous art because they are from the same field of endeavor of personal care compositions for hair and skin. The references are also reasonably pertinent to the problem of enhancing deposition of conditioning agents in rinse-off cleansing systems.
A person of ordinary skill in the art would have had a reasonable expectation of success in combining Cunningham's HBHEC with Peffly's rinse-off shampoo coacervate system for several reasons. The mechanism of coacervate formation, interaction of cationic polymers with anionic surfactants upon dilution, was well-known in the art (see evidentiary reference Stella et al., US20100322878A1, published 17 June 2010, ¶[0027]). In addition, HBHEC is a cationic compound (see evidentiary reference: Alfa Chemistry product page for hydroxypropyl bis-hydroxyethyldimonium chloride; https://cosmetics.alfa-chemistry.com/product/hydroxypropyl-bis-hydroxyethyldimonium-cas-110528-94-4-394921.html).
Given its cationic character and high charge density, a person of ordinary skill would reasonably expect that HBHEC could interact with anionic surfactants to enhance coacervate formation and the property of deposition enhancement was already known for HBHEC (see evidentiary reference Stella et al., US20100322878A1, published 17 June 2010, ¶[0003]; and evidentiary reference Carnali et al., US20070259803A1, published 11 August 2007, ¶[0002]). Thus, the combination of known ingredients in a known product form of rinse-off shampoo would have been a straightforward and predictable optimization for a person of ordinary skill (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Regarding instant claim 2, Cunningham teaches HBHEC by name, thus its structure is inherent. Regarding instant claim 3, Cunningham teaches these polymers (¶[0083]). Further, evidentiary reference Murray (US5720964A; published 24 February 1998) teaches cationic guar gum derivatives and quaternary nitrogen-containing cellulose ethers (column 3, lines 47-55). Regarding instant claims 4-6, Cunningham teaches polyquaternium-7 (homopolymer), polyquaternium-10 (cationic cellulose), and guar hydroxypropyltrimonium chloride (¶[0083]) and evidentiary reference Carnali et al. (US20070259803A1, published 11 August 2007), teaches cationic synthetic copolymers (¶[0019]-[0025]).
Regarding instant claims 7 and 8, Cunningham teaches surfactant blends (¶[0116]), alkyl sulfates, and alkyl ether sulfates (¶[0087]). Peffly teaches sodium lauryl sulfate, sodium laureth sulfate (Table 1) and cocoamphodiacetate (page 10, paragraphs within 1. Zwitterionic or Amphoteric Surfactant), specifically as disodium cocoamphodiacetate in Table 1. Additionally, evidentiary reference Stella et al. (US20100322878A1, published 17 June 2010), teaches sodium laureth sulfate and cocoamphodiacetate (¶[0054], ¶[0052] and claim 13) and evidentiary reference Cotrell (US20120142571A1; published 07 June 2012), teaches wherein it was known at the time of the invention in the art that acetate-based amphoteric surfactants cocoamphodiacetate and disodium cocoamphodiacetate could be used interchangeably (¶[0050]). Regarding instant claim 9, Cunningham teaches thickeners, viscosity enhancers, colorants, preservatives, pH adjusters, buffering agents (¶[0076] and ¶[0091]).
The method of claim 10 is taught by Cunningham in view of Peffly. Cunningham teaches personal care compositions containing HBHEC, cationic deposition polymers, and anionic surfactants that provide aesthetic benefits to hair and skin (Abstract; ¶[0007]). Peffly teaches rinse-off shampoo coacervate systems for enhanced deposition. Combining these teachings (i.e., incorporating HBHEC into a rinse-off shampoo coacervate system and applying it to hair or skin) would have been obvious for the reasons stated above.
Regarding instant claim 11, Peffly teaches high molecular weight conditioning agents (page 22, last paragraph). Regarding instant claim 12, Cunningham teaches topical personal care compositions (Abstract). Regarding instant claim 13, Peffly teaches shampoo and Cunningham teaches wet wipe compositions (as described above) that would naturally be extended to other product forms. Regarding instant claims 14 and 20, Cunningham teaches HBHEC by name, wherein the structure is inherent. Regarding instant claims 15 and 16, Cunningham teaches these polymers and expressly discloses polyquaternium-10 (¶[0083]).
Regarding instant claim 17, Cunningham teaches thickeners, preservatives, pH adjusters, etc. (¶[0076] and ¶[0091]). Regarding instant claim 18, Peffly teaches rinse-off shampoo compositions (page 1, paragraph 1). Regarding instant claim 19, Peffly teaches aqueous carriers in shampoo compositions (page 23, Table 1). Cunningham teaches aqueous carriers from about 0.1% by weight of the composition to about 99.9% by weight of the composition (¶[0070]), fully encompassing the instant claimed range of 60-95 wt%.
Regarding instant claim 21, Cunningham teaches polyquaternium-10 (¶[0083]), surfactant blends (¶[0116]), alkyl sulfates, and alkyl ether sulfates (¶[0087]). Peffly teaches sodium lauryl sulfate, sodium laureth sulfate (Table 1) and cocoamphodiacetate (page 10, paragraphs within 1. Zwitterionic or Amphoteric Surfactant) ), specifically as disodium cocoamphodiacetate in Table 1. Additionally, evidentiary reference Stella et al. (US20100322878A1, published 17 June 2010), teaches sodium laureth sulfate and cocoamphodiacetate (¶[0054], ¶[0052] and claim 13) and evidentiary reference Cotrell (US20120142571A1; published 07 June 2012), teaches wherein it was known at the time of the invention in the art that acetate-based amphoteric surfactants cocoamphodiacetate and disodium cocoamphodiacetate could be used interchangeably (¶[0050]).
Regarding instant claim 22, Peffly teaches the use of polyquaternium-10 (claim 5 and 18) used at 0.50% (Table 1, Example 4) and Cunningham teaches the use of HBHEC from about 0.01% by weight of the composition to about 10% by weight of the composition (claim 18), encompassing the instant claimed weight of 2%, wherein the specific selection of 2% from the range taught by Cunningham represents routine optimization of known ingredient amounts. Regarding instant claim 23, Cunningham teaches the use of citric acid for pH adjustment (¶[0035]), wherein it is used to adjust the pH to between 3.5-6 (claim 4 and ¶[0036]). The examples adjust the pH to 5.5 (Tables 12-15), wherein “about” can be reasonably assumed to encompass a pH of 5.5, as taught and exemplified by Cunningham.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to combine Cunningham's HBHEC with Peffly's rinse-off shampoo coacervate system involves familiar elements combined according to known methods. Both references are in the same technical field (i.e., personal care compositions) and address the same problem (i.e., enhancing deposition of benefit agents). The result of enhanced deposition is predictable because HBHEC was known to enhance deposition and coacervate systems were known to enhance deposition.
Both Cunningham and Peffly address enhancing deposition of conditioning agents in rinse-off cleansing compositions. As such, a person of ordinary skill would be motivated to combine their teachings. Based on the known cationic character of HBHEC, the known deposition-enhancing function of HBHEC, and the known coacervate-forming mechanism of cationic polymers with anionic surfactants, a person of ordinary skill would have had a reasonable expectation of success in combining Cunningham's HBHEC with Peffly's rinse-off shampoo coacervate system.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 05 June 2026, have been fully considered. The applicant's arguments regarding anticipation have been fully considered and are persuasive to the extent that the prior 35 U.S.C. §102 rejection is withdrawn. The prior 35 U.S.C. §103 have been withdrawn and are restated based on the newly added claim limitations. However, the amendments and arguments do not overcome the newly stated grounds of rejection under 35 U.S.C. §103.
Cunningham teaches personal care compositions comprising HBHEC (claim 12; ¶[0028]). Cunningham further teaches cationic polymers including polyquaternium-10, polyquaternium-7, and guar hydroxypropyltrimonium chloride (¶[0083]); surfactant systems including alkyl sulfates and alkyl ether sulfates (¶[0084]-[0088]); aqueous personal-care formulations (¶[0070]); and topical application to skin and hair (¶[0031]). Thus, Cunningham teaches the precise HBHEC species now recited in claims 1, 2, 14 and 20.
Peffly teaches rinse-off cleansing compositions in which cationic deposition polymers interact with anionic surfactants, dilution generates coacervates, coacervates enhance deposition of conditioning agents onto hair and skin, polyquaternium-10 is a preferred deposition polymer, sodium laureth sulfate is a preferred surfactant, and shampoo formulations are preferred embodiments (claims 1, 5, 6, 8 and 28 and Table 1). Peffly expressly teaches optimizing coacervate formation and deposition through modification of formulation components affecting electrostatic interactions.
The applicant argues that the proposed combination is "based on hindsight" and that "one of ordinary skill in the art would not have reached the same conclusion." This argument is unpersuasive. First, both Cunningham and Peffly are directed to the same technical field: personal care cleansing compositions for hair and skin. Cunningham expressly addresses skin and hair aesthetic benefits (e.g., softness, quietness, drapability), and Peffly addresses conditioning from rinse-off cleansing systems. A person of ordinary skill in the art would be motivated to combine teachings from references in the same field addressing related problems.
Second, Cunningham's HBHEC is a recognized personal care ingredient that is "known to be safe and non-irritating" and "easily formulated into many emulsion products" . The use of HBHEC in personal care compositions is well-established, as reflected in commercial literature describing it as a "conditioning agent" used in "shampoos, conditioners, hair serums, and other hair styling products" with the ability to "enhance the deposition of other active ingredients onto the hair" .
Third, Applicant's argument that HBHEC's function as a coacervation enhancer was "unexpected" and "not predictable" is not supported by the record. The specification itself states that HBHEC "was designed as a cationic humectant with a high charge density" . Given its cationic character and high charge density, a person of ordinary skill in the art would reasonably expect that it could interact with anionic surfactants to enhance coacervate formation.
Fourth, Peffly's teaching of a rinse-off shampoo coacervate system provides an explicit motivation to incorporate Cunningham's HBHEC into such a system. Both references address the same problem—enhancing deposition of conditioning agents onto hair and skin. The combination of a known coacervate system (Peffly) with a known personal care ingredient that enhances ingredient deposition (Cunningham's HBHEC) would have been obvious to try with a reasonable expectation of success.
The applicant argues that neither reference teaches HBHEC as a "coacervation enhancer." This argument is not persuasive. The claims are composition claims. The recited HBHEC structure is identical to the compound taught by Cunningham. A prior-art composition does not become patentable merely because the applicant discovered an additional property or mechanism of action for an old ingredient (see MPEP §2112.01(IV) and In re Spada, 911 F.2d 705 (Fed. Cir. 1990)). HBHEC is a low-molecular-weight dicationic quaternary ammonium compound possessing two permanent positive charges.
Cunningham need not identify HBHEC by the same functional name or recognize the same mechanism, it is sufficient that Cunningham discloses a composition that inherently possesses the claimed structure and function. A person of ordinary skill in the art would have understood that introducing an additional cationic species into a cationic polymer/anionic surfactant coacervate system would predictably alter electrostatic interactions and potentially influence coacervate formation, phase separation behavior, and deposition.
Accordingly, one of ordinary skill in the art would have found it obvious to incorporate Cunningham's HBHEC into Peffly's shampoo coacervate system to evaluate and optimize deposition performance because both references are directed to personal-care delivery systems utilizing cationic materials to improve deposition and conditioning performance. Such optimization represents routine experimentation (see MPEP §2144.05, In re Aller, 220 F.2d 454 (CCPA 1955), and In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)).
The applicant asserts that the rejection reconstructs the invention by using the applicant's disclosure as a roadmap is not supported by the record. However, the prior Office Correspondence identifies the specific paragraphs in Cunningham that disclose each claim limitation. This is not reconstruction, but rather is a proper analysis. Cunningham's disclosure contains the elements within its four corners. Cunningham explicitly teaches personal care compositions and personal care products for topical application to skin and hair (Abstract, ¶[0007]). While the primary embodiment is a wet wipe, Cunningham teaches that these compositions are "liquid personal care compositions" (¶[0032]) that can be incorporated into "personal care compositions and personal care products" generally. The specification explains that "wipes are taught to historically be used for cleaning" (¶[0002]) and that "additional components, such as cleansers can be included in aqueous solution formulation embodiments of the invention" (¶[0056]). A wet wipe composition, which is applied to skin and then removed, inherently functions as a rinse-off or wipe-off cleansing system.
Cunningham explicitly teaches that the emulsifying agent "can be selected from a list including hydroxypropyl bis-hydroxyethyldimonium chloride (HBHEC)" (claim 12, ¶[0028]). The specific chemical structure of HBHEC is inherent to the named compound. The fact that Cunningham discloses this compound as an emulsifying agent does not negate anticipation; the compound is still present in the composition. Cunningham also expressly discloses that the composition "also includes cationic deposition polymers, such as polyquaternium-7 (cationic synthetic homopolymer), polyquaternium-10 (cationic cellulose) and guar hydroxypropyltrimonium chloride (cationic guar derivative)" (¶[0083]). This disclosure is not merely optional, Cunningham describes these as part of the composition's formulation.
Cunningham teaches that the composition includes "one or more surfactants" (¶[0084]), "including anionic surfactants as alkyl sulfates and alkyl ether sulfates" (¶[0087]), "which encompasses sodium lauryl sulfate and sodium laureth-n sulfate, respectively." The examples use a surfactant blend including potassium laureth phosphate (¶[0116]), and Cunningham explains that the anionic surfactant "can be an alkali metal (e.g., sodium or potassium)" (¶[0088]). Cunningham's composition is "intrinsically a coacervate or coacervate-like system, as it is formed by acidifying agent protonation of a deprotonated skin agent within an aqueous liquid to produce an emulsified oil phase" (¶[0019], ¶[0032]). The formation of an emulsified oil phase through protonation of a deprotonated agent in aqueous medium is a coacervation phenomenon.
While the applicant argues that this is a "different system" than the cationic polymer/anionic surfactant coacervate of the instant invention, both systems involve the formation of a complex coacervate through electrostatic interactions. Cunningham's system inherently involves the interaction of charged species (protonated skin aesthetic agent, emulsifying agents, and surfactants) to form a coacervate-like phase. Cunningham also teaches that the composition imparts "perceivable aesthetic benefits of increased softness, quietness and drapability to the skin or hair of a user" (Abstract, ¶[0007]). These benefits inherently result from enhanced deposition of the composition's active ingredients onto the substrate (skin or hair). The fact that Cunningham does not use the exact phrase "enhance deposition" does not preclude that the claimed "amount effective to enhance deposition" is a functional limitation that is inherently met when the composition provides the aesthetic benefits described by Cunningham.
The applicant argues that Cunningham's actual exemplary composition using Cola®Moist 200 is Composition L, which allegedly lacks the claimed elements. This argument is unpersuasive. A reference's preferred or exemplary embodiments are not required meet every claim limitation. It is sufficient that the reference describes the claimed invention in general terms or in one embodiment. Cunningham's Composition L is merely one example; Cunningham's broader teaching encompasses the claimed combination.
The applicant relies on specification data indicating HBHEC alone exhibits minimal deposition, and HBHEC combined with polyquaternium-10 improves deposition and combing performance. However, the claimed composition requires both a cationic deposition polymer and an anionic surfactant to form a coacervate. The evidence has been considered but is insufficient to overcome the prima facie case.
The claims encompass any cationic deposition polymer, any amount of HBHEC, any anionic surfactant, and any rinse-off cleansing composition. The experimental evidence appears limited to polyquaternium-10, particular surfactant systems, and specific formulation compositions. The evidence directed to a single species is not commensurate in scope with broad genus claims (see MPEP §716.02(d)). Also, the comparison data do not appear to test the full claimed composition against a control lacking only HBHEC.
The specification's assertion that HBHEC "was known as a cationic humectant" and is "not polymeric" does not establish that its coacervation-enhancing properties were unexpected. HBHEC's cationic nature and high charge density would suggest to one of ordinary skill that it would interact with anionic surfactants and enhance coacervate formation. Moreover, the prior art has recognized that "[t]he combination of polymers and surfactants is an important means to create various functions in recent detergents and personal care products" and that "detergents mixing oppositely charged anionic surfactants and cationic polymers induce coacervation by the dilution of the washing and rinsing process" .
In addition, the specification provides performance comparisons but does not establish statistical significance across the claimed breadth. Further, because Peffly already teaches optimizing deposition through coacervate modification, improved deposition obtained by introducing an additional cationic ingredient constitutes the type of result a skilled artisan would reasonably expect from routine formulation optimization. Accordingly, the evidence presently of record is insufficient to outweigh the prima facie case of obviousness.
Claim 10, as amended, recites a method comprising "providing a hair and skin conditioning agent; adding a coacervate composition to the agent; and applying the enhanced hair and skin conditioning agent to the hair or skin." This method would have been obvious over Cunningham in view of Peffly. Cunningham teaches the use of HBHEC in personal care compositions to provide aesthetic benefits to skin and hair. Peffly teaches rinse-off shampoo coacervate systems for enhanced deposition. Combining these teachings (i.e., incorporating HBHEC into a rinse-off shampoo coacervate system) would have been obvious for the reasons stated above.
For the same reasons, dependent claims 11-20 are unpatentable over Cunningham in view of Peffly. Peffly expressly teaches rinse-off shampoo compositions. Aqueous carriers encompassing the claimed range of 60-95 wt% are taught.
Regarding new claim 21, Peffly expressly teaches polyquaternium-10, sodium laureth sulfate, and amphoteric co-surfactants including amphodiacetates in shampoo systems. Cunningham teaches HBHEC. Combining the references yields the claimed composition. Regarding new claim 22, the recited concentrations approximately 0.5 wt% polyquaternium-10, and approximately 2 wt% HBHEC active represent optimization of known result-effective variables. No evidence establishes criticality for these values (see MPEP §2144.05 and In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)). Regarding new claim 23, citric acid adjustment to approximately pH 6 is a conventional personal-care formulation practice. Both Cunningham and Peffly teach pH adjustment and aqueous formulation systems. Selection of pH 6 would have been an obvious matter of routine optimization.
Conclusion
No claims are allowed.
The 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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