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 .
Claims Status
Claims 1-19 are pending and under current examination in this application.
Amendments to the Claims filed 24 October 2023 are acknowledged. Claims 1-15 have been amended and new claims 16-19 have been added and are supported by the original disclosure.
Claim Objections
Claims 1, 2, 14 and 16-19 are objected to because of the following informalities:
Claim 1 is objected to because it refers to “the concentrated cleansing composition” at the end of the claim that hasn’t previously been introduced in the claim. The Examiner believes this may be an editing error and is intended to read “the concentrated surfactant composition” and has evaluated the claim as such in the interest of compact prosecution. The Applicant is advised to amend the claim to change the wording to be consistent with the reference wording at the beginning of the claim to avoid formal rejection.
Claim 2 is objected to because it contains a typographical error as, “20%I by weight”. The Applicant is advised to amend the claim to remove the extraneous “l” after the “%”.
Claim 14 is objected to because it contains a typographical error as, “c t recovering the end-use cleansing composition”. The Applicant is advised to amend the claim to “c) recovering the end-use cleansing composition”.
Claims 16-19 are objected to for improperly stating the dependency as, “the end-use cleansing composition according to claim to 14 wherein…”, by typographical error. The Applicant is advised to amend the claims to correct the dependency to, “the end-use cleansing composition according to claim 14 wherein…”, removing the extraneous “to”. Claim 17 also refers to the “the structurant”, whereas it should be referred to as “the structuring agent” to be consistent with the terminology used in claim 1 in which it ultimately depends.
Claim 19 is also objected to for the grammatical error, “…wherein the end-use composition comprises has less than 0.15% by weight oil.”. The Applicant is advised to amend the claim to state, “wherein the end-use composition comprises less than 0.15% by weight oil.” and remove the extraneous “has”.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12 and 14-19 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the full scope of the invention without requiring undue experimentation, which is/are critical or essential to the practice of the invention but not included in the claims (see In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976)).
Claim 12 claims a hydratable concentrated surfactant composition comprising an anionic surfactant from 35-100% by weight taurate based on the total weight of the anionic surfactant and wherein less than 0.0075% by weight of the anionic surfactant is an isethionate, an amphoteric and/or zwitterionic surfactant, a C6-C14 acid, C6-C14 alcohol and/or C6-C14 amide, from 40-70% by weight water, and a structuring agent; wherein the concentrated surfactant composition has <1% by weight sulfate comprising surfactants, the pH is from 4.5-7.5, the viscosity is from 250-3500 cps and the viscosity increases when diluted with water.
Claim 14 claims a method for making an end-use cleansing composition comprising the steps of: (a) combining with water a hydratable concentrated surfactant composition comprising an anionic surfactant from 35-100% by weight taurate based on the total weight of the anionic surfactant and wherein less than 0.0075% by weight of the anionic surfactant is an isethionate, an amphoteric and/or zwitterionic surfactant, a C6-C14 acid, C6-C14 alcohol and/or C6-C14 amide, from 30-85% by weight water, and a structuring agent; wherein the concentrated surfactant composition has <1% by weight sulfate comprising surfactants, the pH is from 4.5-9; (b) agitating and/or shearing the mixture; and (c) recovering the end-use cleansing composition. Wherein, the hydratable concentrated surfactant composition viscosity increases when diluted with water (the end-use composition).
Claim 15 add the limitations of claim 14 by specifying the amphoteric and/or zwitterionic surfactant specifically as a zwitterionic betaine surfactant. Claim 16 requires the limitations of claim 14 to also include that the end-use cleansing composition has a pH from 4.8-7, a viscosity from 1000-20,000 cps, and comprises a humectant and a preservative. Claim 17 requires the limitations of claim 14 to also include that the structurant [structuring agent] is specifically PEG150 pentaerythritol tetrastearate. Claim 18 requires the limitations of claim 14 to also include that the end-use cleansing composition additionally comprises 12-hydroxystearic acid, niacinamide, a resorcinol, vitamin B6, vitamin C, vitamin A, vitamin D, vitamin E, vitamin K, petroleum jelly, retinoic acid precursor, colorant, sunscreen, extract of sage, aloe vera, green tea, grapeseed, thyme, chamomile, yarrow, cucumber, liquorice, rosemary or a mixture thereof. Claim 19 requires the limitations of claim 14 to also include that the end-use cleansing composition additionally has < 0.15% by weight oil.
Thus, the claims read on any taurate anionic surfactant with any zwitterionic surfactant, any C6-C14 acid, alcohol, and/or amide, and any structuring agent, in combination with water, to achieve associative thickening across the entire, unbounded scope of these functional limitations. The scope of the claims is not commensurate with the enablement of the instant disclosure, because practice of the claimed invention would require undue experimentation by an artisan of ordinary skill in the art. The instant specification is not enabling for claims 12 and 14-19.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
In the instant case, the quantity of experimentation requires an exhaustive screening of countless possible combinations. Associative thickening depends on specific molecular interactions between surfactants, the structuring agent, and other components. The claims encompass many possible substances within a listed genera, making the number of potential combinations vast and the experimentation required to find working examples unduly extensive. The specification provides insufficient guidance or working examples to direct the skilled artisan to the full range of claimed embodiments without resorting to a research project.
The specification provides limited guidance, defined solely by functional results using generic components. The specification lacks a range of working examples encompassing the scope of the claims to direct the skilled artisan. For instance, it does not specify which "structuring agent" would be effective, even though their functionality varies greatly (e.g., HEUR, HASE, cellulosics).
The specification includes limited examples of the invention being practiced. The specification does not provide working examples for all of the claimed combinations. The specification only disclosed two examples (i.e., Example 1, Sample 1 and 2; ¶[0088]) of the hydratable concentrated surfactant composition and an example of the two hydratable concentrated surfactant composition diluted in water as the end-use cleansing composition (absent any additional constituents beyond water; Example 2; ¶[0089]). Both Sample 1 and 2 specifically use sodium lauroyl taurate as the anionic surfactant, cocamidopropyl betaine as the zwitterionic surfactant, lauric acid (C12 acid) as the C6-C14 acid, alcohol, and/or amide, Versathix (PEG 150 pentaerythritol tetrastearate) as the structuring agent and sodium chloride. No claims require the use of all these constituents, nor the combination of the betaine, PEG 150 pentaerythritol tetrastearate and sodium chloride. The formulations exemplified as Samples 1 and 2, merely support the use of the anionic surfactant as sodium lauroyl taurate alone (100%) or as a 4.435:1 mixture of sodium lauroyl taurate alone (approximately 81.6%) to sodium lauroyl glycinate (approximately 18.4%) as acceptable embodiments of the invention.
Most notably, the use of any structuring agent as claimed for the specific Versathix™ PEG 150 pentaerythritol tetrastearate structuring agent in Example 1 would be highly unpredictable and would likely result in significant changes to thickness, stability, and sensory feel of the composition. PEG 150 pentaerythritol tetrastearate is a nonionic associative structuring agent that provides pourable shear-thinning rheology and has a unique ability to thicken sulfate-free and amino-acid-based surfactant systems that is salt tolerant and stable at lower pH levels (see evidentiary reference Trulux, https://trulux.com/products/versathix/) which is not interchangeable with any structuring agent. Direct substitution with other thickeners that work through different mechanism (e.g., HEUR nonionic/hydrophobic associative structuring agents, HASE anionic associative structuring agents, cellulosics non-associative structuring agents) is not straightforward. Other thickeners may fail to build adequate viscosity in the sulfate-free/low surfactant system of the composition, may be incompatible at all pH levels within the range of 4.5-7.5 (e.g., HASE), could make the formulation unstable and cause separation or cloudiness or alter sensory properties impacting consumer perception and acceptability.
The specification examples only disclose the PEG 150 pentaerythritol tetrastearate structuring agent and does not provide a person skilled in the art with enough guidance to practice the full, claimed scope without engaging in undue experimentation. They would have to systematically test numerous structuring agents with a variety of mechanisms and compatibility restrictions to determine which combinations actually work, confirming that the claimed result (associative thickening) is not achieved across the entire broad scope of all known structuring agents. A careful and systematic approach is required rather than a simple one-to-one swap, even for other bio-derived PEG-based nonionic associative thickeners (e.g., PEG-120 methyl glucose dioleate or PEG-120 methyl glucose trioleate). Any potential substitute must be tested in your specific formulation and evaluated for associative thickening ability, viscosity, clarity, pH stability, foam quality, etc. to determine if it is compatible and suitable for substitution of PEG 150 pentaerythritol tetrastearate. Broadening the claims to any structuring agent makes the behavior of the composition highly unpredictable and is not supported by the disclosure.
Also notable is the absence of any requirement for sodium chloride or a similar salt in all of the claims, however the presence of 3% sodium chloride in the examples. It is unclear as to if compositions formulated in the absence of sodium chloride or a similar salt, which is not explicitly required by any of the claims, would be expected to cause a major or complete loss in associative thickening of the composition since the salt is critical for charge shielding the negative charges on the anionic surfactants so they can pack more closely and spherical micelle can grow into long entangled wormlike micelles to create the associative thickening viscosity increase (see evidentiary reference Yaser Chem, Xie, Mastering Detergent Formulations: The Key Role of Salt in Modulating Detergent Viscosity,19 July 2023; https://yeserchem.com/the-key-role-of-salt-in-modulating-detergent-consistency/).
A composition substituting the any taurate or taurate/glycinate mixed anionic surfactant or any acyl chain taurate or taurate/glycinate mixed anionic surfactant for sodium lauroyl taurate or a mixture of sodium lauroyl taurate with sodium lauroyl glycinate as in Example 1, as claimed, would have a significant and unpredictable impact on the compositions associative thickening, stability (e.g., precipitation, temperature sensitivity), and sensory properties (i.e., lathering). The change from a specific, known chain length from lauroyl (C12) to a broad genus of any acyl introduces a high degree of uncertainty.
The properties of surfactants, especially their ability to form the micellar structures necessary for thickening, are highly dependent on the length and structure of their hydrophobic tail. A C12 chain length provides a predictable high viscosity and strong hydrophobic association without being too insoluble- ideal for forming long, flexible wormlike micelles with cocamidopropyl betaine. Shorter chains (C6-C10) have weaker hydrophobic effects and form smaller micelles that are less effective in building the elongated entangled network required for high viscosity causing the formulation to likely be too thin an watery to produce associative thickening. Longer acyl chains (C14 and C16) have reduced water solubility and can cause crystalline structures that precipitate from solution rather than the desired fluid wormlike micelles, resulting in gel formation or unpredictable and clumpy viscosity. Thus, introducing a different chain length would disrupt the ideal packing in the micelle, potentially weakening the overall thickening structure that may result in a failure to generate associative thickening when diluted with water.
The specification examples only disclose the lauroyl (C12) species, does not provide a person skilled in the art with enough guidance to practice the full, claimed scope without engaging in undue experimentation. They would have to systematically test numerous chain lengths to determine which combinations actually work, confirming that the claimed result (associative thickening) is not achieved across the entire genus. Broadening the claims to any taurate or taurate/glycinate mixed anionic surfactant or any acyl chain taurate or taurate/glycinate mixed anionic surfactant makes the behavior of the composition highly unpredictable and is not supported by the disclosure.
A composition substituting the any broad amphoteric and/or zwitterionic surfactant or any betaine zwitterionic surfactant for cocamidopropyl betaine in Example 1 as claimed would have a significant and unpredictable impact on the compositions associative thickening, foaming, and stability. "Zwitterionic" or "amphoteric" describes a broad class of surfactants, not a set of interchangeable parts. The specific molecular structure dictates performance. Thickening efficacy varies significantly with the specific surfactant’s structure and its interaction with other formula components (see evidentiary reference Humblebeeandme; https://www.humblebeeandme.com/faqs/how-can-i-substitute-one-surfactant-for-another/).
The specification examples only disclose cocamidopropyl betaine and does not provide a person skilled in the art with enough guidance to practice the full, claimed scope without engaging in undue experimentation. They would have to systematically test numerous surfactants, even in the same specific sub-class (e.g., coco betaine, babassuamidopropyl betaine, disodium lauroampho diacetate, and sodium cocoamphoacetate) to determine true functional equivalents in the specific formulation that actually work, confirming that the claimed result (associative thickening) is not achieved across all amphoteric and/or zwitterionic surfactant or any betaine zwitterionic surfactant. It cannot be assumed that a different zwitterionic surfactant will provide the same viscosity, stability, or sensory properties without comprehensive lab testing. Broadening the claims to all amphoteric and/or zwitterionic surfactant or any betaine zwitterionic surfactant is not supported by the disclosure.
A composition substituting any claimed C6-C14 acid, C6-C14 alcohol and/or C6-C14 amide for lauric acid as in Example 1 would have a significant and unpredictable impact on the compositions associative thickening and final product properties. The specific carbon chain length and the type of functional group (acid, alcohol, or amide) are critical for the thickening mechanism. The change from a specific C12 chain length fatty acid to a broad genus of any C6-C14 acids introduces a high degree of uncertainty. Chain length critically impacts micelle formation and viscosity. Medium chains (C8-C10) may disrupt networks and reduce viscosity. Varying acids create less predictable, potentially unstable thickening compared to the specific lauric acid structure. The change from a specific C12 chain length fatty acid to a different broad genus of any C6-C14 alcohols introduces a high degree of uncertainty and would participate differently in the surfactant packing at the micelle interface. Their interaction with associative thickeners would differ from acids, altering the strength and properties of the transient network. The change from a specific C12 chain length fatty acid to a different broad genus of any C6-C14 amides introduces a high degree of uncertainty and introduces different hydrogen-bonding capabilities and polarity. This changes surface activity and interactions with thickeners, leading to different rheological effects compared to fatty acids.
The specification examples only disclose the lauric acid (C12 acid) species, does not provide a person skilled in the art with enough guidance to practice the full, claimed scope without engaging in undue experimentation. They would have to systematically test numerous chain length acids, alcohols and amides to determine which combinations actually work, confirming that the claimed result (associative thickening) is not achieved across the entire broad groups claimed. Associative thickeners function through specific hydrophobic associations, and the random inclusion of various chain lengths and functional groups would make it impossible to achieve consistent, reliable thickening without extensive experimentation for each possible combination. Salt level, surfactant ratio and structuring agent are likely to need readjustments and optimizations. Broadening the claims to any C6-C14 acid, C6-C14 alcohol and/or C6-C14 amide makes the behavior of the composition highly unpredictable and is not supported by the disclosure.
Formulations containing a pH from 7.5-9, as in some of the claims, would significantly impact the formulation because the higher pH would disrupt the anionic and zwitterionic surfactant interaction by causing a loss in optimal charge balance leading to a weakened ability to tightly pack and create the long micellar network essential for associative thickening, and would also convert the protonated lauric acid to a deprotonated soluble soap which would further disrupt the packing ability of the anionic and zwitterionic surfactant mixture rather than stabilizing the viscous micelles, leading to collapse in the viscous network. These higher pH levels would result in major or complete loss in associative thickening of the composition (see evidentiary reference Vu et al., Thickening mechanisms for an amino acid-derived surfactant composition, Colloids and Surfaces A: Physicochemical and Engineering Aspects, Volume 589,124424, ISSN 0927-7757; published 20 February 2020.). Formulations above a pH of 7.5 would be more susceptible to base hydrolysis, impacting the length of composition stability.
Formulations having a viscosity outside of the range of 250-3500 cps prior to dilution with water to generate the end-use cleansing composition with significantly impact the ability to undergo associative thickening upon dilution. A viscosity <250 cps would provide a weak or absent foundation for the formation of the long entangled wormlike micelles and dilution with water will thin the product further with no associative mechanism to counter act the thinning and behave as a simple Newtonian liquid, rather than achieving a stable thickened diluted product. An initial viscosity >3500 cps indicated an tightly structured or gelled composition which may cause loss of homogeneity, precipitation of constituents and clumping upon dilution with water or require excessive mechanical shear to mix which may damage the microstructures and cause irreversible thinning. A initial viscosity of 250-3500 cps is likely optimal for forming associative thickening upon dilution with water as the viscosity would be strong enough but still fluid and dynamic enough to reorganize upon dilution. Associative thickening is unlikely to occur as desired upon dilution with water outside of this range.
Regarding the nature of the invention, the invention resides in the unpredictable art of formulation chemistry and colloidal science. The interactions that lead to associative thickening (e.g., the association of hydrophobic end-groups with particles and themselves) are highly complex and sensitive to specific chemical structures.
Regarding the state of the prior art, the prior art teaches that these interactions are not generic, but highly specific. For example, research shows that the rheological properties of a model system change dramatically based on the specific surfactant used, indicating that results are not predictable across different components. While the search results show patents with highly specific, narrow examples (e.g., a specific HEUR thickener or a specific synthesized polymer), these do not provide a representative number of species spanning the scope of the claimed genera.
Regarding the relative skill of those in the art, while a skilled formulator would understand the general goal of associative thickening, the prior art does not provide principles that would allow them to predict which of the nearly infinite combinations of claimed components would work without extensive experimentation.
Regarding the predictability or unpredictability of the art, the art is unpredictable. Small changes in a component's chemical structure (e.g., the length of a hydrophobic chain, the nature of a hydrophilic spacer) can prevent the formation of the associative network required for thickening. Claiming "any" component within the listed classes ignores this fundamental unpredictability. Outcomes are largely unforeseeable without experimentation of specific combinations.
Lastly, The claims are exceptionally broad, covering all possible members of multiple genera (e.g., "any taurate," "any zwitterionic surfactant," "any structuring agent") to achieve a complex physical result (associative thickening). The specification's disclosure is not commensurate with this vast scope for reasons mentioned above.
Thus, based on the analysis above the conclusion that the claims are not enabled is inescapable.
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 14-19, 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 14 is rejected for lacking clarity on what constitutes “recovered” in “recovering the end-use cleansing composition”. The term "recovered" in the claim introduces ambiguity as to the claimed feature, which is not further clarified in the Specification. Claims must distinctly set forth the subject matter regarded as the invention, and the scope of what is intended as “recovering the end-use cleansing composition” is unclear. See Halliburton Energy Servs., Inc. v. M-I LLC (Fed. Cir. 2007), which emphasized that claim language must provide reasonable certainty to the public.
To overcome this rejection, the Applicant should clarify and explicitly list all intended claim elements or replace "recovering" with a word that allays the ambiguity. Alternatively, the Applicant may amend the Specification to clearly define which elements are intended by “recovering”.
Dependent claims 15-19 are included in this rejection because they do not cure the defect noted above.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 depends from claim 1 and recites “The hydratable concentrated surfactant composition according to claim 1, wherein the composition comprises sodium benzoate.” However, claim 1 does not recite or include sodium benzoate as a component of the composition. Therefore, the limitation in claim 8 introduces a new element not present in the base claim and does not further limit the subject matter of claim 1, rendering the dependency improper. When a dependent claim improperly introduces a new element (here, “sodium benzoate”) using “comprises” rather than “further comprises”, this is a § 112(d) improper dependent claim objection, consistent with MPEP §§ 608.01(n) and 714.
Applicant is advised to amend the claim and rewrite it o properly depend from claim 1 by reciting, for example: “The hydratable concentrated surfactant composition according to claim 1, wherein the composition further comprises sodium benzoate.” Upon correction of this dependency error, claim 8 will be in proper form for examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-19 are rejected under 35 U.S.C. § 103 as being unpatentable over Kiplinger et al. (WO2015179599A1; published 2015-11-26, hereinafter referred to as “Kiplinger”) in view of Macaulay et al. (US20050043194A1; published 2005-02-24, hereinafter referred to as “Macaulay”) and in further view of Gloor et al. (US5192462A; published 1993-03-09, hereinafter referred to as “Gloor”).
Kiplinger teaches a sulfate-free hydratable personal care composition (claim 1 and ¶[0065], Abstract) including an anionic surfactant (2% Sodium Cocoyl Glycinate), a zwitterionic surfactant (8% wt. Lauramidopropyl Betaine), a C6-C14 acid (Laurie [Lauric] Acid; C12), a structuring agent (PEG 150 Distearate), a preservative, fragrance and water, absent any isethionate or oil in Example 2 (¶[0080]). All of the formulations in Kiplinger’s examples (¶[0073]-[0091]) are isethionate and oil free, thus remaining so in an end-use composition such as a cleanser or shampoo (¶[0071]), which merely adds additional water to the hydratable concentrated surfactant composition.
Examples 4 and 5 use 71.2% and 71.0% water by weight, respectively (¶[0087]-[0091]), encompassed within the range of instant claim 1 and 9. Example formulations 1-5 have pH levels of 6.7, 6.8, 6.5, 6.4 and 6.98, respectively, and Example 2 and 5 formulations have viscosities of 2800 CPS and 2520 CPS, respectively (¶[0076]- [0091]), which are encompassed within the range of the instant claims. The end-use composition pH range when diluted with water would remain within the instant claim range, which is typical for the art and achieved through routine experimental formulation optimization as well as the claimed end-use composition viscosity range.
Regarding the instant claim 8 and 16 limitation requiring sodium benzoate, Kiplinger teaches the addition of preservatives (¶[0069]), wherein selecting the specific preservative known it the art to be as sodium benzoate commonly used in the formulation of personal care compositions (see instant Specification ¶[0073] of preferred preservatives) is obvious. It is recognized in that art that certain commonly used preservatives in personal care formulation are more suitable/compatible for use in formulations within specific pH ranges, however Applicant has not provided support indicating that the specific use of sodium benzoate over other commonly used preservatives in personal care formulations (e.g., other preservatives listed in the instant Specification ¶[0073]) would produce an unexpected result.
Kiplinger teaches wherein the invention further comprises one or more benefiting agents including resorcinol and the humectants castor oil, lanolin and propylene glycol esters (¶[0066]). Acceptable anionic surfactants include taurates, wherein commonly used sulfate free anionic surfactants that are suitable as the anionic surfactant component of the composition of the present invention includes the acyl taurate sodium methyl cocoyl taurate, which can be used in the alternative for the acyl glycinate sodium cocoyl glycinate (¶[0049]) used in the Example formulations 1-5 (¶[0076]- [0091]).
Kiplinger teaches an end-use cleansing composition comprising dilution in water (¶[0065]), wherein the invention is directed towards personal care compositions such as body washes, shampoos, hand soaps (¶[0002]) used as "cleansing compositions"-compositions aimed to the washing/cleaning, more typically a body-care application, including but not limited to body wash, shower gel, liquid hand soap, shampoo or the like (¶[0026]). Although Kiplinger does not explicitly describe a method comprising the steps of combining the hydratable concentrated surfactant composition with water, agitating and/or shearing the mixture, and recovering an end-use cleansing composition, such method steps obvious in view of the express disclosure that the composition is formulated for use as a shampoo or cleanser.
The claimed method differs from Kiplinger only in explicitly reciting the routine handling and conventional steps of dilution and agitation that would naturally occur when employing a body wash, shampoo or hand soap for cleansing with the composition. The art also recognizes that agitation or shear is required to disperse concentrated surfactants into water when use as compositions for cleansing. Thus, it would be obvious to one of ordinary skill in the art at the time the invention to combine a body wash, shampoo or hand soap with water during application to the skin or hair, followed by agitation during use, in order to prepare the end-use cleansing composition. The Applicant’s claimed steps (combining concentrate with water, mixing, recovering a cleanser) are the expected results of the known hydratable surfactant composition being used as intended (see In re Spada, 911 F.2d 705 (Fed. Cir. 1990)).
However, Kiplinger’s does not explicitly teach the range of anionic surfactant (3-20% wt.) required by the limitation of instant claim 2, rather teaches the use of a slightly lower level of 2% anionic surfactant in Example 2 (¶[0080]), nor the composition comprising 40-70% by weight water, as required by the limitation of instant claim 10.
Macaulay teaches single phase dilution thickening cleansing compositions with the use of the use of associative thickeners and anionic surfactant at a concentration range of 5-30% by wt. of the total composition (¶[0044]), thus overlapping and encompassing most of the instant claimed range. The combined teachings of Kiplinger and Macaulay would render the use of an anionic surfactant range of 2-30% wt. obvious, entirely encompassing the range of instant claim 2. The specific use level within the range disclosed by the prior art would be a matter of routine experimental optimization. Further, Macaulay teaches the use of water in the range of 45-95% by wt. of the total composition (claim 1), wherein the water in the example formulation is calculate to be 61% (¶[0107]), encompassed within the instant claim 10 range.
Kiplinger teaches the use of the structuring agent/associative thickener PEG 150 distearate (¶[0027]), however does not teach wherein the structuring agent comprises PEG150 pentaerythritol tetrastearate, as required by the limitations of instant claims 7 and 17.
Gloor teaches the use of the structuring agent PEG-150 pentaerythritol tetrastearate as a thickening agent for formulating shampoos (claim 6), thus it would be obvious to substitute a known structurally similar and functionally equivalent ester-based thickener such as the PEG-150 pentaerythritol tetrastearate taught by Gloor, for that of the PEG 150 distearate taught by Kiplinger. Moreover, Gloor provides the motivation to do so in that, “Specific viscosity modifying agents used in shampoo compositions have included PPG-5-Ceteth-20, and particularly, PEG 150 Distearate (aka. PEG 6000 Distearate), available from Witco. These agents distinguish themselves from other classes of cosmetic thickening agents by their low reactivity, low toxicity and usefulness over a broad pH range. These thickening agents are, however, linear in secondary structure and are able to fold over upon themselves thereby limiting their tendency to behave in a manner characteristic of long chain polymers. In addition, PEG 6000 Distearate is difficult to manufacture, often forming molecules having a different structure from batch to batch, i.e., containing free stearic acid, distearates and monostearates.” (Specification page 1, column 1, paragraph 5) and by the direct comparison of PEG 6000 Distearate [PEG 150 distearate] and PEG 150 pentaerythritol tetrastearate in Drawing Fig 2-4, showing superior viscosity enhancement/thickening efficiency with PEG 150 pentaerythritol tetrastearate.
Regarding the limitation of instant claims 12 and 14, wherein the viscosity of the concentrated surfactant composition increases when diluted with water, Kiplinger teaches thickening compositions using agents like PEG 150 distearate and fatty acids (¶[0027]) with the optional addition of one or more electrolytes (¶[0051]). Kiplinger does not explicitly teach that the composition increases viscosity upon dilution.
Macaulay expressly discloses liquid compositions which thicken upon dilution, using electrolyte and associative thickener (Abstract, claim 1, and background context in ¶[0004]-[0006]; Figure 3 and description thereof in ¶[0033]), which can include N-acyl methyl taurates as an anionic surfactant (¶[0045]) from 5-30% wt. the total composition (¶[0044]), overlapping with the instant claim 2 range.
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 electrolyte and extended anionic surfactant range and water concentration range taught by Macaulay in the invention of Kiplinger for a concentrated surfactant composition that increases viscosity when diluted in water and also substitute the known structurant PEG-150 pentaerythritol tetrastearate (as taught by Gloor) for the similar PEG-150 distearate thickener used by Kiplinger. One of ordinary skill in this art would possess knowledge of surfactant chemistry, personal care formulation, and the functional properties of common ingredients like thickeners, preservatives, and skin benefit agents rendering all the claimed features obvious by combining Kiplinger with the dilution-thickening of Macaulay and substituting the structurant of Gloor in order to achieve conventional structuring and viscosity properties, as taught by the prior art. One would be motivated to do so with a reasonable expectation of success because it was known in the art to be used for the same purpose of developing thicken and structure surfactant-based shampoo or liquid soap compositions, providing desirable rheological properties and improved stability.
Claim Rejections – Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
Claim 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12 and 14 of co-pending U.S. Patent Application Nos. 18/572,036 (hereinafter referred to as the “’036 application”) and claims 1-4 and 6 of 18/572,059 (hereinafter referred to as the “’059 application”). Although the claims at issue are not identical, they are not patentably distinct from each as outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant application independent claim 1 is directed to a hydratable concentrated surfactant composition comprising: (a) an anionic surfactant, (b) an amphoteric and/or zwitterionic surfactant, (c) a C6–C14 acid, alcohol, or amide, (d) 30–85 wt% water, and (e) a structuring agent; wherein the composition contains <0.0075 wt% isethionate, <1 wt% sulfate surfactant, 35–100 wt% taurate (based on anionic fraction), and has pH 4.5–9; with dependent claims specifying taurate/glycinate mixtures, PEG-150 pentaerythritol tetrastearate, 12-hydroxystearic acid, niacinamide, and viscosity increases upon dilution, as well as method claims for reconstitution and end-use cleansing composition preparation.
Claims 1-10, 12 and 14 of the ’036 application are directed to a concentrated surfactant composition comprising anionic taurate and glycinate surfactants, amphoteric surfactants (e.g., betaines), fatty acid/alcohol components (C8–C14), 35–80 wt% water, and structuring agents such as PEG-150 pentaerythritol tetrastearate, with the composition being free of isethionate, substantially free of sulfate, and hydratable to form a cleansing composition of higher viscosity upon dilution, and further optional ingredients including niacinamide, resorcinol, and 12-hydroxystearic acid.
Claims 1-4 and 6 of the ’059 application are directed to a hydratable concentrated surfactant bases comprising anionic taurate and/or glycinate surfactants, amphoteric surfactants, C6–C14 fatty acids or alcohols, 30–80 wt% water, and a structuring agent, explicitly including PEG-150 pentaerythritol tetrastearate, and compositions that are substantially sulfate-free and isethionate-free, having viscosity 50–10,000 cps, pH 4.5–8.5, and exhibiting increased viscosity upon dilution, further containing preservatives (sodium benzoate) and vitamin actives. These compositions and methods of reconstitution are not patentably distinct from those of the instant claims.
The instant application and the ’036 and ’059 applications claim hydratable, sulfate-free, taurate-based surfactant concentrates that employ similar surfactant systems (taurate/glycinate + betaine), utilize PEG-150 pentaerythritol tetrastearate as a structuring agent, include C6–C14 fatty materials (fatty acids, alcohols, amides), have 30–85% water, pH 4.5–9, and viscosity increase upon dilution, and optionally contain niacinamide, resorcinol, or 12-hydroxystearic acid.
The only apparent differences in scope between the instant claims and those of the ’036 and ’059 applications are minor variations in compositional ranges or optional ingredients (e.g., preservatives, actives, viscosity limits). Accordingly, the subject matter of the instant claims is not patentably distinct from that claimed in the ’036 and ’059 applications.
This rejection may be overcome by filing a terminal disclaimer in compliance with 37 CFR § 1.321(c), which would disclaim any portion of the term of a patent granted on this application extending beyond the term of the patent(s) issuing from the ’036 or ’059 applications, and agree that the patents shall be commonly owned.
Conclusion
No claims are allowed.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615