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
The listing of claims filed 29 April 2024, have been examined. Claims 1, 2, 5-8, 10, 11, 15, 16, 22, 24, 26-30, 32 and 33 are pending. Claims 3, 4, 9, 12-14, 17-21, 23, 25 and 31 have been canceled.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 recites “butylated (BHA)”. The term is incomplete. BHA stands for butylated hydroxyanisole and the claim should be amended to “butylated hydroxyanisole (BHA)”.
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 10, 11, 22, 26-33 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.
The emollient composition of claim 1 is defined in the specification as “wherein the emollient composition includes an edible solid fat, an edible liquid fat, or combinations thereof. As used herein, the terms “edible solid fat”, “edible liquid fat”, or “edible oil” refer to a fat or oil that is suitable for human consumption.” (¶[0047]), therefore claim 10 restates the scope of protection of claim 1, as defined by the specification to require the components of claim 10. The redundancy between the claim language in view of the definition in the specification creates confusion making the scope of the claims unclear. To overcome this rejection, the applicant is advised to amend the claims to cancel claim 10 or amend claim 10 to add a further non-redundant limitation. Dependent claim 11 is included in this rejection as it does not cure the defect noted for claim 10, from which it depends.
Claims 22 and 32 recite a cone penetration of about 90 mm to about 140 mm, however the specification indicates a cosmetic deodorant stick formulation (¶[0036]), wherein, “The deodorant composition as described herein in any aspect can be in a solid form. As such, the deodorant composition as described herein exhibits good structural hardness such that the deodorant maintains a desirable stick shape. In any aspect disclosed herein, the deodorant composition may have a cone penetration of about 90 mm to about 140 mm…as measured according to ASTM D 937-97 (Reapproved 2002). In certain aspects, the deodorant composition as described herein can be formulated as a solid deodorant stick.” (¶[0059]). A composition having a cone penetration measurement of 90-140 mm as measured according to ASTM D 937-97 would be consistent with a very runny gel or liquid, and would be so soft it would be unsuitable for a stick deodorant format because it would not have the structural integrity required, whereas 90-140 mm/10 (tenths of a millimeter; i.e., 9-14 mm) would be consistent with a medium to medium-soft hardness stick deodorant that is firm enough to stand in a container while soft enough to provide a smooth glide application. To overcome this rejection, the applicant is advised to amend the claims to provide the correct unit of measure. Appropriate correction of the Drawings and Specification should be made as well to be consistent with the claim and reflect the proper units of measure (i.e., mm/10).
Claims 26 and 33 recite that the composition “exhibits one or more improved functional properties comprising excellent processability, good pay-off, easy spreadability, improved skin feel.” These terms are subjective, relative, and lack objective boundaries or standardized test methods. What is considered “excellent” processability and “easy” spreadability are not defined as quantifiable metrics. A “good pay-off” is described as wherein the product when applied onto skin will deposit a thin layer on the skin (¶[0035]), however a standard application amount and the layer thickness that is considered thin is not provided and a quantifiable metric for “good”. The desired pay-off is also described in ¶[0074] as obtaining a good film when the product is applied/rubbed on the skin, however it is not clear what would be considered a “good” film. Skin feel is described as non-sticky/tacky in ¶[0032], ¶[0036], and ¶[0037], and improved skin feel is described as “such as improved non-sticky, non-tacky skin feel” in ¶[0061], however what “improved” is relative to is not described (a baseline for “improved”). Objective test methods for evaluating these properties or data to define these properties have not been provided. A mere recitation of a desired result is not a sufficient description of the invention (see In re Wolfensperger, 302 F. App'x 917 (Fed. Cir. 2008)). Thus, the scope of the claims is not reasonably certain.
Claim 27, depending from claim 1, lacks proper antecedent basis for “the hydroxypropyl starch”. Claim 1 recites "a hydroxypropylated starch", wherein claim 27 attempts to narrow "the hydroxypropyl starch", however, no "hydroxypropyl starch" is recited in claim 1, "hydroxypropylated starch" used in claim 1 is a different term. While often used interchangeably in the art, failing to use the exact same term to match the antecedent can create confusion. TO overcome this rejection, the applicant is advised to amend the claim to recite proper antecedent basis (e.g., "The deodorant of claim 1, wherein the hydroxypropylated starch is a hydroxypropyl starch phosphate.").
Regarding claim 28, the phrase "stabilized cosmetic deodorant" is indefinite. The specification does not define what property is being stabilized. For instance, it is not clear if "stabilized" refers to emulsion stability, microbial stability, thermal stability (e.g., resistance to melting), or rheological stability over time. The term is purely subjective without a clear metric or definition provided in the specification. Dependent claims 29-33 are included in this rejection as well as they do not remedy the defect.
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, 2, 5-8, 10, 11, 15, 16, 24, 26-30 and 33 are rejected under 35 U.S.C. § 103 as being unpatentable over Workman and Ratnikova (CA-2495129-A1; published 24 July 2006, hereinafter referred to as “Workman”) in view of Belhaj and Ollagnier (WO-2020190697-A1; published 24 September 2020, hereinafter referred to as “Belhaj”).
Workman teaches a natural-based deodorant composition suitable for application onto the skin, primarily free of ethoxylates or other petrochemical derivatives (Abstract; claim 1), wherein the composition comprises a carrageenan gelling agent, water, and a glycerin(e) humectant/emollient (¶[0015]). Texturizing agents disclosed in the invention by Workman includes optional texturizers of tara, guar, xanthan, Arabic, tragacanth, agar, locust bean gum, ghatti and microcrystalline celluloses (claim 1) and functional texturizers sodium stearate, soapnut, larch and rice bran extracts (¶[0016]), wherein one or more of sodium stearate is used at a concentration from about 0.1-10%, soapnut at a concentration of from about 0.001-10%, rice bran extract from about 0.001-0.5% or larch arabinogalactan at a concentration from about 0.1- 5% (claim 2).
The carrageenan gelling agent/thickener is noted to be used in the prior art (“'702 patent”, referring to US-6312702-B2) at ≥ 2% (¶[0010]), and at <2% (claim 1) and 0.6-2% in stick deodorant embodiments (¶[0017]), thus teaching a range encompassing 0.5-2.5% kappa carrageenan as per the limitation of instant claim 1 and the sub-range specified in instant claim 8, wherein the specific selection of the ranges in instant claims 1 and 8 are obvious as a matter of routine experimental optimization. Workman teaches the emollient glycerine is present from about 3-30% in roll-on embodiments, flowable gels from about 5-30%, creams and lotions from about 1-20%, and solid stick embodiments from about 15-55% (¶[0027]), wherein water is also present, encompassing the water and emollient limitations of instant claim 1.
Workman Example 1 lists embodiments of the invention comprising 5% wt/wt sodium stearate texturizer, 0.5% wt/wt kappa carrageenan, 35% wt/wt glycerine emollient, and 50% wt/wt water (pages 16-17, ¶[0033]-[0035]), meeting the compositional weigh range limitations of instant claim 1. Example 7 comprises 6% wt/wt sodium stearate texturizer (page 19, ¶[0041]), meeting the limitation of instant claim 2.
Workman however, does not disclose wherein the texturizer is specifically a n-octenyl succinate anhydride (nOSA) modified starch and a hydroxypropylated (HP) starch at a ratio of about 3:1-20:1.
Belhaj teaches topical cosmetic formulations including deodorants (¶[0024]) comprising a 2-10% concentration of a starch component that includes an nOSA starch and an HP starch at a ratio between 3:1-20:1 (claim 1), to achieve stable formulations with desirable sensory characteristics (¶[0001] and [0002]), encompassing this specific limitation in instant claim 1 and the instant claim 2 and 5 sub-ranges, wherein selection of the specific sub-ranges are an obvious optimization of a result-effective variable. Further Belhaj provides working Example 1 with ratios of 80:20 and 75:25 (¶[0034]), which fall within the claimed sub-range of about 3:1 to about 10:1.
In addition, Belha teaches that the starch blend may optionally include additional texturizers, such as carrageenan, typically present in an amount of 0.1-7% and preferably from 0.5-5% (¶[0033]). Belhaj also teaches that nOSA starch is modified by partial substitution "from about 0.1% to about 3%" with n-octenyl succinic anhydride (¶[0009]) and a blend wherein nOSA is present in an amount of 75-95% of the blend (¶[0032]), directly matching the limitations of instant claims 6 and 7. The hydroxypropyl starch taught by Belha is a hydroxypropyl starch phosphate (¶[0032]), thus teaching the limitation of instant claim 27.
One of ordinary skill in the art, seeking to improve the texture, stability, and sensory properties of the natural deodorant composition of Workman, would have been motivated by the teachings of Belhaj to substitute the superior texturizing system of a specific nOSA/HP starch blend at a ratio of 3-20:1 taught by Belhaj, explicitly described as solving the problem of greasiness in high-oil formulations and providing desirable spreadability and skin feel (¶[0002] and ¶[0028]), to achieve these predictable and desirable improvements in texture and sensory characteristics for the conventional texturizers used by Workman. The 2-10% concentration ranges taught by the Belhaj are directly applicable to the formulation of Workman.
Regarding the gelling agent, Workman teaches the use of carrageenan and specifically kappa-carrageenan, the instant claimed range of about 0.5-2.5 wt% is taught directly by the combination of the invention of Workman (less than 2%; claim 1) and by Workman’s reference to the prior art “'702 Patent” (US-6312702-B2 by Roulier and Quemin, published 06 November 2001) teaching a gelling system comprising at least 2% kappa-carrageenan (see “'702 Patent” US-6312702-B2 by Roulier and Quemin claim 2, claiming compositions comprising 2-15% kappa-carrageenan based on the total weight of the composition) as, “The hydrophilic gelling system taught in the '702 patent consists essentially of a combination of at least 2% kappa-carrageenan, relative to the total weight of the composition.” (¶[0010]). One of ordinary skill would have been motivated to incorporate the kappa-carrageenan gelling system taught by the “'702 Patent” into the Workman formulation to ensure the final product had the requisite solidity, stability, and non-greasy application properties for a deodorant stick.
Workman does not explicitly teach wherein the emollient composition comprises an edible solid fat, an edible liquid fat, or combinations thereof. Workman does teach the inclusion of liquid rosewood, lavender, litsea cubeba (mountain pepper), lemon, lime, orange, petitgrain (bitter orange), geranium, and lemongrass which are used in small quantities as flavoring agents in food and beverages (edible) at a combined concentration of from about 0.1-20% (claims 4 and 5), which under the broadest reasonable interpretation could be considered included as “a fat or oil that is suitable for human consumption” under the instant specification definition (¶[0047]).
Closer matching the overall teachings of the instant specification (e.g., typically compositions including triacylglycerols), Belha teaches, an oil phase comprising edible solid fat emollients (preferably coconut oil, more preferably cocoa butter) and an edible liquid vegetable oil emollient (e.g., almond oil) (¶[0017]), thus encompassing the limitation of instant claim 10. Belha teaches most preferably, the oil phase contains caprylic/capric acid triglycerides, cocoa butter and a vegetable oil of different triglycerides, e.g. almond oil (¶[0017]), and lists “caprylic/capric acid triglycerides, such as those sold by Stearineries Dubois or those sold under the names Miglyol 810, 812 and 818 by Dynamit Nobel” as suitable fat emollients (¶[0016]), wherein the Miglyol 810 and 812 emollients are a mixture of caprylic (C8; liquid at room temperature) and capric (C10; solid at room temperature) triglycerides differing in the C8 to C10 ratio (see evidentiary reference Sasol Miglyol Product Information Sheet, page 3, Individual Descriptions MIGLYOL 810/812). Miglyol 810 has a C10 solid to C8 liquid proportion of 20-35% to 65-80% (approximately 1:2.29-1:3.25 ratio) and Miglyol 812 has a C10 solid to C8 liquid proportion of 30-45% to 50-65% (approximately 1:1.44-1:67 ratio; see evidentiary reference Sasol Miglyol Product Information Sheet, page 2, Composition of fatty acids table for “810” and “812”). Miglyol 810 and 812 ratio range of 1:1.44-3.25 very strongly match the about 1:1-3 ratio recited in instant claim 11 and the choosing the specific ratio of the instant claim is an obvious optimization as a matter of routine experimentation for one of skilled in the art seeking to achieve a desired melt point and consistency.
Thus, Workman teaches glycerine as an emollient and Belha teaches the use of a wide variety of oils, including edible vegetable oils and fats such as coconut oil, almond oil, and cocoa butter at a ratio range of solid to liquid consistent with the instant claimed range. One of ordinary skill would have found it obvious to substitute the emollient system described by Belha for the glycerine described by Workman as they both serve the same purpose of offering emollient properties to the formulations. Selecting from known edible solid and liquid fats, as taught by Belha, to modify the sensory feel and hardness of the deodorant stick, notoriously well-known in the art for this purpose would have been obvious to one of ordinary skill in the art.
Consequently, it would have been obvious would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to modify the deodorant composition of Workman by replacing its conventional texturizer with the specific nOSA/HP starch blend taught by Belha at the disclosed ratio and concentration, incorporate the kappa-carrageenan-based gelling system taught by the “'702 Patent” at an effective concentration ranging from that of the Workman invention (up to 2%) to that of the “'702 Patent” (over 2% to 2.5%), and selecting from the known emollients disclosed by Belha. One of skill would have had a reasonable expectation of success in combining these known elements, as each component is a known formulation tool, to yield predictable results of achieving a stable, natural-based deodorant with improved textural and sensory properties.
Both Workman and Belha teach the optional inclusion of various additives, including thickeners, humectants, antioxidants, fragrances, and plant extracts (Workman, ¶[0016] and ¶[0028]; Belha, ¶[0020] and ¶[0029]), encompassing the limitation of instant claim 15.
Workman teaches deodorant compositions comprising one or more of sodium stearate, potassium stearate or calcium stearate, each at a concentration of from about 0.1% to about 10% (claim 2), at least one of glycerine and sorbitol (claim 1), antioxidants and vitamins (claim 16), optionally leaves, powder or liquid extracts of green tea, white tea, and/or rooibos tea (¶[0017]) inherently containing antioxidants, and wherein Examples 1-4 and 6 (¶[0033-[0040]) also provide embodiments of the invention that include Bio-citrus (see ¶[0025]) and natural plant extracts inherently containing antioxidants, mineral salts (¶[0016]) and extracts derived from seeds (¶[0022]), wherein plant seeds inherently contain phytic acid and sodium phytate is the sodium salt thereof. Thus, at least one of the ingredients listed in instant claims 16 and 29 are included in the teachings of Workman and furthermore, the list of thickeners, humectants, antioxidants and chelating agents recited by instant claim 16 are well-known conventional additives in the cosmetic art.
Workman teaches the addition of sodium bicarbonate in Example 2 (¶[0036]), that it is known in the art to include bacteriostatic agent such as triclosan and quaternary ammonium compounds in deodorant formulations (¶[0005]), and aluminum or aluminum/zirconium salt (¶[0003]), thus teaching the limitations of instant claims 24 and 30. Workman also teaches the use of carrageenans in her invention to achieve improved application of deodorant sticks and gels, impart a non-greasy skin feel and reduce whitening similar to volatile silicone compounds (¶[0009]), thus meeting the limitation of instant claims 26 and 33.
Regarding instant claim 28, the method of preparing a stabilized deodorant composition is rendered obvious by the combination of the references. Workman teaches a basic method of mixing and heating water phase ingredients to 80°C and reducing to approximately 60°C to 65°C when combining ingredients thereafter (¶[0031]). Belha teaches a detailed method for preparing an emulsion using the starch blend (a nOSA and hydroxypropylated starch at a weight ratio of about 3-20:1, as described previously above), involving preparing a first mixture (aqueous phase with texturizer), a starch-oil premix, and a second mixture (remaining oil), followed by combining them under mixing (¶[0034]). One of ordinary skill would have combined these known process steps to arrive at the claimed method.
Claims 1, 22, 28 and 32 are rejected under 35 U.S.C. § 103 as being unpatentable over Workman and Ratnikova (CA-2495129-A1; published 24 July 2006, hereinafter referred to as “Workman”) in view of Belhaj and Ollagnier (WO-2020190697-A1; published 24 September 2020, hereinafter referred to as “Belhaj”) and in further view of Arora et al. (WO-2020152224-A1; published 30 July 2020, herein after referred to as “Arora”).
Workman and Belhaj teach the limitations of instant claims 1 and 28, as described above, from which instant claims 22 and 32 depend, however does not explicitly teach the specific limitations of instant claims 22 and 32.
Workman teaches deodorant compositions including stick (¶[0017]), cream (¶[0018]), lotion (¶[0019]), flowable gel (¶[0020]), and spray or roll-on (¶[0021]) formulations that are adjusted to the desired hardness or softness in given embodiments by adjusting thickeners and emulsifiers as, “…one or more thickeners or gums selected from the group consisting of tara, guar, xanthan, Arabic, tragacanth, agar, locust bean gum, ghatti and microcrystalline celluloses. Sodium stearate, soapnut, larch and rice bran extracts function as emulsifiers and also control hardness and texture…” (¶[0016]) and, “Varying viscosities are achieved by combining the glycerine, water and carrageenan in the following weight/weight ratios…” (¶[0027]). Thus, Workman indicates that the hardness/softness of a formulation is a matter of routine adjustment of ratio of thickeners and emulsifiers to liquid carriers and emollients in the formulation and adjusting the hardness of a formulation to the instant claimed cone penetration value is a matter routine experimentation, wherein the specific instant claimed range of about 90-140 mm would have been an obvious choice for one of skill in the art given that is a desirable hardness range for stick deodorants, as evidence of desirable hardness ranges indicated by Sturgis and Britt in US-20190000747-A1, published 03 January 2019.
US-20190000747-A1 is directed towards more natural, aluminum-free, mostly silicone-free deodorant sticks that are not that is not too hard (¶[0003]-[0004]), wherein the Abstract clearly states an ideal hardness for such a stick is from about 80 mm*10 to about 140 mm*10, as measured by ASTM D1321 needle penetration (subjectively a soft to medium-soft stick). ASTM D937-97 is a closely related standard test to that of ASTM D1321 in the prior art. Both ASTM D937-97 (cone shaped probe) and ASTM D1321 (needle shaped probe) standards are direct proxies for consistency/hardness of semi-solid formulations via measuring penetration depth under load.
Arora teaches deodorant stick compositions has a hardness of ≥600-gram force (claim 8), measured via cone penetration, as “The deodorant stick preferably has a hardness of at least 600 gram force, most typically from 600 gram force [medium-soft to medium hardness stick] to 5000 gram force [very hard stick], preferably from 750 gram force to 2000 gram force, more preferably from 800 gram force [medium hardness stick] to 1400 gram force [hard stick]. This enables the stick to withstand the lateral forces encountered when it is topically applied. More particularly, it enables the stick to stay attached to its retaining member during such use. Herein, the term "hardness" relates to how much force is required to move a penetration cone a specified distance and at a controlled rate into a deodorant stick composition under the following test conditions. Values are measured at 27°C, 15% relative humidity, using a TA-XT2 Texture Analyzer, available from Texture Technology Corp., Scarsdale, NY., USA. The product hardness value represents the peak force required to move a standard 45° angle penetration cone through the composition for a distance of 10 mm at a rate of 2 mm/second. The standard cone is available from Texture Technology Corp. , as part number TA-15, and has a total cone length of about 24.7 mm, angled cone length of about 18.3 mm, a maximum diameter of the angled surface of the cone of about 15.5 mm. The cone is a smooth, stainless steel construction and weighs 17. 8 grams.” (page 4, line 26-page 5, line 7; variant of the standard ASTM D937 cone penetration test).
A 600-gram force to penetrate 10 mm deodorant measured via the method described by Arora indicates a subjectively medium-soft to medium hardness stick, which would likely range from about 120-160 mm using the ASTM D937 cone penetration test with 150 g load (given the instant specification Example 4 description of cone penetration evaluation in ¶[0081]-[0095]), with the preferable 800–1400-gram force range indicating a medium to hard stick, likely ranging from about 50-120 mm using the ASTM D937 cone penetration test with 150 g load. Thus, Arora teaches that solid compositions have measurable hardness via cone penetration methods. The method described by Arora is a variant of the standard ASTM D937-97 method directed towards indicating consistency/hardness of semi-solid formulations via measuring cone probe penetration depth under load. Substituting one know standard penetration test method for another constitutes a routine choice of measurement technique and would have been obvious to one of ordinary skill in the art since they both measure the same physical property.
Achieving a specific cone penetration value, such as about 90 mm (medium hardness) to about 140 mm (medium-soft hardness) as per the limitations of instant claims 22 and 32, would be an obvious target for one of skill optimizing a stick formulation based on the teachings of Arora of sticks having at least a medium-soft to hard hardness and the teachings of the evidentiary reference Sturgis and Britt in US-20190000747-A1 of achieving optimal soft to medium-soft hardness to overcome undesirable sticks that are too hard. Further, the instant claim 22 and 32 cone penetration range represents a recitation of a property inherent to the evidentiary reference and prior art compositions hardness, irrespective of the specific test method used.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615