DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of Applicant's claim for priority from U.S. Provisional Application No. 63/402,915, filed on August 31, 2022.
Response to Amendment
Applicant's amendment filed July 10, 2026 amending claims 1, 2, 4, 6, 8, 9, and 14 has been entered. Claims 19, 25 and 32 are withdrawn. Claims 7, 12, 20-24 and 26-31 are canceled.
Newly amended claims 2, 6, and 8 are now withdrawn in view of the amendments since said claims now do not read on the elected species of inulin as the polysaccharide and sodium pyruvate and lactic acid as the post-biotic blend as elected on January 30, 2026.
Accordingly, claims 1, 3-5, 9-11, 13-18 and 33 are being examined as they read on the elected species.
Response to Arguments
Applicant's arguments filed July 10, 2026 have been fully considered but they are
not persuasive.
Applicant argues that Cruz fails to teach or fairly suggest claim 1 as a whole, particularly "wherein the polysaccharide comprises inulin, the fatty alcohol comprises butyloctanol, and the post-biotic blend comprises lactic acid, pyruvic acid, salts thereof, or a combination thereof.” Applicant argues that the Table 3 formulation of Cruz fails to teach, suggest or motivate a skilled artisan in the field to arrive at claim 1 as amended. Applicant further argues that Li cannot remedy the deficiencies of Cruz because Li relates to personal care compositions comprising a complex comprising a plurality of short chain fatty acids, and Li fails to teach, suggest or motivate a skilled artisan in the field to modify the Table 3 formulation of Cruz to arrive at claim 1 as amended. Applicant argues that Kosturko cannot remedy the deficiencies of Cruz either because Kosturko discloses a semi-translucent bar soap composition that provides an effective antimicrobial benefit against gram positive and gram negative bacteria.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the instant case, claim 1 of the instant application claims a personal care composition comprising: from about 0.1 to about 5 wt.% of a polysaccharide; from about 0.01 to about 12 wt.% of a fatty alcohol; from about 0.5 to about 7 wt.% of a post-biotic blend; and from about 0.1 to about 10 wt.% of calcium carbonate, wherein the polysaccharide comprises inulin, the fatty alcohol comprises butyloctanol, and the post-biotic blend comprises lactic acid, pyruvic acid, salts thereof, or a combination thereof.
Table 3 of Cruz teaches a formulation containing 0.01-1 wt. % of a Humectant, 0.1-2 wt. % of an Organic Acid, and 2 wt. % of Fructan (polysaccharide). Cruz et al. specifically provides guidance on how to select each component and the suitable amounts as detailed below.
Cruz et al. specifically teaches the organic acid is selected from: citric acid; lactic acid; acetic acid; formic acid; oxalic acid; uric acid; malic acid; and a combination of two or more thereof, and preferably the organic acid comprises lactic acid [0011]. Moreover, Cruz et al. further teaches the organic acid may be selected from lactic acid, tartaric acid, adipic acid, succinic acid, ascorbic acid, malonic acid, oxalic acid, pyruvic acid, picolinic acid, dipicolinic acid, citric acid, formic acid, acetic acid, propionic acid, other aliphatic or aromatic mono- or poly-carboxylic acids, and combinations thereof, the organic acid is preferably lactic acid [0048]. In certain embodiments, the active organic acid is present in an amount of from about 0.3 to about 2 wt. %, from about 0.3 to about 1 wt. %, or from about 0.3 to about 0.8 wt. % [0058]-[0059].
Thus Cruz et al. teaches a formulation containing a post-biotic blend which preferably comprises lactic acid which may be combined with another organic acid such as pyruvic acid in amounts that overlap with the claimed amount for the post-biotic blend.
Cruz et al. further teaches the personal care composition further comprises a humectant selected from: glycerin; butyloctanol; hyaluronic acid; urea; sodium lactate; propylene glycol; glycolic acid; sorbitol; and a combination of two or more thereof [0017]. Preferably the humectant is butyloctanol present in an amount of from about 0.005 wt. % to about 0.5 wt. %, optionally from about 0.01 wt. % to about 0.1 wt. %, further optionally 0.01 wt. % or 0.05 wt. % ([0017] and [0062]).
Thus, Cruz et al. specifically teaches a composition containing a fatty alcohol, which is preferably butyloctanol in amounts that overlap with the claimed amounts for the fatty alcohol.
Cruz et al. further teaches the personal care composition further comprises a prebiotic polysaccharide selected from fructan or inulin ([0023] and [0068). In certain embodiments, the prebiotic polysaccharide is inulin and is present in an amount of from about 0.1 wt. % to about 5 wt. %, optionally from about 0.5 wt. % to about 3 wt. %, further optionally about 2 wt. % ([0023] and [0068]).
Thus, Cruz et al. specifically teaches a composition containing a polysaccharide, which is selected from either fructan or inulin in amounts that overlap with the claimed amounts for a polysaccharide.
Thus the disclosure of Cruz provides specific guidance to select inulin, butyloctanol and lactic acid in overlapping amounts as claimed to be included in the personal care composition of Cruz.
Although Cruz et al. suggests the use of another organic acid such as pyruvic acid in combination with lactic acid, the secondary reference Li et al. provides specific motivation to combine lactic acid with pyruvic acid. Li et al. teaches that when applied to the skin the short chain fatty acid (SCFA) blend reduces the amount of harmful bacteria and increases the amount of beneficial bacteria [0084]-[0085]. Li et al. teaches the combination of a first short chain fatty acid such as lactic acid and a second short chain fatty acid such as pyruvic acid [0089]. Thus Li et al. provides motivation to combine lactic acid and pyruvic acid to improve the properties of the formulation of Cruz et al. by specifically reducing the amount of harmful bacteria and increasing the amount of beneficial bacteria.
Moreover, Cruz et al. specifically teaches that a bar soap is a suitable form for the personal care composition and the secondary reference Kosturko teaches that one or more insoluble filler materials are typically present in bar soap compositions (page 18 line 8). Non-limiting examples of inorganic particulate materials includes talc and calcium carbonate (page 18 line 18). Kosturko teaches the one or more insoluble filler material are included in an amount of from about 0.01%wt. to about 10%wt. (page 19 lines 10-12). Thus Kosturko specifically teaches that calcium carbonate in amounts that overlap with the claimed amounts is typically included as a filler material in bar soaps. Thus when formulating a bar soap according to the teachings of Cruz et al. an ordinary skilled artisan would necessarily include typical filler components including calcium carbonate that are well-known in the art to be included in bar soap formulations.
Thus Applicant’s arguments are found not persuasive since Cruz et al. and the secondary prior art references cited provide ample guidance to select and combine the claimed components in amounts that overlap with the amounts as claimed.
It must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect ....the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have selected the various combinations of features claimed from within the prior art disclosure as detailed above, to arrive at the instantly claimed subject matter.
Applicant further argues that they have discovered that personal care compositions formulated to have specific components in certain ratios provide synergistic benefits to the skin microbiome, including, e.g., reducing undesirable bacteria and increasing desirable bacteria. For instance, Applicant argues that the personal care compositions disclosed therein may reduce undesirable bacteria on the skin, such as E. coli and odor producing bacteria (e.g., Corynebacterium striatum), while simultaneously promoting the growth of desirable bacteria, such as Staphylococcus epidermidis.
These arguments are found not persuasive since as detailed above, Cruz et al. specifically provides guidance to select the combination of inulin, butyloctanol and lactic acid as components of the personal care compositions in overlapping amounts as claimed. Moreover, it would not have been considered surprising or unexpected that this combination which contains lactic acid and pyruvic acid reduces undesirable bacteria on the skin, such as E. coli and odor producing bacteria (e.g., Corynebacterium striatum), while simultaneously promoting the growth of desirable bacteria, such as Staphylococcus epidermidis, since Li et al. specifically teaches that when applied to the skin the short chain fatty acid (SCFA) blend reduces the amount of harmful bacteria and increases the amount of beneficial bacteria [0084]-[0085]. Li et al. teaches the combination of a first short chain fatty acid such as lactic acid and a second short chain fatty acid such as pyruvic acid and thus Li et al. provides specific motivation to combine lactic acid and pyruvic acid as suggested by Cruz et al. to improve the properties of the formulation of Cruz et al. by specifically reducing the amount of harmful bacteria and increasing the amount of beneficial bacteria. “Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.” In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) (resultant decrease of dental enamel solubility accomplished by adding an acidic buffering agent to a fluoride containing dentifrice was expected based on the teaching of the prior art); Ex parte Blanc, 13 USPQ2d 1383 (Bd. Pat. App. & Inter. 1989) (Claims at issue were directed to a process of sterilizing a polyolefinic composition which contains an antioxidant with high-energy radiation. Although evidence was presented in appellant’s specification showing that particular antioxidants are effective, the Board concluded that these beneficial results would have been expected because one of the references taught a claimed antioxidant is very efficient and provides better results compared with other prior art antioxidants.).
Applicant further argues that the personal care compositions typically include a Calcium Carbonate in an amount that may vary depending on the form of the personal care composition and other components and it was surprisingly discovered that the synergistic benefits to the skin microbiome achieved by particular combinations of components (e.g., certain polysaccharide(s), fatty alcohol(s) and post-biotic blend(s)) is further enhanced by Calcium Carbonate. For example, the unexpected improvement in the growth of S. epidermidis in conjunction with the reduction in growth of C. striatum is significantly enhanced by the particular combination of certain polysaccharide(s), fatty alcohol(s) and post-biotic blend(s) in particular amounts/ratios in conjunction with Calcium Carbonate.
Applicant’s data is found not persuasive since the difference in results for Example E which contains all components including calcium carbonate and comparative example 8 which contains all components except that titanium dioxide is substituted for the calcium carbonate, is minimal and thus there is no evidence that this small difference will lead to any practical advantage. For example, figure 8B demonstrates a value of about 3.65 for Ex. E and about 3.9 for Ex. 8, and figure 8C demonstrates a value of about 2.05 for Ex. E and a value of about 1.85 for Ex. 8. Although there is some difference, any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091,231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Exparte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) ("we generally consider a discussion of results in terms of 'differences in degree' as compared to 'differences in kind'.., to have very little meaning in a relevant legal sense").
Applicant has not provided further evidence that these differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Furthermore, the claims are drawn to a concentration range of from about 0.1 to about 10 wt. % of calcium carbonate and Applicant has not demonstrated improved results over the entire claimed range. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at “elevated temperatures” using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100°C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110°C and 130°C. The court affirmed the rejection of claims 1-7 and 9-10 because the term “elevated temperatures” encompassed temperatures as low as 60°C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100°C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).
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Thus for these reasons, the previous rejection under 35 USC 103 is hereby maintained and detailed below with modification necessitated by Applicant’s amendments.
For these same reasons, the previous double patenting rejections are hereby maintained since Applicant has not provided any additional arguments for the double patenting rejections.
This action is FINAL.
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).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-5, 9-11, 13-18 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,201,713 in view of Seidling et al. WO 2010/070501 A2. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application are rendered obvious over the cited claims of ‘713.
The cited claims of the instant application claim a personal care composition comprising from about 0.1 to about 5 wt.% of a polysaccharide; from about 0.01 to about 12 wt.% of a fatty alcohol; from about 0.5 to about 7 wt.% of a post-biotic blend; from about 0.1 to about 10 wt.% of calcium carbonate, wherein the polysaccharide comprises inulin, the fatty alcohol comprises butyloctanol, and the post-biotic blend comprises lactic acid, pyruvic acid, salts thereof, or a combination thereof; and wherein all weight percentages are based on the total weight of the personal care composition.
Claims 1-17 of ‘713 claim a personal care composition comprising: a polysaccharide comprising inulin present in an amount of from about 0.1 to about 1 wt. %; from about 0.01 to about 12 wt. % of a fatty alcohol; from about 0.5 to about 7 wt. % of a post-biotic blend; and optionally, from about 0.1 to about 2 wt. % of ethylhexylglycerin, wherein all weight percentages are based on the total weight of the personal care composition; wherein the post-biotic blend comprises lactic acid, or a salt thereof; and pyruvic acid, or a salt thereof; wherein the personal care composition has a weight ratio of lactic acid, or a salt thereof, to pyruvic acid, or a salt thereof, of from about 6:1 to about 2:1; wherein the personal care composition is a body wash, a body lotion, a deodorant, or an antiperspirant.
The claims of ‘713 do not claim the inclusion of from about 0.1 to about 10 wt.% of calcium carbonate.
However, prior to the effective filing date, calcium carbonate was a known filler component for personal care compositions as taught by Seidling et al.
Seidling et al. teaches that additional agents that impart a beneficial effect on skin or hair and/or further act to improve the aesthetic feel of the personal care compositions include examples having suitable skin benefit such as clays, starch, cellulose, particulates, and the like (page 10 lines 3-10). Examples of suitable particulates for personal care compositions include calcium carbonate (page 15 lines 14-21). The personal care composition may suitably include one or more particulate in an amount of from about 0.01 % (by weight of the composition) to about 20% (by weight of the composition) (page 15 lines 24-26).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to further include components well-known in the art that impart a beneficial effect on skin or hair and/or further act to improve the aesthetic feel of the personal care compositions including examples having suitable skin benefit such as clays, starch, cellulose, particulates, and the like such as calcium carbonate in an amount of from about 0.01 % (by weight of the composition) to about 20% (by weight of the composition) as taught by Seidling et al., in the personal care composition of ‘713 with a reasonable expectation of predictable results. Thus, the addition of calcium carbonate to the formulation of ‘713 is rendered obvious in view of the cited prior art teachings.
With respect to instant claim 33 which claims the form is a bar soap, although ‘713 does not specifically claim a bar soap form, since the prior art renders obvious a composition comprising the same components in overlapping amounts, the composition rendered obvious over the claims of ‘713 is necessarily capable of being in bar soap form. Thus claim 33 is rendered obvious over the cited claims of ‘713.
Claim 1, 3-5, 9-11, 13-18 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8-11, 13 and 14 of copending Application No. 18/977,205 (U.S. Publication No. 2025/0107993 A1) in view of Seidling et al. WO 2010/070501 A2. Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application are rendered obvious over the cited claims of copending ‘205.
The cited claims of the instant application claim a personal care composition comprising from about 0.1 to about 5 wt.% of a polysaccharide; from about 0.01 to about 12 wt.% of a fatty alcohol; from about 0.5 to about 7 wt.% of a post-biotic blend; from about 0.1 to about 10 wt.% of calcium carbonate, wherein the polysaccharide comprises inulin, the fatty alcohol comprises butyloctanol, and the post-biotic blend comprises lactic acid, pyruvic acid, salts thereof, or a combination thereof; and wherein all weight percentages are based on the total weight of the personal care composition.
Claims 1-4, 6, 8-11, 13 and 14 of copending ‘205 claim a personal care composition comprising from about 0.1 to about 5 wt.% of a polysaccharide; from about 0.01 to about 12 wt.% of a fatty alcohol; from about 0.5 to about 7 wt.% of a post-biotic blend; and optionally, from about 0.1 to about 2 wt.% of ethylhexylglycerin, wherein all weight percentages are based on the total weight of the personal care composition.
The claims of copending ‘205 do not claim the inclusion of from about 0.1 to about 10 wt.% of calcium carbonate.
However, prior to the effective filing date of the claimed invention, calcium carbonate was a known filler component for personal care compositions as taught by Seidling et al.
Seidling et al. teaches that additional agents that impart a beneficial effect on skin or hair and/or further act to improve the aesthetic feel of the personal care compositions include examples having suitable skin benefit such as clays, starch, cellulose, particulates, and the like (page 10 lines 3-10). Examples of suitable particulates for personal care compositions include calcium carbonate. The personal care composition may suitably include one or more particulate in an amount of from about 0.01 % (by weight of the composition) to about 20% (by weight of the composition) (page 15 lines 14-26).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to further include components well-known in the art to the personal care composition of copending ‘205 that impart a beneficial effect on skin or hair and/or further act to improve the aesthetic feel of the personal care composition including examples having suitable skin benefit such as clays, starch, cellulose, particulates, and the like such as calcium carbonate in an amount of from about 0.01 % (by weight of the composition) to about 20% (by weight of the composition) as taught by Seidling et al., with a reasonable expectation of predictable results. Thus, the addition of calcium carbonate to the formulation of copending ‘205 is rendered obvious in view of the cited prior art teachings.
With respect to instant claim 33 which claims the form is a bar soap, although copending ‘205 does not specifically claim a bar soap form, since the prior art renders obvious a composition comprising the same components in overlapping amounts, the composition rendered obvious over the copending application claims is necessarily capable of being in bar soap form. Thus claim 33 is rendered obvious over the cited claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-5, 9-11, 13-18 and 33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-11, 13-18 and 23 of copending Application No. 18/240,795 (U.S. Publication No. 2024/0065954 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application are rendered obvious over the cited claims of copending ‘795.
The cited claims of the instant application claim a personal care composition comprising from about 0.1 to about 5 wt.% of a polysaccharide; from about 0.01 to about 12 wt.% of a fatty alcohol; from about 0.5 to about 7 wt.% of a post-biotic blend; from about 0.1 to about 10 wt.% of calcium carbonate, wherein the polysaccharide comprises inulin, the fatty alcohol comprises butyloctanol, and the post-biotic blend comprises lactic acid, pyruvic acid, salts thereof, or a combination thereof; and wherein all weight percentages are based on the total weight of the personal care composition.
The cited claims of copending ‘795 claim an intimate care composition comprising from about 0.5 to about 7 wt.% of a post-biotic blend, and further comprising a polysaccharide such as inulin, a fatty alcohol, wherein the fatty alcohol comprises butyloctanol.
The claims of copending ‘795 do not claim the inclusion of from about 0.1 to about 10 wt.% of calcium carbonate.
However, prior to the effective filing date of the claimed invention, calcium carbonate was a known filler component for personal care compositions as taught by Seidling et al.
Seidling et al. teaches that additional agents that impart a beneficial effect on skin or hair and/or further act to improve the aesthetic feel of the personal care compositions include examples having suitable skin benefit such as clays, starch, cellulose, particulates, and the like (page 10 lines 3-10). Examples of suitable particulates for personal care compositions include calcium carbonate. The personal care composition may suitably include one or more particulate in an amount of from about 0.01 % (by weight of the composition) to about 20% (by weight of the composition) (page 15 lines 14-26).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to further include components well-known in the art to the personal care composition of copending ‘795 that impart a beneficial effect on skin or hair and/or further act to improve the aesthetic feel of the personal care composition including examples having suitable skin benefit such as clays, starch, cellulose, particulates, and the like such as calcium carbonate in an amount of from about 0.01 % (by weight of the composition) to about 20% (by weight of the composition) as taught by Seidling et al., with a reasonable expectation of predictable results. Thus, the addition of calcium carbonate to the formulation of copending ‘795 is rendered obvious in view of the cited prior art teachings.
With respect to instant claim 33 which claims the form is a bar soap, although copending ‘795 does not specifically claim a bar soap form, since the prior art renders obvious a composition comprising the same components in overlapping amounts, the composition rendered obvious over the copending application claims is necessarily capable of being in bar soap form. Thus claim 33 is rendered obvious over the cited claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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, 3-5, 9-11, 13-18 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Cruz et al. U.S. Publication No. 2021/0299020 A1 (Provided on IDS dated 09/16/2023) in view of Li et al. U.S. Publication No. 2021/0275419 A1 and Kosturko WO 2016/024090 A1.
The cited claims of the instant application claim a personal care composition comprising from about 0.1 to about 5 wt.% of a polysaccharide such as inulin; from about 0.01 to about 12 wt.% of a fatty alcohol such as butyloctanol; from about 0.5 to about 7 wt.% of a post-biotic blend such as lactic acid and sodium pyruvate; from about 0.1 to about 10 wt.% of calcium carbonate, wherein the polysaccharide comprises inulin, the fatty alcohol comprises butyloctanol, and the post-biotic blend comprises lactic acid, pyruvic acid, salts thereof, or a combination thereof; and wherein all weight percentages are based on the total weight of the personal care composition.
Cruz et al. teaches personal care compositions comprising a sulfate-free surfactant system and a preservative system comprising an organic acid (abstract). Cruz et al. teaches a personal care composition comprising: a cosmetically acceptable carrier; a preservative system comprising an organic acid; and a sulfate-free surfactant system comprising an anionic surfactant and an amphoteric surfactant [0008]. Cruz et al. teaches the organic acid is selected from: citric acid; lactic acid; acetic acid; formic acid; oxalic acid; uric acid; malic acid; and a combination of two or more thereof, and preferably the organic acid comprises lactic acid [0011].
Cruz et al. further teaches the personal care composition further comprises a humectant selected from: glycerin; butyloctanol; hyaluronic acid; urea; sodium lactate; propylene glycol; glycolic acid; sorbitol; and a combination of two or more thereof [0017]. Preferably the humectant is butyloctanol present in an amount of from about 0.005 wt. % to about 0.5 wt. %, optionally from about 0.01 wt. % to about 0.1 wt. %, further optionally 0.01 wt. % or 0.05 wt. % ([0017] and [0062]).
Cruz et al. further teaches the personal care composition further comprises a prebiotic polysaccharide such as inulin ([0023] and [0068). In certain embodiments, the prebiotic polysaccharide is present in an amount of from about 0.1 wt. % to about 5 wt. %, optionally from about 0.5 wt. % to about 3 wt. %, further optionally about 2 wt. % ([0023] and [0068]).
Cruz et al. teaches the personal care composition is in a form selected from: a hand soap, a body wash, a face wash, a shower gel, a shampoo, a conditioner, a cleanser, an exfoliating scrub, and a facial scrub [0025]. Cruz et al. further teaches the personal care compositions include hair care, skin care, sun care, facial care, and nail care compositions and examples of personal care compositions include an antiperspirant, a deodorant, a body wash, face wash, a shower gel, a lotion, a bar soap, a soft soap, a shampoo, a hair conditioner, a sunscreen, a facial cleanser, a facial toner, an exfoliant, a mask, a serum, a moisturizer, and a cosmetic (e.g. lipstick, concealer, blush, eye shadow, etc.) [0039].
Cruz et al. teaches that in certain embodiments, the personal care compositions comprise a preservative system comprising an organic acid [0047]. The organic acid may be selected from lactic acid, tartaric acid, adipic acid, succinic acid, ascorbic acid, malonic acid, oxalic acid, pyruvic acid, picolinic acid, dipicolinic acid, citric acid, formic acid, acetic acid, propionic acid, other aliphatic or aromatic mono- or poly-carboxylic acids, and combinations thereof, the organic acid is preferably lactic acid [0048]. In certain embodiments, the active organic acid is present in an amount of from about 0.3 to about 2 wt. %, from about 0.3 to about 1 wt. %, or from about 0.3 to about 0.8 wt. % [0058]-[0059].
Cruz et al. does not specifically teach the combination of lactic acid and sodium pyruvate. Cruz et al. does not teach the addition of calcium carbonate. Cruz et al. does not specifically exemplify a bar soap.
Although Cruz et al. does not specifically teach the combination of lactic acid and sodium pyruvate, Cruz et al. teaches in certain embodiments, the personal care compositions comprise a preservative system comprising an organic acid preferably lactic acid and another organic acid which may be selected as pyruvic acid [0047]-[0048].
In addition, Li et al. teaches personal care compositions comprising a complex comprising a plurality of short chain fatty acids (abstract). Li et al. specifically teaches the combination of lactic acid and pyruvic acid or sodium pyruvate for personal care compositions ([0032], [0034], [0039]-[0040], [0050], [0066]) These personal care compositions include hair care, skin care, sun care, nail care, and oral care compositions and examples of personal care compositions include an antiperspirant, a deodorant, a body wash, a shower gel, a lotion, a bar soap, a soft soap, a shampoo, a hair conditioner, a sunscreen, a peel (e.g., a chemical peel), and a cosmetic [0033]. Li et al. teaches that the composition comprises about 0.1 wt. % to about 2.0 wt. % of the short chain fatty acid (SCFA) blend [0059]-[0065].
Li et al. teaches that when applied to the skin the SCFA blend reduces the amount of harmful bacteria and increases the amount of beneficial bacteria [0084]-[0085]. Li et al. teaches a personal care composition wherein the weight ratio of the first short chain fatty acid (e.g., lactic acid) to the second short chain fatty acid (e.g. succinic acid or pyruvic acid) is about 15:1, or about 4:1 [0089]. In other embodiments, the weight ratio of the first short chain fatty acid (e.g. lactic acid) to the second short chain fatty acid (e.g., mandelic acid or pyruvic acid) is about 4:1 [0089]. In some embodiments, the weight ratio of the first short chain fatty acid (e.g., lactic acid) to the second short chain fatty acid (e.g. mandelic acid or pyruvic acid) is about 2:1 [0089].
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Cruz et al. which teaches in certain embodiments, the personal care compositions comprise a preservative system comprising an organic acid preferably lactic acid and another organic acid which may be selected as pyruvic acid, with the teachings of Li et al. which specifically teaches the combination of lactic acid and pyruvic acid or sodium pyruvate for personal care compositions in an amount of about 0.1 wt. % to about 2.0 wt. % wherein when applied to the skin the SCFA blend reduces the amount of harmful bacteria and increases the amount of beneficial bacteria and wherein the weight ratio of the first short chain fatty acid (e.g., lactic acid) to the second short chain fatty acid (e.g. succinic acid or pyruvic acid) is about 15:1, or about 4:1 or about 2:1. Thus an ordinary skilled artisan would have been motivated to add the short chain fatty acid blend of Li et al. to the formulation of Cruz et al. in order to obtain the added benefit of reducing the amount of harmful bacteria and increasing the amount of beneficial bacteria of the skin and further improving the properties of the personal care composition.
Although Cruz et al. does not specifically exemplify a bar soap, Cruz et al. specifically teaches that a bar soap is a suitable form for the personal care composition. Thus an ordinary skilled artisan following the teachings of Cruz et al. would have been motivated to prepare a bar soap with a reasonable expectation of predictable results. It would have been within the skill of an ordinary artisan to formulate a bar soap based on procedures routine in the art.
Kosturko teaches the preparation of bar soap compositions (abstract). Kosturko teaches that one or more insoluble filler materials are typically present in bar soap compositions (page 18 line 8). These filler materials may be inorganic or organic or a combination as long as they are insoluble in water (page 18 lines 11-12). Non-limiting examples of inorganic particulate materials includes talc and calcium carbonate (page 18 line 18). Calcium carbonate or as it is interchangeable referred to as "chalk" exists in three crystal forms: calcite, aragonite and vaterite (page 18 lines 21-22). Kosturko teaches the one or more insoluble filler materials may comprise up to about 20%wt. of the bar soap of which it forms a part, but advantageously, when present in included in an amount of from about 0.01%wt. to about 10%wt. (page 19 lines 10-12).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to prepare a bar soap composition according to the teachings of Cruz et al. and Li et al. and further include from about 0.01%wt. to about 10%wt. of calcium carbonate as a filler component known in the art to be useful in bar soap formulations to arrive at the instant invention.
Thus since the prior art renders obvious a personal care composition comprising the same components as claimed in the same or overlapping amounts as claimed, the properties of the composition as claimed in claims 13 and 15-18 of the instant application are also rendered obvious. Thus since the prior art specifically teaches the use of the same post-biotic blend in the same amount and ratio as claimed, the composition rendered over the prior art is necessarily adapted to mimic lactobacillus ferment as claimed in claim 13 of the instant application. For the same reasons, the composition rendered over the prior art is necessarily formulated to inhibit the growth of the bacteria and increase the growth of the bacteria as claimed in claims 15-18 of the instant application. "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Claims 15-18 are further rendered obvious since Li et al. specifically teaches that when applied to the skin the SCFA blend (post-biotic blend) reduces the amount of harmful bacteria and increases the amount of beneficial bacteria on the skin [0084]-[0085].
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 2, 6, 8, 19, 25 and 32 are withdrawn. Claims 1, 3-5, 9-11, 13-18 and 33 are rejected. Claims 7, 12, 20-24 and 26-31 are canceled. No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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