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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 March 2025 has been entered.
Claim Status
Applicant’s claim amendments and arguments in the response filed 26 March 2025 are acknowledged.
Claims 1-12 & 16-23 are pending.
Claims 13-15 are cancelled.
Claim 16 is withdrawn.
Claims 1-12 & 17-23 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
It is noted foreign priority has not been perfected. An English language translation of the foreign application has not been filed. Should Applicant choose to file an English translation, the English language translation should be accompanied with a statement that the translation of the certified copy is accurate. See 37 CFR 1.55 and MPEP §§ 215 and 216. The effective filed date of the instant application is 12/05/2019.
New & Maintained Objections/Rejections
Specification
The disclosure is objected to because of the following informalities: Page 9, ll. 25 contains the misspelled word “Ceteares”.
Applicant may wish to consider whether an amendment to recite “Ceteareth” would obviate the objection.
Appropriate correction is required.
Claim Objections
Claim 21 is objected to because of the following informalities: claim 21 contains the misspelled word “Ceteares”.
Applicant may wish to consider whether an amendment to recite “Ceteareth” would obviate the objection.
Appropriate correction is required.
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 20 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 20 depends from claim 17. Claim 17 recites the ratio is 0.7 to 3. Claim 20 fails to further limit claim 17 by expanding to the lower limit to 0.3.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-12 & 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Botto (US 2019/0365623; Published 12/05/2019; Filed: 05/31/2018; previously cited), The Herbarie (Published: 10/25/2012; previously cited) and Snow White (Published: 09/21/2014; previously cited).
With regard to claims 1-13 & 15, Botto teaches a nonsulfate concentrated rinse off cleansing composition (title). Botto in the Example 2 concentrated shampoo Formulation 4 teaches inclusion of sodium stearoyl glutamate (i.e. acyl acidic amino acid) in an amount of 3.0% and an amphoteric surfactant which may be cocoamidopropyl betaine and/or coco-betaine in an amount of 5.4%. With regard to claim 4, The ratio of the acyl acidic amino acid to the amphoteric surfactant is 0.55 (Math: 3/5.4 =0.555). With regard to claim 5, The mass of the acyl acidic amino acid and the amphoteric surfactant is 8.4% of the composition. More broadly, Botto teaches amphoteric surfactants for use in their invention include coco betaine, cocamidopropyl betaine cocamidopropyl hydroxysultaine, lauryl hydroxysultaine and mixtures thereof as non-limiting examples [0020]. With regard to claims 1 & 21, it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified Botto’s shampoo composition by substituting cocamidopropyl hydroxysultaine and lauryl hydroxysultaine for the cocoamidopropyl betaine and/or coco-betaine as suggested by Botto because Botto teaches the compositions of their invention may comprise amphoteric surfactants including cocamidopropyl betaine, coco-betaine, cocamidopropyl hydroxysultaine and lauryl hydroxysultaine. With regard to claims 8 & 9, Botto also teaches inclusion of high melting point, non-silicone, fatty compounds including cetyl alcohol in their invention (i.e. oil agent; [0141] & [0149]). With regard to claims 7 & 21, Botto teaches inclusion of acrylates/C10-C30 alkyl acrylate crosspolymers, for inclusion in the composition as a thickener ([0191] & [0195]). It would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified Botto’s shampoo by adding acrylates/C10-C30 alkyl acrylate crosspolymers to the shampoo as directed by Botto. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to thicken the shampoo with a thickener taught as suitable by Botto. More broadly, with regard to claims 10-12, Botto teaches inclusion of water soluble solvents which include glycerin and polyhydric alcohols for inclusion in their invention in an amount between about 0.01 to about 25 wt% and exemplifies inclusion of glycerin in the Example 2 Formulae 2, 3 & 5 shampoos in an amount between 0.7, 0.7 & 5 % respectively ([0210]-[02130] & [0292]). With regard to claims 1 & 21, Botto teaches the viscosity of their composition can be from about 2500 cP to about 15,000 cp at a temperature of 25° C (i.e. about 2,500 mPa*s to about 15,000 mPa*s; [0284]). Botto teaches inclusion of water-soluble synthetic polymers including starch derivatives (for example, starch oxide, dialdehyde starch, dextrin, British gum, acetyl starch, starch phosphate, carboxymethyl starch, hydroxyethyl starch, hydroxypropyl starch) [0208] .
Botto does not teach the starch derivative is hydroxypropyl starch phosphate, its amount, or the pH of the cleaning composition.
With regard to claims 1, 2, 21 & 22, In the same field of invention, The Herbarie teaches hydroxypropyl starch phosphate is water soluble, is used in an amount of 1-10%, and is used as a co-emulsifier and thickener for shampoos (pg. 3).
With regard to claims 1 & 21, in the same field of invention of cleansers, Snow White teaches that natural skin surfaces have an average pH of below 5 which is beneficial for the skin’s resident flora and acidic cleansers don’t disrupt the skin’s pH like alkaline ones and a low pH is inhospitable to acne (pg. 2 & 5). Snow White concludes “the pH of your cleanser really does matter” and “[y]our cleanser should be acidic, no more than pH 5.6; anything higher could compromise your skin and worsen acne” (pg. 7).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified Botto’s shampoo by substituting Botto’s generically taught water-soluble starch derivative with 1-10% hydroxypropyl starch phosphate as suggested by The Herbarie and adjusting the pH of the shampoo to be 5 or less as suggested by Snow White because Botto, The Herbarie, and Snow White are directed to cleansers (including shampoos) which are applied to the skin/scalp and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with expectation of success, in order to thicken and improve the stability of Botto’s shampoo formulation through inclusion of 1-10% hydroxypropyl starch phosphate and select a pH for the shampoo that is art recognized as suitable for the skin/scalp which does not disrupt the resident flora of the skin/scalp.
With specific regard to the relationship value for the formula 1 recited by claims 3 & 23, the combined teachings of Botto and The Herbarie teach a formula 1 value between 0.84-8.4 (Math: 8.4/1= 8.4; 8.4/10 = 0.84).
With regard to the recited amounts of hydroxypropyl starch phosphate, acyl acidic amino acid; acyl acidic amino acid and amphoteric surfactant; and polyhydric alcohol; Formula 1 relationship; weight ratio of acyl acidic amino acid to amphoteric surfactant; viscosity; and pH range; the combined teachings of Botto, The Herbarie, and Snow White teach these parameters with values that fall within or overlap with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 1-12 & 17-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kranzmann (WO 2018/206215; Published: 11/15/2018) in view of Snow White (Published: 09/21/2014; previously cited) and The Herbarie (Published: 10/25/2012; previously cited).
With regard to claims 1, 4, 6, 17, 20, & 21, Kranzmann in Table 5, Formula 22 teaches a composition comprising 3.04% sodium cocoyl glutamate and 1.6% cocoamidopropylhydroxysultaine (i.e. amphoteric surfactant) which yields an ( A/B) ratio of 1.9 [Math: 3.04: 1.6= 1.9:1]. With regard to claims 1, 17 & 21, more broadly, Kranyzmann teaches the viscosity range of the composition is 20,000cP to 300,000cP (i.e. 20,000 mPa*s to 300,000 mPa*s; Kranzmann’s claim 10). With regard to claims 1, 17 & 21, Kranzmann teaches inclusion of thickeners which include polyethylene glycol distearates and starch derivatives and teaches sodium hydroxypropyl starch phosphate to be an example of a starch derivative (pg. 16, ll. 29-end). With regard to claim 5, more broadly, Kranzmann teaches hydroxysultaines to be an amphoteric surfactant with amphoteric surfactants used in levels as low as 1 to levels as high as 6% by weight and acyl glutamates present in a preferred amount of 0.5 to 12% (pg. 9, ll. 1 to pg. 11, ll. 10). As such, with regard to claim 5, Kranzmann teaches the combined amount of (A) + (B) to be 1.5 to 18%. With regard to claim 7, more broadly, Kranzmann teaches inclusion of terpolymers which can bind the skin (pg. 20, ll. 15-25). With regard to claims 8 & 9, more broadly, Kranzmann teaches inclusion of emollients with petrolatum and partially hydrogenated triglyceride oils preferred (pg. 16, ll. 20-25). With regard to claims 10-12, more broadly, Kranzmann teaches inclusion of polyhydric alcohols, which may be glycerin at a minimum amount of 1% and a maximum amount of 10% by weight (pg. 15, ll. 10-20). Kranzmann teaches the composition of their invention have a pH of 6.0 to 8.0 (pg. 23, ll. 20-25). Kranzmann teaches the compositions of their invention are for cleansing the human body such as skin and hair (pg. 1, ll. 5-10). Kranzmann teaches their cleansing composition for hair and skin has a lotion-like appearance and may comprise sodium hydroxyl propyl starch phosphate (abstract).
Kranzmann does not teach the pH of the composition is 5.3 or less or that the starch derivative is hydroxypropyl starch phosphate.
With regard to claims 1, 17, & 21, the teachings of Snow White are described above.
With regard to claims 1, 2, 17, 18, 21 & 22, the teachings of The Herbarie are described above.
With regard to claims 1, 17, & 21, at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified Kranzmann’s skin and hair cleansing composition by adjusting the pH of the composition to be 5 or less as suggested by Snow White because Kranzmann and Snow White are directed to cleansers (including shampoos) which are applied to the skin/scalp and hair and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with expectation of success, in order to select a pH for the skin and hair cleanser that is art recognized as suitable for the skin/scalp and hair which does not disrupt the resident flora of the skin/scalp and hair.
With regard to claims 1, 2, 17, 18, 21 & 22, at least rationale (B) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified Kranzmann’s skin and hair cleansing composition by substituting Kranzmann’s generically taught water-soluble starch derivative with 1-10% hydroxypropyl starch phosphate as suggested by The Herbarie because Kranzmann and The Herbarie are directed to cleansers and lotions which are applied to the skin/scalp and hair and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with expectation of success, in order to thicken and improve the stability of Kranzmann’s skin and hair cleansing composition through inclusion of 1-10% hydroxypropyl starch phosphate.
With specific regard to the relationship value for the formula 1 recited by claims 3, 19, & 23, the combined teachings of Kranzmann and The Herbarie teach a formula 1 value between 0.464 to 4.64 (Math: 4.64/1= 4.64; 4.64/10 = 0.464).
With regard to the recited amounts of hydroxypropyl starch phosphate, acyl acidic amino acid; acyl acidic amino acid and amphoteric surfactant; and polyhydric alcohol; Formula 1 relationship; weight ratio of acyl acidic amino acid to amphoteric surfactant; viscosity; and pH range; the combined teachings of Kranzmann, Snow White and The Herbarie and teach these parameters with values that fall within or overlap with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
In the traverse of the rejection of claims 1-12, Applicant argues the instant claims require an acyl glutamic acid salt or at least one amphoteric surfactant that comprises a sultaine-type surfactant and the prior art does not recognize this (reply, pg. 8).
This is not persuasive. Botto teaches sodium stearoyl glutamate (i.e. acyl acidic amino acid) and cocamidopropyl hydroxysultaine. Kranzmann teaches sodium cocoyl glutamate and cocoamidopropylhydroxysultaine.
Applicant argues that when Botto’s shampoo is modified with the addition of the hydroxypropyl starch phosphate and the pH is adjusted to that of 5.3 or less, it is expected the viscosity will increase significantly, will not function well and the foam performance will not function well (reply, pg. 8).
This is not persuasive. These are attorney’s arguments and not evidence. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Further, The Herbarie teaches the suitability of hydroxypropyl starch phosphate as a thickener for shampoos. There is an expectation of success in using it to thicken shampoos.
Applicant reiterates arguments pertaining to Examination Example 1, stating the claims are commensurate in scope because they now recite at least one acyl amino acid and a sultaine type surfactant.
This is not persuasive. Applicant’s Examination Example 1 is not commensurate with the scope of the claims. Claim 1 is generic to the at least one acyl acidic amino acid, their amounts and the pH. However, Examination Example 1 used ONE specific acyl acidic amino acid (i.e. disodium N-cocoyl L-glutamate) in ONE specific amount. Examination Example 1 also used ONE specific mixture of amphoteric surfactants (i.e. sodium cocoamphoacetate and lauramidopropyl hydroxysultaine) in one specific amount (i.e. 8.6% combined) at one specific pH (i.e. 5.3). "[O]bjective 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).
Applicant argues Botto does not teach new claims 17-20 because Botto teaches sodium stearoyl glutamate but the instant claims require cocoyl glutamic acid or a salt thereof (reply, pg. 9-10).
Applicant’s arguments are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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/LORI K MATTISON/Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619