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 .
Election/Restrictions
Newly submitted claim 89 is directed to a species of invention in which the premixture has a weight ratio of (a):(b) ranging from about 2:1 to about 1:2. Applicant elected examination of the molar ratio in the response to the restriction requirement 04 August 2023. As such, claim 89 is directed to the unelected species of weight ratio and is withdrawn.
Claim Status
Applicant’s claim amendments, filed 23 March 2026 are acknowledged.
Claims 65-69, 74, 76-84 & 86-90 are pending.
Claims 87-90 are new.
Claims 1-64, 70-73, 75 & 85 are cancelled.
Claims 65, 66, 69, 74, 76-80 & 86 are amended.
Claims 67, 82-84 & 89 are withdrawn.
Claims 65, 66, 68, 69, 74, 76-81, 86-88 & 90 are under consideration.
Examination on the merits is to the extent of the following species:
(a) at least one carboxylic acid - citric acid;
(b) at least one cyclodextrin or derivative - β-cyclodextrin;
(c) at least one solvent - water; and
(d) mole ratio and/or weight ratio - mole ratio.
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.
Withdrawn Objections/Rejections
The objection to claim 75 is withdrawn due to cancellation of the claim.
The rejection of claims 69 & 78-81 under 35 U.S.C. 112(b) is withdrawn due to amendments which clarify that phytic acid is not inappropriately included among the genera of carboxylic acids.
The rejection of claims 74 & 77 under 35 U.S.C. 112(b) is withdrawn due to amendments which provide antecedent basis for “at least one solvent” .
The rejection of claim 80 under 35 U.S.C. 112(b) and under 35 U.S.C. 112(d) is withdrawn due to amendments which delete limitations pertaining to "the β-cyclodextrin and/or a derivative thereof".
The rejection of claims 72, 75, and 85 under 35 U.S.C. 102(a)(1), 35 USC 103(a) and nonstatutory double patenting is withdrawn due to cancellation of the claims.
The rejection of claims 65, 66, 68, 69, 74, & 86 under 35 U.S.C. 102(a)(1) over Peng [as evidenced by Hydroxypropyl beta cyclodextrin]; claims 65, 66, 68, 69, 74 & 86 under 35 U.S.C. 103 over Peng [as evidenced by Hydroxypropyl beta cyclodextrin (Published: 10/11/2017)]; claims 77-79 & 81 under 35 U.S.C. 103 over Peng [as evidenced by Hydroxypropyl beta cyclodextrin] and further in view of Juzo; and claim 80 under 35 U.S.C. 103 over Peng [as evidenced by Hydroxypropyl beta cyclodextrin] and Juzo, and further in view of Lederman is withdrawn due to claim amendments which delete limitations pertaining to β-cyclodextrin derivatives.
The provisional rejection of claims 65, 66, 68, 69, 74, & 86 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/539,954 (hereinafter ‘954; claims filed 06/24/2026) and Peng (CN 107550749; Published: 01/09/2018) is withdrawn due to the ‘954 being limited to citric acid, the product-by-process limitations of the instant claims, and the showing that the product-by-process limitations with citric acid, β-cyclodextrin, and water results in a different product than a simple admixture as shown in the instant specification at pg. 21 & 22.
The provisional rejection of claims 65, 66, 68, 69, 74, & 86 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/355,516 (claims filed 03/23/2026) and Prose (Published: 07/31/2019) is withdrawn due to the ‘516 being limited to citric acid, the product-by-process limitations of the instant claims, and the showing that the product-by-process limitations with citric acid, β-cyclodextrin, and water results in a different product than a simple admixture as shown in the instant specification at pg. 21 & 22.
The provisional rejection of claims 65, 66, 68, 69, 74, & 86 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/539,865 (claims filed 03/24/2026) and Peng (CN 107550749; Published: 01/09/2018) is withdrawn due to the ‘865 being limited to citric acid, the product-by-process limitations of the instant claims, and the showing that the product-by-process limitations with citric acid, β-cyclodextrin, and water results in a different product than a simple admixture as shown in the instant specification at pg. 21 & 22.
Maintained Objections/Rejections
Claim Objections
Claim 78 is objected to because of the following informalities: Claim 78 doesn’t make grammatical sense. Claim 78 recites “at least one compound chosen from citric acid, ..salts of citric acid.. phytic acid, salts thereof...” which results in a salt of a citric acid salt.
Applicant may wish to consider whether writing claim 78 in parallel to claim 80 would obviate the objection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 the applicant regards as his invention.
Claim 68 is 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 68 recites the limitation "the at least one carboxylic acid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Applicant may wish whether a claim 68 amendment to recite “the at least one compound (i)(a) is chosen from…” would obviate the rejection.
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 65, 66, 68, 69, 74, 76, 86, 88 & 90 are rejected under 35 U.S.C. 103 as being unpatentable over Karnerud (US 6,406,708; Published: 06/18/2002).
Claim Interpretation: The Examiner notes that the instant specification discloses “For purposes of the present disclosure, it should be noted that to provide a more concise description, some of the quantitative expressions given herein are not qualified with the term “about.” It is understood that whether the term “about” is used explicitly or not, every quantity given herein is meant to refer to the actual given value, and it is also meant to refer to the approximation to such given value that would reasonably be inferred based on the ordinary skill in the art, including approximations due to the experimental and/or measurement conditions for such given value” (Specification-pg. 66).
Claim 74 is interpreted as comprising propylene glycol.
Claim Analysis: Claim 65 recites "A cosmetic composition…made by (i) forming a mixture…(ii) heating the mixture to form a premixture… (iii) forming the cosmetic composition by combing the premixture with : (d) at least one cosmetically acceptable component chosen from solvents…” which is a product-by-process recitation. Claim 86 recites “A cosmetic composition…made by a process comprising (i) forming a mixture….(ii) heating the mixture…and (iii) combining the premixture with (d) at least one second solvent” …” which is a product-by-process recitation.
M.P.E.P. § 2113-PRODUCT BY PROCESS CLAIMS states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
M.P.E.P. § 2113 further states: "Once a product appearing to be substantially identical is found and a 35 U.S.C. 102 /103 rejection made, the burden shifts to the Applicants to shown an unobvious difference.” “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).”
*The molecular weight of citric acid is 192.14 g/mol; the molecular weight of lactic acid is 90.1 g/mol; the molecular weight of β-cyclodextrin is 1135.0 g/mol.
Karnerud in Example 1 teaches an ointment for the treatment of acne (i.e. cosmetic composition for treating keratin fibers; Example 1- col. 4 , ll. 40-end). With regard claims 65 ( i),(a), (b), (c), 65 ( ii); 68, 69, 74, 76, 86 (i), a), b) c); 86 (ii), Karnerud in Example 1 teaches mixing 5.0% lactic acid (i.e. monocarboxylic acid; molecular weight 90.078 g/mol), water (i.e. solvent/first solvent) and 6.0 % cyclodextrin (i.e. “about 5.0 %”) as a water phase and heating the water phase to 75° C ( i.e. heating the mixture to form a premixture where step (ii) is performed simultaneous with step (i); Example 1- col. 4 , ll. 40-end). With regard to claim 65 (i), (b), Karnerud more broadly teaches the cyclodextrin for use in their invention consists α-, β-, y-,cyclodextrin and teaches the prior art taught a skin care composition comprising conjugate of vitamin A derivative (a vitamin) and β-cyclodextrin (col. 2, ll. 1-10; col. 3, ll. 25-30). With regard to claim 65, Karnerd teaches combining the phase B composition with squalane (i.e. a solvent/second solvent; Example 1-col. 4). With regard to the molar ratio, as recited by claims 65, 76 & 86, Karnerud teaches acids in an amount as low as 1.5% and cyclodextrins in an amount as high as 8% , yielding a ratio 2.3:1 (col. 3, ll. 15-20 & 25-30). With regard to claims 66, 76, 86 (a) & 88, Karnerud teaches acids in an amount between 1.5 to 8% (Moles of lactic acid 0.02-0.09; col. 3, ll. 15-20). With regard to claims 66, 76 & 86 (b), Karnerud teaches cyclodextrins which include β-cyclodextrin in an amount between 1.5 to 8% (Moles of citric acid 0.001-0.007; col. 3, ll. 25-30). This yields a 2.8:1-90:1 ratio which overlaps with the claimed range. With regard to claims 66, 76, 86 & 88, Karnerud’s Example 1 yields an (a): (b) ratio of 10:1 which falls within the claimed range (col. 4). 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). This is important because Karnerud teaches the amount of cyclodextrins and acids to be optimizable parameters with cyclodextrins having the properties of forming a chelate or inclusion effect in addition to a healing and anti-inflammatory effect and the acids having an antibacterial effect (col. 2, ll. 55-end; col. 3, ll. 30-35).
With regard to claims 69 & 90 and the elected species of citric acid, Karnerud teaches the pharmaceutically and/or cosmetically acceptable carboxylic acid may be “selected from… lactic …citric …” (Karnerud-claims 2 & 3; col. 3, ll. 1-15). It would have been prima face obvious to the ordinary skilled artisan before the effective date to have substituted Karnerud’s Example 1 lactic acid with citric acid because Karnerud teaches citric acid and lactic acid are both pharmaceutically and/or cosmetically acceptable carboxylic acids suitable for use in their invention. With regard to claim 74, Karnerud more broadly teaches ethanol and propylene glycol as cosmetic alcohols for inclusion in the hydrophilic medium used to dissolve the cyclodextrin (col. 4, ll. 15-25).
With regard to the recited amounts of at least one compound/citric acid/lactic acid, β-cyclodextrin, and the mole ratio of (a) : (b), Karnerud teaches these parameters with values which overlap or fall within the recited 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 65, 66, 68, 69, 74, 76-81, 86-88 & 90 are rejected under 35 U.S.C. 103 as being unpatentable over Price (US 2002/0111285; Published: 08/15/2002) in view of GE (CN 109837749; Published: 06/04/2019) and Tada (US 2014/0328917; Published: 11/06/2014)].
Claim Interpretation: As above.
Claim 74 is interpreted as comprising ethylene glycol, propylene glycol and glycerin.
Claim Analysis: Claims 65 & 86 as above. Claim 78 recites "A composition made by a process comprising (i) forming a mixture…(ii) heating the mixture to form a premixture; and (iii) forming the composition by combining the premixture with a second solvent in a weight ratio of pre-mixture:second solvent ranging from about 1:99 to about 50:50…” which is a product-by-process recitation.
M.P.E.P. § 2113-PRODUCT BY PROCESS CLAIMS states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
M.P.E.P. § 2113 further states: "Once a product appearing to be substantially identical is found and a 35 U.S.C. 102 /103 rejection made, the burden shifts to the Applicants to shown an unobvious difference.” “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).”
*The molecular weight of citric acid is 192.14 g/mol; the molecular weight of β-cyclodextrin is 1135.0 g/mol.
** All references refer to the English language translation.
With regard to claims 65 (a), 68, 69, 76, 78 (a), 79, 80, 86 (a) & 90, Price in Example 1 Compositions A, C, D, & J teaches rinse compositions comprising 1-6 % acidifying agent which is citric acid (mole range = 0.005-0.03; [0291] & [0292]). More broadly Price teaches the acidifying agent, which may be citric acid, in a typical amount of “ from 0.1 % to 50%, and preferably from 0.5 to 10% by weight of the composition” (typical mole range = 0.0005-0.26; preferable mole range = 0.003-0.05; [0062]). More broadly, with regard to claims 65 (a), 68, 69, 76, 78 (a), 79, & 86 (a), Price teaches the acidifying agent may be lactic acid, glycolic acid, and maleic acid [0062]. It would have been prima facie obvious to the ordinary skilled artisan, before the effective filing date, to substitute Price’s citric acid with any one of lactic acid, glycolic acid, and maleic acid because Price teaches these are suitable acidifying agents in which to practice their invention. With regard to claims 65 (b), 78 (b), 86 (b), Price in Example 1 Compositions A, C, D, & J recite rinse compositions comprising 0.5% β-cyclodextrin (β -cyclodextrin = 0.0004; [0291] & [0292]). More broadly with regard to claims 65, 66, 76, 78 (b), 86 (b) & 88, Price teaches “Non-derivatised (normal) beta-cyclodextrin can be present at a level up to its solubility limit of about 1.85% (about 1.85g in 100 grams of water) at room temperature” (0.002 moles β -cyclodextrin; [0186]). As such Price teaches a molar ratio of (a):( b) is 125:1 to 1.5 : 1, including 10:1 when 4% citric acid is selected (i.e. 0.02 moles) and 1.85% β-cyclodextrin is selected (i.e. 0.002 moles). With regard to claims 65 ( c), 74, 76, 77, 78 (c) & 86 (c), Price in Example 1 Compositions A, C, D, & J teaches rinse compositions comprising water (i.e. solvent/first solvent; [0291] & [0292]). With regard to claim 74, Price teaches inclusion of the solvents ethylene glycol, propylene glycol and glycerol (i.e. glycerin) to enhance the formation of the cyclodextrin inclusion complexes [0192]. With regard to claims 65 ( c), 78 (c) & 86 (c), Price in Example 1 Compositions A, C, D, & J teaches forming a mixture/premixture comprising citric acid, β-cyclodextrin, and water. With regard to claims 65 (iii), 65 (iii) (d), 78 (iii), 86 (iii) & 87, Price teaches the rinse-added fabric treatment is used to remove laundry residue and can be used neat (i.e. 1:0) or is added to water and is diluted in a ratio of 1 to 500 for hand-washing and 1 to 10,000 for automated washing machines to water (i.e. solvent) to form a rinse bath; a 50:50 ratio is an obvious place to start optimization for removal of laundry residue while reducing cost through dilution of water (i.e. the at least one first solvent/water is the same as the at least one second solvent/water; [0285], [0308], [0310] & [0322]). With regard to claims 76, 77, 78 & 81, Price in Example 1 Compositions A, C, D, & J teaches the at least one solvent 1 (i)( c) is water and more broadly teaches the rinse-bath has a pH below about 6.5, “preferably less than about 5.75 and even more preferably less than about 5 “ ([0020] & [0023]). Price teaches cyclodextrin in their composition to absorb odors [0190].
Price does not teach heating the mixture to a temperature from about 40 °C to 100 °C to form a premixture comprising an acid, β-cyclodextrin and water before combining the premixture with a solvent.
In the same field of invention of fabric deodorant, Ge teaches a composition comprising water, glycerol/glycerin and hydrophilic cyclodextrin which may be beta-cyclodextrin (pg. 10). With regard to claims 65 (ii), 78 (ii) & 86 (ii), Ge teaches increasing the temperature to 40-60°C after mixing evenly in a reaction kettle (pg. 5 & 6). Ge teaches their method provides hydrophilic modification to the cyclodextrin with effective improvement in its water solubility (pg. 6). Ge teaches the production cost of the deodorant is low, and can realize industrialized production (pg. 6).
Tada teaches citric acid and glycerin/glycerol are physiologically acceptable polyols [0058]. The ordinary skilled artisan, at the time of filing, knew citric acid and glycerin/glycerol were water soluble.
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 Price’s deodorant rinse aid by heating the citric acid, beta-cyclodextrin and water mixture to 40-60°C as suggested by Ge because Price and Ge are both directed to deodorant compositions for fabrics comprising water, polyol, and β-cyclodextrin and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to hydrophilically modify the β-cyclodextrin and improve its solubility in a low cost production method that can be used on an industrial scale as taught by Ge using a physiologically acceptable polyol as taught by Tada.
With regard to the recited amounts of at least one compound/citric acid, β-cyclodextrin, the mole ratio of (a) : (b), the pH of the composition, and the weight ratio of the pre-mixture: second solvent, the combined teachings of Price, Ge and Tada suggest these parameters with values which overlap or fall within the recited 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
With regard to the rejection of claims 65, 66, 68, 69, 72, 74, 75, 85 and 86 under 35 U.S.C. § 103(a) over Peng; claim 76 was rejected under 35 U.S.C. § 103(a) over Peng in view of Lederman; claims 77-79 and 81 under 35 U.S.C. § 103(a) over Peng in view of Juza; and claim 80 under 35 U.S.C. § 103(a) as allegedly unpatentable over Peng in view of Lederman, Applicant argues the claims recite a product-by- process format and none of Peng, Lederman, or Juzo teach forming the mixture of components (i)(a) and (i)(b) and heating the mixture to obtain a premixture which is then used to form the final composition (reply, pg. 10). Applicant also argues Peng is drawn to adding hydroxypropylcyclodextrin to water and citric acid is added after cooling (pg. 10).
Applicant’s arguments with have been considered but 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. Applicant’s arguments are also not commensurate with the scope of the claims. The claims recite that (a) at least one compound can be non-polymer, mono, di, or tricarboxylic acids including lactic acid. Notably, Karnerud in Example 1 teaches mixing 5.0% lactic acid (i.e. monocarboxylic acid; molecular weight 90.078 g/mol), water (i.e. solvent/first solvent) and 6.0 % cyclodextrin (i.e. “about 5.0%”) which may be β-cyclodextrin as a water phase and heating the water phase to 75° C (i.e. heating the mixture to form a premixture where step (ii) is performed simultaneous with step (i); Example 1- col. 4 , ll. 40-end). Karnerud also teaches the suitability of citric acid as the acid for use in the invention. In a second 35 USC 103(a) rejection, the combination of Price and Ge suggest heating a mixture of citric acid or lactic acid, β-cyclodextrin, and water to a temperature from about 40 °C to 60 °C to form a uniform mixture in which the β-cyclodextrin is rendered more soluble/hydrophilic.
Applicant reiterates data from the specification pointing to the composition of Example 1 A which was formed by the recited product-by-process methods (reply, pg. 10-15; Specification-pg. 21 & 22). This product resulted in better curl definition/retention/curl hold and frizz control, including during high humidity conditions (reply, pg. 10-15).
This is not persuasive. Applicant’s data are not commensurate with the scope of the claims. The data were generated with a composition comprising citric acid, water, and β-cyclodextrin (specification-pg. 21 & 22). However, claims 65 (a), 78 (a) and 86 (a) are generic permitting phytic acid; and non-polymeric mono, di, or tricarboxylic acids having a molecular weight of less than about 900 g/mol including lactic acid, malic acid, maleic acid, tartaric acid, glycolic acid, salts of citric acid, lactic acid, malic acid, maleic acid, tartaric acid, glycolic acid, phytic acid, salts thereof. Applicant has not shown these unexpected results occur with these other species when the product-by-process steps are applied. This is important because not all of the species fall into the same class of acids or share a common chemical core structure. For example, phytic acid comprises phosphorus and is not a carboxylic acid like citric acid.
With regard to Applicant’s arguments pertaining to the better curl definition/retention/curl hold and frizz control, this pertains to the recited composition being used on hair (i.e. intended use). The instant claims are drawn to a “cosmetic composition” and a “composition”. However as shown by the 35 USC 103(a) rejections above, Applicant has not yet distinguished their recited composition in terms of reagents or amounts from an acne ointment or a laundry-rinse aid that is subsequently diluted. The claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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 65, 66, 68, 69, 74, 76-79, 81, & 86-88 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-49 of copending Application No. 18/231,735 (hereinafter ‘735; claims filed 01/26/2026; previously cited) in view of Peng (CN 107550749; Published: 01/09/2018; previously cited). Both the instant claims and the ‘735 claims recite a composition comprising water (solvent), at least one carboxylic acid which may be lactic acid, malic acid, maleic acid, tartaric acid, glycolic acid, phytic acid in an amount of about 1 to about 5% by weight [yielding 0.011-0.055 moles of lactic acid] and at least one cyclodextrin which may be β-cyclodextrin in an amount of about 1% to about 5% by weight [yielding 0.0009- 0.004 moles of β-cyclodextrin and a mole ratio of lactic acid to beta-cyclodextrin from about 2.75:1 to about 61.11]. The combined amount of carboxylic acids, β-cyclodextrin, polysaccharide thickener and polyol range from 2.10-15.5, leaving 84-97 for water which results in a premixture to second solvent ratio of 1: 8.4 to 1:48.5. The ’735 patent recites inclusion of at least one polysaccharide gum (i.e. thickener), at least one polyol (i.e. solvent which is a moisturizing agent) and water. The ‘735 recites the pH of the composition is less than 7. The ‘735 recites the composition is used in a method for treating hair. The ‘735 does not recite the species of polyol. Peng teaches inclusion of butylene glycol/butanediol in a hair restorer. It would have been prima facie obvious before the effective filing date to have modified the hair treatment composition recited by the ‘735 claims by substituting the ‘735’s generic polyol with Peng’s butylene glycol because the compositions of the ‘735 and Peng are both applied to the head/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 an expectation of success, in order to increase the humectancy/moisturization of the composition.
With regard to the recited pH; mole ratio of (a) : (b); the amounts of the at least one carboxylic acid, and β-cyclodextrin; and the ratio of the premixture: second solvent, the combined teachings of the ‘735 and Peng teach these parameters with values which overlap or fall within the recited 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).
With regard to the recited product by process limitation recited by claims 65, 78 & 86, the Applicant in the as-filed specification has shown a non-obvious difference with only citric acid, β-cyclodextrin and water (see M.P.E.P. § 2113 II). M.P.E.P. § 2113-PRODUCT BY PROCESS CLAIMS states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). M.P.E.P. § 2113 further states: "Once a product appearing to be substantially identical is found and a 35 U.S.C. 102 /103 rejection made, the burden shifts to the Applicants to shown an unobvious difference.” “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). For the purpose of examination, claims 65, 78 & 86 are understood to be a compositions comprising “about 0.01% to about 5% of a least one carboxylic acid chosen from mono, di, or tricarboxylic acid having a molecular weight… other than citric acid, about 0.01 to about 5 % β-cyclodextrin and/or derivative; c) at least one solvent, and at least one cosmetically acceptable component chosen from…”
The pending claims are therefore an obvious variant of the conflicting, pending claims.
This is a provisional nonstatutory double patenting rejection.
Claims 65, 66, 68, 69, 74, 76-81, & 86-88 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35-49 of copending Application No. 18/231,729 (hereinafter ‘729; claims filed 06/05/2026; previously cited). Both the instant claims and the ‘729 claims recite a composition comprising at least one carboxylic acid which may be lactic acid and/or salts in an amount of about 0.1 to about 20% by weight; at least one cyclodextrin which may be β-cyclodextrin or derivatives in an amount of about 0.01% to about 20% by weight; at least one polysaccharide thickening agent chosen from gums in an amount of about 0.05% to about 5%; at least one polyol which may be “ethylene glycol….polyethylene glycols, or mixtures of two or more thereof..” (moisturizing agent), and water (solvent) in which the composition has a pH range from about 2 to about 6 with a mole ratio ranging from about 1:3 to about 6:1 . The ‘729 recites the composition is a composition for treating keratin fibers so a 50:50 ratio of the composition to a second solvent which is water is an obvious dilution in which to start optimization for find the ratio suitable for treating hair.
With regard to the recited pH; mole ratio of (a) : (b); and the amounts of the at least one carboxylic acid, and β-cyclodextrin; the ‘729 recites these parameters with values which overlap or fall within the recited 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).
With regard to the recited product by process limitation recited by claims 65, 78 & 86, the Applicant in the as-filed specification has shown a non-obvious difference with only citric acid. β-cyclodextrin and water (see M.P.E.P. § 2113 II). M.P.E.P. § 2113-PRODUCT BY PROCESS CLAIMS states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). M.P.E.P. § 2113 further states: "Once a product appearing to be substantially identical is found and a 35 U.S.C. 102 /103 rejection made, the burden shifts to the Applicants to shown an unobvious difference.” “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). For the purpose of examination, claims 65, 78 & 86 are understood to be a compositions comprising “about 0.01% to about 5% of a least one carboxylic acid chosen from mono, di, or tricarboxylic acid having a molecular weight… other than citric acid, about 0.01 to about 5 % β-cyclodextrin and/or derivative; c) at least one solvent, and at least one cosmetically acceptable component chosen from…”
The pending claims are therefore an obvious variant of the conflicting, pending claims.
This is a provisional nonstatutory double patenting rejection.
Claims 65, 66, 68, 69, 74, 76-81, 86-88 & 90 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 & 11-18 of copending Application No. 17/332,695 (hereinafter ‘695; claims filed 08/28/2025) in view of Prose (Published: 07/31/2019). Both the instant claims and the ‘695 claims recite a composition comprising water (solvent), at least one acid which may be lactic acid in an amount of about 0.1 to about 5% by weight [yielding 0.001-0.055 moles of lactic acid] and at least one cyclodextrin which may be β-cyclodextrin in an amount of about 0.1% to about 1% by weight [yielding 0.00009- 0.0009 moles of β-cyclodextrin and a mole ratio of lactic acid to beta-cyclodextrin from about 11.11:1 to about 61.1:1]. The ‘695 recites inclusion of a solvent and the ordinary skilled artisan would immediately envisage water since water is a conventional solvent. The ‘695 recites inclusion of an additional solvent which is hexylene glycol (moisturizing agent). The ‘695 recites the acid may be phytic acid. The ‘695 recites the composition is for treating keratin fibers. It would be obvious to dilute the mixture of the ‘695 comprising lactic acid and β-cyclodextrin with water in a 50:50 ratio as a place to start optimizing for treating hair . The ‘695 does not recite a pH for the composition. The teachings of Prose are described above. It would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the composition recited by the ‘695 claims by adjusting the pH of the composition to be between 4.5 and 5.5 as suggested by Prose because the composition recited by the ‘695 is for treating keratin fibers and hair is a keratin fiber having a pH of 4.5 to 5.5. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide a composition for treating keratin fibers such as hair, at a pH suitable for hair.
With regard to the recited product by process limitation recited by claims 65, 78 & 86, the Applicant in the as-filed specification has shown a non-obvious difference with only citric acid, β-cyclodextrin and water (see M.P.E.P. § 2113 II). M.P.E.P. § 2113-PRODUCT BY PROCESS CLAIMS states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). M.P.E.P. § 2113 further states: "Once a product appearing to be substantially identical is found and a 35 U.S.C. 102 /103 rejection made, the burden shifts to the Applicants to shown an unobvious difference.” “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). For the purpose of examination, claims 65, 78 & 86 are understood to be a compositions comprising about 0.01% to about 5% of a least one carboxylic acid chosen from mono, di, or tricarboxylic acid having a molecular weight… other than citric acid, about 0.01 to about 5 % β-cyclodextrin and/or derivative; c) at least one solvent, and at least one cosmetically acceptable component chosen from…
The pending claims are therefore an obvious variant of the conflicting, pending claims.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues the instant claims recite product-by-process limitations and none of the claims in the cited applications contain product-by-process limitations and none of Peng or Prose remedy these deficiencies (reply, pg. 16).
This is not persuasive. While Applicant’s instant specification shows that the product-by-process limitations when performed with a mixture of citric acid, β-cyclodextrin and water results in a different product than just an admixture, Applicant has not shown this feature over the full scope of acids recited by their claims. The claims encompass mono-, di-, and tricarboxylic acids and phytic acid. This showing is important because the acids do not share a common chemical core, nor do they fall into the same class (e.g. phytic acid which comprises a phosphorous atom).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (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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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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