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 .
DETAILED ACTION
Status of Claims
Claims 1-13 are pending.
Election/Restrictions
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
I. Group I, claims 1-6, drawn to a cosmetic composition comprising a molecular association in which bile acid molecule or bile salt are physically bonded.
II. Group II, claim(s) 7-13, drawn to a method for locally reducing fat comprising administering the cosmetic composition wherein the cosmetic composition is skin permeable.
The inventions listed as Groups I and II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features.
An international application should relate to only one invention or, if there is more than one invention, the inclusion of those inventions in one international application is permitted if all inventions are so linked as to form a single general inventive concept (PCT Rule 13.1). With respect to a group of inventions claimed in an international application, unity of invention exists only when there is a technical relationship among the claimed inventions involving one or more of the same or corresponding special technical features.
The expression “special technical features” is defined in PCT Rule 13.2 as meaning those technical features that define a contribution which each of the inventions, considered as a whole, makes over the prior art. The determination is made on the contents of the claims as interpreted in light of the description and drawings (if any). Whether or not any particular technical feature makes a “contribution” over the prior art, and therefore constitutes a "special technical feature," should be considered with respect to novelty and inventive step.
In this case, the common technical feature in both groups is the cosmetic composition comprising a molecular association in which bile acid molecule or bile salt are physically bonded. This element cannot be a special technical feature under PCT Rule 13.2 because the element is shown in the prior art. Djavanbakht et al. (J. Colloid and Interface Science, 59 (1): 139-148, March 15, 1977; cited in the IDS filed on 9/22/2025) teach a bile salt solution wherein the bile salt is in the state of aggregates (molecular association) (p140, col 2, Materials, see 102 rejection below for more details). As such, the feature linking the claims does not constitute a special technical feature as defined by PCT Rule 13.2 as it does not define a contribution over the prior art. Accordingly, Groups I-II are not so linked by the same or a corresponding special technical feature as to form a single general inventive concept. Therefore, unity of invention is considered to be lacking and restriction of the invention in accordance with the rules of unity of invention is considered to be proper.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product, and the product claims are subsequently found allowable, withdrawn process claims that depend from or otherwise require all the limitations of the allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must require all the limitations of an allowable product claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product are found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone restriction with Sunhee Lee on Jan. 21 2026, a provisional election was made to prosecute the invention of Group I, claims 1-6, without traverse. Affirmation of this election must be made by applicant in replying to this Office action.
Accordingly, claims 7-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 1-6 are under examination in the instant office action.
Claim Objections
Claim 5 is objected to because of the following informalities: typographical errors. It appears that “a salt of” is missing before “any one” in line 3.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. All the dependent claims are included.
Claim 1 recites “wherein when the molecular association is formed in a composition containing water, the molecular association has an associated structure in the composition”. It is unclear whether the claimed composition requires water or it only intend to recite a process how the molecular association is formed, i.e., the claim to be a product-by-process claim. In addition, it is unclear what the “associated structure” means. The meanings of “associated structure” is confusing and vague.
Also, claim 3 recites “the molecular association has the pH of exceeding 8.5 and less than 10. In chemistry, pH is a logarithmic scale used to specify the acidity or basicity of a solution. According to the specification, the molecular association means a structure in which bile acid molecules stick together (see [0040]). Thus, it cannot be understood how the molecular association itself can have pH when it is a compound, not a solution. Is it intended to recite that the composition, which is a solution, has the pH of exceeding 8.5 and less than 10? Clarification is required.
In addition, claim 6 recite “the molecular association has a concentration change rate….”
It is unclear how the concentration of the molecular association can be measured when the product of claimed molecular association is not clearly defined. According to Djavanbakht et al., the molecular association of bile salts are formed by the series of bimolecular reactions, e.g., between two monomers, or between an aggregate and a monomer, and between two aggregates (see p145, col 2, para 1-2). Thus, the molecular association encompasses various aggregates containing different numbers of monomers. It is not clear on which aggregates the concentration change rate is based on and how it can be measured.
Accordingly, one of ordinary skill in the art would ascertain the metes and bounds of the claims.
For the examination purpose, the claim 1 is interpreted to recite “the cosmetic composition is a solution containing water” and claim 3 is interpreted to recite “the solution has the pH of exceeding 8.5 and less than 10”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Djavanbakht et al. (J. Colloid and Interface Science, 59 (1): 139-148, March 15, 1977; cited in the IDS filed on 9/22/2025).
Djavanbakht et al. teach a bile salt solution wherein the bile salt is in the state of aggregates (molecular association) with fairly well-defined shape (associated structure) (p139, col 2, para 1).
As to 1 and 5, Djavanbakht et al. disclose that sodium or potassium salts of cholic acid, deoxycholic acid (DOC), and dehydrocholic acid (DHC) are prepared by mixing a certain amount of the bile acid and the stoichiometric amount of 1 N NaOH or KOH, wherein the mixture is stirred until complete dissolution and water added to complete the volume of solution to the 50 ml mark (p140, col 2, Materials). Djavanbakht et al. further teach that the excess ultrasonic absorption pattern of the solutions comprising the bile salts indicates molecular association of bile acid anions wherein the bile acid molecules are associated via physical bonding such as hydrogen bonding (p141, col 2, para 1 and Fig. 1). It is disclosed that the pH for aqueous solution is 8.4 (Fig. 1). Also, Djavanbakht et al. further teach that the bile acid aggregates are formed by the series of bimolecular reactions (the bile salt molecules are physically bonded) (p145, col 1 last para -col 2, para 1).
As to the preamble, “cosmetic composition”, it is an intended use. Since the instant claims are directed to a composition, an intended use, which is for cosmetic use, does not have a patentable weight. An intended use of 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. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In this case, the prior art teaches the same composition comprising bile salt aggregates (molecular association of bile salt) in water as the instant claims and the composition does not include any other components that would make it unfit as a cosmetic composition. Thus, it would be capable of performing the intended use as claimed. In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
As to claims 4 and 6, the prior art discloses the same composition comprising the same bile salt aggregates (molecular association of bile salt molecules) in water as the instant claims. Thus, the formed molecular association is necessarily amorphous as recited in claim 4 and intended results recited in claim 6 necessarily occurs. It is noted that products of identical chemical composition cannot have mutually exclusive properties and 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). When the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
As such, the instant claims are anticipated by Djavanbakht et al.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mukhopadhyay et al. (Current Science, 87 (12): 1666-1683, 2004).
Mukhopadhyay et al. disclose that in aqueous environments, bile salt aggregates to form micelles (molecular association) and these micelles, under physiological conditions, are transformed into mixed-micelles with lecithin and glycerides, which are responsible for fat/ cholesterol solubilization in the small intestine (p1673, col 1, last para). Mukhopadhyay et al. also teach that aggregation of bile salts in aqueous solution is largely driven by the hydrophobic association of apolar β-faces of steroid backbones while further aggregation occurs through hydrogen bonding interaction (physically bonded) (p1673, col 2 para 2 and figure 8). The figure 8 shows associated structure of the molecule association in which the molecular association of bile salts is formed in a composition containing water.
As to claim 2, Mukhopadhyay et al. disclose that QLS-studies have suggested that the hydrodynamic radius increases from 10 to 16 Å (1-1.6 nm) for smaller primary micelles to about 100 Å (10 nm) for larger secondary micelles (the bile salt molecules are physically bonded) (p145, col 2, para 3).
Also, Mukhopadhyay et al. teach that the aggregation number increases with increasing added salt (NaCl), increase in the aggregation number is more pronounced in the case of dihydroxy bile salts (deoxycholic acid and chenodeoxycholic acid) (p1673, col 2, para 2).
In addition, it teaches that a lowering of pH (from 9 to 7.3) further increases the aggregation number (>500) for dihydroxy bile salts, which is responsible for thickening of the aqueous solution to afford gel or gel-like materials (p1673, col 2, para 2). Thus, this teaching appears to implicitly disclose a composition having pH of 9, which falls within the range recited in claim 3.
As to the preamble, “cosmetic composition”, it is an intended use. Since the instant claims are directed to a composition, an intended use, which is for cosmetic use, does not have a patentable weight. An intended use of 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. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In this case, the prior art teaches the same composition comprising bile salt aggregates (molecular association of bile salt) in water as the instant claims and the composition does not include any other components that would make it unfit as a cosmetic composition. Thus, it would be capable of performing the intended use as claimed. In accordance with the patent statutes, an article or composition of matter, in order to patentable, must not only be useful and involve invention, but must also be new. If there is no novelty in an article or composition itself, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is.
As to claims 4 and 6, the prior art discloses the same composition comprising the same bile salt aggregates (molecular association of bile salt molecules) in water as the instant claims. Thus, the formed molecular association is necessarily amorphous as recited in claim 4 and intended results recited in claim 6 necessarily occurs. It is noted that products of identical chemical composition cannot have mutually exclusive properties and 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). When the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
As such, the instant claims are anticipated by Mukhopadhyay et al.
Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR 20210079570 (cited in the IDS filed on 1/12/2024).
KR 20210079570 teaches a composition as an external preparation comprising deoxycholic acid (bile acid) and hyaluronic acid as active ingredients which is prepared using saline or water as solvent (abstract and claims 3-4). KR 20210079570 further teaches that the composition is a lipolytic substance which removes fat from local areas such as chin for cosmetic purpose ([0051]).
According to the instant claim 1, claimed molecular association is formed in a composition containing water. The prior art discloses a composition comprising a bile acid such as deoxycholic acid in water, thus a molecular association in which the bile acid molecules are physically bonded as claimed is necessarily present in the composition of the prior art. Also, the formed molecular association is necessarily amorphous as recited in claim 4 and intended results recited in claim 6 necessarily occurs. It is noted that products of identical chemical composition cannot have mutually exclusive properties and 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). When the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
As such, the instant claims are anticipated by KR 20210079570.
In the alternative, the following 103 rejections is applied.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Mukhopadhyay et al. (Current Science, 87 (12): 1666-1683, 2004) in view of KR 20210079570.
Mukhopadhyay et al. as applied supra is herein applied for the same teachings in their entirety.
Mukhopadhyay et al. do not disclose a specific embodiment of a cosmetic aqueous solution comprising bile salt aggregates, which has the pH of exceeding 8.5 and less than 10.
However, Mukhopadhyay et al. already teach that a lowering of pH from 9 to 7.3 increases the aggregation number (>500) for dihydroxy bile salts, which is responsible for thickening of the aqueous solution to afford gel or gel-like materials (p1673, col 2, para 2).
Also, KR 20210079570 teaches a composition as an external preparation (cosmetic composition) comprising deoxycholic acid (bile acid) and hyaluronic acid as active ingredients which is prepared using saline or water as solvent and the use of the composition as lipolytic substance for cosmetic purpose (abstract, claims 3-4, and [0051]).
As to the claimed pH range, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize pH of the solution for obtaining desired size of the bile salt aggregates because Mukhopadhyay et al. teach and suggest the number of the bile salt aggregation can be adjusted depending on pH. Based on the pH range taught by Mukhopadhyay et al. the skilled artisan would have been capable of optimizing pH around 9 if a solution with the low viscosity is desired. Also, the range of the prior art overlaps those claimed. In cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
As to the cosmetic composition, one of ordinary skill in the art would have been motivated to prepare a cosmetic composition with the bile salt aggregates as taught by KR 20210079570 because the bile salt aggregates are taught to solubilize fat/ cholesterol and such cosmetic use has been suggested. The skilled artisan would have reasonably expected that the resulting cosmetic composition comprising bile salt aggregates would be useful for cosmetic purpose of reducing fat/lipid.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of copending application 18/579262.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘262 application are drawn to a molecular association in which bile acid molecule or bile salt molecules are physically bonded, wherein when the molecular association is formed in a composition containing water, the molecular association has an associated structure in the composition, and wherein the average particle diameter of the molecular association is 1.0 to 10 nm or less and the molecular association is amorphous and has the pH of exceeding 8.5 and less than 10 as claimed. Also, the dependent claims of the ‘262 application further recites the use of the molecular association as an external skin preparation (cosmetic composition).
As such, the instant claims are anticipated by or would have been obvious over the claims of the ‘262 application.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611