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 1-16 are pending.
Election/Restrictions
Applicants’ election of Group I, in the reply filed on 7/20/2026 is acknowledged. The election was made without traverse.
Accordingly, claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 1-8 are under examination in the instant office action.
Claim Objections
Claim 8 is objected to because of the following informalities: typographical errors. It appears that --selected-- is missing before “from the group consisting of” in line 2. Also, “any one salt from the group consisting of” in line 3-4 should be corrected to --a salt of any one selected from the group consisting of”.
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 1-8 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 4 recites “the molecular association has the pH of exceeding 8.5 and less than 10 and claim 7 recites “the molecular association has a pH change rate….”. 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 and pH change rate? Clarification is required.
In addition, claims 5-6 recite “the molecular association has a “concentration change rate” and a “particle size change rate”, respectively”
It is unclear how the concentration and particle size of the molecular association can be measured when the product of claimed molecular association is not clearly defined. According to Djavanbakht et al. (J. Colloid and Interface Science, 59 (1): 139-148, March 15, 1977; cited in the IDS filed on 9/22/2025), 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 and thus having different particle sizes. It is not clear on which aggregates the concentration change rate is based on and how it can be measure. It is also not clear on which aggregates the particle size 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 “a composition containing a molecular association in water”. Also, claim 4 is interpreted to recite “the composition has the pH of exceeding 8.5 and less than 10” and claim 7 is interpreted to recite “the composition has a pH change rate…..”.
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, 3, and 5-8 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 claims 1 and 8, 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 claims 3 and 5-7, 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 3 and intended results recited in claims 5-7 (concentration change rate, particle change rate, and pH change rate) necessarily occur. 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 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mukhopadhyay et al. (Current Science, 87 (12): 1666-1683, 2004; cited in the IDS filed on 9/22/2025).
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 claims 3 and 5-7, 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 3 and intended results recited in claims 5-7 (concentration change rate, particle change rate, and pH change rate) necessarily occur. 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, 3, and 5-8 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 3 and intended results recited in claims 5-7 (concentration change rate, particle change rate, and pH change rate) necessarily occur. 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 1-8 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 an 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 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 for preparing a cosmetic composition as lipolytic substance as taught by KR 20210079570. 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).
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 1-8 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 4-13 of copending application 18/578902.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘902 application are drawn to a cosmetic composition comprising 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 molecular association is prepared by applying shear stress to bile acid molecules or bile salt molecules, the average particle diameter of the molecular association is 1.0 to 10 nm, and the molecular association is amorphous and has the pH of exceeding 8.5 and less than 10 as claimed.
As such, the instant claims are anticipated by or would have been obvious over the claims of the ‘902 application.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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