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
The amendment filed on April 29, 2026 is acknowledged. Claims 2-3 have been canceled and claims 7-13 have been withdrawn. Claims 1 and 4-6 are under examination in the instant office action. Applicant affirmed provisional election of Group I.
Applicants' arguments, filed on April 29, 2026, have been fully considered but they are not found to be persuasive or moot in view of a new ground of rejection necessitated by the amendments (new limitation). Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The terminal disclaimer filed on 5/5/2026 disclaiming the terminal part of the statutory term of any patent granted on the instant application which would extend beyond the expiration date of the full statutory term of any patent granted on pending reference application number: 18/579262 has been reviewed and accepted. The terminal disclaimer has been recorded. In view the terminal disclaimer, the provisional rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of copending application 18/579262 is hereby withdrawn.
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 and 4-6 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. For the examination purpose, the claim 1 is interpreted to recite “the cosmetic composition is a solution containing water”.
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.
Accordingly, one of ordinary skill in the art would not ascertain the metes and bounds of the claims.
Response to Applicant’s arguments
Applicant stated that the term “associated structure” in claim 1 is amended to specify that the molecular association is prepared by applying shear stress to bile molecules or bile salt molecules and this specific structure formed via external shear stress is clearly distinguishable from conventional micelle structure. However, adding such preparation method does not address the indefiniteness of the claims as stated above because it is still unclear what specific associated structure is formed via external shear stress and also it does not make it clear whether the claimed cosmetic composition requires comprising water.
Also, adding a step of how to measure the concentration of the molecular association does not make claim 6 clear because it is still unclear which molecular association the concentration change rate is based on. For example, the concentration change is based on changing from dimers to monomers, from oligomers to dimers, oligomers to monomers, or combination thereof? Accordingly, the above rejection is properly mainlined.
Claim Rejections - 35 USC § 102/103
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.
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 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as being unpatentable over 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.
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) (p1673, col 2, para 3). Thus, the average particle diameter of the molecular association falls within the claimed range (1.0 to 10 nm).
Also, Mukhopadhyay et al. teach that the aggregation number increases with increasing added salt (NaCl) and 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).
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 discloses 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 the new limitation, “wherein the molecular association is prepared by applying shear stress to bile acid molecules or bile salt molecules” in amended claim 1, the prior art does not teach claimed process of preparing the molecular association. However, the prior art teaches the same product comprising molecular association of bile acid or bile salt molecules in a composition containing water. There is no indication that there is any structural difference resulted from claimed process. “[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, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113.
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 when the concentration is measured by using HPLC analysis as claimed. 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]."
Thus, the claims are anticipated by or, in the alternative, obvious over Mukhopadhyay et al.
Response to Applicant’s arguments
Applicant argued that Mukhopadhyay et al. require the addition of NaCl (salt) and describes micelle formation via lipid dissolution. Applicant further argued that this is fundamentally different from our process of applying shear stress to bile acid/salt molecules as recited in amended claim 1. Also, Applicant argued that this difference results in the differences in the structure of the molecular association. In addition, Applicant argued that after particle formation, claimed molecular associations have sizes of 1 to 10 nm while the micellar structures of Mukhopadhyay actually have sizes of several hundred nanometer.
On the contrary to Applicant’s assertion, Mukhopadhyay et al. do not state that the addition of NaCl (salt) is required for formation of bile salt aggregates (molecular association), but Mukhopadhyay et al. only state that the aggregation number increases with increasing added salt (NaCl) (see p1673, col 2, para 2). According to the instant specification, the “molecular association of bile acid or bile salt” refers to a molecular association prepared by applying shear stress to a solution containing bile acid so that bile acid molecule or bile salt molecules are physically bonded, and it means a structure in which bile acid molecules stick together (see [0040]). Mukhopadhyay et al. do show bile salt micelles in which bile salt molecules are physically bonded and the bile salt molecules stick together (see figure 8). Thus, Mukhopadhyay et al. disclose “molecular association” of bile acid or bile salt as defined by the instant application. In addition, Mukhopadhyay et al. disclose 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. Thus, the average particle diameter of the molecular association falls within the claimed range (1 nm to 10 nm=10-100 Å).
While the amended claim 1 recites a product by process limitation, it should be noted that product-by-process claims are not limited to the manipulations of the recited steps, only the structure. While the prior art does not teach process of preparing the molecular association by applying shear stress to bile acid molecules or bile salt molecules, the prior art teaches the same product comprising molecular association in which bile acid or bile salt molecules are physically bonded and stick together. There is no indication that there is any structural difference resulted from claimed process. “[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, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP §2113. In this case, Applicant only stated that the difference in process results in the differences in the structure of the molecular association. However, Applicant did not explain what structural difference was resulted in due to the claimed process. Also, no factual evidence regarding structural difference of the claimed molecular association was provided. Arguments of counsel cannot take the place of evidence in the record. See: In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
For the forgoing reasons, Applicant’s arguments have not been found to be persuasive.
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 extension fee 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 date of this final action.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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