DETAILED ACTION
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 .
The amendment filed 24 February 2026 is acknowledged and has been entered.
Status of the claims
Claims 2-6, 16, 26, 28, 29, 32 and 34-43 have been cancelled.
Claims 23, 24 and 33 have been withdrawn.
Claims 1, 7-15, 17-22, 25, 27 and 30-31 are presented for examination on the merits.
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 1, 7-15, 17-22, 25, 27 and 30-31 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it is unclear if the recited list of components, that is – the lipid phase, aqueous phase, supporting compound, etc., are accumulative or alternatives. In other words, the term “and” or “or” need to precede the final component listed.
Claim 7 is rendered vague and indefinite by the phrase “of claim
6, wherein the acid is ferulic acid”. Firstly, claim 6 has been cancelled. Secondly, it is unclear to what “the acid” is meant to refer. Is this one of the plurality of acids?
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 7-15, 17-22, 25, 27 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Stasko et al. (US2019/0015358) and Lambers et al. (2006) in view of Trombino et al. (2009) and Eckert et al. (US4,263,313) and the online
article “Atomy Absolute Cellactive Serum. Anti-aging serum” uploaded by Banandemon. [refs. cited by Applicant in IDS filed 6/20/23].
Stasko et al. beneficially teaches a topical composition (abstract; para [0091], [0147]; Provided herein are compositions useful for treating inflammation in a subject and methods of decreasing inflammation in the skin, mucosa, and/or eye of a subject comprising applying a pharmaceutical composition that includes an nitric oxide-releasing compound to the skin, mucosa, and/or eye of the subject in an amount
sufficient to decrease inflammation. In some embodiments, a nitric oxide-releasing pharmaceutical composition of the present invention may comprise two compositions that may be and/or are admixed together, a first composition comprising a hydrophobic composition and a second composition comprising a hydrogel. Thus, in some embodiments, the nitric oxide-releasing pharmaceutical composition is an
admixture. Further, an admixture of the present invention may be suitable for topical administration.), comprising: a) an acid comprising a plurality of carboxylic acid groups, wherein at least one carboxylic acid group has a pKa around 4.7, at least one carboxylic acid group has a pKa between 4.7 and 6.5, and at least one carboxylic acid group has a pKa between 3 and 4.7; and its conjugate base (para [0119]; The hydrogel may comprise means for maintaining and/or stabilizing the pH of an admixture of the present invention. The means for maintaining and/or stabilizing the pH of an admixture may be configured to control the pH of the admixture within a desired pH range.
Example means for maintaining and/or stabilizing the pH of an admixture include, but are not limited to, buffers. Examples of buffers that may be used in a hydrogel include citric acid/citrate buffers.); wherein the topical composition, when applied to human skin, maintains a skin surface pH of around 4.7 for at least 6 hours (para [0147], [0124], [0095}; An admixture of the present invention may be suitable for topical administration. The pH of the admixture may be maintained and/or stabilized when the admixture is formed and/or at the site of application (e.g., the skin of a subject and/or a wound bed) for the admixture. In some embodiments, a pH-controlled composition of the present invention may have a pH in a range from 4.5 to 5.0, 4.5 to 4.75, or 4.75 to 5.0 at a time point from 1 to 48 hours after administration and/or combination.). Further, Stasko et al. teaches a composition with an optimal pH buffer capacity at around pH 4.7 (para [0122], [0125]; The hydrogel may comprise a buffering agent having a pKa of about 4.5 or 5. Further, a hydrogel of the present invention/ may have any suitable pH, such as a pH of about 4 to about 5, and such as a pH of about 4.5. Thus, this indicates that a hydrogel that has a pH of about 4.5, and comprises of a buffering agent having a pKa value of about 4.5, would provide optimal buffer capacity at around pH 4.5, Please see the article "Human skin buffering capacity: an overview" to Levin et al. (hereinafter Levin), pg 121, col 1, para 2: "A buffer is a chemical system that can limit changes in pH when an acid or a base is added. Buffer solutions consist of a weak acid and its conjugated base. The system has its optimum buffering capacity when about 50% of buffer is dissociated, or in other words at a pH about equal to its pKa.". Further, please also see instant specification, instant para [0036]; "In some variations, “around 4.7" in the context of pH or pKa refers to 4.7 plus/minus 0.3.". Thus, here, an optimal pH buffer capacity at around pH 4.7 includes an optimal pH buffer capacity at pH 4.7 plus/minus 0.3.).
Stasko et al. does not provide a specific example/embodiment for a composition with an optimal pH buffer capacity at around pH 4.7.
However Lambers et al. beneficially teaches that it is estimated that the "natural" skin surface pH is on average 4.7, i.e. below 5 (pg 359, col 1, para 1). Lambers also teaches that it can be rationalized that products with buffered pH levels around pH 4.7 or lower will minimize disturbance of the "natural" skin surface pH (pg 365, col 1, para 3).
Lambers et al. does not specifically teach a composition with an optimal pH buffer capacity at around pH 4.7. However, as Lambers teaches the natural skin surface pH is on average 4.7 (pg 359, col 1, para 1); and as Stasko et al. teach that the hydrogel can provide optimal buffer capacity at around pH 4.5, i.e. pH 4.2
to pH 4.8 (para [0122], [0125]); then it would have been obvious to one ordinary skilled in the art to provide a composition with an optimal pH buffer capacity at around pH 4.7; because it is estimated that the natural skin surface pH is on average 4.7, i.e. below 5
(pg 359, col 1, para 1). Further, because it can be rationalized that products with buffered pH levels around pH 4.7 or lower will minimize disturbance of the natural skin surface pH (pg 365, col 1, para 3). Moreover, because we have shown that the average
natural pH value of the skin is 4.7, lower than currently assumed; this acid mantle, next to factors like hydration and presence of minerals as nutrients, creates an environment where resident flora (mainly members of staphylococci, micrococci, coryneforms and
propionibacteria) can grow, while growth of transient flora (e.g. Gram negative bacteria like Escherichia and Pseudomonas specs or Gram positive, coagulase positive Staphylococcus aureus or Candida albicans) is inhibited (see also figure 6). Growth and presence of the resident flora effectively contributes to preventing these potentially pathogenic microorganisms to colonize the skin (pg 366, col 2, para 2; figure 6).
Neither Stasko et al. nor Lambers et al. do not teach a hydrogel comprising an acid having one carboxylic acid group and its conjugate base, wherein the acid has a pKa around 4.7, and wherein the acid has a molecular weight of at least 140 g/mol.
However, Trombino et al. teaches a hydrogel comprising an acid having one carboxylic acid group, wherein the acid has a pKa around 4.7, and wherein the acid has a molecular weight of at least 140 g/mol (abstract; pg 142, para 2; In the present work, we report the synthesis of cellulose hydrogel containing ferulic moieties and the evaluation of its antioxidant and scavenger activity. With the aim of taking advantage of the antioxidant properties of the trans-ferulic acid, an hydrogel containing this residue has been synthesized.) The results suggested that ferulate material poses an excellent antioxidant and radical scavenger activity (pg 145, para 1). Therefore, it
would have been obvious to one ordinary skilled in the art to utilize ferulic acid, as taught by Trombino; with the topical composition that Stasko et al. and Lambers et al. teach; because in the present work, we report the synthesis of cellulose hydrogel containing ferulic moieties and the evaluation of its antioxidant and scavenger activity. Hydrogel was found to be very efficient scavengers of DPPH (1-diphenyl-2-
picrylhydrazyl) radicals. The results strongly suggested that the antioxidant hydrogel neutralize free radicals (Trombino; abstract). The so obtained antioxidant biopolymer could be used in cosmetic and pharmaceutical fields and would substantially reduce free radical damage and oxygen depletion (Trombino; pg 145, para 1).
Eckert et al. beneficially teaches a topical composition wherein
at least one supporting compound comprises one medium chain fatty acid (col 1, In 8-12; col 2, In 12-15; col 4, In 20-21; The present invention relates to a permeability-enhancing carrier composition for topical pharmaceutical formulations. Preferably the carrier composition further comprises a pharmaceutical additive having viscosity-improving gel-forming or structuring properties and/or a free fatty acid of medium chain length. Capric- and caprylic acids are especially preferred.). Therefore, it would have been obvious to one ordinary skilled in the art to utilize a medium chain fatty acid, such as capric- and caprylic acids, as taught by Eckert; with the topical composition that Stasko et al. and Lambers teach; because these free acids serve to maintain the desirable acid-level of the skin. The free fatty acids of medium chain length preferably also contain from about 6 to about 12 carbon atoms. Capric- and caprylic acids are especially preferred since they are substantially odorless (Eckert; col 4, In 12-25).
Stasko et al. and Lambers do not teach a topical composition comprising: a ceramide complex; niacinamide; phytosphingosine; and hyaluronic acid. However, Banandemon, teaches a topical composition comprising: a ceramide complex; niacinamide; phytosphingosine: and hyaluronic acid (title; pg 3, para 2; pg 4, para 1; pg 20, para 3; Atomy Absolute Cellactive Serum. Key ingredients include Niacinamide, Phytosphingosine, Ceramide NG, Ceramide NP, and Sodium hyaluronate. Further, as far as skincare goes, sodium hyaluronate and hyaluronic acid are pretty much the same and the two names are used interchangeably. As cosmetic chemist Kindofstephen writes on reddit "sodium hyaluronate disassociates into hyaluronic acid molecule and a sodium atom in solution".).
Therefore, it would have been obvious to one ordinary skilled in the art to utilize a ceramide complex such as Ceramide NP, niacinamide; phytosphingosine; and hyaluronic-acid/ sodium-hyaluronate, as taught by Banandemon; with the topical composition that Stasko et al. and Lambers teach; because ceramide NP is one of the many types of ceramides that can be found naturally in the upper layer of the skin.
Ceramides make up about 50% of the goopy stuff that is between our skin cells and play a super important role in having a healthy skin barrier and keeping the skin hydrated (Banandemon; pg 29, para 4; pg 30, para 1).
Furthermore, because phytosphingosine is a type of lipid, a so-called sphingoid
base that can be found naturally in the upper layer of the skin. It's found both in "free-form" and as part of famous skin lipids, ceramides. There is emerging research about phytosphingosine that shows that it has antimicrobial and cell-communicating properties and is considered part of the skin's natural defense system (Banandemon; pg 36, para 2-3). Moreover, because in some embodiments, a composition of the present invention may be antimicrobial (Novan; para [0061]). in addition, because hyaluronic acid is a huge polymer found in the skin that acts as a sponge helping the skin to hold onto water, making it plump and elastic (Banandemon; pg 20, para 2; pg
31, para 1). Finally, because niacinamide is multi-functional skincare superstar with several proven benefits for the skin. It is a great anti-aging, wrinkle smoothing ingredient used at 4-5% concentration. It fades brown spots alone or in combination with amino sugar, acetyl glucosamine. It increases ceramide synthesis that results in a stronger, healthier skin barrier and better skin hydration. It can help to
improve several skin conditions including acne, rosacea, and atopic dermatitis (Banandemon; pg 29, para 1).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the Application to employ ferulic acid within a topical skin care product to maintain the pH of the skin at about 4.7 as taught by the prior art exemplified by the cited references. The claimed topical composition merely employs well-known skin care ingredients and there is a high level of agreement that topical products should be acidified and possess pH in the range of 4 to 6.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
The adjustment of particular conventional working conditions (e.g., determining an appropriate daily dose thereof and/or employing one or more commonly-employed excipients/adjuvants) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Response to Arguments
Applicant’s amendment of the claimed composition to a cream with respect to 35 USC 101 rejection have been fully considered and are persuasive. The 35 USC 101 rejection of the previous Office action has been withdrawn.
However, the extensive amendments have introduced some indefiniteness into the claims, as put forth above.
Applicant's amendments/arguments filed with respect to the 35 USC 103 rejection have been fully considered but they are not persuasive.
It should be noted that the claims are directed to a composition not its method of use or its intended use. However, the claims are drafted more towards the objectives of maintaining the skin at an optimal pH, rather than actually reciting the component ingredients used to obtain that result. As stated previously, maintenance of the skin at the recited pH range is well-known on the prior art. Thus it would be well within the purview of the skilled practitioner to choose acids with pKa within a certain range. Such is determined to be routine optimization.
However, if Applicant has found a particular combination of components that results is some unexpected/surprising results, this could be evidence of something more than simple optimization. But the claimed composition needs to recite the constituent composition used to obtains such results. With respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
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.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655