DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Request for Continued Examination (RCE), Amendments and Remarks, filed 19 September 2025, in the matter of Application N° 16/464,026. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been amended or canceled. Claim 33 is newly added and the subject matter that is present, is supported by the originally-filed disclosure (see e.g., claim 1).
No new matter has been added.
Thus, claims 1, 3, 4, 8-11, 14, 16, 17, 21-23, and 29-33 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statement(s) (IDS) have been filed for consideration.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
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.
Newly added claim 33 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.
As mentioned above, the subject matter that is present within the newly added claim is newly redundant to independent claim 1. However, the claim ends with a comma instead of a period, and it is therefore unclear if the claim is complete. It is unclear, for instance, if it was Applicants’ intent to also add the final two ‘wherein’ clauses to claim 33 like those present in claim 1.
Herein, for the purposes of continued consideration on the merits, the Examiner will consider the subject matter present within claim 33 as though it were properly punctuated.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 20 March 2025 since the art that was previously cited continues to read on the previously and newly recited limitations.
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 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.
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. Applicants are 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.
Claims 1, 3, 4, 8-11, 14, 16, 17, 21-23, and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Cyril et al. (FR 2 946 253 A1; IDS reference) in and Portolan et al. (WO 2016/007461 A1; IDS reference). [emphasis added to reflect the newly added claim]
Claim 1 continues to recite a method of treating keratin material comprising the topical administration of a composition comprising at least one aqueous, aqueous-alcoholic, or aqueous-glycolic truffle extract and neohesperidin dihydrochalcone, wherein the former is present in an amount ranging from 0.00011% to 0.01% by weight, relative to the total weight of the composition, and the latter is present in an amount ranging from 0.01% to 0.2% by weight, relative to the total weight of the composition. Neohesperidin dihydrochalcone (DHC) has the following formula:
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Cyril discloses a cosmetic kit or assembly composition which comprises neohesperidin dihydrochalcone (see e.g., Abstract; claim 1). The amount of neohesperidin DHC disclosed as being present in the composition is taught as ranging from 0.01% to 6% by weight relative to the total weight of the mixture, and preferably from 0.1% to 3.5% by weight relative to the total weight of the mixture (see e.g., pg. 8, lines 4-9). Disclosed as first and second compositions combined to form the resulting mixture, neohesperidin DHC resides within the second composition and comprises 0.01-7.5% by weight and, more preferably, 0.1% to 4% neohesperidin DHC relative to the total weight of the second composition (see e.g., pg. 8, lines 11-14).
Claims 16 and 17 disclose a process for improving the appearance of skin comprising administering the composition of the claims to the skin. Claim 17 elaborates on the improvement of the skin disclosing that the method will treat oxidative stress and/or the effects of sun exposure and/or aging of the skin or its appendages.
The reference additionally discloses that after about 25-30 years an imbalance towards oxidative stress will cause not only structural damage, but also a loss of performance in the body’s protection and repair systems. The process of skin aging is a complex phenomenon that is influenced by both genetic and environmental factors. During cellular aging, regardless of the stimulus, there is an accumulation of damaged cell components (i.e., nucleic acids, lipids, proteins, etc.) and the elimination and/or repair of those damaged components becomes less effective compared to younger cells. The defense systems are essentially unable to neutralize all of the free radicals produced by the body. The formation of these damaged cellular components is primarily affected by reactions involving reactive oxygen species (ROS) (see e.g., pg. 2, entire page). Thus, what this passage conveys to the ordinarily skilled artisan is that the presence and/or long-term accumulation of reactive oxygen species (ROS) ultimately results in the presence of damaged cellular components in the skin. The accumulation of the damaged components thus presents the skin with an aged and tacky (roughened) appearance.
Thus, the method and compositions disclosed by the teachings of Cyril are considered to meet each of the instantly claimed limitations with one notable exception.
Cyril does not expressly teach combining neohesperidin DHC with anyone of an aqueous, aqueous-alcoholic, or aqueous-glycolic extract of truffle. At best, Cyril teaches and suggests that plant extracts, in general, may be added to the practiced composition as an additional active ingredient to the formulation (see pg. 39, lines 13-20).
The teachings of Portolan, however, are considered to bridge the gap in and remedy the deficiency in Cyril’s teachings.
Portolan is directed specifically to aqueous truffle extract compositions which are for topical (skin) cosmetic use (see e.g., Abstract). Claims 7-10 disclose a cosmetic composition adapted for topical application, wherein said composition comprises the aforementioned aqueous truffle extract in a concentration ranging from about 0.0001% by weight to about 20% by weight of the composition at its broadest. More narrowly, the concentration of the extract is taught as ranging from about 0.0005% by weight to about 5% by weight of the topical composition. The Examiner notes that this range clearly overlaps the concentration as instantly recited. The reference is also noted as providing clear and inarguable motivation for employing truffle extract concentrations that reside at the lower end of the ranges; specifically at a part of the range which falls squarely within the instantly recited range of 1.1x10-4% (0.00011%) to 0.01% by weight of the composition. Figure 1 of the reference provides said motivation:
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As is clearly set forth in the title of the Figure and in the descriptions of the drawings (see pg. 3, lines 25-27), the Figure measures the ability of truffle extract to reduce the presence of reactive oxygen species (ROS). What is made evident from the Figure is that the weight percent of truffle extract present is directly proportional to the presence of ROS. Thus, from the above showing a person of ordinary skill in the art would be provided with clear motivation to employ a concentration of 0.01-0.05% by weight of truffle extract in a topical formulation and have a reasonable expectation that the formulation will accomplish the disclosed method. Therein, the disclosed method of Portolan is directed to a cosmetic treatment designed to reduce and/or correct the signs of aging and photo-aging of the skin and keratinous appendages, and to protect the skin against aggressions due to ultraviolet radiation (see e.g., Abstract).
The key deficiency of Portolan is that it does not teach or suggest combining its aqueous truffle extract formulations with other such active ingredients as neohesperidin DHC in a topical formulation.
Despite their respective deficiencies, the Examiner concludes that a person of ordinary skill in the art at the time the instant invention was filed would have had a reasonable expectation of producing the instantly claimed composition and achieving the claimed methods of treatment.
MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.”
The Examiner respectfully submits that a person of skill in the art in possession of the teachings of both Cyril and Portolan, would be presented with clear motivation to produce a composition containing both neohesperidin DHC and an aqueous truffle extract. Upon application to the skin of such a composition, the same artisan would quite reasonably expect a reduction in the presence of reactive oxygen species (ROS), thereby reducing the signs of chronobiological and/or photo-induced aging of the epidermis as instantly claimed.
Both references individually teach the topical application of neohesperidin DHC and aqueous truffle extract compositions to accomplish the same result: cosmetically reducing the signs of aging and damage to the skin by reducing the presence of ROS. As each compound is taught to do this individually, the skilled artisan would thus reasonably expect that formulation containing both would also accomplish the same result.
The foregoing is considered to immediately teach and suggest the limitations recited in claims 1, 3, 4, 8-11, 14, 16, 17, and 33.
Regarding the recited ratios of the neohesperidin DHC to truffle extract, said ratio, at its broadest is recited as ranging from 10:1 NDHC:extract to 1:100 (0.01:1). Within the preferred compositional weight percentages of the two components, a person of skill in the art would not that a composition containing, for instance, 0.1% by weight of neohesperidin DHC and 0.01-0.05% by weight of the aqueous truffle extract would have a weight ratio of 10:1 to 2:1. The ratio limitations of claims 1, 22, and 23 are considered by the Examiner as being met.
The limitations recited in claims 1, 14, and 21 are directed to the source of the truffle extract. Here, the Examiner considers the truffle extract to be met by the showing of the aqueous truffle extract, notably since it is the extract that is claimed and the extract that is disclosed. However, the Examiner notes that the reference also teaches that different sources may be relied upon in defining the source of the extract. “Truffle” is defined by the reference as being inclusive of both black and white truffles (see e.g., pg. 4, lines 10-17).
The Examiner considers this ratio to be met by the above teachings, notably as the amounts for each of the recited components are individually met by their respective references.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 3, 4, 8-11, 14, 16, 17, 21-23, and 29-33 under 35 USC 103(a) as being unpatentable over the combined teachings of Cyril et al. and Portolan et al. have been fully considered but they are not persuasive.
Applicants initial argument traversing the rejection is that there is a difference between immediate and long-term biological effects and conditions for achieving the different types of biological effects.
More specifically, it is Applicants’ position that the combination of Cyril and Portolan teach the recited property of increasing filaggrin expression in keratinocytes because the reduction in ROS production data relied upon by the Examiner is indicative of an “immediate effect” following exposure to the combination of white truffle extract and neohesperidin dihydrochalcone. Instead, Applicants allege distinction over the cited prior art because “longer exposure after application to the inventive neohesperidin DHC/truffle extract combination is important for increasing filaggrin expression in a more-than-additive/synergistic manner.” Applicants attempt to further support this position stating that “[f]ilaggrin (or filagrin), a protein present in keratohyalin granules, is produced during the final stages of the differentiation of the epidermis” (Spec.; pg. 2, lines 15-18).
The Examiner does not disagree with Applicants’ characterization of filaggrin or its association with late-stage dermal differentiation. However, Applicants’ position is unpersuasive for two key reasons.
First, in response to the argument that the references fail to show certain features of the invention, it is noted that the feature upon which Applicants rely (i.e., duration of exposure to the applied composition) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicants’ remark above indicates that the purported synergistic effect relies upon exposure to the skin for periods of time that are longer than disclosed by the art of record.
Secondly, Applicants’ admit on the record that “[e]pidermal differentiation is known to be a complex, multi-day biological process. It is not instantaneous or immediate.”
The Examiner acknowledges and agrees with this statement. That being said skin cells are well-understood as being in any given stage of cellular differentiation as they are constantly and continually being naturally replaced. The state-of-the-art recognizes this (see e.g., Sandilands et al.; J Cell Sci.; 2009, Figure 1). In view of such evidence, the Examiner advances that the application of the composition would have an immediate effect as cells in the final stage of differentiation are arguably, always present on the surface of the skin.
Furthermore, it seems as though Applicants’ data appear to require three continuous days of exposure to the composition following application in order to exhibit the alleged effect.
Thus, while the Examiner acknowledges that neither reference mentions filaggrin at all, it is respectfully submitted that the positively recited limitations of the method, namely the application of the subject composition to the skin are disclosed. Portolan’s data, though drawn to a more “immediate effect” as argued by Applicants, is respectfully, not commensurate in scope with the breadth of the claimed method.
Applicants next argue that “the different purposes/effects of the claimed methods vs. the asserted art provide evidence of alternative biological pathways for the claimed methods as compared to those pathways in ROS reduction. They are not the same methods yielding the same results by the same pathways. Immediately addressing ROS on the skin after application as in the asserted art would not have led one of ordinary skill in the art to expect any activity within the skin later in time.”
In response to Applicants’ argument that “[t]he purpose/effect of the asserted art is immediate, whereas the purpose/effect of the claimed methods is longer term, during the final stages of epidermal differentiation,” the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicants are additionally directed to MPEP §2112.02(II) which states that “[t]he discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using” and that “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated.”
As maintained above, the Examiner has established a showing of obviousness whereby an advantage to combining the two claimed components provides an improved effect. Though the improvement is not aligned with Applicants’ recited property, it is respectfully pointed out that the result of the prior art does not introduce any new “use,” merely simple dermal application.
The remainder of the filed remarks are noted by the Examiner as already being made of record in the previous responses, and are reproduced here for Applicants’ convenience:
Applicants assert that the ordinarily skilled consumer’s use of Cyril does not include an emulsification process to prepare a composition containing both vitamin C and neohesperidin prior to use. One following Cyril would not prepare an emulsion composition, and one of ordinary skill in the art would not be able to prepare an emulsion composition.
It is similarly alleged that Portolan does not compensate for Cyril’s perceived deficiencies. It is Applicants’ position that each of Cyril and Portolan are directed to independently prepared compositions, neither of which are emulsions, and that it would not be obvious to prepare an emulsion from the practiced compositions.
The Examiner disagrees.
At the outset, the preparation of an emulsion, let alone a composition, is not at issue. The claimed invention is directed to the administration of a composition.
Here Applicants’ response offers the assertion that the Examiner is erring in the interpretation of the claimed invention in that the element of an emulsion is not at issue. To this, the Examiner respectfully submits that the previous comment was not intended to be dismissive of the emulsion limitation in claim 1. Rather it was meant to address that the claimed invention is not directed to a method of preparing an emulsion. Clearly, the administration of an emulsion is at issue, which is why the art of record is maintained.
Applicant additionally asserts that the Examiner has misinterpreted the teachings of the art insomuch that that “Cyril suggests using emulsifying surfactants when it is actually distinguishing emulsifying surfactants from (which are not part of Cyril’s composition) from foaming surfactants. Nothing in Cyril teaches, suggests or enables production of an emulsion. One of ordinary skill in the art following Cyril would not produce an emulsion. Accordingly, one of skill in the art, seeking to modify Cyril, would not produce an emulsion, and one of ordinary skill in the art, following Cyril wound not apply an emulsion to keratinous material as set forth in the pending claims.”
The Examiner again disagrees.
The teachings of Cyril are inclusive of emulsions since the teachings disclose the incorporation of foaming surfactants as admitted to by Applicants on the record. The Examiner respectfully submits that while Applicants’ claims do recite the administration of an emulsion (which necessarily includes an emulsifying component), the instant claims fail to provide any recitation directed to the type of emulsifying agent used. The Examiner additionally submits that a person of ordinary skill in the art understand that surfactants and emulsifying agents, absent any further distinguishing definition, are synonymous.
The Examiner additionally points out that the practiced compositions of Cyril, which are topically applied, preferably contain silicone elastomer which may be either emulsifying or non-emulsifying (see pg. 8, lines 16-19). Therein, Cyril discloses that the emulsifying silicone elastomers may be chosen from polyoxyalkylenated silicone elastomers (see pg. 11, lines 28-32).
Furthermore, the Examiner notes Cyril’s teachings discussing “emulsifying” surfactants versus “foaming surfactants,” but disagrees that this presents a teaching away from the claimed invention, notably as Applicants’ instant claims. Cyril teaches and suggests the inclusion of surfactants, which by chemical definition possess both a hydrophilic and hydrophobic component, and thus are expected by the ordinarily skilled artisan as being present in an emulsion.
The cited passage within Cyril distinguishes between the different types of surfactants on the basis of their HLB values, and nothing more.
Thus, contrary to the assertion, the Examiner has not dismissed the claimed term, Cyril does teach and suggest emulsion formulations, and Cyril does teach and suggest the application of emulsions applied to the skin, as instantly claimed.
Next, both Cyril and Portolan teach and suggest that their respective compositions may be formulated as emulsions, with Portolan teaching that the emulsion may be either a water-in-oil, or an oil-in-water emulsion (see e.g., pg. 9, line 15 to pg. 10, line 4). Cyril teaches that its practiced compositions advantageously use foaming surfactants as opposed to emulsifying surfactants and defines the different surfactants for the different intended functions by the practiced ranges of HLB values. Thus, while Cyril may not expressly teach that its formulations are necessarily in the form of emulsions, it does provide defining guidance for the ordinarily skilled artisan to select an emulsifying surfactant based on the desired emulsion (see pg. 33, line 18 to pg. 34, line 3). As Portolan teaches and suggests the compositions being formed as emulsions, the combined teachings are considered to teach the skilled artisan which surfactants are useful depending on the type of emulsion being prepared.
Applicants’ remaining remarks are noted as being a re-summarization of earlier filed remarks directed to unexpected results and assertions of synergism.
The Examiner maintains that these remarks are not persuasive as detailed in the Non-Final Office Action mailed 21 March 2023.
For these reasons, Applicants’ arguments are found unpersuasive. Said rejection is therefore maintained.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615