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 .
Priority
This application is a national stage entry under 35 USC 371 of PCT/EP2021/0161729 filed 4 May 2021 which receives the benefit of foreign priority from French Application no. 2004500 filed 6 May 2020.
Response to Amendment
The preliminary amendment filed 14 October 2022 has been acknowledged. Claims 1-20 are pending, wherein claims 13-20 are new.
Claim Objections
Claim 14 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 13. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature and/or natural principle) and the additional elements, considered both individually and in combination, do not amount to significantly more than the judicial exception itself.
Step 1
The claims are drawn a process (claims 1-6 and 17-20) and to an apparatus (claims 7-16). Accordingly, they fall within one of the four statutory categories of invention.
Step 2A, Prong 1
The claims recite applying to the skin of an individual a topical composition containing niacinamide and illuminating the skin with one or more light sources emitting light of specific wavelength ranges. The claimed subject matter therefore relies upon the natural principle that exposure of human skin to light of certain wavelengths produces biological and cosmetic responses (e.g., the increase in collagen synthesis, anti-inflammatory effects, etc). This principle of photobiomodulation represents a law of nature, i.e., the naturally occurring relationship between light energy and cellular response in skin tissue.
Step 2A, Prong 2
The additional elements in the claims (E.g., applying a conventional niacinamide composition, performing illumination before, during, or after application, or using conventional light-emitting devices as known cosmetic wavelengths) do not integrate the judicial exception into a practical application. The claims merely instruct a practitioner to apply known topical active composition and expose the skin to known light ranges in order to obtain the expected natural result. No improvement to any technology or technical field is recited; no particular light delivery mechanism, control logic, or non-routine operation is specified. The steps amount to nothing more than applying the natural principle with generic instructions and conventional features.
Step 2B
The additionally elements, considered individually and in combination, fail to amount to significantly more than the judicial exception itself. Each recited feature is well-understood, routine, and conventional in the cosmetic and dermatological arts:
Topical application of niacinamide at concentrations of 0.5-10 % is well known prior to the effective filing date (EP 3 060 311 B1 para 18-19);
Illumination of the skin with red (620-690 nm), blue (410-470 nm), and near-infrared (750-970 nm) and mixed wavelengths uses LEDS or lasers was well-established in LED facial/dermatological skin treatments and devices (Decaux et al. US Publication no. 2018/0071547, para 9, 22, 23, 26, and 27);
Sequencing illumination before, during, or after topical application is also considered well-known, routine, and conventional in the art prior to the effective filing date (Decaux et al. US Publication no. 2018/0071547, para 9).
Thus, the claims as a whole recite a combination of known cosmetic agents and conventional light exposure steps to utilize a natural principle, without adding and non-routine feature that would transform the exception into a patent-eligible application.
Because the claims are directed to a law of nature and do not include additional elements that amount to significantly more than the law of nature, claims 1-20 are ineligible under 35 USC 101.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 7, 10, 11, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Decaux et al. (US Publication no. 2018/0071547 – disclosed by Applicant).
In regard to claim 1, Decaux et al. disclose a nontherapeutic cosmetic treatment process comprising (Decaux et al. provides a method for cosmetic and therapeutic skin care, however the present invention fails to adequately define what comprises a “nontherapeutic” treatment which fails provide objective criteria to distinguish between cosmetic and therapeutic benefit, therefore the term is interpreted broadly to encompass both aesthetic and physiological skin effects from topical and light based procedures even if the underlying effect may have therapeutic and medical benefit; see para 49 and 162-177 for a cosmetic related procedure and device)
applying to the skin of an individual an active composition comprising at least niacinamide (para 49 and 162-177, a preferred embodiment of the cosmetic method for providing skin care according to the present invention, said method further comprises the application, preferably topical application, of a skin care active ingredient including niacimide (niacinamide)), and
illuminating the skin with at least one light source emitting at a wavelength in a range of from 620 to 690 nanometers (para 49 and 162-177; In a preferred embodiment of the cosmetic method for providing skin care according to the present invention, said method further comprises the application, preferably topical application, of a skin care active ingredient prior, during or after the step of illuminating the skin; para 52, 140, and 162-163, explicitly teaches range of 650-670 nm which anticipates the claimed range, MPEP 2131.03 I)
the illumination being performed before, simultaneously with or after the application of the composition (para 49 and 162-177, In a preferred embodiment of the cosmetic method for providing skin care according to the present invention, said method further comprises the application, preferably topical application, of a skin care active ingredient prior, during or after the step of illuminating the skin).
In regard to claim 7, Decaux et al. disclose a nontherapeutic cosmetic treatment process comprising (Decaux et al. provides a device for cosmetic and therapeutic skin care, however the present invention fails to adequately define what comprises a “nontherapeutic” treatment which fails provide objective criteria to distinguish between cosmetic and therapeutic benefit, therefore the term is interpreted broadly to encompass both aesthetic and physiological skin effects from topical and light based procedures even if the underlying effect may have therapeutic and medical benefit; see para 49 and 162-177 for a cosmetic related procedure and device):
means for applying to the skin of an individual an active composition comprising at least niacinamide (para 159-161 referring to figures 9A,B,C, and D show an embodiment of a device for both applying a skin care active ingredient or pharmaceutical ingredient and illuminating the skin, para 162-177 describe its use for a cosmetic treatment, the application of niacinamide is merely a recitation of intended use of the device as the recitation of niacinamide does not imply any form of structure to the recited means for applying; Moreover MPEP 2114 I states that for apparatus claims the structure must only be capable of meeting the intended use. Here, Decaux et al. is capable because it explicitly teaches the device for applying a skin care active ingredient, and also teaches that the active ingredient may be niacimide (niacinamide)), and
means for illuminating the skin with at least one light source emitting a wavelength in a range from 620 to 690 nanometers (para 159-161 referring to figures 9A,B,C, and D show an embodiment of a device for both applying a skin care active ingredient or pharmaceutical ingredient and illuminating the skin, para 162-177 describe its use for a cosmetic treatment with LEDS that may applying light explicitly in the range of 650-670 nm which anticipates the claimed range, MPEP 2131.03 I,
the means for illumination and applying the active composition being configured so that he illumination can be performed before, simultaneously, or after the application of the composition (para 49 and 162-177; In a preferred embodiment of the cosmetic method for providing skin care according to the present invention, said method further comprises the application, preferably topical application, of a skin care active ingredient prior, during or after the step of illuminating the skin).
In regard to claim 10, in Decaux et al. the LEDs for illuminating the skin include at least one light source for emitting light at a wavelength in the range of 750 to 810 nanometers (para 162-177 describe its use for a cosmetic treatment with LEDS that may applying light explicitly in the range of 768-780 as well as 792, 795, 800, 805, and 810 nm which anticipates the claimed range, MPEP 2131.03 I, additionally MPEP 2114 I states that the device claim must be capable of use in the claimed range, wherein para 162-177 suggests this capability).
In regard to claim 11, in Decaux et al. the LEDs for illuminating the skin include at least one light source for emitting light at a wavelength in the range of 910 to 970 nanometers (para 162-177 describe its use for a cosmetic treatment with LEDS that may apply light at 495-768 nm, but also 900 nm, 1000 nm, 2000 nm, etc which anticipates the claimed range since MPEP 2114 I states that the device claim must be capable of use in the claimed range, wherein para 162-177 suggests this capability).
In regard to claim 12, in Decaux et al. the LEDs may illuminate the skin at a wavelength of 660 nanometers (para 164 and 165).
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) 2, 3, 4, 8, 9, 13-15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decaux et al. (US Publication no. 2018/0071547 – disclosed by Applicant) in view of Marmur et al. (US Publication no. 2018/0200174 – disclosed by Applicant).
In regard to claim 2, Decaux et al. substantially discloses the invention as claimed except for applying an active composition also comprises photolyase. Marmur et al. discloses a system and method for using a cosmetic mask (i.e., a nontherapeutic cosmetic procedure and device for its use) that applies a topical active composition contained in a mask followed by illumination (para 11 and 39, Upon application of the mask, one can also expose the mask to light of a wavelength). The mask applies a topical active composition include niacinamide (para 31, as in Decaux et al. to improve health skin tone and texture) and may also apply photolyase (para 25-26). Modification of the technique and means for applying the active composition to include the use of photolyase since Marmur et al. explicitly teaches its use in a technique similar to Decaux et al., and since Marmur et al. explicitly teaches that photolyase absorbs visible light to directly cleave and reverse damage caused by shorter wavelength UV to enhance cosmetic appearance of the skin.
In regard to claim 3, Decaux et al. explicitly teaches that the illumination of the skin is also performed with at least one light source emitting at a wavelength, however does not teach the wavelength range of 410-470 nm. Marmur et al. as described above teaches that the applied topical agent may be illuminated following application, wherein the illumination light includes a wavelength of 420-460 nm (this range anticipates the claimed range, MPEP 2131.03 I). Modification of Decuax et al. to apply light to the applied active composition in the wavelength range of 420-460 nm is considered to have been obvious to one of ordinary skill in the art since Marmur et al. explicitly teach this wavelength because light in this wavelength kills unwanted surface acne causing bacteria, while also activating the light activated enzymes embedded in the mask.
In regard to claim 4, Decaux et al. explicitly teaches that the illumination of the skin is also performed with at least one light source emitting at a wavelength in a range from 750 to 810 (para 140 and 162-163, explicitly teaches range of 768-792 nm which anticipates the claimed range, MPEP 2131.03 I).
In regard to claim 8, Decaux et al. substantially discloses the invention as claimed except for applying an active composition also comprises photolyase. Marmur et al. discloses a system and method for using a cosmetic mask (i.e., a nontherapeutic cosmetic procedure and device for its use) that applies a topical active composition contained in a mask followed by illumination (para 11 and 39, Upon application of the mask, one can also expose the mask to light of a wavelength). The mask applies a topical active composition include niacinamide (para 31, as in Decaux et al. to improve health skin tone and texture) and may also apply photolyase (para 25-26). Modification of the technique and means for applying the active composition to include the use of photolyase since Marmur et al. explicitly teaches its use in a technique similar to Decaux et al., and since Marmur et al. explicitly teaches that photolyase absorbs visible light to directly cleave and reverse damage caused by shorter wavelength UV to enhance cosmetic appearance of the skin.
In regard to claim 9, Decaux et al. explicitly teaches that the illumination of the skin is also performed with at least one light source emitting at a wavelength, however does not teach the wavelength range of 410-470 nm. Marmur et al. as described above teaches that the applied topical agent may be illuminated following application, wherein the illumination light includes a wavelength of 420-460 nm (this range anticipates the claimed range, MPEP 2131.03 I). Modification of the LEDs Decuax et al. to apply light to the applied active composition in the wavelength range of 420-460 nm is considered to have been obvious to one of ordinary skill in the art since Marmur et al. explicitly teach this wavelength because light in this wavelength kills unwanted surface acne causing bacteria, while also activating the light activated enzymes embedded in the mask.
In regard to claims 13 and 14, Decaux et al. explicitly teaches that the illumination of the skin is also performed with at least one light source emitting at a wavelength, however does not teach the wavelength range of 440 nm. Marmur et al. as described above teaches that the applied topical agent may be illuminated following application, wherein the illumination light includes a wavelength of 420-460 nm. While Marmur et al. does not explicitly teach 440 nm, the discovery of 440 nm from the disclosed range is considered to have been obvious to one of ordinary skill in the art since Marmur et al. teach wavelengths sufficiently close to the claimed value wherein discovery of the value would only require routine experimentation within the range set as a starting guide by Marmur et al. Modification of the LEDs Decuax et al. to also apply light to the applied active composition at 440 nm is considered to have been obvious to one of ordinary skill in the as the optimization within prior art conditions through routine experimentation of a disclosed range known to provide cosmetic for killing unwanted surface acne causing bacteria, while also activating the light activated enzymes embedded in the mask. Moreover, it is considered to only require routine skill to add LEDs configured to emit light in any desired wavelength.
In regard to claim 15, Decaux et al. disclose that the applied wavelength may be 780 nm (para 165).
In regard to claims 17 and 18, Decaux et al. explicitly teaches that the illumination of the skin is also performed with at least one light source emitting at a wavelength, however, does not teach the wavelength range of 440 nm. Marmur et al. as described above teaches that the applied topical agent may be illuminated following application, wherein the illumination light includes a wavelength of 420-460 nm. While Marmur et al. does not explicitly teach 440 nm, the discovery of 440 nm from the disclosed range is considered to have been obvious to one of ordinary skill in the art since Marmur et al. teach wavelengths sufficiently close to the claimed value wherein discovery of the value would only require routine experimentation within the range set as a starting guide by Marmur et al. Modification of Decuax et al. to also apply light to the applied active composition at 440 nm is considered to have been obvious to one of ordinary skill in the as the optimization within prior art conditions through routine experimentation of a disclosed range known to provide cosmetic for killing unwanted surface acne causing bacteria, while also activating the light activated enzymes embedded in the mask.
In regard to claim 19, Decaux et al. disclose that the applied wavelength may be 780 nm (para 165).
Claim(s) 5, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decaux et al. (US Publication no. 2018/0071547 – disclosed by Applicant) in view of Marmur et al. (US Publication no. 2018/0200174 – disclosed by Applicant), further in view of Morariu (US Publication no. 2006/0216251).
In regard to claim 5, Decaux et al. in view of Marmur et al. substantially disclose and suggest the invention as claimed except for illuminating the active composition with wavelength in the range of 910-970 nm. Morariu disclose a technique and device for applying a topical active composition to the skin for performing a cosmetic treatment (para 10). Morariu teaches that light therapy may be applied to encourage enzymatic activity (e.g., ATP formation) and enhance the penetration of active agent into the skin (para 162). The light may be applied by LEDS, wherein a light in the infrared range of 940 nm is disclosed as exemplary (para 163-164; this value anticipates the claimed range, MPEP 2131.03 I). Modification of Decuax et al. and Marmur et al. to apply light to the applied active composition in the wavelength range of 910-970 nm is considered to have been obvious to one of ordinary skill in the art since Morariu explicitly teach this wavelength for use in cosmetic treatments to enhance the effect of applied active compositions.
In regard to claim 16, Decaux et al. in view of Marmur et al. substantially disclose and suggest the invention as claimed except for illuminating the active composition with wavelength of 940 nm. Morariu disclose a technique and device for applying a topical active composition to the skin for performing a cosmetic treatment (para 10). Morariu teaches that light therapy may be applied to encourage enzymatic activity (e.g., ATP formation) and enhance the penetration of active agent into the skin (para 162). The light may be applied by LEDS, wherein a light in the infrared range of 940 nm is disclosed as exemplary (para 163-164). Modification of the LEDs Decuax et al. to apply light to the applied active composition with the wavelength of 940 nm is considered to have been obvious to one of ordinary skill in the art since Morariu explicitly teach this wavelength for use in cosmetic treatments to enhance the effect of applied active compositions. Moreover, it is considered to only require routine skill to add LEDs configured to emit light in any desired wavelength.
In regard to claim 20, Decaux et al. in view of Marmur et al. substantially disclose and suggest the invention as claimed except for illuminating the active composition with wavelength of 940 nm. Morariu disclose a technique and device for applying a topical active composition to the skin for performing a cosmetic treatment (para 10). Morariu teaches that light therapy may be applied to encourage enzymatic activity (e.g., ATP formation) and enhance the penetration of active agent into the skin (para 162). The light may be applied by LEDS, wherein a light in the infrared range of 940 nm is disclosed as exemplary (para 163-164). Modification of Decuax et al. and Marmur et al. to apply light to the applied active composition with the wavelength of 940 nm is considered to have been obvious to one of ordinary skill in the art since Morariu explicitly teach this wavelength for use in cosmetic treatments to enhance the effect of applied active compositions.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Decaux et al. (US Publication no. 2018/0071547 – disclosed by Applicant) in view of Hakozaki et al. (EP 3060311 B1).
In regard to claim 6, Decaux et al. substantially discloses the invention as claimed except for applying an active composition niacinamide in the range of 0.5% to 10%. Hakozaki et al. describes skin lightening cosmetic compositions and methods. Various compositions applied to the skin surface include niacinamide, wherein the concentration of this compositions may be from about 0.05%, 0.5%, 1%, 2%, 3%, 4% or 5% to about 15%, 10%, 8% or 6% by weight of the cosmetic composition (para 18-19). Modification of Decuax et al. to apply the niacimide (i.e., niacinamide) with a concentration in the range of 0.5% to 10% since Hakozaki et al. explicitly teach that niacinamide in this concentration is well-known to provide the desired cosmetic effect.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al. (US Publication no. 2019/0142138) discloses 660 nm and 940 nm for cosmetic purposes;
McDaniel (US Publication no. 2006/0212025) discloses treatment of acne and suggest topical agents such as niacinamide and photolyase with illumination in the range of 410-420 nm as well as 575 nm and 605;
Gupta (US Publication no. 2004/0219124) discloses a cosmetic mask for applying topical agents such as niacinamide;
McDaniel(US Publication no. 2003/0004556) discusses cosmetic treatments applying light in the 400-450nm range or more 440 nm with the application of photolyase and niacinamide.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 7 October 2025