*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 .
Applicant’s response dated August 5, 2026 is acknowledged.
Priority
This application is a 371 of PCT/EP2023/025074 filed on 02/16/2023, and claims foreign
priority in EP2202007l.l filed on 02/18/2022.
Claim Status
Claims 1-4, 6-9, and 11-17 are pending and examined. Claims 14-17 were newly added and read on the examined invention. Claims 5 and 10 were canceled. Claims 1-4, 6-9, and 11-13 were amended.
Withdrawn Claim Rejections - 35 USC § 112
Rejections of claims 1-13 are withdrawn because rejections were obviated with amendments of claims 1 and 2.
Withdrawn Claim Rejections -35 USC § 102
Rejections of claims 1, 2, 11, and 12 as being anticipated by Osborne (WO 2006/116731 A2 Published November 2, 2006) are withdrawn because claim 1 was amended to require the presence of a, b, and c, which is not anticipated by Osborne.
Withdrawn Double Patenting Rejections
Rejections of claims 1-13 as being unpatentable over claims 1-17 of copending Application No. 18/839,511 in view of Osborne are withdrawn because applicant filed a terminal disclaimer that was approved on August 5, 2026.
Terminal Disclaimer
The terminal disclaimer filed on August 5, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on U.S. Application No. 18/839,511 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Maintained and New Claim Rejections - 35 USC § 103
Necessitated by Amendment
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 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. 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.
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.
Claims 1, 2, 8, 9, 11-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne (WO 2006/116731 A2 Published November 2, 2006) and Oblong (WO 97/39734
Published October 30, 1997).
The claims encompass a cosmetic composition and a method of using the composition.
The teachings of Osborne are related to personal care compositions comprising a
dipeptide and methods of using said compositions to treat the condition of keratinous tissue by
applying topically (Abstract). Methods of using such compositions to regulate the condition of
mammalian keratinous tissue (e.g., skin, hair, or nails) comprise the step of topically applying a
composition to the keratinous tissue (e.g., skin, hair, or nails) of a mammal in need of such
treatment (page 2 lines 24-27). The term "effective amount" of dipeptide means an amount of a
compound or composition sufficient to significantly induce a positive keratinous tissue benefit,
including independently or in combination with other benefits disclosed herein. This
means that the content and/or concentration of dipeptide in the formulation is sufficient
that when the formulation is applied with normal frequency and in a normal amount, the
formulation can result in the treatment of one or more undesired keratinous tissue conditions (e.g., skin wrinkles). For instance, the amount can be an amount sufficient to inhibit
or enhance some biochemical function occurring within the keratinous tissue. This
amount of dipeptide may vary depending upon the type of product, the type of keratinous
tissue condition to be addressed, and the like (page 4 lines 13-22). In one embodiment, the
composition comprises a dipeptide, a dermatologically acceptable carrier, and optional
components (page 7 lines 3-6). Peptides and derivatives include Lys-Thr (lysine-threonine)
among others (page 8 lines 8-30). The dipeptide is preferably included in an amount of from
about lxl0-6% to about 10%, more preferably from about lx10-6% to about 0.1 %, and even more
preferably from about lxl0-5% to about 0.01 %, by weight of the personal care composition (page
10 lines 6-8). Optional components include retinoids (page 11 lines 15-31), plant extracts, plant
tissue extracts, plat seed extracts, plant oils, botanicals, and botanical extracts (page 13 lines 20-
21). The topical compositions comprise a dermatologically acceptable carrier for the
composition. In one embodiment, the carrier is present at a level of from about 50% to about
99.99%, preferably from about 60% to about 99.9%, more preferably from about 70% to about
98%, and even more preferably from about 80% to about 95%, by weight of the composition.
The carrier can be in a wide variety of forms. Non-limiting examples include simple solutions
(water or oil based), emulsions, and solid forms (gels, sticks). For example, emulsion carriers can
include, but are not limited to, oil-in-water, water-in-oil, water-in-silicone, water-in-oil-in-water,
and oil-in-water-in-silicone emulsions (page 14 lines 5-14). Examples 1-5 teach moisturizing oil-in-water lotions and creams (pages 19-21).
Osborne does not teach an extract of Centella asiatica.
The teachings of Oblong are related to methods of regulating skin conditions with
Centella Asiatica extract, especially for regulating tactile and visible signs of skin aging, e.g.
ameliorating lines and wrinkles and prophylactically treating loss of elasticity (Abstract).
Extracts of Centella asiatica are well known to contain one or more of the pentacyclic
triterpenoids asiatic acid, madecassic acid, and their glycosolated forms asiaticoside and
madecassoside (page 5 lines 12-14 and page 8 lines 1-4). The composition contains a safe and
effective amount of an extract of Centella asiatica. The composition contains from about 0.01%
to about 50%, more preferably from about 0.1% to about 10%, even more preferably from about
0.5% to about 10%, and most preferably from about 1% to about 5% of the Centella asiatica
extract (page 8 lines 9-13). The composition contains a dermatologically acceptable carrier
within which the Centella asiatica extract is incorporated to enable the extract and optional other
actives to be delivered to the skin at an appropriate concentration (page 8 lines 15-18). The
composition comprises optional components (page 24 lines 1-6). The composition contains
retinoids in a concentration of 0.001-0.5 wt.%, where suitable retinoids include retinal (page 26
lines 26-34). Optional components include dipalmitoyl hydroxyproline, palmitoyl hydroxy wheat
protein, and biopeptide CL (page 34 lines 20-32).
The teachings of Osborne and Oblong are related to skin care compositions comprising
retinoids, peptides, and plant extracts and it would have been obvious to have combined them
because they are in the same field of endeavor.
Regarding claim 1, it would have been prima facie obvious to a person of ordinary skill
in the art before the effective filing date of the claimed invention to have formed a skin care
composition comprising a retinoid, Lys-Thr (lysine-threonine), a plant extract, and
dermatologically acceptable carrier, with a reasonable expectation of success because Osborne
teaches a skin care composition comprising the dipeptide lysine-threonine, a dermatologically
acceptable carrier, and an optional component comprising retinoids and plant extracts. Osborne
does not teach extract of Centella asiatica. It would have been obvious to have formed Osborne's
composition with an extract of Centella Asiatic because Osborne teaches forming the
composition with a plant extract and it was known from Oblong that extract of Centella Asiatic is
known to have benefits in skin care compositions and is suitable for making a skin care
composition for regulating skin conditions. The selection of a known material based on its
suitability for its intended purpose supports obviousness.
It would have been obvious to have incorporated retinoid in a concentration range of from about 0.001 % to about 0.5% wt. because Oblong teaches said range as suitable. The claimed range of at least 0.5 wt. % is obvious because it overlaps with the prior art range.
It would have been obvious to have formed the composition to comprise from about 0.01 % to about 0.5% of the Centella asiatica extract because Oblong teaches concentration ranges of 0.01-50% and 0.5-10%. The claimed concentration range is obvious because it overlaps with the claimed range.
Regarding claim 2, it would have been obvious to have selected retinal as the retinoid
because Oblong teaches that retinal is a suitable retinoid for use in skin care compositions.
Alternatively, it would have been obvious to have used retinyl propionate because Osborne
teaches it in example 12.
Regarding claim 8, it would have been obvious to have used the extract of Centella
asiatica obtained from leaves of the plant because Oblong teaches that Centella asiatica leaf
extract is suitable for use in the skin care composition.
Regarding claim 9, Oblong teaches that the extract contains madecassoside.
Regarding claim 11, Osborne teaches the dipeptide Lysine-Threonine.
Regarding claim 12, it would have been obvious to have formed the composition to
contain the dipeptide in a concentration range from about lxl0-6% to about 10% by weight because Osborne teaches said concentration range as suitable for dipeptides in the formulation. The claimed concentration range is obvious because it overlaps with Osborne's range.
Regarding claim 13, it would have been obvious to have used the composition of
Osborne as modified by Oblong to cosmetically treat skin by applying the composition to the
skin with a reasonable expectation of success because Osborne teaches using the composition in
a method of treating signs of ageing by topically applying the composition to skin.
Regarding claim 16, it would have been obvious to have formulated the composition with bisabolol, with a reasonable expectation of success because Osborne teaches that the composition further comprises optional components including bisbolol (page 11 lines 15-24).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne and
Oblong as applied to claims 1, 2, 8, 9, 11-13, and 16 above, and further in view of Wilmott (WO
86/06275 Published November 6, 1986).
The teachings of Osborne and Oblong are relied upon as summarized above. They do not
teach concentration ranges of retinoid as required by claims 6 and 7.
The teachings of Wilmott are related to a composition and methods for reducing
wrinkles. The composition is a stable retinal composition containing 0.005-1.0 wt.% retinal
(Abstract). The compositions are applied to the skin (page 3 lines 7-13). With daily application,
skin texture, color and tone will improve. Winkles and fine lines will be reduced with minimal
irritant effects (page 7 line 13-15).
The teachings of Wilmott and Osborne modified by Oblong are related to compositions
containing retinal where the compositions are intended for application to skin for the purpose of
treating signs of aging.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Osborne by including the retinoid in a concentration of 0.005-1 wt.%, with a reasonable expectation of success because it was known from Wilmott that 0.005-1 wt.% is a suitable concentration of retinal for use in formulations intended for direct application to skin for the purpose of treating wrinkles. The claimed concentration ranges are obvious because they overlap with Wilmott' s concentration range.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne and
Oblong as applied to claims 1, 2, 8, 9, 11-13, and 16 above, and further in view of Golz-Barner (WO 2009/053414 A2 Published April 30, 2009 - English language machine translation appended thereto).
The teachings of Osborne and Oblong are relied upon as summarized above. They do not
teach the limitations of claims 3 and 4.
The teachings of Golz-Barner are related to retinal containing cosmetic product
containing saturated phosphatidylcholine in the lamellar structure of which 20,000-100,000 IU of
retinal are incorporated, liposomes of unsaturated phosphatidylcholine or chitosan microcapsules
containing 3000 to 200,000 IU of retinal, cyclodextrin containing 80,000 to 100,000 IU of
retinal, a free retinyl derivative and cosmetic auxiliaries and carriers. The product shows an
increased anti-wrinkle effect, which occurs for a short period of time as well as a long-lasting,
significantly improved anti-wrinkle effect (Abstract). It has been found that retinal incorporated
into lamellar structure is released very slowly from the barrier layer of the skin into the
environment, and together with encapsulated retinal in chitosan microcapsules and free retinyl
derivative, a total anti-aging effect is achieved that the individual systems added do not reach
(first full paragraph on page 3 of the translation).
The teachings of Golz-Barner and Osborne modified by Oblong are related to skin care
compositions comprising a retinoid where the compositions are intended for application to skin
to treat wrinkles, and it would have been obvious to have combined their teachings because they
are in the same field of endeavor. It would have been prima facie obvious to a person of ordinary
skill in the art to have formed Osborne's composition with Golz-Barner's mixture of retinoids
that comprise retinal encapsulated in chitosam microcapsules, with a reasonable expectation of
success because Golz-Barner teaches a mixture of retinoids that comprises retinal encapsulated
in chitosan microcapsules is suitable for use in compositions intended for treating wrinkles. The
selection of a known material suitable for its intended purpose supports obviousness. One of skill
would have been motivated to use Golz-Barner' s retinoid composition because it was shown to
provide increased and significantly improved anti-wrinkle effect compared to the individual
components. Limitations of claim 4 are met because chitosan is a positively charged molecule.
Claims 14, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Osborne and Oblong as applied to claims 1, 2, 8, 9, 11-13, and 16 above, and further in view of Montanari (Pub. No. US 2007/0148118 A1 Published June 28, 2007).
The claims further limit the peptide to acetyl dipeptide 1 cetyl ester.
The teachings of Osborne and Oblong are relied upon as summarized above, however they do not teach the specific peptide required by claims 15 and 17.
The teachings of Montanari are related to a cosmetic composition for skin application suitable for relaxing expression wrinkles which combines a selected active peptide component with a decontracting or relaxing action on the muscular fiber with a micro-element which reduces the muscular contraction level by acting directly or indirectly on a muscular fiber
component. The active principles of the cosmetic composition of the invention are conveniently carried by liposomes (Abstract). According to an embodiment, the active peptide component of the composition comprises a gly-pro-arg-pro-ala-NH2 pentapeptide, associated with a dipeptide having a decontracting or relaxing action of the muscular fiber, conveniently comprising the amino acids tyrosine and arginine which intervene in the neurotransmission processes causing a relaxation of the muscular fiber and the consequent relaxation of the musculature itself (paragraph 0033). According to an embodiment, the tyrosine-arginine dipeptide is acetylated to make it more lipophilic, more stable and bio-available on a cutaneous level. Acetyl tyrosine-arginine 1 cetyl ester, a form capable of effectively modulating the release of neurohumors, is particularly suitable for skin and cosmetic application (paragraph 0037). According to an embodiment, the composition comprises from 0.001% to 5% of acetyl tyrosyl-arginyl-(dipeptide)-1-cetyl ester, among other components (paragraphs 0050-0054). The cosmetic compositions or preparations are provided in any suitable form for skin application, such as creams, emulsions, lotions, gels, oils, pastes, ointments, sprays, etc. for obstructing and reducing cutaneous micro-contractions with the final effect of relaxing expression wrinkles (paragraph 0062).
The teachings of Montanari and Osborne modified by Oblong are related to topical cosmetic compositions comprising dipeptides and it would have been obvious to have combined their teachings because they are in the same field of endeavor.
It would have been obvious to have modified the composition of Osborne as modified by Oblong by adding a gly-pro-arg-pro-ala-NH2 pentapeptide and from 0.001% to 5% of acetyl tyrosyl-arginyl-(dipeptide)-1-cetyl ester, with a reasonable expectation of success because Osborne teaches that the composition comprises one more dipeptides and combinations thereof, and it was known from Montanari that combination of a gly-pro-arg-pro-ala-NH2 pentapeptide and acetyl tyrosyl-arginyl-(dipeptide)-1-cetyl ester is suitable for treating wrinkles by relaxing the muscle when applied topically; and further teaches the concentration range from 0.001% to 5% as suitable for the dipeptide. The selection of a known material based on its suitability for its intended purpose supports obviousness. Osborne’s modified composition is suitable for treating wrinkles by topically applying the composition to skin and Montanari teaches a gly-pro-arg-pro-ala-NH2 pentapeptide and acetyl tyrosyl-arginyl-(dipeptide)-1-cetyl ester as a known active agent for treating wrinkles by topically applying to skin. Osborne intended for the composition to comprise combinations of therapeutic peptides, thus it would have been obvious to include combinations of peptides known for treating wrinkles. The claims concentration range is obvious because it overlaps with 0.001% to 5%.
Response to Arguments
Applicant’s arguments submitted in the remarks dated August 5, 2026 were fully considered but are not persuasive for the following reasons.
Arguments against the combination of Osborne and Oblong is not persuasive because Oblong teaches a concentration range of retinoid from about 0.001 to about 0.5%, which overlaps with the claimed concentration range of at least 0.5%.
In response to applicant's argument that a combination of extract of Centella asiatica and a dipeptide manage the irritation associated with high retinoid concentrations as recited in pending claims, 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).
Oblong teaches a concentration ranges from about 0.001% to about 0.5%, which overlaps with the range in claim 1 and applicant has not presented any evidence that Oblong’s concentration range causes irritation.
Argument’s against Wilmott are not persuasive because Wilmott is not limited by its preferred range. Wilmott teaches ranges that render the ranges in claims 6 and 7 obvious.
A person of ordinary skill in the art would have been motivated to form a composition comprising retinoid in a concentration from about 0.001% to about 0.5% because said concentration was known from Oblong; and in a concentration range of 0.005-1.0 wt.% because said concentration range was known from Wilmott. The claimed concentration ranges are obvious because the ranges overlap with prior art ranges, and the references do not teach away from said ranges.
Arguments against Golz-Berner are not persuasive because Osborne and Oblong are not deficient for reasons described above.
Newly added claims are rejected as described above.
Applicant’s argument that the claimed invention produced an unexpected effect is not persuasive because applicant has not met the requirements set forth in MPEP 716.02.
Page 23 of the specification provides comparison data. The data is not sufficient for at least the following reasons. The claims are not commensurate in scope with the composition that provided the asserted unexpected property. Applicant provided data for a retinol concentration of 0.5% and 1%, which are only two points that fall in the claimed range. Claim 1 recites a range of at least 0.5% which includes concentrations up to 99%. The two data points are not sufficient to cover the entire claimed range. The tested composition contains bisabolol in an unknown amount, whereas claim 1 does not contain the ingredient. The tested composition contains Inumax which is a commercially available encapsulated retinol. The specification does not state the encapsulant. Claim 1 does not require the retinol to be encapsulated. The specification does not state the concentration of bisabolol, dipeptide, and centella asiatica in the composition that exhibited the asserted unexpected results. It is unknown which dipeptide was used in the composition that produced the asserted unexpected result. Claim 1 does not limit the dipeptide concentration. The applicant has not demonstrated that the asserted unexpected properties would have occurred over the entire claimed breadth. Additionally, the chemical composition of the composition that produced the asserted unexpected results is unknown. The bar graph does not provide error bars and it is unknown if the results are of statistical significance.
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 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.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617
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