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 .
Status of claims
Claims 1-2 are original. Claims 3-15 are currently amended. Claims 16-19 are new. Claims 1-19 are pending and under examination.
Priority
This application is a 371 of PCT/IB2022/061150, filed on 11/18/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. ITALY 102021000029171, filed on 11/18/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/14/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-15 are objected to because of the following informalities:
Claim 1 recites a “Liquid composition…”. Proper syntax is “A Liquid composition…”.
Claim 1 recites “…-glutamate wherein R1 is a straight…”. Proper syntax is “…-glutamate; wherein R1 is a straight…”
Claim 1 recites “hydroxyl group, a C4-C6 cycloalkyl”. Proper syntax is “hydroxyl group, and a C4-C6 cycloalkyl”.
Claim 2 is objected to for “selected from….and…..” when the structure here should be “selected from….or….” since the claim is not in “selected from the group consisting of…..and….” format.
Claims 2-8 recite “Liquid composition according to…”. Proper syntax is “The liquid composition according to…”
Claim 9 states “Topical formulation comprising…”. Proper syntax is “A topical formulation comprising…”.
Claims 10-13 recite “Topical formulation according to claim 9.…”. Proper syntax is “The topical formulation according to claim 9.…”
Claims 14 recites “Topical formulation for preventing…”. Proper syntax is “A topical formulation for preventing…”.
Claim 15 recites “Topical formulation according to claim.…”. Proper syntax is “The topical formulation according to claim.…”
Appropriate correction is required.
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 14 and 15 are rejected under 35 U.S.C. 101 because they are directed to products and processes of nature and amount to nothing more than that. These claims are directed to a topical formulation for preventing and treating skin inflammatory processes without specifying which structures comprise the composition. The skin has endogenous components such as IL‐4, IL‐10, IL‐13 and TGF‐β that polarize its macrophages toward a resolutory anti‐inflammatory or M2 macrophage as evidenced by Narayanan et al. [page 8, column 2, paragraph 2] (Narayanan D, Sim SL, Kumari S. Skin immunity and inflammation: cellular interactions and communication. Clin Transl Immunology. 2025;14(11):e70053. Published 2025 Nov 3. doi:10.1002/cti2.70053). With regards to preventing inflammation, animal proteins such as ATG9A facilitates the degradation of multiple inflammatory signaling complexes to prevent an inflammatory skin disease as evidenced by Priem et al. [Abstract] (Priem D, Bertrand MJ. ATG9A-dependent, LC3-independent autophagy curbs the immune system to protect against disease. Autophagy Rep. 2026;5(1):2614147. Published 2026 Jan 12. doi:10.1080/27694127.2026.2614147). The above teachings thus make the compositions and processes of claim 14 and 15 to encompass forms that are naturally occurring.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for formulating topical compositions, does not reasonably provide enablement for preventing and treating skin inflammatory processes using the non-specific topical compositions of clam 14 and 15. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
Breadth of the claims: claims 14 and 15 are extremely broad. Claim 14 covers any topical formulation that prevents and trats skin inflammatory processes. Claim 15 covers such formulations where the inflammatory processes are associated with skin inflammatory disease or skin aging process. The claims are not limited to the disclosed liquid composition, to any particular active ingredient, to ceramides, to palmitic acid amides, to any solvent system, or to any particular dermatological condition. The breadth weighs strongly against enablement.
Nature of the invention: the disclosed invention is a specific formulation/solubilization invention involving ceramides, palmitic acid amides, and di-(phytosteryl-2-octyldodecyl)-N-lauroyl-L-glutamate [¶¶39-43, 54-65]. The claims, however, are written at the level of a desired therapeutic/cosmetic result: preventing and treating skin inflammatory processes. This functional scope is much broader than the formulation system actually taught.
State of the prior art: the state-of-the-art shows that topical ceramide formulation and skin-barrier treatment are technically complex. A review by Kahraman et al. (Kahraman E, Kaykın M, Şahin Bektay H, Güngör S. Recent Advances on Topical Application of Ceramides to Restore Barrier Function of Skin. Cosmetics. 2019;6(3):52. doi:https://doi.org/10.3390/cosmetics6030052) explains that alterations in ceramide content are associated with numerous skin disorders and that ceramides are poorly water soluble, highly lipophilic, with limited percutaneous absorption when topically applied. The review also states that there is confusion regarding skin permeability and efficacy of ceramides in conventional carrier systems, that penetration remains controversial, and that developing skin-friendly topical ceramide remains a challenge. This supports that the art does not provide predictable, routine path for achieving the broad treatment/prevention functionality claimed here.
Level of ordinary skill in the art: a Person of ordinary skill in the art would likely be a dermatological formulation scientist or a dermatologist––More specifically, a person who would have knowledge of cosmetic/topical formulation, skin-barrier physiology, dermatology, and dermatological actives.
Predictability of the art: The art is not sufficiently predictable to support this claim scope. Skin inflammatory diseases and ageing-related inflammatory processes involve different mechanisms, severities, pathways, skin-barrier states, and clinical endpoints. The specification itself describes skin ageing as heterogenous and involving numerous mechanisms [¶¶2-6]. The external state-of the art review (i.e., Kahraman et al.) likewise notes unresolved issues regarding ceramide topical delivery, efficacy, and formulation design. Thus, efficacy of one disclosed ceramide/palmitic acid amide formulation does not predict efficacy of all topical formulations across all claimed inflammatory processes.
Amount of direction or guidance provided: The specification provides guidance for preparing the disclosed liquid composition and incorporating that composition into certain topical formulations [¶¶54-65, 68-83]. However, it does not provide direction for identifying or preparing the many other topical formulations encompassed by claim 14, including formulations lacking the disclosed liquid composition. Nor does it provide general principles allowing one of ordinary skill to determine, without undue experimentation, which topical formulations would prevent and treat the full range of skin inflammatory processes recited in claims 14 and 16.
Existence of working examples: The working examples are primarily solubilization and stability examples involving ceramides, isopalmide, PMEA, and the disclosed glutamate solvent system [¶¶68-83]. They do not demonstrate prevention or treatment of skin inflammatory processes across the broad scope of claims 14 and 15. The listed diseases in ¶67 are not supported by representative therapeutic examples across atopic dermatitis (DIC, DAC), psoriasis, seborrheic dermatitis, acne, rosacea, actinic keratosis and ichthyosis, and skin ageing processes. The examples are therefore not commensurate with the claimed therapeutic/cosmetic scope.
Quantity of experimentation needed: A person of ordinary skill in the art would need to engage in extensive experimentation to determine which topical formulations, active ingredients, vehicles, concentrations, and treatment regimens prevent and treat skin inflammatory processes, diseases, or ageing related inflammatory conditions. This would include formulation development, stability testing, penetration testing, tolerability testing, and biological or clinical efficacy testing across diverse skin conditions. In view of the claim breadth and limited guidance, this experimentation would be undue.
Accordingly, based on the evidence as a whole, the specification does not enable one of ordinary skill in the art to make and use the full scope of claims 14 and 15 without undue experimentation. The disclosure may enable certain topical formulations comprising the specific composition described in the specification, but claims 14 and 15 currently are not limited to those formulations and instead encompass a far broader class defined mainly by functional result of preventing and treating skin inflammatory processes.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-6, 8, 11-12, and 14-18 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 3 recites the limitation "the palmitic acid amides are selected from" with the prior recitation being “at least one palmitic acid amide…”. There is insufficient antecedent basis for this limitation in the claim. A suggested amendment is to alter the language to “the at least one palmitic acid amide is selected from”.
Claims 4 and 16 recite the limitation "said ceramide". There is insufficient antecedent basis for this limitation in the claim with the prior recitation being “at least one ceramide”. A suggested amendment is to alter the language to “said at least one ceramide”.
Claim 4 recites “(ceramide 2 or NS)” and “(Ceramide 3 or NP)”. The parenthesis does not establish whether the recited terms within them are mere abbreviations, or are exemplary species that are optional or required, rendering the claim indefinite. Applicant may delete these entire parenthetical notations.
Claim 16 is rejected as being dependent on an indefinite claim 4.
Claim 5 recites the limitation “said association”. There is insufficient antecedent basis for this limitation in the claim. It is thus unclear whether the concentration is relative, for example, to the total weight of the composition or the ratio of component a) and b).
Claims 5-6 and 8 utilize the open-ended transitional phrase "comprised" while being dependent to claim 1 which recites the closed transitional phrase "consisting of". It is unclear if the use of “comprised” in these claims, which are dependent on a closed claim with the transition phrase “consisting of”, will open these claims to other elements of the prior art where claim 1 teaches that the composition is closed, thus rendering these claims indefinite. The suggested amendment is to remove the word “comprised”.
Claim 17 is rejected as being dependent on an indefinite claim 5.
Claim 8 recites the limitation " the N-isopropylpalmitoyl amide and the palmitoylethanolamide". There is insufficient antecedent basis for this limitation in the claim. A suggested amendment is to alter the dependency of this claim from claim 1 to claim 3.
Claim 18 is rejected as being dependent on indefinite claim 8.
The term “substantially” in claims 11 and 12 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the degree of hydrophilicity and lipophilicity respectively recited in claims 11 and 12 is unknown, thus rendering the claims indefinite.
Claim 14 recites a “topical formulation for preventing and treating skin inflammatory processes”, while claim 15 recites that the “skin inflammatory processes are associated or involved in skin inflammatory diseases or are associated or involved in skin ageing processes.” The metes and bounds of these limitations are unclear because the claims do not Identify the structural or compositional characteristics required for the formulation to prevent such processes, nor do the claims provide an objective standard for determining which ‘skin inflammatory processes,” “skin inflammatory diseases”, or “skin ageing processes” fall within the scope of the claims. As written, the claims could encompass numerous materially different ingredients, concentrations, structures, and mechanisms, so as long as they are alleged to be useful for the broadly recited function. Therefore, one of ordinary skill in the art would not be able to determine, with reasonable certainty, the scope of the claimed topical formulation, thus rendering it indefinite.
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.
Claims 14-15 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Nieuwenhuizen et al. (US20030064936A1).
Nieuwenhuizen et al. discloses the use of an active compound including a sphingoid base, a derivative of a sphingoid base, a salt of a sphingoid base, a ceramide or a mixture of two or more of these compounds for manufacturing a composition for topical application for inhibiting mammalian ceramidase activity in the skin and microbial ceramidase originating from micro-organisms present on the skin [¶abstract]. Nieuwenhuizen et al. teaches that the composition of the invention is intended to treat inflammatory skin diseases including dermatitis and psoriasis [¶65]. Nieuwenhuizen et al. further teaches that animals may benefit from topical application of the inventive composition as such animals also suffer from itchy, dry, and/or scaly skin and/or skin diseases such as dermatitis [¶27].
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 9-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nieuwenhuizen et al. (US20030064936A1) In view of Brener et al. (US20190183914A1) in further view of Willemin et al. (US20080159970A1) as evidenced by Dop (US20100260701A1).
Nieuwenhuizen et al. discloses an active compound including a sphingoid base, a derivative of a sphingoid base, a salt of a sphingoid base, a ceramide or a mixture of two or more of these compounds for manufacturing a composition for topical application [¶abstract]. Nieuwenhuizen et al. teaches that the composition may be an emulsion [¶67]. Nieuwenhuizen et al. teaches that the composition of the present invention is intended for use as a pharmaceutical composition for treating skin diseases such as, for example, dermatitis (i.e., inflammation of the skin), psoriasis, and ichthyosis [¶65]. Nieuwenhuizen et al. teaches that the composition may comprise at least an active compound that includes a ceramide [¶10, claim 1 of Nieuwenhuizen et al.]. Nieuwenhuizen et al. teaches that Ceramide 2 (N-monoacetyl sphingosine) and Ceramide 3 (N-stearoyl phytosphingosine) can be used in the composition [¶¶40, 41]. Nieuwenhuizen et al. teaches that the composition may include additional active ingredients [¶¶46, 58]. Nieuwenhuizen et al. teaches that the concentration of the active compounds of the present invention will preferably be varied from 0.0001-15 wt.% [¶43], which overlaps with all claimed percentages and ratios in the instant claims.
However, Nieuwenhuizen et al. fails to teach the palmitic acid amide of formula I and its species, nor does it teach the di-(phytosteryl-2-octyldodecyl)-N-lauroyl-L-glutamate as a solvent per claim 1.
Brener et al. discloses compositions and methods for potentiating various antimicrobials and/or minimizing their side-effects, particularly relating to compositions comprising combinations of antimicrobials and cannabinoids [¶2]. Brener et al. teaches that such compositions may be applied topically to the skin [claim 34 of Brener et al.; ¶¶37, 43, 141, 168]. Brener et al. teaches that the composition may be emulsions in oily or aqueous vehicles. Brener et al. teaches that N-acylethanolamines functions to reduce side effect and prolong the therapeutic window of antimicrobials [¶167], thus rendering it an active ingredient. Brener et al. discloses that the pharmaceutical composition may comprise at least one form of N-acylethanolamine such as palmitoylisopropylamide (N-isopropyl-palmitoyl amide) and palmitoylethanolamine (synonymous to Palmitoylethanolamide per ¶17), and combinations thereof [¶90]. Brener et al. teaches that such forms of N-acylethanolamine, particularly Palmitoylethanolamide, has anti-inflammatory effects [¶17].
Willemin et al. discloses a kit for keratin materials, containing at least 0.01% by weight relative to the total weight of the composition of a moisturizer agent [¶abstract]. Willemin et al. teaches that the composition may be anhydrous compositions or emulsions [¶673], with such emulsions including oil-in-water (O/W) emulsions and water-in-oil (W/O) emulsions [¶676]. Willemin et al. teaches that the kits according to the invention may be makeup or care products for keratin materials, in particular for the skin [¶12]. Willemin et al. teaches that such moisturizing agents can include Phytosteryl/octyldodecyl Lauroyl glutamate (“di-(phytosteryl-2-octyldodecyl)-N-lauroyl-L-glutamate”) [¶328], which is also known to be a non-volatile oil used as a medium/carrier in skincare compositions as evidenced by Dop [¶¶108, 169-201]. Willemin et al. teaches that the composition may include at least one cosmetic and/or dermatological active agents in a content ranging from 0.001% to 20% relative to the total weight of the composition [¶¶5,509]. Willemin et al. teaches that such active ingredients include anti-inflammatory agents and [¶288].
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the topical ceramide compositions of Nieuwenhuizen et al. with the of N-acylethanolamines taught by Brener et al., and to incorporate such active ingredients into the Phytosteryl/octyldodecyl Lauroyl glutamate-containing compositions of Willemin et al. as evidenced by Dop. This is because Nieuwenhuizen et al., Brener et al., and Willemin et al. are all directed to topical skin treatment compositions containing anti-inflammatory and dermatologically active agents. A person of ordinary skill in the art would have thus been motivated to combine these teachings to obtain a topical composition providing the known additive effects of skin barrier, anti-inflammatory, moisturizing, and dermatological benefits of the respective active ingredients while utilizing the known carrier/medium properties of Phytosteryl/octyldodecyl Lauroyl glutamate for formulation of such compositions, with a reasonable expectation of success because each reference teaches compatible formulations, including emulsions and anhydrous systems, for delivery of dermatologically active agents. Further, the concentration ranges disclosed by Nieuwenhuizen et al. and Willemin et al. encompass all of the claimed concentration ranges of the instant application, and therefore, selection of particular concentrations, weight percentages, and weight ratios would have merely been routine optimization of result-effective variables to achieve desired formulation characteristics and therapeutic performance.
Allowable Subject Matter
Claims 1-8 would be allowable if the objections made to them are corrected. Claims 3-6, 8, and 16-18 would be allowable if the 35 USC § 112 (b) rejections imposed upon them are corrected. The closest prior art to claims 1-8 and 16-18 are the combined teachings of Nieuwenhuizen et al., Brener et al., and Willemin et al., which are collectively required to cover all required limitations of independent claim 1. However, claims 1-8 and 16-18 use the closed transitional phrase “consisting of”, which limits the claims to only the components recited in those claims. both Brener et al. and Willemin et al. require additional components (e.g., cannabinoids) that fall outside of the scope of these closed claims. Therefore, the above prior arts collectively fail to meet the required limitations of claims 1-8 and 16-18, rendering them novel and allowable once the objections and 35 USC § 112 (b) rejections to them are remedied.
Conclusions
No claim is allowable in its current form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 9:00AM - 5:00 PM.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/Primary Examiner, Art Unit 1613
Prosecution Insights