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 .
DETAILED ACTION
The amendment to the claims filed after non-final office action on February 6, 2026 is acknowledged. Claims 9 and 16 were amended, claims 10, 12 were canceled and claims 1-9, 11, 13-16 are pending in the instant application. The restriction was deemed proper and made final previous office action.
Claims 1-8 and 13-15 remain withdrawn from consideration as being drawn to a non-elected invention/species. Claims 9, 11, 16 are examined on the merits of this office action.
Withdrawn Rejections/Objections
The rejection of claim(s) 9, 11, 16 under 35 U.S.C. 102(a)(1) as being anticipated by Munivar (WO2015184134 A1, cited previously) is withdrawn in view of amendment of the claims filed February 6, 2026. In particular, Applicant’s amended the claims to restrict the length of the peptide.
The rejection of claim 9, 11, 16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed February 6, 2026.
The rejection of claims 9, 11 and 16 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of amendment of the claims filed February 6, 2026.
Claim Interpretation
Regarding the amendment of the claims to include the limitation “wherein the isolated peptide is less than about 150 amino acids in length”, the limitation is interpreted in view of Applicant’s definition of “about” as encompassing variations of +/-20%, +/-10%, +/-5%, +/-1% or +/-0.1% from the stated value. Accordingly, “less than about 150 amino acids in length” includes values less than 150 and values above 150 within the disclosed tolerances of “about”. For example, with +/-20% this includes up to 180 under this broadest reasonable interpretation.
Maintained/Revised Rejections
Claim Rejections – 35 USC § 112, first paragraph
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 9, 11 and 16 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 using specific filaggrin peptides in the skin and treating specific skin disorders does not reasonably provide enablement for treating any skin barrier or disorder with any one of SEQ ID Nos:1-25 and less than about 150 amino acids in length.. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
To comply with the enablement requirements of 35 U.S.C. §112, first paragraph, a specification must adequately teach how to make and how to use a claimed invention throughout its scope, without undue experimentation. Plant Genetic Systems N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003). There are a variety of factors which may be considered in determining whether a disclosure would require undue experimentation. These factors include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The Nature of the Invention/ The breadth of the claims
The claims are drawn to “A method for treating a skin barrier disease or disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of a composition comprising an agent that increases SD67 level or activity, an agent that increases SD150 level or activity, or a combination thereof , wherein the isolated peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NOs:1-25 wherein the isolated peptide is less than about 150 amino acids in length (claim 9). The instant application further claims “wherein the skin barrier disease or disorder is selected from the group consisting of cutaneous aging, a skin condition due to trauma, an allergy, psoriasis, eczema, ichthyosis vulgaris, atopic dermatitis (AD), rosacea, eczema herpeticum, a chronic inflammatory skin disease, and clinical dry skin” (claim 16).
The claims are broad with respect to the conditions for which the claimed composition is effective to treat including any “skin barrier disease or disorder” which is not defined in the specification. Given there is no specific definition the term will be interpreted as any disease or disorder involving, affecting, impairing, or associated with the skin barrier function (any nexus to skin barrier). Although claim 16 narrows the recited diseases to skin related conditions, the listed conditions remain clinically and mechanistically distinct. For example, cutaneous gaining involves degenerative and environmental processes, trauma related skin conditions involve would healing and tissue repair, allergy may involve immune related hypersensitivity pathways, psoriasis is a chronic immune mediated disorder, rosacea involves vascular and inflammatory components, while ichthyosis vulgaris and clinical dry skin are primary barrier function disorders. The claims are very broad with respect to the patient population being treated which is any disorder or disease associated with the skin barrier. Furthermore, Applicants have not described how the peptides of the instant claims will treat the large number of diseases potentially encompassed by the claims.
The State of the Prior Art and the predictability or unpredictability of the art
The state of the art is relatively high with regard to treatment of specific skin disorders/diseases with specific peptides. However, there is lack of art regarding using filaggrin derived peptides (in particular SD67 derived and SD150 derived peptides) for treatment of a variety of disorders that are distinct pathologically and in their mode of treatment encompassed by the claims.
Sandilands (J Cell Sci. 2009 May 1; 122(9): 1285–1294, cited previously) teaches “Recent human genetic studies strongly suggest that perturbation of skin barrier function as a result of reduction or complete loss of filaggrin expression leads to enhanced percutaneous transfer of allergens. Filaggrin is therefore in the frontline of defense, and protects the body from the entry of foreign environmental substances that can otherwise trigger aberrant immune responses” (see Abstract). Thus, there appears to be a nexus between the Filaggrin protein and the skin barrier and the potential of being protective to the skin. However, this does not translate to treating any skin disease/disorder or any disease/disorder such as an autoimmune disease, neurological diseases, AIDS all of which are very different, have very different mechanisms of pathogenesis and treatment protocols.
Furthermore, there is a lack of significant guidance from the present specification or prior art with regard to actual treating the skin or treating any one of the disorders listed in instant claim 16.
Given the unpredictability in the art regarding treatment of the variety of diseases listed in instant claim 16 or any dermatological disease or disorder with one therapeutic, i.e. a Filaggrin peptide, Applicants are not enabled for treating any of the conditions listed in the claim with peptides comprising any one of SEQ ID Nos:1-25.
The claims are broad with respect to the conditions for which the claimed composition is effective to treat and the agents to use for treatment. The breadth of the claim exacerbates the complex nature of the subject matter to which the present claims are directed. Furthermore, the specification does not provide any examples of treating any disease/disorder let alone the large number of diseases listed in the claims.
The art of dermatologic disease mechanisms and treatments is known to be unpredictable, particularly where the claims encompass disorders having differing etiologies, including inflammatory disease, degenerative or aging related conditions, trauma related conditions and other keratinization disorders.
The Relative Skill of Those in the Art
It is not of skill to those in the art to treat the variety of diseases and disorders encompassed by the claims with any peptide comprising any one of SEQ ID Nos:1-25 without substantial experimentation. While a person of ordinary skill in the art may be highly trained, the breadth of the disease states and uncertainty as to which peptides will provide therapeutic benefit would still necessitate an undue amount of screening and experimentation.
Amount of Guidance/ the Presence or Absence of Working Examples
The guidance provided in the specification with respect to treating any skin barrier disease is non-existent. Applicant’s specification states “The present invention provides methods for restoring a defective or deficient filaggrin-keratin complex. In one embodiment, the invention provides a method for the treatment or prevention of a dermatological disease or disorder, in a subject in need thereof. In one embodiment, the invention provides a method for the treatment or prevention of skin diseases or disorders, in a subject in need thereof. In one embodiment, the methods of the invention treat or prevent skin diseases or disorders are associated with filaggrin-keratin binding. In one embodiment, the skin disease or disorder includes, but is not limited to dry skin, ichthyosis vulgaris, eczema, psoriasis, atopic dermatitis (AD), Rosacea, allergic-skin disease, cutaneous barrier defect. In one embodiment, the method of the invention treats or prevents food allergy, asthma, or allergic rhinitis” (see paragraph 0136). However, Applicants have not described or shown how the peptides encompassed by the instant claims are any agent capable of increasing SD67/SD150 would be capable of treating the full range of the claimed skin barrier diseases or disorders including those listed in instant claim 16. There are not sufficient working examples demonstrating efficacy across the breadth of the claims, including examples directed to treatment of cutaneous aging, trauma related skin conditions, rosacea, psoriasis, chronic inflammatory skin diseases, or multiple distinct disease states using the various SD67 derived or SD150 derived peptides encompassed by claim 11.
The Quantity of Experimentation Necessary
Considering the factors above, the skilled artisan would be burdened with undue experimentation in determining what peptides as defined by the instant claims would have the desired functional properties of the instant claims (treating any skin barrier disease or disorder). 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.
Therefore, in view of the Wands factors, the claims require undue experimentation to use the full scope of the claimed invention.
Response to Applicant’s Arguments
Applicants argue “While not necessarily agreeing with the Examiner, but rather in an earnest effort to advance prosecution, Applicant has amended claim 9, upon which claims 11 and 16 depend, to recite a method for treating a skin barrier disease or disorder in a subject in need thereof, the method comprising administering to the subject an effective amount of a composition comprising an isolated peptide that increases SD67 level or activity, increases SD150 level or activity, or a combination thereof, wherein the isolated peptide comprises an amino acid sequence selected from the group consisting of SEQ ID NOs:1-25, wherein the isolated peptide is less than about 150 amino acids in length. Applicant respectfully submits that the Specification clearly enables and reasonably conveys the subject matter of the amended claims. For example, the sequences are clearly and unambiguously identified on pages 18-20 of the Specification. Furthermore, the application demonstrates that SD67 and SD150 specifically bind to keratin (Figure 5, Figure 6, and page 66 of the Specification). Furthermore, the Specification demonstrates that mutations in profilaggrin (including its processed fragment filaggrin) are associated with the recited skin barrier diseases or disorders. In particular, mutations in filaggrin that impede their ability to aggregate keratin intermediate filaments (KIFs) have been correlated to epidermal phenotypes. Some of these skin barrier diseases and disorders include atopic dermatitis, ichthyosis vulgaris, epidermolytic ichthyosis, cyclic ichthyosis with epidermolytic hyperkeratosis, and palmoplantar keratoderma. Thus, it would require no undue experimentation on the part of the skilled artisan to make and use peptides of SEQ ID NOs:1-25 to treat a skin barrier disease or disorder. For at least the foregoing reasons, Applicant respectfully requests withdrawal of the rejection of claims 9, 11, and 16 under 35 U.S.C. § 112(a).
Applicant’s arguments have been fully considered but not found persuasive. While Applicants identify disclosed peptide sequences and evidence of SD67/SD150 binding to keratin, such disclosures do not reasonably enable the full scope of the claimed therapeutic methods. Demonstrating peptide identify or keratin binding does not establish that the claimed peptides effectively treat the full range of recited skin barrier diseases or disorders, including psoriasis, rosacea, trauma related conditions, cutaneous aging, chronic inflammatory skin disease, and allergy related conditions. Further, evidence that filaggrin mutations are associated with certain epidermal phenotypes may support relevance to some barrier related disorders, but does not render predictable treatment of all claimed conditions using all peptides encompassed by claims 9 and 11. Even if certain disorders may be associated with or linked to skin barrier dysfunction, such association does not reasonably establish that the full scope of the claimed peptides is enabled to treat all such disorders. A condition being correlated or linked to impaired skin barrier function does not render it predictable that administration of any peptide encompassed by claims 9 and 11, including peptides comprising SEQ ID Nos:1-25, will provide therapeutic benefit for every disorder allegedly associated with the skin barrier. Disorders linked to skin barrier dysfunction may nonetheless arise from distinct and multifactorial mechanisms, including inflammatory, immunologic, structural, vascular, degenerative, or trauma related pathways, each of which may require different therapeutic approaches. The specification does not provide sufficient representative examples, mechanistic guidance, or treatment data demonstrating that the claimed peptides are effective across the full range of such disorders without undue experimentation.
The specification lacks sufficient representative working examples or guidance demonstrating which peptides are effective for which recited disorders without undue experimentation. Accordingly, the rejection under 35 U.S.C 112(a) is maintained.
New Rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 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.
Claim 11 recites that the isolated peptide comprises “a SD67 peptide, a SD150 peptide, a SD67-derived peptide, or a SD150 derived peptide”, while depending from amended claim 9, which already requires an isolated peptide comprising an amino acid sequence selected from SEQ ID Nos:1-25. It is unclear whether the peptides of SEQ ID Nos:1-25 are themselves the recited “SD67 peptide” or “SD150 peptide”, whether any of the recited SEQ ID Nos:1-25 are instead “SD67 derived peptide” or “SD150 derived peptide”, or what objective distinction exists between a peptide and a derived peptide in this context. The claim therefore fails to clearly define the relationship between the inherited sequence limitations of claim 9 and the terminology of claim 11, such that one of ordinary skill in the art could not readily determine the metes and bounds of the claimed subject matter. It is suggested that claim 11 be canceled or amended to further limit by including specific SEQ ID Nos from claim 9.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 depends from claim 9 and does not further limit the subject matter of the claimed from which it depends. Claim 9 already recites a method comprising administration of an isolated peptide comprising an amino acid sequence selected from SEQ ID Nos:1-25. Claim 11 adds that the peptide comprises a SD67 peptide, a SD150 peptide, a SD67-derived peptide, or a SD150 derived peptide. However, it is unclear whether these recited categories merely restate the peptides already encompassed by SEQ ID Nos:1-25 or whether the “derived peptide “encompasses additional fragments, derivatives or variants beyond the scope of claim 9. To the extend the recited categories are coextensive with the peptides already required by claim 9, claim 11 does not further limit claim 9. To the extent “derived peptide” encompasses additional subject matter, claim 11 broadens rather than narrows the scope of claim 9. Accordingly, claim 11 is of improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Closest Prior Art Made of Record
Closest prior art made of record include the following: Whitfill (US20210121504 A1, filing date of 4/5/2019) teaches of filaggrin polypeptide for treatment of a skin disease or disorder including atopic dermatitis (see claims 29-31, claims 1 and 11). Whitfill discloses smaller fragments (174mer) of filaggrin (see Example 5, SEQ ID Nos:4-5, 7-9, 10, 12 and 14). However, these were discussed with regards to the overall structure-activity relationships of the protein and are not contemplated in the use of the method of Whitfill. There is no teaching, suggestion or motivation (or rationale) to use the smaller truncated fragments (SEQ ID Nos:4-5, 7-10, 12 and 14) in the method of treating the skin disease or disorder of Whitfill.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654
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