Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The amendment dated 10 February 2026, in which claims 12, 17, 21 have been amended, is acknowledged.
Claims 1-4, 11-26 are pending in the instant application.
Claims 1-4, 11-26 are being examined herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 January 2026 is acknowledged and considered.
Response to arguments of 10 February 2026
On 10 February 2026, Applicant has amended claim 21 to recite
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as the isothiocyanate functional surfactant. In view of Applicant’s amendment of 10 February 2026, the rejection of claim 21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description/possession, is herein withdrawn.
Applicant’s arguments (Remarks of 10 February 2026, pages 9-13) against the rejection of claims 1-4, 11-26 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, written description/possession, have been considered.
Applicant argues (page 10, last 4 lines, page 11, first paragraph) that there is disclosure in the Specification of relevant identifying characteristics in the name itself, an isothiocyanate functional surfactant.
Applicant argues (page 11) that that the Specification discloses the chemical structure and what constitutes an isothiocyanate functional surfactant [0039]. Applicant argues (page 12) that the Specification relies on [0039] and on chemical structures and possible variants claimed. Applicant argues that the disclosure of the application as filed is much broader than a single species. Applicant argues that the Specification describes the claimed subject matter in a manner that a POSITA will recognize that Applicant was in possession of the claimed invention. Applicant argues (page 12, last paragraph) that the chemical structure of the genus is explicitly provided in the Specification, given a sufficient written description of the isothiocyanate functional surfactant genus under 35 USC 112.
Applicant argues (page 13, first paragraph) that the Specification provides a clear structure-function correlation, as the disclosed structure containing -NCS group is directly linked to the function of interacting with skin proteins to treat psoriasis.
In response, these arguments are not persuasive. Contrary to Applicant’s argument that the chemical structure of the genus is explicitly provided in the Specification, the Specification teaches [0039] that an “isothiocyanate functional surfactant” comprises at least one isothiocyanate functional group (–NCS) linked to an aliphatic and/or aromatic carbon atom of the isothiocyanate functional surfactant. The Specification also discloses that an “isothiocyanate functional surfactant” comprises a non-polar moiety and a polar moiety, and that at least one isothiocyanate functional group (–NCS) is linked to either the non-polar moiety or to the polar moiety [0031].
The Specification also teaches that such isothiocyanate functional surfactants are prepared by conversion of an amine functionality into an isothiocyanate functionality [0043]. Thus, based on the Specification, any surfactant that has an amine group attached to an aliphatic or aromatic carbon atom can be converted into an isothiocyanate functional surfactant.
Thus, the claims, together with the specification, embrace millions of isothiocyanate functional surfactants, which treat psoriasis when applied topically to the skin.
There is absolutely no structural information given, beyond the existence of a polar moiety and a non-polar moiety in the molecule and of at least one -NCS group present in the molecule. This description cannot account for what Applicant considers as chemical structure “being explicitly provided in the Specification.” For these reasons, the rejection is herein maintained, and a modified rejection is made below, based on Applicant’s amendment of 10 February 2026.
Applicant’s arguments (pages 13-15) against the rejection of claims 1, 2, 11-13, 16-17, 20-22, 25 under 35 U.S.C. 102(b) as being anticipated by Sussan, have been considered. Similar arguments were presented (pages 15, last paragraph) against the rejection of claims 3, 4, 14, 15, 18, 19, 23, 24, 26 under 35 U.S.C. 103(a) over Sussan.
Applicant argues (page 14, first paragraph) that an isothiocyanate functional surfactant is not taught by Sussan.
The Declaration under 37 CFR 1.132, signed by inventor Dr. Michael Silver, submitted on 10 February 2026, is acknowledged and has been considered.
Dr. Silver states (points 4, 5 Declaration) that the compounds disclosed by Sussan are isothiocyanate compounds, but are not surfactants as well.
Dr. Silver states (point 6, Declaration) that an isothiocyanate functional surfactant compound is not a surfactant blended with an isothiocyanate compound/ingredient.
In response, the term “isothiocyanate functional surfactant” of claims 1-4, 11-20, 22-26 is defined by Applicant in the Specification [0039] to be any compound that comprises at least one isothiocyanate functional group (–NCS) linked to an aliphatic and/or aromatic carbon atom of the isothiocyanate functional surfactant. In view of Applicant’s own definition in [0039], the examiner had interpreted that any compound having at least one -NCS group attached to an aliphatic or aromatic carbon atom of the compound is an isothiocyanate functional surfactant.
Yet, the Specification also discloses that an “isothiocyanate functional surfactant” comprises a non-polar moiety and a polar moiety, and that at least one isothiocyanate functional group (–NCS) is linked to either the non-polar moiety or to the polar moiety [0031]. The Specification also teaches [0040] that a ”surfactant” necessarily has both a hydrophilic and a hydrophobic moiety. Since Sussan describes alkyl or aryl isothiocyanates (without a hydrophilic moiety), these rejections are herein withdrawn.
Applicant’s arguments (pages 16-18) against the rejection of claims 1-4, 11-26 under 35 U.S.C. 103(a) over Perez Arcas, Molenda, and Nakanishi, in view of Sussan, have been considered. Applicant has persuasively argued that none of the prior art references disclose the isothiocyanate elected species
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(of amended claim 21); that none of the prior art references of record, alone or in combination, teaches how to make the instantly claimed isothiocyanate of claim 21; and that a non-obvious synthetic route employing biphasic aqueous conditions was developed specifically to access the instantly claimed isothiocyanate of instant claim 21.
The rejection of claims 1-4, 11-26 under 35 U.S.C. 103(a) over Perez Arcas, Molenda, and Nakanishi, in view of Sussan, is herein withdrawn.
On 11 February 2026, Applicant has filed terminal disclaimer against U.S. patents 9,532,969; 10,532,039; 11,517,552; 8,865,765; 9,585,860; 9,649,290; 9,655,874; 9,687,463; 10,111,851; 9,962,361; 10,363,236; 10,885,540; 11,654,129; 10,308,599; 11,407,713, and the over co-pending applications 19/030,013; 17/882,737; 17/884,292. As a result, the rejections of instant claims under the judicially created doctrine of obviousness type double patenting as being unpatentable over claims U.S. patents 9,532,969; 10,532,039; 11,517,552; 8,865,765; 9,585,860; 9,649,290; 9,655,874; 9,687,463; 10,111,851; 9,962,361; 10,363,236; 10,885,540; 11,654,129; 10,308,599; 11,407,713, and the provisional rejections over co-pending applications 19/030,013; 17/882,737; 17/884,292, are herein withdrawn.
Applicant’s amendment of 10 February 2026 necessitated the following new/modified objections and rejections.
Claim objection
Claims 12, 17, 21 are objected to because they were amended, yet the text of the added subject matter is not shown by underlining the added text. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text.
See MPEP 714 reciting 37 CFR 1.121, (c) (2).
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Appropriate correction is required.
Claim 17 is objected to for lack of clarity regarding an additional step of adding the isothiocyanate functional surfactant to a formulation. The claim seems to try to state the concentration of the isothiocyanate functional surfactant in a formulation, yet it is unclear what is the relationship between the formulation and the method of treating psoriasis. Appropriate clarification is required.
Claim Rejections - 35 USC § 112
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 theinvention, 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 itis most nearly connected, to make and use the same, and shall set forth the best modecontemplated 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 themanner and process of making and using it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains, or with which it is most nearlyconnected, to make and use the same, and shall set forth the best mode contemplated by theinventor of carrying out his invention.
Claims 1-4, 11-20, 22-26 are rejected 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. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the art that the inventors, at the time the application was filed, had possession of the claimed invention. See MPEP 2163. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filling date of the application, of the specific subject matter claimed by him. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
Claims 1-4, 11-20, 22-26 are drawn to a method of treating psoriasis comprising applying an isothiocyanate functional surfactant to a portion of a skin affected by psoriasis […]. The Specification teaches [0039] that an “isothiocyanate functional surfactant” comprises at least one isothiocyanate functional group (–NCS) linked to an aliphatic and/or aromatic carbon atom of the isothiocyanate functional surfactant. The Specification also discloses that an “isothiocyanate functional surfactant” comprises a non-polar moiety and a polar moiety, and that at least one isothiocyanate functional group (–NCS) is linked to either the non-polar moiety or to the polar moiety [0031].
The Specification also teaches that such isothiocyanate functional surfactants are prepared by conversion of an amine functionality into an isothiocyanate functionality [0043]. Thus, based on the Specification, any surfactant that has an amine group attached to an aliphatic or aromatic carbon atom can be converted into an isothiocyanate functional surfactant.
Thus, claims 1-4, 11-20, 22-26, together with the specification, imply that any isothiocyanate surfactant applied topically to the skin can treat psoriasis.
Claims 1-4, 11-20, 22-26, taken together with the Specification, embrace millions of isothiocyanate functional surfactants, used to treat psoriasis.
Zuang et al. (Subgroup 2. Skin Irritation/Corrosion, in Cosmetics- European Commission, <http://ec.europa.eu/consumers/sectors/cosmetics/files/doc/antest/(5)_chapter_3/2_skin_irritation_en.pdf>, accessed 27 September 2015, cited in IDS) teaches that some ingredients or chemicals in formulations applied to the skin cause skin irritation and skin corrosion. Zuang teaches that there are several testing strategies for evaluating the skin irritation potential of ingredients and products applied to skin or mucous membranes. Zuang also teaches that there are studies aimed at correlating the primary skin irritation index with the structure of organic chemicals used as ingredients in topical/cosmetic formulations, as well as models developed to predict skin irritation and skin corrosion based on the chemical structure (see section on electrophiles) of ingredients.
Thus, Zuang teaches that there is unpredictability in the field of chemical ingredients such as surfactants applied to the skin, in terms of skin compatibility and exposure.
The level of skill in the art is that of the authors of the references cited to support the examiner’s position (MDs, PhDs, or those with advanced degrees and the requisite experience in dermatology drug research).
A disclosure should contain representative examples which provide reasonable assurance to one skilled in the art that ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter claimed by him. Applicant has broadly claimed a method of treating psoriasis with an isothiocyanate functional surfactant.
The genus above encompasses millions of surfactants which comprise at least one isothiocyanate functional group. MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claims 1-4, 11-20, 22-26 are broad and generic, with respect to all possible isothiocyanate surfactants encompassed by the instant claims. There is a very large number of structural variations encompassed by the claimed genus of surfactants encompassed by the broad language of claims 1-4, 11-20, 22-26. The claims lack in written description because there is no disclosure of a representative number of species within the very broad claimed genus.
Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus. The specification provides guidance to the synthesis of one such isothiocyanate surfactant, namely N-a-lauroyl-N-e-isothiocyanate-L-lysine (which corresponds to a compound of the structure above, wherein R1 is C4 alkyl, R2 is –N=C=S; R3 is alkanoyl; R4 = R5 = H, in protonated form or as a salt (sodium salt, Example I-IV).
Generally, in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See Enzo Biochem, 323 F.3d 956, 966, 63 USPQ2d 1609, 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004); Regents of the University of California v. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (Fed. Cir. 1997).
Applicant has disclosed the synthesis of one surfactant comprising an isothiocyanate functional group, namely N-a-lauroyl-N-e-isothiocyanate-L-lysine, in protonated form or as a salt; Applicant has described topical formulations comprising N-a-lauroyl-N-e-isothiocyanate-L-lysine for the treatment of psoriasis (Examples III, IV).
The specification does not provide sufficient descriptive support for practicing the claimed method with any isothiocyanate functional surfactant. The specification does not provide sufficient descriptive support for practicing the claimed method with the myriad of surfactants embraced by the claim. Applicant has claimed millions of isothiocyanate functional surfactants to be used in treating psoriasis.
Considering the state of the art and the high unpredictability in the art, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of claims 1-4, 11-20, 22-26.
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 12, 16 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.
Amended claim 12 is drawn to the method of treating psoriasis of claim 1, wherein the isothiocyanate functional surfactant is prepared from Na-lauroyl lysine. Claim 1 provides no information regarding the chemical structure of the isothiocyanate functional surfactant. The Specification broadly defines the term “isothiocyanate functional surfactant” [0039] as a compound that comprises at least one isothiocyanate functional group (–NCS) linked to an aliphatic and/or aromatic carbon atom of the isothiocyanate functional surfactant. It is unclear what is being “prepared from Na-lauroyl lysine” and how, because claim 1 offers no information related to the structure of the product being prepared, and claim 12 offers no clue regarding the structural relationship between the starting material Na-lauroyl lysine and the product isothiocyanate functional surfactant, nor does claim 12 contain any synthetic steps that would help a POSITA understand what is being claimed. For these reasons, the metes and bounds of the present claims cannot be determined and one having ordinary skill in the art would not necessarily be reasonably apprised of the scope of the claims.
Appropriate clarification of the claim language is required.
Conclusion
Claims 1-4, 11-20, 22-26 are rejected.
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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