Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 11/21/2025.
As filed, claims 22-31 and 33-43 are pending, wherein claims 42 and 43 are new; and claims 1-21 and 32 are cancelled.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 11/21/2025, with respect to claims 22-41, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The improper Markush grouping rejection of claims 22, 23, 31-35, and 38-40 is withdrawn per amendments and cancellation of claim 32.
The § 112(a) written description rejection of claim 32 is withdrawn per cancellation of the claim.
The § 112(a) written description rejection claims 22, 23, 31, 33-35, and 38-40 is maintained because Applicant’s remarks are not persuasive. As mentioned in the previous office action, the specification and the originally filed claims did not provide sufficient descriptive support for the myriad of surfactants embraced by the abovementioned claims. The genus of the formulas depicted in claims 22 and 34 is very broad: it includes hundreds of thousands of compounds, including any linkage to a dimer, or to any oligomer or to any polymer. 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 concluded that the inventor did not possess all of the surfactants depicted in claims 22 and 34. For the reasons stated above, and the rationale recited in the previous office action, the claims lack written description.
The § 112(a) new matter rejection of claim 35 is withdrawn per amendments.
The § 112(b) indefinite rejection of claim 32 is withdrawn per cancellation of the claim.
The § 112(b) indefinite rejection of claim 22, 23, 31, and 33 is maintained because not all the “comprising” languages are amended. For details, see rejection below.
The § 112 fourth paragraph rejection of claim 35 is withdrawn per amendments.
The claim objection of claims 24 and 30 is withdrawn per amendments.
Claim objection of claims 25-29 is withdrawn per amendments.
The claim objection of claims 36 and 37 are maintained because claims 24 and 36 are dawn to the same compound, which has the same scope. In addition, claims 25 and 37 are drawn to the same compound, which has the same scope.
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(claim 24)
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(claim 36)
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(claim 25)
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(claim 37)
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 22, 23, 31, 33-35, 38-40, 42, and 43 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 claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
(1) The nature of the invention and (2) the breadth of the claims:
Claim 22 is drawn to a surfactant or a pharmaceutically acceptable salt thereof, wherein said surfactant is represented by the following chemical formula:
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, wherein the substituent R1 consists of alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containing 1 to 25 carbon atom(s), wherein the carbon atom(s) may be a linking group to, or part of, a halogen, a N, O, and/or S containing moiety, and/or one or more functional groups comprising alcohols, esters, ammonium salts, phosphonium salts, and combinations thereof; a linkage to a dimer; a linkage to an oligomer; and/or a linkage to a polymer; wherein R2 is NCS; wherein R3-R5 are the same or different and are chosen from the group consisting of H; OH; an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containing 1 to 25 carbon atom(s), wherein the carbon atom(s) may be a linking group to, or part of, a halogen, a N, an O, and/or a S containing moiety, and/or one or more functional groups consisting of alcohols, esters, ammonium salts, phosphonium salts, and combination thereof; a linkage to a dimer; a linkage to an oligomer; and/or a linkage to a polymer with the proviso that at least one of R3-R5 consists of an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containing 8 to 25 carbon atom(s).
Claim 34 is drawn to a surfactant or a pharmaceutically acceptable salt thereof, wherein said surfactant is represented by the following chemical formula:
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wherein R1 is chosen from the group consisting of: an alkyl, a cycloalkyl, a polycycloalkyl, a heterocycloalkyl, an aryl, an alkaryl, an aralkyl, an alkoxy, an alkanoyl, an aroyl, an alkenyl, an alkynyl and a cyano group containing 1 to 25 carbon atom(s); wherein R2 is NCS; wherein R3 and R4 are the same or different and are chosen from the group consisting of: H; OH; an alkyl, a cycloalkyl, a polycycloalkyl, a heterocycloalkyl, an aryl, an alkaryl, an aralkyl, an alkoxy, an alkanoyl, an aroyl, an alkenyl, an alkynyl and a cyano group containing 1 to 25 carbon atom(s), wherein the at least one of R3-R4 are chosen from the group consisting of: an alkyl, a cycloalkyl, a polycycloalkyl, a heterocycloalkyl, an aryl, an alkaryl, an aralkyl, an alkoxy, an alkanoyl, an aroyl, an alkenyl, an alkynyl and a cyano group containing 8 to 25 carbon atom(s); and wherein R5 is H.
The instant specification teaches that the compounds of the instant invention, for instance, are applied to the skin to treat phytophotodermatitis [0033] and [0036].
The genus of the formulas above is very broad: it includes hundreds of thousands of compounds, including any linkage to a dimer, or to any oligomer or to any polymer.
Thus, claims 22 and 34 embrace hundreds of thousands of surfactants that can used to treat phytophotodermatitis, etc.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
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 filed 10/6/2022) 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.
(5) The relative skill of those in the art:
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).
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
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. The applicant has broadly claimed a surfactant of the formula:
Claim 22:
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, wherein the genus of such surfactants substituent R1 comprises alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containing 1 to 25 carbon atom(s), wherein the carbon atom(s) may be a linking group to, or part of, a halogen, a N, O, and/or S containing moiety, and/or one or more functional groups comprising alcohols, esters, ammonium salts, phosphonium salts, and combinations thereof; a linkage to a dimer; a linkage to an oligomer; and/or a linkage to a polymer; wherein R2 comprises NCS; wherein R3-R5 are the same or different and comprise H; OH; an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containing 1 to 25 carbon atom(s), wherein the carbon atom(s) may be a linking group to, or part of, a halogen, a N, O, and/or S containing moiety, and/or one or more functional groups comprising alcohols, esters, ammonium salts, phosphonium salts, and combinations thereof; a linkage to a dimer; a linkage to an oligomer; and/or a linkage to a polymer with the proviso that at least one of R3-R5 comprise an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containing 8 to 25 carbon atom(s).
Claim 34:
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wherein R1 is chosen from the group consisting of: an alkyl, a cycloalkyl, a polycycloalkyl, a heterocycloalkyl, an aryl, an alkaryl, an aralkyl, an alkoxy, an alkanoyl, an aroyl, an alkenyl, an alkynyl and a cyano group containing 1 to 25 carbon atom(s); wherein R2 is NCS; wherein R3 and R4 are the same or different and are chosen from the group consisting of: H; OH; an alkyl, a cycloalkyl, a polycycloalkyl, a heterocycloalkyl, an aryl, an alkaryl, an aralkyl, an alkoxy, an alkanoyl, an aroyl, an alkenyl, an alkynyl and a cyano group containing 1 to 25 carbon atom(s), wherein the at least one of R3-R4 are chosen from the group consisting of: an alkyl, a cycloalkyl, a polycycloalkyl, a heterocycloalkyl, an aryl, an alkaryl, an aralkyl, an alkoxy, an alkanoyl, an aroyl, an alkenyl, an alkynyl and a cyano group containing 8 to 25 carbon atom(s); and wherein R5 is H.
The genera above encompassed hundreds of thousands of surfactants which comprise at least one isothiocyanate functional group R2. 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 22 and 34 is broad and generic, with respect to all possible isothiocyanate (as R2) surfactants encompassed by the instant claims. There is a very large number of structural variations encompassed by the claimed genera of surfactants represented by the structure
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.
The claim lacks in written description because there is no disclosure of a representative number of species within the very broad claimed genera. Moreover, the instant specification lacks sufficient variety of species to reflect this variance in the genera. The instant specification provides guidance to the synthesis of one such isothiocyanate (R2 is –NCS) surfactant, namely N-α-lauroyl-N-ε-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, [0053], Example IV, salt with TEA, [0051], Example III).
There is no teaching in the instant specification regarding a surfactant of the general structure above where R1 is any moiety beyond alkyl; R2 is any moiety beyond –N=C=S; R3 is any moiety beyond alkanoyl C8-C25.
The specification does not provide sufficient descriptive support for the myriad of surfactants embraced by the claim.
(8) The quantity of experimentation necessary:
There are hundreds of thousands of combinations of structural elements in a surfactant represented by the structure
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, embraced by claims 22 and 34.
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 at least one isothiocyanate functional group, namely N N-α-lauroyl-N-ε-isothiocyanate-L-lysine, in protonated form or as a salt (sodium salt, [0063], Example IV, salt with TEA, [0059], Example III).
Applicant has claimed hundreds of thousands of surfactants represented by the structure
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, to be used in a method of treating phytophotodermatitis.
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 22 and 34. In addition, a person of ordinary skill in the art would reasonably concluded that the inventor did not possess all of the surfactants depicted in claims 22 and 34 and thus, the claims lack written description.
Regarding claims 23, 31, 33, 42, and 43, these claims are directly or indirectly dependent of claim 22, and they failed to correct the defective issue of claim 22, which rendered these claims improper.
Regarding claims 35 and 38-40, these claims are directly or indirect dependent of claim 34, and they failed to correct the defective issue of claim 34, which rendered these claims improper.
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 22, 23, 31, 33, and 42 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 pre-AIA the applicant regards as the invention.
Regarding claim 22, the claims recite the following phrase (as shown by box):
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Firstly, variable R1 recites the term "comprises." Forms of the term “comprise” are considered open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed.
The structure of
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depicted in claim 22 is synonymous as the term “compound”, which contradicts the open language "comprises." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means. Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148 (see PTO-892 form mailed on 2/12/2024). By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules.
The transitional term "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”).
Thus, a contradiction arises within the definition of R1 because a "compound" with this variable requires a definite chemical formula, and the open-ended term "comprises" does not exclude unrecited elements. Furthermore, "comprising", used in conjunction with "compound" fails to articulate exactly what subject matter is excluded from the claimed scope of compounds, thereby rendering the scope of claim 22 indefinite.
Regarding claims 23, 31, 33 and 42, these claims are directly or indirectly dependent of claim 22, and they failed to correct the indefiniteness issue of claim 22, which rendered these claims indefinite.
Allowable Subject Matter
Claim 41 is allowed.
Claims 24-30 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.
Claim Objections
Claims 36 and 37 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 24 and 25, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Conclusion
Claims 22, 23, 31, 33-35, 38-40, 42, and 43 are rejected.
Claim 41 is allowed.
Claims 24-30, 36 and 37 are objected.
Claims 1-21 and 32 are cancelled.
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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621