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 .
Prosecution Reopened
In view of the Appeal Brief filed on July 21, 2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654
Election/Restrictions
Applicant’s election of Group I and the species RFAACAA in the reply filed on May 20, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The elected species RFAACAA was searched and prior art was found. Therefore, the search was not extended in accordance with MPEP § 803.02.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome art rejections because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Withdrawn Claim Rejections - 35 USC § 101
The rejection of claims 36-55 under 35 U.S.C. 101 is withdrawn in view of the arguments presented in the appeal brief filed July 21, 2026.
New 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 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 36-37, 41-50, and 52-55 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.
The claims are drawn to a preparation, wherein the preparation is suitable for topical application to skin and comprises one or more peptides selected from HHHHHH (SEQ ID NO: 1), RFAALAA (SEQ ID NO: 3) and its N-acetylated derivative, RFAACAA (SEQ ID NO: 2) and its N-acetylated derivative, RAACAA (SEQ ID NO: 4) and its N-acetylated derivative, RFACAA (SEQ ID NO: 5) and its N-acetylated derivative, RFACA (SEQ ID NO: 6) and its N-acetylated derivative in a concentration such that when the preparation is applied to skin, the preparation (i) forms a skin barrier against urushiols and/or (ii) prevents or reduces a penetration and/or accumulation of urushiols on the skin and/or in the skin and/or (iii) prevents or attenuates contact dermatitis caused by urushiols.
The claims use functional language to limit the concentration of the peptides in the composition. That is, rather than require a specific physical concentration or range of concentrations, the claims recite a function that must be achieved by the preparation, and the concentration of peptides within it. The claims recite the feature of peptide concentration by what it does rather than by what it is. In the instant case, one embodiment of the claimed preparation forms a skin barrier against urushiols, the allergen commonly found in plants such as poison ivy, thereby preventing, reducing, or attenuating atopic dermatitis caused by the urushiol. In another embodiment, the preparation forms a skin barrier against urushiols. In another embodiment, the preparation as claimed prevents or reduces accumulation of urushiols on the skin. According to the specification, the peptide functions by binding to or reacting with the urushiol.
The specification does not present a reduction to practice of a preparation tested in a cell-based assay, skin tissue-based assay, or animal model. The specification presents a single in vitro assay, the direct peptide reactivity assay (DPRA), which is an art-recognized assay for assessing skin sensitization of chemicals. The specification conducts the DPRA in which RFAACAA (SEQ ID NO: 2) and its N-acetylated derivative are tested for the ability to react with urushiol allergens. Urushiols at a concentration of 5 mM were combined with the peptide at a concentration of 0.5 mM. The unbound peptide is detected by reaction with Ellman’s reagent and corresponding absorbance at 415 nM. The better the urushiol reacts with the peptides, the less peptide remains available for reaction with Ellman’s reagent, resulting in less yellow color. The specification concludes on page 14 that the RFAACAA (SEQ ID NO: 2) peptide and its N-acetylated derivative exhibit “very high reactivity and thus protective activity” against urushiols. However, Figure 2 does not include any error bars nor is a statistical analysis presented in the specification. It is not clear whether the reduction in absorption measured for the peptide alone versus the peptide plus urushiol is statistically significant within the context of the assay nor is it clear how the results predict behavior on skin and at real-world concentrations of urushiols.
The specification does not include a reduction to practice of the in vitro DRPA with any other concentrations of RFAACAA (SEQ ID NO: 2) peptide and its N-acetylated derivative or urushiols. In addition, the specification fails to present a reduction to practice of the in vitro DRPA with any other claimed peptide. Therefore, the specification has failed to demonstrate possession of the claimed genus of concentrations of peptides by actual reduction to practice of a representative number of species.
In addition, the specification has failed to demonstrate possession of the claimed genus of concentration of peptides by a description of the distinguishing characteristics of the genus. The specification fails to provide a structure-function correlation that will allow POSITA to predict which concentrations for each of the claimed peptides are capable of forming a preparation such that when the preparation is applied to skin, the preparation (i) forms a skin barrier against urushiols and/or (ii) prevents or reduces a penetration and/or accumulation of urushiols on the skin and/or in the skin and/or (iii) prevents or attenuates contact dermatitis caused by urushiols. The specification does not explain how RFAACAA (SEQ ID NO: 2) peptide and its N-acetylated derivative react with urushiols. The other claimed peptides have different amino acid sequences containing different reactive groups. Therefore, it is not clear how to use data on the reactivity of a single peptide at a single concentration to predict how and at what concentrations other peptides with different reactive groups will interact with urushiols. Furthermore, it is not clear how for even RFAACAA (SEQ ID NO: 2) peptide and its N-acetylated derivative changing the concentration will impact function. Furthermore, it is not clear how for even RFAACAA (SEQ ID NO: 2) peptide and its N-acetylated derivative an ability to react with an urushiol correlates with an ability to prevent or reduce accumulation on the skin when the peptide is also
For these reasons, claims 36-37, 41-50, and 52-55 fail to meet the written description requirement of 35 U.S.C. 112(a).
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 36-37, 41-50, and 52-55 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.
The claims are drawn to a preparation, wherein the preparation is suitable for topical application to skin and comprises one or more peptides selected from HHHHHH (SEQ ID NO: 1), RFAALAA (SEQ ID NO: 3) and its N-acetylated derivative, RFAACAA (SEQ ID NO: 2) and its N-acetylated derivative, RAACAA (SEQ ID NO: 4) and its N-acetylated derivative, RFACAA (SEQ ID NO: 5) and its N-acetylated derivative, RFACA (SEQ ID NO: 6) and its N-acetylated derivative in a concentration such that when the preparation is applied to skin, the preparation (i) forms a skin barrier against urushiols and/or (ii) prevents or reduces a penetration and/or accumulation of urushiols on the skin and/or in the skin and/or (iii) prevents or attenuates contact dermatitis caused by urushiols.
The claims use functional language to limit the concentration of the peptides in the composition. That is, rather than require a specific physical concentration or range of concentrations, the claims recite a function that must be achieved by the preparation, and the concentration of peptides within it. The claims recite the feature of peptide concentration by what it does rather than by what it is. In the instant case, one embodiment of the claimed preparation forms a skin barrier against urushiols, the allergen commonly found in plants such as poison ivy, thereby preventing, reducing, or attenuating atopic dermatitis caused by the urushiol. In another embodiment, the preparation forms a skin barrier against urushiols. In another embodiment, the preparation prevents or reduces accumulation of urushiols on the skin. According to the specification, the peptide functions by binding to or reacting with the urushiol.
In the instant case, the functional language renders the claim ambiguous. The specification demonstrates in Figure 2 and by using the DRPA that 0.5 mM SEQ ID NO: 2 reacts with a urushiol at a concentration of 5 mM. It is not clear how any ability to react with a urushiol prevents accumulation of the urushiol on the skin if the peptide is present in the preparation. On the contrary, it seems that the peptide would trap the urushiol in the preparation on the skin by reacting with it. This may prevent penetration but the claim also recites the function of “prevents or reduces…accumulation of urushiols on the skin”.
It is not clear how to distinguish concentrations of peptides that would achieve at least one of claimed functions of the preparation from concentrations of peptides that fail to achieve any of the claimed functions of the preparation. It is not clear to what extent a barrier must be formed, and/or prevention or reduction of accumulation and/or penetration of urushiols and/or atopic dermatitis must be achieved for a concentration to be considered within the scope of the claim. Furthermore, it is not clear to what extent other components of the preparation bring about the claimed function or whether the claimed function is dependent solely on the peptides. As a result, the metes and bounds of the claim with respect to peptide concentration are indefinite.
Maintained and Revised 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 36-38 and 48-50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pastorin et al. (WO 2019/098948 A1).
Pastorin et al. teach the peptide Ac-RFAACAA (p. 27, lines 20-21, referred to in the reference as “the cysteine peptide”). The peptide is an N-acetylated derivative of the elected species RFAACAA. Pastorin et al. teach a preparation comprising 20 mM Ac-RFAACAA in 100 mM Sodium Phosphate buffer of pH 7.5 (Tables 19-20; p. 70, lines 1-2) and a preparation comprising 200 mM Ac-RFAACAA (Table 19, initial concentration).
MPEP § 2112.01(II) states: "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
In the instant case, the prior art teaches a preparation comprising 200 mM Ac-RFAACAA (Table 19, initial concentration) but is silent as to when the preparation is applied to skin, the preparation (i) forms a skin barrier against urushiols and/or (ii) prevents or reduces a penetration and/or accumulation of urushiols on the skin and/or in the skin and/or (iii) prevents or attenuates contact dermatitis caused by urushiols. Because the prior art teaches a composition that meets all of the structural and physical limitations of the claim, the claimed property of when the preparation is applied to skin, the preparation (i) forms a skin barrier against urushiols and/or (ii) prevents or reduces a penetration and/or accumulation of urushiols on the skin and/or in the skin and/or (iii) prevents or attenuates contact dermatitis caused by urushiols is inherent to the prior art composition.
The concentration reported by Pastorin et al. as the initial concentration, 200 mM Ac-RFAACAA, is 0.014 wt%1, which falls within the claimed range of 0.01%-10% recited in claim 38. The dependent claim 38 provides evidence that the concentration disclosed in Pastorin et al., 200 mM Ac-RFAACAA, is capable of performing the claimed functions.
The inventors have found a new property of an old composition and such a discovery does not constitute a new composition.
Therefore, Pastorin et al. anticipates claims 36-38 and 48-50.
Response to Arguments
Applicant's arguments filed July 21, 2026, have been fully considered but they are not persuasive.
First, Applicant argues that the reference fails to teach a preparation “suitable for topical application to skin”. This is not persuasive. The phrase “suitable for topical application to the skin” is an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the preparation contains the claimed peptides in an aqueous sodium phosphate buffer. Although this preparation is taught by the reference to be an in-chemico laboratory assay reagent, it is capable of being topically applied to the skin because it is a liquid and does not contain agents that would be incompatible with skin application. Furthermore, the prior art preparation includes the identical active agent, the N-acetylated derivative of SEQ ID NO: 4, at concentration that the instant claims designates as effective.
Second, Applicant argues that the Examiner has provided no evidence that the prior art preparation would form a urushiol barrier and/or prevent penetration and/or prevent or attenuate contact dermatitis. This is not persuasive. The evidence is the fact that the prior art preparation includes the identical active agent, the N-acetylated derivative of SEQ ID NO: 4, at concentration that the instant claims designates as effective. Identical structures must have identical functions. Applicant has not provided any evidence to rebut this assertion.
Third, Applicant argues that the concentration 20 mM falls outside of the claimed ranges. This argument is not persuasive. Pastorin et al. teach the peptide Ac-RFAACAA (p. 27, lines 20-21, referred to in the reference as “the cysteine peptide”). The peptide is an N-acetylated derivative of the elected species RFAACAA. Pastorin et al. teach a preparation comprising 20 mM Ac-RFAACAA in 100 mM Sodium Phosphate buffer of pH 7.5 (Tables 19-20; p. 70, lines 1-2) and a preparation comprising 200 mM Ac-RFAACAA (Table 19, initial concentration). The concentration reported by Pastorin et al. as the initial concentration, 200 mM Ac-RFAACAA, is 0.014 wt%2, which falls within the claimed range of 0.01%-10% recited in claim 38.
For these reasons, the rejection is maintained.
Maintained and Revised Claim Rejections - Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
I. Application No. 17/759,634
Claims 36-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 29, and 31-47 of copending Application No. 17/759,634 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 26 recites a cosmetic or dermatological preparation, wherein the preparation comprises a cosmetically or dermatologically acceptable carrier and comprises one or more peptides selected from HHHHHH (SEQ ID NO: 1), Ac-RFAACAA (SEQ ID NO: 2), Ac-RFAALAA (SEQ ID NO: 3), RFAALAA (SEQ ID NO: 7), RFAACAA (SEQ ID NO: 8), Ac-RAACAA (SEQ ID NO: 4), RAACAA (SEQ ID NO: 9), Ac-RFACAA (SEQ ID NO: 5), RFACAA (SEQ ID NO: 10), Ac-RFACA (SEQ ID NO: 6) or RFACA (SEQ ID NO: 11), the one or more peptides being present in an amount from 0.01% to 10% by weight, based on total weight of the preparation, such that when the preparation is applied to skin, the preparation (i) prevents or reduces a penetration and/or accumulation of foreign substances and/or allergens on skin and/or in skin, and/or (ii) prevents or reduces a penetration and/or accumulation of contact allergens on the skin and/or in the skin, and/or (iii) prevents or reduces allergic reactions in or on the skin.
The reference claims do not require that the peptide is effective in the treatment of allergic contact dermatitis caused by urushiols. However, this property is inherent to the reference claims because a chemical composition and its properties are inseparable (MPEP § 2112.01). In the instant case, the same compounds, the peptides, are present in the same concentration as required by the instant claims, along with a carrier that is suitable for the skin (i.e. a cosmetically or dermatologically acceptable carrier)
Therefore, claims 36-38 and 48-50 are anticipated.
Regarding claims 39-40 and 51, reference claim 29 requires that the preparation comprises from 0.01% to 10% by weight of the one or more peptides, based on a total weight of the preparation, respectively. This range overlaps with the ranges in claims 39-40 and 51.
Regarding claims 41-45 and 52-55, reference claim 31 requires that the preparation is present in the form of at least one of an emulsion, a gel or a spray.
Regarding claim 46, reference claim 46 requires that the preparation comprises a film former.
Regarding claim 47, reference claim 29 requires that the preparation comprises a carrier.
II. Application No. 17/759,635
Claims 36-45 and 48-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-35 of copending Application No. 17/759,635 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 25 recites a preparation, wherein the preparation is topically applicable and comprises at least one of the peptides HHHHHH (SEQ ID NO: 1), Ac-RFAACAA (SEQ ID NO: 2), Ac-RFAALAA (SEQ ID NO: 3), RFAALAA (SEQ ID NO: 7), RFAACAA (SEQ ID NO: 8), Ac-RAACAA (SEQ ID NO: 4), RAACAA (SEQ ID NO: 9), Ac-RFACAA (SEQ ID NO: 5), RFACAA (SEQ ID NO: 10), Ac-RFACA (SEQ ID NO: 6) or RFACA (SEQ ID NO: 11), wherein the concentration of the peptides is 0.01% to 10% by weight.
Reference claims 29-32 require that the preparation is capable of preventing or reducing allergic reactions in or on skin, is capable of forming a skin barrier against foreign substances and/or allergens, is capable of preventing or reducing a penetration and/or accumulation of foreign substances and/or allergens on skin and/or in skin, and is capable of attenuating atopic dermatitis and/or allergic contact dermatitis.
The reference claims do not require that the peptide is effective in the treatment of allergic contact dermatitis caused by urushiols. However, this property is inherent to the reference claims because a chemical composition and its properties are inseparable (MPEP § 2112.01). In the instant case, the same compounds, the peptides, are present in the same concentration as required by the instant claims, along with a carrier that is suitable for the skin (i.e. a cosmetically or dermatologically acceptable carrier)
Therefore, claims 36-38 and 48-50 are anticipated.
Regarding claims 39-40 and 51, reference claims 26-27 require that the preparation comprises from 0.1% to 5%, and 0.2% to 5% by weight of the one or more peptides, based on a total weight of the preparation, respectively.
Regarding claims 41-45 and 52-55, reference claim 28 requires that the preparation is present in the form of at least one of an emulsion, a gel or a spray.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 8:30 am - 5 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, Lianko G Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654
1 The molecular weight of the peptide is 708.83 g/mol.
2 The molecular weight of the peptide is 708.83 g/mol.
