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
Claim Status
Claims 1, 5-6, 8-9 and 11-20 are pending. Claims 2-4, 7 and 10 have been canceled. Claim 1 has been amended. Claims 1 and 16-17 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I, SEQ ID NO: 1, caprylyl glycol and colloidal sulfur. Claims 5-6, 8-9, 11-15 and 18-20 are withdrawn as being drawn to a nonelected species.
Claim Rejections - 35 USC § 112
The rejection of claims 16-17 under 35 USC 112(a) is withdrawn in view of the amendments to the claims.
The rejection of claim 2 under 35 USC 112(b) is withdrawn in view of the amendments to the claims.
Claim Rejections - 35 USC § 103
The rejection of claims 1-2 and 16-17 under 35 U.S.C. 103 as being unpatentable over Zaveri in view of Schmaus et al. is withdrawn in view of the amendments to the claims.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This rejection is maintained.
Claims 1 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zaveri (US 2005/0250685) in view of Schmaus et al. (US 2016/0206571) and Challis et al. (The Best Sulfur Treatments For Seb Derm And Psoriasis; July 12, 2017).
Zaveri teaches a skin preparation comprising a peptide having wound healing activity, wherein the peptide is TB4 (SEQ ID NO: 7; Ac-A-N-K-G-Q-A-P-G-E-A-M-K-P-S-F-L-K-E-K-K-E-V-V-E-R-S-K-E-E-E-G-P-A-K-M-N-L-V-I-E-M-P-K-D) (paras [0069], [0124]-[0125], [0128], [0130]-[0133]; claim 1; passim).
Zaveri also teaches that the preparation further comprises a moisturizer (claim 8).
Zaveri further teaches that the peptide TB4 is used to treat mycotic ulcerations, such as those associated with superficial fungal infection or deep fungal infection (para [0097]).
Zaveri does not teach that the preparation comprises caprylyl glycol and colloidal sulfur.
Schmaus et al. teach a cosmetic or pharmaceutical composition comprising an active mixture comprising (a) 1,2-hexanediol and (b) 1,2-octanediol (i.e. caprylyl glycol) (claim 1).
Schmaus et al. also teach that 1,2-octanediol is a skin moisturizing agent (para [0183]).
Schmaus et al. further teach that “[P]referred compositions according to the present inventions are selected from the group of products for treatment, protecting, care and cleansing of the skin and/or hair or as a make-up product, preferably as a leave-on product (meaning that the one or more compounds of formula (I) stay on the skin and/or hair for a longer period of time, compared to rinse-off products, so that the moisturizing and/or antiaging and/or wound healing promoting action thereof is more pronounced)” (para [0231]).
Challis et al. teach that “[c]olloidal sulfur used in some soaps and shampoos. Sulfur has a long history of use in skin conditions, and any effect is likely due to the anti-infective properties” (page 5, “Summary”), and further teaches that sulfur is an excellent antifungal agent (page 4, “How effective is sulfur”).
The MPEP 2144.06 states that it is obvious to substitute equivalents known for the same purpose.
In the instant case, it would have been obvious to substitute the moisturizer of Zaveri with the moisturizer of Schmaus et al. (i.e. caprylyl glycol).
Alternatively, the MPEP 2144.06 states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that the peptide TB4 (which comprises instant SEQ ID NO: 1) and mixtures comprising 1,2-octanediol (i.e. caprylyl glycol) have wound healing activity, it would have been obvious to combine the two with the expectation that such a combination would have wound healing activity. Thus, combining them flows logically from them having been individually taught in prior art.
One of ordinary skill in the art would have reasonably expected caprylyl glycol to support wound healing by creating a moisture barrier, thus increasing the wound healing activity of the peptide TB4.
Furthermore, the MPEP 2144.06 states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that the peptide TB4 and colloidal sulfur are effective in treating fungal infections, it would have been obvious to combine the two compounds with the expectation that such a combination would be effective in treating fungal infections. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 16, Zaveri teaches a skin preparation comprising a peptide (i.e. TB4) having wound healing activity, wherein the peptide is used to treat bacterial infections (para [0097]).
On the other hand, Schmaus et al. teach that “[P]referred compositions according to the present inventions are selected from the group of products for treatment, protecting, care and cleansing of the skin and/or hair or as a make-up product, preferably as a leave-on product (meaning that the one or more compounds of formula (I) stay on the skin and/or hair for a longer period of time, compared to rinse-off products, so that the moisturizing and/or antiaging and/or wound healing promoting action thereof is more pronounced)” (para [0231]); and further teach that the hair product is a shampoo (paras [0027], [0232]).
Therefore, it would have been obvious to one of ordinary skill in the art to make an antibacterial shampoo comprising the peptide TB4, colloidal sulfur and caprylyl glycol. The skilled artisan would have reasonably expected said shampoo to be antibacterial because Zaveri teaches that the peptide TB4 is used to treat bacterial infections.
With respect to claim 17, it is noted that hair growth is an inherent property of the claimed peptide. Therefore, since it would have been obvious to make an antibacterial shampoo comprising the peptide, one of ordinary skill in the art applying said shampoo to a subject would have necessarily achieved hair growth on the subject.
Response to Arguments
Applicant’s arguments filed on 6/12/2026 have been fully considered but they are not persuasive.
Applicant argues that “[a] peptide comprising an amino acid sequence having 100% sequence identity to L-K-E-K-K (SEQ ID NO: 1) has a neutral leucine residue, an acidic glutamate residue, and three basic lysine residues, making the L- K-E-K-K peptide highly basic. Colloidal sulfur, which has a slightly negative charge, is only stable at slightly acidic to neutral pH. Thus, one of skill in the art would not expect colloidal sulfur to be stable in the presence of the highly basic L-K-E-K-K peptide, and, for at least this reason, there would be no motivation to combine the compounds”.
Applicant’s arguments are not persuasive.
First of all, it is noted that the peptide of Zaveri does NOT consist of L-K-E-K-K , it consists of Ac-A-N-K-G-Q-A-P-G-E-A-M-K-P-S-F-L-K-E-K-K-E-V-V-E-R-S-K-E-E-E-G-P-A-K-M-N-L-V-I-E-M-P-K-D, which has a net charge of +0.01.
Furthermore, Applicant did not provide any evidence showing that colloidal sulfur is only stable at slightly acidic to neutral pH.
Even assuming arguendo, that colloidal sulfur is only stable at slightly acidic to neutral pH, as discussed above, the peptide of Zaveri is neutral, thus one of ordinary skill in the art would have expected colloidal sulfur to be stable in the presence of the neutral peptide of Zaveri.
For the reasons stated above the rejection is maintained.
Double Patenting
The rejection of claims 1-2 and 16-17 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 6767891 in view of Schmaus et al. is withdrawn in view of the amendments to the claims.
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.
This rejection is maintained.
Claims 1 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 6767891 (hereafter Zaveri) in view of Schmaus et al. (US 2016/0206571).
Zaveri teaches a pharmaceutical composition comprising a substantially purified peptide having wound healing activity, the peptide comprising a sequence of 44 amino acids, that is: K-K-L-K-K-E-E-N-P-L-E-L-K-E-K-L-K-E-K-K-N-P-L-P-S -K-E-E-E-K-A-S-P-F-D-K-1-T-E-T-P-DM-S (SEQ ID NO: 8), the peptide being linear (claim 1).
Zaveri also teaches that the preparation further comprises a moisturizer (claim 3).
Zaveri further teaches that the peptide is used to treat mycotic ulcerations, such as those associated with superficial fungal infection or deep fungal infection (column 9, lines 47-49).
Zaveri does not teach that the preparation comprises caprylyl glycol and colloidal sulfur.
Schmaus et al. teach a cosmetic or pharmaceutical composition comprising an active mixture comprising (a) 1,2-hexanediol and (b) 1,2-octanediol (i.e. caprylyl glycol) (claim 1).
Schmaus et al. also teach that 1,2-octanediol is a skin moisturizing agent (para [0183]).
Schmaus et al. further teach that “[P]referred compositions according to the present inventions are selected from the group of products for treatment, protecting, care and cleansing of the skin and/or hair or as a make-up product, preferably as a leave-on product (meaning that the one or more compounds of formula (I) stay on the skin and/or hair for a longer period of time, compared to rinse-off products, so that the moisturizing and/or antiaging and/or wound healing promoting action thereof is more pronounced)” (para [0231]).
Challis et al. teach that “[c]olloidal sulfur used in some soaps and shampoos. Sulfur has a long history of use in skin conditions, and any effect is likely due to the anti-infective properties” (page 5, “Summary”), and further teaches that sulfur is an excellent antifungal agent (page 4, “How effective is sulfur”).
The MPEP 2144.06 states that it is obvious to substitute equivalents known for the same purpose.
In the instant case, it would have been obvious to substitute the moisturizer of Zaveri with the moisturizer of Schmaus et al. (i.e. caprylyl glycol).
Alternatively, the MPEP 2144.06 states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that the peptide TB4 (which comprises instant SEQ ID NO: 1) and mixtures comprising 1,2-octanediol (i.e. caprylyl glycol) have wound healing activity, it would have been obvious to combine the two with the expectation that such a combination would have wound healing activity. Thus, combining them flows logically from them having been individually taught in prior art.
One of ordinary skill in the art would have reasonably expected caprylyl glycol to support wound healing by creating a moisture barrier, thus increasing the wound healing activity of the peptide TB4.
Furthermore, the MPEP 2144.06 states that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that the peptide TB4 and colloidal sulfur are effective in treating fungal infections, it would have been obvious to combine the two compounds with the expectation that such a combination would be effective in treating fungal infections. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 16, Zaveri teaches that the peptide is used to treat bacterial infections (para [0097]). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
On the other hand, Schmaus et al. teach that “[P]referred compositions according to the present inventions are selected from the group of products for treatment, protecting, care and cleansing of the skin and/or hair or as a make-up product, preferably as a leave-on product (meaning that the one or more compounds of formula (I) stay on the skin and/or hair for a longer period of time, compared to rinse-off products, so that the moisturizing and/or antiaging and/or wound healing promoting action thereof is more pronounced)” (para [0231]); and further teach that the hair product is a shampoo (paras [0027], [0232]).
Therefore, it would have been obvious to one of ordinary skill in the art to make an antibacterial shampoo comprising the peptide of Zaveri and caprylyl glycol. The skilled artisan would have reasonably expected said shampoo to be antibacterial because Zaveri teaches that the peptide is used to treat bacterial infections.
With respect to claim 17, it is noted that hair growth is an inherent property of the claimed peptide. Therefore, since it would have been obvious to make an antibacterial shampoo comprising the peptide, one of ordinary skill in the art applying said shampoo to a subject would have necessarily achieved hair growth on the subject.
Response to Arguments
Applicant’s arguments filed on 6/12/2026 have been fully considered but they are not persuasive.
Applicant arguments have been addressed above under “Response to Arguments” on page 7.
For the reasons stated above the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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