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
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/3/2025 is acknowledged.
Applicant's election with traverse of SEQ ID NO: 1, caprylyl glycol and colloidal sulfur in the reply filed on 11/3/2025 is acknowledged. The traversal is on the ground(s) that the Examiner has not “clearly identified each….of the disclosed species, to which the claims are to be restricted”. This is not found persuasive because the open language “comprising” encompasses anything else in addition to the preparation of claim 1. Therefore, it is impossible to identify what species could be present or not is said preparation.
The requirement is still deemed proper and is therefore made FINAL.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/3/2025.
Claims 5-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/3/2025.
Status of the Claims
Claims 1-20 are pending in this application.
Claims 5-15 and 18-20 are withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1-4 and 16-17 are presently under consideration as being drawn to the elected species/invention.
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 16-17 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 an antibacterial shampoo (or a hair growth product) comprising a preparation comprising: a peptide comprising a sequence of L-K-E-K-K (SEQ ID NO: 1); and caprylyl glycol.
It is noted that the phrase “a sequence of L-K-E-K-K” encompasses any sequence (i.e. any 2 or more consecutive amino acids) contained in L-K-E-K-K.
The specification does not provide any teaching demonstrating that peptides sequences contained in L-K-E-K-K, other than L-K-E-K-K itself, are antibacterial, or are capable of inducing hair growth.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
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 2 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 2 is drawn to the preparation of claim 1, is present at a concentration between 0.1 mg and 0.5 mg and the caprylyl glycol is present at a concentration between 1 gram and 5 grams.
It is noted that concentrations should be expressed as a percentage, or as a weight/volume ratio. In the instant case, since the volume is not disclosed, the claim is indefinite.
Claim Rejections - 35 USC § 103
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.
Claims 1-2 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).
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-EK-K-E-V-V-E-R-S-K-E-E-E-G-P-A-K-M-N-L-V-I-E-M-PK-D) (paras [0069], [0124]-[0125], [0128], [0130]-[0133]; claim 1; passim).
Zaveri also teaches that the preparation further comprises a moisturizer (claim 8).
Zaveri does not teach that the preparation comprises caprylyl glycol.
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]).
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.
With respect to claim 2, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum concentration of TB4 and caprylyl glycol by normal optimization procedures known in the pharmaceutical 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 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.
Claims 1-4 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) as applied to claims 1-2 and 16 above, and further in view of Challis et al. (The Best Sulfur Treatments For Seb Derm And Psoriasis; July 12, 2017).
The teachings of Zaveri and Schmaus et al. with respect to claims 1-2 and 16-17 have been discussed above.
Zaveri also 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 and Schmaus et al. do not teach that the preparation further comprises colloidal sulfur.
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 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.
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.
Claims 1-2 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 does not teach that the preparation comprises caprylyl glycol.
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]).
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 of Zaveri (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 of Zaveri.
With respect to claim 2, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum concentration of the peptide of Zaveri and caprylyl glycol by normal optimization procedures known in the pharmaceutical 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.
Claims 1-4 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) and Challis et al. (The Best Sulfur Treatments For Seb Derm And Psoriasis; July 12, 2017).
The teachings of Zaveri and Schmaus et al. with respect to claims 1-2 and 16-17 have been discussed above.
Zaveri also 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 and Schmaus et al. do not teach that the preparation further comprises colloidal sulfur.
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 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 of Zaveri 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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658