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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 4-5, 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by van der Weerden et al. (US20160106807) as evidenced by US6264927. van der Weerden teaches topically administering to the nail plate (the nail itself) a composition comprising defensins and optionally additional antifungal agents which are synergistic with the defensin (which also read on the claimed cosmetically acceptable ingredient (which is not at all limited in scope)), wherein the composition penetrates the nail to treat aesthetic/cosmetic concerns of the nail, e.g. nail fungus, in infected nails and penetrates the nail with cosmetically acceptable carriers/cosmetically acceptable ingredients as claimed because they apply the HXL008, HXL 035 or HXL036 in a composition with carriers to infected nails (see entire document; claims; Example 7; [0031]; [0078, synergistic combination of defensin and antifungal applied topically to nails to treat fungal infection comprising onychomycosis, specifically Trichophyton rubrum] [0087]; [0130-0131, defensin is administered directly to infected site at a concentration of between 0.1% and 10% w/g at a frequency of 1x a day, 2x a day, etc., and includes amelioration of symptoms of onychomycosis (nail fungal infection)]; [0151, Still another aspect provides a method for reducing or controlling fungal infection or infestation on a human nail, the method comprising topically applying a plant defensin or a functional natural or synthetic derivation or variant thereof and optionally another antifungal agent to a potentially infected region on the human. In an embodiment, the medicament is in the form of a solution, powder, spray, atomizer, nanoparticle, gel, paste, impregnated bandage, paint, aerosol, drench or other liquid. The anti-fungal formulation may also be a slow release composition.]; [0078]; etc.). As van der Weerden expressly teaches the active steps of the claimed method and applying the compositions comprising the defensins to nails, specifically the nail body/plate, etc. then van der Weerden is also inherently treating nail brittleness as claimed because nail fungus makes nails brittle as is evidenced by US6264927 (US6264927: see Col. 1, ln. 31-32) (see van der Weerden: entire document, specifically all sections cited above). Further, by treating/controlling the nail fungus with the defensin formulation of van der Weerden the treatment with this defensin formulation would also inherently be stimulating a regeneration of the nail because by treating the infection, healthy nails can then grow to replace the fungal infected nail which reads on stimulating a regeneration of the nail.
van der Weerden as evidenced by US6264927 teaches all limitations of the claims and thereby anticipates the claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 7-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giesen et al. (WO2011009757) in view of WO2018071640 as evidenced by Skincare physicians (www.skincarephysicians.net/services/skin-care-conditions-and-treatments/lips-lip-wrinkles/).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 4-5, 7, 18-19, Giesen teaches methods of applying topical compositions which are for treating skin and skin appendages to alleviate cosmetic concerns, and specifically exemplify topical compositions for treating hair/scalp comprising at least one human beta-defensins, specifically beta-defensin 2 or 3 and additional active agents including the claimed ubiquinone, niacinamide, panthenol. Giesen teaches applying their compositions topically to and around lips thus because Giesen broadly teaches applying to lips/mucous membranes of a individual the claimed compositions the compositions of Giesen when applied to lips would be alleviating the claimed concerns of the lip especially since the claimed individual treated need not even be in need of said treatment/application (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claims 1-2, Giesen teaches methods for alleviating cosmetic concerns comprising applying to skin and skin appendages, including mucous membranes, which would broadly include the lip and the skin around the lip a topical formulation comprising at least one beta-defensin and a cosmetically acceptable ingredient, and they specifically teach wherein the cosmetic concerns which are treated alleviated include discoloration of the skin which reads on the claimed appearance of aging of the lip, specifically that their composition influence the natural pigmentation of the skin which would obviously include the lip since they teach skin and mucous membranes as being included in their definition of skin and skin appendages (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claims 7-15, Giesen teaches methods of applying compositions which are for treating skin and skin appendages to alleviate cosmetic concerns, which includes all skin and mucosal membrane which includes lips/skin around lips and Giesen teaches wherein the at least one beta-defensins which can include both a first defensin and a second defensin are used in amounts which overlap/read on those instantly claimed (wherein they specifically prefer beta-defensin 2 and/or 3), specifically Giesen teaches using the at least one defensin in amounts of 0.01-10 µg/mL which overlaps the claimed ranges first defensin and second defensin both being present in amounts of 0.01 ng/mL to about 1000 ng/mL, more specifically, about 0.01 to about 100 ng/mL, even more specifically about 1 ng/mL to about 100 ng/mL for each of the defensins as claimed which because they overlap/read on the claimed amounts would obviously be amounts which recruit Lgr6+ stem cells as is instantly claimed (see entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claim 21, Giesen teaches applying the beta-defensins at concentrations/amounts which overlap those instantly claimed and as such are sub-antimicrobially effective concentrations (see entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claim 22, Giesen teaches applying the defensins/compositions thereof daily for 7 days in their examples on hair which reads on the at least once daily as claimed (See entire document; see paragraph beginning: To investigate the melanin content, three-dimensional organotypic hair follicle cell cultures from dermal papilla cells, hair follicle melanocytes and outer root sheath keratinocytes were treated with human beta-defensin 2 and human beta-defensin 3…).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claims 7, 16-17, Giesen does not teach any examples which comprise more than one beta-defensin. However, as discussed above Giesen teaches wherein their compositions can comprise at least one beta-defensin and they specifically prefer the use of the beta-defensin 2 or beta-defensin 3. It would be obvious to use both beta-defensin 2 and beta-defensin 3 in the compositions of Giesen. It also would have been obvious to optimize the ratios of the two defensins, e.g. beta-defensin 2 and beta-defensin 3 into the claimed ratios, specifically a 1:1 ratio which would obviously be the easiest ratio for one of ordinary skill to try in the compositions of Giesen and this ratio would read on the claimed ranges. It would have been obvious to optimize the ratios of the two defensins since Giesen clearly teaches that more than one beta-defensin can be used in their compositions which are being used for the same and/or similar purposes of alleviating cosmetic concerns as instantly claimed and it would be obvious to optimize the ratios to for instance the claimed 1:1 mass ratio as this 1:1 ratio would be the easiest starting point for one of ordinary skill in the art when forming the most effective cosmetic compositions for treating skin, and specific skin areas such as the lip/around the lip as claimed. “Generally, 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 18-20, Giesen does not teach wherein the cosmetically acceptable ingredient comprises the claimed/elected Caesalpinia spinosa fruit extract. However, this deficiency in Giesen is addressed by WO2018071640.
WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips and nails (see abstract; title; [0151]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have added the Caesalpinia spinosa fruit extract to the compositions of Giesen in order to develop the claimed method because Giesen teaches that it was known to use compositions comprising the claimed first and second defensins and cosmetically acceptable ingredients and applying these topical formulations comprising to skin or skin appendages, which expressly can include mucous membranes, e.g. lips, etc. to alleviate cosmetic concerns of lips of individuals and by teaching applying the claimed compositions to lips which also fall within the scope of skin and skin appendages for discoloration by influencing the natural pigmentation process (which is an appearance of aging, as lip discoloration is an appearance of aging as evidenced by Skincare physicians (See lips& lip wrinkles section)) and can thereby be used to treat discoloration/appearance of aging of the lip as claimed. It would be obvious to add the Caesalpinia spinosa fruit extract into the composition for use in the method of Giesen which together render obvious the claimed method because WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips (see abstract; title; [0151]).
It also would be obvious to form the claimed compositions with two defensins in the claimed amounts and ratios because Giesen clearly teaches that more than one beta-defensin can be used in their compositions which are being used for the same and/or similar purposes of alleviating cosmetic concerns as instantly claimed and it would be obvious to optimize the ratios to for instance the claimed 1:1 mass ratio as this 1:1 ratio would be the easiest starting point for one of ordinary skill in the art when forming the most effective cosmetic compositions for treating skin areas such as the lip/around the lip as claimed. “Generally, 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It also would have been obvious to optimize the effective dosing/administration of the defensin composition of Giesen when used on lips because they teach daily for 7 days for hair and it is known in the art to optimize the dosing regimen/application timings of formulations for treating/alleviating skin conditions as this is something one of ordinary skill in the art routinely does without undue burden in effort to develop the most effective methods of treating lips/mucous membranes for appearances of aging, e.g. skin/lip discolorations.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 1-2, and 7-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Turovets (US20190022182) in view of WO2018071640, and evidenced by Skincare physicians (www.skincarephysicians.net/services/skin-care-conditions-and-treatments/lips-lip-wrinkles/).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1-3, 7-11, and 18-19, Turovets teaches methods comprising applying to spots of melasma which is commonly found on skin above the lip and/or reducing wrinkles in skin which would include lip skin/wrinkles around the lip a composition comprising a first defensin, specifically the claimed defensins, e.g. alpha-defensin 1, alpha-defensin 5, alpha-defensin 6, neutrophil defensin 1, neutrophil defensin 2, neutrophil defensin 3, neutrophil defensin 4, theta-defensin, beta-defensin 1, beta-defensin 2, beta-defensin 3, or beta-defensin 4, in amounts effective to recruit LGR6+ stem cells, specifically the same concentrations instantly claimed, specifically 0.01 and 100 ng/ml or between 1 and 30 ng/ml and wherein the cosmetically acceptable agent includes the claimed ubiquinone or albumin or Leuconostoc/radish root ferment filtrate, etc. (see entire document; claims; [0003, skin of upper lip]; [0007]; [0011-0014]; [0016]; [0022-0025]; [0030-0033]; [0035]; [0043-0044]; [0047-0048]; [0064-0065]; figures).
Regarding claims 12-17, Turovets teaches wherein their topical formulations/compositions used in their methods can further comprise a second defensin, specifically the same defensins instantly claimed and wherein the second defensin is different from the first defensin, but which is selected from the same list of defensins, and is also present in amounts to recruit LGR6+ stem cells and they specifically prefer combinations wherein the first and second defensins are alpha-defensin 5 and beta-defensin 3 and wherein the defensins are used in the claimed ratios to each other, e.g. 1:1.5, 1:2, etc. which also obviously means that the second defensin when present is used in concentrations which read on the claimed amount/concentration and in concentrations effective to recruit LGR6+ stem cells as is instantly claimed (see entire document; claims; [0003, skin of upper lip]; [0007]; [0011-0014]; [0016]; [0022-0025]; [0030-0033]; [0035]; [0043-0044]; [0064-0065]; figures).
Regarding claim 21, Turovets teaches wherein their definsins are used in sub-antimicrobially effective concentrations/amounts which reads on wherein the first defensin is present in sub-antimicrobially effective concentrations as newly claimed (See entire document; abstract; [0009-0011]; [0013-0014]; [0018]; [0022-0023]; [0025]; [0032]; [0037]; [0048]).
Regarding claim 22, Turovets teaches wherein their composition comprising defensins, etc. is applied for about once daily or twice daily or four times daily, etc. or once weekly, etc. which read on the claimed dosing frequencies (See entire document; [0040-0041]; [0037]).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Regarding claims 1-2, 7-22, Turovets does not teach applying the claimed composition specifically to the lips of a subject. However, as discussed above Turovets does teach applying a composition comprising the claimed first defensin and cosmetically acceptable ingredient to skin areas above/around the lip to treat melasma (which is skin discoloration an appearance of aging as evidenced by Skincare physicians (See lips & lip wrinkles section)) and that it is effective in reducing wrinkles (an appearance of aging) which are alleviating a cosmetic concern(s) of the lip/area around the lip and as such it does read on claim 1, e.g. alleviating a cosmetic concern of the lip (which includes the skin around the lip because of the contour of the lip being claimed) because the applying to treat melasma above the lip/around the contour of the lip would also obviously be alleviating/reducing wrinkles on the skin around the lip, wrinkles around contour of the lip. Turovets also does not teach wherein the cosmetically acceptable ingredient is the claimed Caesalpinia spinosa fruit extract. However, these deficiencies in Turovets are addressed by WO2018071640.
WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips and nails (see abstract; title; [0151]).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have added the Caesalpinia spinosa fruit extract to the compositions of Turovets in order to develop the claimed method because Turovets teaches that it was known to use compositions comprising the claimed first and second defensins and cosmetically acceptable ingredients and applying these topical formulations comprising to skin including the skin of the upper lip which is the skin around the lip but not the lip itself as per applicants own claims which distinguish the lip itself from the skin around the lip. It would be obvious to add the Caesalpinia spinosa fruit extract into the composition for use in the method of Turovets which together render obvious the claimed method because WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips (see abstract; title; [0151]).
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have applied the compositions of Turovets to the claimed lips because Turovets teaches applying to skin around the lip to treat melasma and to the skin around the lip for anti-aging/anti-wrinkle effects the same topical compositions instantly claimed but further shows in their figures that the compositions that their compositions also alleviate wrinkles and as such it would be obvious to apply the compositions to the lip/around the contour of the lip to alleviate wrinkles and around the lip and/or around the contour of the lip.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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, 7-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-10 of U.S. Patent No. 11491096 (‘096) in view of Giesen et al. (WO2011009757), and WO2018071640, and US201701578015, and as evidenced by Skincare Physicians (https://web.archive.org/web/20190825195334/www.skincarephysicians.net/services/skin-care-conditions-and-treatments/lips-lip-wrinkles/).
‘096 teaches a method of reducing brown spots in non-injured skin comprising applying topical compositions which overlap with those instantly claimed and specifically comprise beta-defensin 3 and alpha-defensin 5 which read on the claimed first and second defensins which are present in amounts which are effective to recruit LGR6+ stem cells in amounts which overlap those instantly claimed. ‘096 does not claim wherein the brown spots are around the lip/discoloration of the lips/signs of aging of lips or wherein the topical composition comprises the claimed additional active agent, specifically caesalpinia spinosa fruit extract. However, these deficiencies in ‘096 are addressed by Giesen, and WO2018071640, US201701578015 (the pg pub from which US 11491096 derives).
Giesen teaches methods of applying topical compositions which are for treating skin and skin appendages to alleviate cosmetic concerns, and specifically exemplify topical compositions for treating hair/scalp comprising at least one human beta-defensins, specifically beta-defensin 2 or 3 and additional active agents including the claimed ubiquinone, niacinamide, panthenol (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claims 1-2, Giesen teaches methods for alleviating cosmetic concerns comprising applying to skin and skin appendages, including mucous membranes, which would broadly include the lip (including the skin around the contour of the lip) a topical formulation comprising at least one beta-defensin and a cosmetically acceptable ingredient, and they specifically teach wherein the cosmetic concerns which are treated alleviated include discoloration of the skin which is an appearance of aging and as such still reads on the instantly claimed method. Giesen specifically teaches that their composition influences the natural pigmentation of the skin which would obviously include the lip since they teach skin and mucous membranes as being included in their definition of skin and skin appendages (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claims 7-15, Giesen teaches methods of applying compositions which are for treating skin and skin appendages to alleviate cosmetic concerns, wherein the skin includes all skin and mucosal membrane which includes lips and Giesen teaches wherein the at least one beta-defensins which can include both a first defensin and a second defensin are used in amounts which overlap/read on those instantly claimed, specifically Giesen teaches using the at least one defensin in amounts of 0.01-10 µg/mL which overlaps the claimed ranges first defensin and second defensin both being present in amounts of 0.01 ng/mL to about 1000 ng/mL, more specifically, about 0.01 to about 100 ng/mL, even more specifically about 1 ng/mL to about 100 ng/mL for each of the defensins as claimed which because they overlap/read on the claimed amounts would obviously be amounts which recruit Lgr6+ stem cells as is instantly claimed (see entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
It would be obvious to use both beta-defensin 2 and beta-defensin 3 in the compositions of ‘096 and to use this composition to treat the lips/skin around the lips for the claimed discolorations/appearance of aging because ‘096 and Giesen both teach teaches using at least one beta-defensin in their compositions which are used for treating discolorations of skin including the lips and as evidenced by Skincare physicians (See lips& lip wrinkles section) lip discoloration is an appearance of aging. It also would have been obvious to optimize the ratios of the two defensins, e.g. beta-defensin 2 and beta-defensin 3 of Giesen into the claimed ratios in the composition of ‘096, specifically a 1:1 ratio which would obviously be the easiest ratio for one of ordinary skill to try in the compositions taught by ‘096 and Giesen and this ratio would read on the claimed ranges. It would have been obvious to optimize the ratios of the defensins into the composition and method of ‘096 since Giesen clearly teaches that more than one beta-defensin can be used in their compositions which are being used for the same and/or similar purposes of alleviating cosmetic concerns as taught by ‘0096 and the methods instantly claimed and it would be obvious to optimize the ratios to for instance the claimed 1:1 mass ratio as this 1:1 ratio would be the easiest starting point for one of ordinary skill in the art when forming the most effective cosmetic compositions for treating skin areas such as the lip/around the lip as claimed. “Generally, 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, ‘096 and Giesen do not teach wherein the cosmetically acceptable ingredient comprises the claimed Caesalpinia spinosa fruit extract. However, this deficiency in ‘096 and Giesen is addressed by WO2018071640.
WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips (see abstract; title; [0151]).
Regarding new claims 21-22, US201701578015 teaches that the defensins are used in sub-antimicrobially effective amounts and wherein the compositions were used at least once daily, etc. (See examples; abstract; claims; [0008-0010]; [0012]; [0017]; [0021], [0035], etc.)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the composition which utilizes a topical composition comprising the claimed Caesalpinia spinosa fruit extract into the compositions of ‘096 and the combined references to form the claimed method because Caesalpinia spinosa fruit extract are known to be used in cosmetic compositions for treating skin and lips to improve symptoms of skin aging (e.g. wrinkles, etc.). Thus, it would be obvious to add this active into the compositions of ‘096 and Giesen and to develop the instantly claimed method because each of the claimed agents was already known in the art as taught by the combined references to be applied topically to skin, including skin around lips to alleviate cosmetic concerns including discolorations, wrinkles, which would broadly include the claimed concerns and it is known to combine compositions which are useful for the same purpose to form another composition which is also to be used for the same purpose of alleviating cosmetic concerns, specifically discolorations/appearance of aging of the claimed areas.
It also would have been obvious to use the claimed application rates/dosing schedules because these were dosing schedules already used when applying the same defensins to skin in the same sub-antimicrobially effective amounts which were useful for alleviating dark spots, etc. which read on the claimed appearance of aging of lips.
Thus, one of ordinary skill in the art would conclude that the instant claims are obvious when taken in view of US11491096 (‘096) and the secondary references for the reasons discussed above.
Claims 1-2, 7-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11806384 (‘384) in view of in view of US20190022182, Giesen et al. (WO2011009757), WO2018071640, and US201701578015, and as evidenced by Skincare Physicians (https://web.archive.org/web/20190825195334/www.skincarephysicians.net/services/skin-care-conditions-and-treatments/lips-lip-wrinkles/).
‘384 teaches kits for treating melasma (e.g. skin discoloration) comprising first defensin and second defensins, specifically the same defensins instantly claimed in the same sub-antimicrobially effective amounts and wherein the composition further comprises the claimed additional components, e.g. albumin and/or ubiquinone, etc. and wherein the defensins are present in the composition/kit are present in amounts of sub-antimicrobial concentrations. ‘384 does not teach the claimed method or wherein the defensins are specifically present in the claimed amounts or ratios or wherein the additional compound is/includes the claimed Caesalpinia spinosa fruit extract, etc.. However, these deficiencies in ‘384 are addressed by US20190022182, Giesen, and WO2018071640, and US201701578015.
US20190022182 is the PGPub from which US11806384 issued. It qualifies as prior art. US20190022182 teaches kits comprising topical compositions for treating melasma, including melasma of the upper lip (e.g. discoloration of the upper lip) that the sub-antimicrobial concentrations are preferably between 0.01 and about 100 ng/ml, even more typically between about 1 and about 30 ng/ml for each of the defensins (see entire document; e.g. [0003]; [0025]; [0011-0013]; claims) which are the same concentrations for each defensin instantly claimed. US20190022182 also teaches wherein the kit is intended to treat/reduce melasma which is typically found on the upper lip and causes discoloration/hyperpigmentation of the skin in this area (upper lip) and other areas and the defensins are used in amounts to recruit LGR6+ stem cells as claimed and wherein each defensin may be present in equal quantities or at the claimed mass ratios ([0003]; [0011-0013]; [0022-0023]; [0025]; claims).
Giesen teaches methods of applying topical compositions which are for treating skin and skin appendages to alleviate cosmetic concerns and specifically exemplify topical compositions for treating hair/scalp comprising at least one human beta-defensins, specifically beta-defensin 2 or 3 and additional active agents including the claimed ubiquinone, niacinamide, panthenol. (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claims 1-2, Giesen teaches methods for alleviating cosmetic concerns comprising applying to skin and skin appendages, including mucous membranes, which would broadly include the lip (including the skin around the contour of the lip) a topical formulation comprising at least one beta-defensin and a cosmetically acceptable ingredient, and they specifically teach wherein the cosmetic concerns which are treated alleviated include discoloration of the skin which is an appearance of aging and as such still reads on the instantly claimed method. Giesen specifically teaches that their composition influences the natural pigmentation of the skin which would obviously include the lip since they teach skin and mucous membranes as being included in their definition of skin and skin appendages (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claims 7-15, Giesen teaches methods of applying compositions which are for treating skin and skin appendages to alleviate cosmetic concerns, which includes all skin and mucosal membrane which includes lips. Giesen teaches wherein the at least one beta-defensins which can include both a first defensin and a second defensin are used in amounts which overlap/read on those instantly claimed, specifically Giesen teaches using the at least one defensin in amounts of 0.01-10 µg/mL which overlaps the claimed ranges first defensin and second defensin both being present in amounts of 0.01 ng/mL to about 1000 ng/mL, more specifically, about 0.01 to about 100 ng/mL, even more specifically about 1 ng/mL to about 100 ng/mL for each of the defensins as claimed which because they overlap/read on the claimed amounts would obviously be amounts which recruit Lgr6+ stem cells as is instantly claimed (see entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
It would be obvious to use both beta-defensin 2 and beta-defensin 3 in the compositions of ‘384 and to use this composition to treat the lips/skin around the lips for the claimed discolorations which are an appearance of aging because ‘384 and Giesen both teach teaches using at least one beta-defensin in their compositions which are used for treating discolorations of skin including the lips and as evidenced by Skincare physicians (See lips& lip wrinkles section) lip discoloration is an appearance of aging. It also would have been obvious to optimize the ratios of the two defensins, e.g. beta-defensin 2 and beta-defensin 3 of Giesen into the claimed ratios in the composition of ‘384, specifically a 1:1 ratio which would obviously be the easiest ratio for one of ordinary skill to try in the compositions taught by ‘384 and Giesen and this ratio would read on the claimed ranges. It would have been obvious to optimize the ratios of the defensins into the composition and method of ‘384 since Giesen clearly teaches that more than one beta-defensin can be used in their compositions which are being used for the same and/or similar purposes of alleviating cosmetic concerns as taught by ‘384 and the methods instantly claimed and it would be obvious to optimize the ratios to for instance the claimed 1:1 mass ratio as this 1:1 ratio would be the easiest starting point for one of ordinary skill in the art when forming the most effective cosmetic compositions for treating skin areas such as the lip/around the lip as claimed. “Generally, 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, ‘384 and Giesen do not teach wherein the cosmetically acceptable ingredient comprises the claimed Caesalpinia spinosa fruit extract. However, this deficiency in ‘384 and Giesen is addressed by WO2018071640.
WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips and nails (see abstract; title; [0151]).
Regarding new claims 21-22, US201701578015 teaches that the defensins are used in sub-antimicrobially effective amounts and wherein the compositions were used at least once daily, etc. (See examples; abstract; claims; [0008-0010]; [0012]; [0017]; [0021], [0035], etc.)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the composition which utilizes a topical composition comprising the claimed Caesalpinia spinosa fruit extract into the compositions of ‘384 and the combined references to form the claimed method because Caesalpinia spinosa fruit extract are known to be used in cosmetic compositions for treating skin to improve symptoms of skin aging (e.g. wrinkles, discoloration, etc.). Thus, it would be obvious to add this active into the compositions of ‘384 and Giesen, etc. and to develop the instantly claimed method because each of the claimed agents was already known in the art as taught by the combined references to be applied topically to skin, including skin around lips to alleviate cosmetic concerns including discolorations, wrinkles, which would broadly include the claimed concerns and it is known to combine compositions which are useful for the same purpose to form another composition which is also to be used for the same purpose of alleviating cosmetic concerns, specifically discolorations of the claimed areas.
It also would have been obvious to use the claimed application rates/dosing schedules because these were dosing schedules already used when applying the same defensins to skin in the same sub-antimicrobially effective amounts which were useful for alleviating dark spots, etc. which read on the claimed appearance of aging of lips.
It would be obvious to use both beta-defensin 2 and beta-defensin 3 in the compositions of ‘384, US20190022182 and Giesen because Giesen teaches using at least one beta-defensin in their compositions which are used for treating skin for cosmetic concerns. It also would have been obvious to optimize the ratios of the two defensins, into the claimed ratios, specifically a 1:1 ratio because the disclosure of US20190022182 would lead one in ‘384 which is the patent arising from US20190022182 that the claimed ratios and amounts of the two defensins are preferred and because “Generally, 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
‘384, US20190022182, Giesen do not teach wherein the cosmetically acceptable ingredient comprises the claimed Caesalpinia spinosa fruit extract. However, this deficiency is addressed by WO2018071640.
WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips (see abstract; title; [0151]).
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the composition which utilizes a topical composition comprising the claimed Caesalpinia spinosa fruit extract into the compositions of ‘384 and the combined references to form the claimed method because Caesalpinia spinosa fruit extract are known to be used in cosmetic compositions for treating skin to improve symptoms of skin aging (e.g. wrinkles, etc.). Thus, it would be obvious to add this active into the compositions of ‘384 and Giesen and to develop the instantly claimed method because each of the claimed agents was already known in the art as taught by the combined references to be applied topically to skin), including skin around lips to alleviate cosmetic concerns including discolorations, wrinkles, which would broadly include the claimed concerns and it is known to combine compositions which are useful for the same purpose to form another composition which is also to be used for the same purpose of alleviating cosmetic concerns, specifically discolorations of the claimed areas.
Claims 1-2, 7-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11020452 (‘452) in view of in view of in view of US20190022182, Giesen et al. (WO2011009757), and WO2018071640, and US201701578015 and as evidenced by Skincare Physicians (https://web.archive.org/web/20190825195334/www.skincarephysicians.net/services/skin-care-conditions-and-treatments/lips-lip-wrinkles/).
‘452 teaches methods for treating melasma (e.g. skin discoloration), which is a sign/appearance of aging, comprising providing and applying to skin a topical composition comprising a first defensin and second defensin in the same amounts/concentrations which are instantly claimed and the same defensins instantly claimed (e.g. the same defensins instantly claimed) and wherein the composition further comprises the claimed additional components, e.g. albumin and/or ubiquinone, etc. ‘384 does not teach the claimed method or wherein the defensins are specifically present in the claimed ratios or wherein the additional compound is/includes the claimed Caesalpinia spinosa fruit extract. However, these deficiencies in ‘384 are addressed by US20190022182, Giesen, and WO2018071640.
However, these deficiencies in ‘452 are addressed by US20190022182, Giesen, and WO2018071640, and US201701578015.
US20190022182 is the PGPub from which US11806384 issued. It qualifies as prior art. US20190022182 teaches kits comprising topical compositions for treating melasma, including melasma of the upper lip (e.g. discoloration of the upper lip) that the sub-antimicrobial concentrations are preferably between 0.01 and about 100 ng/ml, even more typically between about 1 and about 30 ng/ml for each of the defensins (see entire document; e.g. [0003]; [0025]; [0011-0013]; claims) which are the same concentrations for each defensin instantly claimed. US20190022182 also teaches wherein the kit is intended to treat/reduce melasma which is typically found on the upper lip and causes discoloration/hyperpigmentation of the skin in this area (upper lip) and other areas and the defensins are used in amounts to recruit LGR6+ stem cells as claimed and wherein each defensin may be present in equal quantities or at the claimed mass ratios ([0003]; [0011-0013]; [0022-0023]; [0025]; claims).
Giesen teaches methods of applying topical compositions which are for treating skin and skin appendages to alleviate cosmetic concerns and specifically exemplify topical compositions for treating hair/scalp comprising at least one human beta-defensins, specifically beta-defensin 2 or 3 and additional active agents including the claimed ubiquinone, niacinamide, panthenol (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claims 1-2, Giesen teaches methods for alleviating cosmetic concerns comprising applying to skin and skin appendages, including mucous membranes, which would broadly include the lip (including the skin around the contour of the lip) a topical formulation comprising at least one beta-defensin and a cosmetically acceptable ingredient, and they specifically teach wherein the cosmetic concerns which are treated alleviated include discoloration of the skin which is an appearance of aging and as such still reads on the instantly claimed method. Giesen specifically teaches that their composition influences the natural pigmentation of the skin which would obviously include the lip since they teach skin and mucous membranes as being included in their definition of skin and skin appendages (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Regarding claims 7-15, Giesen teaches methods of applying compositions which are for treating skin and skin appendages to alleviate cosmetic concerns, and which also includes all skin and mucosal membrane which includes lips. Giesen teaches wherein the at least one beta-defensins which can include both a first defensin and a second defensin are used in amounts which overlap/read on those instantly claimed, specifically Giesen teaches using the at least one defensin in amounts of 0.01-10 µg/mL which overlaps the claimed ranges first defensin and second defensin both being present in amounts of 0.01 ng/mL to about 1000 ng/mL, more specifically, about 0.01 to about 100 ng/mL, even more specifically about 1 ng/mL to about 100 ng/mL for each of the defensins as claimed which because they overlap/read on the claimed amounts would obviously be amounts which recruit Lgr6+ stem cells as is instantly claimed (see entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
It would be obvious to use both beta-defensin 2 and beta-defensin 3 in the compositions of ‘452 and to use this composition to treat the lips/skin around the lips for the claimed discolorations which are an appearance of aging because ‘452 and Giesen both teach teaches using at least one beta-defensin in their compositions which are used for treating discolorations of skin including the lips and as evidenced by Skincare physicians (See lips& lip wrinkles section) lip discoloration is an appearance of aging. It also would have been obvious to optimize the ratios of the two defensins, e.g. beta-defensin 2 and beta-defensin 3 of Giesen into the claimed ratios in the composition of ‘452, specifically a 1:1 ratio which would obviously be the easiest ratio for one of ordinary skill to try in the compositions taught by ‘452 and Giesen and this ratio would read on the claimed ranges. It would have been obvious to optimize the ratios of the defensins into the composition and method of ‘452 since Giesen clearly teaches that more than one beta-defensin can be used in their compositions which are being used for the same and/or similar purposes of alleviating cosmetic concerns as taught by ‘452 and the methods instantly claimed and it would be obvious to optimize the ratios to for instance the claimed 1:1 mass ratio as this 1:1 ratio would be the easiest starting point for one of ordinary skill in the art when forming the most effective cosmetic compositions for treating skin areas such as the lip/around the lip as claimed. “Generally, 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 20, ‘452 and Giesen do not teach wherein the cosmetically acceptable ingredient comprises the claimed Caesalpinia spinosa fruit extract. However, this deficiency in ‘452 and Giesen is addressed by WO2018071640.
WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips (see abstract; title; [0151]).
Regarding new claims 21-22, US201701578015 teaches that the defensins are used in sub-antimicrobially effective amounts and wherein the compositions were used at least once daily, etc. (See examples; abstract; claims; [0008-0010]; [0012]; [0017]; [0021], [0035], etc.)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the composition which utilizes a topical composition comprising the claimed Caesalpinia spinosa fruit extract into the compositions of ‘452 and the combined references to form the claimed method because Caesalpinia spinosa fruit extract are known to be used in cosmetic compositions for treating skin to improve symptoms of skin aging (e.g. wrinkles, discolorations, etc.). Thus, it would be obvious to add this active into the compositions of ‘452 and Giesen, etc. and to develop the instantly claimed method because each of the claimed agents was already known in the art as taught by the combined references to be applied topically to skin, including skin around lips to alleviate cosmetic concerns including discolorations, wrinkles, which would broadly include the claimed concerns and it is known to combine compositions which are useful for the same purpose to form another composition which is also to be used for the same purpose of alleviating cosmetic concerns, specifically discolorations of the claimed areas.
It also would have been obvious to use the claimed application rates/dosing schedules because these were dosing schedules already used when applying the same defensins to skin in the same sub-antimicrobially effective amounts which were useful for alleviating dark spots, etc. which read on the claimed appearance of aging of lips.
It would be obvious to use both beta-defensin 2 and beta-defensin 3 in the compositions of ‘452, US20190022182 and Giesen because Giesen teaches using at least one beta-defensin in their compositions which are used for treating skin for cosmetic concerns. It also would have been obvious to optimize the ratios of the two defensins, into the claimed ratios, specifically a 1:1 ratio because the disclosure of US20190022182 would lead one in ‘452 which is the patent arising from US20190022182 that the claimed ratios and amounts of the two defensins are preferred and because “Generally, 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
‘452, US20190022182 and Giesen do not teach wherein the cosmetically acceptable ingredient comprises the claimed Caesalpinia spinosa fruit extract. However, this deficiency is addressed by WO2018071640.
WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips (see abstract; title; [0151]).
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the composition which utilizes a topical composition comprising the claimed Caesalpinia spinosa fruit extract into the compositions of ‘452 and the combined references to form the claimed method because Caesalpinia spinosa fruit extract are known to be used in cosmetic compositions for treating skin to improve symptoms of skin aging (e.g. wrinkles, discoloration, etc.). Thus, it would be obvious to add this active into the compositions of ‘452 and Giesen and to develop the instantly claimed method because each of the claimed agents was already known in the art as taught by the combined references to be applied topically to skin, including lip skin/skin around lips to alleviate cosmetic concerns including discolorations, wrinkles, which would broadly include the claimed concerns and it is known to combine compositions which are useful for the same purpose to form another composition which is also to be used for the same purpose of alleviating cosmetic concerns, specifically discolorations of the claimed areas.
Thus, one of ordinary skill in the art would conclude that the instant claims are obvious when taken in view of US ‘452 and the secondary references for the reasons discussed above.
Claims 1-2, 7-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 19, 21 of copending Application No. 17930842 (‘842) in view of US20190022182, Giesen, and WO2018071640.
‘842 teaches methods of improving (e.g. alleviating) a skin condition, specifically wherein the skin conditions include skin discoloration and skin aging and they do not limit the areas of skin and as such it would broadly include the claimed lip/discoloration of lip and/or areas/skin around the lip, wrinkles of the lip and around the lip as claimed. ‘842 teaches the same active steps as are instantly claimed specifically applying the topical formulation to the skin of the the subject and wherein the topical formulation comprises the same first and second defensins that are instantly claimed and which can comprise the claimed niacinamide, panthenol, or leuconostoc/radish root ferment filtrate, etc. and ‘842 claims wherein the defensins are used in the same effective amounts as instantly claimed, e.g. 1 to 30 ng/mL, and wherein the topical formulations are present in amounts effective to stimulate LGR6+ stem cells as claimed.
‘842 does not teach wherein the defensins are used in the same ratios as instantly claimed or wherein the compositions used in the method contain the claimed Caesalpinia spinosa fruit extract. However, these deficiencies are addressed by US20190022182, Giesen, and WO2018071640.
US20190022182 teaches kits comprising topical compositions for treating melasma, including melasma of the upper lip (e.g. discoloration of the upper lip) that the sub-antimicrobial concentrations are preferably between 0.01 and about 100 ng/ml, even more typically between about 1 and about 30 ng/ml for each of the defensins (see entire document; e.g. [0003]; [0025]; [0011-0013]; claims) which are the same concentrations for each defensin instantly claimed. US20190022182 also teaches wherein the kit is intended to treat/reduce melasma which is typically found on the upper lip and causes discoloration/hyperpigmentation of the skin in this area (upper lip) and other areas and the defensins are used in amounts to recruit LGR6+ stem cells as claimed and wherein each defensin may be present in equal quantities or at the claimed mass ratios ([0003]; [0011-0013]; [0022-0023]; [0025]; claims).
Giesen teaches methods of applying topical compositions for treating skin and skin appendages to alleviate cosmetic concerns and specifically exemplify topical compositions for treating hair/scalp comprising at least one human beta-defensins, specifically beta-defensin 2 or 3 and additional active agents including the claimed ubiquinone, niacinamide, panthenol (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Giesen teaches methods for alleviating cosmetic concerns comprising applying to skin and skin appendages, including mucous membranes, which would broadly include the lip and the skin around the lip a topical formulation comprising at least one beta-defensin and a cosmetically acceptable ingredient, and they specifically teach wherein the cosmetic concerns which are treated alleviated include discoloration of the skin, specifically that their composition influence the natural pigmentation of the skin which would obviously include the lip since they teach skin and mucous membranes as being included in their definition of skin and skin appendages (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
As discussed above, Giesen teaches using the composition to influence the natural pigmentation process which reads on wherein the composition can help with skin and skin appendage discoloration (which includes the lip/skin around the lip) as claimed (See entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
Giesen teaches methods of applying compositions which are for treating skin which includes all skin and mucosal membrane which includes lips/skin around lips and Giesen teaches wherein the at least one beta-defensins which can include both a first defensin and a second defensin are used in amounts which overlap/read on those instantly claimed, specifically Giesen teaches using the at least one defensin in amounts of 0.01-10 µg/mL which overlaps the claimed ranges first defensin and second defensin both being present in amounts of 0.01 ng/mL to about 1000 ng/mL, more specifically, about 0.01 to about 100 ng/mL, even more specifically about 1 ng/mL to about 100 ng/mL for each of the defensins as claimed which because they overlap/read on the claimed amounts would obviously be amounts which recruit Lgr6+ stem cells as is instantly claimed (see entire document; e.g. paragraph beginning: Under skin and skin appendages in the context of the invention, the skin, the mucosa, the hair and its hair follicles, glands and nails, especially skin, mucous membranes, hair and hair follicles to understand.; paragraph beginning: For the purposes of the present invention, the term "influencing the natural pigmentation process" means the positive or negative influence on the natural coloration/coloring and/or pigmentation of the skin and/or skin appendages, in particular the stimulation or the partial or complete inhibition of the natural, i. understood biological pigmentation process in skin and/or skin appendages, in particular hair or hair follicles.; paragraph beginning: The object is achieved by the use of at least one human beta-defensin, its analogues or agents that can stimulate expression of human beta-defensins, to influence the natural pigmentation process of the skin and/or skin appendages; paragraph: The invention relates to the use of at least one human beta-defensin, its analogues or agents which can stimulate expression of human beta-defensins, to influence the natural pigmentation process of skin and/or skin appendages.; paragraph beginning: hair treatment composition embodiments; see section: The present invention is in a further embodiment, a hair treatment agent containing…through the end of the listing of components in the compositions and the percentages used in the compositions.).
It would be obvious to use both beta-defensin 2 and beta-defensin 3 in the compositions of ‘842, US20190022182 and Giesen because Giesen teaches using at least one beta-defensin in their compositions which are used for treating skin for cosmetic concerns. It also would have been obvious to optimize the ratios of the two defensins, into the claimed ratios, specifically a 1:1 ratio because the disclosure of US20190022182 teaches that this is an effective ratio for using two defensins in similar applications which would lead one in ‘842 to try the claimed 1:1 ratio as a starting point to determine the most effective ratio on ‘842 because “Generally, 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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
‘842, US20190022182 and Giesen do not teach wherein the cosmetically acceptable ingredient comprises the claimed Caesalpinia spinosa fruit extract. However, this deficiency is addressed by WO2018071640.
WO2018071640 teaches that it is known to use Caesalpinia spinosa fruit extract in cosmetics to improve symptoms of skin aging, specifically as an anti-wrinkle or anti-aging agent and can be applied to lips and nails (see abstract; title; [0151]).
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have formed the composition which utilizes a topical composition comprising the claimed Caesalpinia spinosa fruit extract into the compositions of ‘842 and the combined references to form the claimed method because Caesalpinia spinosa fruit extract are known to be used in cosmetic compositions for treating skin and lips to improve symptoms of skin aging (e.g. wrinkles, discoloration, etc.). Thus, it would be obvious to add this active into the compositions of ‘842 and Giesen and to develop the instantly claimed method because each of the claimed agents was already known in the art as taught by the combined references to be applied topically to skin, including skin around lips to alleviate cosmetic concerns including discolorations, wrinkles, which would broadly include the claimed concerns and it is known to combine compositions which are useful for the same purpose to form another composition which is also to be used for the same purpose of alleviating cosmetic concerns, specifically discolorations of the claimed areas.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments/Remarks
Applicant’s amendments have overcome the previous 112 rejections which are hereby withdrawn. Applicant’s amendments to the claims have prompted the new grounds of rejection presented herein. Applicant’s abandonment of previously copending 17930840 has rendered moot that double patenting rejection which is hereby withdrawn.
Applicants argue that their amendments have overcome the previous 102 because they no longer claim nail discoloration. This is persuasive. However, applicant’s amendments have prompted the new grounds of rejection presented herein which is discussed above which discusses that treating nail fungus also treats nail brittleness, etc. as nail fungus is a known to increase nail brittleness and/or cause brittle nails as is discussed above.
Applicants then argue that Giesen is overcome because of their amendments to exclude discoloration of lip or nail as their conditions alleviated. The examiner respectfully disagrees that applicant’s amendments have excluded Giesen as applicants still claim appearance of aging and discoloration of lips/dark spots are signs of aging/appearance of aging and as such still read on the instant claims as is discussed in the revised grounds of rejection above.
Applicants then argue the instant claims are not obvious over Turovets in view of Keraguard and WO2018071640 because they argue that they have amended claim 2 to remove or skin around the lip (Keraguard has been removed from this rejection due to applicant’s amendments). This is not persuasive because claim 1 now recites treating the lip to alleviate cosmetic concerns of the lip, wherein these cosmetic concerns include wrinkles around the contour of the lip which would be wrinkles on the skin around the lip at the contour/the skin that adjoins to the lip skin/ and therefore include/be wrinkles in the skin around the lip therefore because the skin around the lip is still claimed and Turovets teaches treating the skin around the lip for multiple concerns including anti-aging (e.g. anti-wrinkle) then contrary to applicant’s arguments Turovets still reads on the instantly claimed method and still renders the instant method obvious for the reasons discussed above which are incorporated herein.
Applicants then argue that all of the double patenting rejections are moot in light of their amendments because they no longer recited the same scope of cosmetic concerns previously claimed and as such have overcome the double patenting rejections in view of Giesen. The examiner disagrees for the reasons discussed above with respect to the 103 rejection over Giesen. Applicant’s claims still containing appearance of aging which is not at all limited or defined by applicant’s specification and as such would include pigmentation/discoloration concerns, e.g. dark spots, etc. with evidence provided above to support this. However, the rejections have been revised to address applicant’s amended claim scope as contained herein.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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/ERIN E HIRT/ Primary Examiner, Art Unit 1616
