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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/18/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 03/18/2026, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-2, 4-13, 15-22 are pending and being examined on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-8, 11-12 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over James Vincent Gruber (EP2473159A2), Cir-safety.org (https://www.cir-safety.org/sites/default/files/tripep062014final.pdf), Z Fiume (Final report on the safety assessment of Lecithin and Hydrogenated Lecithin, Int J Toxicol, 2001: 20) and Cir-safety.org (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cir-safety.org/sites/default/files/ADIOLS042017TR.pdf) and Rolf Petersen (US9114077B2). This is a new rejection based on the amendments filed on 03/18/2026.
Gruber’s invention is related to compositions for delaying cellular senescence (see abstract).
Gruber teaches “the present invention generally relates to compositions for delaying cellular senescence; and more particularly to cosmetic compositions containing hexapeptide-11 effective for delaying intrinsic or stress-induced cellular senescence in skin cells. The present invention also relates to methods for delaying senescence in skin cells” (see page 2, field of invention).
Gruber teaches “a composition containing from about 0.01 wt% to about 5 wt% of hexapeptide-11, based on the total weight of the composition, and a dermatologically-acceptable carrier for the peptide” (see page 2, 0013-0014).
Gruber teaches “the present invention is especially useful for therapeutically regulating visible and/or tactile discontinuities in mammalian skin texture, including texture discontinuities associated with skin aging. As used herein, therapeutically regulating such discontinuities includes ameliorating, e.g., diminishing, minimizing and/or effacing visible and/or tactile discontinuities in the texture of mammalian skin, to thereby provide improved skin appearance and/or feel, e.g., a smoother, more even appearance and/or feel. Such visible and/or tactile discontinuities in skin texture include crevices, bumps, pores, fine lines, wrinkles, scales, flakes and/or other forms of textural unevenness or roughness associated with skin aging. For example, the length, depth, and/or other dimension of lines and/or wrinkles are decreased, the apparent diameter of pores decreases, or the apparent height of tissue immediately proximate to pore openings approaches that of the interadnexal skin. The present invention is also especially useful for prophylactically regulating visible and/or tactile discontinuities in mammalian skin texture, including texture discontinuities associated with skin aging. As used herein, prophylactically regulating such discontinuities includes delaying, minimizing and/or preventing visible and/or tactile discontinuities in the texture of mammalian skin, to thereby provide improved skin appearance and/or feel, e.g., a smoother, more even appearance and/or feel.” (see pages 7-8, 0030-0031).
Gruber teaches that the peptide can also be incorporated into delivery systems that enhance topical penetration of the peptide into the skin such as those which are known to those skilled in the art for example liposomes (see 0036).
Gruber does not specifically teach the composition to comprise of the hexapeptide-12 or tripeptide-1 in the instantly disclosed amounts, lecithin and propanediol in the instantly claimed amounts or the size of the liposomes.
Cir-Safety.org’s webpage teaches the 2014 Cosmetic Ingredient Review Expert Panel (herein after referred to as CIREP) discloses safety assessments for tripeptide-1, hexapeptide-12 their metal salts and fatty acyl derivatives and palmitoyl tetrapeptide-1. CIREP teaches that tripeptide-1, hexapeptide-12, their metal salts and fatty acyl derivatives, function primarily as skin conditioning agents and are also used in cosmetic products. Typical use concentrations of these ingredients are < 10 ppm (see abstract). It would be expected that such skin conditioning agents would improve the skins texture as these are known in the art for making skin smoother and more supple.
“Cosmetic products containing tripeptide-1, hexapeptide-12 and related amides may be applied to the skin and hair, or, incidentally, may come in contact with the eyes and mucous membranes. Products containing these ingredients may be applied as frequently as several times per day and may come in contact with the skin or hair for variable periods following application. Daily or occasional use may extend over many years” (see page 5, para. 2).
CIREP teaches “tripeptide-1 in amounts of 3ppm in creams that were effective for a noticed 39% reduction in wrinkle length, 23% decrease in wrinkle depth, and a 17% decrease in overall skin roughness at the end of the 4-week period” and “a small but statistically significant increase in skin thickness (~ 4%, compared to vehicle alone) was observed at the site treated with palmitoyl tripeptide” (see page 9, other skin studies).
CIREP also teaches “the peptide palmitoyl oligopeptide, modeled on repair-signaling sequences, has been marketed as a cosmetic ingredient that rejuvenates skin. The extracellular matrix (ECM) in the basement membrane that separates the epidermis from the dermis also serves as a mediator of receptor-induced interactions between cells, guiding growth and differentiation. Damage to the ECM leads to repair that is initiated through processes such as protein synthesis and cell differentiation and proliferation. Most of these functions are controlled by signaling peptides that are released from the ECM to cells through cell membrane receptors. Over time, aged skin is characterized by decreased production of new collagen and increased proteolytic activity, resulting in increased collagen degradation. In senescent fibroblasts, there is decreased synthesis of type I collagen, and these cells proliferate at a much slower rate when compared to fibroblasts in young skin. Peptides modeled on repair-signaling sequences have been claimed to be cosmetic ingredients that enhance skin rejuvenation” (see page 9, 2nd para. from bottom). Furthermore, the peptide was shown to have angiogenesis activity, collagen and fibronectin synthesis, growth factor production, enzyme upregulation/release, and wound healing abilities (see page 10, 2nd para.).
CIREP teaches “collectively, the ingredients reviewed in this safety assessment are being used at concentrations ranging from 0.0000001% (palmitoyl tripeptide-1and palmitoyl hexapeptide-12) to 0.002% (palmitoyl hexapeptide-12). “In addition to the data included in the survey of ingredient use concentrations, one submission indicated that peptides are being used in cosmetic products at concentrations between 1 ppm and 30 ppm, and that their use at concentrations of < 10 ppm is customary” (see page 12. Para 3 after summary).
Regarding claims 11 and 12, CIREP teaches uses of palmitoyl tripeptide-1 and palmitoyl hexapeptide-12 (see abstract and introduction).
Regarding claims 2, 15-16 and 20-21 these limitations “to wherein the composition when applied to skin, is effective to achieve at least one selected from: reduced skin laxity; improved skin texture; decreased skin crepiness; improved body contouring; accelerated fat reduction; and elimination of lipid droplets is only an intended use of the composition”, “wherein the composition is applied to skin before or after a body shaping or body contouring procedure comprising at least one of: low-level laser therapy; infrared light therapy; pulsed focused ultrasound therapy; radiofrequency induced electroporation; injection of lipolytic agents; liposuction; cryolipolysis; and surgical body contouring”, “wherein the composition is applied to skin of the submental region, abdomen, face, flank, back, neck, arm, leg, buttock, or combination thereof”, and “wherein the composition is applied to skin before or after a surgical procedure” are all intended uses of the composition and do not impart any structural changes to the composition itself. Furthermore, the art teaches the peptides to be used in cosmetics for moisturizing, increased collagen production, reducing wrinkle depth and length and overall skin roughness, collagen and fibronectin synthesis which would be expected to improve skin texture after being applied.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Fiume teaches that “Lecithin and Hydrogenated Lecithin are used in a large number of cosmetic formulations as skin conditioning agents-miscellaneous and as surfactant-emulsifying agents. Hydrogenated Lecithin is also used as a suspending agent-nonsurfactant. Historical data on concentration of use of Lecithin reveals that 0.1% to 1.0% is the concentration range most frequently seen, with concentrations up to 50% reported for two moisturizing products” (see abstract).
Cir-Safety.org’s webpage teaches that propanediol, for example, is used as a solvent and viscosity decreasing agent (see Introduction, page 2) and that it is one of the most common diols used in cosmetics (see under “USE” page 3), in give working examples when being tested at 0.12% (see “In Vitro” page 4).
Petersen’s general disclosure is to nanocrystals for use in tropical cosmetic formulations (see abstract).
Petersen teaches that a pharmaceutical formulation approach to formulate poorly soluble drugs is nanocrystals. Drug nanocrystals are crystals with a size of a few nanometers up to 1000 nanometer. They can be prepared by bottom-up technologies and top-down technologies. Bottom-up technologies are precipitation, the drug is dissolved in a solvent and this solution Subsequently poured into a non-solvent leading to the so-called hydrosols.
In the top-down technologies, one starts from larger sized particle powders, diminution by several wet milling techniques leads to nanocrystals. In general the drug powder is dispersed in an aqueous or non-aqueous dispersion medium, containing a stabilizer (surfactant or polymeric stabilizer). This macro-Suspension is Subsequently milled for example by using a pearl mill (see column 1 bottom to column 2 top).
The objectives are also met by a formulation for topical application to the skin or mucosal Surfaces comprising: particles of a cosmetic or pharmaceutical active in the nanometer range (nanocrystals), having a PCS size below 1000 nm, being dispersed in at least one of an aqueous phase or lipidic phase of a monophasic system, an aqueous phase or lipidic phase of an oil-in water emulsion, water-in-oil emulsion, microemulsion, liposomal dispersion or a macro Suspension,” (see column 3, lines 46-53).
Then high-pressure homogenization was applied, that means a combination production technology was used by combining low energy pearl milling to reduce the particle size initially, followed by high energy high-pressure homogenization, typically 1 to 5 homogenization cycles (examples 8 and 9). Surprisingly it was found that after this pre-treatment only one homogenization cycle—in contrast to the published up to 20 cycles (1. Grau, M. J., Kayser, O. Müller, R. H., Int. J. Pharm. 196, 155-157, 2000, 2. Jacobs, C., Kayser, O. Müller, R. H., Int. J. Pharm. 214, 3-7, 2001, 3. Jacobs, C., Miller, R. H., Pharmaceutical Research 19(2), 189-194, 2002) was sufficient to achieve a nanocrystalline product, whereby the drop in size compared to the starting material was very pronounced by several hundred nanometers in one cycle (example 8) (see column 6, lines 31-45).
To Summarize, a combination of pearl milling with Subsequent high-pressure homogenization leads to nanosuspensions with improved physical stability on long-term and
against electrolytes, consequently improved stability in general. The pearl pre-milling can be performed to a size of a few micrometer (typically 1-5 um, diameter 50% of laser diffractometry, volume distribution) or alternatively to the upper nanometer range (e.g. 400-1000 nm). The subsequent high pressure homogenization process can be performed at higher
pressures (e.g. 1000 or 1500 bar, in special cases 2000 bar to 4000 bar) leading not only to improved physically stable nanosuspensions but simultaneously also to a further reduction in size for most cosmetic actives (see column 7, lines 15-27).
The solubility is increasing with decreasing size of the crystals. From this, the mean PCS size of the crystals has to be below 1 um (1,000 nm), preferentially lower than 500 nm or
even more preferably below 200 nm, being optimal for highest solubility increase below 100 nm (see column 7, lines 59-63).
Therefore, it would have been obvious to any person having skill in the art at the effective filing date to combine Tripeptide-1 and hexapeptide-12 taught by CIREP for having properties for improving the skins texture along with the composition taught by Gruber which comprises of hexapeptide-11 and within the instantly claimed ranges because Gruber teaches activities of evening out the skin with that peptide and within the instantly claimed ranges. Combining equivalents such as peptides known for having skin smoothing properties into a single composition and within already taught ranges is prima facie obvious. Optimizing to have the tripeptide-1 and hexapeptide-12 to be in a range wherein the hexapeptide-12 is 1 part to every tripeptide-1 at 0.2-10 parts is also obvious given the functionally and safe ranges taught by CIREP. Optimizing ranges of active ingredients is well within the purview of any artisan especially given that the activity of those ingredients is already known.
It would have also been obvious to add both lecithin and propanediol within the instantly claimed ranges because both are commonly used formulation enhancers used in cosmetics as discussed and recognized in the prior art.
Determining the most effective range and ratios does not patentably distinct the instant invention over the prior art, unless those ranges had some unexpected reported activity. The activity reported does not seem to be considerably different than what the art already recognizes which is improving the skins texture. ‘[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).”
Finally it would have been obvious to create liposomes with an average particle size of 185 nm +/- 10% as claimed because as Petersen teaches this can help create more stable formulations and ones that can help solubilize insoluble cosmetically active components.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over James Vincent Gruber (EP2473159A2), Cir-safety.org (https://www.cir-safety.org/sites/default/files/tripep062014final.pdf), Z Fiume (Final report on the safety assessment of Lecithin and Hydrogenated Lecithin, Int J Toxicol, 2001: 20) and Cir-safety.org (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cir-safety.org/sites/default/files/ADIOLS042017TR.pdf), and Rolf Petersen (US9114077B2) as applied to claims 1-2, 4-8, 11-12 and 15-18 above, and further in view of Sallander (WO2008045766A2). This rejection is new based on the amendments filed on 03/18/2026.
Gruber, CIREP, Fiume and Petersen’s combined art teach the topical composition comprising the tripeptide-1, hexapeptide-11 and hexapeptide-12 and within the instantly claimed ranges and liposome sizes however are silent on the composition comprising a tetrapeptide-2.
Sallander teaches “a surprising discovery is that tripeptides act upon and stimulate the elastin receptors” (see page 3 at line 1) and “More particularly, it was surprisingly discovered that a cream that contains tripeptide-1 participates in tissue repair and restarts extra cellular matrix renewal” (see page 3 at line 30).
Sallander also teaches that “It was surprisingly discovered that peptides act directly on the keratinocytes. More particularly, acetyl tetrapeptide-2 acts directly upon the cytokine of the keratinocytes” (see page 8 at line 24).
Sallander teaches that “The acetyl tetrapeptide-2 regulates the cytokine hormone secretion so that the cell building is indirectly affected by affecting the hormones of the cell.
The cytokine is a growth hormone that not only stimulates keratinocytes but also Langerhans cells. Because the cytokine hormone affects the production of Langerhans cells, it is useful as a day cream when the skin needs a good immune system the most. In this way, both the production of the immune cells and the cell building are stimulated at the same time.
The peptide, acetyl tetrapeptide-2L is a biomimetic of the cell maturation factors produced by the thymus. Oxytosine acts topically on the keratinocytes, inducing endocellular synthesis of paracrine and autocrone mediators. Oxytosine then stimulates the production of GM-CSF (Granulocyte Macrophage-15 Colony Stimulating Factor) by the keratinocytes. This cytokine stimulates not only keratinocytes renewal but also Langerhans cell maturation and improves the epidermis profile and stimulates the skin immune system” (see page 8 at line 32 and on).
Therefore, it would have been obvious to persons skilled in the art before the effective filing date to include tetrapeptide-2 as taught by Sallander in the composition taught by Gruber and CIREP because tetrapeptide-2 is known to act directly on keratinocytes through activation of cytokines which not only affect keratinocytes but also Langerhans cells which ultimately improves the epidermis and skins immunity.
Claims 10, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gruber (EP2473159A2), Cir-safety.org (https://www.cir-safety.org/sites/default/files/tripep062014final.pdf), Z Fiume (Final report on the safety assessment of Lecithin and Hydrogenated Lecithin, Int J Toxicol, 2001: 20) and Cir-safety.org (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cir-safety.org/sites/default/files/ADIOLS042017TR.pdf) and Rolf Petersen (US9114077B2) as applied to claims 1-2, 4-8, 11-12 and 15-18 above, and further in view of Doring (from IDS, DE102004055541A1). This is a new rejection based on the amendments filed on 03/18/2026.
Gruber, CIREP, Fiume and Petersen’s combined art teach the topical composition comprising the tripeptide-1, hexapeptide-11 and hexapeptide-12 and within the instantly claimed ranges and liposome size, however is silent on the composition comprising the fatty acids of claim 10.
Doring’s general disclosure relates to topical cosmetics for treating mature or intrinsically aged skin (see abstract).
“The Synthesis of collagen in dermal fibroblasts may be due to growth factors like TGF-β (tissue growth factor). Specific chemoattractant Peptides are capable of immune system cells, such as mast cells and macrophages, which then recruit via the release of growth factors Repair processes in the tissue, e.g. induce collagen synthesis. Such peptides are used in the context of the present invention as a type designated a-peptides. Examples of such type a-peptides are Lys-Thr-Thr-Lys-Ser (INCI name: Pentapeptide-3) or Gly-His-Lys (INCI name: tripeptide-1), which differ from the α1-pro-collagen or the α2-chain of the Derive collagen I” (see page 2, para. 3).
Doring teaches that preferred, N-acylated and / or esterified hexapeptides according to the invention include hexapeptide-11 (see page 5, first para.).
Regarding claims 1 and 4-8, Doring teaches the peptides to be in amounts ranging from 0.01-5000 pp, preferably 0.1-25 ppm for peptide a, 0.015000 ppm, preferably 0.1-50 ppm for peptide b, and 0.015000 ppm, preferably 0.1-10 ppm for peptide c (see claims).
Regarding claims 10 and 13, Doring teaches “In a preferred embodiment of the invention, at least one peptide of the type a, b or c is N-acylated and / or esterified with a, preferably linear, C -C -fatty acid to improve the penetration into the skin. Particularly preferred for N-acylation and / or esterification are C -C fatty 8 22 12 18 acids, very particular preference being given to palmitic acid (C)” (see page 2, 2nd para.).
Therefore it would have been obvious to persons having skill in the art before the effective filing date to select palmitic acid in functioning the peptides because as Doring teaches these fatty acids can help improve the penetration into the applicants skin.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over James Vincent Gruber (EP2473159A2), Cir-safety.org (https://www.cir-safety.org/sites/default/files/tripep062014final.pdf), Z Fiume (Final report on the safety assessment of Lecithin and Hydrogenated Lecithin, Int J Toxicol, 2001: 20) and Cir-safety.org (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cir-safety.org/sites/default/files/ADIOLS042017TR.pdf) and Rolf Petersen (US9114077B2) as applied to claims 1-2, 4-8, 11-12 and 15-18 above, and further in view of Florence et. al. (CA2835291A1). This rejection is new based on the amendments filed on 03/18/2026.
Gruber, CIREP, Fiume and Petersen’s combined art teach the topical composition comprising the tripeptide-1, hexapeptide-11 and hexapeptide-12 and within the instantly claimed ranges and liposome size however are silent on the composition comprising one of the ingredients in instant claim 19.
Florence’s general disclosure is to topical compositions for skin repair (see abstract).
Regarding claims 19, Florence teaches compositions which comprise of tripeptide-1 and Centella asiatica extract because these are ingredients known for increasing extracellular matrix proteins (e.g., collagen, elastin, and hyaluronic acid) and proteins localized in the dermal-epidermal junction (e.g., laminin and fibronectin) of the skin (see 0011 and abstract).
Therefore, it would have been obvious to any person having skill in the art to combine Centella asiatica with that of Gruber and CIREP’s teachings in creating a skin care composition because Centella asiatica extract along with tripeptide-1 are known to increase production of collagen, elastin and hyaluronic acid and combining known equivalents into a composition is prima facie obvious.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gruber (EP2473159A2), Cir-safety.org (https://www.cir-safety.org/sites/default/files/tripep062014final.pdf), Z Fiume (Final report on the safety assessment of Lecithin and Hydrogenated Lecithin, Int J Toxicol, 2001: 20) and Cir-safety.org (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.cir-safety.org/sites/default/files/ADIOLS042017TR.pdf) and Rolf Petersen (US9114077B2) as applied to claims 1-2, 4-8, 11-12 and 15-18 above, and further in view of Sarah A Ibrahim and S Kevin Li, Efficiency of Fatty Acids as Chemical Penetration Enhancers: Mechanisms and Structure Enhancement Relationship, Pharm Res 2010 January; 27(1): 115-125). This is a new rejection based on the amendments filed on 03/18/2026.
Gruber, CIREP, Fiume and Petersen’s combined art teach the topical composition comprising the tripeptide-1, hexapeptide-11 and hexapeptide-12 and within the instantly claimed ranges and liposome size however are silent on wherein the peptides are functionalized with palmitoleic acid.
Ibrahim’s general disclosure is to fatty acids being used as penetration enhancers (see abstract).
Ibrahim teaches many fatty acids are generally recognized as safe (GRAS listed) and are approved by the FDA as inactive ingredients in a number of products. Ibrahim teaches wherein palmitoleic acid demonstrated the highest enhancement effect (enhancement ratio of 13.4 at 20% palmitoleic acid). Fatty acids therefore exhibit synergistic enhancement effects with cosolvents present in transdermal formulations, and the sole permeation enhancement effects of many fatty acids are not known. (See page 2, para. 4).
Therefore it would have been obvious before the effective filing date to persons having ordinary skill in the art to select palmitoleic acid as a penetration enhancer for the composition taught by Gruber and CIREP, because one would want to increase the peptides absorption into the applicant’s skin.
Response to Arguments
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive. The applicant argues that the present inventors discovered that topical compositions within the scope of amended claim 1 (wherein hexapeptide-11 is present within liposomes formed from lecithin and propanediol, with an average size of 185 nm) afford unexpected activity which was in no way predicted by the prior art. The applicant describes instant examples 6 and 17 showing clinical studies showing that subjects treated post-procedure with topical compositions within the scope of amended claim 1 (comprising tripeptide-1, hexapeptide-12 and liposomal hexapeptide-11) exhibit substantially greater and faster reductions in arm and abdominal fat volume and improved contour and skin laxity versus control sides treated with bland moisturizer or no topical composition (see Fig 17-19).
As argued previously, Gruber teaches that hexapeptide in amounts of 0.01% is effective to regulate discontinuities in mammalian skin texture associated with aging. As used herein, therapeutically regulating such discontinuities includes ameliorating, e.g., diminishing, minimizing and/or effacing visible and/or tactile discontinuities in the texture of mammalian skin, to thereby provide improved skin appearance and/or feel, e.g., a smoother, more even appearance and/or feel. Such visible and/or tactile discontinuities in skin texture include crevices, bumps, pores, fine lines, wrinkles, scales, flakes and/or other forms of textural unevenness or roughness associated with skin aging. For example, the length, depth, and/or other dimension of lines and/or wrinkles are decreased, the apparent diameter of pores decreases, or the apparent height of tissue immediately proximate to pore openings approaches that of the interadnexal skin. Expecting the same components within the same range to contour skin and improve skin laxity would have been expected as this is what the prior art already describes. Furthermore, the applicant argues that the same ingredients claimed in amended claim 1 are within the scope of the activities being argued which is not the case. The applicant’s activity noted for tested examples 6 and 11-17 was from formulation 1M which discloses many more active ingredients than the three peptides being claimed. For example the formulation comprises of avocado extract, shea butter and bentonite which the applicant states “Avocado extract, shea butter, and bentonite, in some embodiments, provide tightening, elastase inhibition inhibits elastin breakdown and encourages some fat breakdown and turnover; it also aids in stretch mark alleviation” (see 0062). The formulation also comprises Acetyl tetrapeptide-2 which the applicant states stimulate LOX1, which cross links elastin components; binds tropoelastin; builds elastin; and increases Fibulin 5, which binds to tropoelastin to integrin to fibroblast stimulating fibroblast to produce elastin. Palmitoyl Tripeptide-1 provides collagen and elastin stimulation, ECM recycling, anti-inflammation, and with Palmitoyl Hexapeptide-12, an elastin binding protein, draws in newly produced elastin. Dill extract (Anethum graveolens extract) stimulates LOXL reinduction encouraging elastin formation and formulation 1M comprises of these active ingredients also, among others. The claims are most definitely not in scope with the argued activity.
The applicant argues that example 5 shows that liposomal hexapeptide-11 treatment increases macrophage clustering around adipocytes and enhances lipid droplet breakdown in a co-culture model indicating accelerated digestion of fat fragments. The applicant has merely determined a mechanism of action for hexapeptide-11. Example 5 is testing the effects of hexapeptide-11 treatment on macrophage clustering on 3T3-L1 adipocytes. This does not give evidence of some unexpected properties from the claimed composition. This testing merely shows properties for hexapeptide-11. Determining a mechanism of action for one molecule within the instantly claimed composition does not make the composition patentably distinct from that of the prior art.
The applicant argues that example 4 shows that hexapeptide-11 produces marked modulation of autophagy/proteostasis pathways in human fibroblasts (see tables 16A-16B). Again this testing merely describes properties of hexapeptide-11 and is not a property from the claimed combination of ingredients or the applicant’s invention. This testing does not warrant a new invention as instantly claimed, it merely describes the mechanisms of action for hexapeptide-11. It is well established that “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Baxter Travenol Labs, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991). "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
The applicant argues that the convergence of robust autophagy, enhanced macrophage-mediated clearance of adipocyte lipid droplets and superior clinical fat reduction and contour outcomes when hexapeptide-11 is delivered in the claimed lecithin-propanediol liposomal system, together with tripeptide-1 and hexapeptide-12 constitutes an unexpected, synergistic activity not predicted in the prior art. As just explained the instant claims are not in scope with the argued activity and much of the argued activity stems from hexapeptide-11 alone. The applicant has not described any synergy as just argued.
The applicant argues that there is no reason to combine lecithin and propanediol together as components in a liposomal system for encapsulating hexapeptide-11, let alone any mention of the unexpected robust autophagy gene activation, adipocyte lipid droplet clearance and clinical fat reduction and contour outcomes discussed. The reasons to combine lecithin and propanediol in the composition do not need to be the same as the applicants. The prior art recognizes reasons to include these ingredients because Fiume teaches lecithin acts as skin conditioning agents and as surfactant-emulsifying agents and Cir-Safety.org teaches propanediol is used as one of the most common solvents and viscosity decreasing agents in cosmetics and both are described to be in ranges that are claimed.
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, 4-10, 13, 15, 17-18 and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 13-15 of U.S. Patent No. US10493011 and Rolf Petersen (US9114077B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims as currently written are not distinct from the claims of the US patent US10493011 because they require the same ingredients within the same ranges and for the same purposes. It would have been obvious to optimize the size of the liposomes to be within the instantly claimed range given Petersen’s art cited above.
Claims 1-2, 4-10, 13, 15-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-13 and 16-17 of U.S. Patent No US11052032 and Rolf Petersen (US9114077B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims as currently written require the same composition as taught in the prior patent and the only modification would be the use of the composition which is made obvious when considering the dependent claims of the instant invention. The intended uses and what is being claimed would make obvious reasons to use the composition as a method for improving skin laxity, texture, or crepiness or for improving body contouring. It would have been obvious to optimize the size of the liposomes to be within the instantly claimed range given Petersen’s art cited above.
Claims 1-2, 4-9, 11-13, 15-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 9-20 of U.S. Patent No. US11752084 and Rolf Petersen (US9114077B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite the same ingredients within the same ranges and for the same effects. It would have been obvious to use the instant invention as a method for accelerating fat reduction because the instant invention claims this as an effect (see claim 2). Therefore, the inventions are not patentably distinct. It would have been obvious to optimize the size of the liposomes to be within the instantly claimed range given Petersen’s art cited above.
Claims 1-2, 4-9, 11-13, 15-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, 11, 15, 18, 25 of U.S. Patent No. US12053547 and Rolf Petersen (US9114077B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims recite the same ingredients within the same ranges and for the same effects. It would have been obvious to create the same invention as patented because the ingredients are the same and claimed within the same ranges. It would have been obvious to optimize the size of the liposomes to be within the instantly claimed range given Petersen’s art cited above.
Response to Arguments
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive. Applicant has argued that the nonstatutory double patenting rejection be held in abeyance. However, this is not persuasive as the MPEP does not provide for holding the rejection in abeyance. The rejection is still deemed proper and stands for the reasons of record.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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