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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Mexico on October 24th, 2022. It is noted, however, that applicant has not filed a certified copy of the MX/A/2022/013371 application as required by 37 CFR 1.55. Since the certified copy has not been received, written description support for the priority date of October 24th, 2022 cannot be made. Hence, the effective filing date, October 20th, 2023, is given as the priority date.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 5th, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is acknowledged by the examiner.
Claim Status
Claims 1-9, filed on October 20th, 2023 are pending. Claims 1-9 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for promoting skin cell regeneration, does not reasonably provide enablement promoting all cellular regeneration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claim 5’s breadth embodies the regeneration of all types of cells using the present invention. However, the invention is a topical composition that has a cosmetically acceptable vehicle and currently, the prior art does not support the logic that a topical composition can penetrate further than the epidermis and regenerate other cells.
Ashley, E. (2024, April 7). How Do Skincare Ingredients Penetrate into Your Skin? Dr Emmaline
As Dr. Emmaline Ashley explains,
Absorption refers to when an ingredient reaches the bloodstream. This is not what cosmetic skincare products do or what we want them to do. Penetration refers to when a chemical gets past the stratum corneum into the deeper layers of the epidermis. For most skincare ingredients, we are aiming for good penetration into the skin.
Thus, one of ordinary skill cannot use the invention to regenerate all type of cells like hepatocytes or cardiomyocytes. There is a lack of predictability that the present invention is enabled to do so. The applicant provides examples using the marker TRPA1 in keratinocytes [0069-0073] to show the relationship of skin regeneration. To use the invention based on the present disclosure, undue experimentation would be required to show that the present invention is enabled to regenerate every type of cell. Accordingly, the applicant is only enabled for the scope of the composition to promote skin cell regeneration.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-2, 5-6, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kazimierska et al (Kazimierska, K., & Kalinowska-Lis, U. (2021). Milk Proteins-Their Biological Activities and Use in Cosmetics and Dermatology. Molecules (Basel, Switzerland), 26(11), 3253.) in view of Chadwick et al. (Chadwick, M. R., & Murphy-Rose, B. (2019). Pantothenic Acid for Skin: Benefits and How to Use. Byrdie) and Rubin (Rubin SH. The comparative stability of pantothenic acid and panthenol. J Am Pharm Assoc Am Pharm Assoc. 1948 Dec;37(12):502-4.), as evidenced by Nakamura et al. (Nakamura, T., Kawase, H., Kimura, K., Watanabe, Y., Ohtani, M., Arai, I., & Urashima, T. (2003). Concentrations of sialyloligosaccharides in bovine colostrum and milk during the prepartum and early lactation. Journal of dairy science, 86(4), 1315–1320), and Dande et al (Dande, Nivedita Deepak; Nande, Prajakta Jayant. Nutritional Composition of Bovine Colostrum: Palatability Evaluation of Food Products Prepared Using Bovine Colostrum. International Journal of Nutrition, Pharmacology, Neurological Diseases 10(1):p 8-13, Jan–Mar 2020).
Kazimierska et al. teaches that milk and colostrum have many uses in cosmetics and dermatology due to its natural origin and non-toxicity:
Milk products are widely used in the treatment of dermatological diseases for promoting the healing of chronic wounds, hastening tissue regeneration, and the treatment of acne vulgaris or plaque psoriasis. They are also increasingly regarded as active ingredients that can improve the condition of the skin by reducing the number of acne lesions and blackheads, regulating sebum secretion, ameliorating inflammatory changes as well as bestowing a range of moisturizing, protective, toning, smoothing, anti-irritation, whitening, soothing, and antiaging effects [Abstract].
The κ-casein in colostrum releases glycomacropeptides, which has antibacterial activity [Fig 1].
GMP has been found to inactivate microbial toxins of Escherichia coli and Vibrio cholerae, inhibit the adhesion of cariogenic Streptococcus mutans and Streptococcus sobrinus, and hemagglutination by four strains of influenza virus in in vitro tests. It also modulates immune system responses, promotes the growth of Bifidobacteria, suppresses gastric hormone activities, and regulates blood circulation through antihypertensive and antithrombotic activity [Section 2.1.2].
Kazimierska et al. goes on to provide examples of milk and colostrum-based products in cosmetics and dermatology that would motivate and artisan of ordinary skill to incorporate colostrum in a cosmetically acceptable vehicle. For example, an emulsion with 20% horse colostrum when used for moderate atopic dermatitis resulted in a reduction in erythema and pruritus and had softening, moisturizing, soothing, and anti-inflammatory effects [Table 4]. Kazimierska does not teach that a colostrum cosmetic composition inherently has sialic acid and pantothenic acid. Colostrum inherently comprises GMP, sialic acid and pantothenic acid as evidence by Nakamura and Dande. Nakamura et al. teaches that there is an average of 1.70 g/L of sialic acid in colostrum [Results section]. Dande et al teaches there is 150 μg. of pantothenic acid per 100 mg [Results and Conclusions section]. The difference between the compositions of Kazimierska et al. and the instant invention is the colostrum inherently comprise pantothenic acid and not panthenol as claimed.
Chadwick explains panthenol is the provitamin or precursor for vitamin B5, also known as pantothenic acid [section What is Pantothenol?]. When panthenol is applied topically, it is quickly converted to pantothenic acid. Chadwick teaches there is no difference in making a topical composition with panthenol versus pantothenic acid because the composition when applied becomes one comprising of pantothenic acid Chadwick does not elaborate on the motivation to use pantothenol in place of pantothenic acid.
Rubin teaches that panthenol displays the vitamin activity, qualitatively and quantitatively, of pantothenic acid [Abstract]. Under certain conditions of dosage, the physiological availability of panthenol is superior to that of pantothenic acid and is more stable in acid solutions at pH 3 to 5.
At the time before the effective filing date of the claimed invention, it would have been obvious to the artisan of ordinary skill to substitute panthenol for pantothenic acid in the compositions of Kazimierska because Rubin teaches panthenol is more stable. This constitutes a simple substitution of one known element for another to obtain predictable results because Chadwick teaches there is no difference in making a topical composition with panthenol versus pantothenic acid because the composition when applied becomes one comprising of pantothenic acid [MPEP 2143].
Regarding claim 2, colstrum inherently has GMP linked to sialic acid as evidenced by Wongkuna et al. (Wongkuna, S., Prasoodanan P K, V., Holmberg, S. M., Bjørnshave, A., & Schroeder, B. O. (2025). Milk-derived casein glycomacropeptide improves colonic mucus function under Western-style diet feeding in a sialylation-dependent manner. Food research international (Ottawa, Ont.), 221(Pt 1), 117206.).
Wongkuna et al. teaches that the casein glycomacropeptide that is a part of κ-casein “features O-linked glycans composed of mucin-type sugars, including N-acetylgalactosamine (GalNAc), galactose (Gal), and sialic acid” [Introduction pgh 6].
Regarding claim 5, Kazimierska states: “Milk products are widely used in the treatment of dermatological diseases for promoting the healing of chronic wounds, hastening tissue regeneration…” [Abstract]. Also, of the topical applications using colostrum, cream containing 30% horse colostrum resulted in complete skin regeneration [Table 4]. Since an artisan of ordinary skill knows that skin is a tissue and tissues are made out of cells, it would have been obvious prior to the effective filing date to use colostrum topically to promote the regeneration of cells.
Regarding claim 6, the Kazimierska demonstrates that the topical application of an emulsion with 20% horse colostrum to treat moderate atopic dermatitis resulted in a reduction in erythema and pruritus and had softening, moisturizing, soothing, and anti-inflammatory effects [Table 4]. Fermented horse colostrum also had the same effects for atopic dermatitis (atopy and psoriasis) [Table 4]. Thus, it would have been obvious prior to the effective filing date to use colostrum topically to diminish inflammation in human skin cells because Kazimierska teaches colostrum’s efficacy to do so.
Regarding claim 7, Kazimierska et al, in view of Chadwick et al and Rubin teach the topical composition comprising of glycomacropeptide, sialic acid, and panthenol, as previously discussed in claim 1’s rejection. According to the MPEP, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device [See MPEP 2112.02]. Namely, the topical compositions taught by Kazimierska to treat skin inflammation (detailed in claim 6’s rejection) anticipate the process of doing so. Therefore, it is prima facie obvious to claim the method of using the topical composition taught by Kazimierska et al, Chadwick et al, and Rubin.
Regarding claim 8, the topical compositions listed in Kazimierska incorporating colostrum treat wounds, psoriasis, contact skin lesions (worded by applicant as contact dermatitis), acne, and post sun exposure [Table 4]. It would have been obvious for the applicant to apply the taught composition to the listed conditions because Kazimierska gives a reasonable expectation of success.
Regarding claim 9, Kazimierska et al, in view of Chadwick et al and Rubin teach the topical composition comprising of glycomacropeptide, sialic acid, and panthenol, as previously discussed in claim 1’s rejection. According to the MPEP, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device [See MPEP 2112.02]. Namely, the topical compositions taught by Kazimierska to promote skin cell regeneration (detailed in claim 5’s rejection) anticipate the process of doing so. Therefore, it is prima facie obvious to claim the method of using the topical composition taught by Kazimierska et al, Chadwick et al, and Rubin.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kazimierska et al in view of Chadwick et al and Rubin as applied to claim 1 above, and further in view Gallegos-Alcalá et al. (Gallegos-Alcalá P, Jiménez M, Cervantes-García D, Córdova-Dávalos LE, Gonzalez-Curiel I, Salinas E. Glycomacropeptide Protects against Inflammation and Oxidative Stress, and Promotes Wound Healing in an Atopic Dermatitis Model of Human Keratinocytes. Foods. 2023 May 9;12(10):1932.) as evidenced by Nakamura, Dande and Schneider et al. (Schneider, F., & Wehrend, A. (2019). Qualitätsbeurteilung von bovinen und equinen Kolostrum – Eine Übersicht [Quality Assessment of Bovine and Equine Colostrum - An Overview]. Schweizer Archiv fur Tierheilkunde, 161(5), 287–297.)
As previously discussed, Kazimierska discusses how colostrum can be used topically to treat atopic dermatitis and other skin conditions [Table 4 and section 3.2]. Kazimierska also states:
Irrespective of the composition, cosmetic formulations based on a combination of horse colostrum and horse milk demonstrate a number of skin benefits, including antiaging, moisturizing, protective, tensio-distensive, tonic, smoothing, anti-irritant, emollient, bleaching, decongestant, and sebostatic activities [Section 3.3]
Kazimierska makes obvious to one of ordinary skill that colostrum is a cosmetic formulation is beneficial to the skin. Kazimierska, Nakamura and Dande are used to determine the weight per volume of each component in bovine colostrum when used in a cosmetic formulation. Schneider et al. teaches the density of bovine colostrum (1047 g/mL) [Overview]; this is used to find the mass per volume of pantothenic acid from Dande et al. The weight percentages for sialic acid and panthenol are within the applicant’s ranges.
Component
Mass per volume
Equiv. w/v (%)
Source
Glycomacropeptide
2.5 g/L
0.25
Kazimierska [Table 2]
Sialic acid
1.7 g/L
0.17
Nakamura [Results]
Panthenol
1.57 g/L
0.157
Dande [Results and Conclusions section]
It is prima facie obvious where the claimed ranges overlap or lie inside ranges disclosed by prior art [see MPEP 2144.05]. Kazimierska et al., Chadwick et al, and Rubin do not teach why a greater w/v of glycomacropeptide can be used for a topical treatment.
Gallegos-Alcalá et al. aim to evaluate the effect of GMP on the inflammatory, oxidative, proliferative, and migratory responses of HaCaT keratinocytes [Abstract]. They found that GMP protected keratinocytes from death and apoptosis in a dose dependent manner from 6.3 to 25 mg/mL (Section 3.2; Fig 2A). GMP also protected keratinocytes from oxidative damage by 70.5% and 61.6% when cells were GMP-treated at 6.3 and 25 mg/mL [Section 3.3; Fig 3C]. These concentrations showed efficacy of reduction atopic inflammatory responses [Section 3.4] and modifying gene expression related to itch and neurogenic inflammation, by 6.3 and 25 mg/mL GMP inducing levels of cGRP mRNA 1.42- and 3.14-fold higher [Section 3.5]. The equivalent weight per volume percentages of 6.3 and 25 mg/mL are 0.63 and 2.5% w/v- encompassed by the present range. Therefore, Gallegos-Alcalá et al. provides sufficient motivation to increase the amount of glycomacropeptide of the compositions suggested by Kazimierska, Chadwick, and Rubin to that of the present range because there is a reasonable expectation of success that such a composition would be effective at treating keratinocytes with conditions related to oxidative damage and inflammation.
Claims 3 and 4 can also be rejected in further view of Leahy et al. (WO2005037248A1: Published 2005), if the foreign priority date is established. Leahy et al. disclose a glycomacropeptide containing preparation to act in the vicinity of the surface to promoted the healing of wounds and treatment of skin lesions and disorders [Abstract 0018]. The glycomacropeptide is covalently attached to sialic acid, which comprises of about 7-8% of the glycomacropeptide [0029]. Leahy does not claim the glycomacropeptide in terms of weight per volume so the specifications are used to reasonably approximate the weight per volume. Leahy provides an example of the use of GMP for the treatment of wounds [0104]. One embodiment has 1 g of GMP (A) and the other has 2 g (B) for every 100 g. The density of water, known to one of ordinary skill, is used to reasonably approximate the weight per volume percentage of the embodiments because most of the formulation comprises of water (97.21 g for (A) and 96.21 for (B)). This translates to a weight percentage of about 1-2% w/v. Leahy also claims the topical preparation in an ointment, cream, gel, lotion, spray and solid [claim 6].
Prior to the effective filing date, one of ordinary skill would find it obvious to improve upon using colostrum (a base device), as taught by Kazimierska et al, by adding more glycomacropeptide in a cosmetically acceptable vehicle, as taught by Leahy et al. because it is predictable to add an improvement from a comparable invention to a base product. Making a topical composition comprising of more glycomacropeptide is an improvement because Leahy teaches that such a composition can promote the healing of wounds and treatment of skin lesions.
Regarding claim 4, of the colostrum-based products in cosmetics and dermatology Kazimierska presents, colostrum is incorporated in ointments, creams, emulsions, gels, and cosmetic formulations [Table 4]. Also, Leahy’s formulation is claimed to be in the form of an ointment, cream, gel, lotion, spray or solid [claim6]. Therefore, it would have been obvious to one of ordinary skill to make a composition with the present claimed ranges using colostrum in a cosmetically acceptable vehicle with a reasonable expectation of success for topical application because Kazimierska and Leahy provide sufficient suggestion of such.
Summary
Claim 5 is rejected under 35 U.S.C. 112(a). Claims 1-9 are rejected under 35 U.S.C. 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SACHI JAUHARI whose telephone number is (571)272-3769. The examiner can normally be reached Mon-Fri 9-4.
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/SACHI JAUHARI/ Examiner, Art Unit 1654
/LIANKO G GARYU/ Supervisory Patent Examiner, Art Unit 1654