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
The instant application is a Divisional of U.S. Application No. 17/112,911 (filed 12/04/2020; corresponding to U.S. Patent No. 12,077,780). Acknowledgement is made of Applicants’ claim for benefit of Provisional U.S. Application No. 62/977,002 (filed 02/14/2020).
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 01/08/2025 contains a typographical error for Foreign Patent Document No. 7. The Foreign Document Number is listed as 20200223543; the correct number is 2020223543. The incorrect number has been lined through with the appropriate number added by the Examiner.
All references listed in the IDS have been considered by the Examiner.
Claim Interpretation
The following comments are made to establish broadest reasonable interpretation for the record.
Regarding claims 1-3: Claim 1 is to a composition comprising two components: a conditioned medium and at least one additive. Lines 6-8 of claim 1 describes the two components being stored in separate containers, and then mixed prior to use. The description of the separate containers and directions to mix prior to use are being interpreted as product-by-process limitations. Product-by-process limitations are considered only in as far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore if the product, as claimed, is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113.
In the instant case, the broadest reasonable interpretation of the composition of claim 1 is a composition comprising the mixture of conditioned medium collected from culturing fibroblasts under hypoxic conditions and at least one additive. The limitations recited in claims 1 and 2, directed to the storage of the conditioned medium and the additive in separate containers (or separate chambers in a dual-chamber tube, as recited in claim 2) and mixing the two components prior to application on the skin, do not affect the final composition, and thus are not given any patentable weight.
Additionally, claim 3 recites, “…under 1-5% oxygen thereby producing embryo-like properties.” This limitation clearly communicates the 1-5% oxygen concentration is for the embryo-like properties conferred thereby. The specification of the disclosure states “Growth of cells under hypoxic conditions demonstrate a unique ECM with fetal properties and growth factor expression” (par. 0030); additionally, par. 0081 states, “As used herein, hypoxic conditions are characterized by a lower oxygen concentration as compared to the oxygen concentration of ambient air (approximately 15%-20% oxygen)”. Thus, hypoxic conditions are clearly defined as an oxygen concentration lower than ambient air. Absent a clear definition for the term embryo-like properties, and under the principles of broadest reasonable interpretation, conditioned medium collected from human fibroblasts cultured under any hypoxic conditions (e.g., 1-10% oxygen) is encompassed by the scope of claim 3.
Regarding claims 1, 19: Claims 1 and 19 both recite a composition comprising conditioned medium from culturing human fibroblast cells under hypoxic conditions, and at least one additive. Absent a definition for the “additive” limitation of these claims in the instant specification, the term additive is interpreted as any substance added to said composition; e.g., a botanical or botanical extract.
Further, for clarity of record, the preambles of claims 1 and 19 are considered intended use limitations. Intended use limitations only limit the product in so far as the product must be capable of being used as recited; see MPEP 2111.02.
Regarding claims 5-6, 9-10, 21, 24, 30: Claims 5-6, 21, and 30 recite the limitation “botanical or botanical extract”, for which the instant specification lacks a definition. Thus, under broadest reasonable interpretation, botanical is interpreted as any plant; botanical extract is interpreted as any part (e.g., stem), product, compound, or molecule derived from any plant. Claims 9-10 and 24 recite the limitation “seed extract”, which is interpreted as any product, compound, or molecule derived from a seed of any plant.
Regarding claims 11-12, 25: These claims recite the limitation “marine extract”. Lacking a definition in the specification, the term marine extract is interpreted as any marine product, compound, or molecule; e.g., a molecule obtained from marine algae, seaweed, fish, plankton, coral, mollusks, inter alia.
Regarding claims 15-16: These claims recite the limitation “stem cell factors”. Absent a definition in the instant specification, the term stem cell factors is interpreted as molecules secreted by stem cells.
Claim Objections
Claim 1 is objected to because of the following informalities: line 2 of claim 1 appears to contain a typographical error; the semicolon should be a colon, consistent with the formatting of claim 19.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4, 15-16, and 19-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 3, 19: Claim 3 is directed to the composition of claim 1, and recites (emphasis added), “…wherein the human fibroblast cells are cultured under hypoxic conditions on a substrate grown in a suitable cell culture medium under 1-5% oxygen thereby producing embryo-like properties.” Claim 19 is directed to a method of producing a composition for improvement of a tissue in a subject; the first active step of the instant method recites (emphasis added), “…culturing human fibroblast cells under hypoxic conditions on microcarrier beads or a three dimensional surface in a suitable cell culture medium, under 1-5% oxygen, thereby producing cells having embryo-like properties…”. In par. 0081, the instant specification states, “As used herein, hypoxic conditions are characterized by a lower oxygen concentration as compared to the oxygen concentration of ambient air (approximately 15%-20% oxygen).” The same paragraph goes on to recite several embodiments regarding hypoxic conditions, including an embodiment of 1% to 5% oxygen.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). As the specification defines hypoxic conditions as an oxygen concentration lower than ambient air (i.e., an oxygen concentration range greater than 1-5%), there is a lack of clarity as to whether the under 1-5% oxygen limitation is required, or even if it is indeed directed to the hypoxic cell culture conditions.
Claim interpretation for the product-by-process limitations recited in claim 3 are set forth above. As supported by the specification (par. 0081), the culturing step of claim 19 is interpreted as culturing human fibroblast cells under hypoxic conditions on microcarrier beads or a three dimensional surface in a suitable cell culture medium, wherein the hypoxic conditions comprise an oxygen concentration of 1-5%, thereby producing cells having embryo-like properties.
As currently written, the metes and bounds of the instant claims are not clearly defined; this renders claims 3 and 19 indefinite.
Claims 4 and 20-29 depend from claim 3 or 19, inherit their deficiencies, and are likewise rejected as indefinite.
Regarding claims 15-16: Claim 15 recites, “…wherein the composition further comprises stem cell factors”; claim 16 recites, “…wherein the stem cells factors are present within a range of….”. It is set forth above the broadest reasonable interpretation for stem cell factors is molecules secreted by stem cells. However, there is no clear definition or guidance in the instant specification; it would not be immediately understood by a person having ordinary skill in the art if stem cell factors is indeed directed to molecules/growth factors secreted by stem cells into a conditioned media of the instant claims, or if this term is directed to the specific cytokine Stem Cell Factor (SCF), which is also known as KIT-Ligand. Thus, the metes and bounds of claims 15 and 16 are not clearly or precisely defined, rendering these claims indefinite.
Regarding claim 27: This claim recites, “The method of claim 19, further comprising cytokines.” It is unclear to which part of the method of claim 19 the cytokines limitation applies. The method only comprises three active steps: culturing human fibroblasts cells under hypoxic conditions on microcarrier beads or a three-dimensional surface in a suitable cell culture medium; collecting the cell culture medium; and adding an additive to the cell culture medium. Is the cytokines limitation meant to further narrow the scope of one of these steps (e.g., culturing the cells with exogenous cytokines, adding cytokines to the medium in addition to an additive)? Does this limitation further narrow the scope of the cell culture medium conditioned by the cells (e.g., specifying the composition secreted by cells into the growth medium comprises cytokines)? As currently written, the metes and bounds of the instant claim are not clearly or precisely defined, rendering the claim indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9, 11, 13, 15, 17-18, and 30 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Al-Qahtani, et al. (US 2015/0023908).
Al-Qahtani, et al. (hereinafter Al-Qahtani) teaches skin care compositions comprising exosomes and cell culture medium conditioned by cells grown in culture (Abstract).
Regarding claims 1-5, 7, 9: Al-Qahtani teaches a method of making a skin cream, the method comprising: culturing a first population of cells and harvesting the medium thereof; optionally, culturing a second population of cells and harvesting the medium thereof; isolating exosomes from the conditioned medium of the first or second cell population; adding the isolated exosomes to the conditioned medium from the first or second cell population; and adding the conditioned medium containing the enriched population of exosomes to a formulation comprising one or more solvents, a base solvent, one or more botanicals, and one or more emollients to form a cream (par. 0025), wherein the cells are foreskin-derived fibroblast cells (par. 0010) and the culturing is performed on microcarriers (par. 0080). In an embodiment, the exosome production is induced/enhanced in the cells by hypoxia during culturing (par. 0072).
In an embodiment, the composition further comprises biotinyoyl tripeptide-1, Lonicera caprifolium flower extract, Lonicera japonica flower extract, Simmondsia chinensis seed oil, and/or Rosmarinus officinalis leaf oil (par. 0018). These components are all additives; specifically, the biotinyoyl tripeptide-1 is a peptide, the Lonicera caprifolium and japonica flower extracts and Rosmarinus officinalis leaf oil are botanical extracts, and the Simmondsia chinensis seed oil is a seed extract.
Further, conditions treated by said composition include inducing increased skin integrity by cell renewal; enhancing water content or moisture of skin; reducing trans epidermal water loss, skin flaking, and scaling; improving skin thickness; enhancing skin tensile properties; reducing the appearance of dermal wrinkles and improving skin texture; reducing skin pores size and enhancing skin smoothness; rejuvenating or renewing vulvo-vaginal structures; improving the appearance of scars and skin abrasions; decreasing oily skin by minimizing sebaceous gland secretion; reducing chronological, intrinsic, and extrinsic dermal aging of the skin; improving skin age spots; enhancing hair pigmentation; and improving skin tone (par. 0019).
Thus, the composition produced by the method of Al-Qahtani anticipates:
the composition for repair and regeneration of skin tissue on a subject, the composition comprising: a conditioned medium collected from culturing human fibroblast cells under hypoxic conditions in a suitable cell culture medium; and at least one additive; wherein the conditioned medium is stored in a first container and the additive is stored in a second container, and wherein the conditioned medium and the additive are mixed prior to application to the skin tissue limitations recited in claim 1;
the wherein the first container and the second container are separate chambers in a dual chamber container limitation recited in claim 2;
the wherein the human fibroblast cells are cultured under hypoxic conditions on a substrate grown in a suitable cell culture medium under 1-5% oxygen thereby producing embryo-like properties limitations recited in claim 3;
the wherein the substrate is microcarrier beads limitation recited in claim 4;
the wherein the composition further comprises at least one botanical extract limitation recited in claim 5;
the wherein the composition further comprises at least one peptide limitation recited in claim 7; and
the wherein the composition further comprises at least one seed extract limitation recited in claim 9.
Regarding claim 6: Following the above discussion, Al-Qahtani teaches an embodiment wherein the composition comprises Rosmarinus Officinalis leaf oil at about 0.80% (w/w) (par. 0020); this anticipates the wherein the at least one botanical or botanical extract is present within a range of about 0.5 to about 2.0% by weight of the composition limitation recited in claim 6.
Regarding claims 11, 13: Following the above discussion, Al-Qahtani teaches the conditioned medium may be formulated with a hydrogel; in an embodiment, modified alginate derived from seaweed is used to form the hydrogel (par. 0125); this anticipates the wherein the composition further comprises at least one marine extract limitation recited in claim 11.
In an alternative embodiment, the hydrogel is formed with polysaccharides, such as bacterial polysaccharides (par. 0126); this anticipates the wherein the composition further comprises at least one bacterial ferment limitation recited in claim 13.
Regarding claim 15: Following the above discussion, Al-Qahtani teaches an embodiment wherein the conditioned medium is derived from multiple cell types; e.g., fibroblasts, mesenchymal stem cells, and/or embryonic stem cells (pars. 0096-0097, 0099). The molecules secreted by the mesenchymal stem cells and/or embryonic stem cells anticipate the wherein the composition further comprises stem cell factors limitation recited in claim 15.
Regarding claim 17: Following the above discussion, Al-Qahtani teaches the conditioned medium comprises cytokines (par. 0210); this reads on the wherein the composition further comprises at least one cytokine limitation recited in claim 17.
Regarding claim 18: Matters related to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art; see MPEP 2144.04(I) and In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947).
Regarding claim 30: Following the above discussion, Al-Qahtani teaches an embodiment wherein the cells are embryonic stem cells and/or mesenchymal stem cells (par. 0071); this anticipates the composition comprising: a growth medium, wherein the growth medium is collected from multipotent stem cells produced under hypoxic conditions; at least one botanical; at least one extract; and at least one peptide limitation recited in claim 30.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 9-11, 13, 15-18, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Qahtani, et al. (US 2015/0023908).
The teachings of Al-Qahtani are set forth above; claims 1-7, 9, 11, 13, 15, 17-18, and 30 are anticipated by the same.
Regarding claim 10: Following the above discussion, Al-Qahtani does not teach the composition as comprising the at least one seed extract at about 0.5 to about 2% by weight, as required by the instant claim.
However, the concentration of the seed extract would have been routinely optimized by one having ordinary skill in the art based on the other components in the composition. Al-Qahtani clearly teaches the Simmondsia chinensis seed oil (i.e., jojoba) is included in the composition as an emollient effective to soften and smooth skin while helping it to retain moisture (par. 0193). That means the conditions necessarily to achieve the softened and smoothed skin with improved moisture retention were result effective variables. Result effective variables would be optimized by routine experimentation by one having ordinary skill in the art. Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A).
This renders obvious the wherein the at least one seed extract is present within a range of about 0.5 to about 2% by weight of the composition limitation recited in claim 10.
Regarding claim 16: Following the above discussion, Al-Qahtani is silent in reference to the particular concentration of the stem cell factors secreted into the conditioned medium by the mesenchymal stem cells and/or embryonic stem cells. However, the concentration of the stem cell factors in the composition would have been routinely optimized by one having ordinary skill in the art based on the cell culture conditions and cells used to condition the medium.
Al-Qahtani clearly teaches it is the extracellular proteins secreted into the conditioned medium (e.g., growth factors, cytokines, peptides, structural and extracellular matrix proteins) effective to provide beneficial properties (e.g., treatment of age-related loss of skin vitality, inducing increased skin integrity, reducing the appearance of dermal wrinkles and improving skin texture) to the composition(s) of the disclosure (see e.g. pars. 0019, 0059, 0121). Further, Al-Qahtani explicitly teaches concentrations of the protein products secreted by the cells may be adjusted or optimized in order to improve the concentration of the final product (see e.g. pars. 0088, 0107).
This means the conditions necessarily to achieve said beneficial properties were result effective variables. Result effective variables would be optimized by routine experimentation by one having ordinary skill in the art. Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). This renders obvious the limitations recited in claim 16.
Claims 1-7, 9, 11, 13-15, 17-18, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Qahtani, et al. (US 2015/0023908) in view of Kanlayavattanakul and Lourith (Polysaccharides. 2015).
The teachings of Al-Qahtani are set forth above; claims 1-7, 9, 11, 13, 15, 17-18, and 30 are anticipated by the same.
Kanlayavattanakul and Lourith (hereinafter Kanlayavattanakul) teaches skin hydrating polysaccharides (Abstract).
Regarding claim 14: Following the above discussion, Al-Qahtani does not teach the composition as comprising at least one bacterial ferment present within a range of about 0.5 to about 3.0% by weight, as required by the instant claim.
However, Al-Qahtani does teach an embodiment wherein the composition comprises xanthan gum at a concentration of 1.00% by weight, as a thickener (par. 0293).
Kanlayavattanakul teaches xanthan gum produced by Xanthomonas campestris bacteria (pg. 1872; par. 2.2.7).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have further modified the composition of Al-Qahtani by substituting the xanthan gum with the xanthan gum obtained from X. campestris, as taught by Kanlayavattanakul. This conclusion of obviousness is based on the ‘substitution rationale’. The use of the xanthan gum obtained from X. campestris of Kanlayavattanakul in place of the generic xanthan gum of Al-Qahtani is a predictable use of prior art elements according to their established function as a thickener, leading to the predictable result of a composition with a suitable consistency, or viscosity. This rationale aligns with the principle of a simple substitution of one known element for another to obtain predictable results; see MPEP 2143(I)(B).
This renders obvious the wherein the at least one bacterial ferment is present within a range of about 0.5 to about 3.0% by weight of the composition limitation recited in claim 14.
Claims 1-7, 9, 11, 13, 15, 17-28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Qahtani, et al. (US 2015/0023908) in view of Naughton, et al. (US 2010/0047305).
The teachings of Al-Qahtani are set forth above; claims 1-7, 9, 11, 13, 15, 17-18, and 30 are anticipated by the same.
Naughton, et al. (hereinafter Naughton) teaches a method of producing compositions including embryonic proteins (Abstract).
Regarding claims 19-22, 24: Following the above discussion, Al-Qahtani does not teach specific oxygen levels suitable for hypoxic conditions.
However, Naughton teaches cells cultured under hypoxic conditions demonstrate a unique extracellular matrix (ECM) with fetal properties and growth factor expression, wherein the ECM is similar to fetal mesenchymal tissue in that it is relatively rich in collagens type III, IV, and V, and glycoproteins such as fibronectin and hyaluronic acid (par. 0047). Naughton further discloses a method for making an ECM composition by culturing fibroblasts on microcarriers under hypoxic conditions, wherein applications for the composition include repair and/or regeneration of damaged cells or tissues, promotions of tissue regeneration, promoting soft tissue repair, augmentation, and/or improvement of a skin surface, such as wrinkles (pars. 0045-0046, 0053, 0075). Hypoxic conditions are characterized by an oxygen concentration of less than 10%, with disclosed embodiments wherein the oxygen concentration is 1-10%, 1-9%, 1-8%, 1-7%, 1-6%, 1-5%, 1-4%, 1-3%, and 1-2% (par. 0097).
Therefore, it would have been prima facie obvious for a person having ordinary skill in the art to have modified the method of Al-Qahtani by using 1-5% oxygen for the hypoxic conditions, as taught by Naughton. This conclusion of obviousness is based on the ‘obvious to try rationale’. Al-Qahtani discloses a need for more effective topical formulations for the treatment and/or prevention of skin damage, wrinkles and/or other defects due to aging and environmental factors, where the formulations comprise conditioned medium enriched with vesicles, growth factors, and/or extracellular matrix compositions (par. 0008); matrix proteins useful for such purposes include collagen type III and fibronectin (par. 0191). Naughton discloses ECM produced in hypoxic conditions are rich in collagen type III and fibronectin (par. 0047), and only discloses nine oxygen concentration ranges for hypoxic conditions. Therefore, it would have been obvious to try these different concentrations, which, as evidenced by Naughton, is well within the purview of the skilled artisan. This rationale aligns with choosing from a finite number of identified, predictable solutions with a reasonable expectation of success; see MPEP 2143(I)(E).
Thus, the composition produced by the modified method of Al-Qahtani set forth above renders obvious:
the method of producing a composition for improvement of a tissue in a subject, the method comprising: culturing human fibroblast cells under hypoxic conditions on microcarrier beads or a three dimensional surface in a suitable cell culture medium, under 1-5% oxygen, thereby producing cells having embryo-like properties, wherein the cells having embryo-like properties produce and secrete into a growth medium a composition that promotes repair and regeneration of damaged tissue when administered to the region of tissue in need of repair in the subject; and collecting the cell culture medium; and adding an additive to the cell culture medium to produce the composition limitations recited in claim 19;
the further comprising adding at least one extract to the composition limitation recited in claim 20;
the further comprising adding at least one botanical extract to the composition limitation recited in claim 21;
the further comprising adding at least one peptide to the composition limitation recited in claim 22; and
the further comprising adding a seed extract to the composition limitation recited in claim 24.
Regarding claim 23: Following the above discussion, Al-Qahtani does not explicitly teach the culturing is performed for at least two weeks, as required for the instant claim. However, the length of time for culturing fibroblasts in hypoxic conditions to produce the conditioned medium would have been routinely optimized by one having ordinary skill in the art. Al-Qahtani clearly teaches the conditioned medium is provided in order to re-establish the natural environment of nascent skin by delivering critical structural proteins and relevant growth factors directly to the skin (par. 0098). This means the conditions necessary for the fibroblasts to secrete into the conditioned medium sufficient structural proteins and relevant growth factors were result effective variables. Result effective variables would be optimized by routine experimentation by one having ordinary skill in the art; see MPEP 2144.05(II)(A). Further, Naughton discloses fibroblasts were cultured under 1-5% oxygen for 2-4 weeks with a 50-70% media exchange every 2-3 days while cells proliferate and then began depositing ECM (par. 0162); thus, one having ordinary skill in the art would have more than a reasonable expectation of success in culturing the fibroblasts for two weeks in the modified method of Al-Qahtani, rendering obvious the limitation recited in the instant claim.
Regarding claims 25-26: It is set forth above Al-Qahtani teaches the conditioned medium may be formulated with a hydrogel; in an embodiment, modified alginate derived from seaweed is used to form the hydrogel (par. 0125); this reads on the further comprising adding a marine extract to the composition limitation recited in claim 25.
In an alternative embodiment, the hydrogel is formed with polysaccharides, such as bacterial polysaccharides (par. 0126); this reads on the further comprising adding a bacterial ferment to the composition limitation recited in claim 26.
Regarding claim 27: Following the above discussion, Al-Qahtani teaches an embodiment wherein the conditioned medium of the composition comprises cytokines (par. 0210); this reads on the further comprising cytokines limitation recited in claim 27.
Regarding claim 28: Following the above discussion, Al-Qahtani teaches an embodiment wherein conditioned medium from keratinocyte cultures rich in extracellular proteins is added to the conditioned medium from the fibroblast cultures (par. 0106); this reads on the further comprising adding at least one extracellular matrix protein limitation recited in claim 28.
Claims 1-9, 11-13, 15, 17-18, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Qahtani, et al. (US 2015/0023908) in view of Naughton, et al. (US 2010/0047305), further in view of Doucet, et al. (US 2014/0127286).
The teachings of Al-Qahtani and Naughton are set forth above; claims 1-7, 9, 11, 13, 15, 17-18, and 30 are anticipated by Al-Qahtani.
Doucet, et al. (hereinafter Doucet) teaches a cosmetic composition for increasing collagen synthesis in skin cells (Abstract).
Regarding claim 29: Following the above discussion, Al-Qahtani does not teach the composition as comprising dimer tripeptide 43 and/or trifluoroacetyl tripeptide-2, as required by the instant claim.
However, Doucet teaches Phaeodactylum tricornutum extract combined with Dimer Tripeptide-43 significantly enhances the effect of collagen-I synthesis surpassing the effect of collagen-I synthesis-enhancing substances on normal human fibroblasts (par. 0016); P. tricornutum is a marine algae (pars. 0009-0010). Doucet teaches the use of the P. tricornutum extract in a cosmetic composition at a concentration of 0.001-0.5% by weight; the concentration of the dimer tripeptide-43 in cosmetic compositions is disclosed as 0.00001-2.0% by weight (par. 0017). Thus, the P. tricornutum extract/dimer tripeptide-43 combination of Doucet reads on:
the wherein the at least one peptide is present within a range of about 0.0001 to about 0.001% by weight of the composition limitation recited in claim 8;
the wherein the at least one marine extract is present within a range of about 0.01 to about 0.1% by weight of the composition limitation recited in claim 12; and
the wherein the at least one peptide comprises dimer tripeptide-43 limitation recited in claim 29.
It would have been prima facie obvious to a person having ordinary skill in the art to have further modified the method of Al-Qahtani by including the P. tricornutum extract and dimer tripeptide-43, as taught by Doucet. This conclusion of obviousness is based on the ‘teaching, suggestion, or motivation rationale’. Al-Qahtani teaches the loss of collagen present in the dermal layers of the skin causes a breakdown of resiliency and skin thickness over time, leading to fine lines and wrinkles (par. 0003); thus, one would be motivated to include the P. tricornutum extract and dimer tripeptide-43 for the significantly enhanced collagen-I synthesis, as disclosed by Doucet (par. 0016). Further, as Doucet teaches the use of these two components in a cosmetic composition (par. 0017), the skilled artisan would have more than a reasonable expectation of success. This renders obvious the limitations recited in claims 8, 12, and 29.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA PRONZATI whose telephone number is (571)270-5725. The examiner can normally be reached Monday - Friday 9:00a - 5:00p ET.
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/GINA PRONZATI/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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