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 .
Specification
The disclosure is objected to because of the following informalities:
On page 25, letter “O”, “Nymphae alba” should read “Nymphaea alba”
Claim Objections
Claims 15 and 17 are objected to because of the following informalities:
In claim 15, “Nymphae alba” should read “Nymphaea alba”
In claim 17, “Nymphae alba” should read “Nymphaea alba”
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 1-15 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,102,707 in view of Kornhauser et al (Dermatology Research and Practice, (Year: 2012), vol. 2012, pp. 1-6). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to a skin care composition claimed in the conflicting references ‘707, for example, each recite a skin care composition comprising:
(a) a hydrolysate comprising an aqueous extract of Nymphaea alba flowers and thermally inactivated enzymes; wherein the hydrolysate comprises from about 20% to about 70% carbohydrate, by weight of the dry matter of the hydrolysate; (b) a vitamin B3 compound; and (c) a dermatologically acceptable carrier (claim 1 of ‘707),
the skin care composition of claim 1, wherein the vitamin B3 compound is niacinamide and is present at about 0.001% to about 10%, by weight of the composition (claim 2 of ‘707),
the skin care composition of claim 1, wherein the composition comprises about 0.0001% to about 10%, by weight of the composition, of the hydrolysate (claim 3 of ‘707),
the skin care composition of claim 1, wherein the hydrolysate comprises about 20% to about 60% mineral based on the weight of the dry matter of the hydrolysate (claim 4 of '707),
the skin care composition of claim 1, wherein the hydrolysate comprises less
than about 3% polyphenol based on the weight of the dry matter of the hydrolysate (claim 5 of '707),
the skin care composition of claim 1, wherein the composition further comprises at least one additional ingredient chosen from vitamins, minerals, sugar amines, sunscreen agents, oil control agents, flavonoid compounds, anti-oxidants, preservatives, protease inhibitors, tyrosinase inhibitors, anti-inflammatory agents, moisturizing agents, exfoliating agents, skin lightening agents, lubricants, anti-acne actives, chelating agents, anti-wrinkle actives, anti-atrophy actives, phytosterols, N-acyl amino acid compounds, antimicrobials, and antifungals, conditioning agents, emulsifiers, rheology modifiers, or mixtures thereof (claim 6 of ‘707),
the skin care composition of claim 6, wherein the additional ingredient is chosen from superabsorbent polymer thickening agent selected from sodium polyacrylate, starch grafted sodium polyacrylate, or mixtures thereof (claim 7 of ‘707),
the skin care composition of claim 1, wherein the hydrolysate comprises less than 15% peptide, based on the weight of dry matter of the hydrolysate (claim 8 of ‘707),
The skin care composition of claim 1, wherein the hydrolysate comprises less than 10% peptide, based on the weight of dry matter of the hydrolysate (claim 9 of ‘707),
the skin care composition of claim 1, wherein the hydrolysate and vitamin B3 compound are present at a volume/weight ratio of hydrolysate to vitamin B3 of 1:4 to 5:1 (claim 10 of ‘707),
the skin care composition of claim 1, wherein the hydrolysate and vitamin B3 compound are present at a volume/weight ratio of hydrolysate to vitamin B3 compound of 1:2 to 2:5:1 (claim 11 of ‘707),
the skin care composition of claim 1, wherein the vitamin B3 compound is niacinamide (claim 12 of ‘707),
the skin care composition of claim 1, wherein the vitamin B3 is present at about 0.0001% to about 10%, by weight of the composition (claim 13 of ‘707).
The claims of ‘707 do not include lactobionic acid, as stated within the claims of the present invention. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the skin care composition recited in claim 1 of ‘707 (dependent claims 2-13) to include a reasonable amount of lactobionic acid as taught by Kornhauser et al, in order to provide enhanced skin benefits within a skin care composition. In addition to the lactobionic acid as taught by Kornhauser et al, one would reasonably expect to include within a skin care composition, sufficient amounts of a hydrolysate and/or the water lily plant material from a Nymphaea alba flower (e.g. water lily) extract, along with a vitamin B3 compound (which can be niacinamide), percentage or amount of carbohydrate from the hydrolysate, glycerin (e.g. glycerol), and water (one of ordinary skill would be motivated to use water within a skin care composition in general). One would have reasonably expected to use the combinations, as described above, within the necessary compositions, as describe within patents ‘707 to create a general skin care composition for a subject.
Claims 1-15 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-9, 11-12, 16, 18-26 of U.S. Patent No. 11,786,451 in view of Kornhauser et al (Dermatology Research and Practice, (Year: 2012), vol. 2012, pp. 1-6).
The instant claims of ‘451 recite a method of synergistically inhibiting PAR2 activation, comprising:
a) identifying a target portion of skin on a person where treatment is desired; and b) applying a composition comprising: i) a hydrolysate comprising an aqueous extract of Nymphaea alba flowers and thermally inactivated enzymes; wherein the hydrolysate comprises from about 20% to about 70% carbohydrate, by weight of the dry matter of the hydrolysate; and ii) a vitamin B3 compound; wherein the composition targets a portion of skin during a treatment period, wherein the hydrolysate and vitamin B3 compound are present at a volume/weight ratio of hydrolysate to niacinamide of 1:4 to 5:1 (claim 1 of ‘451),
the method of claim 1, wherein the hydrolysate and vitamin B3 compound are present at a volume/weight ratio of hydrolysate to vitamin B3 of 1:2 to 2:5:1 (claim 3 of ‘451),
the method of claim 1, wherein the vitamin B3 compound is niacinamide (claim 4 of ‘451),
the method of claim 3, wherein the niacinamide is present at about 0.0001% to about 10% by weight of the composition (claim 5 of ‘451),
the method of claim 1, wherein the composition comprises about 0.00001% to about 10% hydrolysate, by weight, based on the weight of the composition (claim 7 of ‘451),
the method of claim 7, wherein the synergistic inhibition of PAR2 activation is at least 10% more than a calculated additive effective according to the PAR2 Inhibition Assay (claim 8 of ‘451),
a topical skin care composition, comprising: a) about 0.4%, by weight of the skin care composition, of a hydrolysate comprising an aqueous extract of Nymphaea alba flowers and thermally inactivated enzymes; wherein the hydrolysate comprises from about 20% to about 70% carbohydrate, by weight of the dry matter of the hydrolysate; and b) about 5%, by weight of the skin care composition, of a vitamin B₃ compound; c) a dermatologically acceptable carrier (claim 9 of ‘451),
the skin care composition of claim 9, wherein the vitamin B3 compound is niacinamide and is present at about 0.001% to about 10% by weight of the composition (claim 11 of ‘451),
the skin care composition of claim 9, wherein the composition comprises about 0.0001% to about 10% hydrolysate, by weight, based on the weight of the composition (claim 12 of ‘451),
the skin care composition of claim 9, wherein the
hydrolysate comprises about 20% to about 60% mineral based on the weight of the dry
matter (claim 16 of '451),
the skin care composition of claim 9, wherein the hydrolysate comprises less than about 3% polyphenol based on the weight of the dry matter of the hydrolysate (claim 18 of '451),
the skin care composition of claim 9, wherein the composition further comprises at least one additional ingredient chosen from vitamins, minerals, sugar amines, sunscreen agents, oil control agents, flavonoid compounds, anti-oxidants, preservatives, protease inhibitors, tyrosinase inhibitors, anti- inflammatory agents, moisturizing agents, exfoliating agents, skin lightening agents, lubricants, anti-acne actives, chelating agents, anti-wrinkle actives, anti-atrophy actives, phytosterols, N-acyl amino acid compounds, antimicrobials, and antifungals, conditioning agents, emulsifiers, rheology modifiers, or mixtures thereof (claim 19 of ‘451),
the skin care composition of claim 19, wherein the additional ingredient includes a superabsorbent polymer thickening agent chosen from sodium polyacrylate, starch grafted sodium polyacrylate, or mixtures thereof (claim 20 of ‘451),
the method of claim 1, wherein the hydrolysate comprises less than 15% peptide, based on the weight of dry matter of the hydrolysate (claim 21 of ‘451),
the method of claim 1, wherein the hydrolysate comprises less than 10% peptide, based on the weight of dry matter of the hydrolysate (claim 22 of ‘451),
the skin care composition of claim 9, wherein the hydrolysate comprises less than 15% peptide, based on the weight of dry matter of the hydrolysate (claim 23 of ‘451),
a topical skin care composition, comprising: a) about 0.4%, by weight of the skin care composition, of a hydrolysate comprising an aqueous extract of Nymphaea alba flowers and thermally inactivated enzymes; wherein the hydrolysate comprises from about 20% to about 70% carbohydrate, by weight of the dry matter of the hydrolysate; and b) about 5%, by weight of the skin care composition, of a niacinamide; c) about 5%, by weight of the skin care composition, glycerin; and d) water (claim 24 of ‘451),
the topical skin care composition of claim 24, wherein the composition further comprises: a) about 2%, by weight of the composition, dimethicone/ dimethiconol b) about 0.5%, by weight of the composition, dexpanthenol; and c) tocopherol acetate (claim 25 of ‘451),
the topical skin care composition of claim 25, wherein the composition further comprises: about 0.05%, by weight of the composition, disodium EDTA; and about 0.1%, by weight of the composition, PEG-100 Stearate (claim 26 of ‘451).
The claims do not include lactobionic acid, as stated within the claims of the present invention. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the skin care composition recited in claims 1, 9 and 24 of ‘451 (dependent claims 3-5, 7, 11-12, 16, 18-23, 25-26) to include a reasonable amount of lactobionic acid as taught by Kornhauser et al, in order to provide enhanced skin benefits within a skin care composition. In addition to the lactobionic acid as taught by Kornhauser et al, one would reasonably expect to include within a skin care composition, sufficient amounts of a hydrolysate and/or the water lily plant material from a Nymphaea alba flower (e.g. water lily) extract, along with a vitamin B3 compound (which can be niacinamide), percentage or amount of carbohydrate from the hydrolysate, glycerin (e.g. glycerol), and water (one of ordinary skill would be motivated to use water within a skin care composition in general). One would have reasonably expected to use the combinations, as described above, within the necessary compositions or ratios, as described within patent ‘451 to create a general skin care composition for a subject that would have the desired efficacy based on the products used within the composition.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-15 and 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising a Nymphae alba flower (e.g. N. alba or water lily) extract, lactobionic acid and a dermatologically acceptable carrier (e.g. glycerol) of claims 1, 10, 15 and 17 encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite an extract from Nymphae alba is a naturally occurring plant and lactobionic acid which is a naturally occurring compound. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, the closest naturally occurring counterpart for lactobionic acid is the compound itself. In regards to the water lily extract, extraction of plants only concentrates and portions the naturally occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the plant. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the plant and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the plant. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant material; i.e., the compound is not inventive or “man-made.” Thus, the extract in turn is a mixture of the naturally occurring compounds found in the particular plant. The extract from the individual plant leads to a combination of the naturally occurring compounds from the plant. Thus, the claim is drawn to a mixture of naturally occurring products.
There is no indication that the specified extract with lactobionic acid as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract and the lactobionic acid in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the plant extract contains only a mixture of the naturally occurring compounds found in the plant. The extract composition appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to an extract, lactobionic acid, and a dermatologically acceptable carrier (e.g. glycerol). MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment of the skin’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the presence of a lactobionic acid and a dermatologically acceptable carrier (e.g. glycerol). However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific components within the extract of N. alba as taught by Hakozaki (U.S. Pub. No. US 2020/0405621 A1), such as lactobionic acid as taught by Kornhauser et al (Dermatology Research and Practice, (Year: 2012), vol. 2012, pp. 1-6) and a dermatologically acceptable carrier, like glycerol as taught by Hakozaki (U.S. Pub. No. US 2020/0405621 A1) does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
Moreover, applicant’s intended use of treating the skin using the extract of N. alba along with lactobionic acid and a dermatologically acceptable carrier, like glycerol is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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.
Claim(s) 1-15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hakozaki (U.S. Pub. No. US 2020/0405621 A1) in view of Paufique (U.S. Pub. No. 2020/0405622 A1), Fang (U.S. Pub. No. US 2020/0405614 A1), Merz Pharma (AT 501699 A1 – English translation provided), Luo (CN 110638732 A – English translation provided), and Kornhauser et al (Dermatology Research and Practice, (Year: 2012), vol. 2012, pp. 1-6).
Hakozaki teaches that the composition comprises about 0.00001% to about 10% water lily extract, by weight, based on the weight of the composition (claim 3), teaches the water lily extract is obtained from a flower of Nymphaea alba (claim 4), teaches the water lily extract comprises a hydrolysate (claim 2), Hakozaki teaches that the [dermatologically acceptable carrier can be] glycerol (paragraph 0044), teaches the dermatologically acceptable carrier can be silicone oils (paragraph 0042), teaches topical skin care compositions comprising water lily extract [such as] disodium EDTA, benzyl alcohol, phenoxyethanol (column 6, paragraph 0067 and table 2), teaches select ingredients [such as] niacinamide (paragraph 0054), and teaches Nymphaea alba extract comprises less than about 20% protein, based on the weight of the dry matter (claim 15).
Hakozaki does not teach from about 0.05% to about 0.5% lactobionic acid and does not teach that the composition inhibits %yellowness by greater than 50% and inhibits %glycation by greater than or equal to 35% according to the Advanced Glycation End Product Assay.
Paufique teaches at least one hydrolysate of Nymphaea alba flowers (abstract), teaches the cosmetic active ingredient according to claim 1, characterized in that the hydrolysate comprises at least 23% of carbohydrates by weight of dry matter of the hydrolysate (claim 3), teach the cosmetic active ingredient according to claim 1, characterized in that the hydrolysate comprises at least 30% of minerals by weight of dry matter of the hydrolysate (claim 4), teaches [that] the cosmetic active ingredient according to claim 1, characterized in that the hydrolysate comprises less than 0.2% of polyphenols by weight of dry matter of the hydrolysate (claim 12), and teaches [the] use of an extract of Nymphaea alba flowers for improving skin (abstract).
Fang teaches vitamin B3 compound is niacinamide and is present at about 0.001% to about 10% by weight of the composition (claim 11).
Merz Pharma teaches ingredients that can be present within a composition such as xanthan gum (page 29, example 7).
Luo teaches a composition containing lauroyl lysine (page 3).
Kornhauser et al teaches that PHAs (polyhydroxy acids) constitute a new generation of HAs with multiple skin benefits, making them very popular in cosmetic/skin care products…[one of them is] lactobionic acid (page 2, figure 1), Kornhauser also teaches that the authors confirmed that lactobionic acid resulted in improved skin benefits (page 3).
Regarding claims 1, 10, 15, 17 and 19, one skilled in the art would reasonably expect that the dermatologically acceptable carrier and the addition to the skin care composition (as stated in claim 19 of the present invention) can be glycerol as taught by Hakozaki.
Regarding claims 1-4, 10, 15 and 17, one skilled in the art would reasonably expect that the range of the flower material of N. alba or the hydrolysate, as taught by Hakozaki would encompass all of the ranges stated within these claims of the present invention.
Regarding claims 5-8, one skilled in the art would find it obvious that the carbohydrates, minerals, and polyphenols as taught by Paufique and proteins as taught by Hakozaki would encompass all of the ranges stated within the claims of the present invention.
Regarding claims 9, 14 and 18, one skilled in the art would reasonably expect that niacinamide can be one of the vitamin B3 compounds (vitamin B3 was mentioned in claims 9 and 14), thereby using the Fang reference that teaches niacinamide (which is one of the vitamin B3 compounds) can be present within the necessary ranges as stated within the present invention.
The composition as taught by Hakozaki can be modified to include the teachings of Paufique, Fang, Merz Pharma, Luo, and Kornhauser et al that would be used to treat the skin or as a skin care composition. These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients within a skin care composition.
In addition, the references do not explicitly teach the percentage or amount of the inhibit[ion] of %yellowness by greater than 53% and %glycation by greater than or equal to 35% as stated within claims 1, 10 and 20. Moreover, the reference (Kornhauser et al) does not explicitly teach the lactobionic acid ranges as claimed within claims 1, 10-13, 15 and 17 of the present invention. However, as discussed in MPEP section 2144.05(II)(A), “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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention. In addition, one of ordinary skill in the art would reasonably expect for a composition to contain a sufficient amount of a dermatologically acceptable carrier, like glycerol as taught by Hakozaki necessary to be within specification of the Advanced Glycation End Product Assay as stated within claims 1, 10 and 20 of the present invention. One would have also been motivated to include a sufficient amount of lactobionic acid as taught by Kornhauser et al, and also stated within claims 1, 10-13, 15 and 17 of the present invention because Kornhauser et al teaches that the addition of lactobionic acid provides enhanced skin care benefits in order to achieve an overall optimum skin care composition, using the composition as taught by Hakozaki.
Conclusion
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655