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 .
Applicant’s amendment and response filed April 28, 2026 has been received and entered.
Claim(s) 1-15 and 18-20 are currently pending.
Withdrawn Objections
Applicant’s argument filed April 28, 2026 have been fully considered. In regards to the objection of the claims for a typographical error, applicant has elected to cancel claim 17 and amend claim 15 to include the corrected term and therefore, the objection of claim 15 has been withdrawn.
In regards to the objection of the specification for a typographical error, applicant has elected to amend the specification to include the corrected term and therefore, the objection of the specification has been withdrawn.
Withdrawn Rejections
Applicant’s arguments filed April 28, 2026 have been fully considered. In regards to the 35 U.S.C. 101 rejection for natural products, applicant has elected to amend claim(s) 1, 10 and 15 and based on the claim amendment for claim 15, the rejection under 35 U.S.C. 101 for claim 15 has been withdrawn.
Claim Rejections - 35 USC § 112
Claim(s) 1-14 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The amended claims of the present invention state that the claimed skin care composition exhibits synergism. More specifically, within page 10 of applicant arguments, applicant alleges that the claimed skin care composition exhibits “an unexpected synergistic effect”. It is noted that applicants’ specification discusses the advanced glycation end product assay (AGE Assay) and how AGE’s are measured when testing a material of interest, such as lactobionic acid and/or white water lily extract (pg. 13 of the specification). It is noted that applicants specification discusses six samples; three under “%∆b* (yellowness) from a treatment vs positive glycation control” and three from “convert to %∆b* inhibition (100%-%∆b*)” along with a “mean %∆b* inhibition for each group” for tables 1, 3 and 5. In addition, applicant’s specification also discusses six samples, three under “%∆FLR (glycation) normalized vs positive glycation control” and three samples under “convert to %∆FLR inhibition (100-%∆FLR)” along with a “mean %∆FLR inhibition for each group” for tables 2, 4 and 6. Within each of the tables, it lists the percentage of white water lily extract by itself and with varying percentages of LBA, and there is also varying percentages of LBA by itself, also, there is a calculated theoretical percentage section that is the sum of the percentage of the white water lily extract that is combined with varying percentages of LBA. Furthermore, there is an observed numerical result for the two combined ingredients (e.g. the percentage of LBA with the percentage of the white water lily extract) which translates to the “synergistic” result number (in bold to the furthest right of the table) that the applicant of the present invention is claiming. Given the information presented within the specification of the present invention, the applicant is stating that through the application of a percentage of LBA and a percentage of water lily extract to a gelatin sample, a glycating reagent is added to the material in order to produce AGE’s and thus, a spectrophotometer can determine the fluorescence intensity (“FLR”) or yellowness (b*) associated with the resulting AGE’s which then correlates to the amount of glycation that would occur within collagen (because gelatin can effectively mimic collagen – in which, collagen is present within humans) (pg. 13 of the specification).
However, beginning with table 1, table 1 does not have all of the values filled in for samples 1-3 in terms of the “calculated theoretical 0.1% LBA + 0.4% v/v white water lily extract” and “calculated theoretical 0.2% LBA + 0.4% v/v white water lily extract” under the column “%∆b* (yellowness) from a treatment vs positive glycation control”. The absence of information is critical because the values missing could have contributed to the number obtained within the “mean %∆b* inhibition for each group” column. This is a reoccurring phenomenon across tables 1-6; the only difference is that for the even-numbered tables (e.g. tables 2, 4 and 6), under the column “%∆FLR (glycation) normalized vs positive glycation control”, the row for the calculated theoretical values has information missing there as well. The information that could have been retrieved from the areas that are incomplete would have contributed to the mean column to the furthest right of each of the tables listed (tables 1-6) which would allow the applicant of the present invention to achieve a substantially different calculated mean value in which, the calculated mean value may or may not have been substantially different from the results from what was actually observed (within the section that contains the percentage of LBA combined with a percentage of white water lily extract that contains the bolded number to the far right of the table). Based on the specification and data supporting tables 1-6, within the mean column of each of the tables, the bolded number is the observed average of %yellowness inhibition or the measured %glycation inhibition that represents the synergistic result. Lastly, a scientist in general understands that when an experiment is occurring, there are one of three things that can happen: the experiment can go as expected, the experiment does not go as expected or the experiment must be modified throughout due to unforeseeable events. Generally, it is expected that calculated theoretical values are in other words, predictions or estimates. It is known in the art to have a prediction or estimate in which, the results may differ significantly or not. In this situation, applicant makes it clear that the skin care composition of the present invention exhibits synergy as a result of comparing a calculated mean theoretical value to real time (or observed) mean value. Thus, the data presented in the specification is not considered to support the claim limitation that the results are synergistic. Given that synergism is unpredictable, in order to determine if the claimed composition is actually synergistic, the artisan would be forced to create a large list of varying solvents used to extract white water lily and measure the results from each type of solvent used (e.g. water, ethanol, methanol), also create a varying list of the percentages of LBA used and then combine each type of extract with the varying percentages of LBA in order to record more calculated results and compare those calculated results to what was obtained in real time. All of the values of what was calculated and what was obtained in real time should be analyzed separately and compared to the mean values within their respected section and the mean value from the two sections should be compared to each other in order to see how much of the calculated mean and analyzed mean values differ from one another. In other words, if the mean number of the calculated values and the mean number of the analyzed values are compared to one another and are substantially different (e.g. a calculated mean value of 25 and a observed mean value of 50 at the very least), then that would be more so considered a convincible way to prove synergism because the applicant is taking into account different solvents used for extracts with also understanding that depending on the solvent, that will dictate what components may be present within an extract that would greatly alter the measured %yellowness inhibition or the measured %glycation inhibition. Applicant’s specification does not necessarily prove synergism but more so provides an estimated value and compares that to unexpected values, in which, it is expected to have values differ from an estimate especially in an experimentation setting. In addition, when the calculated mean values are compared to the observed mean values to the far right of the column of each of the tables, the difference between the two mean values are not substantial (e.g. are not at least a 25% or a quarter of a difference). Thus, based on the analysis conducted stated within the 112(a) enablement rejection combined with information from the specification of the present invention and from the amended claims of the present invention, proof of synergism will greatly exceed beyond applicant’s current data. This is clearly a burden of undue experimentation. Thus, the claims are not considered to be enabled for the synergistic skin care composition claims of the present invention.
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 Ormum, 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.
Claim(s) 1-15 and 18-20 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 18-20 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) 1-14 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 and 10 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 Nymphaea 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-15 and 18-20 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, does not teach from about 0.1% to about 0.2% lactobionic acid, does not teach 0.101% 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 (as stated across claim(s) 1, 10 and 15 of the amended claims of the present invention).
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 claim(s) 1, 10, 15 and 19, one skilled in the art would reasonably expect that the dermatologically acceptable carrier and the addition to the skin care composition (also stated in claim 19 of the present invention) can be glycerol as taught by Hakozaki.
Regarding claim(s) 1-4, 10 and 15, 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 claim(s) 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 claim(s) 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 and 15 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 claim(s) 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 claim(s) 1, 10-13 and 15 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.
Response to Arguments
Applicant’s arguments filed April 28, 2026 have been fully considered, and the arguments regarding the rejection under 35 U.S.C. 101 for natural products, the non-statutory double-patenting rejection and the rejection under 35 U.S.C. 103 are found to be non-persuasive.
Regarding applicant remarks for the 35 U.S.C. 101 rejection for natural products, applicant alleges beginning on page 6 of applicant’s arguments that the claimed compositions are not directed to a product of nature because the combination as a whole is not naturally occurring and possess markedly different characteristics (Step 2A, Prong 1). Generally speaking, in terms an extraction, an extraction from a water lily does not make a difference in the sense that an extraction only concentrates particular components of a plant and therefore the component is still considered to be natural. In addition, applicant is correct that lactobionic acid (LBA) is not a natural constituent of the Nymphaea alba plant nor was the rejection under 35 U.S.C. 101 geared towards applicant interpreting the language as such. Although LBA is produced through the oxidation of lactose, that does not make the component synthetic – LBA is still a natural phenomenon, it is not man made, however, the process for obtaining both the extract of N. alba and of LBA has to have some type of human intervention to achieve its state but both products are still considered natural components. Although the applicant has explained that the combination of the two products exhibit synergism, that does not take away from the fact that the products are still naturally occurring, rather, it is expected that the combination of specific materials from nature may exhibit a particular effect that one would not expect which is why experimentation is necessary, thus, the claimed composition is directed to a product of nature because the combination as a whole are naturally occurring and does not possess markedly different characteristics under Step 2A, Prong 1. Moving onto the bottom of page 7, applicant alleges that the claims integrate the components into a practical application, however, examiner argues that an intended use of a skin care composition does not structurally limit the claimed composition. Therefore, the intended use unfortunately cannot be given patentable weight regardless of the fact that the composition provides “effective anti-glycation and anti-yellowness benefits without the skin irritation associated with high concentrations of acids” (as stated on pages 7 and 8 of applicant arguments). Applicant must understand that a “skin care composition” is naturally meant to be applied to the skin and is intended to improve the skin using components at particular concentrations (high or low) such as N. alba and LBA that are both already known in the art prior to the non-final office action dated February 06, 2026 to be beneficial for the skin. Regardless of the concentration of both components, that will not change the fate of the intended use that is apparent within applicant’s arguments. Therefore, the claims do not integrate the components into a practical application under Step 2A, Prong 2. Regarding applicant’s arguments beginning on page 8, applicant alleges that independent claim(s) 1 and 10 “inventive concept is the specific combination of a low level of lactobionic acid with a specific level of Nymphaea alba extract to achieve a synergistic result. As disclosed in the specification, this discovery was surprising. This specific, functional combination is not a “well-understood, routine, conventional” activity”. It is known in the art that a skin care composition (also known as a cosmetic composition), would have low concentrations of materials within its products which are required in order to create a succinct composition for use. In this case, given that the components being used (e.g. N. alba and LBA) are already very widely known in the art to be used in these types of compositions, altering the amount or percentage within the composition is not inventive if it is already known to use low concentrations in cosmetic products when introducing specific ingredients and/or compounds. Therefore, independent claim(s) 1 and 10 do not recite an inventive concept that’s amounts to “significantly more” under Step 2B. For amended independent claim 15, applicant has overcome the 101 rejection due to the incorporation of a component – silicone oil into the composition; silicone oil is a man-made compound that would structurally alter the skin care composition therefore contributing to the inventive concept of a specific, man-made formulation under Step 2B. Moving further to page 9 of applicant arguments, the addition of a vitamin B3 compound from claim 9 does not provide a further limitation because vitamin B3 is a naturally occurring compound and it is not man-made, however, the addition of the vitamin B3 compound will contribute to the overall function of the composition in the sense that now with the addition of vitamin B3, there are more natural components within a natural composition. For claim 19, claim 19 includes a mix of natural and non-natural components; for example, disodium EDTA is a synthetic or man-made material and thus, when it is incorporated into the composition, it does overcome the 101 rejections. Based on the applicant’s amended claims, claim 15 is an independent claim where 18 depends from claim 15, furthermore, claim 19 depends from claim 18 and claim 20 depends from claim 19 in which, the entire combination is sufficient enough to be considered as an inventive concept solely off of the basis of the independent claim 15 having the addition of silicone oils and then dependent claim 19 further including even more man-made components; thus, the composition from claim 15 that includes claim(s) 18-20 would structurally alter the skin care composition and exhibiting specific effects based on the combination alone and therefore contributing to the inventive concept of a specific type of formulation under Step 2B. Restated, independent claim 15 along with the combination of the dependent claim(s) are sufficient to overcome the 35 U.S.C. 101 rejection in regards to natural products whereas independent claim(s) 1 and 10 along with their dependent claims do not overcome the 35 U.S.C. 101 rejection in regards to natural products.
In regards to the 103 rejection, moving forward to the bottom of page 9 and going into page 10 of applicant arguments, applicant states “the examiner’s rejection is based on impermissible hindsight and lacks a proper motivation to combine… the rejection pieces together six disparate documents to reconstruct the claimed composition. Such an approach is permissible only if the prior art contained a teaching, suggestion, or motivation to combine the specific elements in the claimed manner. Here, no such motivation exists”. Beginning with Hakozaki, Hakozaki may teach a composition that functions to reduce bilirubin levels, however, that does not mean that the composition that contains the water lily extract (obtained from N. alba) doesn’t or would not exert any other effects; the Hakozaki reference just teaches that the composition has effects on bilirubin levels as a result of the applicant of that specific invention focusing on that specific area. In addition, Hakozaki teaches various components stated within the claims of the present invention (e.g. disodium EDTA, benzyl alcohol, phenoxyethanol and glycerol) that can also be included within the composition. Next, Kornhauser et al teaches the benefit of having PHA’s like lactobionic acid (LBA) within a cosmetic composition. Given that Hakozaki’s composition is unlimiting as to what can be included within the composition, one of ordinary skill in the art would have been motivated to include a skin enhancer agent (e.g. LBA) within Hakozaki’s composition which would replicate the composition of the present invention given that, one would have been motivated to optimize the concentrations of LBA and the water lily extract. Paufique teaches various components of what can be included within the composition, including that of the components of the hydrolysate of N. alba, such as carbohydrates, minerals and polyphenols and also the extract of N. alba. Fang teaches a composition comprising N. alba and vitamin B3, with vitamin B3 present within a certain amount. Merz Pharma teaches an example of a cosmetic composition that can comprise xanthan gum. Lastly, Luo teaches a composition that can comprise lauroyl lysine. Given that each of the reference’s compositions are open-ended (e.g. using the term “comprising”) and seeing as though the claims of the present invention are also open-ended, the applicant is incorrect in stating that there is no motivation to combine the references. Given that each of the references clearly depict that the ingredients that are to be used can be used within an open-ended composition speaks volumes to the impact in terms of obviousness. Also, the claims of the present invention are directed for use on the skin, therefore, one of ordinary skill in the art could teach the motivation to combine all of the six aforementioned references in order to achieve the skin care composition of the present invention. The sole purpose of the 35 U.S.C. 103 obviousness rejection in this situation is to vividly depict that each and every single component that has been recited in the claims of the present invention have been shown within the aforementioned references to be used in cosmetics or skin care compositions prior to the filing date of this invention. In addition, even if a reference taught using the composition that contains N. alba, for example to target a different area of biological function of the skin, that does not mean that the composition would have that sole function, depending on what is placed within the composition, that will dictate the overall skin care composition function when applied to the skin. Thus, the combination of all of the aforementioned references is legitimate and one of ordinary skill in the art would have reasonably expected to make those combinations using the aforementioned references. Furthermore, applicant states at the bottom of page 10 of applicant arguments that “the claimed composition exhibits unexpected and synergistic results that rebut the finding of obviousness”. For the reasons set forth above within the 112(a) enablement rejection above explains why the data provided does not enable one to perform what is needed in order to achieve the claims of the present invention in order to view the skin care composition as exhibiting “synergistic” results. Thus, the rejection is not based on impermissible hindsight and does not overlook the evidence of synergistic results that are presented within the specification of the present invention (as stated at the bottom of page 11 of applicant arguments).
Lastly, on page 12 of applicant’s arguments in regards to the non-statutory double-patenting rejection, applicant believes that “this conclusion relies on hindsight and ignores the unexpected synergy that results from this specific combination”. As stated above within Kornhauser et al, it is widely popular to include a PHA like LBA within cosmetics because it assists skin function, thus, given that ‘707 and ‘451 patents already discuss the use of a N. alba hydrolysate that comprises an extract of N. alba, the only difference in this case, is the lack of LBA. Thus, one of ordinary skill in the art would be motivated to include LBA as a result of LBA being used in cosmetic compositions or skin care compositions prior to the filing date of this present invention. In addition, one of ordinary skill in the art would have been motivated to optimize the amounts of the hydrolysate that comprises an extract of N. alba along with optimizing LBA in order to create a skin case composition that would too exhibit the same effects when applied to the skin, much like the claims of the present invention. Needless to say, depending on the amounts of the extract of N. alba along with LBA, the skin care composition will exhibit certain results that may exceed what is expected due to the fact of there being more or less of a particular component when measuring two or more components together. Thus, the non-statutory double patenting rejection, natural products rejection under 35 U.S.C 101 and the obviousness rejection under 35 U.S.C. 103 are maintained.
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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