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 claims priority as follows:
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Claims 1-9 are currently pending and are the subject of this Office Action.
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.
1. Claims 1-9 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.
In claims 1-9, the phrase “a niacinamide derivative having a free binding energy with HCA of -10 Kcal/mol or more” does not provide a standard for ascertaining the particular combination of hydroxycinnamic acid structure and niacinamide derivative permitted in the claimed composition. The claims do not contain any parameters describing how the free binding energies are obtained. In the disclosure, the “free binding energy” is obtained by computations using DFT. However, the artisan can use different methods to do this. Even within DFT, the artisan can use different functionals and basis sets, which will result in completely different estimates for binding, such that the artisan could produce binding free energies arbitrarily different from those specified in the claims. In addition, factors such as the temperature and the selected orientation of the molecules within the complex (binding pose/binding site) for calculation are not identified. Different temperatures and orientations will also result in different binding energies for the same molecules in a complex.
For any combination of hydroxycinnamic acids and niacinamide derivatives, a chemist artisan would be able to select a computational method with parameters that will provide binding energies of -10 Kcal/mol or more, -7.5 Kcal/mol or more and -5 Kcal/mol or more. Thus, it is unclear how one of ordinary skill could reasonably determine the scope of the specific niacinamide derivatives having free binding energy of -10 Kcal/mol or more, -7.5 Kcal/mol or more and -5 Kcal/mol or more, truly encompassed by the claims. The objective boundaries of the scope of the claims based on the aforementioned terms cannot be ascertained.
Claims 5 and 6 recite that the niacinamide derivative is chosen from methyl niacinamide and salt of methyl niacinamide and others. However, methyl niacinamide
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only exists in salt form; it is an N-methyl pyridinium derivative which cannot exist without a counterion in normal conditions. Thus, it is unclear what is meant by “chosen from methyl niacinamide and salt of methyl niacinamide”. It is also unclear how can any of the niacinamide derivatives in claim 5 and 6 have a pyridine portion in which a nitrogen is protonated.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 5 and 6 recite that the niacinamide derivative is chosen from various 1-substituted niacinamides/nicotinamides. These are substituted at the pyridyl nitrogen, making a pyridinium, in which the nitrogen atom has a formal oxidation state of +1. Claims 5 and 6 depend of claim 4, and claim 4 recites that the niacinamide derivative has a pyridine portion in which a nitrogen is protonated in the composition. Claims 5 and 6 fail to include all the limitations of claim 4 because the niacinamide derivatives recited in claims 5 and 6 cannot have a pyridine portion in which the nitrogen is protonated. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a lack of written description rejection.
The instant claims are drawn to a low-pH aqueous skin care composition comprising a hydroxycinnamic acid (HCA) and a niacinamide derivative having a free binding energy with HCA of -10 Kcal/mol or more (-7.5 Kcal/mol or more and -5 Kcal/mol or more for claims 2 and 3, respectively). Thus, the hydroxycinnamic acid compound (HCA) and the niacinamide derivative must be selected from some that, when the energy of their combinations is computed, show a free binding energy of the complex of -10 Kcal/mol or more (-7.5 Kcal/mol or more and -5 Kcal/mol or more for claims 2 and 3, respectively).
In addition, claim 4 requires that the niacinamide derivative has a pyridine portion in which the nitrogen is protonated.
The specification describes that the particular method for the calculation of binding free energy used in this application was the DFT method with the B3LYP functional and 6-311++G(d,p) basis set. The orientation of the molecules within the complex for which the free binding energy was calculated was not provided; the temperature was not provided. The specification only details three specific complexes that provide support for the claims, with molecules indicated in the table at paragraph [0045]:
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,
where the hydroxycinnamic acid compound (HCA) is p-coumaric acid
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and the niacinamide derivative computed to have the free binding energy with p-coumaric acid of -10Kcal/mol or less as claimed is always a niacinamide/nicotinamide substituted only at the nitrogen of the pyridine portion with a methyl group, as in methyl niacinamide
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, or a O-phosphono-beta-D-ribofuranosyl, as in nicotinamide mononucleotide
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and nicotinamide adenine dinucleotide
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.
There is no teaching or guidance in the specification that would allow one to extrapolate the calculated results to additional complexes. One or ordinary skill in the art is not able to find out from the specification what other niacinamide derivatives-HCA complexes are encompassed by the claims.
Applicant is reminded of the written description guidelines set out by the USPTO in MPEP 2163:
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To satisfy the written description requirement, a specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319 (Fed. Cir. 2003). Where, as here, the claims cover a broad genus, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are “representative of the full variety or scope of the genus,” or by the establishment of “a reasonable structure-function correlation.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not 36 supported by a disclosure that “only describe[d] one type of structurally similar antibodies” that “are not representative of the full variety or scope of the genus.”).
The generic description is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention at the time of filing. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described. MPEP 2163 describes what a “representative number of species” is:
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The instant disclosure does not reflect the structural diversity of the claimed genus. The three species of complexes described and calculated for in the specification do not represent the entire genus such that it is a representative sample of the genus. Note that the HCA is only p-coumaric acid, and the “niacinamide derivative” species only describe an extremely small portion of the claimed genus because they are so close together in structure. In addition, no species has been described to support the subject matter of claim 4. There is no guidance in the application for selecting a niacinamide derivative with the characteristics claimed in claim 4. The artisan would not know what niacinamide derivative applicant is using in this invention in which the nitrogen in the pyridine portion is protonated. As can be seen, support for the entirety of the claimed genus cannot be extrapolated from the numbers calculated and the three complexes in the disclosure.
Accordingly, it is deemed that the specification does not describe in sufficient detail the genus in the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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.
4. Claims 1-4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sanzgiri et al. (US 2005/0100517, May 12, 2005), further in view of Pan et al. (US 2018/0116936, May 3, 2018) for claim 8.
This rejection is applied with the interpretation that the “niacinamide derivative” of the instant claims encompasses any of a niacinamide salt, nicotinic acid ester, nicotinyl amino acid, nicotinyl alcohol ester of carboxylic acid, nicotinic acid N-oxide and niacinamide N-oxide.
Sanzgiri teaches a cosmetic composition comprising vitamin B6, vitamin B3 or a derivative thereof, and an organic acid that acts synergistically to enhance skin lightening (Abstract). According to a preferred embodiment the composition comprises: 0.05-10 wt. % vitamin B6; 0.05-10 wt.% vitamin B3 or a derivative thereof; and 0.05-20 wt.% of at least one organic acid selected from the group consisting of C1-C16 monocarboxylic acids, dicarboxylic acids, polycarboxylic acids, phenolic acids, and esters/salts or other derivatives thereof; and/or a cosmetically acceptable vehicle and/or 10-85% detergent active, wherein the pH of the composition is most preferred to be between 3.5 and 6 (satisfies pH of claim 1) (¶ [0019]-[0025]). Suitable vehicles/solvents include water. An essential ingredient of the composition is niacinamide/nicotinamide and vitamin B3 derivatives, such as nicotinic acid esters (satisfies claim 4), nicotinyl amino acids, nicotinyl alcohol esters or carboxylic acids (satisfies claim 4), nicotinic acid N-oxide and niacinamide N-oxide (¶ [0030] and claim 10). Particularly preferred phenolic acids include ferulic acid (satisfies claims 1-4, 7 and 9) (¶ [0038] and claim 19). In Example 2, the inventive compositions contained 1 wt.% vitamin B3 (niacinamide), 1 wt.% ferulic acid, co-solvents and water (¶ [0085-0089]).
Pan discloses compositions containing phenolic compounds having synergistic antioxidant benefits (Title). Suitable phenolic compounds include ferulic acid and p-coumaric acid (¶ [0036]). The composition may be topically applied to the skin (¶ [0069]).
Ascertainment of the Difference Between the Prior Art and the Claims
(MPEP §2141.012)
The teachings of Sanzgiri differ from the instant claims in that compositions with niacinamide derivatives/vitamin B3 derivatives were not exemplified, and the pH of Sanzgiri’s compositions is between 3.5 and 6 compared to about 3.5 to less than 5.0 of the instant claims.
For claim 8, Sanzgiri additionally differs in not disclosing coumaric acid as the phenolic acid in the composition. Sanzgiri taught ferulic acid.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR prongs (A) or (G), it would have been prima facie obvious to the ordinary skilled artisan to determine the composition’s workable pH ranges within the preferred pH range of the prior art. Pursuant to MPEP 2144.05 (I): “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” The pH recited in the instant claims (3.5 to 5) lies inside the preferred narrow range (3.5 to 6) disclosed by Sanzgiri. Accordingly, it would have been prima facie obvious to select the claimed pH range from withing the working pH range of the prior art. “[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 ordinary skilled artisan would have been motivated to make the compositions of Sanzgiri with the vitamin B3 derivatives selected from those disclosed in claim 10 of Sanzgiri because a synergistic skin lightening composition was expected:
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Regarding claim 8, Pan discloses compositions containing phenolic compounds having synergistic antioxidant benefits (title). The composition may be topically applied to the skin (9 [0069]). Examples of phenolic compounds include ferulic acid, hydroxytyrosol, cinnamic acid, caffeic acid, and p-coumaric acid (0036]). The ordinary skilled artisan would have known that ferulic acid and p-coumaric acid are of similar structure, have similar properties, and are used for similar benefits in the same compositions. Thus, it would have been prima facies obvious to incorporate p-coumaric acid into the skin care composition of Sanzgiri. Moreover, it would have been obvious to one of ordinary skill in the art to have incorporated p-coumaric acid into the composition of Sanzgiri since it is a known and effective phenolic acid providing synergistic antioxidant benefits as taught by Pan.
Alternatively, it would have been obvious to one of ordinary skill in the art to have selected p-coumaric acid and ferulic acid as the at least one organic acid in the composition of Sanzgiri, since "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
With respect to the recitation in claims 1, 2 and 3, that a niacinamide derivate has a free binding energy with HCA of -10 Kcal/mol or more, of -7.5 Kcal/mol or more, and of -5 Kcal/mol or more, respectively, as explained in the indefinite rejection above, for any combination of hydroxycinnamic acids and niacinamide derivatives, a chemist artisan will be able to select a computational method and parameters that will provide binding energies of -10 Kcal/mol or more, -7.5 Kcal/mol or more and -5 Kcal/mol or more. In addition, the 1(N)-substituted compounds of the prior art have less free nitrogen atoms available to interact with ferulic acid or coumaric acid. Less interactions are expected to yield higher binding free energy. Additionally, since the pH of the prior art’s composition is 3.5 to 5 as claimed, which is acidic, niacinamide (or a free nitrogen) would be protonated to form the pyridinium salt, and pyridinium salts appear to have a higher binding free energy than the free-nitrogen pyridine, per the specification.
Regarding instant claim 9, wherein the composition is free of HCA crystals, first, the prior art did not observe crystallization. Second, the specification disclosed that the specific niacinamide derivatives having the claimed free binding energy reduces or does not form co-crystals. Thus, the artisan would have reasonably expected no HCA crystals in the obvious compositions.
5. Claim(s) 1-3 and 5-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sanzgiri et al. (US 2005/0100517, May 12, 2005), as applied to claims 1-3 and 7 and 9 above, and further in view of Damodaran (US2020/0108002A1), Gebicki (US 2008/0112968A1) and Biedron et al. (Arch. Immuno. Ther. Exp., 2008, 56, 127-134).
The teachings of Sanzgiri are discussed above.
Ascertainment of the Difference Between the Prior Art and the Claims
(MPEP §2141.012)
Sanzgiri does not teach methyl niacinamide chloride as the vitamin B3 derivative in their skin lightening composition.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
However, Sanzgiri recognized that niacin and niacinamide are normally used as skin lightening agents. See page 1.
Damodaran discloses topical skin lightening compositions comprising a nicotinamide compound, such as nicotinamide riboside (cl. 2) and N-methylnicotinamide (cl. 4).
Gebicki identifies 1-methylnicotinamide chloride as a preferred vitamin B3 derivative for topical compositions for the treatment of skin diseases selected from the group consisting of sunburn, bums, scalds, skin wounds, wrinkles, oxidative damage in the skin and UV-induced skin damage. See at least [0036], examples and claims 8-10 and 22.
Biedron disclosed:
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It would have been prima facie obvious to select 1-methylnicotinamide chloride as a derivative of vitamin B3 for the skin lightening compositions of Sanzgiri, based on its recognized suitability for its intended use (see MPEP § 2144.07) and, additionally, in view of advantages of topical administration of 1-methylnicotinamide over the use of nicotinamide (B3). See Biedron et al. In addition, it has been held that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, , 1072 (CCPA 1980). MPEP 2144.06.
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 1-3 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 of U.S. Patent No. 12,409,119.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 14 of the patent anticipates the instant claims. Claim 1 of the patent recites
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and in claim 14, the HCA is p-coumaric acid. For the vitamin B3 compound, the patented claim includes:
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(p. 9).
For example, nicotinamide riboside, together with the HCA coumaric acid, will have a calculated binding free energy of less than -5 kcal/mol or more, based on the table in applicant’s specification. Thus, claim 14 of the patent reads on claims 1-3 and 7-9 of this application.
Claims 1-3 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim4s 4 of U.S. Patent No. 12,280,132.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of the patent anticipates the instant claims. The claim of the patent recites a skin care composition comprising: a. 0.1 % to 1% of hydroxycinnamic acid (CA) which comprises coumaric acid and ferulic acid; b. 0.1 % to 3% of a hydrotrope selected from sodium salicylate, 2,3-dihyroxybenzoic acid and others; c. water; wherein the pH of the composition is 3.5 to about 4.5; wherein the composition is free of hydroxycinnamic acid crystals and further comprising from 0.1% to 10% of a vitamin B3 compound. For the vitamin B3 compound, the patented claim includes:
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(p. 9).
For example, nicotinamide riboside, together with the HCA coumaric acid, will have a calculated binding free energy of less than -5 kcal/mol or more, based on the table in applicant’s specification. Claim 4 of the patent reads on claims 1-3 and 7-9 of this application.
Claims 1-3 and 7-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,036,298 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a skin care composition comprising: i. about 0.1 % to about 10% of a vitamin B3 compound; ii. about 0.1 % to about 10% of a hydroxycinnamic acid; iii. water; v. a co-solvent with a Hansen solubility parameter distance of less than 15 from the hydroxycinnamic acid; wherein a pH of the composition is 5.0 or less; wherein the composition is free of hydroxycinnamic acid crystals. Patented claim 11 recites p-coumaric acid.
For the vitamin B3 compound, the patented claim includes:
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(see specification).
Thus, at least nicotinamide riboside, together with the HCAs, will have a calculated binding free energy of less than -5 kcal/mol or more, based on the table in applicant’s specification.
The difference between the instant claims and the claims of ‘298 lie in the fact that the claims of ‘298 further recite a method of reducing the appearance of post-acne marks. However, there is no patentable distinction between the compounds as claimed in the reference application, and the method of using the compounds, as claimed here. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use].
It would have been obvious for one of ordinary skill in the art to make the composition of the method of ‘298, and therefore, arrive at the instant claims.
Claims 1-3 and 7-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,144,882 B.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a skin care composition comprising: i. about 0.1 % to about 10% of a vitamin B3 compound; ii. about 0.1 % to about 10% of a coumaric acid; iii. a glycol solvent, iv. one or more hydrotrope selected from sodium salicylate, 2,3-dihyroxybenzoic acid and others; v. water; wherein a pH of the composition is 5.0 or less; wherein the composition is free of hydroxycinnamic acid crystals.
For the vitamin B3 compound, the patented claim includes:
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(see specification).
Thus, at least nicotinamide riboside, together with the HCAs, will have a calculated binding free energy of less than -5 kcal/mol or more, based on the table in applicant’s specification.
The difference between the instant claims and the claims of ‘882 lie in the fact that the claims of ‘882 further recite a method of using the composition. However, there is no patentable distinction between the compounds as claimed in the reference application, and the method of using the compounds, as claimed here. See Mosler Sage & Lock Co. V. Mosler, Bahmann & Co., 127 U.S. 354, 218 S.Ct. 1148 (1888) [The first patent was of an article; the second patent, held invalid, was for a method of making it]. See also Ex parte MacAdams, 206 USPQ 445 [The patent had a composition of matter; the application had the method of use].
It would have been obvious for one of ordinary skill in the art to make the composition used in the method of ‘882, and therefore, arrive at the instant claims.
Conclusion
Claims 1-9 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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