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 .
Claim Status
Claims 1-20 are pending and under consideration.
Claim Objections
Claims 1, 4-5 and 17 are objected to because of the following informalities: “oxyalkylenated ester” in line 3 of claim 1 should read “oxyalkylated ester”. Oxyalkylation is a process where alkylene oxide (e.g. ethylene oxide or propylene oxide) is reacted with alcohol to form poly(oxyalkylene) chains. However, the process is called oxyalkylation instead of oxyalkylenation. Therefore, “oxyalkylenated ester” in line 3 should read “oxyalkylated ester”. Appropriate correction is required.
Same reasoning applies to claims 4-5 and 17.
Claim 1 is objected to because of the following informalities: “esters of fatty acids and of sorbitan” in line 3 should read “esters of fatty acids and sorbitan” (i.e. second “of” should be deleted). The ester is formed by carboxylic acid (e.g. fatty acid) and alcohol (e.g. sorbitan) and therefore must be recited by “ester of carboxylic acid and alcohol” instead of “ester of carboxylic acid and of alcohol”. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “ascorbic acid and its derivatives” should read “ascorbic acid and derivatives thereof”; “its fractions” in line 4 should read “fractions thereof”; “its metabolites” in line 5 should read “metabolites thereof”. Applicants are advised to avoid pronoun because pronoun can cause confusion when there are multiple nouns are recited before pronoun and it is unclear which noun the pronoun refers to. Appropriate correction is required.
Claims 2-17 are objected to because of the following informalities: “Composition according to claim X” should read “The composition according to claim X”. Appropriate correction is required.
Claims 3, 5, 7, 9, 11, 14 and 16 are objected to because of the following informalities: It is suggested that Applicant delete limitation “with respect to the total weight of the composition” because one of ordinary skill in the art would understand 1% by weight means 1 gram of the component in 100 grams of composition and the total weight of the composition is not needed to define the concentration of the component.
Appropriate correction is required.
Claims 10, 12, 15 and 17 are objected to because of the following informalities: “it” in line 2 of claim 10 should read “said composition” for better clarity because pronoun can cause confusion about which noun the pronoun refers to. Likewise, “it” in line 2 of claims 12, 15 and 17 should read “said composition” for better clarity. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: “sorbitol” in line 3 of claim 17 should read “sorbitan” because subpart (ii) of claim 1 recites “sorbitan”, not “sorbitol”. Appropriate correction is required.
Claims 18-20 are objected to because of the following informalities: “a composition as defined in claim 1” should read “the composition as defined in claim 1”. Appropriate correction is required.
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) 19 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 19 recite(s) “use” and therefore attempt to claim a method/process, but the claim does not set forth any process step involved in the method/process. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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.
Claim 1 (iii) recites three components; (a) one or more microorganisms of the genus Bifidobacterium species, (b) one of its fractions, (c) one of its metabolites or their mixtures. However, claim 1 (iii) does not recite conjunction “and” or “or” between these components and therefore it is unclear if claim 1(iii) requires all of three components or if claim 1(iii) requires only one of them.
Dependent claims are also rejected because they depend from claim 1 and therefore contain same claim limitation as claim 1.
Claims 2 and 3 recite “antioxidant (i)”. It is unclear if there is another antioxidant (ii) or if Applicant intends to recite “antioxidant of subpart (i)”. If Applicant intends to recite the latter, it is suggested that Applicant amend “antioxidant (i)” to “antioxidant”. In other words, Applicant is advised to delete “(i)” because the antioxidant was recited by only subpart (i) and therefore “(i)” is not needed.
Same reasoning applies to “sorbitan (ii)” in line 2 and second from last line of claim 4; line 3 of claim 5; line 3 of claim 17.
Same reasoning applies to “microorganisms (iii)” in line 2 and last line of claim 6; and line 3 of claim 7.
Same reasoning applies to “yeast (iv)” in line 2 of claim 8; line 3 of claim 9.
Claim 3 recites “preferably” and “more preferentially”. It is unclear if the claim requires the limitation following “preferably”, “preferentially” and “more preferentially” because “preferably”, “preferentially” and “more preferentially” refer to exemplary claim language. See MPEP 2173.05(d).
Same reasoning applies to claims 4-12 and 14-17.
Claim 3 recites “the total content of the antioxidant”. It is unclear what Applicant intends to mean by “total content”. It is unclear if “total content” means what is present or if “total content” means how much is present. If Applicant means concentration by “total content”, it is suggested that Applicant amend “total content” to “concentration”. Because same concentration unit (e.g. % by weight) can be used for both solid mixtures and liquid solutions, “% by weight” recited by instant claims can be used for composition of solid mixtures encompassed by instant claims.
Same reasoning applies to claims 5, 7, 9, 11, 14, and 16.
Claim 7 recites “the lysate of the microorganism” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites “microorganism of the genus Befidobacterium species”, but does not recite “a lysate of the microorganism”. It is unclear what “the lysate of the microorganism” refer to because claim 1 recites two types of microorganisms, “microorganism of the genus Befidobacterium species” and “extracts of yeast of the genus Saccharomyces”. If Applicant refer to the former, it is suggested that Applicant amend “the lysate of the microorganism” to “the microorganism of the genus Befidobacterium species”.
Claim 9 recites “(as dry matter or active material)” which is exemplary claim language and it is unclear the content in parenthesis is limiting or merely exemplary.
Claim 18 recites “in particular human keratin materials” and “such as the scalp and the hair”. It is unclear if the claim requires the limitation following “in particular” and “such as”. It is unclear the limitation following “in particular” and “such as” is limiting or merely exemplary.
Claim 19 recites “use” and therefore attempt to claim a method/process, but the claim does not set forth any process step involved in the method/process. Therefore, it is unclear what method/process Applicant intends to encompass. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection.
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the 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. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Regents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. The Federal Circuit has cautioned that, for claims reciting a genus of antibodies with particular functional properties (e.g., binding to antigen, high affinity, neutralization activity, competing with a reference antibody for binding), “[c]laiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011).
“[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention. For antibodies, the Federal Circuit has found that possession of a mouse antibody heavy and light chain variable regions provides a structural "stepping stone" to the corresponding chimeric antibody, but not to human antibodies. Centocor, 97 USPQ2d at 1875 (“[T]he application only provides amino acid sequence information (a molecular description of the antibody) for a single mouse variable region, i.e., the variable region that the mouse A2 antibody and the chimeric antibody have in common. However, the mouse variable region sequence does not serve as a stepping stone to identifying a human variable region within the scope of the claims.”). A chimeric antibody shares the full heavy and light chain variable regions with the corresponding mouse antibody; that is, the structure shared between a mouse and chimeric antibody would generally be expected to conserve the antigen binding activity.
Even if a selection procedure is disclosed that was, at the time of the invention, sufficient to enable the skilled artisan to identify antibodies with the recited functional properties, the written description provision of 35 U.S.C § 112 is severable from its enablement provision. Ariad, 94 USPQ2d at 1167; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
Additionally, “An adequate written description must contain enough information about the actual makeup of the claimed products—“a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” which may be present in “functional” terminology “when the art has established a correlation between structure and function.” Ariad, 598 F.3d at 1350. But both in this case and in our previous cases, it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies.” Amgen Inc v. Sanofi 124 USPQ2d 1354, 1361 (Fed. Cir. 2017). “Further, the “newly characterized antigen” test flouts basic legal principles of the written description requirement. Section 112 requires a “written description of the invention.” But this test allows patentees to claim antibodies by describing something that is not the invention, i.e., the antigen. The test thus contradicts the statutory “quid pro quo” of the patent system where “one describes an invention, and, if the law's other requirements are met, one obtains a patent.” Ariad, 598 F.3d at 1345.” Amgen at 1362.
Claim Analysis
Instant claims are drawn to composition comprising: (i) one or more antioxidants chosen from ascorbic acid and its derivatives, (ii) one or more oxyalkylenated esters of fatty acids and of sorbitan, (iii) one or more microorganisms of the genus Bifidobacterium species, one of its fractions, one of its metabolites or their mixtures, the microorganism(s) being in the lysate form, and (iv) one or more extracts of yeast of the genus Saccharomyces.
Instant specification disclosed compositions A, B and C comprising ascorbyl glucoside (corresponds to subpart (i) of claim 1), polysorbate 21 (corresponds to subpart (ii) of claim 1), Bifida ferment lysate (corresponds to subpart (iii) of claim 1), extract of yeast Saccharomyces cerevisiae (corresponds to subpart (iv) of claim 1) and Ecoskin RS (Solabia) (page 31, Table 1; page 35, Table 5). As evidenced by Solabia website (https://www.solabia.com/cosmetics/product/ecoskin/), Ecoskin includes Lactobacillus casei and Lactobacillus acidophilus.
Claim 1(i) encompasses all possible types of the derivatives of ascorbic acid such as ascorbyl glucoside, sodium ascorbyl phosphate, magnesium ascorbyl phosphate, tetrahexyldecyl ascorbate, ascorbyl tetraisopalmitate, 3-O-ethyl ascorbic acid, ascorbyl palmitate, and calcium ascorbate. However, as discussed above, instant specification disclosed compositions comprising only a single species of derivative, ascorbyl glucoside (page 31, Table 1; page 35, Table 5). Only a single species disclosed by instant specification cannot be considered as a representative number of species falling within the scope of genus encompassing all possible types of the derivatives of ascorbic acid. Instant specification did not show that compositions comprising different types of derivatives will have same effect on skin as instant invention comprising ascobyl glucoside. In the unpredictable art like instant invention, one of ordinary skill in the art would not be able to predict that different derivatives will have same effect on skin as ascobyl glucoside of instant invention. Furthermore, ascorbyl glucoside, sodium ascorbyl phosphate, and magnesium ascorbyl phosphate are water-soluble derivatives and tetrahexyldecyl ascorbate and ascorbyl tetraisopalmitate are oil-soluble derivatives. Because different derivatives have different characteristics, one of ordinary skill in the art would predict that compositions comprising different type of derivative will have functional characteristics different from instant invention and will have different effect on skin.
Claim 1(ii) encompasses all possible types of polysorbate non-ionic surfactants such as polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, polysorbate 21, polysorbate 61, polysorbate 65, polysorbate 81, and polysorbate 85. However, as discussed above, instant specification disclosed only a single species polysorbate 21. Only a single species disclosed by instant specification cannot be considered as a representative number of species falling within the scope of genus encompassing all possible types of polysorbates. Instant specification did not show that compositions comprising different types of polysorbate will have same effect on skin as instant invention. In the unpredictable art like instant invention, one of ordinary skill in the art would not be able to predict that different polysorbate will have same effect on skin as polysorbate 21 of instant invention.
Claim 1(iii) encompasses all possible species of genus Bifidobacterium. However, as evidenced by instant specification at page 9 and Table 1 at page 31, instant invention comprises Bifida Ferment Lysate Repair Complex CLR PF (CLR) which is formed of an inactivated lysate of the species Bifidobacterium longum (page 9, line 21-23). Therefore, only a single species cannot be considered as a representative number of species falling within the scope of genus encompassing all possible species of Bifidobacterium. Instant specification did not show that compositions comprising different species will have same effect on skin as instant invention comprising Bifidobacterium longum. In the unpredictable art like instant invention, one of ordinary skill in the art would not be able to predict that different species will have same effect on skin as Bifidobacterium longum of instant invention.
Same reasoning applies to claim 6.
Furthermore, claim 1(iii) also recites “one of its fractions” and “one of its metabolites or their mixtures”. Broadest reasonable interpretation of these limitations can be, for example, a molecule of glucose or even a water molecule. Instant specification did not show that composition comprising glucose molecule instead of Bifida Ferment Lysate has same effect on skin as instant invention. It is suggested that Applicant delete limitations “one of its fractions” and “one of its metabolites or their mixtures”.
Claim 1(iv) encompasses all possible species of genus Saccharomyces. However, the composition of instant invention comprises Saccharomyces cerevisiae (Table 1, page 31). Instant specification did not show that compositions comprising different species of Saccharomyces will have same effect on skin as instant invention comprising Saccharomyces cerevisiae. In the unpredictable art like instant invention, one of ordinary skill in the art would not be able to predict that different species will have same effect on skin as Saccharomyces cerevisiae of instant invention.
Same reasoning applies to claim 8.
Claims 10-11 encompass any type of monosaccharide. However, instant invention comprises only a single species mannose (Table 1, page 31). Because a single species cannot be considered as a representative number of species falling within the scope of genus, instant specification does not provide adequate written description for instant claims 10-11.
Claims 12-14 encompass any type of monosaccharide, oligosaccharide, and polysaccharide. However, instant invention comprises a single species of specific oligosaccharide (glucan oligosaccharide; Table 1, page 31). Instant specification did not show that any possible composition comprising any possible type of monosaccharide, oligosaccharide, and polysaccharide have same effect on skin as instant invention. Therefore, instant specification did not provide adequate written description for instant claims 12-14.
Claims 15-16 encompass any type of additional probiotic microorganism other than Bifidobacterium. However, as discussed above, instant invention comprises Ecoskin RS (Solabia) (page 31, Table 1; page 35, Table 5) which includes Lactobacillus casei and Lactobacillus acidophilus. Therefore, instant specification did not show that any compositions comprising any possible types of additional microorganism will have same effect on skin as instant invention comprising Lactobacillus casei and Lactobacillus acidophilus.
The disclosure therefore does not show that applicant was in possession of the necessary common attributes or features possessed by the members of the claimed genus. Accordingly, the skilled artisan would not recognize that applicants were in possession of the invention as broadly claimed at the time the application was filed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 12-13, 15 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Missha (Time Revolution Night Repair Science Activator Ampoule, https://incidecoder.com/products/missha-time-revolution-night-repair-science-activator-ampoule-3; published 2/2/2019; PTO-892).
Regarding claim 1, according to the website above, Time Revolution Night Repair Science Activator Ampoule is the one of Missha’s star products. The website was uploaded on 2/2/2019 as shown on the page and therefore it is available as 102(a)(1) art. The website disclosed ingredients which include ascorbyl tetraisopalmitate, sodium ascorbyl phosphate, polysorbate 20, Bifida ferment lysate (corresponds to subpart (iii) of claim 1, same as Bifida ferment lysate of instant invention, Table 1, page 31 of instant specification), and Saccharomyces ferment filtrate (corresponds to “extract of yeast of the genus Saccharomyces” of claim 1).
Regarding claim 4, it is well known in the art that polysorbate 20 of Missah comprises 20 oxyethylene units.
Regarding claims 12-13, Missha comprises alpha-glucan oligosaccharide which is gluco-oligosaccharide.
Regarding claim 15, Missha comprises Lactobacillus ferment.
Regarding claim 19, Missha’s website disclosed “The key ingredient for this anti-aging serum is Bifida Ferment Lysate, a fermented yeast that visibly reduces signs of aging and improves skin elasticity while protecting the skin”. Therefore, Missha teaches the cosmetic use of the composition.
Regarding claim 20, because cosmetic composition must be contained in a container and the container itself can be considered as a device, Missha’s Ampoule is also the device claimed by claim 20.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674