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 1-6 are pending and under consideration.
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.
Claims 1-6 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to a judicial exception (natural phenomenon), specifically, the claims are drawn to bacterial strains of Bacillus sp. pfbarrier 01, Lactobacillus pentosus pfbio035, and Lactobacillus sakei subsp. sakei pfbio005, or a compound extract thereof. Furthermore, the claims do not integrate said judicial exception into practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The 2019 Patent Subject Matter Eligibility Guidance (“Guidance”) provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101. The Guidance requires an analysis of multiple steps, Steps 1, 2A, and 2B:
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a composition, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to a natural phenomenon, specifically, the claims are drawn to bacterial strains of Bacillus sp. pfbarrier 01, Lactobacillus pentosus pfbio035, and Lactobacillus sakei subsp. sakei pfbio005, or a compound extract thereof. Instant specification disclosed at page 17 that Applicant isolated these bacterial strains from soybeans and kimchi. Therefore, the bacterial strains of Bacillus sp. pfbarrier 01, Lactobacillus pentosus pfbio035, and Lactobacillus sakei subsp. sakei pfbio005 are a natural phenomenon which exist in a nature. In addition, because instant specification did not define special meaning of “compound extract” recited by claim 1, the claim limitation “compound extract” will be interpreted as broadest reasonable interpretation known in the art. One of ordinary skill in the art would understand “compound” as a chemical compound which exists inside bacteria or which is released by bacteria into a culture solution. Therefore, a compound extract can be any chemical compound which exist in a nature and therefore is a natural phenomenon.
With respect to prong two of Step 2A, the claim does not recite additional elements that integrate the judicial exception into a practical application. Claim 2 recites “the composition inhibits the expression of matrix metalloproteinase-1 (MMP-1) gene and increases the expression of type 1 procollagen gene to improve skin wrinkles”. Claim 3 recites “the composition promotes the synthesis of hyaluronic acid to moisturize skin”. Claim 4 recites “the composition increases the expression of filaggrin gene to strengthen skin barrier”. Claim 5 recites “the composition promotes the regeneration of a wounded skin”. These limitations are functional characteristics of the claimed product. Because instant claims claim product, not process, these functional limitations of the claimed product do not recite active process steps of applying the claimed product into a practical application. Therefore, claims 2-5 do not recite additional elements that integrate the judicial exception into a practical application. Said limitations do not integrate the recited judicial exception, for example, by applying or using said judicial exception to effect a particular treatment for a disease or medical condition. Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, instant claims recite only natural product of bacterial strains and compound extract, and do not recite any additional elements that amount to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
See the 2019 Revised Patent Subject Matter Eligibility Guidance and Federal Register https://www.federalregister.gov/documents/2019/10/18/2019-22782/october-2019-patent-eligibility-guidance-update; and FDsys.gov.
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 1-6 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 a cosmetic or food composition comprising mixed bacterial strains of Bacillus sp. pfbarrier 01 deposited under the accession number KCTC 14628BP, Lactobacillus pentosus pfbio035 deposited under the accession number KCTC 14684BP and Lactobacillus sakei subsp. sakei pfbio005 deposited under the accession number KCTC 14130BP, a culture solution thereof, or a compound extract thereof as an active ingredient.
Instant specification disclosed that bacterial strains of Bacillus sp. pfbarrier 01, Lactobacillus pentosus pfbio035 and Lactobacillus sakei subsp. sakei pfbio005 were isolated from soybeans and kimchi (page 17) and the supernatants after centrifugation of the cell culture of these strains were freeze-dried into a culture extract (page 18). These extracts were used to evaluate cytoprotective effect (example 2), to show the inhibition of the protein expression of MMP-1 and promotion of the protein expression of type 1 procollagen in skin cells (example 3), to show the promotion of the production of hyaluronan in skin cells (example 4), to show the promotion of the expression of profilaggrin protein (example 5), and to show the wounded skin regenerating activity (example 6).
Instant claims 1 and 6 recite “compound extract”. As discussed above, because instant specification did not define special meaning of “compound extract” recited by claims 1 and 6, the claim limitation “compound extract” will be interpreted as broadest reasonable interpretation known in the art. One of ordinary skill in the art would understand “compound” as any chemical compound which exists inside bacteria or which is released by bacteria into a culture solution. Instant specification did not disclose any specific chemical structure or chemical name for these compounds. As discussed above, “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. Because instant specification did not disclose “a precise definition, such as by structure, formula, or chemical name” for the claim limitation “compound extract” recited by claims 1 and 6, instant specification does not provide adequate written description for instant claims.
Instant claims recite “composition comprising mixed bacterial strains”. Instant specification disclosed that bacterial strains of Bacillus sp. pfbarrier 01, Lactobacillus pentosus pfbio035 and Lactobacillus sakei subsp. sakei pfbio005 were isolated from soybeans and kimchi (page 17) and the supernatants after centrifugation of the cell culture of these strains were freeze-dried into a culture extract (page 18). Instant specification disclosed several experimental results using these culture extracts from supernatant. Instant specification did not disclose any example wherein mixture of bacterial strains themselves were used for experiments. Therefore, one of ordinary skill in the art would not able to predict that bacterial strains themselves will have same effect on human skin cell line as culture extract from supernatant. Therefore, instant specification does not provide adequate written description for composition comprising mixed bacterial strains.
Instant claim 6 claims a food composition comprising mixed bacterial strains. Examples 1-6 disclosed by instant specification shows experimental data on human skin cell line. Instant specification did not provide any example showing that composition comprising bacterial strains can be used for food. Therefore, instant specification does not provide adequate written description for “food composition” claimed by instant claim 6.
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.
Conclusion
No claim is allowed.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645