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 .
DETAILED ACTION
Claims 1-16 are pending.
For clarity of record, a statement fulfilling the requirement for biological material for strain Lactobacillus sakei TCI147 with an accession number of DSM 33913 is disclosed in the specification paragraph [0051].
Election/Restrictions
Applicant’s election without traverse of Invention II, claims 2-16, in the reply filed on 05/28/2026 is acknowledged. Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 2 and 15 are objected to because of the following informalities:
In claim 2, the term “administrating” should be replaced with “administering”.
In claim 15, the phrase “increasing glutathione S-transferase in red blood cells (GST-RBC) content” should be replaced with “increasing content of glutathione S-transferase in red blood cells (GST-RBC)”.
Appropriate correction is required.
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 2-16 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.
The claims are drawn to a method comprising administering a composition comprising Lactobacillus sakei TCI147 and/or metabolites thereof. The claims are drawn to a large and variant genus of metabolites of Lactobacillus sakei TCI147. The genus is large and variant because “metabolite” encompasses several components of Lactobacillus sakei TCI147 including small molecules, compounds, and byproducts produced by the bacterium.
The specification discloses production of Lactobacillus sakei TCI147 supernatant filtered using 0.2 µm membrane and referred to as “sample” ([0097]). This sample was then used in the subsequent experiments.
The specification does not disclose metabolites capable of improving skin condition. The filtered supernatant of Lactobacillus sakei TCI147 was not analyzed to identify the specific metabolites capable of improving skin condition.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire 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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)
Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.").
The specification does not disclose a representative number of Lactobacillus sakei TCI147 metabolites that have the function of improving skin condition.
It is unpredictable which metabolite of Lactobacillus sakei TCI147 has the function of improving skin condition. The metabolites produced by Lactobacillus sakei TCI147 are diverse and different. The specification discloses the cultured strain and its filtered supernatant (Example 2).
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. See MPEP 2163.02. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69USPQ2d at 1895. The written description provision of 35 U.S.C. § 112 are severable from its enablement provision Vas-Cath, Inc. v. Mahurkar, 1115.
In view of the above considerations, the claims do not comply with the written description requirement and therefore, Applicant, as of the effective filing date was not in possession of the full genus of metabolite of Lactobacillus sakei TCI147 having skin improvement properties.
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 3-16 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 3-16 recite the limitations “wherein the Lactobacillus sakei TCI147 is used for delaying cellular aging or oxidation”, “wherein the Lactobacillus sakei TCI147 is used for enhancing mitochondrial activity”, “wherein the Lactobacillus sakei TCI147 is used for promoting autophagy”, “ wherein the Lactobacillus sakei TCI147 is used for increasing skin collagen content”, “wherein the Lactobacillus sakei TCI147 is used for fading skin spots”, “wherein the Lactobacillus sakei TCI147 is used for reducing skin roughness”, “ wherein the Lactobacillus sakei TCI147 is used for reducing skin fine lines and/or wrinkles”, “wherein the Lactobacillus sakei TCI147 is used for promoting skin moisture retention capacity”, “ wherein the Lactobacillus sakei TCI147 is used for promoting spermidine production”, “wherein the Lactobacillus sakei TCI147 is used for preventing and/or reducing oxidative stress of cells”, “wherein the Lactobacillus sakei TCI147 is used for increasing glutathione (GSH) content”, “wherein the Lactobacillus sakei TCI147 is used for enhancing glutathione S-transferase (GST) activity”, “wherein the Lactobacillus sakei TCI147is used for reducing malondialdehyde (MDA) content and/or increasing glutathione S-transferase in red blood cells (GST-RBC) content”, and “wherein the Lactobacillus sakei TCI147is used for delaying skin aging”, respectively. These claims recite beneficial results or desired outcomes of the method of claim 2, but do not further limit the method step recited in claim 2.
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.
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.
Claims 2-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 20210155989 A, published 12/24/2021, reference is herein made to text in the corresponding English language machine translated application; see attached copy) in view of CP046037.1 (GenBank: CP046037.1, Latilactobacillus sakei strain CBA3614 chromosome, complete genome, published 11/20/2019).
Regarding claim 2, Kim teaches administering to a subject a composition comprising Lactobacillus sakei strain, a culture medium thereof, or an extract thereof as an active ingredient to improve skin condition (Title, [0001], [0038]). Kim teaches the blanc001 strain (Accession No: KCTC 14206BP) or its culture have skin elasticity or skin wrinkle improvement activity, skin wound regeneration activity, and skin barrier strengthening activity (Title). Kim teaches that the strain, its culture medium, or extract may be included in a composition in an amount of 0.0005% by weight to 10% by weight of the total weight of the composition and teaches that within this range, there is an advantage of exhibiting excellent efficacy for skin elasticity or skin wrinkle improvement ([0037]).
Kim does not teach that the strain is Lactobacillus sakei TCI147 with an accession number of DSM 33913.
However, CP046037.1 teaches Latilactobacillus sakei strain CBA3614 (also referred to as Lactobacillus sakei CBA3614) (page 1 “Definition”, “Title”) isolated from kimchi (page 2 “source”). Applicant discloses that the 16S rRNA of Lactobacillus sakei CBA3614 is 100% identical to 16S rRNA of instant claimed strain (See specification [0090] and Table 1). Since the 16S rRNAs are identical, Lactobacillus sakei CBA3614 is understood as being an obvious variant of the claimed strain or necessarily containing the same metabolites.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim’s method by substituting Lactobacillus sakei CBA3614, its culture medium, or its extract, as suggested by CBA3614, for Kim's Lactobacillus sakei, and to optimize the concentration of the strain, its culture medium, or its extract in the composition, as suggested by Kim. One of ordinary skill in the art would be motivated to do so in order to improve skin condition. Since Kim teaches a correlation and a desire to use a Lactobacillus sakei strain, its culture medium, or its extract to improve skin condition, and since CP046037.1 teaches an isolated Lactobacillus sakei from food source (i.e., safe for consumption), there is a reasonable expectation of success in the L. sakei strain, its culture medium, or its extract containing the same metabolites as claimed. One of ordinary skill in the art would be motivated to optimize the concentration of the strain in the composition depending on the severity of the skin condition and the patient’s response. Kim teaches a correlation between administering a Lactobacillus sakei probiotic and improving skin conditions, and CP046037.1 teaches an isolated probiotic Lactobacillus sakei strain. It is obvious to substitute one Lactobacillus sakei probiotic for another Lactobacillus sakei probiotic with the same function, which would predictably result in improvement of skin condition.
Regarding claim 3, Kim teaches the composition prevents skin aging ([0024]).
Regarding claim 6, Kim teaches the composition increased the production of type 1 procollagen protein ([0066]).
Regarding claim 9, Kim teaches the composition reduces wrinkles ([0066]).
Regarding claims 4-5, 7-8, and 10-16, the limitations of wherein the Lactobacillus sakei TCI147 is used for enhancing mitochondrial activity, for promoting autophagy, for fading skin spots, for reducing skin roughness, for promoting skin moisture retention capacity, for promoting spermidine production, for preventing and/or reducing oxidative stress of cells, for increasing glutathione (GSH) content, for enhancing glutathione S-transferase (GST) activity, for reducing malondialdehyde (MDA) content and/or increasing glutathione S-transferase in red blood cells (GST-RBC) content, and for delaying skin aging, do not require further method steps and are the result of the method step recited in claim 2. Claim scope is not limited by claim language that suggest or makes optional but does not require steps to be performed, and whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/MARY A CRUM/Examiner, Art Unit 1657
Prosecution Insights