DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-11 are pending in this application.
Election
Applicant’s election without traverse of
Group I, corresponding to claims 1-6, drawn to Dunaliella salina OH214 (KCTC 14434BP) having an ability to produce lutein, a culture of Dunaliella salina OH214, and a composition comprising Dunaliella salina OH214 and/or a culture thereof, classified in CPC C12N1/12,
in the reply filed 02/03/2026 is acknowledged.
Claims 7-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/03/2026.
Claims 1-6 are being examined on the merits.
Priority
The instant application is a CIP of PCT/KR2022/007255 filed 05/20/2022 and claims foreign priority to Korean Application No. 10-2021-0066938 filed 05/25/2021.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 11/24/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
The listing of references on page 4 of the specification filed 12/12/2023 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections to Specification
The disclosure is objected to because of the following informalities.
The use of the terms DOKDO-PREP, SHIMADZU, PROMINENCE, WHATMAN, and SPHERISORB, which are trade names or marks used in commerce, have been noted in this application on pages 21, 26, and 30. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Objections
Claim 4 is object to for the phrase “A composition comprising Dunaliella salina OH214 (KCTC 14434BP) and/or a culture thereof”. In the interest of improving claim form, Applicant may consider an amendment to recite “A composition comprising Dunaliella salina strain OH214 deposited with Korean Collection of Type Cultures under the Accession No. KCTC 14434BP, a culture of the Dunaliella salina strain OH214, or the Dunaliella salina strain OH214 and a culture thereof”.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 (claims 2-6 dependent therefrom) is indefinite for the phrase of “Dunaliella salina OH214 (KCTC 1443BP)” as the term “KCTC 1443BP” can be considered exemplary language according to MPEP 2731.05(d). Therefore it is unclear whether the term recited in parentheses is intended to limit the claimed Dunaliella salina OH214. If Applicant intends the term to be limiting, Applicant may consider an amendment to recite “Dunaliella salina strain OH214 deposited with Korean Collection for Type Cultures under Accession No. KCTC 1443BP”.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-6 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims recite a Dunaliella salina OH214 strain deposited under the Budapest treaty on January 5, 2021 at the Korean Collection for Type Cultures under an accession number KCTC 1443BP. It is apparent that the recited strain is required to practice the claimed invention. Since the biological material is required for the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If the biological material is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit of the biological materials.
The recited Dunaliella salina OH214 strain is disclosed in the specification [page 9, paragraph 51; and page 31] as having been deposited at Korean Collection for Type Cultures under an accession number KCTC 1443BP since January 5, 2021 in accordance with the Budapest Treaty.
However, it is unclear if the deposit meets all the criteria set forth in 37 CFR 1.801-1.809. For example, the specification does not provide the address of the depository as set forth by 37 CFR 1.809(d)(4). Furthermore, the Applicant has not stated that restrictions on the availability to the public of the materials so deposited will be irrevocably removed upon the granting of a patent. If the deposit was made under the Budapest treaty, then an affidavit or declaration by Applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein.
Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number in the following manner:
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and stating the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material:
Identifies declarant.
States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
States that the deposited material has been accorded a specific (recited) accession number.
States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g., see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
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. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014.
Claims 1-3
Claim Interpretation: Claims 1-3 are drawn to a Dunaliella salina OH214 strain (KCTC 1443BP) and a culture thereof. The instant specification at [page 20] describes the isolation of the claimed strain from Yeongjong-do salt fields in the West Sea, with strain designation resulting from genomic analysis. Given a broadest reasonable interpretation, claims 1-6 are directed to a naturally-occurring Dunaliella salina strain.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claims recite a naturally occurring organism, which is considered to be a law of nature or natural phenomena (a natural product). Accordingly, claims 1-3 are directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claims only recite the product of nature, without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claim is rejected under section 101 as being directed to non-statutory subject matter.
Claims 4-6
Claim Interpretation: Claims 4-6 are drawn to a composition comprising Dunaliella salina OH214 strain (KCTC 1443BP) and/or a culture thereof. The instant specification at [page 20] describes the isolation of the claimed strain from Yeongjong-do salt fields in the West Sea, with strain designation resulting from genomic analysis. The limitations in “wherein the composition is for oral administration…” [claim 5] and “wherein the composition is for enhancing or maintaining eye health…” [claim 6] are considered to be intended use limitations (see MPEP 2111.02), as they do not impart any structural limitations on the claimed composition. Therefore, given that the composition recited in claims 4-6 is only require to comprise the recited organism, the composition of claims 4-6 is considered to encompass a naturally occurring composition.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claims recite a naturally occurring composition, which is considered to be a law of nature or natural phenomena (a natural product). Accordingly, the composition of claims 4-6 is directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claims only recite the product of nature, without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claim is rejected under section 101 as being directed to non-statutory subject matter.
Examiner Comment
The closest prior art of record to the subject matter of claims 1-6 is considered to be Fu et al. (Appl Microbiol Biotechnol, 2013, 97:2395; cited on the attached Form PTO-892) which discloses a Dunaliella salina strain UTEX LB200 capable of producing carotenoids such as β-carotene and lutein [abstract], wherein the UTEX LB200 strain comprises an 18S rRNA gene disclosed by NCBI Accession No. DQ009779.1 (2 pages, March 28, 2007; cited on the attached Form PTO-892). The instant specification beginning at [para 117] discloses the claimed OH214 strain was identified by phylogenetic analysis of 18S rRNA gene sequences to related strains of the same clade, and sets forth the 18S rRNA gene sequence of OH214 to be SEQ ID NO: 3. As the 18S rRNA gene sequence of the claimed OH214 strain shares 97.9% sequence identity with the 18S rRNA gene sequence of the UTEX LB200 strain of Fu [see Appendix A], Fu does not disclose or suggest a
“Dunaliella salina OH241 (KCTC 14434BP) having an ability to produce lutein” as recited in claims 1-2,
“A culture of Dunaliella salina OH241 (KCTC 14434BP)” as recited in claim 3, or
“A composition comprising Dunaliella salina OH241 (KCTC 14434BP) and/or a culture thereof” as recited in claims 4-6.
Therefore claims 1-6 are considered free of the prior art of record.
Conclusion
Status of the Application:
Claims 1-11 are pending.
Claims 7-11 are withdrawn.
Claims 1-6 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH SPANGLER whose telephone number is (571)270-0314. The examiner can normally be reached M-F 7:30 am - 4:30 pm.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
APPENDIX A
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Sequence alignment of SEQ ID NO: 3 to NCBI Accession No. DQ009779.1
Prosecution Insights