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
1. Original claims 1-11 filed on 2/28/24 are present and under consideration in this Office Action.
2. Priority
Receipt is acknowledged of papers (foreign priority filed 8/30/21) submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
3. IDS filed 2/28/24 is acknowledged. A signed copy of the IDS is provided with this Office Action.
4. Drawings
The drawings filed on 2/28/24 are acknowledged.
5. Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
6. Deposit Requirement
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing 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.
It is apparent that the [plasmid/microorganism/vector] is required to practice the claimed invention. As such the [plasmid/microorganism/vector] must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the [plasmid/microorganism/vector]. The specification lacks complete deposit information for the deposit of microorganism [fungal strain Alternaria alternata FB1, deposited in the Guangdong Provincial Microbial Culture Collection Center, whose address is 5th Floor, Building 59, Courtyard, No. 100 Xianlie Middle Road, Guangzhou City, under the GDMCC Accession No: 61788 on July 7, 2021]. If a deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that (a) during pendency of the application, access to the invention will be afforded to the Commissioner upon request, (b) all restrictions upon availability to the public will be irrevocable removed upon granting of the patent, (c) the deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer, (d) a test of the viability of the biological material at the time of deposit (see 37 CFR 1.807) and (e) the deposit will be replaced if it should ever become inviable.
Claims 1-11 are rejected under 35 U.S.C. § 112, first paragraph, for the reasons set forth in the objection to the specification. Claims 2-11 are included in the rejection for using the GDMCC Accession No: 61788 lacking complete deposit information.
2404.01
The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b) ), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
7. 35 U.S.C. § 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 therefore, subject to the conditions and requirements of this title".
Claims 1-11 are rejected under 35 U.S.C. § 101 because the claimed invention is directed toward non-statutory subject matter.
Claims 1 & 6-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter because the claimed invention is directed to a naturally-occurring marine fungal strain, even though assigned a GDMCC Accession No: 61788, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., --U.S.—(June 13, 2013).
Claims 1 & 6-8 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 1 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
Claims 1 & 6-8 are directed to a naturally-occurring marine fungal strain whether isolated, synthetic or recombinant or not, that are not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (June 13, 2013), as they are not markedly different than the marine fungal strain as it occurs in nature. Instant specification present no comparison between the naturally-occurring marine fungal strain and the wild-type. Applicants claim a genetic modification in claims 3, 6 & 8. However, no specific genetic modification of the naturally-occurring marine fungal strain is presented in the instant specification.
In view of the lack of evidence of record, the marine fungal strain of claim 1 and claims 2-11 directly or indirectly depending on claim 1 encompasses a naturally occurring product that is not markedly different from a corresponding product that occurs in nature. As such, the claimed marine fungal strain is considered to be a law of nature and a judicial exception.
There is no indication in the specification that the claimed marine fungal strains has any characteristics (structural, functional, or otherwise) that are different from the individual marine fungal strains as they occur in nature. Thus, the marine fungal strain does not have markedly different characteristics from what occurs in nature, and is considered to be a “product of nature” exception. Accordingly, claim 1 is directed to a judicial exception. Because the claim does not include any additional features that could add significantly more to the exception, the claim does not qualify as eligible subject matter. For all the above reasons claims 1-11 are rejected under section 101 as being directed to non-statutory subject matter.
8. Claim Rejections - 35 USC § 112 (second paragraph)
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 3 & 6-8 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 pre-AIA the applicant regards as the invention.
Claims 3, 6 and 8 recite – “ fungal strain resulting from the genetic modification of the marine fungus”. However, no specific genetic modification of the naturally-occurring marine fungal strain is presented in the instant specification.
Claim 7 is included in the rejection for failing to correct the defect present in the base claim(s) 6.
9. No claim is allowed.
10. US-20240254433-A1 is the PGPub of the instant application.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEKCHAND SAIDHA whose telephone number is (571)272-0940. The examiner can normally be reached on M-F 8.00-5.30. 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, Robert B Mondesi can be reached on 408 918 7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TEKCHAND SAIDHA/
Primary Examiner, Art Unit 1652
Recombinant Enzymes, Hoteling
Telephone: (571) 272-0940
Fax: (571) 273-0940