DETAILED ACTION
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 .
Election/Restrictions
This action is in response to the papers filed on 04/13/2026. Claims 1-16, 18-19, and 21-22 are currently pending as per claims filed on 04/13/2026.
Applicant’s election of Group I, which includes claim 1 drawn to a HEK293T cell strain, in the reply filed on 04/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2-16,18-19 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim..
The requirement for restriction between Groups I-IV is still deemed proper and is therefore made FINAL.
Therefore, claim 1 is subject to examination to which the following grounds of rejection are applicable.
Priority
The instant application is a 371 of PCT/CN2021/141958 filed on 12/28/2021, which claims foreign priority to CHINA 202011592436.6 filed on 12/29/2020.
Receipt is acknowledged of certified untranslated copies of papers required by 37 CFR 1.55 filed on 6/15/2023.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 12/29/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/17/2026 and 06/15/2023 was filed before the mailing date of the non-final office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112-Enablement
The following is a quotation of the first paragraph of 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.
Claim 1 is rejected under 35 U.S.C. 112, 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 is more nearly connected, to make and/or use the invention.
The application discloses a strain HEK293T human embryonic kidney cells that are encompassed by the definitions for biological material set forth in 37 C.F.R. § 1.801. Because it is apparent that this biological material is essential for practicing the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be known and readily available to the public as detailed in 37 C.F.R. §§ 1.801 through 1.809.
It is apparent that the HEK293T strain PowerS™-293T characterized by the following: which was deposited at the China General Microbiological Culture Collection Center (CGMCC) on December 7, 2020 according to the Budapest Treaty and has a deposit number of CGMCC No.: 21100. The cell strain can grow in suspension culture in a serum-free medium. The serum-free medium can be selected from LV-MAX production medium, Expi293 expression medium and OPM-293 CD03 medium. Cell clumping cannot appear during the suspension culture of the cell strain. This cell strain can be used to produce a viral vector. PowerS™-293T cell strain can grow in suspension culture in the serum-free medium, with high proliferation density, good viability, and no cell clumping, that is, with high dispersibility. Therefore, no additional anti-clumping agent is needed in the suspension culture process. Compared with Gibco's CTS™ virus production cells (Pub. No. MAN0018590), PowerS™-293T has a shorter cell doubling time and produces more viral vectors after transfection with viral plasmids (Pg. 5, Paragraph [0022]-[0026], is required to practice the claimed invention of claim 1. Thus, this must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. §112, first paragraph, may be satisfied by a deposit of the strain.
It is unclear whether this biological material is known and readily available to the public or that the written instructions in the Specification are sufficient to reproducibly construct this biological material from starting materials known and readily available to the public. Accordingly, availability of such biological material is deemed necessary to satisfy the enablement provisions of 35 U.S.C. § 112. If this biological material is not obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological material. In order for a deposit to meet all criteria set forth in 37 C.F.R. §§ 1.801-1.809, applicants or assignee must provide assurance of compliance with provisions of 37 C.F.R. §§ 1.801-1.809, in the form of a declaration or applicant's representative must provide a statement. The content of such a declaration or statement is suggested by the enclosed attachment. Because such deposit will not have been made prior to the effective filing date of the instant application, applicant is required to submit a verified statement from a person in a position to corroborate the fact, which states that the biological material which has been deposited is the biological material specifically identified in the application as filed (37 C.F.R. § 1.804). Such a statement need not be verified if the person is an agent or attorney registered to practice before the Office.
It is noted that the Applicant list the name of the HEK293T cell strain PowerS™-293T, which was deposited at the China General Microbiological Culture Collection Center (CGMCC) on December 7, 2020 according to the Budapest Treaty and has a deposit number of CGMCC No.: 21100. However, Applicant is reminded that a deposit of the HEK293T strain has to be made under the Budapest Convention and the specification must contain reference to the deposit, and name and address of the depository. A statement that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon granting of a patent is also required.
Please see the deposit information below, especially the paragraph following section 7.
A suggestion for deposit of biological materials is provided:
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection or rejection based on a lack of availability of biological material. See 37 CFR 1.801 through 1.809. Such a declaration:
1. Identifies declarant.
2. 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.
3. States that the deposited material has been accorded a specific (recited) accession number.
4. States that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of the patent.
5. States that the material has been deposited under conditions that assure 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 C.F.R. 1.14 and 35 U.S.C. § 122.
6. 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 or for the enforceable life of the patent, whichever period is longer.
7. 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 Purposes of Patent Procedure (e.g., see 961 OG 21, 1977), that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent, and that the deposited material will be maintained for a period of at least thirty (30) years after the date of deposit or for the enforceable life of the patent, whichever period is longer.
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.
It is noted that Applicant has deposited the biological materials (p.1 and also see p. 53 of the specification), but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon an issuance of patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably 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 effective life of the patent, whichever is longer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KODYE LEE ABBOTT whose telephone number is (703)756-1111. The examiner can normally be reached M-F 8-5.
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, Maria G. Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KODYE LEE ABBOTT/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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