DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 7, 2026 has been entered. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Please note that the only reason that claims 5-8 (now amended to method claims instead of product claims) are not withdrawn from consideration is that they are dependent on claim 1 (i.e., limited to the Sf-RVN cell line). If the claims were amended to be generic (i.e., not limited to the Sf-RVN cell line), then claims 5-8 would be withdrawn from consideration, being directed to an invention that is independent or distinct from the originally presented invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Claims Summary
Claim 1 is directed to a Spodoptera frugiperda (S. frugiperda) rhabdovirus negative (Sf-RVN) cell line subcloned from a Sf9 cell line. Please note that “Sf-RVN” is a particular cell line, not a generic description of a cell line. The Sf-RVN cell line is characterized by 1) a lack of a persistent Sf-rhabdovirus infection, 2) is structurally different from cells from Sf9 cell line, and 3) has no intact, assembled Sf-rhabdovirus genome in the transcriptome. The Sf-RVN cell line is characterized by a cell density, a doubling time, an average cell diameter, a morphology, and a N-glycosylation pattern that is the same or substantially the same as the Sf9 cell line, wherein the Sf-RVN cell line and the Sf9 cells are propagated under the same conditions (claim 3). The Sf-RVN cell line is characterized by increased production of infectious recombinant baculovirus particles compared to production in the Sf9 cells under the same conditions (claim 4), wherein the baculovirus particles are AcP(-)p6.9hEPO, or AcP(-)p6.9hSEAP (claim 14).
Claim 5 is directed to a method by which the cell line is manufactured, comprising:
Isolating a Sf9 cell from a Sf-rhabdovirus-contaminated Sf9 cell line by limiting dilution;
Combining the isolated cell with a cell culture media comprising an antiviral compound to form a first culture composition; the antiviral compound is a nucleoside analog (claim 7); wherein the antiviral compound is 6-azauridine (claim 8);
Incubating the first culture composition under conditions suitable for the cell to grow and divide, thereby generating a multiplicity of cells;
Removing a portion of the multiplicity of cells or the cell culture media and testing for the presence or absence of a Sf-rhabdovirus; testing comprises RT-PCR, or RT-PCR and nested PCR, or quantitative RT-PCR, or an antibody-based detection technique (claims 6 and 8, respectively);
Combining at least some of the multiplicity of cells with cell culture media without an antiviral compound to form a second culture composition; and
Incubating the second culture composition under conditions suitable for the cells to grow and divide, thereby obtaining a Sf-rhabdovirus negative cell line.
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, 3-8 and 14 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 enablement requirement. The claim 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.
Deposit of Sf-RVN and baculoviruses AcP(-)p6.9hEPO and AcP(-)p6.9hSEAP
It is apparent that the cell line Sf-RVN, and baculoviruses AcP(-)p6.9hEPO and AcP(-)p6.9hSEAP are required to practice the claimed invention because they are a necessary limitation for the success of the invention as stated in the claims. As required elements, they must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If they are not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of the cell line Sf-RVN (see further explanation below about Sf-RVN), and baculoviruses AcP(-)p6.9hEPO and AcP(-)p6.9hSEAP. See 37 CFR 1.802. One cannot practice the claimed invention without the cell line and viruses that are required to show improved production. Therefore, access to the cell line and the baculoviruses AcP(-)p6.9hEPO and AcP(-)p6.9hSEAP is required to practice the invention. The specification does not provide a repeatable method for obtaining the cell line and viruses without access to them and they do not appear to be readily available material.
Deposit of the Sf-RVN cell line and baculoviruses AcP(-)p6.9hEPO and AcP(-)p6.9hSEAP in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112, because the strains would be readily available to the public to practice the invention claimed, see 37 CFR 1.801- 37 CFR 1.809.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants 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, 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 requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants 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, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of this application, access to the invention will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements.
In the remarks filed April 7, 2026, Applicant points to the declaration filed April 7, 2026 under 37 CFR 1.132 by Dr. Donald Jarvis. The Office acknowledges and has considered the declaration. In the declaration, Dr. Jarvis states that the cell line “Sf-RVN” from GlycoBac, LLC, is the cell line disclosed in this application. Dr. Jarvis points to a journal article authored by himself and co-inventor Dr. Ajay Maghodia (Maghodia and Jarvis, Virology, 2017, 512:234-245) as evidence that the Sf-RVN® Insect Cell Line is an embodiment of the cell line encompassed by the claims, and that the cell line was deposited at the ATCC® on November 5, 2015 as “Sf-Clean”, PTA-122653. Applicant has provided the certificate of deposit as Appendix C.
In response, it is clear that the Sf-RVN cell line now claimed in claims 1, 3-8 and 14 is the same Sf-RVN referenced in Maghodia and Jarvis (Virology, 2017, 512:234-245) and that it has been deposited at the ATCC® on November 5, 2015 as “Sf-Clean”, PTA-122653. However, the requirements of 37 CFR 1.808 need to be addressed. If the deposit was made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants 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, 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 requirements. Also, the specification needs to state the name/address of the repository, and the date of the deposit. See 37 CFR 1.808.
Applicant’s arguments filed April 7, 2026 have been considered but fail to persuade. Applicant argues that the viruses “AcP(-)p6.9hEPO” and “AcP(-)p6.9hSEAP” are fully characterized in the literature such that a deposit is not required. Applicant points to the known nomenclature for AcP(-)p6.9hEPO and AcP(-)p6.9hSEAP, as well as known methods for producing viruses.
In response, claim 14 is directed to particular viruses, not a class of viruses having certain characteristics. “AcP(-)p6.9hEPO” and “AcP(-)p6.9hSEAP” are laboratory designations that indicate two particular viruses. Making similar viruses is not the same as making these two particular ones. Thus, the rejection is maintained because Applicant has not provided the viruses in the form of a deposit, or the complete genome of AcP(-)p6.9hEPO and AcP(-)p6.9hSEAP. Applicant may wish to consider that since they are now claiming the cell line Sf-RVN, there may not be a need to claim the embodiment of claim 14 since the cell line inherently possesses the characteristic described in claim 14.
Methods of manufacturing Sf-RVN
Claims 5-8, as amended on April 7, 2026, are directed to methods of manufacturing the Sf-RVN cell line. Since the Sf-RVN cell line is a particular cell line, not just a generic cell line have certain characteristics, the methods of its production must result in the manufacture of Sf-RVN exactly, not a cell line that is similar to it. The method outlined in claims 5-8 is general in nature and would result in a cell line that has similar characteristics to Sf-RVN but would not be exactly Sf-RVN in terms of its genome content being identical to Sf-RVN. The breadth of the claims encompasses producing Sf-RVN by a method comprising isolating any Sf9 cell from any Sf-rhabdovirus-contaminated Sf9 cell line, using any cell culture media comprising any antiviral compound, using any incubation conditions, etc. It would require undue experimentation to arrive at the production of Sf-RVN using the method outlined in claims 5-8, given the breadth of the claims and the low level of predictability that a generic method would result in the exact cell line Sf-RVN having an identical genome.
Conclusion
No claim is allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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