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 .
Applicants’ response, filed 07/30/2026, has been received and entered. Claim 1, and 4-6 remain pending.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities:
Claim 5 is objected to for being grammatically incorrect. The examiner suggests amending the claim as follows:
5. A method for any one or more of the following purposes:
(1) studying tumor drug resistance mechanisms in vitro;
(2) analyzing chemotherapeutic drug susceptibility in vitro;
(3) preparing a tumor cell model or a tumor animal model;
(4) screening and evaluating chemotherapeutic drugs in vitro;
(5) developing drug resistance reversal agents in vitro;
wherein the method comprises preparing progeny cells, established from the Niraparib-resistant cell strain of claim 1 or established by the Niraparib-resistant cell strain of claim 1 through transfection of fluorescent-labeled genes, thereby producing the tumor cell model;
optionally, introducing the progeny cells into an animal to produce the tumor animal model;
optionally, applying a potential drug to the tumor animal model and comparing said tumor animal model with an untreated group for screening and evaluating an effective chemotherapeutic drug in vitro and/or developing an effective drug resistance reversal agent in vitro.
Claim 6 is objected to for reciting “claims 5”. The claim should be corrected to recite “claim 5”.
Status of Prior Rejections/Response to Arguments
RE: Objection to claim 1
The amendments to claim 1 overcome the objection of record. The objection is withdrawn.
RE: Objection to claim 5
Applicants amended claim 5 correcting “claims 1” to “claim 1” and specifying the claim requires any one or more of (1-5). While amendments to the claims overcome the objection of record, the amendments introduce new informalities. The objection is amended and maintained.
RE: Rejection of claims 1-4 over 35 U.S.C. 112(a)
Applicants submitted a deposit receipt, on 07/30/2026, stating the Niraparib-resistant cell strain A2780-NiraR was deposited in China Center for Type Culture Collection (CCTCC) under registration number C202299. The deposit receipt further states the deposit will be kept for thirty years from the deposit date and will be extended for another five years after receiving a request to provide a culture sample before the expiration date. Additionally, survival of the cells was tested.
In the remarks filed 07/30/2026, applicants state the CCTCC is an international depositary authority under the Budapest Treaty. Applicants further declare the cells strain A2780-NiraR will be available to the public under the conditions specified in 37 CFR 1.808 upon issuance of the patent. Applicants further state the deposit will be maintained in a public depository for a period of 30 years after the date of deposit or 5 years after the last request for the cell strain.
While applicants have complied with some of the requirements under the Budapest Treaty, applicants have not made a statement indicating the following requirements
During the pendency of the application, access to the invention will be afforded to the Commissioner upon request
The deposit will be replaced if it should ever become inviable.
The rejection is therefore maintained.
RE: Rejection of claim 5 under 35 U.S.C. 112(b)
Claim 5 has been amended to recite a method thus overcoming the rejection of record. The rejection is withdrawn.
RE: Rejection of claims 2 and 3 under 35 U.S.C 112(d)
Claims 2 and 3 have been cancelled rendering the rejection moot.
RE: Rejection of claim 5 under 35 U.S.C. 101
Claim 5 has been amended to recite a method thus overcoming the rejection of record. The rejection is withdrawn.
RE: Rejection of claims 1-4 under 35 U.S.C. 102 over Harrison et al
Applicants traverse the rejection of record on the grounds that the A2780-NiraR cells of the instant claim are mainly round whereas the parent A2780 strain was mainly spindle-shaped. Additionally, A2780-NiraR cells are cross-resistant to Taxol. Applicants assert Harrison et al fails to describe or teach morphological changes and cross-resistance and stability effects attributed to the A2780-NiraR cells of claim 1.
In response, the argument have been considered but is not found persuasive. Harrison does not disclose the Niraparib-resistant A2780 cells are spindle shaped or Taxol resistant. However, the Niraparib-resistant A2780 cells of Harrison possess inherent characteristics which might not be displayed in the tests used the reference. Clear evidence that the strains of the cited prior art do not possess a critical characteristic that is possessed by the claimed strain, would advance prosecution and might permit allowance of claims to applicants' strain.
The rejection over claims 1 and 4 is maintained.
Claims 2 and 3 have been cancelled rendering their rejection moot.
Maintained Rejections
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.
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 and 4 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 claims 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 invention appears to employ novel biological materials, specifically a human ovarian cancer Niraparib-resistant cell strain name A2780-NiraR, and/or progeny thereof. Since the biological material is essential to the claimed invention it must be 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 USC 112(a) or pre-AIA 35 USC 112, first paragraph, may be satisfied by a deposit of the [biological material].
It is noted that Applicants have deposited biological material at China Center for Type Culture Collection under accession number CCTCC NO: C202299, but there is no indication in the specification as to the public availability. If the deposit was made and accepted under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by the attorney of record over his/her signature and registration number, stating such is required. To satisfy the deposit requirement made herein, the affidavit, declaration, or statement must state that the specific cell line (i.e. A2780-NiraR) has been deposited and accepted under the Budapest Treaty and that they will be available to the public under the conditions specified in 37 CFR 1.808.
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 CFR 1.80-1.809, applicants may provide assurance or compliance by an affidavit or declaration, or by a statement by an attorney of record over their signature and registration number showing that:
during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
upon granting of the patent the A2780-NiraR will be available to the public under the conditions specified in 37 CFR 1.808;
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;
a test of the validity of the biological material at the time of the deposit will be made (See 37 CFR 1.807); and
the deposit will be replaced if it should ever become inviable.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Harrison et al (WO2021058967A1).
Regarding claims 1 and 4: The claims are directed to a human ovarian cancer Niraparib-resistant cell strain named A2780-NiraR.
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not applicants' strain/cell line differs, and if so to what extent, from the strains/cell lines discussed in the references. Accordingly, it has been established that the prior art teaches Niraparib-resistant A2780 cells (See pg. 18, lns11-12) which share the properties of having an 8.27 resistance index (17272 in resistant cells vs. 2087 in wt cells, See Table 3) and reducing proliferation (See Table 4) demonstrating a reasonable probability that the cells are identical to the cell strain as claimed. Therefore, the burden of establishing novelty by objective evidence is shifted to applicants.
Merely because a characteristic of a strain/cell line is not disclosed in a reference does not make the known strain patentable. The known strain possesses inherent characteristics which might not be displayed in the tests used the reference. However, the cell line disclosed may be the same cell line as claimed. Clear evidence that the strains of the cited prior art do not possess a critical characteristic that is possessed by the claimed strain, would advance prosecution and might permit allowance of claims to applicants' strain.
Regarding claim 5: Harrison et al discloses Niraparib-resistant A2780 cells which read on the cell strain of claim 1. Harrison discloses culturing the cells in Olaparib for one month to generate resistance then culturing in medium for up to two months prior to use which reads on preparing progeny cells established from the cell strain (See pg. 15, lns 27-32). The Niraparib-resistant A2780 cells of Harrison et al are used to test cancer drug compounds (See pg. 17, ln 1 – pg. 21 ln 6). Thus, the progeny cells of Harrison et al read on a tumor cell model.
Regarding claim 6: Following the discussion of claim 5 above, Harrison et al discloses testing the effects of Auranofin and Auranofin with Niraparib on proliferation of the Niraparib-resistant A2780 cells which reads on adding a chemotherapeutic drug to the cell strain (See Tables 1-6). The drug test of Harrison et al are performed on cells cultured in a 384 well plate with DMEM and cells were incubated with drugs for 30 min which reads on adding a chemotherapeutic drug in a culture medium (See pg. 16, lns 6-23). The results of the experiments are used to calculate IC50 which reads on observing cytotoxicity to obtain a preliminarily effective candidate drug and applying the candidate drug to the cell strain to calculate IC50 to obtain a drug with the lowest IC50 as the potential drug (See Table 3).
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
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, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISOL ANN O'NEILL/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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