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 .
Claims 1-5, 7-20 are pending in the application. Claims 14-20 are withdrawn. Claims 1-5 and 7-13 are currently under examination.
This office action is in response to the amendment filed on 8/5/2025.
All previous rejection not reiterated in this office action are withdrawn.
Specification
In response to the previous objection, Applicant submitted amended specification with the response.
However, the submitted copies of specification needs to be labeled with “clean copy” and “marked up copy” (with amended text underlined). None of the copy submitted on 8/5/2025 was labeled.
Claim Rejections - 35 USC § 112
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.
Claim 1-5, 7-13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the amended claim recites “wherein the plasmids are obtained by constructing GHR, STAT5B, and 3HIGF-1-P2-Luc reporter genes onto a lentiviral vector.” This amendment does not clarify how the lentiviruses stably expressing both GHR and 3H-IGF-1-P2-Luc, and STAT5B separately are generated when the only step involved is transfecting plasmids stably expressing GHR, STAT5B, and 3HIGF-1-P2-Luc reporter genes. Further, the recitation of “3H-IGF-1-P2 has a sequence of SEQ ID NO: 5” renders the claim indefinite because it is unclear whether 3H-IGF-1-P2-Luc comprises the entire sequence of SEQ ID NO: 5, or a fragment within SEQ ID NO:5.
Claims 2-5, 7-13 are rejected for same reason because they depend on claim 1.
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.
The following rejection is based on the filing date of the present application 2/10/2025 since the foreign priority document has not been perfected. A certified English translation of the foreign priority document would remove the availability of the reference under 102(a) if all the claimed subject matter is disclosed in the foreign priority document.
Claim(s) 1-5, 7-13 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by Zhang et al (Journal of Pharmaceutical Analysis, Journal Pre-proof, 8-16-2024).
Zhang teaches a method for constructing a cell line for stably detecting the biological activity of growth hormone (GH) medicine, comprises generating viral vectors expressing GHR, STAT5B, and 3H-IGF-1-P2-Luc, wherein HEK293LT cells were cotransfected with lentiviral transfer construct PLVX-Flag-GHR-IRES-Hyg, Plenti-myc-STAT3B-IRES-Blast and pLV-Puro-3H-P2-Luc2P with packaging construct PMD2.G and pCMV-DR8.91 (1.2.3 section of supplemental data). The method further comprises infecting HepG2 cells with said lentiviral vector (1.2.3. section of supplemental data). Although Zhang does not disclose sequence for 3H-IGF-1-P2-Luc, it still meets this claim limitation because it has same name and structure as shown in Figure 1A of Zhang. Therefore, the disclosure from Zhang anticipates claims 1-5.
Regarding claim 7, Zhang teaches lentivirus-containing supernatants were harvested on two consecutive days and concentrated. Although Zhang does not specify how the virus are concentrated, it is well known in the art that ultracentrifugation is routinely used to concentrate lentiviruses for producing high titer as evidenced by teaching from Tiscornia (Nature Protocols, 2006, Vol.1, No.1, pages 241-245, esp. page 243, paragraph 12).
Regarding claims 8 and 9, Zhang teaches target cells after screening using antibiotics following infection (section 1.2.3 supplemental data).
Regarding claim 10-13, Zhang teaches cells expressing GHR and STAT5B were obtained by antibiotic selection and limited dilution, followed by culturing cells after limited dilution (section 1.2.3 supplemental data).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Response to Arguments
Applicant states that an English translation of the priority document is submitted with the response.
However, no translation of said application has been received in accordance with 37 CFR 1.55.
Applicant argues that Zhang does not teach “transfecting cells with plasmids for stably expressing GHR, STAT5B, and 3H-IGF-1-P2-Luc reporter genes mix with plasmids pMD2.G and pSD, respectively.”
This argument is not persuasive because section 1.2.3 of Zhang teaches packaging plasmids encoding HIV-1 gag-pol, and VSV-G envelope, which is required to produce lentivirus stably expressing GHR, STAT5B, and 3H-IGF-1-P2-Luc reporter genes. Therefore, Zhang teaches each and every element of claim 1 and dependent claims thereof.
Conclusion
THIS ACTION IS MADE FINAL. 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 CELINE X QIAN whose telephone number is (571)272-0777. The examiner can normally be reached M-F (8-4:00).
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, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CELINE X QIAN/Primary Examiner, Art Unit 1637