DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicants’ response of 12/23/2024 has been received and entered into the application file. Claims 1-9 remain pending.
Election/Restriction
Applicants previously elected Group 1, drawn to a method for producing a monoclonal antibody, and the species wherein SEQ ID NO: 1 is the antigen. The originally elected species has been cancelled, thus examination has been extended to a different species: a method of producing a monoclonal antibody wherein SEQ ID NO: 3 is the antigen.
Claims 1-6 read on the examined species of the elected invention. Claims 7-9 are withdrawn from consideration as being directed to non-elected species and/or inventions.
Priority
Acknowledgement is made of Applicants’ claim for benefit under 35 USC 121 as a divisional of prior-filed US application no 16/793780 (filed 2/18/2020, now abandoned), which claims benefit under 35 USC 120 as a continuation of prior-filed US application no 14/653759 (filed 6/18/2015, now abandoned), which is a national stage entry under 35 USC 371 of PCT/US13/77299 (filed 12/20/2013), which claims benefit under 35 USC 119(e) to prior-filed US Provisional application no. 61/745007 (filed 12/21/2012).
Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 121, 120 or 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos 16/793780, 14/653759 (PCT/US13/77299) and 61/745007, all fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, while all of the prior-filed applications provide support for ‘a monoclonal antibody that binds to SEQ ID NO: 3’, none of the prior-filed applications provide support for ‘a method of producing said monoclonal antibody [via the steps of current claim 1]’.
It is recognized that each of the prior-filed applications provides general mention that the monoclonal antibodies “may be made by the hybridoma method first described by Kohler et al, Nature 256: 495 (1975)” (See ¶0034 of 61/745007, ¶0038 of the non-provisional applications); however, none of the original filings provide details of the hybridoma method. While it is recognized the ‘hybridoma method’ disclosed by Kohler et al involves the claimed steps, and Kohler is incorporated by reference, essential details (such as the steps required in a claimed method) cannot be incorporated by reference through NPL.
The first disclosure of the currently claimed method is in the original claims of the instant application (filed 4/10/2023). Thus the effective filing date of the current claims is considered the filing date of the instant application: 4/10/2023. (It is noted that in application 16/793780, the currently claimed subject matter was introduced into the claims in an amendment filed 7/17/2020; however, as this was not part of the original disclosure of the application, it was new matter as of filing of the 7/17/2020 amendment and cannot be relied upon for an earlier effective filing date).
Status of Previous Rejections/Response to Arguments
RE: Priority:
Applicants have traversed the holding that the first disclosure of the current claims is in the current application. Applicants assert that the detailed steps recited in the current claims are described in Kohler et al (Nature, 1975).
Applicants’ arguments are unpersuasive of error. As was previously stated, and reiterated above: It is recognized that each of the prior-filed applications provides general mention that the monoclonal antibodies “may be made by the hybridoma method first described by Kohler et al, Nature 256: 495 (1975)” (See ¶0034 of 61/745007, ¶0038 of the non-provisional applications); however, none of the original filings provide details of the hybridoma method. While it is recognized the ‘hybridoma method’ disclosed by Kohler et al involves the claimed steps, and Kohler is incorporated by reference, essential details (such as the steps required in a claimed method) cannot be incorporated by reference through NPL.
The effective filing date of the current claims is 4/10/2023.
RE: Rejection of claims 1-6 under 35 USC 102(b) over Abo et al: Applicant have traversed on the grounds that the claims have been amended to no longer recite SEQ ID NO: 2 as the antigen.
The amendment is effective to overcome the previous issue. However, a new ground of rejection is made over the same reference for the modified claim scope.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-6 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Abo et al (WO 09/064944).
Abo et al disclose anti-Lrp6 antibodies and methods of producing such (See abstract).
Abo et al describe production of anti-Lrp6 antibodies at page 103-109.
Regarding claims 1-6: Abo et al teach Lrp6 antigens can be used to produce Lrp6-specific polyclonal and monoclonal antibodies (See Pg 103, ln 18-20). In certain embodiments the antibodies can be produced by immunizing with full-length Lrp6 (i.e. SEQ ID NO: 2) (See Pg 103, ln 32-33). Full-length Lrp6 (SEQ ID NO: 2 of Abo et al) contains SEQ ID NO: 3 of the instant application: Qy: SEQ ID NO: 2 of Abo et alDb: SEQ ID NO: 3 of instant application
ALIGNMENTS
RESULT 1
US-18-298-105-3
Query Match 0.8%; Score 68; DB 1; Length 14;
Best Local Similarity 100.0%;
Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 567 VIIDQLPDLMGLKA 580
||||||||||||||
Db 1 VIIDQLPDLMGLKA 14
Abo et al teach monoclonal antibodies can be produced in a mammal of interest using the standard somatic cell hybridization technique of Kohler and Milstein (Nature, 256: 495 (1975)). Abo et al briefly describe the process in the murine system, in which mice are immunized with the antigen (i.e. full length Lrp6, which comprises SEQ ID NO: 3 of the instant application), B cells are isolated from the mice spleens, and then fused with immortalized fusion partner cells, such as murine myeloma cells, to form a hybridoma. Following fusion, the cells are cultured in a selective medium (e.g. HAT medium) to select hybridoma cells, then the selected hybridoma cells are cultured in vitro or in vivo to produce the antigen-specific antibodies (See Pg 104, ln 14-32 and Pg. 106, ln 7-18). The method of Abo et al anticipates the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633