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
Applicant’s election of Group II, claims 17-19 in the reply filed on 12/22/2025 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Claims 1-16 and 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/22/2025.
Status of the Claims
In response to the Notice to File Corrected papers mailed on 9/27/2023, Applicant
filed a substitute specification. In this response originally filed claims of 5/22/2023 (improperly multi-dependent, claims 1-21) were resubmitted on 11/29/2023, however on 5/22/2023 as part of a preliminary amendment, Applicant filed amended claims (claims 1-22) to correct for the improperly multiple dependent claims. While the originally filed (non-amended) claims of 5/22/2023 are currently the most recent claims of record, in the interest of compact prosecution it is the amended claims of 5/22/2023 which are under examination.
Claim Objections
Claim 18 is objected to because of the following informalities: claim 18 is not formatted correctly and the bullet points before steps (c) and (d) should be removed. Appropriate correction is required.
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 19 is 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.
The term “more homogenously” in claim 19 is a relative term which renders the claim indefinite. The term “more homogenously” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of how a polypeptide chain is more homogenous is unclear since the term “more” is a relative term with respect to determining homogeneity between two polypeptide chain samples.
The term “correctly assembled” in claim 19 is a relative term which renders the claim indefinite. The term “correctly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “correctly” is a relative term since what can be considered correct by one of ordinary skill in the art may differ from others skilled in the art.
The term “relative amount” in claim 19 is a relative term which renders the claim indefinite. The term “relative amount” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “relative amount” is a relative term since what can be considered a relative amount by one of ordinary skill in the art may differ from others skilled in the art.
Claim 19 recites the limitation "the antibody product" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the relative amounts of correctly assembled antibody constructs" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (WO 2015/175639 A1) in view of Mikayama et al. (US Pat. No. 8,003,106, issued 8/23/2011).
Regarding claim 17, Wilson et al. teach a method of making an antibody construct by:
(a) providing a host cell comprising a nucleic acid encoding an antibody construct comprising at least three different polypeptide chains wherein:
the antibody comprises a heavy chain,
at least two different polypeptide chains of the antibody construct are encoded in the same ORF; and
consecutive polypeptide chains encoding within the ORF are connected by a 2A peptide (see Abstract, Fig. 1A/B, Fig. 2 - reproduced below, pg. 2 lines 8-16 and Example 2).
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Wilson continues to teach that they successfully produced their antibody in culture and that the antibody was functional via binding in an ELISA assay (see Examples 2 and 3).
Wilson does not teach:
(b) cultivating the host cell for production of the antibody construct; and
(c) obtaining the antibody construct from the cell culture.
While Wilson teaches successful production of an antibody in culture from an AAV comprising a vector encoding an antibody as claimed, Wilson only teaches isolation of the AAV from culture and not the antibody produced. However, it would have been obvious at the time of filing to isolate an antibody from culture.
Regarding cultivating a host cell and obtaining an antibody in claims 17 and 18, Mikayama et al. teach a method of cultivating a host cell and isolating an antibody from the host cell (claim 58, col. 16 line 49 bridge col. 17 line 3 and col. 43 lines 14-37).
Regarding the functional limitations in claim 19, as taught above, Wilson teaches functional expression of their antibody and subsequent binding in an ELISA assay, thus the antibody produced was assembled and functional. Since Wilson teaches the exact same structural arraignment of heavy/polypeptide chains and ORFs as recited in the claims, the function of antibody would be identical to the recited functions claimed in claim 19 and thus any functional limitations recited in claim 19 would be inherent to the antibody construct taught by Wilson.
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of Wilson regarding a method of producing an antibody construct with the teachings of Mikayama regarding isolating antibodies from cell culture to arrive at the claimed invention.
One or ordinary skill in the art would have been motivated to make such a combination since Mikayama teaches that at the time of filing that antibodies could routinely be isolated from cell culture from antibody expressing cells.
There would have been a reasonable expectation of success that the antibody construct produced in Wilson could be isolated from their cell culture since Mikayama teaches successful isolation of antibodies from cell culture.
Thus the cited art provides the requisite teaching and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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