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 .
Application Status
This action is written in response to applicant’s correspondence received 03/24/2026. Claims 9, 39, 49-50, 52-54 and 56 are currently pending. Claims 15-16, 45-46 and 51 were cancelled by the Applicant in the amendments received on 03/24/2026.
Claim 9 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 39, 49-50, 52-54 and 56, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 10/07/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Any rejection or objection not reiterated herein has been overcome by amendment. Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 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, provisional Application No. 63/049,380, filed 07/08/2020, fails 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.
Claim 9 is drawn to an isolated nucleic acid encoding an immunoglobulin heavy chain wherein the nucleotide sequences of introns 1, 2 and 3 have been deleted, and the nucleotide sequence of intron 3 has been replaced with that of intron 1. However, the prior filed application only discloses immunoglobulins which have had either all 3 introns or only intron 2 deleted (see p. 42/46, slide 21). The prior filed disclosure is silent regarding substitution of intron 3’s sequence with that of intron 1. Accordingly, claim 9 is not entitled to the benefit of the prior application.
Response to Arguments
Applicant’s argument that, “the disclosure of prior filed application 63/211,648, filed 06/17/2021, provides adequate support and enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of the application, and including Claim 9” (see the remarks of 03/24/2026, p. 1). Applicant’s argument is acknowledged. For clarification, it is further respectfully noted that the statement above specifically regards provisional application number 63/049,380, filed 07/08/2020, not application number 63/211,648, filed 06/17/2021. Accordingly, while it is acknowledged that application number 63/211,648 provides adequate support, application number 63/049,380 does not, as described above.
The instant claims enjoy a priority date to the provisional application filed on 06/17/2021.
Claim Rejections - 35 USC § 112(b)
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.
Claims 52-54 and 56 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.
Claim 54 recites the limitation "the immunoglobulin”. There is insufficient antecedent basis for this limitation in the claim. Claim 39, from which claim 54 depends, recites multiple immunoglobulins, including the human IgG immunoglobulin produced by the method in the host cell and the control immunoglobulin and host cell expressing it.
Claims 53 and 54 recite a pool of clones. This language is considered indefinite because it is not clear from which host cell the pool of clones is derived.
Claims 52 and 56 are indefinite because they depend on cancelled claims 51 and 55, respectively.
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
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 39, 49-50, 52-54 and 56 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of producing a human IgG1 immunoglobulin, does not reasonably provide enablement for a method of producing the full scope of the genus of IgG immunoglobulins. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claim 39 is drawn to a method of producing a human IgG immunoglobulin. The method comprises a step of culturing a host cell in a medium under conditions in which the cell expresses the immunoglobulin, wherein the host cell expresses the intact immunoglobulin heavy chain at a higher titer than a host cell comprising a nucleic acid encoding an immunoglobulin heavy chain comprising either all of introns 1-3 or none of introns 1-3 in the immunoglobulin heavy chain constant region nucleic acid.
Claim 9, from which claim 39 depends, is drawn to an isolated nucleic acid comprising a nucleotide sequence encoding a human IgG1 immunoglobulin heavy chain, which is a species within the genus of IgG immunoglobulins. The specification exemplifies the nucleic acid of claim 9 (FIG. 6B, ‘1 in 3’), which produces a higher titer of IgG1 than the gDNA comprising all three introns, or than the gcDNA/WT gcDNA (i.e., a sequence from which all three introns have been removed). However, claim 39 is missing the method steps necessary to produce the full genus of IgG based on the limited method steps provided, using the specific isolated nucleic acid encoding solely a human IgG1 as recited in claim 9 and disclosed by the instant specification. Per Vidarsson, there are four human IgG subtypes, which differ in their constant regions and have different effector functions (Vidarsson et al. IgG subclasses and allowtypes: from structure to effector functions.)(Abstract). Given that the four subtypes are structurally distinct genes encoded by structurally distinct coding sequences, the ordinary artisan would not expect that a nucleic acid encoding a human IgG1 heavy chain region would successfully express, for example, a human IgG4 region. As a result, the claim is not enabled for the full scope of all human IgG immunoglobulins.
REASONS FOR ALLOWANCE
The prior art does not teach or suggest an isolated nucleic acid comprising a nucleotide sequence encoding a human IgG1immunoglobulin heavy chain, wherein the nucleotide sequence of intron 1 of the human immunoglobulin heavy chain constant region is deleted from its native position and the nucleotide sequence of intron 2 and intron 3 of the human immunoglobulin heavy chain constant region are deleted, and wherein the nucleotide sequence of intron 3 is substituted with the nucleotide sequence of human intron 1, as recited in claim 9.
The closest prior art is WIPO Publication 2006/041934 A2 to Sinacore (cited on an IDS), as discussed in the office action of 01/02/2026. As described in that office action, Sinacore teaches nucleic acids encoding human IgG1 or IgG4 heavy chain constant regions (p. 3 ln 19-20; p. 6 ln 18-31), in which the three introns of the heavy chain constant region are deleted (p. 4 ln 4-7, Figure 7). Sinacore does not teach the nucleic acids encoding an IgG1 heavy chain constant region in which the three introns are deleted and intron 3 is substituted with the sequence of intron 1 (i.e., intron 1 has effectively been inserted into the site previously occupied by intron 3). Sinacore further suggests generally rearranging the 5’-3’ order of the introns (p. 3 ln 10-11) or retaining one intron, but does not exemplify either approach, and is thus silent as to the effects of those changes on harvest titer.
Sinacore differs from the instantly claimed invention in that it does not explicitly suggest substituting intron 3 with the nucleotide sequence of intron 1. However, the instant specification provides objective evidence of nonobviousness. As noted by Applicant on page 5 of the remarks received 03/24/2026, the instant specification evidences that the instantly claimed nucleic acid showed unexpectedly superior results to that of the prior art. FIG. 6B shows that the cDNAs (i.e., sequences from which all introns had been removed), which are the closest analogue to the constructs taught by Sinacore, yielded a significantly lower titer than the ‘1 in 3’ (intron 1 in intron 3’s position) construct.
Conclusion
Claim 9 is allowed.
Applicant's 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 AMANDA M ZAHORIK whose telephone number is (703)756-1433. The examiner can normally be reached M-F 8:00-16:00 EST.
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/A.M.Z./ Examiner, Art Unit 1636
/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636
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