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 .
DETAILED ACTION
The amendment filed December 8, 2025, is acknowledged and has been entered. Claim 23 has been amended.
Claims 23-44 are pending in the application. Claims 28-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected species of the invention, there being no allowable generic or linking claim.
Claims 23-27 and 42-44 are under examination. The species of heteromultimer with a specific combination of substitutions with a first CH3 with a K370D substitution and a second CH3 with E357K and K360E substitutions is under consideration.
Information Disclosure Statement
The information disclosure statement has been considered.
Claim Rejections - 35 USC § 102
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 23-27 and 42-44 are rejected under 35 U.S.C. 102(a)(1) or 35 U.S.C. 102(a)(2) as being anticipated by Liu et al (US 2014/0112926 A1).
With respect to claims 23-27 and 42-43, Liu et al disclose methods of modifying IgG1 Fc regions using genetic engineering techniques and PCR that include making an amino acid modification in a first CH3 domain of K370D and making amino acid modifications in a second CH3 domain of E357K and K370D wherein the numbering is according to the EU index (see entire document, e.g., pages 6 and 10-12).
With respect to claim 44, Liu et al disclose that the heterodimer can be a bispecific or multispecific antibody (see pages 6, 11, 13 and claims).
Then with respect to the intended use of stabilizing the heteromultimer at about pH 5.0, Applicant has amended claim 23 to append the intended use of the preamble into the body of the claim which now recites “introducing an amino acid modification at position K360 of the first CH3 domain to stabilize the heteromultimer at about pH 5.0”. As set forth in MPEP 2103:
The following types of claim language may raise a question as to its limiting effect:
(A) statements of intended use or field of use, including statements of purpose or intended use in the preamble,
(F) terms with associated functional language.
Accordingly, intended use or terms with associated functional language recited in the body of the claim also raises a question as to its limiting effect. While the claim has been amended to append the intended use onto the process step and recites functional language, the process step still stands on its own because the method step recites introducing an amino acid modification at position K360 of the CH3 domain to achieve the intended use of stabilizing (functional language) the heteromultimer at about pH 5.0. This appended phrase could also be characterized as an intended result (as evidenced by Applicant’s reply that the amendment was made “to clarify the purpose of introducing the K360 modification”, but merely reciting an intended result also does not distinguish a method claim from the prior art when it simply expresses the intended result of a process step positively recited (see MPEP 2111.04). The amino acid modification at position K360 of the CH3 domain achieves the use or result, so prior art that teaches the same modification also must necessarily achieve the same use or result.
Accordingly, Liu et al anticipate the claims absent a showing otherwise.
Applicant has traversed the rejection arguing that “Liu fails to disclose or suggest introducing an amino acid modification at position K360 of the first CH3 domain to stabilize the heteromultimer at about pH 5.0”. In response, Liu et al disclose methods of modifying IgG1 Fc regions using genetic engineering techniques and PCR that include making an amino acid modification in a first CH3 domain of K370D and making amino acid modifications in a second CH3 domain of E357K and K370D wherein the numbering is according to the EU index which is materially and manipulatively indistinguishable from the claimed method. Merely appending an intended use or result by adding functional language necessarily present in the claimed method onto the method step does not distinguish the claimed method from the prior art method.
As set forth in MPEP 2145 .“Granting a patent on the discovery of an unknown but inherent function "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.)” In this case, granting the claimed methods would prevent others from using the methods of modifying IgG1 Fc regions using genetic engineering techniques and PCR that include making an amino acid modification in a first CH3 domain of K370D and making amino acid modifications in a second CH3 domain of E357K and K370D wherein the numbering is according to the EU index disclosed by Liu, so the rejection is being maintained.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
January 9, 2026