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 .
Please note that the correspondence for this application has changed (below).
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 April 2026 has been entered.
Response to Amendment
Claims 1-53, 55-58, 60-61, 64-69, 71-72, and 78-81 are cancelled. Claims 54 and 63, have been amended and Claim 82 has been newly added as requested in the amendment filed on 15 April 2026. Following the amendment, Claims 54, 59, 62-63, 70, 73-77 and 82 are pending in the instant application.
Claims 62 and 73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 54, 59, 63, 70, 74-77 and 82 are under examination in the instant office action.
Withdrawn Rejections:
As currently amended, the rejection of Claims 54, 59, 63, 70, 74-77, and 82 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, new matter written description, is withdrawn. The independent claim 54 has been amended to remove language directed to the tailpiece deletion and to remove reference to the residues that were the subject of the previous new matter rejection (ex. N459). Applicant’s arguments are persuasive to overcome the rejection. The specification provides written support for “optimizing glycosylation” throughout. Figure 12A describes the asparagine residues that are conserved N-glycosylation consensus sequences that are now recited by instant claim 54; and these are the specific residues N459 and N263, as currently recited in new claim 82 (see pg. 8 Remarks, second paragraph). With respect to written description, the courts have said that one need not describe what is known in the art. Between the guidance in the disclosure as filed, and with what was known regarding these analogous sites in the art of record (specifically Chuang and Rifai), the examiner finds that there is adequate written description for the invention as currently claimed. Therefore, Applicant has demonstrated written support for all of the elements of the claims as currently amended, and the rejection is withdrawn.
As currently amended, the rejection of Claims 54, 57, 59, 74, 76, 78-80 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph set forth in the previous action, is withdrawn. The independent claim no longer recites residues N459 and N26 and the indefinite “or” conjunction has been removed. Thus, the rejection is withdrawn.
The rejection of Claims 63, 68, 69, 70, 75, 77, 81 under 35 U.S.C. 103 as being unpatentable over Lohse (Cancer Res; 76(2) January 15, 2016)(published online first December 3, 2015)(of record) and further in view of Atkin (J Immunol 1996; 157:156-159)(of Record), is withdrawn. As currently amended, the claims no longer recite the deletion of the tailpiece region (18 amino acids) (Bur scheme residues 455-472).
The rejection of Claims 54, 57, 58, 59, 74, 76, 78, 79, 80 under 35 U.S.C. 103 as being unpatentable over Lohse and further in view of Chuang and Rifai, is withdrawn. As currently claims do not recite the C terminal tailpiece N459 (Bur Scheme) in an IgA2(m)(1). Chuang and Rifai were relied upon as teaching variants of the IgA1 which are mutated at the locations of N263 (CH2) region and/or N459 (tailpiece,CH3) to remove N glycosylation sites. However, neither Lohse nor Chuang taken with Rifai teach the amino acid changes within SEQ ID NO:11 as currently claimed.
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.
As currently amended, Claims 54, 59, 63, 70, 74-77 and 82 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 is indefinite wherein it recites, “(vii) at least one substitution of an asparagine amino acid that is a conserved N-glycosylation site of a corresponding wildtype IgA2 heavy chain constant region”. There is no explicit definition within the disclosure for “conserved N-glycosylation sites” and SEQ ID NO: 11 provides no details about what asparagines are conserved. Thus, when read in light of the specification as a whole, it is unclear what the metes and bounds of “an asparagine amino acid that is a conserved N-glycosylation site” encompass. Applicant may obviate this rejection by clearly indicating which asparagine residues these correspond to within SEQ ID NO:11. This rejection affects the scope of all depending claims.
Claim 54 is further indefinite because it recites functional language that imposes no structural/material limitation upon the scope of the product claim. The invention is directed to a dimeric engineered antibody but the claim recites, “wherein said dimeric engineered antibody comprising said modified IgA2 heavy chain constant region exhibits reduced glycosylation relative to a corresponding dimeric engineered antibody comprising an IgA2 heavy chain constant region that does not comprise said at least one glycosylation reducing amino acid change, wherein said dimeric engineered antibody exhibits an increased serum half- life, as compared to an IgA2 antibody comprising an amino acid sequence of SEQ ID NO: 11, and wherein said engineered dimeric antibody comprising said modified IgA2 heavy chain constant region, when administered to a subject in need thereof, exhibits reduced dose-dependent toxicity relative to corresponding IgG antibody comprising the same antigen binding domain.” It is unclear whether the scope of the claim requires assessing “reduced glycosylation”, “increased serum half- life” and “reduced dose-dependent toxicity” upon administration to a subject in need thereof. For purposes of applying prior art, these limitations will be interpreted as mere inherent effects of the engineered dimeric antibody that comprises all of the material limitations set forth in the claim. In this way, Applicant may eliminate the functional language of the claim and have the claim read upon the same material/structural scope. Or, if Applicant wishes the functional language to remain, an acknowledgement that these limitations merely read upon inherent features of the product invention, and do not require methodology for infringement, would obviate this rejection.
Similarly, Claim 63 is indefinite wherein it “a tailpiece region with respect to SEQ ID NO: 13”. When read in light of the specification, Figure 12A appears to indicate the region of the tailpiece, however from the drawing, it is not clear what residues are encompassed (see reproduction below). Applicant may obviate this rejection by stating what residues correspond to the “tailpiece” of SEQ ID NO: 13. This rejection affects the scope of all depending claims.
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Claim 63 is further indefinite wherein it recites, “wherein said engineered monomeric antibody comprising said modified IgA2 heavy chain constant region has an increased serum half-life, as compared to a wildtype IgA2 antibody comprising said wildtype IgA2 heavy chain constant region, and wherein said engineered monomeric antibody comprising said modified IgA2 heavy chain constant region, when administered to a subject in need thereof, exhibits reduced dose-dependent toxicity relative to corresponding IgG antibody comprising the same antigen binding domain” These limitations fail to impose any material/structural difference upon the scope of the claim. It is unclear if infringement occurs with the composition itself, or if assessing increased serum half-life, etc. are required for infringement. For purposes of applying prior art, these limitations will be interpreted as merely inherent effects of the engineered dimeric antibody that comprises the material limitations set forth in the claim. This rejection affects the scope of all depending claims. As stated above, Applicant may eliminate the functional language of the claim and have the claim read upon the same material/structural scope. Or, if Applicant wishes the functional language to remain, an acknowledgement that these limitations merely read upon inherent features of the product invention, and do not require methodology for infringement, would obviate this rejection.
Claims 59, 70, and 76-77 are indefinite wherein they recite a product and a process in the same claim. MPEP 2173.05(p)(II) states: “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112, second paragraph.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303 (Fed. Cir. 2011). In Katz, a claim directed to “A system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. In re Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.2d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); < Ex parteLyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph). The case law applies to the instant claim(s) which recite because the invention is a composition but the claim recites “wherein the …antibody exhibits antibody-dependent cell mediated cytotoxicity (ADCC) as measured in suitable in vitro ADCC assay.” For both claims 59 and 70, it is unclear whether infringement of these claims occurs with the pharmaceutical composition or upon assessing ADCC after performing an assay. This affects the scope of depending claims 76 and 77, which merely further limit the ADCC assay. For purposes of applying prior art, these claims will be interpreted as being anticipated by the structure/material product of the parent claim.
Claim 82 depends from claim 54 which recites in part “(vii) at least one substitution of an asparagine amino acid that is a conserved N- glycosylation site of a corresponding wildtype IgA2 heavy chain constant region”, and claim 82 states, “wherein said conserved N-glycosylation site is selected from a group consisting of an amino acid residues N459 and N263, numbering of each according to Bur scheme, which corresponds to N329 and N147 of SEQ ID NO: 11, respectively.” However, as one can see from the sequence of SEQ ID NO: 11 (reproduced on the next page below), residue 147 is not an asparagine but it is Alanine (see square within sequence).
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Therefore, when read in light of the specification, the scope of the claim is indefinite and the claim is rejected.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675
