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 .
Status of Claims
Claim 1 was originally filed on April 19, 2023.
The amendment received on July 10, 2024, amended claim 1; and added new claims 2-8. The amendment received on March 31, 2025, amended claim 1.
Claims 1-8 are currently pending and is under consideration.
Priority
The present application is a continuation of U.S. Non-Provisional Application No. 16/688,772, filed November 19, 2019, which is a continuation of U.S. Non-Provisional Application No. 15/985,288, filed May 21, 2018, which is a continuation of U.S. Non-Provisional Application No. 15/028,917, filed April 12, 2016, which claims status as a 371 (National Stage) of PCT/US2014/060363 filed October 14, 2014, and claims priority under 119(e) to U.S. Provisional Application No. 61/891,778 filed on October 16, 2013.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 12, 2025, is being considered by the examiner. Please note that the FP documents A9, A11-A14, and A16 have been crossed out and not considered because an English language abstract, statement of relevance or English equivalent has not been provided pursuant to 37 CFR 1.98.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Regarding claim 1, it is noted that the instant specification defines “IVIG” as a preparation of pooled, polyvalent IgG, including all four IgG subgroups, extracted from plasma of at least 1,000 human donors (See instant specification, pg. 6, last paragraph). As such, the instantly claimed IVIG are full length immunoglobulin antibodies. Thus, the claimed IVIG would necessarily have Fab and Fc domains containing glycan motifs. Further, it is noted that the claimed invention does not encompass IVIG fragments such as Fc fragments or Fab fragments.
Additionally, with respect to an ST6 sialyltransferase, the instant specification defines “ST6 sialyltransferase” as a polypeptide whose amino acid sequence includes at least one characteristic sequence of and/or shows at least 70% identity with a protein involved in transfer of a sialic acid to a terminal galactose of a glycan through an alpha 2,6 linkage (See instant specification, 5th paragraph). Thus, the claimed ST6 sialyltransferase used to sialylate the IVIG encompasses any sialyltransferase that is involved in transferring a sialic acid to a terminal galactose of a glycan through an alpha 2,6 linkage.
Maintained/Modified Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,661,456 B2 (Schultes et al.) in view of Kasermann et al. U.S. Publication No. 2012/0009189 A1 published on January 12, 2019.
Schultes et al. claims:
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(See Schultes claim 1 corresponds to previously pending claim 31). As such, the ‘288 claimed preparation satisfies the claim limitations with respect to a pharmaceutical preparation comprising sialylated IVIG wherein at least 80% of the branched glycans in the Fc domain are sialylated on both the alpha-1,3 arm and the alpha-1,6 arm by way of NeuAc-alpha 2,6-Gal terminal linkages and where at least 60% of the branched glycans in the Fab domain are sialylated on the both the alpha-1,3 arm and the alpha 1,6 arm (i.e., di-sialylated) by way of NeuAc-alpha 2,6-Gal terminal linkages as recited in instant claim 1. Claims 2-4 of the ‘456 further limit the method of using the pharmaceutical preparation.
Schultes et al. does not claim where at least 65% of branched glycans are sialylated on both the alpha-1,3 arm and the alpha-1,6 arm by way of NeuAc-alpha 2,6-Gal terminal linkages as recited in instant claim 1. However, given that Schultes expressly claims the di-sialylation percentages in the Fab and Fc domains by way of NeuAc-alpha 2,6-Gal terminal linkages, it must follow that the level of total sialylation of branched glycans on both the alpha-1,3 arm and the alpha-1,6 arm by way of NeuAc-alpha 2,6-Gal terminal linkages is at least 65%. Thus, Schultes’ claimed invention inherently encompasses where at least 65% of branched glycans are sialylated on both the alpha-1,3 arm and the alpha-1,6 arm by way of NeuAc-alpha 2,6-Gal terminal linkages as recited in instant claim 1.
Moreover, the ‘456 claimed invention does not expressly claim where the sialylated IVIG is sialylated in vitro via a ST6 sialyltransferase as recited in instant claims 1-3, the means of administration as recited in instant claims 4-6 and 8, and where the preparation is formulated in a sterile composition in combination with a vehicle as recited in instant claims 7-8.
Regarding the method of sialylating IVIG as recited in instant claims 1-3, this limitation constitutes a product-by-process. Pursuant to MPEP 2113, the Federal Circuit has found that "[e]ven through product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim in the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, the Federal Circuit found that “[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.” See Amgen, Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). Although ‘456 does not expressly claim that the IVIG is sialylated in vitro via a ST6 sialyltransferase such as a ST6GalI having a specific amino acid sequence, such limitations are not structural limitations of the resulting sialylated IVIG preparation. Thus, the ‘456 claimed invention renders obvious the instant product-by-process limitations.
Regarding the means of administering the preparation, although ‘456 does not expressly claim how the preparation is administered to the subject in order to increase reticulated platelets, it is unnecessary for the ‘456 claimed invention to teach these limitations because the means by which the preparation is administered does not state a condition that is material to patentability or provide a structural limitation that would further limit the claimed preparation. The court has found that the determination of whether clauses such as “wherein” and “whereby" is a limitation in a claim is dependent on the specific facts of the case. If the “wherein" or “whereby” clause limits a process claim where the clause gives meaning and purpose to the manipulative steps, it should be given patentable weight. However, the court also found (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” In the instant case, means by which the preparation is administered is an intended result of the claimed preparation that gives little meaning and purpose to the structure of the claimed preparation other than requiring the preparation to be in a form capable of being administered via these routes, e.g., in the form of a solution. Thus, the ‘456 claimed invention satisfies the claim limitations as recited in instant claims 4-6 and 8.
Regarding the composition being sterile as recited in instant claim 8, although ‘456 does not claim that the preparation is formulated as a sterile composition, it would necessarily follow that the ‘456 preparation is a sterile composition given that the ‘996 preparation is to be administered to a subject for treatment. Therefore, the ‘456 claimed invention is not patentably distinct from the instantly claimed invention.
Applicants’ Arguments
Applicants contend that the rejection should be withdrawn given that Applicant filed a corrected ADS to indicate that the instant application is a divisional of US Application No. 15/985,288, and thus, the 121 Bar applies precluding an obviousness-type double patenting rejection to be made (See Applicants Response received on 12/12/25, pg. 5).
Response to Arguments
Applicant's arguments filed 12/12/25 have been fully considered but they are not persuasive. Applicant’s corrected ADS received on 12/12/25 is acknowledged. However, an updated filing receipt has not yet been mailed out. It is noted that the Examiner does not handle consideration of corrected ADSs and cannot issue an updated filing receipt. Given that the filing receipt has not yet been updated and the priority chain of the instant application has not yet been perfected, the rejection over the ‘288 application is maintained.
Examiner Comment
Notwithstanding the obviousness-type double patenting rejection, it is noted that the instantly claimed IVIG in the pharmaceutical preparation requires a particular structure; namely, at least 60% of the branched glycans in the Fab domain are sialylated on both the α 1,3 arm and the α 1,6 arm by way of NeuAc-α 2,6-Gal terminal linkages and at least 80% of the branched glycans in Fc domain are sialylated on both the α 1,3 arm and the α 1,6 arm by way of NeuAc-α 2,6-Gal terminal linkages whereby at least 65% of the total branched glycans are sialylated on both the α 1,3 arm and the α 1,6 arm by way of NeuAc-α 2,6-Gal terminal linkages. However, there is no motivation in the prior art to achieve at least 60% sialyation of the branched glycans in the Fab domain.
The closest prior art regarding sialyation of IVIG in the Fab domain is Kasermann et al. U.S. Publication No. 2012/0009189 A1 published on January 12, 2019 (cited in the Action mailed on 4/12/21). Kasermann et al. teaches a population of antibodies, preferably IVIG, obtainable by enrichment by an antibody preparation, wherein the enriched population of antibodies has an altered amount of sialylation in the Fab region of the antibodies as compared to the antibody preparation prior to enrichment. Moreover, Kasermann et al. examined the glycan profile of Fab fragments in Example 4 (See Kasermann specification, paragraph [0136]-[0137]; Example 4). As depicted in Figure 4, there are three N-glycan motifs disialylated on both the alpha-1,3 arm and alpha-1,6 arm, i.e., A2, A2F, and A2F+HexNac, and linked to galactose moieties (See Kasermann specification, paragraph [0139]; Figure 4). As such, Figure 4 depicts the total level of sialylated N-glycans in the Fab region as approximately 50% (i.e., ~5% for A2 and ~22.5% for A2F and A2F+HexNac). Notably, Kasermann et al. found that the sialylation level within the Fc region did not increase significantly in the presence of sialic acid, i.e., from 10.3% to 12.1%. Although, Wang et al. U.S. Publication No. 2015/0087814 A1 published on March 26, 2015 (effective filing date of February 10, 2012) (cited in the Action mailed on 8/11/20) teaches methods of increasing the sialylation level within the Fc domain to greater than 90%, these methods do not alter the sialylation level within the Fab domain. As such, an ordinary skilled artisan would not be motivated with a reasonable expectation of success to increase the sialylation level within the Fab domain of IVIG to at least 60% because Kasermann only achieves about 50% sialylation within the Fab domain and Wang only increases the sialylation level within the Fc domain. Therefore, the instantly claimed sialylated IVIG in the pharmaceutical preparation containing a structural component (i.e., at least 60% of the branched glycans in the Fab domain are sialylated) is free of the prior art.
Conclusion
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 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 THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached on M-F 11:00 to 8:00 pm.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654