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
Claim status
Claims 1-3 are pending
Claims 1-3 are under examination
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted.
Furthermore, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objection to Specification
Sequence Listing
The amendments filed in the Sequence Listing (XML filed) filed 11/21/2023, as well as the Sequence Listing in Computer Readable Format filed 1/22/2024 are objected to under 35 U.S.C. 132(a) because they introduce new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the sequence listings filed for SEQ ID NO: 1 comprise a single mismatch within SEQ ID NO:1 compared to the originally filed disclosure corresponding to V196J.
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Applicant is required to cancel the new matter, and file a corrected Sequence Listings in the reply to this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities: instant claim uses the abbreviation “ST6 Gal 1”, which has not been spelled out upon first use. Although claims are allowed abbreviations, only abbreviations that are well known and would be clear to someone who had not read the invention description.
Claim 1 is objected to because of the following informalities: instant claim comprises run-on sentences at “a galactose..” and at “an ST6-Gal1…”.
Appropriate correction is required.
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 1-3 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 1 recites the broad recitation "a galactose donor”, and the claim also recites “uridine-diphosphate galactose” which is the narrower statement of the limitation.
In addition, claim 1 recites the broad recitation "ST6 Gal 1 sialyltransferase”, and the claim also recites “ST6 beta-galactoside alpha-2,6-sialyltransferase 1 having at least 95% identity to amino acids 95-416 of SEQ ID NO:1” which is the narrower statement of the limitation.
In addition, claim 1 recites the broad recitation "sialic acid donor”, and the claim also recites “CMP-NANA” which is the narrower statement of the limitation.
Dependent claims 2 and 3 are included in the basis of this rejection because they do not clarify the full scope of donors and sialyltransferase.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Stadheim et al. (US2013/0071390, filed 5/25/2011, published 3/21/2013), in view of Barb et al., (Biochemistry, 2009, 48, 9705-9707)
Broad embodiment of ST6-Gal1
In regard to the preamble of claim 1, Stadheim teaches methods of producing sialylated IgG antibodies, wherein at least 60% of the branched glycans on the Fc domain of the IgG antibodies comprise a terminal sialic acid on both the alpha 1,3 arm and the alpha 1,6 arm of the biantennary glycan (Abstract, [0021, 0023-0024], see Claims 1, 2, 5, 7, 11, 23, and 26 of Stadheim). Specifically, Stadheim provides a preferred embodiment of disialylation of an Fc domain in a galactosyltransferase and ST6-Gal1 sialyltransferase expressing cell line, wherein the F243A/V264A mutations in the Fc domain increase the disialylated alpha-2,6 linkages (i.e, NANA2Gal2GlcNAc2Man3GlcNAc2 glycan) to 66% of the branched glycans ([0048, 0231], Example 9, Table 3, see Fig. 8).
However, in regard to claim 1, although the preferred embodiments of Stadheim for Fc galactyosylation and sialylation occur in cyto, Stadheim does teach in vitro methods for sialylation using a purified recombinant sialyltransferase (albeit ST3) in a buffer comprising necessary cofactors such as MnCl2 and a CMP-sialic acid donor, which are incubated for a sufficient time to allow sialylation (Example 21, [0312]).
Nevertheless, Stadheim is silent to a preferred embodiment of both galactosylation and ST6-Gal1 sialylation of the Fc domain in vitro, as well as including the step of adding addition CMP-NANA sialic acid donor to the sialylation reaction.
In regard to claim 1, Barb teaches the method steps galactosylation and ST6-Gal1 sialylation of the Fc domain in vitro. Specifically, Barb teaches the steps of providing a IgG Fc fragment and combining and incubating it with bovine beta 1,4 galactosyl transferase and UDP-galactose to allow galactosylation of branched glycans on the Fc fragment, which is followed by dialyzing and incubating for sufficient periods of time the galactosylated Fc domain with a sialylation mixture comprising human ST6 beta-glactoside alpha-2,6-sialyltransferase 1, CMP-NANA, and MnCl2 (see Remodeling the Fc N-glycans, 2nd para.). Furthermore, Barb teaches the periodic supplementation of CMP-NANA to the vitro sialylsation reaction (Remodeling the Fc N-glycans of Experimental Procedures of Barb).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have practiced the method of galactosylation and disialylation according to Stadheim in cyto and substitute the galactosylation and ST6-Gal1 sialylation steps of the Fc domain in vitro with supplementation of the CMP-NANA sialic donor as taught by Barb with a reasonable expectation of success. One of ordinary skill would have been motivated to do so for several reasons. First, Stadeim teaches that some of the problems with in cyto galactosylation/sialylation is the poor transport of donor molecules such as UDP-Gal into the Golgi apparatus of the cell, suboptimal cell culture and protein expression conditions, and steric hindrance by amino acid residues neighboring the oliogosaccharide [0102]. In addition, Barb teaches that another advantage of the in vitro reactions is the ease of analyzing each step to assess the completeness of the reactions. Furthermore, Barb teaches that periodic supplementation of the CMP-NANA generates an enzymatic reaction where donor substrate was not limiting because of the labile nature of the sugar nucleotide (Remodeling the Fc N-glycans of Experimental Procedures of Barb).
In regard to claim 2, both Stadheim and Barb teach and/or suggest the CMP-NANA donor (see [0021, 0092, 0313] of Stadheim, and Materials of Experimental Procedures of Barb).
In regard claim 3, as stated supra, Stadheim teaches the sialylation reaction comprises MnCl2, while Barb teaches both the galactosylation and sialylation reactions comprise MnCl2 (Remodeling the Fc N-glycans of Experimental Procedures), which would have been obvious to include in the in vitro reactions considering it was a known cofactor for catalysis.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Stadheim et al. (US2013/0071390, filed 5/25/2011, published 3/21/2013), in view of Barb et al., (Biochemistry, 2009, 48, 9705-9707) and Donadio et al., (Biochemie, 2003, 85:311-321), as evidenced by NCBI Reference sequence NP_001240845
Narrow embodiment of ST6-Gal1 with 95% identity to 95-416 of SEQ ID NO:1
In regard to the preamble of claim 1, Stadheim teaches methods of producing sialylated IgG antibodies, wherein at least 60% of the branched glycans on the Fc domain of the IgG antibodies comprise a terminal sialic acid on both the alpha 1,3 arm and the alpha 1,6 arm of the biantennary glycan (Abstract, [0021, 0023-0024], see Claims 1, 2, 5, 7, 11, 23, and 26 of Stadheim). Specifically, Stadheim provides a preferred embodiment of disialylation of an Fc domain in a galactosyltransferase and ST6-Gal1 sialyltransferase expressing cell line, wherein the F243A/V264A mutations in the Fc domain increase the disialylated alpha-2,6 linkages (i.e, NANA2Gal2GlcNAc2Man3GlcNAc2 glycan) to 66% of the branched glycans ([0048, 0231], Example 9, Table 3, see Fig. 8).
However, in regard to claim 1, although the preferred embodiments of Stadheim for Fc galactyosylation and sialylation occur in cyto, Stadheim does teach in vitro methods for sialylation using a purified recombinant sialyltransferase (albeit ST3) in a buffer comprising necessary cofactors such as MnCl2 and a CMP-sialic acid donor, which are incubated for a sufficient time to allow sialylation (Example 21, [0312]).
Nevertheless, Stadheim is silent to a preferred embodiment of both galactosylation and ST6-Gal1 sialylation of the Fc domain in vitro, as well as including the step of adding addition CMP-NANA sialic acid donor to the sialylation reaction.
In regard to claim 1, Barb teaches the method steps galactosylation and ST6-Gal1 sialylation of the Fc domain in vitro. Specifically, Barb teaches the steps of providing a IgG Fc fragment and combining and incubating it with bovine beta 1,4 galactosyl transferase and UDP-galactose to allow galactosylation of branched glycans on the Fc fragment, which is followed by dialyzing and incubating for sufficient periods of time the galactosylated Fc domain with a sialylation mixture comprising human ST6 beta-glactoside alpha-2,6-sialyltransferase 1, CMP-NANA, and MnCl2 (see Remodeling the Fc N-glycans, 2nd para.). Furthermore, Barb teaches the periodic supplementation of CMP-NANA to the vitro sialylsation reaction (Remodeling the Fc N-glycans of Experimental Procedures of Barb).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have practiced the method of galactosylation and disialylation according to Stadheim in cyto and substitute the galactosylation and ST6-Gal1 sialylation steps of the Fc domain in vitro with supplementation of the CMP-NANA sialic donor as taught by Barb with a reasonable expectation of success. One of ordinary skill would have been motivated to do so for several reasons. First, Stadeim teaches that some of the problems with in cyto galactosylation/sialylation is the poor transport of donor molecules such as UDP-Gal into the Golgi apparatus of the cell, suboptimal cell culture and protein expression conditions, and steric hindrance by amino acid residues neighboring the oliogosaccharide [0102]. In addition, Barb teaches that another advantage of the in vitro reactions is the ease of analyzing each step to assess the completeness of the reactions. Furthermore, Barb teaches that periodic supplementation of the CMP-NANA generates an enzymatic reaction where donor substrate was not limiting because of the labile nature of the sugar nucleotide (Remodeling the Fc N-glycans of Experimental Procedures of Barb).
However, in regard to claim 1, although Stadheim is directed to galactyosylation and sialylation the Fc domain of human antibodies (p. 17, Production of Human Glycosylated Antibodies Having Increased Levels of Sialyation), they use a truncated version of the mus musculus ST6-Gal1 enzyme (Example 3, see “MmST6-33), which is not at least 95% identical to the human ST6-Ga1 enzyme embodied by amino acids 95-416 of SEQ ID NO:1.
In regard to claim 1, Donadio teaches truncations of the human ST6-Gal1 enzyme that result in a striking increase in transfer efficiency of sialic acid donors to known exogenous acceptors in vitro ((p. 314, Section 3.2, see also Fig. 1, top). In regard to the amino acid sequence of the hST6-Gal1 used by Donadio, she refers to previous publications of sequences that were deposited in the NCBI database as reference sequence NP_001340845 (lower sequence) that aligns with greater than 95% identity to amino acids 95-416 of instant SEQ ID NO: 1 (upper sequence of alignment below, note “J” is highlighted).
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Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have practiced the in vitro method of galactosylation and disialylation according to Stadheim in view of Barb and substitute the truncated mouse ST6-Gal1 sialyltransferase with the truncated human ST6-Gal1 sialyltransferase as taught by Donadio with a reasonable expectation of success. One of ordinary skill would have been motivated to do so as taught by Donadio because of the striking increase in transfer efficiency of these truncated hST6Gal1 sialytransferases.
In regard to claim 2, both Stadheim and Barb teach and/or suggest the CMP-NANA donor (see [0021, 0092, 0313] of Stadheim, and Materials of Experimental Procedures of Barb).
In regard claim 3, as stated supra, Stadheim teaches the sialylation reaction comprises MnCl2, while Barb teaches both the galactosylation and sialylation reactions comprise MnCl2 (Remodeling the Fc N-glycans of Experimental Procedures), which would have been obvious to include in the in vitro reactions considering it was a known cofactor for catalysis.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-2, 6-7, 48-52, 54-57 of copending Application No. 17/508,026, in view of Barb et al., (Biochemistry, 2009, 48, 9705-9707). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of sialylation of the Fc domain of an IgG of cited application makes obvious the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims include the step of adding addition CMP-NANA sialic acid donor to the sialylation reaction so as to reach a 60% disialylated glycan.
Nevertheless, the step of supplying additional donor substrate to an enzymatic reaction was well known in the art. Specifically, Barb teaches the supplementation of CMP-NANA to an in vitro sialylsation reaction when the reaction time is carried out over the course of many hours, and achieves nearly 90% disialylsation of the glycan (Fig. S1B).
Accordingly, it would have been obvious to have claimed the method of disialylation according to cited application and combine the step of supplementation of the CMP-NANA sialic donor as taught by Barb with a reasonable expectation of success. One of ordinary skill would have been motivated to claim so in order to generate an enzymatic reaction where donor substrate was not limiting.
Since the instant application claims are obvious over cited application claims, in view of Barb, said claims are not patentably distinct.
Claims 1-3 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 45-46, 48, 50, 52-57, 59, 61-64 of copending Application No. 17/802,441. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of sialylation of the Fc domain of an IgG of cited application anticipates the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claims 1-3 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/909,282, in view of Barb et al., (Biochemistry, 2009, 48, 9705-9707). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of sialylation of the Fc domain of an IgG of cited application makes obvious the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims include the step of adding addition CMP-NANA sialic acid donor to the sialylation reaction.
Nevertheless, the step of supplying additional donor substrate to an enzymatic reaction was well known in the art. Specifically, Barb teaches the supplementation of CMP-NANA to an in vitro sialylsation reaction when the reaction time is carried out over the course of many hours, and achieves nearly 90% disialylsation of the glycan (Fig. S1B).
Accordingly, it would have been obvious to have claimed the method of disialylation according to cited application and combine the step of supplementation of the CMP-NANA sialic donor as taught by Barb with a reasonable expectation of success. One of ordinary skill would have been motivated to claim so as taught by Barb in order to generate an enzymatic reaction where donor substrate was not limiting because of the labile nature of the sugar nucleotide (Remodeling the Fc N-glycans of Experimental Procedures of Barb).
Since the instant application claims are obvious over cited application claims, in view of Barb, said claims are not patentably distinct.
Claims 1-3 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-15, 18-20, 22-23, 27, 32 of copending Application No. 17/925,999. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of sialylation of the Fc domain of an IgG of cited application anticipates the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are more specific. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
Claims 1-3 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 69, 75, 77-83 of copending Application No. 17/926,102, in view of Barb et al., (Biochemistry, 2009, 48, 9705-9707). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of sialylation of the Fc domain of an IgG of cited application makes obvious the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims include the step of adding addition CMP-NANA sialic acid donor to the sialylation reaction.
Nevertheless, the step of supplying additional donor substrate to an enzymatic reaction was well known in the art. Specifically, Barb teaches the supplementation of CMP-NANA to an in vitro sialylsation reaction when the reaction time is carried out over the course of many hours, and achieves nearly 90% disialylsation of the glycan (Fig. S1B).
Accordingly, it would have been obvious to have claimed the method of disialylation according to cited application and combine the step of supplementation of the CMP-NANA sialic donor as taught by Barb with a reasonable expectation of success. One of ordinary skill would have been motivated to claim so as taught by Barb in order to generate an enzymatic reaction where donor substrate was not limiting because of the labile nature of the sugar nucleotide (Remodeling the Fc N-glycans of Experimental Procedures of Barb).
Since the instant application claims are obvious over cited application claims, in view of Barb, said claims are not patentably distinct.
Claims 1-3 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-5, 7,15, 37-40, 45-46 of copending Application No. 18/022,061. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of sialylation of an IgG of cited application makes obvious the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims are more specific with respect to the Fc domain of the IgG. Nevertheless, the Fc domain of IgG was a well known glycosylated/siaslylated portion of the IgG and would have been immediately envisioned as such from the limited genus of glycosylated/siaslylated domains in an IgG.
Since the instant application claims are obvious over cited application claims, said claims are not patentably distinct.
Claims 1-3 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/218,535. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the method of sialylation of an IgG of cited application makes obvious the method of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims are more specific with respect to the Fc domain of the IgG. Nevertheless, the Fc domain of IgG was a well known glycosylated/siaslylated portion of the IgG and would have been immediately envisioned as such from the limited genus of glycosylated/siaslylated domains in an IgG.
Since the instant application claims are obvious over cited application claims, said claims are not patentably distinct
Provisional Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-3 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-3 of copending Application No. 18/218,996. This is a provisional statutory double patenting rejection.
The subject matter claimed in the instant application is fully disclosed in the cited application as follows: the method of sialylation of an Fc domain of cited application is the same invention as the method of instant application. It is clear that all the elements of the cited application claims are to be found in instant claims.
Since the instant application claims are claiming identical subject matter as cited application claims, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631