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 .
Claim Status
The amendment of 06/05/2026 has been entered. Claims 1-5, 7, 15, 37-40, and 45-46 are pending in this US patent application. Claims 2-3 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/23/2025.
Claims 1, 4-5, 7, 15, 37-40, and 45-46 are currently under examination and were examined on their merits.
Withdrawn Rejections
The previous rejections of the claims under 35 U.S.C. 103 as being unpatentable over Washburn and on the ground of nonstatutory double patenting are withdrawn in light of the amendment of 06/05/2026, which amended the concentration range of non-IgG proteins in the starting material for the claimed method. Applicant’s argument in the remarks of 06/05/2026 that Washburn does not teach IgG fractions with at least 30% (w/w) protein that is not IgG has been found persuasive.
Information Disclosure Statement
The information disclosure statement filed in this application on 06/05/2026 has been received and considered.
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, 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 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, 4, 7, 15, 38-40, and 45-46 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), in view of Aghaie et al., Human Antibodies 19: 1-6 (2010).
Washburn teaches that intravenous immunoglobulin (IVIg) is a complex heterogeneous mixture of IgG subclasses and low amounts of IgA, IgM, and other plasma proteins (see entire document, including page E1297, left column, paragraph 2). IVIg was incubated with MOPS buffer, 8 mM MnCl2, 5 mM UDP-Gal, and B4GalT. After incubation, 48 mM CMP-sialic acid and ST6Gal1 was added to the reaction mixture and incubated again. The sialylated IVIg was purified over multiple chromatography columns to remove enzymes used in the process (page E1305, right column, paragraph 3; cf. claims 1, 4, 7, 15, 38-40, and 45; the Examiner notes that CMP-sialic acid is a synonym for CMP-NANA as instantly recited; the Examiner further notes that claim 7 does not require any period of time to pass between the additions of CMP-NANA, and so this claim is sufficiently broad to encompass, for example, the first and second halves of any aliquot of CMP-NANA added to the reaction mixture). After 20 hr of incubation, 71% of the IVIg was in the A2F form, which is sialylated on both the α1,3 and α1,6 branches (page E1298, right column, paragraph 3; page E1299, Figure 1; cf. claims 1 and 46). IVIg is a product with broad heterogeneity, and limited physicochemical description is typically used in the industry to describe these products (page E1302, left column, paragraph 3). The sialylated antibodies must be extensively purified following sialylation to remove the enzymes and sugar nucleotides used in the sialylation reactions (page E1305, right column, paragraph 3).
However, Washburn does not teach that the non-IgG proteins in the IVIg composition comprise at least 30% of the protein in the IVIg as recited in amended instant claim 1.
Aghaie teaches the purification of IVIg from plasma (see entire document, including page 1, left column, paragraph 1). One of the intermediates in the purification process was Cohn Fraction II/III, comprising IgA, IgM, IgG, coagulation factors, and alpha- and beta-globulins (page 2, right column, paragraph 1).
The instant specification indicates that Cohn Fraction II/III is about 35% non-IgG protein (see instant specification as filed, Example 2). As such, the Cohn Fraction II/III paste of Aghaie intrinsically falls within the concentration range of non-IgG proteins recited in instant claim 1.
While Washburn does not teach the use of an IgG-containing protein composition in which the non-IgG proteins in the composition comprise at least 30% of the protein in the composition as recited in instant claim 1 in their method for producing sialylated IgG, it would have been obvious to one of ordinary skill in the art to do so because Washburn does teach the use of a substrate that is a commercial product with broad heterogeneity and limited physicochemical description and that extensive purification is required following sialylation to remove all of the enzymes and sugar nucleotides required for that process. In addition, Aghaie teaches that fractions comprising additional proteins are intermediates in the process of purifying IVIg. As such, one of ordinary skill in the art would be motivated to use the process of Washburn on any composition comprising IgG, including the Cohn Fraction II/III of Aghaie, because doing so would require fewer purification steps (i.e., would avoid the need to extensively purify IgG from Fraction II/III and then extensively purify sialylated IgG following sialylation, as Washburn teaches is necessary). One of ordinary skill in the art would have a reasonable expectation that doing so would successfully result in the disialylation of the IgG proteins and the higher level of activity of the IVIg composition in preventive and therapeutic treatments (see Washburn, page E1305, left column, paragraphs 2-4).
The method rendered obvious by Washburn and Aghaie teaches concentrations of UDP-Gal and CMP-NANA that are given in different units than the units recited in instant claims 39-40, so it cannot be determined if Washburn’s concentrations fall within the instantly recited ranges. However, even if Washburn’s concentrations are outside of the ranges in claims 39-40, the instantly recited ranges would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of substrates in the enzymatic reactions of Washburn because the concentrations of substrates in enzymatic reactions are art-recognized, result-effective variables known to affect the amount of product produced, which would have been optimized in the art to provide the desired amount of product.
Therefore, claims 1, 4, 7, 15, 38-40, and 45-46 are rendered obvious by Washburn in view of Aghaie and are rejected under 35 U.S.C. 103.
Claims 1, 4-5, 7, 15, 38-40, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), in view of Aghaie et al., Human Antibodies 19: 1-6 (2010), and Afonso et al., Biomolecules 6(15): 1-20 (2016).
As discussed above, claims 1, 4, 7, 15, 38-40, and 45-46 are rendered obvious by Washburn in view of Aghaie. However, these references do not teach that the plasma from which IgG was purified was derived from at least 1000 human subjects.
Afonso teaches that IVIg may be made of plasma from pools of minimum 1000 human donors (see entire document, including page 3, paragraphs 2-3; cf. claim 5).
While Washburn and Aghaie do not teach the use of plasma pooled from at least 1000 human donors in the method of producing sialylated IgG rendered obvious by their teachings, it would have been obvious to one of ordinary skill in the art to do so because Afonso teaches that pooled plasma from at least 1000 human donors is a source for intravenous immunoglobulins. One of ordinary skill in the art would have a reasonable expectation that using the pooled plasma of at least 1000 human donors, as taught by Afonso, in the method of producing disialylated IgG rendered obvious by Washburn and Aghaie would successfully result in the production of disialylated IgG.
Therefore, claims 1, 4-5, 7, 15, 38-40, and 45-46 are rendered obvious by Washburn in view of Aghaie and Afonso.
Claims 1, 4, 7, 15, 37-40, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), in view of of Aghaie et al., Human Antibodies 19: 1-6 (2010), and Hopax, “The families of biological buffers,” https://www.hopaxfc.com/en/blog/the-families-of-biological-buffers, 01/22/2019.
As discussed above, claims 1, 4, 7, 15, 38-40, and 45-46 are rendered obvious by Washburn in view of Aghaie. In addition, Washburn teaches that the enzymatic reaction is performed at pH 7.4 in 50 mM buffer (page E1305, right column, paragraph 3; cf. claim 37). However, Washburn does not teach that the buffer used in the sialylation reactions at a concentration of 50 mM is BIS-TRIS as recited in instant claim 37.
Hopax teaches that MOPS and BIS-TRIS are art-known buffers with an overlapping pH range (see entire document, including, for example, pages 2/8-3/8; cf. claim 37). Note that the recitation of a buffer provided throughout Washburn is very general, such that any buffer would have been expected to perform its known function of buffering. As such, BIS-TRIS would have been viewed by the artisan as an obvious and predictable substitution for MOPS (see MPEP §2143(I)(B) and 2144.06(II)), and one of ordinary skill in the art would have a reasonable expectation that using BIS-TRIS as the buffer in the reaction of Washburn instead of MOPS would successfully result in the sialylation of the IVIg proteins in the same manner as seen with MOPS buffer.
Therefore, claims 1, 4, 7, 15, 37-40, and 45-46 are rendered obvious by Washburn in view of Aghaie and Hopax and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially 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 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 7, 15, 37-40, and 45-46 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12-16, 18-20, 22-23, 27, and 32 of copending Application No. 17/925999 in view of Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), and Aghaie et al., Human Antibodies 19: 1-6 (2010). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘999 recite a sialylation method that is narrower than that recited in the instant claims. The claims of ‘999 do not recite the concentration of non-IgG proteins recited in instant claim 1. However, this limitation is rendered obvious in methods for the sialylation of IgG proteins by Washburn and Aghaie, as discussed above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘999 in view of Washburn and Aghaie and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 15, 37-40, and 45-46 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 45-46, 48, 50, 52-57, 59, and 61-64 of copending Application No. 17/802,441 in view of Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), Aghaie et al., Human Antibodies 19: 1-6 (2010), and Hopax, “The families of biological buffers,” https://www.hopaxfc.com/en/blog/the-families-of-biological-buffers, 01/22/2019. Although the claims at issue are not identical, they are not patentably distinct from each other because both relate to means for producing sialylated antibodies. While the cited claims of ‘441 do not recite all of the limitations recited in the instant claims, these limitations are rendered obvious in the field of sialylating IgG proteins by the teachings of Washburn, Aghaie, and Hopax, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘441 in view of Washburn, Aghaie, and Hopax and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 15, 37-40, and 45-46 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/217,401 in view of Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), Aghaie et al., Human Antibodies 19: 1-6 (2010), and Hopax, “The families of biological buffers,” https://www.hopaxfc.com/en/blog/the-families-of-biological-buffers, 01/22/2019. Although the claims at issue are not identical, they are not patentably distinct from each other because both relate to means for producing sialylated antibodies. While the cited claims of ‘401 do not recite all of the limitations recited in the instant claims, these limitations are rendered obvious in the field of sialylating IgG proteins by the teachings of Washburn, Aghaie, and Hopax, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘401 in view of Washburn, Aghaie, and Hopax and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 15, 37-40, and 45-46 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/218,535 in view of Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), Aghaie et al., Human Antibodies 19: 1-6 (2010), and Hopax, “The families of biological buffers,” https://www.hopaxfc.com/en/blog/the-families-of-biological-buffers, 01/22/2019, as evidenced by Afonso et al., Biomolecules 6(15): 1-20 (2016). Although the claims at issue are not identical, they are not patentably distinct from each other because both relate to means for producing sialylated antibodies. While the cited claims of ‘535 do not recite all of the limitations recited in the instant claims, these limitations are rendered obvious in the field of sialylating IgG proteins by the teachings of Washburn, Aghaie, and Hopax as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘535 in view of Washburn, Aghaie, and Hopax, as evidenced by Afonso, and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 15, 37-40, and 45-46 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 18/218,996 in view of Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), Aghaie et al., Human Antibodies 19: 1-6 (2010), and Hopax, “The families of biological buffers,” https://www.hopaxfc.com/en/blog/the-families-of-biological-buffers, 01/22/2019. Although the claims at issue are not identical, they are not patentably distinct from each other because both relate to means for producing sialylated antibodies. While the cited claims of ‘996 do not recite all of the limitations recited in the instant claims, these limitations are rendered obvious in the field of sialylating IgG proteins by the teachings of Washburn, Aghaie, and Hopax, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘996 in view of Washburn, Aghaie, and Hopax and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 15, 37-40, and 45-46 are newly provisionally rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 17/909,282 in view of Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), Aghaie et al., Human Antibodies 19: 1-6 (2010), and Hopax, “The families of biological buffers,” https://www.hopaxfc.com/en/blog/the-families-of-biological-buffers, 01/22/2019. Although the claims at issue are not identical, they are not patentably distinct from each other because both relate to means for producing sialylated antibodies. While the cited claims of ‘282 do not recite all of the limitations recited in the instant claims, these limitations are rendered obvious in the field of sialylating IgG proteins by the teachings of Washburn, Aghaie, and Hopax, as discussed extensively above. As such, the instant claims are ‘rendered obvious’ by the cited claims of ‘282 in view of Washburn, Aghaie, and Hopax and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 7, 15, 37-40, and 45-46 are newly rejected as necessitated by amendment on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of US Patent No. 11352415 in view of Washburn et al., Proc. Nat’l. Acad. Sci. USA 112(11): E1297-E1306 (2015), Aghaie et al., Human Antibodies 19: 1-6 (2010), and Hopax, “The families of biological buffers,” https://www.hopaxfc.com/en/blog/the-families-of-biological-buffers, 01/22/2019. Although the claims at issue are not identical, they are not patentably distinct from each other because both relate to means for producing sialylated antibodies. While the cited claims of ‘415 do not recite all of the limitations recited in the instant claims, these limitations are rendered obvious in the field of sialylating IgG proteins by the teachings of Washburn, Aghaie, and Hopax, as discussed extensively above. As such, the instant claims are rendered obvious by the cited claims of ‘415 in view of Washburn, Aghaie, and Hopax and are rejected on the ground of nonstatutory double patenting.
Response to Arguments
Applicant has traversed the previous rejections of the claims under 35 U.S.C. 103 as being unpatentable over Washburn. While these rejections have been withdrawn in light of the amendments of 06/05/2026, as discussed above, the Examiner wishes to address certain aspects of Applicant’s arguments that are applicable to the rejections presented above.
Applicant states that Washburn is directed to generating a sialylated IVIg drug candidate and, accordingly, must remain highly purified. Applicant states that one of ordinary skill in the art would not have expected that efficient hypersialylation could be achieved using a substantially impure pooled IgG composition (remarks, pages 12-14).
The Examiner notes that those of ordinary skill in the art understand how to purify desired proteins from other components in the solution and would certainly have a reasonable expectation that making a solution comprising an enzyme and its substrate would result in the enzyme catalyzing a reaction with its substrate. The presence of potential solubility issues or potential inhibition/alteration of the reaction, as cited by Applicant, do not somehow negate a reasonable expectation that an enzyme will react with its substrate. Determining the optimal conditions under which that reaction may occur is well within ordinary skill in the art of enzymatic reactions.
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are 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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Tuesday-Thursday, 6:30-4:00.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 09/19/2026
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