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
Claim listing filed on December 22, 2025 is pending. Claims 2-3 and 13-17 are canceled. Claims 1 and 11 are amended. Claims 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species. Claims 1, 4-5, and 11-12 are examined upon their merits.
Information Disclosure Statement
The information disclosure statement filed on 12/22/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claims 2-3 has rendered all previous rejections directed to these claims moot.
The amendments to the specification have overcome the objections of record, and the specification objections are withdrawn.
The rejection of claims 1, 4-5, and 11-12 under 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement and enablement requirements is withdrawn in view of Applicant’s remarks filed 12/22/2025. It is persuasive that In re Herschler, 591 F.2d 693, 697, 200 USPQ 711, 714 (CCPA 1979) a disclosure of corticosteroid in DMSO was sufficient to support claims drawn to a method of using a mixture of a "physiologically active steroid" and DMSO because "use of known chemical compounds in a manner auxiliary to the invention must have a corresponding written description only so specific as to lead one having ordinary skill in the art to that class of compounds” (MPEP § 2163.II.A.3.(a).(ii)). Applicant argues that for the purpose of the claimed method, one species of PEG molecule is sufficient to demonstrate PEGylation because PEGylated IL-2 is well understood in the art. Examiner finds this persuasive as evidenced by Bossard et al. US 9,861,705 (of record in IDS) which teaches how IL-2 can be conjugated to various PEG molecules that vary in molecular weights, end capping groups, and geometric shapes (col. 1 lines 26-32, col. 4 lines 6-24, Table 1). One of ordinary skill would understand that PEGylation of IL-2 could comprise any of the PEG structures known in the art prior to the time of filing.
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Mejia-Manzano et al. J Chem Technol Biotechnol 2017 is withdrawn in view of Applicant’s amendments. Mejia-Manzano fails to teach wherein the biomolecule is specifically IL-2 and the barrier is IL-2Rα as required by amended Claim 1. Note, “the IL-2 receptor includes IL-2Rα receptor, IL-2Rβ receptor and IL-2γ receptor” is interpreted as “the IL-2 receptor is selected from the list consisting of IL-2Rα receptor, IL-2Rβ receptor and IL-2γ receptor.” Support for this interpretation can be found in the species (A) election requirement filed 05/29/2025 that was made final in the non-final office action filed 09/22/2025.
Claim Rejections - 35 USC § 103 (Maintained)
The rejection of Claims 1, 4, and 11-12 under 35 U.S.C. 103 as being unpatentable over Mejia-Manzano et al. J Chem Technol Biotechnol 2017 (of record) in view of Pettit WO 1998/40409 (of record) is maintained.
Applicant's arguments filed December 22, 2025 have been fully considered but they are not persuasive.
Applicant argues that Mejia-Manzano does not teach or suggest PEGylation of IL-2 with an IL-2Rα barrier and instead teaches PEGylation of lysozyme with a heparin barrier. Examiner relies on Mejia-Manzano to teach the methodological steps of (1) PEGylating a biomolecule followed by (2) binding a barrier to at least one binding site in the PEGylated molecule, (3) separating the PEGylated biomolecule not bound to the barrier, and (4) separating the barrier and the PEGylated biomolecule wherein steps (2)-(4) are known as affinity chromatography (of record). Mejia-Manzano teaches that affinity chromatography is widely applicable to proteins, enzymes, antibodies, hormones, receptors, factors, vitamins, nucleic acids, cell components, viruses and phages (of record). Therefore, the lysozyme/heparin pair acts as a proof-of-concept for the PEGylation and affinity chromatography purification method, and one of ordinary skill would understand that the methodology can be applied to other proteins (such as the IL-2/IL-2Rα pair taught by Pettit) with a reasonable expectation of success.
Applicant argues that Pettit teaches binding a barrier agent to IL-2 before performing PEGylation which differs from the instant methodological steps and causes divergence in screening principles and technical outcomes. Pettit is not relied upon to teach the methodological steps of PEGylation and affinity chromatography, because Mejia-Manzano teaches the claimed method (as explained above and on record). Instead, Pettit is relied upon to teach that the known methodology can be applied to an IL-2 biomolecule paired with an IL-2Rα barrier. MPEP § 2145.IV states that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.
Applicant argues that Pettit teaches away from the instant method by emphasizing that pre-protection is essential to maintain bioactivity. MPEP § 2143.01.I states that the disclosure of desirable alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004), the court stated that "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed..." 391 F.3d at 1200-01, 73 USPQ2d at 1145-46. Pettit teaching that pre-protection of binding sites before PEGylation can maintain bioactivity does not teach away or negate that Mejia-Manzano teaches PEGylation followed by affinity chromatography improves yields, purities, and saves time as compared to other PEGylation techniques (of record). Applicant’s arguments have been considered but are not persuasive.
The rejection of Claims 1, 4-5, and 11-12 under 35 U.S.C. 103 as being unpatentable over Mejia-Manzano et al. J Chem Technol Biotechnol 2017 (of record) in view of Pettit WO 1998/40409 (of record) as applied to Claims 1, 4, and 11-12 above, and further in view of Gillies US 7,186,804 (of record) is maintained.
Applicant's arguments filed December 22, 2025 have been fully considered but they are not persuasive.
Applicant argues that Gillies does not teach or suggest the specific steps of separating and purifying PEGylated IL-2 as recited in the claims. Mejia-Manzano is relied upon to teach the methodological steps of PEGylation and purification, and Pettit is relied upon to teach the IL-2 biomolecule and IL-2Rα barrier pair. As stated above, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references (MPEP § 2145.IV).
Applicant points to the experimental results demonstrated on page 23 of the specification without distinctly and specifically pointing out how these results apply to the supposed errors in the Examiner’s action as is required in a complete response (MPEP § 714.02). Therefore, these arguments do not warrant a complete response and are not persuasive.
Double Patenting (Maintained)
1. The provisional rejection of Claims 1, 4-5, and 11-12 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 6, and 9 of copending U.S. App. No. 17/418,671 (of record) in view of Mejia-Manzano et al. J Chem Technol Biotechnol 2017 (of record) is maintained.
Applicant's arguments filed December 22, 2025 have been fully considered but they are not persuasive. Applicant argues that that Mejia-Manzano does not teach or suggest PEGylation of IL-2 with an IL-2Rα barrier and instead teaches PEGylation of lysozyme with a heparin barrier, and it is unreasonable to assume methods for other proteins (e.g. lysozyme) can be directly applied to the IL-2 system. Mejia-Manzano teaches the methodological steps of (1) PEGylating a biomolecule followed by (2) binding a barrier to at least one binding site in the PEGylated molecule, (3) separating the PEGylated biomolecule not bound to the barrier, and (4) separating the barrier and the PEGylated biomolecule wherein steps (2)-(4) are known as affinity chromatography (of record). Mejia-Manzano teaches that affinity chromatography is widely applicable to proteins, enzymes, antibodies, hormones, receptors, factors, vitamins, nucleic acids, cell components, viruses and phages (of record). Therefore, the lysozyme/heparin pair acts as a proof-of-concept for the PEGylation and purification method, and it would be obvious to one of ordinary skill that the methodology can be applied to other proteins such as the IL-2/IL-2Rα pair taught by the copending claims with a reasonable expectation of success.
Applicant argues that the amended claims explicitly limit the biomolecule to IL-2 and the barrier to IL-2 receptors, and this further distinguishes the scope from that of the US 17/418,671 application. On the contrary, the copening claims are directed to PEGylating IL-2 and protecting the binding sites with an IL-2Rα barrier (of record). Applicant’s arguments have been considered but are not persuasive.
2. The provisional rejection of Claims 1, 4-5, and 11-12 on the ground of nonstatutory double patenting as being unpatentable over claims 7-9, 12, and 22 of copending U.S. App. No. 17/792,998 (of record) is maintained.
Applicant's arguments filed December 22, 2025 have been fully considered but they are not persuasive. Applicant requests that this provisional double patenting rejection be held in abeyance until otherwise allowable subject matter is found. MPEP § 804.I.B.1 states that “as filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance.” As no terminal disclaimer has been filed and no showing has been made that the claims are patentably distinct, the provisional double patenting rejection is maintained.
Conclusion
No claim is 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 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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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