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 .
Applicant’s response filed on 12/19/2025 and the declaration of Zylberberg under 37 CFR §1.132 filed on 1/22/2026 are acknowledged and fully considered.
Status of Application, Amendments, And/Or Claims
The amendments of claims 1,8, 17 and 21, and the addition of claim 22 have been made of record.
Claims 1-12, 14-17, 19 and 21-22 are pending.
Claims 1-11 remain withdrawn for the reasons of record at pg. 2 of the office action of 3/29/2024.
Claims 12, 14-17, 19 and 21-22 are under examination.
Information Disclosure Statement
The Information Discloser Statements fled on 12/29/2025 (2) have been considered. The crossed-out reference of one reference is duplicate of the reference on other IDS of 12/29/2025.
Response to Arguments
Claim Rejections - 35 USC § 112-withdrawn
The rejection of claims 17, 19 and 21 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of applicant’s amendments of claims 17,19 and 21 to replace the term “or” with the term “and”.
Claim Rejections - 35 USC § 103-maintained
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.
Claim(s) 12 and 14-21 remain rejected under 35 U.S.C. 103 as being unpatentable over Mariau et al. ( US Pat. No. 2018030375 filed on 10/20/2016) in view of Chiron Corp. (Hora, Maninder, IDS) for the reasons of record at pg.4-6 of the office action of 6/30/2025.
Applicants argue that Mariau et al. do not teach aldesleukin/SDS microaggregate in the liquid composition in a range of 4-18 nm with a peak of about 8 nm as determined by dynamic light scattering recited in claim 12 and that the specific activity of the composition is from 9-20 million IU/mg as recited in claim 22. They argue that Mariau et al mention aggregate only once in the disclosure. They argue that Mariau et al measure the stability of aldesleukin in vitro and not in an animal model and they argue that it is not necessary that in vitro stability can always be translated into in vivo model. They argue that Mariau et al do not teach to use an osmolyte selected from mannitol, sorbitol and xylitol. They argue that the reference Chiron teaches aldesleukin/SDS microaggregate of 10-50 nm but the peak is about 11.7 nm. They argue that the specific activity of new claim 22 is different (from 9 million IU /mg to 20 million IU/mg) is different as presented by Zylberberg under 37 CFR 1.132 from the specific activity presented in Mariau et al (1.2 to 24 million IU/mL) showing different dynamic light scattering pattern.
Applicants’ arguments have been considered fully but they are not persuasive because claim 22 does not have support in the specification at pg. 14, Example 2 discloses that the specific activity of 20 independent lots are in a range of 16.6-19.5 million IU/mg and it is supported in Table 1. The declaration by Zylberberg under 37 CFR 1.132 have been fully considered but the data provided by the co-inventor Zylberberg cannot replace the data presented in the specification at pg. 14, Example 2. Therefore, claim 22 as being drawn to a specific activity ranges from 9-20 million IU/mg introduces a New Matter. Additionally, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a specific activity from 9 million IU/mg to 20 million IU/mg) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Chiron teaches to use sugars (e.g., sucrose, trehalose, mannitol) in a concentration between 40-50 mg for 1.1 mg IL-2 (see paragraph [0087]). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
A New Ground of Rejection Necessitated by Applicant’s Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. THIS IS A NEW MATTER REJECTION. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The new claims are not described in the Specification or the Claims as originally filed.
The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981). See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985). Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads). While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure. MPEP 2105.
In the instant application, there is no support in the specification, as originally filed, for the claim limitation “ wherein the specific activity ranges from 9 million IU/mg up to 20 million IU/mg”. The specification at pg. 14, Example 2 discloses that the specific activity of 20 independent lots are in a range of 16.6-19.5 million IU/mg and it is supported in Table 1. The declaration filed by Zylberburg, a coinventor, under 37 CFR 1.132 supports the data for specific activity in a range being claimed but this cannot replace the disclosure at pg. 14, Exampled 2 that discloses that the specific activity of 20 independent lots are in a range of 16.6-19.5 million IU/mg. The limitation that the specific activity is from 9-20 million IU/mg is broadening of the claim. Therefore, claim 22 is rejected under 35 USC 112, first paragraph-new matter.
Double Patenting-maintained
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 12, 14-17, 19 and 21 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-15 of copending Application No. 18/519,193 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because a liquid composition comprising aldesleukin/SDS aggregate stable for a year and the liquid composition aldesleukin/SDS aggregate is distributed in a range about 4-18 nm with a peak at about 8 nm as measured by dynamic light scattering, wherein the composition is for treating disease or disorder comprising an autoimmune disease, cancer, a viral infection, a bacterial infection and others are taught in claim 11-15 of US Application No. 18/519,193.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants argue that until an allowable subject matter is present in the case, the rejection be held in abeyance.
Applicants arguments have been fully considered but they are not persuasive because the obviousness double patenting rejection is an independent rejection.
Conclusion
No claim is 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 GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674