DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/15/2024 has been considered by the examiner.
Status of the Claims
The response and claims filed 07/17/2026 is acknowledged.
Claims 1-20 are pending.
Applicant’s election without traverse of Group I, claims 1-10 in the reply filed on 07/17/2026 is acknowledged.
Applicant’s election without traverse of SEQ ID NO: 10 as species of interleukin or interleukin-Fc in the reply filed on 07/17/2026 is acknowledged.
The species elected by Applicant is directed to the linker GGGGS (Spec, e.g., 0025) rather than a species of interleukin or interleukin-Fc construct. Applicant indicates claims 1-4, 6, and 7 of the elected invention.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 07/17/2026.
Claims 5, 8, and 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/17/2026.
Claims 1-4, and 6-7 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
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.
Claim 2 is 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.
There is no antecedent basis for “the hydrophobic polymer segment” in claim 2. Claim 1 does not establish a hydrophobic polymer segment.
Clarification is required.
Claim 3 is 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.
There is no antecedent basis for “the hydrophobic polymer segment” in claim 3. Claim 1 does not establish a hydrophobic polymer segment.
Clarification is required.
Claim 6 is 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.
Claim 6 includes the limitation wherein the cytokine active agent comprises an Fc region of human IgG. It is not clear which cytokine active agent claim 6 was intended to refer to since claim 1 states the cytokine active agent is an interleukin or an interleukin-Fc construct. Since claim 1 recites an interleukin-Fc construct, the skilled artisan may assume claim 6 was intended to further limit that option. Alternatively, Applicant may have intended the wherein clause of claim 6 to refer to either option in claim 1. Thus, the skilled artisan cannot understand how to avoid infringement.
To overcome this rejection, claim 6 may be amended to recite wherein the interleukin-Fc construct comprises an Fc region of human IgG.
Clarification is required.
Claim 7 is 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.
The specification, e.g., 0025, discloses SEQ ID NO: 10 is a linker. Neither claim 1 nor claim 6 establishes that the interleukin or interleukin-Fc construct comprises a linker. Since SEQ ID NO: 10 is a linker, claim 7 lacks antecedent basis for a linker. Claim 7 needs to say wherein the Fc region of human IgG further comprises a linker and wherein the linker comprises an amino acid sequence of SEQ ID NO: 10.
Clarification 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.
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 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Onconano, WO 2021091924 A1 (cited previously) in view of Hu, US 20230265148.
Onconano teaches therapeutic pH responsive compositions comprising a block copolymer and a therapeutic agent useful for the treatment of cancer (Onconano, entire document, e.g., Abstract), which contain micelles (Onconano, entire document, e.g., Title, claims, e.g., claim 58). The polymer of the micelles has a formula generally encompassing that of formula (I) as claimed (Onconano, e.g., 0008, claim 58) and wherein the therapeutic agent is a cytokine, e.g., IL-2 (Onconano, e.g., 0009, claim 76-77).
Applicable to claims 2-3: Onconano teaches PEG-PDBA-IL-2 micelles (Onconano, e.g., 0196). PDBA has the structure of claims 2-3. See also Onconano, e.g., 0084-0085.
Applicable to claim 4: Onconano teaches n1 is 10-200, x1 is 40-300, and y1 is 0-6, and z1 is 0-10 and in the case of PEG-PDBA, y is 0 and z is 0. X is the same as claimed (Onconano, e.g., 0008, claim 58). The claimed ranges for n1, x1, and y1 overlap with or are within the prior art ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. The prior art discloses overlapping ranges of composition. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Onconano teaches IL-2 but does not expressly teach an interleukin-Fc construct comprising the sequence ggggs.
Hu teaches interleukin Fc constructs comprising the sequence ggggs. There are several interleukin Fc constructs disclosed in Hu which fall within the scope of the elected species. For example, SEQ ID NO:50.
Hu, SEQ ID NO: 50 which is referred to therein as mut11.08-linker2- hFc (Hu, e.g., pg. 14, table 4). The sequence is
APTSSSTKKTQLQLEHLLLDLQMILNGINNVKNPKLTRMLTFKFYM
PKKATELKHLQCLEEELKPLEEVLNLLQSKNFQLRPRDLISNINRIV
LELKGSETTFMCEYADETATIVEFLNRWITFAQSIISTLT GGGGSGG
GGSGGGGS EPKSSDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMIS
RTPEVTCVWDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYGS
TYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQP
REPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPEN
NYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHN
HYTQKSLSLSPGK
The sequence in bold contains the elected species ggggs (Hu, e.g., 0134). The sequence in italics is interleukin 2. The last sequence in regular font is the Fc region of IgG.
Hu teaches the interleukin peptide modified with a sequence comprising a linker comprising ggggs and the Fc region of IgG results in an interleukin with improved therapeutic efficacy (Hu, e.g., 0252) and improved terminal half-life (Hu, e.g., 0268 and table 25) and improved stability (Hu, e.g., Abstract, examples).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a micelle comprising a pH sensitive polymer of formula I in Onconano, e.g., PEG-PDBA, by including an interleukin 2 peptide modified with a sequence comprising a linker comprising ggggs and the Fc region of IgG. The skilled artisan would have seen this modification as the use of a known technique to improve Onconano’s micelles in the same way with a reasonable expectation of success. Since Onconano teaches micelles comprising IL2 for treating tumors, the skilled artisan would have been motivated to incorporate Hu’s improved IL2 peptide for improved therapeutic efficacy and prolonged terminal half-life. The skilled artisan could have substituted Hu’s improved IL2 peptides for those of Onconano in the micelles or combined the two peptides in the micelles to achieve this improvement. The skilled artisan would have had a reasonable expectation of success because Hu teaches the modified interleukins for treating cancer and tumors.
Accordingly, the subject matter of claims 1-4 and 6-7 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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