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 .
Election/Restrictions
Applicant's election without traverse of the below listed species in the reply filed on 06/30/2026 is acknowledged. Applicant elected the following species:
A protein containing an IL-10 variant: an IL-10 variant without an additional polypeptide fusion;
An IL-10 variant protein: SEQ ID NO:3, containing N18A substitution;
A linker: SEQ ID NO:19, corresponding to the sequence (GGGGS)n;
A polypeptide: YP7G IgG1 wherein the VH is SEQ ID NO:26 and the VL is SEQ ID NO:27; and,
An antibody variations: the antibody is a full length antibody of class IgG, optionally, wherein the class IgG antibody has an isotype selected from IgG1, IgG2, IgG3, and IgG4 as recited in (2) of claim 18.
Elected species (ii), corresponding to an IL-10 variant protein containing N18A substitution, was search thoroughly and is deemed novel in view of the prior art, rendering it art-free subject matter. Therefore, the next species (ii) that shall be examined is an IL-10 variant protein containing N18R substitution.
Claim Status
Claims 1-23 are pending. Claims 4-6 and 10-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 06/30/2026.
Claims 1-3, 7-9, and 19-23 are currently under consideration for patentability under 37 CFR 1.104.
Priority
This application claims benefit of Provisional U.S. Application No. 63/385,130 filed on 11/28/2022. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claims 1, 3, 7-9, and 19-23 have an effective filing date of 11/28/2022 corresponding to Provisional U.S. Application No. 63/385,130.
Information Disclosure Statement
The information disclosure statement(s) filed on 05/17/2024 has/have been considered. Signed copies are enclosed.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 9 is objected to because of the following informalities: missing “the” in front of “amino acid sequence”. 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 2 and 21-23 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 applications subject to pre-AIA 35 U.S.C. 112, 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) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “at least 80%”, and the claim also recites “preferably at least 90%, at least 95%, at least 98%, and more preferably at least 99%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purposes of claim interpretation, only the broad recitation of “at least 80%” will be treated as the required feature of the claim, referring to at least 80% sequence identity to the naturally occurring IL-10 without artificial mutations as delineated in SEQ ID NO: 2.
Regarding claim 2, the phrases "preferably" and “more preferably” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purposes of claim interpretation, limitations following the phrases "preferably" and “more preferably” will not hold patentable weight.
Regarding claim 21, the phrase "an IL-10 variant protein or fusion protein" renders the claim indefinite because it is unclear 1) if Applicant is referring to the IL-10 variant protein of claim 1 or a different IL-10 variant protein and 2) if the fusion protein comprises the IL-10 variant protein of claim 1.
For the purposes of claim interpretation, the phrase "an IL-10 variant protein or fusion protein" will be treated as the IL-10 variant protein of claim 1 or a fusion protein comprising the IL-10 variant protein of claim 1.
Regarding claim 22, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
For the purposes of claim interpretation, limitations following the phrase "optionally" will not hold patentable weight.
Regarding claim 23, the phrase “use of the IL-10 variant protein of claim 1 for the manufacture of a medicament” (claim 23, lines 1-3) renders the claim indefinite because, as the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to claim.
Given that these claims may have dual interpretation either as a composition or as a method of manufacture, these claims are being interpreted herein as optionally both a composition and a method/process.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 23 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “use of the IL-10 variant protein of claim 1 for the manufacture of a medicament” (claim 23, lines 1-3) does not positively recite any steps involved in a method/process and, therefore, it is unclear what method/process applicant is intending to claim. The claim may have dual interpretation either as a composition or as a method of manufacture.
Given that these claims may have dual interpretation either as a composition or as a method of manufacture, these claims are being interpreted herein as optionally both a composition and a method/process.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-8, and 19-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US20250042966A1 (claims benefit to PRO 63/285,019 filed on 12/01/2021; hereinafter referred to as US ‘966).
Regarding instant claims 1-3 and 7, US ‘966 teaches “hIL10 monomer (instant claim 7) variant comprising one or more amino acid substitutions selected from the group consisting of… N18R (instant claim 1 and 3)… numbered in accordance with SEQ ID NO:1” (¶ 0026). US ‘966 uses the term IL-10 mutein to describe said variant. SEQ ID NO: 1 of US ‘966 is identical to SEQ ID NO: 2 of the instant application and corresponds to wild-type IL-10 (instant claim 2). This teaching reads on an IL-10 variant protein comprising a single substitution of amino acid at position 18 relative to amino acids of wild-type IL-10 (instant claim 1), wherein the substitution of amino acid at position 18 comprises N18R (instant claim 3), and the IL-10 variant protein is a monomer (instant claim 7).
Regarding instant claim 8, US ‘966 further teaches “hIL10 monomer is expressed as a proprotein… the first 18 amino acids of which comprise a signal peptide” (¶ 0005). This teaching reads on the IL-10 variant protein comprising a signal peptide.
Regarding instant claims 19-21, US ‘966 further teaches a method of producing the IL-10 mutein comprising “a) providing one or more recombinantly modified cells (instant claim 20) comprising a nucleic acid molecule or vector comprising a nucleic acid sequence encoding a hIL10 mutein (instant claim 19) disclosed herein; and b) culturing the one or more cells in a culture medium such that the cells produce the hIL10 mutein encoded by the nucleic acid sequence (instant claim 21)” (¶ 0049). This teaching reads on an isolated vector encoding the IL-10 variant protein (instant claim 19), an isolated host cell comprising the isolated vector (i.e. recombinantly modified cell; instant claim 20), and culturing the host cell so that an IL-10 variant protein is produced (instant claim 21).
Regarding instant claim 22, US ‘966 further teaches a “pharmaceutical composition comprises a hIL10 mutein monomer… [and] a pharmaceutically acceptable carrier” (¶ 0051). This teaching reads on a pharmaceutical composition comprising the IL-10 variant protein and a pharmaceutically acceptable carrier (instant claim 22).
Regarding instant claim 23, US ‘966 further teaches “a method of treating an autoimmune or inflammatory disease, disorder, or condition, or a viral infection in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of… a pharmaceutical composition described herein” (¶ 0054). This teaching indicates the pharmaceutical composition comprising the IL-10 mutein is used as a medicament (i.e. used as a medication to treat disease), reading on use of the IL-10 variant protein for the manufacture of a medicament (instant claim 23).
Accordingly, instant claims 1, 3, 7-8, and 19-23 are anticipated by US ‘966.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over US20250042966A1 (claims benefit to PRO 63/285,019 filed on 2021-12-01; hereinafter referred to as US ‘966) in view of US20170368144A1 (filed 2017-06-22, published 2019-07-02; hereinafter referred to as US ‘114).
US ‘966 teaches an IL-10 mutein comprising a single substitution of amino acid at position 18 relative to amino acids of wild-type IL-10 wherein the substitution of amino acid at position 18 comprises N18R (instant claim 1) and a signal peptide (instant claim 8) as fully described in the 102 rejection section.
US ‘966 does not teach the signal peptide comprises SEQ ID NO: 25 (instant claim 9).
Regarding instant claim 9, US ‘144 teaches “scIL-10 [single chain IL-10] polypeptides” (¶ 0007) and “[a]n exemplary N-terminal leader sequence for production of polypeptides in a mammalian system is MYRMQLLSCIALSLALVTNS (SEQ ID NO: 48)” (¶ 0099). SEQ ID NO: 49 of US ‘144 is identical to SEQ ID NO: 25 of the instant application. This teaching reads on the signal peptide comprises the amino acid sequence of instant SEQ ID NO: 25 (instant claim 9).
US ‘144 does not teach an IL-10 variant protein comprising a single substitution of amino acid at position 18 relative to amino acids of wild-type IL-10 wherein the substitution of amino acid at position 18 comprises N18R.
A signal peptide comprising instant SEQ ID NO: 25 was known and used prior to the effective filing date of the application. In addition, both US ‘966 and US ‘144 are in analogous arts (i.e. IL-10 proteins fused to signal peptides). Since US ‘144 teaches a signal peptide comprising instant SEQ ID NO: 25 is an exemplary N-terminal leader sequence for production of IL-10 polypeptides in a mammalian system, there is motivation for using instant SEQ ID NO: 25 for the sequence of the signal peptide as taught in US ‘144 in an IL-10 mutein comprising a single substitution of amino acid at position 18 relative to amino acids of wild-type IL-10 wherein the substitution of amino acid at position 18 comprises N18R and a signal peptide as taught in US ‘966.
MPEP § 2141(III)(G) states a rationale that may support a conclusion of obviousness includes “[s]ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” MPEP § 2143(I)(G) states this rationale should explain why “[a] person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006).
The teaching, suggestion, or motivation in the prior art (i.e. instant SEQ ID NO: 25 is an exemplary N-terminal leader sequence for production of IL-10 polypeptides in a mammalian system as taught in US ‘144) would have led one of ordinary skill to modify the prior art reference (i.e. an IL-10 mutein comprising a single substitution of amino acid at position 18 relative to amino acids of wild-type IL-10 wherein the substitution of amino acid at position 18 comprises N18R and a signal peptide as taught in US ‘966) to arrive at the claimed invention. There is a reasonable expectation of success as a signal peptide comprising instant SEQ ID NO: 25 was known and used prior to the effective filing date of the application. In addition, both US ‘966 and US ‘144 are in analogous arts (i.e. IL-10 proteins fused to signal peptides).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the instant application to use instant SEQ ID NO: 25 for the sequence of the signal peptide as taught in US ‘144 in an IL-10 mutein comprising a single substitution of amino acid at position 18 relative to amino acids of wild-type IL-10 wherein the substitution of amino acid at position 18 comprises N18R and a signal peptide as taught in US ‘966.
Accordingly, instant claim 9 is rendered obvious over US ‘966 in view of US ‘144.
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.
Claim 1-6, 10-13, 16-17, and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24, and 28-31 of copending Application No. 18/478,363 (reference application; hereinafter referred to as copending ‘363). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 20-21 of copending ‘363 teaches a fusion protein comprising an anti-PD-L1 antibody fused to IL-10 (instant claims 10 and 16) with at least 90% sequence identity to SEQ ID NO: 73 (claim 20 of copending ‘363) or comprising SEQ ID NO: 73 (claim 21 of copending ‘363). SEQ ID NO: 73 of copending ‘363 is identical to the wild-type sequence of IL-10, corresponding to instant SEQ ID NO: 2 (instant claim 2). Variation up to 90% of SEQ ID NO: 73 of copending ‘363 reads on 1) an IL-10 variant protein comprising a first substitution of amino acid at position 18, a second substitution of amino acid at position 104, and/or a third substitution of amino acid at position 107, relative to amino acids of wild-type IL-10 (instant claim 1), and 2) an IL-10 variant protein comprising any of the substitutions listed in instant claims 3-6.
Claim 22 of copending ‘363 teaches IL-10 is fused C-terminal (instant claim 13). Claim 23 of copending ‘363 teaches a linker (instant claim 11). Claim 24 of copending ‘363 teaches the linker comprises SEQ ID NO: 76. SEQ ID NO: 76 of copending ‘363 is identical to instant SEQ ID NO: 19 (instant claim 12).
Claims 28-29 of copending ‘363 teach the anti-PD-L1 antibody having at least 90% sequence identity to heavy and light chain SEQ ID NOs (claim 28 of copending ‘363) or comprises heavy and light chains SEQ ID NOs (claim 29 of copending ‘363), which overlap with the heavy and light chains having at least 80% sequence identity to the SEQ ID NOs of instant claim 17.
Claims 30-31 of copending ‘363 teach a polynucleotide encoding the fusion protein (claim 30 of copending ‘363; instant claim 19) in a host cell (claim 30 of copending ‘363; instant claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-2, 4-5, 7-13, 15, and 18-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 13, 15-16, 19, and 21-22 of copending Application No. 18/698,803 (reference application; hereinafter referred to as copending ‘803). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1 and 3-4 of copending ‘803 teach an IL-10 mutein (i.e. IL-10 variant protein) comprising a substitution on amino acids in position 104, position 107, and a combination thereof, relative to amino acids of a wild-type IL-10 (claim 1 of copending ‘803; instant claim 1), wherein said substitutions are selected from R104Q, R107A, R107E, R107Q, and/or R107D (claim 3-4 of copending ‘803; instant claims 4-5). Claim 2 of copending ‘803 teaches the IL-10 mutein having at least 80% sequence identity to SEQ ID NO: 2, which is identical to instant SEQ ID NO: 2 (instant claim 2). Claim 5 of copending ‘803 teaches the IL-10 mutein is a monomer or dimer (instant claim 7). Claims 6-7 of copending ‘803 teach the IL-10 mutein comprises a signal peptide (claim 6 of copending ‘803; instant claim 8) with SEQ ID NO: 14, which is identical to instant SEQ ID NO: 25 (claim 7 of copending ‘803; instant claim 9).
Claim 8 of copending ‘803 teaches a fusion protein comprising 1) a polypeptide which binds to a target protein, wherein the polypeptide comprises an antibody or a fragment thereof, an antagonist, a receptor or a ligand of the target protein, or a protein-Trap and 2) an IL-10 mutein (instant claim 10).
Claim 9 of copending ‘803 teaches a linker (instant claim 11). Claim 10 of copending ‘803 teaches the linker comprises SEQ ID NO: 15, which is identical to instant SEQ ID NO: 19 (instant claim 12). Claim 11 of copending ‘803 teaches IL-10 is fused C-terminal or N-terminal (instant claim 13). Claims 13 and 15 of copending ‘803 teaches the fusion protein has at least 80% sequence identity to SEQ ID NO: 29, which overlaps with instant SEQ ID NO: 18 (instant claim 15). Claim 16 of copending ‘803 teaches the fusion protein has the properties or specifications listed in (1)-(6) of instant claim 18.
Claims 19 and 21 of copending ‘803 teach a host cell (claim 19 of copending ‘803; instant claim 20) comprising a polynucleotide encoding the fusion protein (claim 19 of copending ‘803; instant claim 19) and producing the protein from culturing said cell (claim 21 of copending ‘803; instant claim 21). Claim 22 of copending ‘803 teaches a pharmaceutical composition of the fusion protein and a pharmaceutical acceptable carrier, diluent, or excipient (instant claim 22).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
An IL-10 variant protein containing N18A substitution, was search thoroughly and is deemed novel in view of the prior art, rendering it art-free subject matter. The closest prior art is delineated in the 102 rejection section, describing an IL-10 variant protein containing N18R substitution.
Conclusion
Claims 1-23 are pending. Claim 4-6 and 10-18 are withdrawn. Claim 9 is objected to. Claims 1-3, 7-9, and 19-23 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica M Priest whose telephone number is (571)272-8469. The examiner can normally be reached Mon-Fri 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.P./Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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