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 .
Applicant’s election without traverse of group I, claims 1, 3, 8, 11, 16, 19, 24, 27, 30, 33, 44, 57, 81-82, 124, 126, 150-151, in the reply filed on 11/5/25, is acknowledged. Applicant has further elected a species of masked IL-2 wherein IL-2 and masking moiety are on separate polypeptides, SEQ ID NO: 9 and 12 as the species of half-life extending domains, a species of IL-2 wherein the first linker is proteolytically cleavable, and has SEQ ID NO: 17 and 24, a non-cleavable linker species of SEQ ID NO: 23, and a polypeptide chain comprising SEQ ID NO: 40. Applicant indicates that claim 19 reads on the elected species. However, Applicant has elected a first linker that is proteolytically cleavable, and claims 19 requires that the first linker is non-proteolytically cleavable and does not read on the elected species of first linker. Likewise, claim 82 represents a cleavage product from a masked cytokine wherein the polypeptide chain having IL-2 has a proteolytic cleavage site (Applicant elected a species wherein the proteolytic cleavage linker is on the first polypeptide comprising a masking moiety and wherein the non-proteolytic linker is on the IL-2 polypeptide). Therefore, claims 19, 24, and 82 are non-elected species. Claim 57 is also a non-elected species that do not read on the elected species of masked IL-2 wherein the masking moiety and IL-2 are on separate polypeptides. Claims 19, 24, 57, and 82 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected species.
Claims 1,3, 9, 11,16, 27, 30, 33, 44, 81, 124, 126, 150-151, as they read on the elected invention, are being acted upon.
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequences appear in the specification without an associated SEQ ID from the sequence listing. See, for example, Table starting on page 143. Additionally, the specification is objected to for reference to sequences that are skipped sequences in the sequence listing (see, for example, page 5 of the specification which references SEQ ID NO:29, which has no associated sequence in the sequence listing). Applicant must amend the specification to remove reference to SEQ ID NO: 29 and all other skipped sequences.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting or removing the relevant sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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.
Claims 1,3, 9, 11,16, 27, 30, 33, 44, 81, 124, 126, and 150 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. 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 or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of masked IL-2 cytokines.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP 2163.
The instant claims encompass a genus of masked IL-2 cytokines, comprising any first and second half-life extending domains that function to associate with each other, any “functional fragment” of IL-2, and any masking moiety, including fragments, portions or variants of IL-2Rb. This represents a large genus of structurally distinct proteins with different amino acid sequences and any variant or fragment thereof. The state of the art is such that protein chemistry is one of the most unpredictable areas of biotechnology. Whisstock et al (Quarterly Review of Biophysics, 2003, 36, pp307-340) teach that the prediction of protein function from sequence and structure is a difficult problem, because homologous proteins often have different functions. Even single amino acid changes in a proteins amino acid sequence can have dramatic effects on protein function. For example, Wang et al., 2001, show that a single amino acid determines lysophospholipid specificity of the S1P1 (EDG1) and LPA1 (EDG2) phospholipids growth factor receptors (e.g., abstract). These references demonstrate that even a single amino acid substitution or what appears to be an inconsequential chemical modification will often dramatically affect the biological activity and characteristic of a peptide. The instant specification does not disclose a correlation between structure and function for the half-life extension moieties, masking moieties, and function fragments, variants thereof encompassed by the present claims. Nor does the specification disclose a representative number of species. For example, the only species of half-life extension moieties disclosed that function to associate with each other are Fc domains, which is not sufficiently representative of the enormous genus of structurally distinct “half-life extending domains” or “fragments thereof” encompassed by the present claims. Likewise, the only species of masking moiety for IL-2 is IL-2Rb of SEQ ID NO: 4, or a specific C122S,C168S variant thereof in SEQ ID NO: 5. This is not sufficiently representative of the genus of masking moieties, or fragments, or variants thereof of IL-2Rb as encompassed by the present claims. Likewise, the claims encompass any functional fragment of IL-2, and no species of “fragment” are disclosed.
The instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of antibodies and inhibitors encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3.
Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
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.
Claim(s) 1, 3, 11, 16, 30, 81, 124, 126 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO2019/173832 (of record).
WO2019/173832 teaches a masked IL-2 polypeptide comprising a first polypeptide comprising an masking moiety fused to an Fc domain, and a second polypeptide comprising an IL-2 polypeptide fused to an Fc domain, wherein each Fc domain has knobs in holes mutations to facilitate dimer formation (i.e. see pages 1-4 and the drawings, in particular). WO2019/173832 teaches that the IL-2 is a mutant of IL-2 of SEQ ID NO: 2 of the instant application (see page 3, in particular). WO2019/173832 teaches that the masking moiety comprises human IL-2Rb (See page 3, in particular). WO2019/173832 teaches that said first polypeptide having the masking moiety is linked to the Fc domain via a cleavable peptide linker (see page 4 and drawings, in particular). WO2019/173832 teaches that the IL-2 is fused to the Fc domain via a noncleavable linker (See page 7, 23, and Fig. 3, in particular). WO2019/173832 teaches a pharmaceutical composition and kits comprising the masked IL-2 (See pages 7 and 24, in particular). WO2019/173832 teaches that the cleavable linkers are flanked by spacer domains (See, for example, page 41). WO2019/173832 teaches that said masked IL-2 represents a prodrug, and that cleavage of said cleavable linker leads to activation of the prodrug, masked polypeptide, i.e. a cleavage product of claim 81 (See page 4 and 42, in particular).
Claim(s) 1, 3, 9, 11, 16, 27, 30, 33, 81, 124, 126 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2020/069398 (of record).
WO2020/069398 teaches a masked IL-2 polypeptide comprising a first and second polypeptide comprising SEQ ID NO: 716 and 699, respectively (See paragraph 143). Said SEQ ID NO: 699 is 100% identical to SEQ ID NO: 51 of the instant application (see attached alignment, i.e. it is an polypeptide comprising an IL-2 cytokine modified compared to SEQ ID NO: 2, comprising an Fc half-life extending domain of SEQ ID NO: 12, and a non-cleavable linker of SEQ ID NO: 23 of the instant application). Said SEQ ID NO: 716 is 99.6% percent identical to SEQ ID NO: 40 of the instant application (see attached alignment), and comprises an IL-2Rb masking moiety linked via a cleavable linker to an Fc half-life extending domain comprising SEQ ID NO: 12 of the instant application, wherein the linker comprises SEQ ID NO: 17 and 24 of the instant application (SEQ ID NO: 24 being a species of proteolytically cleavage peptide flanked on both sides by a a spacer domain). WO2020/069398 teaches cleavage products thereof, compositions, and kits comprising the masked cytokines (see paragraphs 34-35 and 649, in particular).
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.
Claims 1, 3, 9, 11, 16, 27, 30, 33, 44, 81, 124, 126, 150-151 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2020/069398 (of record).
The teachings of WO2020/069398 are described above. The only difference between the polypeptide of SEQ ID NO: 716 in WO2020/069398 and SEQ ID NO: 40 of the instant claims are the C122S and C168S substitutions in the IL-2Rb masking domain. However, WO2020/069398 also teaches a IL-2Rb masking domain species of SEQ ID NO: 826 comprising said C122S and C168S mutations. It would be obvious to substitute the IL-2Rb masking moiety in SEQ ID NO: 716, with the masking moiety of SEQ ID NO: 826, since they are technical equivalents for the same purposed. Doing so would result in a sequence identical to SEQ ID NO: 40 of the instant application. Selecting from known IL-2 masking moieties would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. V. Telefex Inc 82 USPQ2d 1385).
Claims 1, 3, 9, 11, 16, 30, 81, 124, and 126 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/173832 (of record), in view of 2015/0218250 and Qi, 2018.
The teachings of WO2019/173832 are described above. WO2019/173832 also teaches that the Fc domain can be human IgG1, and that the first and second Fc domain can have knobs and hole mutations.
The reference differs from the claimed invention in that it does not explicitly teach SEQ ID NO: 9 and 12.
The ‘250 publication teaches various mutations that can be combined in each Fc domain to promote heterodimerization (i.e. knobs in hole mutation) including wherein one Fc chain has SEQ ID NO: 5 and one Fc chain has SEQ ID NO: 6, which are identical to SEQ ID NO: 9 and 12 of the instant application, except that they are lacking the N297A mutation. However, the ‘250 publication teaches that the Fc region can also comprise N297A. See also Qi which teaches that combining N297A in the context of heterodimeric Fc knobs in holes mutations is advantageous since it provides for an aglycosylated Fc region that exhibits extended circulatory time (see page abstract and page 5468, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to make to use the Fc regions of the ‘250 publication and Qi, as the first and second Fc domain in the IL-2 polypeptides of WO2019/173832. Doing so would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. V. Telefex Inc 82 USPQ2d 1385). Additionally, the ordinary artisan would also be motivated to do so since the ‘250 publication and Qi teach that the knobs and holes mutations achieve preferential heterodimerization, and that the N297A mutation is advantageous since it provides for aglycosylation and extended circulatory time.
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 1,3, 9, 11,16, 24, 27, 30, 33, 81, 124, 126, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 38-47, 52-55 of copending Application No. 19/001,131.
The ‘131 application claims a heterodimeric masked IL-2, comprising a first polypeptide comprising an Fc domain, linker, and cytokine and a second polypeptide comprising Fc domain, linker, masking moiety. The ‘131 application claims wherein the first or second linker is cleavable linker comprising SEQ ID NO: 15, which comprises SEQ ID NO: 17 and SEQ ID NO: 24 of the instant application and non-cleavable linker of SEQ ID NO: 348, which comprises SEQ ID NO: 23 of the instant application.. The ‘131 application claims Fc domains of SEQ ID NO: 155 and 156, which are identical to SEQ ID NO: 9 and 12 of the instant application. The ‘131 application claims a masking moiety of SEQ ID NO: 10, i.e. IL-2Rb.
This is a provisional nonstatutory double patenting rejection.
It is noted that although the WO2020/069398 reference cited above renders obvious SEQ ID NO: 40, it is not being cited as a prior art reference to establish obviousness in the double patenting rejection, since the ‘131 application is a continuation application that claims priority to the 371 filing of WO2020/069398. In other words, WO2020/069398 represents the specification of the ‘131 application, and therefore cannot be used as a prior art reference.
Claims 1,3, 9, 11,16, 27,30,33,44, 81, 124, 126, 150-151 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,053,294 (of record), in view of WO2019/173832.
The ‘294 patent claims a masked IL-2, comprising a first Fc domain and a second Fc domain, a masking moiety and an IL-2 polypeptide, wherein the masking moiety and the first Fc domain are linked via a cleavable linker, and the second Fc domain and IL-2 are linked via a second linker, wherein the first and second Fc domain associate with each other (i.e. a masked IL-2 within the scope of instant claim 1). The ‘294 patent claims a masking moiety of SEQ ID NO: 826 (i.e. IL-2Rb). The ‘294 patent claims that the first and second Fc domain have SEQ ID NO: 155 and 156, which are identical to SEQ ID Nos: 9 and 12 of the instant application. The ‘294 patent claims that the first linker has SEQ ID NO: 15, which comprises SEQ ID NO: 17 and SEQ ID NO: 24 of the instant application, and the second linker comprises SEQ ID NO: 339 (i.e. non-cleavable), which comprises SEQ ID NO: 23 of the instant application. The ‘294 application claims a pharmaceutical composition and kit comprising said masked cytokine. Regarding SEQ ID NO: 40, it would be obvious to directly link the elements of claim 11 in the ‘294 patent in the order specified in claim 1 (i.e. Fc domain of SEQ ID NO: 155, first cleavable linker of SEQ ID NO: 15, masking domain of SEQ ID NO: 826) based on the teachings of WO2019/173832, which teach suitable arrangements of masked IL-2. Doing so would result in a polypeptide 100% identical to SEQ ID NO: 40. Likewise, SEQ ID NO: 51 would be obvious based on claim 11 for the same reasons (i.e. arranging Fc domain of SEQ ID NO: 156, linker of SEQ ID NO: 339, IL-2 of SEQ ID NO: 3 would arrive at a sequence 100% identical to SEQ ID NO :51 of the instant application). Furthermore, as taught by WO2019/173832, the purpose of the masked cytokine is to provide a prodrug, wherein the cleavable linker is cleaved resulting in a cleavage product, and it would be obvious to cleave the linker in the masked IL-2 claimed in the ‘294 patent, which would results in a cleavage product identical to claim 81 of the instant application.
Claims 1,3, 9, 11,16, 27,30,33,44, 81, 124, 126, 150-151 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,827,686, or claims 1-18 of 11,827,685 in view of WO2019/173832.
The patents claims methods of making and using the same masked IL-2 as set forth above for the 294 patent, and therefore anticipate/render obvious the instant claims for the same reasons set forth above.
Claims 1,3, 9, 11,16, 27, 30, 33, 81, 124, 126, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,866,476, in view of WO2019/173832.
The ‘476 patent claims a masked IL-2, comprising a first Fc domain and a second Fc domain, a masking moiety and an IL-2 polypeptide, wherein the masking moiety and the first Fc domain are linked via a first linker, and the second Fc domain and IL-2 are linked via a second cleavable linker, wherein the first and second Fc domain associate with each other (i.e. a masked IL-2 within the scope of instant claim 1). The ‘476 patent claims a masking moiety of SEQ ID NO: 826 (i.e. an IL-2Rb polypeptide). The ‘476 patent claims that the first and second Fc domain have SEQ ID NO: 155 and 156, which comprise SEQ ID Nos: 9 and 12 of the instant application. The ‘294 application claims a pharmaceutical composition and kit comprising said masked cytokine. Furthermore, as taught by WO2019/173832, the purpose of the masked cytokine is to provide a prodrug, wherein in the cleavable linker is cleaved resulting in a cleavage product, and it would be obvious to cleave the linker in the masked IL-2 claimed in the ‘294 patent, which would results in a cleavage product within the scope of claim 81 of the instant application. The ‘476 patent discloses that the first and second linkers can comprise SEQ ID NO: 15, which comprises SEQ ID NO: 17 and SEQ ID NO: 24 SEQ I D NO: 339 (i.e. non-cleavable), which comprises SEQ ID NO: 23 of the instant application. Thus, claim 1 of the ‘476 patent covers the linkers of SEQ ID NO: 17,23-24 of the instant application. See MPEP 804 IIB1, the specification may be used as a dictionary and the parts of the specification that describe subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claims.
Claims 1,3, 9, 11,16, 27,30,33,44, 81, 124, 126, 150-151 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32, 36-38, 52, 57, 155 of copending Application No. 18/936,737.
The ‘737 application claims a heterodimeric masked cytokine, comprising a first polypeptide comprising a masking moiety linked to a first half-life extension moiety via a first linker and a second polypeptide comprising a cytokine moiety linked to a second half life extension moiety, wherein the first half-life extension moiety is associated with the second half-life extension moiety, and wherein the first or second linker is proteolytically cleavable peptide linker and the other linker is non-cleavable. The other limitations of the present claims would be obvious (i.e. IL-2 as the cytokine in combination with the masking moiety, Fc, and linkers as taught by WO2020/069398 or WO2019/173832 2015/0218250 and Qi, 2018), for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
Claims 1,3, 9, 11,16, 27,30,33,44, 81, 124, 126, 150-151 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending applications 18/115,527, 18,352,762, 18/819,975, or 18/821,234, in view of WO2020/069398 or WO2019/173832 2015/0218250 and Qi, 2018.
The applications all claim masked IL-2 or a masked cytokine, wherein the other features of the instant claims are either claimed or obvious over WO2020/069398 or WO2019/173832 2015/0218250 and Qi, 2018, for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker, can be reached at telephone number 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644