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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/09/2026 has been entered.
Applicant’s amendment, filed on 2/09/2026, is acknowledged.
Claims 2, 4, 5, 7-14, 16, 18, 19, 23, 26-32, 34, 36, and 38-49 are cancelled.
Claims 1 and 33 are independent claims.
Claims 1, 3, 6, 15, 17, 20-22, 24, 25, 33, 35, 37, and 50-56 are currently pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/09/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner in its entirety.
Nucleotide and/or Amino Acid Sequence Disclosures
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 - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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(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 24 and 55 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.
The recitation "from decorin on von Willebrand factor” in claims 24 and 55 are indefinite because it is unclear what changes or how many changes could have occurred to result in the decorin or VWF derivatives. The claims only describe the source and not the result.
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.
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, 3, 6, 15, 17, 21, 25, 33, 35, 37, 50-53, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Winston et al. (U.S. PGPub 20190367576, in Office Action mailed on 10/09/2025) in view of Deming et al. (U.S. PGPub 20160186150, in Office Action mailed on 10/09/2025) and Bianchini et al. (Oncol Rep. 2006 Mar;15(3):709-14. PMID: 16465434).
Instant claim 1 claims a method of treating melanoma comprising administration of an IL-12 linked to an IL12R through a linker that comprises SEQ ID NO: 49, 50, and 138, wherein the subject has or will receive anti-PD1 or anti-PDL1 immunotherapy. Thus, the claim encompasses a method of treating melanoma comprising administration of an IL-12 linked to an IL12R through a linker that comprises SEQ ID NO: 49, 50, and 138, as “will receive anti-PD1 or anti-PDL1 immunotherapy” is interpreted as not receiving this therapy.
Instant claim 33 claims the IL12-IL12R fusion polypeptide itself, and not a method of treatment comprising administration of the fusion polypeptide.
Winston et al. teaches a fusion polypeptide comprising an IL-12 polypeptide, a IL-12 blocking moiety, and a protease-cleavable linker (claim 1). Winston et al. teaches the blocking moiety can be a IL-12 cognate receptor (i.e., “IL-12R”; claim 9). Winston et al. teaches that the purpose of this is to reduce off-target cytotoxicity (¶[0007]): “[t]he linker is designed to be cleaved at the site of desired cytokine activity, for example in the tumor microenvironment, avoiding off-target cytokine activity and reducing overall toxicity of cytokine therapy.”
Winston et al. further teaches that the linker can comprise two or more cleavage sites that can be cleaved by different proteases, including MMPs and plasminogen activators/PAs (¶[0012], claim 10). Winston et al. teaches one of the protease cleavage sites can be SEQ ID NO: 85, which comprises a sequence that is 100% identical to instant SEQ ID NO: 50:
Qy 1 VPLSLYS 7
|||||||
Db 1 VPLSLYS 7
Winston et al. teaches motivation and rationale to select different protease cleavable sites for the linker based on the tumor microenvironment (¶[0157]): “[p]referably, the desired protease is enriched or selectively expressed at the desired site of cytokine activity ( e.g., the tumor microenvironment). Thus, the fusion protein is preferentially or selectively cleaved at the site of desired cytokine activity.”
Winston et al. further teaches methods of treating melanoma comprising administration of the fusion polypeptides (¶[0186]), and combination therapies comprising administration of the IL-12/IL12R fusion polypeptide and an immune checkpoint inhibitor such as an anti-PD-1 or anti-PD-L1 therapy (i.e., “has or will receive anti-PD1 or anti-PDL1 immunotherapy”; ¶[0187]).
Winston et al. does not teach the IL-12/IL12R fusion polypeptide linker further comprising instant SEQ ID NO: 49 and 138.
Note that the instant specification discloses instant SEQ ID NO: 49 is a uPA (urokinase-type plasminogen activator) cleavage site (¶[0204]), and instant SEQ ID NO: 138 is a MMP2 cleavage site (¶[0084]).
Deming et al., in the same field of endeavor, teaches cleavable linkers that can be cleaved by tumor microenvironment associated enzymes (¶[0011]): “[i]n some embodiments, the cleavable linker is cleaved by a tumor-associated enzyme. In some embodiments, the tumor-associated enzyme is a protease. In some embodiments, the protease is selected from the group consisting of matriptase (MTSP1), urinary-type plasminogen activator (uPA), legumain, PSA (also called KLK3, kallikrein-related peptidase-3), matrix metalloproteinase-2 (MMP-2), matrix metalloproteinase-9 (MMP9) human neutrophil elastase (HNE), and proteinase 3 (Pr3).”
Demin et al. further teaches the cleavage site of SEQ ID NO: 47 (¶[0011]), which is a uPA cleavable linker that is 100% identical to instant SEQ ID NO: 49:
Qy 1 LSGRSDNH 8
||||||||
Db 1 LSGRSDNH 8
Demin et al. additionally teaches the cleavage site of SEQ ID NO: 87 (Table 7), which is a MMP9 cleavable linker that is 100% identical to instant SEQ ID NO: 138:
Qy 1 HPVGLLAR 8
||||||||
Db 1 HPVGLLAR 8
Bianchini et al., in the same field of endeavor, teaches that melanoma tumors express MMP2, MMP9, and uPA (Introduction): “[a]mong the different proteases that might play a role in tumor dissemination, we focused our attention on matrix metalloproteinases 2 and 9 (MMP-2, MMP-9) and urokinase-type plasminogen activator (uPA) and its receptor (uPAR). Both systems of proteases are markers of melanoma progression…”
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the invention of Winston et al. in view of Demin et al. and Bianchini et al. to have introduced the uPA (SEQ ID NO: 47 of Demin et al.) and MMP9 (SEQ ID NO: 87 of Demin et al.) cleavable sites taught by Demin et al. into the IL12/IL12R fusion protein of Winston et al. with a reasonable expectation of success, as Winston et al. teaches that the fusion protein can comprise a linker with multiple protease cleavage sites from different proteases, and Demin et al. teaches that these are functional protease cleavable sites that can be incorporated into the linker of Winston et al. One would have been motivated to make this change for the purposes of making to make a cleavable linker that is only cleaved at a melanoma tumor microenvironment to reduce off-target toxicities as taught by Winston et al., and Bianchini et al. teaches that MMP2, MMP9, and uPA are expressed by melanoma tumors, leading one with ordinary skill in the art to use MMP2, MMP9 and/or uPA cleavage sites such as those taught by Deming et al.
Combining the references would lead to a IL12/IL12R fusion polypeptide with a linker that comprises instant SEQ ID N: 49, 50, and 138 (i.e., the limitations of instant claim 33), as well as methods of treating melanoma with such a fusion polypeptide in a subject that is receiving PD1 or PD-L1 therapy (i.e., the limitations of instant claim 1).
Regarding claims 3 and 50, Winston et al. teaches that IL-12 comprises a p35/p40 heterodimer (claim 17).
Regarding claims 6 and 51, Winston et al. teaches the IL12R comprises IL12Rβ1 (¶[0091]): “…the blocking moiety can be the full length or fragment or mutein of the first molecule of IL-12 receptor (IL-12Rβ1)…”
Regarding claims 15 and 52, Winston et al. teaches the IL12/IL12R fusion polypeptide further comprising a tumor targeting peptide (claim 2), which comprises an antibody (¶[0151]): “[s]uitable targeting and/or retention domains include antigen-binding domains, such as antibodies and fragments thereof…”
Regarding claims 17 and 53, Winston et al. teaches the tumor targeting antibody can target tumor associated stromal antigens such as EpCAM, CEA, and CD73 (¶[0149] and [0154]): “…the suitable targeting and/or retention domains comprise those who have a cognate ligand that is overexpressed in tumor tissue, e.g., Epcam, CEA or mesothelin…the targeting and/or retention antigen can be an immune checkpoint protein. Examples of immune checkpoint proteins include…CD73…”.
Regarding claims 25 and 56, Winston et al. teaches the fusion polypeptide further comprises an albumin domain (claim 11).
Regarding claims 35 and 37, Winston et al. teaches nucleic acids encoding the fusion polypeptide (claim 12) and methods of making the polypeptide comprising culturing a host cell expressing the nucleic acid and collecting the polypeptide (claim 15).
Applicants arguments, filed on 2/09/2026, have been full considered, but have been found to be not convincing.
Applicants argues: i) a prima facie case of obviousness from laundry lists; ii) the references teach away from the claimed invention; and iii) the instantly claimed invention has surprising results over the prior art. This has been found to be not convincing.
Applicant argues that Winston et al. and Deming et al. teach a laundry list of protease cleavable sequences that could encompass a great deal of combinations that one with ordinary skill in the art would need to select from. Applicant further argues that neither of the Winston et al. or Deming et al. references do not teach a motivation to select the three instantly claimed cleavage sequences in instant claims 1 and 33 to treat melanoma.
This has been found to be not persuasive. Winston et al. and Deming et al. teach the three protease cleavage sequences that can be used in fusion proteins such as the activatable IL12/IL12R polypeptide of Winston et al., and Bianchini et al. teaches that MMP2, MMP9 and uPA are expressed in melanoma tumors, providing motivation to use protease cleavage sites for these tumor-associated proteases to treat melanoma.
Applicant argues that the prior art teaches away from the instant claimed invention (remarks pg. 10): “[b]oth IL-12 and checkpoint inhibitor therapy have been reported to resulted in a high rate of adverse events with many patients requiring discontinuation of the therapy. "CPI treatment also shows severe side effects, including immune-related adverse events (8-10). In combination therapy, 96% of patients experienced adverse events, and 36% of patients discontinued therapy due to adverse events (8)" (emphasis added; see Ishihara at Introduction). "IL-12 seemed ideal candidate for tumor immunotherapy in humans. However, severe side effects associated with systemic administration of IL-12 in clinical investigations and the very narrow therapeutic index of this cytokine markedly tempered enthusiasm for the use of this cytokine in cancer patients (Lasek et. al., 2014)" (see Winston at ¶[0075]).”
This has been found to be not persuasive. Winston et al. teaches masked IL12/IL12R fusion proteins that are activated in the tumor microenvironment with reduced off-target toxicity cytotoxicity to be used in a combination therapy (discussed supra).
Applicant argues that the instantly claimed invention has surprising results (remarks pg. 10 and 11), as the masked IL-12 protein of Winston et al. only achieved modest results in a mouse model of MC38 colon adenocarcinoma, and the masked IL12 disclosed in the instant specification in Figure 4D has much greater efficacy at a lower dosage (remarks pg. 11).
This has been found to be not persuasive. It is the Examiner’s positions that: (1) the showing of unexpected results is not commensurate in scope with the invention as claimed. The claims are directed to a genus of IL12 polypeptides, which may or may not comprise both the p35 and p40 subunits, linked to a genus of IL12R polypeptide, which may or may not be IL12Rβ1, by the linker in claim 1. However, Applicant has disclosed that a specific IL-12 polypeptide comprising both the p35 and p40 subunits linked to a IL-12Rβ1 that binds to both the p35 and p40 subunits via the claimed linker sequences, alone or in combination with a specific anti-PD-1 antibody therapy. There is no showing that other embodiments falling within the claims will behave in a similar unexpected manner.
(2) The unexpected results must be due to the claimed features, not to unclaimed features. The instant claims does not recite the IL12 and IL12Rβ polypeptide sequences linked by the instant claimed linker that were found to have surprising efficacy alone and in combination with a specific anti-PD-1 antibody.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 20, 22, 24, 54, and 55 are rejected under 35 U.S.C. 103 as being unpatentable over Winston et al. (supra) in view of Deming et al. (supra) and Bianchini et al. (supra) as applied to claims 1, 3, 6, 15, 17, 21, 25, 33, 35, 37, 50-53, and 56 above, and further in view of Frey et al. (Exp Dermatol. 2011 Aug;20(8):685-8. doi: 10.1111/j.1600-0625.2011.01314.x. Epub 2011 Jun 7).
The combined teachings of Winston et al., Deming et al., and Bianchini et al., have been discussed supra.
The combined teachings do not teach an IL12/IL12R fusion protein or methods of treating melanoma in a subject comprising administration of the fusion protein further comprising a Fab that binds to fibronectin EDA (i.e., the limitations of instant claims 20), or the VWF collagen binding domain (i.e., the limitations of instant claims 22, 24, 54, and 55).
Frey et al., in the same field of endeavor, teaches that melanoma tumors express the fibronectin EDA antigen in primary and metastatic melanoma (Figure 1a and Results): “…intense staining of the basal lamina in in situ melanomas was detectable for the F8 antibody (which recognizes the EDA domain of fibronectin)… metastatic melanomas consistently revealed diffuse and intense stromal staining of the interstitium for all three…”. Frey et al. teaches the F8 antibody, which comprises a Fab that binds to fibronectin EDA (Methods): “…clinical-stage antibodies F8, specific to the EDA of fibronectin…”.
Frey et al. further teaches that the melanoma tumors express collagen that is bound by Von Willebrand factor (Figure 1, green fluorescence in tumors), as well as compositions comprising the VWF (Methods): “…tumor sections together with a rabbit-anti-human von Willebrand Factor antibody…”.
Frey et al. additionally provides motivation to use such antibodies to target therapies to tumors, such as melanoma, that express EDA and other antigens such as the target for VWF (Introduction): “[t]he precise biological function of the EDA and EDB domains of fibronectin and of tenascin-C is still unknown, because single knockout mice devoid of EDA, EDB or tenascin-C develop normally with some abnormalities in the case of tenascin-C. However, these targets appear to be ideally suited for antibody-based pharmacodelivery applications, in view of their restricted expression in normal tissue and their abundant expression in a variety of different human malignancies…”.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant application, to have modified the combined teachings of Winston et al., Deming et al., and Bianchini et al., further in view of Frey et al. to add either a EDA targeting F8 antibody, or collagen targeting VWF to the IL12/IL12R fusion protein taught by the combined references of Winston et al., Deming et al., and Bianchini et al. with a reasonable expectation of success, as Frey et al. teaches that F8 and WVF can be used to target melanoma that one with ordinary skill would appreciate can be applied to the IL12/IL12R fusions proteins of Winston et al., Deming et al., and Bianchini et al. One would have been motivated to make this change for the purposes of targeting the IL12/IL12R fusion therapeutic protein to melanoma tumors to treat the tumor.
Applicants previous arguments have been rendered moot in light of this new rejection.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 1, 3, 6, 15, 17, 20-22, 24, 25, 33, 35, 37, and 50-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 12, 17, 29, 34, 36, 39, 40, 45, 54, and 59-62 of copending Application No. 18/559,180 (herein App ‘180, in Office Action mailed on 10/06/2025, supra) in view of Winston et al. (U.S. PGPub 20190367576, in Office Action mailed on 10/09/2025, supra), Deming et al. (U.S. PGPub 20160186150, in Office Action mailed on 10/09/2025), and Bianchini et al. (Oncol Rep. 2006 Mar;15(3):709-14. PMID: 16465434, supra).
App ‘180 claims polypeptides comprising IL-12 linked to IL-12R via a linker (claim 1), wherein the IL-12 comprises the p35 and p40 subunits (i.e., the limitations of instant claims 3 and 50; App ‘180 claim 9), and the IL-12R comprises IL12β1 (i.e., the limitations of instant claims 6 and 51; App ‘180 claim 12).
App ‘180 additionally claims the limitations of instant claims 15, 17, 21, 22, 24, and 52-55 (claims 34, 36, 39, and 40), the limitations of instant claim 20 (claim 39), the limitations of instant claim 35 and 37 (claims 59-61), and methods of treating cancer comprising administration of the masked IL12/IL12R (claim 62).
App ‘180 does not claim the fusion polypeptide and methods of treatment comprising administration of the polypeptide with all of the protease cleavage sites recited in instant claim 1 and 33.
The invention encompassed by the instant claims is a prima facie variant of App ‘180 in view of Winston et al., Deming et al., and Bianchini et al. for the same reasons discussed in the 35 § U.S.C. 103 rejection supra.
Claims 25 and 56 are included because App ‘180 claims the masked IL-12 further comprising a serum protein (claim 45), and Winston et al. teaches albumin as a serum protein to use with the fusion polypeptides and methods of treating melanoma comprising administration of the polypeptide.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641