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 .
DETAILED ACTION
1. The Amendment filed December 12, 2026 in response to the Office Action of August 25, 2025 is acknowledged and has been entered. Claims 1, 5, 29, 32, 33, 36, 37, and 42 have been amended. Claims 2, 3, 10, 11, 16, 18, and 27 have been cancelled. New claims 87-98 have been added.
2. Claims 1, 5, 29-34, 36-38, 42, 43 and 87-98 are currently being examined.
Rejections Maintained
Claim Rejections - 35 USC § 102
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.
3. Claim(s) 1, 5, 29-34, 36-38, 42, 43, 87-90 and 95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0190481 A1 (Finn JD, July 9, 2015), “Finn”.
Finn teaches using a combination of CD39 and CD73 to treat inflammatory disorders. See abstract and ¶¶ 0001-0008.
Finn teaches a CD39 and CD73 fusion protein and a vector encoding it, wherein the polypeptide comprises a structure from N-terminus to C-terminus: A-(E-NTPDase)-L-eN-B; or A-eN-L-(E-NTPDase)-B; wherein A is absent or is an amino acid sequence of one or more amino acids; B is absent or is an amino acid sequence of one or more amino acids; and L is absent or is a chemical linker or a polypeptide linker of one or more amino acids. See Fig. 3.
Finn teaches CD39 SEQ ID NOs: 1 and 11, which have 100% identity to SEQ ID NO: 1, for use in the CD39/CD73 fusion proteins . See ¶¶ 0009, 0013, 0022-0026, and 0077-00080 and Appendix of the Office Action of 08/25/2025.
Finn teaches CD73 SEQ ID NOs: 3 and 15 which have 100% identity to SEQ ID NO: 2, for use in the CD39/CD73 fusion proteins. See ¶¶ 0045-0049 and 0077-00080 and Appendix of the Office Action of 08/25/2025.
Finn teaches the CD39/CD73-IgG1 Fc fusion protein SEQ ID NO: 53. See ¶¶ 0066-0068, and 0096 and Table 4.
SEQ ID NO: 53 has 98.6% identify to the IgG1 Fc domain of SEQ ID NO: 5. See Appendix Office Action of 08/25/2025.
SEQ ID NO: 53 has 86.6% identity to SEQ ID NO: 10. See Appendix Office Action of 08/25/2025.
Finn teaches the CD39/CD73 fusion protein SEQ ID NO: 19 which has 81.7% identity to SEQ ID NO: 11. See ¶¶ 0065, 0066 and 0068 and Appendix Office Action of 08/25/2025.
SEQ ID NO: 19 of Finn has 97% identity to SEQ ID NO: 9. See Appendix.
Finn teaches using the poly-glycine containing flexible linker SEQ ID NO: 21 in the CD39/CD73 SEQ ID NO: 19 fusion protein. See ¶¶ 0063-0065 and Appendix Office Action of 08/25/2025..
Finn teaches that the fusion protein further comprises an Fc-tag for the purification of the protein. See ¶¶ 0066 and 0096.
Finn teaches nucleic acid vectors for expression of the CD39/CD73 fusion protein in host cells for production and isolation of the CD39/CD73 fusion protein from cultured host cells. See ¶¶ 0083, 0093, 0098-0100 and 0190-0197.
Finn teaches the CD39/CD73 fusion protein hydrolyzes ATP to ADP in an in vitro inflammation assay. See ¶¶ 0245 and 0280, Fig. 10 A-E.
Finn teaches treating inflammatory conditions or diseases, including disorders of platelet function by administration of CD39 and CD73. See ¶¶ 0124-0127, 0132 and claims 35-37 and 39.
Finn teaches that CD39 inhibits platelet activation. See ¶ 0278.
Finn teaches CD39 converts ATP into ADP and ADP into AMP or adenosine. See ¶¶ 0006, 0013, 0037 and 0094.
Finn teaches that the treatments with the CD39/CD73 fusion protein could lead to a decrease in symptoms of the inflammatory conditions or diseases, such as a decrease in in cartilage and/or bone destruction (mechanical perturbations) in a rheumatoid arthritis patient (RA). See ¶¶ 0132-0140 and 0144.
Finn teaches pharmaceutical compositions with pharmaceutically acceptable carriers for the CD39/CD73 fusion proteins of the invention. See ¶¶ 0120-0121 and 0166 and claim 38.
Finn teaches the invention provides a combination and/or a composition and/or a preparation which is in the form of a kit of parts comprising CD39 and/or CD73. See ¶ 0167.
With regard to the instructions in the kit, it is noted that patentable weight is not given to instructional limitations in a product claim absent a new and unobvious functional relationship between the instructional limitations and the product See MPEP 2111.05. Instructions for use of a the CD39/CD73 fusion protein composition is not a new and unobvious functional relationship between the instructional limitations and the product.
Response to Arguments
4. Applicant argues that without assenting to this rejection and solely to expedite prosecution, Applicant has amended claim 1 to recite a fusion protein with a CD39 polypeptide and a CD73 polypeptide, in which the fusion protein has at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOs: 8-11. Finn fails to teach a fusion protein with the structure recited in present independent claim 1 and its dependent claims. Consequently, the present claims are novel over Finn.
Applicant’s arguments have been considered, but have not been found persuasive. First it is noted that independent claim 1 is not drawn to wherein the fusion protein has at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOs: 8-11. Rather claim 1 is drawn to wherein the fusion polypeptide comprises an amino acid sequence of any one of SEQ ID NOs:8-11 or a variant thereof with up to 90% sequence identity thereto. A variant thereof with up to 90% sequence identity thereto reads on variants of SEQ ID NOs:8-11 that have 90% or less identity to SEQ ID NOs:8-11. SEQ ID NO: 53 has 86.6% identity to the claimed SEQ ID NO: 10. See Appendix Office Action of 08/25/2025. Additionally, an amino acid sequence of any one of SEQ ID NOs: 8-11 reads on fragments of SEQ ID NOs: 8-11. Further, even if the claims did were limited to a fusion protein that has at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOs: 8-11, SEQ ID NO: 19 of Finn has 97% identity to SEQ ID NO: 9. See Appendix. Thus, Finn meets the limitations for the claimed fusion protein for the reasons previously set forth and above and the rejection is maintained.
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, 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.
5. Claims 1, 5, 29-34, 36-38, 42, 43, 87-90 and 95 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0190481 A1 (Finn JD, July 9, 2015), “Finn”.
Finn teaches as set forth above, but does not teach a working example of a CD39/CD73 fusion protein with both the poly-glycine linker and an Fc domain.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Finn and make a CD39/CD73 fusion protein with both the poly-glycine linker and an Fc domain of Finn because Finn teaches both can be used in the fusion proteins, the poly-glycine linker provides flexibility (¶¶ 0064-0065) and the Fc domain can be used for purification. Thus, one of skill in the art would have been motivated to make a CD39/CD73 fusion protein with both the poly-glycine linker and an Fc domain given the advantages taught by Finn.
Additionally, in regard to the kit of claim 43, it would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to provide for instructions for use of the CD39/CD73 fusion protein so that a user of the kit could effectively use the CD39/CD73 fusion protein.
Response to Arguments
6. Applicant argues that Finn fails to teach or suggest a fusion protein with at least 90% sequence identity to any one of SEQ ID NOs: 8-11. Instead, as is acknowledged by the Office, Finn describes a polypeptide with no more than 81.7% sequence identity to SEQ ID NO: 11. In addition, Applicant respectfully disagrees with the Office's conclusion that SEQ ID NO: 53 of Finn shares 86.6% sequence identity to SEQ ID NO: 10 of the present claims, as this sequence appears to have only 56.6% sequence identity relative to the entire sequence of SEQ ID NO: 10. In particular, the N-terminal portion of SEQ ID NO: 10 and the C-terminal portion of SEQ ID NO: 53 of Finn do not have any overlapping sequence, as is shown in the alignment in the remarks.
Applicant argues that consequently, Finn fails to teach or suggest any polypeptide with at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOs: 8-11. Thus, Finn fails to render present independent claim 1 and its dependent claims obvious. Applicant respectfully requests the withdrawal of this rejection.
Applicant’s arguments have been considered, but have not been found persuasive. As noted above, independent claim 1 is not drawn to wherein the fusion protein has at least 90% sequence identity to the amino acid sequence of any one of SEQ ID NOs: 8-11. Rather claim 1 is drawn to wherein the fusion polypeptide comprises an amino acid sequence of any one of SEQ ID NOs:8-11 or a variant thereof with up to 90% sequence identity thereto. A variant thereof with up to 90% sequence identity thereto reads on variants of SEQ ID NOs:8-11 that have 90% or less identity to SEQ ID NOs:8-11. SEQ ID NO: 53 has 86.6% identity to the claimed SEQ ID NO: 10. See Appendix Office Action of 08/25/2025. Additionally, an amino acid sequence of any one of SEQ ID NOs: 8-11 reads on fragments of SEQ ID NOs: 8-11. Also the percent identity does not require identity to the full length of SEQ ID NOs: 8-11. Further, even if the claims were limited to a fusion protein that has at least 90% sequence identity to an amino acid sequence of any one of SEQ ID NOs: 8-11, SEQ ID NO: 19 of Finn has 97% identity to the claimed SEQ ID NO: 9. See Appendix. Thus, Finn meets the limitations for the claimed fusion protein for the reasons previously set forth and above and the rejection is maintained.
Conclusion
7. All other objections and rejections recited in the Office Action of August 25, 2025 are withdrawn in view of Applicant’s amendments and arguments. Claims 1, 5, 29-34, 36-38, 42, 43, 87-90 and 95 are rejected. Claims 91-94 and 96-98 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
8. No claims allowed.
9. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet L Epps-Smith can be reached on 571-272-0757. 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 the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Peter J Reddig/
Primary Examiner, Art Unit 1642
APPENDIX
SEQ ID NO 9 Alignment with SEQ ID NO: 19
US-14-411-047-19
Sequence 19, US/14411047
Publication No. US20150190481A1
GENERAL INFORMATION
APPLICANT: Arthrogen B.V.
TITLE OF INVENTION: Combination for treating an inflammatory disorder
FILE REFERENCE: P6040380PCT
CURRENT APPLICATION NUMBER: US/14/411,047
CURRENT FILING DATE: 2014-12-23
PRIOR APPLICATION NUMBER: US 61/664,818
PRIOR FILING DATE: 2012-06-27
PRIOR APPLICATION NUMBER: EP 12173853.8
PRIOR FILING DATE: 2012-06-27
NUMBER OF SEQ ID NOS: 57
SEQ ID NO 19
LENGTH: 1009
TYPE: PRT
ORGANISM: Artificial
FEATURE:
OTHER INFORMATION: soluble CD73-CD39 fusion derived from homo sapiens
Query Match 80.3%; Score 5099; Length 1009;
Best Local Similarity 97.1%;
Matches 971; Conservative 2; Mismatches 7; Indels 20; Gaps 2;
Qy 3 LLL--LLLLLPSPLHGWELTILHTNDVHSRLEQTSEDSSKCVNASRCMGGVARLFTKVQQ 60
||| | |:| | ||||||||||||||||||||||||||||||||||||||||||||
Db 10 LLLAGLCCLVPVSLAEWELTILHTNDVHSRLEQTSEDSSKCVNASRCMGGVARLFTKVQQ 69
Qy 61 IRRAEPNVLLLDAGDQYQGTIWFTVYKGAEVAHFMNALRYDAMALGNHEFDNGVEGLIEP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 70 IRRAEPNVLLLDAGDQYQGTIWFTVYKGAEVAHFMNALRYDAMALGNHEFDNGVEGLIEP 129
Qy 121 LLKEAKFPILSANIKAKGPLASQISGLYLPYKVLPVGDEVVGIVGYTSKETPFLSNPGTN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 130 LLKEAKFPILSANIKAKGPLASQISGLYLPYKVLPVGDEVVGIVGYTSKETPFLSNPGTN 189
Qy 181 LVFEDEITALQPEVDKLKTLNVNKIIALGHSGFEMDKLIAQKVRGVDVVVGGHSNTFLYT 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 190 LVFEDEITALQPEVDKLKTLNVNKIIALGHSGFEMDKLIAQKVRGVDVVVGGHSNTFLYT 249
Qy 241 GNPPSKEVPAGKYPFIVTSDDGRKVPVVQAYAFGKYLGYLKIEFDERGNVISSHGNPILL 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 250 GNPPSKEVPAGKYPFIVTSDDGRKVPVVQAYAFGKYLGYLKIEFDERGNVISSHGNPILL 309
Qy 301 NSSIPEDPSIKADINKWRIKLDNYSTQELGKTIVYLDGSSQSCRFRECNMGNLICDAMIN 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 310 NSSIPEDPSIKADINKWRIKLDNYSTQELGKTIVYLDGSSQSCRFRECNMGNLICDAMIN 369
Qy 361 NNLRHADETFWNHVSMCILNGGGIRSPIDERNNGTITWENLAAVLPFGGTFDLVQLKGST 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 370 NNLRHADETFWNHVSMCILNGGGIRSPIDERNNGTITWENLAAVLPFGGTFDLVQLKGST 429
Qy 421 LKKAFEHSVHRYGQSTGEFLQVGGIHVVYDLSRKPGDRVVKLDVLCTKCRVPSYDPLKMD 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 430 LKKAFEHSVHRYGQSTGEFLQVGGIHVVYDLSRKPGDRVVKLDVLCTKCRVPSYDPLKMD 489
Qy 481 EVYKVILPNFLANGGDGFQMIKDELLRHDSGDQDINVVSTYISKMKVIYPAVEGRIKFSG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||:
Db 490 EVYKVILPNFLANGGDGFQMIKDELLRHDSGDQDINVVSTYISKMKVIYPAVEGRIKFAS 549
Qy 541 GG------------------GTQNKALPENVKYGIVLDAGSSHTSLYIYKWPAEKENDTG 582
|| ||||||||||||||||||||||||||||||||||||||||
Db 550 GGGAGGGAGGGAGGGAGGGTGTQNKALPENVKYGIVLDAGSSHTSLYIYKWPAEKENDTG 609
Qy 583 VVHQVEECRVKGPGISKFVQKVNEIGIYLTDCMERAREVIPRSQHQETPVYLGATAGMRL 642
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 610 VVHQVEECRVKGPGISKFVQKVNEIGIYLTDCMERAREVIPRSQHQETPVYLGATAGMRL 669
Qy 643 LRMESEELADRVLDVVERSLSNYPFDFQGARIITGQEEGAYGWITINYLLGKFSQKTRWF 702
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 670 LRMESEELADRVLDVVERSLSNYPFDFQGARIITGQEEGAYGWITINYLLGKFSQKTRWF 729
Qy 703 SIVPYETNNQETFGALDLGGASTQVTFVPQNQTIESPDNALQFRLYGKDYNVYTHSFLCY 762
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 730 SIVPYETNNQETFGALDLGGASTQVTFVPQNQTIESPDNALQFRLYGKDYNVYTHSFLCY 789
Qy 763 GKDQALWQKLAKDIQVASNEILRDPCFHPGYKKVVNVSDLYKTPCTKRFEMTLPFQQFEI 822
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 790 GKDQALWQKLAKDIQVASNEILRDPCFHPGYKKVVNVSDLYKTPCTKRFEMTLPFQQFEI 849
Qy 823 QGIGNYQQCHQSILELFNTSYCPYSQCAFNGIFLPPLQGDFGAFSAFYFVMKFLNLTSEK 882
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 850 QGIGNYQQCHQSILELFNTSYCPYSQCAFNGIFLPPLQGDFGAFSAFYFVMKFLNLTSEK 909
Qy 883 VSQEKVTEMMKKFCAQPWEEIKTSYAGVKEKYLSEYCFSGTYILSLLLQGYHFTADSWEH 942
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 910 VSQEKVTEMMKKFCAQPWEEIKTSYAGVKEKYLSEYCFSGTYILSLLLQGYHFTADSWEH 969
Qy 943 IHFIGKIQGSDAGWTLGYMLNLTNMIPAEQPLSTPLSHST 982
||||||||||||||||||||||||||||||||||||||||
Db 970 IHFIGKIQGSDAGWTLGYMLNLTNMIPAEQPLSTPLSHST 1009