DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group I (claims 1, 3-6 and 8) in the reply filed on May 20, 2026 is acknowledged.
3. Claims 1, 3-11 and 13-20 are pending.
Claims 7, 9-11 and 13-20, non-elected claims are withdrawn from examination.
Claims 2 and 12 have been cancelled.
Claims 1, 5, 11 and 19 have been amended.
Claims 1, 3-6 and 8 are examined on the merits.
Claim Objections
4. Claims 1 and 3 are objected to because of the following informalities:
a. the term “Targeted Masked IFN” cited in claims 1 and 3 is noted within quotation marks, while other claims, claims 4-6 and 8 are not recited in the same manner. These marks are superfluous. Applicant should delete the quotation marks.; and
b. the term, type-1 interferon is cited in two different styles, one with a capital “T” and the other a smaller case “t”. Applicant should select one citation consistent with the citation within the Specification.
Correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 4 and 5 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. Claims 4 and 5 read on a “functionally active mutant”. And while claim 5 cites an example of said mutant it is not clear how the mutant differs in its role or ability than the wild-type type-1 interferon. Accordingly, the metes and bounds cannot be determined.
b. Claim 4 references Table II on line two. The claim is indefinite because it fails to point out what is included or excluded by the claim language. In particular, it is being indefinite as the claim fails to point out what is included or excluded by the claim language reciting a table. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted)., see MPEP 2173.05(s).
Claim Rejections - 35 USC § 102
7. 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.
8. Claim(s) 1, 3-6 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NammiTM Therapeutics (pages 1-3, 2019), as evidenced by Stover et al., US Patent No. 11,136,353 B2 (effectively filed April 15, 2020). NammiTM discloses “QXL138AM, Interferon alpha 2 (IFNα2) Masked ImmunoCytokine (MIC) fused to antibody targeting CD138”, see pages 1 and 2. As evidenced by Stover, QXL138AM is the same as that claimed, wherein an anti-CD138 antibody is fused to the MIC and “…binds to its antigen on the tumor cell surface (where the proteases are located)…”, see 2nd bullet on page 1; and Stover, Figure 9. The sequences of the QXL138AM are the same as those set forth in claim 1, absent evidence to the contrary, see Stover, Figure 9 and in particular lines 1-3 and 12 of the sequence; and column 4, line 14. “The masks are attached through a peptide sequence that is sensitive to cleavage by tumor-selective proteases”, see page 1, 3rd bullet. The N-terminal of the type-1 interferon is fused to the C-terminal of the CD138 targeting antibody by a flexible peptide linker set, see page 2.
QXL138AM demonstrated tumor growth inhibition, see page 3. And as evidenced by Stover, QXL138AM was administered to mice to assess efficacy of the therapeutic agent in vivo, see Example 18 spanning cols. 39 and 40; and col. 4, lines 58-60. These teachings evidence QXL138M was within a pharmaceutical composition, see NammiTM page 2, page 3; and Stover, Example 18 spanning cols. 39 and 40.
9. Claim(s) 1, 3-6 and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stover et al., US Patent No. 11,136,353 B2 (effectively filed April 15, 2020). Stover discloses a composition including “[a] targeted masked IFN comprising:
a. an antibody comprising a heavy chain and/or a light chain which specifically binds to a tumor associated antigen;
b. a Type-I interferon, wherein the N-terminal of said Type-I interferon is fused to the C-terminal of said antibody heavy and/or light chains [further comprising a flexible peptide linker]; and
c. an interferon mask which comprises (SEQ ID NO: 14) whereby said interferon mask is attached at the C-terminal of said Type-I interferon.”, see column (col.) 31, segments 17-19; col. 30., segment 1); and claims 17-22 spanning columns (cols.) 64 and 65. Applicant’s SEQ ID NO: 34 is the same as Stover’s sequence 14, see sequence alignment; and col. 30, segment 1).
The type-I interferon comprises IFNa2, see col. 22, lines 47-49. Table II in col. 44 lists interferon(s) and functional mutants including interferon alpha 2 (IFNA2) and YNS mutant. “[T]he IFN or functionally active mutants are set forth in Table II. In a preferred embodiment, the IFN comprises IFNA2.”, see col. 3, lines 18-20.
“In some aspects, IFNs and proteins containing or derived from IFNs can be used as a therapeutic agent. In some of any of the provided embodiments, the IFN component of the fusion protein, e.g., targeted masked IFN, is used as a therapeutic agent for treatment of the disease or disorder, such as a cancer.”, see col. 18, lines 57-62.
“In some embodiments, the provided fusion protein or composition comprises an antibody that binds to a CD138 antigen. In some embodiments, the antibody binds to, such as specifically binds to, one of the [Tumor Associated Antigen] TAA set forth in Table I [including CD138].”, see col. 13, lines 3-23; col. 43; and Example 13 in col. 36.
“Also provided are pharmaceutical compositions comprising a therapeutically effective amount of any of the compositions or any of the fusion proteins, such as any of the targeted Masked IFNs described herein. In some of any of the embodiments, the pharmaceutical composition is for use in therapy including treatment of cancer. In some of any of the embodiments, the cancer comprises a cancer found in a solid tumor; or the cancer arises in the hematopoietic system. In some of any of the embodiments, the pharmaceutical composition further comprises one or more anti-neoplastic agents.”, see col. 3, lines 43-53.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
RESULT 1 from 34.rai database.
US-16-849-889A-14; 100% 16-849-889A-15; 16-849-889A-9; 16-849-889A-20; 16-849-889A-19; 16-849-889A-13; 16-849-889A-12; 16-849-889A-18; 16-849-889A-17; 16-849-889A-10
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
Sequence 14, US/16849889A
Patent No. 11136353
GENERAL INFORMATION
APPLICANT: Qwixel Therapeutics
TITLE OF INVENTION: Fusion Protein Composition(s) Comprising
TITLE OF INVENTION: Masked Type I Interferons (IFNa and IFNb) For Use in The
TITLE OF INVENTION: Treatment of Cancer and Methods Thereof
FILE REFERENCE: 16580-20001.00
CURRENT APPLICATION NUMBER: US/16/849,889A
CURRENT FILING DATE: 2020-04-15
PRIOR APPLICATION NUMBER: 62/920,140
PRIOR FILING DATE: 2019-04-15
NUMBER OF SEQ ID NOS: 21
SEQ ID NO 14
LENGTH: 14
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic
Query Match 100.0%; Score 85; Length 14;
Best Local Similarity 100.0%;
Matches 14; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TDVDYYREWSWTQV 14
||||||||||||||
Db 1 TDVDYYREWSWTQV 14
RESULT 13 from 7.rai database.
US-16-849-889A-21; result 17, seq-6; result 28, seq-18; result 30, seq-17.
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 21, US/16849889A
Patent No. 11136353
GENERAL INFORMATION
APPLICANT: Qwixel Therapeutics
TITLE OF INVENTION: Fusion Protein Composition(s) Comprising
TITLE OF INVENTION: Masked Type I Interferons (IFNa and IFNb) For Use in The
TITLE OF INVENTION: Treatment of Cancer and Methods Thereof
FILE REFERENCE: 16580-20001.00
CURRENT APPLICATION NUMBER: US/16/849,889A
CURRENT FILING DATE: 2020-04-15
PRIOR APPLICATION NUMBER: 62/920,140
PRIOR FILING DATE: 2019-04-15
NUMBER OF SEQ ID NOS: 21
SEQ ID NO 21
LENGTH: 451
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic
Query Match 100.0%; Score 655; Length 451;
Best Local Similarity 100.0%;
Matches 122; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLQQSGSELMMPGASVKISCKATGYTFSNYWIEWVKQRPGHGLEWIGEILPGTGRTIY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLQQSGSELMMPGASVKISCKATGYTFSNYWIEWVKQRPGHGLEWIGEILPGTGRTIY 60
Qy 61 NEKFKGKATFTADISSNTVQMQLSSLTSEDSAVYYCARRDYYGNFYYAMDYWGQGTSVTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 NEKFKGKATFTADISSNTVQMQLSSLTSEDSAVYYCARRDYYGNFYYAMDYWGQGTSVTV 120
Qy 121 SS 122
||
Db 121 SS 122
RESULT 1 from 37.rai database.
US-16-849-889A-16; 100.0% US-16-849-889A-13; US-16-849-889A-12; US-16-849-889A-18; US-16-849-889A-17
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 16, US/16849889A
Patent No. 11136353
GENERAL INFORMATION
APPLICANT: Qwixel Therapeutics
TITLE OF INVENTION: Fusion Protein Composition(s) Comprising
TITLE OF INVENTION: Masked Type I Interferons (IFNa and IFNb) For Use in The
TITLE OF INVENTION: Treatment of Cancer and Methods Thereof
FILE REFERENCE: 16580-20001.00
CURRENT APPLICATION NUMBER: US/16/849,889A
CURRENT FILING DATE: 2020-04-15
PRIOR APPLICATION NUMBER: 62/920,140
PRIOR FILING DATE: 2019-04-15
NUMBER OF SEQ ID NOS: 21
SEQ ID NO 16
LENGTH: 25
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: Synthetic
Query Match 100.0%; Score 131; Length 25;
Best Local Similarity 100.0%;
Matches 25; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GSSGLSGRSDNHGSSGGSGGSGGSG 25
|||||||||||||||||||||||||
Db 1 GSSGLSGRSDNHGSSGGSGGSGGSG 25
1 131 100.0 25 US-16-849-889A-16 2020-04-15 2 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-17-465-727A-16 2021-09-02 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-18-467-206-16 2023-09-14 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
2 131 100.0 65 US-16-849-889A-13 2020-04-15 2 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-17-465-727A-13 2021-09-02 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-18-467-206-13 2023-09-14 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
3 131 100.0 66 US-16-849-889A-12 2020-04-15 2 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-17-465-727A-12 2021-09-02 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-18-467-206-12 2023-09-14 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
4 131 100.0 664 US-16-849-889A-18 2020-04-15 2 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-17-465-727A-18 2021-09-02 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-18-467-206-18 2023-09-14 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
5 131 100.0 688 US-16-849-889A-17 2020-04-15 2 Fusion Protein Composition(s) Comprising Masked Type I Interferons (IFNa and IFN
US-17-465-727A-17 2021
Double Patenting
10. 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.
11. Claims 1, 3-6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 11, 12, 16-24 and 29 of U.S. Patent No. 11,136,353 B2 (issued October 5, 2021). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on a targeted masked interferon (IFN) comprising all the components cited as a., b., c. and within a pharmaceutical composition, wherein the components are:
a. an antibody comprising a heavy chain variable region and/or a light chain, which specifically binds to a tumor associated antigen;
b. a type-1 interferon, wherein the N-terminal of said Type-1 interferon is fused to the C-terminal of said antibody heavy and/or light chains by a flexible peptide linker; and
c. an interferon mask which comprises (SEQ ID NO: 48) whereby said interferon mask is attached at the C-terminal of said type-1 interferon.
12. Claims 1, 3-6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 11-14 and 19-21 of U.S. Patent No. 11,795,198 B2 (issued October 24, 2023). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on a targeted masked interferon (IFN) comprising all the components cited as a., b., c. and within a pharmaceutical composition, wherein the components are:
a. an antibody comprising a heavy chain variable region and/or a light chain, which specifically binds to a tumor associated antigen;
b. a type-1 interferon, wherein the N-terminal of said Type-1 interferon is fused to the C-terminal of said antibody heavy and/or light chains by a flexible peptide linker; and
c. an interferon mask which comprises (SEQ ID NO: 48) whereby said interferon mask is attached at the C-terminal of said type-1 interferon.
13. Claims 1, 3-6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 11, 12, 16-24 and 28 of U.S. Patent No. 12,162,958 B2 (issued December 10, 2024). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on a targeted masked interferon (IFN) comprising all the components cited as a., b., c. and within a pharmaceutical composition, wherein the components are:
a. an antibody comprising a heavy chain variable region and/or a light chain, which specifically binds to a tumor associated antigen;
b. a type-1 interferon, wherein the N-terminal of said Type-1 interferon is fused to the C-terminal of said antibody heavy and/or light chains by a flexible peptide linker; and
c. an interferon mask which comprises (SEQ ID NO: 48) whereby said interferon mask is attached at the C-terminal of said type-1 interferon.
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma. ClinicalTrials.gov ID NCT06582017. First posted September 3, 2024.
15. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
July 1, 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
Prosecution Insights