DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
1. The Election filed July 16, 2026, in response to the Office Action of April 17, 2026, is acknowledged and has been entered. Applicant's election without traverse of Group I, claims 1-16 is acknowledged.
2. Claims 1-20 are pending.
3. Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
4. Claims 1-13 are currently under consideration.
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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). In particular, the antisense nucleic sequences in Figures 7-9. Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
5. Claim(s) 1-4 and 11-13 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by US 2009/0148449 A1 (De Weers et al. June 11, 2009, effectively filed July 1, 2005), “De Weers”.
De Weers teaches human antibodies to CD38 for use in therapeutic methods. See abstract.
De Weers teaches treating disease expressing CD38, including rheumatoid arthritis, lupus nephritis, and systemic lupus erythematosus with the anti-CD38 antibodies. See ¶¶ 0125-0127, 0553, 0554, 1034, 1035, 1037 and 1057-1061 and claims 76 and 77.
De Weers teaches the CD38 antibody can be a Fab fragment, F(ab') 2 fragment, or a scFv. See ¶¶ 0581, 0784, and 0805.
De Weers teaches the CD38 antibody can be an IgG1 antibody. See ¶¶ 0073 and 0306.
6. Claim(s) 1, 4 and 11-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 2002/0164788 (Ellis et al. Nov. 7, 2002), “Ellis”.
Ellis teaches a CD38 antibody for the treatment of cancer and autoimmune diseases. See abstract and ¶¶ 0062-0067.
Ellis teaches treating rheumatoid arthritis with a CD38 antibody. See ¶¶ 0069 and 0071 and claims 15 and 17.
Ellis that CD38 is expressed on the surface of cells, which allows the antibody to target CD38 expressing cells for lysis. See ¶¶ 0071-0072.
Ellis teaches the CD38 antibody can be a Fab fragment, F(ab') 2 fragment, or a scFv. See ¶¶ 0024.
Ellis teaches the CD38 antibody can be an IgG1 antibody. See ¶¶ 0024-0025.
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.
7. Claims 1, 5, and 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 8,486,394 (Tesar et al. July 16, 2013) evidenced by Saluja et al. (Frontiers Oncol. March 2024), “Saluja”.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘394 claims are drawn to a method for treating a haematological malignancy associated with CD38+ cells, comprising administering to a subject in need thereof an effective amount of an isolated antibody or antigen binding fragment thereof that binds to CD38 and which comprises an H-CDR1, H-CDR2 and H-CDR3 region having at least 90% identity to that depicted in SEQ ID NO: 21 and an L-CDR1, L-CDR2 and L-CDR3 region having at least 90% identity to that depicted in SEQ ID NO: 51, wherein said haematological malignancy is taken from the list of multiple myeloma, chronic lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia and acute lymphocytic leukemia.
Cancer and hematological malignancies are inflammatory diseases. See Saluja, abstract and pp. 03-11. Thus, ‘394 claims are treating inflammatory disease.
The ‘394 claims also teach:
10. The method according to claim 1, wherein the antigen binding fragment is an scFv, Fab or F(ab')2 fragment.
11. The method according to claim 1, wherein the antibody is an IgG.
12. The method according to claim 11, which is an IgG1.
8. Claims 1, 5, and 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,184,005 (Tesar et al. Jan. 22, 2019) evidenced by Saluja et al. (Frontiers Oncol. March 2024), “Saluja”.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘ 005 claims are drawn to a method of inducing specific killing of tumor cells that express CD38, comprising the step of contacting said cells with a sufficient amount of an isolated anti-CD38 antibody or antigen-binding fragment thereof, which comprises the three variable heavy chain complementarity determining regions (H-CDRs) and the three variable light-chain complementarity determining regions (L-CDRs) that are in the variable heavy chain and variable light chain pairs selected from: (i) SEQ ID NO: 18 and 48, (ii) SEQ ID NO: 20 and 50, (iii) SEQ ID NO: 21 and 51, (iv) SEQ ID NO: 22 and 52, and (v) SEQ ID NO: 25 and 55, wherein said antibody or antigen-binding fragment thereof binds CD38 and has the ability to mediate killing of a CD38+ target cell.
Cancer and hematological malignancies are inflammatory diseases. See Saluja, abstract and pp. 03-11. Thus, ‘005 claims are treating inflammatory disease.
The ‘005 claims also teach:
22. The method according to claim 1, wherein the antigen binding fragment is an scFv, Fab or F(ab')2 fragment.
23. The method according to claim 1, wherein the antibody is an IgG.
24. The method according to claim 11, which is an IgG1.
Conclusion
9. Claims 1-5 and 9-13 are rejected. Claims 6-8 are 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.
No claims allowed.
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 M-F 8:30-5:30 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Greg Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER J REDDIG/ Primary Examiner, Art Unit 1646
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