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 .
Status of Application, Amendments, and/or Claims
2. The Preliminary Amendment filed on 05 September 2023 has been entered in full. 1-20 have been cancelled, and claims 21-33 have been added. Therefore, claims 21-33 are pending and the subject of this Office Action.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 06 September 2023, 17 April 2024 and 24 September 2024 have been considered by the examiner.
Drawings
4. Figures 1-2 are objected to because 37 CFR 1.84 states that “[P]artial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter”. In the instant case, Figures 1-2 have multiple panels/pages which should be labeled, for example, FIG. 1A, FIG. 1B, and be referred to as such in the Brief Description of the Figures.
5. The Drawings are objected to because Figure 2 discloses amino acid sequences without an accompanying sequence identifier (i.e., SEQ ID NO: #). The SEQ ID NO: may be inserted into the Figure or the Brief Description of the Drawings. If the Sequence Identifiers are added to the Figures, corrected drawing sheets will be required in reply to the Office action to avoid abandonment of the application.
6. Moreover, with regard to Figure 1, Pursuant to 37 CFR 1.83(a), sequences that are included in the "Sequence Listing XML" should not be duplicated in the drawings. With the use of feature keys and qualifiers in a "Sequence Listing XML" to represent and describe features of a nucleotide or amino acid sequence, the need to re-present a sequence in a drawing is less critical. However, in certain instances, a significant sequence characteristic may not be readily conveyed by the sequence-associated data of the "Sequence Listing XML" and may need to be depicted in a figure. For example, in view of the fact that the representation of double stranded nucleic acids is not permitted in the "Sequence Listing XML," many significant nucleic acid features, such as "sticky ends" and the like, may only be shown effectively by reference to a drawing figure. Further, the similarity or homology between/among sequences may only be depicted in an effective manner in a drawing figure. Similarly, drawing figures are recommended for use with amino acid sequences to depict structural features of the corresponding protein, such as epitopes and interaction domains. The situations discussed herein are given by way of example only and there may be many other reasons for including a sequence in a drawing. However, when an enumerated sequence is presented in a drawing, the sequence must still be included in the "Sequence Listing XML" if the sequence falls within the definition set forth in 37 CFR 1.831(b), and a sequence identifier (preceded by "SEQ ID NO:X" or the like) must be used, either in the drawing itself or in the Brief Description of the Drawings.
7. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
8. Furthermore, if the sequences are not present in the sequence listing, Applicant is required to provide (1) a substitute computer readable form (CRF) copy of a “Sequence Listing” which includes all of the sequences that are present in the instant application and encompassed by these rules, (2) a substitute paper copy of that “Sequence Listing”, (3) an amendment directing the entry of that paper into the specification, and (4) a statement that the content of the paper and computer readable copies are the same, and, where applicable, include no new matter, as required by 37 C.F.R. § 1.821 through 1.825. The claims and/or instant specification will also need to be amended so that it complies with 37 C.F.R. § 1.821(d) which requires a reference to a particular sequence identifier (i.e., SEQ ID NO: #) be made in the specification and claims wherever a reference is made to that sequence (See M.P.E.P. 2422.04).
Specification
9. The disclosure is objected to because of the following informalities: The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Appropriate correction is required.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 29, 31 and 33 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.
12. Claims 29, 31 and 33 are rejected as indefinite for reciting “a disease associated with CD123.” Since neither the specification nor the prior art provide a limiting definition of what constitutes “a disease associated with CD123”, the metes and bounds of the claims cannot be determined.
Claim Rejections - 35 USC § 112 (Scope of Enablement)
13. The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
14. Claims 29, 31 and 33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of treating a cancer that expresses CD123, does not reasonably provide enablement for methods of treating a disease associated with expression of CD123 (See also 112(b) rejection supra). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
15. Factors to be considered in determining whether a disclosure enables one skilled in the art to make and use the claimed invention in its full scope without resorting to undue experimentation include: (1) the quantity of experimentation necessary; (2) the amount of direction or guidance presented; (3) the presence or absence of working examples; (4) the nature or complexity of the invention; (5) the state of the prior art; (6) the relative skill of those in the art; (7) the predictability or unpredictability of the art; and (8) the breadth of the claims. See In re Wands, 8 USPQ2d. 1400 (Fed. Cir. 1988).
16. In the instant case, the claims are broadly drawn to methods of treating a disease associated with expression of CD123 comprising administering the claimed CD123 antibody. Thus the claims encompass complex and unpredictable subject matter, involving the effects of complex biological molecules on diseased physiological states. As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. This invention is in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology”, Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert, denied, 502 U.S. 856 (1991).
17. The specification provides detailed direction and guidance regarding the tumor growth inhibiting effects of the claimed CD123 antibody, and antibody drug conjugates comprising the same, in a human AML xenograft model where human cells expressing CD123 were inoculated into the animal (See pp. 83-84, for example). However, the data presented in the Specification does not provide any guidance on the treatment of every disease associated with expression of CD123, nor does it provide adequate guidance on the breadth of “diseases associated with expression of CD123.” While the art recognizes that upregulation and aberrant expression of CD123 has been observed in a variety of hematologic malignancies, including AML, ALL, myelodysplastic syndrome (MDS), and blastic plasmacytoid dendritic cell neoplasms (Slade et al., Best Practice and Research Clinical Haematology. 33(4):101219; 2020), such does not provide support for the breadth of the claims which merely recite “a disease associated with expression of CD123.
18. Therefore, while administration of the claimed antibody would be expected to treat a cancer that expresses CD123, one skilled in the art would not predict that it would treat every type of disease associated with expression of CD123. There are no working examples provided in the instant application which demonstrate the treatment of any other disease associated with expression of CD123.
19. Thus, in view of the breadth of the claims, the lack of guidance, and the lack of working examples, the instant specification is not found to be enabling for a method of treating a disease associated with expression of CD123. It would require undue experimentation and making a substantial inventive contribution for the skilled artisan to discover how to make and/or use the claimed invention in its full scope.
Double Patenting
20. 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.
21. Claims 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,001,636. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘636 patent are drawn to antibody conjugates which comprise the same species of CD123 antibodies recited in the instant claims, and also recite a method of treating a cancer which expresses CD123 with said conjugate. Therefore, the claims are overlapping in scope since the antibody of the patented antibody conjugate and method of treatment utilizing the same anticipates the instantly claimed antibody and methods of treatment.
22. Claims 21-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,443,140. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘140 patent are drawn to antibody conjugates which comprise the same species of CD123 antibodies recited in the instant claims, and also recite a method of treating a cancer or tumor which overexpresses CD123 with said conjugate. Therefore, the claims are overlapping in scope since the antibody of the patented antibody conjugate and method of treatment utilizing the same anticipates the instantly claimed antibody and methods of treatment.
Summary
23. No claim is allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jon M. Lockard whose telephone number is (571) 272-2717. The examiner can normally be reached on Monday through Friday, 8:00 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached on (571) 272-2911. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JON M LOCKARD/
Examiner, Art Unit 1647
January 9, 2026