Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application, Amendments, and/or Claims
2. The Preliminary Amendment filed on 26 February 2025 has been entered in full. Claims 1-62 have been cancelled, and claims 63-70 have been added. Therefore, claims 63-70 are pending and the subject of this Office Action.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 26 February 2025 has been considered by the examiner. NPL reference C140 has been lined through. The reference has been considered, but will not appear on the cover of the issued patent as it does not provide a date. 37 CFR 1.98(b) requires that each item of information in an IDS be identified properly, and provides that where the actual publication date of a non-patent document is not known, the applicant must, at a minimum, provide a date of retrieval (e.g., the date a webpage was retrieved) or a time frame (e.g., a year, a month and year, a certain period of time ) when the document was available as a publication.
Specification
Nucleotide and/or Amino Acid Sequence Disclosures
4. 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’s electronic filing system (see Section I.1 of the Legal Framework for EFS-Web or Patent Center (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), 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 EFS-Web or Patent Center 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 EFS-Web or Patent Center 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:
The file name and file size are incorrect (See image below for correct file name and size).
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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), with the file size in bytes;
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 § 112 (Written Description)
5. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
6. Claims 63-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
7. The claims are drawn to methods for treating a heart failure comprising administering neuregulin 1, wherein the neuregulin 1 comprises a sequence set forth in SEQ ID NO: 1. It is noted that the recitation “a sequence set forth in SEQ ID NO: 1” can be interpreted to mean a partial sequence comprising as few as 2 amino acids of SEQ ID NO: 1.
8. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, and any combination thereof. However, there does not appear to be an adequate written description in the specification as filed of proteins which are encompassed by the limitation of “a sequence set forth in SEQ ID NO: 1”. While the specification provides adequate written description for the NRG-1 β2 isoform comprising the amino acid sequence of SEQ ID NO: 1 that has the required activity for treating heart failure, it does not provide adequate written description for the genus of protein fragments encompassed by the claims that would also be useful in the claimed methods. The distinguishing characteristics of the claimed genus are not described. The only adequately described species is the neuregulin 1 comprising the amino acid sequence of SEQ ID NO: 1. Accordingly, the specification does not provide adequate written description of the claimed genus.
9. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
10. With the exception of the polypeptide referred to above, the skilled artisan cannot envision the detailed chemical structure of the encompassed agonists, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
11. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
12. Therefore, only the neuregulin 1 comprising the amino acid sequence of SEQ ID NO: 1., but not the full breadth of the claims, meet the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Double Patenting
13. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
14. Claims 63 and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Pat. No. 10,098,834. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘834 patent are drawn to a method of treating heart failure in a subject, comprising subcutaneous administration extended release of neuregulin in an amount of 03µ/kg/day to 3.0 µg/kg/day, including induction regiments and maintenance regimens.
15. While the claims in '834 patent do not recite evaluating New York Association (NYHA) heart function classification in the subject prior to treatment, and then administering neuregulin to the patient when the patient’s heart function is NYHA class II or III, this would be obvious when reading the claims in light of the Specification to identify those with heart failure, as the Specification of the '834 patent discloses treatment of patients having a heart function of NYHA class II or III with neuregulin as a preferred embodiment of the invention (See Example 1 at columns 12-13). Therefore the claims are overlapping in scope.
16. Claims 63 and 69-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Pat. No. 11,179,323. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘834 patent are drawn to a method of treating chronic heart failure in a subject, comprising subcutaneous administration extended release of neuregulin in an amount of 03µ/kg/day to 3.0 µg/kg/day, including induction regiments and maintenance regimens.
17. While the claims in '323 patent do not recite evaluating New York Association (NYHA) heart function classification in the subject prior to treatment, and then administering neuregulin to the patient when the patient’s heart function is NYHA class II or III, this would be obvious when reading the claims in light of the Specification to identify those with heart failure, as the Specification of the '323 patent discloses treatment of patients having a heart function of NYHA class II or III with neuregulin as a preferred embodiment of the invention (See Example 1 at columns 12-13). Therefore the claims are overlapping in scope.
18. Claims 63-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Pat. No. 11,253,573. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘573 patent recite a method of treating chronic heart failure, comprising measuring a plasma level of NT-proBNP or BNP of a patient before treatment, administering neuregulin-1 to the patient when the plasma level of NT-proBNP is ≤4000 fmol/ml; wherein the neuregulin-1 is administered at an amount of 0.6 or 1.2 µg/kg. The claims of the ‘573 patent also recite further comprising performing a test for the NYHA heart function classification of the patient, and wherein the NYHA heart function classification is class II or class III. Therefore the claims are overlapping in scope.
19. Claims 63-70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Pat. No. 12,076,370. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ’370 patent are drawn to a method of treating heart failure in a subject, comprising subcutaneous administration extended release of neuregulin 1 in an amount of 03µ/kg/day to 3.0 µg/kg/day, including induction regiments and maintenance regimens. The claims of the ‘370 patent also recite performing a companion diagnostic test prior to treatment, including a measurement of plasma level of NT-proBNP or BNP ≤4000 fmol/ml; or performing a test for the NYHA heart function classification of the patient, including wherein the NYHA heart function classification is class II or class III. Therefore the claims are overlapping in scope.
Summary
20. 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.
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.
/JON M LOCKARD/
Examiner, Art Unit 1647
September 29, 2025