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
Status of Application, Amendments, and/or Claims
1. Claim 1 is pending and currently under consideration.
Information Disclosure Statement
2. The information disclosure statement filed on 08/22/2024 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
3. The drawings filed on 05/16/2024 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
4. The following is a quotation of the first paragraph of 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.
5. Claim 1 is rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. 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, or any combination thereof.
Claim 1 is drawn to a method of treating a subject having anemia, wherein the subject is identified as having a level of glomerular filtration rate (GFR) of less than 90 m/min per 1.73m, the method comprising administering to the subject and effective amount of a hemojuvelin antagonist. The claim does not require that the hemojuvelin antagonist possess any particular conserved structural features. Thus, the claim encompasses a genus of hemojuvelin antagonists.
Vas-Cath Inc. v Mahurkar, 19 USPQ2d 1111 (Fed. Cir.1991), 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 purpose 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). Adequate written description requires more than a mere statement that it is part of the invention are reference to a potential method of isolating it. The compound 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 (Fed. Cir.1991).
An adequate written description of a chemical invention “requires a precise definition, such as by structure, formula, chemical name, or physical properties." University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 927 (Fed. Cir.2004); Regents of the Univ. of Cal. V. Eli Lilly & Co., Inc., 119 F.3d 1559, 1556 (Fed. Cir.1997); Fiers v. Revel, 984F.2d 1164, 1171 (Fed. Cir.1993). “A description of what a material does, rather than of what it is, usually does not suffice.” Rochester, 358F.3d at 923; Eli Lilly, 119 F.3d at 1568. In addition, possession of a genus “may be achieved by means of a recitation of a representative number of [compounds]…falling within the scope of the genus.” Eli Lilly, 119 F.3d at 1569. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus. See Rochester, 358 f. 3d at 927.
In the instant case, the specification states that the term “hemojuvelin antagonist” refers to a molecule that reduces expression of hemojuvelin or inhibits hemojuvelin, e.g., by binding to hemojuvelin. The specification discloses a hemojuvelin antagonist, an anti-hemojuvelin antagonist antibody (paragraph [0011]; Table 1). However, such a disclosure is insufficient to support the broad genus of hemojuvelin antagonists.
Due to the breadth of the genus of hemojuvelin antagonists, and lack of the definitive structural features of the genus, one skilled in the art would not recognize from the disclosure that Applicant was in possession of the recited genus of hemojuvelin antagonists, and thus the instantly claimed method of using the same.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
6. 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.
7. Claim 1 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 10,118,958 B2 (Nov. 6, 2018).
US 10,118,958 B2 teaches a method of treating anemia of chronic kidney disease comprising administering to a subject in need thereof a therapeutically effective amount of the anti-human RGMc antibody (see, e.g., claims 1 and 6). Repulsive guidance molecule C (RGMc) is also known as hemojuvelin (HJV). It is also known that normal glomerular filtration rate (GFR) in healthy adults is typically 90–120 mL/min/1.73 m², the GFR for of a patient with chronic kidney disease would be less than 90 /min/1.73 m². Thus, the teachings of US 10,118,958 B2 meet the limitations of claim 1.
Claim Rejections[Symbol font/0xBE] Nonstatutory Obviousness-Type Double Patenting
8. Basis for nonstatutory 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. See 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 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/ guidance/eTD-info-I.jsp.
9. Claim 1 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 6 of US Patent No.10,118,958 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claim 6 of US Patent No. 10,118,958 B2 are drawn to a method of treating anemia of chronic disease or anemia of chronic kidney disease comprising administration to a subject in need thereof a therapeutically effective amount of the anti-human RGMc antibody (or anti-human hemojuvelin antibody). On the other hand, claim 1 of the instant application is drawn to a method of treating a subject having anemia, wherein the subject is identified as having a level of glomerular filtration rate (GFR) of less than 90 m/min per 1.73 m2, the method comprising administering to the subject an effective amount of a hemojuvelin antagonist. Claim 1 of US Patent No. 10,118,958 B2 and claim 1 of the instant application vary in scope and are obvious over each other.
Claim Objection
10. Claim 1 is objected to because of a typographic error in line 2: “per 1.73 m” should be amended to “—per 1.73 m2--.
Conclusion
11. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/ Examiner, Art Unit 1674
September 24, 2026
