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
This application is a 371 of PCT/EP2023/067193.
The amendment filed on January 10, 2025 has been entered.
Status of Claims
Claims 9-23 are pending.
Claims 9-23 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 10, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 21 is objected to due to the recitation of “ius” instead of “is”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 9-23 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.
It is noted that MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' In the instant case, the claims have been broadly interpreted to encompass (A) a method of treating any disease or any condition by administering to a subject a therapeutically effective amount of any prethrombin-1 and (B) a method of promoting hemostasis/treating hemorrhage by administering to a subject a therapeutically effective amount of any prethrombin-1. Therefore, the claims are directed to (A) a method of treating a genus of diseases and conditions and (B) a method of promoting hemostasis/treating hemorrhage by administering (C) a genus of prethrombin-1.
MPEP 2163 I. states that 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.
MPEP 2163. II.A.3.(a) sates that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The recitations of “disease”, “condition”, “hemostasis”, “hemorrhage”, “coagulation disorder”, and “prothrombin-1” fail to provide a sufficient description of the claimed method as it merely describes the functional features of the genus without providing any definition of the structural features of the species within the genus. The specification does not specifically define any of the species that fall within the genus. The specification does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus.
The prior art discloses treating thrombosis by administering human prethrombin-1, see Di Cera (US 2019/0153419 - PTO-892, claims 10 and 14 and Example 1). Prior art also discloses that prethrombin-1 is an inactive protein, see Mallet (WO 2007/076033 – form PTO-892, paragraph [4]). Therefore, neither the prior art nor the instant specification provide guidance on a method of treating any diseases or conditions or a method of promoting hemostasis/treating hemorrhage by administering any prethrombin-1.
The specification is limited to a method of promoting hemostasis by administering prethrombin-1 of unknown source. While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” In view of the widely variant species encompassed by the genus, the example described above is not enough and does not constitute a representative number of species to describe the whole genus. Therefore, the specification fails to describe a representative species of the claimed genus.
Given this lack of description of the representative species encompassed by the genus of the claims, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants were in possession of the inventions of claims 9-23.
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 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.
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Cera (US 2019/0153419 - PTO-892).
Regarding claim 9, Di Cera discloses a method of treating thrombosis by administering human prethrombin-1 (claims 10 and 14).
Regarding claim 16, the prethrombin-1 of Di Cera is a recombinant prethrombin-1 (Example 1).
Therefore, the reference of Di Cera anticipates claims 9 and 16.
Other Relevant Art
Graus (Prethrombin-1 as a Drug Substance Promoting Hemostasis with Reduced Risk of Thrombosis. Thromb Haemost. 2025 Jan;125(1):36-45. Epub 2024 Jun 12. – form PTO-892) discloses a method of treating hemostasis by administering human prethrombin-1 (abstract) but is not available as prior art because the reference was published or made known to the public after the instant invention was filed.
Conclusion
Claims 9-23 are pending.
Claims 9-23 are rejected.
Claim 21 is objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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/YONG D PAK/Primary Examiner, Art Unit 1652
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