DETAILED ACTION
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 .
Priority
The instant application is a national stage entry of PCT/US22/76195 filed on 9/09/2022, which claims priority benefit of U.S. Provisional Application No. 63/242809 filed on 9/10/2021 under 35 U.S.C. 119(e).
Power of Attorney
There is no Power of Attorney on file and it is recommended that applicant submits one to facilitate prosecution.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 3/13/2024 and 8/20/2025 are in compliance with the provisions of 37 C.F.R. 1.97. Accordingly, all references cited in both IDSs have been fully considered.
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.
Claims 15-17 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for certain cleaved proteins such as EFEMP1 and ADAMTS7, does not reasonably provide enablement for all cleaved proteins. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). But MPEP § 2164.04 also states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
The nature of the invention is a method of treating or preventing vascular disease and/or heart disease in a subject. The method comprises the initial step of determining whether serum of the subject comprises a level of a cleaved protein above a threshold level, followed by a second step of administering an antagonist of ADAMTS7 (A disintegrin and metalloproteinase with thrombospondin motifs 7) to the subject if the serum is characterized by a level above the threshold level.
The state of the prior art is that ADAMTS7 antagonists are known to be effective in treating or preventing vascular/heart disease as substantiated by Meibom et al. (WO 2021/094436 A1; Abstract). Previous studies like Mizoguchi et al. (Circulation Research 2021, Vol. 129, pages 458-470) have also demonstrated that genetic variants of ADAMTS7 is associated with coronary artery disease and loss of ADAMTS7’s catalytic function provides protection again. There is no prior art found showing that the level of a cleaved protein like EFEMP1 or ADAMTS7 itself in a subject’s serum indicates that said subject has, or is at risk of having, vascular disease and/or heart disease.
Claim 15 requires assessing whether a level of any cleaved protein in a subject’s serum is higher than a threshold level. However, the instant application only discloses 24 cleaved proteins that are ADAMSTS7 substrates and can be considered a biomarker for vascular disease and/or heart disease (Table 3, pages 74-77 of specification). Since there are countless cleaved proteins in the body, claim 15 and some of its dependent claims are considered broad. MPEP §2164.02 states “For a claimed genus, representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art (in view of level of skill, state of the art and the information in the specification) would expect the claimed genus could be used in that manner without undue experimentation”. Since applicant has not provided sufficient guidance, and in the absence of prior art, a person with ordinary skill in the art would have to perform undue experimentation in order to practice the claimed method. And when results are unpredictable, the disclosure of a few species does not provide an adequate basis to support generic claims.
Hence, the full breadth of the claims is not supported by the disclosure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Meibom et al. (WO 2021/094436 A1). Meibom et al. discloses substituted hydantoinamides of formula I as ADAMTS7 antagonists, as well as methods of preparing and using them to treat diseases including cardiovascular diseases like coronary artery disease (Abstract; lines 2-9, page 50). Meibom et al.’s method of use comprises administering to a human or other mammal in need thereof a therapeutically effective amount of one or more disclosed ADAMTS7 antagonists or a pharmaceutical composition thereof, alone or in combination with other pharmacologically active compounds (lines 35-36, page 58; lines 1-8, page 59). However, this method does not entail determining whether the level of a cleaved protein is above a threshold level before administering one or more disclosed ADAMTS7 antagonists.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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