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 is a response to Applicant’s communication filed on June 10, 2024. Application No. 18/555,388, filed October 13, 2023, is a 371 of PCT/US2022/024806, filed April 14, 2022, which claims the benefit of U.S. Provisional application No. 63/175,976, filed April 16, 2021. In a preliminary amendment filed June 10, 2024, Applicant cancelled claims 7-9, 19, and 23. Claims 1-6, 10-18, 20-22 and 24 are pending.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-6, 10-18, 20-22 and 24 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method of treating drug-induced thrombocytopenia (DITP) or vaccine-induced thrombosis and thrombocytopenia syndrome (VITT), the specification does not reasonably provide enablement for preventing these thrombocytopenia syndromes. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims are drawn to a method of preventing both DITP and VITT via the administration of the BTK inhibitors, Compound (I) (rilzabrutinib) or Compound (II) (atuzabrutinib). The specification teaches that BTK inhibitors block platelet activation thereby preventing platelet aggregation in patients already presenting thrombosis and/or thrombocytopenia. (Specification, p. 20-31, Examples.) The specification provides no direction as to how BTK inhibitors can be employed to prevent platelet aggregation in patients who are not yet suffering from thrombosis and/or thrombocytopenia of DITP or VITT patients. In addition, the prior art fails to provide compensatory guidance. In this case, there is no correlation between platelet activation and preventing either DITP or VITT. It would require undue experimentation for the artisan to practice the invention as broadly claimed.
Claim Rejections - 35 USC § 102(a)(1)
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.
Claims 2-5, 10-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by von Hundelshausen et al., 121(11) Thromb. Haemost., 1395-1399 (2021) (Publ’d April 13, 2021) (cited in the June 10, 2024, IDS) Von Hundelshausen discloses a method for treating vaccine-induced thrombosis and thrombocytopenia syndrome (VITT) with the Bruton Tyrosine Kinase Inhibitor of Compound (I), rilzabrutinib. See von Hundelshausen et al., p. 1398, 1st col., last paragraph.
Similarly, Claims 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by von Hundelshausen (above). Von Hundelshausen also discloses a method for treating drug-induced thrombocytopenia (DITP) (i.e., heparin induced thrombocytopenia (HIT)). Von Hundelshausen discloses that the mechanism of action of VITT is similar to that of HIT. See Id., Abstract. HIT is a DITP. (See the present invention, Claim 6, subsection (b).) Therefore, rilzabrutinib is also effective in treating DITP.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 10-18, 20-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over von Hundelshausen et al., 121(11) Thromb. Haemost., 1395-1399 (2021) (cited above), in view of Gourlay et al., US2018/0050027 A1. As stated in the 35 U.S.C. 102(a)(1), rejection above, von Hundelshausen discloses a method for treating both vaccine-induced thrombosis and thrombocytopenia syndrome (VITT) and drug-induced thrombocytopenia (DITP) with the Bruton Tyrosine Kinase (BTK) inhibitor of Compound (I), i.e., rilzabrutinib. The difference between the prior art and present invention is the use of Compound (II), atuzabrutinib.
Gourlay teaches that Compound (II), atuzabrutinib is a BTK inhibitor similar to that of compound (I), rilzabrutinib. See Gourlay et al., p. 12, paras. [0272]–[0273]. Accordingly, all the elements of the present invention were known in the art at the time of the invention.
It would have been obvious for to the ordinary artisan to use the BTK inhibitor atuzabrutinib as taught by Gourlay in the methods of the claimed invention as taught by Hundelshausen. In this case, the present invention combines prior art elements according to known methods to yield predictable results.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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/TIMOTHY R ROZOF/Primary Examiner, Art Unit 1625