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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 11-13, 16 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
i) The term “heterocycloalkyl” in the definition of R3 is unclear. Is it an alkyl attached to a heterocycle intended or a saturated heterocycle or a hetero-cycloalkyl? This is not normal nomenclature. In heterocycle, it is not known how many atoms make up the ring, which atoms are present and what kind of a ring (monocyclic, bicyclic, spiro, fused, bridged, saturated, etc.) is intended.
ii) In claim 5, the group corresponding to R3 is substituted. However, claim 1 does not permit substituents at R3. Thus, the pladienolide B of formula (II) of claim 5 lacks antecedent basis.
iii) Claim 7 (and claims 8, 9, 11-13 dependent thereon) are improperly presented. See also claims 16 and 17. An independent claim should be complete and cannot rely on another claim to define the variables. Note, these claims are drawn to pharmaceutical compositions and would not be properly dependent on claim 1.
iv) In claim 17, it is unclear who the subject is who gets administration of the compound of formula (I). Is it everyone?
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 1-9 and 11-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating hepatocellular carcinoma, does not reasonably provide enablement for its prevention. 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.
Regarding prevention, one skilled in the art would not know how to identify the subject who needs prevention, cannot say whether prevention was achieved or whether the subject did not come down with hepatocellular carcinoma in the first place. The specification does not provide any guidance for this. Prevention outside of the infectious diseases, where vaccines are used, is generally not enabled.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification does not say who the subject is in claim 17. The how to use portion of the statute has not been met. This means that Applicants must teach the skilled practitioner, in this case a physician, how to treat a given subject. The physician clearly must know what diseases and what symptoms are to be treated. In this case, Applicants have not provided what is being treated by claim 17, who the subject is, how one can identify said subject (i.e. how one can identify a subject in need), given no specific dose, given no specific dosing regimen, given no specific route of administration, and do not specify what diseases or symptom they intend to treat.
Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.”
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.
Claims 1-9, 1-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Anufrieva et al. (Genome Medicine 2018, 10, 49/1-49/18) in view of Zhu et al. (Genes Dis. 2020 Apr 7;7(3):328-335). The primary reference of Anufrieva teaches the use of pladienolide B as increasing sensitivity of cancer cells to cisplatin, a known anti-cancer agent. The claims differ be requiring treatment of hepatocellular carcinoma (HCC) using pladienolide derivatives in combination with an antiangiogenic agent. HCC is one of the most vascular solid tumors in which angiogenesis plays an important role in its development, progression and metastasis (see Coulon et al. Liver Int. 2011 Feb;31(2):146-62). The secondary reference of Zhu et al. that “all the approved systemic therapies for HCC are molecular targeted therapies with anti-angiogenic effects targeting the vascular endothelial growth factor signaling pathway. Sorafenib and lenvatinib are the first-line treatment, and regorafenib, ramucirumab, and cabozantinib are second-line treatment options” and also that “Anti-angiogenic treatment remains the backbone of systemic therapy for HCC.” Therefore, one skilled in the art knowing that pladienolide is good candidate drug for improving the efficiency of cancer drugs will combine this with the teaching of Zhu et al in a method for treating hepatocellular carcinoma with the expectation of achieving similar results.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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April 3, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624