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
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 24 December 2024 and 14 August 2026 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Response to Restriction
2. Applicant’s election of Group I (claims 2-4, 6, 10, 12, 14, 16, 18, 19, 28, 29, 31, and 57-61) and species of
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and pharmaceutical composition in the reply filed on 14 August 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). However, upon further search and consideration, the restriction is withdrawn.
Status of Application
3. The instant application is a national stage entry of PCT/US2022/051366 filed 30 November 2022. Claims 2-4, 6, 10, 12, 14, 16, 18-19, 28, 29, 31, 57-61, 64, and 79 are currently pending. Claims 1, 5, 7-9, 11, 13, 15, 17, 20-27, 30, 32-56, 62-63, 65-78, and 80-87 are cancelled. Claims 2-4, 6, 10, 12, 14, 16, 18-19, 28, 29, 31, 57-61, 64, and 79 are examined on the merits within.
Allowable Subject Matter
4. Claims 2, 12, 14, 16, 19, 28-29, 31, 57-61, and 64 are free of the prior art. The prior art does not teach nor make obvious the compound of Formula III.
Claim Rejections – 35 U.S.C. 112(a)
5. 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.
6. Claim 79 is 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 a disease, does not reasonably provide enablement for 1) prevention of 2) any disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The claimed invention is a method of treating or preventing a disease, disorder, or condition in a subject, the method comprising administering to the subject a composition of the compound of claim 2 and an agent.
The state of the prior art: There are no methods described in the prior art or in the specification to completely prevent any and all diseases, disorders, or conditions.
The relative skill of those in the art: The relative skill of those in the pharmaceutical development and medical treatment arts is high, requiring advanced education and training.
The predictability or unpredictability of the art/breadth: The instant claimed invention is highly unpredictable since one skilled in the art would recognize the breadth of the instant claims encompass prevention of any disease, disorder, or condition. This can range from a headache, to a wound/scrape, to cancer, to a common cold, to a genetic abnormality, etc. Without a definition, the types of diseases, disorders and conditions can be endless. The specification only states diseases, disorders or conditions can be used interchangeably. Based on the disclosure of the prior art, one skilled in the art would view prevention of any disease, disorder or condition as being highly unpredictable.
The amount of direction or guidance presented, and the presence or absence of working examples: It has been established that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970). There are no working examples showing treatment of any diseases, disorders, or conditions. The specification does discuss micronutrient deficiencies, but does not show 100% prevention of a micronutrient deficiency or any other disease, disorder or condition.
The quantity of experimentation necessary: Given that the instant claims encompass complete prevention of any disease, disorder or condition, one skilled in the art would undertake a novel and extensive research program to show that the instant claimed compositions reduce the risk of developing any ailment ranging from a cough, or a broken arm, to terminal illnesses. There are no teachings in the prior art to completely prevent such dysfunctions. Applicant fails to provide information sufficient to practice the claimed invention, absent undue experimentation. The burden of enabling the prevention of a disease would be much greater than that of enabling the treatment of such conditions. The specification does not provide guidance as to how one skilled in the art would accomplish the objective of preventing such conditions, or how a patient could be kept from every being susceptible to these conditions. There is no guidance provided as to a specific protocol to be utilized in order to show the efficacy of the presently claimed active ingredients for preventing the above claimed conditions, thereby presenting an undue burden of unpredictable experimentation necessary to practice the claimed invention.
Genentech, 108 F.3d at 1366, states, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “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.”
Therefore, in view of the Wands factors as discussed above, particularly the unpredictability of the art and the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for a method of prevention of a disease, disorder, or condition. It is noted that this rejection is regarding the scope of “prevention” as well as the scope of “disease, disorder, and condition”.
Claim Rejections – 35 U.S.C. 112(b)
7. 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.
8. Claims 3, 4, 6, 10, and 18 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.
Claim 3 recites the compound of Formula (I-A) represents the compound of Formula (III). However, Formula (III) comprises Ra and Rb. Ra and Rb have been removed from Formula (I-A). It is unclear how Formula (I-A) can represent Formula (III) when Ra and Rb are missing, since Ra is selected from ORC, SRC, N(RC)2, ZRC or a specific ligand and Rb is one of two ligands. Clarification is requested. Claims 4, 6, 10, and 18 are included in this rejection for the same deficiencies regarding the substituents Ra and Rb being seemingly missing.
Conclusion
9. No claims are allowed at this time.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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