DETAILED ACTION
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
Status of the Claims
The listing of claims filed 18 August 2024 has been examined.
Claims 1–10 are pending.
Priority
The instant application was filed 18 August 2024; is a continuation application of PCT/CN2023/103672, filed 29 June 2023, and claims priority to CN 202211289198.0, filed 20 October 2022. Applicant’s claim for foreign priority is acknowledged, and a copy of the priority document has been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 August 2024 is acknowledged and has been considered.
Claim Rejections - 35 U.S.C. § 101 and/or 35 U.S.C. § 112
35 U.S.C. § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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.
Claims 1–3 are rejected under 35 U.S.C. § 101 because the claims are not drawn to a single statutory category. The claims refer to a drug combination and a process (because “use” implies a process). Furthermore, the recitation of a use without setting forth any steps involved in the process results in an improper definition of a process.
Claims 1–3 are rejected under 35 U.S.C. § 112(b) because the claims provide for a use of a drug combination without setting forth any steps involved with the process.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation 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 4–10 are rejected under 35 U.S.C. § 112(a) because 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 the claims.
MPEP § 2164.01(a) explains how enablement for the claimed invention can be analyzed:
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” . . . These factors 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.
The Wands factors are analyzed with respect to the claimed invention in turn below.
The breadth of the claim is limited in scope, as it is limited to treating or preventing multiple myeloma with a drug combination comprising 2-bromopalmitate (2-BP) and lenalidomide.
The nature of the invention generally relates to the pharmaceutical art and more specifically to a drug combination “for preventing and/or treating multiple myeloma.” Thus, the nature of the invention is sophisticated.
The state of the prior art is discussed in the instant specification, which states: “Multiple myeloma is developed slowly and has no obvious symptoms in the early stage.” (Spec., p.1). The specification further states: “The development of lenalidomide (Len) and other immunomodulatory drugs has greatly prolonged the survival of patients with multiple myeloma.” (Id., p.2).
Generally, in order to treat a disease, one of skill in the art must identify a biological target for affecting the disease, demonstrate a first drug candidate some way modulates the normal processes of the biological target, and demonstrate that a subject would benefit from such modulation without detrimental side effects. Typically, the process includes in vitro laboratory screening, in vivo testing, and clinical testing. Once that process has been successfully completed by the first drug candidate, subsequent drug candidates can benefit from the established proof of concept if a substantial correlation can be established between the first drug candidate and the subsequent drug candidates.
In order to prevent a disease, one of skill in the art would need to identify the subjects likely to acquire such as disease, carry out the claimed invention (e.g., administer the claimed compound/composition), and demonstrate the subject did not have any cells infected by the pathogen and/or demonstrate the subject did not develop the disease as a result of the administration of the compound/composition.
Based on the disclosures in the instant specification, the drug lenalidomide can be used to treat multiple myeloma, but there is no evidence to support a claim for preventing multiple myeloma. In fact, the specification states the disease has no symptoms and therefore suggests it cannot be prevented. Thus, the state of the prior art is in its infancy for preventing multiple myeloma.
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
The level of predictability in the art is generally unpredictable. The relevant art requires each potential drug candidate to be assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18, 24 (CCPA 1970). The more unpredictable an area is the more specific disclosure is necessary to satisfy the statutory requirement. MPEP § 2164.02(II) explains that a correlation between the claimed invention and the evidence provided in an application, along with a correlation between the evidence and the models recognized in the art, are required:
“Correlation” as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a “working example” if that example “correlates” with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute “working examples.” In this regard, the issue of “correlation” is also dependent on the state of the prior art. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441 (Fed. Cir. 1995) (reversing a USPTO decision based on finding that in vitro data did not support in vivo applications).
Further, treatments may be effective for some subjects and ineffective for other subjects. Thus, each candidate for pharmaceutical or veterinary medicine must be evaluated on its own even when a nexus to an existing drug or class of drugs has been established.
The amount of direction provided by the inventor is limited to particulars related to preparing a drug composition, such as dosage form and amount. (Spec., pp. 3–5). There is no guidance for ascertaining healthy patients who may develop multiple myeloma.
The existence of working examples relate to in vitro treating multiple myeloma cells with the drug combination. (Id., pp. 5–6). There are no examples demonstrating the prevention of multiple myeloma in a patient.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure includes developing a protocol to ascertain those subjects who may develop multiple myeloma, administer the drug combination to those subjects, and determine whether the drug combination prevented the patient from developing multiple myeloma. Thus, the quantity of experimentation is extensive.
Scope of Enablement Conclusion
In view of the Wands factors discussed above, the disclosure of the instant application does not reasonably enable a person having ordinary skill in the art to use the full scope of the claimed invention. The breadth of the claims is limited in scope; the nature of the invention is sophisticated; the state of the prior art is in its infancy for preventing multiple myeloma; the level of skill in the art is high; the pharmaceutical art is unpredictable; the direction provided by the inventor is limited to preparing a drug composition; there are no working examples demonstrating the prevention of multiple myeloma in a patient; and the quantify of experimentation needed to practice the claimed invention is extensive. Thus, when the evidence is considered as a whole, undue experimentation would be required to practice the full scope of the claimed invention.
Examiner recommends amending the claims to delete “preventing.”
Conclusion
No claims are allowed.
Allowable Subject Matter
Claims 4–10 are directed to a drug combination comprising 2-bromopalmitate (2-BP) and lenalidomide. The drug combination is not disclosed or suggested in the prior art. Close prior art includes WO 2017/053706 (“Wu”), which describes a drug combination having lenalidomide and a compound of Formula (I) (defined therein). (Wu, p.55). Wu notes that 2-BP was used to develop a chemical probe (Id., p.8), but does not suggest using 2-BP in a drug with lenalidomide.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/J.M.N./Patent Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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