DETAILED ACTION
Claims 25-39 are pending in the instant application.
Applicant's election with traverse of group (VI) in the reply filed on 06/18/2026 is acknowledged. The applicant’s traverse is on two grounds as followed:
Applicants traverse the division between the groups because there has been no showing that the claims lack unity of invention and/or that all the groups have a single general inventive concept. The common proteasome activity and common structure of the compounds of formula (I) unifies the claims.
It is Examiner’s position there are 10 different variables for A. There is different search for each A group. The search is extremely burden for different A group. The search for each A structure is extremely burdensome.
This case is a 371, therefore, its lack of unity is under US rules of 35 USC 121 and 372 due to this, instant application contains the f inventions or groups of inventions. The instant application is 371 and 35 USC 121. due to the reference, it is been shown to form a single general inventive concept under PCT Rule 13.1.
Rejoinder condition has been clearly delineated to applicant and if proper claim is presented for rejoinder, it will be considered when any allowable compounds of group I can be identified. The method claims depend solely on the novel compounds without 112 issued should be presented for rejoinder.
The requirement is still deemed proper and is therefore made FINAL.
Claims 25-39 in part of compounds of formula (I) and formula (1-2*), wherein A is
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are examined. Claims 25-39 remaining subject matter being drawn to the non-elected invention are withdrawn per 37 CFR 1.142(b).
2. Claim Rejections - 35 USC § 101
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.
Claims 33-37 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. V. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). These claims are withdrawn from consideration.
3. Claim Rejections - 35 USC § 112
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 33-34 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for inhibition of proteasome and treating specific cancer in claim 35 and specific infectious disease in claim 36 and specific autoimmune disease selected from claim 37, does not reasonably provide enablement for treating a disease associated with and/or caused by proteasome or immunoproteasome other than treating specific cancer in claim 35 and specific infectious disease in claim 36 and specific autoimmune disease selected from claim 37. 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 and/or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors 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. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
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,
8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The nature of the invention: The instant invention is drawn to method for treating a disease associated with and/or caused by proteasome or immunoproteasome, said method comprising administration of the compound or pharmaceutically acceptable salt thereof according to claim 25.
The state of the prior art: As indicated by the prior art, there is not any association between proteasome inhibitors and treating a disease associated with and/or caused by proteasome or immunoproteasome other than treating specific cancer in claim 35 and specific infectious disease in claim 36 and specific autoimmune disease selected from claim 37. There is no guidance in the prior art that proteasome inhibitor could be useful to treat a disease associated with and/or caused by proteasome or immunoproteasome other than treating specific cancer in claim 35 and specific infectious disease in claim 36 and specific autoimmune disease selected from claim 37.
The predictability in the art: At present using proteasome inhibitor to a disease associated with and/or caused by proteasome or immunoproteasome other than treating specific cancer in claim 35 and specific infectious disease in claim 36 and specific autoimmune disease selected from claim 37 is purely speculative. It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. They have not shown a nexus to treat diseases but have provided only reports in vitro which, absent a correlation to treat of diseases, are not sufficient to enable the invention.
The level of the skill in the art: The level of skill in the art is high.
Amount of guidance/working examples: Applicant provides examples of the test compounds to inhibit proteasome on pages 457-497. However, there is no guidance for using a therapeutically effective amount of a compound of Formula (I) to treat a disease associated with and/or caused by proteasome or immunoproteasome other than treating specific cancer in claim 35 and specific infectious disease in claim 36 and specific autoimmune disease selected from claim 37.
The breadth of the claims: The claims encompass a method for treating a disease associated with and/or caused by proteasome or immunoproteasome.
The quantity of experimentation needed: Since the guidance and teaching provided by the specification is insufficient for treating diseases associated with therapeutically effective amount of a compound of formula (I) is efficacious, one of ordinary skill in the art, even with high level of skill, is unable to use the instant compounds as claimed without undue experimentation.
Taking all of the above into consideration, it is not seen where the instant claims 33-34, for treating diseases associated with therapeutically effective amount of a compound of Formula (I) is efficacious, have been enabled by the instant specification.
4. Claim 34-37 are rejected under 35 U.S.C. 112, first paragraph, because the specification, does not reasonably provide enablement for preventing a disease associated with and/or caused by proteasome or immunoproteasome. The specification does not enable any person skilled in the art to which, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. Applicants are not enabled for preventing any of these diseases. The only established prophylactics are vaccines not the compounds such as present here. In addition, it is presumed that “prevention” of the claimed diseases would require a method of identifying those individuals who will develop the claimed diseases before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing diseases requires identifying those patients who will acquire the disease before occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2) The passage spanning line 31, page 39 to line 32, page 40 lists the diseases Applicant intend to treat. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to medical treatment and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become afflicted before the fact. 6) The artisan using Applicants invention would be a Board Certified physician who specialized to treat diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of disorder diseases generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent disorders generally. That is, the skill is so low that no compound effective generally against disorders has ever been found let alone one that can prevent such conditions. 7) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the multitude of compounds embraced by Formula (I).
The Examiner suggests deletion of the word “prevention”.
5. Allowable Subject Matter
Claims 25-32, 38-39, wherein in part of compounds of formula (I) and formula (1-2*), wherein A is
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are patentable over Kanamaru et al., US 5922767, which includes the exemplified compound:
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which has different structure than the instant claim 25. Therefore, the claims are free of prior art.
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
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/NILOOFAR RAHMANI/
07/06/2026
Prosecution Insights