DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2025 December 29 has been entered. Newly amended pending claims 1, 2, 5, 25, 27, 31, 33, 37, 68, 72, 76, 124, 129, 136, 138, and 139 are examined on the merits.
Claims 1, 2, 5, 25, 27, 31, 33, 37, 68, 72, 76, 124, 129 are allowable. Claims 136, 138, and 139, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement between inventions I and II, as set forth in the Office action mailed on 2024 November 19, is hereby withdrawn and claims 136, 138, and 139 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
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 136, 138, and 139 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for the inhibiting or relieving of acute myeloid leukemia and colon cancer and non-enabling for the prophylaxis, inhibiting or relieving the scope of disorders recited in claims 136, 138, and 139. 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.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating a disorder in a mammal with a compound of claim 1. Thus, the claims taken together with the specification imply that a compound of claim 1 can treat a disease. The definition of treatment includes prophylaxis (specification, pages 14-15, paragraph [0051]).
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The state of the prior art and (4) the predictability or unpredictability of the art:
SYKES (Expert Opinion on Therapeutic Targets, 2018, 22:11, 893-898) describes dihydroorotate dehydrogenase (DHODH) inhibition in the alleviation of acute myeloid leukemia is presently in clinical trials (page 895, column 1, paragraph 3).
MADAK (Pharmacology & Therapeutics, 2019, 195, 111-131) describes the following ideas: increased levels of dihydroorotate dehydrogenase (DHODH) are present in colon cancers (page 116, figure 4C);and more research is needed to understand the biological diseases related to DHODH (page 126, column 1, paragraph 1 to page 127, column 1, paragraph 2).
Leukemia is difficult to prevent due to the causes being unknown (“Leukemia Prevention - Can Leukemia Be Prevented?”, http://cancer.about.com/od/leukemia/a/leukemiaprevent.htm?p=1, 2006 June 2, accessed 2013 August 29).
The relative skill of those in the art:
While the artisan generally would have an advanced degree in [area of claims], their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how dihydroorotate dehydrogenase functions in the body or to overcome the art recognition that this disease is poorly understood and treatments have generally failed.
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for inhibiting, relieving, mitigating, or ameliorating acute myeloid leukemia.
The specification does not provide guidance for prevention of a disease related to DHODH.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to ameliorating or preventing a disease with a compound of claim 1 and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Allowable Subject Matter
Claims 1, 2, 5, 25, 27, 31, 33, 37, 68, 72, 76, 124, and 129 are allowed. Claims 136, 138, and 139 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: Hesson (EP 0133244, published 20 February 1985, cited in 25 June 2022 IDS) does not describe compounds in which the following conditions are met: examined variable R5b or R5c is -C1-10alkylamino, O-alkyl, O-carbocycle, O-alkylene-carbocycle, or O-carbocycle-alkyl; and one of variables R6a-R6d is other than H.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699