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 .
Response to Amendment
Claims 1, 3, 10, 14, 19-21, 26, 36, 42, 43, 51-53, and 63-70 filed 2026 March 2 are examined on the merits. The 35 U.S.C. 102 rejections of the nonfinal rejection is overcome because examined variable L is now C2-40 alkyl interrupted by an arylene or heteroarylene group and terminally substituted by another moiety. In the compounds of the non-final action, L is a benzyl group.
Claims 1, 3, 10, 14, 19-21, 26, 36, 42, 43, and 63-70 are allowable. Claims 51-53, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim.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restriction requirement between inventions I and II, as set forth in the Office action mailed on 2025 July 2, is hereby withdrawn and claims 51-53 are hereby rejoined and fully examined for patentability under 37 CFR 1.104.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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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 51-53 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 alleviation of rheumatoid arthritis and non-enabling for the alleviation of the scope of disorders recited and the prevention of the same. 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 alleviating or preventing a disease related to TNF-alpha with a compound of formula (I). The definition of the “treatment” concept includes prevention (specification, page 94, [paragraph [00141]): “delaying the progression of the disease”.
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Thus, the claims taken together with the specification imply a compound of formula (I) can alleviate or prevent a disease related to TNF-alpha..
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The state of the prior art and (4) the predictability or unpredictability of the art:
FELDMANN (Nature Medicine, 2003,9(10), 1245-1250, 1433) describes following ideas: TNF-alpha is linked to alleviation of rheumatoid arthritis (page 1249, column 1, paragraph 3); and that more research is required to understand TNF-alpha as therapeutic target (page 1244, last column, last paragraph to page 1250. Column 1, second paragraph).
Philippou (Autoimmunity Reviews, 2018, 17, 1074-1077) describes the chance of getting rheumatoid arthritis can be reduced but not delayed (page 076, column 2, paragraphs 3 and 4).
The relative skill of those in the art:
While the artisan generally would have an advanced degree in what diseases are linked to TNF-alpha, their high level of skill and knowledge is insufficient to overcome the lack of understanding as to how [disease] 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 alleviation of rheumatoid arthritis.
The specification does not provide guidance for the alleviation of the scope of disorders recited and the prevention of the same.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to alleviation or prevention of a disease linked to TNF-alpha with a compound of formula (IU) 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.
Conclusion
Claims 1, 3, 10, 14, 19-21, 26, 36, 42, 43, and 63-70 allowed. Claims 51-53 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: LEE (CA3011254, published 2017 July 20) describes compounds L706 and K706-1 (page 55). These compounds do not anticipate or render obvious a compound of claim 1 because an amino group is not a permissible substituent on the quinazoline ring.
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THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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