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
Status of Claims
Claims 43-69 are new claims and pending in the instant application. The claims are drawn to the elected invention and an action on the merits of these claims is contained herein.
New Objections and Rejections
Claim Objections
Claims 43-57 are objected to because of the following informality:
In claim 43, Applicant recites hereditary angioedema as a disease intended to be treated more than once (see near end of the claim) which is superfluous. Thus the second recitation is objected to and the claims dependent on it are objected to. The examiner recommends deletion of the second recitation to obviate the objection. Correction is required.
Claim Rejections - 35 USC § 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 58-69 are 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 a method of treatment of diseases selected from the group consisting of diabetic macular edema, age-related macular degeneration, choroidal neovascularization, edema after stroke, and/or the treatment or prevention of hereditary angioedema using the claimed compounds, does not reasonably provide enablement for the prevention of the full scope of diseases claimed therein. 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 the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required:
(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.
Some experimentation is not fatal; the issue is whether the amount of experimentation is "undue"; see In re Vaeck, 20 USPQ2d 1438, 1444. Analysis of sections (A)-(F) is described below:
(A) Breadth of claims:
(B) The nature of the invention and predictability in the art: The invention is directed toward and is therefore physiological in nature. 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).
(C) State of the Prior Art:
These compounds are so far as the examiner is aware, have been used in a prophylactic manner the full scope of diseases claimed. Specification teaches PKK inhibitory data of a few selected number of compounds but appears to lack any substantial in vivo data. Thus, one of ordinary skill would look to the art for further guidance. A published article after the filing date of the instant application by Abdel-Magid (ACS Med. Chem. Lett. 2023, 14, 129−130) discloses the state of the art regarding PKK inhibitors and methods of treatment. Outlining that PKK inhibitors have been shown to treat diabetic macular edema in rodents in vivo (see page 130, left paragraph) and that there are FDA approved drugs for the treatment and even prevention of hereditary angioedema (see page 129, right column). Applicants have provided additional references to support the treatment of other diseases selected from the group consisting of diabetic macular edema, age-related macular degeneration, choroidal neovascularization, and/or edema after stroke. However, the additional references appear to not provide enablement for preventing the aforementioned diseases in any prophylactic manner with the exception of hereditary angioedema as stated of record by the examiner.
(D) Skill of those in the art:
(F) Direction or Guidance: That provided is very limited. The dosage range information. Moreover, this is generic, the same for the many disorders covered by the specification. Thus, there is no specific direction or guidance regarding a regimen or dosage effective specifically for treating the full scope of diseases encompassed by the claims.
Due to the level of unpredictability in the art, the very limited guidance provided, and the lack of working examples, the applicant has shown lack of enablement. MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)." That conclusion is clearly justified here.
Conclusion
Claims 58-69 are rejected. Claims 43-57 are objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN MCDOWELL/
Primary Examiner, Art Unit 1624
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