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
Claim Status
Claims 1 and 3-16 are pending. Claims 11-16 have been added. Claim 1 has been amended.
Claims 1 and 10-15 are allowable. Claims 7-9, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim.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the restriction requirement between inventions I-III, as set forth in the Office action mailed on 1/15/2026, is hereby withdrawn and claims 7-9 are hereby rejoined and fully examined for patentability under 37 CFR 1.104.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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Claims 1 and 3-16 are being examined in this application.
Claim Objections
Claims 4, 6 and 16 are objected to because of the following informalities: Claim 4 should be amended to recite “……. -yGlu-8xPEG-, and -yGlu-3xOEG-y-Glu-8xPEG-”. Claim 6 should be amended to recite “…..comprises a sequence selected from SEQ ID NOs: 6-8”. Claim 16 should be amended to recite “…..comprises . Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1 and 10 under 35 USC 112(b) is withdrawn in view of the amendments to the claims.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
This is a new rejection.
Claims 3 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “each n is independently 3 to 28”, and the claim also recites “preferably 6 to 28, more preferably 17, 18 or 19” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 is drawn to the long-acting glucagon derivative according to claim 1, wherein X13 represents Y, X14 represents L, X1o represents K conjugated to a fatty acid chain, and the linker is -2xOEG-yGlu-; and/or, X13 represents Aib, X14 represents L, X10 represents K conjugated to a fatty acid chain, and the linker is -2xOEG-yGlu-; and/or, X13 represents Aib, X10 represents Y, X14 represents K conjugated to a fatty acid chain, and the linker is -2xOEG-yGlu-. The phrases “and/or” render the claim indefinite. For instance, how can X13 be Y and Aib at the same time? To overcome the rejection of claim 5, the claim should be amended to recite “…… or, X13 represents Aib, X14 represents L, X10 represents K conjugated to a fatty acid chain, and the linker is -2xOEG-yGlu-; or, X13 represents Aib……”.
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.
This is a new rejection.
Claims 8-9 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 the treatment of obesity and type 2 diabetes, does not reasonably provide enablement for each and every metabolic disease. 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 these claims.
The MPEP states:
“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, 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.”
(A) The breadth of the claims; and (B) The nature of the invention;
The claims are drawn to a method for treating a metabolic disease, comprising: administering the long-acting glucagon derivative according to claim 1 to a subject in need thereof.
(C) The state of the prior art;
No prior art has been found that teaches treating each and every metabolic disease with a long-acting glucagon derivative.
(D) The level of one of ordinary skill;
The skill of those skilled in the art is high.
(E) The level of predictability in the art;
Considering that no prior art has been found that teaches treating each and every metabolic disease with a long-acting glucagon derivative, the unpredictability of treatment of every metabolic disease with the claimed long-acting glucagon derivative is very high.
(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 specification does not provide any examples with respect to the use of the claimed long-acting glucagon derivative to treat any metabolic disease other than obesity and type 2 diabetes.
The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that
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“Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”
In the instant application, the specification does not provide any guidance to allow for the treatment of every metabolic disease.
Working examples are necessary since the art has indicated unpredictability of treatment of such diseases is very high.
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
Claim Rejections - 35 USC § 103
The rejection of claims 1 and 10 under 35 U.S.C. 103 as being unpatentable over Dimarchi is withdrawn in view of the amendments to the claims.
Allowable Subject Matter
Claims 1, 7 and 10-15 are allowed.
Conclusion
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 SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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