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
The amendment filed 7/28/2025 has been entered. Claims 5 and 11 have been amended and are the only claims pending in the application as all other claims have been canceled.
New grounds of rejection
Claim Rejections - 35 USC § 112
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.
Claims 5 and 11 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.
Claim 5 is indefinite because it recites IFP-088 (Sephin-1) having the formula and recites two formulae both a generic formula and the specific formula (species) for Sephin-1. Since no line is drawn through the generic formula, it is still present in the claim which renders the claim indefinite because it is unclear if it part of the claim.
Claim 11 falls therewith.
Clearly removing the generic formula (while leave the formula for the species, Sephin-1) would obviate this rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over PORCO, WO 2011140334 [892 attached] in view of Ruiz et al. [IDS, dated 2/13/2023].
Regarding claim 5, PORCO disclose methods of treating various disease by administering compounds which inhibit eIF2, including, eIF2-alpha, see abstract, page 2, esp. para [0010] wherein the disease includes idiopathic pulmonary fibrosis (IFP), see page 65 esp. [00174].
PORCO fails to teach that the eIF2-alpha inhibitor is Sephim-1, as instantly claimed.
Ruiz teaches that Sephin-1 is an eIF2-alpha inhibitor with therapeutic potential since it does not have an adverse effects on the alpha2 adrenergic system.
It would have been obvious to either substitute or additionally add Sephin-1 in the methods taught by PORCO of treating IFP with eIF2 inhibiting compounds because Ruiz teaches the Sephin-1 is an eIF2-alpha inhibitor with therapeutic potential that provides the advantage of not have an adverse effects on the alpha2 adrenergic system.
Regarding claim 11, since the prior art as modified above may encompass the same steps as the instant claims, the same functions of not causing side effects would also be expected to be present, as a compound and its properties are inseparable. It is noted the instant specification does not describe any specifics that would lead to the properties set forth in claim 11.
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.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618