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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/7/2026 has been entered.
Response to Amendment
The amendment filed 5/07/2026 has been entered. Claims 5 has been amended and new claim 19 has been added. Claims 6-18 are canceled.
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 19 are rejected under 35 U.S.C. 103 as being unpatentable
over PORCO, WO 2011140334 [892] in view of Ruiz et al. [IDS, dated
2/13/2023].
Regarding claim 5, PORCO discloses a method of treating 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 Sephin-1, as instantly
claimed.
Ruiz teaches that Sephin-1 is an eIF2-alpha inhibitor with therapeutic
potential since it does not have adverse effects on the alpha2 adrenergic
system.
It would have been obvious to a person having ordinary skill in the art 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 having adverse effects on the alpha2 adrenergic system.
Regarding the limitation that the method does not simultaneously cause side effects as claimed, since the prior art, as modified above, has the same steps as the instant claims, the same property of not causing side effects must also be present. Note, a compound and its properties are inseparable. Additionally, this limitation flows from the combination of references since Ruiz teaches that Sephin-1 does not have adverse effects.
Response to Arguments
Applicant’s arguments filed 5/7/2026 have been fully considered but they are not persuasive.
Applicant asserts that the instant specification provides superior results that could not be obtained from the prior art because, applicant has shown that Sephin-1 directly interacts with NMDAR and selectively antagonizes the NMDAR NR2B subunit.
This is not found persuasive because what is alleged here is not an unexpected result but rather the discovery of a new property of a known compound/composition.
The mere discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for its functioning, does not render the old composition patentably new to the discoverer (Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347). See MPEP §2112. Applicant’s arguments are clearly directed to the discovery of a new property of the known drug Sephin-1.
As discussed in the rejection above PORCO disclose methods of treating IFP by administering compounds which inhibit eIF2-alpha and Ruiz teaches that Sephin-1 is an eIF2-alpha inhibitor that does not have adverse effects.
Applicant argues that the examiner’s position could have only been arrived at by improper hindsight.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the above rejection, there is clear rationale for the conclusion of obviousness. PORCO teaches treating IFP by administering eIF2-alpha inhibitors and Ruiz teaches that Sephin-1 is an eIF2-alpha inhibitor that does not have adverse effects. Thus, clearly one of ordinary skill in the art would have looked to eIF2-alpha inhibitors without side effects when looking to improve the methods of PORCO. Applicant asserts that Ruiz teaches away from the present claims.
This is not found persuasive since there is no teaching away in Ruiz, rather the contrary, Ruiz teaches that Sephin-1 is an eIF2-alpha inhibitor with therapeutic potential that does not have an adverse effects.
Conclusion
No claims are allowed at this time.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Michael G Hartley whose telephone number is
(571)272-0616. The examiner can normally be reached 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the
examiner's supervisor, Jennifer Michener can be reached at 5712721424. The fax
phone number for the organization where this application or proceeding is assigned
is 571-273-8300.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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