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 . 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.
Election/Restrictions
Applicants elected group III and SEQ ID 186 with traverse in the reply filed on 4 Aug, 2025. The traversal was rendered moot by the finding of group III being patentable and rejoinder of associated method claims.
Applicants have requested rejoinder of new claims 181-190, but those claims are drawn to sequences different than the claims determined to be allowable, nor does applicant’s traversal (that the product claims should be examined with the method claims) apply to these claims. The criteria for rejoinder is that the rejoined claims require all the limitations of an allowed claim (MPEP 821.04). These new claims do not. Thus, rejoinder is improper.
Claims Status
Claims 52, 58, 59, 62, 65, 68, 69, 72, 75, 78, 79, 82-86, 89, 92, 95, 98, 101, 104, 107, 110, 112, 113, 116, 119, and 122-190 are pending.
Claims 68, 83, 84, 107, 110, 112, 113, 116, 119, 123-130, and 149-178 have been amended.
Claims 179-190 are new.
Claims 181-190 have been withdrawn due to an election/restriction requirement.
Claims 52, 58, 59, 62, 65, 68, 69, 72, 75, 78, 79, 82-86, 89, 92, 95, 98, 101, 104, 107, 110, 112, 113, 116, and 122-180 are allowable.
Withdrawn Rejections
The rejection of claims 107, 110, 112, 113, 116, 119, 123-133, and 149-154 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of enablement is hereby withdrawn due to amendment.
The rejection of claim 68 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to multiple cutoffs of percent identity is hereby withdrawn due to amendment.
The rejection of claims 83 and 84 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to dependency from canceled claims is hereby withdrawn due to amendment.
New Rejections
Claim Rejections - 35 USC § 112(a)
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.
Claim 119 is 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 treatment of disorders where expression of DcR3 ligands is pathological, does not reasonably provide enablement for treating all disorders involving the expression of DcR3 ligands. 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: 1) the breadth of the claims; 2) the nature of the invention; 3) the state of the prior art; 4) the level of one of ordinary skill; 5) the level of predictability in the art; 6) the amount of direction provided by the inventor; 7) the existence of working examples; and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure” (MPEP 2164.01(a).
1 and 2) the breadth of the claims and the nature of the invention: The claim is drawn to a method of treating a disorder involving the expression of DcR3 ligands.
3) the state of the prior art: Zhan et al (Structure (2011) 19 p162-171, previously cited) discusses DcR3 (abstract), modified versions of which are used in applicant’s claimed methods. The protein binds three distinct TNF molecules, FasL, LIGHT, and TL1A (p162, 2nd column, 3d paragraph, continues to p163, 1st column, 1st paragraph), all of which are involved in immune response (p163, 1st column, 2nd and 3d paragraphs, continues to 2nd column, 1st paragraph).
Krzyzowska et al (Viruses (2024) 16(1363)) discusses the interaction of FasL with apoptosis and inflammation in HSV-2 mediated spinal cord infection (title). FasL deficient mice had impaired infection induced CNS induced inflammatory response, and higher morbidity, mortality, and viral load (abstract). In other words, in this disease, FasL plays a role in fighting the infection, and binding the cytokine would reasonably be expected to be detrimental.
4) the level of one of ordinary skill: The level of one of skill in the art is high.
5) the level of predictability in the art: The immune system is complex and not completely understood, making the level of predictability moderate at best.
6 and 7) the amount of direction provided by the inventor and the existence of working examples: Applicants demonstrate binding of the various ligands to the sequences used in the methods (example 7, paragraph 274-289) and ability to neutralize the ligands in vitro (example 9, paragraphs 298-306), and a mouse GVHD was mentioned (example 19, paragraphs 360-364), but there appears to be no effort to use the model.
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure: Applicant’s invention is variants of DcR3 that bind the same ligands as the native sequence, but with lower aggregation than prior art derivatives (specification, p5, line 5-17), binding to LIGHT, TL1A, and FasL (spec, p2, line 11). However, these are immune system molecules, which play a role in the natural immune system. There are disorders, such as the CNS infection of Krzyzowska et al, where binding these ligands will be detrimental. In those cases, it will take undue experimentation to use the invention as claimed.
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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658