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 .
Claims 1, 5, 6, and 10 have been amended. Claims 11 and 12 have been added. Claims 1-12 are pending and under consideration.
The rejection of claims 5 and 10 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendment of claims 5 and 10.
The rejection of claims 6-10 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in light of applicant’s amendment.
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 11 and 12 are rejected and claims 1-4remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh (WO2016/065323, reference of an IDS filed 10/10/2022) for reasons of record.
Singh discloses the treatment of uveitis by administration of an anit-STAT3 sdAb (paragraph [0066]) which meets the same limitation in claim 1. Singh discloses that an anti-STAT3 sdAb of the invention has the amino acid sequence of SEQ ID NO:3 (paragraph [0086]).
SEQ ID NO:3 of Singh is identical to the instant SEQ ID NO:1:
OM protein - protein search, using sw model
Run on: July 30, 2025, 23:15:28 ; Search time 1 Seconds
(without alignments)
0.016 Million cell updates/sec
Title: AASEQ1_07302025_231526
Perfect score: 683
Sequence: 1 HVQLVESGGGSVQAGGSLRL..........WFNRYMYNSWGQGTQVTVSS 127
Scoring table: BLOSUM62
Gapop 10.0 , Gapext 0.5
Searched: 1 seqs, 127 residues
Total number of hits satisfying chosen parameters: 1
Minimum DB seq length: 0
Maximum DB seq length: inf
Post-processing: Minimum Match 0%
Maximum Match 100%
Listing first 1 summaries
Database : US-17-859-861A-1.pep:*
SUMMARIES
%
Result Query
No. Score Match Length DB ID Description
----------------------------------------------------------------------------
1 683 100.0 127 1 US-17-859-861A-1 Suppression of Uve
ALIGNMENTS
RESULT 1
US-17-859-861A-1
Query Match 100.0%; Score 683; DB 1; Length 127;
Best Local Similarity 100.0%;
Matches 127; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 HVQLVESGGGSVQAGGSLRLSCAASGANGGRSCMGWFRQVPGKEREGVSGISTGGLITYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 HVQLVESGGGSVQAGGSLRLSCAASGANGGRSCMGWFRQVPGKEREGVSGISTGGLITYY 60
Qy 61 ADSVKGRFTISQDNTKNTLYLQMNSLKPEDTAMYYCATSRFDCYRGSWFNRYMYNSWGQG 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISQDNTKNTLYLQMNSLKPEDTAMYYCATSRFDCYRGSWFNRYMYNSWGQG 120
Qy 121 TQVTVSS 127
|||||||
Db 121 TQVTVSS 127
Singh discloses that the target of the anti-STAT3 can be in a human or animal (paragraph [0072]) which meets those limitations in claims 2 and 3. Singh discloses that the sdAbs of the invention can be used with one or more compounds, such as JAK/STAT inhibitors (paragraph [0068]) which meets the limitations of claim 4 calling for “one or more compounds”. The anti-STAT3 sdAb of SEQ ID NO:3 would inherently cross the blood-retinal barrier, reduce inflammatory cell infiltration, preserve retinal visual function, preserve or increases ERG A-wave amplitude and preserve or increases ERG-B wave amplitude in the subject because these are properties taught in the instant specification to be inherent in the sdAb.
Section 2112.02 of the M.P.E.P. states:
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
In the instant case, Singh discloses a method of treating uveitis comprising the administration of a sdAb comprising the sequence of SEQ ID NO:3 which is identical to the sdAb of instant SEQ ID NO:1. Thus, the instant method claims are not directed to a new use for the sdAb of SEQ ID NO: 1, The instant “use” resulting in the sdAb crossing the blood-retinal barrier, reducing inflammatory cell infiltration, preserving retinal visual function, preserving or increases ERG A-wave amplitude and preserving or increases ERG-B wave amplitude in the subject is thus anticipated by the inherent properties of the sdAb of SEQ I NO:3 of Singh et al.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (WO2016/065323) in view of Boyd et al (Survey of Ophthalmology, 2001, Vol. 46, pp. 200-233).
Singh teaches the limitations of claims 1-4 for the reasons set forth above. Singh does not specifically teach that the uveitis is the result of sympathetic ophthalmia, birdshot retino choroidopathy, Bechet’s disease, Vogt-Koyanagi-Harada disease or ocular sarcoidosis.
Boyd et al teach autoimmune diseases associated with the development of uveitis include sympathetic ophthalmia, birdshot retino choroidopathy, Bechet’s disease, Vogt-Koyanagi-Harada disease or ocular sarcoidosis (page 200, first column, lines 5-10 of the bottom paragraph).
It would be prima facie obvious at the time prior to the effective filing date to treat patients with uveitis resulting from sympathetic ophthalmia, birdshot retino choroidopathy, Bechet’s disease, Vogt-Koyanagi-Harada disease or ocular sarcoidosis with the antibody of Singh. One of skill in the art would have been motivated to do so because Singh teaches the treatment of uveitis, and Boyd et al teach that sympathetic ophthalmia, birdshot retino choroidopathy, Bechet’s disease, Vogt-Koyanagi-Harada disease or ocular sarcoidosis are associated with the occurrence of uveitis.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Singh (WO2016/065323) in view of Yu et al (PLoS One, 2012, Vol. 7, No. 1, e29742, 9 pages, reference of the IDS filed 1/30/2026).
Singh teaches a method of preventing recurrence of a disease mediated by STAT3 comprising administering an anti-STAT3 sdAb, or a polypeptide, to a subject in need thereof wherein the sdAb comprises an anti-STAT3 sdAb comprising an amino acid sequence set forth in SEQ ID NO:3 (paragraph [0014]). Singh teaches the treatment of uveitis by administration of an snit-STAT3 sdAb (paragraph [0066]) which meets the same limitation in claim 1. Singh teaches that an anti-STAT3 sdAb of the invention has the amino acid sequence of SEQ ID NO:3 (paragraph [0086]. SEQ ID NO:3 of Singh is identical to the instant SEQ ID NO:1: Singh teaches the limitations of claims 1-4 for the reasons set forth above and also the limitations of claims 7-9. Singh does not explicitly state that uveitis is a disease “mediated” by STAT3.
Yu et al teach a mouse model wherein deletion of STAT3 in T cells prevented the mice from developing experimental autoimmune uveitis (page 3, lines 1-5. Under the heading “A STAT3 inhibitor…”. Yu et al also teach that mice with deleted STAT3 ci not develop autoimmune uveitis in response to IRBP as did wild-type mice (page 3, lines 1-5 under the heading “STAT3 signal is required… “). One of skill in the art would reasonably conclude that uveitis was mediated by STAT3 because its absence prevents the disease from occurring.
It would have been prima facie obvious before the effective filing date to prevent the recurrence of uveitis by administration of the sdAb of SEQ ID NO:3 of Singh. One of skill in the art would have been motivated to do so by the teachings of Singh that sdAb anti-STAT3 is administered to prevent recurrence of diseases mediated by STAT3, and the teachings of Yu et al that uveitis is mediated by STAT3.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Singh and Yu et al as applied to claims 6-9 above, and further in view of Boyd et al (Survey of Ophthalmology, 2001, Vol. 46, pp. 200-233).
The combined teachings of Singh and Yu et al render obvious the limitations of claims 6-9 for the reasons set forth above. Neither Singh nor Yu et al specifically address uveitis is the result of sympathetic ophthalmia, birdshot retino choroidopathy, Bechet’s disease, Vogt-Koyanagi-Harada disease or ocular sarcoidosis.
Boyd et al teach autoimmune diseases associated with the development of uveitis include sympathetic ophthalmia, birdshot retino choroidopathy, Bechet’s disease, Vogt-Koyanagi-Harada disease or ocular sarcoidosis (page 200, first column, lines 5-10 of the bottom paragraph).
It would be prima facie obvious at the time prior to the effective filing date to treat patients with uveitis resulting from sympathetic ophthalmia, birdshot retino choroidopathy, Bechet’s disease, Vogt-Koyanagi-Harada disease or ocular sarcoidosis with the antibody of Singh. One of skill in the art would have been motivated to do so because Singh teaches the treatment of uveitis, and Boyd et al teach that sympathetic ophthalmia, birdshot retino choroidopathy, Bechet’s disease, Vogt-Koyanagi-Harada disease or ocular sarcoidosis are associated with the occurrence of uveitis.
All claims are rejected.
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 KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643