DETAILED ACTION
This action is in reply to papers filed 6/28/2023. 1-21 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230381343A1, Published 11/30/2023.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Prior Art Rejection 1
Claim(s) 1-11, 14-15 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US20130143814A1, Published 6/24/2014 ; Ref. 17 in IDS filed 11/17/2023) in view of Asokan et al. (PgPub US20230242938A1, Filed 2/28/2019) , Olsen et al. (U.S. Patent 5837498, Published 11/18/1998) and Verhaagen et al. (WO2010005296A1, Published 1/14/2010).
Rosa et al. teaches methods, compositions, and devices for treating an ocular disease, disorder or condition in a mammal. In particular aspects, Rosa teaches the invention includes administration of a therapeutic polypeptide such as a stanniocalcin family member protein for the treatment of an eye disease. Also included are fusion proteins and cells stimulated or modified to express the therapeutic polypeptides (Abstract). Regarding claim 1, claim 18, and claim 20, Rosa teaches a method of treatment for reducing intraocular pressure (IOP) in an eye of a human patient (Pg. 2, para. 11) having an ocular disorder, such as glaucoma (as in claim 15) (Pg. 15, para. 168), wherein the method comprises: administering to the anterior chamber of the patient's eye (Pg. 2, para. 14) a therapeutically effective amount of a composition comprising a recombinant adeno-associated virus (rAAV) (Pg. 14, para. 140) comprising a nucleic acid encoding a stanniocalcin-1 (STC-1) polypeptide (Pg. 2, para. 11) operably linked to a promoter (Pg. 3, para. 21). Rosa teaches the composition can be injected at least twice (as in claim 2, claim 19 and claim 21) (Pg. 7, para. 64; Pg. 22, para. 239). Rosa teaches the composition is administered intravitreally, subconjuntivally (as further in claim 18), subretinally (as in claim 20), intracamerally (as in claim 5) or topically (Pg. 18, para. 206).
However, Rosa et al. fails to teach the rAAV vector comprises an rAAV capsid (as further in claim 1, claim 18 and claim 20).
Before the effective filing date of the claimed invention, Asokan et al. taught AAV capsid (as further in claim 1, claim 18 and claim 20) proteins comprising a modification in the amino acid sequence and virus vectors comprising the modified AAV capsid (Abstract). In one embodiment, Asokan teaches the capsid is an AAV2 capsid (as in claim 14) (Pg. 11, para. 115-116) protein. Asokan notes that a subsequent rAAV particle is administered within 12 months of the previously received or administered rAAV particle (Pg. 28,para. 286), which reads on the “at least 120 days apart” and “at least 1 year apart” recited in claim 3 and claim 4. Moreover, Asokan teaches the disclosure also provides methods of administering the virus vectors and virus capsids of the disclosure to a cell or to a subject in vivo. Asokan teaches the nucleic acid vector comprises promoters such as the constitutive promoter (as in claim 8) chicken β-actin promoter(as in claim 8 and claim 9, in-part) (Pg. 16,para. 169). Alternatively, Asokan teaches the nucleic acid vector comprises promoters such as the airway epithelial cell-specific promoters (as in claim 11) (Pg. 16,para. 171).
However, neither Rosa et al. nor Asokan et al. teach the STC-1 polypeptide comprises an amino acid sequence selected from SEQ ID Nos: 2, 4, 6, or 14 (as in claim 6).
Before the effective filing date of the claimed invention, Olsen et al. taught human stanniocalcin (STC) polynucleotides, polypeptides, and other Stanniocalcin compositions and to novel methods based thereon.
The alignment between SEQ ID NO: 4 (Qy, query) and the stanniocalcin polypeptide sequence taught by Olsen et al. (Db, database) is provided below (as in claim 6).
RESULT 3
US-08-208-005C-2
(NOTE: this sequence has 43 duplicates in the database searched.
See complete list at the end of this report)
Sequence 2, US/08208005C
Patent No. 5837498
GENERAL INFORMATION
APPLICANT: OLSEN, ET AL.
TITLE OF INVENTION: Corpuscles of Stannius Protein, Stanniocalcin
CURRENT APPLICATION NUMBER: US/08/208,005C
CURRENT FILING DATE: 8 MARCH 1994
NUMBER OF SEQ ID NOS: 5
SEQ ID NO 2
LENGTH: 247
TYPE: PRT
Query Match 99.6%; Score 1191; Length 247;
Best Local Similarity 100.0%;
Matches 229; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 2 HEAEQNDSVSPRKSRVAAQNSAEVVRCLNSALQVGCGAFACLENSTCDTDGMYDICKSFL 61
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 19 HEAEQNDSVSPRKSRVAAQNSAEVVRCLNSALQVGCGAFACLENSTCDTDGMYDICKSFL 78
Qy 62 YSAAKFDTQGKAFVKESLKCIANGVTSKVFLAIRRCSTFQRMIAEVQEECYSKLNVCSIA 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 79 YSAAKFDTQGKAFVKESLKCIANGVTSKVFLAIRRCSTFQRMIAEVQEECYSKLNVCSIA 138
Qy 122 KRNPEAITEVVQLPNHFSNRYYNRLVRSLLECDEDTVSTIRDSLMEKIGPNMASLFHILQ 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 139 KRNPEAITEVVQLPNHFSNRYYNRLVRSLLECDEDTVSTIRDSLMEKIGPNMASLFHILQ 198
Qy 182 TDHCAQTHPRADFNRRRTNEPQKLKVLLRNLRGEEDSPSHIKRTSHESA 230
|||||||||||||||||||||||||||||||||||||||||||||||||
Db 199 TDHCAQTHPRADFNRRRTNEPQKLKVLLRNLRGEEDSPSHIKRTSHESA 247
Olsen teaches the coding sequence which encodes the mature polypeptide may be identical to the coding sequence shown in FIG. 1 (SEQ ID NO:1) (as in claim 7). The alignment between SEQ ID NO: 1 (Qy, query) and the stanniocalcin nucleic acid sequence taught by Olsen et al. (Db, database) is provided below.
RESULT 6
US-08-208-005A-1
(NOTE: this sequence has 5 duplicates in the database searched.
See complete list at the end of this report)
Sequence 1, US/08208005A
GENERAL INFORMATION
APPLICANT: OLSEN, ET AL.
TITLE OF INVENTION: Corpuscles of Stannius Protein, Stanniocalcin
CURRENT APPLICATION NUMBER: US/08/208,005A
CURRENT FILING DATE: 8 MARCH 1994
NUMBER OF SEQ ID NOS: 2
SEQ ID NO 1
LENGTH: 771
TYPE: DNA
Query Match 100.0%; Score 537; Length 771;
Best Local Similarity 100.0%;
Matches 537; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ATGTATGACATCTGTAAATCCTTCTTGTACAGCGCTGCTAAATTTGACACTCAGGGAAAA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 223 ATGTATGACATCTGTAAATCCTTCTTGTACAGCGCTGCTAAATTTGACACTCAGGGAAAA 282
Qy 61 GCATTCGTCAAAGAGAGCTTAAAATGCATCGCCAACGGGGTCACCTCCAAGGTCTTCCTC 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 283 GCATTCGTCAAAGAGAGCTTAAAATGCATCGCCAACGGGGTCACCTCCAAGGTCTTCCTC 342
Qy 121 GCCATTCGGAGGTGCTCCACTTTCCAAAGGATGATTGCTGAGGTGCAGGAAGAGTGCTAC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 343 GCCATTCGGAGGTGCTCCACTTTCCAAAGGATGATTGCTGAGGTGCAGGAAGAGTGCTAC 402
Qy 181 AGCAAGCTGAATGTGTGCAGCATCGCCAAGCGGAACCCTGAAGCCATCACTGAGGTCGTC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 403 AGCAAGCTGAATGTGTGCAGCATCGCCAAGCGGAACCCTGAAGCCATCACTGAGGTCGTC 462
Qy 241 CAGCTGCCCAATCACTTCTCCAACAGATACTATAACAGACTTGTCCGAAGCCTGCTGGAA 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 463 CAGCTGCCCAATCACTTCTCCAACAGATACTATAACAGACTTGTCCGAAGCCTGCTGGAA 522
Qy 301 TGTGATGAAGACACAGTCAGCACAATCAGAGACAGCCTGATGGAGAAAATTGGGCCTAAC 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 523 TGTGATGAAGACACAGTCAGCACAATCAGAGACAGCCTGATGGAGAAAATTGGGCCTAAC 582
Qy 361 ATGGCCAGCCTCTTCCACATCCTGCAGACAGACCACTGTGCCCAAACACACCCACGAGCT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 583 ATGGCCAGCCTCTTCCACATCCTGCAGACAGACCACTGTGCCCAAACACACCCACGAGCT 642
Qy 421 GACTTCAACAGGAGACGCACCAATGAGCCGCAGAAGCTGAAAGTCCTCCTCAGGAACCTC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 643 GACTTCAACAGGAGACGCACCAATGAGCCGCAGAAGCTGAAAGTCCTCCTCAGGAACCTC 702
Qy 481 CGAGGTGAGGAGGACTCTCCCTCCCACATCAAACGCACATCCCATGAGAGTGCATAA 537
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 703 CGAGGTGAGGAGGACTCTCCCTCCCACATCAAACGCACATCCCATGAGAGTGCATAA 759
And although Rosa et al. teach the rAAV vector comprises a chicken beta actin promoter, none of Rosa et al., Asokan et al. or Olsen et al. teach said chicken beta actin promoter comprises the sequence selected from SEQ ID Nos: 33, 34 or 35 (as in claim 10).
Before the effective filing date of the claimed invention, Verhaagen et al. relates to novel transcription units that can be used in expression vectors (Abstract).
The alignment between SEQ ID NO: 34 (Qy, query) and the chicken beta actin promoter taught by Verhaagen et al. (Db, database) is provided below (as in claim 10).
RESULT 39
AXV32015
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID AXV32015 standard; DNA; 959 BP.
XX
AC AXV32015;
XX
DT 01-APR-2010 (first entry)
XX
DE Chicken- beta-actin promoter DNA SEQ ID:34.
XX
KW alzheimers disease; antimicrobial-gen.; antiparkinsonian;
KW bovine spongiform encephalopathy; cerebroprotective;
KW cerebrovascular trauma; creutzfeldt jakob disease; dementia;
KW diagnostic test; ds; growth-disorder-gen.; huntingtons chorea;
KW immunosuppressive; injury; motor neurone disease; multiple sclerosis;
KW neurodegenerative disease; neuroprotective; nootropic;
KW parkinsons disease; promoter; therapeutic; vasotropic; vulnerary.
XX
OS Gallus gallus.
XX
CC PN WO2010005296-A1.
XX
CC PD 14-JAN-2010.
XX
CC PF 16-JUN-2009; 2009WO-NL050346.
XX
PR 16-JUN-2008; 2008EP-00158319.
PR 16-JUN-2008; 2008US-0061741P.
XX
CC PA (NENE-) NEDERLANDS INST NEUROWETENSCHAPPEN.
XX
CC PI De Bree FM, Franssen EHP, Smit AB, Van Kesteren RE, Verhaagen J;
XX
DR WPI; 2010-A66415/08.
XX
CC PT Promoting regeneration of a neuronal cell comprises altering the activity
CC PT or the steady state level of a polypeptide of interest in a neuronal
CC PT cell.
XX
CC PS Disclosure; SEQ ID NO 34; 93pp; English.
XX
CC The present invention relates to a novel method of promoting regeneration
CC of a neuronal cell comprises altering the activity or the steady state
CC level of a polypeptide in a neuronal cell, where the polypeptide is
CC selected from Scavenger receptor class B member 2, a Leprecan, BM385941,
CC Mesothelin, Serine (or cysteine) peptidase inhibitor, clade I, member 1,
CC 5100A9, NP-1, and NCAM. The methods are useful for promoting regeneration
CC of a neuronal cell; for treating a neurotraumatic injury or a
CC neurodegenerative disease; and for diagnosing the status of generation or
CC regeneration of a neuron. The nucleotide sequence, polypeptide, or a
CC nucleic acid construct is used as a medicament or is useful for
CC manufacturing a medicament for promoting regeneration of a neuronal cell
CC or for the treatment of a neurotraumatic injury or neurodegenerative
CC disease. The neurodegenerative disease is selected from: cerebrovascular
CC accidents (CVA), Alzheimer's disease (AD), vascular-related dementia,
CC creutzfeldt jakob disease (CJD), bovine spongiform encephalopathy (BSE),
CC Parkinson's disease (PD), brain trauma, multiple sclerosis (MS),
CC amyotrophic lateral sclerosis (ALS - Lou Gehrig's disease) and
CC Huntington's chorea. The present sequence represents the chicken- beta-
CC actin promoter DNA useful for manufacturing a medicament for promoting
CC regeneration of a neuronal cell or for the treatment of a neurotraumatic
CC injury or neurodegenerative disease
XX
SQ Sequence 959 BP; 175 A; 275 C; 274 G; 235 T; 0 U; 0 Other;
Query Match 97.0%; Score 947; Length 959;
Best Local Similarity 100.0%;
Matches 947; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CTAGTTATTAATAGTAATCAATTACGGGGTCATTAGTTCATAGCCCATATATGGAGTTCC 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 13 CTAGTTATTAATAGTAATCAATTACGGGGTCATTAGTTCATAGCCCATATATGGAGTTCC 72
Qy 61 GCGTTACATAACTTACGGTAAATGGCCCGCCTGGCTGACCGCCCAACGACCCCCGCCCAT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 73 GCGTTACATAACTTACGGTAAATGGCCCGCCTGGCTGACCGCCCAACGACCCCCGCCCAT 132
Qy 121 TGACGTCAATAATGACGTATGTTCCCATAGTAACGCCAATAGGGACTTTCCATTGACGTC 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 133 TGACGTCAATAATGACGTATGTTCCCATAGTAACGCCAATAGGGACTTTCCATTGACGTC 192
Qy 181 AATGGGTGGACTATTTACGGTAAACTGCCCACTTGGCAGTACATCAAGTGTATCATATGC 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 193 AATGGGTGGACTATTTACGGTAAACTGCCCACTTGGCAGTACATCAAGTGTATCATATGC 252
Qy 241 CAAGTACGCCCCCTATTGACGTCAATGACGGTAAATGGCCCGCCTGGCATTATGCCCAGT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 253 CAAGTACGCCCCCTATTGACGTCAATGACGGTAAATGGCCCGCCTGGCATTATGCCCAGT 312
Qy 301 ACATGACCTTATGGGACTTTCCTACTTGGCAGTACATCTACGTATTAGTCATCGCTATTA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 313 ACATGACCTTATGGGACTTTCCTACTTGGCAGTACATCTACGTATTAGTCATCGCTATTA 372
Qy 361 CCATGGTCGAGGTGAGCCCCACGTTCTGCTTCACTCTCCCCATCTCCCCCCCCTCCCCAC 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 373 CCATGGTCGAGGTGAGCCCCACGTTCTGCTTCACTCTCCCCATCTCCCCCCCCTCCCCAC 432
Qy 421 CCCCAATTTTGTATTTATTTATTTTTTAATTATTTTGTGCAGCGATGGGGGCGGGGGGGG 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 433 CCCCAATTTTGTATTTATTTATTTTTTAATTATTTTGTGCAGCGATGGGGGCGGGGGGGG 492
Qy 481 GGGGGGGGCGCGCGCCAGGCGGGGCGGGGCGGGGCGAGGGGCGGGGCGGGGCGAGGCGGA 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 493 GGGGGGGGCGCGCGCCAGGCGGGGCGGGGCGGGGCGAGGGGCGGGGCGGGGCGAGGCGGA 552
Qy 541 GAGGTGCGGCGGCAGCCAATCAGAGCGGCGCGCTCCGAAAGTTTCCTTTTATGGCGAGGC 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 553 GAGGTGCGGCGGCAGCCAATCAGAGCGGCGCGCTCCGAAAGTTTCCTTTTATGGCGAGGC 612
Qy 601 GGCGGCGGCGGCGGCCCTATAAAAAGCGAAGCGCGCGGCGGGCGGGAGTCGCTGCGACGC 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 613 GGCGGCGGCGGCGGCCCTATAAAAAGCGAAGCGCGCGGCGGGCGGGAGTCGCTGCGACGC 672
Qy 661 TGCCTTCGCCCCGTGCCCCGCTCCGCCGCCGCCTCGCGCCGCCCGCCCCGGCTCTGACTG 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 673 TGCCTTCGCCCCGTGCCCCGCTCCGCCGCCGCCTCGCGCCGCCCGCCCCGGCTCTGACTG 732
Qy 721 ACCGCGTTACTCCCACAGGTGAGCGGGCGGGACGGCCCTTCTCCTCCGGGCTGTAATTAG 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 733 ACCGCGTTACTCCCACAGGTGAGCGGGCGGGACGGCCCTTCTCCTCCGGGCTGTAATTAG 792
Qy 781 CGCTTGGTTTAATGACGGCTTGTTTCTTTTCTGTGGCTGCGTGAAAGCCTTGAGGGGCTC 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 793 CGCTTGGTTTAATGACGGCTTGTTTCTTTTCTGTGGCTGCGTGAAAGCCTTGAGGGGCTC 852
Qy 841 CGGGAGCTAGAGCCTCTGCTAACCATGTTCATGCCTTCTTCTTTTTCCTACAGCTCCTGG 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 853 CGGGAGCTAGAGCCTCTGCTAACCATGTTCATGCCTTCTTCTTTTTCCTACAGCTCCTGG 912
Qy 901 GCAACGTGCTGGTTATTGTGCTGTCTCATCATTTTGGCAAAGAATTC 947
|||||||||||||||||||||||||||||||||||||||||||||||
Db 913 GCAACGTGCTGGTTATTGTGCTGTCTCATCATTTTGGCAAAGAATTC 959
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Rosa et al., wherein Rosa teaches administration of an AAV vector comprising a nucleotide encoding STC-1 polypeptide operably linked to a promoter for the purposes of reducing IOP, with the teachings of Asokan et al., Asokan teaches AAV2 capsid proteins comprising a modification in the amino acid sequence and virus vectors comprising the modified AAV capsid protein and their use as gene delivery vehicles, with the teachings of Olsen et al. wherein Olsen teaches an STC-1 nucleic acid encoding a STC-1 polypeptide, with a reasonable expectation of arriving at the claimed invention. That is, one of ordinary skill in the art would have found it prima facie obvious to administer the AAV vector comprising an AAV2 capsid comprising an STN-1 nucleic acid encoding a STC-1 polypeptide to a human patient that is in need of reducing IOP in a retina of a human subject. Moreover, the skilled artisan would have found it prima facie obvious to operably link the AAV vector comprising a chicken-beta promoter because Verhaagen teaches its use in retinal neurons.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the claimed invention, as a whole, was clearly prima facie obvious.
Prior Art Rejection 2
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. (US20130143814A1, Published 6/24/2014 ; Ref. 17 in IDS filed 11/17/2023) in view of Asokan et al. (PgPub US20230242938A1, Filed 2/28/2019) , Olsen et al. (U.S. Patent 5837498, Published 11/18/1998) and Verhaagen et al. (WO2010005296A1, Published 1/14/2010) as applied to claims 1-11, 14-15 and 18-21 above, and further in view of Zolotukhin et al. (PgPub US20200002386A1, Published 1/2/2020).
The teachings of Rosa et al., Asokan et al., Olsen et al. and Fontayne et al. as relied upon as detailed above. However, none of the aforementioned references teach the cell specific promoter is a human rhodopsin kinase I promoter (as in claim 12).
Before the effective filing date of the claimed invention, Zolotukhin et al. teach variant serotype 2 (AAV2) capsid proteins and variant capsid protein containing particles with enhanced ability to transduce retinal cells (Abstract). Zolotukhin teaches tissue- specific promoters and/or regulatory elements are also contemplated herein. In some embodiments, it may be beneficial to combine a variant rAAV (e.g., variant rAAV2) particle as disclosed herein, with a promoter that also targets the same cells, tissue, or organ as the variant rAAV (e.g., variant rAAV2) particle (Pg. 9,para. 103). In one embodiment, Zolotukhin teaches a cell-type- specific promoter targeting the retina is human rhodopsin kinase promoter (as in claim 12) (Pg. 9, para. 103).
When taken with the teachings of Zolotukhin et al., one of ordinary skill in the art would have found it prima facie obvious to use the retina cell specific promoter of Zolotukhin in the method of treating glaucoma in a human patient by reducing IOP, wherein said method comprises administering an AAV vector comprising a nucleotide encoding a STC-1 polypeptide operably linked to a promoter, as set forth in Rosa et al., Asokan et al., Olsen et al. and Verhaagen et al. with a reasonable expectation of success. That is, the skilled artisan would have found it prima facie obvious to substitute the retina specific promoter for the generic promoter in order drive expression of the STC-1 in the relevant cells.
Thus, the combination would have been prima facie obvious.
Prior Art Rejection 3
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. Rosa et al. (US20130143814A1, Published 6/24/2014 ; Ref. 17 in IDS filed 11/17/2023) in view of Asokan et al. (PgPub US20230242938A1, Filed 2/28/2019) , Olsen et al. (U.S. Patent 5837498, Published 11/18/1998) and Verhaagen et al. (WO2010005296A1, Published 1/14/2010) as applied to claims 1-11, 14-15 and 18-21 above, and further in view of Zheng et al. (US20170072025A1, Published 3/16/2017).
The teachings of Rosa et al., Asokan et al., Olsen et al. and Fontayne et al. as relied upon as detailed above. However, none of the aforementioned references teach the disorder is glaucomatous optic neuropathy (as in claim 16).
Before the effective filing date of the claimed invention, Okada et al. taught AAV vectors for treating or preventing the eye disease or the disease associated therewith (Pg. 4, para. 58). In one embodiment Zheng teaches the eye disease is glaucomatous optic neuropathy (Pg. 5, para. 59) (as in claim 16).
When taken with the teachings of Zolotukhin et al., one of ordinary skill in the art would have found it prima facie obvious to treat the glaucomatous optic neuropathy of Zheng et al. using the method of Rosa et al., Asokan et al., Olsen et al. and Verhaagen et al., wherein said method comprises administering an AAV vector comprising a nucleotide encoding a STC-1 polypeptide operably linked to a promoter for the purposes of reducing IOP with a reasonable expectation of success. The skilled artisan would have been motivated to do so because a symptom of glaucomatous optic neuropathy is an elevated IOP (see instant PgPub at para. 2).
Prior Art Rejection 4
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rosa et al. Rosa et al. (US20130143814A1, Published 6/24/2014 ; Ref. 17 in IDS filed 11/17/2023) in view of Asokan et al. (PgPub US20230242938A1, Filed 2/28/2019) , Olsen et al. (U.S. Patent 5837498, Published 11/18/1998) and Verhaagen et al. (WO2010005296A1, Published 1/14/2010) as applied to claims 1-11, 14-15 and 18-21 above, and further in view of Gondo et al. (Clin Ophthalmol. 2011 Aug 30;5:1217–121).
The teachings of Rosa et al., Asokan et al., Olsen et al. and Fontayne et al. as relied upon as detailed above. However, none of the aforementioned references teach the ocular disorder is radiation papillopathy (as in claim 17).
Before the effective filing date of the claimed invention, Gondo et al. teach a patient with radiation maculopathy and papillopathy (as in claim 17) was treated with intravitreal bevacizumab (1.25 mg). Gondo teaches the main outcome measures included fundus photography, angiography, and optical coherence tomography (OCT). Two weeks after intravitreal bevacizumab, visual acuity improved from 0.4 to 1.2. Fundus examination revealed decreased disc swelling, peripapillary hemorrhage, and macular edema. OCT demonstrated complete resolution of serous retinal detachment. At the 12-month follow-up, there was no exudation recurrence (Pg. 1217, ‘Case Report’).
Previously cited Rosa et al. teach fusion proteins and polynucleotides encoding them are also contemplated as part of the invention. Rosa teaches the fusion proteins include a first domain that includes a stanniocalcin family member polypeptide and a second domain comprising a second therapeutic polypeptide. In a particular aspect, the second therapeutic polypeptide is an antiangiogenic polypeptide. In one embodiment, Rosa teaches the antiangiogenic/angiostatic polypeptides include bevacizumab (Pg. 3, para. 22).
When taken with the teachings of Gondo et al., one of ordinary skill in the art would have found it prima facie obvious to fuse the STI-1 polypeptide with a bevacizumab polypeptide for the purposes of treating radiation papillopathy, as taught in Gondo et al. The skilled artisan would have found it prima facie obvious to do because Gondo teaches bevacizumab treats radiation papillopathy. Moreover, one of ordinary skill in the art would have found it prima facie obvious to combine the polypeptides for the purposes of treating radiation papillopathy because the specification teaches a symptom of radiation papillopathy is IOP (Pg. ,para. 85) and Rosa teaches STC-1 reduces IOP. Thus, the combination would have been prima facie obvious.
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Authorization to Initiate Electronic Communications
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Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632