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 5, 6, 8-12, 17, 19, 20, 23-32 have been canceled. Claims 1-4, 7, 13-16, 18, 21, 22, 33 remain pending.
Applicant's arguments filed 8-6-26 have been fully considered but they are not persuasive.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Newly submitted claim 7 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the protein in claim 7 has a different structure/function than the nucleic acid sequence in claim 1 (and previous claim 7 drawn to a nucleic acid). The protein in claim 7 requires different considerations under art and obviousness than the nucleic acid sequence in claim 1 (and previous claim 7 drawn to a nucleic acid).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 7 has been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1-4, 13-16, 18, 21, 22, 33 remain under consideration.
Claim objections
Claim 1 is missing the fact that it encodes a truncated USH2A protein. It can be written more clearly as ---An isolated nucleic acid encoding a truncated USH2A protein, wherein the nucleic acid consists of the nucleotide sequence of any one of SEQ ID NO: 3-14---.
The phrase “wherein further comprising” in claim 2 does not make grammatical sense.
Claims 2, 3 and 33 are objected to because a nucleic acid consisting of the nucleotide sequence of any one of SEQ ID NO: 3-14 cannot consist of more. “Consisting of” is closed claim language. Therefore, the nucleic acid cannot further comprise a promoter as required in claim 2, 3 and 33.
Claim 4 is objected to because a nucleic acid consisting of the nucleotide sequence of any one of SEQ ID NO: 3-14 cannot consist of more. “Consisting of” is closed claim language. Therefore, the nucleic acid cannot further comprise ITRs from AAV as required in claim 4.
Claim 7 is objected to because the protein is not isolated and does not say it is a truncated USH2A protein.
The concept of a “lipid/DNA nanoparticle” in claim 14 does not further limit the vector in claim 13. While the “vector” may be DNA, the vector does not contain a “lipid” or a “nanoparticle”.
The cell in claim 16 should be isolated.
Claim Rejections - 35 USC § 112
Written Description
Claims 1-4, 13-16, 18, 21, 22, 33 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Withdrawn rejection
The rejection regarding delivering the rAAV to cells of mammals with Usher syndrome to administering the rAAV to a cell from any plant, invertebrate, insect, fish, amphibian, reptile, bird or mammal in vivo or vitro with or without Usher syndrome as broadly encompassed by claim 23 has been withdrawn because the claim has been canceled.
Pending rejection
The specification lacks written description for any “isolated nucleic acid consisting of the nucleotide sequence [of] any one of SEQ ID NOs: 3-14” as required in claim 1 other than an isolated nucleic acid sequence encoding a truncated USH2A protein, wherein the nucleic acid sequence consists of the nucleotide sequence of SEQ ID NO: 3,4,5,6,7,8,9,10,11,12,13, or 14. While an isolated nucleic acid sequence may consist of the nucleotide sequence of SEQ ID NO: 3,4,5,6,7,8,9,10,11,12,13, or 14, the specification does not contemplate making/using a nucleic acid consisting of the nucleotide sequence of any one of SEQ ID NOs: 3-14 as required in claim 1. Accordingly, the concept lacks written description any “isolated nucleic acid consisting of the nucleotide sequence [of] any one of SEQ ID NOs: 3-14” as required in claim 1 other than an isolated nucleic acid sequence encoding a truncated USH2A protein, wherein the nucleic acid sequence consists of the nucleotide sequence of SEQ ID NO: 3,4,5,6,7,8,9,10,11,12,13, or 14.
Response to argument
Applicants argue the amendment overcomes the rejections. Applicants’ argument is not persuasive for reasons set forth above.
Enablement
Claims 1-4, 13-16, 18, 21, 22, 33 remain 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 administering an AAV vector encoding USH2A to the eye of a mammal that has Usher Syndrome such that symptoms of Usher Syndrome are ameliorated, does not reasonably provide enablement for the claims as broadly written. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
Withdrawn rejection
The rejection regarding delivering the rAAV to cells of mammals with Usher syndrome to administering the rAAV to a cell from any plant, invertebrate, insect, fish, amphibian, reptile, bird or mammal in vivo or vitro with or without Usher syndrome as broadly encompassed by claim 23 has been withdrawn because the claim has been canceled.
Pending rejection
The specification does not enable any “isolated nucleic acid consisting of the nucleotide sequence [of] any one of SEQ ID NOs: 3-14” as required in claim 1 other than an isolated nucleic acid sequence encoding a truncated USH2A protein, wherein the nucleic acid sequence consists of the nucleotide sequence of SEQ ID NO: 3,4,5,6,7,8,9,10,11,12,13, or 14. While an isolated nucleic acid sequence may consist of the nucleotide sequence of SEQ ID NO: 3,4,5,6,7,8,9,10,11,12,13, or 14, the specification does not contemplate making/using a nucleic acid consisting of the nucleotide sequence of any one of SEQ ID NOs: 3-14 as required in claim 1. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to make/use any “isolated nucleic acid consisting of the nucleotide sequence [of] any one of SEQ ID NOs: 3-14” as required in claim 1 other than an isolated nucleic acid sequence encoding a truncated USH2A protein, wherein the nucleic acid sequence consists of the nucleotide sequence of SEQ ID NO: 3,4,5,6,7,8,9,10,11,12,13, or 14.
Response to argument
Applicants argue the amendment overcomes the rejections. Applicants’ argument is not persuasive for reasons set forth above.
Indefiniteness
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 2-4, 33 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.
Claims 2, 3 and 33 are indefinite because a nucleic acid consisting of the nucleotide sequence of any one of SEQ ID NO: 3-14 cannot consist of more. “Consisting of” is closed claim language. Therefore, the nucleic acid cannot further comprise a promoter as required in claim 2, 3 and 33.
Claim 4 is indefinite because a nucleic acid consisting of the nucleotide sequence of any one of SEQ ID NO: 3-14 cannot consist of more. “Consisting of” is closed claim language. Therefore, the nucleic acid cannot further comprise ITRs from AAV as required in claim 4.
Claims 13-16 and 18 have not been included because a vector, host cell, or AAV may comprise the nucleic acid of claim 1.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 13, 22 under 35 U.S.C. 102a1 as being anticipated by NM_007123 as supported by Baux (Human Mutation, 2007, Vol. 28, No. 8, pg 781-789) and Roux (J. Mod. Genet. 2006, Vol. 43, pg 763-768) has been withdrawn. While nucleotides 440-3439 of NM_007123 (6372 bp) are 100% identical to nucleotides 1-3000 of SEQ ID NO: 3 (3279 bp), NM_007123 did not teach nucleotides 3001-3279 of SEQ ID NO: 3. See alignment provided in the office action sent 9-12-25 which ends in nucleotide 3000 on pg 20 (SEQ ID NO: 3 is the “Query” vs NM_007123 which is the “Subjt”).
Claim Rejections - 35 USC § 103
Withdrawn rejections
The rejection of claims 1-4, 13-16, 18, 21, 22, 33 under 35 U.S.C. 103 as being unpatentable over Hildinger (20070042462) in view of NM_007123 and Baux (Human Mutation, 2007, Vol. 28, No. 8, pg 781-789) has been withdrawn. Hildinger taught an adeno-associated viral (AAV) vector encoding Usherin-2A (USH2A) (para 7, 71, 75, 214). Hildinger did not teach the vector comprised a nucleic acid consisting of the nucleotide sequence of SEQ ID NO: 3 as required in claim 1. While nucleotides 440-3439 of NM_007123 (6372 bp) are 100% identical to nucleotides 1-3000 of SEQ ID NO: 3 (3279 bp), NM_007123 did not teach nucleotides 3001-3279 of SEQ ID NO: 3. See alignment provided in the office action sent 9-12-25 which ends in nucleotide 3000 on pg 20 (SEQ ID NO: 3 is the “Query” vs NM_007123 which is the “Subjt”).
The rejection of claims 1, 13, 22 under 35 U.S.C. 103 as being unpatentable over NM_007123 in view of Luzzio (20210292316), Chung (210190337987) and supported by Baux (Human Mutation, 2007, Vol. 28, No. 8, pg 781-789) and Roux (J. Mod. Genet. 2006, Vol. 43, pg 763-768) has been withdrawn. While nucleotides 440-3439 of NM_007123 (6372 bp) are 100% identical to nucleotides 1-3000 of SEQ ID NO: 3 (3279 bp), NM_007123 did not teach nucleotides 3001-3279 of SEQ ID NO: 3. See alignment provided in the office action sent 9-12-25 which ends in nucleotide 3000 on pg 20 (SEQ ID NO: 3 is the “Query” vs NM_007123 which is the “Subjt”).
The rejection of claims 1-4, 13-16, 18, 21, 22, 33 under 35 U.S.C. 103 as being unpatentable over Hildinger (20070042462) in view of NM_007123, Luzzio (20210292316), Chung (210190337987) and Baux (Human Mutation, 2007, Vol. 28, No. 8, pg 781-789) has been withdrawn. Hildinger taught an adeno-associated viral (AAV) vector encoding Usherin-2A (USH2A) (para 7, 71, 75, 214). Hildinger did not teach the vector comprised a nucleic acid sequence encoding USH2A consisting of the nucleotide sequence of SEQ ID NO: 3 as possibly encompassed by claim 1. While nucleotides 440-3439 of NM_007123 (6372 bp) are 100% identical to nucleotides 1-3000 of SEQ ID NO: 3 (3279 bp), NM_007123 did not teach nucleotides 3001-3279 of SEQ ID NO: 3. See alignment provided in the office action sent 9-12-25 which ends in nucleotide 3000 on pg 20 (SEQ ID NO: 3 is the “Query” vs NM_007123 which is the “Subjt”).
New rejections
A) Claims 1, 13, 22 as newly amended are rejected under 35 U.S.C. 103 as being unpatentable over AZF41383 described by Nakanishi (JP 2011024467) in view of Luzzio (20210292316) and Chung (210190337987).
AZF41383 - a 15609 bp cDNA sequence encoding USH2A – was described in 2011 by Nakanishi. Nucleotides 12001-15609 of AZF4183 are 100% identical to the nucleic acid sequence of SEQ ID NO: 4.
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Nakanishi did not teach an isolated nucleic acid sequence encoding USH2A consisting of the nucleotide sequence of SEQ ID NO: 4 as encompassed by claim 1.
However, truncating coding sequences was well-within the purview of the skilled artisan at the time of filing (Luzzio - para 80; claims 140-143; Chung - para 18). Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to isolate cDNA encoding USH2A as described by AZF41383 and truncate it as was well-known in the art. Those of ordinary skill in the art at the time of filing would have been motivated to do so to determine where functional domains lie within the protein and the coding sequence.
Claims 13 has been included because Nakashiki implicitly taught a vector comprising the nucleic acid sequence of AZF41383 for sequencing using the Big Dye Terminator v3.1 Cycle Sequencing Kit (pg 14-15 of the translation).
Claim 22 has been included because the sequencing inherently MUST occur in a pharmaceutically acceptable excipient as indicated by successful sequence. The Big Dye Terminator v3.1 Cycle Sequencing Kit inherently MUST have used a pharmaceutically acceptable excipient capable of maintaining the structure of the nucleic acid sequence.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
B) Claims 1-4, 13-16, 18, 21, 22, 33 as newly amended are rejected under 35 U.S.C. 103 as being unpatentable over Hildinger (20070042462) in view of AZF41383 described by Nakanishi (JP 2011024467), Luzzio (20210292316) and Chung (210190337987).
Hildinger taught an adeno-associated viral (AAV) vector encoding Usherin-2A (USH2A) (para 7, 71, 75, 214).
Hildinger did not teach the vector comprised a nucleic acid sequence encoding USH2A consisting of the nucleotide sequence of SEQ ID NO: 4 as encompassed by claim 1.
However, AZF41383 - a 15609 bp cDNA sequence encoding USH2A – was described in 2011 by Nakanishi. Nucleotides 12001-15609 of AZF4183 are 100% identical to the nucleic acid sequence of SEQ ID NO: 4. See description and alignment above. While Nakanishi did not teach an isolated nucleic acid sequence encoding USH2A consisting of the nucleotide sequence of SEQ ID NO: 3 as encompassed by claim 1, truncating coding sequences was well-within the purview of the skilled artisan at the time of filing (Luzzio - para 80; claims 140-143; Chung - para 18). Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to isolate cDNA encoding USH2A as described by AZF41383 and truncate it as was well-known in the art. Those of ordinary skill in the art at the time of filing would have been motivated to do so to determine where functional domains lie within the protein and the coding sequence.
It would have been obvious to those of ordinary skill in the art at the time of filing to make a vector encoding USH2A as described Hildinger using AZF41383 described by Nakashiki. Those of ordinary skill in the art at the time of filing would have been motivated to replace the USH2A coding sequence of Hildinger with the nucleic acid sequence consisting of SEQ ID NO: 4 to investigate the role of the variant in disease.
Claim 2 has been included because Hildinger taught expressing USH2A in a vector under the control of a promoter (para 148), e.g. a tissue-specific or inducible promoters (para 151), e.g. muscle-specific, liver-specific, photoreceptor-specific (para 152).
Hildinger taught expressing USH2A in a vector under the control of a CMV promoter (para 148) which is a “constitutive promoter” as required in claim 3, a tissue-specific or inducible promoter (para 151) as set forth in claim 3, specifically a muscle-specific, liver-specific, photoreceptor-specific (para 152) which is a “tissue-specific” promoter as encompassed by claim 3, or a Dex-inducible promoter (para 154) as encompassed by “inducible promoter” in claim 3.
Hildinger taught the vector was AAV encoding USH2A flanked by ITRs (end of para 148) as required in claim 4.
Hildinger taught expressing USH2A in a vector (para 148) as required in claim 13.
Hildinger taught the vector was AAV (end of para 148) which is a viral vector as required in claim 14.
Hildinger taught the vector was AAV (end of para 148) as required in claim 15.
Hildinger taught expressing the protein in a cell (para 106, 148, 151, 154, 187, 189, 198, 275; claims 17-24) as required in claim 16.
Hildinger taught expressing the protein using AAV with a capsid (para 20, 22, 38, 65, 66, 86, 90, 94, 95, 98, 118, 119, 123, 132, 134, 140, 142, 143, 170, 171, 178, et al.) as required in claim 18.
Hildinger taught expressing the protein in the eye (para 40, 220, 269) and using AAV8 (para 134, 142, 170, 185, 251, 252, 253) which is equivalent to formulation for delivery to the eye as required in claim 21.
Hildinger taught formulating the vector in a pharmaceutically acceptable excipient (para 204, 205, 233, 267, 272, 281, 300) as required in claim 22.
Hildinger taught expression is under the control of a rhodopsin kinase promoter for “photoreceptor-directed promoters” (para which is “to the eye of a subject” as required in claim 33.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
C) Claims 1, 13, 22 as newly amended are rejected under 35 U.S.C. 103 as being unpatentable over NM_206933 described by Fu (Mol Med Rep, 2018, Vol. 18, No. 6, pg 5016-5022) in view of Luzzio (20210292316) and Chung (210190337987).
NM_206933 - a 18938 bp mRNA sequence encoding USH2A – was described in 2018 by Fu.
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Nucleotides 12440-16048 of NM_206933 are 100% identical to the nucleic acid sequence of SEQ ID NO: 4.
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Fu did not teach an isolated nucleic acid sequence encoding USH2A consisting of the nucleotide sequence of SEQ ID NO: 4 as encompassed by claim 1.
However, truncating coding sequences was well-within the purview of the skilled artisan at the time of filing (Luzzio - para 80; claims 140-143; Chung - para 18). Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to isolate a nucleic acid encoding USH2A as described by NM_206933 and truncate it as was well-known in the art. Those of ordinary skill in the art at the time of filing would have been motivated to do so to determine where functional domains lie within the protein and the coding sequence.
Claims 13 has been included because Fu implicitly taught a vector comprising the nucleic acid sequence of NM_206933 for sequencing using Sanger Sequencing (pg 5017, col. 2).
Claim 22 has been included because the sequencing inherently MUST occur in a pharmaceutically acceptable excipient as indicated by successful sequence. The Big Dye Terminator v3.1 Cycle Sequencing Kit inherently MUST have used a pharmaceutically acceptable excipient capable of maintaining the structure of the nucleic acid sequence.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
D) Claims 1-4, 13-16, 18, 21, 22, 33 as newly amended are rejected under 35 U.S.C. 103 as being unpatentable over Hildinger (20070042462) in view of NM_206933 described by Fu (Mol Med Rep, 2018, Vol. 18, No. 6, pg 5016-5022), Luzzio (20210292316) and Chung (210190337987).
Hildinger taught an adeno-associated viral (AAV) vector encoding Usherin-2A (USH2A) (para 7, 71, 75, 214).
Hildinger did not teach the vector comprised a nucleic acid sequence encoding USH2A consisting of the nucleotide sequence of SEQ ID NO: 4 as encompassed by claim 1.
However, NM_206933 - a 18938 bp mRNA sequence encoding USH2A – was described in 2018 by Fu. Nucleotides 12440-16048 of NM_206933 are 100% identical to the nucleic acid sequence of SEQ ID NO: 4. See description and alignment above. While Fu did not teach an isolated nucleic acid sequence encoding USH2A consisting of the nucleotide sequence of SEQ ID NO: 3 as encompassed by claim 1, truncating coding sequences was well-within the purview of the skilled artisan at the time of filing (Luzzio - para 80; claims 140-143; Chung - para 18). Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to isolate cDNA encoding USH2A as described by NM_206933 and truncate it as was well-known in the art. Those of ordinary skill in the art at the time of filing would have been motivated to do so to determine where functional domains lie within the protein and the coding sequence.
It would have been obvious to those of ordinary skill in the art at the time of filing to make a vector encoding USH2A as described Hildinger using NM_206933 described by Fu. Those of ordinary skill in the art at the time of filing would have been motivated to replace the USH2A coding sequence of Hildinger with the nucleic acid sequence consisting of SEQ ID NO: 4 to investigate the role of the variant in disease.
Claim 2 has been included because Hildinger taught expressing USH2A in a vector under the control of a promoter (para 148), e.g. a tissue-specific or inducible promoters (para 151), e.g. muscle-specific, liver-specific, photoreceptor-specific (para 152).
Hildinger taught expressing USH2A in a vector under the control of a CMV promoter (para 148) which is a “constitutive promoter” as required in claim 3, a tissue-specific or inducible promoter (para 151) as set forth in claim 3, specifically a muscle-specific, liver-specific, photoreceptor-specific (para 152) which is a “tissue-specific” promoter as encompassed by claim 3, or a Dex-inducible promoter (para 154) as encompassed by “inducible promoter” in claim 3.
Hildinger taught the vector was AAV encoding USH2A flanked by ITRs (end of para 148) as required in claim 4.
Hildinger taught expressing USH2A in a vector (para 148) as required in claim 13.
Hildinger taught the vector was AAV (end of para 148) which is a viral vector as required in claim 14.
Hildinger taught the vector was AAV (end of para 148) as required in claim 15.
Hildinger taught expressing the protein in a cell (para 106, 148, 151, 154, 187, 189, 198, 275; claims 17-24) as required in claim 16.
Hildinger taught expressing the protein using AAV with a capsid (para 20, 22, 38, 65, 66, 86, 90, 94, 95, 98, 118, 119, 123, 132, 134, 140, 142, 143, 170, 171, 178, et al.) as required in claim 18.
Hildinger taught expressing the protein in the eye (para 40, 220, 269) and using AAV8 (para 134, 142, 170, 185, 251, 252, 253) which is equivalent to formulation for delivery to the eye as required in claim 21.
Hildinger taught formulating the vector in a pharmaceutically acceptable excipient (para 204, 205, 233, 267, 272, 281, 300) as required in claim 22.
Hildinger taught expression is under the control of a rhodopsin kinase promoter for “photoreceptor-directed promoters” (para which is “to the eye of a subject” as required in claim 33.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638
