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 .
Claim Objections
Claim 1 is objected to because of the following informalities: the claims recite an AADC polynucleotide as imperative to the claimed invention but do not first identify the complete name of the acronym. Appropriate correction is required.
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.
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.
Claim(s) 1, 4, 9, 11, 23, 26, 28, 32, 35, 38, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yamada et al (Human Gene Therapy, 2005) in view of Bosch-Tubert et al (WO 12/007458), Hwu et al (U.S. 2012/0220648), and Palfi et al (U.S. 2012/0295960), all of record in the parent application 15/524,986.
Yamada et al teach an AAV vector genome for the treatment of Parkinson’s disease (dyskinesia), wherein the AAV vector was constructed from the commercially available (Stratagene) pAAV-MCS vector (pg 263, col. 2, Preparation of rAAV). Yamada et al do not provide the nucleotide sequence of the rAAV vector. Bosch-Tubert et al the (Stratagene) pAAV-MCS vector (pg 10, lines 9-11; pg 19, lines 19-22), as per Yamada et al, from which they inserted their transgene of interest, wherein the recombinant AAV vector comprises:
a) a 5' inverted terminal repeat (ITR),
b) a cytomegalovirus (CMV) sequence region comprising an enhancer region and promoter region,
c) an immediate early 1 (IEl) exon 1/intron1 sequence region (a 5’ UTR),
d) a human beta globin (HB) sequence region that is the human beta globin intron 2 and exon 3 sequences (a 3’ UTR),
e) a sequence region encoding the artisan’s gene of interest,
f) a poly(A) signal sequence region derived from the human growth hormone gene that is the hGH poly(A) signal sequence, and
g) a 3' ITR.
Yamada et al teach a pharmaceutical composition comprising the recombinant AAV virus (pg 263, col. 2, Injection of rAAV), as do Bosch-Tubert et al (claims 12-16).
Neither Yamada et al nor Bosch-Tubert et al teach the gene to treat Parkinson’s disease is an AADC sequence region, or a codon optimized AADC sequence.
Hwu et al teach an AAV vector genome for treatment of Parkinson’s/sleep disorders comprising, in order:
a) a 5' inverted terminal repeat (ITR),
b) a cytomegalovirus (CMV) promoter sequence region,
d) a human beta globin (HB) sequence region derived from a HB gene,
e) an AADC sequence region,
f) a poly(A) signal sequence region, and
g) a 3' ITR, wherein said 3' ITR (Figure 1) and ¶[0003].
Palfi et al teach a viral gene therapy vector, which may be AAV, comprising a codon-optimized AADC gene for the gene therapy of Parkinson’s/sleep improvement, abstract, ¶’s [0016, 82-84, 0102, 0103, 158, 0203, 0204].
Prior to the filing date of the instantly claimed invention, it would have been obvious to one of ordinary skill in the art to substitute a first therapeutic transgene, to wit, alpha synuclein (Yamada et al) with a second therapeutic transgene, to wit, codon optimized AADC (Hwu et al; Palfi et al) in a rAAV expression vector, to wit, the commercially available rAAV vector of Yamada et al and/or Bosch Tubert et al (pAAV-MCS) with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06. An artisan would be motivated to substitute an alpha synuclein transgene for an AADC transgene in an rAAV expression vector, to wit, the commercially available pAAV-MCS, because, prior to the filing date of the instantly claimed invention, those of ordinary skill in the art were previously aware of the scientific and technical concepts of expressing AADC from an rAAV expression vector (Hwu, Palfi et al), and the AADC amino acid sequence was previously known to be used for therapeutic expression vectors (Hwu and Palfi et al) for the treatment of Parkinson’s disease. Furthermore, prior to the filing date of the instantly claimed invention, those of ordinary skill in the art recognized and successfully reduced to practice the scientific design concepts of an rAAV expression vector comprising the artisan’s gene of interest operably linked to the instantly recited CMV enhancer/promoter region, the immediate early 1 exon 1/intron 1 region, the human beta globin intron 2/exon 3 region, the human growth hormone poly(A) signal region, and the 5’ and 3’ ITRs (Bosch-Tubert et al). Those of ordinary skill in the art immediately recognize that the commercially available pAAV-MCS is designed so that the artisan may clone their transgene of interest into the rAAV vector.
Further, an artisan would be motivated to substitute a first AADC-encoding nucleotide sequence for a second AADC-encoding nucleotide sequence that has been codon-optimized in an rAAV expression vector because, prior to the filing date of the instantly claimed invention, those of ordinary skill in the art were previously aware of the scientific and technical concepts of using codon optimization to improve the expression of the artisan’s gene of interest in the corresponding host cell species of interest, and Palfi et al disclosed that the codon-optimized expression vector yielded a greater therapeutic result as compared to the non-optimized vector ¶[0158].
It is proper to "take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741,82 USPQ2d 1385, 1396 (2007). See also Id. At 1742, 82 USPQ2d 1397 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton.").
The cited prior art meets the criteria set forth in both Graham and KSR, and the teachings of the cited prior art provide the requisite teachings and motivations with a clear, reasonable expectation of success. Thus, absent evidence to the contrary, the invention as a whole is prima facie obvious.
Claim Rejections - 35 USC § 112
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.
Claim 58 is 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.
Claim 58 recites the limitation "the pharmaceutical composition" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4, 9, 11, 19, 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11 of U.S. Patent No. 10,335,466. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘466 claims anticipate the instant generic claims. The AAV genome comprising SEQ ID NO: 17 (claim 1 of ‘466), which is also known as pHAADC-1K in Table 7; inherently comprises the recited AAV vector elements: such elements are listed in Table 4.
Claims 1, 4, 9, 11, 19, 21, 23, 26, 28, 32, 35, 38, 40, 44, 58, 60, 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 19, 20, 23-26 of U.S. Patent No. 11,027,000. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘000 claims anticipate the instant generic product claims, or anticipates or renders obvious the instant method claims. The AAV genome comprising SEQ ID NO: 17 (claim 1 of ‘000), which is also known as pHAADC-1K in Table 7; inherently comprises the recited AAV vector elements: such elements are listed in Table 4.
Claims 1, 4, 9, 11, 19, 21, 23, 26, 28, 32, 35, 38, 40, 44, 58, 60, 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 16,17, 20, 22-24 of U.S. Patent No. 11,975,056. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘056 claims anticipate the instant generic product claims, or anticipates or renders obvious the instant method claims. The AAV genome comprising SEQ ID NO: 17 (claim 1 of ‘056), which is also known as pHAADC-1K in Table 7; inherently comprises the recited AAV vector elements: such elements are listed in Table 4.
Conclusion
No claim is allowed.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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