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 .
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 53-68 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.
In claim 53 (and all that depend from 53) recites use of BLAST parameters to locate the positions of the mutations. The parameters can change and thus the positions of the mutants are unclear. It is suggested that reference is made to a specific SEQ ID#.
In claims 53 and 57, use percent identity to refer to AAV VP1 but no specific sequence to compare to. It is unclear as to what the metes and bounds of the percent identity are. It is suggested that reference be made to a specific SEQ ID#.
Claim 53 contains the trademark/trade name BLAST (marked ® (R in circle) on NLM webpage). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an alignment algorithm and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 53-68 is/are rejected under 35 U.S.C. 102(a2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Nakai et al. (20170067908).
For claims 53-54, Nakai et al. teach an AAV VP1 with mutation R471A (471-00009 in Table 1). Because no specific SEQ ID# was recited to determine 95% as noted above, the AAV2 VP1 meets the limitation. For claim 56, the mutants are in AAV2 VP1 (Table 1). For claim 57, no specific SEQ ID# was recited to determine 96% as noted above, the AAV2 VP1 meets the limitation. For claim 58, the mutations are made into infectious viral particles (Fig 1D). For claim 59, the mutation 471A inherently mees the limitation of higher transduction relative to control. For claim 61, the intended target is humans (para 29). For claim 62, administration can be systemic (para 5). For claim 63, the mutation 471A inherently mees the limitation lower liver toxicity relative to control. For claim 64, the AAV is used in pharmaceuticals (para 4). For claims 65-68, nucleic acid, vectors encoding the mutation are used to make infectious particles (Figure 1D) of the modified VP1.
For claims 55 and 60, Nakai et al. teach AAV VP1 471s mutation (clone# 471-16000 Table 1).
Thus, Nakai et al. anticipate the claimed invention.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671