DETAILED ACTION
This Action is in response to the communication filed on 05/26/2026.
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 .
Status of the Claims
Claims 24-26, 32-36, 38, 44, 46, 48-52 are pending.
Claims 32-36, 38, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Claims 24-26, 44, 46, 48-52 are under consideration.
Claim Rejections - 35 USC § 102
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 24-26, 44, 46, 48-50, 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2005/001092 A2 (hereafter, “Be”).
Regarding claim 24, Be teaches an interfering nucleic acid molecule having a nucleotide sequence complementary to a target sequence within a gene encoding the CaV1.3 protein to reduce the expression of the CaV1.3 protein. For instance, see paragraph [0154] and Table 3 on page 29, wherein Table 3 explicitly teaches RNAi target sequences and double stranded siRNA sequences to the CACNA1D gene including SEQ ID NO: 2676 identified as CACNA1D siRNA antisense sequence which is 21 nucleotides fully (100%) complementary to nucleotides 1376-1396 of instant SEQ ID NO: 12 (see sequence alignment information below). It is noted that since the siRNA taught by Be has an antisense strand fully complementary to 21 contiguous nucleotides of instant SEQ ID NO: 12, it is necessarily complementary to a target sequence within a gene encoding the Cav1.3 protein encoded by the human CONCA1D gene of instant SEQ ID NO: 12. Be also teaches gene delivery vehicles for delivery of polynucleotides to cells for expression and explicitly teaches adeno-associated viral (AAV) vector (see [0228]), which would be a recombinant AAV (rAAV) vector encapsidating (comprising) an expression construct encoding an interfering nucleic acid molecule for delivery of the expression construct to a target cell. It is also noted that “for reducing expression of a calcium channel… in a cell in the substantia nigra and/or putamen of a primate…” is present in the preamble and only sets forth an intended use for the claimed system, specifically, for “reducing expression of a calcium channel in a cell in the substantia nigra and/or putamen of a primate.”
It is noted that MPEP 2111.02 (II) states:
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
Such is the case here, where the preamble merely states the purpose or intended use of the claimed system.
Regarding claim 25, Be teaches that the expression construct expresses an shRNA operable linked to a promoter (e.g., see [0144]).
Claim 26 is drawn to “The vector-mediated system of claim 24, wherein the vector provides continuous, high-potency, and target-selective mRNA-level silencing of striatal CaV1.3 channels.” It is noted that claim 26 only adds a “wherein” clause that only adds functional requirements and does not impart any specific further structural limitations. Therefore, since Be teaches a vector system which meets the structural requirements of claim 24, it must necessarily have the same functional characteristics as well, including providing continuous, high-potency, and target-selective mRNA-level silencing of striatal CaV1.3 channels, as required by claim 26.
Regarding claim 44, since Be teaches a vector system of claim 24, including a nucleic acid expression construct and rAAV vector, as indicated above, Be teaches a nucleic acid construct that meets the structural limitations of claim 44, including the intended use requirement “for reducing expression of a CaV1.3 protein in a target cell.”
Regarding claim 46, Be also teaches a kit comprising the vector system of claim 24 (e.g., see [0277]).
Regarding claim 48, the recitation “wherein the cell in the primate substantia nigra and/or putamen is a medium spiny neuron” only further limits part of the purpose/intended use of the claimed system
Similarly, regarding claims 49-50, the recitation “wherein the cell in the primate substantia nigra and/or putamen is a substantia nigra neuron” (claim 49) and “wherein the substantia nigra neuron is a substantia nigra dopamine neuron” (claim 50) only further limits part of the purpose/intended use of the claimed system.
Regarding claim 52, the recitation “wherein the system reduces CaV1.3…” also only further limits part of the purpose/intended use of the claimed system.
Therefore, Be anticipates the instant claims.
SEQUENCE ALIGNMENT INFORMATION
DE CACNA1D siRNA antisense sequence, SEQ ID 2676.
XX
KW Cytostatic; Gene therapy; Vaccine; RNA Interference; cancer; ss;
KW short interfering RNA; gene silencing.
XX
OS Synthetic.
XX
CC PN WO2005001092-A2.
XX
CC PD 06-JAN-2005.
XX
CC PF 19-MAY-2004; 2004WO-US015645.
XX
PR 20-MAY-2003; 2003US-0471729P.
XX
CC PA (AMHP ) WYETH.
XX
CC PI Be X, Wei L, Slonim DK, Howes SH;
CC PS Claim 3; SEQ ID NO 2676; 113pp; English.
XX
CC The pharmaceutical composition may also comprise a
CC polynucleotide capable of inhibiting or decreasing the expression of the
CC CRTP by RNA interference or an antisense mechanism. The CRTPs of the
CC invention are selected from ABCC4, C20orf103, CACNA1D, CDH6, CST, ENPP3,
CC FLJ11856, GPR54, HAVCR1, SLC6A3, SLC30A4, TRG, and TRPM4. The
CC pharmaceutical composition is useful for treating cancer, e.g. colon
CC cancer, lung cancer, breast cancer, prostate cancer, liver cancer, kidney
CC cancer, stomach cancer, and esophageal cancer. The present sequence is a
CC CRTP short interfering RNAs (siRNA) oligonucleotide.
Score over Length 100.0%;
Best Local Similarity 100.0%;
Matches 21; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1376 AAGGCAAACGAAATACTAGCA 1396
|||||||||||||||||||||
Db 21 AAGGCAAACGAAATACTAGCA 1
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 51 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/001092 A2 (hereafter, “Be”), as applied in the rejection above, in view of U.S. 20180021364 (hereinafter “Stewart”).
Regarding claim 51, Be teaches a vector-mediated system as in claim 24 for the reasons indicated in the rejection above, but does not teach that the rAAV vector comprises an AAV2 capsid.
However, Stewart teaches a viral vector which comprises AAV2 capsid proteins (e.g., see [0098]), and further teaches that the viral vector can be used to deliver/transfer a payload of interest to neuron in the Substantia Nigra (SN) region of the central nervous system (see [0089]), and teaches that the payload can be a RNAi nucleic acid expression inhibitor (e.g., see [0037).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, prior to the day the claimed invention was filed, to modify the vector system taught by Be and use a viral vector which comprises AAV2 capsid proteins, as taught by Stewart, with a reasonable expectation of success. It would have been a matter of substitution of a known vector system useful for the same purpose – thus providing sufficient motivation, and there would have been a reasonable expectation of success based on the teachings of Stewart which indicate that the vector could be used to deliver/express an RNAi nucleic acid inhibitor in neurons of the central nervous system.
Accordingly, the claim is not patentable over the cited prior art.
Response to Arguments
Applicants’ arguments filed 05/26/2026 have been fully considered but they are not persuasive. Applicant argues that the amendment to claim 24 requiring that the vector-mediated system now requires reducing expression “in a cell in the substantia nigra and/or putamen of a primate” and Be does not teach this limitation.
In response, as indicated in the rejection above, “in a cell in the substantia nigra and/or putamen of a primate” is present in the preamble and only sets forth an intended use for the claimed system, specifically, for “reducing expression of a calcium channel in a cell in the substantia nigra and/or putamen of a primate.” Since Be teaches a vector system which meets the structural limitations of the claims, Be anticipates the claimed vector system.
It is noted that new claims 48-50, 52 have been addressed in the 102 rejection and new claim 103 has been addressed in the 103 rejection above.
Accordingly, Applicant’s arguments are not persuasive.
Conclusion
Applicants’ 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.
Conclusion
Applicants’ 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 J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637
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