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 .
Priority
This application is a CON of 16/487,587 (filed on 8/21/2019 PAT 11,739,333), which is national stage entry under 35 U.S.C. 371 of PCT/US2018/020795 (filed on 03/02/2018), which claims benefit of U.S. provisional 62/466,138 (filed on 03/02/2017).
Election/Restrictions
Applicant’s election without traverse of Group I in reply filed on 02/17/2026 is acknowledged. Claims 28-43 read on elected group.
Claim Status
Claims 28-63 are pending.
Claims 44-63 are withdrawn per election per election without traverse.
Claims 28-43 have been examined on the merits.
Claim Objections
Claims 28 and 37 are objected to because of the following informalities:
Claims 28 and 37 have a grammatical error. The article ‘a’ needs to be added between the terms ‘comprising’ and ‘sequence’. The claims should read “comprising a sequence…”.
Appropriate correction is required.
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.
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Claims 28-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 22-24 of U.S. Patent No. 11,739,333 B2 and evidenced by Barciszewska et al (Molecular bioSystems, 2016).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Regarding claim 28, the reference patent claim 1 recites a polynucleotide cassette for the regulation of the expression of a target gene the cassette encoding an RNase P substrate sequence linked to a riboswitch, this reads on a polynucleotide cassette sequence.
The RNase P substrate sequence comprises a sequence encoding a tRNA, with a leader sequence and an acceptor stem, this reads on (b) an RNase P substrate sequence comprising (i) a leader sequence, (ii/iv) an acceptor stem, (iii) a D stem loop, an anticodon, and a T stem loop. A tRNA inherently has a D stem loop, an anticodon, and a T stem loop, therefore the structure disclosed in the patent anticipates the instant claim; evidence by Barciszewska et al Figure 1 shows the 5’ and 3’ of the acceptor stem, T stem loop, D stem loop, and anticodon (See, p13 col 1-2; Figure 1).
The riboswitch is recombinant and comprises an effector region linked to an aptamer sequence, this reads on (a) a recombinant riboswitch comprising, effector stems and an aptamer. Reference patent teaches that the riboswitch comprises an effector region, the effector region is the same as an effector stem.
Reference patent claim 3 recites, the polynucleotide cassette of claim 1, such that the aptamer sequence is located 5’ to the RNase P substrate sequence, this reads on the sequence encoding the riboswitch is 5’ of the sequence encoding the RNase P substrate sequence. Since the aptamer sequence is a part of the riboswitch sequence, the aptamer sequence includes the riboswitch.
Reference claim 3 continues with the effector region comprises sequence complementary to the leader sequence of the RNase P substrate, this reads on wherein the 3’ stem arm of the effector stem comprises some or all of the leader sequence and wherein the 5’ stem arm of the effector stem comprises sequence complementary to the 3’ stem arm of the effector stem. While the reference does not specify on the 5’ or 3’ arm of the effector region, there are a finite number of known effector regions (5’ or 3’) in this polynucleotide sequence. Therefore, a person having ordinary skill in the art could have pursued the known ways with a reasonable expectation of success (See, MPEP 2143 (I)(E)).
Regarding claim 29, reference patent claim 1 recites, the aptamer can specifically bind a small molecule ligand, this reads on wherein the aptamer specifically binds a small ligand.
Regarding claim 30, reference patent claim 1 recites, the RNase substrate sequence comprises a sequence encoding tRNA, mascRNA, MEN beta tRNA-like structure, or a viral tRNA-like structure, this reads on wherein the RNase substrate sequence comprises a sequence encoding a tRNA,….
Regarding claim 31, reference patent claim 2 recites, wherein the stem comprising the RNase P substrate sequence and the portion of the effector region complementary thereto comprises 6 to 12 base pairs, this reads on wherein the effector stem is 6 to 12 base pairs.
Regarding claim 32, reference patent claim 4 recites, wherein the acceptor stem of the RNase P substrate and the riboswitch effector region are separated by 0,1,2,3 or 4 nucleotides, this reads on wherein the 3’ stem arm of the effector stem and the 5’ stem arm of the acceptor stem are separated by….
Regarding claim 33, reference patent claim 5 recites, wherein the effector region additionally comprises sequence complementary to the 5’ arm of the acceptor stem of the RNase P substrate sequence, this reads on wherein the 3’ stem arm of the effector stem additionally comprises some or all of the 5’ stem arm of the acceptor stem.
Regarding claim 34 and 41, reference patent claim 21 recites, a vector comprising a target gene that contains a polynucleotide cassette according to claim 1, this reads on a vector comprising a target gene that contains a polynucleotide cassette according to claim 28.
Regarding claim 35 and 42, reference patent claim 22 recites, the vector of claim 21, wherein the vector is a viral vector, this reads on vector of claim 24, wherein the vector is a viral vector.
Regarding claim 36 and 43, reference patent claim 24 recites, wherein the viral vector is selected from group consisting adenoviral vector,…, and this reads on wherein the viral vector is selected from the group consisting of adenoviral vector,….
Regarding claim 37, the recitation of reference patent claim 1 is above and that reads on the claim elements (a) and (b).
Reference patent claim 6 recites, wherein the aptamer sequence is located 3’ to the RNase P substrate sequence, this reads on wherein the sequence encoding the RNase P substrate sequence is 5’ of the sequence encoding the riboswitch.
Reference claim 6 also recites, and the effector region comprises sequence complementary to the 3’ arm of the acceptor stem of the RNase P substrate sequence, this reads on wherein the 5’ stem arm of the effector stem comprises some or all of the 3’ stem arm of the acceptor stem, and wherein the 3’ stem arm of the effector stem comprises sequence complimentary to the 5’ stem arm of the effector stem. While the reference does not specify on the 5’ or 3’ arm of the effector region, there are a finite number of known effector regions (5’ or 3’) in this polynucleotide sequence. Therefore, a person having ordinary skill in the art could have pursued the known ways with a reasonable expectation of success (See, MPEP 2143 (I)(E)).
Regarding claim 38, reference patent claim 1 recites, that the aptamer binds a small ligand, this reads on wherein the aptamer binds a small molecule ligand.
Regarding claim 39, reference claim 1 recites, that the RNase P substrate sequence encodes a tRNA, mascRNA,…., this reads on wherein the RNase P substrate sequence comprises a sequence encoding a tRNA,….
Regarding claim 40, reference patent claim 7 recites, wherein the effector region sequence complementary to the 3’ arm of the acceptor of the RNase P substrate is 1 to 7 nucleotides. The reference claim recites 1 to 7 nucleotides and the instant claim requires 3 to 6 nucleotides, not disclosed by the claims of reference patent.
However, it would have been routinely optimized by one having ordinary skill in the art based on the polynucleotide cassette. Reference patent claim 7 provides necessary elements required to create a polynucleotide cassette, it would have been readily determinable by one having ordinary skill in the art by routine experimentation to find the optimal number of nucleotides for the 5’ stem arm of the effector stem. Wherein the general conditions of a claim are disclosed in the reference patent, it is not inventive to discover the optimum or workable ranges by routine experimentation (See, MPEP 2144.05).
Therefore claims 28-43 are anticipated by US Patent 11,739,333 B2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Caroline M Lara whose telephone number is (571)272-4262. The examiner can normally be reached 7:00 to 4:30pm M-Th.
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/CAROLINE M LARA/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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