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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 5, 7, 8 in the reply filed on 08/21/2026 is acknowledged.
Claims 1-4 and 9-69 are cancelled. New claims 70-75 are added.
Upon further consideration species election is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 7-8, 70-75 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.
Claims are broadly drawn to methods of modulating protein expression by administering tRNA effector molecule (TREM) comprising non-naturally occurring modification.
Claims encompass a wide genus of TREMs comprising a wide genus of non-naturally occurring modifications.
Instant specification does not provide a clear definition of what a TREM is. Specification teach some functional and structural characteristics of TREM in paragraphs [0023, 0097-0141], wherein only some of those are required to be present in a molecule to be defined as TREM. Thus, a genus of such TREMs is extremely wide and varied, but there is no specific function and structure correlation described.
Concerning non-naturally occurring modifications specification defines such modifications as the one that does not occur in cells or is present on a different structural feature than in natural cell, with such modifications listed in Tables 5-9 (see paragraph [0072]). Again, there is no specific description of where such modification and which specific modification has to be present to be different from natural cell. For example, 2’OMe modification is described herein as non-natural (see claim 72). Prior art by Satoh et al (RNA, 2000, 6: 680-686) teach that methylation of 2’-hydroxyl groups is one of the most common in naturally occurring tRNAs at the first position of anticodon of some specific tRNAs, but not at the second and third (see Abstract). Therefore, 2’-OMe modification is natural at the first position of anticodon, but it is not clearly defined if such modification is non-natural at any other positions than anticodon. Instant specification does not describe any specifics like that.
The genuses encompasse a large number of unknown structures and one of skilled in the art cannot reliably predict which member of the genuses is a TREM and non-natural modification, and which is not.
There is no description of the necessary and sufficient elements of the species encompassed by the breadth of the claims.
The only species described in specification are some specific TREMs without specifying what functions those are capable of carrying out or a variety of non-natural modifications without specifying what exactly makes them non-natural. Applicant fails to describe representative members of Applicant's broadly claimed genuses.
One of the skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genuses, and because the genuses are highly variant, lists of TREMs or non-natural modifications are not sufficient to describe the claimed genuses. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, it is not clear that Applicant was in possession of the claimed genuses at the time this application was filed.
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 8, 70 and 73 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.
Claim 8 recites the limitation "the first sequence" in the eleventh line. There is insufficient antecedent basis for this limitation in the claim.
Claim 70 recites Formula A, wherein specific components of the Formula are not defined anywhere in specification or claims, such as “ASt Domain1” or “Ast Domain2”. Therefore, meets and bounds of the claim are not defined. For the purpose of examination it is considered that Formula A describes general structure of natural tRNA, but appropriate correction is required.
Claim 73 recites nucleotide positions 73-76 of instant SEQ ID NO: 622, but the sequence is only 72 nucleotides long.
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)(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.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahern et al (WO 2019/090154, 9 May 2019).
Concerning claim 8 Ahern disclose methods of treating diseases associated with premature stop codon comprising administering modified tRNA to a patient in need thereof (see lines 20-25 on page 4). Ahern disclose acquiring status of premature stop codon in cystic fibrosis (see lines 3-7 on page 42) and further administration of modified tRNA capable of recognizing an aminoacyl-tRNA synthetase specific for Trp, with anticodon pairing with premature stop codon (see lines 20-30 on page 3), therefore treating the disease (see lines 19-22 on page 42).
Claim Rejections - 35 USC § 103
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) 5, 7-8, 70-72, 74-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahern et al, above, as applied to claim 8, and in further view of Satoh et al, above.
Teachings of Ahern are discussed above. Ahearn further teach introduction of modifications into tRNA to increase its stability or biological activity (see lines 4-7 on page 11). Such tRNA satisfies structural requirements of instant Formula A (see examples on Figures 2 and 3). Ahern teach treatment of Usher syndrome and Duchenne muscular dystrophy as diseases associated with premature termination codon (see lines 20-30 on page 48).
Ahern do not teach presence of 2’-OMe modifications in modified tRNAs.
Satoh teach that 2’-OMe modifications are present in many RNAs and they can stabilize RNA duplexes (see Abstract, first column on page 680).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to include 2’-OMe modifications in tRNAs taught by Ahern based on teachings of Satoh. One of the ordinary skill in the art would be motivated to do so because Ahern suggest introduction of stabilizing modifications into tRNAs and Satoh teach such stabilizing modification.
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 5, 7-8, 70-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 13, 18, 20-21, 27-28, 35-36, 41, 51-55, 57, 59-60, 62-63, 66, 68, 73-74 of copending Application No. 17/928,450. Claims from ‘450 recite methods comprising contacting subject cells with TREMs comprising 2’-OMe modifications leading to protein expression. One of such TREM is of SEQ ID NO: 622 (see paragraph [0118] of ‘450 specification), identical to instant SEQ ID NO: 622. Therefore, claims from ‘450 anticipate instant claims.
This is a provisional nonstatutory double patenting rejection.
Claims 5, 7-8, 70-72, 74-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-7, 9, 12-13, 15-23, 25 of copending Application No. 17/774,410 and in further view of Satoh, above. Claims from ‘410 recite methods comprising contacting subject cells with TREMs leading to protein expression. Such TREMs can target stop codons (see paragraph [0184] of ‘410 specification). Teachings of Satoh are discussed above. It would have been obvious to introduce modifications of Satoh into TREMs of ‘410, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection.
Claims 5, 7-8, 70-72, 74-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,121,531. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘531 recite methods comprising administration of TREMs of specific sequence comprising non-natural modifications to a subject having a premature termination codon disorder, anticipating instant claims.
Claims 5, 7-8, 70-72, 74-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,648,958. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘958 recite compositions comprising TREMs of specific sequence comprising non-natural modifications, which can be used in methods of treatment of a subject having a premature termination codon disorder.
Conclusion
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
