DETAILED ACTION
This Action is in response to the communication filed on 07/13/2026.
Claims 1-20 are pending.
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 I and the species (i), (a), and (ii.) as indicated in the reply filed on 07/13/2026 is acknowledged.
Claims 2, 5-6, 11, 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/13/2026.
Claims 1, 3-4, 7-10, 12-18 are under consideration as they read on the elected subject matter.
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.
Claim 18 is 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.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117.
To satisfy the written description requirement, MPEP §2163 states, in part “…a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.” Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between functional and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.”
Claim 18 is drawn to the linear RNA precursor of claim 1, wherein the catalytic intron comprises a heterologous sequence that tunes the catalytic activity of the catalytic intron.
The application provides explicit support for the recitation “wherein the catalytic intron comprises a heterologous sequence that tunes the catalytic activity of the catalytic intron”, but the specification does not disclose any specific heterologous sequence that tunes the catalytic activity of the catalytic intron (emphasis added), nor does the prior art appear to teach any heterologous sequence that can tune the catalytic activity of a catalytic intron.
“Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin, 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representatives, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The court and the Board have repeatedly held (Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,18 USPQ2d 1016 (CA FC, 1991); Fiers v. Revel, 25 USPQ2d 1601 (CA FC 1993); Fiddes v. Baird, 30 USPQ2d 1481 (BPAI 1993) and Regents of the Univ. Calif. v. Eli Lilly & Co., 43 USPQ2d 1398 (CA FC, 1997)) that an adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it, irrespective of the complexity or simplicity of the method; what is required is a description of the nucleic acid itself.
The specification provides no description or guidance that would indicate to one of skill in the art that applicant was in possession of a heterologous sequence that can be inserted into a catalytic intron and tune the catalytic activity of the catalytic intron, nor does there appear to be any evidence that such heterologous sequences which can tune catalytic activity of a catalytic intron was known in the prior art. Thus, one of skill in the art at the time of invention could not have concluded that Applicant was in possession of the claimed heterologous sequence required by claim 18.
Therefore, a rejection under 35 USC 112(a) is appropriate.
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.
(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.
Claims 1, 3-4, 9-10, 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200080106 (hereinafter “Anderson”).
Regarding claim 1, Anderson teaches a vector which encodes a linear RNA molecule (i.e., a linear RNA precursor) comprising, in order (i.e., from the 5’ end to the 3’ end): a catalytic intron, an exon fragment 2 (E2) (i.e., a 3’ exon sequence), a coding sequence (i.e., an effector RNA sequence), and an exon fragment 1 (E1) (i.e., a 5’ exon sequence), wherein the catalytic intron is capable of splicing the 3' exon sequence (E2) and the 5' exon sequence (E1) from the linear RNA precursor, thereby forming a circular RNA ("circRNA") comprising the effector RNA (e.g., see abstract; paragraphs [0034], [0049]. [0171], FIG. 1, Table 1, etc.).
Regarding claims 3-4, Anderson teaches that the catalytic intron is a catalytic Group 1 intron that can be a catalytic intron of the T4 phage Td gene or of the Cyanobacterium Anabaena sp. pre-tRNA-Leu gene. (e.g., see abstract, [0016], [0049], [0137], etc.). it is noted that the intron of the T4 phage Td gene and the Cyanobacterium Anabaena sp. pre-tRNA-Leu gene are well known catalytic Group I introns (official notice taken, if necessary).
Regarding claims 9-10, Anderson teaches that a heterologous sequence comprising an IRES, a GLuc message, two spacer sequences, two short regions corresponding to exon fragments is inserted into a 3’ intron segment or a 5’ intron segment of the permuted catalytic group I intron (e.g., see [0212], FIG. 7A, etc.).
Regarding claims 12-14, Anderson teaches that the effector sequence comprises a coding RNA sequence that encodes a therapeutic polypeptide that is a functional protein (e.g., see [0019], [0138], etc.).
Regarding claim 15, Anderson teaches that the RNA further comprises an IRES sequence (e.g., see [0009], [0028], [0034], etc.).
Regarding claims 16, Anderson teaches that the effector sequence comprises a noncoding RNA sequence that can be a miRNA or long noncoding RNA (e.g., see [0034], [0007]).
Therefore, Anderson anticipates the instant claims.
Claims 1, 3-4, 7-10, 12, 15, 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US20240093185A1 (hereinafter “Dai”).
Regarding claim 1, Dai teaches a linear RNA precursor (or a DNA encoding the linear RNA precursor) comprising, in order (i.e., from the 5’ end to the 3’ end): a catalytic intron, an exon fragment 2 (E2) (i.e., a 3’ exon sequence), a target fragment that encodes a peptide (i.e., an effector RNA sequence that is a gene of interest (GOI that can be a coding or noncoding RNA sequence), and an exon fragment 1 (E1) (i.e., a 5’ exon sequence), wherein the catalytic intron is capable of splicing the 3' exon sequence (E2) and the 5' exon sequence (E1) from the linear RNA precursor, thereby forming a circular RNA ("circRNA") comprising the effector RNA (e.g., see abstract, [0006], [0014]-[0016], FIG. 22, etc.).
Regarding claims 3-4, Dai teaches that the catalytic intron is a catalytic Group 1 intron that can be a catalytic intron of the T4 phage Td gene or of the pre-tRNA-Leu gene of the genus Anabaena. (e.g., see [0021], [0103], [0225], etc.). It is noted that the intron of the T4 phage Td gene and the Anabaena pre-tRNA-Leu gene are well known catalytic Group I introns (official notice taken, if necessary).
Regarding claims 7-8, Dai teaches that the 3' exon sequence or 5' exon sequence is no more than about 60 nucleotides long or no more than about 10 nucleotides long (e.g., see [0022], [0055], [0105], [0106], [0220], Table 1, FIG. 22, etc.).
Regarding claims 9-10. Dai teaches that a heterologous sequence is inserted into the linear precursor in a catalytic intron, including in a 3’ catalytic intron fragment or a 5’ catalytic intron fragment (e.g., see FIG. 22, [0225], etc.).
Regarding claim 12, Dai teaches that the effector sequence comprises a coding RNA sequence that encodes a polypeptide (e.g., see [0016], etc.).
Regarding claim 15, Dai teaches that the RNA further comprises an IRES sequence (e.g., see [0017], etc.).
Regarding claim 17, Dai teaches that the effector RNA (i.e., the sequence that comprises the GOI) can be in the range of about 50 to about 25000 nt long (e.g., see [0121] where it states that GOI can have the sequence of SEQ OD NO: 6 (221 nt) or SEQ ID NO: 7 (1118 nt), which are in the required range).
Claims 1, 3-4, 7-9-10, 12-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2023115732 (hereinafter “Wei”).
The applied reference has a common Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1, Wei teaches linear RNA precursor comprises from the 5'-end to the 3' end: a 3' catalytic Group I intron fragment, a 3' exon sequence, an effector RNA sequence, a 5' exon sequence,
Regarding claims 3-4, 7-8 Wei teaches that the catalytic intron is a catalytic Group 1 intron that can be a catalytic intron derived from the Anabaena Group[ I intron and comprise SEQ ID NO: 3 (which meets the broad limitation of less than ABOUT 60 nucleotides long) or SEQ ID NO: 4 (which meets the broad limitation of less than ABOUT 10 nucleotides long) (e.g., see [0068] etc.). It is noted that Anabaena catalytic group I intron is well known catalytic Group I introns (official notice taken, if necessary).
Regarding claims 9-10, Wei teaches FIG 1A which diagrams the linear RNA precursor where a heterologous sequence is inserted into the catalytic intron sequence in a 3’ catalytic intron fragment or a 5’ catalytic intron fragment (e.g., see FIG 1, [0022], etc.).
Regarding claims 12-15, Wei teaches that the effector sequence comprises a coding RNA sequence that encodes a therapeutic polypeptide that is a functional protein and further comprises an IRES (e.g., see [0018], etc.).
Regarding claim 16, Wei teaches that the effector sequence comprises a noncoding RNA sequence that is an siRNA, gRNA, dRNA miRNA or shRNA (e.g., see [0107], etc.).
Regarding claim 17, Wei teaches that the effector RNA can be in the range of about 50 to about 25000 nt long (e.g., see [0071], etc.).
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200080106 (hereinafter “Anderson”) in view of US20240093185A1 (hereinafter “Dai”).
It is noted that Anderson is described in the rejection above. It is noted that Anderson also explicitly teaches that the 3’ or 5’ exon sequence is “at least 1 nucleotide in length (e.g., at least 5 nucleotides in length, at least 10 nucleotides in length, at least 15 nucleotides in length, at least 20 nucleotides in length, at least 2Conclusion
5 nucleotides in length, at least 50 nucleotides in length).” (see [0125]).
Anderson does not explicitly teach that the 3' exon sequence or 5' exon sequence is no more than about 60 nucleotides long or no more than about 10 nucleotides long as required by claims 7-8.
However, Dai teaches that the 3' exon sequence or 5' exon sequence is no more than about 60 nucleotides long or no more than about 10 nucleotides long (e.g., see [0022], [0055], [0105], [0106], [0220], Table 1, FIG. 22, etc.).
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 3’ and 5’ exon fragments taught by Anderson so that they were no more than about 60 nucleotides long or no more than about 10 nucleotides long, as taught by Dai, with a reasonable expectation of success. Since Anderson provides explicit teaching of “at least 1 nucleotide in length (e.g., at least 5 nucleotides in length…)” this provides a reasonable basis for making the exon sequences no more than 10 nucleotides in length, as is explicitly taught by Dai. Furthermore, the functional linear precursors taught by Dai also provide a reasonable expectation of success.
Therefore, the instant claims are unpatentable for being prima facie obvious in view of Anderson and Dai.
Conclusion
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).
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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
Prosecution Insights