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 .
Applicant’s reply dated 03/13/2026 has been received. Claims 6 and 12-17 are canceled.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 and 18-20 in the reply filed on 11/20/2025 is acknowledged.
Claims 12-17 are now canceled.
Claim Interpretation
Claim 1 is drawn to a compound for overexpression of a tRNA wherein the compound comprises a tRNA and a vector wherein the vector is coupled to the tRNA. The term “coupled” is not defined by the specification. The claim could be interpreted as a tRNA physically joined to a vector (a nucleic acid vector). This is not supported by the specification. Th claim does not recite what is encoded on the vector. Because the compound is for overexpression of a tRNA, it is presumed that the term “coupled to” is meant to mean that the vector encodes the tRNA.
Claim Rejections - 35 USC § 112
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 1-5,7-11 and 18-20 remain 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. THe rejection of claim 6 is rendered moot by its cancelation.
In claim 1, Applicant has replaced the term “coupled” with “incorporates” which clarifies that the tRNA isn’t merely attached to the vector but is part of the vector. This, however, remains unclear. The vector of claim 1 is limited to AAV in claim 4. AAV is a DNA vector and tRNA is an RNA. Thus, it remains unclear if applicant is intending for the claim to read on a tRNA comprising ribonucleic acid, within an DNA vector or if is intending to claim a DNA vector encoding a tRNA. Alternatively, the vector of claim 1 could be something other than DNA, such as a liposome.
Claims 2-5, 7-11 and 18-20 are unclear based on their dependency from claim 1.
The rejections specific to claims 5 and 6 are withdrawn and moot, respectively.
Claim 7 remains unclear how the compound of claim 1 can be either a viral gene delivering vector or a synthetic tRNA. Claim 1 is interpreted as a nucleic acid vector encoding a tRNA, which when transcribed, results in a tRNA. Thus, it is unclear how the compound of claim 1 can be both a viral vector and a synthetic tRNA. Also, the Specification does not define “synthetic”. The specification, at paragraph 6, discusses increasing cognate tRNA by administering synthetic tRNA. Thus, synthetic tRNA is considered that made in vitro using the viral vector as opposed to synthesized in a cell from genomic DNA. However, clarification is requested.
The rejection of claim 9 is withdrawn in light of the amendment to the claim.
Claim 10 remains unclear in wording. It does not definitively limit claim 1 in that it can be interpreted as “wherein when the compound is used in gene transfer…” and thus it can be interpreted as a limitation of an intended use. Claim 11 is unclear based on its dependency from claim 10. Because claims 10 and 11 depend from claim 1, it is unclear in that their recited limitations are with regard to viral particles while claim 1 fails to require any virus. Claims 10 and 11 are interpreted to be reciting limitations with regard to intended use.
Claim 18 remains unclear because the newly added term “incorporates” is unclear with regard to what structure is imposed on the composition by incorporating a promoter. The term “coupled” was removed from line 2 but remains in line 3. It remains unclear if it is Applicant’s intent to physically attach an RNA PolIII promoter (DNA) to a tRNA (RNA).
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.
The rejection of claim(s) 1-11 and 18-20 under 35 U.S.C. 102(a)(1) as being anticipated by Smith (Antiviral Research 32 (1996) 99-115) is withdrawn because Smith taught the tRNAmet, which has been deleted from the claims. Smith did not teach the remaining, recited tRNAs. Applicant’s remarks with regard to the design of RNA decoys and the purpose of the work of Smith are not persuasive. Applicant argues that Smith should be considered as an accidental document. This is not persuasive.
Claim(s) 1-5,7-11 and 18-20 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mefford (RNA, Vol. 21, No. 9, pages 1683-1689).
Given the teachings in the specification, claim 1 is being interpreted as being drawn to a vector encoding a tRNA wherein the tRNA is selected from tRNAAla, tRNAGly, tRNATyr, tRNAHis, and tRNATrp. The intended use is not given patentable weight.
Mefferd teaches an DNA vectors (plasmid or AAV; in vivo delivery vector, as claimed) encoding a tRNAGly (see Figure 3). Thus, Mefford meets the limitations of claim 1. Claims 2-3,19-20 limit the intended use, which is not given patentable weight. Thus, these claims fall with claim 1. Regarding claim 4, Mefford teaches use of the tRNA/PolIII system for its ability to drive gene expression while not taking up the limited storage space in AAV vectors that PolII and the larger U6 PolIII promoter require. Thus, Mefford teaches AAV vectors that incorporate tRNAGly as an RNAIII promoter (claim 5). With regard to claim 7, AAV is a viral vector. Claim 8 is also an intended use claim but it is held that the viral stock (page 03, para 1) can be administered via the routes listed in claim 8. Claim 9 recites that the compound is embedded in a carrier. Mefferd teaches calcium phosphate transfection, which embeds the DNA vector in phosphate. was used to facilitate transduction and thus the particles were partially embedded in polybrene. Claims 10 and 11 are interpreted as limitations to an intended use and do not actively or definitively limit the concentration of the compound.
With regard to claim 18, the promoter is within the sequence encoding the tRNA. Claims 19 and 20 limit the intended use and are not given patentable weight and, therefore, fall with claims 1-3.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3,5,8-9,18-20 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring NA and vector without significantly more. The claim(s) recite(s) a compound comprising a tRNA coupled to a vector (interpreted as a vector encoding a tRNA, see above) which does not differ from a tRNA encoded on a chromosome in nature. Claims 4,10 and 11 are not included in this rejection because, while unclear, it is implied that there is a viral vector as part of the compound. The rejection of claim 6 is rendered moot by its cancelation.
The Office published Office' s new guidance document entitled 2019 Revised Patent Subject Matter Eligibility Guidance, published January 7, 2019. Applicant is directed to the Federal Register, Volume 4, No. 4, pages 50-57 at page 74621.
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Step 1 of the USPTO’s eligibility analysis entails considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: Process, machine, manufacture, or composition of matter. The claims are directed to a composition of matter (step 1, yes).
Step 2A of the 2019 Revised Patent Subject Matter Eligibility Guidance is a two-prong inquiry. In Prong One, examiners evaluate whether the claim recites a judicial exception. The composition of matter (a vector encoding a tRNA) is directed to a natural phenomenon (Step 2A, prong 1, yes). In Prong Two, examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This judicial exception is not integrated into a practical application because the claims do not recite additional elements and merely recite intended uses or additional characteristics of a tRNA encoding gene in nature (polIII promoter, claim 5) (Step 2A, prong 2, No). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite additional elements. With no additional elements, there is no inventive concept (Step 2B, No).
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product’s naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘‘product of nature’’ exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception. It is concluded, here, that the claimed natural products are not markedly different from their natural counterparts as a result of an isolation process. Removal of a tRNA-encoding gene from the genome does not provide it with any markedly different characteristics.
Based on the guidance, The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. Limitations that may be enough to qualify as ‘‘significantly more' ' when recited in a claim with a judicial exception include: Improvements to another technology or technical field; improvements to the functioning of the computer itself; applying the judicial exception with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
In the instant case, the limitations of the claims do not impose limits on the claim scope such that they qualify as significantly more. Accordingly, as a whole, based upon an analysis with respect to the claim as a whole, claim(s) 1-3,5,6,8-9,18-20 do not recite something significantly different than a judicial exception. Thus, based upon this analysis, the claims are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
Applicant argues that claim 1 is amended to relate to a gene-delivering vector with a tRNA incorporated therein. This argument is not persuasive. Claim 1 does not recite “gene-delivery vector” and “gene-delivering vector” is not limited by the specification in a way that limits the structure to a chromosome comprising a gene encoding one of the recited tRNAs in nature.
Conclusion
Applicant's 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 VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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