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 .
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 taught 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) 7 and 19-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kahvejian (WO 2018/232017 A1) in view of Mushahwar (Molecular and biophysical characterization of TT virus: Evidence for a new virus family infecting humans, 1999) and Mankotia (Cloning and expression of N22 region of Torque Teno virus (TTV) genome and use of peptide in developing immunoassay for TTV antibodies, 2014) as evidenced by Butkovic et al. (Evolution of anelloviruses from a circovirus-like ancestor through gradual augmentation of the jelly-roll capsid protein, 2023)
Regarding claim 7: Kahvejian teaches an embodiment of the invention in which the synthetic curon binds to an arginine-rich region of the proteinaceous exterior. (Pg 14, claim 45) In addition to this, Kahvejian teaches that the curon may match 100% to an Anellovirus ORF1 protein. (Pg 46, ln 17-19) Taken together, this reads on claim 7 of a composition comprising an isolated Anellovirus ORF1 molecule comprising an arginine-rich region that does not substantially comprise a genetic element.
Kahvejian teaches synthetic curons which can be used as delivery vehicles for delivering a therapeutic agent to a cell which may comprise a payload such as a nucleic acid effector. (Pg 1, ln 19-24) Kahvejian further teaches an embodiment in which the nucleic acid molecule may share between 70-100% sequence to an Anellovirus ORF1 protein. (Pg 46, ln 17-19) In addition to this, Kahvejian teaches that the synthetic curon is defined as having at least one structural difference when compared to a wild-type virus. (Pg 1, ln 32-33) Therefore, Kahvejian reads on synthetic Anellovirus ORF1 protein comprising at least one difference relative to a wild-type Anellovirus ORF1 protein, as taught by claim 18. Kahvejian fails to teach that the construct comprises a jelly-roll domain.
Mushahwar teaches an isolated Anellovirus ORF1 molecule that was derived from the serum of a patient and isolated. (Pg 3177, Abstract) As evidenced by Butkovic, Anelloviruses inherently comprise a jelly-roll domain as part of the structure of the ORF1 region of the plasmid, therefore making it inherent that the isolated Anellovirus ORF1 molecule as taught by Mushahwar also comprises a jelly-roll domain in the ORF1 region.
Regarding claim 19: Kahvejian teaches that the synthetic curon of the invention must have at least one structural difference when compared to a wild-type virus such as a deletion, insertion, or substitution (Pg 1, ln 32-33) and that the synthetic curon may share 70-100% sequence to an Anellovirus ORF1 protein. (Pg 46, ln 17-19) Taken together, this reads on the limitations of claim 19 of the composition comprising a mutation or chemical modification relative to a wild-type Anellovirus ORF1 protein.
Regarding claims 20 and 21: Kahvejian teaches that the curon of the claimed invention may comprise a deletion. (Pg 1, ln 32-33)
Regarding claim 22: Kahvejian fails to explicitly state use of an HVR, N22, or CTD region. Mankotia et al. teaches that the N22 region may be safely used as an antigen for blot assay in the detection of anti-TTV antibodies in sera (Pg 1, Abstract) and demonstrated that use of the N22 region as a detection tool provided better rates of detection when compared to detection via PCR, indicating use of N22 as a superior method of detecting TTV infection. (Pg 7, Discussion)
Regarding claim 23: Kahvejian teaches that the genetic element of the curon may be the full length of the genome of a wild-type Anellovirus sequence, or optionally less than the full length. (66) Furthermore, Kahvejian teaches the full sequence of the curon as being an exemplary example of the invention. (Pg 235, Table 16-2)
Regarding claim 24: Kahvejian teaches Anellovirus amino acid sequences sourced from the Anellovirus Alphatorquevirus in Table 6 and further specifies that the taught sequences are exemplary embodiments of the invention (pg 71, Table 6), and SEQ ID NO. 22 fully reads on the claimed SEQ ID NO. 185 as shown in the alignment chart below:
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Regarding claim 25: Kahvejian teaches exemplary Anellovirus amino acid sequences sourced from the Anellovirus Betatorquevirus in Table 12 (pg 81) and SEQ ID NO. 45 fully matches the claimed SEQ ID NO. 215 as shown in the alignment chart below:
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It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kahvejian with the teachings of Mushahwar, Mankotia, and Butkovic (as evidenced) to create a composition comprising an isolated Anellovirus ORF1 molecule. One skilled in the art would have had motivation due to the teachings of Mankotia who states that use of the N22 region as a detection tool provided better rates of detection when compared to detection via PCR and Butkovic and Mushahwar who prove inherency of the ORF1 molecule comprising a jelly-roll domain in the ORF1 region.
Response to Arguments
Applicant has successfully overcome the previous 35 U.S.C. 101 and35 U.S.C. 112(a) rejections on the record by the cancellation of claims 37 and 17 and by amending claim 7 to incorporate the teachings of claims 17 and 18, making it substantially more than a product of nature.
Applicant's arguments filed 04/02/2026 have been fully considered but they are not persuasive. Applicant has combined former claims 17 and 18 into the teachings of amended claim 7, simultaneously overcoming both previous 35 U.S.C. 102(a)(1) rejections by virtue of incorporating teachings from each respective 102 rejection into the same base claim. While this does overcome the current 102 rejections on the record, newly amended claim 7 as necessitated by amendment has been rejected under the now combined teachings of Kahvejian, Mushahwar, Butkovic, and new source Mankotia.
As such, the 35 U.S.C. 103 rejections of independent claim 7 and dependent claims 19-25 are upheld.
Allowable Subject Matter
Claim 12 is allowed. There is no existing prior art which links, in order, a first transposase recognition sequence, an Anellovirus genetic element region comprising a promoter operable linked to a sequence encoding an exogenous effector, and a second transposase recognition sequence.
Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. There is no sequence in the prior art matching the claimed SEQ ID NO. 925 by at least 80%, thereby making SEQ ID NO. 925 free of the prior art.
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 extension fee 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 HANNA M THUESON whose telephone number is (571) 272-3680. The examiner can normally be reached M-F 7:30-5 EST. 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.
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/HANNA MARIE THUESON/ Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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