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 response and amendment of 4/9/26 are entered.
Claims 1, 4-5, 30, and 33-34 are amended.
Claims 2-3, 10, 18, and 31-32 are canceled.
Claims 36-37 are newly added.
Claims 1, 4-8, 19-20, 30, and 33-37 are presently pending.
Claim Status – Canceled Claims
In light of the cancelation of Claims 2-3, 10, 18, and 31-32, all objections/rejections against the same, are withdrawn.
Election/Restrictions
Applicant’s election without traverse of invention group I, as in present claims 1-8, 10, 18-20, and 30-35 in the reply filed on 11/24/25 is acknowledged.
Applicant has previously canceled all claims to non-elected inventions and has not introduced new non-elected invention claims with the amendment of 4/9/26.
Claims 1, 4-8, 19-20, 30, and 33-37 are presently considered.
Drawings
In light of the amended drawings of 4/9/26, the objections to the same of record, are withdrawn.
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.
In light of the amendments to Claims 4-5 and 33 the rejections of record 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a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, are withdrawn.
Non-Statutory Double Patenting
It should be noted that several other applications were considered for NSDP purposes, but none provided the structure required in the viruses, and others were abandoned. In fact, the closest prior art was Application Publication 2020/00123203, which has common inventors and assignee, but it was abandoned and no further children were present in the continuity, so no NSDP rejections were deemed proper.
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 1, 4-8, 19-20, 30, and 33-37 remain 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 claims are generic for delivering a generic exogenous effector (Claim 1 and depending), or a generic sequence or a generic expression product (Claim 30 and depending), to a generic human (All claims). Claim 20 limits the generic exogenous effector (of Claim 1) to being a generic intracellular nucleic acid, or encoding a generic antibody, generic enzyme, generic hormone, generic cytokine, generic complement inhibitor, generic growth factor, generic growth factor inhibitor, or a generic variant of these, or encoding a generic peptide that, in mutated form, causes a generic human disease, or a generic functional variant thereof, or a generic regulatory nucleic acid (Claim 20). Claim 35 limits the generic sequence, or generic expression product to a generic nucleic acid, a generic intracellular nucleic acid, a generic nucleic acid encoding a generic antibody molecule, a generic enzyme, generic hormone, a generic cytokine, a generic complement inhibitor, a generic growth factor, a generic growth factor inhibitor a generic functional variant of any of these, or generic peptide that when mutated causes a generic human disease, or a generic functional variant of these.
Considering the claims are limited to human, the specification only provides one patentable utility, that of treating disease, which is generic for any form of improvement, stabilizing, palliative, preventative, and supportive treatments (e.g., p. 57, paragraph 3). Other than that, the use would be to see what happens, and such is not a patentable utility, much less a patentable described use.
The specification teaches the effectors at high level, being, e.g., therapeutic proteins, polypeptides, miRNA, siRNA, shRNA, mRNA, lncRNA, RNA, DNA, antisense RNA or gRNA (p. 69, et seq.). Exemplary regulatory nucleic acids, e.g., miRNAs, are provided in Table 40, Table 50 provides exemplary cytokines and cytokine receptors, Table 51 provides exemplary polypeptide hormones and hormone receptors, Table 52 provides exemplary growth factors, Table 53 teaches clotting-associated factors, Table 54 teaches exemplary enzymatic effectors and corresponding indicators, Table 55 teaches non-enyzme effectors and corresponding indications, Table 56 teaches exemplary regeneration, repair and fibrosis factors, Table 57 teaches exemplary transformation factors, Table 58 provides proteins that stimulate cellular regeneration, and throughout the specification there are many, many proteins, and often with diseases they appear to be useful for including gene editing (e.g., p. 176). From this we see an extremely large number of encoded sequences, as well as sequences themselves that affect their own effects.
The problem is that this is simply a laundry list of things that could be delivered, twice, to a patient, but fails to demonstrate a possession of the sole use, that of therapy, when limited to humans. In addition, there exist many issues with therapy. For example multifactorial disorders have multiple genes that need correction to treat the disease. One tissue that is suffers multifactor disorders is found coronary heart disease (e.g., Poulter (1999) “Coronary Heart Disease is a Multifactorial Disease”, American Journal of Hypertension, 12(1): part 2, 92S-95S, e.g., ABSTRACT and TITLE). It should be noted that delivery to heart tissue is taught by the specification (e.g., p. 210, last paragraph). Thus, even if the correct exogenous effector were chosen, the Artisan, recognizing that this, as well as many other disorders are multifactor, would not predict any form of therapy to occur. Another issue is many disorders with just one gene, are caused by a dominant negative mutations or gain of function mutants, or haploinsufficiency (e.g., Sottas, et al. (2016) “Negative-dominance phenomenon with genetic variants of the cardiac sodium channel Nav1.5”, Biochimica et Biophysica Acta, 1863(7, part B): 1791-98). It is noted that ion channels are taught for delivery (e.g., p. 207, paragraph 3). In these instances, providing a correct channel would not be understood to treat the disease associated, because it’s the dominant negative/gained-function that causes the disease. In essence, Applicant has provided many disorders and many diseases, but has failed to provide even one instance of a disease that has been treated, in any form, and the Art introduces many problems that makes the artisan recognize that there is no possession, for the breadth of generic disorders and generic effectors claimed.
Thus, given the extremely large number of effectors, diseases and disorders, and lack of linkage and showing of any therapies, combined with the issues identified in the Art, the Artisan would not have understood Applicant to have been in possession of the claimed invention.
Response to Argument – Description Requirement
Applicant’s argument of 4/9/26 have been considered but are not found persuasive.
Applicant argues that the claims have been amended to recite that the ORF1 molecule that is in the proteinaceous exterior of the anellovectors are the same, and that the Artisan, having read the specification, would understand that the specification describes embodiments of multiple dose administration, and thus the invention claimed is properly described (p. 10, paragraph 4).
Such is not persuasive. The amendment does not address the argument made. The Examiner noted that the claims are to delivering exogenous effectors, which may be sequences or expression products, to a human subject. Applicant has provided a laundry list of possible types of effectors, along with many tables of more specific examples, for the exogenous effectors, and the idea of delivery. However, simple delivery of these must be provided a patentable description of use. The only use that is patentable in humans, is therapy. The problem of such therapies is that diseases can be multifactorial or dominant negative, etc., as shown above, and Applicant has not shown each of these instances such that the Artisan would know which effector/sequence/protein to use in each case of such therapy. The use which applicant has proposed (i.e., less immunogenic after repeated administration) might be efficacious, i.e., it may not cause immune response, allowing multiple administrations, but Applicant is delivery a product to the cells, and the product must be described, for its patentable use. The Artisan would not understand Applicant to be in possession of such use, given the knowledge in the art.
Applicant avers the specification provides examples and guidance sufficient to demonstrate possession (Id.).
Such is not persuasive. The argument is conclusory.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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