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 to restriction requirement and amendment of 11/24/25 are entered.
Claims 1, 5, and 20 are amended.
Claims 30-35 are newly added.
Claims 11, 12-16, 21, 25, and 29 are canceled.
Claims 1-8, 10, 18-20, and 30-35 are presently pending.
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 canceled all claims to non-elected inventions.
Claims 1-8, 10, 18-20, and 30-35 are presently considered.
Drawings
Figures 1-5, 13-17A, 21-23, 25-27C, 27F, 27I, 28-32, 34, 36, 37-40, 42C-43, 45A-45B, 46, and 49 contain characters less than 1/8th an inch in height (37 CFR 1.84(p)(3) and/or the characters or lines in the figures are not clean (37 CFR 1.84(l)).
The drawings are objected to for the reasoning above. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 2 limits claim 1 to the method “compris[ing] administering to the subject the first plurality of anellovectors”. However, Claim 1 requires the human subject “has been previously administered a first plurality of anellovectors”, and thus, this step is required to be present, albeit written in past-tense form. Either way, the scope is the same, i.e., in each case, the human is administered the first plurality of anellovectors. Thus despite a slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 30 be found allowable, claim 31 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 31 limits claim 1 to the method “compris[ing] administering to the subject the first plurality of anellovectors”. However, Claim 30 requires the human subject “has been previously administered a first plurality of anellovectors”, and thus, this step is required to be present, albeit written in past-tense form. Either way, the scope is the same, i.e., in each case, the human is administered the first plurality of anellovectors. Thus despite a slight difference in wording, these claims have substantially the same scope.
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 3-5, 18, and 33 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 3: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation 95%, and the claim also recites 96, 97, 98, or 99 percent which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 4: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “at least 1”, and the claim also recites “at least … 3, 4, or 4” weeks, which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “a third … plurality”, and the claim also recites “fourth, fifth, and/or further” plurality which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 18: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation at least 80%”, and the claim also recites “85%, 90%, 95%, 96%, 97%, 98%, 99% or 100%” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 33: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 33 recites the broad recitation “at least 1”, and the claim also recites “at least … 3, 4, or 4” weeks, which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-8, 10, 18-20, and 30-35 are 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 exogen 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 the 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.
Conclusion
No claim is allowed.
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