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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17€, was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17€ has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 5/8/2026 has been entered.
Withdrawn Rejections
The rejection of claims 1, 2, 4-13, 20-21, and 24-26, 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. The amended claims no longer recite the genuses that was the subjection of the written description rejection.
Claim 1, 2, and 4, rejected on the basis that they contain an improper Markush grouping of alternatives, is withdrawn. The amendments or arguments overcome the rejection.
The rejection of claims 1-2, 4-13, 20-21, 24-26, under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, is withdrawn. Applicant amendments and arguments overcome the rejection.
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 1-2, 4-9, 12-13, 20-21, 24-26, and 50-56 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.
Claims 1 and 26 recites, “a viral envelop protein comprising amino acid mutation at lysine position 47 (K47) and/or arginine position 354 (R354), said position with reference to SEQ ID NO:13”. This recitation is indefinite because the intend scope of this recitation is not apparent. The amino acid mutations are defined inferences to position in SEQ ID NO:13. However, the claim does not actually recite that the viral envelop protein actual comprise SEQ ID NO:13. As such, it is not apparent if the envelop protein is required to have the sequence of SEQ ID NO:13 or mutations at analogous position in a viral envelop protein. Claims 1 and 26 further recite “wherein the amino acid mutations diminish the native viral tropism of the VSV-G envelop protein compared to the non-mutated VSV-G envelop protein.” This recitation is indefinite because the claims more broadly recite, “a viral envelop protein” and later refers to a species of viral envelop protein, VSV-G. As discussed above, it is not apparent if SEQ ID NO:13 the sequence of the viral envelop protein or not and the further broad and then narrower limitations the viral envelop protein following by VSV-G renders it further indefinite because it is not apparent if the viral envelop protein is intended to be limited VSV-G or not.
Claim 1 also recites, “wherein a non-viral membrane-bound protein comprises an extracellular targeting domain that binds to a protein of the surface of the HSC”. This recitation is indefinite because it is not apparent how it relates to the method of the claim, is an actual non-viral membrane-bound protein required to be provided with the lentivirus or not?
The remainder of the claims depend upon claim 1 or 26. As such, the dependent claims are also indefinite for the reasons discussed above.
Claim 12 recites, “wherein the VSV-G envelop protein comprises a mutation selected from the group consisting of H8, I41, K47, Y209, and R354”. As discussed above it is not apparent if the mutated VSV-G envelop protein is required by the claims. If it is required by the base claim, the VSV-G protein is already recited to have mutations at K47 and R354. However, claim 12 recites that these two mutations are options that can be selected. As such, it is not apparent if they are required as the base claim may suggest or not.
Claim 13 recites, “The method of claim 11”. However, claim 11 is canceled. As such it is not apparent from which claim 13 depends.
Claim 20 recites, “the membrane bound domain” and refers to claim 1. However, claim 1 does not have any explicit or implicit reference to a membrane bound domain. As such, the recitation lacks sufficient antecedent basis and further it is not apparent to what it refers.
Claim Objections
Claim 51 is objected to because of the following informalities: The claim recites “domain is or thrombopoietin”. This recitation is believed to contain a typographical error. Removing “or” would be remedial. Appropriate correction is required.
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 52-56 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.
All of the claims recite, “an amino acid sequence of SEQ ID NO:” 55-59. “An amino acid sequence” includes fragments comprises at least two contiguous amino acid residues of the listed SEQ ID NOS. “An amino acid sequence” also broadly includes sequences of any length comprising the SEQ ID NOS or fragments thereof and deletions, substitution, or insertions of any number of residues. As such, the breadth of “an amino acid sequence of SEQ ID NO:” is vastly broad including a heterogenous group of protein and polypeptides sequences have divergent structure and function.
The specification how solely provide specific description of the full length sequences of SEQ ID NO:55-59. Further, the specification provides not further description of any of the possible fragments or variants species that would be members of these vastly broad genuses. As such, the specification does not provide sufficient number of species examples to be considered a representative number of species examples that describe the complete structure of the genus. Further, while means of making fragments and variant are known in the prior art, the imparted functional changes that result from such changes are unpredictable. As such, since the specification only provide full length sequences for the listed SEQ ID NOS and the art does not sufficiently supplement the lack of description by the specification and further describes unpredictability, one or ordinary skill would not be able to envision the complete structure of the claimed genus by the few examples provided and would conclude the application was not in possession of the full genuses at the time of effective filing.
No claims are allow.
Below are the proposed amendments offered to Applicant that were not accepted.
Proposed Examiner Amendment
Claim 1. A method of delivering one or more nucleic acids to a hematopoietic stem cell (HSC), the method comprising:
a) providing a lentivirus comprising the one or more nucleic acids and a mutated vesicular stomatitis virus (VSV)-G envelope protein comprising
(i) the amino acid sequence set forth in SEQ ID NO: 13, wherein the amino acid sequence comprises an amino acid substitution at position 47 (K47) and/or position 354 (R354), wherein the amino acid substitution(s) diminish the native viral tropism of the VSV-G envelope protein compared to the non-mutated VSV-G envelope protein; and
(ii) a non-viral membrane-bound protein comprising an extracellular target domain that binds to a protein on the surface of the HSC, wherein the protein on the surface of the HSC is CD90, CD133, CD49f, CD201, c-kit, FMS-like tyrosine kinase 3 (Flt-3) or thrombin receptor; and
b) contacting an HSC with the lentivirus, thereby delivering the one or more nucleic acids to the HSC.
Claim 12. The method of claim 1, wherein the mutated VSV-G envelop protein further comprises a mutation selected from the group consisting of H8, I41, and Y209.
Claim 13. The method of claim 1, wherein the mutated VSV-G envelop protein comprising the amino acid sequence set for in SEQ ID NO:16 or SEQ ID NO:17.
Claim 20. The method of claim 1, wherein a linker is positioned between a member-bound domain and the extracellular targeting domain of the non-viral membrane-bound protein.
Claim 26. A method of gene editing a hematopoietic stem cell (HSC), the method comprising: a) providing a lentivirus comprising one more nucleic acids encoding a gene editing composition and a mutated vesicular stomatitis virus (VSV)-G envelope protein comprising:
(i) the amino acid sequence set forth in SEQ ID NO: 13, wherein the amino acid sequence comprises an amino acid substitution at position 47 (K47) and/or position 354 (R354), wherein the amino acid substitution(s) diminish the native viral tropism of the VSV-G envelope protein compared to the non-mutated VSV-G envelope protein; and
(ii) a non-viral membrane-bound protein comprising an extracellular target domain that binds to a protein on the surface of the HSC, wherein the extracellular binding domain is an antibody, or fragment thereof, that binds to CD90, CD133, CD49f, CD201, c-kit, FMS-like tyrosine kinase 3 (Flt-3) or thrombin receptor; and
b) contacting an HSC with the lentivirus, such that the one or more nucleic acids the gene editing composition are deliver to the HSC, wherein the gene editing composition specifically targets a section of chromosomal DNA in the HSC to cause a genetic modification.
Claim 51. The method of claim 1, wherein the extracellular targeting domain is thrombopoietin (TPO).
Claim 52. The method of claim 1, wherein the extracellular targeting domain comprises the amino acid sequence of SEQ ID NO:55.
Claim 53. The method of claim 1, wherein the extracellular targeting domain comprises the amino acid sequence of SEQ ID NO:56.
Claim 54. The method of claim 1, wherein the extracellular targeting domain comprises the amino acid sequence of SEQ ID NO:57.
Claim 55. The method of claim 1, wherein the extracellular targeting domain comprises the amino acid sequence of SEQ ID NO:58.
Claim 56. The method of claim 1, wherein the extracellular targeting domain comprises the amino acid sequence of SEQ ID NO:59.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632
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