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 .
Election/Restrictions
1. Applicant’s election without traverse of the invention of Group I (drawn to an expression cassette) and the species CRTAC1/SEQ ID NO: 1, SP-B, and lentiviral vector, in the reply filed on 04/14/2026 is acknowledged.
Upon further considerations, the restriction/species election requirement between the invention of Group I and the inventions of Groups II and III, between the species CRTAC1 and synthetic signal peptides (SEQ ID NOs: 1 and 11, respectively), and between the therapeutic genes SB-P, AAT, Factors VII-XI, von Willebrand factor, GM-CSF, and monoclonal antibody against an infectious disease are withdrawn.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 8, 16, 18, and 20-24 have been cancelled.
Claims 3 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1, 2, 4-7, 9-12, 14, 15, 17, 19, and 25-28 are under examination.
Claim Objections
2. Claim 4 is objected to because of the recitation “a” in (a)-(j). Correction to replace “a” with “the” is required.
3. Claim 4 is objected to because of the recitation “an ATT signal peptide” in (j). Correction to replace this recitation with “the AAT signal peptide” is required.
4. Claim 12 should recite “comprising the nucleic acid cassette of claim 1”.
5. Claim 19 is objected to because of the recitation “delivering a nucleic acid cassette as defined in claim 1 into the target cells”. Correction to “delivering the nucleic acid cassette of claim 1 into the target cell” is required.
6. Claims 25 and 26 are objected to because of the recitation “a nucleic acid cassette as defined in claim 1”. Correction to “the nucleic acid cassette of claim 1” is required.
7. Claim 27 is objected to because of the recitation “of gene therapy vector as defined in claim 12”. Correction to “of the gene therapy vector of claim 12” is required.
8. Claim 28 is objected to because of the recitation “The gene therapy vector for use of claim 27”. Correction to “The gene therapy method of claim 27” is required.
Claim Rejections - 35 USC § 112(b)
9. 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.
10. Claim 10 is 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.
Regarding claim 10, the recitation “an anti-inflammatory protein (e.g., IL-10 or TGFβ)” renders the claim indefinite because it is unclear whether the limitations within parenthesis are part of the claimed invention.
The embodiment within parenthesis may be set forth in another dependent claim; when stated in a single claim, the embodiment within parenthesis leads to confusion over the intended scope of the claim because it is not clear whether the claim is limited by the genus of anti-inflammatory proteins or the specific species recited within parenthesis. Thus, the metes and bounds of the claim cannot be determined and the claim is indefinite.
Claim Rejections - 35 USC § 102
11. 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 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.
12. Claims 1, 2, 6, 10, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de Fougerolles et al. (US 8,680,069), as evidenced by Hartung (Curr. Opin. Hematol., 1998, 5: 221-225; Abstract).
de Fougerolles et al. teach an expression cassette comprising a nucleic acid encoding a heterologous signal peptide operably linked to the 5’ end of a nucleic acid encoding G-CSF; heterologous signal peptide increases secretion as compared to the native signal peptide or the absence of signal peptide (1, 2, 6, and 11) (see Example 44). As evidenced by Hartung, G-CSF is an anti-inflammatory protein (claim 10) (see Abstract). Thus, de Fougerolles et al. teach all claim limitations and anticipate the claimed invention.
Claim Rejections - 35 USC § 103
13. 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 disclosed 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.
14. Claims 1, 2, 4-7, 9-12, 14, 15, 17, 19, and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Alton et al. (US 2017/0096684), in view of both Gϋler-Gane et al. (Plos One, 2016, p. 1-15; cited on the IDS filed on 10/13/2023) and Steck et al. (Matrix Biology, 2007, 26: 30-41).
Alton et al. teach (1) a simian lentiviral vector pseudotyped with the Sendai virus HN and F proteins (F/HN-SIV) capable of efficiently transducing the airway epithelial cells (such as submucosal gland duct cells, neuroendocrine cells, bronchioalveolar stem cells, and type II pneumocytes); F/HN-SIV comprises an expression cassette containing the hCEF hybrid promoter operably linked to a nucleic acid encoding a secreted therapeutic protein (such as SB-P, AAT, Factors VII-XI, von Willebrand factor, GM-CSF, and monoclonal antibody against an infectious disease); and (2) using the F/HN-SIV to deliver the therapeutic protein to cells ex vivo or in vivo to treat respiratory, cardiovascular, or blood diseases/disorders (i.e., the F/HN-SIV is formulated with a pharmaceutically acceptable excipient) (claims 1, 6, 7, 10-12, 14, 15, 17, 19, and 25-28) (see [0013]; [0020]-[0030]; [0034]-[0036]; [0055]-[0056]; [0059]-[0060]; [0074]-[0076]; [0100]-[0101]). Since the secreted therapeutic protein is expressed (i.e., translated), one of skill in the art would have reasonably understood that the expression cassette comprises a translation initiation sequence (claim 9).
Since the therapeutic proteins taught by Alton et al. are secreted and since Alton et al. do not teach a heterologous signal peptide, one of skill in the art would have readily understood that these therapeutic proteins comprise the native, not a heterologous or synthetic signal peptide (claims 1, 2, 4, and 5). Gϋler-Gane et al. teach that that the native signal peptides are not optimal for expression in heterologous systems; replacing them with heterologous or synthetic signal peptides increase expression levels. Gϋler-Gane et al. teach secrecon, a synthetic signal peptide, which mediates efficient expression and could be used for the production of therapeutic proteins (see Abstract; p. 7, Table 1; p. 12, first full paragraph, the last seven lines; p. 13, first paragraph, the first three lines and the last paragraph). Based on these teachings, one of skill in the art would have found obvious to modify Alton et al. by replacing the native signal peptides in the expression cassettes encoding AAT, Factors VII-XI, von Willebrand factor, GM-CSF, and the monoclonal antibody with a signal peptide derived from a lung secreted protein or with secrecon, with the reasonable expectation that doing so would improve their expression and secretion from the heterologous airway epithelial cells (claims 1 and 2). A comparison between the sequence of secrecon (disclosed by Gϋler-Gane et al. in Table 1) and the claimed SEQ ID NO: 11 revealed that they are identical (claims 4 and 5).
Alton et al. and Gϋler-Gane et al. do not teach that the signal peptide derived from the lung secreted protein is the CRTAC1 signal peptide set forth by SEQ ID NO: 1 (claims 4 and 5). Steck et al. teach that CRTAC1 is efficiently expressed in the lung; Steck et al. teach that CRTAC1 comprises the signal peptide having the amino acid sequence MAPSADPGMSRMLPFLLLLWFLPITEG (see p. 32, column 1, p. 33, Fig. 3A and column 2, third paragraph). One of skill in the art would have found obvious to use the CRTAC1 signal peptide as the heterologous signal peptide, with the reasonable expectation that doing so would improve expression and secretion from the heterologous airway epithelial cells (claims 1 and 2). A comparison between the sequence MAPSADPGMSRMLPFLLLLWFLPITEG and the claimed SEQ ID NO: 1 revealed that they are identical (claims 4 and 5).
With respect to SP-B, which is expressed and secreted by the type II pneumocytes, there is no evidence of record indicating that the CRTAC1 signal peptide is superior to the native SP-B signal peptide with respect to inducing SP-B expression/secretion. Absent evidence of unexpected results, replacing the native signal peptide with the CRTAC1 signal peptide or with secrecon (taught by the prior art being efficient and suitable for the production of therapeutic proteins) would have been obvious to one of skill in the art, with the reasonable expectation that doing so would result in efficient SP-B expression and secretion from the airway epithelial cells.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
15. No claim is allowed. No claim is free of prior art.
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/ILEANA POPA/Primary Examiner, Art Unit 1633
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