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 amendment and argument of 5/27/26 are entered.
Claims 1, 8, 10-11, and 18-19 are amended.
Claims 1-19 are pending and considered herein.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
In light of the amendments, the rejections of Claims 10 and 18-19 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, are withdrawn.
To wit, the claims are no longer of larger scope than parent claims, being made independent.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
In light of the amendments, the rejections of Claims 1-3 and 5-8 under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more, are withdrawn.
To wit, the RNA is now non-native to the virus protein.
In light of the amendments, the rejections of Claims 10-12 and 14-18 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more, are withdrawn.
To wit, the RNA is now non-native to the virus protein.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
While the rejections of Claims 1-3, 5-7, and 9 are withdrawn as the processes of Krupp do not teach it being formed in a plant cell:
Claim(s) 10-12 and 14-18 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by WIPO document WO 2015/118183 A1 to Krupp, et al.; and
Claim(s) 11-12 and 14-17 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by WIPO document WO 2015/118183 A1 to Krupp, et al.
Claims 10-11, and 18: Krupp teaches the encapsidation of RNA in a rod-shaped virus-like particle, where the RNA comprises an origin of assembly for a rod-shaped RNA virus and a heterologous sequence. The virus protein may be from TMV, and requires the TMV OriA (p. 5, last paragraph). The ssRNA may be expressed by transcription (e.g., p. 16, last paragraph), and the coat protein may be expressed in vitro or in bacterial cells (p. 21, paragraph 3). The ssRNA is necessarily a diagnostic for the sequence it detects and a positive control for such. With regard to carriers, it is noted the compositions are maintained with buffers and in the presence of water, meeting the carrier limitation (e.g., Examples). With regard to the amendment to Claim 10, if anything this claim is no longer even required to be made by a particular process. With regard to Claim 11, the heterologous sequence is taught, as shown above. With regard to Claim 18, the 18 the oriA is required and is used to so coat the ssRNA. Further, even if it were limited to the method of making, the product is claimed, and therefore, it can be made by different processes and still anticipate, and it is left to Applicant to show the structure differs when made by Krupp’s methods.
Claim 12: the RNA may comprise an mRNA encoding a sequence associated with disease, like bcr/abl, EGFR, and the like (p. 18, penultimate paragraph).
Claim 14: the RNA may contain another coding sequence from a rod-shaped RNA virus (p. 18, penultimate paragraph).
Claim 15: HIV sequences are taught (e.g., Id.).
Claim 16: SEQ ID NO: 2 is taught (e.g., pp. 18-19, paragraph bridging), which contains at least two nucleotides of present SEQ ID NO: 1, in the same order, and thus it does comprise a sequence of present SEQ ID NO: 1.
Claim 17: TMV is taught (e.g., p. 5, last paragraph).
Response to Argument - Anticipation – Krupp
Applicant’s argument of 5/27/26 has been considered but is not found fully persuasive.
Applicant argues that the claims, as amended, are to formation of the compositions in a plant cell, and thus, it is no longer anticipatory (pp. 8-9). (It is noted the composition claims have not been specifically argued, and therefore it is assumed Applicant is relying on the process claims argument to apply to the composition claims.)
Such is persuasive on the method claims, and they have been withdrawn from the rejection. However, the same structure is still claimed in the composition claims, and the process does not change the structure made.
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 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.
Claim(s) 1-19 remain rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/118183 A1 to Krupp, et al. and WO 2015/011676 A1 to Rybicki, et al.
As shown above, the various aspects are taught in Krupp, however, the aspect of a reporter gene being a member of Claim 13. Nor does Krupp teach to administer it for eliciting an immune response.
However, the Artisan, interested in the use of pseudovirions, would be aware of Rybicki (e.g., TITLE). Rybicki teaches the production of similar pseudovirions in plant cells, and specifically recognizes the use of a construct encoding a reporter which may be, e.g., secreted alkaline phosphatase (e.g., p. 18, paragraph 4). With regard to administration to elicit immune responses, Rybicki teaches administration of similar pseudovirions to produce an immune response (e.g., Brief Description, last paragraph).
Thus, in light of the teachings of Rybicki, the Artisan would utilize a marker including those of Rybicki, in the invention of Krupp, and produce the same constructs in plant cells, as it was shown coexpression could be had to produce pseudovirions. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Response to Argument – 103, Krupp and Rybicki
Applicant’s argument of 5/27/26 have been considered but are not found persuasive.
Applicant argues that Rybicki is drawn to DNA pseudovirions, while Krupp is to an RNA encapsidated pseudovirion, and thus an Artisan would not apply anything from Rybicki to Krupp (pp. 9-10).
Such is not persuasive. Rybicki uses the tobamovirus coat proteins to encapsulate an RNA with a OriA sequence (which is known here to be required for encapsidation). In either case, they are packaged. The information from Rybicki is applicable for the in-cell production of the pseudovirions encapsulating the in-cell genetic material. In each case, the particular protein works on the capsidation of the particular mRNA, and the relations are known. In addition, the use of a plant cell is supported as the Artisan knows the normal encapsidation occurs in plant cells, through the OriA, in the case of the tobomavirus.
Applicant argues that Rybicki relies on non-specific encapsidation, while the RNA and coat proteins here are to sequence specific sequences, and thus, the systems are not interchangeable, being drawn to distinct biological problems. P. 10, paragraph 2.
Such is not persuasive. The relations are already well understood, and the Artisan understood the OriA is utilized by the coat protein for encapsidation of the RNA in the case of Krupps tobamovirus system. The Examiner disagrees that the Artisan would not understood the analogous relation, and that OriA is required for coating, and it would occur in the plant cell, the natural environment of RNA encpasidation for the virus.
Applicant argues that Krupp is to a multi-step system comprising several steps, and Applicant’s advancement is found in a single-step system, allowed by the positioning of OriA in the RNA, and Applicant’s invention requires 3’ location relative to the gene of interest on the RNA (p. 10, penultimate paragraph).
Such is not persuasive. The Artisan understood the system and how OriA is required. As far as 3’ positioning, no claim requires such 3’ positioning.
Art Noted by the Examiner
In the process of working on the present Action, the Examiner noted that the reference Zhou, et al. (2015) “In planta Production of Flock House Virus Transencapsidated RNA and Its Potential Use as a Vaccine”, Molecular Biotechnology, 57: 325-36 (NPL reference 3 in the IDS of 2/27/24). The reference is not allowed to be presented at this time for rejections, as the present Art still anticipates/makes obvious the present claims, however, it is recommended Applicant consider this reference in future responses.
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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