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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on April 2, 2024. Claims 1-20 are pending and currently examined.
Claim Objection
Base claim 9 recites the term “e plant virus-like particles”. The specification does not provide a definition for this term, which does not appear to be a term commonly used in the field of virus-like particles.
It appears that “e plant virus-like particles” refers to empty virus-like particles. If this is the case, Applicant is invited to amend the claim as such.
Claim 3 recites “wherein the freeze drying includes freezing an aqueous solution the plant virus particles”. This phrase appears to lack a connecting word between “solution” and “the plant virus particles”.
Claim Rejections - 35 USC § 112(a) - Written Description
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.
Claims 1-16 and 18-20 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 written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings or structural chemical formulas, or by disclosure of relevant, identifying characteristics, i.e., complete/partial structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, by predictability in the art, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
In Regents of the University of California v. Eli Lilly and Co. 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997), the Court decided that adequate written description of genetic material "requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention." Id. 43 USPQ2d at 1404 (quoting Fiefs, 984 F.2d at 1171, 25 USPQ2d at 1606). In AbbVie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (Court of Appeals, Federal Circuit 2014), the Court ruled that “[W]ith the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that “merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim' s functional boundaries.”).”
Claims 1-16 are drawn to a method of producing plant virus-like particles, comprising freeze drying an aqueous solution of plant virus particles to produce substantially RNA-free plant virus-like particles. Claims 9-16 further specify in general that plant virus particles are frozen at a temperature and for an amount of time that allows the plant virus particles to eject the encapsulated genomic RNA while maintaining an intact capsid conformation. Claims 18-20 are directed to a composition comprising a freeze-dried plant virus-like particle produced by the method of claim 9. These claims are generic in the plant virus types, the aqueous solution compositions, the freezing/drying conditions, among others that may or may not be critical for ejection of encapsulated RNA from a plant virus particle.
The specification teaches that the inventors developed a simple freeze-drying procedure that ejected the RNA from the capsid and RNAse treatment was able to degrade the remaining nucleic acids, to produce lyo-eCPMV. See e.g. [0087]. It teaches that CPMV was first filtered into deionized water using a 100K AmiconTMUltra-4 centrifugal filter at 6,000 rpm (Eppendorf 5810 centrifuge) at least 6 times in order to remove salts and low molecular weight impurities from the product. The filtered CPMV stock was then adjusted to 1 mg/mL with deionized water and slowly frozen at -20° C. in a laboratory freezer for at least 4 days. The tray freeze dryer was used with a shelf temperature of 25° C. and an ultimate chamber pressure of 5 μbar. See [0091]. This teaching indicate that freeze-drying was tested for CPMV virus in an aqueous solution of deionized water with salts removed, instead of in buffers with salts that some plant viruses need to keep virus particles intact.
A publication by the inventors, Zheng et al. (Nano Lett. 2019, 19, 2099−2105) discloses a study related to the instant invention. It teaches that a simple freeze-drying procedure ejected the RNA from the capsid, and RNase treatment was able to degrade the remaining nucleic acids to produce lyo-eCPMV. It teaches that temperature, time, and concentration are critical factors during the freezing step prior to lyophilization. Typical freezing procedures using liquid N2 were unable to fully eject the RNA and resulted in increased aggregation, decreasing the yield (Figure S1). Their optimized conditions were a slow freeze in a laboratory freezer (−20 °C, 4 days), followed by lyophilization. These conditions resulted in ideal capsid uniformity and complete removal of RNA. Furthermore, concentration during freezing is a critical factor in obtaining a sufficient yield. At high concentrations (>10 mg/mL), particles aggregate and significant fractions are unable to resuspend following lyophilization; however, dilute solutions of ∼1 mg/mL lessen particle aggregation and maintain high yields. Following freezing, a four-day negative pressure lyophilization was the shortest time required in order to achieve complete dehydration and RNA ejection based on our observations. See e.g. page 2100, left column.
It is known in the art that not all plant viruses eject encapsulated genome materials when freezing. E.g. Yordanova et al. (Biotechnology & Biotechnological Equipment, 2005, 19:sup1, 46-51) teaches that tobacco mosaic virus could keep high infectivity after freeze-drying, suggesting that a freezing process does not necessarily cause ejection of the viral genome material from the capsid. See e.g. Fig. 2.
Accordingly, based on Applicant’s own studies as well as knowledge in the field, removal of encapsulated viral genome RNA from plant virus has not been shown for a plant virus other than CPMV. Teachings in the instant specification and Zheng et al. do not show working examples that represent plant virus types in general, generic aqueous solutions, and generic freezing conditions as claimed and there is no evidence that the conditions described in the specification or shown publications in the art that function to eject encapsulated viral genetic material from CPMV particles are predictably also effective for other plant viruses.
The courts have indicated that support for a claim must be shown in its full scope; it is not enough to merely identify a plan to study the interaction and only a handful of working examples. See In Re AbbVie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (Court of Appeals, Federal Circuit 2014). Accordingly, the specification does not provide written description support that the applicant is in possession of the invention in the generic form as claimed.
Claim Rejections - 35 USC § 112(a) – Scope of Enablement
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.
Claims 1-16 and 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for removing/ejecting encapsulated RNA from CPMV under certain freezing conditions, does not reasonably provide enablement for all plant virus type to remove/eject encapsulated RNA from virus particles in all aqueous solutions under all conditions.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wriqht, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:1) the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention, 5) the state of the prior art, 6) the relative skill of those in the art, 7) the predictability of the art, and 8) the breadth of the claims. Id. While it is not essential that every factor be examined in detail, those factors deemed most relevant should be considered.
M.P.E.P. §2164.03 [R-2] states: [I]n applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soil, 97 F.2d 623,624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833,839, 166 USPQ 18, 24 (CCPA 1970). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488,496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
The nature of the invention is to produce empty virus-like particles of a plant virus by freeze-drying a plant virus particle wherein the encapsulated genetic material of the virus particle is removed/ejected during freeze-drying.
The teachings in the specification and knowledge in the art about the claimed invention are indicated in the 112(a) written description rejection above. The specification only discloses production of eCPMV free of RNA by freeze-drying CPMV particles in deionized water with salts removed and a slow freezing condition at -20oC followed by lyophilization.
As indicated in the written description rejection above, the working example presented in the specification provides a method for producing eCPMV VLPs by freeze-drying intact CPMV particles, there is no evidence that the same method can be used for other plant viruses under the same conditions as disclosed.
Neither working examples nor theoretical evidence exist indicating or suggesting that the same method disclosed in the specification can be used for other plant viruses to produce the same effect. Accordingly, there would be a large quantity of experimentation necessary for determination of virus types and conditions associated with each virus types to perform the invention as claimed.
Relative skill of those in the art would be high since it need expertise for developing new or modifying existing techniques that can be used in determining conditions that are suitable for different plant virus types. The predictability of the art is low across the full-scale of the claimed scope, since no evidence of freeze-drying may have the effect of removing/ejecting encapsulated genetic materials from a plant virus under any conditions except for CPMV.
Therefore, the specification does not provide sufficient guidance to allow one skilled in the art to practice the claimed invention on the full scope with a reasonable expectation of success and without undue experimentation. In the absence of such guidance and evidence of working examples, the specification fails to provide an enabling disclosure commensurate in scope with the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1-20 are rejected under 35 U.S.C. 102(1) as being anticipated by Zheng et al. (Nano Lett. 2019, 19, 2099−2105; published on Feb. 19, 2019).
Claims 1-16 are directed to a method of producing plant virus-like particles, comprising freezing an aqueous solution of plant virus particles and drying or sublimating the frozen aqueous solution virus particles to produce a virus-like particles substantially free of RNA. Claim 17-20 are drawn to a composition comprising a plurality of freeze dried, endoribonuclease treated cowpea mosaic virus (CPMV)-like particles.
Zheng describes a simple “postprocessing” method to remove RNA from wild-type CPMV, while retaining the structure and function of the capsid. Lyophilization was able to eject encapsulated RNA to form lyo-eCPMV and, when purified, eliminated nearly all traces of encapsulated RNA. Lyo-eCPMV was characterized by cryo-electron microscopy single particle reconstruction to confirm the structural integrity of the viral capsid. Finally, lyo-eCPMV showed equivalent anticancer efficacy as eCPMV, produced by agroinfiltration, when using an invasive melanoma model. These results describe a straightforward method to prepare CPMV VLPs from infectious virions. See Abstract.
Zheng teaches that CPMV was first filtered into deionized water using a 100 K Amicon Ultra-4 centrifugal filter at 6000 rpm (Eppendorf 5810 centrifuge) at least 6 times in order to remove salts and low molecular weight impurities from the product. The filtered CPMV stock was then adjusted to 1 mg/mL with deionized water and slowly frozen at −20 °C in a laboratory freezer for at least 4 days. The tray freeze-dryer was used with a shelf temperature of 25 °C and an ultimate chamber pressure of 5 μbar. The final lyophilized particles exhibited a slightly yellow flocculent appearance. See page 2103, right column, para 3.
Zheng further teaches that RNase A was then added to the resuspended lyo-CPMV at a concentration of 50 μg/mL. The samples were vortexed and incubated at room temperature for 15 min with gentle mixing by vortex at the level of 1.5. Following RNase treatment, 100 K Amicon Ultra-4 centrifugal filters were used to remove RNase A and degraded RNA (6000 rpm in an Eppendorf 5810R, 0.1 M KP, pH 7). Filtration was performed at least 6 times to completely remove degraded RNA fragments. Finally, the recovered particles were centrifuged at 10 000 rpm (Eppendorf 5424) for 5 min to remove any particulate aggregates. See page 2103, right column, para 4.
Accordingly, Zheng teaches a method of producing plant virus-like particles, i.e., CPMV virus-like particles, comprising freeze-drying CPMV particles in frozen aqueous solution and treatment with RNase to produce empty CPMV virus-like particles substantially free of RNA.
Therefore, Zheng anticipates claims 1-20.
Claim Rejections - 35 USC § 103
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Narayanan et al. (Advances in Colloid and Interface Science 248 (2017) 1–19).
Narayanan teaches that viral nanotechnology utilizes virus nanoparticles (VNPs) and virus-like nanoparticles (VLPs) of plant viruses as highly versatile platforms for materials synthesis and molecular entrapment that can be used in the nanotechnological fields. The authors reviewed various functional nanomaterials/nanostructures developed using the VNPs and VLPs of different icosahedral plant viruses and their nano(bio)technological and nanomedical applications. See Abstract.
Narayanan presented several individual studies involving plant virus-like particles that are substantially free of nucleic acids (e.g., VLPs that are empty). It teaches that by the self-assembly of empty CCMV, VLPs lacking genetic material can be expressed using a yeast-based Pichia pastoris expression system for nanomaterials applications (see page 5, right column, para 1); that large amounts of empty (RNA-free) CPMV capsids as CPMV VLPs can be produced by the transient expression of VP60 (the virus capsid precursor of large (L) and small (S) coat proteins) together with the 24 K viral proteinase in plants via agroinfiltration (see page 10, left column, para 1); that, to achieve interior engineering, empty CPMVs (eCPMVs) were generated by treating wild-type CPMV at high pH to eliminate the encapsidated RNA viral genome without compromising the integrity of the coat protein (see e.g. page 11, left column, para 1); that the coat protein of HCRSV reassembles to form empty VLPs, which can be used as nanosized systems for targeted drug delivery in cancer chemotherapy; and that empty TYMV capsids can be artificially generated by treating TYMV particles under high pressure, an alkaline environment, or repeated freeze-thaw cycles (see page 15, right column, para 1).
Narayanan further teaches that wild-type, mutant, and chemically functionalized CPMV nanostrucutres can be lyophilized for long term preservation and maintain capsid integrity in the presence of the cryoprotectant trehalose (see page 10, left column, para 1). Here, the CPMV nanostructures are considered to comprise empty VLPs.
Accordingly, Narayanan teaches studies involving production of various empty plant virus-like particles (i.e. substantially free of RNA). It further teaches that CPMV nanostructures (being considered to include empty VLPs) can be lyophilized for long term preservation and maintaining capsid integrity. However, Narayanan stops short on disclosing freezing drying an aqueous solution of an empty plant virus VLP.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the current invention to lyophilize the empty plant VLPs disclosed in Narayanan for long term preservation and maintain capsid integrity in the presence of the cryoprotectant trehalose or other lyophilizing agents known at the time of invention (lyophilization is commonly carried out in aqueous solution).
Claim 17-20 is rejected under 35 U.S.C. 103 as being unpatentable over Sainsbury et al. (Methods Mol Biol. 2014;1108:139-53) in view of Belval et al. (US 2018/0265552 A1, published on Sept. 20, 2018) and Storni et al. (The Journal of Immunology, 2004, 172: 1777–1785).
These claims are directed to a composition comprising a plurality of freeze dried, endoribonuclease treated cowpea mosaic virus-like particles.
Sainsbury teaches that the development of methods for the production of empty Cowpea mosaic virus (CPMV) virus-like particles (VLPs) that are devoid of RNA, eVLPs, has renewed promise in CPMV capsid technologies. The recombinant nature of CPMV eVLP production means that the extent and variety of genetic modifications that may be incorporated into the particles is theoretically much greater than those that can be made to infectious CPMV virions due to restrictions on viral propagation of the latter. Free of the infectious agent, the genomic RNA, these particles are now finding potential uses in vaccine development, in vivo imaging, drug delivery, and other nanotechnology applications that make use of internal loading of the empty particles. See e.g. Abstract.
Accordingly, Sainsbury teaches production of CPMV eVLPs free of RNAs. However, it is silent on freeze-drying the eVLPs and on treating the eVLPs with endoribonuclease.
Belval teaches an invention relating to conjugated coat proteins derived from nepoviruses, virus-like particles made with such proteins. See e.g. Abstract. Here, nepoviruses are plant viruses containing genetic RNA materials. Belval teaches that recombinant production may be performed in any suitable host such as plant cells, in plants, in bacteria, yeasts, or in an in vitro transcription system, that the VLPs may be collected and purified by conventional techniques such as, for instance, chromatography, centrifugation, and the like, and that because VLPs are stable under physiological conditions, they may be stored in solution or frozen or lyophilized, according to conventional techniques. See e.g. [0109-0110]. Belval mentions VLPs of plant viruses in general and CPMV VLPs in particular by mentioning Sainsbury et al. See e.g. [0004]. Accordingly, teachings of Belval indicate that it is known in the art at the time of invention to store plant virus VLPs in frozen or lyophilized state.
Storni teaches production of HBV core protein VLPs and bacteriophage Qb VLPs. See e.g. Abstract. It teaches contaminating host RNA present in the VLPs could be eliminated by incubating the capsid preparations with RNase A (an endoribonuclease). See e.g. page 1778, left column, para 3. Therefore, even though Storni does not teach treating CPMV VLPs with an endoribonuclease (it teaches VLPs of a mammalian virus and a bacteriophage), its teachings indicate that RNase A, a commonly used endoribonuclease to remove contaminating RNA from a biological sample, has been used in the preparation of viral VLPs when contaminating RNA needs to be removed.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the current invention to combine the teachings of Sainsbury, Belval and Storni to arrive at the invention as claimed. E.g., one would have been motivated to produce the eCPMV VLPs of Sainsbury in lyophilized state for storage and treat the eCPMV with RNase A to remove contaminating RNA, if there is a need to do so, as taught in Storni.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 6-8 and 14-16 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 6-8 and 14-16 of prior U.S. Patent No. 11,390,853. This is a statutory double patenting rejection.
Both sets of claims are identical in scopes.
Obviousness Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-5, 9-13 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,390,853.
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claims 1-5 and 9-13 of both instant claims and the patented claims are directed to a method of producing plant virus-like particles substantially free of RNA by freeze-drying plant virus particles in an aqueous solution. The only difference is that the patented claims require that the plant virus particles have icosahedral structure. Claims 17-20 of the instant claims and claims 17-21 of the patented claims are directed to a composition comprising a plurality of freeze dried and endoribonuclease treated plant virus-like particles. The only difference is that the patented claims 17-20 require that the plant virus particles have icosahedral structure and be produced by the method of claim 1 and patented claim 21 further specify CPMV, while instant claims 17-20 specify that the plant virus is CPMV. The patented claim 1-21 anticipate the instant claims 1-5, 9-13 and 17-20.
Accordingly, claims 1-5, 9-13 and 17-20 are unpatentable over claims 1-21 of U.S. Patent No. 11,390,853.
Claims 1-5 and 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,946,075.
Although the conflicting claims are not identical, they are not patentably distinct from each other. Instant claims 1-5 and 9-13 and patented claims 1-14 are directed to a method of producing plant virus-like particles substantially free of RNA by freeze-drying plant virus particles in an aqueous solution. The only difference between the two sets of claims is that the patented claims require that the plant virus particles comprise a plant virus from the family Tymoviridae (which has the icosahedral structure), while the instant claims are generic in an icosahedral plant virus. The patented claims 1-14 anticipate the instant claims 1-5 and 9-13.
Accordingly, claims 1-5 and 9-13 are unpatentable over claims 1-14 of U.S. Patent No. 11,946,075.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/
Primary Examiner, Art Unit 1671