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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to a nanoparticle comprising a cationic polymer conjugated to the nanoparticle, wherein the nanoparticle is a live virus, or an inactivated virus, classified in B82Y5/00, for example.
II. Claims 20-24, drawn to a method for delivering nucleic acid to plant cells, comprising contacting the plant cells with a nanoparticle according to claim 9, classified in C12N15/8201, for example.
Applicant’s election without traverse of claims 1-19 in the reply filed on June 3, 2026 is acknowledged.
Status of the claims
Claims 1-19 are under examination.
Claims 20-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Election was made without traverse in the reply filed on June 3, 2026.
Specification
(1) The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 2, line 33). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
(2) It is noted that on pages 30-34 of the specification there is a listing of references. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless these references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112 – 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.
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 1-19 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 drawn to any nanoparticle, comprising a cationic polymer conjugated to the nanoparticle, wherein the nanoparticle is a live virus, or an inactivated virus.
The Federal Circuit has recently clarified the application of the written description requirement. The court stated that a written description of an invention “requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials”. University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material”. Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”. Id. See MPEP 2163. In addition, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. The purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.
The entire claim must be considered, including the preamble language and transitional phrases. "Preamble language" is that language in a claim appearing before the transitional phase, e.g., before "comprising," "consisting essentially of," or "consisting of." The transitional term "comprising" is "open-ended" in that it covers the expressly recited subject matter, alone or in combination with unrecited subject matter. See, e.g., Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) ("‘Comprising’ is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim."); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves the "claim open for the inclusion of unspecified ingredients even in major amounts"). It is noted that the transitional phrase, and the body of the claim, must be sufficiently supported to satisfy the written description requirement.
In the instant case, the claims may be construed as any nanoparticle that includes specific structures or elements in addition to a cationic polymer. There is insufficient description of any other structures or elements embraced by the claim, thus, the scope and meaning of the claim is not clear.
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In addition, the claims are drawn to a genus of nanoparticles comprising a cationic polymer. 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 , reduction to drawings or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
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A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. In the instant case, there is no evidence in the specification of a variety of species that reflect any variation of the claimed genus nor is there any evidence that Applicant has invented species sufficient to constitute the claimed genus of nanoparticles comprising a cationic polymer.
See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated."). "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species.
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. The disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." In the instant case, Applicant has not described a representative number of adequately described species of the claimed genus of nanoparticles comprising a cationic polymer. Thus a person skilled in the art would not understand Applicant to have been in possession of the invention as broadly claimed.
Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115 teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification. In the instant case, there is no way that a practitioner would be able to determine if a particular nanoparticle comprising a cationic polymer would infringe the instant claims. Therefore, given the lack of written description in the specification with regard to the claimed genus of nanoparticles having the claimed characteristics, a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Czapar et al (ACS Nano. 2016 April 26; 10(4): 4119-4126), in view of Bolisay et al (Biomacromolecules. 2007, 8:3893-3899), in view of Demirer et al (Nat. Nanotechnol. 2019, May; 14(5): 456-464), in view of Chariou et al (ACS Agricultural Science & Technology. 2021, 1:124-130).
The invention reads on a nanoparticle, comprising a cationic polymer conjugated to the nanoparticle, wherein the nanoparticle is a live virus or an inactivated virus (claim 1).
Limitations include wherein the nanoparticle is selected from the group consisting of tobacco mosaic virus, tobacco mild green mosaic virus (TMGMV), cowpea mosaic virus, and potato virus X (claim 2); wherein the cationic polymer is poly-(allylamine) or salt thereof (claim 3); wherein the poly-(allylamine) or salt thereof has a molecular weight of at least about 1OkDa (claim 4); wherein the nanoparticle has an aspect ratio that is greater than 3 (claim 5); wherein the nanoparticle has a length of about 60- 600nm (claim 6); wherein the nanoparticle has a width of about 15-300nm (claim 7); wherein the nanoparticle has a Zeta potential of about 50-65mV (claim 8); wherein a nucleic acid is adsorbed on the nanoparticle outer surface (claim 9); wherein the nucleic acid is DNA (claim 10); wherein the nucleic acid is RNA (claim 11); wherein the nanoparticle has a Zeta potential of about 10-60mV (claim 12); wherein the mass ratio of nanoparticle to nucleic acid is about 10:1 to 1:12 (claim 13); wherein the mass ratio of nanoparticle to nucleic acid is about 1:3 to 1:6 (claim 14); wherein the nanoparticle is TMGMV (claim 15); wherein the nanoparticle is a live virus (claim 16); wherein the nanoparticle is an inactivated virus (claim 17); the nanoparticle of claim 15, which comprises a Tobacco mild green mosaic virus (TMGMV) coat protein (CP) that is conjugated with poly-(allylarnine) or salt thereof (claim 18); and wherein the poly-(allylamine) conjugated coat protein has a molecular weight of at least about 30kDa (claim 19).
With regard to claims 1, 2 and 16, Czapar et al teach a live virus nanoparticle comprising a cationic polymer conjugated to the nanoparticle wherein the nanoparticle is a live virus. See, for example, page 1, ‘Abstract’ where it teaches tobacco mosaic virus (TMV) as a delivery system for phenanthriplatin and that phenanthriplatin is a cationic monofunctional DNA-binding platinum anticancer drug candidate with unusual potency and cellular response profiles. See, for example, page 2 where it teaches that TMV is a plant virus-based nanoparticle platform. See Figure 1 where it depicts the nanoparticle.
With regard to claim 5, Czapar et al teach wherein the nanoparticle has an aspect ratio that is greater than 3. See, for example, page 2, last paragraph where it teaches an aspect ratio of 16.7.
With regard to claim 6, Czapar et al teach wherein the nanoparticle has a length of about 60-600 nm. See, for example, page 2, last paragraph where it teaches that TMV measures 300 nm in length.
With regard to claim 7, Czapar et al teach wherein the nanoparticle has a width of about 15-300 nm. See, for example, page 2, last paragraph where it teaches that TMV measures 18 nm in width.
Czapar et al do not teach the limitations of claim 3.
Bolisay et al teach the cationic polymer poly(allylamine hydrochloride) which reads on a salt thereof as defined on page 8, lines 20-22 of the instant specification. Bolisay et al teach that polymer-virus aggregates are formed when poly(allylamine hydrochloride) and tobacco mosaic virus (TMV) are mixed. See, for example, the ‘Abstract’. Bolisay et al teach that TMV is a model virus because it has been well studied and characterized and that poly(allylamine hydrochloride) was chosen because it is water soluble and contains primary amine groups. See page 3895, first column, first paragraph. Thus, it would have been obvious to one of ordinary skill in the art to use a cationic polymer such as poly-(allylamine), as claimed in claim 3, to conjugate to a live virus nanoparticle such as TMV and one of ordinary skill in the art would have an expectation of success based on the teachings of Bolisay et al.
Czapar et al do not teach the limitations of claims 8 and 12.
Demirer et al teach Zeta potential of at least 40.2 mV. See, for example, page 4, third paragraph. Though the Zeta potential disclosed in the reference is lower than that claimed in claim 8, the claim is still obvious because there is no evidence of the criticality of the claimed range and one of ordinary skill in the art would have been able to optimize the Zeta potential value to their desired needs.
Czapar et al do not teach the limitations of claims 9-11.
Demirer et al teach the adsorption of a nucleic acid, namely DNA, on the surface of a nanoparticle. See, for example, page 4, first and second paragraphs and Figs. 1a-c. Though the reference is silent with regard to RNA, there is no evidence in the reference that RNA could not be adsorbed to the surface of the nanoparticle using the methods described. The choice of RNA or DNA would be up to the skilled artisan.
Czapar et al do not teach the limitations of claims 13-14.
Demirer et al teach a mass ratio of nanoparticle to nucleic acid is 1:1. See, for example, page 4, last paragraph. Though the mass ratio disclosed in the reference is different from that claimed in claims 13-14, the claims are still obvious because there is no evidence of the criticality of the claimed ratios and one of ordinary skill in the art would be able to determine any particular ratio needed.
Czapar et al do not teach the limitation of claim 15.
Chariou et al teach a nanoparticle that is TMGMV. See, for example, the ‘Abstract’. See, for example, Fig. 1B.
Czapar et al do not teach the limitation of claim 17.
Chariou et al teach a nanoparticle that is an inactivated virus. See, for example, the ‘Abstract’. See, for example, page 126, second column, second paragraph and Fig. 1B.
One of ordinary skill in the art would have been motivated to use the teachings of Chariou et al because Chariou et al have demonstrated the successful inactivation of TMGMV and that TMGMV is the only plant viral nanoparticle that has been approved by the U.S. Environmental Protection Agency for use as a bioherbicide. See page 129, first column, last paragraph.
Czapar et al do not teach the limitation of claim 18.
It would have been obvious to one of ordinary skill in the art to use and/or modify the combined teachings of Czapar et al and Bolisay et al to teach the limitation of claim 18, a nanoparticle comprising TMGMV coat protein that is conjugated with a poly-(allylamine) or salt thereof, because Czapar et al teach a live virus nanoparticle comprising a cationic polymer conjugated to the nanoparticle wherein the nanoparticle is a live virus and Bolisay et al teach that polymer-virus aggregates are formed when poly(allylamine hydrochloride) and tobacco mosaic virus (TMV) are mixed. Thus, one of ordinary skill in the art would have an expectation of success with the combination of the cited reference to produce a nanoparticle comprising a TMGMV coat protein that is conjugated with poly-(allylamine).
With regard to claims 4 and 19, Bolisay et al teach a salt thereof of poly-(allylamine), namely, poly(allylamine hydrochloride); however, Bolisay et al is silent with regard to its molecular weight. The claims are still obvious because it is not inventive to discover optimum or workable ranges by routine experimentation. In addition, there is no evidence of the criticality of the claimed weights and one of ordinary skill in the art would be able to determine any particular weight needed. Furthermore, nothing in the art that teaches that a nanoparticle has to be a particular molecular weight.
It would have been obvious to one of ordinary skill in the art to combine or modify the teachings of the cited references because each of the claimed elements are found within the scope and content of the prior art and one of ordinary skill in the art could have combined and modified the elements as claimed by methods known at the time the invention was made. Thus, one of ordinary skill in the art would have recognized at the time the invention was made that that capabilities or functions of the combination were predictable.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH O. ROBINSON whose telephone number is (571)272-2918. The examiner can normally be reached Monday - Friday, 9:00 a.m. - 5:30 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic, can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEITH O. ROBINSON/Primary Examiner, Art Unit 1661
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