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 .
Remark
Applicant’s response and amendment filed on 08/11, 2025.
The status of claims
Claims 1-17 and 25 were canceled.
Claims 18-24 and 26-35 are pending.
Claims 18-24, 26 and 32-34 with species of non-Influenza virus and MDCK cells are considered.
Claims 27-31 and 35 are withdrawn from consideration.
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.
The rejection of 18-24, 26 and 32-34 are withdrawn based on Applicants ‘clarification of the structural properties of the RNA-VLP cited in the claims and specification presented on pages 8-9 of the response; i.e. the VLP comprising
1). Include functional ribonucleoprotein complexes (RNPs), specifically NP and M, that are capable of expressing viral RNA intracellularly; 2). Explicitly exclude PB1, PB2, and NS2 RNPs and 3). Lack genetic information for RNA-dependent RNA polymerases.
It is worth to notes that the asserted property of NP and M that are capable of expressing viral RNA intracellularly, it is just an intended function if the RNA-dependent RNA polymerases is provided but they are not physically comprises within the structural requirement of the so called RNA-VLP cited in the claims, it is noted that Applicants asserted that is a feature enable the RNA-VLPs to mimic the intracellular phase of viral infection without capable of replication. However, this feature is an intended used rather than a structural elements possessed by the so call RNA-VLPs.
It is well known in that art that an infectious influenza virion contains ribonucleoprotein (RNP) complexes, influenza virus-like particles (VLPs) typically do not, as they are non-replicating and lack viral genetic material. VLPs are engineered to mimic the structure of a virus's outer shell to induce an immune response, but without the infectious risk associated with the viral genome. The followings summary is the comparisons of influenza virions vs. VLPs in general.
The key difference between an infectious influenza virion and a VLP lies in their genetic cargo and internal proteins.
Component
Infectious Influenza Virion
Influenza VLP
Ribonucleoprotein (RNP)
Contains eight RNP complexes, each consisting of a segment of viral RNA (vRNA) encased by nucleoprotein (NP) and a polymerase complex.
Generally lacks RNP. The VLP platform is used to express other viral proteins, but without the genome required for the formation of infectious RNP.
Genetic Material
A segmented, negative-sense, single-stranded RNA genome.
Lacks the infectious viral RNA genome, making it non-replicative and safe.
Structural Proteins
Possesses all necessary viral structural proteins, including the envelope proteins hemagglutinin (HA), neuraminidase (NA), and the matrix (M1) protein.
Expresses key structural proteins like HA, NA, and M1 to trigger an immune response. The M1 protein often acts as the core component to drive particle formation.
Function
Is an infectious, replication-competent virus particle.
Functions as a non-infectious vaccine platform that presents viral antigens to the immune system.
Therefore, applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “RNA expressing VLP (RNA-VLP)”cited in the all pending claims, still means “influenza virus like particle” (VLP) as long as it comprises the same structural elements. All grounds of the prior art rejections in the previous first office action and now final office action hereinto are still based on based on the structural limitations of the claimed VLPs and the ones disclosed or taught by the cited prior art.
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.
Claims 32-34 are still rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph.
Applicants traverse the rejection and submit that
Applicants’ argument are respectively considered , however, it is still unclear how the method for making the influenza virus like particle still comprises the viral replication enzyme, i.e. the PA, PB1 and PB2 that are the components responsible for making viral replication enzyme complexes, i.e. RNPs. In the instant case, the independent claim 18 cites that the claimed virus like particle does not contain the PA, PB1 and PB2 , which is only comprises a nucleoprotein (NP) ribonucleoprotein complex. Applicants are encourage to clarify that the NP ribonucleoprotein is? Does it comprise other component? If it does, what it is or what they are?
During the examination, it is noted by the examiner that the Figures 4 and 6 show there are several RNP complexes and Fig. 10 also show that the virus like particle looks comprising PB1, PB2 and PA etc. Please clarify how many kinds of VLPs are produced and what are each of the viral protein components in detail produced by the method cited in claim 32.
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 by publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18-20 and 24 are still rejected under 35 U.S.C. 102(a) (1) as being anticipated by CAO et al. (CN102373181A).
In the response, applicants traverse the rejection by admitting that the VLP disclosed by Cao et al. is the one composed of HA, NA, M1, and NP but it does not either include PB1, PB2, or NS2 RNPs nor genetic information for RNA-dependent RNA polymerase. . But Applicants still asserted that Cao et al. do not teach the rejected claims because Cao does not teach either RNA expression capability nor polymerase subunits or RNA-dependent RNA polymerase gene included.
Applicants’ argument has been respectfully considered, however, it is not found persuasive. Because the arguments regarding that prior art does not mentioned that the VLP with an RNA expression capability nor polymerase subunits or RNA-dependent RNA polymerase gene described are nevertheless not the structural limitations of the rejected RNA-VLP but an intended use and function. Moreover, if the PB1, PB2, or NS2 RNPs for RNA-dependent RNA is provided, the VLP will inherently produce same viral RNA molecules lie the claimed RNA-VLP. To this context, the rejection of claims 18-21 and 24 are maintained.
Claims 18-20 and 24 are still rejected under 35 U.S.C. 102(a) (1) as being anticipated by Quan et al. (Expert Rev Vaccines, Expert Rev Vaccines. 2016 May 5;15(10):1281–1293).
In the response, Applicants traverse the rejection and provide the same arguments described above, i.e. asserting that Quan et al. did describe non-infectious, genome-less VLPs that are composed of HA, NA, M1, M2, and optionally NP. However, neither RNA expression capability is disclosed. nor polymerase subunits or RNA-dependent RNA polymerase genes are mentioned.
Applicants’ argument has been respectfully considered, however, it is not found persuasive. Because the arguments regarding the prior art does not teach that VLP does neither disclose a RNA expression capability nor mention about polymerase subunits or RNA-dependent RNA polymerase gene. As described above, these two arguments are nevertheless not the structural limitations of the rejected RNA-VLP but an intended use and activity inherently if the PB1, PB2, or NS2 RNPs for RNA-dependent RNA is provided. Therefore, the VLP disclosed by the prior art comprises HA, NA, M1, and one or more nucleoprotein NP from an influenza virus which meets the structural limitations of the claimed RNA-VLP. Therefore, Applicant’ arguments are not persuasive to overcome the rejection. The rejection is therefore, maintained.
Claims 18-20 and 24 are still rejected under 35 U.S.C. 102(a) (1) as being anticipated by Xue et al. (Virus Research 2015, Vol. 195, pages 35-42.
In the response, Applicants traverse the rejection and provide a similar arguments described above, i.e. Xue Describes VLPs composed of HA, NA, M1, and optionally NP, VLPs are non-replicating and genome-less, NP is included for T-cell epitope presentation, not RNA expression. No PB1, PB2, NS2, or polymerase genes are present.
Applicants’ argument has been respectfully considered, however, it is not found persuasive to overcome the rejection. Because Xue rt al. describes VLPs composed of HA, NA, M1, and optionally NP, although the NP including T cell epitopes, which meet the limitations required by the rejected RV-VLPs . But the arguments regarding the prior art that does not teach a RNA expression is just a intended use rather than a structural elements comprised in the RNA-VLPs. Furthermore, the argument that no PB1, PB2, NS2, or polymerase genes are present, which is just not required by the structural property of the claims RNA-VLPs. To this context, the rejection is maintained.
The rejection of Claims 32 -34 under 35 U.S.C. 102(a) (1) as being anticipated by Watanabe et al. (Journal of Virology, 2002, Vol. 76 (2): 767-773) has been removed because Applicants’ argument is persuasive.
Conclusion
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 BAO Q LI whose telephone number is (571)272-0904. The examiner can normally be reached M-F 8 am to 8 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet Andres can be reached at 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/ Primary Examiner, Art Unit 1671