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
Applicant's election with traverse of Group II, claims 94, 96, 99 and 101 in the reply filed on April 6, 2026 is acknowledged. The traversal is on the grounds that, He et al does not sever the unity of invention among the pending claims. Applicant argues that the claims contain specific structural features, such as specific engineered glycosylation sites and particular mRNA configurations, that define a contribution over the cited reference. Applicant argues that the methods are similar and a search for the elected polynucleotides of Group II will inherently encompass search results for the encoded fusion polypeptides of Group I and the methods of Group III. Applicants request rejoinder of the groups or at least a rejoinder of Groups I and II as they all involve the same targeted fusion polypeptide comprising a SARS-CoV or SARS-CoV-2 spike protein.
In response, Examiner notes that the prior art by Graham et al. (WO 2021/163365) cited in the 102(a)(2) rejection below discloses the special technical feature of the claimed invention. The present invention thus lacks unity and the claims are restricted as it applies to the US practice. The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 1, 10-11, 18-19, 33, 40, 55, 57, 59-60, 70, 74, 109, 114, and 119 are withdrawn as being drawn to non-elected invention. Claims 94, 96, 99 and 101 are under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 15, 2023 has been considered by the examiner.
Claim Objection
Claims 94, 96, 99 and 101 are objected to for depending from withdrawn claim 1.
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)(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.
Claims 94, 96, 99 and 101 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Graham et al. (WO 2021/163365).
Claims are drawn to an isolated polynucleotide encoding the fusion polypeptide comprising a) at least one viral polypeptide comprising a SARS-CoV spike protein (S), a SARS-CoV-2 spike protein (S), or an immunogenic fragment thereof; and b) an amino acid sequence that targets the fusion polypeptide to the cell surface or a self- assembling domain capable of forming a nanoparticle. Present claim 94 depends from withdrawn claim 1.
An amino acid sequence that targets the fusion polypeptide to the cell surface or a self- assembling domain capable of forming a nanoparticle can be ferritin, as described in the present specification paragraph [0145].
[0145] In some embodiments, a fusion polypeptide described herein further comprises a self-assembling domain capable of forming a nanoparticle. In some embodiments, the self-assembling domain comprises a type II 3-Dehydroquinase, ferritin or lumazine synthase. In some embodiments, the self-assembling domain comprises a type II 3-Dehydroquinase polypeptide comprising one or more engineered glycosylation site. In some embodiments, the self-assembling domain comprises a Thermus thermophilus type type II 3-Dehydroquinase, optionally comprising one or more engineered glycosylation site.
Graham discloses polynucleotide encoding the fusion polypeptide comprising SARS-CoV spike protein (S), and an amino acid sequence that targets the fusion polypeptide to the cell surface or a self- assembling domain capable of forming a nanoparticle such as LumazineSynthase (LuS) and ferritin (see page 2, lines 10-15, Figure 4A-4E and figure description on page 3, page 4, page 11, lines 1-5, pages 15, 27, 28, Example 3, Table 1).
Regarding present claim 96. Graham discloses mRNA comprising modified ribonucleotides (see pages 9, 10, 13 and 19).
Regarding present claims 99 and 101. Graham discloses a host cell and a recombinant vector comprising the polynucleotide (see page 11, page
Thus, by this disclosure Graham anticipates the present claims.
Pertinent references
Georges et al. (US Patent Application Publication US 2021/0260180) teach olynucleotide encoding the fusion polypeptide comprising a) at least one viral polypeptide comprising a SARS-CoV spike protein (S), a SARS-CoV-2 spike protein (S), or an immunogenic fragment thereof; and b) an amino acid sequence that targets the fusion polypeptide to the cell surface or a self- assembling domain capable of forming a nanoparticle.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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, Thomas Visone can be reached on 571-270-0684. 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.
/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
Prosecution Insights