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
Priority
This Application is a national phase application filed under 35 U.S.C. § 371 claiming priority to International Application No. PCT/EP2022/073144, filed on August 19, 2022, which claims priority to foreign Application No. EP21192317.2, filed on August 20, 2021 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 02/15/2024 is acknowledged. Claims 1-13 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/23/2024 and 06/01/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 02/15/2024 are acknowledged and accepted by the Examiner.
Specification
The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 14). 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. Appropriate correction is required.
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.
(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 1-3 and 8-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Audonnet et al. “Audonnet” (WO2016/049209, IDS of record dated 12/23/2024).
The claims are directed to a method of producing a foot and mouth disease virus (FMDV) virus-like particle (VLP) in a baculovirus expression system, the method comprising: (i) infecting an insect cell with a baculovirus expression vector, wherein the insect cell is capable of recombinantly producing the FMDV VLP, (ii) culturing the insect cell in cell culture medium under conditions under which the insect cell produces the FMDV VLP, wherein culturing is performed for 4 days or more post infection, (iii) separating the insect cells from the cell culture to obtain cell-free cell culture medium, (iv) harvesting the FMDV VLP produced by the insect cells from the cell-free cell culture medium.
Regarding claims 1-3 and 8-13, Audonnet discloses FMDV vaccines or compositions containing FMDV antigens; and encompasses recombinant vectors encoding and expressing FMDV antigens, epitopes or immunogens which can be used to protect animals, in particular ovines, bovines, caprines, or swines, against FMDV (Abstract). Audonnet discloses Sf9 insect cells infected with a recombinant baculovirus containing a vector encoding the polyprotein of FMDV A24 Cruzeiro strain. Insect cells are grown during 4 days and the supernatants (i.e. the cell medium) are shown containing correctly assembled VLPs (see page 35, lines 27 to page 36 line 3). Audonnet discloses baculovirus BacMEB099, generated with transfer plasmid pMEB099, induced FMDV capsid expression and processing in Sf9 insect cells. These FMDV expressed capsids auto-assembled into VLPs with characteristic morphology of FMDV like virions (see Example 1.2); and “Several FMDV serotypes have now been shown to be effectively stabilized by the introduction of the covalent cage mutation, including: A24 Cruzeiro; O1 Manisa (FIG.16, EM & FIG.17, ELISA); Asia 1 Shamir; and A22 Iraq” (serotypes A and O, see page 44 lines 1-9). Audonnet also discloses vaccines comprising the VLPs and their use in cattle (see Example 4) (instant claims 1-3 and 8-13).
Therefore, the cited prior art anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 4-7 are rejected under 35 U.S.C. 103(a) as being unpatentable over Audonnet et al. “Audonnet” (WO2016/049209, IDS of record dated 12/23/2024) as applied to claim 1 above.
The teachings of Audonnet et al. are outlined above and incorporated herein.
Regarding claims 4-5, the culturing being performed for five days or more post infection is not inventive and considered routine and obvious to one of ordinary skill in the art as merely routine experimentation. According to section 2144.05 of the M.P.E.P., "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). A particular parameter must first be recognized as a result-effective variable, i.e., a variable, which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). It would have been obvious to one of ordinary skill in the art to determine an optimal number of days for culturing the cells by routine experimentation procedures known in the art. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success, based on the teachings of Audonnet would have led those of ordinary skill in the art to culture 4, 5 or more days in order to achieve the maximum (production or activity or therapeutic) response from the composition.
Regarding claims 6-7, the cell culture separation from insect cells by one or more of membrane filtration, centrifugation and sedimentation and VLPs concentrated by dialysis, membrane filtration and precipitation is not inventive and considered routine and obvious to one of ordinary skill in the art as merely routine experimentation. The method steps of the claims can be conducted by a membrane filtration, centrifugation and/or sedimentation; and concentration by dialysis, membrane filtration and precipitation is conventional and routine whereby a skilled artisan would have been motivated to do so with a reasonable expectation of success given the knowledge of Audonnet that the methods are merely a means which allows the desired expression product (i.e. FMDV VLPs) in order to a achieve the maximum (production or activity or therapeutic) from the composition.
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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 conflicting claims 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 Langi, 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); 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 nonstatutory double patenting
provided the reference application or patent either is shown to be commonly owned with the
examined 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory
double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be
accompanied by a reply requesting reconsideration of the prior Office action. Even where the
NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For
a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37
CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be
filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used.
Please visit www.uspto.gov/patent/patents-forms. The actual 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
on line using web-screens. An eTerminal Disclaimer that meets all requirements is autoprocessed
and approved immediately upon submission. For more information about eTerminal
Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-5 and 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/684,161. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope and species with one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The copending claims are directed to:
1. A method of producing a foot and mouth disease virus (FMDV) virus-like particle (VLP) of an Asial or SAT2 strain in a baculovirus expression system, the method comprising:
(i) infecting an insect cell with a baculovirus expression vector, wherein the insect cell is capable of recombinantly producing the FMDV VLP,
(ii) culturing the insect cell in cell culture medium under conditions under which the insect cell produces the FMDV VLP, wherein culturing is performed for 5 days or more post infection,
(iii) harvesting the FMDV VLP produced by the insect cells from the cell culture medium (instant claim 1).
2. (Original) The method according to claim 1, wherein culturing is performed for five days post infection (instant claims 4 and 5).
3. (Previously presented) The method according to claim 1, wherein the baculovirus expression vector comprises a nucleic acid sequence encoding a FMDV capsid precursor protein (instant claim 8).
4. (Original) The method according to claim 3, wherein the baculovirus expression vector further comprises a nucleic acid sequence encoding a protease capable of cleaving the FMDV capsid precursor protein into one or more capsid proteins (instant claim 9).
5. (Original) The method according to claim 4, wherein the capsid precursor protein comprises the FMDV capsid precursor P1 and the 2A peptide and the protease is 3C (instant claim 10).
6. (Previously Presented) The method according to claim 1, the method further comprising:
(iv) incorporating the FMDV VLP into a vaccine by addition of a pharmaceutically acceptable carrier (instant claim 11).
There is no patentable difference between the claimed methods and the methods in that the U.S. Application no. 18/684,161 discloses a method of producing a foot and mouth disease virus (FMDV) virus-like particle (VLP) in a baculovirus expression system, the method comprising: (i) infecting an insect cell with a baculovirus expression vector, wherein the insect cell is capable of recombinantly producing the FMDV VLP, (ii) culturing the insect cell in cell culture medium under conditions under which the insect cell produces the FMDV VLP, wherein culturing is performed for 4 days or more post infection, (iii) separating the insect cells from the cell culture to obtain cell-free cell culture medium, (iv) harvesting the FMDV VLP produced by the insect cells from the cell-free cell culture medium. The MPEP states “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
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.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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