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 section 371 of International Application No. PCT/EP2021/058601, filed on April 01,2021, that claims priority to European Patent Application No. EP20167718.4, filed on April 2, 2020 that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 09/30/2022 is acknowledged. Claims 1-32 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/26/2023 and 08/25/2023 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 09/30/2022 are acknowledged and accepted by the Examiner.
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.
Claims 12, 16, 20-21 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 12, 16 and 20-21 are rejected for containing a reference to tables. MPEP 2173.05(s) states “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim. See MPEP § 608.01(m) for information pertaining to the treatment of reference characters in a claim' .
Claims 12, 16 and 20-21 are rejected for reciting “suitable analogues”. It is unclear as to what is determined as a “suitable analogue” in the composition. Further, the specification does not define the terms “suitable analogues” and does not provide a standard for ascertaining the requisite degree, thus a skilled artisan would not be apprised to the metes and bounds of the recitations. Thus, the claims are rendered indefinite.
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 1-5, 9-10 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roymans et al. “Roymans” (WO2009/106580, IDS of record dated 01/26/2023).
The claims are directed to a vaccine composition comprising an immunologically effective amount of a viral fusion protein antigen and a stabilizing amount of an antiviral compound.
Regarding claims 1-3, 9 and 32, Roymans discloses that the invention relates to the use of an inhibitor, as identified by any of the methods according to the present invention, which binds the alphahelical coiled coil protein complex of viruses that use a class I fusion protein, preferably RSV, in the manufacture of a medicament for treating respiratory tract infections (page 7 lines 1-5, claim 14 of Roymans). Roymans discloses the cocrystalization of 52 amino acid fragment of class 1 fusion protein, RSV F protein, with a RSV inhibitor which involves a liquid composition comprising a fusion protein antigen and an antiviral compound that can be used for treating RSV (instant claims 1-3 and 32) (pages 3, 5, 12; Figure 2; claims 1, 6, 10 and 14 of Roymans).
Regarding claim 4, Roymans discloses that the RSV fusion protein folds into a trimer (page 3 last para.).
Regarding claim 5, Roymans discloses the inhibitor is a fusion inhibitor by interfering with the 6HB-formation (page 13 lines 41-42 and page 14 lines 1-8).
Regarding claim 10, Roymans discloses the use of a pre-fusion RSV F protein (page 21 lines 24-30).
Therefore, the cited prior art anticipates the claimed invention.
Claims 1-5, 13-15 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ernst et al. “Ernst” (Angewandte Chemie, Wiley-VCH, DE, 2020, 41(2):278-281, IDS of record dated 01/26/2023).
The claims are directed to a vaccine composition comprising an immunologically effective amount of a viral fusion protein antigen and a stabilizing amount of an antiviral compound, wherein the fusion protein is an HIV envelope (env) protein.
Regarding claims 1-5, 13-15 and 22, Ernst discloses “The design of low molecular weight ligands (< 750 Da) that disrupt protein -protein interactions has remained a challenging endeavor. Conventional means of identifying small molecules from chemical libraries that are inhibitors of protein-protein interactions have resulted in limited success. Therefore, new strategies focusing on the rational design of molecules that recognize protein surfaces could prove fruitful in the development of novel antagonists. Herein we describe such a strategy based on the design of a molecular scaffold that mimics the surface of an a-helix. We have designed a proteomimetic of an a-helical 4-3 hydrophobic repeat that inhibits the assembly of a six-helix bundle corresponding to the fusion-active conformation of the gp41 protein. This intraprotein surface disruption results in reduced levels of HIV-1 entry into host cells” (page 278 first column first para.). Ernst discloses a complex of HIV gp41 trimer complexed with compound 1a which disrupts the helix bundle, and locks the gp41 complex in prefusion conformation (instant claims 1-5, 13-15, 22) (Figure 5).
Therefore, the cited prior art anticipates the claimed invention.
Claims 1-5, 17-22, 26 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kadam et al. “Kadam” (PNAS, 2016, 114(2):206-214, IDS of record dated 01/26/2023).
The claims are directed to a vaccine composition comprising an immunologically effective amount of a viral fusion protein antigen and a stabilizing amount of an antiviral compound, wherein the fusion protein is an influenza A hemagglutinin (HA) protein.
Regarding claims 1-5, 17-22, 26 and 29, Kadam discloses that the broad-spectrum antiviral drug Arbidol shows efficacy against influenza viruses by targeting the hemagglutinin (HA) fusion machinery; determined crystal structures of Arbidol in complex with influenza virus HA from pandemic 1968 H3N2 and recent 2013 H7N9 viruses showing Arbidol binds in a hydrophobic cavity in the HA trimer stem at the interface between two protomers. Kadam also discloses that Arbidol functions as a molecular glue, stabilizing the prefusion conformation of HA that inhibits the large conformational rearrangements associated with membrane fusion in the low pH of the endosome (Abstract); and teaches that this unique binding mode compared with the small-molecule inhibitors of other class I fusion proteins can function as fusion inhibitors and guides the development of broad-spectrum therapeutics against influenza virus (instant claims 1-5, 17-22, 26 and 29) (Abstract).
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 6-8, 11-12, 23-25, 27-28 and 30-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over Roymans et al. “Roymans” (WO2009/106580, IDS of record dated 01/26/2023) as applied to claim 1 above. The teachings of Roymans et al. are outlined above and incorporated herein.
Regarding claims 6-8, as it pertains to the antiviral compound’s sub-therapeutically amount and trimer: compound ratio, it is not inventive and considered routine and obvious to one of ordinary skill in the art to generate the appropriate ratios and concentration in an immunogenic compound through routine experimentation/optimization. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. 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 of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). It would have been obvious for one of ordinary skill to determine the appropriate percentage of the protein in the composition of the methods disclosed by the prior art by routine experimentation procedures known in the art. Routine experimentation based on the teachings of these references would have led those of ordinary skill in the art to the use of the claimed amount ratios and concentration in order to achieve the maximum (production or activity or therapeutic) response from the composition.
Regarding claim 11, Roymans discloses the inhibitor is a fusion inhibitor by interfering with the 6HB-formation (page 13 lines 41-42 and page 14 lines 1-8).
Regarding claim 12, Roymans discloses an inhibitor of Table 1 (page 24 formula I of Roymans).
Regarding claims 23-25 and 30-31, Roymans does not explicitly teach stability and preserving a vaccine comprising the composition of claim 1 at specified temperatures for lengths of time; however, it is understood by the office that the compositions having the same components would have the same functional limitations as the claimed composition. It is not inventive and considered routine and obvious to one of ordinary skill in the art to generate a composition for treating a subject whereby the composition can be stored for longer periods of time. One of ordinary skill in the art would be motivated to do so with a reasonable expectation of success given the fact that compositions are stored at temperatures of 2-8oC for periods of at least 24 months for the benefit of having improved stability and being able to store and/or transport the sample at a suitable temperature to avoid degradation of the composition or any other adverse effect at an unsuitable temperature. Thus, it would be obvious and merely routine to a skilled artisan to store the composition suitable for preserving an immunogenic composition.
Regarding claims 27-28, Roymans discloses the composition according to claim 1; and method of preparing said composition, whereby an immunologically effective amount of a viral fusion protein antigen and a stabilizing amount of an antiviral compound are added to the composition. Roymans discloses that the invention relates to the use of an inhibitor, as identified by any of the methods according to the present invention, which binds the alphahelical coiled coil protein complex of viruses that use a class I fusion protein, preferably RSV, in the manufacture of a medicament for treating respiratory tract infections (page 7 lines 1-5). With respect to the method’s functional result of reducing aggregation, the process of combining/admixing the protein antigen and compound with the fact that it is an immunologically effective amount and a stabilizing amount, the functional result would be the same (i.e. reducing aggregation). A skilled artisan would readily be able to use molecular techniques (i.e. after freeze thawing) to perform the method with the fusion protein and antiviral compound formed in vitro that is suitable for their specific application for the benefit of having the composition function optimally with enhanced efficacy. Thus, it would be obvious and merely routine to a skilled artisan to add the antigen to the sample comprising an antiviral compound suitable for generating the composition having the desired function of reducing aggregation.
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.
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