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 .
Applicants are informed that examination of the instant application will be conducted by Examiner Blumel, see contact information below.
Election/Restrictions
Applicant’s election without traverse of invention I and the required species in the reply filed on 5/12/26 is acknowledged.
Claims 13, 20, 22, 24, 25, 32-35, 51 and 60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/12/26.
Claims 1-4, 7, 9 and 11 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/6/23; 2/7/24; 6/26/24; 3/14/25; 4/22/25 and 9/23/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because drawings 2A, 3C, 3D, 7A and 7B presents data that are difficult to decipher. For example, figure 2A presents line graphs for particle size distribution of 4 different compositions, but the lines appear to have the same size/pattern. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1, 3, 7, 9 and 11 are rejected under 35 U.S.C. 102a1 as being anticipated by Bedu-Addo et al. (US PGPub 2019/0358318).
The claimed invention is drawn to an immunogenic composition comprising one or more non-naturally occurring recombinant influenza antigens, and a cationic lipid. The cationic lipid is DOTAP. The influenza antigens are H1N1 and H3N2 hemagglutinins. The influenza antigens are mixed with preformed cationic lipid nanoparticles at a ration of 1:1.
The specification at paragraph 51 states: “As used herein, the "non-naturally occurring" peptide or antigen means a peptide or antigen that is not found in nature and that is comprised of one or more peptides or antigens, naturally occurring or non-naturally occurring, combined into a single peptide or antigen.”
Bedu-Addo et al. teach the formulation of influenza HA antigens with cationic lipids, such as DOTAP, which can include S-DOTAP and/or R-DOTAP. [see paragraphs 24-27, 32-34] It is also taught that one or more protein antigens from one or more influenza viruses are part of their composition. [see paragraphs 41 and 75-87] Bedu-Addo et al. also teach that the antigen of the pathogen is synthetic or recombinant [see paragraphs 49 and 140] and that protein antigens can be from more than one influenza virus, such as H3N2 and H1N1. [see paragraphs 172-176] Bedu-Addo et al. also teach the generation of cationic lipid based nanoparticles that are used as an adjuvant with antigens and these nanoparticles are effective delivery systems. [see paragraphs 348-350, 352 and 354] Lastly, Bedu-Addo et al. teach a commercial influenza vaccine formulation containing three influenza antigens B Brisbane, A/California/07/2009 (H1N1) A/Perth/16/2009 (H3N2) was diluted to 60 μg/ml or 12 μg/ml in PBS and then mixed 1:1 v/v with 8 mM or 4 mM R-DOTAP. [see paragraph 389] This commercial vaccine possesses influenza antigens, which are different from the virus itself and therefore are interpreted as a non-naturally occurring antigen in view of the applicant’s specification at paragraph 51.
Therefore, Bedu-Addo et al. anticipate the instant invention.
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.
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bedu-Addo et al. as applied to claims 1, 3, 7, 9 and 11 above, and further in view of Strugnell et al. (US PGPub 2020/0215182).
The claimed invention also requires that the one or more non-naturally occurring recombinant influenza antigens comprise a COBRA hemagglutinin (HA).
While Bedu-Addo et al. do teach that synthetic proteins can be produced, and provides examples of influenza HA proteins, they do not teach that COBRA HA as part of their immunogenic composition.
Strugnell et al. the generation of engineered influenza hemagglutinin proteins by using COBRA technology. [see paragraph 18] These HA proteins possess consensus sequences from influenza strains and offering an ability to induce cross-reactive immune responses. [see paragraph 19] Strugnell et al. also teach that a lipid vesicle can encapsulate the engineered hemagglutinins. [see paragraph 170]
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Bedu-Addo et al. in order to incorporate influenza HA proteins generated by COBRA. One would have been motivated to do so, given the suggestion by Bedu-Addo et al. that the influenza proteins, including HA proteins can be combined with DOTAP and that synthetic proteins are also contemplated. There would have been a reasonable expectation of success, given the knowledge that influenza HA proteins can product by COBRA and that these proteins are capable of inducing immune responses and they can be combined with lipid vesicles, as taught by Strugnell et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bedu-Addo et al. as applied to claims 1, 3, 7, 9 and 11 above, and further in view of Chappell et al. (US PG Pub 2020/0040042).
The claimed invention also requires that the one or more non-naturally occurring influenza antigens are at least 80% identical to SEQ ID NO:s 3 and 4.
While Bedu-Addo et al. teach influenza HA proteins, they do not teach the HA proteins with at least 80% identity to SEQ ID NO:s 3 and 4.
Chappell et al. immunogenic compositions comprising viral proteins, such as chimeric influenza HA proteins. [see abstract and paragraph 401 and example 6] Specific examples of these proteins are that of SEQ ID NO: 158, which is 94.5% identical to SEQ ID NO: 4 and SEQ ID NO: 161 of Chappell et al. is 96.1% identical to SEQ ID NO: 3.
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Bedu-Addo et al. in order to incorporate influenza HA proteins of H3 and H1 influenza viruses, which would possess at least 80% sequence identity to SEQ ID NO:s 3 and 4. One would have been motivated to do so, given the suggestion by Bedu-Addo et al. that the influenza proteins, including HA proteins can be combined with DOTAP and that synthetic proteins are also contemplated. There would have been a reasonable expectation of success, given the knowledge that influenza HA proteins have been previously taught as part of an immunogenic composition and shares greater than 80% identity with SEQ ID NO:s 3 and 4, as taught by Strugnell et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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 Longi, 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 online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,904,015. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention is drawn to a lipid based vaccine composition comprising at least one pathogenic antigen, such as an influenza hemagglutinin, which is synthetic, and the lipid is R-DOTAP. Therefore, the patented invention anticipates the instantly claimed immunogenic composition comprising one or more non-naturally occurring recombinant influenza antigens and a cationic lipid, which is DOTAP and includes S- and R- DOTAP.
Claims 1 and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,911,465. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention is drawn to a method of administering a lipid-based vaccine composition comprising at least one pathogenic antigen, such as an influenza antigen that is modified to increase hydrophobicity of the antigen, which is not naturally occurring, and the lipid is R-DOTAP. Therefore, the patented invention anticipates the instantly claimed immunogenic composition comprising one or more non-naturally occurring recombinant influenza antigens and a cationic lipid, which is DOTAP and it includes S- and R- DOTAP.
Claims 1-4, 7, 9 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,904,015 in view of Bedu-Addo et al. (supra), Strugnell et al. (supra) and Chappell et al. (supra).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention is drawn to a lipid based vaccine composition comprising at least one pathogenic antigen, such as an influenza hemagglutinin, which is synthetic, and the lipid is R-DOTAP. The patented invention does not require an influenza antigen being a COBRA hemagglutinin, or that the hemagglutinin is H1N1 and H3N2, or the influenza antigen is at least 80% identical to SEQ ID NO:s 3 and 4, or the influenza hemagglutinin is mixed with preformed cationic lipid nanoparticles at a ratio of 1:1.
However, the teachings of Bedu-Addo et al. (supra), Strugnell et al. (supra) and Chappell et al. (supra) render obvious the addition of a COBRA hemagglutinin, the use of hemagglutinins from H1N1 and H3N2 influenza viruses, such as those with at least 80% identity to SEQ ID NO:s 3 and 4 and the mixing of the influenza antigens with preformed cationic lipid nanoparticles at a ratio of 1:1.
Claims 1-4, 7, 9 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,911,465 in view of Bedu-Addo et al. (supra), Strugnell et al. (supra) and Chappell et al. (supra).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented invention is drawn to a method of administering a lipid-based vaccine composition comprising at least one pathogenic antigen, such as an influenza antigen that is modified to increase hydrophobicity of the antigen, which is not naturally occurring, and the lipid is R-DOTAP. The patented invention does not require an influenza antigen being a COBRA hemagglutinin, or that the hemagglutinin is H1N1 and H3N2, or the influenza antigen is at least 80% identical to SEQ ID NO:s 3 and 4, or the influenza hemagglutinin is mixed with preformed cationic lipid nanoparticles at a ratio of 1:1.
However, the teachings of Bedu-Addo et al. (supra), Strugnell et al. (supra) and Chappell et al. (supra) render obvious the addition of a COBRA hemagglutinin, the use of hemagglutinins from H1N1 and H3N2 influenza viruses, such as those with at least 80% identity to SEQ ID NO:s 3 and 4 and the mixing of the influenza antigens with preformed cationic lipid nanoparticles at a ratio of 1:1.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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