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
1. Claims 1-3, 9 are amended. Claims 13, 14 are canceled. Claims 1-12, 15-17 are under consideration.
Claim Objections
2. (previous objection, withdrawn) Claims 1-3, 9, 13 were objected to because of informalities.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 112
3. (previous rejection, withdrawn) Claims 1-17 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
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.
4. (previous rejection, maintained; withdrawn as to canceled claim 13) Claims 1-3, 5, 6, 9, 10, 12, 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tschopp et al. (WO0149866A1; previously cited)(See also the WIPO English translation of WO0149866A1; previously cited) in view of Hotez et al. (WO2015080973A1; previously cited) and Voloch et al. ("Genomic Characterization of a Novel SARS-CoV-2 Lineage from Rio de Janeiro, Brazil," Journal of Virology, Vol. 95, Issue 10: 1-4 (2021); previously cited).
See claims 1-3, 5, 6, 9, 10, 12, 15-17 as submitted 728/2026.
Applicant contends: the claimed antigen is not taught or suggested by the prior art; Tschopp et al. does not teach vaccine as recited in claim 1; Tschopp et al. is does not teach or suggest that a single fusion protein should contain two component A domains arranged in tandem; Tschopp et al. discloses recombinant fusion proteins comprising at least one biologically active component A and at least one component B, whose function is to promote dimerization, oligomerization, multimerization, or higher-order assembly of the fusion proteins without involvement of third molecules; Tschopp et al. would lead one of ordinary skill in the art to fuse an antigenic component to a separate oligomerization component B; the fusion proteins of Tschopp et al. are directed to a different structural concept; Hotez et al. does not disclose or teach a protein as claimed; Hotez et al. does not point to a tandem RBD fusion protein; Hotez et al. would lead one of ordinary skill in the art to use an optimize a single RBD antigen; Voloch et al. does not teach or suggest a protein as claimed; one of ordinary skill in the art would not have been led to place two such RBDs in tandem within the same fusion protein; the combination proposed would have required one of ordinary skill in the art to make selections and modifications neither taught nor suggested by the cited references; the secondary indicia of non-obviousness is sufficient to rebut; the data in Examples 8, 9, 11, and Figures 12, 14 would have been unexpected; the results show induction of neutralizing antibodies; it is completely unexpected that a fusion protein would be capable of generating immune responses.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action. As to the amendment in claim 1 reciting “consist of”, it is noted that as indicated Tschopp et al. already teaches or suggests recombinant fusion proteins (p. 1); including wherein proteins can be linked in dimers or multimers of oligomers (p. 7); including oligomers employed as vaccines for immunization against infectious diseases (p. 17); including wherein antigens or fragments from viruses are suitable; wherein vaccines containing bi or oligomers, wherein the recombinant
fusion proteins have at least one component A, one or more identical or different antigens of the
pathogens can be used for vaccination (p. 17)(as recited in claim 1); this invention allows for the
combination of different antigens in a bi- or oligomer or a higher order aggregate of bi- or
oligomers, wherein different antigens from the same pathogen can be combined in a bi- or
oligomer (p. 17)(as recited in claims 1, 12). Further, as indicated, Hotez et al. already teaches vaccine consisting of receptor binding domain of SARS-CoV spike protein [0033], which is interpreted as teaching or suggesting RBD of SARS-CoV as a discrete antigen.
Response to Arguments
Turning to applicant’s arguments, first, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
It is maintained that one of ordinary skill in the art would have been motivated and had a reasonable expectation of success in arriving at the instantly claimed invention in view of Tschopp et al. in view of Hotez et al. and Voloch et al. (See MPEP 2143: Examples of Basic Requirements of a Prima Facie Case of Obviousness: I. EXEMPLARY RATIONALES: Examples of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.).
As to Tschopp et al., the reference is not so limited as applicant contends. Rather, Tschopp et al. is cited for the teachings as indicated previously and above. Namely, Tschopp et al. teaches or suggests recombinant fusion proteins (p. 1); including wherein proteins can be linked in dimers or multimers of oligomers (p. 7); including oligomers employed as vaccines for immunization against infectious diseases (p. 17); including wherein antigens or fragments from viruses are suitable; wherein vaccines containing bi or oligomers, wherein the recombinant
fusion proteins have at least one component A, one or more identical or different antigens of the
pathogens can be used for vaccination (p. 17); this invention allows for the
combination of different antigens in a bi- or oligomer or a higher order aggregate of bi- or
oligomers, wherein different antigens from the same pathogen can be combined in a bi- or
oligomer (p. 17)(See MPEP 2121: I. PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING: When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012); … See also MPEP 2121.01: II. 35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART: “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instrumentsv.LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103.” Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991). Further, the vaccine as recited in claim 1 “comprises” at least one antigen consisting of first and second monomers. Thus the vaccine is interpreted in an open ended fashion and does not exclude other components beyond the at least one antigen consisting of first and second monomers as claimed (See MPEP 2111).
Further, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as previously indicated, one of ordinary skill in the art would have been motivated to use RBD antigens as taught by Hotez et al. with the construct as taught by Tschopp et al. Tschopp et al. teaches use of viral antigens in dimer constructs for eliciting immune responses, and Hotez et al., which also teaches viral antigens for eliciting immune responses, teaches such viral antigens (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further, one of ordinary skill in the art would have been motivated to use SARS-CoV-2 and different SARS-CoV-2 lineages as taught by Volokh et al. with the construct of Tschopp et al. and Hotez et al. Tschopp et al. and Hotez et al. teaches the use of different antigens from the same pathogen and use of viral antigens and SARS coronavirus, and Volokh et al., which also teaches SARS-CoV-2 and different lineages of the same pathogen, teaches such pathogens and SARS coronavirus variants (See MPEP 2144.06: Substituting equivalents known for the same purpose). Further, one of ordinary skill in the art would have also been motivated to use or combine different lineages as taught by Volokh et al. for the advantage of eliciting a broader, more complete immune response against SARS-CoV-2.
Further, it is noted that the rejection is in view of the instant claim language. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As indicated above and previously, Tschopp et al. in view of Hotez et al. and Voloch et al. already teaches or suggest vaccine applications, thus, one of ordinary skill in the art would expect generation of immune responses (See also MPEP 2143.02, part II (requiring only at least some degree of predictability, not complete confidence in a desired outcome)).
The rejection is maintained for reasons of record
5. (previous rejection, maintained) Claims 7, 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tschopp et al. in view of Hotez et al. and Voloch et al. as applied to claims 1-3, 5, 6, 9, 10, 12, 15-17 above, and further in view of O'Hagan et al. (WO0226209A2; previously cited).
See claims 7, 11 as submitted 728/2026.
Applicants contends; O’Hagan et al. does not cure the deficiencies.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
Response to Arguments
Turning to applicant’s arguments, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection is maintained for reasons of record.
6. (previous rejection, maintained) Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tschopp et al. in view of Hotez et al. and Voloch et al. as applied to claims 1-3, 5, 6, 9, 10, 12, 15-17 above, and further in view of Cho et al. (US20210275665A1; previously cited).
See claim 8 as submitted 728/2026.
Applicant contends; Cho et al. does not cure the deficiencies.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
Response to Arguments
Turning to applicant’s arguments, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection is maintained for reasons of record.
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.
7. (previous rejection, maintained; withdrawn as to canceled claims 13, 14) Claims 1-12, 15-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/558875.
See claims 1-12, 15-17 as submitted 728/2026.
Applicant contends: the claims of the reference application do not teach or suggest all features of the amended claims; applicant will further address the rejection in parallel with the reference application as prosecution progresses.
See the rejection as recited in the previous Office Action.
The rejection is maintained for reasons of record.
Conclusion
8. No claims are allowed.
9. 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 M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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 at 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 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.
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
Prosecution Insights