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
Election Restrictions
1. Applicant’s election of Group II and species (SARS-CoV-2) in the reply filed on 12/29/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-9, 19-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
Claims 10-18 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 8/24/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
3. Claims 10-18 are 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.
See claims 10-18 as submitted 10/13/2022.
As to claims 10, 15, the claims recite amino acid position numbers 194 and 333. It is not clear where position 1 starts or what the numbers are relative to.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
4. Claims 13, 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 13, 18 as submitted 10/13/2022.
Claim 13 recites the composition according to claim 10, wherein the Coronavirus antigen comprises a fragment of SARS-CoV-2 S that binds to angiotensin-converting enzyme 2. Claim 18 recites kit according to claim 15, wherein the Coronavirus antigen comprises a fragment of SARS-CoV-2 S that binds to angiotensin-converting enzyme 2. Thus, the claims read on and are drawn to a genus of SARS-CoV-2 S binding fragments to ACE2.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the application recites: fragment of SARS-CoV-2 S that binds to angiotensin-converting enzyme 2 (p. 4), generally.
However, the binding domains of SARS-CoV-2 to ACE2 are not well characterized in the art at the time of effective filing. Renzi et al. (“ACE2 fragment as a decoy for novel SARS-Cov-2 virus,” found on bioRxhiv (2020))(See PTO-892:Notice of References Cited) teaches: S glycoprotein is synthesized as a precursor of about 1300 amino acids; S1 containing RBD is cleaved; ACE2 is 805 amino acids (p. 1); the angiotensinII binding site is located quite far from the surface where the viral S-protein binds; double helix is unlikely to interfere with angiotensinII (p. 3); key residues are found in the two N-terminal back to back helices 1 and2; an ideal fragment would include the downstream beta-hairpin carrying the conserved Lys353 (p. 3); the fragment might be employed for diagnostic purposes (p. 4).
However, given the breadth of the term “fragment of SARS-CoV-2 S that binds to angiotensin-converting enzyme 2”. the specification does not identify a representative sample of binding fragments in view of the breadth of the claims and the uncertainty in the art.
There is no apparent common conserved structure to the different binding fragments that distinguishes those S protein fragments that bind to ACE2 as compared to those that do not. There is therefore a high level of uncertainty as to which fragments fall within the scope of the indicated genus.
Further, the specification has identified fragments of SARS-CoV-2 only by function: the ability to bind to ACE2. The specification does not provide a specific structure of any fragments within the genus that correlates with the required function of binding ACE2. Because there is no identification of structures common to each fragment, nor sufficient representative examples by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of fragments through identification of a structure and function. This is because the mere presence of a fragment of S protein does not demonstrate that it would have sufficient binding function to ACE2.
For the reasons above, the application has not provided sufficient written description support for the genus of fragments recited in claims 13, 18.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
5. Claims 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over Dietzschold et al. (WO2014189654)(cited in applicant's IDS submitted 6/24/2024) in view of Chen et al. (CN110951756A)(cited in applicant's IDS submitted 6/24/2024)(See also the WIPO English translation of CN110951756A; previously cited in the Restriction Action of 7/1/2025).
See claims 10-18 as submitted 10/13/2022.
Dietzschold et al. teaches: a nonpathogenic recombinant rabies virus comprising at least three copies of a mutated G gene, wherein said mutated G gene encodes a rabies virus glycoprotein wherein the glycoprotein amino acid 194 is serine and the glycoprotein amino acid 333 is glutamic acid, wherein said recombinant rabies virus does not express a foreign protein antigen (abstract); as well as non-rabies antigen not expressed by the rabies virus (abstract); administering step (abstract); kit, vaccine (abstract)(as recited in claims 14, 15).
Dietzschold et al. does not teach: a Coronavirus antigen, or a nucleic acid
molecule encoding a Coronavirus antigen, wherein the Coronavirus antigen
is not expressed by the rabies virus.
Chen et al. teaches: nucleic acid sequence expressing a SARS-CoV-2 virus antigen
([0002] of the English translation)(as recited in claims 10, 11, 15, 16); spike protein [0006](as recited in claims 12, 17); wherein S protein contains S1 (which binds to ACE2; interpreted as comprising a fragment that binds to ACE2)[0006](as recited in claims 13, 18).
One of ordinary skill in the art would have been motivated to use the antigen of Chen et al. with the composition of Dietzschold et al. Dietschold et al. teaches use of non-rabies antigen, and Chen et al. teaches such an antigen (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using the antigen of Chen et al. with the composition of Dietzschold et al. There would have been a reasonable expectation of success given the underlying materials (antigens as taught by Dietschold et al. and Chen et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole 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 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.
6. Claims 10-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 8282939 in view of Dietzschold et al. and Chen et al. (cited above).
See claims 10-18 as submitted 10/13/2022.
Claims 1-7 of U.S. Patent No. 8282939 recite a nonpathogenic recombinant rabies virus comprising at least three copies of a mutated G gene, wherein said mutated G gene encodes a rabies virus glycoprotein wherein the amino acid 194 is serine and the amino acid 333 is glutamic acid in the glycoprotein; vaccine; composition.
Claims 1-7 of U.S. Patent No. 8282939 do not teach wherein said rabies virus does not
express a foreign protein antigen; Coronavirus antigen.
See the teachings of Dietzschold et al. and Chen et al. above.
One of ordinary skill in the art would have been motivated to use rabies virus as recited
in claims 1-7 of U.S. Patent No. 8282939 in view of Dietzschold et al. and Chen et al. Dietzschold et al. and Chen et al. teach use of rabies virus comprising at least three copies of a mutated G gene, wherein said mutated G gene encodes a rabies virus glycoprotein wherein the amino acid 194 is serine and the amino acid 333 is glutamic acid in the glycoprotein, and claims 1-7 of U.S. Patent No. 8282939 also teach such a rabies virus (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using rabies virus as recited in claims 1-7 of U.S. Patent No. 8282939 in view of Dietzschold et al. and Chen et al. There would have been a reasonable expectation of success given the underlying materials (rabies virus as recited by claims 1-7 of U.S. Patent No. 8282939 and Dietzschold et al. and Chen et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
7. No claims are allowed.
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