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, 5-8, 11, 13, 14 are amended. New claims 36-39 are added. Claims 2-4, 9, 24-29 are canceled. Claims 15-23, 30-35 are withdrawn. Claims 1, 5-8, 10-14, 36-39 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) was submitted on 5/14/2026. 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 Objections
3. (previous objection, withdrawn) Claim 14 was objected to because of informalities.
Applicant contends: the claim has been amended.
In view of applicant’s amendments, the objection is withdrawn.
4. (new objection) Claim 8 is objected to because of the following informalities:
For improved grammar, claim 8 should recite “at least a portion of one or more SARS receptor binding domain sequences has been replaced by DNA coding for a peptide linker.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. (previous rejection, withdrawn) Claims 3, 7, 8, 11, 13, 14, 25, 28, 29 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to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: amendments have been presented; “fully deleted” refers to vectors in which all adenoviral protein-coding sequences have been removed, while retaining only those elements necessary for replication and packaging.
In view of applicant’s amendments, the rejection is withdrawn.
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.
6. (new, necessitated by amendment) Claims 1, 5-8, 10-14, 36-39 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 1, 5-8, 10-14, 36-39 as submitted 4/1/2026.
As to claims 1, 13, the claims recite “a consensus sequence having at least 65% commonality with each member of the homology group”. It is not clear what the percent commonality refers to or where percent identity is calculated from, as it is not clear what would constitute position number 1, or where the ending position is, for which to calculate percent commonality. Further, applicant contends above “ ‘fully deleted’ “ refers to vectors in which all adenoviral protein-coding sequences have been removed, while retaining only those elements necessary for replication and packaging.” In view of such a response, it is not clear if “all endogenous genes” includes “only those elements necessary for replication and packaging” or not. Further, it is not clear what the metes and bounds of “a homology group comprising a plurality of SARS-2 β-CoVs” are. It is not clear what strains are included therein, or how many or included or excluded. Claims 5-8, 10-12, 14, 36-39 depend on these claims.
Further as to claim 13, the claim recites “packaging plasmid” and “packing plasmid”. It is not clear if these terms refer to the same product or not.
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.
7. (new, necessitated by amendment) Claims 1, 5-8, 10-14, 36-39 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 1, 5-8, 10-14, 36-39 as submitted 4/1/2026.
See also the 35 U.S.C. 112(b) rejection above.
Claims 1, 13 recite “a homology group comprising a plurality of SARS-2 ß-CoVs”.
Each of the claims is drawn, inherently or explicitly, to a homology group comprising a plurality of SARS-2 ß-CoVs. Thus, the claims are drawn to compositions comprising or methods of using a genus of a homology group comprising a plurality of SARS-2 ß-CoVs.
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 teaches: The homology groups can be based on similarities in the entirety of the ß-CoVs' genetic sequences, multiple portions of the β-CoVs' genetic sequences, or a single portion of the β-CoVs' genetic sequences. The genetic sequences are selected from the group consisting of DNA sequences, RNA sequences, protein sequences, and combinations thereof. It will be understood that if a single β-CoV is identified, it is the sole member of a single homology group. In a particular embodiment, the β-CoVs comprise a plurality of SARSrs, and the plurality of SARSrs are separated into 1, or at least 2, or at least 3, or at least 4, or at least 5 homology groups. In an embodiment, the homology groups are based on at least a portion, or at least two or more portions, or all, of the genetic sequence associated with the spike protein, the SARS receptor binding domain (RBD), an envelope protein, a nucleoprotein, and combinations thereof [0036-0037].
However, given the indefiniteness as indicated above, the specification does not identify a representative sample of “a homology group comprising a plurality of SARS-2 ß-CoVs” especially in view of the breadth of the claims. Thus, the application does not identify a representative sample of the specific homology groups within the breadth of the claimed genus.
There is no apparent common conserved homology to the different SARS-2 ß-CoVs that distinguishes those that are members of the homology group as compared to those that are not. There is therefore a high level of uncertainty as to which SARS-2 ß-CoVs fall within the scope of the indicated homology group and genus.
Further, the specification has identified SARS-2 ß-CoVs only by homology. The specification does not provide a specific structure that correlates with the required homology. Because there is no identification of structures common to each SARS-2 ß-CoV, nor sufficient representative examples of the SARS-2 ß-CoV by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of a homology group comprising a plurality of SARS-2 ß-CoVs. The mere presence of a plurality of SARS-2 ß-CoVs does not demonstrate that such strains would have or how they would have homology.
For the reasons above, the application has not provided sufficient written description support for the genus of homology groups comprising a plurality of SARS-2 ß-CoVs identified in claims 1, 13.
Claim Rejections - 35 USC § 101
8. (previous rejection, withdrawn) Claims 1, 4-6, 10, 24-27 were rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Applicant contends: the amendments render the rejections moot.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 102
9. (previous rejection, withdrawn) Claims 1-6, 10, 24-27 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (CN110974950A)(cited in applicant's IDS submitted 10/20/2022) (See also the WIPO English translation of CN110974950A; previously cited).
Applicant contends: applicant has amended claims 1 and 13; Chen et al fails to disclose the amended limitations; Chen et al. does not teach consensus SARS-2 β-CoV DNA sequence as claimed; Chen et al. does not teach the packaging plasmid.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 103
10. (previous rejection, withdrawn) Claims 7, 28 were rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. as applied to claims 1-6, 10, 24-27 above, and further in view of Hotez et al. (US20160376321; previously cited).
Applicant contends: the additional reference does not remedy the deficiencies.
In view of the withdrawal of the rejection over Chen et al. on which the instant rejection depends, the instant rejection is also withdrawn.
11. (previous rejection, withdrawn) Claims 9, 11 were rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. as applied to claims 1-6, 10, 24-27 above, and further in view of Tang et al. (US20150071964; previously cited).
Applicant contends: the additional reference does not remedy the deficiencies.
In view of the withdrawal of the rejection over Chen et al. on which the instant rejection depends, the instant rejection is also withdrawn.
12. (previous rejection, withdrawn) Claim 12 was rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. as applied to claims 1-6, 10, 24-27 above, and further in view of Wang et al. ("Serological Evidence of Bat SARS-Related Coronavirus Infection in Humans, China," Virologica Sinica (2018) ; previously cited).
Applicant contends: the additional reference does not remedy the deficiencies.
In view of the withdrawal of the rejection over Chen et al. on which the instant rejection depends, the instant rejection is also withdrawn.
13. (previous rejection, withdrawn) Claims 13, 14 were rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. in view of Tang et al. (references cited above).
Applicant contends: the additional reference does not remedy the deficiencies.
In view of the withdrawal of the rejection over Chen et al. on which the instant rejection depends, the instant rejection is also withdrawn.
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.
14. (new, necessitated by amendment) Claims 1, 5, 6, 7, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Staerz et al. (WO2021202333A1)(See PTO-892: Notice of References Cited) in view of Tang et al. (US20150071964; previously cited) and Hauser al. (WO2021163622A1)(See PTO-892: Notice of References Cited).
See claims 1, 5, 6, 7, 10 as submitted 4/1/2026.
See also the 35 U.S.C. 112(b) rejection above.
Staerz et al. (it is noted that the following teachings are supported by its provisional 63/001758) teaches: fully-deleted adenovirus-based gene delivery vectors (abstract)(as recited in claim 1); used in expression of proteins, vaccine development (abstract); packaging expression plasmid; may be deleted of one or two of the ITRs [0098](it is noted that instant claim 1 recites “comprising a single ITR”, which does not exclude another ITR, as “comprising” is interpreted in an open ended fashion (See MPEP 2111)); co-transfection of fully deleted adenoviral vector with packaging plasmid [0036](as recited in claim 1); packaging cell [0037](as recited in claim 10); one or more expression cassettes of a DNA sequence of interest [0118].
Staerz et al. does not teach: Ad6; SARS-2 ß-CoV DNA sequence derived from a homology group comprising a plurality of SARS-2 ß-CoVs; and the SARS-2 ß-CoV DNA sequence comprises a consensus sequence having at least 65% commonality with each member of the homology group; entire coding sequence of the S protein; partial sequence coding S protein; wherein the SARS-2 ß-CoV DNA sequence is a partial sequence coding the S protein from which at least a portion of a SARS receptor binding domain has been removed.
Tang et al. teaches: adenoviral vector vaccines (abstract); including Ad6 [0043].
Hauser et al. (it is noted that the following teachings are supported by its provisional 62/977402) teaches: heterologous nucleic acid inserts encoding one or more SARS-CoV2 proteins (p. 62); betacoronavirus (p. 62)(as recited in claim 1); including wherein linear epitope of S protein is RBD consensus sequence (p. 86)(as recited in claim 1); full length S protein (p. 5)(as recited in claim 5); partial spike (p. 103)(as recited in claim 6); including linear RBD epitope comprising amino acids 331-598 (p. 8); as well as linear S epitope amino acids 504 to 524 (p. 9)(as recited in claim 7)(interpreted as wherein amino acids of RBD have been removed comparing 504-524 to 311-598).
One of ordinary skill in the art would have been motivated to use Ad6 as taught by Tang et al. as adenovirus in system as taught by Staerz et al. Staerz et al. teaches use of adenovirus in vector systems, and Tang et al. teaches such a known adenovirus (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 gene as taught by Hauser et al. with adenovirus system as taught by Staerz et al. in view of Tang et al. Staerz et al. in view of Tang et al. teaches use of one or more expression cassettes of a DNA sequence of interest, and Hauser et al. teaches such sequence (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 gene as taught by Hauser et al. with adenovirus system as taught by Staerz et al. in view of Tang et al. There would have been a reasonable expectation of success given the underlying materials and methods (gene expression as taught by Hauser et al. and Staerz et al. in view of Tang et al.) 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.
15. (new, necessitated by amendment) Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Staerz et al. in view of Hauser et al. and Tang et al. as applied to claims 1, 5, 6, 7, 10 above, and further in view of Wang et al. ("Serological Evidence of Bat SARS-Related Coronavirus Infection in Humans, China," Virologica Sinica (2018); previously cited).
See claim 12 as submitted 4/1/2026.
See the teachings of Staerz et al. in view of Hauser et al. and Tang et al. above. It is noted Staerz et al. also teaches: one or more expression cassettes of a DNA sequence of interest [0118].
Staerz et al. in view of Hauser et al. and Tang et al. does not teach: SARSr.
Wang et al. teaches: SARSr-CoV (p. 1); spike protein of SARSr-CoV (p. 2).
One of ordinary skill in the art would have been motivated to use SARSr spike protein
taught by Wang et al. with the construct as taught by Staerz et al. in view of Hauser et al. and Tang et al. Staerz et al. in view of Hauser et al. and Tang et al. teaches use of SARS-CoV-2 antigen and one or more expression cassettes, and Wang et al., which also teaches use of SARS-CoV, teaches additional known strains of SARS-CoV such as SARS-CoV as well as such a spike protein (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 SARSr spike protein taught by Wang et al. with the construct as taught by Staerz et al. in view of Hauser et al. and Tang et al. There would have been a reasonable expectation of success given the underlying materials (S protein of SARS-CoV-2 as taught by Wang et al. and Staerz et al. in view of Hauser et al. and Tang 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
16. (previous rejection, withdrawn) Claims 24-27 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-61 of copending Application No. 18/016344.
Applicant contends: the rejection should be held in abeyance until the claims are otherwise found allowable.
In view of applicant’s amendments, the rejection is withdrawn.
17. (previous rejection, withdrawn) Claims 1, 4, 6, 24, 25, 27 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 17/998607.
Applicant contends: the rejection should be held in abeyance until the claims are otherwise found allowable.
In view of applicant’s amendments, the rejection is withdrawn.
Conclusion
18. No claims are allowed.
19. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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