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 .
Disposition of Claims
Claims 1-36 are pending.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2023/0210981 A1, Published 06 July 2023. Applicant’s amended Specification as presented on 08 December 2022 is acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Of note, there is not an attorney of record on file due to a lack of an official power of attorney of record. While a customer number has been provided on the ADS submitted 12/08/2022, this is not the equivalent of a power of attorney or an authorization to act in a representative capacity. In order to expedite prosecution in the instant application, it is suggested that a power of attorney be filed as per MPEP §402 or MPEP §1807, or an Authorization to Act in a Representative Capacity be filed as per MPEP §403 in order for the Office to freely and openly discuss the merits of the case with the applicant's representative(s). Please refer to the MPEP or http://www.uspto.gov/patents/law/poafaqs.jsp#a if you have questions regarding the proper filing of a power of attorney.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The Drawings are objected for containing references to colors. Specifically, Figures 1A, 1B, and 2D refer to colors (i.e., red, yellow, green, blue) either in the figures themselves or the figure legends within the Specification. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: “The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.”
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
The objection to the drawings will not be held in abeyance.
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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains language which can be implied, specifically in the form of the word “disclosed” (i.e., “Disclosed herein…”) [emphasis added]. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1-2, 7-8, 10, 16-18, 20, 22, 25, 27, 32, and 34 are objected to because of the following informalities: in Claims 1 and 16, it is suggested that they say “…from one or more host subjects,…” instead of “…from one or more host subject,…”.
In Claims 2, 4, 8, 10, 18, 20, 25, 27, 32, and 34, it is suggested that all instances of “over an entire length” should be replaced with “over the entire length”.
In Claim 2, it is suggested that it say “The immunogenic composition of claim 1,…” instead of “The composition of claim 1,…”.
In Claims 7 and 22, it is suggested that “a plasma” be replaced with either “a plasma sample” or “plasma”.
In Claim 16, it is suggested that it say “…one or more immunoglobulin molecules…” instead of “…one or more immunoglobulin molecule…”.
In Claim 17, it is suggested that it say “…or is considered cured of a SARS-CoV-2 infection…” instead of “…or has is considered cured of SARS-CoV-2 infection…”. It is also suggested that it say “…having a SARS-CoV-2 infection…” instead of “…having SARS-CoV-2 infection…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
Claims 5 and 12-13 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.
Claims 5 and 12-13 recite the limitation "the nucleic acid" in Line 1 of each respective claim. There is insufficient antecedent basis for this limitation in the claims. Claim 1, which Claims 5 and 12-13 all depend upon, does not introduce the limitation of “a nucleic acid”. As such, it is unclear which nucleic acid is being referenced in Claims 5 and 12-13. This lack of clarity renders the claims indefinite. It is suggested that the claims be amended by properly introducing the limitation of “a nucleic acid” in Claim 1 or Claims 5 and 12-13 or that Claim 5 be amended to be dependent on Claim 4 and Claims 12 and 13 be amended to be dependent on Claim 11, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 5 and 12-13 are rejected on the grounds of being indefinite.
Claims 23 and 30, and dependent claims 24-29 and 31-36 thereof, 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.
Regarding Claims 23 and 30, they recite the limitation “an immunogenic composition of claim 1”. The use of the word “an” renders the claim indefinite because it makes it seem as if it is referring to a different immunogenic composition from the one introduced in Claim 1 as though there are multiple compositions in Claim 1 to choose from and only one is being selected in the respective dependent claims. Alternatively, it can also be interpreted as referring to only a portion of the immunogenic composition in Claim 1. “A/An” is an indefinite article, while “the” is a definite article. “The” refers back to a specific immunogenic composition from Claim 1, while “A” can refer back to any non-specific molecule and is not clear that it is only referencing the immunogenic composition of Claim 1. It is suggested that the claims be amended by replacing “an” with “the”, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 23 and 30 are rejected on the grounds of being indefinite. Claims 24-29 and 31-36 are also rejected since they depend upon Claims 23 and 30, respectively, but do not remedy the deficiencies of Claims 23 and 30.
Claim 23 is 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.
Regarding Claim 23, it recites the limitation “A method of inducing an immune response against SARS-CoV-2 in a subject in need thereof, the method comprising administering an immunogenic composition of claim 1 to the subject”. It is unclear how administering the immunogenic composition of claim 1, which at a minimum only comprises intravenous immunoglobulin, would generate an immune response in a subject upon administration to said subject without the presence of an antigen and/or adjuvant. This lack of clarity renders the claim indefinite. It is suggested that the claims be amended by incorporating the limitations of dependent Claims 15 and/or 24 into Claims 1 and/or 23, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 23 is rejected on the grounds of being indefinite.
Claim 30, and dependent claims 31-36 thereof, is 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.
Regarding Claim 30, it recites the limitation “protecting a subject in need thereof from infection with SARS-CoV-2 or COVID-19”. While it makes sense to protect a subject from infection with SARS-CoV-2, it is unclear how COVID-19 can cause an infection in a subject. SARS-CoV-2 is the virus, while COVID-19 is the disease caused by said virus. This lack of clarity renders the claim indefinite. It is suggested that the claim be amended by removing “or COVID-19”, but Applicant is free to amend the claim as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 30 is rejected on the grounds of being indefinite. Claims 31-36 are also rejected since they depend upon Claim 30, but do not remedy the deficiencies of Claim 30.
Claim Interpretation
In light of the issues raised above, the claims are being interpreted as reading upon the following:
Claim 1 is drawn to an immunogenic composition comprising intravenous immunoglobulin (IVIG) generated from one or more host subjects vaccinated against Coronavirus disease 2019 (COVID-19) or diagnosed as having COVID-19 and subsequently cured of COVID-19.
Claim 16 is drawn to a method of generating an immunogenic composition comprising intravenous immunoglobulin (IVIG) from one or more host subjects, the method comprising: a) administering a nucleic acid molecule encoding a SARS-CoV-2 antigen to the host subject; and b) isolating a biological sample comprising one or more immunoglobulin molecules from the host subject.
Further limitations on the immunogenic composition according to Claim 1 are:
2. The composition of claim 1, wherein the host subject was vaccinated with a nucleic acid molecule comprising a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 2; (b) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 4; (c) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 6; and (d) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 8.
3. The immunogenic composition of claim 1, wherein the host subject was vaccinated with a nucleic acid molecule comprising a nucleotide sequence encoding the amino acid sequence selected from the group consisting of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6 and SEQ ID NO: 8.
4. The immunogenic composition of claim 1, wherein the host subject was vaccinated with a nucleic acid molecule comprising a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 7.
5. The immunogenic composition of claim 4, wherein the nucleic acid molecule comprises the nucleic acid sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 5 and SEQ ID NO: 7.
6. The immunogenic composition of claim 1, wherein the immunoglobulin is extracted from a biological sample.
7. The immunogenic composition of claim 6, wherein the biological sample is plasma, blood, or a combination thereof.
8. The immunogenic composition of claim 1, further comprising a nucleic acid molecule comprising a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 2; (b) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 4; (c) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 6; and (d) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 8.
9. The immunogenic composition of claim 8, wherein the nucleic acid molecule comprises a nucleotide sequence encoding the amino acid sequence selected from the group consisting of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6 and SEQ ID NO: 8.
10. The immunogenic composition of claim 8, wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over an entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 7.
11. The immunogenic composition of claim 8, wherein the nucleic acid molecule comprises the nucleic acid sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 5 and SEQ ID NO: 7.
12. The immunogenic composition of claim 11, wherein the nucleic acid molecule comprises an expression vector.
13. The immunogenic composition of claim 11, wherein the nucleic acid molecule is incorporated into a viral particle.
14. The immunogenic composition of claim 1, further comprising a pharmaceutically acceptable excipient.
15. The immunogenic composition of claim 1, further comprising an adjuvant.
23. A method of inducing an immune response against SARS-CoV-2 in a subject in need thereof, the method comprising administering an immunogenic composition of claim 1 to the subject.
24. The method of claim 23, further comprising administering a nucleic acid molecule encoding a SARS-CoV-2 antigen to the subject.
25. The method of claim 24, wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 2; (b) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 4; (c) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 6; and (d) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 8.
26. The method of claim 24, wherein the nucleic acid molecule comprises a nucleotide sequence encoding the amino acid sequence selected from the group consisting of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6 and SEQ ID NO: 8.
27. The method of claim 24, wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 7.
28. The method of claim 24, wherein the nucleic acid molecule comprises the nucleic acid sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 5 and SEQ ID NO: 7.
29. The method of claim 24, wherein administering includes at least one of electroporation and injection.
30. A method of protecting a subject in need thereof from infection with SARS-CoV-2, the method comprising administering an immunogenic composition of claim 1 to the subject.
31. The method of claim 30, further comprising administering a nucleic acid molecule encoding a SARS-CoV-2 antigen to the subject.
32. The method of claim 30, wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 2; (b) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 4; (c) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 6; and (d) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 8.
33. The method of claim 30, wherein the nucleic acid molecule comprises a nucleotide sequence encoding the amino acid sequence selected from the group consisting of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6 and SEQ ID NO: 8.
34. The method of claim 30, wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 7.
35. The method of claim 30, wherein the nucleic acid molecule comprises the nucleic acid sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 5 and SEQ ID NO: 7.
36. The method of claim 30, wherein administering includes at least one of electroporation and injection.
Further limitations on the method according to Claim 16 are:
17. The method of claim 16, wherein the subject has been diagnosed as having a SARS-CoV-2 infection or COVID-19, or is considered cured of a SARS-CoV-2 infection or COVID-19.
18. The method of claim 16, wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 2; (b) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 4; (c) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 6; and (d) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 8.
19. The method of claim 16, wherein the nucleic acid molecule comprises a nucleotide sequence encoding the amino acid sequence selected from the group consisting of SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6 and SEQ ID NO: 8.
20. The method of claim 16, wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 7.
21. The method of claim 16, wherein the nucleic acid molecule comprises the nucleic acid sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 3, SEQ ID NO: 5 and SEQ ID NO: 7.
22. The method of claim 16, wherein the biological sample is plasma, blood, or a combination thereof.
Claim Rejections - 35 USC § 112(a); First Paragraph
Claims 2, 4, 8-13, 18, 20, 25, 27, 32, and 34 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.
The instant application attempts to tie function to sequence identity in the context of an immunogenic composition comprising intravenous immunoglobulin (IVIG) generated from one or more host subjects vaccinated against Coronavirus disease 2019 (COVID-19) or diagnosed as having COVID-19 and subsequently cured of COVID-19, wherein the host subject was vaccinated with a nucleic acid molecule comprising a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 2; (b) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 4; (c) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 6; and (d) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 8 or wherein the host subject was vaccinated with a nucleic acid molecule comprising a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 7; wherein the immunogenic composition further comprises a nucleic acid molecule comprising a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 2; (b) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 4; (c) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 6; and (d) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 8 or wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 7.
The instant application also attempts to tie function to sequence identity in the context of a method of generating an immunogenic composition comprising intravenous immunoglobulin (IVIG) from one or more host subjects, the method comprising: a) administering a nucleic acid molecule encoding a SARS-CoV-2 antigen to the host subject; and b) isolating a biological sample comprising one or more immunoglobulin molecules from the host subject, wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 2; (b) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 4; (c) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 6; and (d) a nucleotide sequence encoding a peptide comprising an amino acid sequence having at least about 90% identity over the entire length of the amino acid sequence set forth in SEQ ID NO: 8 and wherein the nucleic acid molecule comprises a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 7.
While a percent identity threshold is provided in the Claims, it is unclear which nucleotides or residues are essential and therefore are required to be present and unchanged. The instant Specification provides definitions for terms and phrases such as “fragment”, “immunogenic fragment”, “substantially identical”, and “variant” (see Paragraphs 0080-0081, 0092, 0094-0096), but these terms and phrases are not included in the claim language. Paragraph 0095 states, in part, that a variant “can further be defined as a peptide or polypeptide that differs in amino acid sequence by the insertion, deletion, or conservative substitution of amino acids, but retain at least one biological activity”. Even with these definitions, however, there is no indication in the Specification which regions of the claimed sequences are critical or not. Thus, it would be unclear to a person having ordinary skill in the art to know which nucleotides or amino acids to change and which ones not to change. Additionally, while it is not explicitly stated, it is assumed that the nucleotide and amino acid molecules used in the data provided have sequences that are 100% identical to the claimed sequences. Even if that is not the case, the data shown do not explicitly include any claimed variants having as little as 90% sequence identity, or even 91-99% sequence identity, relative to the claimed sequences, raising questions about how effective these claimed variants would be in the experiments performed. Thus, it is not clear what was tested, it does not appear that any claimed variants were tested, and the essential characteristics of the genera Applicant is claiming have not been disclosed or identified.
As such, it does not appear Applicant was in possession of the full scope of the claimed invention at the time of filing and thus Claims 2, 4, 8-13, 18, 20, 25, 27, 32, and 34 do not meet the written description requirement.
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, 6-7, 14-17, 22-24, 29-31, and 36 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mond and Grossman (US 2021/0277093 A1).
Mond and Grossman teach human plasma compositions and immunoglobulin prepared therefrom containing antibodies specific for SARS-CoV-2 (see Abstract) wherein the plasma is obtained from plasma donors, wherein said donors are either COVID-19 convalescent plasma donors or COVID-19 vaccinated donors (see Paragraphs 0011, 0123), which reads on instant Claims 1, 6-7, and 22. Mond and Grossman also teach compositions further comprising excipients and/or adjuvants (see Paragraphs 0073, 0077, 0140, 0147), which reads on instant Claims 14-15. Furthermore, Mond and Grossman teach a method of inducing an immune response against a coronavirus, such as SARS-CoV-2, by administering an immunogenic or therapeutic composition as well as a SARS-CoV-2 antigen or a nucleic acid encoding said antigen to a subject, wherein said administration is via injection (see Paragraphs 0036, 0067, 0098, 0109-0110, 0141-0145), which reads on instant Claims 23-24 and 29. Additionally, Mond and Grossman teach administering a composition comprising pooled plasma and/or immunoglobulin which provide protective levels of anti-SARS-CoV-2 antibodies to a subject as well as a SARS-CoV-2 antigen or a nucleic acid encoding said antigen to said subject, wherein said administration is via injection (see Paragraphs 0013, 0036, 0067, 0098, 0109-0110, 0141-0145), which reads on instant Claims 30-31 and 36. Finally, Mond and Grossman teach a method of producing an immunoglobulin comprising obtaining a plurality of plasma samples from human plasma donors vaccinated with one or more coronavirus vaccines, such as a SARS-CoV-2 vaccine, or human plasma donors from donors who have recovered from COVID-19 (see Paragraphs 0012, 0026, 0144-0145), which reads on instant Claims 16-17.
For at least these reasons, Mond and Grossman teach the limitations of instant Claims 1, 6-7, 14-17, 22-24, 29-31, and 36 and anticipate the invention encompassed by said claims.
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.
Claims 2-5, 8-13, 18-21, 25-28, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Mond and Grossman (US 2021/0277093 A1) as applied to claims 1, 6-7, 14-17, 22-24, 29-31, and 36 above, and further in view of Yan et al. (US 2023/0338515 A1)
The applied secondary reference, Yan et al. (US 2023/0338515 A1), has a common Assignee and two Inventors in common with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
While Mond and Grossman teach many of the limitations of the instant claims, they do not teach SEQ ID NOs: 1-8 or a nucleic acid wherein said nucleic acid comprises an expression vector or is incorporated into a viral particle.
Yan et al. teach nucleic acid molecules encoding a SARS-CoV-2 spike antigen (see Abstract), wherein said nucleic acid molecules are comprised within vectors or are incorporated into a viral particle (see Paragraphs 0006-0008), which reads on instant Claims 12-13. Yan et al. also teach SEQ ID NOs: 2 and 3, which are each 100% identical to instant SEQ ID NO: 1; SEQ ID NO: 1, which is 100% identical to instant SEQ ID NOs: 2 and 4; SEQ ID NO: 3, which is 99.9% identical to instant SEQ ID NO: 3; SEQ ID NOs: 5 and 6, which are each 100% identical to instant SEQ ID NO: 5; SEQ ID NO: 6, which is 99.9% identical to instant SEQ ID NO: 7; and SEQ ID NO: 4, which is 100% identical to instant SEQ ID NOs: 6 and 8 (see Sequence Listing), which reads on instant Claims 2-5, 8-11, 18-21, 25-28, and 32-35.
A person having ordinary skill in the art would have been motivated to modify the teachings of Mond and Grossman with those of Yan et al. in order to develop an immunogenic composition comprising immunoglobulin. It would have been obvious to use specific antigenic protein or nucleic acids encoding said proteins, as disclosed by Yan et al., to immunize a subject in order to generate an immune response against said specific antigenic protein. This would be an efficient way to tailor an immune response against a desired protein or proteins, such as spike proteins corresponding to new or emerging SARS-CoV-2 variants, for example, and to generate and then extract neutralizing antibodies specific for said variants. This would make the composition disclosed by Mond and Grossman more effective at treating or protecting against new or emerging variants, for example, making the composition more cost-effective and therapeutically effective.
For at least these reasons, Claims 2-5, 8-13, 18-21, 25-28, and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art.
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 1-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, and 21 of U.S. Patent No. 11,660,335 in view of Mond and Grossman (US 2021/0277093 A1) and Yan et al. (US 2023/0338515 A1)
Both claim sets are drawn to a nucleic acid molecule encoding a SARS-CoV-2 antigen, an expression vector encoding said antigen, and an immunogenic composition comprising said expression vector. Both claim sets are also drawn to a method of inducing an immune response against SARS-CoV-2 by administering said immunogenic composition. Patented sequences SEQ ID NO: 3 is 100% identical to instant SEQ ID NO: 1, 99.9% identical to instant SEQ ID NO: 3, 95.1% identical to instant SEQ ID NO: 5, and 94.9% identical to instant SEQ ID NO: 7. The main difference between the instant claims and the patented claims are that the instant claims are drawn to a composition comprising immunoglobulin and a method of generating said composition.
The previous teachings of Mond and Grossman and Yan et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the patented claims with those of Mond and Grossman and Yan et al. in order to generate immunoglobulin against specific antigenic proteins encoded by nucleic acids , as disclosed by the patented claims and Yan et al., to immunize a subject in order to generate an immune response against said specific antigenic protein. This would be an efficient way to tailor an immune response against a desired protein or proteins, such as spike proteins corresponding to new or emerging SARS-CoV-2 variants, for example, and to generate and then extract neutralizing antibodies specific for said variants. This would make the composition disclosed by Mond and Grossman more effective at treating or protecting against new or emerging variants, for example, making the composition more cost-effective and therapeutically effective.
For at least these reasons, instant Claims 1-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, and 21 of U.S. Patent No. 11,660,335 in view of Mond and Grossman and Yan et al.
Claims 1-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10-11, 14, 17, and 23-24 of copending Application No. 17/662,141 (US PGPub 2022/0370598 A1) in view of Mond and Grossman (US 2021/0277093 A1) and Yan et al. (US 2023/0338515 A1)
Both claim sets are drawn to a method of inducing an immune response against SARS-CoV-2 or a method of protecting a subject from infection with SARS-CoV-2 by administrating a composition comprising a nucleic acid via electroporation and/or injection, wherein an additional reagent is also administered to said subject for treating or preventing infection with the virus. Additionally, reference SEQ ID NO: 3 is 100% identical to instant SEQ ID NO: 1, 99.9% identical to instant SEQ ID NO: 3, 95.1% identical to instant SEQ ID NO: 5, and 94.9% identical to instant SEQ ID NO: 7. The main differences between the claims sets is that the instant claims are drawn to a composition additionally comprising an immunoglobulin, while the reference claims are drawn to administering specific amounts of said nucleic acid and yielding specific results as far as measuring the immune response to said nucleic acid. The reference claims also do not specify the type of additional agent which can be administered with the nucleic acid molecule.
The previous teachings of Mond and Grossman and Yan et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the reference claims with those of Mond and Grossman and Yan et al. in order to generate immunoglobulin against specific antigenic proteins encoded by nucleic acids , as disclosed by the reference claims and Yan et al., to immunize a subject in order to generate an immune response against said specific antigenic protein. This would be an efficient way to tailor an immune response against a desired protein or proteins, such as spike proteins corresponding to new or emerging SARS-CoV-2 variants, for example, and to generate and then extract neutralizing antibodies specific for said variants. This would make the composition disclosed by Mond and Grossman more effective at treating or protecting against new or emerging variants, for example, making the composition more cost-effective and therapeutically effective.
For at least these reasons, instant Claims 1-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10-11, 14, 17, and 23-24 of the reference application in view of Mond and Grossman and Yan et al.
This is a provisional nonstatutory double patenting rejection.
Claims 1-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, and 12-19 of copending Application No. 18/990,242 (US PGPub 2025/0121054 A1) in view of Mond and Grossman (US 2021/0277093 A1) and Yan et al. (US 2023/0338515 A1)
Both claim sets are drawn to a nucleic acid encoding a SARS-CoV-2 antigen, an expression vector comprising said nucleic acid, and an immunogenic composition comprising said expression vector and an excipient. Both claim sets are also drawn to a method of inducing an immune response against SARS-CoV-2 and a method of protecting a subject from infection with SARS-CoV-2 by administering said immunogenic composition comprising said expression vector and/or nucleic acid, wherein said composition is administered via electroporation. Reference SEQ ID NO: 5 is 94.8% identical to instant SEQ ID NO: 3, 100% identical to instant SEQ ID NO: 5, and 99.