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 .
Response to Amendment/Disposition of Claims
Applicant’s Amendment filed on 16 January 2026 has been received and entered. Claims 1-22 were pending. Claims 1 and 9-10 have been amended. Claims 2-8 and 11-22 have been cancelled. New Claims 23-38 have been added.
Accordingly, Claims 1, 9-10, and 23-38 are currently pending and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2023/0173060 A1, Published 08 June 2023. Applicant’s amended Specifications as presented on 16 January 2026 and 02 February 2023 are 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.
Response to Arguments
Applicant's arguments filed 16 January 2026 regarding the previous Office action dated 16 October 2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Information Disclosure Statement
The information disclosure statements (IDSes) submitted on 10 January 2023, 04 June 2024, 09 September 2024, 28 October 2024, 09 January 2025, 14 July 2025, and 28 November 2025 have been considered by the examiner. Individual references with strikethroughs, however, have not been considered.
Drawings
Withdrawn Objections
(Objection withdrawn) – The objection to the drawings for containing references to colors either in the figures themselves or the figure legends within the Specification is withdrawn in light of the amendments to the Drawings and the Specification.
New Objections
(New Objection) – The drawings are objected to because some parts of some of the figures are illegible. For example, the axes labels in Figure 21, the sequences in Figures 14 and 22, and the legends for the graphs in Figures 36A and 36B are illegible or difficult to read. Also, the y-axis labels in Figure 35 are illegible as is the writing in the tables shown in Figure 34B. Additionally, the labels for the days for the timeline in Figure 34A are difficult to read as are the domain labels in parts of Figures 24, 28, 31 and the accession numbers and strains in Figure 30. It should say “SEQ ID NO: 234” instead of “234” for the ribbon drawing at the bottom right on the first page of Figure 20A. Furthermore, the graphs in Figure 27 are too small for any details to be discernable and some of the writing in Figures 25 and 26 is illegible. Finally, the sequences in Figure 1 are illegible, the coronavirus strains/names in Figure 2 are illegible, and some of the writing in Figures 4-6, 9, 12C, 13C, 13D, 17C, 18C, and 18D is also illegible and/or too small to be read properly. The Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Drawings and Specification; Sequence Disclosure Requirements
Maintained Objections
(Objection maintained) – The objection to the Drawings and Specification for comprising sequences that do not identify said sequences with corresponding SEQ ID NOs is maintained.
Response to Arguments
Applicant's arguments with respect to the objection to the Drawings and Specification for comprising sequences that do not identify said sequences with corresponding SEQ ID NOs have been fully considered but they are not persuasive.
In their Response, Applicant failed to address the sequences present in Figure 1. Additionally, Applicant argues that the “duplicate SEQ ID NOs have been removed from the Specification and the Sequence Listing” (see Page 2 of Remarks, Paragraph 2). While Applicant attempted to fix the issue of duplicate sequences by filing an amended Sequence Listing, this amended Sequence Listing was apparently not filed correctly as it was never reviewed by the Office. As such, it has not been approved or deemed defective. As such, the original Sequence Listing is the only one officially part of the application and this one contains the duplicate sequences. Therefore, this objection is withdrawn as it relates to Figures 10, 11A, 14, 15, 16A, 19, 20, and 22, as well as Paragraphs 0063, 0065, and 0260, but is maintained as is relates to Figure 1 and the Specification in the context of duplicate sequences 7 and 21; 35 and 49; and 214 and 234.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
New Objections
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because, as noted above, the amended Sequence Listing filed on 16 January 2026 was apparently not filed correctly as it was never reviewed by the Office. As such, it has not been approved or deemed defective. Therefore, it is not officially part of the record of the instant application and the original Sequence Listing filed on 14 October 2022 is the only one officially recognized as being part of the instant application.
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. There is no incorporation by reference statement of the amended Sequence Listing provided. A new one must be included when the next version of the Sequence Listing is filed.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that the amended Sequence Listing filed on 16 January 2026 was never reviewed by the Office, the accompanying incorporation by reference statement is missing, and there are sequences present in the Specification and Drawings which are not part of the Sequence Listing. Specifically, SEQ ID NOs: 424-438, all of which are part of Figure 20A, are not part of the most recent Sequence Listing. Additionally, Applicant attempted to replace some of the duplicate sequences and assigned new sequences to the original SEQ ID NOs. For instance, Applicant assigned GPGPG as SEQ ID NO: 21 instead of SEQ ID NO: 21 being a duplicate of SEQ ID NO: 7. This is not allowed. These sequences cannot be reassigned to existing SEQ ID NOs, but instead must be assigned brand new SEQ ID NOs. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
Withdrawn Objections
(Objection withdrawn) – The objection to the Abstract of the disclosure for containing a sentence fragment is withdrawn in light of the amendments to the Abstract.
New Objections
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 legal phraseology in the form of “e.g.”, which stand for “exempli gratia”. 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).
Claim Objections
Withdrawn Objections
(Objection withdrawn) – the objection to Claim 4 for containing more than one period is withdrawn in light of the cancellation of the claim.
(Objection withdrawn) – The objection to Claims 5, 8-11, 13, 15, 18-20, and 22 for containing minor informalities is withdrawn in light of the amendments to two of the claims and the cancellation of the rest of the claims.
New Objections
(New Objection) – Claims 1, 9-10, and 23-37 are objected to because of the following informalities: it is suggested that the claims recite an “immunogenic composition” instead of just a “composition”.
In Claim 10, it is suggested that it say “…wherein the composition that promotes…” instead of “…wherein the composition promotes…”.
Appropriate correction is required.
(New Objection) – Claim 31 is objected to because of the following informalities: it is unclear what purpose the word “inclusive” serves in the context of the instant claim. It is suggested that the claim be amended by removing the word “inclusive”. It is also suggested that it say “…or a sequence encoded by a nucleic acid…” instead of “…or a sequence encoded by nucleic acid…”.
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.
Withdrawn Rejections
(Rejection withdrawn) – The rejection of Claims 4, and dependent claims 5-6 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of the claims.
(Rejection withdrawn) – The rejection of Claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of the claim.
(Rejection withdrawn) – The rejection of Claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of the claim.
(Rejection withdrawn) – The rejection of Claims 13, 16, and 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the cancellation of the claims.
New Rejections
(New Rejection – necessitated by amendment) – Claims 1, 31, and 38, and dependent claims 9-10, 23-30, and 32-37 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.
As noted above, in the Sequence Compliance objections, the most recent amended Sequence Listing was never reviewed and entered. As such, there are technically no sequences present, so it would be unclear how the sequences can be searched and what the recited sequences are referring to. This lack of clarity renders the claims indefinite. It is suggested that Applicant properly file an amended Sequence Listing.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 1, 31, and 38 are rejected on the grounds of being indefinite. Claims 9-10, 23-30, and 32-37 are also rejected, since they depend upon Claim 1 but do not remedy the deficiencies of Claim 1.
(New Rejection – necessitated by amendment) – Claims 1, 31, and 38, and dependent claims 9-10, 23-30, and 32-37 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 Claim 1, it recites the limitation “A composition comprising one or more nucleic acids, each nucleic acid comprising a sequence selected, independently, from any of SEQ ID NOs: 139-147 or SEQ ID NOs: 295-347”. Regarding Claim 31, it recite the limitation “A composition, comprising at least one protein having a sequence selected, independently, from: a sequence of any one of SEQ ID NO: 186 or SEQ ID NOs: 188-193 inclusive; or a sequence encoded by nucleic acid having a sequence selected from any of SEQ ID NO: 182, SEQ ID NO: 183, SEQ ID NO: 185, SEQ ID NOs: 148-159, SEQ ID NOs:362-369, SEQ ID NOs: 372-377, SEQ ID NOs: 380-383, or SEQ ID NOs:348-359; and wherein the at least one protein is formulated in a lipid nanoparticle, the lipid nanoparticle comprising a cationic lipid, a PEG-modified lipid, a sterol and a non-cationic lipid”. Regarding Claim 38, it recites the limitation “A nucleic acid, comprising a sequence selected from any of SEQ ID NOs: 139-147 or SEQ ID NOs: 295-347”. In all three claims, the recitation of “a sequence” renders the claims indefinite because it reads on fragments of the claimed sequences instead of necessitating that the entirety of the recited sequence be present.
Additionally, for Claims 1 and 31, they can reasonably be interpreted as meaning that each of the at least one sequences present is the same. There is nothing in the claim language that requires that each sequence is different. It is unclear if this was Applicant’s intention, but this lack of clarity renders the claims indefinite.
It is suggested that Claim 1 be amended to recite the limitation “…wherein each nucleic acid comprises a different sequence wherein the sequences are selected from the group consisting of SEQ ID NOs: 139-147 and 295-347” or “…wherein each nucleic acid comprises a different sequence corresponding to any one of SEQ ID NOs: 139-147 or 295-347”, or similar language. It is suggested that Claim 31 be amended to recite the limitation “…at least one protein comprising a sequence wherein said sequence is selected from the group consisting of SEQ ID NOs: 186 and 188-193; or comprising a sequence encoded by a nucleic acid wherein said nucleic acid is selected from the group consisting of SEQ ID NO: 182, SEQ ID NO: 183, SEQ ID NO: 185, SEQ ID NOs: 148-159, SEQ ID NOs: 362-369, SEQ ID NOs: 372-377, SEQ ID NOs: 380-383, and SEQ ID NOs: 348-359”, or “…at least one protein comprising any one of SEQ ID NOs: 186 or 188-193; or comprising a sequence encoded by a nucleic acid wherein said nucleic acid comprises any one of SEQ ID NO: 182, SEQ ID NO: 183, SEQ ID NO: 185, SEQ ID NOs: 148-159, SEQ ID NOs: 362-369, SEQ ID NOs: 372-377, SEQ ID NOs: 380-383, or SEQ ID NOs: 348-359”, or similar language. It is suggested that Claim 38 be amended to recite “A nucleic acid, comprising a sequence wherein said sequence is selected from the group consisting of SEQ ID NOs: 139-147 and 295-347”, or “A nucleic acid, comprising any one of SEQ ID NOs: 139-147 or 295-347”, or similar language. Applicant, however, 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 1, 31, and 38 are rejected on the grounds of being indefinite. Claims 9-10, 23-30, and 32-37 are also rejected, since they depend upon Claim 1 but do not remedy the deficiencies of instant Claim 1.
(New Rejection – necessitated by amendment) – Claims 24, and dependent claims 26, 28-30, and 32-37 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 Claim 24, it recites the limitation “The composition of claim 22”. Claim 22 was cancelled in the most recent claim set. As such, it is unclear which claim is being referenced by Claim 24. This lack of clarity renders the claim indefinite. It is suggested that the claim be amended to depend upon Claim 23, 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 24 is rejected on the grounds of being indefinite. Claims 26, 28-30, and 32-37 are also rejected, since they depend upon Claim 24 but do not remedy the deficiencies of Claim 24.
(New Rejection – necessitated by amendment) – Claims 26, and dependent claims 28-30 and 32-37 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.
Claim 26 recites the limitation "the lipid nanoparticle" in Line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 26 depends upon Claim 24, but Claim 24 does not introduce the limitation of a lipid nanoparticle, only a nanoparticle. This renders the claim indefinite. It is suggested that the claim be amended to be dependent upon Claim 25, which does introduce the limitation of a lipid nanoparticle and would therefore provide proper antecedence, 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 26 is rejected on the grounds of being indefinite. Claims 28-30 and 32-37 are also rejected, since they depend upon Claim 26 but do not remedy the deficiencies of Claim 26.
(New Rejection – necessitated by amendment) – Claims 29 and 30, and dependent claims 32-37 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.
Claim 29 recites the limitations "the cationic lipid", “the non-cationic lipid”, and “the sterol” in Lines 1, 2, and 3. There is insufficient antecedent basis for these limitations in the claim. Claim 29 depends upon Claim 26, but Claim 26 does not introduce any of these limitations. As such, it is unclear which limitations are being referenced in Claim 29. Claim 30 recites the limitation “the cationic lipid” in Line 1. Claim 30 depends upon Claim 26, but Claim 26 does not introduce the limitation of a cationic lipid. As such, it is unclear which limitation is being referenced in Claim 30. It is suggested that both Claims 29 and 30 be amended to depend upon Claim 27 or that Claim 29 be amended to depend upon Claim 27 and then Claim 30 be amended in turn to depend upon Claim 29, 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 29 and 30 are rejected on the grounds of being indefinite. Claims 32-37 are also rejected, since they depend upon Claim 30 but do not remedy the deficiencies of Claim 30.
(New Rejection – necessitated by amendment) – Claims 28 and 35, and dependent claims 29-30, 32-34, and 36-37 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 28 and 35, they both recite the term “about” with regard to the percentages of the lipids and sterol in the claimed lipid nanoparticle. There is no definition for the term “about” provided in the Specification. As such, it is unclear how to interpret this term in the context of the claims and the prior art since it is unclear how much variation is being claimed by its recitation. This lack of clarity renders the claims indefinite. It is suggested that the claims be amended by deleting the word “about”, 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 28 and 35 are rejected on the grounds of being indefinite. Claims 29-30, 32-34, and 36-37 are also rejected, since they depend upon Claim 28 but do not remedy the deficiencies of Claim 28.
(New Rejection – necessitated by amendment) – Claim 31 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 31, it recites the limitation “A composition, comprising at least one protein having a sequence selected, independently, from: a sequence of any one of SEQ ID NO: 186 or SEQ ID NOs: 188-193 inclusive; or a sequence encoded by nucleic acid having a sequence selected from any of SEQ ID NO: 182, SEQ ID NO: 183, SEQ ID NO: 185, SEQ ID NOs: 148-159, SEQ ID NOs:362-369, SEQ ID NOs: 372-377, SEQ ID NOs: 380-383, or SEQ ID NOs: 348-359; and wherein the at least one protein is formulated in a lipid nanoparticle, the lipid nanoparticle comprising a cationic lipid, a PEG-modified lipid, a sterol and a non-cationic lipid”. The use of the term “having” renders the claim indefinite because it is unclear how it should be interpreted in the context of the prior art. Specifically, it is unclear if the term is meant to mean “comprising”, which is open-ended, or “consisting of”, which is closed-ended. The former means that any prior art sequences can have additional amino acids or nucleotides present, while the latter means that additional residues or bases cannot be present. This lack of clarity renders the claim indefinite. It is suggested that the claim be amended by replacing “having” with either “comprising” or “consisting of”, depending on Applicant’s intention, 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 31 is rejected on the grounds of being indefinite.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
For the purposes of examining the claims on their merits, the recitation of “a sequence” in Claims 1, 31, and 38 will be interpreted as reading upon any dinucleotide or dipeptide sequence. For Claims 28 and 35, the term “about” will be interpreted as reading upon any concentration or percentage of the recited lipid nanoparticle components, in light of the lack of a definition for the term “about” in the instant Specification. For Claim 31, the term “having” will be interpreted as “comprising”, which is open-ended, meaning that any prior art sequences can have additional amino acid residues or nucleotide bases present.
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(Rejection withdrawn) – The rejection of Claim 18 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of the cancellation of the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(Rejection maintained and extended) – The rejection of Claims 1-8 and 12-22 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more is withdrawn as it relates to instant Claims 2-8 and 12-22, maintained as it relates to instant Claim 1, and is extended to include instant Claims 23 and 25.
Response to Arguments
Applicant's arguments with respect to the rejection of the claims under 35 U.S.C. 101 as being directed to a natural phenomenon have been fully considered but they are not persuasive.
In their Response, Applicant argues that “Claims 2-8 and 12-22 have been cancelled” and that “claim 1 has been amended to explicitly recite specific sequences, which clearly define patent-eligible subject matter and are not directed to a natural phenomenon” (see Page 3 of Remarks, Paragraph 3). Examiner does not find this argument persuasive. As a result of the 112b indefiniteness issues raised above and how the claims are being interpreted in light of said issues, and the accompanying lack of a definition for the term “composition” in the instant Specification, the claimed composition recited in instant Claim 1 now reads upon a cell comprising any dinucleotide sequence. Additionally, said cell could be measured in nanometers, and thus Claims 23 and 25 also read upon a natural phenomenon without significantly more. As such, the rejection of Claims 1-8 and 12-22 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more is withdrawn as it relates to instant Claims 2-8 and 12-22 in light of the cancellation of these claims, maintained as it relates to instant Claim 1, and is extended to include instant Claims 23 and 25.
Claim Rejections - 35 USC § 112(a); First Paragraph
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.
(New Rejection – necessitated by amendment) – Claims 24, 26, 28-30, and 32-37 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. This is a new matter rejection.
Regarding new Claim 24, it recites the limitation “wherein the nanoparticle has a mean diameter of 20-200 nm”. Regarding new Claims 26 and 34, they both recite the limitation “wherein the lipid nanoparticle has a mean diameter of 20-200 nm”. The recited mean diameter range in these new claims constitutes new matter as the instant specification only discloses nanoparticles have a mean diameter range of 50-200 nm (see Paragraph 0361 of the PGPub of the instant application). Thus, the claim limitations do not have support in the originally-filed disclosure. Therefore, Claims 24, 26, 28-30, and 32-37 do not meet the written description requirement as they contain new matter.
(New Rejection – necessitated by amendment) – Claim 38 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an isolated nucleic acid, does not reasonably provide enablement for a nucleic acid comprising a transgene within a transgenic animal. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). See also MPEP § 2164.01(a) and § 2164.04. Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention/Breadth of the claims. Applicant broadly claims a nucleic acid comprising the nucleic acid sequences of claim 38. The claim reads on a transgene within a transgenic animal, given that the term "isolated" is not denoted in describing the nucleic acid.
State of the prior art/Predictability of the art. With respect to the unisolated transgene as “nucleic acid” of the instant claim discussed above, the state of the art at the time of filing was such that one of skill could not predict the phenotype of transgenics. The art of transgenic animals has for many years stated that the unpredictability lies, in part, with the site or sites of transgene integration into the target genome and that "the position effect" as well as unidentified control elements are recognized to cause aberrant expression of a transgene (Wall et Al., Theriogenology, Vol. 45, Pg. 57-68, 1996).
The elements of the particular construct used to make transgenic animals are also held to be critical, and they must be designed case by case without general rules to obtain good expression of a transgene; e.g., specific promoters, presence or absence of introns, etc. (Houdebine et Al., Journal of Biotechnology, Vol. 34, Pg. 269- 287, 1994). Furthermore, transgenic animals are regarded to have within their cells, cellular mechanisms that prevent expression of the transgene, such as methylation or deletion from the genome (Kappell et Al., Current Opinions in Biotechnology, Vol. 3, Pg. 548-553, 1992). Houdebine (Comparative Immunology, Microbiology, and Infectious Diseases, Vol. 32, Pg. 107-121, 2009) teaches progress has been made in the field of transgenic animals for production of foreign proteins (Abstract); however, constructing an efficient expression vector to produce a therapeutic protein is not a standard operation (Pg. 116, Paragraph, second). Therefore, undue experimentation is required to make and use a transgene and transgenic animal to comprise the nucleic acid of the instant claim.
At the time of filing, the phenotype of a transgene and transgenic cell contained within any animal was unpredictable. The claim as written, encompassing a transgene in a transgenic animal, is not adequately described in the specification as to prevent excessive experimentation by the public to generate and use the invention. Applicants can obviate the instant rejection by amending the claim to recite the term "isolated" before the recitation "nucleic acid" and by amending said claim to specify it is not in a transgenic animal. Applicant may consider using purified in such claims if description is appropriate for such a term and it is not redefined away from standard meaning. Method claims using these products should also carry the appropriate adjectives above.
Working examples. Only two working examples of a transgenic animal are disclosed in the specification, specifically the HLA-A*02:01/DR Double Transgenic mice and the h-ACE2-HLA-A2/DR triple transgenic mice used in the data provided (see Figure 13A; Paragraphs 0008, 0157).
Guidance in the specification. The specification provides guidance towards nucleic acids for use in the compositions disclosed (see Paragraph 0106). The specification also provides guidance for the corresponding protein sequences for any of the nucleic acid sequences disclosed and vice versa (see Paragraph 0123) as well as modified or unmodified nucleic acids (see Paragraph 0330).
Amount of experimentation necessary. In view of the lack of the predictability of the art to which the invention pertains as evidenced by the art above, the lack of guidance and direction provided by Applicant, and the absence of working examples, undue experimentation would be required to make and use the recited nucleic acid, with a reasonable expectation of success, absent a specific and detailed description in Applicant’s specification of how to effectively practice this and absent working examples providing evidence which is reasonably predictive that the claimed nucleic acid is functional, commensurate in scope with the claimed invention. The same can be said for the transgenes and transgenic animals encompassed by the instant claims. Thus, the claims are rejected here.
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.
Withdrawn Rejections
(Rejection withdrawn) – The rejection of Claims 1-7, 10, and 12-22 under 35 U.S.C. 102(a)(2)as being anticipated by Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) is withdrawn in light of the amendments to some of the claims and the cancellation of the rest of the claims.
New Rejections
(New Rejection – necessitated by amendment) – Claims 1, 23-31, and 34-38 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rauch et al. (US 2024/0277830 A1, earliest Priority Date 04 February 2020) (cited in the previous Office Action).
Rauch et al. teach compositions comprising nucleic acids for use in the treatment of an infection with SARS-CoV-2, wherein said nucleic acids are associated with or formulated in a lipid nanoparticle (LNP) (see Abstract; Paragraphs 0860, 0868), wherein said LNPs have a mean diameter from about 50 nm to about 200 nm (see Paragraph 0901), which reads on instant Claims 1, 23-26, and 34. Rauch et al. also teach SEQ ID NO: 26417, which is a nucleic acid sequence which has 50.3% sequence identity to instant SEQ ID NO: 295 (see Sequence Listing), which reads on instant Claims 1 and 38.
Additionally, Rauch et al. teach that said nucleic acids can encode antigenic peptides or proteins derived from SARS-CoV-2 (see Paragraph 0012), as well as SEQ ID NO: 1331, which is an amino acid sequence which comprises a sequence that is 100% identical to instant SEQ ID NO: 186 (see Sequence Listing), wherein said protein is formulated in a lipid nanoparticle as part of an immunogenic composition (see Paragraphs 0954-0957, 0978, 0985), which reads on instant Claim 31.
Furthermore, Rauch et al. teach wherein said LNPs comprise cationic lipids, neutral lipids (see Paragraph 0804), sterols, and PEGylated lipids (see Paragraphs 0810-0816), wherein said sterol is cholesterol, wherein said cationic lipid is an ionizable cationic lipid (see Paragraphs 0811-0817), and wherein said cationic lipid is 2,2-dilinoleyl-4-dimethylaminoethyl-[1,3]-dioxolane or dilinoleyl-methyl-4-dimethylaminobutyrate (see Paragraphs 0818, 0820), which reads on instant Claims 27, 29-31, and 36-37.
Finally, Rauch et al. teach that the LNP comprises a molar ratio of about 20-60% cationic lipid, 0.5-15% PEGylated lipid, 25-55% sterol, and 5-25% neutral lipid (see Paragraphs 0811-0816), which reads on instant Claims 28 and 35.
For at least these reasons, Rauch et al. teach the limitations of instant Claims 1, 23-31, and 34-38 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.
Withdrawn Rejections
(Rejection withdrawn) – The rejection of Claims 8-9 under 35 U.S.C. 103 as being unpatentable over Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) as applied to claims 1-7, 10, and 12-22 above, and further in view of Scholler et al. (US 2012/0258126 A1, Published 11 October 2012) and Rauch et al. (US 2024/0277830 A1, earliest Priority Date 04 February 2020) is withdrawn in light of the cancellation of one some of the claims and the amendments some of the claims.
New Rejections
(New Rejection – necessitated by amendment) – Claims 9-10 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al. (US 2024/0277830 A1, earliest Priority Date 04 February 2020), Gaynor et al. (US 2023/0083931 A1, earliest Priority Date 20 March 2020) (cited in the previous Office Action), and Scholler et al. (US 2012/0258126 A1, Published 11 October 2012) (cited in the previous Office Action).
Rauch et al. teach compositions comprising nucleic acids for use in the treatment of an infection with SARS-CoV-2, wherein said nucleic acids are associated with or formulated in a lipid nanoparticle (LNP) (see Abstract; Paragraphs 0860, 0868), wherein said LNPs have a mean diameter from about 50 nm to about 200 nm (see Paragraph 0901). Rauch et al. also teach SEQ ID NO: 26417, which is a nucleic acid sequence which has 50.3% sequence identity to instant SEQ ID NO: 295 (see Sequence Listing).
Additionally, Rauch et al. teach that said nucleic acids can encode antigenic peptides or proteins derived from SARS-CoV-2 (see Paragraph 0012), as well as SEQ ID NO: 1331, which is an amino acid sequence which comprises a sequence that is 100% identical to instant SEQ ID NO: 186 (see Sequence Listing), wherein said protein is formulated in a lipid nanoparticle as part of an immunogenic composition (see Paragraphs 0954-0957, 0978, 0985).
Furthermore, Rauch et al. teach wherein said LNPs comprise cationic lipids, neutral lipids (see Paragraph 0804), sterols, and PEGylated lipids (see Paragraphs 0810-0816), wherein said sterol is cholesterol, wherein said cationic lipid is an ionizable cationic lipid (see Paragraphs 0811-0817), and wherein said cationic lipid is 2,2-dilinoleyl-4-dimethylaminoethyl-[1,3]-dioxolane or dilinoleyl-methyl-4-dimethylaminobutyrate (see Paragraphs 0818, 0820). Finally, Rauch et al. teach that the LNP comprises a molar ratio of about 20-60% cationic lipid, 0.5-15% PEGylated lipid, 25-55% sterol, and 5-25% neutral lipid (see Paragraphs 0811-0816).
Rauch et al. does not teach immunogenic compositions further comprising chemokines, such as CCL5, CXCL9, CXCL10, and CXCL11, or interleukins, such as IL-7, IL-2, and IL-15.
Gaynor et al. teach immunogenic compositions against coronavirus infection further comprising interleukins, such as IL-2, IL-7, or IL-15 (see Paragraphs 1193-1194), which can be used as an additional therapeutic agent in combination with the viral epitope therapeutic comprised within the immunogenic composition (see Paragraph 1193) to enhance the immune response generated by the immunogenic composition (see Paragraphs 1163, 1174).
Scholler et al. teach immunogenic compositions against coronavirus infection (see Paragraphs 0345-0346, 2583, 2588) further comprising additionally immunologically active molecules (see Paragraph 0190), including chemokines, such as CCL5, CXCL9, CXCL10, and CXCL11 9 (see Paragraph 0216), which can be used to enhance the immunogenicity of the composition (see Paragraphs 0190-0192).
A person having ordinary skill would have been motivated to modify the teachings of Rauch et al. with those of Gaynor et al. and Scholler et al. in order to develop an immunogenic composition against coronavirus infection. Modifying the immunogenic composition of Rauch et al. with the interleukins of Gaynor et al. and/or the chemokines of Scholler et al. would enhance the therapeutic effectiveness of the immunogenic composition and make for a more effective treatment.
Such modifications, combining prior art elements according to known methods in order to yield predictable results, would have had a reasonable expectation of success and arrived at the claimed invention prior to the effective filing date of the claimed invention. For at least these reasons, instant Claims 9-10 and 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art.
Response to Arguments
Applicant's arguments with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In their Response, Applicant “asserts that the Gaynor prior art cannot anticipate the claims because the Gaynor prior art does not teach all the elements in each of these claims”(see Page 3 of Remarks, Paragraph 4), that “Claim 1 has been amended to include the limitations of claim 11, which was not rejected under 35 U.S.C. § 102(a)(2) or 35 § U.S.C. 103” (see Page 3, Last Paragraph), “that Claim 8 has been redrafted as new Claim 30” and “was not challenged for novelty” (see Page 4, First Paragraph), and “that the amended claims, and claims dependent therefrom, are novel and non-obvious over the cited references” (see Page 4, Paragraph 2). As noted above, the 112b indefiniteness issues present in the amended claim set along with the interpretation of said claims in light of said issues means that the instant claims still read upon the prior art references of record. Additionally, Applicant did not present any persuasive arguments against Scholler et al., other than to say that they respectfully disagreed with the rejection of Claims 8-9 under 35 § U.S.C. 103 as being obvious over Gaynor and Scholler et al., and failed to mention Rauch et al. entirely. Any alleged deficiencies in the prior art have been remedied in the new rejections raised above.
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.
Withdrawn Rejections
(Rejection withdrawn) – The provisional rejection of Claims 1-10 on the ground of nonstatutory double patenting as being unpatentable over claims 515-521 and 532-533 of copending Application No. 18/046,462 (reference application) is withdrawn in light of the amendments to the instant claims.
(Rejection withdrawn) – The provisional rejection of Claims 1-6, 9-10, and 12-22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-20 of copending Application No. 18/046,862 (reference application) is withdrawn in light of the amendments to the instant claims and the cancellation of some of the instant claims.
(Rejection withdrawn) – The provisional rejection of Claims 1-4 and 7-8 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, 14, 19, 22, and 31 of formerly copending Application No. 18/601,925 is withdrawn in light of the amendments to the instant claims, the cancellation of some of the instant claims, and the issuance of the formerly copending reference application as U.S. Patent No. 12,558,415 B2.
(Rejection withdrawn) – The provisional rejection of Claims 1-7 and 9-10 on the ground of nonstatutory double patenting as being unpatentable over claims 31-35, 37-38, 41, 44-45, 48, 50-52, 58-60, 65, and 78-79 of copending Application No. 18/872,496 (reference application) is withdrawn in light of the amendments to both the instant claims and the reference claims and the cancellation of some of the instant claims.
(Rejection withdrawn) – The provisional rejection of Claims 1-7 and 9-10 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 12-14 of copending Application No. 18/974,619 (reference application) is withdrawn is light of the amendments to the instant claims and the cancellation of some of the instant claims.
New Rejections
(New Rejection – necessitated by amendment) – Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 515 and 518-519 of copending Application No. 18/046,462 (reference application) in view of Rauch et al. (US 2024/0277830 A1, earliest Priority Date 04 February 2020).
Both claim sets are drawn to compositions comprising proteins. Additionally, reference SEQ ID NOs: 143 and 145-150 are 100% identical to instant SEQ ID NOs: 186 and 188-193, respectively.
The main differences between the instant claims and the reference claims are that the instant claims are also drawn to proteins encoded by specific nucleic acid sequences and a composition wherein the at least one protein is formulated in a LNP, wherein said LNP comprises a cationic lipid, a PEG-modified lipid, a sterol, and a non-cationic lipid, while the reference claims are drawn to a recombinant vaccine composition comprising at least two target epitopes wherein one or more of said target epitopes is in the form of a large sequence, wherein said large sequence is a whole protein expressed by SARS-CoV-2 or a SARS-CoV-2 variant or derived from a partial protein sequence expressed by SARS-CoV-2 or a SARS-CoV-2 variant.
The teachings of Rauch 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 Rauch et al. in order to generate an immunogenic composition for treating a coronavirus infection. Incorporating the LNP of Rauch et al. into the composition of the reference claims would allow for a more efficient and safer delivery of the reference proteins upon administration to a subject, enhancing the effectiveness of the reference composition.
Such modification, combining the teachings of the reference claims with those of the prior art according to known methods in order to yield predictable results, would have had a reasonable expectation of success and arrived at the instantly claimed invention. For at least these reasons, Claim 31 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 515 and 518-519 of the reference application in view of Rauch et al.
Conclusion
No claims are allowed.
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 CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM EST.
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, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671