Notice of Pre–AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Priority
2. The instant application is a National Stage Entry of International Patent Application No. PCT/EP2021/085242 filed on 12/10/2021 and claims priority to United Kingdom Patent Application No. GB2019455.1 filed on 12/10/2020.
Claim Status
3. The cancellation of claims 21 – 25 pursuant to the amendment on 12/19/2023 is acknowledged. Claims 1 – 20 are pending and under review.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 10/31/2023 has been considered by the examiner. However, the IDS fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non–patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. All references have been considered except for Non–Patent Literature (NPL) document Cite No. 30, which has been lined through.
Specification
5. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser–executable code on pages 3, 16, and 30. Applicant is required to delete the embedded hyperlink and/or other form of browser–executable code; references to websites should be limited to the top–level domain name without any prefix such as http:// or other browser–executable code. See MPEP § 608.01.
6. The disclosure is objected to for failing to adhere to the requirements of the sequence rules set forth in 37 CFR 1.821(a)–(d) and MPEP § 2422. Sequences are described by reference to UniProt™ Accession Number: Q6VGT3 on pages 7 and 25 and GenBank® Accession Number: NC_001405.1 on page 25, rather than to sequences set forth in the specification. Furthermore, since the sequences associated are not irrevocably fixed, but are corrected and updated as additional sequence information becomes available, the accession numbers may refer to sequences which change after the application filing date. Applicant is reminded that the incorporation of essential material, i.e., UniProt™ Accession Number: Q6VGT3 as recited in claim 13, in the specification by reference to a foreign application or patent, or to a publication, is improper under 37 CFR 1.57. Applicant must append SEQ ID NOs to all mentions of specific sequences comprising four or more amino acids and ten or more nucleic acids in the specification. Appropriate correction is required. The amendment must be accompanied by an affidavit or declaration executed by the applicant, or a practitioner representing the applicant, stating that the amendatory material consists of the same material incorporated herein by reference. Furthermore, if the recited materials in claim 13 was not set forth in the specification as filed, and was not publicly available at the time that the application was filed, the amendment will be treated as an attempt to introduce new matter. See In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973). Applicant should also note that an amendment introducing an additional sequence corresponding to the intended sequence will likely require a replacement Sequence Listing (CRF) and a statement indicating that the paper and CRF sequence submissions are identical.
7. The use of the terms PER.C6™ on pages 2, 3, 25, and 30; Mobius® on page 4; Expi293™ on pages 5, 24, and 40 – 42;T–REx™ on pages 5, 6, 13 – 15, 24 – 27, 31 – 33, 36, and 40; BalanCD™ on pages 5, 6, 9, 10, 13, 15, 16, 18 – 23, 28, 31 – 33, 37, and 40 – 43; UniProt™ on pages 7 and 25; pcDNA™ on page 24; GenBank® on page 25; Sartobind® on pages 35, 36, and 38; Benzonase® on pages 37, 41, and 42; Millistak+® on page 38; and possibly others in the specification, which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, ℠, or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Applicant is required to properly annotate all trade names and/or marks present in the specification.
8. 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.
Drawings
9. The drawings are objected to because the unlabeled boxes shown in Figure 1A should be shown with descriptive text labels, i.e., a legend. Furthermore, the drawings are also objected to under 37 CFR 1.84(u)(1), which states "view numbers must be preceded by the abbreviation "FIG.". In the instant case, the view numbers of Figures 1 – 10 are preceded by the word “FIGURE” instead of the abbreviation “FIG.”. See MPEP § 608.02(d).
10. 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.
Claim Objections
11. Claims 1 – 20 are objected to because of the following informalities:
In claim 1, line 1, there is a missing colon after “comprising”;
In claim 1, line 2, there is a missing semicolon after “cell”;
In claim 1, line 3, there is a missing semicolon after “adenovirus”;
In claim 1, line 4, there is a missing semicolon after “adenovirus”;
Claim 1 recites the limitation “cell” in line 4. There is insufficient antecedent basis for this limitation in the claim. The limitation “host cell” is recited earlier in line 2 of claim 1. It is suggested that the limitation “cell” in claim 1, line 4 be changed to “host cell” to match the limitation set forth in claim 1, line 2;
In claim 1, line 5, there is a missing semicolon after “cell”;
Claims 2 – 20 recite the limitation “a method”. There is insufficient antecedent basis for this limitation in the claims. The article “a” is an indefinite term. The article “the” is a definite term and should be used when referring back to the specific method of the previous claim. For example, claim 2 should read “the method according to claim 1” as opposed to “a method according to claim 1”;
Claim 4 recites the limitation “cell” in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation “host cell” is recited earlier in line 2 of claim 1, which claim 4 depends upon. It is suggested that the limitation “cell” in claim 4, line 2 be changed to “host cell” to match the limitation set forth in claim 1, line 2;
In claim 15, line 2, there is a missing hyphen in “SARS–CoV2”. The abbreviation should read “SARS–CoV–2”. Additionally, the acronym “SARS–CoV–2” is recited, but not defined in the claim. An acronym should be defined the first time it appears in the claims. For the purposes of examination, “SARS–CoV–2” is interpreted to mean “severe acute respiratory syndrome coronavirus 2”, as defined in the specifications.
Appropriate correction is required.
Claim Rejections – 35 USC § 112
35 USC § 112(b)
12. 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.
13. Claims 1 – 20 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.
14. Claims 1 – 3 contain the trademarks/trade names BalanCD™, T–REx™, and Expi293™. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre–AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe different cell lines and, accordingly, the identification/description is indefinite. This rejection affects all dependent claims.
15. Claim 4 recites the phrase “preferably”, which renders the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. The phrases suggest that the limitation is optional or a preferred embodiment, but is unclear from the claim language itself whether that limitation is essential for infringement or an optional feature. See MPEP § 2173.05(d).
16. Claim 13 requires the sequence of UniProt™ Accession Number: Q6VGT3. However, the recited UniProt™ designation for the requisite sequence fails to clearly identify the precise Ad5 E4orf6 claimed because the accession number is extraneous to the instant disclosure. Since UniProt™ sequences are not irrevocably fixed, but corrected and updated as additional sequence information becomes available, no precise structural information regarded the UniProt™ Accession Number can be gleaned. Moreover, UniProt™ Accession Number: Q6VGT3 is scheduled
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for removal from UniProt™ as it is not part of a reference proteome (see the message from UniProt™ as reproduced below).
35 USC § 112(a)
17. 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.
18. Claim 13 is 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.
19. Claim 13 requires the sequence of UniProt™ Accession Number: Q6VGT3. However, the recited UniProt™ designation for the requisite sequence fails to clearly identify the precise Ad5 E4orf6 claimed because the accession number is extraneous to the instant disclosure. This is an improper incorporation by reference, since the information required to describe and enable the required sequences is found in the databases that are extraneous to the application. Since UniProt™ sequences are not irrevocably fixed, but corrected and updated as additional sequence information becomes available, no precise structural information regarding the UniProt™ Accession Number can be gleaned. The structures corresponding to the UniProt™ accession number may refer to sequences which change or become deleted, which will be occurring with UniProt™ Accession Number: Q6VGT3 (see message from UniProt™ website as reproduced above), and are not guaranteed as a consistent source of information for requisite material. The skilled artisan cannot access the structure submitted to the database or determine what or how the structure has change since the original submission date. For these reasons, the structure representing UniProt™ Accession Number: Q6VGT3 is indeterminable to adequately identify the Ad5 E4orf6 sequence claimed. The instant disclosure does not support an adequate written description of the sequence corresponding to UniProt™ Accession Number: Q6VGT3.
Claim Rejections – 35 USC § 103
20. 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.
21. Claims 1, 2, 5, 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Memarzadeh, B., et. al. (WO 03/078592 A2; Published 09/25/2003; Cited in Applicant’s IDS on 10/31/2023, Foreign Patent Document, Cite No. 5), hereby Memarzadeh; as evidenced by the BalanCD HEK293 System user manual (Published 01/01/2020; Cited in Applicant’s IDS on 10/31/2023, NPL Document, Cite No. 6), hereby the BalanCD user manual.
Memarzadeh teaches a method for the production and purification of replication competent adenovirus in a single workflow (claim 1; page 1, paragraph 01; page 2, paragraph 07; see also part of figure 1 as reproduced below), wherein host cells are contacted and subsequently infected, allowing the virus to be replicated in suspension (claim 11; page 3, paragraph 11; page 5, paragraph 22; page 6, paragraph 27), as recited in instant claim 1. It is further taught that the host cells are from the human embryonic kidney cell line, 293, (HEK293), which are capable of supporting replication of adenovirus serotype 5 (page 5, paragraph 23), as required in instant claim 1. Memarzadeh goes on to teach that the adenovirus is expressed from a vector that is a polynucleotide construct containing a transcriptional regulatory sequence linked to an adenoviral gene (page 4, paragraph 18; page 6, paragraph 28), as required in instant claim 14.
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Memarzadeh does not teach the amount of medium to add, as stated in instant claim 5; or the timing of when the medium is added, as required in instant claims 5 and 6. However, the timing and amount of media added to the system is clearly a result effective parameter that a person having ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient, i.e., the media, needed to achieve the desired results. The principle of law states from MPEP §§ 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages," (see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," (See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). In light of this case law, Memarzadeh does teach that culture medium is fed to the system at a predetermined and constant rate to maintain the dilution of the culture below the maximum growth rate of the cells (page 7, paragraph 31), wherein the medium is serum–free (page 7, paragraph 32), as recited in instant claim 5. It is further taught that the host cells are harvested from 2 days to 7 days after infection (page 6, paragraph 32), as defined in instant claims 5 and 6.
Memarzadeh does not teach the explicit usage of BalanCD HEK293 medium, as defined in instant claims 1 and 2. However, the BalanCD user manual teaches that BalanCD HEK293 is a serum–free, scalable system designed to support the growth and transfection of HEK293 cell lines in suspension cultures (page 1). Memarzadeh and the BalanCD user manual are considered to be analogous to the claimed invention because both are in the field of producing adenoviral vectors. Therefore, it would have been obvious to a person having ordinary skill in the art to have used the BalanCD HEK293 media of the BalanCD user manual as the medium taught by Memarzadeh before the effective filing data of the claimed invention with a reasonable expectation of success to improve the productivity of Adeno–Associated Virus (AAV) in HEK293 cells within 48 hours (BalanCD user manual; page 3; see also figure 2 as reproduced below), as defined in instant claims 1 and 2. The BalanCD user manual also teaches that media optimization is necessary to achieve the required yield and quality of end–product (page 2), as defined by instant claims 5 and 6. All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A
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and 2143.02.
22. Claims 3, 4, 7 – 10, and 18 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Memarzadeh and the BalanCD user manual, as applied to claims 1, 2, 5, 6, and 14 above, and in further view of Fedosyuk, S., et. al., (2019), Simian adenovirus vector production for early–phase clinical trials: A simple method applicable to multiple serotypes and using entirely disposable product–contact components, Vaccine, 37(47), 6951–6961 (Published 04/30/2019; Cited in Applicant’s IDS on 10/31/2023, NPL Document, Cite No. 3), hereby Fedosyuk.
Memarzadeh and the BalanCD user manual fail to teach the usage of HEK293 T–REx™ cells, as defined in instant claim 3; the cell density that infection is carried out at, as stated in instant claim 4; the multiplicity of infection (MOI), as required in instant claim 18; the yield of adenovirus, as recited in instant claim 19; and the usage of a fed batch culture, as described in instant claim 20. While Memarzadeh does teach that the adenovirus employed is adenovirus serotype 5 (page 5, paragraph 23), it does not teach that the adenovirus is a species E simian adenovirus, or is ChAdOx1, as defined in instant claims 7 – 10. However, Fedosyuk investigated the growth of vectors of three simian serotypes, including ChAdOx1, a derivative of the Y25 adenovirus serotype, and ChAdOx2, in HEK293 T–Rex™ cells (page 6952, methods sections 2.2 and 2.3; page 6954, results section 3.1), as required in instant claims 3 and 7 – 10. It is further taught that the cell density at the time of infection was 1.5 x 106 – 2 x 106 cells/mL (page 6953, method section 2.3; page 6954, results section 3.1), as stated in instant claim 4. Fedosyuk also teaches that the host cells are inoculated with virus at an MOI of 3 and 10 (page 6953, methods section 2.3; page 6954, results section 3.1), as defined in instant claim 18. Results section 3.3 on page 6956 and the discussion on page 6957 go on to teach that total yields ranged from 7.2 x 1013 – 2.5 x 1014 VP/L, as defined in instant claim 19. Additionally, while Fedosyuk did not employ fed batch cultures themselves, they state that intensification of the upstream process would be favorable to increase the volumetric yield and is commonly employed in the art with HEK293 cells, including using fed catch cultures (page 6952, introduction; pages 6957 and 6960, discussion), as required in instant claim 20.
Memarzadeh, the BalanCD user manual, and Fedosyuk are considered to be analogous to the claimed invention because all are drawn to the production and purification of adenoviral vectors. Therefore, it would have been obvious to a person having ordinary skill in the art to have replicated the ChAdOx1 in the HEK293 T–REx™ cells of Fedosyuk instead of the HEK293 cells and adenovirus described by Memarzadeh and in conjunction with the media of the BalanCD user manual before the effective filing date of the claimed invention with a reasonable expectation of success to have a high–yielding, but cost–effective adenovirus production process that can be used in early–phase vaccine trials for response to emerging pathogen outbreaks (Fedosyuk; pages 6951 and 6952, abstract and introduction). All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A and 2143.02.
23. Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Memarzadeh, the BalanCD user manual, and Fedosyuk, as applied to claims 1 – 10, 14, and 18 – 20 above, in further view of van Doremalen, N., et. al. (2020), ChAdOx1 nCoV–19 vaccine prevents SARS–CoV–2 pneumonia in rhesus macaques, Nature, 586 (7830), 578–582. (Published 07/30/2023; Cited in Applicant’s IDS on 10/31/2023, NPL Document, Cite No. 7), hereby van Doremalen.
Memarzadeh, the BalanCD user manual, and Fedosyuk fail to teach that the adenovirus is ChAdOx1 nCoV–19, as stated in instant claim 11; and encodes for the SARS–CoV–2 spike protein, as recited in instant claim 15. Fedosyuk does teach that adenovirus–vectored vaccines targeting diseases, including Middle East Respiratory Syndrome (MERS), have been developed following Good Manufacturing Practice (GMP)–compliant processes and commonly employ HEK293 cells in batch–mode stirred–tank upstream processes (page 6952, introduction). Moreover, van Doremalen teaches that ChAdOx1 MERS, which encodes the spike protein for MERS, was previously developed and provided non–human primates with protection against MERS–induced disease (page 578). It is further taught that van Doremalen designed a similar ChAdOx1 nCoV–19 vector–based vaccine that encodes the full–length, codon–optimized spike protein of SARS–CoV–2 (abstract, page 578), as defined in instant claims 11 and 15.
Memarzadeh, the BalanCD user manual, Fedosyuk, and van Doremalen, are considered to be analogous to the claimed invention because all are in the field of adenoviral vectors. Therefore, it would have been obvious to a person having ordinary skill in the art to have replicated the ChAdOx1 nCoV–19 vector of van Doremalen in the HEK293 T–REx™ cells of Fedosyuk following the production method of Memarzadeh and the media of the BalanCD user manual before the effective filing date of the claimed invention with a reasonable expectation of success to provide an adenovirus–vector–based vaccine that elicits a robust immune response (van Doremalen; page 578, abstract) and can be produced in a high–yielding, but cost–effective manner against an emerging pathogen (Fedosyuk; pages 6951 and 6952, abstract and introduction). All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A and 2143.02.
24. Claims 12, 13, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Memarzadeh and the BalanCD user manual, as applied to 1 – 11, 14, 15, and 18 – 20 above, and in further view of Branton, P. E., et. al. (US 6730662 B1; Patented 05/04/2004), hereby Branton.
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The recited UniProt™ Accession Number for the requisite sequence in claim 13 fails to clearly identify the precise adenovirus sequence claimed because the accession number is extraneous to the instant disclosure. In the interest of compact prosecution, claim 13 is interpreted to be a 34 kDa protein with 294 amino acids from human adenovirus C serotype 5 with the sequence shown below.
Memarzadeh, Fedosyuk, and van Doremalen fail to teach that the adenovirus has the nucleotide sequence of Ad5 E4orf6 relative to UniProt™ Accession Number: Q6VGT3, as required in instant claims 12 and 13, correspondingly; or is a polynucleotide sequence with the antigen of interest that is controlled by the Tet repressor, as described in instant claims 16 and 17. Memarzadeh teaches that selectable markers that are activated with appropriate drugs or compounds can be added into a viral vector to allow for preferential or exclusive replication of cells with the marker (page 6, paragraph 28). Moreover, Fedosyuk teaches that the different adenovirus vectors have similar growth characteristics in Tet–repressing cells, wherein incorporation of the Tet operator elements helps with the growth of the cells (page 6954, results section 3.1). Branton teaches that the inducible Tet promoter can explicitly be employed with adenoviral vectors and activated with tetracycline (column 22, lines 42 – 45), as required in instant claims 16 and 17. It is further taught by Branton that the E4orf6 polypeptide described by SEQ ID NO: 2 is obtained from any adenovirus strain (column 4, lines 7 – 14; column 6, lines 55 – 67; column 7, lines 1 – 3), as defined in instant claims 12 and 13. UniProt™ Accession Number: Q6VGT3 has 100% sequence identity to Branton SEQ ID NO: 2, as seen below, and required in instant claim 13. See Geneva Pharms v. GlaxoSmithKline, 349 F.3d 1373 (Fed. Cir. 2003) and Pfizer
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v. Teva Pharms., 518 F.3d 1353 (Fed. Cir. 2008).
Memarzadeh, the BalanCD user manual, Fedosyuk, van Doremalen, and Branton are considered to be analogous to the claimed invention because all are in the field of adenoviral vectors. Therefore, it would have been obvious to a person having ordinary skill in the art to have used the polynucleotide sequence of Branton in the ChAdOx1 nCoV–19 of van Doremalen that are replicated in the HEK293 T–REx™ cells of Fedosyuk and the media of the BalanCD user manual following the production method of Memarzadeh before the effective filing date of the claimed invention with a reasonable expectation to allow for high–yielding processes that are valuable for the rapid, but economical production of large quantities of vectors (instant application; page 1, lines 10, 11, 23 – 27) against an emerging pathogen (van Doremalen; page 578, abstract; Fedosyuk; pages 6951 and 6952, abstract and introduction). All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A and 2143.02.
Conclusion
26. Claims 1 – 20 are rejected. No claims are allowed.
27. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hallie N. Pennington, Ph.D. whose telephone number is (571)272–6781. The examiner can normally be reached M–Th 7:30–5:30 ET.
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.
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/HALLIE N. PENNINGTON, PH.D./Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671