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
Claim Status
2. Claims 1-2, 6, 8-9, 15-16, 18, 20-22, 31-32, 34-35, 40, 42, 52-53, 55, and 57 are currently under consideration.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 15 June 2023 and 13 February 2025 were filed on/after the mailing date of the instant Application on 15 June 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
4. Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
5. Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in ¶ [0094].
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also 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;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
Specification
6. The use of the terms ‘Perc6’ in ¶ [0064] and ‘MEM’ and ‘DMEM’ in ¶ [00113], which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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.
Claim Objections
7. Claims 1, 8, 16, 21, 32, and 57 are objected to because of the following informalities:
Regarding claims 1(d)(iii), 8(d)(iii), 16, and 57, there should be an additional comma before the ‘and’ in lists containing 3 or more items
Regarding claim 1(d)(i), ‘polynucleotide’ should be plural
Regarding claim 1(c), the word ‘cell’ should be added after ‘suspension’
Acronyms should be accompanied by their full name when first used
Regarding claim 21, ‘PEI’ should be written out
Regarding claim 32, the first instance of ‘HEK’ and ‘CHO’ should be written out
Regarding claim 57, ‘GC’ should be written out
Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-2, 6, 8-9, 15-16, 18, 20-22, 31-32, 34-35, 40, 42, 52-53, 55, and 57 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 32 contains the trademark/trade name Per.C6. 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 the cell line and, accordingly, the identification/description is indefinite.
Regarding the following rejections, see Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
The term ‘about’ in claims 1, 6, 8, 16, 18, 22, 34-35, 53, and 57 is a relative term which renders the claim indefinite. The term ‘about’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification attempts to define the term ‘about’, but provides multiple definitions and uses indefinite language, thus making the scope unclear (¶ [0027]). Two practitioners could have two different interpretations to how close a value must be to read upon the claimed range.
Claims 2, 6, 15-16, 18, 20-22, 31-32, 34-35, 40, 42, 52-53, 55, and 57, which depend on claim 1, are similarly rejected.
Claim 9, which depends on claim 8, is similarly rejected.
Regarding claims 1 and 8, it is unclear if the “one or more polynucleotides” in c) is the output of b) or if it is a separate mixture. In addition, it is unclear if i) through v) are separate limitations or if all of them need to be fulfilled, as iii) and iv) contradict each other. iii) requires the transferring step to be “less than about 60 minutes”, whereas iv) requires the transferring step to be “no longer than about 6 hours”.
Claims 2, 6, 15-16, 18, 20-22, 31-32, 34-35, 40, 42, 52-53, 55, and 57, which depend on claim 1, are similarly rejected.
Claim 9, which depends on claim 8, is similarly rejected.
Regarding claim 8, the term ‘increasing’ renders the claim indefinite because no control is present. Since the control has multiple interpretations, so too does ‘increasing’ from there and the presence of multiple interpretations renders the claim indefinite. For compact prosecution, Examiner is interpreting this limitation to read on any rAAV titer (GC/mL) increase when compared to any changing variable.
Claim 9, which depends on claim 8, is similarly rejected.
Regarding claim 15, it is unclear if both of the “admixing one or more polynucleotides” steps use the inline mixer or just one.
Regarding claim 34, it is unclear if the range is (2x10E+6 to 10E+7) or (2x10E+6 to 2x10E+7). The presence of multiple interpretations renders the claim indefinite.
The term ‘sufficient’ in claim 52 is a relative term which renders the claim indefinite. The term ‘sufficient’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, ‘sufficient’ is subject and open to multiple interpretations.
Regarding claim 57, is it unclear if the “same volume” is the same volume as one admix or both admixes combined.
Claim Rejections - 35 USC § 103
10. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
11. Claims 1-2, 6, 8-9, 16, 18, 20-22, 31-32, 34-35, 40, 42, 52-53, 55 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Grieger (Mol. Ther., February 2016, 24(2): 287-297) (See IDS filed 15 June 2023) in view of Panteli (WO 2018208960 A1; published 15 November 2018) (See IDS filed 15 June 2023).
Regarding claims 1, 8, 31-32, 34, 40, and 57, Grieger teaches a method of manufacturing that can be used to produce and purify numerous rAAV serotypes and chimeric capsids (Introduction, ¶ 6), using a suspension of HEK293 cells diluted to a concentration of 1x106 to 2x106 viable cells/mL (Optimization of cell density and plasmid DNA concentration). Grieger does not teach the specific method steps, as claimed. However, Panteli teaches a method of producing rAAV where Figure 2 is the illustration of Example 1:
Figure 2 discloses a culture volume between 50-2000 L that the transfection master mix is added to;
A transfection master mix is made by introducing a DNA solution and a transfection reagent solution into a mixing container, mixing with mechanical rocking, and incubating the transfection master mix (¶ [0006]), wherein the transfection reagent will spontaneously form a complex with DNA in solution (¶ [0007]);
Figure 2 discloses that the master mix can be added in 2-4 batches and Example 1 discloses that the preparation and addition of the master mix can be repeated (Example 1, step 9); it would be obvious to have additional batches (admixing steps) as additional transfections should yield more virus;
i) Figure 1 shows “rAAV vectors are produced by co-transfecting packaging cells with three plasmids containing the genes necessary to produce a complete rAAV” (¶ [0033]);
ii) The transfection mix could be added to the cell culture at 10% v/v (¶ [0041]);
iii) Regarding admixing, Panteli teaches that “the rocking period is 10 minutes or less”
(¶ [0011]) and for incubation, “incubation period is between 5 to 180 minutes” (¶ [0006]). Example 1 discloses that the admixing took 1 minute, the incubation was 20 minutes, and the master mix could be added via an undamped gravity feed, indicating an almost immediate transfer (Example 1, steps 6-8).
iv) See above, wherein the immediate addition of the cell culture is no longer than 6 hours;
v) “For large scale transfection of cells in a bioreactor, the preparation and the addition of master mix can be repeated to enable batch addition of several transfection mixtures in series or parallel” (Example 1, step 9);
Regarding the ‘increasing’ limitation in claim 8, FIG. 3A of Panteli shows an increase in rAAV titer as v/v% decreases. Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the concentration of HEK293 cells that were adapted for rAAV suspension cultures disclosed in Grieger and further apply the rAAV production methods of Panteli to the cells. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding claims 2 and 9, see items c) and v) above, wherein the master mix can be prepared and added in multiple batches. Regarding claim 6, see item d) iii) above, wherein the transferring step happens almost immediately, which reads on 6b) as it is less than 60 minutes. Regarding claims 16 and 18, see item d) iii) above, wherein the admixing, incubation, and transferring all took less than 20 minutes each. Regarding claim 22, see item a) above, wherein the cell culture is between 50-2000 liters.
Regarding claims 20-21, Grieger further teaches using polyethyleneimine (PEI), which is a stable cationic polymer, for transfection of the HEK293 cells (Transfection of suspension HEK293 cells (optimized protocol)). Regarding claims 35 and 55, Grieger further teaches that the transfected cells are cultured for 3-5 days, then the rAAV particles are harvested (¶ [0033]). Regarding claim 42, Grieger further teaches “The manufacturing system can be used to produce and purify numerous rAAV serotypes and chimeric capsids (e.g., 1–9) with significantly reduced empty particles.” (Introduction, ¶ 6), wherein Figure 4 further shows the purification of rAAV2 capsids. Thus, they teach propagation of rAAV with AAV2 capsid.
Regarding claim 52-53, Panteli teaches three plasmids for rAAV production, one with the gene of interest, one with the rep and cap genes, and one with adenovirus helper genes to facilitate replication (¶ [0016] and FIG. 1).
Regarding claim 57, the result of having twice as many rAAV particles produced is not given patentable weight. The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative steps”). In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. Therefore, the claim reads on “the method of claim 1” and is thus rejected for the same reasons as claim 1 above.
The parameters of cell concentrations; cell culture volumes; admixing, incubation, and transferring times; and cell culturing times would have been obvious to use in the methods of claims 1 and 8 above because they are all result effective and can be arrived at through routine experimentation. For example, more cells (higher concentration, larger cell culture volumes) will yield more virus. In addition, mixing and incubation times are known to require optimization, as discussed in Panteli: “The mixing of the PEI and the plasmids requires optimization of the mixing method and incubation time to form PEI/DNA complexes that are effective for scale-up of rAAV manufacturing.” (¶ [0016]). 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 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." (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." (In re Aller, 220 F.2d 454, 456, 105 USPQ 2).
12. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Grieger (Mol. Ther., February 2016, 24(2): 287-297) (See IDS filed 15 June 2023) and Panteli (WO 2018208960 A1; 15 November 2018) (See IDS filed 15 June 2023) as applied to claims 1-2, 6, 8-9, 16, 18, 20-22, 31-32, 34-35, 40, 42, 52-53, and 55 above, and further in view of Hu (US 20110212526 A1; 01 September 2011) (See PTO-892: Notice of References Cited).
Regarding claim 15, Greiger in view of Panteli make the limitations of claim 1 obvious, as seen above in section 11. They do not teach the usage of an inline mixer. However, Hu teaches using a device that functions as a static mixer to cultivate rAAV (¶ [0006]). Therefore, it would have been obvious to one of ordinary skill to take the teachings of Panteli and replace the rocking device with the inline mixer to perform the same function to achieve the same result. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). One of ordinary skill in the art would have had a reasonable expectation of success for simply switching the manner in which the materials are mixed. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Double Patenting
13. 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.
14. Claims 1-2, 6, 8-9, 15-16, 18, 20-22, 31-32, 34-35, 40, 42, 52-53, 55, and 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 20-21, 30-31, 33, 38, and 44-45 of copending Application No. 18/261,551 in view of Grieger, Panteli, and Hu as discussed above in sections 11-12.
Claims 4 and 45 of ‘551 discusses a method of producing a recombinant virus particle, wherein:
A suspension cell culture with a volume between 50 and 20,000 liters that is capable of producing the recombinant virus particle is provided;
The cells are transfected by adding a composition with one or more polynucleotides that contain genes necessary to produce the recombinant virus particle and a transfection reagent;
Maintaining the cell culture under conditions that allow the production of the recombinant virus particle (see claims 1(d) and 8(d) of the Instant Application).
These claims in view of Grieger and Panteli make claims 1-2, 6, 8-9, 16, 18, 20-22, 31-32, 34-35, 40, 42, 52-53, 55, and 57 of the Instant Application obvious, as discussed above in section 11.
Claim 44 of ‘551 discloses a transfection reagent of PEI, which reads on claims 20-21 of the Instant Application. Claim 38 of ‘551 discloses a list of cells that can be used including HEL293 cells, which reads on claims 31-32 of the Instant Application. Claims 20-21 of ‘551 discloses an rAAV particle wherein the particle has a capsid protein of a list of AAV serotypes, which reads on claims 40 and 42 of the Instant Application. Claim 30 of ‘551 discloses that the one or more polynucleotide encodes the same proteins as claim 52 of the Instant Application. Claim 31 of ‘551 discloses the same exact content as claim 53 of the Instant Application. Claim 33 of ‘551 discloses recovering the rAAV particles, which reads on claim 55 of the Instant Application.
Regarding claim 15, it would have been obvious to apply the static mixer of Hu, as discussed above in section 12.
This is a provisional nonstatutory double patenting rejection.
Conclusion
15. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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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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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671