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 .
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 1/2/2025 and 11/3/2025 has been considered by the examiner.
Specification
The use of the term “Capto” in paragraph [0025] of the instant published application (USPgPub 2024/0309337), which is 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.
Applicant is required to properly annotate all trade names and/or marks present in the instant specification, if any additional trade names and/or marks are discovered. Applicant' s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,018,293. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘293 anticipate:
‘293 claim 1: A method for large-scale purification of recombinant viral vectors, wherein the method comprises (recited in instant claim 1):
(a) providing a raw material comprising the recombinant viral vectors, wherein the raw material is a feed liquid, and wherein the feed liquid has a volume of no less than 20 liters; (recited in instant claim 1)
(b) carrying out microfiltration treatment on the feed liquid to obtain a microfiltered filtrate comprising the recombinant viral vectors, wherein the microfiltration treatment is conducted using a microfiltration hollow fiber column, wherein the microfiltration hollow fiber column (recited in instant claim 1), comprises a microfiltration membrane with a cut-off value of 0.4 to 1.0 μm; as required by instant claim 2,
(c) concentrating the filtrate to obtain a concentrated filtrate, wherein the concentrating is conducted using an ultrafiltration hollow fiber column (recited in instant claim 1) with a cut-off value of 200 K to 1000 K; as required in instant claim 4,
(d) purifying the filtrate by chromatography to obtain a crude product comprising the recombinant viral vectors (recited in instant claim 1); and
(e) subjecting the crude product to liquid exchange and purification, thereby obtaining purified recombinant viral vectors; wherein the chromatography in step (d) is selected from the group consisting of anion chromatography, size exclusion chromatography, multi-mode composite resin chromatography, and combinations thereof (recited in instant claim 1).
‘293 claim 2. The method of claim 1, wherein the chromatography in step (d) comprises anion chromatography, followed by multi-mode composite chromatography, as required by instant claim 3.
‘293 claim 3. The method of claim 1, wherein after step (e), the method further comprises: (f) subjecting the purified recombinant viral vectors to liquid exchange to obtain a virus freezing solution comprising the recombinant viral vectors; and (g) sterilizing the virus freezing solution by filtration to obtain sterilized recombinant viral vectors, as required by instant claim 5.
‘293 claim 4. The method of claim 1, wherein the recombinant viral vectors comprise lentiviral vectors, as required by instant claim 6.
‘293 claim 5. The method of claim 1, wherein the filtrate obtained from step (b), or the concentrated filtrate obtained from step (c), is subjected to nuclease treatment before being purified by chromatography, as required by instant claim 7.
‘293 claim 6. A purification device for performing the method of claim 1, which comprises: a microfiltration unit, wherein the microfiltration unit is used to perform microfiltration on the recombinant viral vectors to be purified to obtain a microfiltration filtrate; a concentration unit, wherein the concentration unit is used to concentrate the microfiltration filtrate to obtain a concentrated filtrate; and a chromatography purification unit, wherein the chromatography purification unit is used to perform chromatography purification on the concentrated filtrate to obtain purified recombinant lentiviral vectors, as required by instant claim 8.
‘293 claim 7. The purification device of claim 6, wherein the chromatography purification unit comprises a size exclusion chromatography unit and an anion chromatography unit, as required by instant claim 9.
‘293 claim 8. The purification device of claim 6, wherein the purification device further comprises: a nuclease treatment unit, wherein the nuclease treatment unit comprises an adding device for adding a nuclease, as required by instant claim 10.
Claims 1-4, 6, and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 4-7 of U.S. Patent No. 12,577,541. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘541 anticipate:
‘541 claim 1: A method for large-scale purification of recombinant viral vectors, wherein the method comprises (recited in instant claim 1):
(a) providing a raw material comprising the recombinant viral vectors, wherein the raw material is a feed liquid, and wherein the feed liquid has a volume of no less than 20 liters; (recited in instant claim 1)
(b) carrying out microfiltration treatment on the feed liquid to obtain a microfiltered filtrate comprising the recombinant viral vectors, wherein the microfiltration treatment is conducted using a microfiltration hollow fiber column, wherein the microfiltration hollow fiber column (recited in instant claim 1), comprises a microfiltration membrane with a cut-off value of 0.4 to 0.8 μm; encompassed by instant claim 2,
(c) concentrating the filtrate to obtain a concentrated filtrate, wherein the concentrating is conducted using an ultrafiltration hollow fiber column (recited in instant claim 1) with a cut-off value of 100 K to 800 K; encompassed by instant claim 4,
(d) purifying the filtrate by chromatography to obtain a crude product comprising the recombinant viral vectors (recited in instant claim 1); and
(e) subjecting the crude product to liquid exchange and purification, thereby obtaining purified recombinant viral vectors; wherein the chromatography in step (d) is selected from the group consisting of anion chromatography, size exclusion chromatography, multi-mode composite resin chromatography, and combinations thereof (recited in instant claim 1).
‘541 claim 2. The method according to claim 1, wherein the chromatography in step (d) comprises anion chromatography followed by multimodal composite chromatography, as required by instant claim 3.
‘541 claim 4. A purification device for performing the method of claim 1, wherein the purification device comprises: a microfiltration unit, used for performing microfiltration treatment of the recombinant viral vectors to be purified, so as to obtain a microfiltered filtrate; a concentration unit, used for concentrating the microfiltered filtrate, so as to obtain a concentrated filtrate; and a chromatographic purification unit, used for purifying by chromatography the concentrated filtrate, so as to obtain purified recombinant viral vectors, as required by instant claim 8.
‘541 claim 5. The purification device according to claim 4, wherein the chromatographic purification unit comprises a size exclusion chromatography unit and an anion chromatography unit, as required by instant claim 9.
‘541 claim 6. The purification device according to claim 4, wherein the purification device further comprises: a nuclease treatment unit, comprising an addition device for adding a nuclease, as required by instant claim 10.
‘541 claim 7. The method of claim 1, wherein the recombinant viral vectors comprise lentiviral vectors, as required by instant claim 6.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-8, 10, and 11 of copending Application No. 19/545,623 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘623 anticipates:
A method for large-scale purification of recombinant viral vectors, wherein the method comprises (recited in instant claim 1):
(a) providing a feed liquid comprising the recombinant viral vectors, wherein the feed liquid has a volume of no less than 20 liters; (required in instant claim 1)
(b) carrying out microfiltration treatment on the feed liquid to obtain a microfiltered filtrate comprising the recombinant viral vectors, wherein the microfiltration treatment is conducted using a microfiltration hollow fiber column, wherein the microfiltration hollow fiber column (recited in instant claim 1),
(c) concentrating the filtrate to obtain a concentrated filtrate, wherein the concentrating is conducted using an ultrafiltration hollow fiber column (recited in instant claim 1) with a cut-off value of 100 K to 800 K; encompassed by instant claim 4,
(d) purifying the filtrate by chromatography to obtain a crude product comprising the recombinant viral vectors (recited in instant claim 1); and
(e) subjecting the crude product to liquid exchange and purification, thereby obtaining purified recombinant viral vectors; wherein the chromatography in step (d) is selected from the group consisting of anion chromatography, size exclusion chromatography, multi-mode composite resin chromatography, and combinations thereof (recited in instant claim 1).
Claims 2, 3, 5-8, 10, and 11 of ‘623 correspond to and anticipate the limitations of instant claims 2, 3, and 5-10, respectively.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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