DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 12/29/2025.
Claims 1-6, 8, 11, 14-17, 19-21 and 23-30 are pending.
The present application is a continuation application of U.S. Patent Application No. 18/251,737, filed on May 4, 2023, which is a U.S. national stage of application No. PCT/JP2021/040410, filed on November 2, 2021 which claims priority to Japanese Application No. 2020- 184495, filed November 4, 2020.
Applicant cannot rely upon the foreign priority papers to overcome this rejection because a translation of said papers has not been made of record in accordance with 37 CFR 1.55. See MPEP § 201.15. Hence, the effective filing date of the application is November 2, 2021.
Information Disclosure Statement
An information disclosure statement filed 12/29/2025 has been identified and the documents considered. The corresponding signed and initialed PTO Form 1449 has been mailed with this action. Initials indicate that the document has been considered even if the reference is lined through.
Response to Amendments
Applicants amendments are sufficient to overcome the rejection under 35 USC 112, second.
Claim Objections
Claim 15 is objected to because of the following informalities: the claim appears to have one too may or too few words in reciting “the helper gene is each of any of”. It seems the claim intends that each of the helper genes is from one of the serotypes. Claim modification is necessary. Appropriate correction is required.
Claim Rejections - 35 USC § 112, second paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 8 and 12 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 1 recites that there is a component (v) a replication origin functional in Bacillus subtilits but there is no further mention of this sequence. Hence, the structure of the nucleic acid sequence to be introduced into the host cell is unclear. It is unclear where this sequence is placed. This is a new rejection necessitated by applicants’ amendment.
Claim 8 recites the limitation "a nucleic acid sequence required for constituting the virus is about 10 kb or greater" in claim 1. There is insufficient antecedent basis for this limitation in the claim. There is no sequence required for constituting the virus and hence, it is unclear to what this sequence references. This is a new rejection necessitated by applicants’ amendment.
Claim 12 recites that the nucleic acid sequence further comprises “a terminator from upstream” but the claim does not indicate what a terminator from upstream is. The phrase does not make sense. This is a new rejection.
Claim Rejections - 35 USC § 112, 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.
Claims 1-6, 8, 11, 14-17, 19-21 and 23-30 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection is new based on amendment in part and in part maintained.
Claim 1 reads on methods of making an AAV vector plasmid in Bacillus subtilis. The claim ends part A) stating placing the host cell under the condition effective to from a plasmid in the host cell. The method of the claims simply requires introducing a nucleic acid into a host cell. So, it is not clear what the conditions are that are effective to form a plasmid. The disclosure does not provide these conditions. It is not clear what conditions are required. It appears to the contrary that the nucleic acid is a plasmid and it is simply amplified in the subtilis cell.
Secondly, the claim requires a replication of origin part (v). However, the claim does not indicate where the origin is placed in the nucleic acid sequence. The disclosure to the contrary demonstrate does not place it between the ITR.
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Third, claim 27 requires that the CCC purity of “a plasmid” is 80% or greater. It appears that this means the plasmid of claim 25. To this end, the disclosure teaches,
For both plasmids pGETS103-AAV-Helper-RC2 and pGETS103-RC2, the CCC purity was higher in hay bacillus than in Escherichia coli. The guidance of the FDA specifies that the CCC purity shall exceed 80%. Since a plasmid produced using hay bacillus was observed to have a high CCC purity, said plasmid can reduce the burden of the purification operation for improving the CCC purity and the manufacturing costs. It is believed that CCC purity is also associated with safety, functionality, and transfection efficiency of a plasmid DNA. A plasmid DNA with a high CCC purity is highly useful.
This suggests that simply by producing the vector in hay bacillus, the purity exceeds 80%. There are no other means of achieving this as disclosed. The written description requirement for genus claims may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with known or disclosed correlations between function and structure, or by a combination of such characteristics sufficient to show that the applicant was in possession of the claimed genus.
To this end, the MPEP provides such guidance (emphasis added). If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function. In contrast, without such a correlation, the capability to recognize or understand the structure from the mere recitation of function and minimal structure is highly unlikely. In this latter case, disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing "a result that one might achieve if one made that invention"); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does "little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Compare Fonar, 107 F.3d at 1549, 41 USPQ2d at 1805 (disclosure of software function adequate in that art).
Response to Arguments
Applicants have not addressed the third issue which was previously presented.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-6, 8, 11, 14-17, 19-21 and 23-30 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-35 and 37-47 of copending application 18/251,737. Applicants have requested that the rejection be held in abeyance. The rejections stand until allowable subject matter is found or a terminal disclaimer is filed.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the methods are both directed to making a virus vector plasmid wherein as a whole, the copending claims are drawn to the same steps and products as recited in claims 1-33. Furthermore, a number of the cited claims of the instant invention are generic to all that is recited in claims 34, 35 and 39-47 of copending application 18/251,737. That is, the cited claims of copending application 18/251,737anticipate and fall entirely within the scope of the rejected claims of the instant application.
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending application 18/251,737, then two different assignees would hold a patent to the claimed invention of copending application 18/251,737, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
The closest prior art is U.S. application 20180155740 which teaches construction of a plasmid for producing an AAV. The difference between the U.S. application 20180155740 and the instant claims is that U.S. application 20180155740 does not teach the presence of helper genes in the plasmid nor an origin of replication for replication in a prokaryotic host cell such as bacillus. Both teach plasmids with nucleic acids that are necessary to constitute a virus- rep and cap as well as ITR that are outside of the nucleic acid necessary to constitute the virus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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