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 .
Application Status
The preliminary amendment filed March 24, 2025 is acknowledged. Claims 28-41 are pending and under examination.
This application was filed as a Divisional application of Application 16/619416, which was issued as US Patent 12,098,380. It is noted that a Restriction Requirement was mailed in the ‘416 application restricting between groups directed to Vero cell lines and methods of producing a viral vaccine (See Restriction requirement mailed 10/20/2022). Applicant elected claims directed to Vero cells (see Election filed 1/11/2023). However, the restriction requirement was withdrawn and the method claims rejoined in the office action mailed 1/29/2024. As such the provisions of 35 U.S.C. 121 are no longer applicable.
Specification
The use of the terms Zeocin®, Lipofectamine®, and GeneArt®, which are trade names or marks 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
Claim 31 is objected to because of the following informalities:
Claim 31 recites “wherein the nucleic acid encoding the recombinant protein of interest that is operably linked to a promoter”, which is not a complete phrase. It is suggested that “that” be deleted from the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 28-41 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 28 recites “wherein the Vero cell line comprises a nucleotide sequence that encodes for a HSV-1 ICP0 protein operably linked to a promoter having a sequence of SEQ ID NO: 2.” “A sequence of SEQ ID NO: 2” is interpreted as any 2 or more adjacent nucleotides of SEQ ID NO: 2. However, it is not clear which sub-sequences of SEQ ID NO: 2 are to be considered the claimed promoter. As such the structure of what constitutes the promoter is unclear, rendering the claim indefinite.
Claims 29-41 are rejected for depending from claim 28 and not remedying the indefiniteness.
To overcome this rejection, it is suggested that claim 28 recite “… a promoter comprising SEQ ID NO: 2.”
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 28-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12098380. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Patented claim 1 recites: A Vero cell line comprising a nucleotide sequence that encodes for a Herpes Simplex virus (HSV) ICP0 protein operably linked to a promoter, wherein the promoter comprises SEQ ID NO: 2. SEQ ID NO 2 of the patented application is 100% identical to SEQ ID NO 2 of the examined application. Patented claim 15 recites a method of producing a viral vaccine of interest comprising propitiating a virus to be used for vaccination in a Vero cell line of claim 1. “A viral vaccine” is a species of “a recombinant protein of interest”. Therefore, patented claim 15 anticipates examined claim 1. Patented claim 2 recites The Vero cell line of claim 1, wherein the nucleotide sequence that encodes HSV-1 ICP0 encodes the amino acid sequence of SEQ ID NO: 5. Patented claim 3 recites the Vero cell line of claim 1, wherein, the cell line exhibits Vero cell morphology. Patented claim 4 recites the Vero cell line of claim 1, wherein the cell line is capable of maintaining ICP0 complementation efficiency within 2 standard deviations as measured by a viral replication assay for greater than 20 cell passages, 30 cell passages, or 40 cell passages. Patented claim 5 recites the Vero cell line of claim 1, wherein the cell line further comprises an additional nucleic acid that encodes a tetracycline repressor protein (tetR) operably linked to a promoter. Patented claim 6 recites the Vero cell line of claim 5, wherein the promoter operably linked to the tetracycline repressor protein comprises SEQ ID NO: 9. Patented claim 7 recites the Vero cell line of claim 5, wherein the nucleic acid that encodes a tetracycline repressor protein has the sequence of SEQ ID NO: 11. Patented claim 8 recites the Vero cell line of claim 5, wherein the nucleic acid that encodes tetracycline repressor protein (tetR) operably linked to a promoter comprises or consists essentially of SEQ ID NO: 7. Patented claim 9 recites the Vero cell line of claim 1, further comprising a gene encoding antibiotic resistance. Patented claim 10 recites the Vero cell line of claim 1, further comprising an ICP0 deficient HSV virus (i.e., propagating an ICP0 deficient virus). Patented claim 11 recites the Vero cell line of claim 1, further comprising a nucleic acid encoding a recombinant protein of interest that is operably linked to a promoter. Patented claims 12 and 13 recite the Vero cell line of claim 11, wherein the recombinant protein of interest is a therapeutic protein and a vaccine protein. Therefore, the patented claims to the Vero cells anticipate the limitations for the Vero cell in the examined claims.
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have also used the Vero cells of patented claims 2-13 in the patented method of producing a viral vaccine, which includes a recombinant protein of interest, because the patented claims recite the characteristics of such Vero cells. The skilled artisan would have been motivated to include the limitations of the Vero cells lines for the purpose of producing therapeutic proteins along with the proteins of interest in the vaccine in a regulated manner.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE KONOPKA whose telephone number is (571)272-0330. The examiner can normally be reached Mon - Fri 7- 4.
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/CATHERINE KONOPKA/Primary Examiner, Art Unit 1635
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