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 statement (IDS) submitted on 11/15/2024 has been considered by the examiner.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. In the 7/22/2024 preliminary amendment, PCT/US15/59272 and U.S. Provisional Patent Application No. 62/075,408 are incorporated by reference Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Claim Objections
Claim 1 is objected to because of the following informalities: As recited, the source of “Rep78 gene, Rep 52 gene, VP1 gene, VP2 gene, VP3 gene”, recited in lines 1-2 do not have antecedent context until line 3, “a recombinant adeno-associated virus (rAAV)”. Suggested language to ameliorate this issue would be: “A eukaryotic microalgae that produces a recombinant adeno-associated virus (rAAV) comprising a Rep78 gene, Rep 52 gene, VP1 gene, VP2 gene, VP3 gene and a therapeutic gene sequence, wherein the rAAV comprises inverted terminal repeats flanking the therapeutic gene sequence.” Appropriate correction is required.
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 23-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,907,130 in view of Guo et al. (USPgPub 2011/0162115, cited in the IDS), and Yan et al. (Journal of Virology. 2005; 79 (1): 364-379).
Claims 1, 4, 5, and 7 of ‘130 are drawn to a eukaryotic microalgae that produces a recombinant adeno-associated virus (rAAV), where the rAAV comprises polynucleotides encoding Rep 78, Rep 52, VP1, VP2, and/or VP3, and further comprises an inverted terminal repeat (ITRs) and helper functions for generating AAV infection, as required by instant claims 23, 26, and 28. Claims 2 and 3 of ‘130 correspond to instant claims 24 and 25. Claim 6 of ‘130 corresponds to instant claim 27 and claims 8-11 of ‘130 correspond to instant claims 29 and 30. The claims of ‘130 do not recite the ITRs flanking a heterologous gene, required in instant claim 23.
Yan et al. do, see Figure 1A.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have flanked a heterologous gene between AAV ITRs, as taught by Yan et al., for successful heterologous gene expression, see the abstract and Introduction sections.
The claims of ‘130 do not recite a therapeutic gene expression and Yan et al. also do not teach a therapeutic gene.
Guo et al. teach a viral vaccine vector expressing a heterologous NDV HN, see paragraphs [0137, 0139, and 0151].
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have expressed a therapeutic gene flanked by AAV ITRs, taught by Yan et al. and Guo et al., in the microalgae of ‘130 to induce a therapeutic immune response against the heterologous gene expressed, see claims 9-12 of Guo et al. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have expressed a therapeutic gene flanked by AAV ITRs, taught by Yan et al. and Guo et al., in the microalgae of ‘130 because Guo et al. teach that any green microalgae is contemplated, see the second paragraph under "Algae as a recombinant protein production platform", and Chlamydomonas reinhardtii, Chlorella vulgaris, Chlorella ellipsoidea, Chlorella sorokiniana, Chlorella kessleri, Volvox carteri, Dunaliella salina, Ostreococcus tauri, and Gonium pectoral, recited in claim 2 of ‘130 are green microalgae.
Claims 23-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,077,748. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 4 of ‘130 are drawn to a eukaryotic microalgae that produces a recombinant adeno-associated virus (rAAV), where the rAAV comprises polynucleotides encoding Rep 78, Rep 52, VP1, VP2, and/or VP3, and further comprises an inverted terminal repeat (ITRs) flanking a gene therapy polynucleotide, anticipating instant claims 23 and 26. Claims 2 and 3 of ‘748 anticipate instant claims 24 and 25 and claims 5-8 anticipate instant claims 27-30.
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.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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