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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No and 14/960,333 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The instant claims recite broad genera of potential bacteria comprising any phenylalanine transporter and genes that metabolize phenylalanine. The ‘333 application discloses only ammonia transporters and metabolism of ammonia into, e.g. arginine. The 15/154,934 application specifically discloses phenylalanine transporters and genes for the metabolism of phenylalanine, therefore the instant claims are granted a priority date of 5/13/2016, the filing date of that application.
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 24-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, 22 of U.S. Patent No. 10,933,102. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘102 claims recite bacteria used by the instant method that comprise a heterologous phenylalanine transporter and a heterologous gene that metabolizes phenylalanine under control of an inducible promoter(s). The inducible promoter may be induced by environmental conditions, such as those in the gut or a tumor. The heterologous genes may be on a chromosome or a plasmid. The bacterium may be probiotic, such as E. Coli Nissle. The bacteria may be auxotrophic in genes in the human gut or in the diaminopimelic pathway.
Claims 24-28, 30-35, 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, 13 of U.S. Patent No. 9,943,555. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘555 claims recite bacteria used by the instant method that comprise a heterologous phenylalanine transporter and a heterologous gene that metabolizes phenylalanine (PAL) under control of an inducible promoter(s). The inducible promoter may be induced by environmental conditions, such as those in the gut (low oxygen). The heterologous genes may be on a chromosome or a plasmid. The bacteria may be auxotrophic in genes in the human gut such as the diaminopimelic pathway.
Claims 24-28, 30-32, 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7,8 of U.S. Patent No. 10,610,546. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘546 claims recite bacteria used by the instant method that comprise a heterologous phenylalanine transporter and a heterologous gene that metabolizes phenylalanine (PAL) under control of an inducible promoter(s). The inducible promoter may be induced by those in the gut (low oxygen, anaerobic). The heterologous genes may be on a chromosome.
Claims 24-28, 30-36, 39, 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 12-15 of U.S. Patent No. 10,195,234. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘234 claims recite bacteria used by the instant method that comprise a heterologous phenylalanine transporter and a heterologous gene that metabolizes phenylalanine (PAL) under control of an inducible promoter(s). The inducible promoter may be induced by those in the gut (low oxygen, anaerobic). The heterologous genes may be on a chromosome or a plasmid. The bacteria may be probiotic and auxotrophic in genes in the human gut such as the diaminopimelic pathway.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638