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 .
Status of the Claims
Claims 35-50 are pending.
Claim Rejections - 35 USC § 102- Necessitated by Amendment
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Bruggen as evidenced by Bos
Claims 35-38, 42-44 and 49-50 are rejected under 35 U.S.C. 102 as being unpatentable over:
Bruggen et al. “Bruggen”; (US5965381A) (European application provided in IDS of 9/4/2024)
as evidenced by Bos et al (Bos JL. p21ras: an oncoprotein functioning in growth factor-induced signal transduction. Eur J Cancer. 1995 Jul-Aug;31A(7-8):1051-4) (Provided in IDS of 9/4/2024)
Regarding claim 35, 42, and 49, Bruggen teaches a recombinant Yersinia Pestis cell and the use thereof for delivery of proteins into eukaryotic cells (Bruggen, column 1, paragraph 1.) Bruggen’s Yersinia strain is transformed with a vector comprising a promoter, a first DNA sequence encoding a delivery signal from a bacterial T3SS effector protein, operably linked to said promoter, and a second DNA sequence encoding a heterologous protein fused in frame to the 3’ end of said first DNA sequence (claim 3), wherein the heterologous protein is a GTPase.
Bruggen teaches the use of several heterologous “tumor associated” proteins fused to the YopE delivery signal (Bruggen claim 12). One of Bruggen’s claimed “tumor associated” proteins is p21ras, which is a small GTPase that functions as a molecular switch in intracellular signal transduction pathways activated by a large variety of growth factors (Bruggen claim 12 , Bos, Abstract). In other words, p21ras is a cell signalling protein
Bruggen also teaches that the recombinant gram-negative bacterial strain is a Yersinia strain (Bruggen Claim 1, column 1, paragraph 1), and the delivery signal is a YopE or an N terminal fragment thereof (Bruggen Claim 5, Example 3, Figure 1, claim 30, claim 34).
So, Bruggen teaches a recombinant Yersinia pestis transformed with a vector comprising in the 5’ to 3’ direction a promoter, a first sequence encoding a YopE effector protein linked to the promoter, and a second sequence encoding a heterologous cell signalling protein fused in frame to the 3’ end of the first DNA sequence.
Bruggen anticipates claim 35.
Regarding claim 36 and 43, Bruggen teaches the inclusion of a PstI site (protease cleavage site) between a first DNA sequence, in this case MAGE-1, and an N terminal fragment of the effector protein YoPE. “The sequence encoding protein MAGE-1 was inserted in frame with a sequence encoding a truncated YopE, YopE130 containing the first 130 amino acids of YopE. Such a plasmid is graphically depicted in FIG. 1.” Figure 1 shows a PstI site between the YopE gene and MAGE-1. (Bruggen Example 3, Figure 1)
Regarding claim 37 and 44, Bruggen’s bacteria may be deficient in the production of at least one functional effector protein, and the delivery signal includes YopE (Bruggen claim 30, 34). Bruggen’s claim 34 is not limited to truncated variations, so claim 34 encompasses YopE effector protein, including the claimed N-terminal 138 amino acids of the Yersinia enterocoliticia YopE effector protein. “More preferably, the effector protein is YopE of Yersinia enterocolitica.” (column 7, paragraph 6).
Regarding claim 38, Bruggen discloses that Yops promote adhesion of Yersinia to the surface of host cells (paragraph 4 starting with “Genetic studies…”). Bruggen also teaches that the recombinant bacteria may also be deficient in certain Yop effector proteins, therefore Bruggen teaches a bacteria that is deficient in cell adhesion proteins.
Regarding claim 42, Bruggen teaches the use of a number of heterologous “tumor associated” proteins fused to the YopE delivery signal (Bruggen claim 12). One of the claimed proteins in particular is p21ras. p21ras, is a small GTPase that functions as a molecular switch in intracellular signal transduction pathways activated by a large variety of growth factors. (Bos, Abstract).
Regarding claim 50, Bruggen teaches that the bacteria may be employed as an in vivo regime, i.e., as a recombinant vaccine to treat subjects. (Summary of invention, paragraph 7)
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.
US12091670 (Application 17/111,332)
Claims 35-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 12091670. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 35, 42, and 45, claim 1 of the reference patent encompasses the scope of claim 35, 42 and 45.
Regarding claim 36 and 43, claim 2 of the reference patent encompasses the scope of claim 36 and 43.
Regarding claim 37 and 44, claim 3 of the reference patent encompasses the scope of claim 37 and 43.
Regarding claim 38, claim 4 of the reference patent encompasses the scope of claim 38.
Regarding claim 39, claim 1 of the reference patent encompasses the scope of claim 39.
Regarding claims 40, 41, 46, 47, claim 6 of the reference patent encompasses the scope of claims 40, 41, 46, 47.
Regarding claim 48, claim 8 of the reference patent encompasses the scope of claim 48.
Regarding claim 49, claim 9 of the reference patent encompasses the scope of claim 49.
Regarding claim 50, claim 10 of the reference patent encompasses the scope of claim 50.
US10889823B2 (15/311,424)
Claims 35-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of U.S. Patent No. 12091670. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 35, 42, and 45, claim 1 of the reference patent encompasses the scope of claims 35, 42 and 45.
Regarding claim 36 and 43, claim 2 of the reference patent encompasses the scope of claim 36 and 43.
Regarding claim 37 and 44, claim 3 of the reference patent encompasses the scope of claim 37 and 43.
Regarding claim 38, claim 4 of the reference patent encompasses the scope of claim 38.
Regarding claim 39, claim 1 of the reference patent encompasses the scope of claim 39.
Regarding claims 40, 41, 46, 47, claim 7 of the reference patent encompasses the scope of claims 40, 41, 46, 47.
Regarding claim 48, claim 9 of the reference patent encompasses the scope of claim 48.
Regarding claim 49, claim 10 of the reference patent encompasses the scope of claim 49.
Regarding claim 50, claim 11 of the reference patent encompasses the scope of claim 50.
Conclusion
Claims 35-50 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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/THOMAS R. AMICK/ Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
