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 .
Restriction/Election
Applicant’s election without traverse of Group 2, claims 26-28 and 30, in the reply filed on 05/22/25 is acknowledged.
Claims 1-25 and 29 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/22/25.
Status of Claims/Rejections
Upon amendment, the currently pending claims are 1, 2, 4, 6-15, 19 and 21-30. Claims 26-28 and 20 are under examination. Applicants amendments and remarks were effective to overcome the previous 112(A) rejection. However, the double patenting rejections remain, and there is no power of attorney filed to discuss allowable subject matter and terminal disclaimers. As such, these rejections are made final.
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 26-28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-14 of U.S. Patent No. 11,161,886. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 9-14 of ‘886 teach a composition comprising a first protein and a second protein, said first protein comprising or consisting of an amino acid sequence selected from the group consisting of
(A-vii) the amino acid sequence set forth in SEQ ID NO: 25 (ScolE1c), (A-viii) the amino acid sequence set forth in SEQ ID NO: 26 (ScolE1d),
(B-vii) an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 25,
(B-viii) an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 26
(C-vii) an amino acid sequence having at least 80% sequence similarity to the amino acid sequence of SEQ ID NO: 25
(C-viii) an amino acid sequence having at least 80% sequence similarity to the amino acid sequence of SEQ ID NO: 26
(E-vii) an amino acid sequence comprising or consisting of at least 425 contiguous amino acid residues of SEQ ID NO: 25, and
(E-viii) an amino acid sequence comprising or consisting of at least 425 contiguous amino acid residues of SEQ ID NO: 26.
11. A method of preventing or reducing infection or contamination of an object with Salmonella, comprising contacting said object with a composition according to claim 9.
12. The method according to claim 11, wherein said object is sprayed with said aqueous solution or is immersed into said aqueous solution, or said object is immersed for at least 10 seconds into an aqueous solution of said composition.
13. The method according to claim 11, wherein said object is food or animal feed; or said food is whole animal carcass, meat, eggs, raw fruit or vegetable.
14. The method according to claim 11, wherein said Salmonella is Salmonella enterica.
Claims 11-14 of ‘886 are drawn to the same exact method of preventing or reducing infection or contamination of an object with SEQ ID NOs: 25 and 26, which is identical to those of instant claims 26-28 and 30, and the compositions of claim 1 or 4. Claims 11-14 of ‘886 depend from claim 9, with teaches SEQ ID NOs 25 and 26, which are the same as instantly claimed SEQ ID NOs: 25 and 26.
As such, the instant claims are rendered obvious over the claims of ‘886.
Claims 26-28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9- of U.S. Patent No. 12,264,183. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 9-14 of ‘886 teach a composition comprising a first protein and a second protein, said first protein comprising or consisting of an amino acid sequence selected from the group consisting of a composition comprising a protein comprising or consisting of any one of the following amino acid sequences: (A-x) SEQ ID NO: 28; or
(B-x) an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 28; or
(C-x) an amino acid sequence having at least 80% sequence similarity to the amino acid sequence of SEQ ID NO: 28; or
(D-x) an amino acid sequence having from 1 to 40 amino acid substitutions, additions, insertions or deletions to the amino acid sequence of SEQ ID NO: 28; or
(E-x) an amino acid sequence comprising or consisting of at least 215 contiguous amino acid residues of SEQ ID NO: 28; and wherein the composition further comprises a protein according to item (A-iii), (B-iii), (C-iii), (D-iii) or (E-iii), and/or according to item (A-vii), (B-vii), (C-vii), (D-vii) or (E-vii), and/or according to item (A-viii), (B-viii), (C-viii), (D-viii) or (E-viii), and/or according to item (A-ix), (B-ix), (C-ix), (D-ix) or (E-ix), or any combination thereof: (A-iii) SEQ ID NO: 3,
(A-vii) SEQ ID NO: 25,
(A-viii) SEQ ID NO: 26, or
(A-ix) SEQ ID NO: 27; or
(B-iii) an amino acid sequence having at least 80% sequence identity to the amino acid sequence of SEQ ID NO: 3,
(B-vii) an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 25,
(B-viii) an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 26, or
(B-ix) an amino acid sequence having at least 70% sequence identity to the amino acid sequence of SEQ ID NO: 27; or
(C-iii) an amino acid sequence having at least 85% sequence similarity to the amino acid sequence of SEQ ID NO: 3, (C-vii) an amino acid sequence having at least 80% sequence similarity to the amino acid sequence of SEQ ID NO: 25,
(C-viii) an amino acid sequence having at least 80% sequence similarity to the amino acid sequence of SEQ ID NO: 26, or
(C-ix) an amino acid sequence having at least 80% sequence similarity to the amino acid sequence of SEQ ID NO: 27;
(D-vii) an amino acid sequence having from 1 to 40 amino acid substitutions, additions, insertions or deletions to the amino acid sequence of SEQ ID NO: 25,
(D-viii) an amino acid sequence having from 1 to 40 amino acid substitutions, additions, insertions or deletions to the amino acid sequence of SEQ ID NO: 26,
(D-ix) an amino acid sequence having from 1 to 40 amino acid substitutions, or additions, insertions or deletions to the amino acid sequence of SEQ ID NO: 27; or
(E-iii) an amino acid sequence comprising or consisting of at least 470 contiguous amino acid residues of SEQ ID NO: 3,
(E-vii) an amino acid sequence comprising or consisting of at least 425 contiguous amino acid residues of SEQ ID NO: 25,
(E-viii) an amino acid sequence comprising or consisting of at least 425 contiguous amino acid residues of SEQ ID NO: 26,
(E-ix) an amino acid sequence comprising or consisting of at least 425 contiguous amino acid residues of SEQ ID NO: 27.
2. The composition according to claim 1, said protein being capable of exerting a cytotoxic effect on Salmonella.
3. The composition according to claim 1, wherein said composition is a plant material or extract thereof, wherein the plant material is a material from a plant having expressed said protein; or wherein said composition is an aqueous solution containing said protein.
4. The composition according to claim 1, wherein said composition is an aqueous solution containing said protein.
Instant claims 1 or 4, from which 26-28 and 30 depend, are drawn to the same compositions as those of ‘183. Claim 2 of ‘183 specifically states that the use of the same SEQ ID Nos: 25-28 are used for their cytotoxic effects on salmonella, which renders obvious a method of preventing or reducing the likelihood of infection or contaminating of an object by applying the claimed composition in methods well known in the art, and discussed in the specification of ‘183 at Col. 1-2. As such, instant claims 26-28 and 30 are rendered obvious by the claims of ‘183.
Response to arguments/Remarks
Applicants have only responded that they would like the double rejections to be held in abeyance, which does not overcome these rejections.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654