DETAILED ACTION
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,771,750 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claim 1 recites the limitation “comprising at least any eight consecutive amino acids from amino acids 186-196 of SEQ ID NO: 1 wherein one or both of amino acids 189 and 193 of SEQ ID NO: 1 comprises alanine or is independently substituted with any other amino acids except tyrosine”. The patented claims do not recite the words “at least 8”, but provide members of the Markush group which are ‘at least eight consecutive amino acids from this fragment, e.g., 186-193, 187-194, etc. which are all ‘at least 8’. Accordingly, the sets of claims are not patentably distinct. The instant claims recite “or is independently substituted with any other amino acid except tyrosine’ so allows for the fragments with alanine at positions 189 and 193. With respect to the “0 to 1,” “0 to 2 amino acid” in the instant claims, patented claims 2-6 recite “0 to 1” and “0 to 9” of which “0 to 1” and “0 to 2” are encompassed. Instant claim 11 teaches the same adjuvants recited in patent claim 1. Accordingly, the scope of the claims is not patentably distinct from the patented claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,285,198 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claim 1 recites the limitation “comprising at least any eight consecutive amino acids from amino acids 186-196 of SEQ ID NO: 1wherein one or both of amino acids 189 and 193 of SEQ ID NO: 1 comprises alanine or is independently substituted with any other amino acids except tyrosine”. The patented claims do not recite the words “at least 8”, but provide members of the Markush group which are ‘at least eight consecutive amino acids from this fragment, e.g, 186-193, 187-194, etc. which are all ‘at least 8’. Accordingly, the sets of claims are not patentably distinct. The instant claims recite “or is independently substituted with any other amino acid except tyrosine’ so allows for the fragments with alanine at positions 189 and 193. With respect to the “0 to 1,” “0 to 2 amino acid” in the instant claims, the patent claims read on “0” amino acids substituted and are encompassed in the scope of the instant claims. Instant claim 11 teaches the same adjuvants recited in patent claim 1. Accordingly, the scope of the claims is not patentably distinct from the patented claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,695,413. Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claim 21 recites the limitation “comprising at least any eight consecutive amino acids from amino acids 186-196 of SEQ ID NO: 1wherein one or both of amino acids 189 and 193 of SEQ ID NO: 1 comprises alanine or is independently substituted with any other amino acids except tyrosine”. The patented claims do not recite the words “at least 8”, but provide members of the Markush group which are ‘at least eight consectutive amino acids from this fragment, e.g, 186-193, 187-194, etc. which are all ‘at least 8’. The patented claims also do not recite “wherein one or both of amino acids 189 and 193 of SEQ ID NO: 1 comprises alanine or is independently substituted with any other amino acids except tyrosine”. This limitation was in the originally filed specification in paragraph [0032]. SEQ ID NO: 1 in this application and the parent applications contains an alanine at position 189 and position 193, so even though the patented claims do not explicitly recite this limitation, the composition in the patented claim has an alanine at position 189 and 193. Accordingly, the sets of claims are not patentably distinct. The instant claims recite “or is independently substituted with any other amino acid except tyrosine’ so allows for the fragments with alanine at positions 189 and 193. With respect to the “0 to 1,” “0 to 2 amino acid” in the instant claims, the patent claims read on “0” amino acids substituted and are encompassed in the scope of the instant claims. Instant claim 11 teaches the same adjuvants recited in patent claim 1. Accordingly, the scope of the claims is not patentably distinct from the patented claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,115,215. Although the claims at issue are not identical, they are not patentably distinct from each other because instant independent claim 21 recites the limitation “comprising at least any eight consecutive amino acids from amino acids 186-196 of SEQ ID NO: 1wherein one or both of amino acids 189 and 193 of SEQ ID NO: 1 comprises alanine or is independently substituted with any other amino acids except tyrosine”. The patented claims do not recite the words “at least 8”, but provide members of the Markush group which are ‘at least eight consectutive amino acids from this fragment, e.g, 186-193, 187-194, etc. which are all ‘at least 8’. The patented claims also do not recite “wherein one or both of amino acids 189 and 193 of SEQ ID NO: 1 comprises alanine or is independently substituted with any other amino acids except tyrosine”. This limitation was in the originally filed specification in paragraph [0032]. SEQ ID NO: 1 in this application and the parent applications contains an alanine at position 189 and position 193, so even though the patented claims do not explicitly recite this limitation, the composition in the patented claim has an alanine at position 189 and 193. Accordingly, the sets of claims are not patentably distinct. The instant claims recite “or is independently substituted with any other amino acid except tyrosine’ so allows for the fragments with alanine at positions 189 and 193. With respect to the “0 to 1,” “0 to 2 amino acids” in the instant claims, the patent claims read on “0” amino acids substituted and are encompassed in the scope of the instant claims. Instant claim 11 teaches the same adjuvants recited in patent claim 1. Accordingly, the scope of the claims is not patentably distinct from the patented claims.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 6/30/26
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