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 .
The rejection under section 103 is maintained:
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 6, 8-16 remain rejected under 35 U.S.C. 103 as being unpatentable over Ther. Deliv. (2015) 6(8), 903–910 (Therapeutic Delivery) in view of WO 2008009545 (WO 545).
Therapeutic Delivery demonstrates anti-NKG2/PD-1 combination therapy was expected to have a reasonable expectation of success:
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See pages 905-906.
WO 545 discloses that the recited anti-NKG2A antibodies were known, including their characterization (examples 1-15) as well as their use for treating cancer.
The required CDR’s are taught, see SEQ ID NO’s. 2, 5, 6, 7, 8, 17, 24, 25, 26, 27, 28, 29 of WO 545 corresponding to the CDR’s in SEQ ID NO’s 4-8 and 9 of the instant claims.
See for example, SEQ ID NO. 5 of WO 545, disclosing the recited CDR’s of SEQ ID NO’s: 4-8, see GenCore version 6.4.1, Copyright (c) 1993 – 2020, Biocceleration Ltd., ID No. AOG49485, Anti-NKG2A humanize:
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See GenCore version 6.4.1, Copyright (c) 1993 – 2020, Biocceleration Ltd., ID No. AOG49482, Anti-NKG2A humaniz, corresponding to CDR’s of SEQ ID NO: 9:
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In this way, those of ordinary skill could have combined the recited anti-NKG2A antibodies in the manner required and in a predictable fashion for the purposes of providing the recited anti-NKG2A/PD-1 combination therapy. As outlined above, Therapeutic Delivery teaches the recited anti-NKG2A/PD-1 combination therapy for cancer treatment. WO 545 is added for the proposition that the required anti-NKG2A antibodies is applicable to this combination therapy. Specifically, the WO 545 teaches that using the instant anti-NKG2A antibodies for cancer treatment was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique to cancer treatments, such as the combination treatment taught by Therapeutic Delivery, would have yielded predictable results. Accordingly, using the recited anti-NKG2A in anti-NKG2A/PD-1 combination for cancer therapy would have been prima facie obvious.
The required anti-PD-L1 antibodies, such as MEDI-4736, which, outside of any unexpected result, would have been a matter of choice between those anti-PD-L1 antibodies available to those of ordinary skill, and therefore, prima facie obvious. Similarly, the recited formulations would have been within the purview of those ordinary skill, in view of the applied references.
The combination of Therapeutic Delivery specifically demonstrates that MEDI-4736 in combination with an anti-NKG2 antibody was known and expected to have a reasonable expectation of success in treating cancer. As mentioned above, those of ordinary skill would have recognized that applying the recited antibodies taught by WO 545 to the combination treatment taught by Therapeutic Delivery would have yielded predictable results since this reference demonstrates the anti-NKG activity of these antibodies. Therefore, a prima facie case of obviousness is justified by combining these references. Moreover, those of ordinary skill would have a reasonable expectation that the combination would be effective against cancers, such as lung cancer, based on the references.
Moreover, the combined effects of the antibodies are not unexpected. Rather, those of ordinary skill would expect an additive effect since the agents target different immune checkpoints. Therefore, the rejection is maintained.
The double patenting rejections are maintained:
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 2, 6, 8-16 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10711063. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the methods recited in the conflicting claims anticipate those covered by the rejected claims. Alternatively, the difference between the methods covered in the conflicting claims and those covered by the rejected claims is that the conflicting claims do not recite the instant methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods with sufficient guidance, particularity, and with a reasonable expectation of success, that the instant methods would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Claims 2, 6, 8-16 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11572410. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the methods recited in the conflicting claims anticipate those covered by the rejected claims. Alternatively, the difference between the methods covered in the conflicting claims and those covered by the rejected claims is that the conflicting claims do not recite the instant methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods with sufficient guidance, particularity, and with a reasonable expectation of success, that the instant methods would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
The conflicting claims may recite compositions while the instant claims cover methods of treating. However, the specification of these patents and applications disclose the utility of the recited compositions as covered by the instant methods of use, see Sun Pharmaceutical Industries, Ltd., v. Eli Lilly and Co. where the district court ruled that the claims of the ‘826 patent were invalid in light of the ‘614 patent which disclosed gemcitabine’s use in cancer treatment, but did not claim it. In making this ruling, the district court relied on the Federal Circuit’s earlier rulings on double patenting of compound claims, mainly Geneva Pharmaceuticals, Inc, v. GlaxoSmithKline PLC, 349 F. 3d 1373 (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008). In both of these cases, the Federal Circuit found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. The cases also established that in determining the scope of compound claims for a double patenting rejection one must look to the specification to interpret the utility of the compound.
Claims 2, 6, 8-16 remain are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Application No. 18/164649 in view of WO 2008009545 (WO 545).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the methods recited in the conflicting claims anticipate those covered by the rejected claims. Alternatively, the difference between the methods covered in the conflicting claims and those covered by the rejected claims is that the conflicting claims do not recite the instant methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods with sufficient guidance, particularity, and with a reasonable expectation of success, that the instant methods would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
WO 545 is added for the proposition that the recited NKG2A antibodies, combinations with anti-PD-1 antibodies and compositions were within the purview of those of ordinary skill, as outlined, above.
Based upon the known activity of anti-NKG2A and anti-PD-1 antibodies, those of ordinary skill would expect that the application of these antibodies to NKG2A+/PD-1+ would modulate the anti-cancer activity of lymphocytes.
Claims 2, 6, 8-16 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12209126. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the methods recited in the conflicting claims anticipate those covered by the rejected claims. Alternatively, the difference between the methods covered in the conflicting claims and those covered by the rejected claims is that the conflicting claims do not recite the instant methods with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the elements of the instant methods with sufficient guidance, particularity, and with a reasonable expectation of success, that the instant methods would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Those of ordinary skill would have a reasonable expectation that the combination taught by the conflicting claims and WO 545 would be effective against cancers, such as lung cancer.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646