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 .
DETAILED ACTION
1. Applicant's amendment, filed 07/14/26 is acknowledged.
Claims 1,3-5, 8-10, 12,14,16-20, 24, 38 are pending.
Claims 1,3-5, 8-10, 12,14,16-20, 24, 38 read on a method of treating a human subject with blood cancer are under consideration in the instant application.
2. 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.
3. Claims 1,3-5, 8-10, 12,14,16-20, 24, 38 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20220257762 and WO 2020160156 (IDS) in view of US Patent Application 20180133297 for the same reasons set forth in the previous Office Action, mailed on 04/15/26.
Applicant’s arguments filed on 07/14/26 have been fully considered but have not been found convincing.
Applicant asserts that it is only Applicants own disclosure that teach and suggest interaction between LAG3 and GAL3. None of the prior art references teach or suggest said interaction. Applicant further asserts that though prior art references teach administering anti-LAG3 antibody or anti-Gal3 antibody none of said references teach that said administering inhibit interaction between LAG3 and GAL3.
As initial matter it is noted that the mechanism of action does not have a bearing on the patentability of the invention if the invention was already known or obvious. Even though applicant discover interaction between LAG3 and Gal3 it does not appear to distinguish the prior art teaching the same method of administering the anti-LAG3 antibody or anti-Gal3 antibody for treating the same blood cancer. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent/obvious function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145.
As has been stated previously, US Patent Application’ 762 teaches a method of treating a blood cancer in a patient comprising administering anti-LAG3 antibody, that specifically binds to LAG3. US Patent Application’ 762 teaches that said blood cancer is multiple myeloma or leukemia. ( see entire document paragraphs 0003, 0012, 0019 in particular)
WO’156 teaches a method of treating a blood cancer in a patient comprising administering anti-Gal-3 antibody, that specifically binds to Gal-3 . WO’156 teaches teaches that said blood cancer is multiple myeloma or leukemia. WO’156 teaches that said patient additionally treated with ionizing radiation ( see entire document paragraphs entire document, paragraphs 0060, 0142,0160 in particular)
US Patent Application ‘762 and WO’156 do not teaches administering a multipeptide vaccine comprising a mixture of immunogenic peptide comprising XBP1, CS1 and CD138 or T lymphocytes activated ex-vivo with a mixture of immunogenic peptide comprising XBP1, CS1 and CD138 or wherein immunogenic peptide comprising XBP1, CS1 and CD138 each comprising amino acid sequences as recited in claim 16.
US Patent Application’ 297 teaches an immunogenic multipeptide mixture comprising XBP1, CS1 and CD138 that can be used for treating a human subject with blood cancer. US Patent Application’ 297 teaches that said immunogenic mixture can be used for ex-vivo activation of T lymphocytes that can be used for treatment. US Patent Application’ 297 teaches that of each of XBP1, CS1 and CD138 can be at least 35 amino acid sequences long and comprises amino acid sequences that are 100% identical to the amino acid sequences as recited in claim 16 (see entire document, abstract and paragraphs 0007, 009, 0010, 0026, 0028, 0035, 0042 and sequences alignments.
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to combine anti-LAG-3 and anti-Gal-3 antibody taught by US Patent Application 20220257762 and WO 2020160156 with a mixture of immunogenic peptide comprising XBP1, CS1 and CD138 or T lymphocytes activated ex-vivo with a mixture of immunogenic peptide comprising XBP1, CS1 and CD138 in a method of treating blood cancer a reasonable expectation of success because the prior art suggests each of said compounds can be used for treating blood cancer.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Claims 5 , 9 and 24 are included because said functional feature would be an inherent/obvious feature of administered anti-LAG3 or anti-GAL-3 antibody because the references and instantly claimed antibodies were used for the same purpose, i.e. for treating human subject with a blood cancer. If a prior art method, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated/obviouse by the prior art. When the prior art method is the same as a method described in the specification, it can be assumed the method will inherently/obviously perform the claimed process. See MPEP 2112.02.
It is noted that Applicant provided no evidences and/or Declaration that the antibody of the prior art would not have the same functional properties as instantly claimed.
From the combined teaching of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
4. 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.
5. Claims 1,3-5, 8-10, 12,14,16-20, 24, 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No.9950047 in view of 20220257762 and WO 2020160156 for the same reasons set forth in the previous Office action, mailed on 04/15/26.
Claims 1-46 of U.S. Patent No.9950047 recited a method of treating a human subject with blood cancer, comprising administering a multipeptide vaccine comprising mixture of XBP1, CS1 and CD138 alone or in combination with additional treatment including ionizing radiation.
US Patent Application’ 762 teaches a method of treating a blood cancer in a patient comprising administering anti-LAG3 antibody, that specifically binds to LAG3. US Patent Application’ 762 teaches that said blood cancer is multiple myeloma or leukemia. ( see entire document paragraphs 0003, 0012, 0019 in particular)
WO’156 teaches a method of treating a blood cancer in a patient comprising administering anti-Gal-3 antibody, that specifically binds to Gal-3 . WO’156 teaches teaches that said blood cancer is multiple myeloma or leukemia. WO’156 teaches that said patient additionally treated with ionizing radiation ( see entire document paragraphs entire document, paragraphs 0060, 0142,0160 in particular)
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to combine anti-LAG-3 and anti-Gal-3 antibody taught by US Patent Application 20220257762 and WO 2020160156 with a mixture of immunogenic peptide comprising XBP1, CS1 and CD138 in a method of treating blood cancer with a reasonable expectation of success because the prior art suggests each of said compounds can be used for treating blood cancer.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
It is noted that Applicant indicated that he will provide appropriate response upon an indication of allowable subject matter.
6. Claim 1,3-5, 8-10, 12,14,16-20, 24, 38 provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application 15/689159, 17/172,805; 17/370,412 each in view of 20220257762 and WO 2020160156.
Claims of copending Application 15/689159, 17/172,805; 17/370,412 each recited a method of treating a human subject with blood cancer, comprising administering a multipeptide vaccine comprising mixture of XBP1, CS1 and CD138 alone or in combination with additional treatment including ionizing radiation.
US Patent Application’ 762 teaches a method of treating a blood cancer in a patient comprising administering anti-LAG3 antibody, that specifically binds to LAG3. US Patent Application’ 762 teaches that said blood cancer is multiple myeloma or leukemia. ( see entire document paragraphs 0003, 0012, 0019 in particular)
WO’156 teaches a method of treating a blood cancer in a patient comprising administering anti-Gal-3 antibody, that specifically binds to Gal-3 . WO’156 teaches teaches that said blood cancer is multiple myeloma or leukemia. WO’156 teaches that said patient additionally treated with ionizing radiation ( see entire document paragraphs entire document, paragraphs 0060, 0142,0160 in particular)
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to combine anti-LAG-3 and anti-Gal-3 antibody taught by US Patent Application 20220257762 and WO 2020160156 with a mixture of immunogenic peptide comprising XBP1, CS1 and CD138 in a method of treating blood cancer with a reasonable expectation of success because the prior art suggests each of said compounds can be used for treating blood cancer.
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
It is noted that Applicant indicated that he will provide appropriate response upon an indication of allowable subject matter.
7. No claim is allowed.
8. THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644
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