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
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1, 3-6, 8, 10, 17-19, 27, 29-31, 35-39, 41, and 43 have an effective filing date of 02DEC2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 5/7/2026 Applicant elected, with traverse:
Group III, claims 35-39, 41, and 43
Species
SEQ ID NO: 8
Anti-programmed cell death (PD-1) antibody
Anti-TNF receptor superfamily member 9 (TNFRSF9)
The traversal is on the grounds that “[t]he shared technical feature linking the groups is not merely the use of an IGF-1R antagonist in isolation, but rather the specific combination of administering an IGF-1R antagonist together with an immune response activating agent for the treatment of cancer.”
This argument is not found persuasive, because Group II, which includes independent claim 17, does not require the administration of an immune response activating agent, and as such, the technical feature that links the Groups is the administration of an IGF-1R, which, as indicated in the Requirement for Restriction/Election, is taught by Haskova et al. As such the Requirement is deemed appropriate and is made FINAL.
Status of Claims
Claims 1, 3-6, 8, 10, 17-19, 27, 29-31, 35-39, 41, and 43 are currently pending.
Claims 1, 3-6, 8, 10, 17-19, 27, and 29-31 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 2, 7, 9, 11-16, 20-26, 28, 32-34, 40, 42, and 44-67 are canceled.
Claims 35-39, 41, and 43 are under examination on the merits.
Claim Rejections - 35 U.S.C. 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 38, 39, 41, and 43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 38 is drawn to an antagonist of IGF-1R that is a fragment of SEQ ID NO: 6 or 8. The claim therefore encompasses a genus of fragments of SEQ ID NO: 6 or 8. Following a review of the specification, it appears that two species within said genus has been described, specifically full-length SEQ ID NO(s): 6 and 8; however in view of this disclosure, Applicant is claiming a broad genus of molecules that would be expected to encompass multiple fragments of SEQ ID NO: 6 or 8. Even though Applicant has disclosed two species within said genus, the specification does not provide adequate written description for the entire claimed genus, because one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genus claimed, specifically, which fragments of SEQ ID NO: 6 or 8 give rise to molecules capable of antagonizing IGF-1R. As detailed below Applicant’s disclosure is not sufficient to demonstrate possession of the entire claimed genus, and as such Applicant’s disclosure does not satisfy the written description requirement of 35 U.S.C. 112(a).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
PNG
media_image1.png
18
19
media_image1.png
Greyscale
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. In the instant case, Applicant has disclosed two species within the genus claimed; however given the substantial antibody structure variation within the genus, as well as the high level of unpredictability in the art, the disclosure of two species comprised within the claimed genus is not sufficiently representative of the entire genus.
Furthermore Applicant has not disclosed relevant, identifying characteristics of fragments of SEQ ID NO: 6 or 8 that are capable of antagonizing IGF-1R. Absent a description of the at least minimal structural features correlating with a functional ability to antagonizing IGF-1R which are shared by members of a genus commonly sharing this function, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish which fragments of SEQ ID NO: 6 or 8 are capable of antagonizing IGF-1R.
Although screening techniques can be used to isolate fragments of SEQ ID NO: 6 or 8 that are capable of antagonizing IGF-1R, Applicant is reminded that the written description requirement of 35 U.S.C. 112 is severable from the enablement provision. As stated in Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555, “The purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the applicant must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.”
Accordingly it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish at least most of the members of the genus to which the claims are directed, and therefore the specification would not reasonably convey to the skilled artisan that Applicant was in possession of the claimed invention at the time the application was filed. Applicant is informed that this rejection may be overcome by amending claim 38 to remove the “fragment” language.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 38 recites a variant of the amino acid sequence of SEQ ID NO: 6 or SEQ ID NO: 8. There is no well-settled definition of what makes one protein a variant of another, and as such one skilled in the art would be unable to readily delineate the metes and bounds of the claim. Claims 39, 41, and 43 are included in this rejection, because these claims depend from claim 39 but do not cure the deficiencies of claim 39 with respect to 35 U.S.C. 112(b).
Claim 41 recites the limitation “the anti-cancer immune stimulating agent” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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.
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 35, 39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Ashizawa et al (WO 2018195281 A1).
In regards to claim 35, Ashizawa et al teaches a method of treating cancer comprising administering oligonucleotides that target IGF-1R-encoding polynucleotides [0004] and [0014]. Ashizawa et al further teaches administering a second anti-cancer therapy to the subject [0015]. Ashizawa et al further teaches the second anti-cancer therapy can be immunotherapy [0015]. Ashizawa et al further teaches enhancing the immune response with a vaccination [0015].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Ashizawa’s methods of treating cancer comprising administering oligonucleotides that target IGF-1R-encoding polynucleotides and immunotherapies that enhance immune responses. It would have been prima facie obvious to use Ashizawa’s methods for a combination therapy for alleviating a symptom of or treating a cancer in a subject comprising effective amount of an antagonist of IGF-1R and an immune response activating agent, because Ashizawa teaches treating cancer with oligonucleotides that target IGF-1R-encoding polynucleotides and an additional immunotherapy to enhance the immune response.
In regards to claims 39 and 41, Ashizawa et al teaches the immunotherapy is a PD-1 inhibitor, such as an anti-PD-1 antibody [0125]-[126].
Claims 35-39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Ashizawa et al (WO 2018195281 A1) as applied to claims 35, 39, and 41 above, and further in view of Brodt et al (US 20150044209 A1, IDS 1/24/2025 Brodt US Pat 10538575).
The teachings of Ashizawa et al are discussed above.
Ashizawa et al does not specifically teach that the antagonist of IGF-R comprises a soluble IGF-1 receptor and a human Fc; however, these deficiencies are made up in the teachings of Brodt et al.
Brodt et al teaches a method of treating cancer comprising a soluble IGF receptor Fc fusion protein that specifically binds to IGF-1 [Abstract]. Brodt et al further teaches the Fc portion is a human Fc [0009].
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Ashizawa’s methods of treating cancer comprising administering a chimeric IGF-1R polynucleotide and immunotherapies that enhance immune responses, with Brodt’s method of treating cancer comprising a soluble IGF-1R with a human Fc as the second moiety. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Ashizawa and Brodt’s methods for a method of treating cancer comprising administering a soluble IGF-1R that is chimeric and has a second moiety of a human Fc, because there would have been a reasonable expectation that the resultant invention is effective in treating cancer.
In regards to claim 36-38, Brodt et al teaches a fusion protein comprising nucleic acid sequence of SEQ ID NO: 15. A comparison of instant SEQ ID NO: 8 and SEQ ID NO: 15 of Brodt et al is shown below.
Instant SEQ ID NO: 8 and SEQ ID NO: 15 of Brodt et al.
Query Match 100.0%; Score 6416; Length 1182;
Best Local Similarity 100.0%;
Matches 1182; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKSGSGGGSPTSLWGLLFLSAALSLWPTSGEICGPGIDIRNDYQQLKRLENCTVIEGYLH 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKSGSGGGSPTSLWGLLFLSAALSLWPTSGEICGPGIDIRNDYQQLKRLENCTVIEGYLH 60
Qy 61 ILLISKAEDYRSYRFPKLTVITEYLLLFRVAGLESLGDLFPNLTVIRGWKLFYNYALVIF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ILLISKAEDYRSYRFPKLTVITEYLLLFRVAGLESLGDLFPNLTVIRGWKLFYNYALVIF 120
Qy 121 EMTNLKDIGLYNLRNITRGAIRIEKNADLCYLSTVDWSLILDAVSNNYIVGNKPPKECGD 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 EMTNLKDIGLYNLRNITRGAIRIEKNADLCYLSTVDWSLILDAVSNNYIVGNKPPKECGD 180
Qy 181 LCPGTMEEKPMCEKTTINNEYNYRCWTTNRCQKMCPSTCGKRACTENNECCHPECLGSCS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 LCPGTMEEKPMCEKTTINNEYNYRCWTTNRCQKMCPSTCGKRACTENNECCHPECLGSCS 240
Qy 241 APDNDTACVACRHYYYAGVCVPACPPNTYRFEGWRCVDRDFCANILSAESSDSEGFVIHD 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 APDNDTACVACRHYYYAGVCVPACPPNTYRFEGWRCVDRDFCANILSAESSDSEGFVIHD 300
Qy 301 GECMQECPSGFIRNGSQSMYCIPCEGPCPKVCEEEKKTKTIDSVTSAQMLQGCTIFKGNL 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 GECMQECPSGFIRNGSQSMYCIPCEGPCPKVCEEEKKTKTIDSVTSAQMLQGCTIFKGNL 360
Qy 361 LINIRRGNNIASELENFMGLIEVVTGYVKIRHSHALVSLSFLKNLRLILGEEQLEGNYSF 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LINIRRGNNIASELENFMGLIEVVTGYVKIRHSHALVSLSFLKNLRLILGEEQLEGNYSF 420
Qy 421 YVLDNQNLQQLWDWDHRNLTIKAGKMYFAFNPKLCVSEIYRMEEVTGTKGRQSKGDINTR 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 YVLDNQNLQQLWDWDHRNLTIKAGKMYFAFNPKLCVSEIYRMEEVTGTKGRQSKGDINTR 480
Qy 481 NNGERASCESDVLHFTSTTTSKNRIIITWHRYRPPDYRDLISFTVYYKEAPFKNVTEYDG 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 NNGERASCESDVLHFTSTTTSKNRIIITWHRYRPPDYRDLISFTVYYKEAPFKNVTEYDG 540
Qy 541 QDACGSNSWNMVDVDLPPNKDVEPGILLHGLKPWTQYAVYVKAVTLTMVENDHIRGAKSE 600
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 541 QDACGSNSWNMVDVDLPPNKDVEPGILLHGLKPWTQYAVYVKAVTLTMVENDHIRGAKSE 600
Qy 601 ILYIRTNASVPSIPLDVLSASNSSSQLIVKWNPPSLPNGNLSYYIVRWQRQPQDGYLYRH 660
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 601 ILYIRTNASVPSIPLDVLSASNSSSQLIVKWNPPSLPNGNLSYYIVRWQRQPQDGYLYRH 660
Qy 661 NYCSKDKIPIRKYADGTIDIEEVTENPKTEVCGGEKGPCCACPKTEAEKQAEKEEAEYRK 720
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 661 NYCSKDKIPIRKYADGTIDIEEVTENPKTEVCGGEKGPCCACPKTEAEKQAEKEEAEYRK 720
Qy 721 VFENFLHNSIFVPRPERKRRDVMQVANTTMSSRSRNTTAADTYNITDPEELETEYPFFES 780
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 721 VFENFLHNSIFVPRPERKRRDVMQVANTTMSSRSRNTTAADTYNITDPEELETEYPFFES 780
Qy 781 RVDNKERTVISNLRPFTLYRIDIHSCNHEAEKLGCSASNFVFARTMPAEGADDIPGPVTW 840
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 781 RVDNKERTVISNLRPFTLYRIDIHSCNHEAEKLGCSASNFVFARTMPAEGADDIPGPVTW 840
Qy 841 EPRPENSIFLKWPEPENPNGLILMYEIKYGSQVEDQRECVSRQEYRKYGGAKLNRLNPGN 900
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 841 EPRPENSIFLKWPEPENPNGLILMYEIKYGSQVEDQRECVSRQEYRKYGGAKLNRLNPGN 900
Qy 901 YTARIQATSLSGNGSWTDPVFFYVQAKTGYENFGGGGSGGGGSGGGGSGGGGSGGDKTHT 960
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 901 YTARIQATSLSGNGSWTDPVFFYVQAKTGYENFGGGGSGGGGSGGGGSGGGGSGGDKTHT 960
Qy 961 SPPSPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVH 1020
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 961 SPPSPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVH 1020
Qy 1021 NAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPRE 1080
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1021 NAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPRE 1080
Qy 1081 PQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFF 1140
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1081 PQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFF 1140
Qy 1141 LYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 1182
||||||||||||||||||||||||||||||||||||||||||
Db 1141 LYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 1182
Claims 35, 39, 41, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Ashizawa et al (WO 2018195281 A1) as applied to claims 35, 39, and 41 above, and further in view of Kim et al (WO 2020209645 A1).
The teachings of Ashizawa et al are discussed above.
Ashizawa et al does not specifically teach an immune response activating agent that comprises an anti-TNFRSF9; however this deficiency is made up in the teachings of Kim et al.
In regards to claim 43, Kim et al teaches a method of treating cancer comprising administering a PD-L1 (PD-1 axis) inhibitor [Abstract]. Kim et al teaches PD-L1 binds to its receptor PD-1 [5th paragraph, pg. 2]. Kim et al further teaches administering the additional therapeutic 4-1BB, IGF-1, and PD-1 antibodies [8th paragraph, pg. 10]. Kim et al further teaches administering the additional therapeutic IGF-1 antibodies dalotuzumab, figitumumab, and teprotumumab [19th paragraph, pg. 11]. Kim et al further teaches the PD-1 antibody pembrolizumab [[8th paragraph, pg. 10].
Applicant teaches, pg. 25 of specifications, “TNF receptor superfamily member 9 protein (referred to as TNFRSF9 or CD137 or 41BB)”.
One of ordinary skill in the art, before the effective filing date, would have been motivated to use Ashizawa’s methods of treating cancer comprising administering a chimeric IGF-1R polynucleotide and immunotherapies that enhance immune responses, with Kim’s method of treating cancer comprising administering a PD-L1, 4-1BB, IGF-1, and PD-1 antibody. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine Ashizawa and Kim’s methods, because there would have been a reasonable expectation that the resultant method is effective in treating cancer.
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 35-39, 41, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16-18, and 20 of U.S. Patent No. 10538575 ('575) in view of Ashizawa et al (WO 2018195281 A1), and Kim et al (WO 2020209645 A1).
The primary difference between the instant and conflicting claims is that the instant claims recite a combination therapy comprising an antagonist of IGF-1R and an immune response activating agent.
The teachings of Ashizawa et al and Kim et al are discussed above.
One of ordinary skill in the art, before the effective filing date, would have been motivated to combine the conflicting claims with Ashizawa’s methods of treating cancer comprising administering oligonucleotides that target IGF-1R-encoding polynucleotides and immunotherapies that enhance immune responses. It would have been prima facie obvious to use Ashizawa’s methods for a combination therapy for alleviating a symptom of or treating a cancer in a subject comprising administering effective amount of an antagonist of IGF-1R and an immune response activating agent, because Ashizawa teaches treating cancer with oligonucleotides that target IGF-1R-encoding polynucleotides and an additional immunotherapy to enhance the immune response.
With respect to claims 36-38, conflicting SEQ ID NO: 12 comprises the instant SEQ ID NO: 8.
In regards to claims 39 and 41, Ashizawa et al teaches the immunotherapy is a PD-1 inhibitor, such as an anti-PD-1 antibody [0125] - [126].
With respect to claim 43, one of ordinary skill in the art, before the effective filing date, would have been motivated to use Ashizawa’s methods of treating cancer comprising administering a chimeric IGF-1R polynucleotide and immunotherapies that enhance immune responses, with Kim’s method of treating cancer comprising administering a PD-L1, 4-1BB, IGF-1, and PD-1 antibody. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine the conflicting claims with Ashizawa and Kim’s methods, because there would have been a reasonable expectation that the resultant method is effective in treating cancer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642
Prosecution Insights