DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s species election without traverse of (i) high density arrays, (ii) T-cell epitope, (iii) serum, and (iv) lung cancer in the reply filed on 2/3/2026 is acknowledged.
3. Upon further consideration, the requirement of species election for group (ii) is withdrawn.
4. Claims 1-18 are pending and under examination.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 6/23/2022 has been considered by the examiner.
Claim Objections
6. Claims 1, 3, 12 and 18 are objected to because of the following informalities:
Claim 1 is objected to for reciting “a preventative antibody specific for a cancer of interest”. No antibody has been shown to be able to prevent a cancer. Furthermore, for clarity, step 2 should be amended to “detecting antibodies in the one or more biological samples which bind to the frameshift peptides”.
Claim 3 is objected to because not all methods in the list are antibody assay, e.g. delayed-type hypersensitivity (DTH), mass spectrometry, surface plasmon resonance. Moreover, the term “and” in last line requires all the assays to be used together. The term “or” should be used.
Claim 12 is objected to because not all samples comprise antibodies or sufficient amount of antibodies to perform the assay, e.g. central nervous system, nervous system, eye, heart, lung, muscle, tumor, etc.
Claim 18 is objected to because not all conditions are cancer, e.g. acoustic neuroma, angiomyolipoma, Castleman’s disease, chondroma, Degos disease, dermoid cyst, extramammary Paget’s disease, luteoma, myxoma, ocular oncology, neurinoma, Paget’s disease of breast, fetus in fetu, fibroma, papillomatosis, adenoma, Schwannomatosis, thecoma, etc. Claim 18 is further objected to for reciting duplicate cancers, e.g. “head and neck cancer”, “laryngeal cancer”, etc. Applicant is required to clean up the claim to remove non-cancer conditions and duplicate cancers.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 2-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2 and 3 are indefinite for reciting “wherein the one or more biological samples comprises a set of biological samples obtained from the one or more subjects using antibody reactivity”. It is unclear how to use antibody reactivity to obtain biological samples, e.g. tissue, urine or blood.
Claims 4-10 are indefinite for reciting the limitation “the frameshift peptides”. It is unclear if it refers to the frameshift peptides mentioned in step 1 of claim 1, or the selected frameshift peptides mentioned in the last step of claim 1.
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnston et al. (WO 2018/223094A1, pub. date: 12/6/2018), in view of EP1369126A1 (Von Knebel Doeberitz et al, pub. date: 12/10/2003, IDS filed on 6/23/2022) and Janatpour et al. (US 2011/0135570A1, pub. date: 6/9/2011).
Due to indefinite nature of claims 2-10, claim 2 is interpreted as the method of claim 1, wherein said detecting is detecting antibody reactivity. The limitation “the frameshift peptides” in claims 4-10 is interpreted as the frameshift peptides mentioned in step 1 of claim 1,
Regarding claims 1 and 2, Johnston et al. teaches a method of treating an individual in need of treatment for a cancer, the method comprising
a) identifying peptides that are immunoreactive with a biological sample from
the individual in a first population of peptides (candidate peptides) (which meet the steps 1 and 2 of claim 1);
b) preparing a vaccine composition comprising a second population of peptides comprising one or more peptides identified in step a) or a nucleic acid sequence encoding the second population of peptides (selected frameshift peptides) (which meet the 3rd step of claim 1); and
c) administering an effective amount of the vaccine composition to the individual, thereby treating the cancer (see claim 1 of Johnston)
wherein in some cases, the method comprises obtaining the biological sample from the individual ([0003] and claim 2), the first population of peptides and the second population of peptides comprise frameshift peptides ([0003], [0056]-[0057] and claims 14-15), the first population of peptides (candidate frameshift peptides) is bound to a substrate and is part of an array or a phage display library (claims 20-21, [0056]-[0057]).
Regarding claims 2 and 3, Johnston teaches that the antibody reactivity (immunoreactivity) is detected by assays such as ELISA, phage display, high density array, and microarray (claim 11, [0056]).
Regarding claim 4, Johnston teaches that the first population of peptides comprises peptides encoded by a frameshifted mRNA expressed by a cancer cell (claim 14).
Regarding claim 5, Johnston teaches that the frameshifted mRNA is created in a splicing error or a transcription insertion or deletion error in a microsatellite (claims 15 and 49).
Regarding claim 6, Johnston teaches that each of the first population of peptides
binds to at least one MHC subtype (claim 17).
Regarding claim 7, Johnston teaches that each of the first population of peptides comprises at least one T cell epitope (claim 18).
Regarding claim 8, Johnston teaches that each of the first population of peptides comprises at least one B cell epitope (claim 19).
Regarding claim 9, Johnston teaches that each of the first population of peptides
binds to at least one MHC subtype (claim 17). The identified peptides would be presented by the MHC on the cancer cell surface.
Regarding claim 10, Johnston teaches that the first population of peptides (candidate frameshift peptides) is part of an array or a phage display library (claims 20-21.
Regarding claim 12, Johnston teaches that the biological sample is serum (claim 7).
Regarding claim 13, Johnston teaches that the vaccine composition comprises a
pharmaceutically acceptable adjuvant or excipient (claim 22).
Regarding claim 14, Johnston teaches that the vaccine composition comprises an immune checkpoint inhibitor selected from one or more of the group consisting of a PD-1 inhibitor, a PD-L1 inhibitor, a CTLA-4 inhibitor, Pembrolizumab, Nivolumab, and Atezolizumab (claims 24-25).
Regarding claim 15, Johnston teaches administering the vaccine composition to treat the cancer (claims 1 and 31).
Regarding claim 16, Johnston teaches that treating the cancer comprises reducing tumor size, inhibiting tumor growth, reducing tumor burden, increasing survival, or increasing cancer-free survival (claim 34).
Regarding claim 17, Johnston teaches that administering the vaccine composition elicits an immune response in the individual against the cancer (claim 4).
Regarding claim 18, Johnston teaches that the cancer is lung cancer (claim 30).
Note that Johnston teaches treating cancer using identified frameshift peptides. Regarding all the claims, Johnston does not teach preparing an antibody composition against the identified frameshift peptides and further treating cancer with the antibody composition. Regarding claim 11, Johnston does not teach the antibodies which bind to frameshift peptides are screened for binding to and/or killing tumor cells. Regarding claim 14, Johnston does not teach that the antibody composition further comprises an immune checkpoint inhibitor.
However these deficiencies are made up for in the teachings of EP1369126A1 and Janatpour.
EP1369126A1 teaches that frameshift polypeptides that comprise an immunogenic portion may be used for immunotherapy for the treatment of cancer, and the polypeptides may also be used to generate antibodies for passive immunotherapy ([0037]-[0038], [0045]). EP1369126A1 teaches that monoclonal antibodies directed against frameshift peptides presented on cellular membranes may also be used as therapeutic compounds in order to diminish or eliminate tumors ([0044]).
Janatpour et al. teaches various techniques for generating anti-tumor cell antigen antibodies ([0166]), and methods of selecting antibodies with certain biological characteristic ([0265]). Janatpour et al. teaches that to identify an antibody that promotes cell death, in vitro assays can be performed using cancer cells that express the tumor cell antigen and the antibodies, and to identify growth inhibitory anti-tumor cell antigen antibodies, one may screen for antibodies that inhibit the growth of cancer cells that overexpress the tumor cell antigen ([0267], [0272]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Johnston to prepare an antibody composition against the selected frameshift peptides and further use the antibody composition to treat cancer (passive immunotherapy) in view of EP1369126A1. One of ordinary skill in the art would have been motivated to do so because EP1369126A1 teaches that not only frameshift peptides (active immunotherapy), but also antibodies directed against frameshift peptides presented on cellular membranes can be used as therapeutic compounds in order to diminish or eliminate tumors (passive immunotherapy) ([0044]). One of ordinary skill in the art would have had a reasonable expectation of success because methods of making antibodies were well known in the art at before the effective filing date of the claimed invention as shown by Janatpour.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have screened antibodies generated against the selected frameshift peptide for binding to and/or killing tumor cells in view of Janatpour. One of ordinary skill in the art would have been motivated to do so to confirm that the antibodies are capable of killing cancer cells before proceeding to in vivo treatment. One of ordinary skill in the art would have had a reasonable expectation of success because Janatpour has shown that methods of making and selecting antibodies with anti-cancer properties were well known in the art.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further included in the antibody composition an immune checkpoint inhibitor in view of Johnston and EP1369126A. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Johnston teaches a vaccine comprising the selected frameshift peptides and an immune checkpoint inhibitor, EP1369126A1 teaches that not only frameshift peptides (for active immunotherapy), but also antibodies directed against frameshift peptides presented on cellular membranes can be used as therapeutic compounds in order to diminish or eliminate tumors (passive immunotherapy) ([0044]).
"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, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960).
In the instant case, both antibody and immune checkpoint inhibitor were taught by the prior art to treat cancer. It was known in the art that drug combinations produce higher rates of objective response and longer survival than single agents because it combines two anti-cancer agents, each operating via a different mechanism of action, and as such it could solve problems arising in the clinic, such as, on the one hand, the development of resistance to drugs, and on the other hand, a change in the antigenicity of the tumor cells that would render them unreactive with one antibody. Furthermore, combined therapy allow each agent be administered at levels substantially lower than the levels required when administering a single agent, which are toxic or sub-toxic to the patient.
Double Patenting
11. 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.
12. Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over
(i) claims 1-16 of U.S. Patent No. 12,018,252,
(ii) claims 1-18 of U.S. Patent No. 11,484,581, or
(iii) claims 1-19 of U.S. Patent No. 11,971,410,
in view of EP1369126A1 (Von Knebel Doeberitz et al, pub. date: 12/10/2003, IDS filed on 6/23/2022), and Logsdson et al. (US 20170283509 A1, pub. date: 10/5/2017).
(i) claims 1-16 of U.S. Patent No. 12,018,252 disclose a method of making an anti-cancer therapeutic composition, comprising:
(a) contacting a biological sample obtained from a subject to a peptide array, the peptide array comprising a plurality of frameshift variant peptides, wherein the biological sample comprises antibodies, wherein the plurality of frameshift peptides comprise peptides encoded by an mRNA having an RNA processing error, the RNA processing error comprising a mis-splicing or an insertion or a deletion during transcription;
(b) detecting binding of the antibodies in the biological sample to at least one peptide in the peptide array; and
(c) producing a composition comprising one or more immune reactive neoantigens corresponding to the at least one peptide bound by the antibodies.
wherein the plurality of frameshift variant peptides are fixed on a substrate, wherein the biological sample comprises blood, serum, plasma, cerebrospinal fluid, saliva, urine, or combinations thereof, wherein the frameshift peptide comprises a peptide encoded by an mRNA having an RNA processing error comprising intron retention, wherein the subject has lung cancer
(ii) claims 1-18 of U.S. Patent No. 11,484,581 disclose a method of treating an individual in need of treatment for a cancer, the method comprising:
a) contacting a biological sample from the individual with a frameshift peptide (FSP) array, wherein the FSP array comprises a first population of peptides encoded by a frameshifted mRNA created in a splicing error or a transcription insertion or deletion error;
b) identifying peptides in the FSP array that are immunoreactive with the biological sample;
c) preparing a vaccine composition comprising the immunoreactive peptides identified in step b) or a nucleic acid sequence encoding the immunoreactive peptides; and
d) administering an effective amount of the vaccine composition to the individual, thereby treating the cancer,
wherein the method further comprises obtaining the biological sample from the individual, wherein treating the cancer comprises reducing tumor size, inhibiting tumor growth, reducing tumor burden, increasing survival, or increasing cancer-free survival,
wherein administering the vaccine composition elicits an immune response in the individual against the cancer, wherein the immunoreactive peptides are a subpopulation of the first population of peptides, wherein the identified peptide elicits a positive response in an antibody assay or a T cell assay performed on the biological sample from the individual, wherein the biological sample is selected from the group consisting of blood, plasma, or serum, wherein identifying comprises determining immunoreactivity of the first population of peptides to the biological sample using antibody reactivity using an antibody assay such as ELISA, high density array, or microarray, wherein the first population of peptides comprises peptides encoded by a frameshifted mRNA expressed by a cancer cell, the first population of peptides is bound to a substrate, wherein the vaccine composition comprises a pharmaceutically acceptable adjuvant or excipient, wherein the cancer is lung cancer.
(iii) Claims 1-19 of U.S. Patent No. 11,971,410 disclose a method of treating an individual in need of treatment for a cancer, the method comprising:
a) contacting a biological sample from the individual with a frameshift peptide (FSP) array, wherein the FSP array comprises a first population of peptides encoded by a frameshifted mRNA created in a splicing error or a transcription insertion or deletion error;
b) identifying peptides in the FSP array that are immunoreactive with the biological sample;
c) preparing a vaccine composition comprising the immunoreactive peptides identified in step b) or a nucleic acid sequence encoding the immunoreactive peptides; and
d) administering an effective amount of the vaccine composition to the individual, thereby treating the cancer,
wherein the method further comprises obtaining the biological sample from the individual, wherein treating the cancer comprises reducing tumor size, inhibiting tumor growth, reducing tumor burden, increasing survival, or increasing cancer-free survival, wherein administering the vaccine composition elicits an immune response in the individual against the cancer, wherein the immunoreactive peptides are a subpopulation of the first population of peptides, wherein the identified peptide elicits a positive response in an antibody assay or a T cell assay performed on the biological sample from the individual, wherein the biological sample is selected from the group consisting of blood, plasma, and serum, wherein identifying comprises determining immunoreactivity of the first population of peptides to the biological sample using antibody reactivity using an antibody assay selected from the group consisting of ELISA, radio-immunoassay, western blot, immunohistochemistry, and high density array, wherein the first population of peptides comprises peptides encoded by a frameshifted mRNA expressed by a cancer cell, the first population of peptides is bound to a substrate, the vaccine composition comprises a pharmaceutically acceptable adjuvant or excipient, wherein the cancer is lung cancer.
The claims of each patent do not disclose: preparing an antibody composition against the identified frameshift peptides and further treating cancer with the antibody composition, the antibodies which bind to frameshift peptides are screened for binding to and/or killing tumor cells, and the antibody composition further comprising an immune checkpoint inhibitor. However this deficiencies are made up for in the teachings of EP1369126A1 and Logsdson.
The teachings of EP1369126A1 have been set forth above.
Logsdson teaches screening monoclonal antibodies for target recognition by ELISA, or antibodies with the highest affinity by ELISA, validation of antibody specificity, blocking ability by western blotting. In vitro validation experiments with the selected antibodies included inhibition of cancer cell migration, invasion. Top candidate antibodies with high affinity and functional blocking ability were further purified and further used to conduct in vivo experiments ([0132]). Logsdson teaches that additional immunotherapies such as anti-CTLA-4 antibody, anti-PD1 antibody (immune checkpoint inhibitor) may be used in combination with their therapeutic antibodies ([0115]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of each patent to prepare an antibody composition against the selected frameshift peptides and further use the antibody composition to treat cancer (passive immunotherapy) in view of EP1369126A1. One of ordinary skill in the art would have been motivated to do so because EP1369126A1 teaches that not only frameshift peptides (for active immunotherapy), but also antibodies directed against frameshift peptides presented on cellular membranes can be used as therapeutic compounds in order to diminish or eliminate tumors (passive immunotherapy) ([0044]). One of ordinary skill in the art would have had a reasonable expectation of success because methods of making antibodies were well known in the art at before the effective filing date of the claimed invention.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have screened antibodies generated against the selected frameshift peptide for binding to and/or killing tumor cells in view of Logsdson. One of ordinary skill in the art would have been motivated to do so to confirm that the antibodies are capable of killing cancer cells before proceeding to in vivo treatment. One of ordinary skill in the art would have had a reasonable expectation of success because methods of making and selecting antibodies with anti-cancer properties were well known in the art as shown by Logsdson..
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further included in the antibody composition an immune checkpoint inhibitor in view of Logsdson. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Logsdson teaches that additional immunotherapies such as anti-CTLA-4 antibody, anti-PD1 antibody (immune checkpoint inhibitor) may be used in combination with therapeutic antibodies ([0115]).
13. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 14, 16 and 21-30 of copending Application No. 17/310,461, in view of in view of EP1369126A1 (Von Knebel Doeberitz et al, pub. date: 12/10/2003, IDS filed 6/23/2022), and Logsdson et al. (US20170283509A1, pub. date: 10/5/2017).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 14, 16 and 21-30 of copending Application No. 17/310,461 disclose a method of producing a vaccine for a cancer and/or tumor and stage of interest, comprising: identifying a first population of peptides that are immunoreactive with a set of biological samples obtained from a set of test subjects that have been identified as having the cancer and/or tumor and stage of interest, wherein the first population of peptides comprises peptides encoded by a frameshifted mRNA expressed by a cancer cell, wherein the frameshifted mRNA is created in a splicing error or a transcription insertion or deletion error, wherein identifying the first population of peptides comprises determining immunoreactivity of the first population of peptides to the set of biological samples obtained from the set test subjects by measuring antibody reactivity to a high density array comprising the first populations of peptides; and preparing a cancer vaccine composition specific for the cancer and/or tumor and stage of interest, wherein the cancer vaccine composition comprises a second population of peptides comprising one or more peptides in the first population or a nucleic acid sequence encoding the one or more peptides, thereby producing the vaccine for the cancer and/or tumor and stage of interest,
wherein the second population of peptides is a subpopulation of the first population of peptides, wherein the vaccine composition further comprises a pharmaceutically acceptable adjuvant or excipient, wherein the set of biological samples obtained from the set test subjects comprises one or more of blood, plasma, serum, wherein the method further comprising administering the vaccine composition to the subject, thereby eliciting an immune response or treat the cancer and/or tumor in the subject, wherein the cancer and/or tumor is lung cancer.
The claims of copending application do not disclose: preparing an antibody composition against the identified frameshift peptides and further treating cancer with the antibody composition, the antibodies which bind to frameshift peptides are screened for binding to and/or killing tumor cells, and the antibody composition further comprising an immune checkpoint inhibitor. However this deficiencies are made up for in the teachings of EP1369126A1 and Logsdson.
The teachings of EP1369126A1 and Logsdson have been set forth above.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the copending application to prepare an antibody composition against the selected frameshift peptides and further use the antibody composition to treat cancer (passive immunotherapy) in view of EP1369126A1. One of ordinary skill in the art would have been motivated to do so because EP1369126A1 teaches that not only frameshift peptides (for active immunotherapy), but also antibodies directed against frameshift peptides presented on cellular membranes can be used as therapeutic compounds in order to diminish or eliminate tumors (passive immunotherapy) ([0044]). One of ordinary skill in the art would have had a reasonable expectation of success because methods of making antibodies were well known in the art at before the effective filing date of the claimed invention.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have screened antibodies generated against the selected frameshift peptide for binding to and/or killing tumor cells in view of Logsdson. One of ordinary skill in the art would have been motivated to do so to confirm that the antibodies are capable of killing cancer cells before proceeding to in vivo treatment. One of ordinary skill in the art would have had a reasonable expectation of success because methods of selecting antibodies with anti-cancer properties were well known in the art as shown by Logsdson.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further included in the antibody composition an immune checkpoint inhibitor in view of Logsdson. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Logsdson teaches that additional immunotherapies such as anti-CTLA-4 antibody, anti-PD1 antibody (immune checkpoint inhibitor) may be used in combination with therapeutic antibodies ([0115]).
Conclusion
14. No claims are allowed.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1646