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 .
Applicant’s election without traverse of Group I: claims 1-14 and 16-18 and 21, drawn to a method for preparing cluster of differentiation 103 (CD103)-positive dendritic cells in the reply filed on 05/16/2023 is acknowledged.
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/16/2023.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119
(a)-(d). Acknowledgment is made of Applicants’ claim for benefit to foreign applications KR10-2020-0153308 and KR10-2021-0158012 filed 11/17/2020 and 11/16/2021 respectively.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application Nos. KR10-2020-0153308 and KR10-2021-0158012.
Acknowledgement is made of Applicants' claim for benefit to prior filed to Patent Application Number PCT/KR2021/016813, filed on 11/16/2021.
Information Disclosure Statement
The IDS filed 05/16/2023 has been considered by the Examiner.
Status of Claims
Claims 1-14 and 16-18 and 19-21 are under examination.
Claims 19-20 are withdrawn.
Claims 15 and 22-23 are cancelled.
Claim Rejections - 35 USC § 112
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.
Claims 9-12 and 16-17 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.
Claim 9 recites the limitation "the proportion of the number of CD103-positive type 1 myeloid-derived dendritic cells (cDC1) " in line two of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the dendritic cells induce" in line one of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear which dendritic cells the applicant is referring to because they could be either the progenitor or differentiated dendritic cells.
Claim 11 recites the limitation " the dendritic cells show" in line one of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear which dendritic cells the applicant is referring to because they could be either the progenitor or differentiated dendritic cells.
Claim 12 recites the limitation "the dendritic cells show" in line one of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear which dendritic cells the applicant is referring to because they could be either the progenitor or differentiated dendritic cells.
Claim 16 recites the limitation "the dendritic cells show" in line one of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear which dendritic cells the applicant is referring to because they could be either the progenitor or differentiated dendritic cells.
Claim 17 recites the limitation "the dendritic cells show " in line one of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear which dendritic cells the applicant is referring to because they could be either the progenitor or differentiated dendritic cells.
Claim Rejections - 35 USC § 102
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 8-12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masuda et al. (Clin. Exp. Allergy, 2018) and as evidenced by Mayuzumi et al. (Eur. J. Immunol., 2009) and Zhou et al (Journal for Immunotherapy of Cancer, 2020).
Regarding claim 1, Masuda et al. teach a method for preparing CD103 dendritic cells. Masuda et al. teach the method includes culturing dendritic progenitor cells in a medium comprising FMS-like tyrosine kinase 3 ligand (Flt3L) to induce the dendritic progenitor cells to differentiate into dendritic cells, wherein a treatment with interleukin-33 is performed at day 15 of differentiation (pages 381-382, Section 2.8 CD103+ bone marrow-derived DCs).
Regarding claim 2, Masuda et al. teach the Flt3L is at a concentration of 200 ng/ml in the medium which falls within a concentration of 10 to 1,000 ng/ml in the medium (page 382, Section 2.8 CD103+ bone marrow-derived DCs).
Regarding claim 3, Masuda et al. teach the culturing is performed for 15-16 days (page 382, Section 2.8 CD103+ bone marrow-derived DCs).
Regarding claim 4, Masuda et al. teach the culturing is performed for 15-16 days (page 382, Section 2.8 CD103+ bone marrow-derived DCs), which includes 10 days of culturing.
Regarding claims 8, Masuda et al. do not teach the precise amount of CD103+ cells from the differentiation methods. However, Masuda et al. teach introducing IL-33 on Day 16 to non-adherent cells described as CD103+.
Regarding claim 9, Masuda et al. do not teach the precise amount of CD103+ cells from the differentiation methods, however since they are following the same methods as the present inventor they would produce CD103+ cells at a similar amount. As evidenced Mayuzumi et al. teach a majority greater than 70% of the floating cells recovered from IL-33-supplemented BM cultures were dendritic cells (page 3, Morphological, phenotypic, and functional characteristics of the DC population generated in the presence of IL-33).
Regarding claim 10, Masuda et al. teach generation of CD103 positive dendritic cells, but do not test if they induce interferon gamma. However, CD103+ dendritic cells are known to induce interferon gamma as it is inherent to the cell type. As evidenced by Zhou et al. CD103+ cDC1 vaccination elicits IFN-γ-producing cells.
Regarding claim 11-12, Under the principles of inherency, 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 by the prior art method. When the prior art method is the same as a method described in the specification for carrying out the claimed method, it can be assumed the method will inherently perform the claimed process. See In re Best, 562 F. 2d, 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) and Ex parte Novitski, 26 USPQ 2d 1389 (Bd. Pat. App. & inter. 1993). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of the invention, but only that the subject matter is in fact inherent in the prior art reference. See Schering Corp. v. Geneva Pharm. Inc, 339 F.3d 1373, 1377, 67, USPQ2d 1664, 1668 (Fed. Cir. 2003). See also Toro Co. v. Deere & Co. 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004). See MPEP 2112.02. The specification of the instant application teaches increases in cluster of differentiation 38 (CD38), integrin beta-3 (CD61), T cell immunoreceptor with Ig and ITIM domains (Tigit), and Fcgr3 based on IL-33 stimulation (page 8, lines 10-20). The expression of cluster of differentiation 38 (CD38), integrin beta-3 (CD61), T cell immunoreceptor with Ig and ITIM domains (Tigit), and Fcgr3 are from stimulation of the cells with IL-33. Therefore, the method of Masuda et al. which also involves introducing the cells to IL-33 stimulation will also increase cluster of differentiation 38 (CD38), integrin beta-3 (CD61), and T cell immunoreceptor with Ig ITIM domains (Tigit), and Fcgr3 in the cells produced.
Regarding claim 13, Masuda et al. teach a method for preparing CD103 dendritic cells. Masuda et al. teach production of CD103-positive dendritic cells (page 382, section 2.8 CD103+ bone marrow-derived DCs).
Claim Rejections - 35 USC § 103
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 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 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al. (Clin. Exp. Allergy, 2018).as applied to claim 1 above, and further in view of Mayuzumi et al. (Eur. J. Immunol., 2009).
Masuda et al. teach a method for preparing CD103 dendritic cells, as in claim 1.
Regarding claim 5, Masuda et al. teach stimulating cells with IL-33 but do not teach the treatment is performed on the 3rd through the 7th day of culturing.
Mayuzumi et al. teach culturing BM cells where the IL-33 treatment is performed on the 3rd through the 7th day of culturing (page 3, IL-33-induced expansion of CD11c+ cells in BM cell cultures).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the teachings of Masuda et al. for a method for preparing CD103 dendritic cells with the teachings of Mayuzumi et al. for treating with IL-33 on the 3rd through the 7th day. Mayuzumi et al. provide motivation by teaching that IL-33 supports the generation of CD11c+ (dendritic) cells in a standard BM culture system. Mayuzumi further provide motivation teaching IL-33 increased the number of CD11c+ (dendritic) cells in BM cultures by promoting their generation and/or sustaining their survival (page 3, IL-33-induced expansion of CD11c+ cells in BM cell cultures). One of skill in the art would have had a reasonable expectation of success at combining Masuda et al. and Mayuzumi et al. because they both teach methods of generating dendritic cells from bone marrow.
Regarding claim 6, Masuda et al. teach stimulation of cells with IL-33, but do not teach the precise amount of IL-33.
Mayuzumi et al. teach stimulation of cells with 10 ng/ml IL-33 (page 3, IL-33-induced expansion of CD11c+ cells in BM cell cultures).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Masuda et al. for a method for preparing CD103 dendritic cells including stimulation of cells with IL-33 with the teachings of Mayuzumi et al. for stimulation of cells with 10 ng/ml IL-33. Mayuzumi provide motivation teaching IL-33 increased the number of CD11c+ (dendritic) cells in BM cultures by promoting their generation and/or sustaining their survival (page 3, IL-33-induced expansion of CD11c+ cells in BM cell cultures). One of skill in the art would have had a reasonable expectation of success at combining Masuda et al. and Mayuzumi et al. because they both teach methods of generating dendritic cells from bone marrow.
Regarding claim 7, Masuda et al. teach stimulation of cells with IL-33, but do not teach the precise amount of IL-33.
Mayuzumi et al. teach treatment with cells for 7 days in the presence of IL-33 at various concentrations 1–30 ng/ml (page 3, IL-33-induced expansion of CD11c+ cells in BM cell cultures), which is inclusive of 5ng/mL on day 5 of culturing.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Masuda et al. for a method for preparing CD103 dendritic cells including stimulation of cells with IL-33 with the teachings of Mayuzumi et al. for stimulation of cells 5ng/mL on day 5 of culturing. Mayuzumi provide motivation teaching IL-33 increased the number of CD11c+ (dendritic) cells in BM cultures by promoting their generation and/or sustaining their survival (page 3, IL-33-induced expansion of CD11c+ cells in BM cell cultures). One of skill in the art would have had a reasonable expectation of success at combining Masuda et al. and Mayuzumi et al. because they both teach methods of generating dendritic cells from bone marrow.
Claims 14, 16-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al. (Clin. Exp. Allergy, 2018).as applied to claim 1 above, and further in view of Zhou et al (Journal for Immunotherapy of Cancer, 2020).
Regarding claim 14, Masuda et al. teach a method for preparing CD103 dendritic cells. Masuda et al. do not teach a pharmaceutical composition for cancer immunotherapy.
Zhou et al. teach in vitro generation of CD103+ cDC1 for injection as a vaccine or pharmaceutical composition (page 1, methods). Zhou et al. teach in vitro-generated CD103+ cDC1 vaccine elicits systemic and long-lasting tumor-specific T cell-mediated cytotoxicity, which restrains primary and metastatic tumor growth. Zhou et al. teach D103+ cDC1 vaccine was superior to MoDCs and enhanced response to immune checkpoint blockade. Zhou et al. teach there is a potential for new immunotherapies based on use of cDC1s alone or in combination with checkpoint blockade (page 1, conclusions).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Masuda et al. for a method for preparing CD103 dendritic cells with the teachings of Zhou et al. for injecting CD103+ as an immunotherapy. Zhou et al. provide motivation by teaching that in vitro-generated CD103+ cDC1 vaccine elicits systemic and long-lasting tumor-specific T cell-mediated cytotoxicity, which restrains primary and metastatic tumor growth. One of skill in the art would have had a reasonable expectation of success at combining Masuda et al. and Zhou et al. because they both teach methods of generating CD103+ dendritic cells in vitro.
Regarding claims 16 and 17, Under the principles of inherency, 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 by the prior art method. When the prior art method is the same as a method described in the specification for carrying out the claimed method, it can be assumed the method will inherently perform the claimed process. See In re Best, 562 F. 2d, 1252, 1255, 195 USPQ 430, 433 (CCPA 1977) and Ex parte Novitski, 26 USPQ 2d 1389 (Bd. Pat. App. & inter. 1993). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of the invention, but only that the subject matter is in fact inherent in the prior art reference. See Schering Corp. v. Geneva Pharm. Inc, 339 F.3d 1373, 1377, 67, USPQ2d 1664, 1668 (Fed. Cir. 2003). See also Toro Co. v. Deere & Co. 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004). See MPEP 2112.02. The specification of the instant application teaches increases in cluster of differentiation 38 (CD38), integrin beta-3 (CD61), T cell immunoreceptor with Ig and ITIM domains (Tigit), and Fcgr3 based on IL-33 stimulation (page 8, lines 10-20). The expression of cluster of differentiation 38 (CD38), integrin beta-3 (CD61), and T cell immunoreceptor with Ig, ITIM domains (Tigit), and Fcgr3 are due to stimulation of the cells with IL-33. Therefore, the method of Masuda et al. and Zhou et al. which also teach introducing the cells to IL-33 stimulation will also increase cluster of differentiation 38 (CD38), integrin beta-3 (CD61), and T cell immunoreceptor with Ig ITIM domains (Tigit), and Fcgr3 in the cells produced.
Regarding claim 18, Masuda et al. teach a method for preparing CD103 dendritic cells. Masuda et al. do not teach a kit for cancer immunotherapy.
Zhou et al. teach in vitro generation of CD103+ cDC1 for injection as an immunotherapy (page 1, methods). Zhou et al. teach in vitro-generated CD103+ cDC1 vaccine elicits systemic and long-lasting tumor-specific T cell-mediated cytotoxicity, which restrains primary and metastatic tumor growth. Zhou et al. teach D103+ cDC1 vaccine was superior to MoDCs and enhanced response to immune checkpoint blockade. Zhou et al. teach there is a potential for new immunotherapies based on use of cDC1s alone or in combination with checkpoint blockade (page 1, conclusions). Zhou et al. delivery of CD8α+ cDC1s loaded with dead tumor cell-derived antigens (page 12, discussion). It is obvious that each item would have to be stored in a container. Furthermore, loading DCs with tumor antigens is a common practice in the field therefore mixing dendritic cells and tumor antigen prior to injection is the loading tumor antigen step taught by Zhou et al.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Masuda et al. for a method for preparing CD103 dendritic cells with the teachings of Zhou et al. for CD103+ as an immunotherapy. Zhou et al. provide motivation by teaching that in vitro-generated CD103+ cDC1 vaccine elicits systemic and long-lasting tumor-specific T cell-mediated cytotoxicity, which restrains primary and metastatic tumor growth. One of skill in the art would have had a reasonable expectation of success at combining Masuda et al. and Zhou et al. because they both teach methods of generating CD103+ dendritic cells in vitro.
Regarding claim 21, Masuda et al. teach a method for preparing CD103 dendritic cells. Masuda et al. do not teach administering the CD103-positive dendritic cells as a cancer immunotherapy.
Zhou et al. teach in vitro generation of CD103+ cDC1 injection as an immunotherapy (page 1, methods). Zhou et al. teach in vitro-generated CD103+ cDC1 vaccine elicits systemic and long-lasting tumor-specific T cell-mediated cytotoxicity, which restrains primary and metastatic tumor growth. Zhou et al. teach D103+ cDC1 vaccine was superior to MoDCs and enhanced response to immune checkpoint blockade. Zhou et al. teach there is a potential for new immunotherapies based on use of cDC1s alone or in combination with checkpoint blockade (page 1, conclusions).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Masuda et al. for a method for preparing CD103 dendritic cells with the teachings of Zhou et al. for injecting CD103+ as an immunotherapy. Zhou et al. provide motivation by teaching that in vitro-generated CD103+ cDC1 vaccine elicits systemic and long-lasting tumor-specific T cell-mediated cytotoxicity, which restrains primary and metastatic tumor growth. One of skill in the art would have had a reasonable expectation of success at combining Masuda et al. and Zhou et al. because they both teach methods of generating CD103+ dendritic cells in vitro.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Catherine L McCormick whose telephone number is (703)756-5659. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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, Tracy Vivlemore can be reached at (571) 272-2914. 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.
/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights