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 .
Claims 49-70 are pending as amended 12/10/24 and are considered herein.
Claim Rejections - 35 USC § 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 64-72 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are generic for treating a generic plural disease or condition in a subject, comprising the delivery of polymeric-hydrogel encapsulated RPE cells comprising a heterologous oligonucleotide encoding native human IL-2. Claim 65 provides a list of specific diseases, and the example of idiopathic fibrosis will be used herein.
The specification provides antecedent basis for the generic delivery for treating a generic pleural disease/condition, and including a great number of diseases/conditions (e.g., Summary of the Invention, paragraphs 1-2). The specification however, actually teaches the treatment of cancers through delivery of cytokines (e.g., pp. 6-7) and specifically methotheliomas (e.g., p. 7, last paragraph). There is no teaching, e.g., of how IL-2 will treat the specifically claimed idiopathic fibrosis. The examples teach only the treatment of tumors. Thus, the Artisan would be left looking to the art to find out if IL-2 treatment, through pleural delivery, in an immune-protecting hydrogel, has a beneficial effect on the generic pleural disease/condition, including idiopathic fibrosis.
The Art provides no mention of IL-2 in treating idiopathic fibrosis. For example Glass, et al. (2021) “Idiopathic pulmonary fibrosis, Current and future treatment”, The Clinical Respiratory Journal, 16(2): 84-96 fails to even mention IL-2 in reviewing therapies at the time of invention for idiopathic pulmonary fibrosis. Moreover, none of these diseases and disorders are cancer, and thus, have distinct causes which cannot necessarily have the same treatment. I.e., if something causes a disease/disorder and something else causes a separate disorder/disease, the treatment for one cause does not mean the other cause is similarly treated. They are different.
Given the wide variety of pleural diseases that have distinct causes and effects, and showing of a single pleural treatment, that of pleural cancer, the Artisan would not have understood Applicant to have been in possession of the generic pleural diseases/conditions, other than the cancer.
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.
Claim(s) 49-51, 55-62, 64-65, and 67-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over WIPO Document 2021/026484 to Veiseh, et al. (hereinafter “Rice”) and U.S. Patent Application Publication No. 2018/0273601 to Adusumilli, et al. (hereinafter “Sloan”) and as evidenced by Wen, et al. (2019) “Engineering Protein Delivery Depots for Cancer Immunotherapy”, Bioconjugate Chemistry, 30: 515-24.
Claim 49: Rice teaches the use of implantable constructs designed to deliver therapeutic reagents to a subject, while providing protection from host immune responses (e.g., ABSTRACT). The construct may be polymeric hydrogels, made of, e.g., chitosan (paragraphs 9-10 of the Detailed Description). The hydrogel may contain engineered cells, including RPE cells (Detailed Description, section “B. Cells, paragraph 2). These engineered cells are protected the immune response of the subject, and may be engineered to express a therapeutic agent (e.g., Id.). In Example 7, hydrogels (of alginate, e.g., Example 4) comprising RPE cells expressing IL2 were introduced a mouse model of colorectal cancer, and treated the cancer. It was shown that this, in addition to increasing activation of CD8+ T cells, the treatment also aided in the development of memory T cells that prevent secondary tumors from developing. More is taught to treat mesotheliomas, including malignant mesotheliomas, with the invention (e.g., section “E. Methods of Treatment”, paragraph 4), and there is an inherent understanding that a native IL-2 should be used in such treatments (e.g., Example 1, paragraph 5; Example 3; and Example 8).
What is not taught however, is to treat it by implanting/delivering to the pleural cavity.
On the other hand, the Artisan, interested in treating mesotheliomas as well as T cell potentiation in treatment would also be aware of Slone for its teaching of delivery of therapeutics for treatment of mesotheliomas. Slone teaches the delivery of CAR-T cells (e.g., ABSTRACT/CLAIMS). Slone teaches that it is well known to use intrapleural delivery of therapeutics when treating pleural mesotheliomas (e.g., paragraphs 28-29).
Thus, at the time of invention, it would have been obvious to modify Rice’s treatments by delivering the same to the pleural cavity of the subject, and also the possibility of delivering Rice’s CAR-T cells as the IL-2 would have the added benefit of helping those T cells. The Artisan would do so to treat mesotheliomas. The Artisan would expect success, as it was known to work on cancers, and Rice teaches the delivery method.
Claim 50: Sloan teaches pleural mesotheliomas (e.g., paragraphs 8, 92, 211, 236, and 255).
Claim 51: Sloan teaches, e.g., malignant pleural mesotheliomas (e.g., paragraph 92) and Rice teaches malignant mesotheliomas (e.g., Methods of Treatment, paragraph 4).
Claim 55: Rice teaches the use of human ARPE-19 cells specifically (e.g., Example 1).
Claim 56: e.g., Chitosan is taught (e.g., Detailed Description, paragraph 10).
Claim 57: e.g., alginate is taught (e.g., Detailed Description, paragraph 10 and Example 4).
Claim 58: It is well known in the Art that local delivery has reduced side effects than systemic delivery (e.g., Wen, Section 4. “Conclusions and Future Perspectives:, paragraph 1).
Claim 59: the delivery of the T cells with the invention of Rice is a secondary therapeutic administered.
Claims 60-62: Rice teaches also delivery of Immune check point inhibitors, including PD-1 (e.g., paragraph 14).
Claim 63:
Claims 64-65: as shown above, the treatment of pleural mesothelioma is taught.
Claim 67: As shown above , Rice teaches the use of human ARPE-19 cells specifically (e.g., Example 1).
Claim 68: at least chitosan and alginate are taught (e.g., Detailed Description, paragraph 10).
Claim 69: the additional therapeutic may be considered to be the CAR-T cells and Rice teaches the use of additional antibodies to, e.g., PD-1 (e.g., paragraph 22).
Claim 70: a further immunomodulatory agent that may be delivered may be an anti-PD-1 antibody (e.g., Rice, paragraph 22).
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.
Claim(s) 49-53, 55-62, 64-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over WIPO Document 2021/026484 to Veiseh, et al. (hereinafter “Rice”) and U.S. Patent Application Publication No. 2018/0273601 to Adusumilli, et al. (hereinafter “Sloan”) and as evidenced by Wen, et al. (2019) “Engineering Protein Delivery Depots for Cancer Immunotherapy”, Bioconjugate Chemistry, 30: 515-24, as applied to claims 49-51, 55-62, 64-65, and 67-70, above, and further in view of WO 99/12945 to Mumpter, et al. (hereinafter “Genemedicine”).
As shown above, the base claims are obvious over the Art cited, however, the aspect of utilizing the IL-2 sequence of SEQ ID NO: 1 is not taught.
On the other hand, the Artisan would be interested in utilizing the native sequence, which is human IL-2, and such is well known in art, being taught by e.g., Genemedicine, SEQ ID NO: 23) See here:
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Thus, at the time of invention, the Artisan would be motivated to present SEQ ID NO: 1, and the Artisan would do so to express the native IL-2 in treating human mesotheliomas. The Artisan would expect success, as the components are utilized for Art-recognized purposes.
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.
Claim(s) 49-51, 55-65, and 67-70 is/are rejected under 35 U.S.C. 103 as being unpatentable over WIPO Document 2021/026484 to Veiseh, et al. (hereinafter “Rice”) and U.S. Patent Application Publication No. 2018/0273601 to Adusumilli, et al. (hereinafter “Sloan”) and as evidenced by Wen, et al. (2019) “Engineering Protein Delivery Depots for Cancer Immunotherapy”, Bioconjugate Chemistry, 30: 515-24, as applied to claims 49-51, 55-62, 64-65, and 67-70, above, and further in view of Horita, et al. (2016) “High-resolution crystal structure of the therapeutic antibody pembrolizumab bound to the human PD-1”, Scientific Reports, 6: 35297, 8 pages long.
As shown above, the base art obviates the base claims, however, the aspect of using one of the anti-PD-1 antibodies of Claim 63 is not taught by the Art cited.
On the other hand, it was known in the Art that pembrolizumab is an antibody for such applications (e.g., Horita, ABSTRACT and first paragraph).
Thus, at the time of invention, it would have been obvious to use pembrolizumab as the anti-PD-1 antibody in such treatment. The Artisan would do so because it was known for use against cancers. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Claims Free of the Art
Claim 54 is free of the art of record, as no prior art had disclosed this sequence as a codon optimized sequence coding IL-2, and thus it requires hindsight to arrive at this structure.
Claim 54 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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