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
Status of the Application
Claims 1-20 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed 3/12/2024 having 17 pages fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609.
The NPL document No 16 of Fang et al. does not have all the pages of the document and appears to be missing several pages. Therefore the entire reference cannot be considered and has been lined thru.
The NPL document 40 does not have the required publication year listed and has been lined thru.
The NPL document 305 is not in English and cannot be considered.
The remainder of the documents cited on the IDS has been considered by the examiner and signed copies have been placed in the file. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single see para within the range of 50 to 150 words in length. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure filed 12/11/2023 is objected to because it
contains statements of the alleged merits or value of the claimed invention or its speculative application because it recites the following phrases” “stimulate an immune response that attacks tumors distally”. Appropriate corrected is required.
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 1, 2 and 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 pre-AIA the applicant regards as the invention.
Claim 1 recites in step (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin- like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1. Claim 2 recites The method of claim 1 comprising the step of treating the adherent cells with IGF-1R AS ODN for up to 18 hours prior to encapsulation. The limitation in step (iv) is indefinite because it can be read as the chamber has both the harvested cells and IGF-1R AS ODN as if they are each added separately into the chamber but claim 2 recites the cells are treated with IGF-1R AS ODN before they are added to the chamber. This could mean the cells were pretreated with IGF-1R AS ODN and then there is additional IGF-1R AS ODN added to the chamber upon encapsulation. Claim 1 step (iv) is interpreted such that the harvested cells have been treated with the IGF-1R AS ODN before being added into the chamber and what is added in the chamber is the pretreatment solution comprising both the cells and the IGF-1R AS ODN. Claim 2 is interpreted as defining that the treatment is up to 18 hours prior to encapsulation.
Claim 10 recites in step (a) that the chamber comprising irradiated tumor cells that are pe-incubated with IGF-1R AS ODN and step (b) adds additional irradiated IGF-1R AS ODN. It is unclear if the IGF-1R AS ODN is not irradiated and then additional irradiated IGF-1R AS ODN is added. The claims are interpreted such that the chamber comprises tumor cells and IGF-1R AS ODN where in the cells have been pre-treated and the chamber is irradiated making the tumor cells and IGF-1R AS ODN irradiated before implantation into a subject.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Andrews et al. (Thomas Jefferson University, February 12, 2016, IDS 10/13/2020 hereinafter Andrews 2016 cited on IDS filed 03/12/2024) in view of Andrews et al. (Journal of Clinical Oncology, 2001, 19:2189-2200, IDS 10/13/2020 hereinafter “Andrews 2001”), Day et al. (Cancers, 2013, 5:357-371 cited on IDS filed 03/12/2024), Andrews et al. (US 6,541,036 hereinafter Patent’036 cited on IDS filed 03/12/2024) and Rushing et al. ("High-grade astrocytomas show increased Nestin and Wilms’s tumor gene (WT1) protein expression." International journal of surgical pathology 18.4 (2010): 255-259).
Claim interpretation: the specification does not define “adherent cells” and therefore the broadest reasonable interpretation of this phrase would be vertebrate derived cells that can be grown on a surface (see Wikipedia "Adherent culture." Wikipedia, The Free Encyclopedia. Wikipedia, The Free Encyclopedia, 17 Feb. 2025. Web. 15 Apr. 2026).
Regarding claims 1, 2, 4-6, 8, 9-12, 14, 15, 18 and 19, Andrews 2016 discloses the following at pages 2-3, methods of implanting up to 10 biodiffusion chamber containing irradiated autologous tumor cells and IFG-1R AS ODN in patents having Grade III and IV astrocytomas brain cancer wherein the ODN is identical to SEQ ID No. 1. Andrews 2016 teach incubating the tumor cells with IGF-1R AS ODN overnight and then irradiating the chamber and implanting the chamber in a subject (see page 3). The limitation of “up to 18 hours” is interpreted as any amount of time up to 18 hours and therefore this limitations is taught by Andrews 2016. Regarding the limitation of clam 10 of (a) and (b), irradiation of the chamber would in fact irradiate the tumor cells and irradiate the IGF-1R as ODN so the limitation of the chamber comprising irradiated tumor cells and irradiated IGF-1R AS ODN is met.
Andrews 2016 does not expressly disclose surgically removing tumor tissue. Andrews 2016 refers to Andrews 2001 (Andrews et al., Journal of Clinical Oncology, 2001, 19:2189-2200, of record IDS 06/24/2024) when disclosing the overnight treatment. The 2001 reference discloses that the “viable tumor tissue” cells were resected from subjects and incubated “with a dose of 2 mg IGF-IR/AS/107 cells” and the adherent cells and “Each diffusion chamber accommodated 106 cells/200 L/chamber.” (see page 2190). Andrews 2016 teach this method yielded an effective vaccine with immune responses against the brain cancer (see pages 6-8).
The limitations of the cell amount in the chamber in claim 1 is interpreted as any amount lesser or greater than because of the word “about” and therefore the teaching of Andrews 2016 anticipates this limitation. With respect to the limitations of the range of cells to AS ODN, MPEP §2144.05: states "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." And “conducting clinical trials to test for an optimal dose for a drug ‘is generally a routine process[‘].” Eli Lilly and Co. v. Teva Pharmaceuticals USA, Inc., 619 F.3d 1329, 1342 (Fed. Cir. 2010). “In Mayo, the application of the natural law was merely routine optimization of drug dosage to maximize therapeutic effect.” Ariosa Dignostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015) (Dyk, J., concurring). It would have therefore been obvious for one of skill in the art to test for the optimal number of the ratio of IGF-1R AS ODN to cells to find a ratio for an effective immune response.
Regarding claim 1(i) and 7, Andrews 2016 do not teach obtaining morselized tumor tissue or that the tumor cells are not exposed to temperatures above body temperature. Morselized tumor tissue is described in the specification as tissue that can be obtained by an aspirator-extract to obtain viable tissue (0093).
Day et al. teach that one skilled in the art can readily obtain glioma tumor cells using a surgical aspirate such as a “CUSA EXcelTM ultrasonic aspirator”, which enables one to obtain “viable tumor tissue” and “live tumor cells” that can be used for “culture generation” (emphasis added) (see pages 358-359). Day teach that use of surgical aspirators compared to conventional biopsy provides “a viable source of primary tumor sufficient in quantity and quality”, wherein the “quantity and quality of tissue” can enable “to cryopreserve multiple aliquots” of tumor cells, which “thaw with high viability and can be used to generate cultures in both GNS [glioma neural stem] and neurosphere conditions” (emphasis added) (see page 367) and does not teach the tumor cells were exposed to temperatures above body temperature.
It would have been obvious to one of ordinary skill in the art before the effective filing date to practice Andrews 2016 “Phase 1 Trial” method by utilizing an art-recognized surgical aspirator such as “CUSA EXcelTM ultrasonic aspirator” when obtaining “autologous tumor cells removed at surgery” as disclosed by Andrews 2016. It would have been obvious for one of ordinary skill in the art to try the art-recognized surgical tissue aspirator when performing Andrews’ 2016 “surgery” that provides “autologous tumor cells removed at surgery” for biodiffusion preparation, because use of a surgical aspirator for brain tumor tissue removal surgery was already practiced in the medical field.
Regarding claims 16, 17 and 20, Andrews 2001 do not specifically teach the tissue morselator with the specifications as claimed. The Integra CUSA EXcelTM Users Guide describes the components and operation of the tissue morselator wherein in comprising an inner and outer cannula and a side apertures (see at least Figures 3-1 to 3-2). One of skill would have been capable of following the manual and operating the tissue morselator to harvest adherent cells as claimed.
Regarding claim 3, Patent’036 is drawn to methods of using a diffusion chamber comprising IGF-1R to implant in a subject to induce regression of a tumor (see col. 3 lin 5-10). Patent’036 teach using up to 20 chambers (col 9 lines 5-10). Patent ‘036 teach the chambers are left in the subject for about 48 hours before removal (see col. 15). It would have been obvious to one of ordinary skill in the art to try different lengths of time for implantation of the diffusion chambers to improve the immune response in the subject and given this was known in the art, one would have applied these paraments to yield predictable results.
Regarding claim 13, Rushing et al. found high grade Astrocytomas showed an increased Nestin protein expression level (Figure 1 and Table 1). It would have been obvious to one of ordinary skill in the art when trying to treat Astrocytomas using the methods of Andrews to enrich the harvested tumor cells expressing Nestin to increase the immune response toward this type of brain cancer.
In view of the foregoing, claims 1-9 taken as a whole would have been prima facie obvious before the effective filing date.
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. See 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);and, 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,357,509. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The instant claims are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a tumor tissue surgically removed from the subject; (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained.
Claims of patent ‘509 are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a morselized tumor tissue from the subject (which encompasses surgically removed a tumor tissue from a subject) (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained.
Thus, claims of the instant application and Patent ‘509 are not patentably distinct from each other.
Claims 1-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,772,904. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The instant claims are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a tumor tissue surgically removed from the subject; (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained.
Claims of patent ‘904 are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a morselized tumor tissue from the subject (which encompasses surgically removed a tumor tissue from a subject) (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained.
Thus, claims of the instant application and Patent ‘904 are not patentably distinct from each other.
Claims 1-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,265,339. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The instant claims are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a tumor tissue surgically removed from the subject; (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained and drawn to a biodiffusion chamber encapsulating harvested cells and insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN).
Claims of patent ‘339 are drawn to a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1 and a method of preparing a biodiffusion chamber and it would have been obvious to make and use the biodiffusion chamber in the methods of the instant invention.
Thus, claims of the instant application and Patent ‘339 are not patentably distinct from each other.
Claims 1-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,077,133. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The instant claims are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a tumor tissue surgically removed from the subject; (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained.
Claims of patent ‘133 are drawn to a method of treating a subject having a brain cancer comprising administering a composition comprising IGF-1R AS ODN and a biodiffusion chamber comprising tumor cells and a second IGF-1R AS ODN and the methods of treatment encompass vaccination given the plain meaning of treatment to one of skill in the art.
Thus, claims of the instant application and Patent ‘133 are not patentably distinct from each other.
Claims 1-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 10,543,226. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The instant claims are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a tumor tissue surgically removed from the subject; (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained.
Claims of patent ‘226 are drawn to a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1 and a method of preparing a biodiffusion chamber and it would have been obvious to make and use the biodiffusion chamber in the methods of the instant invention.
Thus, claims of the instant application and Patent ‘226 are not patentably distinct from each other.
Claims 1-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,801,259. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The instant claims are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a tumor tissue surgically removed from the subject; (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained.
Claims of patent ‘259 are drawn to a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1 and it would have been obvious to use in the instant methods of vaccinating a subject.
Thus, claims of the instant application and Patent ‘259 are not patentably distinct from each other.
Claims 1-20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-8, 10, 13-16, 18, 20 and 26-30 of Application No. 18,742,486. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter.
The instant claims are drawn to a method of vaccinating a subject having a brain cancer comprising: (i) obtaining a tumor tissue surgically removed from the subject; (ii) collecting the tissue in a sterile trap; (iii) harvesting adherent cells from the morselized tissue; (iv) encapsulating the harvested cells in a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1; (v) irradiating the chamber, and (vi) implanting the chamber in the subject, wherein an immune response against the brain cancer is obtained.
Claims of APP ‘486 are drawn to a biodiffusion chamber along with insulin-like growth factor receptor-1 antisense oligodeoxynucleotide (IGF-1R AS ODN) having the sequence of SEQ ID NO:1 and methods of vaccination of a subject.
Thus, claims of the instant application and Patent ‘486 are not patentably distinct from each other.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Chong at (571)272-3111. The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm.
If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY CHONG/
Primary Examiner Art Unit 1636
Prosecution Insights