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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed 10/11/2024 has been considered and the references therein are of record.
Examiner notes that in the IDS filed 10/11/2024 the publication date of Ochyl et al. has been corrected to 2018.
Claim Objections
Claim 8 is objected to because of the following informalities: contains a spelling error, reciting "hematopeotic". Appropriate correction is required. For the purposes of compact prosecution, “hematopeotic” will be interpreted as “hematopoietic.”
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 11 and 19 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.
The term “assembly solution” is not a standard term of the art and the specification fails to define what constitutes an assembly solution, which renders the claims indefinite. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7-9, 11-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ochyl et al., 2018 in view of Bartunkova et al., 2017 (JP2017025066A) (see instant PTO-892).
The instant claims are drawn to a method of making an antigen-presenting dendritic cell membrane derived nanovesicle (CDNV), comprising: (a) incubating a dendritic cell (DC) with an antigen presented by a tumor cell and an agent to activate the DC, thereby generating a mature DC displaying a major histocompatibility complex class I (MHC) presenting the antigen; and(b) fragmenting the membrane of the mature DC with sonication and allowing the fragmented membrane to assemble into a CDNV displaying the MHC presenting the antigen. The instant claims are drawn to obtaining the DC from a circulating hematopoietic cell obtained from a subject. The instant claims are drawn to suspending the membrane fragments of the mature DC in a solution comprising cargo such that the CDNV encapsulates the cargo during assembly, where the cargo is genetic material, therapeutic agent, protein, or fluorescent marker. The instant claims are drawn to a method of activating an antigen-specific T cell, comprising: (a) incubating a dendritic cell (DC) with an antigen presented by a tumor cell and an agent to activate the DC, thereby generating a mature DC displaying a major histocompatibility complex class I (MHC) presenting the antigen;(b) fragmenting the membrane of the mature DC with sonication and allowing the fragmented membrane to assemble into a CDNV displaying the MHC presenting the antigen; and (c) delivering the CDNV to an environment including the T cell, thereby directly activating the T cell, or indirectly activating the T cell through a bystander antigen presenting cell (APC) that uptakes the CDNV and presents the antigen. The instant claims are drawn to administering the CDNV to a subject.
Ochyl teaches a method of making an antigen-presenting dendritic cell membrane derived nanovesicle (CDNV) and activating an antigen-specific T cell by first incubating an immature dendritic cell (DC) with the activating agent monophosphoryl lipid A (MPLA) to generate mature DC, then fragmenting the membrane via freeze-thaw cycles and mild probe-tip sonication, then incubated with antigen peptide SIINFEKL in 20 mM CaCl2 solution to load the CDNV with the antigen peptide, then activating T cells with the CDNV composition administered to mice (abstract, graphical abstract pg. 5-6).
Ochyl does not explicitly teach incubating a DC with an antigen presented by a tumor cell obtained from a subject and an agent to activate the DC, thereby generating a mature DC displaying an MHC presenting the antigen. Ochyl does not explicitly teach obtaining the DC from a circulating hematopoietic cell obtained from a subject.
Bartunkova teaches obtaining the DC from a circulating monocyte obtained from a subject (abstract & claims). Bartunkova teaches incubating a DC with an antigen presented by a tumor cell obtained from a subject and an agent to activate the DC, thereby generating a mature DC displaying an MHC presenting the antigen (abstract & claims). Bartunkova teaches a method for producing dendritic cells pulsed with tumor cells for use in immunotherapy, comprising: (A) inducing immunogenic cell death of tumor cells by high hydrostatic pressure treatment; (B) differentiating monocytes of a patient to be treated into immature dendritic cells; (C) pulsing the immune cell-induced tumor cell death obtained in step (a) to immature dendritic cells in step (b), and wherein the tumor cells are obtained from a tumor cell line corresponding to the cancer to be treated or are derived from the tumor of the patient to be treated, the monocytes are obtained by leukocyte removal from a patient, and the dendritic cells pulsed with the tumor cells are then matured (claims). To summarize, Bartunkova therefore teaches both obtaining the DC from a circulating monocyte obtained from a subject and incubating an immature DC with an antigen presented by a tumor cell obtained from a subject and an agent to activate the DC, thereby generating a mature DC displaying an MHC presenting the antigen.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of Ochyl and Bartunkova. One with ordinary skill in the art would be motivated to make and use the claimed invention because Bartunkova teaches that, instead of loading a T-cell specific antigen into a CNVD as taught by Ochyl, the mature dendritic cell can naturally present a tumor-derived antigen on its surface to activate T-cells if the antigen is presented to the immature dendric cells by tumor cells that were extracted from a patient. An ordinary artisan would find it obvious that having the antigen presented on the vesicle’s surface, and not loaded inside of the vesicle, would most closely mimic the body’s natural process of antigen presentation to activate T-cells and it would therefore be advantageous in making the most effective treatment composition. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Thus, the claims do not contribute anything non-obvious over the prior art.
Claims 1-9, 11-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ochyl et al., 2018 and Bartunkova et al., 2017 (JP2017025066A), as applied to claims 1-4, 7-9, 11-17, and 19-20 above, in view of Wikipedia, 2015 (see instant PTO-892).
Instant claims 1-4, 7-9, 11-17, and 19-20 are recited above. Instant claims 5-6 are drawn to an antigen presented by a cell infected with a pathogen that was obtained from a subject.
The teachings of Ochyl and Bartunkova and how they meet the limitations of claims 1-4, 7-9, 11-17, and 19-20 are outlined above in the preceding rejection and are hereby incorporated. Neither prior art reference teaches an antigen presented by a cell infected with a pathogen that was obtained from a subject.
Wikipedia teaches that a cell infected with a pathogen will display a major histocompatibility complex class I (MHC) presenting an antigen on its cell surface to activate T-cells (section Major histocompatibility complex).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosures of Ochyl, Bartunkova, and Wikipedia. One with ordinary skill in the art would be motivated to make and use the claimed invention because Wikipedia teaches that pathogen antigens will also be displayed on the cell surface via MHC to activate T-cells. An ordinary artisan would therefore find it obvious that instead of using tumor cells to present the antigen to the dendric cells, one can also use cells infected with a pathogen to present the antigen to the dendric cells so that they naturally display the antigen on the dendric cell’s surface to activate T-cells. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Thus, the claims do not contribute anything non-obvious over the prior art.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ochyl et al., 2018, Bartunkova et al., 2017 (JP2017025066A), and Wikipedia 2015, as applied to claims 1-9, 11-17, and 19-20 above, in further view of Simpson, 2010 (US20170158690A1) (see instant PTO-892).
Instant claims 1-9, 11-17, and 19-20 are recited above. Instant claims 10 and 18 are drawn to fragmenting a cell by pressurizing the cell under nitrogen and releasing pressure.
The teachings of Ochyl, Bartunkova, and Wikipedia and how they meet the limitations of claims 1-9, 11-17, and 19-20 are outlined above in the preceding rejections and are hereby incorporated. None of the prior art references teach fragmenting a cell by pressurizing the cell under nitrogen and releasing pressure.
Simpson teaches fragmenting a mature DC by pressurizing the mature DC under nitrogen and releasing pressure (abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to arrive at the claimed invention from the disclosure of Robinson, Kurata, Wikipedia, Wu, and Simpson. One with ordinary skill in the art would be motivated to make and use the claimed invention because an ordinary artisan would find it obvious that pressurizing a cell under nitrogen and releasing pressure is interchangeable with sonication to fragment a cell. An ordinary artisan would find it obvious that these are two interchangeable methods of fragmenting cells from which the artisan can pick and choose. It would therefore be obvious for an ordinary artisan to use pressurizing a cell under nitrogen and releasing pressure to fragment the cell instead of using sonication, since they have the same function. The person of ordinary skill in the art would have had a reasonable expectation of success based on the disclosures of these prior art references. Thus, the claims do not contribute anything non-obvious over the prior art.
Conclusion
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CESARE whose telephone number is (571)272-6908. The examiner can normally be reached Monday - Friday 10am-4pm.
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/JOSEPH D. CESARE/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
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