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 and the species iMSCs, growth factor, VEGF, and kidney in the reply filed on 4/3/26 is acknowledged.
Claims 8, 9, 11, 23, and 27-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/3/26.
Drawings
The drawings filed on 5/16/23 are objected to because: Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 10, 12-22, and 24-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) delivery of naturally occurring agents, exosomes comprising mRNAs. This judicial exception is not integrated into a practical application because the treatment is recited at a high level of generality. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are not directed to any specific treatment.
The claims recite a judicial exception, delivery of a naturally occurring product. Therefore, the claims are directed to a judicial exception.
Analysis, step 1. Instant claims are directed to a statutory category, i.e., a process.
Analysis, step 2A, the claim is then analyzed to determine whether it is directed to any judicial exception. The claims are directed to delivery of any extracellular vesicle that comprises any mRNA agent, which includes naturally occurring products such as exosomes comprising mRNAs. Thus, the claim is directed to at least one exception.
For example, Lee et al. (PLOS ONE, 2013, 8, 12, e84256, 1-11) teach that exosomes rom mesenchymal stem cells comprise mRNAs and therefore the claims are directed toa method of delivering a naturally occurring product of nature.
Analysis, step 2B. Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the natural law. In instant case, the method steps of delivering the agent via any means consist of well understood, routine, conventional activity already engaged in by the clinical community. The method is very generally directed to delivery of any mRNA for expression of any protein including VEGF or any growth factor. Thus, the claim does not amount to significantly more than the natural law itself.
Therefore, the product is not markedly different from a product of nature and the treatment step amounts only to a generic instruction to apply the exception. Thus, the claims as a whole do not integrate the recited judicial exception into practical application.
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 1-7, 10, 12-22, and 24-26 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 directed to delivering any “mRNA agent” comprising administering a composition comprising any “extracellular vesicles (EVs) prepared from human stem cells or human progenitor cells”.
The specification does not adequately describe the structure required for the function. The species of the specification are not representative of the entire claimed genus. The specification discloses mRNAs, which is not representative of the entire claimed genus of “mRNA agent”(s). Without further description of the structure required for the function, one would not be able to readily recognize which agents meet the instant litation of being an mRNA agent.
The specification discloses exosomes, which is a single species that is not representative of the entire claimed genus of extracellular vesicles. Without further description of the structure required for the function, one would not be able to readily recognize which naturally occurring delivery vehicles meet the instant limitation of being an extracellular vesicle that encapsulates mRNA agents. The instant claims encompass microvesicles, apoptotic bodies, migrasomes, and oncosomes, for example, which have not been adequately described by the instant specification.
Additionally, claim 26 requires for the administration to use an endoluminal delivery device. The specification discloses an endoluminal delivery cannula, which is a single species of possible endoluminal delivery devices and is not representative of the entire claimed genus. Without further description of the structure required for the function, one would not be able to readily recognize which devices meet the instant limitation of being able to achieve intraluminal delivery.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for each of the instantly recited genuses that have the structure for the required function. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
Claims 1-7, 10, 12-22, and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for delivering an mRNA agent from a mesenchymal stem cell derived exosome via direct delivery to the cell, does not reasonably provide enablement for a method of delivering mRNA or expressing a protein in vivo via any mode of administration from any possible extracellular vesicle comprising a mRNA. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in a determination of lack of enablement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The claims are directed to a method of delivering mRNA or expressing a protein in vivo via any mode of administration from any possible extracellular vesicle comprising a mRNA.
The specification demonstrates in vitro transfection of cells via iMSC-derived exosomes comprising mRNA with resultant protein expression (example 7).
The specification does not draw an adequate nexus between delivery via any means of any possible extracellular vesicle comprising any mRNA in vivo and the predictable outcome of delivering the mRNA to a subject or expression of any protein.
Although applicant has demonstrated mRNA delivery via a specific species of extracellular vesicle in vitro, applicant is not enabled for mediating such delivery in vivo by the broadly recited methods, as delivery and effective action therein is known in the art to be unpredictable with regards to extracellular vesicles. Activity in vitro is not predictable of the in vivo effect in the in vivo complex environment.
The instant claims encompass microvesicles, apoptotic bodies, migrasomes, and oncosomes, for example, each differing in plasma membrane budding, apoptosis, autophagy, migration, size range, and cargo profile. The instant specification is not enabling for delivery of the entire claimed genus of extracellular vesicles and the predictable outcomes as instantly recited.
For example, Sun et al. (Stem Cell Res Ther (2021) 12:561, 1-15) teach that Mesenchymal stem cells-derived exosomes have challenges for drug delivery (abstract). Sun et al. teach that cells as drug carriers still face many problems such as uncertain differentiation accidents, cell embolism, infection, production, and storage (page 1). Sun et al. teach that in current studies, researchers use MSC-EXOs as a carrier to deliver RNA, protein, and molecular drugs to specific parts of the body to achieve targeted therapy. However, problems such as carrier separation and purification, preservation and transportation, drug loading, and targeting still exist (page 1).
Sun et al. teach: The biodistribution and half-life of MSC EXOs in the human body need to be further clarified. The main routes of administration of MSC-EXOs are intravenous injection, local injection, intranasal administration, etc. The different routes of administration will affect the biodistribution of the drug in the body, which requires further comparison and exploration by researchers (page 12).
The instant specification is not enabling for a method of broad systemic delivery of any type of EV encapsulating any mRNA with a resultant predictable delivery or protein expression which encompasses oral delivery and action across the blood-brain barrier, for example.
As outlined above, it is well known that there is a high level of unpredictability in the extracellular vesicle art for therapeutic in vivo applications and design. The scope of the claims in view of the specification as filed together do not reconcile the unpredictability in the art to enable one of skill in the art to make and/or use the claimed invention, namely a broad method of delivering any mRNA or expressing any protein via broad systemic delivery of a broad genus of agents encompassing in vivo effects.
MPEP 2164.01
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
Also, MPEP 2164.01(a)
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Given the teachings of the specification as discussed above, one skilled in the art could not predict a priori whether introduction of any extracellular vesicle of the instant genus in vivo by the broadly disclosed methodologies of the instantly claimed invention, would result in successful delivery of any mRNA or expression of any protein. To practice the claimed invention, one of skill in the art would have to de novo determine; the stability of the molecule in vivo, delivery of the molecule to the whole organism, specificity to the target tissue in vivo, dosage and toxicity in vivo, and entry of the molecule into the cell in vivo and the effective action therein. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation (see MPEP 2164.01(a)).
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.
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.
Claim(s) 1-7, 10, 12-22, and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (WO 2018/209182 A2), in view of Zhu et al. (Journal of Inflammation Research 2022:15 1421–1436), Guise et al. (Am J Physiol Renal Physiol 315: F747–F751, 2018), Kormann et al. (Nature Biotechnology, VOLUME 29 NUMBER 2 FEBRUARY 2011, 154-159).
Nguyen et al. teach: Exosomes and/or extracellular vesicles also play a role in physiological processes and can have regenerative effects. For example, exosomes/extracellular vesicles derived from mesenchymal stem cells (MSCs) have been shown to mediate cardiac tissue repair after myocardial infarction by modulating the injured tissue environment, inducing angiogenesis, and inducing cellular proliferation and differentiation [0005].
Nguyen et al. teach: [0006] There is, therefore, an ongoing and unmet need for compositions and methods that are useful for blocking undesired cellular communication by reprogramming exosomes to halt and/or reverse disease progression, and for reprogramming or loading exosomes with chemical and biological agents so that they can deliver other desirable cargo to target cells. The present disclosure is pertinent to these needs.
Nguyen et al. teach: [0022] Figure 9 shows relative exosomal enrichment of EXO-Codes after electroporation into their parent cell lines (MDA-MB-231 cells, mesenchymal stem cells, Raw 264.7 cells, and HEK 293 cells).
Nguyen et al. teach: [0026] In all shown parameters exosomes derived from mesenchymal stem cells treated with EXO-Code-MSC6/miR-132 showed statistically significant increase in the number of nodes, number of junctions, total length, total branching lengths, and number of branches.
Nguyen et al. teach: [0027] Figure 14 shows a schematic showing assessment of the capabilities of EXO-Codes to deliver different sized cargoes to exosomes. The miRNA/siRNA and mRNA containing multivalent EXO-Codes can be delivered to MDA-MB-231, PC-3, and other cells by (A) electroporation and (B) by liposomal, polymer, and peptide transfection, as well as by other suitable methods. The amount of miRNA/siRNA and mRNA sorted to exosomes can be quantified by stem-loop RT-PCR (for miRNA/siRNA) and RT-PCR for mRNA.
Therefore, Nguyen et al. teach that the exosome can comprise mRNA and can be delivered via different sized cargoes by suitable methods.
Nguyen et al. teach: [0050] The EXO-Code containing polynucleotides may or may not encode a protein, including but not necessarily limited to a protein that is intended to facilitate RNA and/or exosome localization and/or visualization, or a protein that is capable of exerting a function in an exosome and/or in a target cell.
Nguyen et al. teach: [0051] In certain aspects the EXO-Code containing polynucleotides may encode a protein that produces a detectable signal, including but not necessarily limited to a visually detectable signal, a fluorescent signal, etc. In certain approaches the EXO-Code containing polynucleotides may be covalently linked to any peptide or polypeptide. The type, sequence and function of such moieties are not particularly limited, other than by the size constraints of the exosome or other secreted membranous structure. In certain approaches the EXO-Code containing polynucleotide can be linked to a functional protein or fragment thereof. In certain embodiments the protein is selected from enzymes, including but not limited to those described above, or receptor ligands, transcriptional factors, growth factors, antibodies or antigen-binding fragments thereof, peptide or protein immunogens that can be used for stimulating an immune response (i.e., a vaccine), protein-based chemotherapeutic agents, and toxins
Nguyen et al. teach: Polynucleotides comprising EXO-Codes can be introduced directly into exosomes or other vesicular structures as described herein by using any suitable techniques, examples of which include but are not limited to electroporation, incubation, cell activation, and transfection, lipid transfection, lipid delivery, liposomal delivery, polymer transfection, polymeric delivery, through peptide delivery (i.e. but not limited to cationic peptides, amphiphilic peptides, cell penetrating peptides), calcium or magnesium precipitation, and ion precipitation (also known as DNA-calcium phosphate precipitation) [0053].
Nguyen et al. teach: [0089] Delivery of different size cargoes and determining exosomal loading capacity. For optimization of cargo loading, the ability of the EXO-Codes to load cargoes of varying sizes is assessed. Loading of miRNAs, siRNAs, DNA, and larger nucleic acids (such as mRNAs or plasmid DNA) into exosomes is monitored by RT-PCR. Relationships between RNA size and loading efficiency and RNA size and loading kinetics can be determined. Passive strategies that stably transfect cells with siRNAs or miRNAs to indirectly load exosomes are prevalent in the literature. However, these methods are highly inefficient, require high amounts of RNA, and are unsuitable for direct in vivo reprogramming, with loading of larger nucleic acids, such as mRNA and pDNA, especially challenging using conventional methods (about 0.3%) loading efficiency). mRNAs are thought to be loaded into exosomes via sequence-specific sorting. By attaching EXO-Codes to mRNAs, the disclosure mimics the endogenous sorting strategy to efficiently load mRNAs into exosomes. Green fluorescent protein (GFP) can be used as a model protein for mRNA delivery. The miRNA/siRNA and mRNA attached to EXO- Codes are delivered to MDA-MB-231, mesenchymal stem cell s, and other cells by (a) electroporation and (b) by liposomal transfection using our lipids, polymers, or peptides. The amount of miRNA/siRNA and mRNA sorted to exosomes can be quantified by stem-loop RT-PCR (for miRNA/siRNA) and RT-PCR for mRNA.
Nguyen et al. teach: [0092] The effect of multivalency on the kinetics and efficiency of exosomal sorting can be assessed. EXO-Codes can be attached to the cargo (miRNA and mRNA) at different valencies (n=l-3). In this regard, Figure 14 provides a schematic showing assessment of the capabilities of EXO-Codes to deliver different sized cargoes to exosomes. The miRNA/siRNA and mRNA containing multivalent EXO-Codes can be delivered to MDA-MB-231, PC-3, and other cells by (a) electroporation and (b) by liposomal, polymer, and peptide transfection, as well as by other suitable methods. The amount of miRNA/siRNA and mRNA sorted to exosomes can be quantified by stem-loop RT-PCR (for miRNA/siRNA) and RT-PCR for mRNA.
Nguyen et al. teach: The M8 EXO- Code mCherry (containing the sequence AUCUUGUGGUC (SEQ ID NO:207)) enhanced loading of mCherry mRNA into exosomes of MDA-MB-231 cells by ~7-fold compared to unmodified mCherry mRNA. [0106] .
Nguyen et al. teaches treating various types of human cells with the exosomes. [0010] The disclosure includes compositions, including but not limited to pharmaceutical compositions suitable for human and/or veterinary uses, wherein the compositions comprise EXO-Code containing polynucleotides.
Therefore, Nguyen et al. offers motivation to deliver exosomes prepared from human mesenchymal stem cells to deliver mRNA encapsulated in the exosome (instant claims 1, 3, 4, 13, 14, 16, 17, 21). Given that Nguyen et al. teach various cargo sizes, selection of length of mRNA is considered to be a matter of design choice (instant claims 14 and 15).
It would have been obvious for the mesenchymal stem cells to be iMSCs because Zhu et al. teach that iMSC-derived exosomes protect tenocytes from inflammatory stimulation and promote cell proliferation as well as collagen synthesis, thereby relieving pain (page 1421) (instant claims 5 and 18). The benefits of iMSCs derived exosomes were known. One would select this type of MSC as a matter of design choice and reasonably expect the benefits taught by Zhu et al.
It would have been obvious for the mRNA to encode VEGF (instant claims 7, 19, and 20) and for delivery to be to the kidney (instant claims 10, 12, 22, 24, and 25) because Guise et al. teach: Renovascular disease (RVD), which is prevalent in the elderly, significantly increases cardiovascular risk and can progressively deteriorate renal function. The loss of renal function in patients with RVD is associated with a progressive dysfunction, damage, and loss of renal microvessels, which can be combined with decreased renal bioavailability of vascular endothelial growth factor (VEGF) and a defective vascular repair and proliferation. This association has been the impetus for recent efforts that have focused on developing methods to stop the progression of renal injury by protecting the renal microvasculature. This mini-review focuses on recent studies supporting potential applications of VEGF therapy for the kidney and discusses underlying mechanisms of renoprotection (abstract). Therefore, there was motivation in the art to deliver mRNA encoding VEGF to kidneys. It would have been obvious to deliver this mRNA via the exosome of Nguyen et al. with a reasonable expectation of success. It would have been obvious to deliver via an endoluminal delivery device (instant claim 26) as a matter of design choice because this would achieve delivery within the kidney.
It would have been obvious for the mRNA to have a chemical modification (instant claim 2) because Kormann et al. teach that chemical modification of mRNA can facilitate in vivo delivery of mRNA (page 154). Kormann et al. teach that the chemical modification resulted in low immunogenicity and higher stability in mice (page 154) (instant claim 6). One would have been motivated to incorporate the modification of Kormann et al. into the mRNA with a reasonable expectation of the benefits taught by Kormann et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636
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