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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 4-5, 7,10, 13-14, 20, 23-24, 38-39, 55 and 57 drawn to an extracellular vesicle and species VNAR, an anti-phagocytic signal CD47, Scaffold X protein, prostaglandin F2 receptor negative regulator (the PTGFRN protein) and exosome in the reply filed on 12/16/2025 is acknowledged.
Claims 29, 43-44, 68,75-76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
Claims 1, 4-5, 7,10, 13-14, 20, 23-24, 38-39, 55 and 57 are under consideration in the instant Office Action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (www), see page 24, [79] and [81-82]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 4, 14, 20, 24 and 39 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.
Claims 4, 20 and 39 call for properties that are “at least about 10% to 1000%” of the claimed properties. Specifically, claim 4 calls for increasing the transport of the EV across the blood brain barrier by at least about 10% and up to at least about 1000%. Claim 20 calls for a moiety that is present at a concentration of at least about 10 copies per EV and up to at least about 5000 copies per EV. Claim 39 calls for “at least about 70% up to about 100% sequence identity off SE QID NO:1.” These claims suffer from an indefinite issue to due to the “at least about” limitation in the instant claims. There is no definition in the instant specification that sets forth the meaning of this limitation. Does this limitation mean that the “about 95%” encompasses 90-94% or only 94% of these limitations? One of ordinary skill in the art does not have any specific guidance in determining the metes and bounds required by this limitation since it is unclear what percent (%) is or is not included in “at least about 10%”. Since there are multiple interpretations for the instant claim, the claim is considered indefinite. For these reasons, the claims 4, 20 and 39 are found indefinite. Removing the term “about” would overcome this rejection for these specific claims.
Regarding claims 24 and 39, the phrase “optionally” is interpreted as "for example" which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claims “optionally;” language make its it unclear if the limitations that are presented after are requirements in the claim. Further, the claim language of claim 24 is also confusing. Specifically, the limitation “the anti-phagocytic signal is selected from comprises…” is vague and confusing to what it actually means and what it is encompassing.
Finally, claim 14 calls “or is synthetic”, and it is unclear what this is referring to. Does it mean vNAR, VHH or antigen fragment thereof is synthetic? It also unclear what is meant by the term “synthetic”. The instant specification fails to set forth a specific definitions for the term. Therefore, one of ordinary skill in the art does not have any specific guidance in determining the metes and bounds required by this limitation since it is unclear what is encompassed by this term.
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, 4-5, 7, 10, 13-14, 20, 23-24, 38-39, 55 and 57 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.
Claims 1, 4-5, 7, 10, 13-14, 20, 23-24, 38-39, 55 and 57 are directed to any antigen binding moiety that specifically binds transferrin receptors (TfR). The claimed antigen binding moiety reads on antibodies as required in instant claim 5. Dependent claim 7 calls for two different antibodies with different epitopes against TfR. The other dependent claims do not disclose any specific antibodies, but rather further require generic structures and generic epitopes that the claimed antibodies would bind. As such, the claim is directed to an antibody defined entirely by function (binding). See MPEP §2163(I)(A) which states:
"The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
In this case, antibodies generally share certain characteristics such as Fc regions or hinge regions. However, these structures are not correlated with the binding function of the antibody. The hyper variable regions (HVRs), i.e., complementarity determining regions (CDRs) of an antibody, are well established in the art as the portion of the binding region which imparts the specificity of an antibody. However, there is no way to a priori look at an antigen sequence (transferrin receptor) and envisage the combination of six CDRs that will bind that antigen. First, even highly related CDRs may not bind the same target. See for example Kussie (instant PTO-892) who demonstrates that a single amino acid change in the heavy chain of an antibody which binds p-axophenylarsonate (Ars) completely abrogates the ability of the antibody to bind Ars but adds the functionality of binding the structurally related p-azophenylsulfonate (e.g., abstract). Second, even when provided with several related antibodies that bind the desired target, this does not represent the astronomical and potentially unknowable breadth of all possible amino acid sequences which will result in the desired binding properties. This is exemplified by the Court decision in Abbvie (Abbvie v Janssen 759 F.3d 1285 (Fed. Cir. 2014)), where Abbvie developed over 200 antibodies that shared 99.5% identity in the variable regions (p.7) and which bound the target, but in no way allowed one to envisage the unique structure of Centocor’s antibodies which bound the same target but shared only 50% sequence similarity (see table on page 11).
Thus, the art recognizes that the CDRs define the binding properties of an antibody and that even single amino acid changes to this region can completely abrogate the binding specificity of an antibody. As a further example, see Chen et al., 1995 (instant PTO-892) which demonstrates single amino acid changes in the VH CDR2 sequence can increase binding, decrease binding, destroy binding, or have no effect on binding when compared to the wild-type antibody.
See also Koenig 2017 (instant PTO-892), which provides a large mutation analysis study where every amino acid in both variable regions are substituted with every other amino acid. Looking at figure 1 of Koenig, the bottom half of each section (labeled VEGF) relates to the ability of the mutant to bind the original target, with blue meaning a reduced affinity and black meaning a complete loss of binding ability. In VH-CDR2, for example, mutating any given residue to cysteine, which is encompassed by the instant claims, resulted in reduced binding at 12 residues and a complete loss of binding at 5 residues. That is, at 100% of the positions, mutation to cysteine reduced or ablated the antibody’s ability to bind the target. Looking at a specific position, in 100% of the mutations of residue 55, binding was reduced (15/19) or eliminated (4/19). While residues 56-65 appear more tolerant of change, residues 50-55 are generally intolerant of change.
It is appreciated that Koenig is studying one specific antibody and there is no evidence that the instant antibodies would react in the same way. However, this is part of the problem. It is entirely unclear from the specification which residues of Applicant’s CDRs are tolerant or intolerant to change, and whether those tolerant positions are only tolerant to conservative mutations. The fact that some residues might tolerate mutation does not convey to the skilled artisan that Applicant knew which of the claimed residues were tolerant of such, i.e., does not convey that Applicant was in possession of those sequences which are mutated yet preserve the claimed function. In other words, the specification fails to convey possession of an invention commensurate in scope with what is now claimed and therefore fails to meet the written description requirement. Looking at Koenig figure 2A, ~200 mutations in the CDR region of the VH chain completely abrogates any binding. While 2B appears to indicate that the CDRs of VL are more tolerant of change than the heavy chain CDRs, still over half of the mutations reduce binding compared to the parent.
Thus, making changes to the CDR sequence of an antibody is a highly unpredictable process and the skilled artisan could not a priori make any predictions regarding such mutations with any reasonable expectation of success nor envisage the breadth of structurally unrelated CDR combinations that would still possess the required functions.
The instant claims call for specific types of antibodies like vNAR but fail to specifically disclose the CDRs or the light and heavy chain variable regions for the antibodies that would bind transferrin receptors. The specification discloses at [0098] “a "vNAR" refers to a polypeptide comprising a variable region of an IgNAR antibody or an antigen-binding fragment thereof. IgNAR antibodies are heavy-chain homodimers made up of two heavy chains, each heavy chain having a variable heavy region (vNAR) and five constant heavy regions. IgNAR are naturally expressed in cartilaginous fish and sharks ….; In some aspects, the vNAR comprises the general structure (FW1-CDR1-FW2-3-CDR3-FW4); vNAR attributes include high affinity for target, ease of expression, stability, solubility, multi-specificity, and increased potential for solid tissue penetration.” The instant specification does disclose two potential antibodies that are known in the prior art as potential TfR antibodies, OX26 and 8D3, that have been shown to cross the blood brain barrier, see [0113]. However, as discussed above, without any way to determine how broad the genus of such antibodies are, there is no way to determine if these antibodies represent the full breadth of what is claimed. The instant claims are claiming an antibody by the antigen it binds to, which encompasses a far greater number of potential antibodies than Applicant has support for in the instant specification. The disclosure of these specific antibodies would not convey to the artisan that Applicant was in possession of the full genus of all antibodies which possess the required functions nor does it allow the skilled artisan to envisage the specific structure of such antibodies.
As such, the instant disclosure does not provide an adequate number of species of the claimed genus nor does the disclosure provide a structure-function correlation that would allow for a person of ordinary skill in the art to envision what variation can occur to the light and heavy chains, particularly in the CDR regions, such that the obtained structure would result in the claimed functions.
Further note the decision in Amgen v. Sanofi 2017, where the Court supported previous decisions (Centocor 2011; Abbvie 2014) that defining an antibody solely by what it binds does not satisfy the written description requirement, stating that this would allow patentees to “claim antibodies by describing something that is not the invention, i.e., the antigen”. This decision has precipitated guidance to the Office instructing that the portion of MPEP 2163 regarding the “newly characterized antigen test” (indicating a well-characterized antigen is sufficient to satisfy written description for antibodies which bind that antigen) should no longer be used and that contrary materials should not be relied upon as reflecting the current state of the law. As such, the disclosure of two antibodies does not convey possession of other antibodies with the same binding properties; possession of the precisely defined sequence of six CDRs is required.
With respect to product claims 1, 4-5, 7,10, 13-14, 20, 23-24, 38-39, 55 and 57, it is recognized that information which is well known in the art need not be described in detail in the specification (MPEP §2163(II)(A)(2)). See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. MPEP §2163(II)(A)(3)(a) also discusses Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004), where a method of using a PGHS-2 inhibitor did not meet the written description as the inhibitor itself was not sufficiently described, clearly indicating that written description of the compound is still required in a method of using that compound. Thus, the prior art cannot provide sufficient written description of this genus of compounds and the specification as filed, disclosing a few antibodies, does not sufficiently describe the genus either as there is an unknown amount of structurally distinct antibodies in this genus (see Amgen and Centocor decisions discussed above).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Vas-Cath, Inc., v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. An antibody described only by functional characteristic, such as antibody that binds TfR or one of the possible epitopes, without any known or disclosed correlation between that function and the structure of the sequence, is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the biomolecule of interest. In re Bell, 991 F.2d 781, 26 U.S.P.Q.2d 1529 (Fed. Cir. 1993). In re Deuel, 51 F.3d 1552, 34 U.S.P.Q.2d 1210 (Fed. Cir. 1995). In the instant case, the specification provides insufficient direction or guidance concerning the relationship between the structure of the possible antibody to demonstrate possession of the breadth of the genus of anti-transferrin antibodies encompassed by the instant claims, especially in view of the unpredictability of such an endeavor. The prior art as evidenced by Edwards et al., 2003 (instant PTO-892) teaches there is a substantially huge antibody diversity produced to one single antigen target. Edwards provides evidence that over 1000 antibodies, all different amino acid sequences, were generated towards one single protein antigen target (see abstract). Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Without this guidance or direction the skilled artisan would not consider applicant to be in possession of the claimed genus of antibodies because the skilled artisan recognizes that even seemingly minor changes made without guidance or direction as to the relationship between the particular amino acid sequence of the instantly claimed antibody and its ability to bind antigen, can dramatically affect antigen-antibody binding.
Applicant has not described the claimed invention sufficiently to show they had possession of the claimed genus of an antibody that binds transferrin receptors. Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 69 USPQ2d 1886 (Fed. Cir. 2004).
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
To provide adequate written description and evidence of possession of the claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of one generic, broad genus that encompassed a diverse and huge number of possible antibodies that bind the disclosed target of a transferrin receptor. The specification does not provide a consistent structure for all of the possible antibodies and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
With the exception of specifically disclosed antibodies with specific sequences, the skilled artisan cannot envision the detailed chemical structure of all of the encompassed antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Therefore, claims 1, 4-5, 7,10, 13-14, 20, 23-24, 38-39, 55 and 57 do not meet the written description requirement.
Claim Rejections - 35 USC § 103
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, 4-5, 7, 10, 20, 23, 38-39, 55 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Pardridge US2006/0105982 (instant PTO-892) in view of Dooley et al., US2019/0060483 (instant PTO-892).
Pardridge teaches the delivery of gene medicines via liposomes with blood brain barrier receptor technology to the brain and eye (see [0003]) as in instant claims 1 and 4. Pardridge teaches using receptor-mediated transcytosis (RMT) systems operate to transport circulating peptides across the BBB, such as insulin, transferrin, or insulin-like growth factors wherein these endogenous peptides can act as “transporting peptides,” or “molecular Trojan horses”, to ferry drugs across the BBB (see [0007] and claim 11) as instant claim 1. Pardridge teaches that in transport across both the BBB/BRB and the BCM/OCM. For example, insulin or transferrin receptors are located on both the BBB/BRB and the BCM/OCM (see [0017]). Pardridge teaches immunoliposomes with 3000 strands of PEG2000 attached to the liposome surface and about 1% of the PEG strands are conjugated with the OX26 monoclonal antibody against the transferrin receptor (see [0021], [0024]) and meets the requirements of a transferrin receptor antibody on the surface of a vesicle of instant claim 1, the antibody of claim 5 and the at least 30 copies of the antibody on the liposome of instant claim 20 and two copies of instant claim 7. Pardridge teaches another anti-transferrin receptor antibody, 8D3 (see 0070]). Pardridge teaches combining the liposomes comprising therapeutic genes with any suitable pharmaceutical carrier for intravenous administration (see [0050], [070]) as in instant claim 57. Pardridge teaches that to transport the gene encapsulated in the liposome across different barriers that one may use two different peptides (see [0045]) as in instant claim 7 and 10. Pardridge teaches the use of OX26 and 8D3 antibodies to bind the receptors found in the BBB and are used to carry the liposome across these barriers meets the limitations of claims 4 and 23 since they meet all of the required limitations for the required antibodies and meets the intended result of the claimed product. Pardridge also teaches that while their invention uses liposome, that it may be modified with other nanocontainers that are the best option determined by those skilled in the art (see [0049]). Pardridge does not specifically teach the use of extracellular vesicles or exosomes as required in instant claims 1 and 55.
Dooley teaches the use of exosomes as drug delivery vehicles for therapeutic purposes (see [0003-0004]). Dooley teaches that these exosome have markers on their surface that comprises prostaglandin F2 receptor negative regulator (the PTGFRN protein; see [0007]) as required in instant claims 1, and 38-39. Dooley teaches exosomes and therefore meets the limitations of instant claim 1 and 55. Dooley teaches that the therapeutic peptide is an antibody, which is a target moiety, that can be fused to the PTGFRN (see [0031-32]) as in instant claims 38-39. Dooley teaches using different target proteins (see [0033]) as in instant claims 7 and 10. Dooley teaches that the fusion protein of PTGFRN is present at 2-, 4-, 8-, 16-, 32-, 64-, 100-, 200-, 400-, 800-, 1,000-fold or a higher density on the exosome surface (see [0131]) as in instant claim 20. While Dooley teaches target moiety to deliver their therapy to targets, Dooley fails to specifically teach the required antibody that specifically binds transferrin receptor as in instant claim 1.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Pardridge and Dooley. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because both Pardridge and Dooley teach compositions to provide drug delivers across barriers and specific target regions. Further, Pardridge teaches that one may use other nanocarriers to transport drugs to the targets in the brain that need to cross the blood brain barrier. As in stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an “express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)." Moreover, this section of the MPEP teaches "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Accordingly, the cumulative reference teachings render obvious the claimed method. Therefore, the person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Claims 1, 4-5, 7, 10, 20, 23-24, 38-39, 55 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Pardridge US2006/0105982 (instant PTO-892) and Dooley et al., US2019/0060483 (instant PTO-892) in view of Lewis et al., US2019/0202892 (instant PTO-892).
Neither Pardridge or Dooley teach exosomes comprising an anti-phagocytic signal of CD47 as in instant claim 24.
Lewis teaches engineered exosomes and that that specific truncations of PTGFRN are ideal scaffolds for use in engineering therapeutic exosomes (see [0346]) as required in instant claims 1, 38-39 and 55. Lewis teaches that the exosomes express polypeptides on its surface which can be modified to express more polypeptides and that some of these peptides are used to modify the activity of the exosomes such as increasing and decreasing the half-life in vivo and that these embodiments include CD47 (see [0154]) as in instant claim 24. Lewis does no teach the antibody against the transferrin receptor of claim 1.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Pardridge, Dooley and Lewis. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because all three references, Pardridge, Dooley and Lewis, teach compositions involving liposomes and exosomes to provide drug delivers across barriers and specific target regions. One of ordinary skill in the art would be motivated to add the CD47 peptide to the surface of the claimed exosomes since it would increase the half-life of the drug delivery system. Therefore, the person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
No claims are allowed.
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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