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 .
Status of the Claims
Claims 1-4, 6, 10, 20, 22, 29-30, 38, 46, 48-49, 59, 64-65, 68-69, and 72 are pending (claim set as filed on 01/16/2025).
Priority
This application is a 371 of PCT/US2022/075809, which has a provisional application no.: 63/240,637 filed on 09/03/2021.
Drawings
The drawings filed on 02/29/2024 have been accepted.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 02/29/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Interpretation
Regarding the recitation of “optionally”, the MPEP 2111.04 states that “a claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”.
Regarding the recitation of “wherein the method results in”, the MPEP 2111.04 further states that “examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are: (a) “adapted to” or “adapted for” clauses; (b) “wherein” clauses; and (c) “whereby” clauses. Thus, a “wherein” or “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.
Claim Rejections - 35 USC §112, Indefinite
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.
Claims 64-65 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 64-65 recites, in part, “The method of claim 1, wherein the proteinuria” and therefore, is rejected for lacking antecedent support because the proteinuria was not previously introduced in its base claim.
Claim Rejections - 35 USC §103, Obviousness
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claims 1-4, 6, 10, 20, 22, 29-30, 38, 46, 48-49, 59, 64-65, 68-69, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 2015/0017130 A1) in view of Wei (Mononuclear phagocyte system blockade using extracellular vesicles modified with CD47 on membrane surface for myocardial infarction reperfusion injury treatment, 2021) - both references cited by the ISA and in the IDS filed on 02/29/2024.
Yang’s general disclosure relates to methods and compositions for modulating immune responses, and more particularly to methods and compositions the inhibit graft rejection (see ¶ [0002]).
Yang teaches “methods of supplying a graft. The methods include providing a donor
graft, e.g., a kidney, liver, heart, thymus, hematopoietic stem cell, or pancreatic islet cell, wherein said graft expresses a heterologous immune-inhibitory molecule (e.g., CD47 polypeptide) or over express an endogenous immune-inhibitory molecule (e.g., CD47 polypeptide); and implanting said graft in a recipient; thereby supplying a graft. In various
embodiments, the methods reduce hematopoietic-cell-mediated rejection of the graft and/or prolongs acceptance of the graft” and “the donor and recipient are of different species, e.g., the donor is a non-human animal, e.g., a miniature swine, and the recipient is a human. In some
embodiments, the miniature swine graft expresses a human CD47, e.g., under the control of a heterologous promoter, and/or a constitutive promoter” (see ¶ [0024]-[0026], [0099]-[0100], [0120]-[0121]).
Yang teaches transgenic non-human mammals (e.g., rodents, non-human primates, swine, or cows) whose genomes comprise a nucleotide sequence encoding a human immune-inhibitory molecule (e.g., a human CD47 polypeptide); - useful promoter sequences for directing expression include: promoter sequences naturally associated with the recombinant gene (e.g., the recombinant human CD47 sequence) (see ¶ [0035], [0061]).
Yang teaches "Graft", as used herein, refers to a body part, organ, tissue, or cells. Grafts may consist of organs such as liver, kidney, heart or lung; body parts such as bone (see ¶ [0015], [0019], [0063]-[0064], [0121], [0130]). Yang teaches injecting bone marrow cells (see ¶ [0125], [0132]).
However, Yang does not teach: cross-dressing the organ with human CD47 (claim 1(b)); wherein the cross-dressing step comprises exposing the organ to human CD47 comprising extracellular vesicles (EVs) (as seen in the dependent claims).
Wei discloses “CD47 is a transmembrane protein that enables cancer cells to evade clearance by macrophages through CD47- signal regulatory proteinα binding, which initiates a “don’t eat me” signal. This study aimed to explore the biodistribution and delivery efficiency of EVs carrying the membrane protein CD47 and specific anti-apoptotic miRNAs. EVs were isolated from MSCs overexpressing CD47 (CD47- EVs) and identified” (see abstract). Wei further teaches “To study whether CD47-EVs biologically initiate the “don’t eat me” signal that inhibits phagocytosis by macrophages and promotes biodistribution, we designed a transwell system by co-culturing H9c2 cells and RAW264.7 with PKH67 in vitro (Fig. 3A). Eight hours after the competitive uptake of EVs, CD47-EVs were mostly within H9c2 cells, whereas the proteinase-treated CD47-EV lost this advantage, suggesting that CD47-EVs may give full play in vivo (Fig. 3B)” (see pages 2-3: Materials and Methods). Wei discloses where EVs may be from human cells (see page 4).
It would have been obvious to one of ordinary skill in the art to modify the method, as disclosed by Yang to include or instead consider delivery of CD47 via extracellular vesicles to the organ, such that the cells of the organ uptake the CD47 EVs, since this would allow an alternative method of expression of CD47 on the surface of cells, tissues, or organs for transplantation, avoiding the need to create transgenic donor swine and affording any potential improved CD47 expression by, for instance, repeated or high-concentration delivery of EVs to the cells, such as during ex vivo exposure/perfusion.
Conclusion
No claims were allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (ET).
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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