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 .
Election/Restrictions
This action is in response to the papers filed on 02/26/2026. Claims 1-2, 5, 7-11, 15-16, 18, and 21-30 are currently pending as per claims filed on 01/17/2023.
Applicant’s election of Group I, which include claims 1-2, 5, 7-11, 15-16, 18, 21-27 and election of species for Group I, plasma as a single biological material in claim 2, a small molecule as a single biomolecule in claim 22, and kidney disease as a single specific pathology relevant to claim 25 and 26 in the reply filed on 02/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
After further consideration, the requirement for election of species in claim 22 for a specific biomolecule has been withdrawn, as examination of all species together does not represent undue burden.
Claims 28-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter, there being no allowable generic or linking claim.
Claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected species, there being no allowable generic or linking claim.
The requirement for restriction between Groups I-II is still deemed proper and is therefore made FINAL.
Therefore, claims 1-2, 5, 7-11, 15-16, 18, 21-26 are subject to examination to which the following grounds of rejection are applicable.
Priority
The instant application a 371 of PCT/US2021/015488 filed 01/28/2021, which claims priority to PRO 62/966,730 filed 01/28/2020.
Thus, the earliest possible priority for the instant application is 01/28/2020.
Information Disclosure Statement
No IDS has been filed.
Claim Objections
Claim 9 is objected to because of the following informalities: Claim 9 recites, “The process of claim 1, wherein the step of eliminating vesicle content from the biological material is performed by dialysis defiltration, affinity column chromatography, immunoadsorption, centrifugation, ultracentrifugation, cross flow filtration, tangential flow filtration, and ultrafiltration.” However, it appears that the applicants’ intentions was for a single process from this list be selected. The instant specification describes separate embodiments for each of these items recited at Pg. 4 under Depletion. Applicant must amend the claim to clarify the meaning. Appropriate correction is required.
It is recommended to amend claim 9 to a Markush-type claim which recites “selected from the group consisting of .” Appropriate correction 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, 5, 7-11, 15-16, 18, 21-26 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 applicant regards as the invention.
Claim 1 recites “extracorporeal transfusion” in line 7. The term " extracorporeal transfusion " is not defined by the claim, the specification does not provide a definition of the term, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Moreover, a Google® search of this term does not give any hit which demonstrates that this is not commonly used term. As such the metes and bounds of the claim are indefinite.
Claim 1 is indefinite in its recitation of the term “essentially purified”. The term " essentially "in claim 1 is a relative term which renders the claim indefinite. The term " essentially" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate action is required.
Claim 7 which depends on claim 1 recites “the particle size”. There is not proper antecedent bases for the recitation of the particle size” in the claim or parent claim 1.
Claim 16 recites “the sample of therapeutic extracellular vesicles”. There is not proper antecedent bases for “the sample of therapeutic extracellular vesicles” in the claim. Claim 1 recites “a sample of essentially purified therapeutic extracellular vesicles”. Appropriate correction is requested.
Claim 18 depends on canceled claim 17. A claim dependent on a canceled is per se indefinite without any further analysis. See MPEP § 608.01(n) Dependent Claims [R-10.2019] Subsection V. Claim 18 is dependent on a canceled claim (i.e., claim 32) and is therefore “incomplete.” See MPEP § 608.01(n)(V).
Claim 21 recites “the therapeutic extracellular vesicles in the sample”. There is not proper antecedent bases in the claim or claim 1. Claim 1 recites “purified therapeutic extracellular vesicles”.
Claim 18 recites “The process of claim 17, wherein the sample of therapeutic extracellular vesicle is cryopreserved.” Claim 17 is a cancelled claim. Therefore, it is unclear to which claim that claim 18 was meant to depend from. Thus, the metes and bounds of the claim cannot be determined and the claim is rendered indefinite.
Claims 2, 5, 8-11, 15, 22-26 are indefinite insofar as they depend from claim 1.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, 7-9, 16 and 21-22 are rejected under 35 U.S.C. 102 as being unpatentable over Cheng et al. (WO 2018/195393 Al; hereafter “Cheng”). Regarding claim 1, Cheng teaches a process for acellular therapy, including the collection and use of exosomes (Abstract). Cheng teaches obtaining a biological material (Pg. 2, Lines 1-9 and Lines 18-21), providing a sample of essentially purified extracellular vesicles (Pg. 2, Line 2), fusing the extracellular vesicle with the biological material (Pg. 2, Lines 5-7) and transfusing the fused vesicle and biological material (Pg. 4, Lines 3-11; Figure 10; Pg. 27, Lines 3-4). Cheng uses the term infusion, which is considered an equivalent terminology to trans fusion. The transfusion is inherently extracorporeal as described in Pg. 4, Lines 3-11.
Regarding Claim 2, Cheng teaches plasma (elected species) as a biological source (Pg. 13, Line 20).
Regarding Claim 5, Cheng teaches the extracellular vesicles may consist of those from several groups, including platelet membrane derived vesicle, or its fragments, and exosomes (Pg. 2, Lines 2-10)
Regarding Claims 7-8, the particles sizes of the vesicles taught by Cheng can be between 100 and 1000, which anticipates the ranges recited in the instant claims (Pg. 12, Line 36).
Regarding Claim 9, Cheng teaches samples containing exosomes can be purified using centrifugation, ultracentrifugation, filtration or ultrafiltration (Pg. 13, Lines 34-35).
Regarding Claim 16, Claim 16 recites “The process of claim 1, wherein the sample of therapeutic extracellular vesicles is prepared immediately prior to the transfusion step, or in advance of the transfusion step. The teachings of Cheng that anticipate claim 1 as discussed above would necessarily require the sample the be prepared “in advance of the transfusion step”. Therefore, Cheng inherently would anticipate claim 16.
Regarding Claim 21-22, Cheng teaches the that the exosomes of their invention “may contain, or have present in their membrane, nucleic acid, protein, or other biomolecules and may serve as carriers of this cargo between diverse locations in a body or biological (Pg. 13, Line 11-15). The term "exosomes" as used herein advantageously refers to extracellular vesicles that can have therapeutic properties…” (Pg. 13, Lines 11-15).
Thus, by teaching all the claimed limitations, Cheng anticipates claims 1-2, 5, 7-9, 16 and 21-
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.
Claims 10-11, 15, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (WO 2018/195393 Al; hereafter “Cheng”) as applied to claim 1 above and in view of Briggs et al. (US 2004/0127841 Al; hereafter “Briggs”)
Regarding claim 1, Cheng teaches a process for acellular therapy, including the collection and use of exosomes (Abstract). Cheng teaches obtaining a biological material (Pg. 2, Lines 1-9 and Lines 18-21), providing a sample of essentially purified extracellular vesicles (Pg. 2, Line 2), fusing the extracellular vesicle with the biological material (Pg. 2, Lines 5-7) and transfusing the fused vesicle and biological material (Pg. 4, Lines 3-11; Figure 10; Pg. 27, Lines 3-4). Cheng uses the term infusion, which is considered an equivalent terminology to trans fusion. The transfusion is inherently extracorporeal as described in Pg. 4, Lines 3-11.
.
Regarding Claims 10-11, 15, and 23, Cheng does not expressly teach transfusion using a recipient adjusted extracorporeal device as recited in claim 10 or a specific species of the device as recited in instant claim 11. Cheng does not teach the use of a closed-loop system as recited in instant claim 15 or storage of the vesicles to be administered prior to the transfusion as recited in instant claim 23.
Briggs cures the deficiencies of Cheng as Briggs teaches an extracorporeal blood-component collection and treatment system in which whole blood is withdrawn from a source and pumped into a separator. Plasma and or/blood cells are collected and processed extracorporeally prior to returning the processed biological component to the patient (Abstract). Briggs also teaches apheresis systems used with respect to their invention (Pg. 1, Paragraph [0004]). The method taught by Briggs may be performed in a closed-loop process (Pg. 2, Paragraph [0014]). Briggs expressly teaches storage arrangements of the patients biological material prior to administration ( Pg. 2, Paragraph [0014]; Pg. 6, Paragraph [0113]; Claims 7 and 17). It would have been prima facie obvious to a person of ordinary skill in the art at the time of the instant application to have combined the teachings of Cheng who demonstrates collection and engineering of biological material, such as extracellular vesicles for therapeutic usage with the teachings of Briggs which demonstrates the use of multiple systems for collection and administration of biological products such as apheresis type/closed loop systems. These systems have been well document for therapeutic usage and would predictably allow for controlled extracorporeal handing and return of Cheng’s therapeutic biological material.
There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the same field to give predictable results.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (WO 2018/195393 Al; hereafter “Cheng”) in view of Briggs et al. (US 2004/0127841 Al; hereafter “Briggs”) as applied to claim 1 and 23 above and in view of Kusuma et al. (Kusuma GD et al., 2018; hereafter “Kusuma”).
Regarding claims 1 and 3, the combined teachings of Cheng et al. Briggs et al. (US 2004/0127841 Al; hereafter “Briggs”) render obvious claimed method, as iterated above in the 103 rejection the content of which is incorporated herein, in its entirety.
Regarding Claim 24, Cheng et al. Cheng et al. Briggs do not expressly teach the cryopreservation of extracellular vesicles.
However, Kusuma teaches that enhancing long term stability of EVs intended for clinical use was well known in the art prior to the instant application (Introduction) and that “…the commercial and clinical applications of EVs require standard criteria for long-term storage.” (Pg. 5, Section: Conventional Methods for EVs Preservation). Kusuma also teaches strategies related to EV cryopreservation (Pg. 5, Section: Cryopreservation).
It would have been prima facie obvious to a person of ordinary skill in the art at the time of the instant application to have modified the teachings of Cheng and Briggs demonstrating collection and engineering of biological material, such as extracellular vesicles for targeted therapeutic usage and storage of the patients biological material prior to administration by further to incorporate a method of cryopreserving these therapeutics for their clinical use as taught by Kusuma. One would be motivated to include a cryopreservation step as Kusuma demonstrates the importance (deeming it a required criteria) of having therapeutic EVs cryopreserved for clinical use.
There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the prior art to give predictable results.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al. (WO 2018/195393 Al; hereafter “Cheng”) as applied to claim 1 above and in view of Aghajani et al. (Aghajani Nargesi A et al., Stem Cell Res Ther., 2017; hereafter “Aghajani”).
Regarding claim 1, Cheng et al. anticipates the claimed method, as iterated above in the 102 rejection the content of which is incorporated herein, in its entirety.
Regarding Claims 25-26, Cheng et al. does not teach the subject in need of their invention is afflicted with kidney disease or end stage renal disease.
Aghajani cures the deficiencies of Cheng as Aghajani teaches extracellular vesicles as potential therapeutics for kidney disease have been studied in the art prior to the filing of the instant application (Pg. 6, Table 3; Pg. 6, Section: MSC-derived EVs in experimental CKD), specifically consider ESRD when discussing the renal repair capabilities of EVs (Discussion).
It would have been prima facie obvious to a person of ordinary skill in the art at the time of the instant application to have modified the teachings of Cheng who demonstrates collection and engineering of biological material, such as extracellular vesicles for targeted therapeutic usage by further incorporating the teachings of Aghajani which demonstrates the potential capacity of EVs as a therapy for renal disease, including end stage renal disease, and arrive at a method allowing for use of engineered EVs to combat renal pathologies.
There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the prior art to give predictable results.
Conclusion
Claims 1-2, 5, 7-11, 15-16, 18, 21-26 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KODYE LEE ABBOTT whose telephone number is (703)756-1111. The examiner can normally be reached M-F 8-5.
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/KODYE LEE ABBOTT/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634