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 .
Claim Status
In the reply on 20 April 2026, Applicant didn’t file amendment claims. Therefore, to expedite the compact prosecution, the Examiner is pursuing the claims filed 10 November 2023, in which applicant amended claims 1-22. Therefore, claims 1-22 are pending in the application.
Election/Restrictions
Applicant’s election of Group 1, Claims 1-17, drawn to a composition comprising an extracellular vesicle of a regenerative cell population in the reply filed on 20 April 2026 is acknowledged.
Claims 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement with an election that mailed on February 19, 2026. Therefore, the election response filed on 20 April 2026 will be treated without traverse (MPEP § 818.01(a)).
Therefore, claims 1-17 are under current examination.
Priority
This application was filed 11/10/2023 and is a 371 application of PCT/JP2022/ 020222 filed on 05/13/2022, which claims benefit to the foreign application JP2021-081426 filed on 05/13/2021.
Filing of a certified untranslated copy of the JP2021-081426, filed 11/10/2023 is acknowledged. MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 05/13/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/10/2023 and 05/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Abstract Objection
The abstract of the disclosure filed 11/10/2023 is objected to because the abstract is only 33 words in length. Therefore, submitted abstract is considered non-compliant.
Applicant is reminded of the proper language and format for an abstract of the disclosure. MPEP § 608.01(b)(I)(C) states that “the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.”
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Therefore, appropriate correction is required.
Title Objection
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. See MPEP 606.01
The following title is suggested:
“Cell-derived extracellular vesicle comprising microRNA composition and use thereof.”
Claim Rejections - 35 USC § 112(a)
(Written description)
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 1-11 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 contains subject matter that 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 pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the 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. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
REQUIREMENTS TO ESTABLISH ACTUAL REDUCTION TO PRACTICE
"In an interference proceeding, a party seeking to establish an actual reduction to practice must satisfy a two-prong test: (1) the party constructed an embodiment or performed a process that met every element of the interference count, and (2) the embodiment or process operated for its intended purpose." Eaton v. Evans, 204 F.3d 1094, 1097, 53 USPQ2d 1696, 1698 (Fed. Cir. 2000).
The same evidence sufficient for a constructive reduction to practice may be insufficient to establish an actual reduction to practice, which requires a showing of the invention in a physical or tangible form that shows every element of the count. Wetmore v. Quick, 536 F.2d 937, 942, 190 USPQ 223, 227 (CCPA 1976). For an actual reduction to practice, the invention must have been sufficiently tested to demonstrate that it will work for its intended purpose, but it need not be in a commercially satisfactory stage of development. See, e.g., Scott v. Finney, 34 F.3d 1058, 1062, 32 USPQ2d 1115, 1118-19 (Fed. Cir. 1994) (citing numerous cases wherein the character of the testing necessary to support an actual reduction to practice varied with the complexity of the invention and the problem it solved). If a device is so simple, and its purpose and efficacy so obvious, construction alone is sufficient to demonstrate workability. King Instrument Corp. v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402, 407 (Fed. Cir. 1985).
For additional cases pertaining to the requirements necessary to establish actual reduction to practice see DSL Dynamic Sciences, Ltd. v. Union Switch & Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152, 1155 (Fed. Cir. 1991) ("events occurring after an alleged actual reduction to practice can call into question whether reduction to practice has in fact occurred"); Fitzgerald v. Arbib, 268 F.2d 763, 765-66, 122 USPQ 530, 531-32 (CCPA 1959) ("the reduction to practice of a three-dimensional design invention requires the production of an article embodying that design" in "other than a mere drawing"); Birmingham v. Randall, 171 F.2d 957, 80 USPQ 371, 372 (CCPA 1948) (To establish an actual reduction to practice of an invention directed to a method of making a product, it is not enough to show that the method was performed. "[S]uch an invention is not reduced to practice until it is established that the product made by the process is satisfactory, and [ ] this may require successful testing of the product."). See MPEP 2138.05.
Claim 1 encompasses a genus of the any regenerative cell population, any biological sample derived and any culture in an extracellular vesicle composition. The specification discloses that the regenerative cell population includes the cells having a regenerative function capable of inducing from the mononuclear cells. Examples of the cells having a regenerative function include endothelial progenitor cells and anti-inflammatory macrophages, and may include Th2 cells and regulatory T cells (Treg) [0039]. Also, SPEC discloses that a regenerative cell population including EPC colony cells can be induced by culturing the peripheral blood mononuclear cells or the umbilical cord blood mononuclear cells with various factors. [0143], [0152]. Separately, SEPC discloses the biological sample may be a biological sample collected from a subject to be administered, treated, or medically cared with the extracellular vesicle and/or composition of the present invention (hereinafter, collectively referred to as "subject to be administered"), or may be a biological sample collected from a subject other than the subject to be administered [0047-0048]. Regarding the culture SPEC disclose it is composed, for example, of the regenerative cell population and a medium (conditioned medium) thereof. Thus, when the extracellular vesicles are isolated from the culture, the extracellular vesicles may be isolated or extracted from the regenerative cell population or the conditioned medium, or may be separated from both of the regenerative cell population and the conditioned medium [0071]. Therefore, When the conditioned medium is used, the method for isolating or extracting the extracellular vesicles can be performed, for example, by a method using centrifugation, an affinity purification method using a membrane protein derived from a regenerative cell population present in a membrane of the extracellular vesicles or the membrane protein, or filtration using a porous membrane such as a filter. The extracellular vesicle may be isolated or extracted by using a commercially available kit, and as a specific example, qEv isolation kit (manufactured by Izon Science Limited) can be used [0071]. However, specification does not disclose that the any regenerative cell population, any biological sample derived and any culture can prepare an extracellular vesicle composition as claimed in instant claim 1. Therefore, the specification fails to identify the any regenerative cell population, any biological sample derived and any culture, accordingly, the specification doesn't have adequate support in the disclosure for the any regenerative cell population, any biological sample derived and any culture.
Furthermore, the specification discloses that the anti-inflammatory macrophage is a type of macrophage that secretes anti-inflammatory cytokines (IL-10, IL-4) and the like, and is a cell that contributes to angiogenesis or repairing. The anti-inflammatory macrophage can be identified, for example, using cell surface markers such as CD206, CD163, CD169, and the like [0042]. In addition, when anti-inflammatory macrophages are induced from the mononuclear cells, the inducing method can be performed by culturing the mononuclear cells in the presence 15 of IL-10, IL-4, M-CSF and/or G-CSF, for example [0050]. However, the specification does not show any embodiments that meet all the limitations of the claim reduced to practice (e.g., any regenerative cell population, any biological sample derived and any culture can prepare an extracellular vesicle composition). Therefore, an actual reduction to practice of an invention directed to a composition is not established at the time of filling. The successful testing of the method of the current invention is not shows reduced to practice, therefore, it is not established that the product made by the process is satisfactory. See MPEP 2163(I)-(II) and 2163.02.
The genus of regenerative cell population is very large, including many cellular and gene therapy product (FDA approved and otherwise), as well as any biological sample such as tissue engineering, progenitor cells show promising results in treatment of patients with severe heart disease with hematopoietic stem cell transplantation, therefore, large group of cells will be recognized as biological sample. For example, stem cell therapy is potentially applicable to all subspecialties of Medicine are known in the art as per O’Brien et al. (Mayo Clin Proc. 2009 Oct;84(10):859–861; cited in PTO892). Tissue engineering, a combination of cells, a scaffold, and biologically active molecules are used to reconstruct or regenerate damaged tissues or whole organs as known in the Petrosyan et al. (Front Bioeng Biotechnol. 2022 Nov 25; 10:942750; cited in PTO892). EV are involved in restoring tissue and organ damage, and may partially explain the paracrine effects observed in stem cell-based therapeutic approaches can be found in several review articles, including: Jong et al. (De Jong et al; Extracellular vesicles: potential roles in regenerative medicine. Frontiers in immunology, 5, p.608, 201; cited in PTO892). Therefore, prior arts do not support merely any regenerative cell population, any biological sample derived and any culture can prepare an extracellular vesicle composition. Rather, arts disclose several stem cells, scaffold and biological molecule is involved in extracellular vesicle composition for therapeutic application. Accordingly, arts do not identify or support the use of any regenerative cell population, any biological sample derived and any culture to prepare an extracellular vesicle composition as claimed. Furthermore, an actual reduction to practice of instant invention directed to a method is not established at the time of filling and POSITA cannot predictably identify composition an extracellular vesicle of any regenerative cell population induced from any biological sample-derived mononuclear cell or any culture thereof associated with treating ischemic heart disease that exercise in this invention.
The Examiner concludes that the disclosure any regenerative cell population, any biological sample derived and any culture does not constitute a “representative number of species” to show possession of the broad genus presently claimed. Accordingly, the claimed genus any regenerative cell population, any biological sample derived and any culture is involved into extracellular vesicle composition doesn't have an adequate written description. Specifically, doesn't have an adequate written description on actual reduction to practice of instant invention directed to a product is not established at the time of filling. The successful testing of the product of the current invention is not shows reduced to practice, therefore, it is not established that the method steps are satisfactory. Therefore, the Applicant did not sufficiently possess the broader invention as claimed in claim 1 and dependent claims 2-11.
Claim Rejections - 35 USC § 102
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.
Claim 1-7, 10-12, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (CN111249293A, cited in IDS filed 11/10/2023; attached the STIC machine English translation; hereinafter “Wu”).
Regarding claims 1-7, 10, and 12 Wu discloses human endothelial progenitor cell-released exosomes (EPC-Exos, (i.e., regenerative cell population)) derived from mononuclear cell or culture thereof [0079]. EPC-Exos cell population are used as an angiogenesis-promoting drug (claim 7), that EPC-Exos produce miR-126-3p and miR-210 ([0108], claim 8), that CD63 and CD9 are expressed (Figure 4, [0094-0095], table 1), therefore, POSITA could anticipate that the regenerative cell population is induced without sorting CD34 positive cells and/or CD133 positive cells. Wu further discloses that the diameter of EPC-Exos is 88.7-123.5 nm ([0100]), wherein the EPC-Exos have a HUVEC growth promoting effect (paragraphs [0120]-[0121]) and have an angiogenesis-promoting effect and an effect of promoting blood transport to wounds ([0122], [0128], [0132]), that exosomes are used for ischemic heart disease or for a foot angiogenesis disorder or for a lack of blood supply in diabetes ([0007] and [0010]).
Regarding claim 11, Wu teaches that the regenerative cell population is induced by culturing the mononuclear cells in the presence of vascular endothelial cell growth factor [0078].
Regarding claims 16-17, Wu teaches that the biological sample is bone marrow and peripheral blood ([0005]-[0006])
Accordingly, Wu anticipates the instant claims 1-7, 10-12, and 16-17.
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 of this title, 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 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 1-7, 8-9, 10-12, 13-15 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (CN111249293A, cited in IDS filed 11/10/2023; hereinafter “Wu”, in view of Salybekov et al. (PLOS ONE. 13 (11), e0203244; cited in IDS filed 11/10/2023; hereinafter “Salybekov”) and Fan et al. (WO2019168977A1; published on 06 Sept. 2019; cited in PTO892; hereinafter “Fan”), and evidentiary reference Hur, et al. (Arteriosclerosis, thrombosis, and vascular biology, 24(2), pp.288-293; 2004; cited in PTO892; hereinafter “Hur”).
As stated above, Wu discloses human endothelial progenitor cell-released exosomes (EPC-Exos, (i.e., regenerative cell population)) derived from mononuclear cell or culture thereof [0078].
Although with respect to claim 8, Wu indicates that endothelial progenitor cells (EPCs) have an effect of promoting angiogenesis, that the number of EPCs in the human body is limited and the needs in clinical therapeutics are not met (claim 7, [0007] of Wu), that, to achieve an even better effect of EPCs, it is important to promote the release of exosomes produced by the EPCs ([0009]), and that exosomes produced by EPCs are used for angiogenesis therapy (claim 7), however, Wu is silent to fibrosis suppressing activity. Still, such was known in the prior art.
Regarding claims 8-9, and 13-15, Salybekov describes having cultured peripheral blood mononuclear cells in a quality and quantity (QQ) control culture medium including SCF, VEGF, TPO, IL-6, and Flt-3 to obtain a cell population (quality and quantity control culture of blood mononuclear cells (QQMNCs)) (abstract, page 3, "PBMNC isolation and QQ culture") and indicates that QQMNCs are a regenerative cell population (“regeneration-associated cell” (RAC)) including EPCs and anti-inflammatory M2 macrophages (Fig. 1, page 7, lines 20-25 of Salybekov), and have an effect of enhancing vasculogenesis, anti-inflammatory properties, and cardiomyogenesis, and inhibiting fibrogenesis (p. 15, lines 6-9, Fig. 9 of Salybekov). Therefore, QQMNC transplantation promoted vasculogenesis, angiogenesis, and arteriogenesis via accelerating EPC maturation on infarcted tissues (p. 10 3rd ¶). Accordingly, at the time of the invention POSITA would have obvious expectation that the EPC-Exos and anti-inflammatory M2 macrophages will reduce the transplant rejection, and this limitations are not unexpected.
Further, Fan indicates that an administration of endothelial progenitor cells (EPCs) exhibited a beneficial effect on vascular injury, organ dysfunction, and mortality in a preclinical model of sepsis ([0006]), that EPCs modulate endothelial health through the release of exosomes (paragraph [0006]), and that exosomes are used for the therapy of sepsis (claim 1, paragraph [0008]).
Wu and Fan describe using exosomes released by endothelial progenitor cells in order to obtain a therapeutic effect of endothelial progenitor cells, and it can be said that a person skilled in the art having been exposed to the indications of Wu and Fan could predict that it is possible to use exosomes released by QQMNCs for the enhancement of vasculogenesis, anti-inflammatory properties, and cardiomyogenesis, and for the inhibition of fibrogenesis, which are the effects of the QQMNCs described by Salybekov. This being the case, it can be said that it would have been routine work for a person skilled in the art to obtain exosomes from the QQMNCs in the invention described by Salybekov and use same for the enhancement of vasculogenesis, anti-inflammatory properties, and cardiomyogenesis, and for the inhibition of fibrogenesis. Therefore, at the time of the invention POSITA would have obvious expectation that the EPC-Exos and anti-inflammatory M2 macrophages will reduce the transplant rejection, and this limitations are not unexpected (Fig. 8 of Salybekov).
Accordingly, it would have been obvious to practice the EPC-Exos of Wu and include the cell population including EPCs and anti-inflammatory M2 macrophages with a reasonable expectation of success as taught by Salybekov. One of ordinary skill would have been motivated to do so as taught by Salybekov because this will enhance vasculogenesis, anti-inflammatory properties, and cardiomyogenesis, and inhibiting fibrogenesis (p. 15, lines 6-9, Fig. 9 of Salybekov).
The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969). The invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made as evidenced by the teachings of Wu et al. and in view of Fan especially in the absence of unexpected results.
Regarding claim 14, Wu teaches the cultivation of EPCs using 10 ml of umbilical cord blood from full-term newborns was collected, and mononuclear cells were obtained by density gradient centrifugation. The mononuclear cells were plated on a culture plate coated with human fibronectin and cultured for 4 days in M199 medium [0079]. Although Wu does not indicate the endothelial progenitor cell differentiated EPC colony-forming cell, however Hur teaches that Endothelial progenitor cells (EPC) are differentiated from mononuclear cells and form cluster or colony. MPEP 2112.01 states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established,” In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). it is noted that the claimed wherein clauses do not recite any additional active method steps, but simply state a function, characterization or measurement of the results of product positively recited (e.g., colony-forming cell). In here, Hur et al. suggest EPC are differentiated from mononuclear cells and form cluster or colony, so the process of making colony-forming cell would have been obvious. Accordingly, at the time of the invention POSITA would have obvious expectation that the endothelial progenitor cell is a differentiated EPC colony-forming cell, and this limitations are not unexpected.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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