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 amendments and arguments of September 16, 2025.
Claims 8 and 4 have been amended.
Claims 1-3, 5-7, and 9-20 have been canceled.
Drawings
The objections to drawings:
Fig. 5 Part A
Fig. 5 Part B
Fig. 6
under 37 CFR 1.83(a) are withdrawn.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
In light of the amendments, the double patent warning that if claim 1 be found allowable, Claims 7, 8, 9, and 10 will be objected to under 35 CFR 1.75 as being substantial duplicate thereof are withdrawn. Specifically, the canceling of claims 1, 7, 9, and 10 remove the issue of substantial duplication that was previously objected to.
In light of the amendments, the double patent warning that if claim 1 be found allowable, Claim 12 will be objected to under 35 CFR 1.75 as being substantial duplicate thereof are withdrawn. Specifically, the canceling of claim 12 remove the issue of substantial duplication that was previously objected to.
In light of the amendments, the double patent warning that if claim 2 be found allowable, Claims 13 and 17 will be objected to under 35 CFR 1.75 as being substantial duplicate thereof are withdrawn. Specifically, the canceling of claims 2, 13, and 17 remove the issue of substantial duplication that was previously objected to.
In light of the amendments, the double patent warning that if claim 3 be found allowable, Claims 14 and 18 will be objected to under 35 CFR 1.75 as being substantial duplicate thereof are withdrawn. Specifically, the canceling of claims 3, 14, and 18 remove the issue of substantial duplication that was previously objected to.
In light of the amendments, the double patent warning that if claim 4 be found allowable, Claim 15 will be objected to under 35 CFR 1.75 as being substantial duplicate thereof are withdrawn. Specifically, the canceling of claim 15 remove the issue of substantial duplication that was previously objected to.
In light of the amendments, the double patent warning that if claim 5 be found allowable, Claims 16, 19, and 20 will be objected to under 35 CFR 1.75 as being substantial duplicate thereof are withdrawn. Specifically, the canceling of claims 5, 16, 19, and 20 remove the issue of substantial duplication that was previously objected to.
In light of the amendments, the double patent warning that if claim 6 be found allowable, Claims 7 and 9 will be objected to under 35 CFR 1.75 as being substantial duplicate thereof are withdrawn. Specifically, the canceling of claims 6, 7, and 9 remove the issue of substantial duplication that was previously objected to.
Claim Rejections - 35 USC § 112
In light of the canceling of claim 10, the rejection to claim 10 under 35 U.S.C. §112(a) or 35 U.S.C. 112(pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention is withdrawn.
Claim Rejections - 35 USC § 112
In light of the canceling of claims and amending Claim 8, the rejection to claims 1, 6, 7, 8, 10, 11, and 15, and Claims 6, 7, 9, 10, 11, 13, 14, 15, and 16, and Claims 9, 10, and 11 as being 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 are withdrawn.
Claim Rejections – 35 USC §112
In light of the canceling of Claim 3 and amendment to Claim 8, the rejections to Claims 3 and 8 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 are withdrawn.
Claim Rejections – 35 USC §112
In light of the canceling of Claim 5, the rejection to Claim 5 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn.
Claim Rejections - 35 USC § 103
In light of the amendments, Claims 1-7, 9, 10, and 12 being rejected under 35 U.S.C. §103 as being anticipated over Rani et al.[Mesenchymal stem cell-derived extracellular vesicles toward cell free therapeutic applications, Molecular Therapy, 2015], in view of European Pharmaceutical Review (Hereinafter Pharma) [Excipient selection in biologics and vaccine formulations development, 2014], in view of Yamada et al. [Extracellular vesicles containing microRNA 92a-3p facilitate partial endothelial- mesenchymal transition and angiogenesis in endothelial cells, Int. J. Mol Sci., 2019], in view of Drury et al. [The clinical application of microRNA in infectious disease, Front Immunol, 2017], in view of Tahamtan et al. [Anti-inflammatory mircoRNA and their potential for inflammatory disease treatment, Front Immunol, 2018] are withdrawn.
Claim Objections
Claim 8 is newly objected to for the following reasons:
Claim 8 recites “placenta and placental mesenchymal stem cell…” should read as “placenta and placental mesenchymal stem cells…”.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification does not include any disclosure of “cellular vesicles”, including their type, method of isolation, or use. Therefore, “cellular vesicles” as recited in Claim 8 is not supported by the specification.
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 8 and 4 are newly rejected under 35 U.S.C. §101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a physical phenomenon without significantly more. The claim(s) recite(s) “an anti-corona-19 virus composition comprising…extracellular vesicles derived from placenta and placental mesenchymal stem cell; and miRNA contained in the cellular vesicles…of the placental mesenchymal stem cell…”. This judicial exception is not integrated into a practical application because there is no transformation of the realization. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than a judicial exception because the additional elements are simply to make the naturally occurring EV/miRNA composition pharmaceutically usable. However, adding an excipient is well-understood and conventional.
Step 1: Step 1 of the eligibility analysis asks: is the claim to a process, machine, manufacture, or composition of matter? (I.e., a statutory category). Yes. The claim is directed to a composition of matter.
Step 2A: Prong 1: Are the claims directed to a Judicial Exception? Yes, claim 8 recites an extracellular vesicle that is derived from placental tissue and/or placental mesenchymal stem cells. Claim 4 further specifies miRNAs as endogenous human species, including has-miR-92a--3p, hsa-miR-5p, has-miR-424-3p, as well as others. Extracellular vesicles and miRNAs are naturally occurring biological materials and constitute products of nature.
Step 2A: Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the additional limitation recited is a carrier, excipient, or diluent as stated in Claim 8. This does not integrate the natural products into a practical application. These formulation components are well-understood, routine, and conventional. Furthermore, these components do not impart any transformation or markedly different characteristics to the naturally occurring extracellular vesicles. Likewise, Claim 4 is further limiting claim 8 to specific human miRNAs and do not meaningfully alter the naturally occurring nature of the subject matter. Therefore, the claims do not integrate the exception into a practical application.
Step 2B: Does the claim amount to significantly more than the recited judicial exception? No, Claim 8 is directed to a standard formulation that is well known in the pharmaceutical arts. Additionally, the further limitations recited in Claim 4 are also directed to naturally occurring human miRNA, e.g. hsa-miR-92a-3p. Given this, the Claims 8 and 4 do not recite elements or a combination of elements to transform the claimed invention to significantly more than the judicial exception itself, i.e. extracellular vesicles derived from placental tissue and/or placenta derived mesenchymal stem cells, or human derived microRNAs.
Conclusion: For these reasons, Claims 8 and 4 are directed to a judicial exception without reciting significantly more, therefore, lacking transformation of the judicial exception, the claims are properly rejected for being directed to a judicial exception.
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.
Claim 8 is 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.
Claim 8 uses the generic term “cellular vesicles” as it relates to a composition where miRNA is derived from cellular vesicles to be used in a composition for an anti-SARS-CoV2 composition. The same generic scope of “cellular vesicles” is present in each of the dependent claims, i.e. Claim 4.
The specification provides no antecedent basis for “cellular vesicles”.
Applicant’s specification is silent with respect to miRNAs contained in “cellular vesicles found in placental mesenchymal stem cells. However, the specification does state that various biomolecules, including extracellular vesicles derived from placenta, umbilical cord and/or cord blood, and mesenchymal stem cells derived from the placenta contain miRNA and other cargo that is contained in the extracellular vesicles [pg. 1 ln. 14]. On line 16 of page 4, the specification states the miRNA is contained in the extracellular vesicles. The specification further states there are 77 different miRNAs contained in tissue derived extracellular vesicles [pg. 6 ln. 2]. The specification goes onto to restate this information throughout the specification. However, “cellular vesicles” also include intracellular compartments such as endosomes and lysosomes [a. Carriers of Extracellular miRNAs ¶ 1, Boon & Vickers, Intercellular Transport of MicroRNAs, Arterioscler Thromb Vasc Biol., 2013]. These vesicles are involved in the sorting and degradation of cellular materials. While miRNAs can be present within these compartments, their presence is often transient and is associated with the processes of miRNA processing and turnover within a cell [Selective miRNA Export ¶ 1]. On the other hand, extracellular vesicles do encapsulate miRNA, protecting them from degradation and facilitating the delivery to recipient cells. Based on this, a person of ordinary skill would not recognize isolating miRNAs from intracellular vesicles as a practical approach without additional guidance.
Given the generic use of “cellular vesicles” as it relates to miRNAs being derived from cellular vesicles for inclusion into an anti-SARS-CoV2 composition, and the absence of teachings as to how miRNA could be derived from intracellular vesicles that include both endosomes and lysosomes, an Artisan would not understand Applicant to be in possession of the generic scope of “proteins of interest”.
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.
Claim 8 is newly 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.
Claim 8 recites the limitation "the cellular vesicles" in Line 7. There is insufficient antecedent basis for this limitation in the claim. In line 5, the claim recites “extracellular vesicles” whereas in line 7 the claim limitation is directed towards “cellular vesicles”. Because of this, “the” as an antecedent article is incorrect.
Claim 8 recites “extracellular vesicles” in line 5 and “cellular vesicles” in line 7. It is unclear whether “cellular vesicles” is in reference to “extracellular vesicles” or is meant to introduce a new vesicular structure that includes vesicles not secreted such as endosomes, golgi-derived transport vesicles, etc. As written, the terminology is inconsistent given the distinct classes of vesicles that make up the two types of vesicles.
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.
Claims 8 and 4 are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Yaghoubi et al. [Human umbilical cord mesenchymal stem cells derived-exosomes in disease treatment, Life Sciences, 2019].
For claim 8, Yaghoubi et al. teaches an anit-corona-19 virus (NMC-nCoV2) or SARS-CoV-2 virus composition comprising: (i) one or more selected from the group consisting of: extracellular vesicles (EV) derived from the placenta and placental mesenchymal stem cells (pMSC) [Abstract]; and miRNA contained in the cellular vesicles (EV) of the placental mesenchymal stem cells (pMSC) [2.1 Exosome composition ¶ 1]; and (ii) at least one carrier, excipient or diluent [Abstract].
For claim 4, Yaghoubi et al. teaches the composition according to claim 8, wherein the miRNA is one or more selected from the group consisting of hsa-miR-92a-3p, hsa-miR-92b-3p, hsa-miR-181a-5p, hsa-miR-26a-5p, hsa-miR-34a-5p, hsa-miR-23a-3p, hsa-miR-125b-5p, hsa-miR-125a-5p, hsa-miR-103a-3p, hsa-miR-223-3p, hsa-miR-25-3p, hsa-miR-26b-5p, hsa-miR-193a-5p, hsa-miR-1307-3p, hsa-miR-155-5p, hsa-miR-185-5p, hsa-miR-424-3p, and hsa-miR-23b-3p [2.1 Exosome composition ¶ 1].
Absent reason to believe otherwise, the composition is present.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638 /ROBERT M KELLY/Primary Examiner, Art Unit 1638