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 .
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.
Election/Restrictions
Applicant’s election of group I, claims 29, 31, 35-42 (partially), and 30, 32, 34 (fully), in the reply filed on 4/30/26 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)).
Claims 29-48 are currently pending.
Claims 33, and 43-48 are withdrawn as directed to non-elected inventions.
Claims 29, 31, 35-42 (partially), and 30, 32, 34 (fully) are elected and examined on the merits.
Claim Interpretation
With respect to claims 40, applicant's invention is interpreted as comprising product-by-process limitations. Under MPEP § 2113, product-by-process claims are not limited to the recited method steps, but are limited only by the resultant structure. Therefore, method steps are only considered in a patentability analysis to the extent that the method steps result in structural changes to the product. It is not clear that the recited method steps of claim 40 produce extracellular vesicles (EVs) which demonstrate a structural and functional difference to EVs produced by a different methodology (e.g., culturing stem cells in suspension culture). Therefore, these method steps are not considered in the patentability analysis.
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(s) 31, 38, 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramaswamy et al., US Publication No. 2021/0180024 (hereinafter Ramaswamy).
Regarding claims 31, 38, Ramaswamy discloses methods of producing exosomes from fluid-induced shear stress exposed stem cells (Abstract). Ramaswamy explains that stem cells exposed to shear stress produce and release exosomes in relatively high quality and quantities ([0008]). Ramaswamy discloses culturing stem cells on a scaffold and culturing with physiologically relevant shear stress (e.g., 2-10 dynes/cm2), collecting the exosome-containing conditioned media, and isolating the exosomes ([0009], [0013], [0034], [0056], [0069]-[0071], [0074]-[0084]). Ramaswamy discloses that the secreted exosomes comprise a significantly increased quantity of total proteins as compared to exosomes derived from a control condition ([0044]-[0045]).
Regarding claims 42, Ramaswamy discloses that the exosomes may be present in a pharmaceutical composition comprising a pharmaceutically acceptable carrier ([0049]-[0055]).
Therefore, every limitation of claims 31, 38, and 42 is present in Ramaswamy, and the subject matter is anticipated.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 29-30, 32, 34-38, 40-41 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ramaswamy as applied to claims 31, 38, 42 above.
Regarding claims 29-30, 32, 34, Ramaswamy is silent as to upregulation of certain proteins, and downregulation of certain proteins, by the EVs as compared to EVs produced under a control condition. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not EVs of the prior art differ, and if so to what extent, from applicant’s EVs. The prior art discloses exosomes which are similar to applicant’s for these reasons: Ramaswamy discloses seeding BM-MSCs on a 3D scaffold, culturing the cells under physiologically relevant shear stress (e.g., 2-10 dynes/cm2), collecting the exosome-containing conditioned media, and isolating the exosomes ([0009], [0013], [0028], [0031]-[0032], [0034], [0056], [0069]-[0071], [0074]-[0084], [0099]). Ramaswamy discloses that the secreted exosomes comprise a significantly increased quantity of total proteins as compared to exosomes derived from a control condition ([0044]-[0045]). Where an examiner cannot determine whether or not the reference inherently possesses properties which anticipate, or render obvious, the claimed invention a rejection under §§102/103 is appropriate. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the exosomes of Ramaswamy is either identical or sufficiently similar to the claimed EVs that whatever differences exist, they are not patentably significant. Therefore, the burden of establishing novelty or unobviousness by objective evidence is shifted to applicants. See MPEP § 2112(v). Clear evidence that the exosomes of the cited prior art does not possess a critical characteristic that is possessed by the claimed EVs would advance prosecution and might permit allowance of claims to applicant’s EVs. Applicant is requested to specifically point out the support for any amendments made to the disclosure and arguments in response to this Office Action, including the claims. See MPEP §§ 714.02 and 2163.06. Applicant is also requested to refer to pages and line numbers in the as-filed specification. It is noted that other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Regarding claim 35, Ramaswamy discloses that the exosomes contain a conserved set of proteins including CD81, CD63, and CD9 ([0029]).
Regarding claim 36, preferably the exosomes are derived from bone marrow derived mesenchymal stem cells (BM-MSCs) ([0028], [0031]-[0032], [0099]).
Regarding claim 40, Ramaswamy discloses seeding the cells on a scaffold and culturing with physiologically relevant shear stress (e.g., 2-10 dynes/cm2) ([0069]-0070], [0074]-[0084]).
Regarding claim 41, Ramaswamy discloses that the exosomes may be present in a pharmaceutical composition comprising a pharmaceutically acceptable carrier ([0049]-[0055]).
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.
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.
Claim(s) 39 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ramaswamy as applied to claims 29-30, 32, 34-38, 40-41 above, and in further view of Han et al., (2021) Overview and update on methods for cargo loading into extracellular vesicles. Processes, 9:356 (hereinafter Han).
Regarding claim 39, Ramaswamy does not disclose that the EVs are loaded with at least one exogenous cargo.
Han reviews the use of EVs for therapeutic drug delivery purposes (Abstract). Han explains that EVs have the ability to deliver biological information as well as hydrophobic drugs into cells (Abstract, Introduction). Han discloses that cargo may be encapsulated in EVs via cell-based loading or direct loading (EV loading methods, Figs. 1-2). Cargo-loaded EVs have been utilized for many diseases including cardiovascular conditions, autoimmune diseases, inflammatory diseases, and others (Introduction).
As both Ramaswamy and Han are directed to EVs for therapeutic applications, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to incorporate the cargo loading of Han into the methods of Ramaswamy to further enhance the therapeutic efficacy of the EVs. Additionally, Ramaswamy explicitly discloses that the composition comprising the EVs may further contain a therapeutic agent for treating cardiovascular diseases ([0055]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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