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 .
1. Claims 1 – 15 are pending.
Election/Restrictions
2. Applicant’s election of Group I (claims 1 – 5) in the reply filed on 06/29/2026 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)).
3. Claims 6 – 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/29/2026.
Priority
4. This application claims foreign priority to Taiwan patent application No. 112141861 filed on 10/31/2023.
5. 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.
Drawings
6. The drawings filed 12/01/2023 are acknowledged.
Specification
7. The use of the term Immobilon-P, Western Lightning Plus, Mag-Fluo-4, Fura Red, GraphPad Prism, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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.
8. Claims 1 – 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring adipose tissue-derived extracellular vesicle and a biologic without significantly more. The claim(s) recite(s) adipose tissue-derived extracellular vesicle and a biologic which is not shown to differ from that in nature.
Claim 1 is drawn to a pharmaceutical composition for treating arthritis, comprising an adipose tissue-derived extracellular vesicle and a biologic.
Claim 2 is drawn to the pharmaceutical composition according to claim 1, wherein the adipose tissue-derived extracellular vesicle is an adipose tissue-derived mesenchymal stem cell (ADSC)-derived extracellular vesicle (EV).
Claim 3 is drawn to the pharmaceutical composition according to claim 1, wherein the arthritis is rheumatoid arthritis (RA).
Claim 4 is drawn to the pharmaceutical composition according to claim 1, which is in a dosage form for parenteral administration.
The Office published Office's new guidance document entitled 2019 Revised Patent Subject Matter Eligibility Guidance, published January 7, 2019. Applicant is directed to the Federal Register, Volume 4, No. 4, pages 50-57 at page 74621.
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Step 1 of the USPTO' s eligibility analysis entails considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: Process, machine, manufacture, or composition of matter. The claims are directed to a composition of matter (step 1, Yes).
Step 2A of the 2019 Revised Patent Subject Matter Eligibility Guidance is a two-prong inquiry. In Step 2A Prong One, examiners evaluate whether the claim recites a judicial exception. The composition of matter (an adipose tissue-derived extracellular vesicle and a biologic) is directed to a natural phenomenon (Step 2A, prong 1, Yes). Because the claims recite a nature-based product limitation (an adipose tissue-derived extracellular vesicle and a biologic), the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. Tsujimaru (Tsujimaru, Koichiro, et al. Regenerative Therapy 15 (2020): 305-311.) teaches extracellular vesicles (EVs) consist of the membrane of the original cell, and they include proteins, mRNAs, and microRNAs and are secreted by adipose tissue and mesenchymal stem cells derived from adipose tissue (Abstract; page 305; page 306, para. 4 – 6; page 308, left col. and right col. para. 1). Thus, Tsujimaru teaches EVs are naturally found in adipose tissue and contain biologics that include proteins, and RNAs (claim 1 and 3) and are naturally found in adipose tissue-derived mesenchymal stem cells (claim 2). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. Here, the closest natural counterpart is naturally occurring an adipose tissue-derived extracellular vesicle that contain proteins and RNAs. When the claimed an adipose tissue-derived extracellular vesicle and a biologic is compared to this counterpart, the comparison indicates that there are no differences in structure, function or other characteristics. Therefore, the claimed an adipose tissue-derived extracellular vesicle and a biologic is a product of nature exception and recites a judicial exception.
In Step 2A Prong Two, examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the judicial exception, the claim recites the judicial exception is “for treating arthritis” (claim 1) and claim 4 broadly recites “in a dosage form for parenteral administration”. An evaluation of whether these limitations are insignificant extra-solution activity is then performed. Note that because Step 2A Prong Two analysis excludes consideration of whether a limitation is well-understood, routine, conventional activity, this evaluation does not take into account whether or not the limitation is well-known. When so evaluated, the intended use of “for treating arthritis” and the “dosage form” are insignificant extra-solution activity because they are recited so generically. Further, Tsujimaru teaches that the naturally occurring EVs treat rheumatoid arthritis (claim 1 and 3) when formulated at 5 µg per body and injected via tail vein (claim 4) (page 306, right col. para. 2; Figure 2; page 307, left col. para. 2; page 309, right col. para. 3). Therefore, these limitations fail to meaningfully limit the claims because it is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the intended use and dosage form do not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception (Step 2A, prong 2, No).
In Step 2B, the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements adds an inventive concept into the claim. As discussed with respect to Step 2A Prong Two, the claim recites an intended use of treating arthritis, which is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. At Step 2B, the evaluation of the insignificant extra-solution activity consideration takes into account whether or not the extra-solution activity is well-known. Here, recitation of an adipose tissue-derived extracellular vesicle and a biologic for treating arthritis is recited at a high level of generality and does not amount to significantly more and does not provide an inventive concept (Step 2B: No).
Markedly different characteristics can be expressed as the product' s structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product' s naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘‘product of nature” exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception.
Limitations that were found not to be enough to qualify as ‘‘significantly more” when recited in a claim with a judicial exception include: Adding the words ‘‘apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or generally linking the use of the judicial exception to a particular technological environment or field of use.
In the instant case, the limitations of the claim does not impose limits on the claim scope such that they are not markedly different in structure from a naturally occurring product.
Claim Interpretation
9. For the purpose of applying prior art, “in a dosage form for parenteral administration” is interpreted as the composition is a powder, tablet, troche, lozenge, pill, capsule, dispersible powder or granule, solution, suspension, emulsion, syrup, elixir, and slurry for injection based on Applicant’s specification at para. 0031.
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.
10. Claim(s) 1 – 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsujimaru (Tsujimaru, Koichiro, et al. Regenerative Therapy 15 (2020): 305-311.), hereinafter Tsujimaru.
Claim 1 is drawn to a pharmaceutical composition for treating arthritis, comprising an adipose tissue-derived extracellular vesicle and a biologic.
Regarding claims 1 – 3, Tsujimaru teaches a composition of adipose tissue-derived mesenchymal stem cell (AMSC) (claim 2) extracellular vesicles (EVs) (claim 1) that comprise IL-1ra (“biologic” of claim 1) for the treatment of rheumatoid arthritis (claim 3) (page 306, left col. para. 4 – 7 and right col. para. 1 – 2 and last para.; page 307, left col. para. 2; page 307, right col. para. 2; Figure 1, 2, and 4). Tsujimaru teaches the EVs were purified from the AMSCs (page 306, left col. para. 5).
Regarding claim 4, Tsujimaru teaches the EVs were administered at dose of 5 µg per body by tail vein injection (page 306, right col. para. 2).
Therefore, Tsujimaru anticipates claims 1 – 4.
11. Claim(s) 1 – 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by You (You, Dong Gil, et al. Science Advances 7.23 (2021): eabe0083.), hereinafter You.
Claim 1 is drawn to a pharmaceutical composition for treating arthritis, comprising an adipose tissue-derived extracellular vesicle and a biologic.
Regarding claims 1 – 3, You teaches a composition of adipose tissue-derived mesenchymal stem cell (ADSC) (claim 2) exosomes (“extracellular vesicles” of claim 1) that comprise miRNAs, cytosolic proteins, and surface proteins (“a biologic” of claim 1) for treating rheumatoid arthritis (claim 3) (page 1, right col. para. 2; Figure 1; page 2, left col. and right col. para. 2; Figure 3A; page 3, left col. para. 2 and right col. para. 2; page 4, right col.; Figure 5; page 6, right col. para. 2; Figure 7; page 7; page 11, left col. para. 1 – 2). You teaches exosomes are extracellular vesicles (page 1, left col.).
Regarding claim 4, You teaches administering a dosage of exosomes of 1 x 108 particles per head or 1 x 107 particles per head by intravenous injection (page 11, right col. last para.; page 12, left col. para. 1).
Therefore, You anticipates claims 1 – 4.
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.
12. Claim(s) 1 – 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over You (You, Dong Gil, et al. Science Advances 7.23 (2021): eabe0083.), hereinafter You in view of Genovese (Genovese, Mark C., et al. The Journal of rheumatology 32.7 (2005): 1232-1242.), hereinafter Genovese.
You anticipates claims 1 – 4 as set forth above. You does not teach the biologic is Etanercept of claim 5. However, You teaches despite the remarkable advances in therapeutics for rheumatoid arthritis (RA), a large number of patients still lack effective countermeasures (Abstract). You teaches RA is a debilitating and financially burdensome disease that affects up to 2.5% of the population in each country (page 1, left col.). You teaches M1 macrophages are known as the most prominent cells in RA responsible for lesion formation and aggravation by releasing various types of proinflammatory cytokines such as TNF-α, IL-6, and IL-1 (page 1, left col.). You teaches mesenchymal stem cell-derived exosomes (MSC-EXOs) have shown potential to treat osteoarthritis by inducing M1-M2 macrophage polarization in the inflamed tissue (page 1, right col. para. 1). You teaches for RA therapy, there is an unmet need to develop engineered MSC-EXOs, which can effectively regulate the M1-M2 balance of macrophages (page 1, right col. para. 1). You teaches to develop safer and more effective RA therapeutics based on MSC-EXOs, an efficient surface-editing strategy that does not cost their intrinsic biological functions and/or yield is crucial (page 1, right col. para. 2). You teaches surface-edited MSC-EXOs (DS-EXOs) that have enhanced targeting ability to inflamed joints of RA mice (page 10, left col. para. 2). You teaches the DS-EXOs successfully reprogrammed the synovial microenvironment of the inflamed joints through the regulation of macrophage heterogeneity by promoting M1-M2 macrophage polarization in the bone marrow regions of joints inflamed by RA and reduced the activity of surrounding proinflammatory cells, such as M1 macrophages (page 10, left col. para. 1; Figure 7J and K). You teaches the DS-EXOs showed therapeutic efficacy similar to bare EXOs at a lower dose in inflamed joints of RA (Abstract; page 7; Figure 7B - E). You teaches the DS-EXOs showed the lowest levels of cartilage erosion, neutrophil infiltration, and synovial inflammation in the RA mice joints (page 8, left col.). You teaches in the inflamed joints of RA patients, TNF-α and IL-6 are abundant owing to the presence of M1 macrophages (page 9, right col. last para.; page 10, left col. para. 1).
Regarding “Etanercept” of claim 5, Genovese teaches Etanercept is a fully human, soluble p75 TNF receptor fusion protein that binds and neutralizes TNF (page 1232, right col. para. 2). Genovese teaches studies of etanercept monotherapy in patients with early RA have shown rapid onset of significant clinical improvements that are sustained for up to 2 years and the treatment was well tolerated (page 1232, right col. para. 3; page 1239, right col. para. 1). Genovese teaches improvement in disease activity remained constant during long-term treatment with etanercept (page 1239, right col. last para.; page 1240, left col. para. 1). Genovese teaches radiographic analysis showed a substantial reduction in the rate of progression of joint damage compared with rates for early RA patients not treated aggressively or effectively (page 1241, right col. para. 3). Genovese teaches a small group of patients actually showed negative rates of radiographic progression, suggesting that cessation of new erosions and repair of old erosions may be possible, and emphasizing the influence of early treatment with biological therapy in patients with early RA (Abstract; page 1241, right col. para. 3). Genovese teaches in patients with RA, TNF plays a major role in promoting the synovial inflammatory process, which can lead to progressive destruction of cartilage and bone (page 1232, left col. and right col. para. 1). Genovese teaches recent approaches to treatment of RA using biological therapies aimed at reducing biologically active TNF have been successful, and anti-TNF therapies have been shown to reduce signs and symptoms of RA and decrease the rate of progression of radiographic damage to joints (page 1232, right col. para. 1).
It would have been obvious prior to the effective filing date of the invention as claimed for the person of ordinary skill in the art to combine the teachings of You regarding a composition of MSC-EXOs from adipose tissue-derived mesenchymal stem cells for treating RA that could reduce the activity of M1 macrophages that release TNF with the teachings of Genovese regarding a composition comprising etanercept for treating RA by neutralizing TNF to arrive at the claimed composition where the biologic is Etanercept. One would have been motivated to combine the teachings of You and Genovese in a pharmaceutical composition to treat RA as You teaches despite the remarkable advances in therapeutics for RA, a large number of patients still lack effective countermeasures and You teaches RA is a debilitating and financially burdensome disease that affects up to 2.5% of the population in each country and You teaches for RA therapy, there is an unmet need to develop engineered MSC-EXOs, which can effectively regulate the M1-M2 balance of macrophages and You teaches in the inflamed joints of RA patients, TNF is abundant owing to the presence of M1 macrophages and Genovese teaches in patients with RA, TNF plays a major role in promoting the synovial inflammatory process, which can lead to progressive destruction of cartilage and bone and Genovese teaches recent approaches to treatment of RA using biological therapies aimed at reducing biologically active TNF have been successful, and anti-TNF therapies have been shown to reduce signs and symptoms of RA and decrease the rate of progression of radiographic damage to joints. One would have a reasonable expectation of success in combining the teachings as You teaches the DS-EXOs successfully reprogrammed the synovial microenvironment of the inflamed joints through the regulation of macrophage heterogeneity by promoting M1-M2 macrophage polarization in the bone marrow regions of joints inflamed by RA and reduced the activity of surrounding proinflammatory cells, such as M1 macrophages and You teaches the DS-EXOs showed the lowest levels of cartilage erosion, neutrophil infiltration, and synovial inflammation in the RA mice joints and Genovese teaches improvement in disease activity remained constant during long-term treatment with etanercept and Genovese teaches radiographic analysis showed a substantial reduction in the rate of progression of joint damage compared with rates for early RA patients not treated aggressively or effectively.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
13. Claim 1 – 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 – 13 and 20 of copending Application No. 18376459 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and reference claims are drawn to a composition comprising extracellular vesicles.
Instant claim 1 recites a pharmaceutical composition for treating arthritis, comprising an adipose tissue-derived extracellular vesicle and a biologic.
Instant claim 2 recites the pharmaceutical composition according to claim 1, wherein the adipose tissue-derived extracellular vesicle is an adipose tissue-derived mesenchymal stem cell (ADSC)-derived extracellular vesicle (EV).
Instant claim 4 recites the pharmaceutical composition according to claim 1, which is in a dosage form for parenteral administration.
Instant claim 5 recites the pharmaceutical composition according to claim 1, wherein the biologic is Etanercept.
Reference claim 9 recites a composition comprising mesenchymal stem cell cells (MSCs), extracellular vesicles (EVs) produced by the mesenchymal stem cells, and a component, which is prepared by the method according to claim 1.
Instant claims 1 and 3 map to reference claim 9 and anticipates reference claim 9 because instant claim 1 is generic (broader than) reference claim 9 as instant claim 1 broadly recites “adipose tissue-derived extracellular vesicle” while reference claim 9 requires the EV be produced by the MSCs. While, reference claim 9 does not recite “for treating arthritis”, reference claim 11 recites a method for treating arthritis, comprising administering to a subject in need thereof a medicament comprising an effective amount of the composition according to claim 9; reference claim 12 recites the method according to claim 11, wherein the mesenchymal stem cells are human adipose-derived mesenchymal stem cells (ADSCs); reference claim 13 recites the method of claim 11, wherein the arthritis is degenerative arthritis. Instant claim 5 maps to reference claim 1 as reference claim 1 broadly recites “a component”.
Reference claim 10 recites the composition according to claim 9, wherein the mesenchymal stem cells are human adipose-derived mesenchymal stem cells (ADSCs).
Therefore, instant claim 2 maps to reference claim 10.
Reference claim 20 recites the method according to claim 11, wherein the medicament is in a dosage form for parenteral administration.
Therefore instant claim 4 maps to reference claim 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claim 1 – 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 – 7, 15 – 17, and 20 of copending Application No. 18376566 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and reference claims are drawn to a composition comprising extracellular vesicles.
Instant claim 1 recites a pharmaceutical composition for treating arthritis, comprising an adipose tissue-derived extracellular vesicle and a biologic.
Instant claim 2 recites the pharmaceutical composition according to claim 1, wherein the adipose tissue-derived extracellular vesicle is an adipose tissue-derived mesenchymal stem cell (ADSC)-derived extracellular vesicle (EV).
Instant claim 4 recites the pharmaceutical composition according to claim 1, which is in a dosage form for parenteral administration.
Reference claim 4 recites a mesenchymal stem cell (MSC)-derived extracellular vesicle (EV), which is prepared by the method according to claim 1.
Reference claim 5 recites the mesenchymal stem cell (MSC)-derived extracellular vesicle (EV) according to claim 4, wherein the human mesenchymal stem cell is adipose-derived mesenchymal stem cell (ADSC).
Reference claim 6 recites the mesenchymal stem cell (MSC)-derived extracellular vesicle (EV) according to claim 4, having a size of 30 nm - 1 μm
Reference claim 7 recites the mesenchymal stem cell (MSC)-derived extracellular vesicle (EV)
according to claim 4, comprising a cartilage-related gene selected from the group consisting of: interleukin-2 (IL-2), Uteroglobin, alpha-fetoprotein (AFP), angiopoietin-like 6 (ANGPTL-6), fatty acid-binding protein-I (F ABP-1 ), cartilage oligomeric matrix protein (COMP), platelet-derived growth factor AA (PDGF-AA), granulocyte-colony stimulating factor (G-CSF), and a combination thereof
Instant claims 1 – 3 map to reference claims 4 – 7 because all are drawn to an extracellular vesicle and “biologic” of instant claim 1 reads on reference claim 7. While, reference claim 4 does not recite “for treating arthritis”, reference claim 15 recites a method for treating osteoarthritis (OA), comprising administering to a subject in need thereof a pharmaceutical composition comprising an effective amount of the mesenchymal stem cell (MSC)-derived extracellular vesicle (EV) according to claim 4; reference claim 16 the method according to claim 15, wherein the mesenchymal stem cell (MSC)-derived extracellular vesicle (EV) is adipose-derived mesenchymal stem cell (ADSC)-derived extracellular vesicle (EV); reference claim 17 recites the method according to claim 15, wherein the mesenchymal stem cell-derived extracellular vesicle has a size of 30 nm -1 μm.
Reference claim 20 recites the method according to claim 15, wherein the pharmaceutical composition is in a dosage form for parenteral administration.
Therefore instant claim 4 maps to reference claim 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZANNA M BEHARRY whose telephone number is (571)270-0411. The examiner can normally be reached Monday - Friday 8:45 am - 5:45 pm.
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/ZANNA MARIA BEHARRY/Examiner, Art Unit 1632
Prosecution Insights