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 February 6, 2026, are entered.
Claims 1-2, 8-10, 12, 14, and 17-19 haven been amended.
Claims 4-7 have been canceled.
No new claims have been added.
Claim Objections
Objections to claims 1, 4, 9, 12, 14, and 17-18 are withdrawn. Applicant’s amendments overcome the objections for these claims.
The objection for claim 2 where claim 2 recites “cells are human adipose-derived mesenchymal stem cell (ADSC) (ADSCs)” is maintained and is newly objected for Claim 2 reciting “(ADSC) (ADSCs). Claim 2 should read “cells are human adipose-derived mesenchymal stem cells
Claim Rejections - 35 USC § 101
Claims 9 and 10 are 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 in claims 9 and 10 are directed to a physical phenomenon without significantly more. The claim(s) recite “a composition comprising a mesenchymal stem cell (MSC), an extracellular vesicle (EV) produced by the mesenchymal stem cell, and a growth factor, which is prepared by the method of claim 1” and “the composition according to claim 9, wherein the mesenchymal stem cell is a human adipose-derived mesenchymal stem cell (ADSC)”, respectively. 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 the judicial exception is maintained.
Step 1: Step 1 of the eligibility analysis asks: Is the claim or claims to a process, machine, manufacture, or a composition of matter? (I.e., a statutory category). Yes, the claims are drawn to a composition.
Step 2A: Prong 1: Are the claims directed to a Judicial exception? Yes, claims 9 and 10 are drawn toa physical phenomenon, i.e. “a mesenchymal stem cell…, an extracellular vesicle…, and a growth factor…prepared by the method according to claim 1” while claim 10 is directed to a human adipose-derived mesenchymal stem cell. Mesenchymal stem cells, their secreted extracellular vesicles and naturally occurring growth factors are naturally occurring products in the body. Both claims recite naturally occurring entities without sufficient alteration or modification.
Step 2A: Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? No, the only additional limitation in claim 9 is the limitations referenced in claim 1. However, the claim 1 limitations are directed to routine culturing methods for mesenchymal stem cells. There is no additional element recited in claim 1 that would meaningfully transform the naturally occurring mesenchymal stem cells, extracellular vesicles, and growth factor into something different from their natural state. Claim 10, which is dependent upon claim 9, merely recites that the mesenchymal stem cells to be used are human adipose-derived mesenchymal stem cells. Again, this limitation does not transform claim 9 into something different other than naturally occurring mesenchymal stem cells.
As claims 9 and 10 are directed to a judicial exception, i.e. mesenchymal stem cells, extracellular vesicles, and growth factors as they exist in natural form, with no transformation into a meaningful practical application of the judicial exception, claims 9 and 10 are properly rejected for being directed to a judicial exception.
The specification provides antecedent basis for “predetermined time” where is states the predetermined time is 18-24 hours [¶ 0014].
Applicant’s specification states “a predetermined time to obtain the composition” without further elaboration or examples defining the term [¶ 0010]. The closest statement on time is in paragraph [0014] where it states the predetermined time is 18-24 hours. However, cell doubling times are also given in table 2 and paragraph [0054]. In paragraph [0070], thawing and standing for 0-48 hours with PBS or saline at 2-10 degrees Celsius
Response to Argument
Applicant argues that composition involves artificial process modification and possesses a significant new function, and enhances arthritis repair in a short period of time. Applicant further points out that the mesenchymal stem cells are a produced via culture using flask with a specific surface chemistry, with specific standing times where the MSCs are induced to produce different EVs/components and that this leads to improving the amplification rates of MSCs that lead to improved therapeutic effects with respect to alleviating arthritic symptoms within a specific duration.
The examiner does not find this argument persuasive.
The examiner specifically points out that claim 1 is directed to a composition comprising mesenchymal stem cells, extracellular vesicles produced by said mesenchymal stem cells, and “components” which are the listed growth factors produced by the extracellular vesicles per Applicant’s specification [¶ 0070]. Claim 1 does not recite any modification of the mesenchymal stem cells, nor any downregulation of factors such as IL-10 and TGF-α. Claim 8 is what introduces the limitation that the mesenchymal stem cells are downregulated for IL-10 and TGF-α. However, claims 9 and 10 depend from claim 1. Therefore, claim 1does not incorporate the limitation and/or modification as stated in claim 8 with respect to claim 9 and 10’s dependency. Because of this, claim 9 and 10 cover unmodified mesenchymal stem cells, extracellular vesicles produced by said mesenchymal stem cells, and naturally secreted factors such as growth factors or other “components”. Although the mesenchymal stem cells are cultured and expanded in a lab setting, the claimed composition does not recite a markedly different structural or functional characteristic from what exists in nature since the claimed components, per the specification, are secreted by the extracellular vesicles. See MPEP 2106.04(c). Because of this, claim 9 and 10 remain directed to a product of nature. Furthermore, citing MPEP 2113, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As pointed out by the MPEP citing In re Thorpe, the use of specific surface chemistry culture containers and/or standing time in the culturing process does not impart a markedly different characteristic to the mesenchymal stem cells, the extracellular vesicles produced by said mesenchymal stem cells, or the “components” such as the growth factors recited in Applicant’s specification. Based on this the rejection to claims 9 and 10 under §101 is maintained.
Claim Rejections – 35 USC § 112
In light of the amendments, the rejection to claims 19, 11-18, and 20 being rejected under 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 amendments, the rejections to Claims 1-20 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.
In light of the amendments, the rejection to claims to 1, 9, and 10 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.
Claims 6-7 were canceled making the §112(a) written description rejection moot.
Claim Rejections - 35 USC § 112
In light of the amendments, the rejections to claims 1-4 and 8-20 as being 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 are withdrawn.
Claim Rejections - 35 USC § 102
In light of the amendments, claims 1-5, 9-10, 17-18 being rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ra and Kim (Hereinafter Kim) [WO 2018 021879 A1, 2018] is withdrawn.
Claim Rejections - 35 USC § 103
In light of the amendments, claims 7-8, 11-16, and 20 being rejected under 35 U.S.C. 103 as being unpatentable over Ra and Kim (Hereinafter Kim) [WO 2018 021879 A1, 2018], in view of Putra et al. [The role of TNF-α induced MSCs on suppressive inflammation by increasing TGF-β and IL-10, Open Access Maced J Med Sci, 2018], in view of Murray [The JAK-STAT signaling pathway: input and output integration, The Journal of Immunology, 2007] in view of Zhu et al. [Mesenchymal stem cells in osteoarthritis therapy: a review, Am J Transl Res., 2021], in view of
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 19 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 19 recites “wherein the arthritis is ameliorated one week after the medicament is administered”. The term “ameliorated” is inherently subjective and depends on patient-reported outcomes, such as those measured by the WOMAC scoring system. The claim does not provide objective criteria, quantitative thresholds, or clear boundaries defining what constitutes “amelioration” within the one-week timeframe. Because of this, a person of ordinary skill in the art would not be able to reasonably ascertain the scope of the claim or whether the limitation is met.
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.
Claims 1-3 and 8-20 are newly rejected under 35 U.S.C. §103 as being unpatentable in view of Ra and Kim (Hereinafter Kim) [WO 2018 021879 A1, 2018], in view of Putra et al. [The role of TNF-α induced MSCs on suppressive inflammation by increasing TGF-β and IL-10, Open Access Maced J Med Sci, 2018], in view of Murray [The JAK-STAT signaling pathway: input and output integration, The Journal of Immunology, 2007] in view of Zhu et al. [Mesenchymal stem cells in osteoarthritis therapy: a review, Am J Transl Res., 2021].
Regarding claim 1, Kim teaches every element except Kim does not teach specifically teach the use of a flask made with a material with an oxygen-containing functional group at ratio of 20-35%. Although Kim does disclose the use of a flask with no mention of what material makeup the flask is, the use of culture flask comprising oxygen-functional groups, including the ragne of about 20-35%, would have been obvious to a person of ordinary skill in the art. Surface modification of polystyrene cultureware via plasma or corona treatments introducing oxygen-containing functional groups have been well-established since the 1970s and are widely available commercially. There are numerous examples of commercially flasks that inherently posses oxidized surfaces of varying degrees of oxygen incorporation. Therefore, selecting the use of a flask having an oxygen-functionalized surface within the claimed range is merely routine optimization of a known parameter where a person of ordinary skill would have a reasonable expectation of success that these types of flasks would be more amenable to culturing stem cells due to these flasks being better suited for adhesive type cells. Furthermore, the claimed step of “standing” the mesenchymal stem cells for a predetermined time of 18-24 hours represents no more than a routine optimization of a result-effective variable. This duration is used to accumulate extracellular vesicles and secreted factors. A person of ordinary skill would have recognized that the amount of secreted extracellular vesicles and growth factors and/or components would increase with time and would have selected an appropriate incubation period using routine experimentation to balance yield and cell viability. Additionally, the claimed step of “standing” the mesenchymal stem cells for a predetermined time is well known in the art given it refers to allowing the cultured cells to remain undisturbed for a sufficient period of time to permit adhesion of cells and/or secretion of extracellular vesicles and soluble factors into the medium. This is a routine practice commonly employed in mesenchymal stem cell and general mammalian cell cultures. It is nothing more than static incubation which is a widely used technique.
Additionally, the components listed in claim 1 do not represent any structural or functional modification of the extracellular vesicles, but rather reflect the natural contents of the extracellular vesicles. Therefore, the inclusion of the recited components, e.g. growth factors, in the claimed method constitute no more than the recognition of inherent properties of mesenchymal stem cell-derived extracellular vesicles.
For claim 2 where the mesenchymal stem cells are derived from adipose tissue, Kim discloses that the isolated mesenchymal stem cells were derived from adipose tissue [Para starting with “It may be derived from tissues such as fat, uterus, bone marrow” and “Vit. C-MSC cultured in a medium containing vitamin C of Example 1”].
For claim 8 where the growth factor is IL-10 or TGF-α, and expression of the IL-10 and the TGF-α is down regulated, Putra et al. discloses the optimum concentration of IL-10 in a mesenchymal stem cell medium [Figure 3]. Additionally, Murray et al., discussing overexpression of IL-10 induces the Janus kinase/signal transducer signaling pathway, teaches that IL-10 signaling is subject to autoinhibitory negative feedback, which in turn results in downregulation of endogenous IL-10 expression following IL-10 exposure [Is there functional equivalence in signaling from receptors using the same JAK-STAT combination in the same cell ¶ 1].
Here, it would have been prima facie obvious to a person skilled in the art prior to the filing of the claimed invention to modify the systems and methods of Kim that discussed culturing mesenchymal stem cells in a growth factor with the teachings of Putra et al. that discloses using IL-10 as a growth factor in a mesenchymal stem cell culture combined with Murray et al. that teaches IL-10 can cause a self-limiting feedback mechanism that downregulates endogenous IL-10 expression upon exposure to exogenous IL-10. Therefore, there is a reasonable expectation of success to combine the teachings of Kim with the additional teachings of Putra et al. and Murray et al. to culture mesenchymal stem cells in a culture medium containing IL-10 where the result is that the exogenous IL-10 causes the endogenous IL-10 to downregulate due to a negative feedback loop.
Regarding claim 9 where a composition comprising the mesenchymal stem cells prepared by the method of claim 1, Kim discloses a composition of mesenchymal stem cells under the same analysis as claim 1 with the same structure and function as the mesenchymal stem cells, extracellular vesicles, and components, e.g. growth factors, as stated in Applicant’s claim 1.
Regarding claim 10 where the composition comprises mesenchymal stem cells derived from human adipose tissue, Kim discloses that the mesenchymal stem cells are derived from human adipose tissue [Para starting with “it may be derived from tissues such as fat, uterus, bone marrow, muscle, placenta…”].
For claim 11 where a method of treating arthritis involves administering to a subject in need thereof the composition of claim 9, Zhu et al., discussing the use of mesenchymal stem cells as a treatment for osteoarthritis, teaches that mesenchymal stem cells are a promising source of treatment for osteoarthritis due to their multipotency for differentiation into chondrocytes [Abstract].
For claim 12 where the human mesenchymal stem cell is derived from adipose tissue, Zhu et al. teaches treatment for osteoarthritis using mesenchymal stem cells can be derived from humans [AD-MSCs for osteoarthritis therapy and UC-MSCs for osteoarthritis therapy].
For claim 13 where the arthritis is degenerative arthritis, Zhu et al. discloses using mesenchymal stem cells in the treatment of osteoarthritis a degenerative arthritis [Abstract].
For claim 14 where the mesenchymal stem cell has an effective concentration of single intra-articular injection of a certain concentration, Zhu et al. teaches a range of concentrations, including intra-articular injection within the claimed range [Table 2].
For claim 15 where the composition increases cartilage thickness, Zhu et al. discloses that a great number of studies have shown cartilage tissue regeneration in vitro and in animal models [BM-MSCs for osteoarthritis therapy ¶ 1].
For claim 16 where the composition improves arthritis pain, stiffness, and body function, Zhu et al. discloses that in several studies subjects experienced a reduction in pain, stiffness, and body function [Table 2].
For claim 17 where the mesenchymal stem cells are expanded using the keratinocyte serum free medium supplemented with N-acetyl-L-cysteine and L-ascorbic acid-2-phosphate, Kim discloses the use of Keratinocyte serum free medium [Para starting with “As the medium is used for obtaining the adipose stem cell”] where Kim also discloses the where the medium will also include N-acetyl-L-cysteine and/or ascorbic acid 2-phosphate [Para starting with “in the present invention, the medium may be selected from the group consisting of 0.05 to 1mM”].
For claim 18 where the adipose-derived mesenchymal stem cells are expanded using a flask made of a material with a functional oxygen-containing group, Regarding claim 1, Kim teaches every element except Kim does not teach specifically the use of a flask made with a material with an oxygen-containing functional group at ratio of 20-35%. Although Kim does disclose the use of a flask with no mention of what material makeup the flask is, the use of culture flask comprising oxygen-functional groups, including the ragne of about 20-35%, would have been obvious to a person of ordinary skill in the art. Surface modification of polystyrene cultureware via plasma or corona treatments introducing oxygen-containing functional groups have been well-established since the 1970s and are widely available commercially. There are numerous examples of commercially flasks that inherently posses oxidized surfaces of varying degrees of oxygen incorporation. Therefore, selecting the use of a flask having an oxygen-functionalized surface within the claimed range is merely routine optimization of a known parameter where a person of ordinary skill would have a reasonable expectation of success that these types of flasks would be more amenable to culturing stem cells due to these flasks being better suited for adhesive type cells.
For claim 20 where the treatment/dosage is for parenteral administration, Zhu et al. discloses intra-articular injection as a means of administering the stem cell composition directly to the diseased site [Table 2].
Here, it would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the claimed invention to modify the systems and methods of Kim that discussed a method for culturing adipose-derived mesenchymal stem cells in specific culture conditions with the additional teachings of Zhu et al. that discusses using mesenchymal stem cells in the treatment of osteoarthritis. Given this, it would have been obvious to carry out the process of involved in claims 9-18 and 20 given that Zhu et al. discloses a method for treating arthritis with a mesenchymal stem cell composition using adipose-derived human mesenchymal stem cells at a specified concentration within Applicant’s claimed ranges where after administration of the mesenchymal stem cell composition an increase in thickness is observed in the affected cartilage which leads to a reduction in pain, stiffness, and an increase in body function, and lastly the mesenchymal stem cell composition is administered by any means other than oral consumption.
The Supreme court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition..103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton.").
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, 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 references, especially in the absence of evidence to the contrary.
Response to Argument
Applicant argues that the combination of features set forth in the amended claims are not taught nor suggested by the references relied upon by the Office in the Non-Final Office Action mailed on November 5, 2025. Applicant points out that Kim relates to a cell culture medium composition for use in cancer research and treatment, specifically a culture medium comprising vitamin C and aspirin configured to promote cancer cell proliferation while maintaining a high number of mesenchymal stem cells. The main research of Kim focuses on the optimal concentration of aspirin for inhibiting cancer cell proliferation. Whereas the present application is directed at treating arthritis.
Examiner appreciates Applicant’s argument. However, Applicant’s argument is not persuasive. The cited reference is analogous art because it is directed to the same field of endeavor, namely the culturing, expansion, and characterization of mesenchymal stem cells. The specific downstream reasoning for culturing the mesenchymal stem cells, e.g. cancer vs. arthritis, does not discount the reference from the relevant field given the claimed invention relies on the same underlying technology, i.e. mesenchymal stem cell culture and expansion, production of extracellular vesicles by said mesenchymal stem cells, and the secreted factors, e.g. growth factors. Even if considered outside the same field of endeavor, i.e. cancer vs. arthritis, the reference is pertinent to the problem faced by the inventor, i.e. the preparation and expansion of mesenchymal stem cells and their secreted factors. Given this, a person of ordinary skill in the art would have consulted references describing mesenchymal stem cell culture methods regardless of the ultimate therapeutic indication since methods for culturing and expanding mesenchymal stem cells would inherently be applicable across multiple disease contexts whether the disease being studied was cancer, inflammatory disorders, or other types of regenerative medicine. Applicant argues that VEGF expression in the Kim mesenchymal stem cells are reduced. However, the claim 1 is only directed at wherein the component is selected from the group consisting of the Markush listing of components that include vascular endothelial growth factor (VEGF). While Kim does mention that VEGF expression is reduced, Kim does not teach or suggest that VEGF is absent. Additionally, claim 1 is not directed towards an increase in VEGF. The claim is directed only that the “component” be present. Again, a reduction in expression is not the absence of expression. With respect to the oxygen-containing functional group at a ratio of 20-35% for the flask and standing for 18-24 hours, are addressed in the newly rejected claims under §103.
With respect to the downregulation of IL-10 and/or TGF-α in claim 8, Applicant argument is describing a natural response of mesenchymal stem cells as it relates to diminishing inflammatory signals during active tissue repair, and that this change occurs independently of exogenous stimulation. However, the claim recites only that the expressions of IL-10 and TGF-α are downregulated, without reciting any structural modification, genetic alteration, or exogenous intervention that causes this change. Applicant’s argument is that the mesenchymal stem cells in claim 8 exhibit a naturally occurring biological phenomenon, i.e. the reduction of anti-inflammatory cytokine levels by mesenchymal stem cells in response to changes in their environment. This is an inherent property of mesenchymal stem cells, and similar to the “components” of claim 1, the claim limitation, based on Applicant’s argument, is merely observing, measuring and or claiming the natural decrease of IL-10 and TGF-α during tissue healing.
Lastly, Applicant argues that Zhu discloses the general applications of mesenchymal stem cells in the treatment of osteoarthritis but fails to disclose the limitations of claims 1, 9, and 11, i.e. the method for culturing and expanding adipose-derived mesenchymal stem cells. Again, this argument is not persuasive. Although Zhu does not disclose the method in which the mesenchymal stem cells are derived, it discloses the general use of mesenchymal stem cells for the treatment of osteoarthritis. Claim 11 is directed to administering the mesenchymal stem cells of claim 9, which depends from claim 1, for treating arthritis. Zhu demonstrates that mesenchymal stem cells, when delivered to affected joints, can modulate inflammation, support tissue regeneration, and improve joint function. This teaching is directly relevant to the claimed use of mesenchymal stem cells for treating arthritis, and a person of ordinary skill in the art would have recognized or found it obvious to apply the teachings of Zhu and apply it to mesenchymal stem cells cultured by the method of claim 1 given that these mesenchymal stem cells exhibit the same biological functions as mesenchymal stem cells in general. Because of these reasons, Claims 1-2 and 8-20 are newly rejected under 35 U.S.C. §103.
Conclusion
No claims 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN DAVID MOORE whose telephone number is (703)756-1887. The examiner can normally be reached M-F 8-5.
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/JOHN DAVID MOORE/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638