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 .
Remarks
The amendments and remarks filed on 10/23/2025 have been entered and considered. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action. The rejections and/or objections presented herein are the only rejections and/or objections currently outstanding. Any previously presented objections or rejections that are not presented in this Office Action are withdrawn. Claims 1-10 are pending; Claims 1 and 3 are amended; Claims 8-10 are withdrawn; and Claims 1-7 are under examination.
Withdrawal of Objections
The objection to Claims 3 and 4 are withdrawn due to the amendment of the claims.
Claim Rejections - 35 USC § 112, First Paragraph
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The amended claim 1 is directed to a method of fabrication of an ECM-induced self-assembly, with the added limitation that an average size of the ECM-induced self-assembly is 1 cm or more. Support for “an average size” is not found in the specification of the originally filed instant application. Applicant points to Paragraph 0007-8, 0014-15, 0025, and 0042 for a written description of this limitation. It is noted that the disclosure of these paragraphs only provides support for a size of 1 cm or more, but not for an average size of 1 cm or more. Therefore, claims 1-7 are directed to new matter.
Claim Rejections - 35 USC § 112(b), or 112, Second Paragraph
Claims 1-7 are 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite due to the recitation of “the ECM does not comprise an ECM scaffold”. In the broadest and reasonable interpretation, the ECM/ECM powder recited in the claim is a scaffold because it provides support for cell attachment and growth, as evidenced by the disclosure of the specification of the instant application (see [0069] in Example 4, the paragraph spanning pages 11 and 12). It is unclear how the recited ECM/ECM powder can be defined as not comprising an ECM scaffold while the ECM itself acts as a scaffold. For the purpose of examination, this limitation is not examined because its true meaning cannot be determined.
The remaining claims are rejected for depending from an indefinite claim.
Claim Rejections - 35 USC § 103
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (Journal of Biomedical Material Research, 2013, Vol. 102A, Issue 7, pages 2248-2257, of record).
Chang et al. teach that extracellular matrix (ECM) derived from animals has been developed as a cell carrier or scaffold for cartilage tissue engineering, and decellularization of ECM by removing cellular and nuclear materials minimizes adverse host and inflammatory responses; and that acellular matrix products have been applied to clinical practices (the paragraph spanning pages 2248 and 2249). Chang et al. further teach a method for fabricating an engineered cartilage construct by using an acellular matrix (ACM) powder (i.e. a decellularized extracellular matrix powder, or ECM powder) (Abstract), comprising steps: harvesting cartilage tissues from human patients during total knee arthroplasty (TKA) surgery (Note: the cartilage tissues read on the “tissue-derived extracellular matrix” and/or “cartilage” recited in the claims 1 and 2); mincing and freeze-lyophilizing articular cartilage tissues, then pulverizing the dried cartilage tissues to obtain powders of the issues; decellularizing the pulverized tissue powders, followed by centrifuging and then lyophilizing the decellularized tissue powders, to obtain acellular matrix (ACM) powders (i.e. decellularized extracellular matrix powders or ECM powder); directly applying the ACM/ECM powder, and mixing the ACM/ECM powder with SMSCs (synovium-derived mesenchymal stem cells) (Note: the mesenchymal stem cells read on the “stem cell” and/or “mesenchymal stem cell” recited in the claims 3 and/or 4); culturing SMSCs and ACM/ECM powder with or without growth factors in a DMEM medium in 24-well plates, after adding a collagen medium, thereby forming an engineered cartilage construct (abstract/lines 6-13, page 2249/left col/para 3, page 2250/left col/paras 2-3, and paragraph spanning pages 2250 and 2251, Fig. 5), wherein 67.7% of the GAGs and 88.8% of collagen in original cartilage tissue are retained in the decellularized ACM powders (page 2250: right col, last full para, lines 9-11) (Note: collagen and GAGs are extracellular matrix (ECM) components, as evidenced by the specification of the instant application, see paras 0062-63). Chang et al. further teach that the cartilage constructs formed in the presence of ACM powder are larger than those constructs formed without ACM/ECM powders (page 2252/left col/lines 1-2, Fig. 5), and ACM/ECM powders serve as a functional scaffold that benefits chondrogenesis of SMSC stem cells for cartilage tissue engineering (Abstract, last 4 lines). These teachings indicate that ACM powders (i.e. extracellular matrix or ECM powders) induce and benefit the formation of engineered cartilage constructs in the methods of Chang et al. Regarding the limitation “a cell-extracellular matrix powder self-assembly” recited in the step (b) of the claim 1, the cartilage constructs shown in Fig. 5 (from Day 7 to Day 28 in SMSC+ACM and SMSC+ACM+GF groups) are self-assemblies of cells and ACM powder (i.e. extracellular matrix powder), because these constructs are assembled and formed spontaneously after SMSC cells are cultured with the ACM/ECM powder. Indeed, Chang et al. expressively teach that the cells are attached to the ACM/ECM powder/extracellular matrix powder in the cartilage constructs (page 2252, left col, lines 2-4). Thus, the teachings of Chang et al. meet the claimed limitation.
Examiner notes that the scope of the instant claims encompasses mixing cells and ECM powder, because the step of adding ECM power to cells recited in the claim 1 would lead to the cells being mixed with the ECM powder.
The method of Chang et al. differs from the method of the claim 1 in that Chang et al. teach mixing the decellularized ECM powder and SMSC stem cells, but are silent about a specific order of adding the decellularized ECM powder and SMSC cells to a container for mixing these two components, i.e. they are silent about whether adding the ECM powder to the SMSC cells (after first adding the SMSC cells) or adding the SMSC cells to the ECM powder (after first adding the ECM powder) for mixing them. Chang et al. do not expressively teach adding the decellularized ECM powders to the SMSC cells, as required by the step (b) of the claim 1.
However, an order to add the decellularized ECM powder to SMSC cells for mixing these two components is deemed merely a matter of design choice, which is well within the purview of the skilled artisan. According to MPEP 2144.04(IV)(C), an order of adding ingredients (in the instant case, an order of adding decellularized ECM powders and SMSC cells) is prima facie obvious, absence evidence of criticality. Thus, the teachings of Chang et al. render the step of adding a ECM powder to cells recited in the claim 1 to be obvious.
It is noted that Chang et al. uses centrifugation to remove supernatant from the mixture after mixing ECM powder and cells, so as to allow the collagen culture medium to be added to the mixture without be diluted (page 2250/left col/para 2/lines 1-4). However, this centrifugation step is not essential step, because it can be readily omitted in the method of Chang et al. simply by using approaches, such as controlling a liquid volume introduced into the mixture when ECM powder and cells are initially mixed, such that no extra liquid needs to be removed by centrifugation. As such, the method of Chang et al. is an obvious variant of the claimed method consisting of the steps: decellularizing and powdering a tissue-derived ECM, adding the ECM powder to cells and culturing the cells to form a ECM self-assembly.
Regarding the limitation about a range of average size for the self-assembly recited in the claim 1, Chang et al. are silent about a specific size of the assembled constructs. However, generating an assembled construct having an average size of 1 cm or more is directed to the outcome of the claimed method. The method suggested by Chang et al. comprises all the steps recited in the instant claims. In the absence of evidence to the contrary, it is presumed that methods having substantially the same steps are capable of generating substantially the same outcomes. Thus, the teachings of Chang et al. meet the claimed limitation.
Regarding Claim 5, Chang et al. teach mixing 3 mg of ACM power with a suspension of 1.6 x 106 SMSC cells (page 2250, left col/para 2/lines 1-2). Chang et al. are silent about a total volume of the mixture and a specific concentration of the decellularized ECM powder in the mixture. However, it is deemed merely a matter of routine optimization to adjust a total volume of the mixture in the method of Chang et al. for facilitating downstream processes, thus obtaining a desired concentration of the ACM power in the claimed range. For example, if a total volume of the mixture is adjusted to be in a range of 1 ml to 10 ml, the concentration of the ACM power would be in a range from 0.3 mg/ml to 3 mg/ml, which reads on the claimed range of “0.1 to 3 mg/ml”. It is noted that a concentration generally does not support the patentability of the claimed subject matter unless there is evidence indicating such concentration is critical. Thus, the teachings of Chang et al. render the claim to be obvious.
Regarding Claim 6, the self-assembly is formed in a multiple-well plate under in vitro condition in the method of Chang et al., which meets the claimed limitation.
Regarding Claim 7, Chang et al. teach that cartilage extracellular matrix (cartilage fragments) from the knee promotes chondrogenesis of mesenchymal stem cells (abstract, lines 1-3), and ACM/ECM powders in their method serve as a functional scaffold that benefits/promotes chondrogenesis of SMSC stem cells for the formation of engineered cartilage construct (i.e. cell-extracellular matrix powder self-assembly) (abstract: left col/lines 11-13, right col/last 4 lines; Fig. 5). It is noted that chondrogenesis of mesenchymal stem cells taught by Chang et al. is a process comprising chondrogenic differentiation of mesenchymal stem cells. As such, the cell-extracellular matrix powder self-assembly in the method suggested by Chang et al. is formed by inducing cell differentiation (differentiation of the stem cells), meeting the limitation of the claim. Thus, the teachings of Chang et al. render the claim 7 to be obvious.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (Journal of Biomedical Material Research, 2013, Vol. 102A, Issue 7, pages 2248-2257, of record), as applied to Claim 1-7, further in view of Chen et al. (Cell Tissue Res., 2017, 370:41-52, of record).
Examiner notes that this rejection further renders the “meniscus”, a species of tissue-derived extracellular matrix, recited in Claim 2 to be obvious in view of Chang et al. in combination with Chen et al.
The teachings of Chang et al. are described above.
Regarding Claim 2, Chang et al. do not teach the tissue-derived extracellular matrix is meniscus. However, Chang et al. teach a cartilage tissue of the knee as the tissue-derived extracellular matrix.
Chen et al. teach that the meniscus is a fibrocartilage (a cartilage tissue) of the knee, which consists of 72% water, 22% collagen, and 0.8% GAGs (page 41, Introduction, para 1) (Note: collagen and GAGs are extracellular matrix (ECM) components, as evidenced by the specification of the instant application, see paras 0062-63). Chen et al. also teach that there is an increasing rate of injuries to the meniscus and about 50% of arthroscopic knee surgeries in the united states are related to the meniscus; and there is an urgent need to develop effective repair strategies (abstract/lines 1-2, page 41/right col/last para/lines 3-6). In addition, Chen et al. teach that decellularized ECM scaffolds are increasingly investigated as a natural replacement of injured meniscus for facilitating its regeneration, and it is believed that decellularized ECM scaffolds are the future biomaterials for successful meniscus replacement (page 42: left col/para 3/lines 1-3, abstract/last 3 lines). Chen et al. further teach that a general procedure of meniscus regeneration using the ECM scaffolds includes: decellularization of meniscus tissue, recellularization/repopulation of decellularized meniscus ECM scaffolds with appropriate cells, and implantation (page 42: right col/lines 2-7, Fig. 3), wherein mesenchymal stem cells (MSCs) are sources of cells suitable for recellularization of the decellularized ECM scaffolds (page 46, right col/para 2/lines 1-3; Fig. 3). Chen et al. further teach seeding and culturing bone marrow-derived MSCs on the meniscus ECM scaffolds under in vitro condition, and the MSCs showed the benefits of chondroprotective effect and expression of ECM (Fig. 5: Reseeding and Results in the row of Yamasaki et al., 2008; page 46/right col/para 2/lines 4-6).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method suggested by Chang et al. for forming an engineered meniscus construct and for developing an engineered meniscus for repairing damaged meniscus, wherein the articular cartilage tissue in the method of Chang et al. is replaced with meniscus cartilage tissue for preparing ACM powders (i.e. decellularized extracellular matrix powder), and the meniscus-derived ACM powders are then used as scaffolds for culturing SMSC stem cells for forming an engineered meniscus construct (i.e. a cell-extracellular matrix powder self-assembly), as taught by Chen et al. One of ordinary skill in the art would have been motivated to do so, because Chen et al. teach the rate of injuries to the meniscus is increasing and there is an urgent need to develop effective repair strategies, and the engineered meniscus from decellularized ECM scaffolds is a promising natural replacement of injured meniscus for facilitating its regeneration of menisci. Furthermore, Chen et al. teach that the meniscus is a cartilage tissue of the knee, which is rich in extracellular matrix (ECM) components (including collagen and GAGs). Application of a meniscus-derived ACM powder rich in ECM components would facilitate the process of culturing SMSC cells for formation of an engineered meniscus construct. One of ordinary skill in the art has a reasonable expectation of success at forming an engineered meniscus construct by practicing the method of Chang et al. through replacing the articular cartilage tissue with the meniscus cartilage tissue, because mesenchymal stem cells (e.g. SMSCs) are cells suitable for culturing on meniscus ACM scaffolds/powders, and the mesenchymal stem cells can be successfully seeded and cultured with the scaffolds/powders for delivering benefits to the engineered cartilage, as supported by Chen et al. Furthermore, both articular and meniscus cartilage tissues are tissues of the knee and the ACM powders generated from these tissues are decellularized ECM compositions rich in ECM components. Replacement of one ACM powder rich in ECM components with another and the results of the replacement would have been predictable.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments
Applicant's arguments about the rejection of Claims 1-7 under 35 U.S.C. 103 as over Chang et al. in the response filed on 10/23/2025 (pages 4-10) have been fully considered but they are not persuasive for the following reasons.
First, the claim 1 is currently rejected 35 U.S.C. 112(b) as being indefinite due to the limitation “the ECM does not comprise an ECM scaffold (see details above), and Applicant is required to clarify the claimed subject matter. Second, Examiner disagrees with Applicant’s assertation that the claimed invention is a scaffold-free technology or a scaffold-free method in the response (pages: 7/para 5, 8/para 5, 9/paras 2-3, and 9-10/table). As evidenced by the disclosure of the specification of the instant application (Example 4, para [0069] in pages 11 and 12), ECM powder used in the claimed method is a scaffold because the ECM powder provides its surface for stem cells to attach, adhere, and proliferate. As such, the claimed method is a scaffold-based method, not a scaffold-free method, thus not being distinct from the methods of using ECM as scaffold, taught by the cited prior art (Chang and Chen). Furthermore, Applicant’s arguments about the teachings of Chang throughout pages 6-10 of the response are based on features not recited in the claims. It is noted that the disclosure of the specification (including [0025] cited in pages 6-7 of the response by Applicant) does not read on the claims. The instant claims do not recite any limitations to define how the culturing of cells is conducted and what components a cell culture medium comprises; and the claims do not recite any limitations to require that the culturing is conducted without adding any differentiation-inducing additives or any ECM components (e.g. collagen) to the cell culture medium.
In response to Applicant’s remaining arguments based on mixing and centrifuging cells and ECM powders in the method of Chang in the 10/23/2025 response (page 7, page 9/para 3, and Table in page 9), it is noted that the instant claim 1 does not define how ECM powder is added to stem cells, and does not recite any limitation to exclude physically mixing cells and ECM powder in the claimed method. It is further noted that adding ECM power to cells (especially when cells are suspended in a liquid culture medium) would lead to the cells are physically mixed with ECM powder. In the broadest and reasonable interpretation of the claim 1, the scope of the claim encompasses physically mixing ECM power and cells after they are added to each other. Thus, the instantly claimed method is not distinct from the method of Chang with regard to physically mixing cells and ECM powder. With regard to the centrifugation used in the method of Chang, Applicant’s arguments in page 7/para 4 are not persuasive because Applicant failed to provide any factual evidence to support the centrifugation is “indispensable” for mixing cells and ECM powder in the method of Chang. As Chang indicated in page 2250/left col/para 2/lines 1-4, a mixture of cells and ECM/ACM powder had been formed before centrifugation, and the centrifugation was just used for removing supernatant from the mixture, thus allowing collagen culture medium to be added to the mixture without be diluted. This is Examiner’s position that centrifugation is not indispensable in the method of Chang and it can be readily omitted in the method of Chang simply by controlling a liquid volume introduced into the mixture when ECM powder and cells are initially mixed such that no extra liquid needs to be removed by centrifugation. As such, the method of Chang comprising mixing and centrifuging step is an obvious variant of the claimed method.
With regard to Applicant’s arguments based on the collagen culture medium (collagen gel medium) used in the method of Chang in the 10/23/2025 response (page 7/last full para, page 9/paras 2-3, and Table in pages 9-10), they are not persuasive because the instant claims do not recite any limitations to define any specific components in a cell culture medium used in the culturing step, or to require the cell culture medium does not comprise any ECM components (e.g. collagen), as indicated above. Furthermore, the ECM powder used in the claimed method comprises ECM components including collagen. As such, the instantly claimed method cannot be considered as a gel-free or collagen-free method, and it is not distinct from the method of Chang.
With regard to Applicant’s arguments based on exogenous growth factors included in the culture medium in the method of Chang in the 10/23/2025 response (the para spanning pages 7 and 8, page 9/para 3, and Table in page 10), they are not persuasive because the instant claims do not recite any limitations to define any specific components in a cell culture medium used in the culturing step, or to require the cell culture medium does not comprise any exogenous growth factors (e.g. TGF-beta and BMP-2), as indicated above. The scope of the instant claims encompasses culturing cells in the presence of growth factors. As such, the instantly claimed method cannot be considered as a growth factor-free method, and it is not distinct from the method of Chang.
In response to Applicant’s arguments based on self-assembly in the claimed method in the 10/23/2025 response (pages: 7/para 3, 8/paras 2-4, and Table in pages 9-10), it is noted that generating an ECM assembly is directed to the outcome of the culturing step recited in the claimed method. Further, the instant claims have a very broad scope and they comprise steps at a high level of genericity. There is no distinction between the claimed method and the method suggested by Chang, because the method suggested by Chang comprises all the steps recited in the claims, and because the cartilage constructs produced by the method of Chang can be considered as ECM self-assemblies in view of the fact that these constructs are assembled and formed spontaneously after cells are cultured with ECM powder. Furthermore, Applicant’s arguments in paras 2-3 of page 8 are based on features not recited in the claims. Specifically, the instant claims do not recite any limitations to define “a precise and step-by-step control of cell and ECM processing conditions”, “formation of natural musculoskeletal tissue”, or to require “stem cells are aggregated in high concentrations and undergo sufficient interaction before being assembled” (emphasis added) (Examiner notes that none of the claims 1-7 defines cell concentrations). With regard to Applicant’s arguments based on structural differences between the constructs generated by the method of Chang and that by the claimed method, they are not persuasive because Applicant failed to provide factual evidence to support that the constructs of Chang indeed have low expression of cartilage /fibrocartilage-specific markers and poor structural integrity when compared to those of the claimed invention.
In response to Applicant’s arguments based on a size of the construct formed by the claimed method in the 10/23/2025 response (pages: 8/last para, 9/paras 1 and 3, and Table in page 10), it is noted that nowhere of Chang teaches the assemblies or constructs generated by their method have a size of several milliliters, and Applicant failed to provide factual evidence to support these arguments. Furthermore, generating an assembly with an average size of larger than 1 cm is directed to the outcome of the claimed method. As indicated above, the method suggested by Chang comprises the steps same as those recited in the instant claims, and it is presumed that methods having substantially the same steps are capable of generating substantially the same outcomes. Thus, the teachings of Chang meet the claimed limitation.
Accordingly, Applicant’s arguments based on the differences between the claimed method and Chang’s method displayed in the table of pages 9-10 are unpersuasive and they are not commensurate in scope with the instant claims for the reasons indicated above.
Overall, the conclusion of the obviousness of the claims 1-7 over Chang has been established for all the reasons indicated above.
Applicant's arguments about the rejection of Claims 1-7 under 35 U.S.C. 103 over Chang et al. in view of Chen et al. in the response filed on 10/23/2025 (pages 10-13) have been fully considered but they are not persuasive for the following reasons.
First, Applicant’s arguments about the claimed invention is scaffold-free and does not need scaffolds or differentiation-inducing agents in the response (page 11/para 3, page 12/paras 1 and 3, and table of pages 12-13) are not persuasive for the reasons indicated above. In addition, Applicant’s arguments based on cell sources in page 12/para 2 of the response are based on features not recited in the claims, since none of the claims limits cells to be meniscus/cartilage-derived stem cells. It is further noted that the claim 1 does not recite any limitations to limit cells used in the claimed method, and claim 4 is the only claim that limits cells to be stem cells (including mesenchymal stem cells, i.e. MSCs). The fibrochondrocytes and bone marrow SMCs taught by Chen read on the “cells” and “mesenchymal stem cell” in the claims 1 and 4, respectively. As such, there are no fundamental differences between cell sources of Chen and the claims. Furthermore, in response to Applicant’s arguments based on meniscus and cartilage in page 11/last para of the response, regardless of how meniscus is different from cartilage, it is well known in the art that artificially engineered constructs/assemblies of both meniscus and cartilage can be successfully generated through decellularizing meniscus/cartilage and recellularizing the decellularized meniscus/cartilage ECM with stem cells, as supported by Chen and Chang. Thus, it would have been obvious to one of ordinary skill in the art to replace cartilage with meniscus in the method of Chang for preparing meniscus ECM-induced tissues in view of it comprises effectively decellularizing and recellularizing processes for preparing ECM-induced constructs or assemblies.
In response to applicant's remaining arguments based on comparison between the method of Chen and the claimed invention in pages 11-13 of the response, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
As indicated above, Chen teaches artificially engineered meniscus constructs are a promising natural therapy of injured meniscus, and the artificial meniscus constructs can be successfully prepared from decellularizing meniscus and recellularizing the decellularized meniscus ECM with stem cells; and also teaches the meniscus is rich in ECM components, and the decellularized meniscus ECM powders rich in ECM would facilitate recellularization with stem cells and formation of artificial meniscus constructs. Given the method of Chang comprises all of the decellularizing and recellularizing steps needed for preparing artificial ECM-induced tissues, it would have been obvious to prepare artificial ECM-induced meniscus tissues in the method of Chang.
Overall, the conclusion of the obviousness of the claims 1-7 over Chang in view of Chen has been established for all the reasons indicated above.
Conclusion
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 extension fee 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 date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600.
/Qing Xu/
Patent Examiner
Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656