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 .
Applicant’s submission filed on June 23, 2026 has been entered and considered. Rejections and/or objections not reiterated from the previous action mailed April 7, 2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-5 in the reply filed on March 12, 2026 is acknowledged.
Claims 6-13 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claim 1 has been amended to recite suspension culturing and claim 4 has been amended similarly. Claim 2 has been canceled. Claim 14 was previously canceled. Claim 15 is newly added. Claims 6-13 are withdrawn.
Claims 1, 3-5, and 15 are examined on the merits.
Priority
The instant application is a 35 U.S.C 371 national stage filing of the International Application No. PCT/KR2022/007991 filed on June 7, 2022. The instant application claims foreign priority under 35 U.S.C 119(a)-(d) to Korean Patent Applications KR10-2021-0075824, filed on June 11, 2021. Receipt is acknowledged of a certified copy of the foreign patent application in the original language as required by 37 CFR 1.55. Thus, the earliest possible priority for the instant application is June 11, 2021.
Claim Rejections - 35 USC § 103
Claims 1, 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (US 20190070337, hereafter “Yang”, found in IDS) in view of Berniakovich et al. (2012, N-acetylcysteine protects induced pluripotent stem cells from in vitro stress: impact on differentiation outcome. Intl. J. of Dev. Bio., 56(9), 729-735, prior art of action dated 2/26/2026, hereafter “Berniakovich”) and Francis (2010, Albumin and mammalian cell culture: implications for biotechnology applications. Cytotech., 62(1), 1-16) and as evidenced by Corning Costar Ultra-Low Attachment Multiple Well Plates (as cited in 102 rejections above).
This is a new rejection necessitated by Applicant’s amendment. However, this rejection shares substantial similarity to the rejection as previously set forth in the office action dated April 7, 2026. Any aspect of Applicant’s traversal that pertains to the rejection as newly set forth will be provided following the new statement of rejection.
With regard to claim 1, Yang teaches a method of manufacturing a multilayered cell sheet of neural crest stem cells (NCSCs) derived from peripheral nerves (Abstract), which are considered to reasonably read on peripheral nerve derived stem cells (PNSCs) in order to form a composition which can be used to treat peripheral nerve injury (Para. [0010]), which is considered to reasonably read on a peripheral-nerve mimicking microtissue. Yang teaches that isolated PNSCs are cultured and expanded via monolayer culture, collected and subcultured (Para. [0104] and [0106], also see Example 2, 2) In Vitro Proliferation Capacity) for expansion of PNSCs. Additionally, Yang teaches that PNSCs are cultured in “non-stressed” culture conditions which prevent cells from adhesion to the culture plate and induce microsphere formation (Para. [0086, 0124]), which is considered to reasonably read on suspension culture. Further, Yang teaches culture of PNSC microspheres in culture medium comprising 0.1 µM dexamethasone (DEX) (Para. [0124]).
Yang is silent as to the use of N-acetylcysteine (NAC) and human serum albumin (HAS) in the culture media. However, Yang teaches that as culture time increases during suspension culture, the PNSC microspheres suffer from cell damage and death due to lack of availability of oxygen and nutrients and that the frequency of apoptosis is increased in proportion to the culture period (Para. [0140]).
Berniakovich teaches that longer term in vitro culture of stem cells exposes cells to environmental factors, particularly oxidative stress, which can decrease cellular performance and viability (Abstract). Berniakovich et al. teaches that NAC is a potent antioxidant known to be able to inhibit cellular damage and apoptosis and function as a cytoprotective agent (Pg. 730, left col., last para.) and that supplementation of NAC to stem cells in culture, at a concentration of 1mM (Pg. 733, right col. 2nd para of Culture and Differentiation of iPSCs), reduces reactive oxygen species and nitric oxide thereby reducing apoptosis (Abstract and Pg. 733, right col., 1st full para.).
Francis, in a review, teaches that use of albumin, including human serum albumin, has long been known as a design component in cell culture media (Abstract). Francis teaches that albumin is known to have beneficial effects on cell culture including anti-apoptotic effects (Pg. 11, left col., 1st para.), protecting against oxidative stress (Pg. 4, left col., 2nd para.), and helping to deliver substances such as lipids, amino acids, hormones, peptides, etc. which support cellular growth (Pg. 12, right col., 2nd para.). Additionally, specific to stem cell culture, Francis teaches that albumin is beneficial by virtue of its interaction with other biological factors such as insulin and EGF and that human serum albumin is beneficial to stem cell culture while also avoiding regulatory concerns regarding use of animal-derived products which is important in biomedical uses (Pg. 11, right col., 1st para.). Francis references a particular example where use of HSA at 5 mg/mL (i.e., 0.5%) in stem cell culture was superior to bovine serum albumin during differentiation of human embryonic stem cells (Pg. 11, right col., 2nd para.).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cell culture medium for use in the method of manufacturing a peripheral nerve-mimicking microtissue as taught by Yang such that it includes NAC as taught by Berniakovich and HSA as taught by Francis with a reasonable expectation of success. Because Yang teaches that PNSC microspheres suffer from increased apoptosis and cellular damage proportional to their time in culture, a skilled artisan would have been motivated to supplement the cell culture medium of Yang with NAC because Berniakovich teaches that NAC serves as a cytoprotectant which can reduce cellular stress and apoptosis of stem cells caused by in vitro cell culture. Additionally, Francis also teaches that HSA provides beneficial anti-apoptotic effects (Pg. 11, left col., 1st para.), protects against oxidative stress (Pg. 4, left col., 2nd para.), and helps to deliver substances such as lipids, amino acids, hormones, peptides, etc. which support cellular growth (Pg. 12, right col., 2nd para.). Thus, both NAC and HSA were known in the art at the time of filing to be useful in supporting cells in culture.
Further, although Yang teaches use of medium comprising calf serum (Para. [0124]), Francis teaches that use of calf serum/fetal bovine serum is undesirable in large scale mammalian cell culture based on risk of biological contaminants and safety concerns (Pg. 2, left col. 1st para.) and that albumin, including HSA (Pg. 2, right col., 1st full para.), has been used the development of media which avoids animal-derived components (Pg. 2, left col., 1st & 2nd paras.) which is of particular concern for biomedical applications (Pg. 11, right col., 1st para.) including tissue repair and engineering applications (Pg. 11, right col., 2nd para.). Therefore, a skilled artisan would have recognized, at the time of filing, that addition of HSA in stem cell culture media could serve as a replacement for traditional use of calf serum while avoiding regulatory concerns surrounding use of animal products in biomedical applications, given that Yang teaches use of the peripheral nerve mimicking microtissue for use in transplantation (Para. [0097]). One of ordinary skill in the art would have had a reasonable expectation of success as addition of HSA and NAC to culture medium were known in the art at the time of filing to provide beneficial effects during the culture of stem cells.
With regard to claim 3, as detailed above, the combination of Yang, Berniakovich, and Francis teaches a method of making a peripheral-nerve mimicking microtissue comprising monolayer culture and collection of monolayer cultured PNSCs for expansion and suspension culture in order to form PNSC microspheres in a culture medium comprising DEX, NAC, and HSA. As stated above, Yang teaches culture medium comprising 0.1 µM DEX (Para. [0124]), Berniakovich teaches that a concentration of 1mM NAC (Pg. 733, right col. 2nd para of Culture and Differentiation of iPSCs) in culture medium can be used as a cytoprotective agent (Pg. 730, left col., last para.) to reduce oxidative stress and prevent apoptosis (Abstract and Pg. 733, right col., 1st full para.), and Francis teaches that a concentration of 5mg/ml, i.e. 0.5%, of HSA was shown to be beneficial in the differentiation of stem cells in culture (Pg. 11, right col., 2nd para.)
With regard to claim 4, Yang teaches that culture of PNSCs in “non-stressed” or free-floating culture conditions, which prevents cellular adhesion to the culture plate, induces cell-to-cell adhesion and microsphere formation (Para. [0086, 0124]).
Response to Arguments
Applicant's arguments filed June 23, 2026 are acknowledged and have been fully considered but they are not persuasive.
Claims 1-4 were rejected under 35 U.S.C. 103 over Yang in view of Berniakovich and Francis. Claim 2 has been canceled rendering traversal of the rejection of claim 2 moot.
Regarding motivation, Applicant traverses that the prior art of Francis teaches away from using HSA to promote cell-to-cell binding as Francis teaches that albumin coating prevents cell adhesion. Therefore, a skilled artisan would have been led away from use of HSA in order to promote the cell-to-cell binding required to form the claimed microtissue. Applicant further traverses that as Yang does not teach or suggest HSA or NAC, the Office had relied on impermissible hindsight and that the combination of references would change Yang’s principle of operation.
Applicant's traversal has been fully considered but is not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Yang teaches use of culture medium for PNSC microspheres comprising 0.1 µM DEX. Berniakovich teaches use of 1mM NAC as beneficial in stem cell culture for promotion of cell survival. Francis teaches use 0.5% HSA in culture and that use of HSA also promotes cell survival. Further, Francis teaches that HSA has been used as a replacement for animal serums as it eliminates risks of biological contaminants and avoids safety concerns which is critical for therapeutic use of stem cells. Therefore, a skilled artisan would have been motivated to add NAC and replace calf/bovine serum with HSA in stem cell culture medium in order to promote cell survival and eliminate barriers to therapeutic use.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding Applicant’s traversal of teaching away, Francis’s teaching regarding non-adherence is based on albumin coating of non-cellular substrates such a dishes. Regarding albumin adherence, in order to complete the art of record and address Applicant’s arguments Francis cites Yamazoe et al. (2008, Preparation of water‐insoluble albumin film possessing nonadherent surface for cells and ligand binding ability. J. of Bio. Mater. Res. Part A, 86(1), 228-234) which evidences that the use of albumin at 3% and 5% (Table II, Table III), significantly higher than the albumin concentration as instantly claimed and 10 times greater than the amount of albumin Francis teaches for use in cell culture. Francis teaches that albumin is being widely investigated and used in stem cell culture particularly for use in tissue repair and engineering (See Pg. 11). Therefore, a skilled artisan would have been led to use HSA based on the teachings of Francis.
Regarding unexpected results, Applicant traverses on Pg. 9, 2nd para.) that addition of HSA to serum free media increases the frequency of microtissue formation and increases microtissue size based on HSA concentration which is a previously unrecognized function of HSA. Applicant also traverses that the combination of NAC and DEX in the instantly claimed culture medium results in the allegedly unexpected result of increased cytoprotection which is superior to NAC and DEX alone and that the instantly claimed medium comprising HAS, DEX, and NAC confers an allegedly unexpected result of increased cytoprotection as indicated by reduced expression of cell-death regulating factors when compared to monolayer PNSCs (Pg. 10, 1st and 2nd para.).
Applicant's traversal has been fully considered but is not persuasive.
With regard to microtissue formation, Applicant’s microtissues were cultured in DMEM/F12 media with 1µM DEX and 1mM NAC at a particular plating density (1.0 x 105 PNSCs per cm2) (Example 2) and investigated HSA concentrations of 0.01%, 0.1% and 1% in microtissue formation (Fig. 3). Although Applicant asserts that the instant findings that addition of HSA to serum-free media increased frequency of microtissue formation, Applicant’s instant specification does not appear to indicate significant differences in the frequency of microsphere formation related to HSA (See Fig. 3C). Applicant asserts that the relationship between microsphere size and HSA concentration is a previously unknown property of HSA. However, a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements regarding unusually low immune response or unexpected biological activity that were unsupported by comparative data held insufficient to overcome prima facie case of obviousness).
As detailed supra, the prior art of Francis teaches that HSA can be used in place of animal-based serums in stem cell culture and that 0.5% HSA was shown to be beneficial. Therefore, a skilled artisan, looking to use HSA instead of animal-based serums and at a concentration as taught by Francis, or even to replace calf serum at the same concentration as taught by Yang (1%, Para. [0124]), would have experienced the claimed instant effects on microtissue size which appears to be related to the concentration of HSA. Since the HSA concentration is taught by the prior art, the result of use of the concentration taught in the prior art necessarily flows from the teachings of the prior art.
With regard to cytoprotection, as detailed supra, the prior art of Yang teaches use of culture media comprising DEX. The prior art of Berniakovich teaches that NAC serves as a cytoprotectant which reduces cellular stress and apoptosis of stem cells caused by in vitro cell culture. The prior art of Francis teaches that HSA provides anti-apoptotic effects (Pg. 11, left col., 1st para.), protects against oxidative stress (Pg. 4, left col., 2nd para.), and helps to deliver substances such as lipids, amino acids, hormones, peptides, etc. which support cellular growth (Pg. 12, right col., 2nd para.). Therefore, based on the teachings of the prior art, a skilled artisan would expect that addition of NAC and HSA to Yang’s medium would result in increased cytoprotection and enhanced cell survival which would be associated with reduction in cell-death promoting factors. Furthermore, Applicant’s method requires no cryopreservation step, thus any purported unexpected results with regard to cryopreservation are not commensurate in scope with the claimed invention.
With regard to criticality of ranges, Applicant traverses on Pg. 10, last para. that the ranges as claimed in claim 3, 0.01 to 1% HSA, 0.1 to 5 µM DEX, and 0.1 to 10 mM NAC, are critical and that these particular ranges produce the allegedly unexpected cytoprotection and enhanced microtissue formation which is not taught by the prior art. Applicant traverses that although Yang, Berniakovich, and Francis all teach values of the components within the range of the instant claims, no reference teaches or suggests the combination of components.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As detailed supra, the obviousness rejection relies on the combination of Yang’s teaching of 0.1 µM DEX, Berniakovich’s teaching of 1mM NAC, and Francis’s teaching of 0.5% HSA which renders the instantly claimed culture medium comprising DEX, NAC, and HSA obvious. With regard to enhanced microtissue formation, based on Applicant’s disclosure, microtissues were formed in DMEM/F12 media with 1µM DEX and 1mM NAC at a particular plating density (1.0 x 105 PNSCs per cm2) (Example 2), with microsphere formation varying widely based on concentration of HSA (Fig. 3) and well as cell seeding (Fig. 4). Therefore, the “enhanced” microtissue formation as asserted by Applicant has not been shown across the breadth of instantly claimed ranges of DEX, NAC, and HSA.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Berniakovich and Francis as evidenced by Corning Costar Ultra-Low Attachment Multiple Well Plates as applied to claim 1 and in further view of Gil‐Perotín et al. (as cited in 102 rejections above).
With regard to claim 5, as detailed above, the combination of Yang, Berniakovich, and Francis teaches a method of making a peripheral-nerve mimicking microtissue comprising monolayer culture and collection of monolayer cultured PNSCs for expansion and suspension culture in order to form PNSC microspheres in a culture medium comprising DEX, NAC, and HSA. Yang teaches culture of PNSCs in “non-stressed” culture conditions which prevents cells from adhering to the culture plate and induces microsphere formation (Para. [0124]), which is considered to reasonably read on a spheroid cell structure.
Although Yang is silent as to the specific size of the formed microspheres, Yang’s teaching indicates that seeded PNSCs in suspension culture self-aggregate to form microspheres.
Gil-Perotin teaches that neural stem cells have therapeutic potential in regenerative medicine (Abstract) and that isolated neural stem cells in in vitro culture exist as nonadherent aggregates called “neurospheres” (Pg. 1436, left col., 3rd para.) which are spherical in shape (Pg. 1437, right col., 1st para., line 9) and where the number of cells is correlated with neurosphere size, usually between 100-200 µm in diameter (Pg. 1437, right col., 1st para., lines 10-12). Gil-Perotin further teaches that neurospheres that are 200 µm in diameter exhibit high rates of cell death at the core of the neurosphere (Pg. 1443, left col., last para. and Fig. 5) which Gil-Perotin attributes to lack of diffusion of nutrients and oxygen to the center of the neurosphere (Pg. 1445, right col., 1st para.). Thus, based on Gil-Perotin’s teachings, a skilled artisan would be likely to generate neurospheres which are below 200 µm in diameter.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to choose spheroid cell structures which are 100 ± 20 µm in size as taught by Gil-Perotin in Yang’s method of making a peripheral nerve mimicking microtissue because Gil-Perotin teaches that larger cellular spheres, closer in size to 200 µm in diameter, suffer from high rates of apoptosis at the center of the cell based on lack of nutrients and oxygen. A skilled artisan would have recognized that choosing microspheres of the instantly claimed size of 100 ± 20 µm would lead to a peripheral nerve mimicking microtissue which was large enough to be easy to work with but small enough to avoid high apoptosis of the cells. A skilled artisan would have had a reasonable expectation of success as both Yang and Gil-Perotin teach generation of spherical cellular structures derived from nervous system derived stem cells for use in regenerative medicine and Gil-Perotin teaches that neurospheres self-aggregate to a size between 100-200 µm.
Further, using the formula for volume V = 4/3πr3 and based on an average cell diameter of approximately 10 µm, a single cell with a radius of 5µm would have volume of approximately 524 µm3 (Vcell = 4/3π(53). The volume of an 100 µm sphere is approximately 523,599 µm3 (Vsphere = 4/3π(503). Therefore, the maximum number of 10 µm cells which could fit in 100 µm sphere would be approximately 1,000 cells (523,599/524). Since spheres cannot fill 100% of the space and accounting for a packing efficiency of approximately 74%, approximately 740 cells would be contained in a 100 µm sphere. As Yang teaches that some cells in the microsphere are differentiated (Paras. [0124] and [0125]), it is understood that not all the cells in the 100 µm sphere would be PNSCs and therefore expected that the number of PNSCs in a 100 µm sphere would be within the instantly claimed range of 100 to 500 PNSCs.
Additionally, based on Gil-Perotin’s teaching that neurosphere size is based on the number of cells, a skilled artisan could readily envision adjustment of the microsphere size by adjustment of the number of PNSCs seeded per well in order to arrive at the instantly claimed sphere comprising 100 to 500 PNSCs and having an ideal diameter of 100 ± 20 µm, as taught by Gil-Perotin, through routine optimization.
With regard to newly added claim 15, as detailed supra Yang teaches culture of PNSCs in “non-stressed” culture conditions which prevents cells from adhering to the culture plate and induces microsphere formation (Para. [0124]), which is considered to reasonably read on a spheroid cell structure. Gil-Perotin teaches that, in vitro, neurospheres are between 100-200 µm in diameter (Pg. 1437, right col., 1st para., lines 10-12) and that choosing neurospheres having a diameter of 100 ± 20 µm and comprising 100 to 500 cells would avoid apoptosis seen in larger neurospheres.
Yang teaches that extracellular matrix (ECM) is produced and secreted by PNSCs during culture (Para. [0009], [0012], [0016], [0068]) and that the ECM includes laminin and collagen type IV (Para. [0081], Fig. 21). Additionally, Yang teaches that PNSC microspheres are formed by cell-to-cell adhesion (Para. [0124]) and that β-catenin is responsible for cell-to-cell adhesion and that CD29 is involved with cell-to-extracellular matrix adhesion (Para. [0159], Fig. 27).
Response to Arguments
Applicant's arguments filed June 23, 2026 are acknowledged and have been fully considered but they are not persuasive.
Claim 5 was rejected under 35 U.S.C. 103 over Yang in view of Berniakovich and Francis and in further view of Gil-Perotin.
Applicant traverses that Gil-Perotin teaches away from the instantly claimed microtissue because Gil-Perotin identifies that neurospheres which reach 200 µm in diameter exhibit apoptosis at the center and thus points away from a transplantable microtissue. Applicant asserts that Gil-Perotin teaches culture of central nervous system neural stem cells with EGF and FGF-2 and not the instantly claimed cell culture media comprising DEX, NAC, and HSA which solves the apoptosis problem as disclosed by Gil-Perotin. Applicant further traverses that the volumetric and packing calculation used to arrive at the instantly claimed number of cells in a microtissue is based on central nervous system neurospheres and an “assumed average cell diameter” of approximately 10 µm.
Applicant's traversal has been fully considered but is not persuasive.
As detailed supra, since Gil-Perotin discloses neural stem cells self-aggregate in culture, a feature also disclosed in the prior art of Yang, and that larger neurospheres experience apoptosis at the core, a skilled artisan would have known to choose neurospheres (or adjust culture conditions via cell density plating) in order to generate neurospheres which are smaller in size, such as the instantly claimed size of 100 ± 20 µm. In addition to apoptosis, Gil-Perotin also discloses challenges with nutrient delivery (Pg. 1445, right col., 1st para.); the prior art of Berniakovich and Francis disclose that NAC and HSA both provide anti-apoptotic effects and Francis discloses that HA protects against oxidative stress and helps to deliver substances which support cellular growth. Thus, as the combination of DEX, NAC, and HSA is made obvious by the prior art and the cell-survival effects of the combination of DEX, NAC, and HSA is also obvious, a skilled artisan would not conclude from the combination of Yang, Berniakovich, Francis, and Gil-Perotin that use of the instantly claimed media for microtissue culture would reduce viability problems. Regarding the calculation for number of cells in a microsphere, 10 µm is a generally accepted cell size for most mammalian cells which would be well known to one of ordinary skill in the art and the volumetric formula has been used in order to support the approximate number of cells in an approximately 100µm microsphere. Since the Patent Office does not have the facilities for examining and comparing applicants' microspheres with the neurospheres of the prior art reference, the burden is upon applicants to show a distinction between the material structural and functional characteristics of the claimed cells and the cells of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Regarding newly added claim 15, Applicant asserts that Yang, BerniakovicH, Francis, and Gil-Perotin do not teach the instantly claimed cellular architecture of the microsphere. This is not considered persuasive as the claimed architecture is supported by the prior art of Yang as detailed supra.
Conclusion
No claims are 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 ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631
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