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 amendment and response filed on 1/19/2026 has been received and entered into the case.
Claims 2 and 18 have been canceled, and claims 1, 3-17 and 19-22 have been considered on the merits. All arguments have been considered.
The claim rejection under 35 USC 112 has been withdrawn due to the instant amendment.
The claim rejection under 35 USC 103 has been withdrawn due to the instant amendment and replaced with the following claim rejection. It is noted that the following rejection is mainly the same except addressing the limitation directed to the administering step without further culturing the pooled allogeneic MSC population after pooling step (in bold).
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.
Claim(s) 1, 3, 5-17 and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (2020, Stem Cell Research & Therapy; IDS ref.) in view of Ta et al. (WO2012/131618), Balasubramanian et al. (2012, Cytotherapy) and Ardanaz et al. (2016, BMC Veterinary Research) and in further view of Gao et al. (2016, Cell Death and Disease) and Liu et al. (2019, Brain Research)
Zhang et al. teach a method of treating patients with COVID-19 pneumonia by administering human umbilical cord Wharton’s jelly-derived mesenchymal stem cells (hWJCs)(see entire document). Zhang et al. teach that the hWJCs have shown very significant immunomodulation and tissue repair effects with low immunogenicity, which makes them a very ideal candidate for allogeneic adoptive transfer therapy, and may have beneficial effects on preventing or attenuating the cytokine storm (p.2, 1st col., 1st para.). According to the hWJC preparation taught by Zhang et al. (p.2), it is considered that the hWJCs of Zhang et al. are isolated allogeneic MSCs.
Zhang et al. do not teach the isolated allogeneic MSCs utilized by the method of Zhang et al. are pooled MSC population.
Ta et al. teach a method of isolating, culturing and pooled allogeneic Wharton’s jelly-derived mesenchymal cell population from multiple donors (Abstract). Ta et al. teach that Wharton’s jelly derived MSCs (WJ-MSCs) from each individual are cultured and passaged and Master Cell Bank (MCB) of each individual umbilical cord is established, and pooling is from plurality of established MCB to establish a Working Cell Bank (WCB), and both MCB and WCB are cryopreserved in cryopreservation composition for further use or used directly (p.8, lines 16-31; p.15, lines 6-12).
Regarding the MSCs having at most been subject to ten passages, Ta et al. teach that MCB is established at P1 (p.19, lines 21-23). Furthermore, Ta et al. teach WJ-MSCs at passage 2 (P2/P3) can be used for as therapeutic composition (p.20, lines 8-10), and this teaching would meet the limitation.
It would have been obvious to a person skilled in the art to use isolated allogeneic pooled hWJCs taught by Ta et al. in the method of Zhang et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the use of pooled MSCs is known in the art as taught by Ta et al., and the use of pooled MSCs is beneficial because they are more constant or consistent characteristics as compared to the individual cells, and the pooled MSCs have equal if not more efficient effect in suppressing T cell proliferation (p.12, lines 20-22; p.24, lines 2-11). Furthermore, Balasubramanian et al. teach that pooling the MSCs would minimize the donor to donor variability while assuring consistent availability of MSC for both experimental and therapeutic use according to (p.31, 1st col. Discussion).
Regarding the wherein clause directed to the number of MSCs derived from any one donor does not exceed 50% of the total cell number (claim 1), the wherein clause is a product-by-process limitation limiting the pooled MSCs. The product-by-process limitation does not require the process steps as active steps required by the claimed method of treating. Rather the product-by-process limitation would provide a structure limitation to the pooled MSCs but does not require the process steps per se. See MPEP2113.
Therefore, at most, the product produced by the steps of the wherein clauses is isolated pooled allogeneic MSC population comprises the number of cells from any one donor without exceeding 50% of the total cell number, and they are from at least 3 individual donors.
As Ta et al. teach that the pooling is in equal number of MSCs from each cord (p.20, lines 1-2) and Ta et al. exemplified 5 individual samples (Fig. 1), the combined teachings of Zhang et al. in view of Ta et al. and Balasubramanian et al. would meet the limitation.
Regarding the wherein clause directed to the process of obtaining the pooled MSCs (claim 1) including the number of passages, assaying, allocating, selecting and pooling in order to obtain the product of pooled MSCs, the limitations are considered a product-by-process limitation limiting the pooled MSCs, but the product-by-process limitation does not require the process steps as active steps required by the claimed method of treating. Thus, the product-by-process limitation would be considered in terms of structural limitation to the pooled MSCs but does not require the process steps per se. See MPEP2113.
Therefore, at most, the product produced by the steps of the product-by-process limitations is the isolated pooled allogeneic MSC population from at least 3 individual donors. Thus, the combined teachings of Zhang et al. in view of Ta et al. and Balasubramanian et al. would meet the product and the method of using the product as claimed.
It is noted that the assays disclosed in the product-by-process limitation do not provide any structural limitation to the product because the assays is merely stated as a measuring step without requiring any structure/properties of MSCs. Nevertheless, these characteristics measured by the assays, i.e. IDO and PGE2 expression, proliferating PBMCs and/or immunosuppression of T cells, etc. are well known in the art as MSCs inherent properties according to Gao et al. or Liu et al. Gao et al. teach that immunomodulation of MSCs is mediated by soluble factors including TGF-b, PGE2, HGF, IDO, NO and IL-10, and MSCs secrete various enzymes and soluble factors such as COX-2, PGE2 and IDO that mediate immunosuppressive activity (p.2, 2nd col.). Gao et al. teach that PGE2 is dramatically upregulated after co-culture of MSCs with peripheral blood mononuclear cells (PBMCs) and to inhibit T-cell proliferation (p.2, 2nd col.). Liu et al. teach that MSCs enhance microglia M2 polarization (see entire document).
Regarding the administering step of the isolated, pooled allogeneic MSC population without further culturing after the pooling step and before the administering step (claim 1), Zhang et al. in view of Ta et al. and Balasubramanian et al. do not teach the limitation.
Ardanaz et al. teach that pooled allogeneic MSCs from 5 donors are administered to a horse to treat musculoskeletal injuries (Abstract; Method at p.6, 2nd col. “Study design”).
It would have been obvious to a person skilled in the art to use the pooled MSCs populations from multiple donors without further culturing prior to the administration. A person of ordinary skilled in the art would have been motivated to do so because one skilled in the art would recognize that there are two options that the pooled cells can be used directly without further culturing after pooling or the pooled cells can be further cultured. As it is known in the art that pooled cells can be administered without further culturing the pooled cells according to Ardanaz et al., using the pooled MSCs directly without further culturing would be one obvious option, particularly in the absence of any evidence supporting unexpected results.
Regarding claims 3 and 16 directed to an additional step of exposing the isolated pooled allogeneic MSC population to proinflammatory factors before administration, Zhang et al. in view of Ta et al., Balasubramanian et al. and Ardanaz et al. do not teach the limitation. However, Gao et al. teach that the immunomodulation by MSCs is enhanced when the MSCs are pretreated/preconditioned with IFN-g (p.6, 2nd col.; p.8, 1st col., Modification of MSCs).
It would have been obvious to a person skilled in the art to precondition the isolated pooled allogeneic MSCs taught by Zhang et al. in view of Ta et al. Balasubramanian et al. and Ardanaz et al. with IFN-g to enhance their immunomodulatory effect taught by Gao et al. for the method of treating COVID-19 with a reasonable expectation of success.
Regarding claim 5 directed to the MSCs being derived from a native MSC source, the hWJCs of Zhang et al. are considered as native MSCs, and one skilled in the art would utilize pooled hWJCs in the method of Zhang et al. based on the teaching of the teaching by Ta et al. Thus, the combined teachings of Zhang et al. in view of Ta et al., Balasubramanian et al. and Ardanaz et al. would meet the limitation.
Regarding claims 8, 18-11 and 21, the limitations are interpreted as a part of the wherein clause directed to the method steps of obtaining the pooled allogeneic MSC population of claim 1 rather than an additional step to the administering step for treating the COVID-19 infection. As discussed above, this limitation as a part of the product-by-process does not provide any structure to the pooled MSCs, the limitation does not provide patentable weight in determining the patentability of the claimed method of treating COVID-19 infection.
Regarding claims 9, 12-15 and 22, the wherein clause of the claim is directed to the results, and they do not require any active steps to be carried out for the claimed method. Thus, these limitations do not provide any patentable weight in determining patentability of the claimed method. Furthermore, as the combined teachings of Zhang et al. in view of Ta et al., Balasubramanian et al. and Ardanaz et al. meet the claimed steps, the same results as claimed are expected from the method taught by the cited references.
Regarding claim 17, Zhang et al. teach the administration of MSCs is intravenously (Abstract).
Regarding claim 20, as discussed above, Ta et al. teach that pooling MSCs from 5 individual donors (Fig. 1). Thus, it would have been obvious to a person skilled in the art to pool 5 individual donors for the pooled allogeneic MSCs for the method of treating COVID-19.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. in view of Ta et al., Balasubramanian et al. and Ardanaz et al. in further view of Gao et al. as applied to claim 3 above, and further in view of Wang et al. (2016, Human Vaccines & Immunotherapeutics).
Regarding claim 4 directed to an additional step of exposing the isolated pooled allogeneic MSC population to proinflammatory factors for a period of about 1-24 hours before administration, while Gao et al. teach the preconditioning, however, they do not teach the limitation directed to the duration, i.e. about 1-24 hours.
However, Wang et al. teach that the priming or pretreatment of Wharton’s jelly derived human MSCs with IFN-g for 24 hours (Abstract; p.93, 2nd col., 1st full para.).
It would have been obvious to a person skilled in the art to pretreat the pooled hWJCs of Zhang et al. in view of Ta et al. with IFN-g prior to administration because such pretreatment/preconditioning/priming would enhance immunomodulation effect of MSCs in the therapeutic application as taught by Gao et al. as well as Wang et al., and the duration of such pretreatment would be 24 hours as taught by Wang et al. with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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.
Claim 1, 3-17 and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-7, 14-20 and 23 of copending Application No. 17/634,436 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘436 application disclose a method of obtaining an isolated, pooled allogeneic MSC population using at least 3 assays, any one donor not exceeding 50% of the total cell number, and the 3 assays include measuring IDO activity, PGE2 secretion, and measuring proliferation of PBMC, and at least one of the at least 3 assays being MSCs effect on T cells to suppress an immune response, or assay on monocytes or microglia cell, and the selection is based on the scoring system allocated to the results of each assay and the total score value being used for the selection. These are the same method steps disclosed in the claims of the instant application. The type of MSCs of the ‘436 application includes WJ-MSCs as the instant application.
Regarding the step of administering the isolated, pooled allogeneic MSC population to treat COVID-19 infection of the instant application (claim 1), claims 17-19 of the ‘436 application teach the limitation.
Regarding the administering step without further culturing the pooled allogeneic MSC after pooling, the claims of the ‘436 discloses the limitation (claim 1).
Regarding claims 3-4 and 16, claim 20 of the ‘436 application teach an additional step of exposing the isolated pooled allogeneic MSC population to proinflammatory factors for a period of up to about 1 hour or about 1-24 hours before administration.
Thus, the claims of the ‘436 application render the claims of the instant application obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3-17 and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11, 19, 21, 24-26 of copending Application No. 19/003,915 (reference application) in view of Zhang et al. (supra), Wang et al. (supra) and Rogulska et al. (2019, Stem Cells International). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘915 application, while they are directed to the method of using, disclose substantially similar subject matter as the claims of the instant application. The claims of the ‘915 application teach that isolated pooled allogeneic MSC population comprising MSCs derived from at least 3 individual donors, and the step of culturing and assaying using at least 3 assays, and the at least 3 assays comprising IDO activity, PGE2 and proliferation of PBMC, microglial proliferation, marker expression in microglia, etc. The claims of the ‘507 application teach the type of MSCs being WJ-MSCs or UC-MSCs. As indicated above, the wherein clause of claim 1 of the instant application directed to the method steps for obtaining the pooled MSCs does not require any particular active steps to be carried out, rather they are considered to provide structure to the pooled MSCs as an isolated pooled allogeneic MSC population comprises the number of cells from any one donor without exceeding 50% of the total cell number, and they are from at least 3 individual donors. The claims of the ‘915 application disclose the pooled MSCs having the identical structure as the instant application.
Regarding the method of treating COVID-19 infection, the claims of the ‘915 application do not particularly disclose the limitation. However, as the ‘915 application is intended to treat inflammatory disease (claim 11), and it is known in the art that COVID-19 infection which is associated with inflammation can be treated by administering Wharton’s jelly derived MSCs according to Zhang et al. Thus, it would have been obvious to a person skilled in the art to treat COVID-19 infection using the method of the ‘915 application.
Regarding the administering step for treating COVID-19 infection without further culturing the cells after pooling step, while the claims of ‘915 application disclose that the isolated, pooled allogeneic MSC population is not further cultured after the pooling step, however, they do not teach the administering step without further culturing the pooled MSCs for treating COVID-19. However, it would have been obvious to a person skilled in the art that the cryopreserved pooled allogeneic MSC population of the ‘915 application can be thawed and administered without any further manipulation including culturing. Rogulska et al. teach that the cryopreserved MSCs can be used in clinical applications without further manipulation, i.e. direct administration (see Abstract; p.2, 1st col.). Thus, it would have been obvious to a person skilled in the art that the cryopreserved pooled MSCs of the ‘915 application can be directly administered without further culturing after thawing taught by Rogulska et al. with a reasonable expectation of success.
Regarding claim 3 directed to the pretreatment with a proinflammatory factors prior to the administration, the claims of the ‘915 application do not particularly disclose the limitation. However, it is known in the art that preconditioning or pretreatment of MSCs with proinflammatory factors such as IFN-g would enhance the immunomodulatory effect of MSCs including those from Wharton’s jelly according to Wang et al. Thus, it would have been obvious to a person skilled in the art to pretreat the isolated pooled allogeneic MSCs of the ‘915 application with a proinflammatory factor such as IFN-g to enhance the effect of their use in treating inflammation diseases including COVID-19 according to Zhang et al.
Regarding claim 4 directed to the duration of the pretreatment/exposure to the proinflammatory factors being about 1-24 hours, Wang et al. teach the pretreatment of MSCs with IFN-g for 24 hours and thus, it would have been obvious to a person skilled in the art to treat the MSCs of the ‘915 application with IFN-g for 24 hours.
Thus, the claims of the ‘915 application render the claims of the instant application obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. As indicated above, the instant amendment has changed the scope of the claimed invention and now requires that there is no further culturing between the pooling step and the administering step of the isolated pooled allogeneic MSCs.
Applicant argued that the therapeutic composition or the final composition of Ta et al. should only be considered as the MSC composition suitable for therapeutic use, and the WCB cannot be considered as the final composition. The Examiner acknowledged that Ta et al. teach the WCB and the WCB can be further cultured to generate therapeutic composition (p.21, lines 1-3 of Ta et al.). However, Ta et al. teach that the pooled allogenic WJ-MSC described herein are administered either per se or preferably as a part of composition that further comprises a pharmaceutically acceptable carrier or excipients, and the pharmaceutically acceptable carrier as an example includes Plasmalyte or HBSS (p.16, lines 23-30). Ta et al. further teach that the Table 2 provides for the various possibilities and alternatives of the MCB/WCB composition and the final therapeutic composition in combination with serum, cryopreservative or pharmaceutical acceptable carriers. The Table 2 shows that MCB/WCB component can be mixed with Plamalyte A and HBBS, which is pharmaceutically acceptable carriers. This teaching implicates that not only the “final composition” of the pooled MSCs that can be further cultured after pooling but also MCB/WCB can be mixed with the pharmaceutically acceptable carrier for therapeutic purpose. Table 2 further discloses “pooled WJ-MSCs” are combined with Plasmalyte A/HBBS for the same purpose of using in clinical application, and the pooled WJ-MSCs are understood different from the final composition that is further cultured. Thus, pooled WJ-MSCs would be considered as the pooled WJ-MSCs that do not require additional culturing, and the pooled cell population is mixed with the pharmaceutically acceptable carrier for clinical purpose, and these populations are considered to meet the claimed cell population that are not further cultured after pooling and prior to administration.
Assuming arguendo even if Ta et al. do not teach the use of WBC in combination with the pharmaceutically acceptable carriers for therapeutic purpose/application, it is known in the art that the pooled MSCs can be used in an application without further culturing prior to the administration after pooling according to Ardanaz et al. as cited in the claim rejection above.
Applicant presented the significance of no further culturing after the pooling step such that no further culture of the MSCs maintains the desired distribution of MSCs derived from individual donors. As discussed above and the claim rejection, the teaching of Ardanaz et al. in combination with the previously cited references would meet the desired characteristics.
Applicant alleged that the in vitro assays performed by the inventors demonstrate the surprisingly beneficial therapeutic potential of the claimed pooled MSC population (“ProTrans”) in the treatment of COVID-19. It is not clear how these data shown in Figs. 1-3 are considered as surprising, i.e. unexpected results. Figure 1 showed the comparison between a single MSCs and ProTrans; and Figures 2 and 3 showed the effect of ProTrans and the effect is with or without the MSCs (i.e. ProTrans). The presented data do not show any evidence that the MSCs pooled without further culturing have any unexpected results over the MSCs cultured after pooling. Without clearly demonstrating how the presented data show unexpected results, it is the Examiner’s position that the combined teachings of the cited references render the claimed invention obvious.
Regarding the double patenting rejection, applicant indicated that applicant requested the rejections be held in abeyance until allowable claims are acknowledged. Thus, the claim rejections are maintained.
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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631