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 .
Status of the Claims
Claims 1, 4-5, 9, 12, 17, 32, 39, 41, 48, 50, 53-56, 66-69, and 72-75 are pending.
Claims 1, 32, and 41 are newly amended.
Claims 9, 12, 17, 66-69, and 72-75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/21/2025.
Claims 1, 4-5, 32, 39, 41, 48, 50, and 53-56 have been examined on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The previous rejection of claims 1-2, 4, 31-32, 39, and 41 under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) is withdrawn in order to address the claims as amended.
The previous rejection of claim 5 under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view of Kim et al. (US20180228844A1, 2018) is withdrawn in order to address the claims as amended.
The previous rejection of claims 48 and 50 under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view He et al. (Chinese Journal of Cancer, 2012) is withdrawn in order to address the claims as amended.
The previous rejection of claims 53-55 under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view Thermo Fisher (Pen Strep, retrieved from Wayback Machine, 2017) and Hass et al. (Cancer Immunology Research, 2019) is withdrawn in order to address the claims as amended.
The previous rejection of claim 56 under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view Lynn et al. (US20200101108A1, 2020) is withdrawn in order to address the claims as amended.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 32, 39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view of Besser et al. (Cytotherapy, 2009).
In regards to claim 1, Fang teaches a serum free (a cell ingredient) TIL culture medium comprising IL-2 (a cytokine) and anti-CTLA-4 (an immune checkpoint antibody) (Abstract; claims 1 and 3). Fang teaches that the concentration if IL-2 is 1000U/ml (which is the same as 1000 IU/mL of IL2) (claim 2).
While less than the claimed range of 2000-3000 IU/mL, a person of ordinary skill in the art could have arrived at a concentration of 2000-3000 IU/mL by routine optimization, and the disclosure does not point to a criticality in this amount.
See MPEP 2144.05(II), generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
In the instant case, because as taught by Besser it was long known in the art that T cells can be massively expanded in a wide concentrations from 600-6000 IU/mL (Abstract, Results, p206), which overlaps with the claimed range of 2000 to 3000 IU/mL, a person of ordinary skill in the art could have arrived at a concentration range of 2000 to 3000 IU/mL by routine optimization with predictable results and a reasonable expectation of success.
In regards to claim 4, Fang teaches that composition may further comprise the cytokine IL-12 (claim 2).
In regards to claim 32, Fang teaches that the concentration of the CTLA-4 antibody is 3 µg/mL (claim 2), which overlaps with the claimed range of 1 µg/mL to 100 µg/mL.
In regards to claim 39, Fang teaches that the medium also comprises CD28 antibody (a costimulatory receptor antibody) (claim 1).
In regards to claim 41, Fang teaches that the concentration of anti-CD28 is 2 µg/mL (claim 2), which overlaps with the range of 3 µg/mL to 10 µg/mL as in claim 41.
Therefore, the combined teachings of Fang and Besser renders obvious the invention as claimed.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view of Besser et al. (Cytotherapy, 2009) as applied to claims 1 and 4 above, and further in view of in view of Kim et al. (US20180228844A1, 2018, previously cited).
In regards to claim 5, Fang teaches that the concentration of IL-12 is 7 pg/mL (claim 2). While it is unclear what this concentration is in U/mL, a person of ordinary skill in the art could have arrived at a concentration of 200 U/mL to 500 U/mL by routine optimization and the disclosure does not point to a criticality in this amount.
According to MPEP 2144.05(II)(A), generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In the instant case, because Kim teaches that T cells can be cultured in media comprising 150 IU/mL to 300 IU/mL IL-12 (paragraph [0092]), which overlaps with the range as in claim 5, a person of ordinary skill in the art could have arrived at a concentration of 200 IU/mL to 500 IU/mL by routine optimization with predictable results and a reasonable expectation of success.
Furthermore, it would have been predictably obvious to use a concentration of 150 IU/mL to 300 IU/mL IL-12, which lies within the claimed range because Fang teaches that this concentration can be added to T cell expansion media in order to promote development of T cell subsets (paragraph [0091]).
Therefore, the combined teachings of Fang, Besser, and Kim renders the invention unpatentable as claimed.
Claims 48 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view of Besser et al. (Cytotherapy, 2009) as applied to claim 1 above, and further in view of in view of He et al. (Chinese Journal of Cancer, 2012, previously cited).
In regards to claims 48 and 50, in regards to the limitation “The seed cell medium according to claim 1, wherein the serum-containing medium further comprises serum”, it is noted that claim 1 can be either a serum-containing medium or a serum-free medium. Therefore, claim 48 has been interpreted as requiring a serum-containing medium.
While, as discussed above, the medium as taught by Fang is serum-free, as taught by Fang, serum containing media is known in the art (p2 last paragraph to p3 top paragraph). A person of ordinary skill in the art would have been motived to use serum-containing conditions because serum contains growth factors and nutrients essential for cellular growth in vitro, and because He (cited by Fang at p2 last paragraph to p3 top paragraph) teaches that TILs can be effectively cultured in media comprising 5% serum (Generation of young TIL cultures, p288; a concentration of 5% serum lies within the concentration of 1% to 10%). Furthermore, because He teaches that TILs can be cultured in 5% serum, and because Fang cites He as teachings that it is known in the art that TILs can be cultured with serum, a person of ordinary skill in the art could have incorporated serum at a concentration between 1% and 10% into the composition of Fang, with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Fang, Besser, and He renders the invention unpatentable as claimed.
Claims 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view of Besser et al. (Cytotherapy, 2009) as applied to claim 1 above, and further in view of in view of in view Thermo Fisher (Pen Strep, retrieved from Wayback Machine, 2017, previously cited) and Hass et al. (Cancer Immunology Research, 2019, previously cited).
In regards to claims 53-55, Fang does not explicitly teach that the medium comprises an antibiotic penicillin-streptomycin PS mixed solution. However, a person of ordinary skill in the art would have been motivated to use a penicillin-streptomycin PS mixed solution (Pen-Strep) in order to, as taught by Thermo Fisher prevent bacterial or fungal infections in culture (First page). A person of ordinary skill in the art would have been motivated to use a concentration that overlaps with the range of 1 U/mL to 200 U/mL because Haas teaches that T cells can be cultured in 1% (which is 100 U/mL) penicillin/streptomycin (Cell culture, pOF2) (see Thermo Fisher first page; stock Pen Strep has a concentration of 10,000 U/mL (first pag); 1% x 10,000 U/mL = 100 U/mL). Furthermore, because Pen Strep is a well-known antibiotic for cell culture, and because Hass specifically teaches that T cell can be cultured in pen strep, it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Fang, Besser, Thermo Fisher, and Haas renders the invention unpatentable as claimed.
Claim 56 is rejected under 35 U.S.C. 103 as being unpatentable over Fang et al. (CN103374548, 2013, on IDS 11/28/2022, previously cited) in view of Besser et al. (Cytotherapy, 2009) as applied to claim 1 above, and further in view of in view of Lynn et al. (US20200101108A1, 2020, previously cited).
In regards to claim 56, Fang does not explicitly teach that the composition comprises a Treg inhibitor such as dasatinib. However, a person of ordinary skill in the art would have been motivated to include dasatinib because Lynn teaches that dasatinib prevents or reverses T cell exhaustion (paragraph [0013]. Furthermore, because Fang teaches that compositions for treating T cells can comprise dasatinib (claims 25 and 28), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Fang, Besser, and Lynn renders the invention unpatentable as claimed.
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.
Claims 1, 4-5, 32, 39, 41, 48, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13-16, 18 of copending Application No. 18/254,167 (reference application) in view He et al. (Chinese Journal of Cancer, 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions are drawn to compositions for culturing TILs comprising at least IL-2 and a PD-1 antibody that overlap concentration ranges.
While copending Application No. 18/254,167 does not specify whether conditions are serum-free or serum containing, a person of ordinary skill in the arts would have been motivated to use serum-containing conditions because serum contains growth factors and nutrients essential for cellular growth in vitro, and because He (cited by Fang at p2 last paragraph to p3 top paragraph) teaches that TILs can be effectively cultured in media comprising 5% serum (Generation of young TIL cultures, p288; a concentration of 5% serum lies within the concentration of 1% to 10%). Furthermore, because He teaches that TILs can be cultured in 5% serum, a person of ordinary skill in the art could have incorporated serum at a concentration between 1% and 10% into the composition with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 53-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13-16, 18 of copending Application No. 18/254,167 (reference application) in view He et al. (Chinese Journal of Cancer, 2012) as applied to claim 1 above, and further in view of Thermo Fisher (Pen Strep, retrieved from Wayback Machine, 2017) and Hass et al. (Cancer Immunology Research, 2019).
In regards to claims 53-55, while copending Application No. 18/254,167 does not explicitly require the composition to comprise an antibiotic penicillin-streptomycin PS mixed solution. However, a person of ordinary skill in the art would have been motivated to use a penicillin-streptomycin PS mixed solution (Pen-Strep) in order to, as taught by Thermo Fisher prevent bacterial or fungal infections in culture (First page). A person of ordinary skill in the art would have been motivated to use a concentration that overlaps with the range of 1 U/mL to 200 U/mL because Haas teaches that T cells can be cultured in 1% (which is 100 U/mL) penicillin/streptomycin (Cell culture, pOF2) (see Thermo Fisher first page; stock Pen Strep has a concentration of 10,000 U/mL (first pag); 1% x 10,000 U/mL = 100 U/mL). Furthermore, because Pen Strep is a well-known antibiotic for cell culture, and because Hass specifically teaches that T cell can be cultured in pen strep, it could have been done with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 56 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13-16, 18 of copending Application No. 18/254,167 (reference application) in view He et al. (Chinese Journal of Cancer, 2012) as applied to claim 1 above, and further in view of Lynn et al. (US20200101108A1, 2020).
In regards to claim 56, while copending Application No. 18/254,167 does not explicitly require the composition to comprise a Treg inhibitor such as dasatinib, a person of ordinary skill in the art would have been motivated to include dasatinib because Lynn teaches that dasatinib prevents or reverses T cell exhaustion (paragraph [0013]. Furthermore, because Fang teaches that compositions for treating T cells can comprise dasatinib (claims 25 and 28), it could have been done with predictable results and a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-5, 32, 39, 41, 48, 50, and 53-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 18/254,171.
Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions are drawn to compositions for culturing TILs comprising at least IL-2, PD-1 antibody, and serum that are at least close to or could be optimized to the claimed concentration ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant requests rejoinder of claims 9, 12, 17, 66-69, and 72-75 (Remarks, p7).
Applicant’s arguments filed 04/22/2026 have been fully considered but are not found persuasive. The claims are still prima facie obvious as discussed above, and therefore, rejoinder of the withdrawn claims is premature.
Applicant argues that the claims as amended overcome the rejections under 35 USC 102 (Remarks, p7).
Applicant’s arguments filed 04/22/2026 have been fully considered and are found persuasive. Therefore, the prior rejections under 35 USC 102 have been withdrawn. However, upon further consideration in view of the claims as amended, new grounds of rejection based on 35 USC 103 are made as discussed above.
Applicant argues that the claims as amended overcome the rejections under 35 USC 103 (Remarks, p8-11).
Applicant’s arguments filed 04/22/2026 have been fully considered but are not found persuasive. As discussed above, the claims as amended are still prima facie obvious over 35 USC 103.
As discussed above, in regards to the claimed as amended which requires a nIL-2 concentration of 2000 IU/mL to 3000 IU/mL, Fang teaches that the concentration if IL-2 is 1000U/ml (which is the same as 1000 IU/mL of IL2) (claim 2).
While less than the claimed range of 2000-3000 IU/mL, a person of ordinary skill in the art could have arrived at a concentration of 2000-3000 IU/mL by routine optimization, and the disclosure does not point to a criticality in this amount.
See MPEP 2144.05(II), generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
In the instant case, because as taught by Besser it was long known in the art that T cells can be massively expanded in a wide concentrations from 600-6000 IU/mL (Abstract, Results, p206), which overlaps with the claimed range of 2000 to 3000 IU/mL, a person of ordinary skill in the art could have arrived at a concentration range of 2000 to 3000 IU/mL by routine optimization with predictable results and a reasonable expectation of success.
Specifically, Applicant argues that the per paragraph [0003] of the instant application, “The irradiated allogenic PBMCs from multiple donor sources have the potential risk of contamination, and the IL-2 at high concentration may have a risk of cell exhaustion in the subsequent infusion” (Remarks, p9). Applicant also argues that those skilled in the art would have recognized that the use of low-concentration IL-2 may result in insufficient stimulation of signals from T cells, leading to slow expansion and weak viability (Remarks, p9). Applicant argues that produces results similar antitumor to those demonstrated by Sarnaik et al. (2021) which employs 600 IU/mL IL-2, but also abrogates the need to use IL-2 during TIL clinical infusion, eliminates the need for IL-2 post-infusion, allows for sustained in vivo proliferation, and results in significant numbers of expanded TILS (Remarks, p10).
Applicant’s arguments filed 04/22/2026 have been fully considered but are not found persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., sufficiency of T cell stimulation, viability etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regards to Sarnaik et al. (2021), it is noted that if Applicant would like this reference considered, then it needs to be submitted on an IDS. However, as discussed above, it is long-known in the that broad concentrations of IL-2 .
However, as discussed above, as taught by Besser it was long known in the art that T cells can be massively expanded in a wide concentrations from 600-6000 IU/mL (Abstract, Results, p206), which overlaps with the claimed range.
And indeed, as above, the specification doe not demonstrate any specific unexpected results at the claimed concentrations.
Applicant argues that the ODP rejections should be withdrawn for the same reasons (Remarks, p11-12).
Applicant’s arguments filed 04/22/2026 have been fully considered but are not found persuasive. As discussed above, the claims are still prima facie obvious over 35 USC 103. Therefore, the provisional double-patenting rejections are maintained as discussed above.
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.
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