DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendments to the claims and arguments filed on October 21, 2025 have been received and entered. Claims 1-5, 7, 11-15 have been canceled, while claim 6 has been amended. Claims 6, 8-9 and 10 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of claims 6-11 (group II) in the reply filed on April 24, 2024 was acknowledged. Applicant elected delivering polynucleotide encoding Pdx1, Ng3, Mafa and TCf3 during telephone call on May 2, 2024.
Priority
This application is a 371 of PCT/US2019/044718 filed on 08/01/2019 which claims benefit of 62/713,239 08/01/2018.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/21/2025 and 01/30/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claims 6, 8-9 and 10 are under consideration.
New-Claim Rejections - 35 USC § 112- necessitated by amendments
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 6, 8-9 and 10 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the instant case, the recitation of limitation “..delivering intracellularly into the skin cell a first vector consisting of a nucleic acid sequence encoding Tcf3” (claim 6a) and b) one to twelve days later delivering intracellularly into the skin cell a second vector consisting of nucleic acid sequences encoding Pdx1, Ng3, and Mafa (claim 6b) are considered new matter.. However, upon further review of the instant specification, examiner could only find support for delivering intracellularly into the skin cells a polynucleotide comprising nucleic acid sequences encoding Pdx1, Ng3, Mafa, and Tcf3. Each of the PNM-T factors can be delivered simultaneously, sequentially, or any combination thereof.(page 2, para. 2, page 15, para. 2, page 18, para. 2 of the specification). There is no explicit or implicit support for “delivering intracellularly into the skin cell a first vector consisting of a nucleic acid sequence encoding Tcf3 and one to twelve days later delivering intracellularly into the skin cell a second vector consisting of nucleic acid sequences encoding Pdx1, Ng3, and Mafa. In case if applicants have evidence to support otherwise, applicants are invited to indicate page and line number for the written support specifically for the limitation recited in claim 6 of the instant application. Thus, at the time the application was filed, an Artisan of skill would not recognize from the disclosure that Applicant was in possession the invention, as claimed. Claims 8-9 and 10 are included in the rejection because they directly or indirectly depend from the rejected base claim 6. This is a new matter rejection.
Withdrawn-Claim Rejections - 35 USC § 103-necessitated by amendments
Claim 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (CN106467918, page 1-8 dated 3/1/2017) as evidenced by Melton (WO2010022395, dated 2/25/2010, IDS), Ben-Porath (US20170196913, IDS) as evidenced by Glick (J. Biol. Chem, 2000, 275, 2199-2204, IDS), Ho et al (Cell Reports, 2013, 3, 2113-2126) and Liu (Nature Cell Biology, 2013, 15, 829-838, art of record)/Geeta (Nat Cell Biol. 2013; 15(7): 725–727, art of record). In view of Applicants’ amendment of base claims 6, introducing the limitation ““delivering intracellularly into the skin cell a first vector consisting of a nucleic acid sequence encoding Tcf3 and one to twelve days later delivering intracellularly into the skin cell a second vector consisting of nucleic acid sequences encoding Pdx1, Ng3, and Mafa”, the previous rejection is rendered moot and hereby withdrawn. Applicants’ arguments with respect to the withdrawn rejections are thereby rendered moot. The claims are however subject to new rejections over the prior art of record
Claim 6, 8-9 were rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (CN106467918, page 1-8 dated 3/1/2017) as evidenced by Melton (WO2010022395, dated 2/25/2010, IDS), Ben-Porath (US20170196913, IDS) as evidenced by Glick (J. Biol. Chem, 2000, 275, 2199-2204, IDS), Ho et al (Cell Reports, 2013, 3, 2113-2126) and Liu (Nature Cell Biology, 2013, 15, 829-838)/Geeta (Nat Cell Biol. 2013; 15(7): 725–727) as applied above and further in view of Gallego-Perez (Nanomedicine: Nanotechnology, Biology, and Medicine, (2016) 399–409). The rejection is withdrawn for the reasons discussed above.
Claim 6, 9 and 10 were rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (CN106467918, page 1-8 dated 3/1/2017) as evidenced by Melton (WO2010022395, dated 2/25/2010, IDS), Ben-Porath (US20170196913, IDS) as evidenced by Glick (J. Biol. Chem, 2000, 275, 2199-2204, IDS), Ho et al (Cell Reports, 2013, 3, 2113-2126) and Liu (Nature Cell Biology, 2013, 15, 829-838) as applied above and further in view of Gallego-Perez (hereafter 2, Nature Nanotechnology, 2017, 12, 974-979)/Chang ((3D Nanochannel Array Platform for High-throughput Cell Manipulation and Nano-electroporation, dissertation for The Ohio State University ProQuest Dissertations Publishing, 2016. 10305593)/Draghia (US20080091135, dated 4/17/2008). The rejection is withdrawn for the reasons discussed above.
New-Claim Rejections - 35 USC § 103-necessitated by amendments
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.
Claim 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (CN106467918, page 1-8 dated 3/1/2017) as evidenced by Melton (WO2010022395, dated 2/25/2010, IDS), Ben-Porath (US20170196913, IDS), Ho et al (Cell Reports, 2013, 3, 2113-2126) and Liu (Nature Cell Biology, 2013, 15, 829-838, art of record).
Claim is directed to a step of (a) delivering intracellularly into the skin cell a first vector comprising a nucleic acid sequence encoding Tcf3; (b) one to twelve days later delivering intracellularly into the skin cell a second vector comprising nucleic acid sequences encoding Pdx1, Ng3, and Mafa; thereby producing an insulin producing cell.
Claims interpretation: Claim is interpreted to encompass steps of intracellular delivery of nucleic acid encoding Tcf3 followed by nucleic acid encoding three factors (Pdx1, Ngn3 and Mafa) in any skin cell. There is no requirement of expression of any surface marker in any skin cell showing reprogrammed cell showing expression of any surface marker showing presence of transdifferentiated beta cell phenotype or any other insulin producing cells. To the extent, prior art teaches the same active step the resulting cell type must necessarily be an insulin producing cell.
With respect to claim 6, Melton teaches a method of reprogramming cells, for directly reprogramming a somatic cell of a first cell type into a somatic cell of a second cell type (see abstract). It is further disclosed that the term somatic cells refer to any somatic cells including a skin cell (see para. 56). Melton teaches using non-viral vectors (claim 18, page 87) encoding three transcription factors Pdx1, Ngn3, and MafA (claim 13 on page 86) to reprogram cells into insulin secreting cell (claim 9 on page 86) (limitation of claim 6b). This is supported by the teaching of Wu who teaches producing insulin producing cell by delivering to the skin cells a vector comprising nucleic acid encoding Pdx1, Maf1 and Ngn3 to obtain the insulin secretion cells (see abstract, example 1and page 5, para. 150-152) (step b).
Melton as evidenced by Wu teaches delivering non-viral vectors (claim 18, page 87) encoding three transcription factors Pdx1, Ngn3, and MafA (claim 13 on page 86) into somatic cells (somatic cells or skin) to reprogram cells into insulin secreting cell but differs from claimed invention by not disclosing (i) delivering into skin cell a vector comprising nucleic acid encoding Tcf3 (ii) wherein Tcf3 is delivered one to 12 days prior to delivering nucleic acid encoding Pdx1, Ngn3 and Mafa to produce insulin producing cells.
Ben teaches delivering a non-viral vector comprising one or more genes necessary for insulin secretion selected from group consisting of Pdx1, Mafa and Tcf3 for enhancing insulin secretion in response to glucose in an insulin secreting cell (para 51, 64, 88 and 93) (limitation of claim 6a). However, combination of reference fails to provide motivation to deliver vector encoding Tcf3 prior to delivering nucleic acid encoding Pdx1, Maf1 and Ngn3.
Ho teaches overexpressing Tcf3 during early stages of reprogramming one day prior to delivering other transcription factor can promote mesenchymal to epithelial transition a key step of reprogramming (see fig. 4a-e) resulting in improved reprogramming efficiency (see page 2119, col. 1, para. 1). Ho teaches a biphasic response and stage specific effect of Tcf3, wherein an early high level of Tcf3 promotes the initial reprogramming event while a subsequent reduction of TGF3 led to later stages of reprograming (See page 2122, col. 1, last para. to col. 2). Liu teaches optimization of sequential introduction of transcription factors after 1.5 day to 4.6 days to reprogram somatic cells. The results shows that sequential delivery of the transcription factors outperforms the simultaneous introduction of transcription factors (see abstract, fig. 1 and 2). This is further supported by Geeta who reported sequential addition of transcription factors, rather than the simultaneous exposure used in standard protocols, improves reprogramming efficiency (see abstract).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of prior art to modify the method of Melton and Wu to further incorporate polynucleotides encoding Tcf3 as suggested in Ben in prior to delivering any reprogramming factor as suggested in Ho, in the method of reprogramming skin cells into insulin producing cells, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to deliver Tcf3 prior to other factor because art reported that (i) overexpressing Tcf3 during early stages of reprogramming a day prior to delivering other factors could promote mesenchymal to epithelial transition a key step of reprogramming resulting in improved reprogramming efficiency as evident form the teaching of Ho and (ii) Tcf3 (E2A) could subsequently acts in conjunction with other transcription factor for enhanced secretion of insulin as suggested in Ben. It would be further obvious for one of ordinary skill in the art to use a non-viral delivery system instead of viral delivery system as prior art explicitly reported using a number of non-viral delivery system as an alternative to viral delivery system to increase the expression of transcription factors (Pdx1, Ngn3 and MafA) in a cell for the purposes of reprogramming to a pancreatic beta like cells (see para. 184, page 47-para186, page 48 of Melton). Absent evidence of any unexpected superior results, one of skill in the art would have been expected to have a reasonable expectation of success because prior art successfully reported optimizing the duration of sequential delivery of reprogramming factors in cells with different combination of transcription factors as disclosed in Liu and Wu. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claim 6, 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (CN106467918, page 1-8 dated 3/1/2017) as evidenced by Melton (WO2010022395, dated 2/25/2010, IDS), Ben-Porath (US20170196913, IDS), Ho et al (Cell Reports, 2013, 3, 2113-2126) and Liu (Nature Cell Biology, 2013, 15, 829-838) as applied above and further in view of Gallego-Perez (Nanomedicine: Nanotechnology, Biology, and Medicine, (2016) 399–409).
The teaching of Wu, Melton, Ben, Ho and Liu have been described above as discussed above and relied in same manner here. The combination of references differs from claimed invention by not disclosing delivery comprises a 3-dimenstional nanochannel electroporation.
Gallego-Perez cure the deficiency by disclosing a 3-dimenstional nanochannel electroporation novel non-viral nanotechnology-based platform permitting deterministic large-scale transfection with single-cell resolution (see fig. 1, 3D NEP design to deliver high dose plasmid DNA at single cell level). The superior capabilities of this technology show overexpression of the transcription factors and reprogramming efficiencies that are comparable to viral methodologies without the constraints of capsid size and with the ability to control plasmid dosage. The new technology also shows superior performance relative to existing non-viral methods (see abstract). Gallego-Perez further teaches successful reprogramming of human dermal fibroblast cells (skin cells) by delivering polynucleotide encoding reprogramming factor using 3D-NEP device (see Fig. S1, R and page 403, col. 2, para. 1).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of Wu, Melton, Ben and Ho to modify the method of reprogramming skin cells into insulin producing cells by using 3D NEP technology to deliver polynucleotide encoding reprogramming factors as suggested in Gallego-Perez, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so because prior art suggested 3D-NEP deliver high dose plasmid DNA at single cell level and the reprogramming efficiencies are comparable and superior to viral methodologies (supra). One of skill in the art would have been expected to have a reasonable expectation of success because prior art successfully reported delivering polynucleotide encoding reprogramming factors in human skin cells (dermal cell) (Gallego-Perez, Fig. S1, R). It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claim 6, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al (CN106467918, page 1-8 dated 3/1/2017) as evidenced by Melton (WO2010022395, dated 2/25/2010, IDS), Ben-Porath (US20170196913, IDS), Ho et al (Cell Reports, 2013, 3, 2113-2126) and Liu (Nature Cell Biology, 2013, 15, 829-838) as applied above and further in view of Gallego-Perez (hereafter 2, Nature Nanotechnology, 2017, 12, 974-979)/Chang ((3D Nanochannel Array Platform for High-throughput Cell Manipulation and Nano-electroporation, dissertation for The Ohio State University ProQuest Dissertations Publishing, 2016. 10305593)/Draghia (US20080091135, dated 4/17/2008).
The teaching of Wu, Melton, Ben, Ho and Liu have been described above as discussed above and relied in same manner here. The combination of references differs from claimed invention by not disclosing delivery comprises a tissue nano transfection device.
Gallego-Perez (2) teaches a non-viral approach to topically reprogram tissues through a nanochannelled device disclosed by Gallego-Perez (abstract, see page 974, col. 1, para. 1). Gallego-Perez (2) teaches TNT mediates enhanced reprogramming factor delivery and propagation beyond the transfection boundary of skin tissue (see fig. 1) Gallego-Perez (2) teaches intradermally inserting positive electrode and the negative electrode is put in contact with the cargo solution. A pulsed electric field (250 V, 10 ms pulses, 10 pulses) is then applied across the electrodes to nanoporate exposed skin cell membranes and inject the cargo directly into the cytosol (see fig. 1). Likewise, Chang teaches soft 3D NEP patched on the mammalian epidermis for in vivo nanochannel-based electroporation (see fig. 6.1). It is disclosed that Gene / cargo are injected into epithelial cells through the nanochannel array under the condensed electric field between a top electrode and an inserted electrode. The curve of NEP chip can be adjusted to fit the skin or tissues of the animal model (see page 140). Draghia teaches an electroporation devices and methods of using same to effectively facilitate the introduction of a biomolecule including plasmid into cells of a selected tissue in a body, in particular skin such as intradermic or subcutaneous tissue (abstract, para. 25 and 30, example 9).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of Wu, Melton, Ben-, Ho, Liu to modify the method of reprogramming skin cells into insulin producing cells by using modified 3D NEP device as suggested by Gallego-Perez (2)/Chang to deliver polynucleotide encoding reprogramming factors, as instantly claimed, with a reasonable expectation of success, before the effective filing date of the instant invention. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so because prior art suggested 3D-NEP deliver high dose plasmid DNA at single cell level and the reprogramming efficiencies are comparable and superior to viral methodologies (supra). One of skill in the art would have been expected to have a reasonable expectation of success because prior art successfully reported delivering polynucleotide across skin tissue as in Gallego-Perez (2)/ Draghia. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Response to arguments
To the extent that Applicants’ arguments are pertinent to the new rejections, they are addressed as follows:
Applicant disagree with the rejection arguing Melton teaches that the transcription factors Pdx1, Ngn3 and MafA can be used to directly reprogram cells of an endodermal origin (e.g. a pancreatic cell) into an insulin secreting beta cell, i.e. without the need to revert the cells to pluripotent stem cells first.¹ Of course, skin cells are derived from ectoderm, so one of ordinary skill in the art would not presume from Melton that the PMN factors would work on skin cells. None of these references alone or in combination provide a clear and rational motivation to deliver a vector encoding only Tcf3 into skin cells prior to delivering a vector encoding only Pdx1, Ngn3, and MafA as a method for reprogramming skin cells into insulin-producing cells. Moreover, these references do not establish a reasonable expectation of success for delivering Tcf3 prior to Pdx1, Ngn3, and MafA in the context of skin cell reprogramming. Applicants’ arguments have been fully considered, but are not found persuasive.
In response to applicant’s argument that there is no motivation and reasonable expectation of success to use PMN in skin cells, 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, Melton teaches a method of reprogramming cells, for directly reprogramming a somatic cell of a first cell type into a somatic cell of a second cell type (see abstract). It is further disclosed that the term somatic cells refer to any somatic cells including a skin cell (see para. 56). Melton exemplified using non-viral vectors (claim 18, page 87) encoding three transcription factors Pdx1, Ngn3, and MafA (claim 13 on page 86) to reprogram cells into insulin secreting cell (claim 9 on page 86) (limitation of claim 6b). Wu provide explicit motivation to use gene PDX1, Mafa, Ngn3 as a combined core for reverting skin cells into insulin producing cells wherein additional gene could be added (see Wu). It is well established in case law that a reference must be considered not only for what it expressly teaches, but also for what it fairly suggests. In re Burkel, 201 USPQ 67 (CCPA 1979). The teaching of Wu clearly shows the use of gene PDX1, Mafa, Ngn3 that could transdifferentiate skin cells into insulin producing cells.
In response to applicant’s argument that there is no reasonable expectation of success for delivering Tcf3 prior to Pdx1, Ngn3, and MafA, Applicant should note that obviousness does not require absolute predictability of success; for obviousness under 35 U.S.C. § 103, all that is required is a reasonable expectation of success. See In re O’Farrell, 7 USPQ2d 1673 (CAFC 1988). In the instant case, prior art recognized that that overexpressing Tcf3 during early stages of reprogramming one day prior to delivering other transcription factor can promote mesenchymal to epithelial transition a key step of reprogramming (see Ho fig. 4a-e) resulting in improved reprogramming efficiency (see page 2119, col. 1, para. 1). Further, Liu teaches optimization of sequential introduction of transcription factors after 1.5 day to 4.6 days to reprogram somatic cells. The results shows that sequential delivery of the transcription factors outperforms the simultaneous introduction of transcription factors. It is relevant to note that none of the claim requires expression of any surface marker in any skin and/or any other reprogrammed cell showing expression of any surface marker indicating presence of transdifferentiated beta cell phenotype or any other insulin producing cells. Further, claim 6 recite a wide one to twelve days duration foe delivering PMN suggest non-criticality of the limitation To the extent prior art teaches delivering Tcf3 prior to other factor because art reported that overexpressing Tcf3 during early stages of reprogramming a day prior to delivering other factors could promote mesenchymal to epithelial transition a key step of reprogramming resulting in improved reprogramming efficiency as evident form the teaching of Ho, it is appliable to the rejection. It would be further obvious for one of ordinary skill in the art to use a non-viral delivery system instead of viral delivery system as prior art explicitly reported using a number of non-viral delivery system as an alternative to viral delivery system to increase the expression of transcription factors (Pdx1, Ngn3 and MafA) in a cell for the purposes of reprogramming to a pancreatic beta like cells (see para. 184, page 47-para186, page 48 of Melton). Absent evidence of any unexpected superior results, one of skill in the art would have been expected to have a reasonable expectation of success because prior art successfully reported optimizing the duration of sequential delivery of reprogramming factors in cells with different combination of transcription factors as disclosed in Liu and Wu.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kuwahara et al (PLoS One, 2014, e94408, 1-12), Yu et al (Development (2018) 145 (6): dev163162.
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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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632