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 amendments to the claims and arguments and Ichim ’s declaration filed on 08-27-2025 have been received and entered. Claims 2, 3, 4 have been amended. Claims 8-10, 14-20 have been canceled. Claims 1-7, 11-13, 21-23 are pending and under consideration.
Priority
This application is a 371 of PCT/US19/30596 filed on 05/03/2019 that claims priority from US provisional application 62/666,828 filed on 05/04/2018.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08-27-2025 in compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Withdrawn-Claim Rejections - 35 USC § 112
Claims 2-4 were rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In view of Applicants' amendments to the claims, the previous rejections of claims are hereby withdrawn. Applicants' arguments with respect to the withdrawn rejections are thereby rendered moot.
Claim Objections
Claims 3-4 are objected to because of the following informalities:
Claims 3-4 depend from claim 2 which has been amended to recite “further comprising” local administration of the foreskin fibroblasts in addition to the systemic administration from claim 1. The specification of the claimed invention in paragraph [0044] page 14-15 provides support for administering fibroblasts “systemically and/or locally”. Since claims 3-4 depend from claim 2, the antecedent basis for the term “the administration” in each of claims 3-4 is not clear to be systemically or locally. It would be remedial in each case to amend claims 3-4 to read “…wherein the local administration is…”.
Appropriate correction is required.
Maintained - 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.
Claims 1-7, 11-13, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kramer et al (WO 2010/071862 A1, International Publication Date: 24 June 2010) as evidenced by Zeddou et al (World J Stem Cells 2014 July 26; 6(3): 367-370, DOI: 10.4252/wjsc.v6.i3.367) in view of O'Heeron et al (Pub. No.: US 2014/0314726 A1, Pub. Date: Oct. 23, 2014) (This is applicant own work).
Regarding to claim 1, Kramer et al teach umbilical cord tissue derived cells for treating neuropathic pain (Title). Methods for treating chronic pain, neuropathic pain or spasticity are provided. The methods are comprising administering cells obtained from human umbilical cord tissue, or administering pharmaceutical compositions comprising such cells or prepared from such cells (Abstract). the umbilical cord tissue-derived cells are derived from umbilical cord tissue which relative to a human cell that is a fibroblast ([094], page 18). As evidenced by Zeddou et al, the umbilical cord (UC) matrix was cited in different studies as a reliable source from which long-term ex vivo proliferating fibroblasts were isolated (Abstract).
Further, Kramer et al teach pharmaceutical compositions comprising the population of cells can be formulated as liquids. Liquid compositions are formulated for administration by any acceptable route known in the art such as intravenous administration ([0132] - [0133], page 29).
Although Kramer et al teach the gene expression profiles of human fibroblasts derived from human neonatal foreskin ([0332], page 78), Kramer et al do not teach using foreskin fibroblasts in treating pain. O'Heeron et al cure the deficiency.
O'Heeron et al teach fibroblasts are delivered to a joint, such as an intervertebral disc, to treat dysfunction of cartilage therein, including to repair degenerated discs (Abstract). Additionally, in example I, the fibroblast cells that were injected are contained in the disc and are alive to make more matrix (fibrous and cartilaginous tissue) to increase the disc height. The more matrix and increased disc height results in better biomechanical function and less pain for the individual ([0050], page 5). Fibroblast populations could be used: Neo-natal foreskin fibroblasts are a very convenient source of cells, for example. These cells are used commercially and are readily available and easy to grow ([0033], Page 3).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Kramer et al by using foreskin fibroblasts for treating joint pain as taught by O'Heeron et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because O'Heeron et al provide explicit advantage of repairing degenerated discs leading to less pain for the individual ([0050], page 5), and the neo-natal foreskin fibroblasts are a very convenient source of cells that are readily available and easy to grow ([0033], Page 3). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because O'Heeron et al were successful in treating pain by using foreskin fibroblasts with working examples and data.
Regarding to claim 2, Kramer et al provides administering cells locally or systemically to a patient to normalize inflammatory or degenerative or a state of pathology of the nervous system ([002], page 1).
Regarding to claim 3, O'Heeron et al teach methods and compositions for treatment of medical conditions associated with body part(s) in need of cartilage such as the spine or joints ([0002], page 1).
Regarding to claim 4, O'Heeron et al teach in some embodiments, fibroblasts cells are injected between the vertebrae or intervertebral discs ([0044], page 4).
Regarding to claim 5, Kramer et al provide methods for treating chronic and neuropathic pain by administering a population of cells ([012], page 3).
Regarding to claim 6-7, Kramer et al teach agents or compounds administered with the population of cells: The cells of the present invention can be incubated with a number of agents or factors which promote the survival, growth, differentiation, and/or integration of the cells in vitro and/or in the recipient subject, or which further aid in the treatment of chronic pain. The administration of additional agents can begin prior to transplantation of cells, can begin at the time of transplantation, or can begin after transplantation ([0163]-[0164], page 37).
Regarding to claim 11, Kramer et al teach that umbilical cord-derived cells at passage 8, 15, and 20 analyzed by flow cytometry all expressed CD10, CD13, CD44, CD73, CD90, PDGFr-alpha and HLA-A, B, C ([0310], page 69).
Regarding to claim 12, O'Heeron et al teach the fibroblasts may be exposed to hypoxic conditions prior to delivery in vivo ([0037], page 3).
Regarding to claim 13, Kramer et al teach that MCP-1 and IL-6 were secreted by umbilicus-derived cells and dermal fibroblasts (Table 13-1) ([0364], page 87). It should be noted that fibroblasts exposed to hypoxic conditions is rendered obvious as taught by O'Heeron et al, and Kramer et al further teach that MCP-1 and IL-6 were secreted by dermal fibroblasts. Thus, it is expected that the fibroblasts would secrete MCP-1 and IL-6 as same as the claimed invention under hypoxic conditions.
Regarding to claim 21-23, Kramer et al teach umbilical cord-derived cells at passage 8, 15, and 20 analyzed by flow cytometry all expressed CD10, CD13, CD44, CD73, CD90, PDGFr-alpha and HLA-A, B, C ([0310], page 69). Kramer et al also teach that if the population of cells used by the medical practitioner is umbilical cord tissue-derived cells, then transplantation with allogeneic, or even xenogeneic, cells may be tolerated in some instances as these cells have been shown not to stimulate allogeneic PBMCs in a mixed lymphocyte reaction ([0160], page 36). Additionally, O'Heeron et al teach human fibroblasts may be autologous or allogeneic or a mixture thereof ([0007], page 1). Thus, a person of ordinary skill in the art would be able to use CD73 fibroblast cell in allogeneic treatment.
Response to Arguments
Applicant's arguments and the Ichim ’s declaration filed 08-27-2025 have been fully considered but they are not persuasive.
1. Applicant argue that the cited references fail to teach or suggest every element of the claimed invention. Kramer does not teach or suggest that the cells used to treat pain can be fibroblasts. As such, Kramer cannot be used as proposed by the Office to supply the element of utilizing fibroblasts to treat neuropathic pain. Neither Zeddou or O'Heeron cure this deficiency. In view of this, the references do not teach or suggest every element of claim 1 as required to support an obviousness rejection. (Remarks, Page 5).
Response to Arguments:
It is noted that Kramer et al teach umbilical cord tissue derived cells for treating neuropathic pain (Title). As evidenced by Zeddou et al, the umbilical cord (UC) matrix was cited in different studies as a reliable source from which long-term ex vivo proliferating fibroblasts were isolated (Abstract). Furthermore, instant claim 21 specifies the fibroblasts express CD73, and Kramer et al teach “umbilical cord-derived cells at passage 8, 15, and 20 analyzed by flow cytometry all expressed CD10, CD13, CD44, CD73, CD90, PDGFr-alpha and HLA-A, B, C” ([0310], page 69). As evidenced by applicant own disclosure, the fibroblasts express CD10; CD13; CD44; CD73; CD90 etc. (see the instant specification [0009], page 2 and below).
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Thus, umbilical cord tissue contains fibroblasts. Applicant has not provided any evidence to prove umbilical cord tissue does not contain fibroblasts. As per MPEP 716.01(c) (II), arguments by applicant cannot take the place of evidence, Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.
2. Applicant argue that a person of skill in the art (POSITA) would be taught away from systemic administration of fibroblasts to treat neuropathic pain. Kramer goes on to characterize the cells derived from umbilical cord and used for treating pain, and shows that they are different from fibroblasts. Tables 11-2 (page 83) and 13-1 (page 87) of Kramer show that fibroblast expression of IL-8 could not be detected, a characteristic of the umbilical cord-derived cells, as described above in the passage referenced by the Office. Furthermore, in senescence assays, Kramer showed that fibroblasts senesced after 60 days whereas umbilical-derived cells senesced after 80 days (see [0291], with umbilical-derived cells yielding more than twice the amount of cells as fibroblasts (see Table 6-1 in page 64). Kramer also
compared the cells using gene expression and Euclidean distance: "Similarity between the cells is
inversely proportional to the Euclidean distance" (see Table 10-2 in page 72), meaning that a
greater Euclidean distance value represents a greater dissimilarity between the cells. As shown in
Table 10-2 of Kramer, fibroblasts and umbilical cord-derived cells were amongst the cells with the
highest dissimilarity score. Thus, the cells used by Kramer to treat pain are not fibroblasts. (Remarks, page 6).
Response to Arguments:
Applicants have further engaged in selective reading of the teachings of Kramer et al to formulate the grounds for teaching away. It should be noted that the Kramer et al teach umbilical cord tissue derived cells for treating neuropathic pain and spasticity (Title). Kramer et al do not make any statement to exclude/prevent the use of fibroblasts in treating pain. As evidenced by Zeddou et al, the umbilical cord (UC) matrix was cited in different studies as a reliable source from which long-term ex vivo proliferating fibroblasts were isolated (Abstract). Thus, umbilical cord tissue contains fibroblasts.
Applicant cited tables 11-2 and table 13-1 to say fibroblast expression of IL-8 could not be detected. It is noted that Tables 11-2 also shows umbilical cord cells do express IL-8, and specification of the claimed invention teach that in cases when fibroblasts are cultured under hypoxic conditions, the fibroblasts may secrete factor the fibroblasts may secrete factors IL-8 ([0046], page 15). Thus, if applicant’ reasoning to use IL-8 as marker to recognize fibroblast, at least this provides evidence that umbilical cord cells express IL-8 and contain fibroblast. Nevertheless, Tables 11-2 and applicant own disclosure show that expression of IL-8 is unpredictable depending to hypoxic conditions; thus, it is not a persuasive argument. Furthermore, Applicant conveniently ignores factors such as IL-6, MCP-1 that are expressed in both Fibroblast and Umbilical tissue (See table 13-1, page 87). According to specification of the claimed invention, in cases when fibroblasts are cultured under hypoxic conditions, the fibroblasts may secrete factors MCP-1 and IL-6 ([0046], page 15). Thus, with the same rationale of applicant, Fibroblast and Umbilical tissue are the same.
Applicant also argues that fibroblasts senesced after 60 days whereas umbilical-derived cells senesced after 80 days; however, the differences in senescence does not preclude the fact that umbilical tissue contain fibroblasts. It is obvious that cells in different context behave differently. Applicant also attempt to cite the Euclidean distance to formulate the grounds for teaching away. However, umbilical cord tissue is mixture of different cells containing fibroblasts. It is noted that base claim 1 recites “comprising”, and according to MPEP 2111.03 (I), Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) ("Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts").
Further, Kramer et al teach umbilical cord tissue derived cells for treating neuropathic pain (Title), and, the umbilical cord (UC) contains fibroblasts as evidenced by Zeddou et al, and O'Heeron et al (applicant own work) teach in example I, the fibroblast cells that were injected are contained in the disc and are alive to make more matrix (fibrous and cartilaginous tissue) to increase the disc height. The more matrix and increased disc height results in better biomechanical function and less pain for the individual ([0050], page 5). Thus, a person of ordinary skill in the art would be motivated to administer to the individual an effective amount of fibroblasts to treat neuropathic pain because O'Heeron et al provide explicit advantage of repairing degenerated discs leading to less pain for the individual ([0050], page 5), and the neo-natal foreskin fibroblasts are a very convenient source of cells that are readily available and easy to grow ([0033], Page 3).
3. Applicant argue that
The selection against fibroblasts by Kramer, appears to be consistent with the state of the art at the time of filing. Balducci et al, 2017, The differences between mesenchymal stromal cells and fibroblasts. The Biology and Therapeutic Application of Mesenchymal Cells (submitted herewith in an IDS) teaches that fibroblasts cause chronic inflammation (FIG. 30.3) which can lead to a variety of diseases, including myocardial fibrosis (section 30.7). Balducci then shows that fibroblasts are depleted to make homogenous MSC populations for cell therapy (FIG. 30.4). Thus, at the time of filing a POSITA would be taught away from systemic administration of fibroblasts due to the potential for causing chronic inflammation and inflammatory diseases (remarks, page 6).
Response to Arguments:
Applicant cited Balducci et al, 2017 to formulate the ground for teaching away that fibroblasts cause chronic inflammation and should be depleted. However, Kramer et al specifically teach that “the invention provides administering cells locally or systemically to a patient to normalize inflammatory or degenerative or a state of pathology of the nervous system.” ([002], page 1), and “Such results include, but are not limited to, the regeneration, repair, or improvement of neural tissue, the improvement of blood flow, and/or the decrease of inflammation in patients with chronic pain.” ([053], page 8). Thus, one of ordinary skill in the art would have been motivated to use umbilical cord tissue derived cells containing fibroblast for treating neuropathic pain because Kramer et al provided evidence for using umbilical cord tissue derived cells for treating neuropathic pain and spasticity with decreased of inflammation. Furthermore, O'Heeron et al (applicant own work) provide evidence that administration of fibroblast causes less pain “Fibroblast Injection and in Vivo Differentiation: ……… The cells that were injected are contained in the disc and are alive to make more matrix (fibrous and cartilaginous tissue) to increase the disc height. The more matrix and increased disc height results in better biomechanical function and less pain for the individual.” ([0050], page 5, example 1). Thus, Fibroblast can be used to treat pain.
As mention above, Kramer et al teach “umbilical cord-derived cells at passage 8, 15, and 20 analyzed by flow cytometry all expressed CD10, CD13, CD44, CD73, CD90, PDGFr-alpha and HLA-A, B, C” ([0310], page 69). As evidenced by applicant own disclosure, the fibroblasts express CD10; CD13; CD44; CD73; CD90 etc. (see the instant specification [0009], page 2). Additionally, as evidenced by Zeddou et al, the umbilical cord (UC) matrix was cited in different studies as a reliable source from which long-term ex vivo proliferating fibroblasts were isolated (Abstract). Thus, umbilical cord-derived cells contain fibroblasts that can be used to treat pain.
4. Applicant argue that the claimed invention is non-obvious in view of unexpected results. Despite the teaching in the art that fibroblasts cause chronic inflammation, applicant unexpectedly discovered that foreskin fibroblasts can be used to treat neuropathic pain via systemic administration, as shown in Exhibit 2 of the Declaration under 37 C.F.R. § 1.132 submitted on 30 May 2024. This is in part due to the discovery by applicant that foreskin fibroblasts are unexpectedly lowly immunogenic. As shown in the Declaration submitted herewith, control (RPMI media), dermal fibroblasts, umbilical cord fibroblasts, and foreskin fibroblasts were plated at increasing concentrations with allogeneic peripheral blood mononuclear cells. Proliferation of allogeneic peripheral blood mononuclear cells was assessed as a readout of immunogenicity. Unexpectedly, foreskin fibroblasts were found to possess low immunogenicity, which makes them more suitable for systemic administration (Remarks, page 7).
Response to Arguments:
The results of the claimed invention are expected because Kramer et al teach “both locally and systemically administered cells” ([0159], page 36) and “If the population of cells used by the medical practitioner is umbilical cord tissue-derived cells, then transplantation with allogeneic, or even xenogeneic, cells may be tolerated in some instances as these cells have been shown not to stimulate allogeneic PBMCs in a mixed lymphocyte reaction. Accordingly, it is recognized that the cells themselves provide an immunosuppressant effect, thereby preventing host rejection of the transplanted population of cells. In such instances, pharmacological immunosuppression during cell therapy may not be necessary” ([0160], page 36).
Furthermore, O'Heeron et al (applicant own work) teach in example I that the fibroblast cells that were injected are contained in the disc and are alive to make more matrix (fibrous and cartilaginous tissue) to increase the disc height. The more matrix and increased disc height results in better biomechanical function and less pain for the individual ([0050], page 5) and the neo-natal foreskin fibroblasts are a very convenient source of cells that are readily available and easy to grow ([0033], Page 3). Since, the same foreskin fibroblasts as the claimed invention are used to treat pain, it is expected to have the same effects as evidenced by applicant own work.
It is also noted that O'Heeron et al teach spinal cord injury: injecting fibroblasts between the vertebrae or intervertebral discs ([0044], page 4) and improving spinal nerves ([0043], page 4). The following reference is cited as evidence without relying on the rejection that central neuropathic pain is found in spinal cord injury: Kaur et al (Neurorehabilitation and Neural Repair 2020, Vol. 34(11) 1038–1049, https://doi.org/10.1177/1545968320962) teach that “Pain of neuropathic origin in spinal cord injury (SCI) is unbearable and challenging to treat. Research studies conducted in the past have shown that mental imagery (MI) techniques have a significant impact on the reduction of symptoms of central neuropathic pain in people with SCI” (Abstract).
5. Applicant argue that A POSITA would lack motivation to combine the cited references and reasonable expectation of success and that foreskin tissue is a source of fibroblasts, readily available or otherwise, or that fibroblasts can be used to treat disc pain by local administration is not a reason why a POSITA would select fibroblasts from foreskin tissue for systemic administration to treat neuropathic pain amongst every other tissue that contains fibroblasts, and local and systemic administration would stimulate different molecular mechanisms that would not lead a POSITA to use the methods of local treatment for systemic treatment (Remarks, page 7-8).
Response to Arguments:
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, Kramer et al teach methods for treating chronic pain, neuropathic pain or spasticity comprising administering cells obtained from human umbilical cord tissue (abstract) via “Local and Systemic administration of cells” ( example 2, page 42 [0184] – [0193]). These methods and pharmaceutical compositions are designed to stimulate and support neural tissue growth or healing, and to improve the regeneration and repair of tissues surrounding the neural tissue, including but not limited to cartilage, tendons, muscle tissue, or ligaments ([073], page 14). Additionally, O'Heeron et al teach fibroblasts are delivered to a joint, such as an intervertebral disc, to treat dysfunction of cartilage therein, including to repair degenerated discs (Abstract), and the fibroblast cells that were injected are contained in the disc and are alive to make more matrix (fibrous and cartilaginous tissue) to increase the disc height. The more matrix and increased disc height results in better biomechanical function and less pain for the individual ([0050], page 5). Fibroblast populations could be used: Neo-natal foreskin fibroblasts are a very convenient source of cells, for example. These cells are used commercially and are readily available and easy to grow ([0033], Page 3).
Thus, one of ordinary skill in the art would have been motivated to combine the cited references with reasonable expectation of success because O'Heeron et al provide explicit advantage of repairing degenerated discs leading to less pain for the individual ([0050], page 5), and the neo-natal foreskin fibroblasts are a very convenient source of cells that are readily available and easy to grow ([0033], Page 3). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because O'Heeron et al were successful in treating pain by using foreskin fibroblasts with working examples and data.
Conclusion
No claim is 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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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632