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 .
DETAILED ACTION
NOTE: This is a second non-final as original claims 27 and 29-31 should have been rejected over the cited prior art
Claims 1, 6-11, 21-35, 39, and 42 are pending in the instant application.
Claim 1, 7, 22-23, 25-26, and 28-31 are amended.
Claims 27 and 39 have been cancelled.
Claims 1, 6-11, 21-26, 28-35, and 42 are examined herein.
Priority
The instant application claims benefit of priority to US Provisional Application No. 63104350, filed on 22 October 2020, and PCT/US21/55908, filed on 20 October 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 20 October 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 30 May 2023, 07 June 2024, 19 July 2024, and 23 July 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 14 October 2025 has been entered.
The remarks filed on 17 October 2025 have been received and priority to the provisional application is confirmed and amended above.
In view of applicant amendment to claim 1, the 112(a)-written description rejection of record is withdrawn.
In view of applicant amendment to claims 7, 22, 23, and 25-31, the 112(b) rejection of record is withdrawn.
In view of applicant amendment to claim 1, the 102(a)(1) rejection of record is withdrawn.
In view of applicant cancellation of claim 39, the 103 rejection of record over Vaughan in view of Naviaux is withdrawn.
In view of applicant request, the double patenting rejections of record are held in obeyance until patentable matter is identified. The rejections are modified below to reflect the claim amendments.
With respect to the 102(a)(1) rejection over Pakbaz, Applicant amendment has been considered but is not found persuasive for at least the following reasons. Applicant has incorporated the limitation of suramin levels in brain tissue. As the prior art teaches the same patient population, dosing method, and overlapping dosage this limitation would necessarily occur. The rejection is maintained and amended below.
With respect to the 102(a)(1) rejection over Vaughan, Applicant amendment has been considered but is not found persuasive for at least the same reasons outlined above. The rejection is maintained and amended below.
With respect to the 103 rejection over Pakbaz in view of Erdo, Applicant amendment has been considered but is not found persuasive for the same reasons outlined above. The rejection is maintained and amended below.
In addition, new 103 rejections are necessitated by amendment of claims 29-31 and are incorporated into the maintained rejections (see below).
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
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, 6-11, 21-23, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12-14, and 18 of co-pending Application No. 18435069 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claims 1, 11, and 32, the reference application recites a method of treating a nervous system disorder comprising administering a pharmaceutical composition comprising an effective amount of an antipurinergic agent (claim 1). The reference recites suramin as an antipurinergic agent (claim 14). The reference recites adjusting the dosing regimen to reach a desired improvement in a) anxiety or anxiety-like behavior, b) willingness to explore the environment, c) social interaction, d) spatial learning and memory, e) learning and memory, f) irritability, agitation, and/or crying, g) lethargy and/or social withdrawal, h) stereotypic behavior, i) hyperactivity and/or noncompliance, and j) restrictive and/or repetitive behaviors (claim 12).
Regarding claim 6, the reference recites the hexa-sodium salt (claim 18).
Regarding claims 7-10, the reference recites the nervous system disorder is selected from autism spectrum disorder (ASD), fragile X syndrome (FXS), fragile X-associated tremor/ataxia syndrome (FXTAS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), post-traumatic stress syndrome (PTSD), Tourette's syndrome (TS), Parkinson's Disease, Angelman syndrome (AS), chronic Lyme disease and other nervous system disorders associated with tick-born illnesses, and nervous system and central nervous system (CNS) disorders associated with viral infections, including their long term effects (claim 13).
Regarding claim 21-23, the reference recites the loading dose can be administered at a frequency ranging from once daily to once every third month (claim 1).
Claims 1, 6-11, 21, 24, 28-35, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 5, 6, 9, 21- 24, 35-37, 39-43, and 46 of co-pending Application No. 184033194 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the reference application recites a method of treating a nervous system disorder comprising administering a pharmaceutical composition comprising an effective amount of an antipurinergic agent wherein the composition provides improvement in a) anxiety or anxiety-like behavior, b) willingness to explore the environment, c) social interaction, d) spatial learning and memory, e) learning and memory, f) irritability, agitation, and/or crying, g) lethargy and/or social withdrawal, h) stereotypic behavior, i) hyperactivity and/or noncompliance, and j) restrictive and/or repetitive behaviors (claim 1). The reference recites suramin as an antipurinergic agent (claim 5). And the brain tissue level of the antipurinergic agent in the patient is from 1 ng/ml to 1000 ng/ml (claim 37).
Regarding claim 6, the reference recites the hexa-sodium salt (claim 9).
Regarding claim 7, the reference recites the nervous system disorder is selected from autism spectrum disorder (ASD), fragile X syndrome (FXS), fragile X-associated tremor/ataxia syndrome (FXTAS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), post-traumatic stress syndrome (PTSD), Tourette's syndrome (TS), Parkinson's Disease, Angelman syndrome (AS), and the nervous system and CNS disorder manifestations often associated with Lyme disease and other tick-borne diseases, and the nervous system and central nervous system (CNS) disorders associated with COVID-19 and other viruses, including their long term effects (claim 21).
Regarding claims 8, the reference recites the method wherein the nervous system disorder is selected from autism spectrum disorder, FXS, or FXAS (claim 22).
Regarding claim 9, the reference recites the method wherein the nervous system disorder is autism spectrum disorder (claim 23).
Regarding claim 10, the reference recited the method wherein the autism spectrum disorder is selected from autistic disorder, childhood disintegrative disorder, pervasive developmental disorder-not otherwise specified (POD-NOS), and Asperger syndrome (claim 24).
Regarding claim 11, the reference recites the method wherein the autism spectrum disorder manifests one or more symptoms selected from difficulty communicating, difficulty interacting with others, and repetitive behavior (claim 24).
Regarding claim 21, the reference recites the method where the composition is administered at least once daily, or at least twice daily, or at least once weekly, or at least twice weekly, or at least once every two weeks, or at least once monthly, or at least once every 4 weeks (claim 35).
Regarding claim 24, the reference recites the method wherein the composition is delivered
at least once per a time interval based on the average half-life of the antipurinergic agent (claim 36).
Regarding claim 28, the reference recites the method wherein the brain tissue level of the antipurinergic agent in the patient is at least about 1 ng/ml, or at least about 10 ng/ml, or at least about 50 ng/ml, or at least about 100 ng/ml, or at least about 250 ng/ml, or at least about 500 ng/ml (claim 38).
Regarding claim 29, the reference recites the method wherein the brain tissue to blood plasma partitioning ratio for the antipurinergic agent is at least about 0.05, or at least about 0.1, or at least about 0.25, or at least about 0.50 (claim 39).
Regarding claim 32, the reference recites the method wherein treating said autism spectrum disorder, FXS, or FXTAS comprises improving one or more symptoms of said patient relative to symptoms of said patient prior to said administration, wherein said one or more symptoms are selected from difficulty communicating, difficulty interacting with others, and repetitive behaviors (claim 40).
Regarding claim 33, the reference recites the method wherein treating said autism spectrum disorder, FXS, or FXTAS comprises improving an assessment score of said patient relative to a score from said patient prior to said administration (claim 41).
Regarding claim 34, the reference recites the method wherein the assessment score is selected
from ABC, ADOS, ATEC, CARS CGI, and SRS (claim 42).
Regarding claim 35, the reference recites the method wherein the composition is administered nasally (claim 6).
Regarding claim 42, the reference recites a device for performing the method of claim 1, comprising a nasal spray inhaler for intranasally administering said pharmaceutical composition (claim 46).
Claims 1, 6-11, 21-23, 25-26, 28-35, and 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 9, 11, 14, 22, 23, 26, 27, 29, 38-40, 43, 48, 50, and 65 of co-pending Application No. 17615673 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the reference recites A method for treating cognitive, social, or behavioral disabilities and neurodevelopmental disorders, comprising intranasally administering a therapeutically effective amount of a pharmaceutical composition comprising a therapeutically effective amount of an antipurinergic agent, or a pharmaceutically acceptable salt, ester, solvate, or prodrug thereof to a patient in need thereof (claim 1) wherein the antipurinergic agent is suramin (claim 11) and wherein the brain tissue level of the suramin in the patient is from about 1 ng/ml to about 1000 ng/ml (claim 27).
Regarding claim 6, the reference recites the hexa-sodium salt (claim 14).
Regarding claims 7-9, the reference recites the method wherein the cognitive, social, behavioral disability, or neurodevelopmental disorder is selected from the group consisting of autism spectrum disorder, FXS, FXTAS, CFS, and PTSD (claim 3).
Regarding claims 10, 11, and 32, the reference recites the method wherein said autism spectrum disorder is selected from the group consisting of autistic disorder, childhood disintegrative disorder, pervasive developmental disorder-not otherwise specified (PDD-NOS), and Asperger syndrome, and wherein said autism spectrum disorder includes one or more symptoms selected from the group consisting of difficulty communicating, difficulty interacting with others, and repetitive behaviors (claim 9).
Regarding claim 21, the reference recites the method wherein said composition is administered at least once daily, or at least twice daily, or at least once weekly, or at least twice weekly, or at least once biweekly (i.e. every two weeks), or at least once monthly, or at least once every 4 weeks (claim 22).
Regarding claims 22 and 23, the reference recites the method wherein said composition is administered at least once about every 41 days to about 78 days (claim 23).
Regarding claim 25, the reference recites the method wherein the composition exhibits a penetration rate of about 1 micrograms/cm2 per hour to about 200 micrograms/cm2 per hour of suramin, based on the suramin active, through cultured human airway tissue (claim 43).
Regarding claim 26, the reference recites the method wherein the plasma level of the suramin in the patient is maintained at less than about 3 micromolar (μM), or less than about 2.75 micromolar, or less than about 2.5 micromolar, or less than about 2 micromolar, or less than about 1 micromolar, or less than about 0.5 micromolar based on the suramin active (claim 26).
Regarding claim 28, the reference recites the method wherein the brain tissue level of the suramin in the patient is from about 1 ng/ml to about 1000 ng/ml (claim 27).
Regarding claim 29, the reference recites the method wherein the brain tissue to blood plasma partitioning ratio for the suramin is at least about 0.05, or at least about 0.1, or at least about 0.25, or at least about 0.50 (claim 29).
Regarding claim 30, the reference recites the method wherein the AUC for the plasma level for the suramin active for the patient is less than about 80 μg*day/L or is less than about 75 μg*day/L, or is less than about 50 μg*day/L, or is less than about 25 μg*day/L, or is less than about 10 μg*day/L (claim 38).
Regarding claim 31, the reference recites the method wherein the Cmax for the plasma level for the suramin active for the patient is less than about 75 micromolar, or is less than about 7.5 micromolar, or is less than about 0.1 micromolar, and optionally at least about 0.01 micromolar, based on a single dose (claim 39).
Regarding claim 33, the reference recites the method wherein treating said autism spectrum disorder, FXS, or FXTAS comprises improving by 10% or more of an assessment score of said patient relative to a score from said patient prior to said administration.
Regarding claim 34, the reference recites the method wherein the assessment score is selected from ABC, ADOS, ATEC, CARS CGI, and SRS (claim 50).
Regarding claim 35, the reference recites the method wherein said composition is in the form of a nasal spray for intranasal administration (claim 40).
Regarding claim 42, the reference recites a device for patient administration, including administration selected from self-administration and administration to the patient by an individual other than the patient, for treating cognitive, social, or behavioral disabilities and neurodevelopmental disorders according to claim 1, comprising a nasal spray inhaler for intranasally administering a composition comprising an antipurinergic agent (claim 65).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6-11, 21-24, 26, and 29-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaughan et al. (WO2018148580A1; cited by applicant on 1449 IDS).
Regarding claims 1, 7-9, 11, and 29-32, Vaughan discloses a method of treating an autism spectrum disorder comprising administering an antipurinergic agent (claim 1), wherein the antipurinergic agent is suramin (claim 60). Additionally Vaughan discloses the improvement of symptoms including difficulty communicating, difficulty interacting with others, and repetitive behaviors (claim 68) from the administration of suramin. Vaughan teaches administering the claimed compound to the claimed patient population in an effective amount it would appear the claimed limitation of the brain tissue level of the suramin, the brain tissue to blood plasma partitioning ratio, the AUC for the plasma level, and the Cmax for the plasma level would necessarily occur. See MPEP 2112.01:I.
Regarding claim 6, Vaughan discloses the suramin hexa-sodium salt (paragraph [0051]).
Regarding claim 10, Vaughan discloses an autism spectrum disorder comprises DSM-IV-TR diagnostic categories of autism, Asperger syndrome, pervasive developmental disorder not otherwise specified, and childhood disintegrative disorder (paragraph [0098]).
Regarding claim 21, Vaughan discloses the composition is administered daily, weekly, once every two weeks, once every three weeks, once every four weeks, once every five weeks, once every six weeks, once every seven weeks, or once every eight weeks (paragraph [00133]).
Regarding claims 22 and 23, Vaughan discloses the composition can be administered once and then not administered again for a “treatment holiday” ranging from 1 to 100 days (paragraph 00113]).
Regarding claim 24, Vaughan discloses determining the administration dose by determining the half-life of suramin (paragraph [00119]).
Regarding claim 26, Vaughan discloses the plasma level of the suramin is maintained between a range, where the lowest value of the range is about 3 µM (claim 1). Interpreting “about” to mean ±5%, in both the reference and instant application, the range disclosed by Vaughan incudes the about less than 3 µM and overlaps with the about less than 2.75 µM of the instant application.
Regarding claim 33, Vaughan discloses the method of improving an assessment score of the patient relative to the assessment score prior to administration of the composition (paragraph [0016]).
Regarding claim 34, Vaughan discloses the assessment score if selected from ADOS, ABC, ATEC, and CGI (paragraph [0016]).
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.
Claim(s) 1, 7-11, 21, 28-35, and 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pakbaz et al. (WO2018148262A1; cited by applicant on 1449 IDS).
Regarding claims 1 and 28-31, Pakbaz discloses a method of treating a neurodevelopmental disorder (claim 15) comprising intranasally (claim 8) administering a composition comprising suramin (claim 2). Treatment of a neurodevelopmental disorder would lead to the improvement of the recited symptoms.
Pakbaz fails to explicitly teach an anticipatory range.
Pakbaz teaches administering the claimed compound to the claimed patient population in an effective amount up to 1.5 g/kg (paragraph [0123]). The instant specification discloses a composition comprising up to 10 mg/kg of suramin (page 20, line 2). As Pakbaz teaches an overlapping range and the functional outputs of those ranges would be expected to meet the functional properties claimed, i.e. if the range is obvious then the functional property is met. Therefore, it would appear the claimed limitation of the brain tissue level of the suramin, the brain tissue to blood plasma partitioning ratio, the AUC for the plasma level, and the Cmax for the plasma level would necessarily occur and the burden has been shifted to the Applicant. MPEP 2112.01:I states:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
Regarding claims 7-9, Pakbaz discloses a method of treating autism spectrum disorder and Tourette’s syndrome (claim 3).
Regarding claim 10, Pakbaz discloses a method of treating autism, Asperger’s syndrome, pervasive developmental disorder not otherwise specified, and childhood disintegrative disorder (claim 4).
Regarding claims 11 and 32, Pakbaz discloses autism spectral disorders include social deficits, and communication difficulties, and repetitive behaviors (paragraph [04]).
Regarding claim 21, Pakbaz discloses the composition can be administered once daily or twice daily (paragraph [124]).
Regarding claim 33 and 34, Pakbaz discloses an example where ADOS scores were measured before administration of suramin and after (paragraphs [125]-[127]).
Regarding claims 35 and 42, Pakbaz discloses the composition can be formulated as a nasal spray and administration carried out with an intranasal inhaler (paragraph [40]).
Claim(s) 1, 7-11, 21, 25, 28-35, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pakbaz et al. (cited above) in view of Erdo et al. (Brain Research Bulletin. 2018; 143: 155–170).
The teachings of Pakbaz are disclosed above and incorporated by reference herein.
Regarding claim 25, Pakbaz teaches that the compositions and formulations may include penetration enhancers (paragraph [117]) and these enhancers may alter the rate of penetration (paragraph [118]).
Pakbaz does not teach a penetration rate of an antipurinergic agent.
Erdo teaches the intranasal administration of CNS drugs as an effective route to bypass the blood brain barrier (BBB) and deliver a therapeutically effective amount of the drug directly to the brain. Erdo teaches the importance of formulating the drug in order to reach the desired rate of penetration.
It would be routine optimization and prima facie obvious to one of ordinary skill in the art to formulate the composition taught by Pakbaz to a desired rate of penetration to deliver the most efficacious amount of suramin to the patient.
Conclusion
Claims 1, 6-11, 21-26, 28-35, and 42 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621