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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/09/2023 and 07/10/2025 were submitted in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over WO-20211142373-A1 (as filed on the IDS submitted 10/09/2023, PCT/US2021/012842, filed 08 January 2021 and published 15 July 2021), hereinafter Gupta et al. (373)
With regard to claim 1, Gupta et al. (373) teach a method of treating inflammatory bowel disease (IBD) in a subject comprising administering the compound of formula (I), referred to as Compound A (see [0178], [0198]). Further, they teach that the subject has a plasma concentration of the compound between 1-25 ng/mL (see [0178]). Although the range taught by Gupta et al. (373) is not precisely 0.1 ng/mL to 4 ng/mL as claimed in claim 1 of the instant application, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range. Further, although Gupta et al. (373) do not explicitly teach a clinical remission rate, they teach the use of the same physical product, and, as discussed above, the same range of plasma concentration. Here, products of identical chemical composition can not have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With regard to claim 2, Gupta et al. (373) teach that the plasma concentration is 1-25 ng/mL, but they do not explicitly teach that the concentration is about 0.2-0.7 ng/mL (see [0178]). Here, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), wherein the court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties." See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997), wherein under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0. Here, the ranges do not overlap but are close such that one skilled in the art would expect them to have the same properties.
With regard to claims 3 and 4, Gupta et al. (373) teach that in some embodiments, the subject is provided with a dose ranging from about 200 mg to about 1000 mg, optionally taken as a once daily dose or as divided doses (e.g., half the amount) twice daily (see [0173]). Further, in some embodiments, the subject is provided with a dose ranging from about 100 mg to about 1500 mg per day, optionally taken as a once daily dose or as divided doses (e.g., half the amount) twice daily (see [0173]). They also teach embodiments wherein the dose is 5, 6, 7, 8, 9, 10, 12.5, 25.0, 37.5, 50.0, 62.5, 75, 87.5, 100.0, 112.5, 125.0, 137.5, 150.0, 162.5, 175, 187.5, 200.0, 212.5, 225.0, 237.5, 250.0, 262.5, 275, 287.5, 300.0, 312.5, 325.0, 337.5, 350.0, 362.5, 375, 387.5, 400.0, 412.5, 425.0, 437.5, 450.0, 462.5, 475, 487.5, or 500.0 mg (see [0173]). Here, Gupta et al. (373) do not explicitly teach the range of 50 mg to 1000 mg, not do they explicitly teach all of the dosages of 50, 62.5, 75, 87.5, 100.0, 112.5, 125.0, 137.5, 150.0, 162.5, 175, 187.5, 200.0, 212.5, 225.0, 237.5, 250.0, 262.5, 275, 287.5, 300.0, 312.5, 325.0, 337.5, 350.0, 362.5, 375, 387.5, 400.0, 412.5, 425.0, 437.5, 450.0, 462.5, 475, 487.5, 500.0, 512.5, 525, 537.5, 550, 562.5, 575, 587.5, 600, 612.5, 625, 637.5, 650, 662.5, 675, 687.5, 700, 712.5, 725, 737.5, 750, 762.5, 775, 787.5,800, 812.5, 825, 837.5, 850, 862.5, 875, 887.5, 900, 912.5, 925, 937.5, 950, 962.5, 975, 987.5 or 1000 mg, but they teach embodiments from 200 to 1000 mg and a representative sample of embodiments from 50 to 200 mg. Again, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941).
With regard to claim 5, Gupta et al. (373) teach the embodiments of the compound administered at a dosage of 150 mg and 450 mg once or twice per day (see [0173]). Specifically, they teach that the subject is provided with a dose of about any of 100, 150, 200, 250, 300, 250, 400, 450, or 500 mg once or twice daily (see [0173]).
With regard to claim 6, 7, 8, and 9, although Gupta et al. (373) do not explicitly teach a clinical remission rate, they teach the use of the same physical product, and, as discussed above, the same range of plasma concentration. Here, products of identical chemical composition can not have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With regard to claim 10, Gupta et al. (373) teach a method of improving the therapeutic efficacy of treating IBD, specifically with regard to endoscopic improvement or histological improvement, wherein a compound of formula (I) is orally administered to a subject (see [0092], [0178], [0198]). In particular embodiments, the pharmacokinetic parameter, like plasma concentration in ng/mL, is maintained for at least several hours following administration (see [0180]). Here, maintaining a pharmacokinetic parameter, all of which are measures of plasma concentration or related measures in Gupta et al. (373), clearly implies a chosen level of said parameter to maintain. In other words, a person having ordinary skill in the art would know that maintaining a plasma concentration of the compound in a subject implies having a predetermined level at which to maintain it. As such, Gupta et al. (373) teach maintaining plasma concentration of the compound of formula (I) in a subject at a predetermined concentration.
With regard to claims 11 and 12, Gupta et al. (373) teach that the plasma concentration is 1-25 ng/mL, but they do not explicitly teach that the concentration is about 0.1-0.85 ng/mL or 0.2-0.7 ng/mL. Here, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), wherein the court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties." See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997), wherein under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0. Here, the ranges do not overlap but are close such that one skilled in the art would expect them to have the same properties.
With regard to claims 13 and 14, the plasma concentration of the compound of formula (I) and regimen of dosage of said compound are known result-effective variables, variables which achieve a recognized result, in Gupta et al. (373) Specifically, Gupta et al. (373) teach that the plasma concentration of the compound of formula (I) is a result-effective variable in treating IBD, specifically in having the compound traverse the patient’s system (see [0314]). Additionally, they teach that different doses and dosing regimens of compounds of formula (I) is a result-effective variable in treating IBD, specifically in the saturation of blood receptor occupancy (see [0026]). Here, the presence of known result-effective variables provides a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In other words, the presence of the known result-effective variables provides a motivation for routine experimentation and optimization recited in claims 13 and 14 by modifying these variables, namely, dosing regimens or plasma concentrations in subjects.
With regard to claim 15, Gupta et al. (373) teach that the compound of formula (I) is administered once or twice daily (see [0173]).
With regard to claim 16, Gupta et al. (373) teach that the subjects can be human (see [0160]).
With regard to claim 17, Gupta et al. (373) teach that the IBD can be ulcerative colitis (see [0167]).
With regard to claim 18, Gupta et al. (373) teach embodiments wherein the compound of formula (I) is used to treat moderate to severe ulcerative colitis (see [0321]).
With regard to claim 19, Gupta et al. (373) teach embodiments wherein the IBD is Crohn’s disease (see [0031]).
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 22, 27, 28, 29, 35, 37, 38, 56, 57, and 66 of copending Application No. 17/788179 (filed 06/22/2022 with benefit to a provisional application filed 01/10/2020), hereinafter Gupta et al. (179) in view of Sandborn et al. (Sandborn, William J et al. “PTG-100, an Oral α4β7 Antagonist Peptide: Preclinical Development and Phase 1 and 2a Studies in Ulcerative Colitis.” Gastroenterology vol. 161,6 (2021): 1853-1864).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
With regard to claim 1, Gupta et al. (179) claim a method of treating IBD in a subject in need thereof, comprising administering to the subject an α4β7 integrin antagonist of formula (I) of the instant application, wherein the antagonist is administered to the patient orally at a dose of about 100 mg to about 500 mg, once or twice daily, wherein the subject reaches pharmacokinetic parameters in plasma concentration of 1-25 ng/mL (see claims 1, 8, 29). Although the range claimed by Gupta et al. (179) is not precisely 0.1 ng/mL to 4 ng/mL as claimed in claim 1 of the instant application, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941). The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range. Further, although Gupta et al. (179) do not explicitly teach a clinical remission rate, they teach the use of the same physical product, and, as discussed above, the same range of plasma concentration. Here, products of identical chemical composition can not have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With regard to claim 2, Gupta et al. (179) claim that the plasma concentration is 1-25 ng/mL, but they do not explicitly claim that the concentration is about 0.2-0.7 ng/mL (see claim 29). Here, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), wherein the court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties." See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997), wherein under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0. Here, the ranges do not overlap but are close such that one skilled in the art would expect them to have the same properties.
With regard to claims 3, 4, and 5, Gupta et al. (179) claim the method discussed above wherein the peptide dimer compound or pharmaceutically acceptable salt thereof is administered to the subject at a dose of about 5, 6, 7, 8, 9, 10, 12.5, 25.0, 37.5, 50.0, 62.5, 75, 87.5, 100.0, 112.5, 125.0, 137.5, 150.0, 162.5, 175, 187.5, 200.0, 212.5, 225.0, 237.5, 250.0, 262.5, 275, 287.5, 300.0, 312.5, 325.0, 337.5, 350.0, 362.5, 375, 387.5, 400.0, 412.5, 425.0, 437.5, 450.0, 462.5, 475, 487.5, or 500.0 mg once a day or twice a day (see claims 56, 57).
With regard to claim 6, 7, 8, and 9, although Gupta et al. (179) do not explicitly claim a clinical remission rate, they teach the use of the same physical product, and, as discussed above, the same range of plasma concentration. Here, products of identical chemical composition can not have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With regard to claim 10, Gupta et al. (179) claim the method discussed above wherein the effective amount of the antagonist or pharmaceutically acceptable salt thereof or the pharmaceutical composition is sufficient to achieve at least one of the following: a) about 50% or greater saturation of MAdCAM1 binding sites on α4β7 integrin molecules; b) about 50% or greater inhibition of α4β7 integrin expression on the cell surface; and c) about 50% or greater saturation of MAdCAM1 binding sites on α4β7 molecules and about 50% or greater inhibition of α4β7 integrin expression on the cell surface, wherein i) the saturation is maintained for a period consistent with a dosing frequency of no more than twice daily; ii) the inhibition is maintained for a period consistent with a dosing frequency of no more than twice daily; or iii) the saturation and the inhibition are each maintained for a period consistent with a dosing frequency of no more than twice daily (see claim 66). Here, a person having ordinary skill in the art would know that maintaining the saturation of MAdCAM1 binding sites is a direct function of the plasma concentration of the compound of formula (I) and thereby a function of the regimen and dosage of the compound administered to the subject. In other words, maintaining or regulating the saturation as described above is functionally equivalent to regulating or maintaining the plasma concentration of the compound in the patient by controlling the dosing regimen of the compound. Here, Gupta et al. (179) have a predetermined saturation of MAdCAM1 binding sites, which, as discussed above, has a direct relationship with the plasma concentration of the compound, thereby implying a predetermined plasma concentration that is regulated or maintained in maintaining the saturation.
With regard to claims 11 and 12, Gupta et al. (179) claim that the plasma concentration is 1-25 ng/mL, but they do not explicitly teach that the concentration is about 0.1-0.85 ng/mL or 0.2-0.7 ng/mL (see claim 29). Here, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985), wherein the court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties." See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997), wherein under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0. Here, the ranges do not overlap but are close such that one skilled in the art would expect them to have the same properties.
With regard to claims 13 and 14, the plasma concentration of the compound of formula (I) and regimen of dosage of said compound are known result-effective variables, variables which achieve a recognized result, in Gupta et al. (179) Specifically, Gupta et al. (179) claim that different doses and dosing regimens of compounds of formula (I) is a result-effective variable in treating IBD, specifically in altering the saturation of blood receptor occupancy (see claim 22). As such, seeing as one having ordinary skill in the art knows that plasma concentration of a drug is a function of the dosing regimen, plasma concentration is a result-effective variable in treating IBD insofar as it is modulated by dosing and affects the saturation of blood receptor occupancy (see claim 22). Here, the presence of known result-effective variables provides a motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In other words, the presence of the known result-effective variables provides a motivation for routine experimentation and optimization recited in claims 13 and 14 by modifying these variables, namely, dosing regimens or plasma concentrations in subjects.
With regard to claim 15, Gupta et al. (179) claim the method discussed above wherein the dose is administered to the subject once a day or twice a day (see claim 57).
With regard to claim 16, Gupta et al. (179) do not explicitly claim that the patient is human, but they do claim the method for treating human immunodeficiency virus (HIV) infection in the GI tract, which a person of ordinary skill in the art would know is a condition specific to humans, revealing that the scope of the claims include human patients (see claim 35). Claiming the treatment of the human-specific condition also directly supplies a teaching that the patient can be human.
With regard to claim 17, Gupta et al. (179) claim the method discussed above wherein the IBD is ulcerative colitis (see claims 27, 35, 37).
With regard to claim 18, Gupta et al. (179) claim the method of treating ulcerative colitis discussed above, but they do not explicitly claim that the ulcerative colitis can be moderate to severe ulcerative colitis (see claims 27, 35, 37). The prior art does, however, show that α4ß7 antagonist peptides like those discussed in the instant application and Gupta et al. (179) can be effective in treating moderate to severe ulcerative colitis. Specifically, Sandborn et al. show that another α4ß7 antagonist peptide, PTG-100, showed proof-of-concept efficacy in patients with moderate to severe active ulcerative colitis (see page 1862, paragraph 4). Seeing as α4ß7 antagonist peptides were known to treat moderate to severe ulcerative colitis, it would have been obvious to a person having ordinary skill in the art to try to use the α4ß7 antagonist peptide of Gupta et al. (179) in treating moderate to severe ulcerative colitis.
With regard to claim 19, Gupta et al. (179) claim the method discussed above wherein the IBD is Crohn’s disease (see claims 28, 35, 38).
Summary
Claims 1-19 are rejected as unpatentable under 35 U.S.C. 103 on the grounds of obviousness. Claims 1-19 are rejected as unpatentable on the grounds of non-statutory double patenting.
Conclusion
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/BRENDAN P. OLISS/Examiner, Art Unit 1658
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654