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 . Claims 1-27 filed December 31, 2025 are currently pending.
Status of Claims
As indicated in the Office Action of 10/01/2025, claims 22-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2025.
Response to Amendment
Applicant’s amendments, filed 12/31/2025 are acknowledged. Claims 3, 5, 7 and 10 have been amended to recite proper Markush language of “selected from the group consisting of”. In view of Applicant’s amendments, the pending 35 U.S.C 112 paragraph B rejections have been withdrawn
Applicant's arguments, filed 12/31/2025 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and objections presently being applied to the instant application.
Claim Rejections - 35 USC § 102-Rejection(s) Maintained
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) 1-9, 11-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by El-Shabrawi (WO2019/043169 published 03/07/2019).
El-Shabrawi teaches the ophthalmic aqueous gel composition comprising the anti-inflammatory agents 0.5% wt. prednisone and 0.1% wt. diclofenac along with the fluoroquinolone ofloxacin (0.3% wt.). Both the NSAID diclofenac and fluoroquinolone are formulated with 2-hydroxypropyl gamma-cyclodextrin, wherein 2-hydroxypropyl gamma cyclodextrin is present in 1.8% wt. of the composition ([0113]-[0114], [0128], claim 86). Regarding claims 9, 11-14 and 19, said ophthalmic composition further comprises the water soluble polymer methyl cellulose, the pH buffering components NaOH/HCl, and the preservative sodium disulfite (0.02% wt.). Regarding claims 15-16, administration to the eye as an ophthalmic drop or gel 1-3 times per day is embodied within the teachings of El-Shabrawi ([0097]-[0100], claim 1, claim 31). Regarding claims 17-18, El-Shabrawi teaches preparing dissolved aqueous solutions comprising ofloxacin with gamma-cyclodextrin and diclofenac and gamma cyclodextrin prior to formulating said aqueous solution comprising ofloxacin, diclofenac and gamma-cyclodextrin with a gel comprising methylcellulose and prednisone to yield a gel formulation. ([0113]-[0114], [0128], claim 86).
MPEP 2131 teaches that when the prior art discloses a range which touches or overlaps the claimed range, but no specific examples falling within the claimed range are disclosed, a case by case determination must be made as to anticipation. In order to anticipate the claims, the claimed subject matter must be disclosed in the reference with "sufficient specificity to constitute an anticipation under the statute." What constitutes a "sufficient specificity" is fact dependent. If the claims are directed to a narrow range, and the reference teaches a broader range, other facts of the case, must be considered when determining whether the narrow range is disclosed with "sufficient specificity" to constitute an anticipation of the claims. Compare ClearValue Inc. v. Pearl River Polymers Inc., 668 F.3d 1340, 101 USPQ2d 1773 (Fed. Cir. 2012) with Atofina v. Great Lakes Chem. Corp, 441 F.3d 991, 999, 78 USPQ2d 1417, 1423 (Fed. Cir. 2006).
In the present case, El-Shabrawi teaches the pH of said ophthalmic gel is from 5.5-8.5 which lies inside one end-point of a pH 4-8 range embodied within the present claims. Additionally, there is no allegation of criticality of a pH of 8 within the specification or any evidence demonstrating any difference across the pH range of the claimed composition to one embraced within El-Shabrawi.
Applicant traverses. Applicant argues that the present invention is directed to a composition comprising 0.5-0.7% w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with 0.1-1.0% wt. benzalkonium chloride, while the prior art composition embraced within El-Shabrawi is directed to 0.5% wt. prednisone, 0.1% wt. diclofenac and 0.3% wt. ofloxacin and stabilized with sodium disulfite. Applicant further asserts that the composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride comprises unexpected synergistic therapeutic effects that are not taught by the prior art.
Response to Arguments
Applicant’s arguments, filed 12/31/2025 are acknowledged and have been carefully considered. Regarding Applicant’s contention that the present invention is different from the composition of El-Shabrawri as the present invention is directed to a composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride, while the prior art composition embraced within El-Shabrawi is directed to 0.5% wt. prednisone, 0.1% wt. diclofenac and 0.3% wt. ofloxacin and stabilized with sodium disulfite, this argument is unpersuasive. The ophthalmic aqueous gel composition of El-Shabrawi comprises the anti-inflammatory agents 0.5% wt. prednisone and 0.1% wt. diclofenac along with the fluoroquinolone ofloxacin (0.3% wt.). Both the NSAID diclofenac and fluoroquinolone are formulated with 2-hydroxypropyl gamma-cyclodextrin, wherein 2-hydroxypropyl gamma cyclodextrin is present in 1.8% wt. of the composition ([0113]-[0114], [0128], claim 86). Said composition still reads on a composition comprising a combination of the genus of ANY fluoroquinolone antibacterial agent, the genus of ANY anti-inflammatory agent and water, wherein the composition is having a pH between 4 and 8 as embodied within the present claims. As recited in MPEP 2131, a species will anticipate a claim drawn to a genus and a generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.
Lastly, regarding Applicant’s contention that the presently claimed invention comprises unexpected synergistic therapeutic effects that are not taught by the prior art, this argument is unavailing. As recited in MPEP 2131.04, evidence of secondary considerations, such as unexpected results or commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538, 543, 179 USPQ 421, 425 (CCPA 1973).
Claim(s) 1,4-18, 20-21 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller (WO2001/008689 published 02/08/2001).
Muller teaches an ophthalmic composition comprising the elected NSAID ketorolac in combination with the fluoroquinolone antibacterial agent ofloxacin. Muller exemplifies a composition comprising 0.5% w/v ketorolac, 0.6% w/v ofloxacin, 0.1% of the chelating agent EDTA, 1.0% w/v boric acid, wherein the pH of the composition is 6.4 (page 17). In addition, regarding claims 9-14, Muller teaches a composition comprising 0.5% w/v ketorolac, 0.3% w/v ofloxacin, 0.1% of water soluble polymer methyl cellulose (methocel), 0.005% w/v of the preservative benzalkonium chloride, the tonicity adjusting agent NaCl, the viscosity increasing agent/thickener Carbopol and wherein the pH of the composition is 6.4 (composition 10, page 18). Regarding claims 15-18, Muller teaches topical administration of said composition as an aqueous solution to the eye of a subject in need in a frequency of 3 times a day (pages 11 line 30-page 12 line 5, pages 15-16, pages 24-25).
Applicant traverses. Applicant argues that the present invention differs from that of Muller. The present invention is directed to a composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride, while the prior art composition embraced within Muller is directed towards an ophthalmic composition comprising 0.5% w/v ketorolac, 0.6% w/v ofloxacin, 0.1% of the chelating agent EDTA, and 1.0% w/v boric acid. Applicant additionally traverses that the present invention uses HCl/NaOH to buffer the ophthalmic composition while Muller uses uses 1.0% w/v boric acid to stabilize the pH of their composition.
Response to Arguments
Applicant’s arguments, filed 12/31/2025 are acknowledged and have been carefully considered. Regarding Applicant’s contention that the present invention is directed to a composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride, while the prior art composition embraced within Muller is directed towards an ophthalmic composition comprising 0.5% w/v ketorolac, 0.6% w/v ofloxacin, 0.1% of the chelating agent EDTA, and 1.0% w/v boric acid, this argument is unpersuasive. The ophthalmic aqueous gel composition of Muller comprises the anti-inflammatory agent 0.5% w/v ketorolac along with the fluoroquinolone ofloxacin (0.6% wt.) and the pH adjusting agent boric acid (1.0% wt.). The composition of Muller still reads on a composition comprising a combination of the genus of ANY fluoroquinolone antibacterial agent, the genus of ANY anti-inflammatory agent and water, wherein the composition is having a pH between 4 and 8 stabilized by ANY pH adjusting agent and ANY preservative as embodied within the present claims. As recited in MPEP 2131, a species will anticipate a claim drawn to a genus and a generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.
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.
Claim(s) 1-21 remain rejected under 35 U.S.C. 103 as being unpatentable over El-Shabrawi (WO2019/043169 published 03/07/2019).
El-Shabrawi (WO2019/043169 published 03/07/2019) teaches an ophthalmic aqueous composition comprising the anti-inflammatory steroid, an NSAID and a fluoroquinolone antibiotic agent (claims 1, 19-22). El-Shabrawi exemplifies said ophthalmic composition comprising anti-inflammatory agents 0.5% wt. prednisone and 0.1% wt. diclofenac along with the fluoroquinolone ofloxacin (0.3% wt.). Both the NSAID diclofenac and fluoroquinolone are formulated with 2-hydroxypropyl gamma-cyclodextrin, wherein 2-hydroxypropyl gamma cyclodextrin is present in 1.8% wt. of the composition ([0113]-[0114], [0128], claim 86). El-Shabrawi teaches the pH of the ophthalmic composition is from 5.5-8.5, which overlaps with the pH embraced within the present claims. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
El-Shabrawi further teaches that the elected NSAID ketorolac tromethamine and the elected fluoroquinolone levofloxacin are suitable alternatives for the ophthalmic aqueous composition comprising the anti-inflammatory steroid, an NSAID and a fluoroquinolone antibiotic agent (claims 1, 3, 19-23 and 31).
Regarding claims 10-14 and 19, said ophthalmic composition further comprises the water soluble polymer methyl cellulose, the pH buffering components NaOH/HCl, and the preservative sodium disulfite (0.02% wt.). El-Shabrawi additionally teaches alternative preservatives such as benzalkonium chloride and chelating agents EDTA are suitable to incorporate into the ophthalmic composition ([0075]).
Regarding claims 15-16, El-Shabrawi teaches administration to the eye as a topical drop or gel 1-3 times per day ([0076]-[0077],[0097]-[0100], claim 1, claim 31). Regarding claims 17-18, El-Shabrawi teaches preparing dissolved aqueous solutions comprising ofloxacin with gamma-cyclodextrin and diclofenac and gamma cyclodextrin prior to formulating said aqueous solution comprising ofloxacin, diclofenac and gamma-cyclodextrin with a gel comprising methylcellulose and prednisone to yield a gel formulation ([0113]-[0114], [0128], claim 86).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to formulate the ophthalmic composition comprising 0.5% wt. prednisone, 0.1% wt. diclofenac, 0.3% wt. ofloxacin, 1.8% wt. 2-hydroxypropyl gamma cyclodextrin, the water soluble polymer methocel, the pH buffering components NaOH/HCl, and the preservative sodium disulfite (0.02% wt.) in a pH of 4-8 in order to arrive at the presently claimed composition in view of El-Shabrawi. Motivation to formulate said ophthalmic composition in a pH of 4-8 logically flows from the fact that El-Shabrawi teaches that overlapping pH range of 5.5 to 8.5 is a suitable pH range for the ophthalmic composition.
Secondly, said skilled artisan would have found it prima facie obvious to substitute the NSAID diclofenac for the elected NSAID ketorolac tromethamine, substitute the fluorinated quinolone antibiotic ofloxacin for levofloxacin and substitute the preservative sodium sulfite for benzalkonium chloride in the ophthalmic composition of El-Shabrawi in order to arrive at the presently claimed.
MPEP 2143 provides rationale for a conclusion of obviousness including (B): Simple substitution of one known element for another to obtain predictable results;
In the present case, it was known in the art that the elected NSAID ketorolac tromethamine and the elected fluoroquinolone levofloxacin are each suitable alternatives for the ophthalmic aqueous composition comprising the anti-inflammatory steroid, an NSAID and a fluoroquinolone antibiotic agent, coupled with the knowledge that benzalkonium chloride is a suitable preservative to formulate with the NSAID and fluoroquinolone antibiotic agent ([0075], claims 1, 3, 19-23 and 31). Accordingly, one of ordinary skill in the art would have readily predicted that an ophthalmic composition comprising an anti-inflammatory steroid, an NSAID, a fluoroquinolone antibiotic agent and a preservative wherein the NSAID is the elected NSAID ketorolac tromethamine, the fluoroquinolone antibiotic is the elected fluoroquinolone levofloxacin and the preservative is benzalkonium chloride, said composition would be an efficacious composition to treat ocular pain in a subject in need.
Applicant traverses. Applicant argues that the present invention is directed to a composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride, while the prior art composition embraced within El-Shabrawi is directed to 0.5% wt. prednisone, 0.1% wt. diclofenac and 0.3% wt. ofloxacin and stabilized with sodium disulfite. Applicant further asserts that the composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride comprises unexpected synergistic therapeutic effects that are not taught by the prior art.
Response to Arguments
Applicant’s arguments, filed 12/31/2025 are acknowledged and have been carefully considered. Regarding Applicant’s contention that the present invention is directed to a composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride, while the prior art composition embraced within El-Shabrawi is directed to 0.5% wt. prednisone, 0.1% wt. diclofenac and 0.3% wt. ofloxacin and stabilized with sodium disulfite, this argument is unpersuasive. The ophthalmic aqueous gel composition of El-Shabrawi comprises the anti-inflammatory agents 0.5% wt. prednisone and 0.1% wt. diclofenac along with the fluoroquinolone ofloxacin (0.3% wt.). Both the NSAID diclofenac and fluoroquinolone are formulated with 2-hydroxypropyl gamma-cyclodextrin, wherein 2-hydroxypropyl gamma cyclodextrin is present in 1.8% wt. of the composition still reads on a composition comprising a combination of the genus of ANY fluoroquinolone antibacterial agent, the genus of ANY anti-inflammatory agent and water, wherein the composition is having a pH between 4 and 8 as embodied within the present claims ([0113]-[0114], [0128], claim 86). While the exemplified composition of El-Shabrawi is stabilized with sodium sulfite, El-Shabrawi additionally teaches alternative preservatives such as benzalkonium chloride and chelating agents EDTA are suitable to incorporate into the ophthalmic composition ([0075]).
As such, said skilled artisan would have found it prima facie obvious to substitute the NSAID diclofenac for the elected NSAID ketorolac tromethamine, substitute the fluorinated quinolone antibiotic ofloxacin for levofloxacin and substitute sodium disulfite for benzalkonium chloride in the ophthalmic composition of El-Shabrawi in order to arrive at the presently claimed.
MPEP 2143 provides rationale for a conclusion of obviousness including (B): Simple substitution of one known element for another to obtain predictable results;
Applicant is also reminded of MPEP 2144.07 wherein the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). In the present case, it was known in the art that the elected NSAID ketorolac tromethamine and the elected fluoroquinolone levofloxacin are each suitable anti-inflammatory or anti-bacterial alternatives for the ophthalmic aqueous composition comprising the anti-inflammatory steroid, an NSAID and a fluoroquinolone antibiotic agent, coupled with the knowledge that, El-Shabrawi teaches alternative preservatives such as benzalkonium chloride and chelating agents EDTA are suitable to incorporate into the ophthalmic composition instead of sodium disulfite ([0075]). Accordingly, one of ordinary skill in the art would have readily predicted that an ophthalmic composition comprising an anti-inflammatory steroid, an NSAID and a fluoroquinolone antibiotic agent wherein the NSAID is the elected NSAID ketorolac tromethamine and the fluoroquinolone antibiotic is the elected fluoroquinolone levofloxacin would be an efficacious composition to treat ocular pain in a subject in need.
Lastly, regarding Applicant’s contention that unexpected synergistic therapeutic effects afforded by a composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride is sufficient to overcome a prima facie case, the examiner has reviewed the data in the response and instant specification, however said unexpected results do not overcome a prima facie case for the following reasons.
As shown in MPEP 716.02 (E); An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960).
In the instant case, the closest prior art is Muller (WO2001/008689 published 02/08/2001) who teaches an ophthalmic composition comprising the same NSAID ketorolac in combination with the fluoroquinolone antibacterial agent ofloxacin. Muller exemplifies a composition comprising 0.5% w/v ketorolac, 0.6% w/v ofloxacin, 0.1% of the chelating agent EDTA, 1.0% w/v boric acid, wherein the pH of the composition is 6.4 (page 17). In addition, regarding claims 9-14, Muller teaches a composition comprising 0.5% w/v ketorolac, 0.3% w/v ofloxacin, 0.1% of water soluble polymer methyl cellulose (methocel), 0.005% w/v of the same preservative benzalkonium chloride, the tonicity adjusting agent NaCl, the viscosity increasing agent/thickener Carbopol and wherein the pH of the composition is 6.4 (composition 10, page 18).
Applicants have provided no comparative data to the closest prior art of record to show that 1) the claimed ophthalmic composition results in improved therapeutic efficacy than the prior art 0.5% w/v ketorolac and 0.3% w/v ofloxacin ophthalmic composition taught by Muller above. In essence, there is no positive control experiment between the instantly claimed ophthalmic composition and the composition of Muller.
Data must be provided that demonstrates that the instantly claimed ophthalmic composition performs better than the prior art composition of Muller in order to demonstrate that the claimed combination possesses a property not shared with the closest prior art. Applicant must also show that the different results of the between the instantly claimed and those of the prior art are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(B) and Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Because Applicant has not done so, this argument is unavailing.
Applicant is also reminded of MPEP 716.02(d) which addresses the subject of unexpected results commensurate in scope with the claimed invention: "[W]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See In re Peterson, 315 F. 3d 1325, 1329-31 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003).
As discussed above, Applicant's data presented above is directed to one specific composition comprising 0.5-0.7%w/v levofloxacin hemihydrate and 0.3-0.5% ketorolac tromethamine and stabilized with benzalkonium chloride at a pH between 4-8. Meanwhile, the present claims are directed to a combination comprising the genus of ANY fluoroquinolone antibacterial agent, the genus of ANY anti-inflammatory agent, the genus of ANY preservative and water, wherein the composition is having a pH between 4 and 8. Such results at one specific composition are not commensurate in scope with the claimed ranges of fluoroquinolone antibacterial agent, anti-inflammatory agent or preservative as recited in the claims. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
In view of the rejections set forth above, 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLINTON A 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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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621