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 .
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1 and 10 have been amended.
Claims 1-12 are pending.
Claims 13-25 are cancelled.
Claim 2 is withdrawn.
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.
Claim 1 and 3-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US11285223B2 in view of IACUCCI (Looking beyond symptom relief: evolution of mucosal healing in inflammatory bowel disease. Therapeutic Advances in Gastroenterology. 2011.).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patent recites A method for assessing gut function in a subject in need thereof, comprising the steps of: a. administering an effective amount of a composition for assessing gut function, the composition comprising a fluorescent challenge molecule, wherein the fluorescent challenge molecule is not substantially absorbed by a healthy gut; b. irradiating the fluorescent challenge molecule absorbed by the subject's gut with non-ionizing radiation, wherein the radiation causes the fluorescent challenge molecule to fluoresce; c. detecting the fluorescence of the fluorescent challenge molecule; and d. assessing gut function in the subject based on the detected fluorescence, wherein the subject is a human, wherein the fluorescent challenge molecule is a fluorescent dye selected from the group consisting of 3,6-diamino-2,5-bis{N-[(IR)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine and 3,6-N,N′-bis(2,3-dihydroxypropyl)-2,5-pyrazinedicarboxamide, wherein the non-ionizing radiation has a wavelength of at least 350 nm, and wherein the fluorescent challenge molecule absorbed by the subject's gut is irradiated and detected in the subject's skin, blood, urine, or fascia (claim 1).
The reference does not teach treating the patient for the digestive disease and measuring gut permeability of the patient before and after treatment or the amount of the doses.
IACUCCI teaches mucosal healing is an important prognostic feature of the efficacy of treatment in IBD (Assessment and quantification of mucosal healing). It is important to monitor mucosal healing so that treatment can be individualized and tailored to the predicted disease course (Assessment and quantification of mucosal healing). Mucosal healing is an important prognostic feature of the efficacy of treatment in IBD (Assessment and quantification of mucosal healing). Patients with Crohn’s disease were treated and then had their mucosal healing monitored after 26 weeks (Page 137, paragraph 5). Monitoring before and after therapy is important (page 133, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate treating the patient for Crohn’s disease and monitoring healing before and after treatment. The person of ordinary skill in the art would have been motivated to make those modifications, because it is important to monitor mucosal healing so that treatment can be individualized and tailored to the predicted disease course, and reasonably would have expected success because both references are in the same field of endeavor, such as assessing gut function in patient.
The references do not specifically teach the dosage concentration as claimed by the Applicant. The dosage concentration is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal dosage concentration in order to best achieve desired results, such as having the appropriate concentration needed for detection due to the photoactive agent employed or the area to be examined. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the dosage concentration would have been obvious at the time of Applicant’s invention.
With regard to claim 1, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).). This is in regard to “wherein the second total percentage of the administered dose recovered correlates to mucosal healing”.
Claims 1 and 3-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US11077211B2 in view of IACUCCI (Looking beyond symptom relief: evolution of mucosal healing in inflammatory bowel disease. Therapeutic Advances in Gastroenterology. 2011.).
Although the claims at issue are not identical, they are not patentably distinct from each other because A method for assessing gut function in a human subject in need thereof, the method comprising the steps of: a. orally administering to the subject an effective amount of a composition comprising two fluorescent challenge molecules, wherein the first fluorescent challenge molecule is not substantially absorbed by a healthy gut, and wherein the second fluorescent challenge molecule is substantially absorbed by a healthy gut into the subject's gut; b. irradiating the composition absorbed by the subject's gut with non-ionizing radiation, wherein the radiation causes the composition to fluoresce; c. detecting the fluorescence of the fluorescent challenge molecules in the composition; and d. assessing gut function in the subject based on the detected fluorescence, wherein the first fluorescent challenge molecule is selected from the group consisting of 3,6-diamino-2,5-bis {N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine and 3,6-N,N′-bis(2,3-dihydroxypropyl)-2,5-pyrazinedicarboxamide, and wherein the second fluorescent challenge molecule is selected from the group consisting of acridines, acridones, anthracenes, anthracylines, anthraquinones, azaazulenes, azo azulenes, benzenes, benzimidazoles, benzofurans, benzoindocarbocyanines, benzoindoles, benzothiophenes, carbazoles, coumarins, cyanines, dibenzofurans, dibenzothiophenes, dipyrrolo dyes, flavones, fluoresceins, imidazoles, indocarbocyanines, indocyanines, indoles, isoindoles, isoquinolines, naphthacenediones, naphthalenes, naphthoquinones, phenanthrenes, phenanthridines, phenanthridines, phenoselenazines, phenothiazines, phenoxazines, phenylxanthenes, polyfluorobenzenes, purines, pyrazines, pyrazoles, pyridines, pyrimidones, pyrroles, quinolines, quinolones, rhodamines, squaraines, tetracenes, thiophenes, triphenyl methane dyes, xanthenes, xanthones, and derivatives thereof, and wherein the non-ionizing radiation has a wavelength of at least 350 nm (claim 1).
The reference does not teach treating the patient for the digestive disease and measuring gut permeability of the patient before and after treatment or the doses administered.
IACUCCI teaches mucosal healing is an important prognostic feature of the efficacy of treatment in IBD (Assessment and quantification of mucosal healing). It is important to monitor mucosal healing so that treatment can be individualized and tailored to the predicted disease course (Assessment and quantification of mucosal healing). Mucosal healing is an important prognostic feature of the efficacy of treatment in IBD (Assessment and quantification of mucosal healing). Patients with Crohn’s disease were treated and then had their mucosal healing monitored after 26 weeks (Page 137, paragraph 5). Monitoring before and after therapy is important (page 133, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate treating the patient for Crohn’s disease and monitoring healing before and after treatment. The person of ordinary skill in the art would have been motivated to make those modifications, because it is important to monitor mucosal healing so that treatment can be individualized and tailored to the predicted disease course, and reasonably would have expected success because both references are in the same field of endeavor, such as assessing gut function in patient.
The references do not specifically teach the dosage concentration as claimed by the Applicant. The dosage concentration is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal dosage concentration in order to best achieve desired results, such as having the appropriate concentration needed for detection due to the photoactive agent employed or the area to be examined. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the dosage concentration would have been obvious at the time of Applicant’s invention.
With regard to claim 1, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).). This is in regard to “wherein the second total percentage of the administered dose recovered correlates to mucosal healing”.
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 and 4-12 are rejected under 35 U.S.C. 103 as being unpatentable over DORSHOW (US 2015/0147277A1) in view of IACUCCI (Looking beyond symptom relief: evolution of mucosal healing in inflammatory bowel disease. Therapeutic Advances in Gastroenterology. 2011.).
Regarding claim 1, DORSHOW teaches a method for assessing gut function comprising: administering a composition comprising a fluorescent molecule that is not substantially absorbed by a healthy gut (claim 2). The composition is administered orally (claim 3), which reads on enterally administering. The fluorescence is then measured by irradiating the composition absorbed by the subject's gut with non-ionizing radiation, wherein the radiation causes the composition to fluoresce (claim 1), which reads on measuring, via fluorescence, an amount of the administered dose that can be found outside the gut over a period of time. The gut function is assessed in the subject based on the detected fluorescence (claim 1), which reads on determining a total percentage of the administered dose recovered. Common gut issues associated with gut permeability are Crohn’s disease and ulcerative colitis (Page 1, paragraph 3). This method can be used to determine response to treatments (paragraph 0028). The detected fluorescence of the fluorescent challenge molecules is measured over time (claim 7), which reads on measuring, via fluorescence, after treating the patient since time can be considered a treatment.
Additional disclosures: common gut issues associated with gut permeability are Crohn’s disease and ulcerative colitis (Page 1, paragraph 3). The dosage of the composition may vary depending upon the particular integrated photoactive agent employed, the areas to be examined, the equipment employed in the clinical procedure, and the efficacy of the treatment achieved (paragraph 0083).
DORSHOW does not teach measuring gut permeability of the patient before and after treatment.
IACUCCI teaches mucosal healing is an important prognostic feature of the efficacy of treatment in IBD (Assessment and quantification of mucosal healing). It is important to monitor mucosal healing so that treatment can be individualized and tailored to the predicted disease course (Assessment and quantification of mucosal healing). Mucosal healing is an important prognostic feature of the efficacy of treatment in IBD (Assessment and quantification of mucosal healing). Patients with Crohn’s disease were treated, which reads on selecting an intervention, and then had their mucosal healing monitored after 26 weeks (Page 137, paragraph 5). Monitoring before and after therapy is important (page 133, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate treating the patient for Crohn’s disease and monitoring healing before and after treatment. The person of ordinary skill in the art would have been motivated to make those modifications, because it is important to monitor mucosal healing so that treatment can be individualized and tailored to the predicted disease course, and reasonably would have expected success because both references are in the same field of endeavor, such as assessing gut function in patients and DORSHOW states that the method can be used to determine response to treatments.\
Regarding claim 1 and 10, the references do not specifically teach the dosage concentration as claimed by the Applicant. The dosage concentration is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal dosage concentration in order to best achieve desired results, such as having the appropriate concentration needed for detection due to the photoactive agent employed or the area to be examined. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the dosage concentration would have been obvious at the time of Applicant’s invention.
Note with regard to claim 1, the recitation of “determining a baseline total percentage of the administered dose recovered”, “determining a second total percentage of the administered dose recovered” and “comparing the second total percentage of the administered dose recovered to the baseline total percentage of the administered dose recovered” appear to be mental steps.
With regard to claim 1, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).). This is in regard to “wherein the second total percentage of the administered dose recovered correlates to mucosal healing”.
Note with regard to claim 4, the recitation of “assessing the patient's mucosal healing based on the comparison of the second total percentage of the administered dose recovered to the baseline total percentage of the administered dose recovered and to a distribution of values the administered dose recovered in a normal population” appears to be a mental step.
With regard to claims 5 and 6, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).). This is in the regards of the recitations of “wherein when the second total percentage of the administered dose recovered is less than the baseline total percentage of the administered dose recovered and less than or equal to two standard deviations above the mean of the recovered administered dose in a normal population, the patient likely has mucosal healing” and “wherein when the second total percentage of the administered dose recovered is less than the baseline total percentage of the administered dose recovered but remains above 2 standard deviations above the mean of the recovered administered dose in a normal population, the patient likely does not have mucosal healing.”.
Note with regard to claim 7, the recitation of “selecting an intervention for the patient and assessing mucosal healing after the intervention” appears to be a mental step. Furthermore, IACUCCI teaches patients with Crohn’s disease were treated, which reads on selecting an intervention (Page 137, paragraph 5).
Regarding claim 8, IACUCCI teaches patients with Crohn’s disease were treated, which reads on selecting an intervention, and then had their mucosal healing monitored after 26 weeks (Page 137, paragraph 5), which reads on at least 1 week.
Regarding claim 9, DORSHAW teaches common gut issues associated with gut permeability are Crohn’s disease and ulcerative colitis (Page 1, paragraph 3). IACUCCI teaches patients with Crohn’s disease were treated, which reads on selecting an intervention, and then had their mucosal healing monitored after 26 weeks (Page 137, paragraph 5).
Regarding claims 11 and 12, DORSHAW teaches the fluorescent molecule used is 3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (paragraph 0042).
Claims 1 and 3-12 are rejected under 35 U.S.C. 103 as being unpatentable over DORSHOW (US 2015/0147277A1) and IACUCCI (Looking beyond symptom relief: evolution of mucosal healing in inflammatory bowel disease. Therapeutic Advances in Gastroenterology. 2011.) in further view of DORSHOW 2 (Transdermal fluorescence detection of a dual fluorophore system for noninvasive point-of-care gastrointestinal permeability measurement. Biomedical Optics Express. 2019.)
DORSHOW and IACUCCI teach Applicant’s invention as discussed above. DORSHAW further teaches the fluorescence is detected by irradiating the composition absorbed by the subject's gut with non-ionizing radiation, wherein the radiation causes the composition to fluoresce (claim 1) and is detected transcutaneously (claim 6).
DORSHOW and IACUCCI do not teach measuring fluorescence transdermally.
Regarding claim 3, DORSHOW 2 teaches a method for measuring gut function, via measuring the gastrointestinal integrity (abstract). A fluorescence composition is administered, excited and measured transdermally or transcutaneously (Page 5105, paragraph 5 and page 5106, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate measuring the fluorescence transdermally. The person of ordinary skill in the art would have been motivated to make those modifications, because measuring transdermally or transcutaneously are functional equivalents of measuring fluorescence, and reasonably would have expected success because the references are in the same field of endeavor, measuring fluorescence to determine gut integrity.
Response to Arguments
Applicant argues that the amended claims overcome the art, specifically an amount of fluorescent tracer used and determining a second total percentage of the administered dose recovered.
Examiner does not find the argument persuasive because as discussed above, the references do not specifically teach the dosage concentration as claimed by the Applicant. The dosage concentration is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal dosage concentration in order to best achieve desired results, such as having the appropriate concentration needed for detection due to the photoactive agent employed or the area to be examined. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the dosage concentration would have been obvious at the time of Applicant’s invention.
Furthermore with regard to claim 1, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).). This is in regard to “wherein the second total percentage of the administered dose recovered correlates to mucosal healing”.
Conclusion
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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618