Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 22, 2025 has been entered.
Specification
The amendment filed August 5, 2020 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Incorporations by reference to foreign priority documents when added by amendment at the time of entry to the national stage raise new matter (see MPEP 608.01(p) I B and 1893.03(b)).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17-18 and 21-28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fehr (WO 2010/139762) in view of Torabinejad et al. (2003/0235804) in view of Fischer et al. (2003/0156980) as evidenced by Bergheim (2012/0237893).
With respect to claim 17, Fehr teaches a method for treating periimplantitis, comprising the following steps: a first step (a) consisting of cleaning and/or disinfecting a site of microbial infection on an implant, in situ with a brush comprising bristles, the bristles consisting of titanium or titanium alloy (see abstract, pg. 6, ll. 20-34, pg. 7, ll. 27-30, pg. 13, l. 31) and a first cleaning solution (see abstract, pg. 26, ll. 31-35, pg. 27, ll. 1-8, 27-32 pg. 28, ll. 1-19, such that the step only includes the claimed cleaning step with the brush and a first cleaning solution) and a second step (b) consisting of cleaning or disinfecting the site of microbial infection with the brush and a second cleaning solution (see pg. 27, ll. 6-8, pg. 34, ll. 17-25, pg. 36, ll. 20-23, see specifically pg. 27, ll. 7-8, such that the additional step of a second solution to be used with the brush is taught and pg. 34, ll. 18-25 teaching a second different solution from the first being introduced through the brush. Such that it is noted that the step only has the claimed limitations of cleaning with a brush and solution). Fehr teaches the method as substantially claimed and discussed above, however, does not specifically teach the first cleaning solution which is a 0.01-0.1 weight % sodium hypochlorite solution and the second cleaning solution which is chlorhexidine (CHX) solution.
Torabinejad teaches a method for treating periimplantitis (see pars. 24, 46, 93-97, such that the solution is used to removed bacteria and can be used on implant, including dental implants) comprising the following steps a first step a) consisting of cleaning a site of microbial infection in situ with physical means (see pars. 46-47, 49) and a first cleaning solution which is a 0.65% weight sodium hypochlorite solution (pars. 1-2 regarding cleaning site in situ, pars. 6 and 94-97 regarding bacteria, par. 49 regarding the concentration of the sodium hypochlorite being 1%, par. 90 regarding the concentration of NaOCl being less than 1%, claims 66-68, 72, see further claim 65 regarding the first step of the the method only consisting of cleaning with a solution of NaOCl) and thereafter a second step b) consisting of cleaning the site of microbial infection with the physical means (pars. 47, 49) and a second cleaning solution which is a chlorhexidine solution (pars. 49, claims 65, 87, see further claim 65 regarding the second step of the method only consisting of a second solution which includes the claimed chlorhexidine). It would have been obvious to one having ordinary skill in the art before the invention was made to modify Fehr with the first and second cleaning solution taught by Torabinejad in order to achieve better bacterial effect (see pars. 49, 93-97 which teaches the solutions taught by Torabinejad provide better antibacterial effects than the disclosed EDTA solution of Fehr). It is noted that Fehr also teaches the method for treating hard tissue including removing debris including a smear layer (see pg. 7, ll. 19-25 of Fehr). Fehr/Torabinejad teaches the invention as substantially claimed and discussed above, however, does not specifically teach the first cleaning solution has 0.01-0.1 weight % of sodium hypochlorite.
Fischer teaches a cleaning solution for removing bacteria (as taught by Fehr and Torabinejad, see abstract of Fischer) wherein the concentration of sodium hypochlorite (NaCIO) in the first cleaning solution is 0.01-0.1 weight % (pars. 30-31, the broad range of 0.01-50% is taught). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the concentration of sodium hypochlorite (NaClO) as taught by Fehr/Torabinejad to be within the claimed range of 0.01-.01 weight % as taught by Fischer in order to provide the effective cleaning and reduce the toxicity to the patient. Such that it is well known that by providing the cleaning agent in a higher concentration it may provide better cleaning results but result in more irritation or damage to the patient while reducing the concentration of the cleaning agent, the cleaning results may be less or slower but the patient is protected (see par. 271 of evidentiary reference Bergheim). It is further noted that Fischer teaches a broad range of known acceptable amounts including amounts taught by Torabinejad, therefore it is noted that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the range of sodium hypochlorite as taught by Torabinejad to be within the claimed range as taught by Fischer since it has been held that were the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05, I).
It is noted that the applicant does not seem to show that anything less than 0.1% weight provides any unexpected results or advantage and it is noted that Torabinejad teaches a concentration of 0.65%.
With respect to claim 18, Fehr teaches a method for treating periimplantitis, comprising the following steps: a first step (a) consisting of cleaning and/or disinfecting a site of microbial infection on an implant, in situ with a brush comprising bristles, the bristles consisting of titanium or titanium alloy (see abstract, pg. 6, ll. 20-34, pg. 7, ll. 27-30, pg. 13, l. 31) and a first cleaning solution (see abstract, pg. 26, ll. 31-35, pg. 27, ll. 1-8, 27-32 pg. 28, ll. 1-19, such that the step only includes the claimed cleaning step with the brush and a first cleaning solution) and a second step (b) consisting of cleaning or disinfecting the site of microbial infection with the brush and a second cleaning solution (see pg. 27, ll. 6-8, pg. 34, ll. 17-25, pg. 36, ll. 20-23, see specifically pg. 27, ll. 7-8, such that the additional step of a second solution to be used with the brush is taught and pg. 34, ll. 18-25 teaching a second different solution from the first being introduced through the brush. Such that it is noted that the step only has the claimed limitations of cleaning with a brush and solution). Fehr teaches the method as substantially claimed and discussed above, however, does not specifically teach the first cleaning solution which is a 0.01-0.1 weight % sodium hypochlorite solution and the second cleaning solution which is 0.2-3 weight% chlorhexidine (CHX) solution.
Torabinejad teaches with respect to claim 18, a method comprising the following steps a first step a) consisting of cleaning a site of microbial infection in situ with a first cleaning solution which is solution which is a 0.65% weight sodium hypochlorite solution (pars. 1-2 regarding cleaning site in situ, par. 6 regarding bacteria, par. 49 regarding the concentration of the sodium hypochlorite being 1%, par. 90 regarding the concentration of NaOCl being less than 1%, claims 68-66, 72, see further claim 65 regarding the first step of the method only consisting of cleaning with a solution of NaOCl) and thereafter b) cleaning the site of microbial infection with a second cleaning solution which is a 1-3% weight chlorhexidine solution (pars. 30, 37, 49, claims 22-24, 74-75 87, see further claim 65 regarding the second step of the method only consisting of a second solution which includes the claimed chlorhexidine). Torabinejad teaches the method as substantially claimed and discussed above, however, does not specifically teach the first cleaning solution has 0.01-0.1 weight % of sodium hypochlorite.
Fischer teaches a cleaning solution for removing bacteria (as taught by Fehr and Torabinejad, see abstract of Fischer) wherein the concentration of sodium hypochlorite (NaCIO) in the first cleaning solution is 0.01-0.1 weight % (pars. 30-31, the broad range of 0.01-50% is taught). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the concentration of sodium hypochlorite (NaClO) as taught by Fehr/Torabinejad to be within the claimed range of 0.01-.01 weight % as taught by Fischer in order to provide the effective cleaning and reduce the toxicity to the patient. Such that it is well known that by providing the cleaning agent in a higher concentration it may provide better cleaning results but result in more irritation or damage to the patient while reducing the concentration of the cleaning agent, the cleaning results may be less or slower but the patient is protected (see par. 271 of evidentiary reference Bergheim). It is further noted that Fischer teaches a broad range of known acceptable amounts including amounts taught by Torabinejad, therefore it is noted that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the range of sodium hypochlorite as taught by Torabinejad to be within the claimed range as taught by Fischer since it has been held that were the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05, I).
It is noted that the applicant does not seem to show that anything less than 0.1% weight provides any unexpected results or advantage and it is noted that Torabinejad teaches a concentration of 0.65%.
With respect to claims 21-22, Fehr/Torabinejad/Fischer teaches the invention as substantially claimed and Fischer further teaches wherein the concentration of NaClO in the first cleaning solution is less than 0.1% weight (pars. 30-31, the broad range of 0.01-50% is taught, therefore it teaches a concentration of less than 0.1%).
With respect to claims 23-24, Fehr/Torabinejad/Fischer teaches the invention as substantially claimed and Fischer further teaches wherein the concentration of NaClO in the first cleaning solution is from 0.01-0005 weight% (pars. 30-31, the broad range of 0.01-50% is taught, therefore it teaches the claimed range).
With respect to claims 25-28, Fehr/Torabinejad/Fischer teaches the invention as substantially claimed including Fehr teaches the first solution consists of water and NaClO (see pg. 19, ll. 4-10), however, does not specifically teach the concentration of NaClO from 0.01 to less than 01 weight % or 0.01-0.05 weight%. Fischer further teaches the concentration of sodium hypochlorite (NaCIO) in the first cleaning solution is from 0.01 to less than 01 weight % or 0.01-0.05 weight%. (pars. 30-31, the broad range of 0.01-50% is taught). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the concentration of sodium hypochlorite (NaClO) as taught by Fehr/Torabinejad to be within the claimed range of 0.01-.01 weight % as taught by Fischer in order to provide the effective cleaning and reduce the toxicity to the patient. Such that it is noted that the combination teaches the claimed limitation such that Fehr teaches the solution consisting of water and NaClO and the modification would teach the solution consisting of the claimed range of NaClO and water.
Claims 17-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fehr (WO 2010/139762) in view Torabinejad et al. (2003/0235804) in view Nakashima et al. (2012/0270177).
With respect to claim 17, Fehr teaches a method for treating periimplantitis, comprising the following steps: a first step (a) consisting of cleaning and/or disinfecting a site of microbial infection on an implant, in situ with a brush comprising bristles, the bristles consisting of titanium or titanium alloy (see abstract, pg. 6, ll. 20-34, pg. 7, ll. 27-30, pg. 13, l. 31) and a first cleaning solution (see abstract, pg. 26, ll. 31-35, pg. 27, ll. 1-8, 27-32 pg. 28, ll. 1-19, such that the step only includes the claimed cleaning step with the brush and a first cleaning solution) and a second step (b) consisting of cleaning or disinfecting the site of microbial infection with the brush and a second cleaning solution (see pg. 27, ll. 6-8, pg. 34, ll. 17-25, pg. 36, ll. 20-23, see specifically pg. 27, ll. 7-8, such that the additional step of a second solution to be used with the brush is taught and pg. 34, ll. 18-25 teaching a second different solution from the first being introduced through the brush. Such that it is noted that the step only has the claimed limitations of cleaning with a brush and solution). Fehr teaches the method as substantially claimed and discussed above, however, does not specifically teach the first cleaning solution which is a 0.01-0.1 weight % sodium hypochlorite solution and the second cleaning solution which is chlorhexidine (CHX) solution.
Torabinejad teaches a method for treating periimplantitis (see pars. 24, 46, 93-97, such that the solution is used to removed bacteria and can be used on implant, including dental implants) comprising the following steps a first step a) consisting of cleaning a site of microbial infection in situ with physical means (see pars. 46-47, 49) and a first cleaning solution which is a 0.65% weight sodium hypochlorite solution (pars. 1-2 regarding cleaning site in situ, pars. 6 and 94-97 regarding bacteria, par. 49 regarding the concentration of the sodium hypochlorite being 1%, par. 90 regarding the concentration of NaOCl being less than 1%, claims 66-68, 72, see further claim 65 regarding the first step of the the method only consisting of cleaning with a solution of NaOCl) and thereafter a second step b) consisting of cleaning the site of microbial infection with the physical means (pars. 47, 49) and a second cleaning solution which is a chlorhexidine solution (pars. 49, claims 65, 87, see further claim 65 regarding the second step of the method only consisting of a second solution which includes the claimed chlorhexidine). It would have been obvious to one having ordinary skill in the art before the invention was made to modify Fehr with the first and second cleaning solution taught by Torabinejad in order to achieve better bacterial effect (see pars. 49, 93-97 which teaches the solutions taught by Torabinejad provide better antibacterial effects than the disclosed EDTA solution of Fehr). It is noted that Fehr also teaches the method for treating hard tissue including removing debris including a smear layer (see pg. 7, ll. 19-25 of Fehr). Fehr/Torabinejad teaches the invention as substantially claimed and discussed above, however, does not specifically teach the first cleaning solution has 0.01-0.1 weight % of sodium hypochlorite.
Nakashima teaches a cleaning solution for removing bacteria (as taught by Fehr and Torabinejad, see abstract of Nakashima) wherein the concentration of sodium hypochlorite (NaCIO) in the first cleaning solution is 0.01-0.1 weight % (pars. 245, 246). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the concentration of sodium hypochlorite (NaClO) as taught by Torabinejad to be within the claimed range of 0.01-.01 weight % as taught by Fischer in order to provide the effective cleaning and reduce the toxicity to the patient (see Pars. 246-248 of Nakashima). It is further noted that Nakashima teaches a range of known acceptable amounts including amounts taught by Torabinejad (see par. 245 of Nakashima such that a 6% weight solution is used) therefore it is noted that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the range of sodium hypochlorite as taught by Fehr/Torabinejad to be within the claimed range as taught by Nakashima since it has been held that were the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05, I).
It is noted that the applicant does not seem to show that anything less than 0.1% weight provides any unexpected results or advantage and it is noted that Torabinejad teaches a concentration of 0.65%.
With respect to claim 18, Fehr teaches a method for treating periimplantitis, comprising the following steps: a first step (a) consisting of cleaning and/or disinfecting a site of microbial infection on an implant, in situ with a brush comprising bristles, the bristles consisting of titanium or titanium alloy (see abstract, pg. 6, ll. 20-34, pg. 7, ll. 27-30, pg. 13, l. 31) and a first cleaning solution (see abstract, pg. 26, ll. 31-35, pg. 27, ll. 1-8, 27-32 pg. 28, ll. 1-19, such that the step only includes the claimed cleaning step with the brush and a first cleaning solution) and a second step (b) consisting of cleaning or disinfecting the site of microbial infection with the brush and a second cleaning solution (see pg. 27, ll. 6-8, pg. 34, ll. 17-25, pg. 36, ll. 20-23, see specifically pg. 27, ll. 7-8, such that the additional step of a second solution to be used with the brush is taught and pg. 34, ll. 18-25 teaching a second different solution from the first being introduced through the brush. Such that it is noted that the step only has the claimed limitations of cleaning with a brush and solution). Fehr teaches the method as substantially claimed and discussed above, however, does not specifically teach the first cleaning solution which is a 0.01-0.1 weight % sodium hypochlorite solution and the second cleaning solution which is 0.2-3 weight% chlorhexidine (CHX) solution.
Torabinejad teaches with respect to claim 18, a method comprising the following steps a first step a) consisting of cleaning a site of microbial infection in situ with a first cleaning solution which is solution which is a 0.65% weight sodium hypochlorite solution (pars. 1-2 regarding cleaning site in situ, par. 6 regarding bacteria, par. 49 regarding the concentration of the sodium hypochlorite being 1%, par. 90 regarding the concentration of NaOCl being less than 1%, claims 68-66, 72, see further claim 65 regarding the first step of the method only consisting of cleaning with a solution of NaOCl) and thereafter b) cleaning the site of microbial infection with a second cleaning solution which is a 1-3% weight chlorhexidine solution (pars. 30, 37, 49, claims 22-24, 74-75 87, see further claim 65 regarding the second step of the method only consisting of a second solution which includes the claimed chlorhexidine). Torabinejad teaches the method as substantially claimed and discussed above, however, does not specifically Nakashima teaches a cleaning solution for removing bacteria (as taught by Fehr and Torabinejad, see abstract of Nakashima) wherein the concentration of sodium hypochlorite (NaCIO) in the first cleaning solution is 0.01-0.1 weight % (pars. 245, 246). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the concentration of sodium hypochlorite (NaClO) as taught by Fehr/Torabinejad to be within the claimed range of 0.01-.01 weight % as taught by Nakashima in order to provide the effective cleaning and reduce the toxicity to the patient (see Pars. 246-248 of Nakashima). It is further noted that Nakashima teaches a range of known acceptable amounts including amounts taught by Torabinejad (see par. 245 of Nakashima such that a 6% weight solution is used) therefore it is noted that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the range of sodium hypochlorite as taught by Fehr/Torabinejad to be within the claimed range as taught by Nakashima since it has been held that were the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05, I).
It is noted that the applicant does not seem to show that anything less than 0.1% weight provides any unexpected results or advantage and it is noted that Torabinejad teaches a concentration of 0.65%.
Response to Arguments
Applicant's arguments filed October 23, 2025 have been fully considered but they are not persuasive.
The applicant argues that the finality of the rejection mailed on 6/23/2025 was improper. However, it is noted that the prior art rejection for claims 17-18 was the same as the rejection in the non-final. It was indicated that a new grounds of rejection was applied since the applicant added new claims 21-24, which added a new grounds of rejection to the final rejection. However, the new grounds of rejection was NOT applied to claims 17-18 which were not amended. Therefore, the finality of the rejection was proper.
The applicant further argues that cited publications teach away from the presently claimed invention. However, it is noted that the cited publications that the applicant is arguing are NOT being used in the rejection above and therefore, the arguments are moot.
The applicant further argues that the concentration NaOCl taught by Torabinejad was diluted and used in combination with ADD and that the examiner fails to consider that according to paragraph 97 of Torabinejad, the bactericidal effect relies far more heavily on ADD than on NaOCl. However, it is noted that as discussed above in the rejection and in previous rejections, the claims limitations are taught. See specifically the board decision mailed on 12/18/2023 affirming the rejection with same or similar claimed limitations. It is noted that the claims do NOT limit the first and second solution to what is being claimed, only what is carried out in the first and second step is being limited. Such that each step can only have the steps using a brush and a solution, which is taught by the prior art.
With respect to new claims 25-28, it is noted that the prior art of Fehr teaches the first solution consisting of only water and NaOCl. It is further noted that Torabinejad teaches the use of NaOCl followed by the ADD solution (see claim 87) such that a first solution of only NaOCl is used followed by a second solution comprising chlorhexidine, as claimed by the applicant. Therefore, the applicant’s arguments regarding the two being combined together are moot as they are two separate solutions applied as different times which reads on the claimed limitations.
The applicant is arguing the effectiveness of the method and claimed concentrations, however, it is noted the effectiveness of the method is not claimed and the claimed steps of the method are taught by the prior art and therefore, the applicant’s arguments related to the effectiveness of the claimed method compared to the prior arts effectiveness are moot.
With respect to the objection to the specification, it is noted that the applicant’s arguments that the sections of the MPEP were reviewed and there is no support for the objection are not persuasive. The MPEP sections are provided below with the relevant sections bolded.
§608.01(p) I B:
As a safeguard against the omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, applicant may include a statement at the time of filing of the later application incorporating by reference the prior application. See MPEP § 201.06(c) and 211 et seq. where domestic benefit is claimed. See MPEP §§ 213 - 216 where foreign priority is claimed. See MPEP § 217 regarding 37 CFR 1.57(b). The inclusion of such an incorporation by reference statement in the later-filed application will permit applicant to include subject matter from the prior application into the later-filed application without the subject matter being considered as new matter. For the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). Although, as discussed above, an incorporation by reference statement can be used as a safeguard against an omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, it should be noted that an incorporation by reference statement will not satisfy the specific reference requirement of 35 U.S.C. 119(e) or 120 or 37 CFR 1.78. See Droplets, Inc. v. E*TRADE Bank, 887 F.3d 1309, 126 USPQ2d 317 (Fed. Cir. 2018)
AND
1893.03(b):
An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Specifically, 35 U.S.C. 363 provides that
An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office.
Similarly, PCT Article 11(3) provides that
...an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.
It is noted that since the filing date of the current application would be the filling date of the PCT and therefore, the preliminary amendment incorporating by reference the foreign application after the filling date (i.e. after the filling of the PCT) introduces new matter. It is suggested that the applicant amend the specification so that the foreign application is not incorporated by reference. It is noted that the applicant is still entitled to the priority date of the foreign application.
Conclusion
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 3/5/2026