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 .
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1 recites “the second inner catheter” on lines 8-9. However, a second inner catheter is not properly introduced until the following line. It appears that applicant is attempting to refer to the first inner catheter.
Claim 6 recites “a valve” on line 2. It is not clear whether applicant is referring to the mitral valve or aortic valve. Based on the language of Claim 1, it appears that applicant is referencing the aortic valve.
Claim 6 recites “deflecting the distal tip by more than 3240 degrees,” which is an obvious typographical error. For examination purposes, this limitation has been interpreted as “by more than 140 degrees,” which is supported in the instant specification.
Claim 11 recites “an outer surface of the outer sheath is flush with an outer surface of the inner sheath” on lines 12-13. It appears that Applicant is attempting to claim that the inner surface of the outer sheath is flush with an outer surface of the inner sheath. This language is mirrors claim 2 and is supported in the instant specification.
Claim 12 recites “the first inner catheter” on line 2. There is no antecedent basis for this limitation. It appears that Applicant is referring to the inner sheath from earlier in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “wherein the second catheter includes a plurality of holes disposed around a body of the second catheter to return the oxygenated blood.” This contradicts independent claim 11, which requires that the second catheter receives oxygen-poor blood from the patient. For examination purposes, Claim 15 has been interpreted to require that the holes of the second catheter receive oxygen-poor blood from the patient.
Claim 16 recites “wherein the outer sheath includes a plurality of holes disposed around a body of the outer sheath to receive the oxygen-poor blood.” This contradicts independent claim 11, which requires that the outer sheath returns oxygenated blood to the patient. For examination purposes, Claim 15 has been interpreted to require that the holes of the outer sheath return oxygenated blood from the patient.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Alaswad (US 2019/0307996) in view of Stack (US 2021/0077084).
With respect to Claim 1, Alaswad teaches a method for performing transseptal extracorporeal membrane oxygenation (ECMO) on a patient (Figures 2A; Figures 7-8E, 32, and 35B; paragraphs [0016] (last sentence), [0057-0058]), the method comprising:
advancing a first inner member (specifically a guidewire 201; see Figure 2A and the last sentences of paragraphs [0062] and [0063]) through a transseptal puncture [0026], deflecting the first inner member within the left atrium so that the distal tip is disposed toward the mitral valve, advancing the first inner member through the mitral valve, deflecting the first inner member toward the aortic valve, advancing the first inner member through the aortic valve so that the distal end of the first inner member is in the ascending aorta (Figure 2A; paragraphs [0006], [0008], [0011], [0091]);
advancing a second inner catheter (705, 725; Figures 7-8E) distally over the first inner member, wherein the second inner catheter is coaxial with and surrounds the first inner member (the catheter is inserted over the guidewire; see the last sentences of paragraphs [0062] and [0063]);
withdrawing the first inner member (implicit); and
receiving from the patient oxygen-poor blood through an outer catheter (710, 720; Figures 7-8E) that is coaxial with the second inner catheter and returning oxygenated blood through the second inner catheter to the ascending aortic arch (paragraphs [0006], [0008], [0011], [0016] (last sentence), [0057-0058], and [0091]).
Alaswad teaches that the second inner catheter may be placed via any number of conventional means, including by guidewire as disclosed in Figures 2A-2E (see paragraphs a [0062-0063]), but does not explicitly teach that the first inner member is a first inner catheter that is withdrawn through the second inner catheter once the second inner catheter has been advanced to the ascending aortic arch.
Stack teaches a delivery catheter assembly comprising a needle assembly 12 and a balloon catheter 16 (i.e. a first inner catheter), wherein the catheter assembly is configured for transseptal catheterization of the heart (Abstract). The needle assembly 12 may be used to pierce the septum such that the balloon catheter 16 may be inserted from the RA into the LA. Thereafter, the needle is withdrawn and the balloon is inflated such that blood flow carries the balloon catheter through the mitral valve into the LV, and through the aortic valve into the aorta [0042]. The catheter system (i.e. a second inner catheter) is then inserted over the balloon catheter, as illustrated in Figures 4-12 (paragraph [0042]). Once the catheter system is in place, the balloon is deflated and the balloon catheter is withdrawn through the catheter system (paragraphs [0042-0043]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Alaswad’s ECMO catheterization method to replace the first inner guidewire with a first inner balloon catheter, as suggested by Stack, in order to provide a well-known means for inserting a catheter into the aorta through a transseptal puncture by allowing blood flow to carry the device through the chambers of the heart and into the aorta [0042-0043].
With respect to Claim 3, Alaswad teaches that the outer catheter (710, 720) surrounds the second inner catheter (705, 725). See Figures 7-8E.
With respect to Claims 4 and 5, Alaswad and Stack reasonably suggest the method as claimed (see the rejection of claim 1 above). Specifically, Stack teaches the step of inflating a balloon at the distal end of the first inner catheter to center the catheter with respect to the mitral valve as it passes therethrough [0042]. After the balloon has advanced through the mitral valve, the balloon is deflated and withdrawn from the second inner catheter [0043].
With respect to Claim 6, Alaswad does not explicitly teach that the step of deflecting the distal tip of the first inner catheter toward the aortic valve comprises deflecting the distal tip by more than 140 degrees with respect to the proximal section of the first inner catheter. However, the examiner notes that Figures 2A and 8A-8E are merely a schematic. Since Alaswad’s catheter is inserted through the same method as disclosed in Applicant’s specification, it is necessarily configured to be deflected at least 140 degrees as claimed in order to navigate the chambers of the patient’s heart.
However, in the event that this interpretation is not clearly envisaged by applicant, Stack teaches a similar catheter system that is implanted over a guidewire from the vena cava, into the right atrium, through the interatrial septum into the left atrium, through the mitral valve into the left ventricle, and into the aorta (see Figures 7- 13; paragraph [0042] and Claim 7 of the PGPub). As clearly shown in Figures 12-13, this path necessarily includes a one turn of at least 140 degrees as it navigates from the left atrium, through the mitral valve, into the left ventricle, and into the aortic arch. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Alaswad’s catheterization method such that the inner sheath is deflected at least 140 degrees, as illustrated by Stack, in order to navigate the path from the vena cava, through the RA and LA, through the LV, and into the ascending aortic arch.
With respect to Claim 7, Alaswad teaches that the second inner catheter (705, 725) comprises a plurality of holes disposed around the body of the second inner catheter to return oxygen to the blood (Figures 7-8E, 32, and 35B; apertures 601 shown most clearly in Figure 6A are clearly present at the distal tip of the second inner catheter in the embodiments of Figures 7-8E, 32, and 35B).
With respect to Claim 8, Alaswad teaches that the outer catheter (710, 720) includes a plurality of holes disposed around a body of the catheter to receive oxygen-poor blood (Figures 7-8E, 32, and 35B; apertures 601 shown most clearly in Figure 6A are clearly present at the distal tip of the outer catheter in the embodiments of Figures 7-8E, 32, and 35B).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Alaswad and Stack as applied to claim 1 above, and further in view of Zawacki (US 2003/0149395).
With respect to Claim 2, Alaswad and Stack reasonably suggest the method of Claim 1, but do not specifically teach that the outer surface of the second inner catheter is flush with an outer surface of the first inner catheter.
Zawacki teaches a coaxial, dual-lumen catheter for use with an extracorporeal system, wherein the inner catheter 30 is capable of sliding with respect to the outer catheter 20 (Figures 1-5). Specifically, the inner tube is secured by a flush fit with the inner wall of the outer tube, specifically an interference fit within the outer tube (Figure 5; paragraph [0042]), thereby enabling the inner catheter to slide relative to the outer catheter. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the catheter system of Alaswad and Stack to have a flush interference fit between the first inner catheter and second inner catheter, as suggested by Zawacki, in order to provide a well-known configuration for allowing for relative movement between the catheters while maintaining a seal between them.
Claims 11-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Alaswad, Stack, and Zawacki.
With respect to Claim 11, Alaswad teaches a method for performing transseptal extracorporeal membrane oxygenation (ECMO) on a patient (Figures 2A; Figures 7-8E, 32, and 35B; paragraphs [0016] (last sentence), [0057-0058]), the method comprising:
advancing an inner member (specifically a guidewire 201; see Figure 2A and the last sentences of paragraphs [0062] and [0063]) through a transseptal puncture [0026],
advancing a second catheter (710, 720) into a large peripheral vein or an inferior vena cava (paragraph [0011]; the second catheter (710, 720) is disposed in the inferior vena cava, as shown in Figures 8A-8E)
deflecting the inner member within the left atrium so that the distal tip is disposed toward the mitral valve, advancing the inner member through the mitral valve, deflecting the distal tip of the inner member toward the aortic valve, advancing the inner member through the aortic valve so that the distal end of the inner member is in the ascending aorta (Figure 2A; paragraphs [0006], [0008], [0011], [0091]);
advancing an outer sheath (705, 725; Figures 7-8E) distally over the inner member until the distal end of the outer sheath is within the ascending aorta, wherein the outer sheath is coaxial with and surrounds the inner sheath (the catheter is inserted over the guidewire; see the last sentences of paragraphs [0062] and [0063]);
withdrawing the inner member (implicit); and
receiving from the patient oxygen-poor blood through the second catheter (710, 720; Figures 7-8E) and returning oxygenated blood through the outer sheath into the ascending aorta (paragraphs [0006], [0008], [0011], [0016] (last sentence), [0057-0058], and [0091]).
Alaswad teaches that the outer sheath may be placed via any number of conventional means, including by guidewire as disclosed in Figures 2A-2E (see paragraphs a [0062-0063]), but does not explicitly teach that the inner member is an inner sheath that is withdrawn through the outer sheath once the outer sheath has been advanced to the ascending aortic arch.
Stack teaches a delivery catheter assembly comprising a needle assembly 12 and a balloon catheter 16 (i.e. an inner sheath), wherein the catheter assembly is configured for transseptal catheterization of the heart (Abstract). The needle assembly 12 may be used to pierce the septum such that the balloon catheter 16 may be inserted from the RA into the LA. Thereafter, the needle is withdrawn and the balloon is inflated such that blood flow carries the balloon catheter through the mitral valve into the LV, and through the aortic valve into the aorta [0042]. The catheter system (i.e. an outer sheath) is then inserted over the balloon catheter, as illustrated in Figures 4-12 (paragraph [0042]). Once the catheter system is in place, the balloon is deflated and the balloon catheter is withdrawn through the catheter system (paragraphs [0042-0043]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Alaswad’s ECMO catheterization method to replace the inner guidewire with an inner balloon catheter, as suggested by Stack, in order to provide a well-known means for inserting a catheter into the aorta through a transseptal puncture by allowing blood flow to carry the device through the chambers of the heart and into the aorta [0042-0043].
Alaswad does not specifically teach the inner surface of the outer sheath being flush with the outer surface of the inner sheath. However, Zawacki teaches a coaxial, dual-lumen catheter for use with an extracorporeal system, wherein the inner catheter 30 is capable of sliding with respect to the outer catheter 20 (Figures 1-5). Specifically, the inner tube is secured by a flush fit with the inner wall of the outer tube, specifically an interference fit within the outer tube (Figure 5; paragraph [0042]), thereby enabling the inner catheter to slide relative to the outer catheter. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Alaswad’s catheter system to have a flush interference fit between the arterial sheath catheter and venous sheath catheter, as suggested by Zawacki, in order to provide a well-known configuration for allowing for relative movement between the catheters while maintaining a seal between them.
With respect to Claims 12 and 13, Alaswad, Stack, and Zawacki reasonably suggest the method as claimed (see the rejection of claim 11 above). Specifically, Stack teaches the step of inflating a balloon at the distal end of the inner sheath to center the sheath with respect to the mitral valve as it passes therethrough [0042]. After the balloon has advanced through the mitral valve, the balloon is deflated and withdrawn from the inner and outer sheaths of the catheter system [0043].
With respect to Claim 14, Alaswad does not explicitly teach that the step of deflecting the distal tip of the inner sheath toward the aortic valve comprises deflecting the distal tip by more than 140 degrees with respect to the proximal section of the inner sheath. However, the examiner notes that Figures 2A and 8A-8E are merely a schematic. Since Alaswad’s catheter is inserted through the same method as disclosed in Applicant’s specification, it is necessarily configured to be deflected at least 140 degrees as claimed in order to navigate the chambers of the patient’s heart.
However, in the event that this interpretation is not clearly envisaged by applicant, Stack teaches a similar catheter system that is implanted over a guidewire from the vena cava, into the right atrium, through the interatrial septum into the left atrium, through the mitral valve into the left ventricle, and into the aorta (see Figures 7- 13; paragraph [0042] and Claim 7 of the PGPub). As clearly shown in Figures 12-13, this path necessarily includes a one turn of at least 140 degrees as it navigates from the left atrium, through the mitral valve, into the left ventricle, and into the aortic arch. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify Alaswad’s catheterization method such that the inner sheath is deflected at least 140 degrees, as illustrated by Stack, in order to navigate the path from the vena cava, through the RA and LA, through the LV, and into the ascending aortic arch.
With respect to Claim 15, Alaswad teaches that the second catheter (710, 720) comprises a plurality of holes disposed around the body of the second catheter to receive oxygen-poor blood from the patient (Figures 7-8E, 32, and 35B; apertures 601 shown most clearly in Figure 6A are clearly present at the distal tip of the second catheter in the embodiments of Figures 7-8E, 32, and 35B).
With respect to Claim 16, Alaswad teaches that the outer sheath (705, 725) includes a plurality of holes disposed around a body of the outer sheath to return oxygen-rich blood to ascending aorta of the patient (Figures 7-8E, 32, and 35B; apertures 601 shown most clearly in Figure 6A are clearly present at the distal tip of the outer sheath in the embodiments of Figures 7-8E, 32, and 35B).
With respect to Claim 19, Alaswad, Stack, and Zawacki reasonably suggest the method as claimed (see the rejection of claim 11 above). Specifically, Alaswad teaches that the transseptal puncture is established prior to inserting the catheter [0011]. Alternatively, Stack teaches that the catheter system comprises a needle 12 that is configured to puncture the septum of the patient prior to insertion of the inner sheath 16 (paragraphs [0034] and [0042].
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-19 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-19 of prior U.S. Patent No. 12,226,564. This is a statutory double patenting rejection.
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,964,091. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method for performing transseptal ECMO, the method comprising: advancing a first inner catheter through a transseptal puncture; deflecting the first inner catheter within the left atrium so that a distal tip of the first inner catheter is disposed substantially toward a mitral valve; advancing the first inner catheter through the mitral valve; deflecting the distal tip of the first inner catheter toward an aortic valve; advancing the first inner catheter through the aortic valve so that a distal end of the second inner catheter is in an ascending aorta; advancing a second inner catheter distally over the first inner catheter, wherein the second inner catheter is coaxial with and surrounds the first inner catheter; withdrawing the first inner catheter; and receiving, from the patient, oxygen-poor blood through an outer catheter and returning oxygenated blood through the second inner catheter to the ascending aortic arch.
Instant claims 1-10 are broader than the ‘091 claims at least because they do not necessarily require that the first inner catheter is distally tapered.
Instant claims 11-19 are broader than the ‘091 claims because they do not require the step of advancing a first catheter that includes an inner sheath and an outer sheath through a transseptal puncture.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-20 of copending Application No. 19/056,723. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of implanting a catheter from through the heart chambers and into the aorta. The instant claims are broader than the ‘723 claims because they do not necessarily require positioning a venous sheath catheter coaxially over an arterial sheath catheter so that a plurality of venous openings are positioned in the IVC, LV, or aortic arch.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No.19/264,838. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of implanting a catheter from through the heart chambers and into the aorta. The instant claims are broader than the ‘723 claims because they do not necessarily require that the arterial sheath catheter is advanced over the inner catheter until the arterial sheath catheter is at least 1 cm distal to the aortic valve. The ‘838 application also uses different terminology for the first inner catheter, second inner catheter, and outer catheter than the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 9-10 and 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and upon overcoming the double patenting rejections set forth above.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art does not teach or suggest the step of inserting at least one guidewire through the inner sheath and outer sheath prior to deflecting the inner sheath within the left atrium. Since Stack’s delivery system is guidewire-less (see Title and entire disclosure), it is unclear why one of ordinary skill in the art would have further modified the system of Alaswad and Stack to include a guidewire, since Stack teaches away from such a configuration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stack (US 2021/0220131) teaches a catheter system for transseptal catheterization.
Heilmann (US 2022/0305250) teaches a coaxial catheter with an interference fit between inner and outer catheters.
Wilson (US 8,591,460) teaches a steerable catheter having a distal balloon for dilating the mitral valve.
Banchieri (US 2011/0152741) teaches a cannula system having a central obturator that is coaxial with the cannula lumen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached at (571) 270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781