DETAILED ACTION
The amendment filed June 13, 2025, has been entered and fully considered. Claims 1-3, 5-7, 17-19, 32, 35, 38, 42, 49, 54-55, 59-60, and 99 are currently pending. Claims 1 and 99 have been amended.
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 .
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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-7, 17-19, 32, 35, 38, 42, 49, 54-55, 59-60 and 99 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 17-18, 32,35, 38, 42, 49, 55, 60, and 101-115 of copending Application No. 18/160,253 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards a system for forming an anastomosis in a heart comprising a first catheter comprising an electrode and a second catheter slidably disposed within the first catheter, the second catheter comprising a barb and a dilator.
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.
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.
Claims 1-3, 5, 18, 49, 59-60 and 99 are rejected under 35 U.S.C. 103 as being unpatentable over Golder et al., (hereinafter ‘Golden,’ U.S. Pat. 11,389,185) in view of Arevalos et al., (hereinafter ‘Arevalos,’ U.S. PGPub. No. 2019/0374254).
Regarding claim 1, Golden (Figs. 2A-4F) disclose a system for forming an anastomosis in a heart (as broadly claimed, the system would be capable of forming an anastomosis in a heart), comprising: a first catheter (205) comprising an internal edge (250); and a second catheter (245) slidably disposed within the first catheter (205), the second catheter (245) comprising a substantially fixed diameter barb (316 as best illustrated in Figs. 3F-G; as broadly claimed, the barb 316 has a ‘substantially fixed diameter’) and a dilator (315) comprising an electrode mating surface (425), wherein a distalmost end of the barb (316) is spaced apart proximally from a proximal most end of the dilator (as best illustrated in Fig. 3G; col. 8, ll. 11-14, “The arms 335 may have a first portion 314 and a second portion 316. The second portion 316 may be adjustable relative to the first portion 314, e.g., the second portion 316 may telescope from the first portion 314.”).
Although Golden discloses “[i]t is also understood that in other embodiments, a cauterizing tool or other electrical cutting device may be used to resect the selected tissue 220” (col. 11, ll. 2-13), Golden is silent regarding a first catheter comprising an electrode.
However, in the same field of endeavor, Arevalos (Figs. 13A-14C; [0184]-[0189]) teaches a similar system for forming an anastomosis in a heart comprising a first catheter (1406) including an electrode (1308, 1408). Arevalos teaches “the cutter further comprises: an electrocautery element; a cryoablation element; an RF (radio-frequency) element; a thermal ablation element; or a chemical or pharmacologic delivery element; configured to retard tissue regrowth. In some embodiments, the electrocautery element comprises: a monopolar element; or a bipolar element.” ([0011]). It is well known in the art (as can be seen in Arevalos) that these various cutter configurations are widely considered interchangeable configurations for forming a fistula. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first catheter as taught by Golden to include an electrode as taught by Arevalos. This modification would have merely comprised a simple substitution of one well known cutter configuration for another in order to produce a predictable result, MPEP 2143(I)(B).
Regarding claim 2, Golden (Figs. 2A-4F) discloses wherein the barb (316) is disposed within a lumen of the electrode when the electrode mating surface engages the electrode (Fig. 4F; col. 10, ll. 50 - col. 11, ll. 13, “may be configured to mate together…”).
Regarding claim 3, Golden (Figs. 2A-4F) discloses wherein an outer diameter of the dilator (315) is less than an outer diameter of the electrode (250; see Figs. 2B and 4F).
Regarding claim 5, Golden (Figs. 2A-4F) discloses wherein the second catheter (245) defines a longitudinal axis, wherein the barb (316) comprises at least one projection (second portion 316, second end 340 b, anchoring mechanism 345) comprising a first portion (316) and a second portion (340 b, 345), the first portion (316) angled relative to the second portion (340 b, 345).
Regarding claim 18, Golden (Figs. 2A-4F) discloses wherein the electrode (250) and the electrode mating surface (425) are configured to compress tissue therebetween without puncturing tissue (Fig. 4F; col. 10, ll. 50 - col. 11, ll. 13, “In embodiments where the tissue resecting device is one or more Edges 250, 420, and/or 425, tissue resection may occur when a sufficient amount of force is applied to the tissue retractor 230 to cleanly resect the tissue…. In some embodiments, shear edges and/or blades may be configured to mate together. It is also understood that in other embodiments, a cauterizing tool or other electrical cutting device may be used to resect the selected tissue 220.” As broadly claimed, the tissue would be ‘compressed’ prior to ‘puncturing’ or resecting the tissue).
Regarding claim 49, Golden in view of Arevalos teach all of the limitations of the system according to claim 18. In view of the prior modification of Golden in view of Arevalos, Arevalos further teaches further comprising a first catheter actuator configured to deflect a distal portion of the first catheter, the first catheter actuator electrically coupled to the electrode (see [0263]-[0264], for actuation mechanism electrically coupled to the electrode).
Regarding claim 59, Golden (Figs. 2A-4F) discloses wherein the electrode mating surface (425) comprises a conductive portion (col. 10, ll. 50 - col. 11, ll. 13, the edges are configured to mate together and may include “a cauterizing tool or other electrical cutting device may be used to resect the selected tissue 220.”).
Regarding claim 60, Golden (Figs. 2A-4F) discloses wherein a proximal portion of the dilator (315) is arranged within a lumen of the electrode (250) when the electrode mating surface (425) engages the electrode (250) (col. 10, ll. 50 - col. 11, ll. 13, “In embodiments where the tissue resecting device is one or more Edges 250, 420, and/or 425, tissue resection may occur when a sufficient amount of force is applied to the tissue retractor 230 to cleanly resect the tissue…. In some embodiments, shear edges and/or blades may be configured to mate together. It is also understood that in other embodiments, a cauterizing tool or other electrical cutting device may be used to resect the selected tissue 220.”).
Regarding claim 99, Golden discloses (Figs. 2A-4F) a system for forming an anastomosis in a heart (as broadly claimed, the system would be capable of forming an anastomosis in a heart), comprising: a first catheter (205); and a second catheter (245) slidably disposed within the first catheter (205), the second catheter (245) comprising a barb (316 in Fig. 3G) and a dilator (315) comprising an electrode mating surface (distal cap 315a), wherein a largest outer diameter of the barb is substantially constant (316 as best illustrated in Fig. 3G; as broadly claimed, the largest outer diameter of barb 316 is ‘substantially constant’) and less than a largest outer diameter of the electrode mating surface (see Figs. 4E-4F). Golden further discloses wherein the first catheter (205) seats against the electrode mating surface (315a) to form a stop, wherein the stop is configured to restrict proximal translation of the dilator relative to the first catheter (see Fig. 4c).
Although Golden discloses “[i]t is also understood that in other embodiments, a cauterizing tool or other electrical cutting device may be used to resect the selected tissue 220” (col. 11, ll. 2-13), Golden is silent regarding a first catheter comprising an electrode.
However, in the same field of endeavor, Arevalos (Figs. 13A-14C; [0184]-[0189]) teaches a similar system for forming an anastomosis in a heart comprising a first catheter (1406) including an electrode (1308, 1408). Arevalos teaches “the cutter further comprises: an electrocautery element; a cryoablation element; an RF (radio-frequency) element; a thermal ablation element; or a chemical or pharmacologic delivery element; configured to retard tissue regrowth. In some embodiments, the electrocautery element comprises: a monopolar element; or a bipolar element.” ([0011]). It is well known in the art (as can be seen in Arevalos) that these various cutter configurations are widely considered interchangeable configurations for forming a fistula. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the first catheter as taught by Golden to include an electrode as taught by Arevalos. This modification would have merely comprised a simple substitution of one well known cutter configuration for another in order to produce a predictable result, MPEP 2143(I)(B).
In view of the prior modification of Golden in view of Arevalos, the combination would necessarily provide wherein the electrode seats against the electrode mating surface to form a stop, wherein the stop is configured to restrict proximal translation of the dilator relative to the electrode, thereby meeting the limitation of claim 99.
Claims 6 -7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Golden in view of Arevalos and Golden.
Regarding claim 6, Golden in view of Arevalos teach all of the limitations of the system according to claim 5, but are silent regarding wherein a length of the first portion to a length of the second portion is in a ratio between about 2:3 and about 1:5.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified a length of the first portion and a length of the second portion as taught by Golden in view of Arevalos such that a length of the first portion to a length of the second portion is in a ratio between about 2:3 and about 1:5, since it has been held that where 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. In re Aller, 105 USPQ 233.
Regarding claim 7, Golden in view of Arevalos teach all of the limitations of the system according to claim 5, but is silent regarding wherein the second portion comprises a length between about 0.1 mm and about 2 cm.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the second portion as taught by Golden in view of Arevalos, such that it comprises a length between about 0.1 mm and about 2 cm, since it has been held that where 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. In re Aller, 105 USPQ 233.
Regarding claim 17, although Golden discloses “[t]he second portion 316 may be adjustable relative to the first portion 314, e.g., the second portion 316 may telescope from the first portion 314.” (col. 8, ll. 12-14, thereby adjusting the length), Golden in view of Arevalos are silent regarding wherein a length of the barb is between about 0.1 mm and about 5 cm.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified a length of the barb as taught by Golden, such that it is between about 0.1 mm and about 5 cm, since it has been held that where 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. In re Aller, 105 USPQ 233.
Claim 19 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Golden in view of Arevalos as applied to claim 1 above, and further in view of Vardi et al., (hereinafter ‘Vardi,” U.S. PGPub. No. 2016/0270810).
Regarding claim 19, although Golden discloses wherein the second catheter defines a longitudinal axis, Golden in view of Arevalos are silent regarding wherein the second catheter defines a longitudinal axis, and the electrode mating surface is non-perpendicular and non-parallel to the longitudinal axis.
However, in the same field of endeavor, Vardi (Fig. 5) discloses a similar system comprising a second catheter (304) defining a longitudinal axis and having a dilator (306) wherein the dilator (306) includes a mating surface. The mating surface is beveled, defining a recess configured to receive a distal end of the cutting device (316). Vardi teaches, “as depicted in FIG. 5, the hooking device may ride over the outside of cutting device 316, e.g., by barbs 312 riding over the outside of cutting blade 316, and cutting blade 316 sitting flush inside the barbs or the cone 306.” ([0143]). This configuration allows the first and second catheter to securely mate, such that all the tissue is cleanly resected, and provides the additional benefit of locking, thereby improving security and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Golden in view of Arevalos to include the electrode mating surface is non-perpendicular and non-parallel to the longitudinal axis, as taught by Vardi in order to securely mate the catheters, such that all the tissue is cleanly resected, and provide the additional benefit of locking, thereby improving security and safety.
Regarding claim 54, Golden in view of Arevalos discloses all of the limitations of the system according to claim 1, but are silent regarding wherein the electrode mating surface defines a recess configured to receive a distal end of the electrode.
However, in the same field of endeavor, Vardi (Fig. 5) discloses a similar system comprising a second catheter (304) having a dilator (306) wherein the dilator (306) includes a mating surface defining a recess configured to receive a distal end of the cutting device (316). Vardi teaches, “as depicted in FIG. 5, the hooking device may ride over the outside of cutting device 316, e.g., by barbs 312 riding over the outside of cutting blade 316, and cutting blade 316 sitting flush inside the barbs or the cone 306.” ([0143]). This configuration allows the first and second catheter to securely mate, such that all the tissue is cleanly resected, and provides the additional benefit of locking, thereby improving security and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Golden in view of Arevalos to include wherein the electrode mating surface defines a recess configured to receive a distal end of the electrode, as taught by Vardi in order to securely mate the catheters, such that all the tissue is cleanly resected, and provide the additional benefit of locking, thereby improving security and safety.
Claims 32, 35 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Golden in view of Arevalos, as applied to claim 1 above, and further in view of Lennox et al., (hereinafter ‘Lennox,’ U.S. PGPub. No 2016/0000499).
Regarding claims 32 and 35, Golden in view of Arevalos discloses all of the limitations of the system according to claim 1, but are silent regarding wherein the dilator comprises a fluid port configured to output a contrast agent, and wherein the first catheter comprises a contrast agent lumen.
However, in the same field of endeavor, Lennox teaches a similar system configured to introduce a contrast agent to facilitate radiological, or ultrasonic guidance for positioning ablation element (114 in Fig. 2) against the wall of external carotid artery (12). The catheter (16) comprises a fluid channel between the vicinity of ablation element (114) and fluid connector (18) ([0134]). The contrast agent aids in the identification of the position of the device within the vasculature under radiographic or ultrasonic imaging ((0134]), thereby increasing control, accuracy and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Golden in view of Arevalos to include wherein the dilator comprises a fluid port configured to output a contrast agent and wherein the first catheter comprises a contrast agent lumen, as taught by Lennox in order to aid in the identification of the position of the device within the vasculature under radiographic or ultrasonic imaging ([0134]), thereby increasing control, accuracy and safety.
Regarding claims 38, Golden in view of Arevalos discloses all of the limitations of the system according to claim 1, but are silent regarding wherein the electrode comprises a fluid port configured to output a contrast agent.
However, in the same field of endeavor, Lennox teaches a similar system configured to introduce a contrast agent to facilitate radiological, or ultrasonic guidance for positioning ablation element (114 in Fig. 2) against the wall of external carotid artery (12). The catheter (16) comprises a fluid channel between the vicinity of ablation element (114) and fluid connector (18) ([0134]). The contrast agent aids in the identification of the position of the device within the vasculature under radiographic or ultrasonic imaging ((0134]), thereby increasing control, accuracy and safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Golden in view of Arevalos to include wherein the electrode comprises a fluid port configured to output a contrast agent, as taught by Lennox in order to aid in the identification of the position of the device within the vasculature under radiographic or ultrasonic imaging ([0134]), thereby increasing control, accuracy and safety.
Claims 42 is rejected under 35 U.S.C. 103 as being unpatentable over Golden in view of Arevalos, as applied to claim 1 above, and further in view of Coker et al., (hereinafter ‘Coker,’ U.S. PGPub. No 2018/0199915).
Regarding claim 42, Golden in view of Arevalos discloses all of the limitations of the system according to claim 1, but are silent regarding wherein the dilator comprises an echogenic region comprising one or more recesses or protrusions comprising a diameter of between about 5 µm and about 100 µm.
However, in the same field of endeavor, Coker (Figs. 11-13) teach a similar system comprising a catheter assembly (10) including one or more echogenic components (30) configured around the outer diameter (23) of the catheter (14) ([0058]). Coker teaches “the echogenic component(s) may include a plurality of discontinuities configured to enhance ultrasonic imaging of the catheter. In another embodiment, the discontinuities may include at least one or more of the following: etchings, indentations, grooves, notches, recesses, threads, protrusions, or similar.” ({0017]; [0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Golden in view of Arevalos to further include wherein the dilator comprises an echogenic region comprising one or more recesses or protrusions as taught by Coker in order to provide and enhance ultrasonic imaging of the catheter, thereby improving tracking and control over the system.
Regarding the diameter, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the one or more recesses or protrusions as taught by Golden in view of Arevalos and further in view of Coker to include a diameter between about 5 µm and about 100 µm since it has been held that where 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. In re Aller, 105 USPQ 233.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Golden in view of Arevalos and Vardi, as applied to claim 1 above, and further in view of Kellerman et al., (hereinafter ‘Kellerman,’ U.S. PGPub. No. 2011/0306959).
Regarding claim 55, Golden in view of Arevalos and Vardi discloses all of the limitations of the system according to claim 54, but are silent regarding wherein the electrode is configured to electrically short when the electrode engages the recess of the electrode mating surface.
However, in the same field of endeavor, Kellerman teaches a similar system for creating a fistula comprising a catheter (10 in Figs. 4-7) including a distal tip (18) having a first electrode (22) and a tube (12) including a second electrode (20). During formation, the distal tip (18) is advanced into the second vessel (28 in Fig. 6) and a slight tension is applied to the distal RF electrode (22) of the distal tip (18) to seat it against the vessel wall. The outer tube (12) and distal tip (18) are further brought together such that the walls of the first and second vessels (26, 28) are captured between the facing blunt surfaces of each of the other outer tube (12) and distal tip (18) ([0039]). Kellerman teaches, “[a] controlled tension is maintained between the distal tip 18 and proximal outer tube 12, and at this juncture, with the vessel walls securely clamped, energy is applied to the RF electrodes 20, 22.” ([0040]). “A variety of RF energy profiles may be applied to achieve the desired coaptation and cutting…. The energy may also be adjusted based upon the impedance of the tissue.” ([0040]), thereby increasing control over fistula formation as well as accuracy and safety. Further, “[w]hen fully retracted, the system 10 is designed so that the two electrodes 20, 22 cannot come into direct contact with one another, thus preventing the electrodes from shorting.” ([0040]). Therefore, it is contemplated that such contact during cutting the compressed portion would comprise an electrical short if controlled tension is not maintained. It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Golden in view of Arevalos such that the electrode is configured to electrically short when the electrode engages the recess of the mating surface, as taught by Kellerman. This modification would have merely comprised a simple substitution of one well know electrode configuration for another in order to produce a predictable result, MPEP 2143(I)(B).
It naturally follows in view of the modification above and teaching of Kellerman that the electrode is configured to electrically short when the electrode engages the recess of the mating surface. This modification would have merely comprised choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, MPEP 2143(I)(E).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-7, 17-19, 32, 35, 38, 42, 49, 54, 55, 59, 60 and 99 have been considered but are moot because the amendment has necessitated a new grounds of rejection.
Applicant argues (p. 8) that “Golden does not teach or suggest either a substantially fixed diameter barb or a largest outer diameter of the barb being substantially constant. Instead, as shown in FIGS. 3A-3J of Golden, the tissue retractor 230 has an extended position 300, 300' and a retracted position 305 such that Golden teaches away from amended claims 1 and 99. Similarly, FIGS. 4A-4G depict symmetrically and/or asymmetrically deployable arms 335, 335'.” This is not found persuasive. If one was to draw a circle around barb 316, such that one could measure the diameter of the barb, such diameter would be “substantially fixed” or “a largest outer diameter of the barb [would be] substantially constant.” Examiner notes that “substantially” is not an exact term, however, Figure 3G of Golden for example illustrates these limitations as broadly claimed.
Applicant’s arguments regarding Arevalos are moot since Golden teaches these features as claimed.
No further arguments have been set forth regarding the dependent claims.
Conclusion
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/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794