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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed on 22 December 2025 (“Reply”). As directed in the Reply:
Claims 1, 6-8, 14, 15, 18, and 20 have been amended;
Claims 4, 5, and 17 have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1-3, 6-16, and 18-20 are presently pending in this application.
Applicant’s amendment to the drawings, Title, and Specification are sufficient to overcome the objections from the previous Action and are therefore withdrawn.
Response to Arguments
Applicant's arguments filed in the Reply have been fully considered but they are not persuasive.
The kernel of Applicant’s argument (Reply, pg. 9, last two lines to pg. 10, line 3) is that the claimed dimensional features, previously separately recited in Claims 4 and 5, are not merely design choice, but balance “a need to achieve a tighter curve while avoiding shaft kinking.” This argument relies on features not recited in the claims, to wit, the specific flexibility of the catheter shaft at the recited location. Divorced from specific flexibility features, the claimed dimensional features are still just a design choice, because whatever ‘balance’ may be achieved, it is equally dependent on a very specific, and unclaimed, flexibility of the catheter shaft, which also dictates if the alleged ‘balance’ is achieved or not.
Thus, in response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the combination of specific, and unclaimed, flexibility of the catheter shaft distal portion and the claimed dimensional features) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
Claims 1, 2, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2022/0040453, by Johnson et al. (“Johnson”).
Johnson describes a steerable catheter substantially as claimed by Applicant, as follows.
Claim 1: A steerable catheter (Figs. 6-13C; 400, 400’, 400’’) comprising:
a catheter shaft (400, 400’, 400’’) having a lumen (416, 416’) defined by a catheter wall, the catheter shaft having a proximal portion (Fig. 6 left end), a distal portion (Fig. 6, right end), and a length extending therebetween (the catheter shaft between the ends); and
at least one pullwire (470, 470’, 470’’) extending along the length of the catheter shaft (see Figs. 6, 12A, 13A) and coupled to the catheter wall (at 472, 472’), the at least one pullwire having a proximal section extending along the proximal portion of the catheter shaft in a first circumferential position (wire 470’ in Fig. 12A, 12B), a distal section extending along the distal portion of the catheter shaft in a second circumferential position (wire 470’ in Fig. 12A, 12C), and a transition zone connecting the proximal section and the distal section (any portion between these two), wherein the second circumferential position is offset circumferentially from the first circumferential position (compare Figs. 12B, 12D; see [0172]-[0181], describing a single catheter including both “circumferential,” as that word is correctly understood by a person of ordinary skill in the art and according to the foregoing definitions, and “circumferential” offsets of the guidewire moving from proximal to distal portions of the wire).
Johnson does not, however, disclose that the transition zone has a length of 0.5 to 2 inches and is positioned 2 to 5 inches from a distal tip of the catheter shaft.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Johnson to have a transition zone with a length of 0.5 inch to 2.0 inches and positioned 2.0 inches to 5.0 inches from a distal end of the inner shaft, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Johnson would not operate differently with the claimed length and distance from the distal end of the shaft, because the length and distal position of the transition zone only affects the location and size of that articulating zone, but not the fact that it will still articulate, and thus the devices would function appropriately having the claimed dimensional limitations as those claimed. Further, Applicant assigns no criticality on the claimed dimensional limitations claimed, indicating simply that the claimed dimensional limitations “may” be within the claimed ranges (Specification @ pg. 12, lines 12-18); see also the discussion above concerning the unclaimed flexibility of the catheter at the accused location.
Claim 2: (The steerable catheter of claim 1,) wherein the at least one pullwire extends within the catheter wall (Figs. 7-11, 12B-12D, 13B, 13C).
Claim 6: (The steerable catheter of claim 1,) wherein the second circumferential position is offset 10% to 50% of a circumference of the catheter shaft from the first circumferential position (Figs. 7 and 8, showing 50%; Figs. 8 and 9, showing 25%).
Claim 7: (The steerable catheter of claim 1,) wherein the second circumferential position is offset 20 degrees to 190 degrees from the first circumferential position (Figs. 7 and 8, showing 180 degrees).
Claim 8: (The steerable catheter of claim 7,) wherein the second circumferential position is offset 45 degrees to 135 degrees from the first circumferential position (Figs. 8 and 9, showing 90 degrees).
Claims 1, 2, 6-15, and 18-20 are rejected under 35 U.S.C. 103 over U.S. Patent App. Pub. No. 2016/0158497, by Tran et al. (“Tran”).
Tran describes a steerable catheter substantially as claimed by Applicant, as follows.
Claim 1: A steerable catheter (10) comprising:
a catheter shaft (48) having a lumen (32) defined by a catheter wall (14), the catheter shaft having a proximal portion (Fig. 2A, right end), a distal portion (Fig. 2A, left end), and a length extending therebetween (the portion in between); and
at least one pullwire (Fig. 6, 104, 106; Fig. 9, 208, 210) extending along the length of the catheter shaft (id.) and coupled to the catheter wall (at their distal ends), the at least one pullwire having a proximal section extending along the proximal portion of the catheter shaft in a first circumferential position (Fig. 6, at 108; Fig. 10, at 212), a distal section extending along the distal portion of the catheter shaft in a second circumferential position (Fig. 6, at 112, 114; Fig. 10, distal of 214, 216), and a transition zone connecting the proximal section and the distal section (portions between), wherein the second circumferential position is offset circumferentially from the first circumferential position ([0048], [0056]).
Tran does not, however, disclose that the transition zone has a length of 0.5 to 2 inches and is positioned 2 to 5 inches from a distal tip of the catheter shaft.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Tran to have a transition zone with a length of 0.5 inch to 2.0 inches and positioned 2.0 inches to 5.0 inches from a distal end of the inner shaft, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Tran would not operate differently with the claimed length and distance from the distal end of the shaft, because the length and distal position of the transition zone only affects the location and size of that articulating zone, but not the fact that it will still articulate, and thus the devices would function appropriately having the claimed dimensional limitations as those claimed. Further, Applicant assigns no criticality on the claimed dimensional limitations claimed, indicating simply that the claimed dimensional limitations “may” be within the claimed ranges (Specification @ pg. 12, lines 12-18); see also the discussion above concerning the unclaimed flexibility of the catheter at the accused location.
Claim 2: (The steerable catheter of claim 1,) wherein the at least one pullwire extends within the catheter wall (Figs. 7, 10).
Claim 6: (The steerable catheter of claim 1,) wherein the second circumferential position is offset 10% to 50% of a circumference of the catheter shaft from the first circumferential position ([0049], 120 degrees is 33.33%).
Claim 7: (The steerable catheter of claim 1,) wherein the second circumferential position is offset 20 degrees to 190 degrees from the first circumferential position (id.).
Claim 8: (The steerable catheter of claim 7,) wherein the second circumferential position is offset 45 degrees to 135 degrees from the first circumferential position (id.).
Claim 9: (The steerable catheter of claim 1,) further comprising an outer shaft (Figs. 2A-2D, 52) having a lumen defined by a shaft wall ([0040], describing catheter 10 within catheter 52), the outer shaft having a steering member extending longitudinally within the shaft wall ([0040], describing steering mechanisms and pull wires, including those of the documents incorporated by reference), the steering member configured to articulate a distal region of the outer shaft (id.), wherein the catheter shaft is moveable within the lumen of the outer shaft ([0041], inner shaft is freely rotatable relative to the outer shaft).
Claim 10: (The steerable catheter of claim 9,) wherein at least the distal portion of the catheter shaft is configured to extend distally out of the outer shaft (Figs. 2A-2D).
Claim 11: (The steerable catheter of claim 10,) wherein the steering member and the at least one pullwire are separately actuatable to articulate the outer shaft and the catheter shaft independently ([0041]).
Claim 12: (The steerable catheter of claim 11,) wherein the outer shaft is articulatable into a first curve lying in a first plane, wherein the distal portion of the catheter shaft extending distally out of the outer shaft is articulatable into a second curve lying in a second plane, wherein the first and second planes are different (id.; because both of Tran’s inner and outer shafts are capable of articulating in a plane at any angle relative to the common longitudinal axis of the assembly, they are fully “articulatable” into the claimed configuration).
Claim 13: (The steerable catheter of claim 12,) wherein the second plane is at an angle of 45 degrees to 135 degrees to the first plane (id.).
Claim 14: A steerable catheter assembly comprising:
an outer sheath (52) having a distal end (Fig. 2A, left end) and a proximal end (Fig. 2A, right end) and a lumen extending therebetween (inner catheter 10 extends through outer catheter 52), the outer sheath having an articulation region adjacent the distal end that is configured to be articulated into a first curve lying in a first plane (Fig. 2A, portion of 52 with curved arrow); and
an inner shaft (10) slidable within the lumen of the outer sheath ([0041], “freely rotatable”), the inner shaft having a lumen (32) defined by an inner shaft wall (14), the inner shaft having a proximal portion (Fig. 2A, right end), a distal portion (Fig. 2A, left end), and a length extending therebetween (the portion in between), the inner shaft having a pullwire extending along the length of the inner shaft (Fig. 6, 104, 106; Fig. 9, 208, 210) and coupled to the inner shaft wall (at the distal end), wherein the pullwire is configured to articulate the distal portion of the inner shaft into a second curve lying in a second plane when the distal portion is moved distally out of the outer sheath, wherein the second plane is at an angle of 45 degrees to 135 degrees to the first plane ([0041]: because both of Tran’s inner and outer shafts are capable of articulating in a plane at any angle relative to the common longitudinal axis of the assembly, they are fully “articulatable” into the claimed configuration).
Tran does not, however, disclose that the transition zone has a length of 0.5 to 2 inches and is positioned 2 to 5 inches from a distal tip of the catheter shaft.
See above concerning Tran and the newly added dimensional features with respect to Claim 1.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Tran to have a transition zone with a length of 0.5 inch to 2.0 inches and positioned 2.0 inches to 5.0 inches from a distal end of the inner shaft, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Tran would not operate differently with the claimed length and distance from the distal end of the shaft, because the length and distal position of the transition zone only affects the location and size of that articulating zone, but not the fact that it will still articulate, and thus the devices would function appropriately having the claimed dimensional limitations as those claimed. Further, Applicant assigns no criticality on the claimed dimensional limitations claimed, indicating simply that the claimed dimensional limitations “may” be within the claimed ranges (Specification @ pg. 12, lines 12-18); see also the discussion above concerning the unclaimed flexibility of the catheter at the accused location.
Claim 15: (The steerable catheter assembly of claim 14,) wherein the pullwire has a proximal section extending along the proximal portion of the inner shaft in a first circumferential position (Fig. 6, at 108; Fig. 10, at 212), a distal section extending along the distal portion of the inner shaft in a second circumferential position (Fig. 6, at 112, 114; Fig. 10, distal of 214, 216), and a transition zone connecting the proximal section and the distal section (portion between), wherein the second circumferential position is offset circumferentially from the first circumferential position (Fig. 7).
Claim 18: (The steerable catheter assembly of claim 15,) wherein the second circumferential position is offset 20 degrees to 190 degrees from the first circumferential position ([0049], 120 degrees is 33.33%).
Claim 19: (The steerable catheter assembly of claim 15,) wherein the outer sheath has a steering member extending longitudinally within a wall of the outer sheath ([0040], describing steering mechanisms and pull wires, including those of the documents incorporated by reference), the steering member configured to articulate the articulation region into the first curve (id.), wherein the steering member and the pullwire are separately actuatable to articulate the outer sheath and the inner shaft independently ([0040]-[0041]).
Claim 20: A steerable catheter assembly comprising:
an outer sheath (52) having a distal end (Fig. 2A, left end) and a proximal end (Fig. 2A, right end) and a lumen extending therebetween (catheter 10 extends through catheter 52), the outer sheath having an articulation region adjacent the distal end (Fig. 2A, portion of 52 with curved arrow), and a steering member configured to articulate the articulation region into a first curve lying in a first plane ([0040]-[0041]); and
an inner shaft slidable (10) within the lumen of the outer sheath (Fig. 2A), the inner shaft having a proximal portion (Fig. 2A, right end), a distal portion (Fig. 2A, left end), and a length extending therebetween (portion between), the inner shaft having a pullwire coupled thereto (Fig. 6, 104, 106; Fig. 9, 208, 210), the pullwire having a proximal section extending along the proximal portion of the inner shaft in a first circumferential position (Fig. 6, at 108), a distal section extending along the distal portion of the inner shaft in a second circumferential position (Fig. 6, at 112, 114), and a transition zone connecting the proximal section and the distal section (portion between),
wherein the second circumferential position is offset circumferentially from the first circumferential position ([0048] and Fig. 7),
wherein the pullwire is configured to articulate the distal portion of the inner shaft into a second curve lying in a second plane when the distal portion is moved distally out of the outer sheath ([0041]: because both of Tran’s inner and outer shafts are capable of articulating in a plane at any angle relative to the common longitudinal axis of the assembly, they are fully “articulatable” into the claimed configuration),
wherein the first plane and the second plane are different (id.).
Tran does not, however, disclose that the transition zone has a length of 0.5 to 2 inches and is positioned 2 to 5 inches from a distal tip of the catheter shaft.
See above concerning Tran and the newly added dimensional features with respect to Claim 1.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Tran to have a transition zone with a length of 0.5 inch to 2.0 inches and positioned 2.0 inches to 5.0 inches from a distal end of the inner shaft, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Tran would not operate differently with the claimed length and distance from the distal end of the shaft, because the length and distal position of the transition zone only affects the location and size of that articulating zone, but not the fact that it will still articulate, and thus the devices would function appropriately having the claimed dimensional limitations as those claimed. Further, Applicant assigns no criticality on the claimed dimensional limitations claimed, indicating simply that the claimed dimensional limitations “may” be within the claimed ranges (Specification @ pg. 12, lines 12-18); see also the discussion above concerning the unclaimed flexibility of the catheter at the accused location.
Claims 1-3 and 6-8 are rejected under 35 U.S.C. 103 over U.S. Patent App. Pub. No. 2015/0174363, by Sutermeister et al. (“Sutermeister”).
Sutermeister describes a steerable catheter substantially as claimed by Applicant, as follows.
Claim 1: A steerable catheter (Fig. 3A) comprising:
a catheter shaft (102) having a lumen (112) defined by a catheter wall (106+110), the catheter shaft having a proximal portion (Fig. 3A, right portion), a distal portion (Fig. 3A, left portion), and a length extending therebetween (portion between); and
at least one pullwire (114) extending along the length of the catheter shaft (Fig. 3A) and coupled to the catheter wall (via braid 109, 109’), the at least one pullwire having a proximal section extending along the proximal portion of the catheter shaft in a first circumferential position (portion proximal of band 140), a distal section extending along the distal portion of the catheter shaft in a second circumferential position (any portion distal of the linear portion which is just distal of band 140, which follows the helical path), and a transition zone connecting the proximal section and the distal section (portion between), wherein the second circumferential position is offset circumferentially from the first circumferential position (portion of distal helical path is circumferentially offset from portion of proximal portion).
Sutermeister does not, however, disclose that the transition zone has a length of 0.5 to 2 inches and is positioned 2 to 5 inches from a distal tip of the catheter shaft.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Sutermeister to have a transition zone with a length of 0.5 inch to 2.0 inches and positioned 2.0 inches to 5.0 inches from a distal end of the inner shaft, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, the device of Sutermeister would not operate differently with the claimed length and distance from the distal end of the shaft, because the length and distal position of the transition zone only affects the location and size of that articulating zone, but not the fact that it will still articulate, and thus the devices would function appropriately having the claimed dimensional limitations as those claimed. Further, Applicant assigns no criticality on the claimed dimensional limitations claimed, indicating simply that the claimed dimensional limitations “may” be within the claimed ranges (Specification @ pg. 12, lines 12-18); see also the discussion above concerning the unclaimed flexibility of the catheter at the accused location.
Claim 2: (The steerable catheter of claim 1,) wherein the at least one pullwire extends within the catheter wall (Fig. 3A; [0053]).
Claim 3: (The steerable catheter of claim 2,) wherein the catheter wall is at least partially defined by a plurality of braided or woven filaments ([0030]; 108, 109, 109’), wherein the at least one pullwire is braided or woven into the plurality of braided or woven filaments (Fig. 3A; [0030], [0053]).
Claim 6: (The steerable catheter of claim 1,) wherein the second circumferential position is offset 10% to 50% of a circumference of the catheter shaft from the first circumferential position (because distal portion can be any portion of the pull wire helical path, there is a point at which the second circumferential position is positioned as claimed).
Claim 7: (The steerable catheter of claim 1,) wherein the second circumferential position is offset 20 degrees to 190 degrees from the first circumferential position (because distal portion can be any portion of the pull wire helical path, there is a point at which the second circumferential position is positioned as claimed).
Claim 8: (The steerable catheter of claim 7,) wherein the second circumferential position is offset 45 degrees to 135 degrees from the first circumferential position(because distal portion can be any portion of the pull wire helical path, there is a point at which the second circumferential position is positioned as claimed).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tran as applied against Claim 15, and further in view of Sutermeister.
Tran describes a device substantially as claimed by Applicant; see above. It does not, however, describe that the inner shaft is at least partially defined by a plurality of braided or woven filaments, wherein the pullwire is braided or woven into the plurality of braided or woven filaments.
Sutermeister relates to reinforced, steerable pull wire catheters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Sutermeister teaches that the pull wires 114 of such catheters can be constructed with a plurality of braided or woven filaments (109, 109’), in which the pullwire is braided or woven into the plurality of braided or woven filaments ([0030]: “In some embodiments, the reinforcing braid 108 may enhance torque control, column strength, crush and/or circumferential collapse resistance, and/or anti-kink ability of the guide catheter 100 for proper positioning of the guide catheter 100 within the patient's vasculature.”).
It 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, to construct Tran’s inner shaft so that it is at least partially defined by a plurality of braided or woven filaments, wherein the pullwire is braided or woven into the plurality of braided or woven filaments, because Sutermeister teaches doing so in a very closely related catheter, for the foregoing reasons.
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 Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/09/2026