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 .
Response to Amendment
The amendment filed 02/23/2026 has been entered. Claims 1, 3-4, 8-9, 11-15, and 27-36 remain pending in the application; claims 2, 5-7, 10, and 16-26 are cancelled, and claims 14-15 are withdrawn. Applicant’s amendments to the claims have not overcome the interpretation of the rejection previously set forth in the Non-Final Office Action mailed 10/21/2025.
Response to Arguments
Applicant's arguments filed 02/23/2026 have been fully considered but they are not persuasive.
With regards to Applicant’s remarks on pages 6-8 with respect to claim 1 in that Bircoll is silent on an exterior surface of an expandable balloon affixed along a longitudinal length of a longitudinally extending surface of the projection in a collapsed configuration, the Office respectfully disagrees. Applicant states that the figures and description in Bircoll show the balloon is carried adjacent the distal end of the shaft, and that the obturator feature 5 mechanically secures the distal end of the balloon 6 to the shaft. Applicant thus says that the balloon 5 “mechanically secured” at “the distal end of the balloon” is not “an exterior surface of an expandable balloon affixed along a longitudinal length of a longitudinally extending surface of the projection in a collapsed configuration.” However, it can be seen in figures 5-6 that the shaft 4 runs through the balloon 6 and even passes the balloon 6 distally. Thus, the exterior surface of the balloon 6 is seen affixed to a longitudinal length of a longitudinally extending surface of the projection 4 in a collapsed configuration in figure 4. Paragraph 98 of Bircoll discloses ““A shaft 4 extends from the handle 2 and carries a balloon 6 adjacent to the distal end of the shaft 4. The distal end of the shaft has an obturator feature 5 which facilitates non-traumatic tissue dissection to occur while the insertion tunnel is being created. Additionally, the obturator feature 5 mechanically secures the distal end of the balloon 6 to the shaft 4.” Thus, the obturator feature 5 is part of the shaft/projection 4 which mechanically secures, or couples, the balloon 6 (and therefore the exterior surface of the balloon 6) to the distal end surface of the projection/shaft 4. Although the balloon is not attached along the full length of the projection, the balloon is attached along some length of the projection, that length being the distal end of the projection 4. Therefore, the rejection is maintained, as the same argument can be applied to claims 30 and 34.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 8-9, 12, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bircoll et al. (WO 2011/140382; attached in the IDS), hereinafter known as “Bircoll.”
With regards to claim 1, Bircoll discloses (Figures 1-6 and 9) an insertion device 1 (paragraph 98), comprising:
a base 2 having a longitudinal axis and defining a cavity (see cavity in figures 5-6), wherein the base 2 includes:
a projection 4 continuously formed to extend from a distal portion of the base 2, the projection 4 parallel to the longitudinal axis (paragraphs 98-99; figures 1-2);
an exterior surface of an expandable balloon 6 affixed along a longitudinal length of a longitudinally extending surface of the projection 4 in a collapsed configuration (see figures 5-6 where shaft 4 extends through the balloon 6 and where the exterior surface of the balloon 6 is seen coupled to the shaft 4; figure 1; paragraph 98 – “A shaft 4 extends from the handle 2 and carries a balloon 6 adjacent to the distal end of the shaft 4. The distal end of the shaft has an obturator feature 5 which facilitates non-traumatic tissue dissection to occur while the insertion tunnel is being created. Additionally, the obturator feature 5 mechanically secures the distal end of the balloon 6 to the shaft 4” – obturator feature 5 is part of the shaft/projection 4 which mechanically secures, or couples, the balloon 6 (and therefore the exterior surface of the balloon 6) to the distal end surface of the projection/shaft 4); and
a flexible lumen 114 (figure 9; akin to the flexible lumen 7 of figure 1) extending proximally from the balloon 6 to a pump (pump disclosed in paragraph 98), the flexible lumen 114 fluidly connecting the balloon 6 to the pump (paragraph 107; figure 9).
With regards to claim 4, Bircoll discloses wherein the longitudinal length of the projection 4 is at least half a longitudinal length of the cavity (see figures 5-6 – projection 4 makes up more than half of the base 2 with the cavity).
With regards to claim 8, Bircoll discloses wherein a distal end of the base 2 includes a tapered atraumatic tip (figures 5-6 – distal end of base 2 tapers proximally from the distal end, flat round distal face is atraumatic).
With regards to claim 9, Bircoll discloses wherein a proximal portion of the base 2 includes a handle (figures 1-2 – proximal portion of base 2 is interpreted as a handle as a user can grip the base at the proximal portion).
With regards to claim 12, Bircoll further discloses wherein the balloon 6 is in fluid communication with a supply of air (paragraph 107).
With regards to claim 27, Bircoll discloses wherein the flexible lumen 114 passes through the cavity (figure 9 – see filling line 114 passing through the cavity in contact with the balloon 6).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Lim et al. (US PGPub 2005/0197668), hereinafter known as “Lim.”
With regards to claim 3, Bircoll discloses the insertion device as claimed in claim 1. Bircoll further discloses the projection 4 carries the balloon 6 and is mechanically secured (paragraph 98). Bircoll is silent wherein the balloon is affixed to the projection with an adhesive.
However, in a similar field of endeavor of balloon catheters, Lim teaches (Figures 1-3) wherein the balloon 20 is affixed to the projection 12 with an adhesive (paragraph 48).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the coupling method of the balloon and projection of Bircoll for the coupling method of the adhesive as taught by Lim. The difference between the prior art and the claimed invention is that Bircoll does not teach an adhesive coupling. Lim teaches (see Figs. 1-3) a similar balloon catheter device comprising an adhesive coupling. Accordingly, the prior art references teach that it is known that coupling methods of Bircoll and the adhesive coupling of Lim are elements that are functional equivalents for providing a coupling between the balloon and the projection. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the adhesive coupling taught by Lim for the coupling methods of Bircoll because both elements were known equivalents and would have resulted in the predictable results for providing a coupling between the balloon and projection within the balloon catheter art.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Crocker et al. (US Patent 5,470,313), hereinafter known as “Crocker.”
With regards to claim 11, Bircoll discloses the insertion device of claim 1. Bircoll further discloses a balloon 6 with a diameter.
Bircoll does not explicitly disclose wherein a diameter of the balloon in the collapsed configuration is between about 10 mm and about 15 mm.
However, in a similar field of endeavor of balloon catheters, Crocker teaches (Figures 1-4) wherein the diameter of the balloon is a result effective variable (Abstract; Col 6 lines 21-38).
There is no evidence of record that establishes that changing the diameter of the balloon would result in a difference in function of the Bircoll insertion device. Further, a person having ordinary skill in the art, being faced with modifying the insertion device of Bircoll, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameter of the balloon. Lastly, applicant has not disclosed that the claimed diameter solves any stated problem, indicating that the diameter is “optionally” between about 10 mm and about 15 mm (Spec. [0008]), and therefore there appears to be no criticality placed on the diameter as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize the diameter of the balloon in the collapsed configuration of Bircoll to be between about 10 mm and about 15 mm through routine experimentation (MPEP 2144.05) as taught by Crocker (Abstract; Col 6 lines 21-38).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Fuqua (US Patent 4,601,713).
With regards to claim 13, Bircoll discloses the insertion device of claim 1. Bircoll further discloses a base 2 with a cross-sectional diameter.
Bircoll does not explicitly disclose wherein a cross-sectional diameter of the base is less than about 3 cm.
However, in a similar field of endeavor of catheters, Fuqua teaches wherein the cross-sectional diameter of the base is a result effective variable (Abstract; Col 5 lines 36-44).
There is no evidence of record that establishes that changing the cross-sectional diameter of the base would result in a difference in function of the Bircoll insertion device. Further, a person having ordinary skill in the art, being faced with modifying the insertion device of Bircoll, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ross-sectional diameter of the base. Lastly, applicant has not disclosed that the claimed diameter solves any stated problem, indicating that the diameter “may” range from about 1.0 cm to about 3.0 cm (Spec. [0008] and [0039]), and therefore there appears to be no criticality placed on the diameter as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to optimize the cross-sectional diameter of the base of Bircoll to be less than about 3 cm through routine experimentation (MPEP 2144.05) as taught by Fuqua (Abstract, Col 5 lines 36-44).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Belfort et al. (US PGPub 2008/0215031), hereinafter known as “Belfort.”
With regards to claim 28, Bircoll discloses the device as claimed in claim 1. Bircoll is silent to further comprising a clip disposed on the flexible lumen to control a flow of fluid through the flexible lumen.
However, in a similar field of endeavor of balloon catheters, Belfort teaches a clip disposed on the lumen to control a flow of fluid through the lumen (paragraph 45).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion device of Bircoll to include the clip disposed on the lumen to control a flow of fluid through the lumen as taught by Belfort for the purpose of regulating the flow (paragraph 45 of Belfort).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Dubrul et al. (US Patent 5,183,464), hereinafter known as “Dubrul.”
With regards to claim 29, Bircoll discloses the insertion device of claim 1. Bircoll further discloses the device 1 having a length.
Bircoll does not explicitly disclose wherein the device has a length ranging from about 15 cm to about 35 cm.
However, Dubrul teaches (Figures 1-3) wherein the device has a length ranging from about 15 cm to about 35 cm (Col 6 lines 22-32).
There is no evidence of record that establishes that changing the length of the device would result in a difference in function of the Bircoll insertion device. Further, a person having ordinary skill in the art, being faced with modifying the insertion device of Bircoll, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed length of the device. Lastly, applicant has not disclosed that the claimed length solves any stated problem, indicating that the length ranges from about 15 cm to about 35 cm, and all of the above measurements are exemplary, and the measurements of embodiments of the present disclosure are not limited thereto (Spec. [0040]), and therefore there appears to be no criticality placed on the length as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the device of Bircoll to range from about 15 cm to about 35 cm as taught by Dubrul for the purpose of providing a long tube to access more remote target locations (Col 6 lines 22-32 of Dubrul).
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Sasse et al. (US PGPub 2018/0098871), hereinafter known as “Sasse,” in view of Belfort et al. (US PGPub 2008/0215031), hereinafter known as “Belfort.”
With regards to claim 30, Bircoll discloses (Figures 1-6 and 9) an insertion device 1 (paragraph 98), comprising:
a base 2 having a longitudinal axis and defining a cavity (see cavity in figures 5-6), wherein the base 2 includes:
a projection 4 continuously formed from a distal surface of the base 2 (paragraphs 98-99; figures 1-2);
an exterior surface of an expandable balloon 6 continuously affixed along a longitudinally extending surface of the projection 4 in a collapsed configuration (see figures 5-6 where shaft 4 extends through the balloon 6 and where the exterior surface of the balloon 6 is seen coupled to the shaft 4; figure 1; paragraph 98 - “A shaft 4 extends from the handle 2 and carries a balloon 6 adjacent to the distal end of the shaft 4. The distal end of the shaft has an obturator feature 5 which facilitates non-traumatic tissue dissection to occur while the insertion tunnel is being created. Additionally, the obturator feature 5 mechanically secures the distal end of the balloon 6 to the shaft 4” – obturator feature 5 is part of the shaft/projection 4 which mechanically secures, or continuously affixes, the balloon 6 (and therefore the exterior surface of the balloon 6) to the distal end surface of the projection/shaft 4); and
a flexible lumen 114 (figure 9; akin to the flexible lumen 7 of figure 1) extending proximally from the balloon 6 to a pump (pump disclosed in paragraph 98), the flexible lumen 114 passing through the cavity (figure 9 – see filling line 114 passing through the cavity in contact with the balloon 6) and fluidly connecting the balloon 6 to the pump (paragraph 107; figure 9).
Bircoll is silent wherein the base includes a plurality of measurement markings on a surface of the base.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to measure the distance of the insertion cannula, Sasse teaches (Figure 35) wherein the base 3500 includes a plurality of measurement markings 3504 on a surface of the base 3500 (paragraph 145).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion device of Bircoll to include the plurality of measurement markings on a surface of the base as taught by Sasse for the purpose of informing the surgeon of the length of the insertion device penetrating the patient’s body (paragraph 145 of Sasse).
Bircoll/Sasse are silent to a clip disposed on the flexible lumen to control a flow of fluid through the flexible lumen.
However, in a similar field of endeavor of balloon catheters, Belfort teaches a clip disposed on the lumen to control a flow of fluid through the lumen (paragraph 45).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion device of Bircoll/Sasse to include the clip disposed on the lumen to control a flow of fluid through the lumen as taught by Belfort for the purpose of regulating the flow (paragraph 45 of Belfort).
With regards to claim 31, Bircoll further discloses wherein a distal end of the base 2 includes a tapered atraumatic tip (figures 5-6 – distal end of base 2 tapers proximally from the distal end, flat round distal face is atraumatic).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Sasse in view of Belfort, and further in view of Lim.
With regards to claim 32, Bircoll/Sasse/Belfort disclose the insertion device as claimed in claim 30. Bircoll further discloses the projection 4 carries the balloon 6 and is mechanically secured (paragraph 98). Bircoll is silent wherein the balloon is affixed to the projection with an adhesive.
However, in a similar field of endeavor of balloon catheters, Lim teaches (Figures 1-3) wherein the balloon 20 is affixed to the projection 12 with an adhesive (paragraph 48).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the coupling method of the balloon and projection of Bircoll for the coupling method of the adhesive as taught by Lim. The difference between the prior art and the claimed invention is that Bircoll does not teach an adhesive coupling. Lim teaches (see Figs. 1-3) a similar balloon catheter device comprising an adhesive coupling. Accordingly, the prior art references teach that it is known that coupling methods of Bircoll and the adhesive coupling of Lim are elements that are functional equivalents for providing a coupling between the balloon and the projection. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the adhesive coupling taught by Lim for the coupling methods of Bircoll because both elements were known equivalents and would have resulted in the predictable results for providing a coupling between the balloon and projection within the balloon catheter art.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Sasse in view of Belfort, and further in view of Snoke et al. (US Patent 5,846,221), hereinafter known as “Snoke.”
With regards to claim 33, Bircoll/Sasse/Belfort disclose the device as claimed in claim 30. Bircoll/Sasse/Belfort are silent wherein the base includes a bulb-shaped grip at or proximate a proximal end of the base.
However, in a similar field of endeavor of balloon catheters, Snoke teaches (Figures 3A-3D) wherein the base 20 includes a bulb-shaped grip 30b at or proximate a proximal end of the base 20 (Col 7 lines 43-49).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bircoll/Sasse/Belfort to include the bulb-shaped grip as taught by Snoke for the purpose of providing a larger handle to be readily held in the hand of a user.
Claims 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Sasse in view of Lim, and further in view of Snoke.
With regards to claim 34, Bircoll discloses (Figures 1-6 and 9) an insertion device 1 (paragraph 98), comprising:
a base 2 having a longitudinal axis and defining a cavity (see cavity in figures 5-6), wherein the base 2 includes:
a projection 4 continuously extending from an outer surface of the base 2 (paragraphs 98-99; figures 1-2);
an expandable balloon 6 including an exterior surface;
wherein the exterior surface of the expandable balloon 6 is affixed along to a longitudinally extending surface of the projection 4 (see figures 5-6 where shaft 4 extends through the balloon 6 and where the exterior surface of the balloon 6 is seen coupled to the shaft 4; figure 1; paragraph 98 - “A shaft 4 extends from the handle 2 and carries a balloon 6 adjacent to the distal end of the shaft 4. The distal end of the shaft has an obturator feature 5 which facilitates non-traumatic tissue dissection to occur while the insertion tunnel is being created. Additionally, the obturator feature 5 mechanically secures the distal end of the balloon 6 to the shaft 4” – obturator feature 5 is part of the shaft/projection 4 which mechanically secures, or affixes, the balloon 6 (and therefore the exterior surface of the balloon 6) to the distal end surface of the projection/shaft 4); and
a flexible lumen 114 (figure 9; akin to the flexible lumen 7 of figure 1) extending proximally from the balloon 6 to a pump (pump disclosed in paragraph 98), the flexible lumen 114 fluidly connecting the balloon 6 to the pump (paragraph 107; figure 9).
Bircoll is silent wherein the base includes a plurality of measurement markings on a surface of the base.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to measure the distance of the insertion cannula, Sasse teaches (Figure 35) wherein the base 3500 includes a plurality of measurement markings 3504 on a surface of the base 3500 (paragraph 145).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion device of Bircoll to include the plurality of measurement markings on a surface of the base as taught by Sasse for the purpose of informing the surgeon of the length of the insertion device penetrating the patient’s body (paragraph 145 of Sasse).
Bircoll further discloses the projection 4 carries the balloon 6 and is mechanically secured (paragraph 98). Bircoll is silent wherein the balloon is affixed to the projection with an adhesive.
However, in a similar field of endeavor of balloon catheters, Lim teaches (Figures 1-3) wherein the expandable balloon 20 is affixed to the projection 12 with an adhesive (paragraph 48).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the coupling method of the balloon and projection of Bircoll for the coupling method of the adhesive as taught by Lim. The difference between the prior art and the claimed invention is that Bircoll does not teach an adhesive coupling. Lim teaches (see Figs. 1-3) a similar balloon catheter device comprising an adhesive coupling. Accordingly, the prior art references teach that it is known that coupling methods of Bircoll and the adhesive coupling of Lim are elements that are functional equivalents for providing a coupling between the balloon and the projection.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the adhesive coupling taught by Lim for the coupling methods of Bircoll because both elements were known equivalents and would have resulted in the predictable results for providing a coupling between the balloon and projection within the balloon catheter art.
Bircoll/Sasse/Lim are silent to a bulb-shaped grip at or proximate a proximal end of the base.
However, in a similar field of endeavor of balloon catheters, Snoke teaches (Figures 3A-3D) wherein the base 20 includes a bulb-shaped grip 30b at or proximate a proximal end of the base 20 (Col 7 lines 43-49).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Bircoll/Sasse/Lim to include the bulb-shaped grip as taught by Snoke for the purpose of providing a larger handle to be readily held in the hand of a user.
With regards to claim 35, Bircoll further discloses wherein the flexible lumen 114 passes through the cavity (figure 9 – see filling line 114 passing through the cavity in contact with the balloon 6).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Bircoll in view of Sasse in view of Lim in view of Snoke, and further in view of Belfort.
With regards to claim 36, Bircoll/Sasse/Lim/Snoke disclose the device as claimed in claim 34. Bircoll/Sasse/Lim/Snoke are silent to a clip disposed on the flexible lumen to control a flow of fluid through the flexible lumen.
However, in a similar field of endeavor of balloon catheters, Belfort teaches a clip disposed on the lumen to control a flow of fluid through the lumen (paragraph 45).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insertion device of Bircoll/Sasse/Lim/Snoke to include the clip disposed on the lumen to control a flow of fluid through the lumen as taught by Belfort for the purpose of regulating the flow (paragraph 45 of Belfort).
Conclusion
THIS ACTION IS MADE FINAL. 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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 04/09/2026
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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