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.
Response to Amendment
The amendment filed 11/06/2025 has been entered. Claims 1-4, 7-18, and 20 remain pending in the application. Claims 5, 6, and 19 have been cancelled. Claims 14 and 20 remain withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on matter specifically challenged in the argument, since the Examiner has changed the way in which the “first and second row of cells” are interpreted in the argument. Under the new interpretation, the first and second rows of cells are now separate components from the coupling arms of the device, therefore enabling the coupling arms to now extend outward from the first row of cells. The Examiner wants to point out that the limitation “end” in “a first row of cells at an inflow end” is very broad, and can be interpreted to be a broader area within a boundary from the inflow terminal end of the stent to another area of the stent.
Applicant’s arguments with respect to claim 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Examiner has added a secondary reference, US 20160310268 A1 (hereafter –Oba--), to teach the limitation of the inner frame having multiple rows of closed diamond shaped cells.
Applicant’s arguments with respect to claim 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Examiner no longer relies upon Granada for the rejection of the claim, as upon further interpretation of the Noe reference and which side of the device is atrial and ventricular (outflow and inflow), the Noe reference does disclose pins at the inflow end pointing toward the outflow end on the outer frame.
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 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180206984 A1 (hereafter --Noe--).
Regarding Claim 1, Noe discloses a prosthetic heart valve comprising: a collapsible and expandable outer frame configured to engage tissue of a native heart valve annulus (see paragraph [0021] and [0072]), the outer frame having an atrial portion adapted to be positioned on an atrial side of the native heart valve annulus (see paragraph [0072], see also annotated atrial portion in Figures 3C and 3B below), a ventricle portion adapted to be positioned on a ventricle side of the native heart valve annulus (see paragraph [0072], see also annotated ventricle portion in Figures 3C and 3B below), a narrowed waist portion between the atrial portion and the ventricle portion (see Figures 3C and 3B below), and a plurality of outer coupling arms having a first end coupled to the outer frame and a second free end (see annotated outer coupling arms, first end of coupling arms, and second end of coupling arms in Figure 3B below), the first ends of the outer coupling arms coupled to the outer frame at a location substantially equidistant between an inflow end of the outer frame and an outflow end of the outer frame (see first end of outer coupling arm in Figure 3B below); a collapsible and expandable inner frame positioned radially inward of the outer frame (see annotated inner frame in Figures 3C and 3B below, see also paragraph [0010]), the inner frame having a first row of cells at an inflow end of the inner frame (see annotated first row of cells in Figure 3B below), the inner frame including a plurality of inner coupling arms having a first end coupled to the inner frame and a second free end (see annotated inner coupling arms, first end of coupling arms, and second end of coupling arms in Figures 3C and 3B below), the plurality of inner coupling arms extending radially outward from the first row of cells at the inflow end of the inner frame (see annotated first row of cells and coupling arms in Figures 3B and 3C below); and a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame (see Abstract); wherein the second free ends of the outer coupling arms are coupled to the second free ends of the inner coupling arms to couple the outer frame to the inner frame (see annotated inner and outer coupling at the second free ends in Figure 3B below).
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This embodiment of Noe fails to disclose wherein in an expanded condition of the outer frame, the outer coupling arms are contoured so that the second free ends of the outer coupling arms are substantially parallel to a central longitudinal axis of the outer frame, the central longitudinal axis extending from the inflow end of the outer frame to the outflow end of the outer frame, wherein in an expanded condition of the inner frame, the inner coupling arms are contoured so that the second free ends of the inner coupling arms are substantially parallel to a central longitudinal axis of the inner frame, the central longitudinal axis extending from an inflow end of the inner frame to an outflow end of the inner frame.
Another embodiment of Noe teaches wherein in an expanded condition of the outer frame, the outer coupling arms are contoured so that the second free ends of the outer coupling arms are substantially parallel to a central longitudinal axis of the outer frame (see annotated outer coupling arm ends in Figure 1B below), the central longitudinal axis extending from the inflow end of the outer frame to the outflow end of the outer frame (see the annotated longitudinal axis in Figure 1B below, see also paragraph [0080] denoting that the atrial tips 129 of inner frame, which are parallel with the longitudinal axis, are attached to the atrial tips of 112 of the outer frame 101, which are also parallel with the longitudinal axis).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the second ends of the coupling arms of the outer frame of the embodiment of Fig. 3B-3C parallel to the longitudinal axis as taught in the embodiment of Fig. 1B as the design enables the inner strut frame to be non-foreshortening to ensure that less strain is placed on the leaflets during delivery and/or packing, which also forces the outer frame and therefore the entire anchor assembly through the connection to be substantially non-foreshortening (see paragraph [0079]).
Furthermore, another embodiment of Noe teaches wherein in an expanded condition of the inner frame, the inner coupling arms are contoured so that the second free ends of the inner coupling arms are substantially parallel to a central longitudinal axis of the inner frame (see annotated outer coupling arm ends in Figure 1B below), the central longitudinal axis extending from an inflow end of the inner frame to an outflow end of the inner frame (see the annotated longitudinal axis in Figure 1B below, see also paragraph [0080] denoting that the atrial tips 129 of inner frame, which are parallel with the longitudinal axis, are attached to the atrial tips of 112 of the outer frame 101, which are also parallel with the longitudinal axis).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the second ends of the coupling arms of the inner frame of the embodiment of Fig. 3B-3C parallel to the longitudinal axis as taught in the embodiment of Fig. 1B as the design enables the inner strut frame to be non-foreshortening to ensure that less strain is placed on the leaflets during delivery and/or packing (see paragraph [0079])..
Regarding Claim 2, Noe discloses the prosthetic heart valve of claim 1, wherein the outer coupling arms are integral with the outer frame, and the inner coupling arms are integral with the inner frame (see annotated inner and outer coupling arms in Figures 3C and 3B above).
Regarding Claim 3, Noe discloses the prosthetic heart valve of claim 1, wherein the second free ends of the outer coupling arms are coupled to the second free ends of the inner coupling arms via mechanical fasteners (see paragraphs [0016] and [0111] denoting that the inner and outer frames can be connected by rivets through the rivet holes on the second ends of the coupling arms, see also paragraphs [0086] and [0089] describing this deeper for other embodiments that have the same rivet hole feature).
Regarding Claim 7, Noe discloses the prosthetic heart valve of claim 1, wherein the inner frame includes a plurality of rows of substantially diamond-shaped cells, including a first row at the inflow end of the inner frame (see Figure 3C below).
Regarding Claim 8, Noe discloses the prosthetic heart valve of claim 7, wherein in a collapsed condition of the inner frame, each inner coupling arm is positioned within one of the cells in the first row of cells at the inflow end of the inner frame (see Figure 3C below, wherein the coupling arm is a part of the struts of the first row of cells at the inflow end).
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Claims 9-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180206984 A1 (hereafter --Noe--), in view of US 20160310268 A1 (hereafter –Oba--).
Regarding Claim 9, Noe discloses a prosthetic heart valve comprising: a collapsible and expandable outer frame configured to engage tissue of a native heart valve annulus (see paragraph [0021] and [0072]), the outer frame having an atrial portion adapted to be positioned on an atrial side of the native heart valve annulus (see paragraph [0072], see also annotated atrial portion in Figures 3C and 3B below), a ventricle portion adapted to be positioned on a ventricle side of the native heart valve annulus (see paragraph [0072], see also annotated ventricle portion in Figures 3C and 3B below), a narrowed waist portion between the atrial portion and the ventricle portion (see Figures 3C and 3B below), and a plurality of outer coupling arms having a first end coupled to the narrowed waist portion and a second free end (see annotated outer coupling arms, first end of coupling arms, and second end of coupling arms in Figure 3B below, the arms are coupled to the narrowed waist portion through the body of the device, although they may not be directly coupled, they are still coupled); a collapsible and expandable inner frame positioned radially inward of the outer frame (see annotated inner frame 305 in Figure 3B below), the inner frame having a first row of closed, generally diamond shaped cells (see annotated first row of cells at the inflow end of the frame in Figures 3C and 3B below) at an inflow end of the inner frame, and a second row of generally diamond shaped cells positioned in an outflow direction relative to the first row of generally diamond shaped (see Figure 3C below), the inner frame including a plurality of inner coupling arms having a first end coupled to the inner frame and a second free end (see annotated inner coupling arms, first end of coupling arms, and second end of coupling arms in Figures 3C and 3B below), the second free ends of the outer coupling arms being coupled to the second free ends of the inner coupling arms to couple the outer frame to the inner frame (see annotated inner and outer coupling at the second free ends in Figure 3B below); and a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame (see Abstract); wherein the inner frame includes a plurality of axial struts extending from the second row of generally diamond shaped cells in a direction away from the inflow end of the inner frame (see paragraph [0010], see also annotated struts in Figure 3C below), wherein a plurality of support struts coupling the axial struts to the second row of generally diamond shaped cells (see simplified Figure 3C below).
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This embodiment of Noe fails to disclose the axial struts defining commissure windows, prosthetic leaflets of the prosthetic valve assembly being coupled to the axial struts via the commissure windows, as well as fails to disclose the second row of generally diamond shaped-cells to be “closed”.
An alternate embodiment of Noe discloses the axial struts defining commissure windows (see annotated commissure windows in Figure 15C below), prosthetic leaflets of the prosthetic valve assembly being coupled to the axial struts via the commissure windows (see paragraph [0116]).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the
effective filing date of the claimed invention to include the commissure windows of the alternate embodiment on the axial struts of the inner frame 305 instead of the area of the axial strut with the three apertures (see annotated Simplified Figure 3C above), as by doing so would benefit the load distribution along the given length of these members, effectively decreasing stress on the implant when the leaflets are attached (see paragraph [0116]).
Furthermore, these embodiments of Noe fail to disclose the generally diamond shaped-cells to be “closed” cells.
Oba discloses a prosthetic heart valve with an inner and outer frame (see annotated inner and outer frame in Figure 13 below). Oba teaches wherein the inner frame has a first and second row of generally diamond shaped cells (see annotated first and second row in Figure 13 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have had the first and second rows of cells have closed diamond shaped cells, since such a modification would have involved a mere change in the shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, the substitution of one known stent frame structure (open diamond shaped cells struts of Noe) for another known stent frame structure (closed diamond shaped cells of Oba) would have been obvious for one of ordinary skill in the art before the effective filing date of the invention, since the substitution of the stent frame structures would have yielded predictable results, namely, an inner frame with closed diamond shaped cells.
Regarding Claim 10, Noe as modified discloses the prosthetic heart valve of claim 9, wherein each axial strut includes a pair of the support struts coupling the axial strut to the second row of generally diamond shaped cells (see Simplified Figure 3C above).
Regarding Claim 11, Noe as modified discloses the prosthetic heart valve of claim 10, wherein each support strut in the pair of support struts has a first end coupled to a terminal end (see annotated terminal end in Figure 3C above) of the axial strut, and a second end coupled to the second row of generally diamond shaped cells (see annotated first and second ends of support struts in Simplified Figure 3C above).
Regarding Claim 12, Noe as modified discloses the prosthetic heart valve of claim 10, wherein each support strut in the pair of support struts extends from the axial strut in opposite circumferential directions (see Simplified Figure 3C above).
Regarding Claim 13, Noe as modified discloses the prosthetic heart valve of claim 10, wherein the pair of the support struts and the axial strut together present a blunted atraumatic surface (see Simplified Figure 3C above).
Regarding Claim 15, Noe as modified discloses the prosthetic heart valve of claim 9, wherein each axial strut is coupled to the second row of generally diamond shaped cells at an outflow apex of a cell in the second row of generally diamond shaped cells (see annotated outflow apex of a cell in the second row in Figure 3C above).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180206984 A1 (hereafter --Noe--), in view of US 20170325948 A1 (hereafter –Wallace--).
Regarding Claim 16, Noe discloses a prosthetic heart valve comprising: a collapsible and expandable outer frame configured to engage tissue of a native heart valve annulus (see paragraph [0021] and [0072]), the outer frame having an atrial portion adapted to be positioned on an atrial side of the native heart valve annulus (see paragraph [0072], see also annotated atrial portion in Figures 3C and 3B below), a ventricle portion adapted to be positioned on a ventricle side of the native heart valve annulus (see paragraph [0072], see also annotated ventricle portion in Figures 3C and 3B below), a narrowed waist portion between the atrial portion and the ventricle portion (see Figures 3C and 3B below), and a plurality of outer coupling arms having a first end coupled to the narrowed waist portion and a second free end (see annotated outer coupling arms, first end of coupling arms, and second end of coupling arms in Figure 3B below, the arms are coupled to the narrowed waist portion through the body of the device, although they may not be directly coupled, they are still coupled); a collapsible and expandable inner frame positioned radially inward of the outer frame (see annotated inner frame in Figures 3C and 3B below, see also paragraph [0010]), the inner frame including a plurality of inner coupling arms having a first end coupled to the inner frame and a second free end (see annotated inner coupling arms, first end of coupling arms, and second end of coupling arms in Figures 3C and 3B below); the second free ends of the outer coupling arms being coupled to the second free ends of the inner coupling arms to couple the outer frame to the inner frame (see annotated inner and outer coupling at the second free ends in Figure 3B below); and a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame (see Abstract); wherein the outer frame includes a first row of cells at an inflow end of the outer frame, and a second row of cells at an outflow end of the outer frame (see annotated first and second row of cells in Figures 3C and 3B below), wherein the first row of cells includes a first type of cell and wherein the outer frame wherein the outer frame includes a pin extending from an inflow apex of each of the first type of cell in the first row of cells in a direction toward the outflow end of the outer frame (see annotated pins extending from the cells at an inflow end, being the “first type” of cell in Figure 3B below).
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This embodiment of Noe fails to disclose wherein the first row of cells and the second row of cells having the same number of cells.
Noe teaches in one embodiment that there can be 30 ventricular cells (being at the inner end of the outer stent, see paragraph [0087]), and discloses in another embodiment that there can be 30 atrial cells (being at the outer end of the outer stent, see paragraph [0091]).
The Instant Application does not disclose the first and second row of cells having the same number of cells solves any problem or is for any particular purpose, nor does it place any criticality on the limitation. Further, a person having ordinary skill in the art would have a reasonable expectation of success in making such a modification and it appears that Noe’s outer frame would perform equally as well and function as intended with the first row of cells and the second row of cells having the same number of cells as claimed. Therefore, it would have been obvious to one having ordinary skill in the art to change the number of atrial and ventricular cells (first and second row of cells) to be equal as an obvious matter of design choice within the skill of the art.
Furthermore, Noe as modified fails to disclose wherein the first row of cells includes a first type of cell alternating with a second type of cell.
Wallace discloses a prosthetic heart valve (see prosthetic heart valve 1800 in Figure 18A) comprising: a collapsible and expandable outer frame configured to engage tissue of a native heart valve annulus (see paragraphs [0028] and Abstract), the outer frame having an atrial portion adapted to be positioned on an atrial side of the native heart valve annulus, a ventricle portion adapted to be positioned on a ventricle side of the native heart valve annulus, a narrowed waist portion between the atrial portion and the ventricle portion (see annotated atrial side, ventricle side, and narrowed waist in Figure 18A below), and a plurality of outer coupling arms having a first end coupled to the narrowed waist portion and a second free end (see annotated outer coupling arm ends in Figure 18A below, the arms are coupled to the narrowed waist portion through the body of the device, although they may not be directly coupled, they are still coupled); a collapsible and expandable inner frame positioned radially inward of the outer frame (see annotated inner frame in Figure 18A below), the inner frame including a plurality of inner coupling arms having a first end coupled to the inner frame and a second free end (see annotated inner coupling arm ends in Figure 18A below), the second free ends of the outer coupling arms being coupled to the second free ends of the inner coupling arms to couple the outer frame to the inner frame (see paragraph [0123], see also Figure 18A below); and a prosthetic valve assembly coupled to, and positioned radially inward of, the inner frame (see Abstract); wherein the outer frame includes a first row of cells at an inflow end of the outer frame, and a second row of cells at an outflow end of the outer frame, the first row of cells and the second row of cells having the same number of cells (see annotated first and second rows in Figures 18A and 18C below). Wallace teaches the first row of cells includes a first type of cell alternating with a second type of cell (see annotated first and second type of cells in Figure 18A below), wherein the outer frame includes a pin extending from the first row of cells in a direction toward the outflow end of the outer frame (see annotated pin in Figure 18A below).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first row of cells includes a first type of cell alternating with a second type of cell as by doing so would enable the device to be cut out of a single tube or piece of material while still providing a large-diameter blunt radial edge as taught by Wallace (see paragraph [0080]).
Regarding Claim 17, Noe as modified discloses the heart valve of claim 16.
Noe as modified fails to disclose wherein the first row of cells and the second row of cells each has twenty-four cells.
An alternate embodiment of Noe teaches wherein the number of the second row of cells (ventricular) is twenty-four (see paragraph [0087]).
The Instant Application does not disclose having exactly twenty-four cells on each end of the outer frame solves any problem or is for any particular purpose, nor does it place criticality on the exact number of cells. Further, a person having ordinary skill in the art would have a reasonable expectation of success in making such a modification and it appears that Noe’s outer frame would perform equally as well and function as intended with the number of cells in the first and second row being twenty-four as claimed. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to change the number of cells in both the first and second row to twenty-four cells as a matter of design choice within the skill of the art.
Regarding Claim 18, Noe as modified discloses the prosthetic heart valve of claim 16.
Noe as modified fails to disclose wherein the first and second type of cells both being generally diamond shaped, the first type of cell being longer in an axial direction than the second type of cell.
Wallace teaches wherein the first and second type of cells both being generally diamond shaped, the first type of cell being longer in an axial direction than the second type of cell (see annotated first and second cell type in Figure 18A below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have wherein the first and second type of cells both being generally diamond shaped, the first type of cell being longer in an axial direction than the second type of cell, since such a modification would have involved a mere change in the shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Additionally, the substitution of one known stent frame structure (cells of Noe) for another known stent frame structure (alternating first and second type of cells of Wallace, one cell type being longer in an axial direction than another) would have been obvious for one of ordinary skill in the art before the effective filing date of the invention, since the substitution of the stent frame structures would have yielded predictable results, namely, a stent frame with alternating first and second type of cells, one cell type being longer in an axial direction than another.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 20180206984 (hereafter --Noe--), as applied to claim 3 above, in view of US 20190262129 A1 (hereafter –Cooper--).
Regarding Claim 4, Noe discloses the prosthetic heart valve of claim 3, wherein the mechanical fasteners are rivets (see paragraphs [0016] and [0111] denoting that the inner and outer frames can be connected by rivets through the rivet holes on the second ends of the coupling arms, see also paragraphs [0086] and [0089] describing this deeper for other embodiments that have the same rivet hole feature).
Noe fails to disclose wherein the mechanical fasteners are sutures.
Cooper discloses a prosthetic heart valve (see Figure 1 below), comprising an outer frame with coupling arms with a first end attached to the frame, and a second free end (see annotated inner frame coupling arms in Figure 6A below), and an inner frame with coupling arms with a first end attached to the frame (see annotated inner frame coupling arms in Figure 2 below), wherein the second free ends of the outer coupling arms are coupled to the second free ends of the inner coupling arms via mechanical fasteners (see paragraph [0151]). Cooper teaches wherein the mechanical fasteners are sutures (see paragraphs [0125], [0151], and [0174]).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the
effective filing date of the claimed invention to have the second ends of the coupling arms of the inner and outer frames be connected by a suture through the eyelets on the two second ends as by doing so would merely involve changing one known mechanical coupling mechanism for another (see paragraph [0151]), as well as would enable the outer frame to also simultaneously be secured to a delivery system during delivery, which would advantageously facilitate recapture and repositioning of the outer frame 140 and the prosthesis in situ as taught by Cooper (see paragraph [0175]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774