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 .
Election/Restrictions
Claim 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/13/2026.
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.
Claims 1-7, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Whisler et al. (US 20190125304 A1), hereinafter Whisler in view of Zhang et al. (US 20160166234 A1), hereinafter Zhang.
Regarding claim 1,
Whisler teaches a method of obtaining a whole breast 3D ultrasound image ([0024] which discloses the ultrasound processor housing may be used for driving an ultrasound transducer and generating volumetric (thus 3D) breast ultrasound data), the method comprising:
Placing an adapter subassembly (at least fig. 3 (310 and 106) and corresponding disclosure in at least [0020], [0035] and [0059] which discloses the housing for the scanning assembly 700 may use, housing 310 of scanning assembly 108 hereinabove with regard to fig. 3 or at least fig. 7 (710 and 720) and corresponding disclosure in at least [0058]-[0059]) of a whole breast 3D ultrasound imaging system (at least fig. 3 (300) and/or at least fig. 7 (700) and corresponding disclosure in at least [0058]) around a whole breast of a subject ([0050] which discloses the padding 410 may comprise a soft rubber, a firm foam or a polyurethane material. The padding 410 cushions the tissue of the patient from the hard surfaces of the scanning apparatus during an ultrasound scan), the adaptor subassembly comprising an annular wall (see at least fig. 3 and fig. 7 both depicting annular walls for the housing 310 and 710) for containing an ultrasound transmission fluid around a breast of a subject (Examiner notes that “for containing an ultrasound transmission fluid around a breast of a subject” is directed toward an intended use of the claimed annular wall. A recitation directed towards intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish from the claimed invention. In other words, the structure of the prior art must have the claimed structure and must merely be capable of functioning to contain an ultrasound transmission fluid around the breast of the subject. Examiner thus notes that since wearable adapter subassembly is configured for compressing and imaging the breast as disclosed in at least [0021], [0023], and [0037], that the annular wall of such an adapter subassembly depicted in figs. 3/7 would thus be capable of containing an ultrasound transmission fluid around the breast of the subject):
Fastening the adaptor subassembly to the subject to provide a seal between a first edge (at least fig. 4 (410) and corresponding disclosure in at least [0048]-[0050] or at least fig. 7 (717) and corresponding disclosure in at least [0061]) of the annular wall and a body surface around the breast of the subject ([0050] which discloses the padding 410 may comprise a soft rubber, a firm foam or a polyurethane material. The padding 410 cushions the tissue of the patient from the hard surfaces of the scanning apparatus during an ultrasound scan and [0064] which discloses when compressing the scanning apparatus 700 against the tissue of the patient, the body of the patient presses against the padding 717 instead of the hard surface of the locking ring 730 or the housing 710. Thus by fastening the adaptor subassembly it would therefore provide a seal. Additionally/alternatively “to provide a seal” is directed towards intended use of the fastening. A recitation directed towards intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish from the claimed invention. Examiner thus notes that since the padding would be capable of providing a seal, that such fastening of the adaptor assembly therefore reads on the claimed invention) to reduce leakage of the ultrasound fluid between the first edge and the body surface of the subject (Examiner notes that “to reduce leakage of the ultrasound fluid between the first edge and the body of the subject” is directed toward an intended use of the claimed first edge. A recitation directed towards intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish from the claimed invention. In other words, the structure of the prior art must have the claimed structure and must merely be capable of functioning to reduce leakage of the ultrasound fluid between the first edge and the body of the subject. Examiner thus notes that since the padding 410/710 (i.e. the first edge) is made of a durable material for pressing the tissue it is therefore capable of reducing leakage of an ultrasound fluid between the first edge and the body of the subject), and
Releasably mounting a compression plate assembly (at least fig. 5 (500) and corresponding disclosure in at least [0051] or at least fig. 7 (730) and corresponding disclosure in at least [0058] and [0052] which discloses the ring 505 is sized and shaped to fit securely into the recess of the bottom side 400 or [0063] which discloses In one example, the locking ring 730 may be adapted to clip mechanically to the housing 710. In another example, at least one of a portion of the housing 710 and the locking ring 730 may be magnetized such that the locking ring 730 is magnetically coupled to the housing 710 and [0064] which discloses the locking ring couples the housing and may be formed to at least partially enclose the exterior of the padding, such that the interior of the locking ring and the exterior of the padding (i.e. the second edge) are in face-sharing contact. See also at least fig. 8 in which the locking ring 730 is mountable on a bottom edge of the housing) of the whole breast 3D ultrasound imaging system on a second edge (at least fig. 4 (405) and corresponding disclosure in at least [0049] see at least fig. 7 (the side edges of the padding or the bottom surface of the housing above the padding) of the adaptor subassembly thereby positioning an ultrasound compression plate of the compression plate assembly above the breast (examiner notes that the system is used from ([0023] which discloses membrane having a bottom surface contacting the breast, thus the compression plate of the compression plate assembly (either 720 or 710) is necessarily position above the breast); and
Adjusting a height of the compression plate to compress the breast ([0021] which discloses the adjustable arm 106 is configured and adapted such that the compression/scanning assembly 108 is either (i) neutrally buoyant in space, or (ii) has a light net downward weight (e.g., 1-2 kg) for breast compression, while allowing for easy user manipulation. In alternate embodiments, the adjustable arm 106 is configured such that the compression/scanning assembly 108 is neutrally buoyant in space during positioning the scanner on the patient's tissue. Then, after positioning the compression/scanning assembly 108, internal components of the scanning apparatus 102 may be adjusted to apply a desired downward weight for breast compression and increased image quality. In one example, the downward weight (e.g., force) may be in a range of 2-11 kg. Examiner notes that such positioning of the assembly on the subject necessarily requires adjusting a heigh of the compression plate to compress the breast. See also [0040])
Releasably mounting a motor plate subassembly (at least fig. 3 (230 and 220) and corresponding disclosure in at least [0026])of the whole breast 3D ultrasound imaging system on the adapter subassembly ([0042] which discloses the module receiver 230 is mechanically coupled to a first end of the housing 310 at the back side wall of the frame 322. In one example, the module receiver is coupled to the first end via a protrusion of the module receiver 230 and the protrusion coupled to a motor 230. Thus a mechanical coupling necessarily means the motor plate subassembly is releasably mounted on the wearable subassembly), the motor plate subassembly (230 and 220) comprising an ultrasound transducer (220) movable relative to the motor plate subassembly ([0045] which discloses the transducer module 220 is removably coupled with the module receiver 230. As a result, during scanning, the transducer module 220 translates horizontally with the module receiver 230. During scanning, transducer module 220 sweeps horizontally across the breast under motor control of the module receiver 230 while a contact surface of the transducer module 220 is in contact with the membrane 118. Where such horizontal movement is considered to be parallel with the ultrasound compression plate 500 or 730 of fig. 7)
While the ultrasound transducer is movable with the motor plate subassembly with respect to the frame, Whisler fails to explicitly teach wherein the ultrasound transducer is movable relative to the motor plate subassembly. Whisler further fails to explicitly teach providing the ultrasound transmission fluid inside the annular wall of the adapter subassembly around the breast of the subject and the ultrasound fluid between the compression plate and the body surface of the subject.
Nonetheless, Zhang in a similar field of endeavor involving ultrasound breast imaging, teaches placing an adapter subassembly of a whole breast 3D ultrasound imaging system around a whole breast of a subject, the adapter subassembly comprising an annular wall for containing an ultrasound transmission fluid around the breast of the subject (see at least fig. 5);
Providing the ultrasound transmission fluid inside the annular wall of the adapter subassembly around the breast of the subject ([0045] which discloses In certain implementations, an acoustic coupling gel or lotion may be applied automatically or by the technologist (block 190) prior to ultrasound imaging. In embodiments employing a mesh compression paddle 152, the mesh structure allows passage of the acoustic gel or lotion to facilitate acoustic coupling of the probe 160 through the paddle 152 and with the breast tissue. Examiner notes that such disclosure of the mesh structure allowing passage of the acoustic gel or lotion means that the coupling gel or lotion is provided inside the annular wall of the adapter subassembly)
Positioning a flexible membrane above the breast with the ultrasound fluid between flexible membrane and the body surface of the subject ([0045] which discloses In certain implementations, an acoustic coupling gel or lotion may be applied automatically or by the technologist (block 190) prior to ultrasound imaging. In embodiments employing a mesh compression paddle 152, the mesh structure allows passage of the acoustic gel or lotion to facilitate acoustic coupling of the probe 160 through the paddle 152 and with the breast tissue); and
a motor plate subassembly (at least figs. 5 and 6 (260 and 160) and corresponding disclosure in at least [0051] or alternatively at least fig. 10 (332 and 160) and corresponding disclosure in at least [0062]) comprising:
An ultrasound transducer (160) movable relative to the motor plate subassembly (see at least fig. 5 and 6 and [0051] which discloses the ultrasound probe 160 along with a fixed track 260 on which the ultrasound probe 160 may move back and forth or see at least fig. 10 and [0062] which discloses the frame defines a track on which the ultrasound probe 160 may move back and forth) in a plane parallel to the wearable adapter subassembly (see at least figs. 5 and 10 where back and forth movement would cause the probe to move in a plane parallel to the frame)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whistler to include providing the ultrasound transmission fluid and flexible membrane of Zhang in order to allow facilitate acoustic coupling of the probe through the compression plate and with the breast tissue (Zhang [0045]). Such a modification would enhance the imaging of Whisler accordingly by ensuring proper acoustic coupling between the probe and the breast.
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to have modified Whistler to include the motor plate subassembly as taught by Zhang in order to allow for a pivotable motor plate sub-assembly to rotate the motor plate assembly from an ultrasound imaging orientation to a tomosynthesis (or other) imaging orientation or to slidably release ([0067]) the motor plate subassembly from the wearable adapter subassembly such that ultrasound components are out of the way with respect to the other imaging modality (Zhang [0053]). Such a modification would thus enhance the system of Whistler by providing an easily moveable/removable motor plate subassembly for performing other imaging procedures of the breast while still allowing for translation of the ultrasound probe across the breast as desired by Whistler.
Examiner notes that in the modified system, that the transmission fluid is between the compression plate (730 of Whisler) and the breast accordingly.
Regarding claim 2,
Whisler, as modified, teaches the elements of claim 1 as previously stated. Whisler, as modified, further teaches wherein the ultrasound fluid directly contacts the breast (Zhang [0045] In embodiments employing a mesh compression paddle 152, the mesh structure allows passage of the acoustic gel or lotion to facilitate acoustic coupling of the probe 160 through the paddle 152 and with the breast tissue. thus with the mesh compression paddle the ultrasound fluid directly contacts the breast).
Regarding claim 3,
Whisler, as modified teaches the elements of claim 1 as previously stated. Whisler, as modified, further teaches wherein the adapter subassembly comprises a flexible membrane (Whisler 720 or 152 of Zhang) covering a lower open face of the adapter subassembly (see at least fig. 7 of Whisler), the flexible membrane deformed by the breast when the breast is housed within the annular wall (Whisler [0017] which discloses at least partially conformable, substantially taut membrane or film sheet and Zhang [0041] which discloses using a non-rigid paddle structure 152, such as a mesh paddle structure, that is accommodative or conformable to the breast tissue size and shape).
Regarding claim 4,
Whisler further teaches wherein the adapter subassembly comprises a compressible gasket (at least fig. 4 (410) and corresponding disclosure in at least [0050] or at least fig. 7 (717) and corresponding disclosure in at least [0060]. Examiner notes that the padding is considered a compressible gasket in its broadest reasonable interpretation in that it is disclosed in [0050] as comprising a soft rubber, firm foam or a polyurethane material and is shown in an annular configuration around the frame 310/710, therefore would function as a gasket and is compressible due to its material being soft rubber, foam, or polyurethane) on the first edge (see at least fig. 4 and 7 where the first edge is considered to be the padding 410 or 717, thus is on the first edge) to assist with providing the seal between the first edge to the body surface of the subject ([0050] which discloses the padding 410 cushions the tissue of the patient from the hard surfaces of the scanning apparatus during an ultrasound scan, thereby improving the comfort for the patient when the patient's tissue is being compressed against the scanning apparatus and [0064] which discloses the body of the patient presses against the padding 717 instead of the hard surface of the locking ring 730 or the housing 710)
Regarding claim 5,
Whisler, as modified, teaches the elements of claim 1 as previously stated. Whister further teaches wherein the adapter subassembly (310) is permitted to flex to assist with conforming the first edge of to the body surface of the subject ([0050] which discloses the padding 410 may comprise a soft rubber or a polyurethane material. The padding cushions the tissue of the patient from the hard surfaces thus, due to its material is permitted to flex to assist with conforming the first edge of the body surface of the subject).
Whistler, as currently modified, fails to explicitly teach wherein the adapter subassembly comprises a hinge.
Nonetheless, in an alternative embodiment, Whistler teaches wherein the wearable adapter subassembly (at least fig. 6 (600) and corresponding disclosure in at least [0054]) comprises a hinge (at least fig. 6 (622) and corresponding disclosure in at least [0056]) permitting an annular wall (at least fig. 6 (612) and corresponding disclosure in at least [0054] which discloses padding that extends around an opening 614 in the bottom side 606) to flex to assist with conforming a first edge (612) to the body surface of the subject (Examiner notes that the padding of the annular wall and thus the first edge is permitted to flex due to it’s material disclosed in [0050] as a soft rubber or polyurethane material, such that the padding would cushion the tissue of the patient accordingly).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whisler, as currently modified, to include a hinge as taught by the alternative embodiment of Whisler in order to secure the membrane to the frame (Whisler [0056]).
Regarding claim 6,
Whisler further teaches wherein the adapter subassembly comprises a compressible gasket (at least fig. 4 (410) and corresponding disclosure in at least [0050] or at least fig. 7 (717) and corresponding disclosure in at least [0060]. Examiner notes that the padding is considered a compressible gasket in its broadest reasonable interpretation in that it is disclosed in [0050] as comprising a soft rubber, firm foam or a polyurethane material and is shown in an annular configuration around the frame 310/710, therefore would function as a gasket and is compressible due to its material being soft rubber, foam, or polyurethane) made of an elastomeric material (examiner notes that soft rubber and polyurethane are elastomeric materials) on the first edge (see at least fig. 4 and 7 where the first edge is considered to be the padding 410 or 717, thus is on the first edge) to assist with providing the seal between the first edge to the body surface of the subject ([0050] which discloses the padding 410 cushions the tissue of the patient from the hard surfaces of the scanning apparatus during an ultrasound scan, thereby improving the comfort for the patient when the patient's tissue is being compressed against the scanning apparatus and [0064] which discloses the body of the patient presses against the padding 717 instead of the hard surface of the locking ring 730 or the housing 710).
Regarding claim 7,
Whisler, as modified, teaches the elements of claim 6 as previously stated. Whister further teaches wherein the adapter subassembly (310) is permitted to flex to assist with conforming the first edge of to the body surface of the subject ([0050] which discloses the padding 410 may comprise a soft rubber or a polyurethane material. The padding cushions the tissue of the patient from the hard surfaces thus, due to its material is permitted to flex to assist with conforming the first edge of the body surface of the subject).
Whistler, as currently modified, fails to explicitly teach wherein the adapter subassembly comprises a hinge.
Nonetheless, in an alternative embodiment, Whistler teaches wherein the wearable adapter subassembly (at least fig. 6 (600) and corresponding disclosure in at least [0054]) comprises a hinge (at least fig. 6 (622) and corresponding disclosure in at least [0056]) permitting an annular wall (at least fig. 6 (612) and corresponding disclosure in at least [0054] which discloses padding that extends around an opening 614 in the bottom side 606) to flex to assist with conforming a first edge (612) to the body surface of the subject (Examiner notes that the padding of the annular wall and thus the first edge is permitted to flex due to it’s material disclosed in [0050] as a soft rubber or polyurethane material, such that the padding would cushion the tissue of the patient accordingly).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whisler, as currently modified, to include a hinge as taught by the alternative embodiment of Whisler in order to secure the membrane to the frame (Whisler [0056]).
Regarding claim 11,
Whisler further teaches wherein the adapter subassembly moves with the subject when the subject moves in any direction (Examiner notes that with force applied by the adjustable arm that a person having ordinary skill in the art would recognize the adapter subassembly would move with the subject (e.g. minor movements or translational movements))
Regarding claim 13,
Whisler, as modified, teaches the elements of claim 1 as previously stated. Zhang, as applied to claim 1 above, further teaches wherein the motor plate subassembly further comprises an actuator (at least fig. 5 (262) and corresponding disclosure in at least [0051]) operatively coupled to the ultrasound transducer (160) to translate the ultrasound transducer.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Whisler and Zhang, as applied to claims 1, 6 and, 7 above, and further in view of Davis et al. (US 20160166217 A1), hereinafter Davis.
Regarding claim 8,
Whisler, as modified teaches the elements of claim 1 as previously stated. Whisler, as modified, fails to explicitly teach wherein the adapter subassembly is fastened to the subject with adjustable straps.
Davis, in a similar field of endeavor involving ultrasound breast imaging, teaches wherein an adaptable subassembly is fastened to a subject with an adjustable strap ([0046] which discloses in certain embodiments the paddle 152 may include a wrap or strap that may extend partly or completely around the torso of the patient so as to affix the paddle of the chest wall of the patient during use).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whisler, as currently modified, to include a strap as taught by Davis in order to affix the wearable adapter subassembly to the chest wall of the patient during use. Such a modification would enhance the system of Whisler, by ensuring that the wearable adapter subassembly is affixed to the patient during use, thereby reducing any effects of movement during the patient with respect to the wearable adapter subassembly accordingly.
Furthermore, while the modified method does not teach plural adjustable straps, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whisler, as currently modified, to include at least an additional adjustable strap, to provide further security of the wearable adapter subassembly to the patient by providing additional points of contact. Furthermore, such a modification amounts to merely a duplication of parts resulting in expected results with respect to fastening devices, thereby rendering the claim obvious (MPEP 2144).
Regarding claim 9,
Whisler, as modified, teaches the elements of claim 6 as previously stated. Whisler, as modified, fails to explicitly teach wherein the adapter subassembly is fastened to the subject with adjustable straps and wherein the straps are adjusted to compress the compressible gasket relative to the body surface of the subject.
Davis, in a similar field of endeavor involving ultrasound breast imaging, teaches wherein an adaptable subassembly is fastened to a subject with an adjustable strap ([0046] which discloses in certain embodiments the paddle 152 may include a wrap or strap that may extend partly or completely around the torso of the patient so as to affix the paddle of the chest wall of the patient during use).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whisler, as currently modified, to include a strap as taught by Davis in order to affix the wearable adapter subassembly to the chest wall of the patient during use. Such a modification would enhance the system of Whisler, by ensuring that the wearable adapter subassembly is affixed to the patient during use, thereby reducing any effects of movement during the patient with respect to the wearable adapter subassembly accordingly.
Furthermore, while the modified method does not teach plural adjustable straps, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whisler, as currently modified, to include at least an additional adjustable strap, to provide further security of the wearable adapter subassembly to the patient by providing additional points of contact. Furthermore, such a modification amounts to merely a duplication of parts resulting in expected results with respect to fastening devices, thereby rendering the claim obvious (MPEP 2144).
Examiner notes that in providing such a wrap or strap, that adjustment is necessarily required to affix the paddle to the chest wall of the patient and such affixing would necessarily cause compression of the compressible gasket relative to the body surface.
Regarding claim 10,
Whisler, as modified, teaches the elements of claim 7 as previously stated. Whisler, as modified, fails to explicitly teach wherein the adapter subassembly is fastened to the subject with adjustable straps and wherein the straps are adjusted to compress the compressible gasket relative to the body surface of the subject and wherein the straps are adjusted to cause the annular wall to flex.
Davis, in a similar field of endeavor involving ultrasound breast imaging, teaches wherein an adaptable subassembly is fastened to a subject with adjustable straps ([0046] which discloses in certain embodiments the paddle 152 may include a wrap or strap that may extend partly or completely around the torso of the patient so as to affix the paddle of the chest wall of the patient during use).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whisler, as currently modified, to include a strap as taught by Davis in order to affix the wearable adapter subassembly to the chest wall of the patient during use. Such a modification would enhance the system of Whisler, by ensuring that the wearable adapter subassembly is affixed to the patient during use, thereby reducing any effects of movement during the patient with respect to the wearable adapter subassembly accordingly.
Furthermore, while the modified method does not teach plural adjustable straps, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Whisler, as currently modified, to include at least an additional adjustable strap, to provide further security of the wearable adapter subassembly to the patient by providing additional points of contact. Furthermore, such a modification amounts to merely a duplication of parts resulting in expected results with respect to fastening devices, thereby rendering the claim obvious (MPEP 2144).
Examiner notes that in providing such a wrap or strap, that adjustment is necessarily required to affix the paddle to the chest wall of the patient and such affixing would necessarily cause compression of the compressible gasket relative to the body surface and cause the annular wall to flex. Furthermore to compress and to cause are considered intended use limitations where it is noted that adjusting the straps would necessarily be capable of compressing the compressible gasket and causing the annular wall to flex.
Allowable Subject Matter
Claims 14-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner notes that the closest prior art of claim 14 remains to be Whisler and Zhang. Examiner notes that while Whisler teaches a compression plate subassembly comprising a securement portion configured to be releasably secured to the second edge of the annular wall of the adapter subassembly, and a frame (730) with the with a compression plate (e.g. 720) mounted to the frame, there is no teaching nor suggestion that the frame comprises mounting bolts secured thereon and the mounting bolts engaging the securement portion to connect the frame to the securement portion, and wherein to adjust the height of the compression plate, at least on of the mounting bolts is rotated in a threaded aperture in the securement portion to cause the frame and the compression plate to move relative to the securement portion when the securement portion is secured on the adapter subassembly. A person having ordinary skill in the art would not have been motivated to modify the teachings of Whisler or Whisler and Zhang to have modified the compression plate subassembly to include such mounting bolts and rotating the mounting bolts in a threaded aperture to cause the frame and the compression plate to move relative to the securement portion accordingly. Such a modification would have required impermissible hindsight reasoning. For at least these reasons, the combination of elements distinguishes over the prior art collectively.
Conclusion
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797