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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
FIG. 10: Although the specification states “Like the inlet(s) 724 and outlets 726 of the canopy 720, 920, the canopy 1020 may have an inlet 1024 that is attached to an outlet of the reservoir 110 and a plurality of outlets 1026 that are spaced apart from each other on an underside of the canopy 1020” [0059], this figure does not include the label 1024.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIG. 9: Although this claim includes the label 920b, the label does not appear within the specification.
FIG. 11: Although this claim includes the label 1027, the label does not appear within the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0057]: As written it reads “As shown in the closeup view of Figure 8A, each of the outlets 726 may be provided with an external directable vent 727 like the vents in an automobile air conditioning system. The directable vents 717 may be a fixed or attachable accoutrement to the canopy 720. Each of the directable vents 727 may be arranged to direct the medium 20 exiting from a corresponding one of the plurality of outlets 726”. However, the examiner believes “717” is a typo since the directable vent was previously defined with the label “727”.
[0064]: As written it reads “It will provide data […] 4) that is secure and confidential by encryption of infrared image data equal to or greater than HIPPA requirements”. However, this is the first indication of the term “HIPPA”, therefore, the term should be spelled out to provide clarity.
[0066]: As written it reads “The functionality described above in relation to the one or more processors 140 may be wholly or partly embodied in one or more computers including a processor (e.g., a CPU), a system memory (e.g., RAM), and a hard drive or other secondary storage device”. However, this is the first indication of the terms CPU and RAM, therefore, the terms should be spelled out to provide clarity.
[0067]: As written it reads “[…] an optical recording medium such as a CD, DVD, or Blu-ray Disk, a magneto-optic recording medium such as an MO, a semiconductor memory such as an IC card”. However, this is the first indication of the terms “CD”, “DVD”, “MO” and “IC”, therefore, the terms should be spelled out to provide clarity.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, and 7 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Berman et al. US 2007/0213617 A1 “Berman”.
Regarding claim 1, Berman teaches “A system for infrared analysis of a target surface region of a subject, the system comprising:” (See FIG. 1 and “On the right hand side of FIG. 1 we see an inventive IR-imaging means 5, preferably also having an infrared lens 5A looking leftward at breast 1 with a cone-shaped or rectangular field-of-view generally defined by phantom lines such as lines 5B. It will be noted that the inventive IR camera or imaging device 5/5A includes or is communicative with a CPU or calculation means and a GUI or graphical user interface situated in schematic function block 6A as well as with some memory and a data bus shown situated in functional block 6B” [0047]; “The invention here offers advancements in two areas, both of which can help thermography. The first is improvements to the mid-IR thermography technique itself and the second is near-IR or NIR plus MIR imaging wherein both data or image types are co-analyzed to sort tumors from normal tissues and vasculature” [0015]. In this case, the inventive IR camera (i.e. imaging device 5/5A) depicted in FIG. 1, is used to obtain the near-IR and MIR imaging data and the CPU (i.e. processor) is used to perform the analysis to sort tumors from normal tissues and vasculature (see [0015]). Therefore, FIG. 1 depicts a system for infrared analysis of a target surface region of a subject.);
“a reservoir containing a medium at a predetermined temperature” (“There are several ways to utilize a plate or IR window to heat or cool tissue or to temperature control tissue on which it is laid or held in very close proximity. We prefer physical contact, but include proximity placement to tissue wherein any gap […] For cooling of the breast using such a plate or window, it is desirable not to condense water vapor in the optical path, so we expressly include in the scope of the invention the use of a thermal insulation and or dry gas in, on or around the plate to prevent this” [0038]. In order to deliver a dry gas to the breast when performing cooling, a reservoir containing a medium at a predetermined temperature, must be present.);
“a conduit defining a channel for transmitting the medium from the reservoir to the target surface region, the conduit having a first end that is attached to an outlet of the reservoir and a second end that is flexibly conformable to a shape corresponding to a perimeter of the target surface region” (See [0038] above, and “In a third embodiment, a preferably IR (mid-IR and/or near-IR) transparent window is utilized as a means of delivering or removing heat from the breast. The window adds or removes heat from the breast either because of its own heat capacity and conductivity or because it includes or is used with a heating or cooling means such as a flowed coolant, electric heater or radiant heater. In any event, heat can be injected or removed in a much more controlled manner and at a much faster and more uniform rate than using prior art cooling means such as blown air or sprayed alcohol” [0021]; “The inventive IR window may have any shape or pliability including flat, cup-shaped, rigid or flexible and may even be custom-molded to the patient. By applying force to the breast with the inventive IR window, then any of compression, tension, suction or shear can be delivered to the tissues” [0042]; “The second embodiment is essentially the use of a preferably IR (MIR and/or NIR) transmissive or transparent window that can be IR-imaged through while it is also utilized to distort, shear or compress the breast. The preference is to have the window be IR transparent such that IR imaging can be performed while the tissue is distorted. […] As described earlier, the window may be flat, curved, rigid or flexible. It may be applied and/or held on the tissue by the clinician’s hand, the patient’s hand, by straps, clamps or actuator arms, or by suction or adhesive” [0077]; “We again explicitly state here that the IR window material may be rigid and flat, as it might be for pressing the breast flat using the window material, or it might be cup-shaped or conical in shape such that it fits the breast shape somewhat. It may also be flexible such that it adapts to the breast shape to some degree. The IR-polymer material mentioned in the GM Tech Corp. reference can be molded or formed to be flexible in that manner” [0086].
In this case, since the transmissive or transparent window (i.e. IR window), is flexible and is applied/held on the tissue and the dry gas is delivered via the IR window to cool the breast (see [0038]), the transmissive or transparent window represents a conduit having a first end that is attached to an outlet of the reservoir and a second end that is flexibly conformable to a shape corresponding to a perimeter of the target surface region and a canopy that is deployable above and at least partially surrounding the target surface region.);
“an infrared camera operable to capture infrared image data of the target surface region” (See [0047] above. Therefore the system includes an infrared camera operable to capture infrared image data of the target surface region.); and
“one or more processors operable to produce a representation of the captured infrared image data at a plurality of timings relative to the transmission of the medium from the reservoir to the target surface region” (See CPU in FIG. 1 and “As a specific example, we could gather mid-IR surface images and near-IR penetrating images of the same region, say the region shown in FIGS. 2A-2B. From these two images, one can recognize that one has a “point” heat source (the tumor) superimposed on a linear heat source (the lumen). From having near-IR images at an angle or at multiple angles, it can be ascertained in the near-IR that the tumor underlies the lumen, if that is not already obvious to the clinician” [0112]. In order to obtain both mid-IR surface images and near-IR penetrating images, the infrared camera must emit IR light at two different wavelengths, these wavelengths being emitted at different times (i.e. a plurality of times). Furthermore, in order to obtain near-IR images at multiple angles, the infrared image data must be captured at a plurality of timings relative to the transmission of the medium from the reservoir to the target surface region. Therefore, the system includes one or more processors operable to produce a representation of the captured infrared image data at a plurality of timings relative to the transmission of the medium from the reservoir to the target surface region.).
Regarding claim 2, Berman discloses all features of the claimed invention as discussed with respect to claim 1 above, and Berman further teaches “wherein the medium is a gas” (see [0038] as discussed with respect to claim 1 above. Therefore, the reservoir (i.e. inherently present) contains a medium that is a gas.).
Regarding claim 5, Berman discloses all features of the claimed invention as discussed with respect to claim 1 above, and Berman further teaches “wherein the conduit is infrared transparent” (“The second embodiment is essentially the use of a preferably IR (MIR and/or NIR) transmissive or transparent window that can be IR-imaged through while it is also utilized to distort, shear or compress the breast. The preference is to have the window be IR transparent such that IR imaging can be performed while the tissue is distorted” [0077]. Therefore, since the IR window is a transparent such that IR imaging can be performed while the tissue is distorted, the conduit (i.e. IR window) is infrared transparent.).
Regarding claim 7, Berman discloses all features of the claimed invention as discussed with respect to claim 1 above, and Berman further teaches “further comprising an adhesive provided on the second end of the conduit” (“The second embodiment is essentially the use of a preferably IR (MIR and/or NIR) transmissive or transparent window that can be IR-imaged through while it is also utilized to distort, shear or compress the breast […] It may be applied and/or held on the tissue by the clinician’s hand, the patient’s hand, by straps, clamps or actuator arms, or by suction or adhesive” [0077]. Therefore, since the IR transmissive or transparent window is applied to and/or held on the tissue by an adhesive, the system further comprises an adhesive provided on the second end of the conduit.).
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.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” as applied to claim 1 above, and further in view of McKinney et al. US 2018/0303406 A1 “McKinney”.
Regarding claim 3, Berman discloses all features of the claimed invention as discussed with respect to claim 1 above, Berman further teaches “to drive the medium from the reservoir to the target surface region via the conduit” (see [0038] and [0077] as discussed with respect to claim 1 above.).
However, Berman does not teach that the system “further comprising a fan” which is operable to drive the medium from the reservoir to the target surface region via the conduit.
McKinney is within a related field of endeavor to the claimed invention because it involves systems for characterizing skin type including an illumination source (see [Abstract]).
McKinney further teaches “a fan” which is operable to drive the medium from the reservoir to the target surface region via the conduit (“Referring now to FIG. 7, the refrigeration unit 501 can also include a compressor 701, a condenser 703, and an evaporator (not shown). The refrigeration unit 501 can provide forced convection cooling of the condenser 703 through a plenum 705 using a fan 707” [0086]; “In some embodiments, the coolant can be directed to a coolant inlet 503a of a heat exchanger 503, flowed through the heat exchanger 503, and exited from the heat exchanger 503 via coolant outlet 503b. The heat exchanger 503 can be any suitable device for cooling air or other gases driven through the heat exchanger 503 via gas inlet 505a and exited via gas outlet 505b. The air or gas flowing in the heat exchanger 503, in some embodiments, can be used for cooling the skin of a patient during a procedure. For example, in some embodiments, the air or gas can cool the patient skin to a target temperature in the range of 15 to 20°C via a gas impingement cooling of the skin during the procedure in order to maintain a therapeutically acceptable temperature range” [0087]; “In some embodiments, the air or gas can be driven through the heat exchanger 503 by a pump 507. The pump 507, in some embodiments, can be any suitable device capable of driving the gas through the heat exchanger 503 and onward to a jet impingement nozzle (not shown)” [0088]. As shown in FIG. 5, the refrigeration unit 501 is connected to the heat exchanger 503 via the coolant inlet 503a. Furthermore, FIG. 7 shows that fan 707 is within the refrigeration unit 501.
In this case, the examiner is interpreting a fan to be any device capable of moving air (i.e. a gas) from one location to another. Since the pump 507 of McKinney is any suitable device capable of driving the gas through the heat exchanger 503, under broadest reasonable interpretation, the pump 507 represents a fan. Therefore, since the heat exchanger 503 receives coolant from a coolant inlet 503a (i.e. connected to the refrigeration unit 501) and includes a pump 507 which is any device capable of driving the gas through the heat exchanger 503, the system includes a fan operable to drive the medium from the reservoir (i.e. refrigeration unit 501, for example), to the target surface region (i.e. via the conduit/transparent window of Berman, for example.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Berman so as to include a fan (i.e. pump 507) as disclosed in McKinney in order to effectively direct air to a patient’s skin, such that it is maintained within a target temperature in the range of 15 to 20°C via a gas impingement cooling of the skin during the procedure (see McKinney: [0088]). A fan/pump is one of a finite number of devices which can be used to direct the flow of air/gas with a reasonable expectation of success. Therefore, modifying the system of Berman such that it includes a fan (i.e. pump 507) as disclosed in McKinney would yield the predictable result of directing air to the target region of a patient’s skin to perform cooling during a procedure.
Regarding claim 4, Berman discloses all features of the claimed invention as discussed with respect to claims 1 above, however Berman does not teach “wherein the predetermined temperature is less than 35°C”.
McKinney teaches “wherein the predetermined temperature is less than 35°C” (“In some embodiments, the coolant can be directed to a coolant inlet 503a of a heat exchanger 503, flowed through the heat exchanger 503, and exited from the heat exchanger 503 via coolant outlet 503b. The heat exchanger 503 can be any suitable device for cooling air or other gases driven through the heat exchanger 503 via gas inlet 505a and exited via gas outlet 505b. The air or gas flowing in the heat exchanger 503, in some embodiments, can be used for cooling the skin of a patient during a procedure. For example, in some embodiments, the air or gas can cool the patient skin to a target temperature in the range of 15 to 20°C via a gas impingement cooling of the skin during the procedure in order to maintain a therapeutically acceptable temperature range” [0087]. In this case, in order for the gas impinging on the skin to cause the skin to be within the range of 15 to 20°C, the gas in the reservoir must be maintained at a predetermined temperature which is less than 35°C.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Berman such that the medium in the reservoir is at a predetermined temperature, which is less than 35°C as disclosed in McKinney in order to effectively direct air to a patient’s skin, such that the skin is maintained within a target temperature in the range of 15 to 20°C during the procedure (see McKinney: [0088]). When the medium (i.e. gas) is less than 35°C, this gas can provide a cooling effect. By directing air to the skin of the patient with a predetermined temperature of less than 35°C the skin can be cooled and maintained within a therapeutically acceptable temperature range. Therefore, modifying the medium of Berman to be at a predetermined temperature of less than 35°C as disclosed in McKinney in order to maintain the skin at a therapeutic acceptable temperature range during a procedure (see McKinney: [0087]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” as applied to claim 1 above, and further in view of Schilling et al. US 2010/0080345 A1 “Schilling”.
Regarding claim 6, Berman discloses all features of the claimed invention as discussed with respect to claim 1 above, however Berman does not teach “wherein the conduit includes one or more vents allowing the medium to pass from the channel to outside the conduit”.
Schilling is within a related field of endeavor to the claimed invention because it involves a device for locating a breast (see [Abstract]).
Schilling teaches “wherein the conduit includes one or more vents allowing the medium to pass from the channel to outside the conduit” (“In one embodiment, a vacuum system is provided for conforming a breast to the shape of the locating device. […] When air is extracted from the inner space of the locating device (e.g., by means of suction channels 45), the breast conforms exactly to the shape of the locating device, and the locating device is held firmly against the breast. In one embodiment, the locating device may be provided with a multitude of suction channels 45 and air exit openings through which air can pass from the inside of the locating device into the suction channels” [0040]. In this case, the opening (i.e. inner space) of the cup 40 (see FIG. 1), represents the conduit. Furthermore, since air exits the opening (i.e. conduit) through the air exit openings (i.e. vents) and into the suction channels 45, the system includes a conduit with one or more vents allowing the medium (i.e. air) to pass from the channel (i.e. tubing connector 43/inside the opening), to outside the conduit (i.e. and into the suction channels.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Berman such that the conduit includes one or more vents (i.e. air exit openings) as disclosed in Schillings in order to allow the conduit to conform exactly to the shape of the breast (see Schilling: [0040]). In this case, by allowing the medium to pass outside of the conduit, the breast can be held more firmly against the breast. Therefore, modifying the conduit of Schilling to include one or more vents (i.e. air exit openings) as disclosed in Schillings would yield the predictable result of ensuring firm contact between the conduit and the surface of the breast.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” as applied to claim 1 above, and further in view of Morton et al. US 2003/0073951 A1 “Morton”.
Regarding claim 8, Berman discloses all features of the claimed invention as discussed with respect to claim 1 above, however Berman does not teach “wherein the conduit comprises a detachable endpiece that has the second end”.
Morton is within a related field of endeavor because it involves a disposable patient interface with a flexible tubular distal member for contacting a patient (see [Abstract]), particularly the breast (see [0051]).
Morton teaches “wherein the conduit comprises a detachable endpiece that has the second end” (“The housing 22 is provided with a patient or breast interface 24, which can either be permanently attached to the housing 22 or removably attached such as for cleaning or disposal. Breast interface 24 has a proximal end 26, a distal end 28 and a body 30 extending therebetween. The interface 24 has a tissue contacting surface 32 defining a first concavity 34 for receiving a breast and a second concavity 38 for receiving a nipple” [0051]. This breast interface 24 is shown in FIG. 1. Therefore, since the breast interface 24 (i.e. containing tissue contacting surface 32) can be removably attached to the housing 22, and includes a distal end 28 (i.e. second end), the breast interface 24 constitutes a conduit which comprises a detachable endpiece that has the second end (i.e. distal end 28).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the conduit of Berman such that is comprises a detachable endpiece (i.e. that has the second end) as disclosed in Morton in order to allow the conduit to be cleaned or disposed of between patients. In order to ensure sanitary conditions for each patient, it is important to be able to clean or dispose of a component which has directly attached to a patient. Modifying the conduit of Berman such that the conduit comprises a detachable endpiece (i.e. breast interface 24) as disclosed in Morton would yield the predictable result of allowing the conduit to be effectively cleaned between patients in order to provide sanitary conditions to each patient.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” as applied to claim 1 above, and further in view of Young et al. US 6,419,636 B1 “Young”.
Regarding claim 9, Berman discloses all features of the claimed invention as discussed with respect to claim 1 above, however “wherein the conduit terminates in at least one flap by which the second end of the conduit is divided into two or more segments that are sealable together”.
Young is within the same field of endeavor as the claimed invention because it involves a system for thermometry based assessment of a patient’s breast(s) (see [Abstract]).
Young teaches “wherein the conduit terminates in at least one flap by which the second end of the conduit is divided into two or more segments that are sealable together” (“FIG. 12, is a diagrammatic perspective view indicating the principal elements of the system of the new and most preferred embodiment of the instant invention” [Column 24, Lines 1-3]; “The dispositions on flexible breast accommodating frustrum structures 500 and 510, of folded flap closures 604; 608 and 606; 610, forming securing means for elasticated transverse anterior straps 588 and 590, and the geometry of mutual permanent attachments 592 and 594, between these straps, are selected to optimize contact between frustrum contactor pads 328 and 330 and the subject’s breasts” [Column 38, Lines 1-7]. As shown in FIG. 12, the flap closures 604, 608, 606 and 610 provide connection between the straps 588 and 590 which contact the subject’s breasts through the connector pads 328, 330. In this case, the device shown in FIG. 12, represents a conduit which terminates in at least one flap (i.e. straps 588, 590) by which the second end of the conduit is divided into two or more segments that are sealable together (i.e. via the flap closures 604, 606, 608 and 610).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the conduit of Berman such that it terminates in at least one flap by which the second end of the conduit is divided into two or more segments that are sealable together as disclosed in Young in order to optimize contact with a patient’s breast (see Young: [Column 38, Lines 1-7]). Utilizing straps (i.e. flaps) that are sealable together via flap closures (i.e. 604, 606, 608 and 610 in Young) is one of a finite number of techniques which can be used to secure a device to a patient with a reasonable expectation of success. Modifying the conduit of Berman to include at least one flap (i.e. straps 588 and 590 of Young, for example), by which the second end of the conduit is divided into two or more segments that are sealable together (i.e. via flap closures 604, 606, 608, 610 of Young, for example), would yield the predictable result of securing and optimizing contact with a patient’s breast.
Claim(s) 10-11, 14-15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” and further in view of Schilling et al. US 2010/0080345 A1 “Schilling”.
Regarding claim 10, Berman teaches “A system for infrared analysis of a target surface region of a subject, the system comprising:” (See FIG. 1 and “On the right hand side of FIG. 1 we see an inventive IR-imaging means 5, preferably also having an infrared lens 5A looking leftward at breast 1 with a cone-shaped or rectangular field-of-view generally defined by phantom lines such as lines 5B. It will be noted that the inventive IR camera or imaging device 5/5A includes or is communicative with a CPU or calculation means and a GUI or graphical user interface situated in schematic function block 6A as well as with some memory and a data bus shown situated in functional block 6B” [0047]; “The invention here offers advancements in two areas, both of which can help thermography. The first is improvements to the mid-IR thermography technique itself and the second is near-IR or NIR plus MIR imaging wherein both data or image types are co-analyzed to sort tumors from normal tissues and vasculature” [0015]. In this case, the inventive IR camera (i.e. imaging device 5/5A) depicted in FIG. 1, is used to obtain the near-IR and MIR imaging data and the CPU (i.e. processor) is used to perform the analysis to sort tumors from normal tissues and vasculature (see [0015]). Therefore, FIG. 1 depicts a system for infrared analysis of a target surface region of a subject.);
“a reservoir containing a medium at a predetermined temperature” (“There are several ways to utilize a plate or IR window to heat or cool tissue or to temperature control tissue on which it is laid or held in very close proximity. We prefer physical contact, but include proximity placement to tissue wherein any gap […] For cooling of the breast using such a plate or window, it is desirable not to condense water vapor in the optical path, so we expressly include in the scope of the invention the use of a thermal insulation and or dry gas in, on or around the plate to prevent this” [0038]. In order to deliver a dry gas to the breast to cool it, a reservoir containing a medium at a predetermined temperature, must be present.);
“a canopy that is deployable above and at least partially surrounding the target surface region, the canopy having an inlet that is attached to an outlet of the reservoir […]” (See [0038] above and “The second embodiment is essentially the use of a preferably IR (MIR and/or NIR) transmissive or transparent window that can be IR-imaged through while it is also utilized to distort, shear or compress the breast. The preference is to have the window be IR transparent such that IR imaging can be performed while the tissue is distorted. […] As described earlier, the window may be flat, curved, rigid or flexible. It may be applied and/or held on the tissue by the clinician’s hand, the patient’s hand, by straps, clamps or actuator arms, or by suction or adhesive” [0077]. In this case, since the transmissive or transparent window (i.e. IR window), is flexible and is applied/held on the tissue and the dry gas is delivered via the IR window to cool the breast (see [0038]), the transmissive or transparent window represents a conduit having a first end that is attached to an outlet of the reservoir and a second end that is flexibly conformable to a shape corresponding to a perimeter of the target surface region and a canopy that is deployable above and at least partially surrounding the target surface region.);
“an infrared camera operable to capture infrared image data of the target surface region” (Claims 1 and 10) (See [0047] above. Therefore the system includes an infrared camera operable to capture infrared image data of the target surface region.); and
“one or more processors operable to produce a representation of the captured infrared image data at a plurality of timings relative to the transmission of the medium from the reservoir to the target surface region” (See CPU in FIG. 1 and “As a specific example, we could gather mid-IR surface images and near-IR penetrating images of the same region, say the region shown in FIGS. 2A-2B. From these two images, one can recognize that one has a “point” heat source (the tumor) superimposed on a linear heat source (the lumen). From having near-IR images at an angle or at multiple angles, it can be ascertained in the near-IR that the tumor underlies the lumen, if that is not already obvious to the clinician” [0112]. In order to obtain both mid-IR surface images and near-IR penetrating images, the infrared camera must emit IR light at two different wavelengths, these wavelengths being emitted at different times (i.e. a plurality of times). Furthermore, in order to apply near-IR images at multiple angles, the infrared image data must be captured at a plurality of timings.).
Berman does not teach the canopy as “having a plurality of outlets spaced apart from each other on an underside of the canopy”, or “the canopy defining a plurality of channels for transmitting the medium from the reservoir to the target surface region via the inlet and the plurality of outlets”.
Schilling is within a related field of endeavor to the claimed invention because it involves a device for locating a breast (see [Abstract]).
Schilling is within a related field of endeavor to the claimed invention because it involves a device for locating a breast (see [Abstract]).
Schilling teaches the canopy as “having a plurality of outlets are spaced apart from each other on an underside of the canopy” and “the canopy defining a plurality of channels for transmitting the medium from the reservoir to the target surface region via the inlet and the plurality of outlets” (“Referring to FIGS. 1 and 7, air is drawn off from an inner space of the cup 40 through at least one suction channel 45 incorporated, e.g., within a reinforcing rib 44. Drawing air off from the inner space holds the locating device firmly against the breast and causes the breast to exactly conform to the shape of the up of the locating device. In some embodiments, a plurality of suction channels and corresponding openings may be provided to increase suction” [0023]. In this case, the examiner is interpreting the outer surface of the cup 40 (i.e. canopy) to be the upper side of the canopy, and the inner space of the cup 40 (i.e. canopy) to be the underside of the canopy. As shown in FIG. 1, for example, the plurality of suction channels 45 (i.e. and their corresponding openings) are spaced apart from each other and are located within the inner space of the cup 40 (i.e. canopy). Therefore, the system includes a plurality of outlets (i.e. corresponding to the suction channels 45) which are spaced apart from each other on an underside of the canopy and the canopy defines a plurality of channels (i.e. suction channels 45) for transmitting the medium from the reservoir to the target surface region (i.e. the breast) via the inlet (i.e. tubing connector 43, see FIG. 1) and the plurality of outlets (i.e. openings).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the canopy of Berman so as to include a plurality of outlets spaced apart from each other on an underside of the canopy as disclosed in Schilling in order to allow for more uniform distribution of the medium through the canopy. By including multiple outlets within the canopy each at different locations, the air (i.e. medium) being directed to the breast tissue located within the canopy can be more evenly distributed so as to provide cooling, suction or the like. Therefore, modifying the canopy of Berman to include a plurality of outlets (i.e. suction channels 45 and their corresponding outlets) as disclosed in Schilling would yield the predictable result of distributing the medium to the tissue surface of the subject being examined.
Regarding claim 11, Berman in view of Schilling discloses all features of the claimed invention as discussed with respect to claim 10 above, and Berman further teaches “wherein the medium is a gas” (see [0038] as discussed with respect to claim 1 above. Therefore, the reservoir (i.e. inherently present) contains a medium that is a gas.).
Regarding claim 14, Berman in view of Schilling discloses all features of the claimed invention as discussed with respect to claim 10 above, and Berman further teaches “wherein the canopy is infrared transparent” (“The second embodiment is essentially the use of a preferably IR (MIR and/or NIR) transmissive or transparent window that can be IR-imaged through while it is also utilized to distort, shear or compress the breast. The preference is to have the window be IR transparent such that IR imaging can be performed while the tissue is distorted” [0077]. Therefore, since the IR window is a transparent such that IR imaging can be performed while the tissue is distorted, the conduit (i.e. IR window) is infrared transparent.).
Regarding claim 15, Berman in view of Schilling discloses all features of the claimed invention as discussed with respect to claim 10 above, and Schilling further teaches “wherein the canopy comprises a plurality of directable vents each of which is arranged to direct the medium exiting from a corresponding one of the plurality of outlets” (“In one embodiment, a vacuum system is provided for conforming a breast to the shape of the locating device. […] When air is extracted from the inner space of the locating device (e.g., by means of suction channels 45), the breast conforms exactly to the shape of the locating device, and the locating device is held firmly against the breast. In one embodiment, the locating device may be provided with a multitude of suction channels 45 and air exit openings through which air can pass from the inside of the locating device into the suction channels” [0040]. In this case, the opening (i.e. inner space) of the cup 40 (see FIG. 1), represents the conduit. Furthermore, since air exits the opening (i.e. conduit) through the air exit openings (i.e. vents) and into the suction channels 45, the system includes a conduit with one or more vents allowing the medium (i.e. air) to pass from the channel (i.e. tubing connector 43/inside the opening), to outside the conduit (i.e. and into the suction channels.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Berman such that the conduit includes one or more vents (i.e. air exit openings) as disclosed in Schillings in order to allow the conduit to conform exactly to the shape of the breast (see Schilling: [0040]). In this case, by allowing the medium to pass outside of the conduit, the breast can be held more firmly against the breast. Therefore, modifying the conduit of Schilling to include one or more vents (i.e. air exit openings) as disclosed in Schillings would yield the predictable result of ensuring firm contact between the conduit and the surface of the breast.
Regarding claim 17, Berman in view of Schilling discloses all features of the claimed invention as discussed with respect to claim 10 above, and Berman further teaches “wherein the canopy comprises a flexible drape” (“The second embodiment is essentially the use of a preferably IR (MIR and/or NIR) transmissive or transparent window that can be IR-imaged through while it is also utilized to distort, shear or compress the breast. […] As described earlier, the window may be flat, curved, rigid or flexible. It may be applied and/or held on the tissue by the clinician’s hand, the patient’s hand, by straps, clamps or actuator arms, or by suction or adhesive” [0077]. Therefore, since the IR transmissive window (i.e. canopy) may be flexible to compress the breast, the IR transmissive window represents a flexible drape.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” and Schilling et al. US 2010/0080345 A1 “Schilling” as applied to claim 10 above, and further in view of McKinney et al. US 2018/0303406 A1 “McKinney”.
Regarding claim 12, Berman in view of Schilling discloses all features of the claimed invention as discussed with respect to claim 10 above, and Berman further teaches “to drive the medium from the reservoir to the target surface region via the conduit” (see [0038] and [0077] as discussed with respect to claim 1 above.).
However, the combination does not teach that the system “further comprising a fan” which is operable to drive the medium from the reservoir to the target surface region via the conduit.
McKinney is within a related field of endeavor to the claimed invention because it involves systems for characterizing skin type including an illumination source (see [Abstract]).
McKinney further teaches “a fan” which is operable to drive the medium from the reservoir to the target surface region via the conduit (“Referring now to FIG. 7, the refrigeration unit 501 can also include a compressor 701, a condenser 703, and an evaporator (not shown). The refrigeration unit 501 can provide forced convection cooling of the condenser 703 through a plenum 705 using a fan 707” [0086]; “In some embodiments, the coolant can be directed to a coolant inlet 503a of a heat exchanger 503, flowed through the heat exchanger 503, and exited from the heat exchanger 503 via coolant outlet 503b. The heat exchanger 503 can be any suitable device for cooling air or other gases driven through the heat exchanger 503 via gas inlet 505a and exited via gas outlet 505b. The air or gas flowing in the heat exchanger 503, in some embodiments, can be used for cooling the skin of a patient during a procedure. For example, in some embodiments, the air or gas can cool the patient skin to a target temperature in the range of 15 to 20°C via a gas impingement cooling of the skin during the procedure in order to maintain a therapeutically acceptable temperature range” [0087]; “In some embodiments, the air or gas can be driven through the heat exchanger 503 by a pump 507. The pump 507, in some embodiments, can be any suitable device capable of driving the gas through the heat exchanger 503 and onward to a jet impingement nozzle (not shown)” [0088]. As shown in FIG. 5, the refrigeration unit 501 is connected to the heat exchanger 503 via the coolant inlet 503a. Furthermore, FIG. 7 shows that fan 707 is within the refrigeration unit 501.
In this case, the examiner is interpreting a fan to be any device capable of moving air (i.e. a gas) from one location to another. Since the pump 507 of McKinney is any suitable device capable of driving the gas through the heat exchanger 503, under broadest reasonable interpretation, the pump 507 represents a fan. Therefore, since the heat exchanger 503 receives coolant from a coolant inlet 503a (i.e. connected to the refrigeration unit 501) and includes a pump 507 which is any device capable of driving the gas through the heat exchanger 503, the system includes a fan operable to drive the medium from the reservoir (i.e. refrigeration unit 501, for example), to the target surface region (i.e. via the conduit/transparent window of Berman, for example.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Berman so as to include a fan (i.e. pump 507) as disclosed in McKinney in order to effectively direct air to a patient’s skin, such that it is maintained within a target temperature in the range of 15 to 20°C via a gas impingement cooling of the skin during the procedure (see McKinney: [0088]). A fan/pump is one of a finite number of devices which can be used to direct the flow of air/gas with a reasonable expectation of success. Therefore, modifying the system of Berman such that it includes a fan (i.e. pump 507) as disclosed in McKinney would yield the predictable result of directing air to the target region of a patient’s skin to perform cooling during a procedure.
Regarding claim 13, Berman in view of Schilling discloses all features of the claimed invention as discussed with respect to claim 10 above, however the combination does not teach “wherein the predetermined temperature is less than 35°C”.
McKinney teaches “wherein the predetermined temperature is less than 35°C” (“In some embodiments, the coolant can be directed to a coolant inlet 503a of a heat exchanger 503, flowed through the heat exchanger 503, and exited from the heat exchanger 503 via coolant outlet 503b. The heat exchanger 503 can be any suitable device for cooling air or other gases driven through the heat exchanger 503 via gas inlet 505a and exited via gas outlet 505b. The air or gas flowing in the heat exchanger 503, in some embodiments, can be used for cooling the skin of a patient during a procedure. For example, in some embodiments, the air or gas can cool the patient skin to a target temperature in the range of 15 to 20°C via a gas impingement cooling of the skin during the procedure in order to maintain a therapeutically acceptable temperature range” [0087]. In this case, in order for the gas impinging on the skin to cause the skin to be within the range of 15 to 20°C, the gas in the reservoir must be maintained at a predetermined temperature which is less than 35°C.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Berman such that the medium in the reservoir is at a predetermined temperature, which is less than 35°C as disclosed in McKinney in order to effectively direct air to a patient’s skin, such that the skin is maintained within a target temperature in the range of 15 to 20°C during the procedure (see McKinney: [0088]). When the medium (i.e. gas) is less than 35°C, this gas can provide a cooling effect. By directing air to the skin of the patient with a predetermined temperature of less than 35°C the skin can be cooled and maintained within a therapeutically acceptable temperature range. Therefore, modifying the medium of Berman to be at a predetermined temperature of less than 35°C as disclosed in McKinney in order to maintain the skin at a therapeutic acceptable temperature range during a procedure (see McKinney: [0087]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” and Schilling et al. US 2010/0080345 A1 “Schilling” as applied to claim 10 above, and further in view of Angott et el. US 2014/0276091 A1 “Angott”.
Regarding claim 16, Berman in view of Shilling discloses all features of the claimed invention as discussed with respect to claim 10 above, however, the combination does not teach “wherein the canopy comprises a top panel and two side panels, the two side panels hinged to the top panel at opposite sides thereof”.
Angott is within the same field of endeavor as the claimed invention because it involves a diagnostic assembly for detecting a presence of cancer in a breast of a patient (see [Abstract]).
Angott teaches “wherein the canopy comprises a top panel and two side panels, the two side panels hinged to the top panel at opposite sides thereof” (“In the first enabling embodiment of the diagnostic assembly 20, as best presented in FIG. 1, the frame 22 further includes a top 84, a front wall 86, a rear wall 88, and the pair of sidewalls 30. The track 36 includes a pair of tracks 36 that each extend along one of the sidewalls 30 between the top 84 and the base 28 of the frame 22” [0034]; “The frame 22 defines a chamber 96 between the top 84, base 28, front wall 86, rear wall 88 and sidewalls 30. […] The top 84 further defines an opening 100 that extends to the chamber 96 for receiving the breasts of the patient” [0036]. As shown in FIG. 1, the top 84 includes an opening 96 to which the breast is input. The sidewalls 30 extend from the top 84. Since the diagnostic assembly 20 covers the breast when it is placed inside, under broadest reasonable interpretation, the diagnostic assembly represents a canopy. Therefore, the canopy comprises a top panel and two side panels, the two side panels hinged to the top panel at opposite sides thereof.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the canopy of Berman such that is comprises a top panel and two side, panels, the two side panels hinged to the top panel at opposite sides thereof as disclosed in Angott in order to ensure that the canopy encompasses the breast. Forming a canopy/housing with a top and side panels is one of a finite number of techniques which can be used to create a device to conform to the shape of an object with a reasonable expectation of success. Modifying the canopy of Berman to include the top panel and two sides as disclosed in Angott would yield the predictable result of creating a device to which the breast can be inserted for analysis thereof.
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” and further in view of Parsons et al. US 6,757,412 B1 “Parsons”.
Regarding claim 18 , Berman teaches “A method of conducting infrared analysis of a target surface region of a subject, the method comprising:” (“The present inventors herein provide a new apparatus and methods to further improve the performance of breast IR imaging, and indeed of any IR-imaging technique used to image any type of subsurface defect in any type of target anatomy or object” [0028]. The examiner notes that the system for performing this method is described in paragraphs [0015] and [0047] and in FIG. 1 of Berman (see claim 1 above) Therefore, Berman describes a method of conducting infrared analysis of a target surface region of a subject.);
“providing a reservoir containing a medium at a predetermined temperature” (“There are several ways to utilize a plate or IR window to heat or cool tissue or to temperature control tissue on which it is laid or held in very close proximity. We prefer physical contact, but include proximity placement to tissue wherein any gap […] For cooling of the breast using such a plate or window, it is desirable not to condense water vapor in the optical path, so we expressly include in the scope of the invention the use of a thermal insulation and or dry gas in, on or around the plate to prevent this” [0038]. In order to deliver a dry gas to the breast when performing cooling, a reservoir containing a medium at a predetermined temperature, must be provided. Thus, the method carried out by the system involves providing a reservoir containing a medium at a predetermined temperature.);
“transmitting the medium from the reservoir to the target surface region” (See [0038] as discussed above. In order to perform cooling of the breast through the use of a dry gas (i.e. medium), the method must transmit the medium from the reservoir (i.e. necessarily present) to the target surface region.);
“capturing infrared image data of the target surface region at a plurality of timings relative to the transmission of the medium from the reservoir to the target surface region […]” and “producing a representation of the captured infrared image data at the plurality of timings” (“On the right hand side of FIG. 1 we see an inventive IR-imaging means 5, preferably also having an infrared lens 5A looking leftward at breast 1 with a cone-shaped or rectangular field-of-view generally defined by phantom lines such as lines 5B. It will be noted that the inventive IR camera or imaging device 5/5A includes or is communicative with a CPU or calculation means and a GUI or graphical user interface situated in schematic function block 6A as well as with some memory and a data bus shown situated in functional block 6B” [0047] and “As a specific example, we could gather mid-IR surface images and near-IR penetrating images of the same region, say the region shown in FIGS. 2A-2B. From these two images, one can recognize that one has a “point” heat source (the tumor) superimposed on a linear heat source (the lumen). From having near-IR images at an angle or at multiple angles, it can be ascertained in the near-IR that the tumor underlies the lumen, if that is not already obvious to the clinician” [0112]. In order to obtain both mid-IR surface images and near-IR penetrating images, the infrared camera 5 (see [0047] must emit IR light at two different wavelengths, these wavelengths being emitted at different times (i.e. a plurality of times). Furthermore, in order to obtain near-IR images at multiple angles, the infrared image data must be captured at a plurality of timings relative to the transmission of the medium from the reservoir to the target surface region. Therefore, the method carried out by the system involves capturing infrared image data of the target surface region at a plurality of timings relative to the transmission of the medium from the reservoir to the target surface region, and producing a representation of the captured infrared image data at the plurality of timings.).
Berman does not teach “the plurality of timings including at least a first timing during the transmission of the medium and a second timing during a recovery phase, the recovery phase being after cessation of the transmission but before the target surface region returns to a pre-transmission temperature”.
Parsons is within the same field of endeavor as the claimed inventor because it involves a system and method for determining a condition of a selected tissue based on a set of thermal images (see [Abstract]).
Parsons teaches that “the plurality of timings including at least a first timing during the transmission of the medium and a second timing during a recovery phase, the recovery phase being after cessation of the transmission but before the target surface region returns to a pre-transmission temperature” (“FIG. 3 illustrates a typical temporal response of a pixel for about 100 image frames of image data. The pixel has a temperature characteristic or profile indicative of the temperature condition for an associated spatial region of the patient’s tissue during the image acquisition time period. Approximately, the first twenty frames were obtained prior to applying the thermal challenge (e.g. step 108 of FIG. 2). The remaining pixel values are from subsequent image frames, which illustrate a cooling response for the corresponding spatial region of tissue” [Column 7, Lines 8-17]; “FIG. 6 is a graphical representation of image data corresponding to an annotated version of the image data shown in FIG. 5” [Column 3, Lines 4-6]; “For example, a differential feature may include T+10, which corresponds to the average differential temperature 10 frames after cooling was initiated (e.g., about 20 seconds); T+50, which corresponds to the average differential temperature 50 frames after cooling was initiated (e.g., about 100 seconds); and final, which corresponds to the average differential temperature at the end of the image acquisition time period. FIG. 6 illustrates the same response as illustrated in FIG. 5, but with simple differential features being indicated” [Column 10, Lines 6-15]; “From step 106, the process proceeds to step 108 in which a thermal challenge is applied to the surface of the tissue sample being images. As shown in FIG. 1, for example, the control circuit 18 activates the source of cooling air 24 to initiate the cooling challenge. […] Referring back to FIG. 2, the process next proceeds to step 110 in which an image frame is acquired during the application of the thermal challenge” [Column 6, Lines 9-27].
As shown in FIG. 2, cooling is applied during the step 108 (i.e. as a distinct step with a beginning and an end). In step 110, thermal images are acquired during the thermal challenge (i.e. the delivery of cooling aid 24, see [Column 6, Lines 9-27] and step 116 involves acquiring more image sets, if the yes path is selected. Therefore, the plurality of timings including at least a first timing during the transmission of the medium (i.e. the first about 20 seconds, shown in FIG. 6) and a second timing during a recovery phase, the recovery phase being after cessation of the transmission but before the target surface region returns to a pre-transmission temperature (i.e. second about 60 seconds).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Berman to include acquiring a plurality of images at a plurality of timings during and after the transmission of the medium (i.e. gas) as disclosed in Parsons in order to monitor the response of the tissue to cooling and thus detect an internal condition such as cancer (see Parsons: [Column 1, Lines 25-31]). Performing imaging during and after a cooling process is one of a finite number of techniques which can be used to identify regions of higher temperature which are indicative of the potential tumor tissue. Therefore, modifying the method of Berman to acquiring images during and after a cooling process as disclosed in Parsons would yield the predictable result of identifying areas of tumor tissue within the breast of the patient.
Regarding claim 20, Berman in view of Parsons discloses all features of the claimed invention as discussed with respect to claim 18 above, and Berman further teaches “wherein the target surface region comprises only one of the subject’s breast” (“FIG. 1 depicts a sectional view of a human breast containing subsurface tumors, near-surface tumors as well as near-surface and subsurface vasculature, wherein an embodiment of the inventive infrared imaging apparatus is depicted imaging the breast while an external heat-flow is introduced along with an external deformation force” [0023]. Therefore, since the infrared imaging apparatus is depicted as imaging the breast (i.e. one breast), the target surface region comprises only one of the subject’s breast.).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berman et al. US 2007/0213617 A1 “Berman” and further in view of Parsons et al. US 6,757,412 B1 “Parsons” as applied to claim 18 above, and further in view of Angott et el. US 2014/0276091 A1 “Angott”.
Regarding claim 19, Berman in view of Parsons discloses all features of the claimed invention as discussed with respect to claim 18 above, however, the combination does not teach “wherein the target surface region comprises both of the subject’s breasts”.
Angott is within the same field of endeavor as the claimed invention because it involves a diagnostic assembly for detecting a presence of cancer in a breast of a patient (see [Abstract]).
Angott teaches “wherein the target surface region comprises both of the subject’s breasts” (“The top 84 further defines an opening 100 that extends to the chamber 96 for receiving the breasts of the patient. The thermographic camera mechanism (not expressly shown) is disposed inside the frame 22” [0036], Therefore, the opening 100 is configured to receive both breasts of the subject, such that the thermographic camera can take images of them. Therefore, the target surface region comprises both of the subject’s breasts.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Berman in view of Parsons so as to include the target surface region comprises both of the subject’s breasts as disclosed in Angott in order to assess both breasts for identifying areas of abnormality (i.e. tumors, for example, see Angott: [0005]) within each breast. Modifying the method of Berman in view of Parsons such that both of the subject’s breasts are imaged as discussed in Angott would yield the predictable result of imaging both breasts such that tumors can be identified therein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Neelakanta et al. US 2014/0336502 A1 “Neelakanta” is pertinent to the applicant’s disclosure because it discloses “According to an embodiment herein, the positioning assembly positrons the infrared imaging system and the X-ray imaging system at a same coordinate point to acquire an image of both a right breast and a left breast of a patient for comparison” [0029].
Any inquiry concerning this communication or earlier communications from the examiner Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SEBASTIAN whose telephone number is (571)272-6190. The examiner can normally be reached Mon.- Fri. 7:30-4:30 (Alternate Fridays Off).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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