B 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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the lid or second substrate as now claimed must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “12” has been used to designate a lid, a substrate and a second substrate. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 45-54 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claims 45 and 48, the examiner is unclear how the lid or a second substrate is bonded to the substrate to define a flow channel. The examiner notes that this appears disclosed in figure 9, however figure 9 shows a stamp, not a lid. This is a compounding issue as noted above as applicant labels the lid, the substrate and the second substrate all as 12. As such it is entirely unclear as to what form the lid/second substrate take. How it interfaces with what the examiner will assume is the substrate 12. For example since applicant has just claimed a second substrate, it is assumed the second substrate could potentially be in the same form as the first substrate 12 actually shown. However, this would not make sense as it would interfere with any primers 36 as shown in figure 10. So again it is unclear as to how in any manner the lid/second substrate are geometrically formed or configured to interface with the actual substrate 12 shown in the figures. As such the examiner will interpret for examination that any material design of layer will read on the noted limitations. The examiner notes that the only reason a 112(a) enablement rejection was not written at this time is the idea of a lid itself is known, and therefore cannot meet the bar of the Wands factors. Claims 46-47 and 49-54 are likewise rejected for the dependency on instant claims 45 and 48.
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.
Claim(s) 45 and 46, are rejected under 35 U.S.C. 103 as being unpatentable over Amorese (U.S. Patent No. 2004/0126766 A1) in view of Kim et al. (U.S. Patent No. 7,794,799 B1) further in view of Huff et al (US PGPub. No. 2018/126381 A1).
As to claim 45 and 48, Amorese discloses and shows in figures 1-2. a flow cell, comprising ([0056], ll. 1-9):
a substrate (106) ([0046], ll. 1-5);
a plurality of sub-sets (any two squares defined by zones 124), each of the plurality of sub-sets including ([0048], ll. 8-13):
a plurality of nano-pads positioned on the substrate (110, where again applicant has defined nano to encompass micro, as such the pads being 1µ wide clearly discloses the noted feature) ([0040], ll. 1-17; [0046], ll. 1-7); and
interstitial regions (area around and between array 110 and barrier 122/120) of exposed surface portions of the substrate separating individual nano-pads of the plurality of nano-pads ([0048], ll. 1-4); and
a hydrophobic barrier (120/122) defining a perimeter around each sub-set of the plurality of sub-sets, the hydrophobic barrier including a hydrophobic material having a top surface that is at least substantially co-planar with a top surface of the nano-pads (i.e. where the bottom surfaces of pads 110 and barrier 120 are coplanar where they contact substrate 106, the examiner notes that the term top/bottom are merely a function of frame of reference, and obviously if the image of figure 1-2 were simply rotated 180 degrees 110 and 120 could be said to be top surface) ([0051], ll. 1-5).
where each of the nano-pads having a thickness less than about 2 µm ([0040], ll. 1-17; where if the width is 1µm then clearly based on the relative size shown in figure 2, the pads would been less than 2 µm thick)
wherein the substrate and the hydrophobic material are different materials ([0047], ll. 1-5; [0051], ll. 1-9; glass vs any of the disclosed chemical barriers that make barrier 120 hydrophobic, these were incorporated by reference via Brennan U.S. Pat No. 6,210,894)
Amorese does not explicitly disclose where the nano-pads are a gel material.
However, Kim does disclose in (col. 5, ll. 3-15) the use of gel based hydrophilic binding sites as preferable.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the nano-pads to be made of a gel material in order to provide the advantage of expected results and increased versatility in using such binding sites one can obviously perform a DNA based reaction for analysis, while also using an incredibly common binding site material (i.e. gel), and in being hydrophilic will attract any sample under test.
Amorese does disclose the use of a lid (240-) or a second substrate bonded to the substrate ([0064], ll. 11-16).
Amorese in view of Kim does not explicitly disclose a flow channel defined between the substrate and the lid or the second substrate, or where the sub-sets are in fluid communication with the flow channel or where the exposed surface portions are exposed to the flow channel.
However, Huff does disclose and show in figure 5, and in ([0272], ll. 1-19) the basic concept of creating a “flow cell”(i.e. an within which fluid flows such as droplets 62) via the use of an extremely basic concept of a lid (52) over another substrate (54) which also contains wells (59) similar to the primary reference. This configuration would obviously result in the exposed surface portions being exposed to the flow channel as explicitly shown in figure 5 of Huff.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Amorese in view of Kim with a flow channel defined between the substrate and the lid or the second substrate, or where the sub-sets are in fluid communication with the flow channel or where the exposed surface portions are exposed to the flow channel in order to provide the advantage of expected results in using a lid to provide a flow path obviously one can flood a plurality of wells in a more rapid manner for higher sample analysis throughput.
Claim(s) 45-46, and 48-52 are rejected under 35 U.S.C. 103 as being unpatentable over Mirzabekov (U.S. Patent No. 5,905,024) in view of Huff et al (US PGPub. No. 2018/126381 A1).
As to claim 45, Mirzabekov discloses and shows in figures 1, 12(a) and 14, a flow cell, comprising (Abstract; where the examiner is interpreting the device of Mirzabekov can be said to be a flow cell in having the same claimed structures):
a substrate (50) (col.. 11, ll. 45-47);
a plurality of sub-sets (explicitly labeled in figure 12a below), each of the plurality of sub-sets including:
a plurality of pads (18) of a gel material positioned on the substrate (col. 12, ll. 28-34; where the examiner notes that said pads are explicitly shown on substrate 50 on figures 12 and 14);
interstitial regions (labeled in figure 12a below, specifically the examiner is interpreting the surface of substrate 50, between the gel pads 18 as an interstitial region, further obviously simply the area between the pads could be interpreted as an interstitial region) of exposed surface portions (without any limitation on what they are exposed to, the examiner is interpreting that the interstitial regions are exposed to the hydrophobic barrier during coating) the substrate separating individual nano-pads of the plurality of nano-pads (col. 11, ll. 26-28); and
a hydrophobic barrier defining a perimeter around each sub-set of the plurality of sub-sets, the hydrophobic barrier(12) including a hydrophobic material having a top surface that is at least substantially co-planar with a top surface of the pads (explicitly shown in figure 12) and ii) positioned to define a hydrophobic barrier around each of the plurality of sub-sets (clearly one can take almost any two sets of pads 18 and as shown there are hydrophobic material layers 12 around them in figure 12) (col. 11, ll. 27-33; col. 12, ll. 47-51; the examiner notes that whether the form is an intermediate form of the microfluidic device or final form, it still provides a teaching of said layer as claimed. Further the examiner notes for compact prosecution that even the final form explicitly also teaches in a different interpretation the hydrophobic material layer. Specifically in (col. 12, ll. 47-51) it is also disclosed that a layer of Repel-Silan (i.e. hydrophobic layer) is applied to the substrate, inherently the surface of the layer applied that contacts substrate 50, is exactly co-planer with the surface of pads 18 that also contact the substrate 50, the examiner notes that the term top/bottom are merely a function of frame of reference, and obviously if the image of figure 1-2 were simply rotated 180 degrees 110 and 120 could be said to be top surface).
Mirzabekov does not explicitly disclose the scale of nano-pads.
However, Mirzabekov does disclose in (col. 11, ll. 38-42) that the spacers shown in figure 12 are 20 mu.m. Where the examiner notes that applicant explicitly defines the nano-pads as having sizes into the micrometer range, as such they are not strictly limited to nano-scale sizes. Further clearly if the spacers are 20 mu.m. as shown in figure 12, the gel pads 18 are on a similar scale. It would have been obvious to one ordinary skill in the art at the time the invention was made to use a pad in the “nano” scale range. Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mirzabekov where the scale of the pads are “nano” scale or similar in order to provide the advantage of increased efficiency and expected results in shrinking the pads down to as small as possible while still being able to take valid measurement one can obviously provide a smaller overall device size and lower the cost of manufacturing with less materials.
Mirzabekov does disclose the use of a lid (44-) or a second substrate bonded to the substrate (col. 11, 26-28).
Mirzabekov does not explicitly disclose a flow channel defined between the substrate and the lid or the second substrate, or where the sub-sets are in fluid communication with the flow channel or where the exposed surface portions are exposed to the flow channel.
However, Huff does disclose and show in figure 5, and in ([0272], ll. 1-19) the basic concept of creating a “flow cell”(i.e. an within which fluid flows such as droplets 62) via the use of an extremely basic concept of a lid (52) over another substrate (54) which also contains wells (59) similar to the primary reference. Mirzabekov discloses wells as 13, but also fluid pockets 12 essentially function as well when combined with a lid. This configuration would obviously result in the exposed surface portions being exposed to the flow channel as explicitly shown in figure 5 of Huff.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mirzabekov with a flow channel defined between the substrate and the lid or the second substrate, or where the sub-sets are in fluid communication with the flow channel or where the exposed surface portions are exposed to the flow channel in order to provide the advantage of expected results in using a lid to provide a flow path obviously one can flood a plurality of wells in a more rapid manner for higher sample analysis throughput.
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As to claims 46 and 48 Mirzabekov discloses and shows in figures 1, 12 and 14, a method, comprising:
Forming a plurality of sub-sets (18; where any two of the pads shown in figure 14 can be interpreted as a set) on a substrate (50) each of the plurality of sub-sets including a plurality of nano-pads of a gel (18 labeled in figure 12a above) material positioned on the substate and interstitial regions (labeled in figure 12a below, specifically the examiner is interpreting the surface of substrate 50, between the gel pads 18 as an interstitial region, further obviously simply the area between the pads could be interpreted as an interstitial region) of the substrate separating the plurality of nano-pads (col. 11, ll. 26-28 and ll. 45-47; col. 12, ll. 28-34), and
selectively applying a hydrophobic material (12) on the substrate around each of the plurality of sub-sets (explicitly shown as around in figure 12), thereby forming a hydrophobic barrier i) around each of the plurality of sub-sets, ii) having a top surface that is at least substantially co-planar with a top surface of the nano-pads (this is also explicitly shown in figure 12), wherein the substrate and the hydrophobic material are different materials (i.e. glass for slide 50 vs Repel-Silan for the hydrophobic material 12) (col. 11, ll. 27-33; col. 12, ll. 47-51; the examiner notes that whether the form is an intermediate form of the microfluidic device or final form, it still provides a teaching of said layer as claimed. Further the method does not detail that time at which the layer is applied and/or removed. Further the examiner notes for compact prosecution that even the final form explicitly also teaches in a different interpretation the hydrophobic material layer. Specifically in (col. 12, ll. 47-51) it is also disclosed that a layer of Repel-Silan (i.e. hydrophobic layer) is applied to the substrate, inherently the surface of the layer applied that contacts substrate 50, is exactly co-planer with the surface of pads 18 that also contact the substrate 50, the examiner notes that the term top/bottom are merely a function of frame of reference, and obviously if the image of figure 1-2 were simply rotated 180 degrees 110 and 120 could be said to be top surface).,
Mirzabekov does not explicitly disclose the scale of nano-pads.
However, Mirzabekov does disclose in (col. 11, ll. 38-42) that the spacers shown in figure 12 are 20 mu.m. Where the examiner notes that applicant explicitly defines the nano-pads as having sizes into the micrometer range, as such they are not strictly limited to nano-scale sizes. Further clearly if the spacers are 20 mu.m. as shown in figure 12, the gel pads 18 are on a similar scale. It would have been obvious to one ordinary skill in the art at the time the invention was made to use a pad in the “nano” scale range. Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mirzabekov where the scale of the pads are “nano” scale or similar in order to provide the advantage of increased efficiency and expected results in shrinking the pads down to as small as possible while still being able to take valid measurement one can obviously provide a smaller overall device size and lower the cost of manufacturing with less materials.
Where the nano-pads having a thickness less than about 2 mu.m and further where the hydrophobic layer has a thickness less than about 2 mu.m.
However, Mirzabekov does disclose in (col. 11, ll. 38-42) that the spacers shown in figure 12 are 20 mu.m. Where the examiner notes that applicant explicitly defines the nano-pads and hydrophobic layer as having sizes into the micrometer range, as such they are not strictly limited to nano-scale sizes. Further applicant explicitly states “Other values are also possible”. Since clearly if the spacers are 20 mu.m. as shown in figure 12, the gel pads 18 are on a similar scale, likewise the hydrophobic layer is essentially identical as it is defined by the space size. It would have been obvious to one ordinary skill in the art at the time the invention was made to use a pad and hydrophobic layer in the “nano” scale range. Since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mirzabekov where the nano-pads having a thickness less than about 2 mu.m and further where the hydrophobic layer has a thickness less than about 2 mu.m in order to provide the advantage of increased efficiency and expected results in shrinking the pads/layer down to as small as possible while still being able to take valid measurement one can obviously provide a smaller overall device size and lower the cost of manufacturing with less materials.
Mirzabekov does disclose the use of a lid (44-) or a second substrate bonded to the substrate (col. 11, 26-28).
Mirzabekov does not explicitly disclose a flow channel defined between the substrate and the lid or the second substrate, or where the sub-sets are in fluid communication with the flow channel or where the exposed surface portions are exposed to the flow channel.
However, Huff does disclose and show in figure 5, and in ([0272], ll. 1-19) the basic concept of creating a “flow cell”(i.e. an within which fluid flows such as droplets 62) via the use of an extremely basic concept of a lid (52) over another substrate (54) which also contains wells (59) similar to the primary reference. Mirzabekov discloses wells as 13, but also fluid pockets 12 essentially function as well when combined with a lid. This configuration would obviously result in the exposed surface portions being exposed to the flow channel as explicitly shown in figure 5 of Huff.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mirzabekov with a flow channel defined between the substrate and the lid or the second substrate, or where the sub-sets are in fluid communication with the flow channel or where the exposed surface portions are exposed to the flow channel in order to provide the advantage of expected results in using a lid to provide a flow path obviously one can flood a plurality of wells in a more rapid manner for higher sample analysis throughput.
As to claim 49, Mirzabekov discloses a method, wherein the selectively applying of the hydrophobic material involves transferring the hydrophobic material in a pattern of the hydrophobic barrier to the substrate (i.e. the pattern being the areas between the gel pads shown as “B” in figure 14) (col. 12, ll. 47-53).
As to claim 50, Mirzabekov discloses a method, wherein the selectively applying of the hydrophobic material involves printing the hydrophobic material in a pattern of the hydrophobic barrier to the substrate (where the examiner is interpreting photolithography as a form of printing which as disclosed helps in part define the hydrophobic area 12) (col. 11, ll. 26-44; and ll. 53-67).
As to claim 51, Mirzabekov discloses a method as defined in claim 48, wherein the selectively applying of the hydrophobic material involves: applying a mask material on the plurality of nano-pads, thereby defining a pattern for the hydrophobic barrier; applying the hydrophobic material according to the pattern, thereby forming the hydrophobic barrier; and removing the mask material (in that it is disassembled) (col. 11, ll. 26-44; and ll. 53-67; col. 12, ll. 28-32).
As to claim 52, Mirzabekov discloses a method, wherein the forming of the plurality of nano-pads involves: applying a gel material on a surface of the substrate; disposing a mask material on the gel material; forming spaces in the mask material and the gel material; and removing the mask material (in that it is disassembled) (col. 11, ll. 27-29; and ll. 53-67; col. 12, ll. 28-32).
Claim(s) 47 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Mirzabekov in view of Huff et al further in view of Lin et al. (U.S. PGPub No. 2012/0316086 A1).
As to claims 47 and 53, Mirzabekov in view of Huff does not explicitly disclose a flow cell, further comprising a plurality of each of two different primers attached to each of the nano-pads.
However, Lin does disclose in ([0073], ll. 9-23) that it is well known to attach either one or more primer types can be applied to a gel in a flow cell to allow for amplification of varying nucleic acids.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mirzabekov in view of Huff with a flow cell, further comprising a plurality of each of two different primers attached to each of the nano-pads in order to provide the advantage of increased versatility, as obviously using on or more primers is commonly known and a simple manner of design choice, but further in doing so one can amplify either one or a plurality of nucleic acids for analysis on the microfluidic chip under inspection.
Claim(s) 54 is rejected under 35 U.S.C. 103 as being unpatentable over Mirzabekov in view of Huff et al further in view of Schieber et al. (U.S. PGPub No. 2016/0126151 A1).
As to claim 54, Mirzabekov does disclose a flow cell, wherein: the substrate is selected from the group consisting of epoxy siloxane, glass, an acrylic, polystyrene, a copolymer of styrene, polypropylene, polyethylene, polybutylene, a polyurethane, a cyclic olefin, a polyimide, silica, fused silica, aluminum silicate, silicon, boron doped p+ silicon, silicon nitride, tantalum pentoxide and hafnium oxide (substrate 50 is defined as glass) (col. 11, ll. 45-47);
Mirzabekov does disclose a hydrophobic layer both as Repel-Silan and Teflon for spacers 48 (col. 11, ll. 33-42).
Mirzabekov in view of Huff does not explicitly disclose where the layer 12 is selected from the group consisting of an amorphous fluoropolymer, polytetrafluoroethylene, parylen, a fluorinated hydrocarbon, a fluoroacrylic copolymer, a fluorosilane, a plasma-deposited fluorocarbon, polydimethylsiloxane, and mixture thereof.
However, the examiner firstly takes Official notice that polytetrafluoroethylene (i.e. Teflon) is one of the most common and well-known hydrophobic layers available and as already noted can be used in Mirzabekov for the spacers, could also be used for layer 12 as it is both widely available and an obvious choice. Further the examiner has provided evidenced to this being one obvious design choice with Schieber ([0013], ll. 9-16) that using a Teflon layer in a fluidic chip is well-known to provide a hydrophobic layer.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mirzabekov in view of Huff where the layer 12 is selected from the group consisting of an amorphous fluoropolymer, polytetrafluoroethylene, parylen, a fluorinated hydrocarbon, a fluoroacrylic copolymer, a fluorosilane, a plasma-deposited fluorocarbon, polydimethylsiloxane, and mixture thereof in order to provide the advantage of expected results and reduction in cost as obviously Teflon is both a low cost and widely available material capable of providing a hydrophobic layer where necessary (e.g. layer 12).
Response to Arguments
Applicant’s arguments with respect to the newly amended limitations of claim(s) 45-54 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive.
As to applicant’s argument that Amorese fails to disclose that the hydrophobic barrier forms a barrier around two the microarrays but is not positioned between the two microarrays, the examiner respectfully disagrees. The better image to support this interpretation is figure 1. The examiner has annotated figure 1A below to more clearly show what was being interpreted by the interstitial regions. As the claim only required that “interstitial regions of exposed surface portions of the substrate separating individual nano-pads of the plurality of nano-pads”. The examiner is unclear how Amorese could be seen to fail to teach this limitation, as such the rejection has been maintained.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P LAPAGE whose telephone number is (571)270-3833. The examiner can normally be reached Monday-Friday 8-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached on 571-272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael P LaPage/Primary Examiner, Art Unit 2877