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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP 2020-095666, filed on 06/01/2020.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 01/26/2026 is acknowledged. The traversal is on the ground(s) that the Groups are not distinct from each other. This is not found persuasive because Groups I and II are distinct from each other as being a product and a process of making the product, respectively, which do not inherently require all the same steps and structures (including different methods of fusing) as described in the Restriction Requirement submitted 12/19/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
However, Applicant’s traversal of the Election of Species Requirement was found persuasive, and as such claims 1-17 are being examined in this office action. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/26/2026.
Specification
The disclosure is objected to because of the following informalities: Examiner requests the title of the application be amended to a more descriptive, less generic title, which describes the claimed invention.
Appropriate correction is required.
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 9 and 17 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.
Claim 9 recites the limitation “a longitudinal extent” and claim 17 recites the limitation “an axial extent.” It is unclear from the claims what structure and/or dimensions the “longitudinal extent” and “axial extent” refer to, rendering the limitations indefinite. For the purposes of examination, Examiner interprets these limitations to both mean extending in the direction of the long central axis of the device.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Eberhardt (US 20170340860) in view of Takemoto (US 20200023133).
Regarding claim 1, Eberhardt discloses a catheter comprising: a shaft possessing a distal end and a proximal end (Fig. 2: catheter shaft 360, distal end at the left end, proximal end at the right end surrounded by 310), the shaft being a tubular body that includes a lumen extending from the distal end of the shaft to the proximal end of the shaft (Fig. 2; Figs. 8 and 9 showing lumen extending through), the shaft including a shaft proximal end surface at the proximal end of the shaft (Fig. 5: surface of 360 abutting 323), the lumen opening to the shaft proximal end surface at the proximal end of the shaft (Fig. 5: lumen through 360 seen reaching proximal end), the shaft also possessing a shaft outer surface that is an outer peripheral surface of the tubular body (Fig. 2: outer surface of 360); a hub attached to the proximal end of the shaft (Fig. 2: hub 310); the hub including a tubular accommodation unit that accommodates a portion of the shaft (accommodation unit being the distal portion of the hub 310; para. [0031], sentences 3 and 5; Figs. 3 and 5: 321 and 323), the accommodation unit including a hub melted surface directly fused to the shaft outer surface (para. [0034], sentence 2). Eberhardt fails, however, to also disclose cavities on the accommodation unit or shaft adjacent to that melted surface.
Takemoto teaches an analogous medical device in which a medical instrument (Fig. 4: needle shaft 3) is inserted into a hub (Fig. 4: 3 inserted into hub h) and fused together via heat-welding and a melted surface of the hub (Fig. 4: 45; para. [0039], sentence 3), and the accommodation unit or the shaft including a plurality of cavities at a position adjacent to the hub melted surface (para. [0039], sentences 2-3, the roughened surface of the shaft forming cavity structures into which the melted material flows into). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Eberhardt device by incorporating the plurality of cavities forming a roughened surface of the proximal end of the shaft, as taught by Takemoto, in order to strengthen the bond between the hub and the shaft and form a liquid-tight bond between them (Takemoto: para. [0039], sentences 3-4).
Regarding claim 5, Eberhardt in view of Takemoto teaches the catheter according to claim 1, as described above, wherein the shaft possesses a shaft inner surface (Eberhardt: Fig. 5: inner shaft surface seen along the inner lumen extending through), the plurality of cavities including a plurality of shaft cavities in the shaft (Takemoto: para. [0039], sentences 2-3), the shaft cavities being located closer to the shaft outer surface than the shaft inner surface (Takemoto: para. [0039], sentences 2-3, the roughened surface having the cavities being on the outer surface of the shaft).
Regarding claim 8, Eberhardt in view of Takemoto teaches the catheter according to claim 1, as described above, wherein the hub includes a hub main body (Eberhardt: Fig. 3: main body being the portion surrounding 313) in addition to the tubular accommodation unit (Eberhardt: Fig. 3: accommodation unit being the left portion surrounding 323), the hub main body being connected to and positioned proximal of the tubular accommodation unit (Eberhardt: Fig. 3: main body around 313 is to the right/proximal to the portion surrounding 323), the hub including a lumen that extends throughout both the hub main body and the tubular accommodation unit (Eberhardt: Fig. 3: lumen at 323 and at 313), the lumen in the hub including a first portion in the tubular accommodation unit (Eberhardt: Fig. 3: lumen at 323) and a second portion in the hub (Eberhardt: Fig. 3: lumen at 313), the hub melted surface surrounding the first portion of the lumen (Eberhardt: Fig. 5; para. [0034], sentence 2), the second portion of the lumen possessing an inner diameter less than an inner diameter of the first portion of the lumen (Eberhardt: Fig. 3: distal part of lumen 323 tapering and being narrower than lumen at 323).
Regarding claim 9, Eberhardt in view of Takemoto teaches the catheter according to claim 8, as described above, wherein a proximal end of the first lumen in the tubular accommodation unit terminates in a radially extending adjacent surface (Eberhardt: Figs. 3 and 5: right/proximal end of accommodation unit lumen extending radially from the adjacent surface of the hub main body, i.e., the proximal end of the accommodation unit lumen is radially larger than the distal lumen in the hub main body), the plurality of cavities including a plurality of shaft cavities in the shaft along a longitudinally extending proximal portion of the shaft (Takemoto: para. [0039], sentences 2-3, the roughened surface of the shaft at portion 45 forming cavity structures into which the melted material flows into), the first portion of the lumen possessing a longitudinal extent that extends from the adjacent surface to a distal end of the tubular accommodation unit (Eberhardt: Figs. 3 and 5: the lumen in the accommodation unit at 323/321 extends distally from the proximal end where it meets with 313), the longitudinally extending proximal portion of the shaft at which the shaft cavities are located being shorter than the longitudinal extent of the first portion of the lumen (Takemoto: portion 45 where the textured cavities exist for the heat-welded portion do not extend as distally as the lumen of the hub surrounding it).
Claims 2-4, 6, 7 and 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Eberhardt (US 20170340860) in view of Takemoto (US 20200023133), and further in view of Giraud (CN 101479090).
Regarding claim 2, Eberhardt in view of Takemoto teaches the catheter according to claim 1, as described above, however, Eberhardt in view of Takemoto does not explicitly disclose the structures of the cavities located at both the shaft and the hub.
Giraud teaches an analogous method for fusing two materials together with heat welding, wherein the first material (Fig. A1: 20) has a textured surface comprising a plurality of cavities (Fig. A1: 29) in which the second material (Fig. A1: 22) is melted and flows into the cavities, forming a surface having a plurality of cavities on the second surface as well (Fig. A1: cavities along surface of 22 between protrusions 29). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Eberhardt-Takemoto device by incorporating the specific fusing technique and cavity structures taught by Giraud, in order to create an interlocking fusion between the materials of the shaft and hub which cannot be separated (page 2 of translation, para. [0007], last 5 lines). Following this incorporation of Giraud’s teaching, it directly follows that in the Eberhardt-Takemoto-Giraud device the plurality of cavities includes hub cavities in the hub (seen in the cavities formed in 22 of Giraud upon fusing with and in between the cavities of the first material 20, being that of the shaft), the accommodation unit possessing an outer surface (Eberhardt: Fig. 2: outer surface of 310), the hub cavities being located closer to the hub melted surface of the accommodation unit than the outer surface of the accommodation unit (Giraud: Fig. A1: the cavities of 22 are on located at the inner, fused surface, relating to the melted hub surface of the accommodation unit).
Regarding claim 3, Eberhardt in view of Takemoto in further view of Giraud teaches the catheter according to claim 2, as described above, wherein the shaft possesses a shaft inner surface (Eberhardt: Fig. 5: inner shaft surface seen along the inner lumen extending through), the plurality of cavities including a plurality of shaft cavities provided in the shaft (Takemoto: para. [0039], sentences 2-3), the shaft cavities being located closer to the shaft outer surface than the shaft inner surface (Giraud: Fig. A1: the cavities of 20 are on located at the inner, fused surface, relating to the outer surface of the shaft; Takemoto: para. [0039], sentences 2-3, the roughened surface having the cavities being on the outer surface of the shaft).
Regarding claim 4, Eberhardt in view of Takemoto teaches the catheter according to claim 1, as described above, however, Eberhardt in view of Takemoto does not explicitly disclose the structures of the cavities located at both the shaft and the hub.
Giraud teaches an analogous method for fusing two materials together with heat welding, wherein the first material (Fig. A1: 20) has a textured surface comprising a plurality of cavities (Fig. A1: 29) in which the second material (Fig. A1: 22) is melted and flows into the cavities, forming a surface having a plurality of cavities on the second surface as well (Fig. A1: cavities along surface of 22 between protrusions 29). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Eberhardt-Takemoto device by incorporating the specific fusing technique and cavity structures taught by Giraud, in order to create an interlocking fusion between the materials of the shaft and hub which cannot be separated (page 2 of translation, para. [0007], last 5 lines). Following this incorporation of Giraud’s teaching, it directly follows that in the Eberhardt-Takemoto-Giraud device the plurality of cavities includes cavities in the hub and cavities in the shaft (Giraud: Fig. 1A: the cavities formed in 22 being the hub, upon fusing with and in between the cavities of the first material 20, being that of the shaft), the hub melted surface and a shaft melted surface of the shaft outer surface that is welded to the hub melted surface having irregularities and being welded so as to enter each other (Giraud: Fig. 1A: the cavities formed in 22 being the hub, upon fusing with and in between the cavities of the first material 20, being that of the shaft; Fig. A6; page 2 of translation, para. [0007], last 5 lines).
Regarding claim 6, Eberhardt in view of Takemoto teaches the catheter according to claim 1, as described above, wherein the hub includes a distal end (Eberhardt: left end of 310 and Fig. 3: 321), however, Eberhardt in view of Takemoto does not explicitly disclose the structures of the cavities located at both the shaft and the hub.
Giraud teaches an analogous method for fusing two materials together with heat welding, wherein the first material (Fig. A1: 20) has a textured surface comprising a plurality of cavities (Fig. A1: 29) in which the second material (Fig. A1: 22) is melted and flows into the cavities, forming a surface having a plurality of cavities on the second surface as well (Fig. A1: cavities along surface of 22 between protrusions 29). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Eberhardt-Takemoto device by incorporating the specific fusing technique and cavity structures taught by Giraud, in order to create an interlocking fusion between the materials of the shaft and hub which cannot be separated (page 2 of translation, para. [0007], last 5 lines). Following this incorporation of Giraud’s teaching, it directly follows that in the Eberhardt-Takemoto-Giraud device the plurality of cavities including hub cavities in the hub (seen in the cavities formed in 22 of Giraud upon fusing with and in between the cavities of the first material 20, being that of the shaft), all of the hub cavities being positioned proximal of the distal end of the hub (Takemoto: Fig. 4: melted portion 45 of hub 4, where the cavities would be located, being positioned proximal of the distal end 44 of the hub). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated this position of the melted and textured portions being proximal to the distal end of the hub, as taught by Takemoto, in order to avoid melting the entire portion of the hub rather than only the one necessary portion for adhesion has Takemoto teaches.
Regarding claim 7, Eberhardt in view of Takemoto teaches the catheter according to claim 1, as described above, wherein the tubular accommodation unit includes a distal end portion that terminates at a distal end of the tubular accommodation unit (Eberhardt: Fig. 3: distal end at label 321), the hub melted surface in the distal end portion of the tubular accommodation unit (Eberhardt: para. [0034], sentence 2) gradually expanding toward the distal end of the tubular accommodation unit (Eberhardt: Fig. 5: the distal end of the accommodation unit tapers such that the inner melted surface expands toward the distal end of the accommodation unit), the plurality of cavities including hub cavities provided in the hub (as evidenced by the cavity structure taught by Giraud, see combination description above), all of the hub cavities being positioned proximal of the distal end portion of the hub (Takemoto: Fig. 4: melted portion 45 of hub 4, where the cavities would be located, being positioned proximal of the distal end 44 of the hub). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated this position of the melted and textured portions being proximal to the distal end of the hub, as taught by Takemoto, in order to avoid melting the entire portion of the hub rather than only the one necessary portion for adhesion has Takemoto teaches.
Regarding claim 10, Eberhardt discloses a catheter comprising: a shaft possessing a proximal portion that terminates in a proximal end of the shaft (Fig. 2: catheter shaft 360, proximal end at the right end surrounded by 310), the shaft being a tubular body that includes a lumen extending through the shaft in a distal direction from the proximal end of the shaft (Fig. 2; Figs. 8 and 9 showing lumen extending through), the shaft also possessing a shaft inner surface (Fig. 5: inner surface of the shaft being the lumen through 360) and a shaft outer surface (Fig. 2: outer surface of 360), the shaft inner surface surrounding the lumen in the shaft; a hub that possesses a proximal end and a distal end (Fig. 2: hub 310), the hub including a lumen extending throughout the hub from the proximal end of the hub to the distal end of the hub (Fig. 3: lumen 313 extending from 311 to 321); the hub including an accommodation unit (accommodation unit being the distal portion of the hub 310; para. [0031], sentences 3 and 5; Figs. 3 and 5: 321 and 323), the lumen in the hub including one portion that extends throughout the accommodation unit (Fig. 3: hub lumen extending through 323 to 321 end), the accommodation unit possessing an inner surface that surrounds the one portion of the lumen in the accommodation unit (Fig. 3: inner surface at 323), the accommodation unit also possessing an outer surface (Figs. 2 and 3: outer surface of distal end of 310), the proximal portion of the shaft being positioned in the one portion of the lumen in the accommodation unit with the inner surface of the accommodation unit fused to the outer surface of the proximal portion of the shaft in a manner connecting the shaft and the hub to one another (Fig. 5: proximal end of shaft 360 inserted into accommodation unit at 321; para. [0006], last sentence). Eberhardt fails, however, to also disclose cavities on the accommodation unit or shaft adjacent to that melted surface.
Takemoto teaches an analogous medical device in which a medical instrument (Fig. 4: needle shaft 3) is inserted into a hub (Fig. 4: 3 inserted into hub h) and fused together via heat-welding and a melted surface of the hub (Fig. 4: 45; para. [0039], sentence 3), and the plurality of cavities being: i) in the accommodation unit of the hub; or ii) in the proximal portion of the shaft (para. [0039], sentences 2-3, the roughened surface of the shaft forming cavity structures into which the melted material flows into). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Eberhardt device by incorporating the plurality of cavities forming a roughened surface of the proximal end of the shaft, as taught by Takemoto, in order to strengthen the bond between the hub and the shaft and form a liquid-tight bond between them (Takemoto: para. [0039], sentences 3-4). However, Eberhardt in view of Takemoto does not explicitly disclose the enclosed structures of the cavities or their radial location on the shaft or hub.
Giraud teaches an analogous method for fusing two materials together with heat welding, wherein the first material (Fig. A1: 20) has a textured surface comprising a plurality of cavities (Fig. A1: 29) in which the second material (Fig. A1: 22) is melted and flows into the cavities, forming a surface having a plurality of cavities on the second surface as well (Fig. A1: cavities along surface of 22 between protrusions 29). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Eberhardt-Takemoto device by incorporating the specific fusing technique and cavity structures taught by Giraud, in order to create an interlocking fusion between the materials of the shaft and hub which cannot be separated (page 2 of translation, para. [0007], last 5 lines). Following this incorporation of Giraud’s teaching, it directly follows that in the Eberhardt-Takemoto-Giraud device the plurality of cavities that each include an inner surface surrounding a closed space (Giraud: Figs. A3 cavity 29, and D3), the plurality of cavities facilitating intermixing of the material of the shaft and the material of the hub (Giraud: Figs. A3, D3 and D6 demonstrating the intermixing of material 22/74 into the cavity), in the accommodation unit of the hub (seen in the cavities formed in 22 of Giraud upon fusing with and in between the cavities of the first material 20, being that of the shaft), with at least some of the cavities being positioned radially closer to the inner surface of the accommodation unit than the outer surface of the accommodation unit (Giraud: Fig. A1: the cavities of 22 are on located at the inner, fused surface, relating to the melted hub surface of the accommodation unit).
Regarding claim 11, Eberhardt in view of Takemoto in further view of Giraud teaches the catheter according to claim 10, wherein the plurality of cavities are in both the accommodation unit and the shaft (Giraud: Fig A1: shaft cavities 29 and accommodation unit cavities along surface of 22 between protrusions 29).
Regarding claim 12, Eberhardt in view of Takemoto in further view of Giraud teaches the catheter according to claim 10, wherein the plurality of cavities are in the accommodation unit of the hub, all of the cavities in the accommodation unit of the hub being proximal of the distal end of the hub (Takemoto: Fig. 4: melted portion 45 of hub 4, where the cavities would be located, being positioned proximal of the distal end 44 of the hub). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated this position of the melted and textured portions being proximal to the distal end of the hub, as taught by Takemoto, in order to avoid melting the entire portion of the hub rather than only the one necessary portion for adhesion has Takemoto teaches.
Regarding claim 13, Eberhardt in view of Takemoto in further view of Giraud teaches the catheter according to claim 10, wherein the accommodation unit includes a distal end portion that terminates at the distal end of the accommodation unit (Eberhardt: Figs. 3 and 5: the left/distal end at/around 321 and 323), the inner surface of the accommodation unit in the distal end portion of the accommodation unit gradually expanding toward the distal end of the accommodation unit (Eberhardt: Fig. 5: the distal end of the accommodation unit tapers such that the inner surface expands toward the distal end of the accommodation unit), the plurality of cavities being in the accommodation unit (as evidenced by the cavity structure taught by Giraud, see combination description above), all of the cavities in the accommodation unit of the hub being proximal of the distal end portion of the accommodation unit (Takemoto: Fig. 4: melted portion 45 of hub 4, where the cavities would be located, being positioned proximal of the distal end 44 of the hub). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated this position of the melted and textured portions being proximal to the distal end of the hub, as taught by Takemoto, in order to avoid melting the entire portion of the hub rather than only the one necessary portion for adhesion has Takemoto teaches.
Regarding claim 14, Eberhardt in view of Takemoto in further view of Giraud teaches the catheter according to claim 10, further comprising a reinforcement body embedded in the shaft (Eberhardt: Fig. 4: reinforcement 364 embedded in shat 360; para. [0032], sentences 1-3).
Regarding claim 15, Eberhardt in view of Takemoto in further view of Giraud teaches the catheter according to claim 14, wherein the plurality of cavities are in the shaft, the reinforcement body extending distally beyond the plurality of cavities (Eberhardt: Fig. 4: reinforcement coils 364 extend distally down the catheter, past the proximal portion which is inserted into the accommodation unit and possesses the cavities).
Regarding claim 16, Eberhardt in view of Takemoto in further view of Giraud teaches the catheter according to claim 10, wherein the hub includes a hub main body (Eberhardt: Fig. 3: main body being the portion surrounding 313) in addition to the tubular accommodation unit (Eberhardt: Fig. 3: accommodation unit being the left portion surrounding 323), the hub main body being connected to and positioned proximal of the tubular accommodation unit (Eberhardt: Fig. 3: main body around 313 is to the right/proximal to the portion surrounding 323), the lumen in the hub including a first portion of the lumen that is in the tubular accommodation unit (Eberhardt: Fig. 3: lumen at 323) and a second portion of the lumen that is in the hub (Eberhardt: Fig. 3: lumen at 313), the inner surface of the accommodation unit of the hub surrounding the first portion of the lumen (Eberhardt: Fig. 3: accommodation unit around lumen at 323), the second portion of the lumen possessing an inner diameter less than an inner diameter of the first portion of the lumen (Eberhardt: Fig. 3: distal part of lumen 323 tapering and being more narrow than lumen at 323).
Regarding claim 17, Eberhardt in view of Takemoto in further view of Giraud teaches the catheter according to claim 16, wherein a proximal end of the first lumen in the accommodation unit terminates in a radially extending adjacent surface (Eberhardt: Figs. 3 and 5: right/proximal end of accommodation unit lumen extending radially from the adjacent surface of the hub main body, i.e., the proximal end of the accommodation unit lumen is radially larger than the distal lumen in the hub main body), the plurality of cavities being in the proximal portion of the shaft (Eberhardt and Takemoto: the proximal portion of the shaft is the portion which is heat welded and therefore is textured with the cavities), the first portion of the lumen possessing an axial extent that extends from the adjacent surface to the distal end of the accommodation unit (Eberhardt: Figs. 3 and 5: the lumen in the accommodation unit at 323/321 extends distally from the proximal end where it meets with 313), the proximal portion of the shaft at which the cavities are provided having an axial extent less than the axial extent of the first portion of the lumen (Takemoto: portion 45 where the textured cavities exist for the heat-welded portion do not extend as distally as the lumen of the hub surrounding it).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783