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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/22/25 has been entered.
Response to Amendment
The amendment filed 09/30/25 has been entered. Claim 1 has been amended. Claims 2-11 and 14-15 are in the original/ previously presented form. Claims 12-13 are cancelled. Thus, claims 1-11 and 14-15 remain pending in the application. There were no objections of 112 rejections previously set forth in the Final Office Action mailed 08/26/25. Therefore, there are no objections or 112 rejections withstanding.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-4, 7-9, 14, and 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jung (U.S. PGPUB No. 2018/0177991) in view of Chen (U.S. PGPUB No. 2017/0348218) and Fleming et al. (U.S. PGPUB No. 2003/0135161), hereinafter Fleming.
Regarding claim 1, Jung discloses a kit (see [0014]: device has microneedle applicator and microneedle sheet, thus forms a ‘kit’ of the recited components) comprising:
at least one microneedle sheet (10, see FIG. 1) comprising a substrate layer (14) and a plurality of microneedles (16) on the substrate layer (14),
and
at least one applicator (20, see FIG. 2) comprising at least one application surface (24); and
wherein
the substrate layer (14, see FIG. 1) of the microneedle sheet (10) is capable of being attached to the application surface (24, see FIG. 2) of the applicator (20, see FIG. 2 and [0061-0062]: substrate layer 14 adheres microneedle patch 20 to coupler 22 of applicator—coupler 22 best seen in FIG. 6. Coupler 22 forms application surface 24. Therefore, substrate layer is ‘capable of’ being attached to the application surface of the applicator).
Jung is silent to “the microneedles comprising at least one water-soluble or water-dispersible polymer;” “at least one container which is capable of storing the microneedle sheet when the microneedle sheet is not used” and “the container comprises at least one porous article selected from woven or non-woven fabrics where the microneedles of the microneedle sheet are placed in the pores of the porous article when the microneedle sheet is not used.”
However, Chen teaches a process comprising attaching at least one microneedle sheet to an application surface (see [0006]: a kit comprising microneedle patch and microneedle patch applicator in see [0015]: treatment of the skin) comprising a microneedle sheet (see FIG. 2D) with the microneedles (see [0013]: microneedle patches include a substrate layer with several microneedles. The microneedles comprise shafts and tips) comprising at least one water-soluble or water- dispersible polymer (see [0028]: shafts of microneedles made of water-soluble polymers).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedles disclosed in Jung to comprise at least one water-soluble or water-dispersible polymer as taught by Chen for the purpose of providing the microneedle with a desired mechanical strength such that the microneedles are not fractured when inserting the microneedles into the skin (see [0028]), thus achieving “the microneedles comprising at least one water-soluble or water- dispersible polymer”.
Jung in view of Chen remain silent to “at least one container which is capable of storing the microneedle sheet when the microneedle sheet is not used” and “the container comprises at least one porous article selected from woven or non-woven fabrics where the microneedles of the microneedle sheet are placed in the pores of the porous article when the microneedle sheet is not used.”
However, Fleming teaches a microneedle sheet (720, see FIG. 14) and at least one container (790) which is capable of storing the microneedle sheet (720) when the microneedle sheet is not used (as seen in Fig. 14 and described in [0080]). Fleming further teaches the container (790, see Fig. 14) comprises at least one article (740, see [0079]: a cover 740) where the microneedles (330) of the microneedle sheet (720) are placed in article when the microneedle sheet is not used (as seen in Fig. 14 and [0079-0081]: microneedles covered by 740 and sealed by ring 748 and therefore must be “placed in” the article 740).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit comprising a microneedle sheet taught by Jung in view of Chen to include a container comprising an article where the microneedles are placed in the article when the microneedle sheet is not in use as taught by Fleming (FIG. 14) for the purpose of enclosing the microneedles in a hermetic moisture-impermeable packaged for transport and storage (see [0080]), thus achieving “at least one container which is capable of storing the microneedle sheet when the microneedle sheet is not used” and “the container comprises at least one” “article” “where the microneedles of the microneedle sheet are placed in the pores of the” “article when the microneedle sheet is not used.”
Jung in view of Chen and Fleming (FIG. 14) remain silent to the container comprises at least one “porous” article “selected from woven or non-woven fabrics” and the microneedles are placed “the pores of the porous” article
However, in a separate embodiment (see FIG. 7), Fleming teaches a microneedle sheet (320, see FIG. 7) comprising microneedles (330) and an article (350, see [0059]: article 350 can function alone as cover 340, analogous to cover 740/640 of embodiment Fig. 14), the article comprising at least one porous article selected from woven or non-woven fabrics (see FIG. 7 and [0058-0059]: 350 is selected from woven or non woven materials and functions as cover for microneedles), where the microneedles (330) of the microneedle sheet (320) are placed in the pores of the porous article when the microneedle sheet (320) is not used (see [0059]: when 350 is the cover, the thickness of the porous layer “above the sheet” defines capillary volume. Thickness “above the sheet” discloses that he microneedles are placed “IN the pores” of 350)
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the article of the container taught by Jung in view of Chen and Fleming (FIG. 14) to be a porous article selected from woven or non-woven fabrics as taught by Fleming (FIG.7) for the purpose of forming the cover article as a compressible cover article to allow additional penetration of the microneedles at the delivery site (see [0059]), thus achieving the container comprises at least one “porous” article “selected from woven or non-woven fabrics” and the microneedles are placed “the pores of the porous” article
Regarding claim 3, the modified system of Jung teaches the kit according to Claim 1, and Jung further discloses wherein the microneedle sheet (10, see FIG. 1) comprises at least one base layer (12), and the base layer (12) is fixed onto (see [0040]) the substrate layer (14).
Regarding claim 4, the modified system of Jung teaches the kit according to Claim 1, and Jung further discloses wherein the microneedle sheet (10, see FIG. 1) comprises at least one adhesive layer (12, see [0040]: 12 characterized as an adhesive portion), and the adhesive layer (12) is fixed onto the substrate layer (14).
Regarding claim 7, the modified system of Jung teaches the kit according to Claim 1, and Jung further discloses wherein the microneedle has a height of from 50 to 1000 microns, preferably from 100 to 750 microns, and more preferably from 150 to 500 microns (see [0149-0150]: microneedle applications disclosed in FIG. 12A and 12B specifically use microneedle height==length of 300 μm or 500 μm).
Regarding claim 8, the modified system of Jung teaches the kit according to Claim 1, and Jung further discloses wherein the application surface (24, see FIG. 2) of the applicator (20) is curved (see FIG. 2 and [0054-0055]: 24 is a curved surface).
Regarding claim 9, the modified system of Jung teaches the kit according to Claim 8, and Jung further discloses wherein the applicator (20, see FIG. 2) comprises at least one cylindrical roller (22, see FIG. 6 for best depiction and [0051]: applicator 20 includes roller 22) having a curved side surface (see [0055]: 24 applied by ‘rolling’ applicator, which includes coupler 22 forming surface 24 and [0058]: rolling motion of 24), and the curved side surface (24) of the cylindrical roller (22) comprises the application surface (see FIG. 2 & 6).
Regarding claim 14, the modified system of Jung teaches the kit according to Claim 1, but Jung is silent to “further comprising at least one cosmetic composition.”
However, Chen teaches a kit (see [0006]: a kit comprising microneedle patch and microneedle patch applicator) comprising a microneedle sheet (see FIG. 2D) and further comprising at least one cosmetic composition (see [0012]: hyaluronic acid and 1+ cosmetic agents delivered to the skin via microneedle sheet).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedle sheet of the kit disclosed in Jung to include at least one cosmetic composition as taught by Chen for the purpose of maintaining and improving the appearance of skin to which the microneedles are applied (see [0012]), thus achieving “further comprising at least one cosmetic composition.”
Regarding claim 15, Jung discloses a cosmetic process for a keratin substance such as the skin or the lips (see [0050]: applicator applied to skin), comprising the steps of:
Attaching (see [0044]: the microneedle patch 10 is wound about the applicator/roller, such as on applicator 20—see [0102-0103]) at least one microneedle sheet (10, see FIG. 1) to at least one application surface (24, see FIG. 2) of at least one applicator (20, see FIG. 2) by attaching (see [0044]: the microneedle patch 10 is wound about the applicator/roller, such as on applicator 20—see [0102-0103]) a substrate layer (14, see FIG. 1 and [0061-0062]: substrate layer 14 adheres microneedle patch 20 to coupler 22 of applicator—coupler 22 best seen in FIG. 6) to the application surface (24, see FIG. 2) of the applicator (20, see FIG. 2) wherein the microneedle sheet (10, see FIG. 1) comprises the substrate layer (14, see FIG. 1) and a plurality of microneedles (16) on the substrate layer (14);
applying the applicator (20, see FIG. 2) onto the keratin substance such that the microneedles contact the keratin substance (see [0055]: applicator is rolled over skin surface to apply microneedles to skin and [0063]: needles rolled onto skin—see FIG. 5 for illustration).
Jung is silent to “the microneedles comprising at least one water-soluble or water-dispersible polymer;” and “storing the microneedle sheet in a container comprising at least one porous article selected from woven or non-woven fabrics by placing the microneedles of the microneedle sheet in the container such that the microneedles are placed in the pores of the porous article.”
However, Chen teaches a process comprising attaching at least one microneedle sheet to an application surface (see [0006]: a kit comprising microneedle patch and microneedle patch applicator in see [0015]: treatment of the skin) comprising a microneedle sheet (see FIG. 2D) with the microneedles (see [0013]: microneedle patches include a substrate layer with several microneedles. The microneedles comprise shafts and tips) comprising at least one water-soluble or water- dispersible polymer (see [0028]: shafts of microneedles made of water-soluble polymers).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedles disclosed in Jung to comprise at least one water-soluble or water-dispersible polymer as taught by Chen for the purpose of providing the microneedle with a desired mechanical strength such that the microneedles are not fractured when inserting the microneedles into the skin (see [0028]), thus achieving “the microneedles comprising at least one water-soluble or water- dispersible polymer”.
Jung in view of Chen remain silent to “storing the microneedle sheet in a container comprising at least one porous article selected from woven or non-woven fabrics by placing the microneedles of the microneedle sheet in the container such that the microneedles are placed in the pores of the porous article.”
However, Fleming teaches a process for delivering a substance to a keratin substance (see [0032]: microneedles deliver agents through the skin) including applying a microneedle sheet (720, see Fig. 14) to a keratin substance (see [0032]: skin) and storing the microneedle sheet (720) in at least one article (740) by placing the microneedles (730) of the microneedle sheet (720) such that the microneedles are placed in the article (740, as seen in Fig. 14 and [0079-0081]: microneedles covered by 740 and sealed by ring 748 and therefore must be “placed in” the article 740. Thus, the microneedles are stored “by” placing the microneedles in the article).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process for delivering a substance to a keratin substance taught by Jung in view of Chen to include storing the microneedle sheet in a container comprising an article by placing the microneedles into the article as taught by Fleming (FIG. 14) for the purpose of enclosing the microneedles in a hermetic moisture-impermeable packaged for transport and storage (see [0080]), thus achieving “storing the microneedle sheet in a container comprising at least one” “article” “by placing the microneedles of the microneedle sheet in the container such that the microneedles are placed in” “the porous article.”
Jung in view of Chen and Fleming (FIG. 14) remain silent to the container comprises at least one “porous” article “selected from woven or non-woven fabrics” and the microneedles are placed “the pores of the porous” article
However, in a separate embodiment (see FIG. 7), Fleming teaches a process for delivering a substance to a keratin substance (see [0032]: microneedles deliver agents through the skin) including applying a microneedle sheet (320, see Fig. 7) to a keratin substance (see [0032]: skin), the microneedle sheet (320, see FIG. 7) comprising microneedles (330) and an article (350, see [0059]: article 350 can function alone as cover 340, analogous to cover 740/640 of embodiment Fig. 14), the article comprising at least one porous article selected from woven or non-woven fabrics (see FIG. 7 and [0058-0059]: 350 is selected from woven or non woven materials and functions as cover for microneedles), where the microneedles (330) of the microneedle sheet (320) are placed in the pores of the porous article when the microneedle sheet (320) is not used (see [0059]: when 350 is the cover, the thickness of the porous layer “above the sheet” defines capillary volume. Thickness “above the sheet” discloses that he microneedles are placed “IN the pores” of 350).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the article of the container used in the process for delivering a substance to a keratin substance taught by Jung in view of Chen and Fleming (FIG. 14) to be a porous article selected from woven or non-woven fabrics as taught by Fleming (FIG.7) for the purpose of forming the cover article as a compressible cover article to allow additional penetration of the microneedles at the delivery site (see [0059]), thus achieving the container comprises at least one “porous” article “selected from woven or non-woven fabrics” and the microneedles are placed “the pores of the porous” article
Claims 2 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Chen and Fleming as applied to claim 1 above, and further in view of Lee et al. (U.S. PGPUB No. 2010/0262081), hereinafter Lee.
Regarding claim 2, the modified system of Jung teaches the kit according to Claim 1, and Jung further discloses wherein the microneedle sheet (10, see FIG. 1) is detachable (see FIG.5) from the application surface (24) of the applicator (20, see FIG. 2), after being attached to the application surface of the applicator (see FIG. 5 and [0014]: microneedles detached after being applied to skin and [0066-0067]: adhesive forces adhere patch to skin and thus overcome adhesive force adhering to application surface 24. Therefore, detachable AFTER being attached to application surface.).
Modified Jung is silent to specifically “the substrate layer” of the microneedle sheet is detachable from the application surface.
However, Lee teaches a kit (see [0009-0010]: a microneedle roller or stamp with microneedle sheet) with a microneedle sheet (3120, see FIG. 8) including a substrate layer (3121), wherein the substrate layer (3121) of the microneedle sheet (3120) is detachable from an application surface (see FIG. 6 and [0056]: outer circumferential surface of applicator 3110 holds microneedles) of an applicator (3110, see FIG. 6), after being attached to (see [0064]: microneedle sheet may be engaged or disengaged from applicator 3110 via attachment structures) the application surface (see [0056]: outer circumferential surface of 3110) of the applicator (3110).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the substrate layer of the microneedle sheet taught in Modified Jung to be detachable from the applicator as taught by Lee for the purpose of forming the entirety of the microneedle sheet as a replaceable unit that may be replaced when damaged or contaminated (see [0006], [0009], and [0011]), thus achieving “the substrate layer” of the microneedle sheet is detachable from the application surface.
Regarding claim 10, the modified system of Jung teaches the kit according to Claim 1, but Modified Jung is silent to “wherein the application surface of the applicator is flat.”
However, Lee teaches a kit (see [0009-0010]: a microneedle roller or stamp with microneedle sheet) with a microneedle sheet (4100, see FIG. 9) adhered to an application surface (4210) of an applicator (4200), wherein the application surface (4210) of the applicator (4200) is flat (see [0071]: application surface 4210 described as “flat”).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the application surface of the applicator taught in Modified Jung to be a flat application surface as taught by Lee for the purpose of forming the microneedle sheet as a stamping applicator with an easily grasped handle portion (see [0070-0071]), thus achieving “wherein the application surface of the applicator is flat”.
Regarding claim 11, the modified system of Jung teaches the kit according to Claim 10, but Modified Jung is silent to “wherein the applicator comprises at least one stamp having at least one flat surface, and the flat surface of the stamp comprises the application surface.”
However, Lee teaches a kit (see [0009-0010]: a microneedle roller or stamp with microneedle sheet) with a microneedle sheet (4100, see FIG. 9) adhered to an application surface (4210) of an applicator (4200), wherein the applicator (4200) comprises at least one stamp (see [0070]: 4200 described as a “stamp”) having at least one flat surface (see [0071]: application surface 4210 described as “flat”), and the flat surface (see [0071]: application surface 4210 described as “flat”) of the stamp (4200) comprises the application surface (4210).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the applicator taught in Modified Jung to be a stamping applicator with a flat application surface as taught by Lee for the purpose of forming the microneedle sheet as a stamping applicator with an easily grasped handle portion (see [0070-0071]), thus achieving “wherein the applicator comprises at least one stamp having at least one flat surface, and the flat surface of the stamp comprises the application surface.”
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Chen and Fleming as applied to claim 3 above, and further in view of Kato et al. (U.S. PGPUB No. 2016/0325082), hereinafter Kato.
Regarding claim 5, the modified system of Jung teaches the kit according to Claim 3, but Modified Jung is silent to “wherein the microneedle sheet comprises at least one adhesive layer, and the adhesive layer is fixed onto the base layer.”
However, Kato teaches a kit (10, see FIG.1) including a microneedle sheet (11), wherein the microneedle sheet (11) comprises at least one adhesive layer (42), and the adhesive layer (42) is fixed onto (see layers 42, 43, 44 fixed together to form section 41 as shown in FIG. 5) a base layer (44).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedle sheet disclosed in Jung to include an adhesive layer fixed onto a base layer as taught by Kato for the purpose of providing high rigidity to the microneedle sheet via the base layer (see [0062-0063]) and providing an adhesive layer with easy-peel properties for keeping the microneedle sheet at the puncture target after application (see [0027], [0057-0060]), thus achieving “wherein the microneedle sheet comprises at least one adhesive layer, and the adhesive layer is fixed onto the base layer.”
Regarding claim 6, the modified system of Jung teaches the kit according to Claim 4, but Modified Jung is silent to “wherein the microneedle sheet comprises at least one releasing layer, and the releasing layer is placed on the adhesive layer.”
However, Kato teaches a kit (10, see FIG.1) including a microneedle sheet (11), wherein the microneedle sheet (11) comprises at least one releasing layer (31), and the releasing layer (31, see [0027]: releasing layer 31 peeled off surface 41a formed of layer 42 and FIG. 6: peeling begins and FIG.7: releasing layer 31 completely peeled off/ released) is placed on the adhesive layer (42).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microneedle sheet with an adhesive layer fixed onto a base layer taught by Jung in view of Kato to include a releasing layer placed on the adhesive layer as taught by Kato for the purpose of ensuring that the microneedle sheet is not touched by a user during application (see [0098], [0102]), thus achieving “wherein the microneedle sheet comprises at least one releasing layer, and the releasing layer is placed on the adhesive layer.”
Response to Arguments
Applicant’s arguments with respect to claim 1 and all subsequent depending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner has made a new rejection under Jung in view of Chen and Fleming, rendering the arguments presented against the previous rejection of claim 1 under Jung in view of Chen, Kato, and Chaillet-Piquand on pages 6-11 of Applicant Remarks moot.
Applicant's arguments filed 09/30/25 directed to claim 15 have been fully considered but they are not persuasive.
On pages 12-13, Applicant argues that the Fleming does not disclose the needles “stored” within the article. However, the examiner disagrees with this characterization of the claim language and has maintained Fleming in the rejection of claim 15. Claim 15 recites “storing the microneedle sheet… by placing the microneedles of the microneedle sheet in the container such that the microneedles are placed in the pores of the porous article”. In response to applicant's argument that the microneedles are not “stored” within the article, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Claim 15 recites the storing achieved by the function of “by placing” the microneedles into the container and the article. Therefore, Fleming meets the limitation as claimed.
Further, Fleming’s disclosure meets the claimed limitation as described by Applicant in the specification. In the current Application, Applicant discloses that the microneedle sheet is stored in the container and the microneedles may penetrate into the porous sheet to be protected (see [0201] and Fig. 6). Therefore, Fleming meets the claimed limitation as much has been described and provided by Applicant (Fleming discloses the microneedle sheet within the container and the microneedles penetrating the porous article. Therefore, “storing” as described by Applicant is achieved in Fleming).
Therefore the examiner was not persuaded by this argument and maintained Fleming in the rejection of claim 15.
Lastly on page 13, Applicant argues that the embodiment including 350 is not taught with embodiment of the container 790 of Fleming and therefore 350 is not “in” the container. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In a 35 U.S.C. § 103 rejection, individual embodiments/ references cannot be attacked to show nonobviousness because the rejection relies on the COMBINATION of the cited references/embodiments (such as at least the embodiment of fig. 14 including the container 790 and the embodiment fig. 7 including the woven article 350 of Fleming in the rejection of claim 15 above).
Therefore, the examiner was not persuaded by this argument and again maintains Fleming in the rejection of claim 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783