FUJIFILM Corporation

Patent Trials and Appeals Board

Mar 10, 2022

2021001771 (P.T.A.B. Mar. 10, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/472,287 03/29/2017 Keio OKANO 69370-US-822 7153 31561 7590 03/10/2022 JCIPRNET 8F-1, No. 100, Roosevelt Rd. Sec. 2, Taipei, 100404 TAIWAN EXAMINER TSCHEN, FRANCISCO W ART UNIT PAPER NUMBER 1712 NOTIFICATION DATE DELIVERY MODE 03/10/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): Belinda@JCIPGROUP.COM USA@JCIPGROUP.COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte KEIO OKANO and YOSHINOBU KATAGIRI ____________ Appeal 2021-001771 Application 15/472,287 Technology Center 1700 ____________ Before CATHERINE Q. TIMM, JENNIFER R. GUPTA, and JANE E. INGLESE, Administrative Patent Judges. INGLESE, Administrative Patent Judge. DECISION ON APPEAL The Appellant1 requests review under 35 U.S.C. § 134(a) of the Examiner’s final rejection2 of claims 1, 3, and 7.3 We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 “Appellant” refers to the “applicant” as defined in 37 C.F.R. § 1.42. The Appellant identifies the real parties in interest as “KEIO OKANO, YOSHINOBU KATAGIRI, the inventors named in the subject application, and FUJIFILM Corporation.” Appeal Brief filed August 13, 2020 (“Appeal Br.”), 1. 2 Final Office Action entered February 28, 2020 (“Final Act.”), 1. 3 Claims 2, 4, 6, and 8 have been withdrawn from consideration, and the Examiner withdrew the rejection of claim 5 under 35 U.S.C. § 103 in the Examiner’s Answer entered November 12, 2020 (“Ans.”), 3. Appeal 2021-001771 Application 15/472,287 2 CLAIMED SUBJECT MATTER The Appellant claims a method of manufacturing a sheet having needle-like protruding portions. Appeal Br. 2. Claim 1, the sole pending independent claim, illustrates the subject matter on appeal, and reads as follows: 1. A manufacturing method of a sheet having needle-like protruding portions, comprising: preparing a mold having needle-like recessed portions, and a solution supply device having a slit-like opening formed at a nozzle distal end portion; supplying a solution from the solution supply device to the mold in a state that the nozzle distal end portion is pressed against a front surface of the mold, and filling the solution in the needle-like recessed portions; and moving the solution supply device relatively to the mold in a state that the nozzle distal end portion is brought into contact with the front surface of the mold, wherein, as a hardness distribution in a thickness direction of the mold, an average value of a Young’s modulus at a part within 40 μm from the front surface of the mold is 3 MPa or higher and 100 MPa or lower. Appeal Br. 10 (Claims Appendix) (emphasis added). REJECTION The Examiner maintains the rejection of claims 1, 3, and 7 under 35 U.S.C. § 103 as unpatentable over Mochizuki, et al., WO 2014/077242, published May 22, 20144 in view of Hawker, et al., US 2009/0096136 Al, 4 On the record before us, the Appellant does not challenge the Examiner’s reliance on Mochizuki, et al., US 2015/0238413 Al, published August 27, 2015 as a “literal English Translation” of WO 2014/077242. Final Act. 2. Citations to “Mochizuki” in this Decision, therefore, refer to the published U.S. application rather than the published PCT application. Appeal 2021-001771 Application 15/472,287 3 published April 16, 2009, in the Examiner’s Answer. Compare Final Act. 2-4, with Ans. 3. FACTUAL FINDINGS AND ANALYSIS Upon consideration of the evidence relied upon in this appeal and each of the Appellant’s contentions, we reverse the Examiner’s rejection of claims 1, 3, and 7 under 35 U.S.C. § 103 for reasons set forth in the Appeal and Reply Briefs, and below. Mochizuki discloses manufacturing a transdermal drug delivery sheet having needle-like protruding portions by (1) preparing a mold having rows of needle-like recesses, (2) preparing a liquid feeding apparatus that includes a nozzle having an opening, (3) aligning the nozzle opening over the needle- like recesses of the mold and applying pressing force P2 onto the nozzle to bring the nozzle and a front surface of the mold into contact with each other, (5) feeding a drug-containing solution from the nozzle opening of the liquid feeding apparatus into the mold recesses to fill the recesses with the drug- containing solution, (6) moving the liquid feeding apparatus along the front surface of the mold while applying pressing force P3 to the nozzle so that the nozzle and the front surface of the mold remain in contact with each other, (7) repeating the feeding and moving steps to fill additional rows of needle-like recesses of the mold with the drug-containing solution, (8) drying and solidifying the drug-containing solution to form a drug-delivery sheet having needle-like protruding portions on a surface of the sheet, and (9) peeling the sheet out of the mold. Mochizuki ¶¶ 11, 14, 21, 107-121; Figs. 7A-7C, 10, 11. Mochizuki discloses minimizing the pressing force P3 applied to the nozzle during movement of the nozzle along the front surface of the mold to Appeal 2021-001771 Application 15/472,287 4 suppress deformation of the mold, and to minimize damage of the mold, so that pressing force P3 is weaker than pressing force P2 applied to the nozzle while the mold recesses are filled with the drug-containing solution. Mochizuki ¶¶ 117, 121. Mochizuki discloses forming the front surface of the mold of a highly elastic, soft, deformable raw material to prevent the drug-containing solution from remaining on the mold except in the needle-like protrusions when the liquid feeding apparatus is moved along the mold. Mochizuki ¶¶ 19, 117. Mochizuki discloses that use of such material to form the mold also prevents destruction of the needle-like protrusions when the sheet is peeled out of the mold. Mochizuki ¶ 140. Mochizuki discloses that suitable materials for forming the mold include a silicone resin containing polydimethylcyloxane (PDMS), such as Sylgard 184®. Mochizuki ¶ 87. Hawker discloses a process of making a stamp for creating micro or nano-scale patterns in surfaces using a soft or imprint lithography technique. Hawker ¶¶ 6, 10, 25. As known to those skilled in the art, soft or imprint lithography involves pressing a stamp having a pattern of protrusions into a soft material to create impressions in the material that mirror the stamp’s protrusions.5 Hawker discloses that Sylgard 184® (PDMS) is commonly used in the art to create stamps for conducting soft lithography, but due to its relatively low Young’s modulus of 2 MPa, use of Sylgard 184 causes complications when forming patterns having dimensions below 1 micrometer. Hawker ¶ 9. Hawker discloses that such complications can be avoided when patterning “features down to a few nanometers” by using 5 See, e.g., Nanoimprint Lithography, http://www.nanopedia.org/index. php?title=Nanoimprint_Lithography (accessed March 6, 2022). Appeal 2021-001771 Application 15/472,287 5 PDMS having a higher Young’s Modulus of 9 MPa-known as “hard- PDMS.” Id. Hawker discloses that its invention involves discovery that poly(mercaptopropylmethylsiloxane) (PMMS) is the “optimum material” for forming imprint lithography stamps. Hawker ¶ 10. Hawker discloses a process for producing such a stamp from PMMS that involves (a) casting a mixture of PMMS, a cross-linker, and an initiator onto a patterned silicon mold coated with a releasing agent, (b) curing the PMMS, and (c) peeling the cured, patterned PMMS from the mold to produce a stamp. Hawker ¶¶ 21, 25, 40; Figures 2A-2C. The Examiner determines that it would have been obvious to one of ordinary skill in the art “to modify the method of Mochizuki and optimize the Young’s modulus of the mold including at 8MPa because Hawker discloses that doing so allow[s] formation of micro and nanometer patterns with reduction in defects,” and discloses that “use of higher modulus MPa prevents complications such as those that happen when utilizing Sylgard 184®.” Final Act. 4. On the record before us, however, for reasons expressed by the Appellant (Appeal Br. 6-7) and discussed below, the Examiner does not establish the prima facie obviousness of the Young’s modulus recited in claim 1. As discussed above, Mochizuki explicitly discloses that using a highly elastic, soft, deformable raw material to form Mochizuki’s mold prevents destruction of needle-like protrusions on a sheet produced with the mold when the sheet is peeled out of the mold, and also prevents the drug- containing solution from remaining on the mold except in the needle-like Appeal 2021-001771 Application 15/472,287 6 protrusions when the liquid feeding apparatus is moved along the mold during the filling process. As also discussed above, Mochizuki discloses that minimizing the pressing force applied to the nozzle during movement of the nozzle along the front surface of the mold suppresses deformation of the soft mold material, and minimizes damage to the material. The Examiner does not provide an explanation supported by objective evidence for why one of ordinary skill in the art would have found it beneficial-or even useful-to increase the Young’s modulus (hardness) of the material of Mochizuki’s mold, particularly when Hawker discloses using a higher Young’s modulus material to form a stamp-rather than a mold-to form impressions in a soft material. Hawker discloses that using a material with a higher Young’s modulus (a harder material) to form a lithography stamp facilitates formation of nano-scale impressions in a soft material when the stamp is pressed into the material, whereas, according to Mochizuki’s disclosures, use of a soft material to produce Mochizuki’s mold provides numerous benefits, while deformation of, and damage to, the soft mold material can be avoided during its use by tuning the pressure applied against the mold. The Examiner also does not identify any disclosure in Mochizuki that teaches or would have suggested that the advantageous results achieved by using a soft material to produce Mochizuki’s mold would be maintained if a material as disclosed in Hawker having a higher Young’s modulus were used to form the mold. The Examiner, therefore, does not establish that when optimizing the Young’s modulus of the material used to form Mochizuki’s mold, one of ordinary skill reasonably would have arrived at a material having a Young’s modulus as recited in claim 1. Appeal 2021-001771 Application 15/472,287 7 We, accordingly, do not sustain the Examiner’s rejection of claims 1, 3, and 7 under 35 U.S.C. § 103. DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 7 103 Mochizuki, Hawker 1, 3, 7 REVERSED