CTFR 17/712,090 CTFR 78117 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. In the amendment filed on 03/20/26, applicants have amended claims 1 and 9. The 102 rejections over the references to WO’627 and Sällberg et al described in the NF action sent on 10/20/25 have been withdrawn. However, amended claims have been found to be rejectable over the reference to WO-2011/034627 A2 in view of Sällberg et al (US 2013/0012865A1) or Sällberg et al (US 2013/0012865A1) in view of WO-2011/034627 A2. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO - 2011/034627 A2 in view of Sällberg et al (US 2013/0012865A1). As to claim 1, WO'627 teaches (see Figs 1, 4A-4B and 8) a direct injection device, comprising: a reservoir (see Fig 1 for the body of the syringe having a reservoir see pages 6-7) to store liquid; a head to control extrusion of the liquid; a plunger (see Fig 1 for the plunger) to compress the liquid in the reservoir, wherein the plunger (see Fig 1 and pages 6-7) is controlled by the head (see Fig 1 and 4A for cell displacement technique); and a plurality of needles (see Figs 4B and 8 for items1 and D), wherein when the head causes the plunger to compress the liquid in the reservoir, the liquid is extruded through the plurality of needles (see Figs 1, 8 and page 28 for compressibility of material). WO’627 further teaches (see page 80 and Fig 15B) the array of needles arranged in any pattern across the surface of a surface/subject (the subject is capable of including openings when needles are inserted) wherein a series of injections applied (see page 41), but lacks teaching a plurality of needles configured to simultaneously dispense the liquid into a plurality of openings in a substrate. However, injection device with a plurality of needles dispensing liquid simultaneously or serially into a plurality of openings in a substrate is known in the art; for instance; as taught by Sällberg et al (see para [0142]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simultaneously or serially dispense the liquid onto the subject in WO’627 depending the desired method of therapeutic applications. Regarding claim 2, WO'627 teaches a needle array module (see Fig 8 and page 7), wherein the needle array module comprises the plurality of needles (see Figs 4B and 8 for items1 and D), and wherein the needle array module is capable of being interchangeable with one or more other needle array modules, wherein each needle array module has a different needle array configuration (see pages 6-7 for a plurality of needle-like elements or penetrating structures arranged in linear arrays, spatial arrays, single tubes or other geometric shapes and two or more working ends for injection cells in linear arrays or spatial arrays, see page 7, lines 17-20). As to claim 3, WO'627 teaches each needle array configuration comprises: a number of needles, an arrangement of needles is capable of having a needle length; or a needle diameter (see page 14, lines 1-7 for the length and diameter of the tip may be different depending on the application and Detailed Description on page 10, 2ⁿᵈ paragraph). Regarding claim 4, WO'627 teaches at least one of the plurality of needles comprises a tapered tip (see Fig 8). Regarding claim 5, WO'627 teaches the head comprises: a screw-driven head; or a pneumatic head (a pneumatic fluid delivery, see plate 41). As to claims 6-7, WO'627 teaches the liquid comprises a liquid metal, wherein the liquid metal capable of comprises gallium, indium, tin, bromine, carbon, or oxygen (See page 37 for syringe containing metallic elements and cell fluid including rare earth metal on page 43). Regarding claim 8, WO'627 teaches the reservoir or the plurality of needles comprises an anti-corrosive material to prevent corrosion from the liquid metal (see Fig 15A page 80 for protective coating of the insertable member preventing corrosion). As to claim 9, WO'627 teaches (see Figs 1, 4A-4B and 8) a direct injection device, comprising: a reservoir (see Fig 1 for the body of the syringe having a reservoir see pages 6-7) to store liquid; a head to control extrusion of the liquid; a plunger (see Fig 1 for the plunger) to compress the liquid in the reservoir, wherein the plunger (see Fig 1 and pages 6-7) is controlled by the head (see Fig 1 and 4A for cell displacement technique); and a plurality of needles (see Figs 4Band 8 for items1 and D), wherein when the head causes the plunger to compress the liquid in the reservoir, the liquid is extruded through the plurality of needles (see Figs 1, 8 and page 28 for compressibility of material). As to the plurality of direct injection devices, WO'627 teaches a device including two or more working ends for injection cells (in linear arrays or spatial arrays, see page 7, lines 17-20), but lacks teaching individual direct injection device with a head a plunger and a plurality of needles and a plurality of needles configured to simultaneously dispense the liquid into a plurality of openings in a substrate. With respect to the plurality of direct injection devices, Sällberg et al teaches a device including three separate syringes 501a, 501b, 501c (see Fig 5C). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include individual direct injection devices each with a head a plunger and a plurality of needles in WO'627 in order the syringes can be configured to contain similar or different volumes of a therapeutic agent for delivery to a patient. As to simultaneously dispensing the liquid into a plurality of opening in a substrate, Sällberg et al teaches (see para [0142]) an injection device with a plurality of needles dispensing liquid simultaneously or serially into a plurality of openings in a substrate. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to simultaneously or serially dispense the liquid onto the subject in WO’627 depending the desired method of therapeutic applications. As to claim 10, WO'627 lacks teaching the reservoir shared by the plurality of direct injection devices. Sällberg et al the reservoir is shared by the plurality of direct injection devices (see Fig 3 for central lumen 315). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include reservoir shared by the plurality of direct injection devices to dispense same material in a larger surface of the patients. Regarding claims 11-12, WO'627 lacks teaching the reservoir comprises a plurality of reservoirs, wherein individual direct injection devices comprise one of the plurality of reservoirs. In Sällberg et al the reservoir comprises a plurality of reservoirs, wherein individual direct injection devices comprise one of the plurality of reservoirs (see Fig 5C and para [0111]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a plurality of reservoirs, wherein individual direct injection devices comprise one of the plurality of reservoirs in WO'627 to deliver different volumes of a therapeutic agent for delivery to a patient (see para [0111]). Regarding claim 13, WO'627 teaches a needle array module (see Fig 8 and page 7), wherein the needle array module comprises the plurality of needles (see Figs 4Band 8 for items1 and D), and wherein the needle array module is capable of being interchangeable with one or more other needle array modules, wherein each needle array module has a different needle array configuration (see pages 6-7 for a plurality of needle-like elements or penetrating structures arranged in linear arrays, spatial arrays, single tubes or other geometric shapes and two or more working ends for injection cells in linear arrays or spatial arrays, see page 7, lines 17-20). As to claim 14, WO'627 teaches each needle array configuration comprises: a number of needles, an arrangement of needles is capable of having a needle length; or a needle diameter (see page 14, lines 1-7 for the length and diameter of the tip may be different depending on the application and Detailed Description on page 10, 2nd paragraph). Regarding claim 15, WO'627 teaches at least one of the plurality of needles comprises a tapered tip (see Fig 8). Regarding claim 16, WO'627 teaches the head comprises: a screw-driven head; or a pneumatic head (a pneumatic fluid delivery, see plate 41). As to claims 17-18, WO'627 teaches the liquid comprises a liquid metal, wherein the liquid metal capable of comprises gallium, indium, tin, bromine, carbon, or oxygen (See page 37 for syringe containing metallic elements and cell fluid including rare earth metal on page 43) . 07-21-aia AIA Claim (s) 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sällberg et al (US 2013/0012865A1) in view of WO-2011/034627 A2. As to claims 1 and 9, Sällberg et al teaches (see Figs 33 and 34) a direct injection device, comprising: a reservoir (see Fig 33B for the body of the syringe 3340 having a reservoir) to store liquid; a head to control extrusion of the liquid; a plunger (see Fig 33B for the plunger inside the syringe 3340) to compress the liquid in the reservoir, wherein the plunger (see Fig 33B) is controlled by the head (see Fig 34 for trigger 3430); and a plurality of needles (see Figs 33B and 34B), wherein when the head causes the plunger to compress the liquid in the reservoir, the liquid is extruded through the plurality of needles (see Para [0139][0022]). With respect to the plurality of direct injection devices, Sällberg et al teaches a device including three separates syringes 501a, 501b, 501c (see Fig 5C, wherein each syringe capable of having a head, a plunger and needles like the syringe provided in Fig 33B), and the injection device with a plurality of needs configured to simultaneously or serially dispense into a plurality of openings in a substrate. Sällberg et al lacks teaching the plurality of needles arranged in pattern corresponding to a pattern of the openings. However, WO’627 teaches (see page 80 and Fig 15B) the array of needles arranged in any pattern across the surface of a surface/subject (the subject capable of including openings when needles are inserted), wherein a series of injections applied (see page 41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the plurality of needles in pattern corresponding to a pattern of the openings in Sällberg et al to simplify the injection of the liquid material onto the object depending the desired method of therapeutic applications, types of liquid components applied, or sizes of the object treated. Regarding claim 2, Sällberg et al teaches a needle array module (see Fig 8 and page 7), wherein the needle array module comprises the plurality of needles (see para [0139] and [0030]), and wherein the needle array module is capable of being interchangeable with one or more other needle array modules, wherein each needle array module has a different needle array configuration (see para [0026] [0030] for a plurality of needles arranged in array of geometric shapes). As to claim 3, Sällberg et al teaches each needle array configuration comprises: a number of needles (see para [0087], an arrangement of needles is capable of having a needle length [0009-0010], [0087], [0092]; or a needle diameter (see para [0029-0030]). Regarding claim 4, Sällberg et al teaches at least one of the plurality of needles comprises a tapered tip (see Figs 1B, 2A, 2D). As to claim 5 and 16, Sällberg et al lacks teaching the head comprises of a screw-driven or a pneumatic head. WO'627 teaches the head comprises: a screw- driven head; or a pneumatic head (a pneumatic fluid delivery, see plate 41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include pneumatic or other mechanism in Sällberg et al to deliver the fluid (see English Translation, under section titled as Fluid delivery of WO'627). Regarding claims 6-7 and 17-18, Sällberg et al lacks teaching the liquid comprises of a liquid metal. WO'627 teaches the liquid comprises a liquid metal, wherein the liquid metal capable of comprises gallium, indium, tin, bromine, carbon, or oxygen (see page 37 for syringe containing metallic elements and cell fluid including rare earth metal on page 43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a liquid metal in Sällberg et al to avoid clumping of the fluid in the needle or to attain imaging contrast of the agent as taught by WO'627 (see pages 37 and 43). Regarding claim 8, Sällberg et al lacks teaching the liquid comprises of anti-corrosive material. WO'627 teaches the reservoir or the plurality of needles comprises an anti-corrosive material to prevent corrosion from the liquid metal (see Fig 15A page 80 for protective coating of the insertable member preventing corrosion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a liquid metal comprises an anti-corrosive material in Sällberg et al to prevent corrosion of the injection device. As to claim 10, in Sällberg et al the reservoir is shared by the plurality of direct injection devices (see Fig 3 for central lumen 315). Regarding claims 11-12, in Sällberg et al the reservoir comprises a plurality of reservoirs, wherein individual direct injection devices comprise one of the plurality of reservoirs (see Fig 5C and para [0111]). As to claim 13, Sällberg et al individual direct injection devices further comprise the needle array module comprises the plurality of needles, and wherein the needle array module is capable of being interchangeable with one or more other needle array modules, wherein each needle array module has a different needle array configuration (See para [0026] [0030] for a plurality of needles arranged in array of geometric shapes). As to claim 14, Sällberg et al teaches each needle array configuration comprises: a number of needles (see para [0087], an arrangement of needles is capable of having a needle length [0009-0010], [0087], [0092]; or a needle diameter (see para [0029- 0030]). Regarding claim 15, Sällberg et al wherein at least one of the plurality of needles comprises a tapered tip (see Figs 2C, 5A, 3). Response to Arguments Applicant’s arguments with respect to claim(s) 1-18 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. 07-39 AIA THIS ACTION IS MADE FINAL. 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 YEWEBDAR T TADESSE whose telephone number is (571)272-1238. The examiner can normally be reached 7.00-3:30 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dah-Wei Yuan can be reached at 571-272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. YEWEBDAR T. TADESSE Primary Examiner Art Unit 1717 /YEWEBDAR T TADESSE/ Application/Control Number: 17/712,090 Page 2 Art Unit: 1717 Application/Control Number: 17/712,090 Page 3 Art Unit: 1717 Application/Control Number: 17/712,090 Page 4 Art Unit: 1717 Application/Control Number: 17/712,090 Page 5 Art Unit: 1717 Application/Control Number: 17/712,090 Page 6 Art Unit: 1717 Application/Control Number: 17/712,090 Page 7 Art Unit: 1717 Application/Control Number: 17/712,090 Page 8 Art Unit: 1717 Application/Control Number: 17/712,090 Page 9 Art Unit: 1717 Application/Control Number: 17/712,090 Page 10 Art Unit: 1717 Application/Control Number: 17/712,090 Page 11 Art Unit: 1717 Application/Control Number: 17/712,090 Page 12 Art Unit: 1717
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