CTNF 18/559,006 CTNF 80323 DETAILED ACTION 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. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 8, 11-12, 28 and 33 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. In the present instance, claim 8 recites the broad recitation “at least 2.0 mm, and the claim also recites “a least about 0.01 mm, at least about 0.01 mm, at least about 0.05 mm, at least about 0.1 mm, at least about 0.5 mm, at least about 1.0 mm, at least about 1.5 mm” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In the present instance, claim 11 recites the broad recitation “at least about 100mL”, and the claim also recites “at least about 50 mL, at least about 60 mL, at least about 70 mL, at least about 75 mL, at least about 80 mL, at least about 90 mL” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In the present instance, claim 12 recites the broad recitation “7 g of beads per about 100 mL of solution”, and the claim also recites “at least about 3 g of beads per about 100 mL of solution, at least about 4 g of beads per 100 mL of about solution, at least about 5 g of beads per about 100 mL of solution, at least about 6 g of beads per about 100 mL of solution” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In the present instance, claim 28 recites the broad recitation ‘ less than about 4 kDa”, and the claim also recites “ less than about 10 kDa, less than about 9 kDa, less than about 8 kDa, less than about 7 kDa, less than about 6 kDa, less than about 5 kDa” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). 07-35-01 Claim 31 contains the trademarks/trade names TRITON X100 and PLURONIC F-68 . Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a surfactant and, accordingly, the identification/description is indefinite. Claim 33 is 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. Applicants recite “an optional cover”, the recitation “optional” renders the scope of the claim unclear because it is ambiguous whether the limitation is required. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 1-4, 7-8, 10-11, 22 and 30-33 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Click (US 2014/0269147) . Regarding claim 1, Click teaches a mixing and delivery system comprising agitating a solution placed in a vessel (12) using a mobile paddle (collapsable paddle); wherein the solution comprises a solute (MMA), a media (46), and a plurality of beads (PMMA); wherein the plurality of beads (Figures 1-4) is positioned between the solute and the mobile paddle; and wherein the mobile paddle (collapsable paddle) is submerged in the solution. Regarding claim 2, prior to the agitating, loading the solution into the vessel by (i) adding the solute (MMA) to the bottom of the vessel (12); (ii) adding the plurality of beads (PMMA) to the bottom of the vessel, wherein the plurality of beads (PMMA) are added on top of the solute; and (iii) adding a volume of media (46) to the vessel, wherein the media is added on top of the solute and the plurality of beads. Regarding claim 3, the media (46) is added without agitating the solute or the plurality of beads (PMMA). (Figures 1-4) Regarding claim 4, the mobile paddle is not in contact with the plurality of beads (PMMA) or the solute while the mobile paddle (collapsable paddle) is in a stationary position. (Figures 1-4) Regarding claim 7, the plurality of beads comprises one or more glass beads, one or more plastic beads, one or more silicate beads, one or more metal beads, or any combination thereof. (Refer to paragraph [0034]) Regarding claim 8, the plurality of beads comprises one or more beads having a diameter of at least about 0.01 mm, at least about 0.05 mm, at least about 0.1 mm, at least about 0.5 mm, at least about 1.0 mm, at least about 1.5 mm, or at least about 2.0 mm. (Refer to paragraph [0034]) Regarding claim 10, the volume of the solution in the vessel is sufficient to submerge the mobile paddle, the plurality of beads, and the solute. (Figures 1-4) Regarding claim 11, the volume of the solution in the vessel is at least about 50 mL, at least about 60 mL, at least about 70 mL, at least about 75 mL, at least about 80 mL, at least about 90 mL, or at least about 100 mL. (Refer to paragraph [0034-0036]) Regarding claim 22, adding a volume of a vehicle solution (158) to the solute and/or the plurality of beads, wherein the volume of the vehicle solution is sufficient to wet but not completely submerge the solute and/or the plurality of beads. Regarding claim 30, the solution further comprises a surfactant (146). Regarding claim 31, the surfactant is selected from the group consisting of polysorbate 20, polysorbate 80, TRITON X100, PLURONIC F-68, and any combination thereof. (Refer to paragraph [0024]) Regarding claim 33, (i) a vessel (12); (ii) a plurality of beads (PMMA); (iii) a media (46); (iv) a mobile paddle (collapsible paddle), wherein the mobile paddle can be positioned inside the vessel (Figures 1-4); (v) an optional cover; and (vi) instructions for dissolving a solute. (Refer to claim 1 rejections) Applicants recite “optional”, the term “optional” makes the element optional and therefore is not required to be taught by the prior art . Allowable Subject Matter Claims 5, 15, 20-21 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art fails to teach the solute comprises a long acting injectable or a long-acting injectable microsphere. 07-43-02 AIA Claim s 12 and 28 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI NAGPAUL whose telephone number is (571)272-1273. The examiner can normally be reached M-F 9am to 5pm, EST. 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, Charles Capozzi can be reached at 571-270-3638. 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. /JYOTI Mutreja/Primary Examiner, Art Unit 1798 Application/Control Number: 18/559,006 Page 2 Art Unit: 1798 Application/Control Number: 18/559,006 Page 3 Art Unit: 1798 Application/Control Number: 18/559,006 Page 4 Art Unit: 1798 Application/Control Number: 18/559,006 Page 5 Art Unit: 1798 Application/Control Number: 18/559,006 Page 6 Art Unit: 1798 Application/Control Number: 18/559,006 Page 7 Art Unit: 1798 Application/Control Number: 18/559,006 Page 8 Art Unit: 1798 Application/Control Number: 18/559,006 Page 9 Art Unit: 1798
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