CTNF 18/710,007 CTNF 90834 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. Election/Restrictions 18-18 REQUIREMENT FOR UNITY OF INVENTION As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e). When Claims Are Directed to Multiple Categories of Inventions: As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and a process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c). 18-06-01 AIA Group 1 , claim(s) 1-19 , drawn to an ampoule . Group 2 , claim(s) 20 , drawn to a method of forming an ampoule . 18-07 AIA The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: 18-07-02 AIA Groups 1 and 2 both lack unity of invention because even though the inventions of these groups require the technical feature of a body and neck , this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Poynter (US 6332876). Since the technical features do not make a contribution over Poynter, there is lack of unity a posteriori . 08-23 AIA During a telephone conversation with Steven Pageau on 03/18/2026 a provisional election was made without traverse to prosecute the invention of Group 1 , claim s 1-19 . Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. 08-23-02 AIA Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). 08-21-04 AIA The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01. 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 Claim s 1-10, 13-19 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Poynter (US 6332876) . Regarding claim 1, Poynter discloses an ampoule comprising: a body (12, figure 1, col 2, lines 46-52) having a cavity (34, figure 1, col 2, lines 46-67) for storing a medicament (capable of storing medicament, col 1, lines 9-16); a neck (20, figure 1, col 2, lines 57-62) coupled to the body and defining a nozzle (outlet for ejected liquid at the top of the neck 20) in communication with the cavity of the body (figure 1, col 2, lines 57-67); a removable cap (24, col 2, lines 57-62) coupled to the nozzle; and an anti-choking miter (23, figure 1) coupled to the removable cap, the anti-chocking miter being wider than the removable cap (figure 1 depicts 23 being wider than cap 24). Regarding claim 2, Poynter discloses wherein the neck is tapered (figure 1, the neck is tapered). Regarding claim 3, Poynter discloses wherein the cap is configured and arranged to twist-off the nozzle (col 3, lines 64-67). Regarding claim 4, Poynter discloses wherein the miter is rectangular (figure 1). Regarding claim 5, Poynter discloses comprising an arm (26) coupled to the miter at a first end and to the body at a second end (figure 1, first end attached to 23 and other end attached to body 12). Regarding claim 6, Poynter discloses further comprising a channel (channel inside 20) defined between the arm and the neck (channel is formed between the far side of the neck 20 and the arm as depicted in figure 1. Regarding claim 7, Poynter discloses wherein the channel extends along at least a portion of the body (channel inside 20 extends into the body 12 as depicted in figure 3). Regarding claim 8, Poynter discloses wherein the channel extends between two portions of the arm (the channel is between the two ends of the arm, figure 1). Regarding claim 9, Poynter discloses further comprising at least one flattened shoulder (flat portion of the bellows 18, figures 1-3) coupled to at least one neck and the body. Regarding claim 10, Poynter discloses further comprising a notch (notch between each individual bellow 32 and 33) defined in the at least one flattened shoulder (32 or 33). Regarding claim 13, Poynter discloses wherein the body comprises a polymer (col 3, lines 40-55, plastic generally a polymer). Regarding claim 14, Poynter discloses wherein the body is formed via blow-fill-sealing (col 3, lines 40-55). Regarding claim 15, Poynter discloses an ampoule comprising: a body (12, figure 1, col 2, lines 46-52) having a cavity (34, figure 1, col 2, lines 46-67) for storing a medicament (capable of storing medicament, col 1, lines 9-16); a neck (20, figure 1, col 2, lines 57-62) coupled to the body and defining a nozzle (outlet for ejected liquid at the top of the neck 20) in communication with the cavity of the body (figure 1, col 2, lines 57-67); a removable cap (24, col 2, lines 57-62) coupled to the nozzle; and an anti-choking miter (23, figure 1) coupled to the removable cap, the anti-chocking miter being wider than the removable cap (figure 1 depicts 23 being wider than cap 24). an arm (26) coupled to the miter at a first end and to the body at a second end (figure 1, first end attached to 23 and other end attached to body 12). Regarding claim 16, further comprising a channel (channel inside 20) defined between the arm and the neck (channel is formed between the far side of the neck 20 and the arm as depicted in figure 1. Regarding claim 17, Poynter discloses wherein the channel extends along at least a portion of the body (channel inside 20 extends into the body 12 as depicted in figure 3). Regarding claim 18, Poynter discloses wherein the channel extends between two portions of the arm (the channel is between the two ends of the arm, figure 1). Regarding claim 19, Poynter discloses further comprising at least one flattened shoulder (flat portion of the bellows 18, figures 1-3) coupled to at least one neck and the body . Claim Rejections - 35 USC § 103 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. 07-20-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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Poynter in view of Trager (US 2008/0228162) . Regarding claims 11-12, Poynter does not disclose the ampoule comprising a platform coupled to the body and disposed distal to the body (claim 11), and a label disposed on the platform (claim 12). Trager discloses ampoules that teach a platform (26) coupled to the body (12) and disposed distal to the body (figure 2, [0024-0025]), and a label ([0024]) disposed on the platform. Trager provides markings or indicia on the tabs to provide information about the ampoule ([0023-0024]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Poynter by adding markings and indicia which labels the ampoule. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm. 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, Rebecca Eisenberg can be reached at (571) 270-5879. 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. /KAI H WENG/Primary Examiner, Art Unit 3781 Application/Control Number: 18/710,007 Page 2 Art Unit: 3781 Application/Control Number: 18/710,007 Page 3 Art Unit: 3781 Application/Control Number: 18/710,007 Page 4 Art Unit: 3781 Application/Control Number: 18/710,007 Page 5 Art Unit: 3781 Application/Control Number: 18/710,007 Page 6 Art Unit: 3781 Application/Control Number: 18/710,007 Page 7 Art Unit: 3781 Application/Control Number: 18/710,007 Page 8 Art Unit: 3781
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