CTNF 19/014,719 CTNF 87920 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. This office action is in response to the set of claims received on . Claims 1-5 are currently pending. 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 Claim 2 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. 07-34-05 AIA Claim 2 recites the limitation " the length " in line 4 . There is insufficient antecedent basis for this limitation in the claim. 07-34-05 AIA Claim 2 recites the limitation " the length " in line 8 . There is insufficient antecedent basis for this limitation in the claim. 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 – 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim s 1-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Haber et al. (US Patent 5,304,165), hereinafter “Haber” . Regarding claim 1, Haber discloses a vial assembly (2, figure 2) comprising: a vial assembly housing having a proximal end and a distal end, said vial assembly housing having side-by-side first and second guide channels (18, figure 1) that extend between the proximal and distal ends of said vial assembly housing; a first vial (4, figure 1) secured to said vial assembly housing, said first vial having a proximal end that is aligned with said first guide channel and a first vial opening at the proximal end thereof that is closed by a first sealing membrane (i.e., spike support 34 includes a pair of hollow, pointed spikes 54, 56 which are positioned to pierce the septum of vial 4 when the vial is mounted within split guide ring 24 as shown in figures 4 and 5); a first piercing element (54, 56) disposed within said first guide channel and being moveable (spring biased, a disk like spike support 34 is movably mounted within each split guide ring 24. Spike support 34 has an annular ledge 36 which presses against a lug 38 extending inwardly from the inner wall 40 of split guide ring 24 by the force of a coil compression spring 42, typically made of a spring-quality stainless steel) between a retracted position (figure 4) in which said first piercing element is located on a proximal side of said first sealing membrane and an extended position (figure 5) in which said first piercing element passes through said first sealing element for piercing said first sealing membrane; a second vial (6, figure 2) secured to said vial assembly housing, said second vial having a proximal end that is aligned with said second guide channel and a second vial opening at the proximal end thereof that is closed by a second sealing membrane: and a second piercing element (i.e. same as the first piercing element) disposed within said second guide channel and being moveable between a retracted position in which said second piercing element is located on a proximal side of said second sealing membrane and an extended position in which said second piercing element passes through said second sealing element for piercing said second sealing membrane. Regarding claim 11, Haber discloses further comprising: said first piercing element having a proximal end and a distal end, a central opening located at the proximal end of said first piercing element that defines a first fluid pathway (i.e. 54, 56 are hollow, figure 7 ) that extends along a length of said first piercing element, and a first piercing spike that projects from the distal end of said first piercing element; and said second piercing element having a proximal end and a distal end, a central opening located at the proximal end of said second piercing element that defines a second fluid pathway (i.e. 54, 56 are hollow, figure 7) that extends along a length of said second piercing element, and a second piercing spike that projects from the distal end of said second piercing element. Regarding claim 3, Haber discloses wherein said first and second fluid pathways are isolated from one another (i.e. fluid pathways are separate in channel 18 figure 2). Regarding claim 4, Haber discloses wherein said vial housing further comprises: a first proximal projection (see the annotated figure 3) extending into said first guide channel that is adapted to contact said first piercing element for holding said first piercing element in the retracted position: a first distal projection (see the annotated figure 3)extending into said first guide channel that is adapted to contact said first piercing element for holding said first piercing element in the extended position; a second proximal projection (i.e. same as the first piercing element) extending into said second guide channel that is adapted to contact said second piercing element for holding said second piercing element in the retracted position: a second distal projection (i.e. same as the first piercing element) extending into said second guide channel that is adapted to contact said second piercing segment for holding said second piercing element in the extended position. PNG media_image1.png 497 473 media_image1.png Greyscale Regarding claim 5, Haber discloses further comprising: said first piercing element including a first resilient flange (i.e. flange 36 may be considered part of the piercing element equally to flange 164A in figure 8A) capable of sequentially engaging said first proximal projection and said first distal projection of said vial assembly housing when moving said first piercing element within said first quide channel from the retracted position to the extended position: said second piercing element including a second resilient flange (i.e. flange 36 may be considered part of the piercing element equally to flange 164A in figure 8A) capable of sequentially engaging said second proximal projection and said second distal projection of said vial assembly housing when moving said second piercing element within said second guide channel from the retracted position to the extended position . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm 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, Kevin Truong can be reached at 571-270-4705 . 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. /Diana Jones/Examiner, Art Unit 3775 /KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775 Application/Control Number: 19/014,719 Page 2 Art Unit: 3775 Application/Control Number: 19/014,719 Page 3 Art Unit: 3775 Application/Control Number: 19/014,719 Page 4 Art Unit: 3775 Application/Control Number: 19/014,719 Page 5 Art Unit: 3775 Application/Control Number: 19/014,719 Page 6 Art Unit: 3775 Application/Control Number: 19/014,719 Page 7 Art Unit: 3775
