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 .
Claim Rejections - 35 USC § 102
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.
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 –
(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.
Claim(s) 1, 3, 6, 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer (WO 0013723 A2).
Regarding claim 1, Meyer discloses a needleless vial stopper (67) for a vial (66) defining a vial opening (A, annotated fig. 7C), the needleless vial stopper (67) comprising:
a body (F, annotated fig. 7C) having a first end (B, annotated fig. 7C) and a second end (C, annotated fig. 7C) positioned opposite the first end, the body (B) comprising a sealing portion (D, annotated fig. 7C) and a flange (E, annotated fig. 7C) extending radially outward from the sealing portion (D, annotated fig. 7C), the sealing portion (D) configured to be received by the vial opening (A) and form a seal with the vial (the seal traps the liquid and forms a leakproof peripheral seal, page 6 lines 13-16, page 7 lines 7-12), wherein the body (B) defines an opening (68) having a first open position (fig. 2, the equivalent for the stopper 64 not placed in a vial or tube; stopper can be opened with a needleless syringe being put in without being placed into a vial, page 10 lines 19-28; note that the claim language does not require the first open position to occur while the vial stopper is in a relaxed resting state - free of any manipulation) prior to insertion of the sealing portion into the vial opening, a closed position (fig. 7C) after insertion of the sealing portion into the vial opening, and a second open position (fig. 7D) when the body is engaged with a luer (63) of a needleless syringe (spigot 64 is fitted with the threads 70 of the stopper 67, fig. 7B, page 10 lines 19-28).
Note: Plug 67 is operationally the same as plug 15; 67 is a variation of plug 15 adapted for a vial top so it has an annular lip (fig. 7C) whereas plug 15 is used on a plain cylindrical container (fig. 1A), so teachings of various elements and functions are used between plug 15 and plug 67 interchangeably—the disclosure also equates the plugs (see abstract and page 10 lines 25-28).
PNG
media_image1.png
295
311
media_image1.png
Greyscale
Regarding claim 3, Meyer discloses the stopper of claim 1 and further discloses wherein the sealing portion (D) is circular in a cross-section extending perpendicular to a longitudinal axis of the body (the vial is circular and the plug fits into the circular opening of the neck, figs. 7C, 7E).
Regarding claim 6, Meyer discloses the stopper of claim 1 and further discloses wherein the flange (E) is configured to engage a top surface of a neck of the vial (annotated fig. 7C).
Regarding claim 13, Meyer discloses the stopper of claim 1 and further discloses wherein the opening (68) of the body (B) is configured such that fluid can flow through the opening in the first and second open positions of the opening (stopper can be opened with a needleless syringe being put in without being placed into a vial, page 10 lines 19-28) and cannot flow through the opening in the closed position of the opening (spigot 64 is fitted with the threads 70 of the stopper 67, fig. 7B, page 10 lines 19-28).
Regarding claim 14, Meyer discloses the stopper of claim 1 and further discloses wherein the body comprises an elastomeric material (page 7 lines 13-16, page 10 lines 25-28).
Regarding claim 15, Meyer discloses the stopper of claim 1 and further discloses a needleless vial stopper (67) for a vial (66) defining a vial opening (A), the needleless vial stopper (67) comprising: a body (F) having a first end (B) and a second end (C) positioned opposite the first end, the body (B) comprising a sealing portion (D) and a flange (E) extending radially outward from the sealing portion (D, annotated fig. 7C), the sealing portion (D) configured to be received by the vial opening (A) and form a seal with the vial (the seal traps the liquid and forms a leakproof peripheral seal, page 6 lines 13-16, page 7 lines 7-12), wherein the body defines a frangible section (the slit 27/68 is precut and the connector is pushed through, page 3 lines 3-9) configured to define an opening (68) through the body upon engagement with a luer (63) of a needleless luer syringe (spigot 64 is fitted with the threads 70 of the stopper 67, fig. 7B, page 10 lines 19-28), the opening configured to move to a closed position when not engaged with the luer of the needleless luer syringe (see figs. 3A-3E that show the opening of the slit 27 which is equivalent to slit 68 and the same operation happens with figs. 7C and 7D; “when the connector is unscrewed, the slit closes up” from abstract).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 2, 4-5, 7-9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (WO 0013723 A2).
Regarding claim 2, Meyer discloses the vial stopper of claim 1, however fails to disclose wherein the sealing portion is oval-shaped in a cross-section extending perpendicular to a longitudinal axis of the body.
Meyer discloses the plugs are made of an elastomeric material and since the claim language does not require the sealing portion to be in contact with any vial opening and could be in that first open state wherein the stopper is outside of a vial, nor requires how the sealing portion arrives at the oval cross-section, the stopper of Meyer is fully capable of achieving an oval-shaped cross-section that extends perpendicular to a longitudinal axis of the body because the elastic material obviously allows for such a shape when compressed.
Regarding claim 4, Meyer discloses the vial stopper of claim 1, however the stopper 67 adapted for a vial does not disclose wherein the sealing portion comprises an annular sealing rib.
The stopper 15 of Meyer has an annular sealing rib (30, 31, 32, page 7 lines 7-12).
Although stoppers/plugs 15 and 67 are functionally the same thing; the stopper 67 for a vial does not have the annular beads to add extra leak protection likely because the flange around the top of the vial provides the necessary protection. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stopper 67 of Meyer and incorporate the annular rib of the stopper 15 of the same reference to add extra leak protection and bolster the peripheral seal (page 7 lines 7-12).
Regarding claim 5, Meyer discloses the vial stopper of claim 2 and further discloses wherein the opening of the body has a width of 0.0-0.020 inches when the opening is in the first open position (the pre-cut slit self-seals in the absence of a spigot present in the vial stopper; therefore, would have a width of zero, abstract and page 3 lines 3-9).
Regarding claims 7-9, Meyer discloses the stopper of claim 1. However, the stopper 67 adapted for a vial does not disclose:
(Claim 7) wherein the body defines a first passageway extending from the first end of the body to a position intermediate the first and second ends of the body, and wherein the body defines a second passageway extending from the second end of the body to a position intermediate the first and second ends of the body;
(Claim 8) wherein the first passageway and the second passageway each comprise a frustoconical surface;
(Claim 9) wherein the opening of the body is positioned between the first passageway and the second passageway.
The embodiment of stopper 15 of Meyer discloses:
(Claim 7) wherein the body defines a first passageway (H, annotated fig. 2) extending from the first end of the body to a position intermediate the first and second ends of the body, and wherein the body defines a second passageway (I, annotated fig. 2) extending from the second end of the body to a position intermediate the first and second ends of the body;
(Claim 8) wherein the first passageway (area H has a recess 28 that fits the narrow spigot end of the incoming syringe, see tapered tip in fig. 3B) and the second passageway (I) each comprise a frustoconical surface (annotated fig. 2);
(Claim 9) wherein the opening (27) of the body is positioned between the first passageway (H) and the second passageway (I).
Although stoppers/plugs 15 and 67 are functionally the same thing; the stopper 67 for a vial does not have the same frustoconical passageways surrounding the opening, but it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stopper 67 of Meyer and incorporate the passageways because Figure 3E shows the tip rested against the second passageway providing stability for the nose of the syringe.
PNG
media_image2.png
307
301
media_image2.png
Greyscale
Regarding claim 12, Meyer discloses the stopper of claim 1. However, the stopper 67 adapted for a vial does not disclose wherein a maximum diameter of the sealing portion of the body is larger than a diameter of the vial opening of the vial.
The embodiment of stopper 15 of Meyer discloses wherein a maximum diameter of the sealing portion of the body is larger than a diameter of the vial opening of the vial (page 7 lines 7-12).
Although stoppers/plugs 15 and 67 are functionally the same thing; the stopper 67 for a vial does not disclose a diameter, but it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stopper 67 of Meyer and incorporate the larger diameter to effectively plug the vial opening and prevent leaks (page 7 lines 7-12).
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer (WO 0013723 A2) in view of Yatsko et al. (US 5433330 A, hereafter “Yatsko”).
Regarding claims 10 and 11, Meyer discloses the stopper of claim 1. However, Meyer fails to disclose:
(Claim 10) wherein the sealing portion comprises a transverse passageway extending in a direction perpendicular to a longitudinal axis of the body;
(Claim 11) wherein the transverse passageway extends across an entire diameter of the sealing portion.
Yatsko teaches a similar device in the same field of endeavor:
(Claim 10) wherein the sealing portion comprises a transverse passageway (cross section 41, fig. 8) extending in a direction perpendicular to a longitudinal axis of the body (column 6 lines 54-67);
(Claim 11) wherein the transverse passageway (41) extends across an entire diameter of the sealing portion (37, fig. 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stopper of Meyer and incorporated the wide slit of Yatsko to have more control over the force needed to penetrate the stopper (column 3 lines 26-40).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (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, 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.
/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 12 February 2026