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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 26 December 2025 is acknowledged. Applicant has amended claims 20-22 to also encompass group I, thus claims 1-22 are examined on the merits.
Claim Objections
Claim 20-21 are objected to because of the following informalities:
Claim 20-21 includes the following limitations multiple times “the hollow elongated body comprising a first body section that includes the first end and a second body section that includes the second end
the first body section having a first inner diameter and the second body section having a second inner diameter less than or equal to the first inner diameter
the hollow elongated body further comprising a third body section between the first body section and the second body section and
the third body section comprising or forming a tapered funnel between the first passage and the second passage”
The repeated instance should be removed.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 19 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.
Claim 19 recites “comprises an overwrap, a pouch, a film, a barrier, a wrap, a sheath, an oxygen scavenger, and a desiccant” This renders the claim indefinite since it is unclear whether the mechanism includes all the listed items or one of the listed structures. In an effort to compact prosecution, the limitation is interpreted as --comprises an overwrap, a pouch, a film, a barrier, a wrap, a sheath, an oxygen scavenger, or a desiccant--.
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.
Claims 1-8, 11-16, 18-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elias (US 4392851).
Regarding claim 1, Elias discloses a pharmaceutical vial (figure 3) for packaging, storing, reconstituting and administering an active pharmaceutical ingredient (col 1, lines 5-10), the pharmaceutical vial comprising:
a hollow elongated body (22);
a first end (top end of 22) defining a first passage (37 as depicted in figure 5);
a second end (bottom end of 22) defining a second passage (47);
a first temporary closure (40) sealing the first passage (col 2, lines 64-67); and
a second temporary closure (49) sealing the second passage (col 3, lines 3-7),
the hollow elongated body comprising a first body section that includes the first end and a second body section that includes the second end (see annotated figure below),
the first body section having a first inner diameter and the second body section having a second inner diameter less than or equal to the first inner diameter (see annotated figure below),
the hollow elongated body further comprising a third body section between the first body section and the second body section (see annotated figure below), and
the third body section comprising or forming a tapered funnel (see annotated figure below) between the first passage and the second passage.
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Regarding claim 2, Elias wherein the first end defines a first opening and the second end defines a second opening (both the top and bottom of container 22 has openings).
Regarding claim 3, Elias discloses wherein the first temporary closure is positioned in the first opening (40 is within the opening on the first end, figures 4-5).
Regarding claim 4, Elias discloses wherein the second temporary closure is positioned in the second passage and recessed from the second opening (49 is within the second and recessed, figure 4).
Regarding claim 5, Elias discloses wherein the second passage forms a receptacle (passage formed by 52 to 49 forms a space) configured to receive a spike (61) on an infusion set (13).
Regarding claim 6, Elias discloses wherein the second temporary closure comprises a breakable member (49) configured to separate from an inner wall of the second passage when a spike (61) on an infusion set (13) is received in the second passage (col 3, lines 55-60, the spike when puncturing the seal would naturally separate the seal and can be configured to separate the seal from the inner wall if placed in an area close to the end of the seal).
Regarding claim 7, Elias discloses wherein the first temporary closure comprises an elastomeric material (col 3, lines 25-30and 65-67) configured to be penetrated by a cannula or a spike (figure 4-5).
Regarding claim 8, Elias discloses wherein the first temporary closure comprises a stopper (col 2, lines 60-67).
Regarding claim 11, Elias discloses wherein the first end comprises a first flange (33 extends outward) extending radially outwardly from the hollow elongated body (figure 3).
Regarding claim 12, Elias discloses wherein the second passage and second temporary closure are covered by a removable barrier (27) applied over the second end (col 3, lines 7-12).
Regarding claim 13, Elias discloses further comprising the active pharmaceutical ingredient stored in the hollow elongated body (col 3, lines 15-20).
Regarding claim 14, Elias discloses wherein the second end is configured to form a dry break connection (the connection outside from the area connected remains dry, col3 ,lines 5-15).
Regarding claim 15, wherein the second end comprises a Luer connector (col 3, lines 5-12).
Regarding claim 16, Elias discloses wherein the second end comprises a stopper (49).
Regarding claim 18-19, Elias furether discloses further comprising one or more mechanisms for preventing or mitigating against oxygen, light and/or moisture penetration (27, 112f interpretation includes an overwrap, a pouch, a film, a barrier, a wrap, a sheath, an oxygen scavenger, and a desiccant) and wherein the one or more mechanisms for preventing or mitigating against oxygen, light and/or moisture penetration comprises an overwrap, a pouch, a film, a barrier, a wrap, a sheath, an oxygen scavenger, or a desiccant (27).
Regarding claim 20, Elias discloses a container assembly for reconstituting an active pharmaceutical ingredient with a diluent to form a solution, and for administering said solution to a patient, the container assembly comprising: (A) the pharmaceutical vial according to claim 1 (see rejection of claim 1 above) and
(B) a diluent container (11) configured to package and store the diluent (12), and configured to administer the solution, the diluent container comprising a connector (23) configured to penetrate the first temporary closure of the pharmaceutical vial to connect the diluent container (figure 5) and the pharmaceutical vial in fluid communication for mixing the active pharmaceutical ingredient with the diluent (col 3, lines 45-65).
Regarding claim 21, Elias discloses system for administering a solution comprised of an active pharmaceutical ingredient and a diluent to a patient, the system comprising: the pharmaceutical vial according to claim 1 (see rejection of claim 1 above) and;
a diluent container (11) configured to package and store the diluent (12), and configured to administer the solution to the patient, the diluent container comprising a first connector (23) configured to penetrate the first temporary closure of the pharmaceutical vial to connect the diluent container and the pharmaceutical vial in fluid communication (figure 5); and
an infusion set (13) comprising a second connector (end connected to the second end as depicted in figure 5) configured to penetrate the second temporary closure of the pharmaceutical vial to connect the infusion set and the pharmaceutical vial in fluid communication (col 3, lines 45-65).
Regarding claim 22, Elias discloses a method for reconstituting and administering an active pharmaceutical ingredient stored in the pharmaceutical vial according to claim 1 (see rejection of claim 1 above), the method comprising the steps of: inserting a spike connected to a diluent container (figure 4-5) containing a diluent (12) through the first temporary closure to connect the diluent container in fluid communication with the pharmaceutical vial (figures 4-5, col 3, lines 35-45); transferring the diluent from the diluent container and into the pharmaceutical vial (figure 5); reconstituting the active pharmaceutical ingredient with the diluent to form a solution (figure 5, col 3, lines 40-55); inserting a fluid drawing member (13) connected to a fluid delivery device (17, figure 1) through the second temporary closure (figure 5) to connect the fluid delivery device in fluid communication with the pharmaceutical vial (figure 5); and administering the solution through the fluid drawing member and the fluid delivery device into a patient (figure 1, col 3, lines 55-65).
Claim Rejections - 35 USC § 103
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 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.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Elias in view of Reynolds (US 5364369).
Regardings claim 9-10, Elias does not disclose wherein the first end comprises a cap that is crimped over the stopper (claim 9), and wherein the first end comprises a cover that is detachably connected to the first body section and over the cap (claim 10).
Reynolds discloses a prefilled medical container relatively pertinent to problem posed by Applicant of moving material using medical containers. Reynolds teaches wherein the first end of the container (end of 6 near 4 and 5) comprises a cap (4, figure 1) that is crimped over the stopper (5, col 7, lines 30-35), and wherein the first end comprises a cover (2) that is detachably connected to the first body section and over the cap (figure 1).
Reynolds provides a cap in order to seal the plug in the front opening (col 7, lines 30-35). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Elias with the Reynolds cap and covering in order to effectively seal the plug until use.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Elias in view of Lynn (US 5522804).
Regarding claim 17, Elias does not teach wherein the second end comprises a displacement valve.
Lynn discloses a flexible fluid reservoir relatively pertinent to problem posed by Applicant of moving material using containers. Lynn teaches wherein the second end of a container (300) comprises a displacement valve (384, figure 15E, col 19, lines 60-67).
Lynn provides a valve in order to prevent reflux and inadvertent mixing (col 6, lines 50-57). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Elias with a valve in order to prevent reflux and inadvertent mixing.
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.
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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.
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/KAI H WENG/Primary Examiner, Art Unit 3781