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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02 June 2026 has been entered.
Response to Arguments
Applicant’s arguments, filed 02 June 2026, with respect to the rejection(s) of claim(s) 1, 3-18 and 20-22 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under 35 USC 102 and 103 in view of Tennican (US 7731678).
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) 24-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tennican (US 7731678).
Regarding claim 24, Tennican discloses a vial adaptor (10e, figure 16A-16B) comprising:
a syringe connection port (708, col 18, lines 1-10) configured to be connected to a syringe (100e);
a vial connection port (703) configured to be connected to a vial (500), the vial connection port comprising a skirt (702) and a spike (400e), the spike comprising a lumen forming a fluid channel(pathway extending inside spike for establishing communication, col 18, lines 15-22), wherein the vial connection port and the syringe connection port are arranged on opposite sides of the vial adapter (figures 16A-16B);
a conduit (706) configured to provide fluid flow between from the syringe connection port and to the vial connection port and configured to provide fluid flow from the vial connection port to the syringe connection port (col 18, lines 5-15), wherein the syringe connection port and the vial connection port are arranged on opposite sides of the vial adaptor, and wherein the conduit is linear or straight (figures 16A-16B); and
a valve (800) for selectively blocking and allowing fluid flow between the syringe and the vial connection port when the syringe is connected to the syringe connection port (col 18, lines 46-52),
wherein the vial adapter adapter manufactured from material resistant to DMSO (col 6, lines 30-35, at least polypropylene is resistant).
Regarding claim 25, Tennican discloses the valve being operable between a first position in which the fluid passageway is aligned with the conduit and allows fluid flow (col 8, lines 14-22, and a second position in which the valve body blocks fluid flow (col 18, lines 46-52).
Regarding claim 26, Tennican discloses wherein the valve comprises a handle for manually operating the valve between the first position and the second position (figures 16A-16B), the handle being integrally formed with the valve body (handle formed on the body).
Regarding claim 27, Tennican discloses wherein the vial adaptor further comprises a casing portion (704), the valve body being arranged in the casing portion (800 is inside 704, figure 16A), wherein the casing portion has a cylindrical shape (cylindrical, figures 16A-16B), the valve body having a cylindrical shape complementary to the cylindrical shape of the casing portion (valve fits inside the casing, figure 16A), the valve body being movable in rotation between the first position and the second position around a longitudinal axis of the casing portion (col 18, lines 45-52).
Regarding claim 28, Tennican discloses wherein the longitudinal axis of the casing portion is substantially orthogonal to a vial connection axis of the vial adaptor defined between the syringe connection port and the vial connection port (col 18, lines 46-52).
Regarding claim 29, Tennican discloses wherein the vial adaptor comprises a first conduit portion (on one side of the valve near the syringe, figure 16A) in fluid communication with the syringe connection port, a second conduit portion (on one side of the valve near the vial, figure 16A) in fluid communication with the vial connection port, the casing portion being arranged between the first conduit portion and the second conduit portion.
Regarding claim 30-31, Tennican discloses the adapter manufactured from at least polypropylene is resistant (col 6, lines 30-35 PE includes HDPE or LDPE).
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.
Claim(s) 1, 3-18, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 7731678).
Regarding claim 1, Tennican discloses a vial adaptor (10e, figure 16A-16B) comprising:
a syringe connection port (708, col 18, lines 1-10) configured to be connected to a syringe (100e);
a vial connection port (703) configured to be connected to a vial (500), the vial connection port comprising a skirt (702) and a spike (400e), the spike comprising a lumen forming a fluid channel(pathway extending inside spike for establishing communication, col 18, lines 15-22), wherein the vial connection port and the syringe connection port are arranged on opposite sides of the vial adapter (figures 16A-16B);
a conduit (706) configured to provide fluid flow between from the syringe connection port and to the vial connection port and configured to provide fluid flow from the vial connection port to the syringe connection port (col 18, lines 5-15), wherein the syringe connection port and the vial connection port are arranged on opposite sides of the vial adaptor, and wherein the conduit is linear or straight (figures 16A-16B); and
a valve (800) for selectively blocking and allowing fluid flow between the syringe and the vial connection port when the syringe is connected to the syringe connection port (col 18, lines 46-52), wherein the valve (800 which can be any valve discussed as stated in col 18 ,lines 29-33) comprises a valve body (valve body 300 can be inserted, figures 2-6) and a fluid passageway (306) formed in the valve body.
While Tennican does not explicitly state the fluid passageway with a diameter smaller than a diameter of the conduit, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Tennican to have a diameter as desired since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Tennican would not operate differently with the claimed diameter and there is no desired reason to make a leak, further the device would function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges and has alternative diameter arrangements (page 9: The fluid passageway may have a diameter smaller than the diameter of the conduit (i.e. the fluid passageway is narrower than the conduit), which improves tightness of the vial adaptor. The diameter of the fluid passageway may, for example, be strictly smaller than the diameter of the conduit. Alternatively, the diameter of the fluid passageway may be substantially equal to the diameter of the conduit).
Regarding claim 3, Tennican discloses the valve being operable between a first position in which the fluid passageway is aligned with the conduit and allows fluid flow (col 8, lines 14-22, and a second position in which the valve body blocks fluid flow (col 18, lines 46-52).
Regarding claim 4, Tennican discloses wherein the valve is movable in rotation between the first position and the second position (col 8, lines 14-22, col 18, lines 46-52).
Regarding claim 5, Tennican discloses wherein the valve comprises a handle for manually operating the valve between the first position and the second position (figures 16A-16B), the handle being integrally formed with the valve body (handle formed on the body).
Regarding claim 6, Tennican discloses wherein the valve is operable between the first position and the second position independent of a syringe being connected to the syringe connection port (col 18, lines 46-52, handle can still movement whether syringe is connected).
Regarding claim 7, Tennican discloses wherein the vial adaptor further comprises a casing portion (704), the valve body being arranged in the casing portion (800 is inside 704, figure 16A), wherein the casing portion has a cylindrical shape (cylindrical, figures 16A-16B), the valve body having a cylindrical shape complementary to the cylindrical shape of the casing portion (valve fits inside the casing, figure 16A), the valve body being movable in rotation between the first position and the second position around a longitudinal axis of the casing portion (col 18, lines 45-52).
Regarding claim 8, Tennican discloses wherein the longitudinal axis of the casing portion is substantially orthogonal to a vial connection axis of the vial adaptor defined between the syringe connection port and the vial connection port (col 18, lines 46-52).
Regarding claim 9, Tennican discloses wherein the vial adaptor comprises a first conduit portion (on one side of the valve near the syringe, figure 16A) in fluid communication with the syringe connection port, a second conduit portion (on one side of the valve near the vial, figure 16A) in fluid communication with the vial connection port, the casing portion being arranged between the first conduit portion and the second conduit portion.
Regarding claim 10-12, Tennican discloses wherein the syringe connection port, the first conduit portion, the casing portion and the second conduit portion are integrally formed (figure 16A-16B), the skirt and the spike are integrally formed with the second conduit portion, or the skirt and the spike are releasably connected to the second conduit portion (figure 16A-16B), wherein the vial adaptor is configured for releasable connection to a syringe or to a syringe adaptor, the syringe connection port comprising a luer lock (col 18, lines 7-12).
Regarding claim 13, Tennican discloses wherein the vial adaptor is manufactured from a material resistant to an aggressive solvent (col 9, lines 5-17).
Regarding claim 14, Tennican discloses further comprising a filter disposed in the conduit (col 17, lines 50-55).
Regarding claim 15, Tennican discloses further comprising a septum configured to seal the conduit (col 21, lines 30-35).
Regarding claim 16, Tennican discloses a method of use of a vial adaptor comprising:
providing a vial (500) containing a drug (col 12, lines 45-50) and a syringe (100e) comprising a reconstitution fluid (col 12, lines 40-48), the reconstitution fluid comprising a solvent or a vehicle (col 12, lines 40-48),
connecting the vial adaptor to the vial (figure 16A-16B), wherein the vial adaptor comprises a syringe connection port configured to be connected to the syringe (figure 16A-16B), a vial connection port comprising a skirt (702) and a spike (400e), the spike comprising a lumen forming a fluid channel (channel through the spike that communicates with the conduit 706), a conduit (706) configured to provide fluid flow from the syringe connection port to the vial connection port (col 18, lines 5-15) and configured to provide fluid flow from the vial connection port to the syringe connection port (col 18, lines 5-15),
and a valve (800) for selectively blocking and allowing fluid flow between the syringe and the vial connection port when the syringe is connected to the syringe connection port (col 18, lines 46-52); wherein the valve (800 which can be any valve discussed as stated in col 18 ,lines 29-33) comprises a valve body (valve body 300 can be inserted, figures 2-6) and a fluid passageway (306) formed in the valve body.
connecting the syringe to the vial adaptor (fully assembled shown in figure 17);
dispensing reconstitution fluid from the syringe inside the vial through the vial adapter for reconstitution of a solution inside the vial, the valve allowing fluid flow during the dispensing (col 12, lines 23-35);
withdrawing the reconstituted solution inside the vial through the vial adaptor with the syringe or with another syringe (col 12, lines 23-36); and
selectively blocking and allowing fluid flow between the syringe and the vial by operation of the syringe and operation of the valve (col 12, lines 36-45).
While Tennican does not explicitly state the fluid passageway with a diameter smaller than a diameter of the conduit, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Tennican to have a diameter as desired since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Tennican would not operate differently with the claimed diameter and there is no desired reason to make a leak, further the device would function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges and has alternative diameter arrangements (page 9: The fluid passageway may have a diameter smaller than the diameter of the conduit (i.e. the fluid passageway is narrower than the conduit), which improves tightness of the vial adaptor. The diameter of the fluid passageway may, for example, be strictly smaller than the diameter of the conduit. Alternatively, the diameter of the fluid passageway may be substantially equal to the diameter of the conduit).
Regarding claim 17, Tennican discloses operating the valve to block fluid flow after the dispensing (col 13, lines 13-20); and manually agitating the vial after the operating to block fluid flow (col 12, lines 63-68).
Regarding claim 18, Tennican discloses operating the valve to allow fluid flow (col 12, lines 38-42; after the withdrawing: disconnecting the syringe or the other syringe from the vial adaptor; and performing an injection of the reconstituted solution with the syringe or the other syringe, the injection being a subcutaneous injection (col 13, lines 1-10, col 19, lines 40-45)).
Regarding claim 20, Tennican discloses a system comprising:
a vial (500) comprising a drug (col 12, lines 45-50);
a syringe (100e) comprising a reconstitution fluid (col 12, lines 40-48), the reconstitution fluid capable of cooperation with a vial adaptor (10e);
a vial adaptor (10e, figure 16A-16B) comprising:
a syringe connection port (708, col 18, lines 1-10) configured to be connected to the syringe (100e);
a vial connection port (703) configured to be connected to the vial (500), the vial connection port comprising a skirt (702) and a spike (400e), the spike comprising a lumen forming a fluid channel(pathway extending inside spike for establishing communication, col 18, lines 15-22), wherein the vial connection port and the syringe connection port are arranged on opposite sides of the vial adapter (figures 16A-16B);
a conduit (706) configured to provide fluid flow between from the syringe connection port and to the vial connection port and configured to provide fluid flow from the vial connection port to the syringe connection port (col 18, lines 5-15), wherein the syringe connection port and the vial connection port are arranged on opposite sides of the vial adaptor, and wherein the conduit is linear or straight (figures 16A-16B); and
a valve (800) for selectively blocking and allowing fluid flow between the syringe and the vial connection port when the syringe is connected to the syringe connection port (col 18, lines 46-52), wherein the valve (800 which can be any valve discussed as stated in col 18 ,lines 29-33) comprises a valve body (valve body 300 can be inserted, figures 2-6) and a fluid passageway (306) formed in the valve body.
While Tennican does not explicitly state the fluid passageway with a diameter smaller than a diameter of the conduit, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Tennican to have a diameter as desired since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Tennican would not operate differently with the claimed diameter and there is no desired reason to make a leak, further the device would function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges and has alternative diameter arrangements (page 9: The fluid passageway may have a diameter smaller than the diameter of the conduit (i.e. the fluid passageway is narrower than the conduit), which improves tightness of the vial adaptor. The diameter of the fluid passageway may, for example, be strictly smaller than the diameter of the conduit. Alternatively, the diameter of the fluid passageway may be substantially equal to the diameter of the conduit).
Regarding claim 21, Tennican discloses another syringe or needle for performing an injection or administration (col 19, lines 40-45).
Regarding claim 22, Tennican discloses the valve is operable between a first position in which the fluid passageway is aligned with the conduit and allows fluid flow (col 8, lines 14-22, and a second position in which the valve body blocks fluid flow (col 18, lines 46-52).
Regarding claim 23, Tennican discloses the adapter manufactured from material resistant to DMSO (col 6, lines 30-35, at least polypropylene is resistant).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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